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UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
FOR
ANNUAL AND TRANSITION REPORTS PURSUANT TO
SECTIONS 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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(Mark One)
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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For the fiscal year ended
December 31, 2006; or
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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For the Transition period
from to .
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Commission File Number
001-15063
Endocare, Inc.
(Exact name of registrant as
specified in its charter)
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Delaware
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33-0618093
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(State of
incorporation)
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(I.R.S. Employer Identification
No.)
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201 Technology, Irvine, CA
(Address
of principal executive offices)
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92618
(Zip
Code)
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Registrants telephone number, including area code:
(949) 450-5400
Securities registered pursuant to Section 12(b) of the
Act: None
Securities registered pursuant to Section 12(g) of the
Act:
Common Stock, $.001 par value
Rights to Purchase Shares of Series A Junior
Participating Preferred Stock
(Title of Class)
Indicate by check mark if the registrant is a well-known
seasoned issuer, as defined in Rule 405 of the Securities
Act. Yes o No þ
Indicate by check mark if the registrant is not required to file
reports pursuant to Section 13 or Section 15(d) of the
Act. Yes o No þ
Indicate by check mark whether the registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of
the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the Registrant
was required to file such reports), and (2) has been
subject to such filing requirements for the past
90 days. (1) Yes þ No o (2) Yes þ No o
Indicate by check mark if disclosure of delinquent filers
pursuant to Item 405 of
Regulation S-K
is not contained herein, and will not be contained, to the best
of the registrants knowledge, in definitive proxy or
information statements incorporated by reference in
Part III of this
Form 10-K
or any amendment to this
Form 10-K. o
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, or a non-accelerated
filer. See definition of accelerated filer and
large accelerated filer in
Rule 12b-2
of the Exchange Act. (Check one):
Large Accelerated
Filer o Accelerated
Filer
þ Non-Accelerated
Filer o
Indicate by check mark whether the registrant is a shell company
(as defined in
Rule 12b-2
of the Exchange
Act). Yes o No þ
The aggregate market value of the common stock of the Registrant
held by non-affiliates as of June 30, 2006 was
approximately $66,852,205 (based on the last sale price for
shares of the Registrants common stock as reported in the
OTC Bulletin Board for that date). Shares of common stock
held by each executive officer, director and holder of
10 percent or more of the outstanding common stock have
been excluded in that such persons may be deemed affiliates.
Exclusion of shares held by any person should not be construed
to indicate that such person possesses the power, direct or
indirect, to direct or cause the direction of management or
policies of the Registrant, or that such person is controlled by
or under common control with the Registrant.
There were 31,215,912 shares of the Registrants
common stock issued and outstanding as of February 28, 2007.
DOCUMENTS
INCORPORATED BY REFERENCE
Certain portions of the Definitive Proxy Statement related to
our 2007 Annual Meeting of Stockholders, which Definitive Proxy
Statement we expect to file under the Securities Exchange Act of
1934, as amended, within 120 days of the end of our fiscal
year ended December 31, 2006, are incorporated by reference
into Part III of this Annual Report on
Form 10-K.
Certain exhibits filed with our prior registration statements,
proxy statement and
Forms 10-K,
8-K and
10-Q are
incorporated herein by reference into Part IV of this
Annual Report on
Form 10-K.
Endocare,
Inc.
Form 10-K
For the
Fiscal Year Ended December 31, 2006
TABLE OF
CONTENTS
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PART I
This Annual Report on
Form 10-K
may contain forward-looking statements that involve risks and
uncertainties. Such statements typically include, but are not
limited to, statements containing the words
believes, intends,
anticipates, expects, hopes,
estimates, should, could,
may, plans, planned and
words of similar import. Our actual results could differ
materially from any such forward-looking statements as a result
of the risks and uncertainties, including but not limited to
those set forth below in Risks Factors and in other
documents we file from time to time with the Securities and
Exchange Commission, including our Quarterly Reports on
Form 10-Q.
Any such forward-looking statements reflect our
managements opinions only as of the date of this Annual
Report on
Form 10-K,
and we undertake no obligation to revise or publicly release the
results of any revisions to these forward-looking statements.
Readers should carefully review the risk factors set forth below
in Risks Factors and in other documents we file from
time to time with the Securities and Exchange Commission,
including our Quarterly Reports on
Form 10-Q.
AutoFreezetm,
CGCtm,
Cryocare®,
Cryocare
CStm,
Cryocare Surgical
System®,
CryoDisc®,
CryoGridtm,
CryoGuide®,
Direct
Accesstm,
Endocare®,
FastTrac®,
Integrated
Ultrasoundtm,
SmartTemptm,
Targeted Cryoablation of the Prostate
TCAP®,
TEMprobe®,
Urethral
Warmertm,
R-Probetm,
V-Probetm,
Cryocare
CN2tm,
Liquid
Icetm,
PerCryo®,
CryoProbe CN2 are our trademarks and Renal
Cryosm,
Salvage
Cryosm,
Focal
Cryosm
, Primary
Cryosm
are our servicemarks. This Annual Report on
Form 10-K
may also include trademarks and trade names owned by other
parties, and all other trademarks and trade names mentioned in
this Annual Report on
Form 10-K
are the property of their respective owners.
Overview
We are a specialty medical device company focused on improving
patients lives through the development, manufacturing and
distribution of health care products for cryoablation. Our
strategy is to achieve a dominant position in the prostate and
renal cancer markets, further developing and increasing the
acceptance of our technology in the interventional radiology and
oncology markets for treatment of liver and lung cancers and
palliative intervention (treatment of pain associated with
metastases), while achieving penetration across additional
markets with our proprietary cryosurgical technology. The term
cryoablation refers to the use of ice to destroy
tissue, such as tumors, for therapeutic purposes. The term
cryosurgical technology refers to technology
relating to the use of ice in surgical procedures, including
cryoablation procedures.
Today, our Food and Drug Administration (FDA)-cleared Cryocare
Surgical System occupies a growing position in the urological
market for treatment of prostate and renal cancer. Because of
our initial concentration on prostate and renal cancer, the
majority of our sales and marketing resources are directed
toward the promotion of our technology to urologists. In
addition to selling our cryosurgical disposal products to
hospitals and mobile service companies, we also contract
directly with hospitals for the use of our Cryocare Surgical
System and disposable products on a
fee-for-service
basis. We believe our proprietary cryosurgical technologies have
broad applications across a number of surgical markets,
including the treatment of tumors in the lung and liver, and the
management of pain caused by tumors. To that end, we employ a
dedicated sales team focused on selling percutaneous
cryoablation procedures related to kidney, liver, lung and
palliative intervention (treatment of pain associated with
metastases) to interventional radiology physicians throughout
the United States.
We were incorporated under the laws of the State of Delaware in
May 1994. We maintain our executive offices at 201 Technology
Drive, Irvine, California 92618, and our telephone number at
that address is
(949) 450-5400.
Information regarding our financial condition and results of
operations can be found in a separate section of this Annual
Report on
Form 10-K,
beginning on
page F-1.
We previously owned Timm Medical Technologies, Inc., a company
focused on erectile dysfunction products. We sold Timm Medical
to UK-based Plethora Solutions Holdings plc on February 20,
2006.
1
Prostate
Cancer and Urology Market Background
The prostate is a walnut-size gland surrounding the male
urethra, located below the bladder and adjacent to the rectum.
Prostate cancer consists of one or more malignant tumors that
begin most often in the periphery of the gland and, like other
forms of cancer, may spread beyond the prostate to other parts
of the body. If left untreated, prostate cancer can metastasize
to the lung or bone and potentially other sites, resulting in
death.
The number of men diagnosed with prostate cancer has risen
steadily since 1980 and it is now the second most common cause
of cancer-related deaths among men in the United States. The
American Cancer Society estimated there would be 218,890 new
cases of prostate cancer diagnosed and 27,050 deaths associated
with the disease in the United States during 2007. Prostate
cancer incidence and mortality increase with age. Prostate
cancer is found most often in men who are over the age of 50.
According to the American Cancer Society, more than
65 percent of men diagnosed with prostate cancer are over
the age of 65. Incidence rates are higher in African American
men. In addition to age and race, other risk factors are linked
to prostate cancer, such as genetics, diet and exposure to
environmental toxins such as Agent Orange.
The dramatic increase in prostate cancer diagnoses has led to
heightened awareness of the disease, which in turn has led to
increased rates of testing and improved diagnostic methods. The
American Cancer Society recommends that men without symptoms,
risk factors and a life expectancy of at least 10 years
should begin regular annual medical exams at the age of 50, and
believes that physicians should offer, as a part of the exam,
the prostate-specific antigen, or PSA, blood test and a digital
rectal examination to detect any lumps in the prostate. The PSA
blood test determines the amount of prostate specific antigen
present in the blood. PSA is found in a protein secreted by the
prostate, and elevated levels of PSA can be associated with,
among other things, prostatitis, a non-cancerous inflammatory
condition, or a proliferation of cancer cells in the prostate.
Transrectal ultrasound tests and biopsies are typically
performed on patients with elevated PSA readings to confirm the
existence of cancer.
Approximately 90 percent of all prostate cancers diagnosed
in the United States are local or regional according to the
American Cancer Society. Thus, approximately
200,000 patients per year are candidates for definitive
local therapies including cryoablation. In addition; it is
estimated that approximately 55,000 patients formerly
diagnosed and treated for prostate cancer in the United States
each year are diagnosed with recurrent prostate cancer following
previous radiation therapy. With the increasing utilization of
radiation therapy, primarily brachytherapy and external beam
radiation for initial treatment in prostate cancer, we believe
that this number will increase. For recurrent tumors that are
detected while still localized, we believe cryoablation is an
appropriate procedure with typically fewer side effects than
salvage radical prostatectomy.
Non-Cryosurgical
Treatment Options
Current treatment options for patients with prostate cancer
include radical prostatectomy, radiation therapy, hormone or
other therapies, watchful waiting, and cryosurgery.
These options are evaluated using a number of criteria,
including the patients age, physical condition and stage
of the disease. Due to the slow progression of the disease,
however, the decision for treatment is typically based upon the
severity of the condition and the resulting quality of life.
Radical prostatectomy has been used for over 30 years and
is most often the therapy of choice due to the surgeons
high degree of confidence in surgically removing the cancerous
tissue. The procedure is dependent on the skill of the surgeon
and is often associated with relatively high incidence of
post-operative impotence and incontinence and can even result in
operative mortality. Radical prostatectomy often requires a
three- to
five-day
hospital stay for patient recovery and therefore a higher cost
to the medical facility than cryoablation.
Radiation therapy for prostate cancer includes both external
radiation beam and interstitial radioactive seed therapies.
External beam radiation therapy emerged as one of the first
alternatives to radical prostatectomy. Interstitial radioactive
seed therapy, also referred to as brachytherapy, is the
permanent placement of radioactive seeds in the prostate.
Other therapies, primarily consisting of hormone therapy and
chemotherapy, are used to slow the growth of cancer and reduce
tumor size, but are generally not intended to be curative. These
therapies are often used during advanced stages of the disease
to extend life and to relieve symptoms. Side effects of hormonal
drug therapy include
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increased development of breasts and other feminine physical
characteristics, hot flashes, impotence and decreased libido. In
addition, many hormone pharmaceuticals artificially lower PSA
levels in patients, which can interfere with the staging of the
disease and the monitoring of its progress. Side effects of
chemotherapy include nausea, hair loss and fatigue. Drug therapy
and chemotherapy require long-term, repeated administration of
medication on an outpatient basis.
Watchful waiting is recommended by physicians in
certain circumstances based upon the severity and growth rate of
the disease, as well as the age and life expectancy of the
patient. The aim of watchful waiting is to monitor the patient,
treat some of the attendant symptoms and determine when more
active intervention is required. Watchful waiting has gained
popularity among those patients refusing treatment due to side
effects associated with radical prostatectomy. Watchful waiting
requires periodic physician visits and PSA monitoring. A study
published in the Journal of the American Medical Association in
December 2006, consisting of 44,630 men between the ages of 65
and 80, found that those patients who chose to treat their
prostate cancer were 31 percent less likely to die than
those who waited. This suggests that all patients with localized
disease regardless of age should consider definitive treatments
rather than watchful waiting.
The
History of Cryosurgery
Cryosurgery, freezing tissue to destroy tumor cells, was first
developed in the 1960s. During this period, the use of
cold probes, or cryoprobes, was explored as a method
to kill prostate tissue without resorting to radical
prostatectomy. Although effective in killing cancer cells, the
inability to control the amount of tissue frozen during the
procedure prevented broad use and development of cryosurgery for
prostate cancer. These initial limitations in the application of
cryosurgery continue to contribute to a lack of widespread
acceptance of the procedure today.
In the late 1980s, progress in ultrasound imaging allowed
for a revival in the use of cryosurgery. Using ultrasound, the
cryoprobe may be guided to the targeted tissue from outside the
body percutaneously. The physician activates the cryoprobe and
uses ultrasound to monitor the growth of ice in the prostate as
it is occurring. When the ice encompasses the entire prostate,
the probe is turned off. This feedback mechanism of watching the
therapy as it is administered allows the physician more precise
control during application.
Long term data suggest that prostate cryosurgery may be able to
deliver disease-free rates comparable to radical surgery and
radiation, but with the benefit of lower rates of incontinence
and mortality, shorter recovery periods and relatively minimal
complications.
Endocare
Cryosurgery Technology Development
We have sought to develop our technology over time to increase
the safety and efficacy of our products. In 1996, we developed
our first generation eight-probe argon-based cryosurgical
system. Argon allows for room temperature gas to safely pass
through the cryoprobe to create a highly sculpted repeatable ice
ball. In 1997, we incorporated temperature-monitoring software
to allow for continual feedback from the thermocouple tips. In
1998, we launched our CryoGuide intraoperative planning
software, which allowed physicians better planning and targeting
technology for use during a procedure. In 2000, we launched our
2.4mm Direct Access cryoprobe and CryoGrid which we believe
shortened the time necessary to perform a procedure and added to
the safety and ease of the procedure. In 2002 we developed and
launched AutoFreeze, our innovative software technology that
provides computer-controlled automated freeze/thaw cycles. In
2003, we launched our second generation Cryocare Surgical
System, which we refer to as Cryocare CS, which
integrated all the past and latest technology, including an
on-board, integrated ultrasound device, into one complete
system. At the Annual Meeting of the American Urological
Association in May 2006, we introduced the first variable
cryoablation probe, referred to as the V-Probe. The
V-Prove
provides physicians the ability to sculpt different
sized isotherms (ice balls) to encompass tumors and tissues
based on individual patient anatomy and needs. As previously
announced, we currently are in the planning and design stage for
the development of a nitrogen-based cryoablation system, which
we refer to as the Cryocare CN2 System. Once development is
complete, we expect to market the Cryocare CN2 System primarily
to our interventional radiology and oncology customers and to
customers in international markets where argon gas is not widely
available.
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Our
System Solution: Cryocare CS
We believe Cryocare CS is the most sophisticated prostate
cryosurgery system currently available and combines the latest
technology to enhance the speed and effectiveness of the
procedure. Exclusive features of the Cryocare CS include an
on-board training module, integrated color Doppler ultrasound
designed specifically for the needs of prostate cryosurgery,
CryoGuide our patented intraoperative planning module, and
AutoFreeze our patented treatment software that provides
computer-controlled automated freeze/thaw cycles based upon
target endpoint temperatures and continual feedback from the
thermocouple tips.
The argon gas-based Cryocare CS accommodates up to eight
independently operated cryoprobes and six thermocouples to allow
physicians to monitor temperatures of tissue adjacent to the
prostate in real-time. Our proprietary suite of cryoprobes is
engineered to consistently produce sculpted ice conforming to
the unique anatomy of the prostate. Our vacuum-insulated
DirectAccess CryoProbes help deliver lethal ice in a
controllable and repeatable fashion. Our CryoGrid, which is
similar to a brachytherapy grid, is affixed to the ultrasound
stepper and aids the physician with placement of the cryoprobes
so that ice formation and lethal temperatures occur where
necessary to destroy cancerous tissue but do not affect areas
where tissue damage could cause harm.
We believe cryosurgery is the first minimally invasive procedure
that urologists can perform independently. With radiation
therapies, urologists must refer the patient for treatment to a
radiation oncologist. Cryosurgery offers the urologist both the
opportunity to maintain continuity of patient care and to
generate additional revenue.
Key
Clinical Advantages of Our Cryocare CS System
Cryocare CS provides the following potential clinical advantages
relative to other principal treatment options for prostate
cancer:
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High quality of life following treatment. Our
minimally invasive procedure typically offers patients a short
recovery period for prostate cancer therapy and may result in a
lower incidence of certain side effects, including incontinence.
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Treatment of patients who have failed radiation
therapy. Patients who have failed radiation
therapy have limited options. Cryosurgery is an option that can
be used to treat these patients effectively with potentially
fewer side effects than radical surgery.
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Treatment can be performed more than
once. Regardless of what therapy is chosen there
is always a chance that the cancer will recur. Unlike radiation
therapy or surgery, cryosurgery can be repeated without
increased morbidity.
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Focal or partial gland treatment. Focal
cryoablation is a prostate cancer treatment in which the
ablation is confined to the known tumor location, thereby
sparing surrounding tissue.
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Marketing
and Strategy
Cryosurgical
Products
Our objective in urology is to establish cryosurgery as a
primary treatment option for prostate and renal cancers. Our
earlier commercial efforts were focused on direct-sales to
hospitals and distributor sales of systems to third party
service providers who would provide systems and technicians to
hospitals where cryosurgical procedures were performed.
In 2003, we redirected our urology strategy away from attempting
to drive acceptance of cryoablation through sales of capital
equipment into the urology market. Our primary objective for the
urology portion of our business is now to grow market share,
measured in terms of procedures and revenues, by establishing
cryosurgery as a primary treatment option for prostate and renal
cancers. In 2004, 2005 and 2006, we derived a significant
percentage of our revenues from recurring sales of disposable
products used with the Cryocare Surgical System.
A cryoablation procedure requires the necessary disposable
products usually provided in the form of a kit. In addition to
the disposable devices, there is a service component. This
service component consists of transportation and provision of
equipment used in the procedure, plus the services of a
technician to assist the urologist with use
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and monitoring of this equipment. In addition to the use of a
Cryocare Surgical System, an ultrasound device is needed for
visual monitoring of the prostate and ice formation, unless our
Cryocare CS is used, since the Cryocare CS includes an on-board,
integrated ultrasound unit. Tanks of argon and helium gas are
needed for freezing and warming during the procedure.
Frequently, this equipment is not stored on site but is
mobilized and brought into the hospital for procedures by an
independent third party who performs the service component of
the procedure.
For urology procedures we typically sell the disposable devices
to hospitals either as part of a procedure fee or separately,
that is, without the service component. We also continue to sell
our Cryocare Surgical Systems both to hospitals and service
providers. For interventional radiology we will often place a
system with a new customer under our placement program and sell
cryoprobes directly to the hospitals or enter into an agreement
to provide cryoablation services to the hospital, which includes
providing the equipment, technicians and cryoablation disposable
products necessary to perform the procedures. These agreements
generally include the services of a third party provider
contracted by us or the hospital to provide these services.
An important challenge we face in the prostate cancer market is
to overcome initial reluctance on the part of urologists to
embrace cryosurgery and to educate physicians so that they are
able to incorporate cryosurgery into their primary treatment
regimen. Part of this reluctance is due to clinical failures
experienced during earlier efforts to introduce the technology
by other companies. See above under The History of
Cryosurgery. In addition, we compete with other therapies
that have proven effective in treating prostate cancer. Over
30 years of clinical data exist documenting the safety and
efficacy of radical prostatectomy for prostate cancer. There are
20 years of clinical data supporting use of various forms
of radiation treatment options such as brachytherapy and beam
radiation treatments, which we estimate are used to treat over
one third of all prostate cancer cases each year in the
United States.
We believe cryoablation has clinical advantages for many
patients over both the current most popular forms of treatment.
While there are long-term clinical data available on radical
prostatectomy, this treatment approach, typical of surgery in
general, is characterized by a long recovery period combined
with a relatively high incidence of side effects, including
impotence and urinary incontinence. The appeal of radiation as a
treatment alternative, particularly to patients, is that it is
less invasive than surgery. Like radiation, cryosurgery is less
invasive and therefore has potentially fewer side effects than
radical prostatectomy. Unlike radiation treatments, however,
cryosurgical treatments can be repeated on the same patient. In
fact, our initial clinical successes in prostate cancer
treatment were in treating patients who had failed radiation
therapy. We also believe that cryosurgery has significant
economic benefits for payers. These benefits include shorter
hospital stays for recovery and shorter procedure time as
compared to radical prostatectomy, long term hormone treatment
or radiation therapies, resulting in reduced expense to the
payer.
Key elements in our strategy for overcoming the challenges we
face in establishing cryosurgery as a primary treatment option
for prostate cancer are:
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Increasing awareness in the urological community regarding the
clinical benefits of cryosurgery through our presence at major
technical meetings and trade shows, publication of numerous
scientific papers and articles on cryosurgery and formation of a
scientific advisory board to provide guidance and counsel to us
regarding clinical matters and physician education;
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Conducting clinical studies to further demonstrate the safety
and efficacy of cryosurgery as a primary treatment of prostate
cancer;
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Conducting clinical studies to further demonstrate the safety
and efficacy of cryosurgery as a salvage treatment for prostate
cancer patients who have failed radiation treatments;
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Conducting clinical studies to further demonstrate the safety
and efficacy of cryosurgery as a treatment for renal tumors
which is another important component of the urology market for
cryosurgery;
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Creating a significant number of new practicing cryosurgeons
each year through our physician education program;
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Endeavoring to ensure that reimbursement for cryosurgery by
Medicare and other payers is appropriate given the costs and
benefits of the treatment;
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Driving patient awareness through our
direct-to-consumer
advertising programs; and
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Marketing our products to physicians and hospitals through our
direct sales force.
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Because of our initial concentration on prostate cancer, the
majority of our sales and marketing resources are directed
towards the promotion of cryoablation technology to urologists
for the treatment of prostate and renal cancers. However, we are
also, however, expanding the reach of our technology across a
number of other markets, including ablation of tumors in the
lung and liver, as well as for palliative intervention
(treatment of pain associated with metastases). Procedures for
treatment of these cancers are typically performed
percutaneously, using CT scanning technology, and are
provided by interventional radiologists. In order to better
understand and address the distinct needs of this new market, we
have formed a dedicated sales team to work in developing these
opportunities for application of our cryosurgical technology.
Key elements in our strategy to establish new markets for
cryosurgical treatment of tumors, specifically in the
interventional radiology and radiation oncology markets, are:
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Conducting key clinical studies to demonstrate the safety and
efficacy of cryosurgery as a primary treatment for lung and
liver tumors as well as for palliative intervention (treatment
of pain associated with metastases), and
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Formation of a dedicated sales group focused on the
opportunities for cryosurgical treatment approaches in these new
markets.
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Products
We currently market the following products:
Prostate
and Renal Cancer:
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Cryocare Surgical System A cryosurgical system with
eight cryoprobe capability.
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Cryocare CS System A Cryocare Surgical System with
onboard ultrasound.
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CryoGuide A computerized cryoprobe placement,
simulation and guidance system for cryosurgery.
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Cryoprobes Disposable probes used with the Cryocare
Surgical System.
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FasTrac Percutaneous access device that allows
one-step insertion of cryoprobes.
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Additional
Cryosurgical Markets:
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Cryocare Surgical System A cryosurgical system with
eight cryoprobe capability specially configured for
interventional radiology and oncology.
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Raw
Materials
We rely on third party suppliers to provide certain critical
components for all of our product lines. In certain cases, the
suppliers are our sole source of supply for these components.
Our policy is to enter into long-term supply agreements that
require suppliers to maintain adequate inventory levels and
which contain other terms and conditions protecting us against
unforeseen interruptions in their production. We endeavor to
maintain adequate stock levels at our own locations to ensure an
uninterrupted source of supply. We typically seek to establish
secondary sources of supply or other manufacturing alternatives.
Nevertheless, despite these efforts, it is possible that we may
experience an interruption in supply of one or more of our
critical components resulting in backorders to our customers.
However, we believe that we could locate alternative sources of
supply upon such terms and within such a timeframe as would not
result in a material adverse effect on our business.
Patents
and Intellectual Property
As of December 31, 2006, we have rights to 41 issued United
States patents relating to cryosurgical ablative technology.
Included within these 41 issued United States patents are 5
patents in which we have licensed-in rights.
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The remainder of the patents are assigned to us. Most of these
patents relate to our cryoprobe technology for creating the
freeze zone and precisely controlling the shape of the freeze
zone produced by the cryoprobes. Additionally, certain patents
relate to our computer guided system for assisting surgeons in
properly placing cryoprobes in a patient, a computer-controlled
cryosurgery apparatus and method, a cryosurgical integrated
control and monitoring system and urethral warming technology.
We also have rights to 17 pending United States patent
applications relative to cryosurgical ablative technology.
Additionally, we have rights to 39 foreign patents and pending
foreign patent applications in this technology area. The
earliest of our patents do not expire until 2011. Most of the
earliest patents in our core technology area do not expire until
about 2016.
Our policy is to secure and protect intellectual property rights
relating to our technology through patenting inventions and
licensing others when necessary. While we believe that the
protection of patents and licenses is important to our business,
we also rely on trade secrets, know-how and continuing
technological innovation to maintain our competitive position.
Given our technology and patent portfolio, we do not consider
the operation of our business to be materially dependent upon
any one patent, group of patents or single technological
innovation.
Our policy is to sell our products under trademarks and to
secure trademark protection in the United States and elsewhere
where we deem such protection important.
No assurance can be given that our processes or products will
not infringe patents or other intellectual property rights of
others or that any license required would be made available
under any such patents or intellectual property rights, on terms
acceptable to us or at all. In the past, we have received
correspondence alleging infringement of intellectual property
rights of third parties. No assurance can be given that any
relevant claims of third parties would not be upheld as valid
and enforceable, and therefore we could be prevented from
practicing the subject matter claimed or could be required to
obtain licenses from the owners of any such intellectual
property rights to avoid infringement.
We seek to preserve the confidentiality of our technology by
entering into confidentiality agreements with our employees,
consultants, customers and key vendors and by other means. No
assurance can be given, however, that these measures will
prevent the unauthorized disclosure or use of such technology.
Research
Strategy
Our research goal is to develop innovative cryoablation
technology that dramatically improves patient outcomes. Our
primary focus is on developing devices for the treatment of
prostate, kidney, lung and liver tumors and for palliative
intervention (treatment of pain associated with metastases). To
that end, we endeavor to develop innovations that improve the
safety and efficacy of our Cryocare Surgical System, as well as
to explore new applications for use of our technology platform
in the body.
We spent approximately $1.9 million, $2.3 million and
$2.8 million for the years ended 2004, 2005 and 2006
respectively, on research and development activities from
continuing operations.
Sales
We sell our products primarily to hospitals and third party
service providers and have both domestic and international
customers. One of our customers, Advanced Medical Partners, Inc.
(AMPI), accounted for 28.8 percent of our net revenues in
2006. The following products and services account for
15 percent or more of total revenues from continuing
operations for each of the years ended December 31:
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2004
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2005
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2006
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Cryoablation and urological
products:
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Cryocare Surgical Systems
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*
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*
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*
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Cryoprobes, disposables and
procedures
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91
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%
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94
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%
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94
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%
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Cardiac products (CryoCath)
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*
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*
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*
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* |
|
These products account for less than 15 percent of total
revenues. |
7
We currently sell our cryosurgical products domestically through
our direct sales force, which, as of December 31, 2006
consisted of 38 people, including 33 sales representatives
and sales managers and 5 cryosurgical field technicians.
Our strategy is to continue to introduce the clinical benefits
of cryosurgery to new physicians as well as educating physicians
already performing cryosurgery so that they are able to
increasingly incorporate cryosurgery into their practice. We
also intend to create patient demand by providing education
regarding the benefits of cryosurgical therapy versus
alternative treatment options and by using national advertising
and other programs targeted directly at prostate cancer patients.
Internationally, our cryosurgical products are sold primarily
through independent distributors. Our international sales from
continuing operations represented approximately
8.1 percent, 6.9 percent and 5.8 percent of our
total revenue in 2004, 2005 and 2006, respectively. As of
December 31, 2006, we had no long-lived assets outside of
the United States.
We derive our revenues from continuing operations from the
following geographic regions for each of the years ended
December 31, based on shipping destination:
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2004
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2005
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2006
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(In thousands)
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United States
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$
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22,234
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$
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26,322
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$
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26,379
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International:
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China
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556
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|
567
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|
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451
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Canada
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|
|
760
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1,015
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796
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Other
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631
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370
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364
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Total international
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1,947
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1,952
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1,611
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Total revenues
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$
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24,181
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$
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28,274
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$
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27,990
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Reimbursement
We sell our Cryocare Surgical System and related disposable
products to hospitals and third party service companies that
provide services to hospitals. Procedures involving the Cryocare
Surgical System are performed in hospitals on an inpatient
basis. While patients occasionally pay for cryosurgical
procedures directly, most patients depend upon third-party
payers to pay for their procedures, including Medicare,
Medicaid, Tricare and other federal health care programs, as
well as private insurers.
Accordingly, our revenue is dependent upon third-party
reimbursement, particularly Medicare, since the majority of
patients receiving prostate cryosurgical treatments using our
products are Medicare beneficiaries. The mix of public/private
payers for other cryosurgical procedures varies by type of
procedure.
Medicare reimbursement for cryosurgical procedures using our
products as a primary treatment alternative for localized
prostate cancer began in July 1999. Effective July 2001,
Medicare coverage was approved for secondary cryosurgical
treatment of prostate cancer patients who have failed radiation
therapy.
When Medicare-reimbursed services are provided on an inpatient
basis, the hospital is reimbursed under the Medicare prospective
payment system, based on the applicable diagnosis related group.
A single payment covers all facility services.
Outpatient reimbursement for cryosurgical procedures for
Medicare beneficiaries is in accordance with the Hospital
Outpatient Prospective Payment System, or HOPPS. Under HOPPS,
the hospital is paid on a per procedure basis, based on the
ambulatory payment classification for the procedure. The payment
to the hospital includes the per procedure share of the cost for
any depreciable equipment, such as our Cryocare Surgical System,
and the provision of disposable devices, such as our temperature
probes and cryoprobes.
Clinical studies are underway regarding percutaneous
cryoablation of cancerous tissue in the kidney, lung and liver
and palliative intervention for pain associated with metastases.
After studies are complete coverage decisions and unique
reimbursement codes will be sought from Medicare and private
payers. As of December 31, 2006, no
8
such codes were in place except for a tracking code established
for percutaneous renal cryoablation. This tracking code is a
significant step towards assignment of a Category I CPT code and
wider acceptance for payment.
Clearance to market a new device or technology by the FDA does
not guarantee payment by Medicare or other payers. Future
devices and technology that we develop would have to be approved
for coverage by Medicare after we obtain FDA approval or
clearance. The Medicare approval process is lengthy and there is
no assurance that Medicare approval would be granted. Each
private insurer makes its own determination whether to cover a
device or procedure and sets its own reimbursement rate.
Backlog
As of December 31, 2006, we had no backlog for our
products. Our policy is to carry enough inventory to be able to
ship most orders within a few days of receipt of order.
Historically, most of our orders have been for shipment within
30 days of the placement of the order. Therefore, we rely
on orders placed during a given period for sales during that
period.
Manufacturing
We manufacture our Cryocare Surgical System and related
disposables at our facilities in Irvine, California. Our
facility has been inspected by the California Department of
Health Services and has been issued a Device Manufacturing
License.
Our current manufacturing facility has been subjected to Quality
System Regulation compliance inspections by the FDA most
recently in June 2004, and also in February and March 2003 and
September 2002. These audits have been closed by the FDA. We
most recently received ISO 13485:2003, CE Marking and Canadian
CMDCAS certifications, indicating compliance with European
standards for a robust Quality Management System, quality
assurance and manufacturing process control.
Government
Regulation
Governmental regulation in the United States and other countries
is a significant factor affecting the research and development,
manufacture and marketing of medical devices, including our
products. In the United States, the FDA has broad authority
under the Federal Food, Drug and Cosmetic Act (the FD&C Act)
to regulate the distribution, manufacture, marketing and sale of
medical devices. Foreign sales of medical devices are subject to
foreign governmental regulation and restrictions that vary from
country to country.
Medical devices intended for human use in the United States are
classified into one of three categories, depending upon the
degree of regulatory control to which they will be subject. Such
devices are classified by regulation into either Class I
general controls, Class II special standards or
Class III pre-market approval, depending upon the level of
regulatory control required to provide reasonable assurance of
the safety and effectiveness of the device.
Most Class I devices are exempt from pre-market
notification or approval. Class II devices are subject to
the pre-market notification requirements under
Section 510(k) of the FD&C Act. For a 510(k) to be
cleared by the FDA, the manufacturer must demonstrate to the FDA
that a device is substantially equivalent to another legally
marketed device that was either cleared through the 510(k)
process or on the market prior to 1976. It generally takes four
to twelve months from the date of submission to obtain 510(k)
clearance although it may take longer, in particular if clinical
trials are required. Class III devices generally include
the most risky devices as well as devices that are not
substantially equivalent to other legally marketed devices. To
obtain approval to market a Class III device, a
manufacturer must obtain FDA approval of a pre-market approval
application, or PMA. The PMA process requires more data, takes
longer and is typically a significantly more complex and
expensive process than the 510(k) procedure.
Our Cryocare Surgical Systems have been cleared for marketing
through the 510(k) process.
We can provide no assurance that we will be able to obtain
clearances or approvals for clinical testing or for
manufacturing and sales of our existing products for all
applications in all targeted markets, or that we will be able to
9
obtain clearances or approvals needed to introduce new products
and technologies. After a device is placed on the market,
numerous regulatory requirements apply.
These include:
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quality system regulation, which requires manufacturers to
follow design, testing, control, documentation and other quality
assurance procedures during the manufacturing process;
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labeling regulations, which prohibit the promotion of products
for unapproved or off-label uses and impose other
restrictions on labeling; and
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medical device reporting regulations, which require that
manufacturers report to the FDA if their device may have caused
or contributed to a death or serious injury or malfunctioned in
a way that would likely cause or contribute to a death or
serious injury if it were to recur.
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Failure to comply with applicable regulatory requirements can
result in enforcement action by the FDA, which may include any
of the following sanctions:
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fines, injunctions, and civil penalties;
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recall or seizure of our products;
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operating restrictions, partial suspension or total shutdown of
production;
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refusing our request for 510(k) clearance or premarket approval
of new products;
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withdrawing 510(k) clearance or premarket approvals that are
already granted; and
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criminal prosecution.
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Medical device laws are also in effect in many of the countries
outside of the United States in which we do business. These laws
range from comprehensive device approval and quality system
requirements for some or all of our medical device products to
simple requests for product data or certifications. The number
and scope of these requirements are increasing. In June 1998,
the European Union Medical Device Directive became effective,
and all medical devices must meet the Medical Device Directive
standards and receive CE mark certification. CE mark
certification involves a comprehensive Quality System program,
and submission of data on a product to the Notified Body in
Europe.
We have obtained the CE mark certification for distribution of
our Cryocare Surgical System in Europe and approval for
distribution in Australia, Canada, New Zealand, China, Taiwan,
Korea and Mexico.
Health
Care Regulatory Issues
The health care industry is highly regulated and the regulatory
environment in which we operate may change significantly in the
future. In general, regulation of health care-related companies
is increasing. We anticipate that Congress and state
legislatures will continue to review and assess alternative
health care delivery and payment systems. We cannot predict what
impact the adoption of any federal or state health care reform
measures may have on our business.
We regularly monitor developments in statutes and regulations
relating to our business. We may be required to modify our
agreements, operations, marketing and expansion strategies from
time to time in response to changes in the statutory and
regulatory environment. We plan to structure all of our
agreements, operations, marketing and strategies in accordance
with applicable law, although we can provide no assurance that
our arrangements will not be challenged successfully or that
required changes may not have a material adverse effect on our
business, financial condition, results of operations and cash
flows.
We believe that the following discussion summarizes all of the
material health care regulatory requirements to which we
currently are subject. Complying with these regulatory
requirements may involve expense to us, delay in our operations
and/or
restructuring of our business relationships. Violations could
potentially result in the imposition of civil
and/or
criminal penalties.
10
Anti-Kickback
Laws
The federal health care program anti-kickback law
prohibits the knowing and willful offer, payment, solicitation
or receipt of any form of remuneration in return for, or in
order to induce, (i) the referral of a person for services,
(ii) the furnishing or arranging for the furnishing of
items or services or (iii) the purchase, lease or order or
arranging or recommending purchasing, leasing or ordering any
item or service, in each case, reimbursable under any federal
health care program. Because our products are reimbursable under
Medicare, Medicaid and other federal health care programs, the
anti-kickback law applies. Many states have similar
anti-kickback or anti-referral laws, and in many cases these
laws apply to all patients, not just federal health care program
beneficiaries. Noncompliance with, or violation of, the federal
anti-kickback law can result in exclusion from federal health
care programs and civil and criminal penalties. Similar
penalties are provided for violation of state anti-kickback
laws. Several federal courts have held that the anti-kickback
law is violated if just one purpose of payment is to induce the
referral of patients. To the extent that we are deemed to be
subject to these federal or similar state laws, we believe that
our activities and contemplated activities comply in all
material respects with such statutes and regulations.
Regulations to the federal anti-kickback law specify payment
practices that will not be subject to prosecution under the
anti-kickback law. These are known as the
safe-harbors. Failure to comply fully within a
safe-harbor does not mean the practice is per se illegal, and
many common arrangements in the health care industry do not fit
with a safe harbor, yet are not violations of the anti-kickback
law. Rather, if a practice does not fit within a safe
harbor, no guarantee can be given that the practice will
be exempt from prosecution; it will be viewed under the totality
of the facts and circumstances.
Many of our relationships with customers, such as volume and
other discounts, fit within a safe harbor. However, our service
agreements with physician-owned entities do not fit completely
within a safe harbor. For example, the safe harbor for equipment
leases and the safe harbor for personal services both require
that the aggregate amount of the rental or service payment be
fixed in advance for the term of the arrangement, which must be
at least one year. However, where the need for medical
procedures is not known in advance, it is sometimes more
appropriate to arrange for payment on a per procedure basis,
rather than determining a years total compensation in
advance. For the reasons described below, certain of our
arrangements with physician-owned entities provide for payment
on a per procedure basis.
In the case of cryosurgery, as well as other procedures that
involve new or expensive technology, hospitals often do not want
to invest in the required capital equipment. Rather, hospitals
enter into arrangements with specialty mobile service providers
or equipment manufacturers to obtain the use of the necessary
equipment and disposable products (such as cryoprobes), as well
as technician services, where applicable, on a per procedure
basis. In the case of cryosurgical equipment and disposables,
some physicians have formed or invested in mobile service
providers that provide cryosurgical equipment, disposables and
services directly to hospitals. In such cases, our relationship
to the physician-owned entities is only as a seller of our
products, where discounts are provided in accordance with the
discount safe harbor. However, in some cases, we contract
directly with hospitals to provide the necessary
equipment/disposables and technical support. These contracts
generally provide for the hospital to pay for the
equipment/disposables and support package on a per procedure
basis. Since we are primarily in the business of selling our
equipment and disposable products, not providing services, when
we contract to provide equipment to hospitals we typically
subcontract with a mobile service provider or other equipment
owner to furnish the equipment as our subcontractor. A
significant number of these businesses are owned entirely or in
part by urologists who purchase the equipment in order to make
cryosurgery available in their communities. Since the hospitals
pay us on a per procedure basis, we in turn pay our
subcontractors on a per procedure basis pursuant to service
agreements. These service agreements do not meet a safe harbor
since, as noted above, the safe harbors for equipment leases and
service arrangements require that the aggregate payment for the
term of the arrangement must be set in advance. Although the
service agreements do not meet a safe harbor, our service
agreements with physician-owned entities include the following
elements intended to address anti-kickback law concerns:
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Physician-owned subcontractors are not compensated or otherwise
treated differently than non-physician-owned entities;
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The per procedure payments under the subcontracts are intended
to reflect fair market value for the products and services
provided by the subcontractors;
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11
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Subcontracts are in writing and include a number of
representations regarding health care regulatory compliance
issues, including requiring the subcontractor to represent that
distributions to physician owners of the subcontractor are not
based on referrals; and
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Physicians must make significant investments in order to
purchase our equipment. The fact that the physicians have
assumed bona fide business risk is an important factor in
demonstrating that the arrangement is not simply a way for
physicians to profit from their referrals.
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Patient
Referral Laws
The Stark law prohibits a physician from referring a Medicare
patient for designated health services, or DHS, to
an entity with which the physician has a direct or indirect
financial relationship, whether in the nature of an ownership
interest or a compensation arrangement, subject only to limited
exceptions. The Stark law also prohibits the recipient of a
prohibited referral from billing for the DHS provided pursuant
thereto. DHS include inpatient and outpatient hospital services.
The entity that bills Medicare for the DHS is considered to be
the provider of the DHS for Stark law purposes. Therefore,
we are not providers of DHS. Rather, the hospitals where the
procedures are performed are the providers of DHS, because they
bill Medicare for the cryosurgery procedures, and inpatient and
outpatient hospital services are DHS.
Physicians who have an ownership or compensation relationship
with the entities (such as mobile vendors) that furnish our
equipment to hospitals, and the hospitals that obtain equipment
and services directly or indirectly from such entities, are
considered to have an indirect compensation
arrangement, and therefore that relationship must meet a
Stark law exception in order for the physicians to make DHS
referrals to the hospital. There is a Stark law exception for
indirect compensation arrangements that applies if:
(1) Fair Market Value Compensation. The
compensation to the physician under the arrangement (or, if the
first link in the chain of arrangements between the parties is
an ownership or investment interest by the referring physician,
the first entity up the chain that has a direct compensation
arrangement with next link in the chain) represents fair market
value and is not determined in a manner that takes into account
the volume or value of referrals or other business generated by
the physician for the DHS entity;
(2) Written Contract. The arrangement is
set out in writing, signed by the parties and specifies the
services covered by the arrangement; and
(3) Anti-Kickback Law Compliance. The
arrangement does not violate the anti-kickback law.
Here, as noted above in connection with discussion of the
anti-kickback law, our service agreements are in writing, the
per procedure payments are intended to reflect fair market value
and are not determined in a manner that takes into account
referrals by owner-physicians to the hospital, and we believe
that the arrangements do not violate the anti-kickback law.
Many states also have patients referrals laws, some of which are
more restrictive than the Stark law and regulate referrals by
all licensed healthcare practitioners for any health care
services to an entity with which the licenses has a financial
relationship unless an exception applies. Such laws in
particular states may prohibit us from entering into
relationships with physicians and physician-owned entities,
which may limit business development.
HIPAA and
Other Privacy Laws
As of April 14, 2003, the privacy regulations developed
under the Health Insurance Portability and Accountability Act of
1996, referred to as HIPAA, took effect. The privacy
regulations place limitations on a covered
entitys use and disclosure of identifiable patient
information, including research data. While Endocare is not a
covered entity under HIPAA, Endocares
relationships with covered entities, such as hospitals and
physicians, sometimes implicate HIPAA. Accordingly, Endocare has
adopted policies and procedures regarding confidentiality and
each employee who comes into contact with Protected Health
Information (PHI or patient data) is trained in the proper
handling of such information. Endocare has also established
procedures to determine when Endocare is required to sign a
business associate agreement with a covered entity
in connection with receipt of PHI and when such measures are not
required.
12
We believe that we have implemented appropriate measures to
ensure that our relationships with covered entities are
appropriate and consistent with HIPAA. However, there are many
uncertainties remaining about how HIPAA applies to medical
device companies, and no assurance can be given that HIPAA will
not be interpreted in a manner that will hamper our ability to
conduct medical research and receive medical information for
other purposes as well.
Other
United States Regulatory Requirements
In addition to the regulatory framework for product approvals,
we are and may be subject to regulation under federal and state
laws, including requirements regarding occupational health and
safety, laboratory practices and the use, handling and disposing
of toxic or hazardous substances. We may also be subject to
other present and future local, state, federal and foreign
regulations.
Seasonality
We believe that holidays, major medical conventions and
vacations taken by physicians, patients and patient families may
have a seasonal impact on our sales of cryosurgical products
because cryosurgical procedures can be scheduled in advance. We
are continuing to monitor and assess the impact seasonality may
have on demand for our products.
Competition
The medical device industry is subject to intense competition.
Significant competitors in the area of prostate cancer and other
tumor ablation (renal, liver, lung and palliative intervention)
include companies that offer: surgical devices (such as robotic
surgery equipment); brachytherapy seeds and other forms of
radiation therapy; and ablation products, including cryoablation
products and radiofrequency ablation (RFA) products. Additional
devices in development such as high intensity focused ultrasound
(HIFU), microwave and others may be competitive devices in the
future. Many of our competitors have significantly greater
financial and human resources than we do.
We believe that currently only Galil Medical offers cryoablation
products that compete with our cryoablation products. However,
we believe that our cryoablation products provide superior
technology and greater functionality, at a price that is
competitive.
We believe the principal competitive factors in the cryoablation
product market include:
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the safety and efficacy of treatment alternatives;
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acceptance of a procedure by physicians and patients;
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technology leadership and superiority;
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price;
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availability of government or private insurance
reimbursement; and
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speed to market.
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Employees
As of December 31, 2006, we had a total of 123 employees.
Of these employees, nine are engaged directly in research and
development activities, seven in regulatory affairs/quality
assurance, 23 in manufacturing, 57 in sales, marketing, clinical
support and customer service and 27 in general and
administrative positions. We have never experienced a work
stoppage, none of our employees are represented by a labor
organization, and we consider our employee relations to be good.
Available
Information
Our website address is www.endocare.com. All filings we make
with the SEC, including our annual report on
Form 10-K,
our quarterly reports on
Form 10-Q,
and our current reports on
Form 8-K,
and any amendments thereto,
13
are available at no charge through links displayed on our
website as soon as reasonably practicable after they are filed
or furnished to the SEC. The reference to our website address
does not constitute incorporation by reference of the
information contained on the website, and the information
contained on the website is not part of this document.
The risks and uncertainties described below are not the only
ones we face. Additional risks and uncertainties not presently
known to us or that we currently deem immaterial may also impair
our operations. The occurrence of any of the following risks
could harm our business. In that case, the trading price of our
common stock could decline, and you may lose all or part of your
investment.
Risks
Associated With our Business
We have a
limited operating history with significant losses and expect
losses to continue for the foreseeable future.
We have yet to establish any history of profitable operations.
We have incurred annual operating losses from continuing
operations of $15.4 million, $16.6 million and
$31.6 million, respectively, during the fiscal years ended
December 31, 2006, 2005 and 2004. As a result, at
December 31, 2006 we had an accumulated deficit of
$176.4 million. We have incurred net losses from continuing
operations of $11.1 million, $14.8 million and
$31.9 million, respectively, during the fiscal years ended
December 31, 2006, 2005 and 2004. Our revenues have not
been sufficient to sustain our operations. We expect that our
revenues will not be sufficient to sustain our operations for
the foreseeable future. We can give no assurances when or
whether we will ever be profitable.
We may
require additional financing to sustain our operations and
without it we may not be able to continue operations.
We had an operating cash flow deficit of $13.6 million for
the year ended December 31, 2006 and $14.7 million for
the year ended December 31, 2005.
The availability of funds under the $16.0 million common
stock purchase agreement with Fusion Capital Fund II, LLC
(Fusion Capital) and our $4.0 million credit agreement with
Silicon Valley Bank is subject to many conditions, some of which
are predicated on events that are not within our control.
Accordingly, we cannot guarantee that these capital resources
will available or will be sufficient to fund our ongoing
operations.
We only have the right to receive $100,000 every four business
days under the agreement with Fusion Capital unless our stock
price equals or exceeds $1.50, in which case we can sell greater
amounts to Fusion Capital as the price of our common stock
increases. Fusion Capital does not have the obligation to
purchase any shares of our common stock on any business day that
the market price of our common stock is less than $1.00. Since
we have authorized 8,000,000 shares for sale to Fusion
Capital under the common stock purchase agreement, the selling
price of our common stock to Fusion Capital will have to average
at least $2.00 per share for us to receive the maximum
proceeds of $16.0 million. Assuming a purchase price of
$1.75 per share (the closing sale price of the common stock
on February 28, 2007) and the purchase by Fusion
Capital of the full 8,000,000 shares under the common stock
purchase agreement, gross proceeds to us would be
$14.0 million.
Under the credit agreement, funds available for borrowing are
based on eligible trade receivables and inventory as defined.
The credit agreement contains a subjective acceleration clause
and a requirement to maintain a lockbox with the lender to which
all receivable collections are deposited. Under the subjective
acceleration clause, the lender may accelerate repayment of
amounts borrowed
and/or cease
making advances to us if it determines that a material adverse
change has occurred in our business or our ability to meet our
obligations under the agreement. In addition, the proceeds from
the lock box will be applied to reduce the outstanding
borrowings upon an event default (including the occurrence of a
material adverse change) or if trigger events occur. Our ability
to access funds under the credit agreement will be subject to
our ability to meet all restrictive covenants and comply with
all representations and warranties.
The extent to which we rely on Fusion Capital as a source of
funding will depend on a number of factors including the
prevailing market price of our common stock and the extent to
which we are able to secure working
14
capital from other sources, such as through the sale of our
products. If sufficient financing from Fusion Capital were to
prove unavailable or prohibitively dilutive and if we are unable
to sell enough of our products, we may need to secure another
source of funding in order to satisfy our working capital needs.
Even if we are able to access the full $16.0 million under
the common stock purchase agreement with Fusion Capital, we may
still need additional capital to fully implement our business,
operating and development plans. Should the financing we require
to sustain our working capital needs be unavailable or
prohibitively expensive when we require it, the consequences
could have a material adverse effect on our business, financial
condition, results of operations and cash flows.
Our
independent auditor has issued an unqualified opinion with an
explanatory paragraph, to the effect that there is substantial
doubt about our ability to continue as a going
concern.
Even despite the availability of funds from Fusion Capital and
Silicon Valley Bank, our independent auditor has issued an
unqualified opinion with an explanatory paragraph to the effect
that there is substantial doubt about our ability to continue as
a going concern due to, among other factors, the subjective
acceleration provisions and conditions that must be met in order
to access the funds under the Fusion Capital common stock
purchase agreement and the Silicon Valley Bank credit facility.
This unqualified opinion with an explanatory paragraph could
itself have a material adverse effect on our business, financial
condition, results of operations and cash flows. See
Liquidity and Capital Resources in
Part II, Item 7, Managements Discussion
and Analysis of Financial Condition and Results of
Operations.
The sale
of our common stock to Fusion Capital may cause dilution and the
sale of the shares of common stock acquired by Fusion Capital
could cause the price of our common stock to decline.
In connection with entering into the common stock purchase
agreement with Fusion Capital, we authorized the sale to Fusion
Capital of up to 8,000,000 shares of our common stock, in
addition to the 473,957 shares that we issued to Fusion
Capital as a commitment fee. The number of shares ultimately
offered for sale by Fusion Capital is dependent upon the number
of shares purchased by Fusion Capital under the agreement. The
purchase price for the common stock to be sold to Fusion Capital
pursuant to the common stock purchase agreement will fluctuate
based on the price of our common stock. All
8,473,957 shares that we have registered pursuant to our
registration rights agreement with Fusion Capital are freely
tradable. It is anticipated that shares registered will be sold
over a period of up to 24 months. Depending upon market
liquidity at the time, a sale of shares by Fusion Capital at any
given time could cause the trading price of our common stock to
decline. Fusion Capital may ultimately purchase all or some of
the 8,000,000 shares of common stock authorized for sale to
Fusion Capital under the common stock purchase agreement. After
it has acquired such shares, it may sell all, some or none of
such shares. Therefore, sales to Fusion Capital by us under the
common stock purchase agreement may result in substantial
dilution to the interests of other holders of our common stock.
The sale of a substantial number of shares of our common stock
by Fusion Capital, or anticipation of such sales, could make it
more difficult for us to sell equity or equity-related
securities in the future at a time and at a price that we might
otherwise wish to effect sales. However, we have the right to
control the timing and amount of any sales of our shares to
Fusion Capital and the agreement may be terminated by us at any
time at our discretion without any cost to us. As of
February 28, 2007, we had sold an aggregate of
566,978 shares to Fusion Capital under the common stock
purchase agreement, in addition to the 473,957 shares that
we issued to Fusion Capital as a commitment fee.
Our
business may be materially and adversely impacted by the loss of
our largest customer or the reduction, delay or cancellation of
orders from this customer; in addition, our business may be
materially and adversely impacted if this customer delays
payment or fails to pay for products sold to this
customer.
For the three and twelve months ended December 31, 2006 our
largest customer accounted for 39.8% and 28.8%, respectively, of
our revenues, and as of December 31, 2006 this customer
accounted for 45.7% of our accounts receivable. Our sales to
this customer may be materially and adversely impacted by
various factors relating to this customers business,
financial condition, results of operations and cash flows. Our
business, financial condition, results of operations and cash
flows may be materially and adversely impacted by the loss of
this
15
customer, or the reduction, delay or cancellation of orders. In
addition, our business, financial condition, results of
operations and cash flows may be materially and adversely
impacted if this customer delays payment or fails to pay for
products sold. This customer is not obligated to purchase a
specific quantity of our products or provide binding forecasts
of purchases for any period.
We may be
required to make tax payments that exceed our settlement
estimates.
As of December 31, 2005 and 2006 we estimated that we owed
$3.4 million and $2.8 million, respectively, as of
each balance sheet date in state and local taxes, primarily
sales and use taxes, in various jurisdictions in the
United States. We are in the process of negotiating
resolutions of the past due tax obligations with the applicable
tax authorities. While we hope that these obligations can be
settled for less than the amounts accrued, we cannot predict
whether we will obtain favorable settlement terms from the
various tax authorities, or that, after settling, we will
satisfy the conditions necessary to avoid violating the
settlements. Our failure to obtain favorable settlement terms or
to satisfy the settlement conditions may result in a material
adverse effect on our business, financial condition, results of
operations and cash flows.
We may
incur significant expenses in the future as a result of our
obligation to pay legal fees for and otherwise indemnify former
officers and former directors.
As described below under Part I, Item 3, Legal
Proceedings, certain former officers and former directors
continue to be involved in investigations and related legal
proceedings brought by the SEC and the DOJ. We are contractually
obligated to pay legal fees for and otherwise indemnify these
former officers and former directors. We may incur significant
expenses in the future as a result of these obligations. The
amount of these expenses is unpredictable and outside of our
control and could have a material adverse effect on our
business, financial condition, results of operations and cash
flows.
Our
success will depend on our ability to attract and retain key
personnel.
In order to execute our business plan, we need to attract,
retain and motivate a significant number of highly qualified
managerial, technical, financial and sales personnel. If we fail
to attract and retain skilled scientific and sales personnel,
our research and development and sales and marketing efforts
will be hindered. Our future success depends to a significant
degree upon the continued services of key management personnel.
None of our key management personnel is covered by an insurance
policy of which we are the beneficiary.
Our
success is reliant on the acceptance by doctors and patients of
the Cryocare Surgical System as a preferred treatment for tumor
ablation.
Cryosurgery has existed for many years, but has not been widely
accepted primarily due to concerns regarding safety and efficacy
and widespread use of alternative therapies. Because the
technology previously lacked precise monitoring capabilities,
prostate cryosurgical procedures performed in the 1970s resulted
in high cancer recurrence and negative side effects, such as
rectal fistulae and incontinence, and gave cryosurgical
treatment negative publicity. To overcome these negative side
effects, we have developed ultrasound guidance and temperature
sensing to enable more precise monitoring in our Cryocare
Surgical System. Nevertheless, we will need to overcome the
earlier negative publicity associated with cryosurgery in order
to obtain market acceptance for our products. In addition, use
of our Cryocare Surgical System requires significant physician
education and training. As a result, we may have difficulty
obtaining recommendations and endorsements of physicians and
patients for our Cryocare Surgical System. We may also have
difficulty raising the brand awareness necessary to generate
interest in our Cryocare Surgical System. Any adverse side
effects, including impotence or incontinence, recurrence of
cancer or future reported adverse events or other unfavorable
publicity involving patient outcomes from the use of
cryosurgery, whether from our products or the products of our
competitors, could adversely affect acceptance of cryosurgery.
In addition, emerging new technologies and procedures to treat
prostate cancer may negatively affect the market acceptance of
cryosurgery. If our Cryocare Surgical System does not achieve
broad market acceptance, we will likely remain unprofitable.
16
We are
faced with intense competition and rapid technological and
industry change, which may make it more difficult for us to
achieve significant market penetration.
The medical device industry generally, and the cancer treatment
market in particular, are characterized by rapid technological
change, changing customer needs and frequent new product
introductions. If our competitors existing products or new
products are more effective than or considered superior to our
products, the commercial opportunity for our products will be
reduced or eliminated. We face intense competition from
companies in the cryosurgical marketplace as well as companies
offering other treatment options, including radical
prostatectomy, radiation therapy and hormone therapy. If we are
successful in penetrating the market for treatment of prostate
cancer with our cryosurgical treatment, other medical device
companies may be attracted to the marketplace. Many of our
potential competitors are significantly larger than we are and
have greater financial, technical, research, marketing, sales,
distribution and other resources than we do. We believe there
will be intense price competition for products developed in our
markets. Our competitors may develop or market technologies and
products that are more effective or commercially attractive than
any that we are developing or marketing. Our competitors may
obtain regulatory approval and introduce and commercialize
products before we do. These developments could have a material
adverse effect on our business, financial condition, results of
operations and cash flows. Even if we are able to compete
successfully, we may not be able to do so in a profitable manner.
If we are
unable to continue to enhance our Cryocare Surgical System, our
business will suffer.
Our growth depends in part on continued ability to successfully
develop, manufacture and commercialize enhancements to our
Cryocare Surgical System. We may experience difficulties that
could delay or prevent the successful development, manufacturing
and commercialization of these products. Our products in
development may not prove safe and effective in clinical trials.
Clinical trials may identify significant technical or other
obstacles that must be overcome before obtaining necessary
regulatory or reimbursement approvals. In addition, our
competitors may succeed in developing commercially viable
products that render our products obsolete or less attractive.
Failure to successfully develop, manufacture and commercialize
new products and enhancements could have a material adverse
effect on our business, financial condition, results of
operations and cash flows.
There is
uncertainty relating to third-party reimbursement, which is
critical to market acceptance of our products.
Hospitals and other health care providers in the United States
generally rely on third-party payers, principally federal
Medicare, state Medicaid and private health insurance plans, to
reimburse all or part of the cost of medical procedures
involving our products. While private health insurers in some
areas of the United States provide reimbursement for procedures
in which our products are used, we can provide no assurance that
private insurance reimbursement will be adopted nationally or by
additional insurers. Furthermore, those private insurance
companies currently paying for procedures in which our products
are used may terminate such coverage. If reimbursement levels
from Medicare, Medicaid, other governmental health care programs
or private insurers are not sufficient, physicians may choose
not to recommend, and patients may not choose, procedures using
our products.
International market acceptance of our products may depend, in
part, upon the availability of reimbursement within prevailing
health care payment systems. Reimbursement and health care
payment systems in international markets vary significantly by
country, and include both government sponsored health care and
private insurance. We may not obtain international reimbursement
approvals in a timely manner, if at all. Our failure to receive
international reimbursement approvals may negatively impact
market acceptance of our products in the international markets
in which those approvals are sought.
From time to time significant attention has been focused on
reforming the health care system in the United States and
other countries. Any changes in Medicare, Medicaid or
third-party medical expense reimbursement, which may arise from
health care reform, may have a material adverse effect on
reimbursement for our products or procedures in which our
products are used and may reduce the price we are able to charge
for our products. In addition, changes to the health care system
may also affect the commercial acceptance of products we are
currently developing and products we may develop in the future.
Potential changes that have been considered include controls on
health care spending and price controls. Several proposals have
been made in the United States
17
Congress and various state legislatures recently that, if
adopted, would potentially reduce health care spending, which
may result in a material adverse effect on our business,
financial condition, results of operations and cash flows.
If we
fail to protect our intellectual property rights, our
competitors may take advantage of our ideas and compete directly
against us.
Our success will depend to a significant degree on our ability
to secure and protect intellectual property rights and to
enforce patent and trademark protections relating to our
technology. From time to time, litigation may be advisable to
protect our intellectual property position. However, these legal
means afford only limited protection and may not adequately
protect our rights or permit us to gain or keep any competitive
advantage. Any litigation in this regard could be costly, and it
is possible that we will not have sufficient resources to fully
pursue litigation or to protect our other intellectual property
rights. Litigation could result in the rejection or invalidation
of our existing and future patents. Any adverse outcome in
litigation relating to the validity of our patents, or any
failure to pursue litigation or otherwise to protect our patent
position, could have a material adverse effect on our business,
financial condition, results of operations and cash flows. Also,
even if we prevail in litigation, the litigation would be costly
in terms of management distraction as well as in terms of money.
In addition, confidentiality agreements with our employees,
consultants, customers, and key vendors may not prevent the
unauthorized disclosure or use of our technology. It is possible
that these agreements could be breached or that they might not
be enforceable in every instance, and that we might not have
adequate remedies for any such breach. Enforcement of these
agreements may be costly and time consuming. Furthermore, the
laws of foreign countries may not protect our intellectual
property rights to the same extent as the laws of the United
States.
Because
the medical device industry is litigious, we may be sued for
allegedly violating the intellectual property rights of
others.
The medical technology industry has in the past been
characterized by a substantial amount of litigation and related
administrative proceedings regarding patents and intellectual
property rights. In addition, major medical device companies
have used litigation against emerging growth companies as a
means of gaining or preserving a competitive advantage.
Should third parties file patent applications or be issued
patents claiming technology also claimed by us in pending
applications, we may be required to participate in interference
proceedings in the United States Patent and Trademark Office to
determine the relative priorities of our inventions and the
third parties inventions. We could also be required to
participate in interference proceedings involving our issued
patents and pending applications of another entity. An adverse
outcome in an interference proceeding could require us to cease
using the technology or to license rights from prevailing third
parties.
Third parties may claim we are using their patented inventions
and may go to court to stop us from engaging in our normal
operations and activities. These lawsuits are expensive to
defend and conduct and would also consume and divert the time
and attention of our management. A court may decide that we are
infringing a third partys patents and may order us to
cease the infringing activity. A court could also order us to
pay damages for the infringement. These damages could be
substantial and could have a material adverse effect on our
business, financial condition, results of operations and cash
flows.
If we are unable to obtain any necessary license following an
adverse determination in litigation or in interference or other
administrative proceedings, we would have to redesign our
products to avoid infringing a third partys patent and
could temporarily or permanently have to discontinue
manufacturing and selling some of our products. If this were to
occur, it would negatively impact future sales and, in turn, our
business, financial condition, results of operations and cash
flows.
18
If we
fail to obtain or maintain necessary regulatory clearances or
approvals for products, or if approvals are delayed or
withdrawn, we will be unable to commercially distribute and
market our products or any product modifications.
Government regulation has a significant impact on our business.
Government regulation in the United States and other countries
is a significant factor affecting the research and development,
manufacture and marketing of our products. In the United States,
the Food and Drug Administration (FDA) has broad authority under
the federal FD&C Act to regulate the distribution,
manufacture and sale of medical devices. Foreign sales of drugs
and medical devices are subject to foreign governmental
regulation and restrictions, which vary from country to country.
The process of obtaining FDA and other required regulatory
clearances and approvals is lengthy and expensive. We may not be
able to obtain or maintain necessary approvals for clinical
testing or for the manufacturing or marketing of our products.
Failure to comply with applicable regulatory approvals can,
among other things, result in fines, suspension or withdrawal of
regulatory approvals, product recalls, operating restrictions
and criminal prosecution. In addition, governmental regulations
may be established which could prevent, delay, modify or rescind
regulatory approval of our products. Any of these actions by the
FDA, or change in FDA regulations, could have a material adverse
effect on our business, financial condition, results of
operations and cash flows.
Regulatory approvals, if granted, may include significant
limitations on the indicated uses for which our products may be
marketed. In addition, to obtain such approvals, the FDA and
foreign regulatory authorities may impose numerous other
requirements on us. FDA enforcement policy prohibits the
marketing of approved medical devices for unapproved uses. In
addition, product approvals can be withdrawn for failure to
comply with regulatory standards or unforeseen problems
following initial marketing. We may not be able to obtain or
maintain regulatory approvals for our products on a timely
basis, or at all, and delays in receipt of or failure to receive
such approvals, the loss of previously obtained approvals or
failure to comply with existing or future regulatory
requirements could have a material adverse effect on our
business, financial condition, results of operations and cash
flows.
Our
products may be subject to product recalls even after receiving
FDA clearance or approval, which would harm our reputation and
our business.
The FDA and similar governmental authorities in other countries
have the authority to request and, in some cases, require the
recall of our products in the event of material deficiencies or
defects in design or manufacture. A governmental mandated or
voluntary recall by us could occur as a result of component
failures, manufacturing errors or design defects. Any recall of
product would divert managerial and financial resources and harm
our reputation with customers and our business.
We could
be negatively impacted by future interpretation or
implementation of the federal anti-kickback and Stark laws and
other federal and state anti-self-referral and anti-kickback
laws.
The federal Stark law prohibits a physician from referring
Medicare patients for certain services to an entity with which
the physician has a financial relationship. A financial
relationship includes both investment interests in an entity and
compensation arrangements with an entity. The federal
anti-kickback law prohibits the offer or receipt of any
remuneration in order to induce referrals of federal health care
program business. Many states have similar and often broader
laws. These state laws generally apply to services reimbursed by
both governmental and private payers. Violation of these federal
and state laws may result in prohibition of payment for services
rendered, loss of licenses, fines, criminal penalties and
exclusion from governmental and private payer programs, among
other things. We have financial relationships with physicians
and physician-owned entities, which in turn have financial
relationships with hospitals and other providers of designated
health services. Although we believe that our financial
relationships with physicians and physician-owned entities, as
well as the relationships between physician-owned entities that
purchase or lease our products and hospitals, are not in
violation of applicable laws and regulations, governmental
authorities might take a contrary position. If our financial
relationships with physicians or physician-owned entities or the
relationships between those entities and hospitals were found to
be illegal, we
and/or the
affected physicians and hospitals could be subject to civil and
criminal penalties, including fines, exclusion from
participation in government and private payer programs and
requirements to refund amounts previously received from
government and private payers. In addition, expansion of our
operations to new jurisdictions, or new interpretations of laws
in our existing jurisdictions, could require structural and
organizational
19
modifications of our relationships with physicians,
physician-owned entities and others to comply with that
jurisdictions laws. For a further description of these
laws see above in Part I, Item 1, under
Health Care Regulatory Issues.
We believe that the arrangements we have established with
physician-owned entities and hospitals comply with applicable
Stark law exceptions. However, if any of the relationships
between physicians and hospitals involving our services do not
meet a Stark law exception, neither the hospital nor we would be
able to bill for any procedure resulting from a referral that
violated the Stark law. Although in most cases we are not the
direct provider and do not bill Medicare for the designated
health services, any Stark law problem with our business
arrangements with physicians and hospitals would adversely
affect us as well as the referring physician and the hospital
receiving the referral.
Many states also have patient referral laws, some of which are
more restrictive than the Stark law and regulate referrals by
all licensed health care practitioners for any health care
service to an entity with which the licensee has a financial
relationship unless an exception applies. Such laws in
particular states may prohibit us from entering into
relationships with physicians and physician-owned entities,
which may limit business development.
We believe that our business practices comply with the Stark
law, the federal anti-kickback and applicable state
anti-kickback and anti-self-referral laws. No assurance can be
made, however, that these practices would not be successfully
challenged and penalties, such as civil money penalties and
exclusion from Medicare and Medicaid,
and/or state
penalties, imposed. And again, mere challenge, even if we
ultimately prevail, could have a material adverse effect on our
business, financial condition, results of operations and cash
flows.
If we
become subject to product liability claims, we may be required
to pay damages that exceed our insurance coverage.
Our business exposes us to potential product liability claims
that are inherent in the testing, production, marketing and sale
of medical devices. While we believe that we are reasonably
insured against these risks, we may not maintain insurance in
amounts or scope sufficient to provide us with adequate
coverage. A claim in excess of our insurance coverage would have
to be paid out of cash reserves, which could have a material
adverse effect on our business, financial condition, results of
operations and cash flows. In addition, any product liability
claim could harm our reputation in the industry and our business.
Our
intangible assets could become impaired.
Intangible assets acquired in a purchase, such as intellectual
property or developed technology, are generally amortized over
various periods depending on their anticipated economic benefits
or useful lives. Long-lived assets, including amortizable
intangibles, are reviewed for impairment whenever events or
changes in circumstances indicate that the carrying amount of an
asset may not be recoverable. Recoverability of assets to be
held and used is measured by a comparison of the carrying amount
of an asset to undiscounted future net cash flows expected to be
generated by the asset. Following a review, if such assets are
considered to be impaired, the impairment to be recognized is
measured by the amount by which the carrying value of the assets
exceeds the fair value of the assets. Significant estimates,
including assumptions regarding future events and circumstances
that cannot be easily predicted, are required to perform an
analysis of the value of intangible assets. These estimates and
assumptions may differ materially from actual outcomes and
occurrences.
Our
facilities and systems are vulnerable to natural disasters or
other catastrophic events.
Our headquarters, cryosurgical products manufacturing
facilities, research facilities and much of our infrastructure,
including computer servers, are located in California, an area
that is susceptible to earthquakes and other natural disasters.
A natural disaster or other catastrophic event, such as an
earthquake, fire, flood, severe storm, break-in, terrorist
attack or other comparable problems could cause interruptions or
delays in our business and loss of data or render us unable to
accept and fulfill customer orders in a timely manner, or at
all. We have no formal disaster recovery plan and our business
interruption insurance may not adequately compensate us for
losses that may occur. In the event that an earthquake, natural
disaster or other catastrophic event were to destroy any part of
our facilities or interrupt our operations for any extended
period of time, or if harsh weather conditions prevent us
20
from delivering products in a timely manner, it could have a
material adverse effect on our business, financial condition,
results of operations and cash flows.
Risks
Associated with an Investment in Our Common Stock
The
market price of our common stock is highly volatile.
The market price of our common stock has been and is expected to
continue to be highly volatile. Various factors, including
announcements of technological innovations by us or other
companies, regulatory matters, new or existing products or
procedures, concerns about our financial position, operating
results, litigation, government regulation, developments or
disputes relating to agreements, patents or proprietary rights,
may have a significant impact on the market price of our stock.
If our operating results are below the expectations of
securities analysts or investors, the market price of our common
stock may fall abruptly and significantly.
Future
sales of shares of our common stock may negatively affect our
stock price.
Future sales of our common stock, including shares issued upon
the exercise of outstanding options and warrants or hedging or
other derivative transactions with respect to our stock, could
have a significant negative effect on the market price of our
common stock. These sales also might make it more difficult for
us to sell equity securities or equity-related securities in the
future at a time and price that we would deem appropriate.
We had an aggregate of 30,679,176 shares of common stock
outstanding as of December 31, 2006, which includes
5,635,378 shares of our common stock that we issued on
March 11, 2005 in connection with the financing described
in the
Form 8-K
that we filed on March 16, 2005. Investors in that
financing also received warrants to purchase an aggregate of
1,972,374 shares of our common stock at an exercise price
of $3.50 per share and 1,972,374 shares of our common
stock at an exercise price of $4.00 per share. In addition,
on October 25, 2006, under the terms of the common stock
purchase agreement with Fusion Capital, we issued
473,957 shares of our common stock to Fusion Capital as a
commitment fee. We may sell up to 8,000,000 additional shares to
Fusion Capital pursuant to the common stock purchase agreement.
As of February 28, 2007, we had sold an aggregate of
566,978 shares to Fusion Capital under the common stock
purchase agreement, in addition to the 473,957 shares that
we issued to Fusion Capital as a commitment fee. The warrants
issued on March 11, 2005 have an anti-dilution clause that
in certain circumstances reduces the effective exercise price of
the warrants and proportionately increases the number of shares
underlying the warrants to preserve the ownership of the warrant
holders. As a result of the issuance of the 473,957 plus an
additional 30,242 shares to Fusion capital in 2006 the
exercise price of the warrants decreased to effectively provide
holders an additional 47,769 shares. Additionally, through
February 28, 2007 we issued an additional
536,736 shares to Fusion Capital, which decreased the
warrant price to effectively provide holders an additional
54,862 shares.
We entered into registration rights agreements in connection
with these financings pursuant to which we agreed to register
for resale by the investors the shares of common stock issued.
Sales of shares covered by these registration statements could
have a material adverse effect on the market price of our shares.
Our
common stock was delisted from the Nasdaq Stock Market and, as a
result, trading of our common stock has become more
difficult.
Our common stock was delisted from the Nasdaq National Market on
January 16, 2003 because of our failure to keep current in
filing our periodic reports with the SEC. Trading is now
conducted in the
over-the-counter
market on the Nasdaq OTC Bulletin Board Market.
Consequently, selling our common stock is more difficult because
smaller quantities of shares can be bought and sold,
transactions can be delayed and security analyst and news media
coverage of us may be reduced. These factors could result in
lower prices and larger spreads in the bid and ask prices for
shares of our common stock as well as lower trading volume. We
hope that our common stock will eventually be relisted with the
American Stock Exchange (AMEX), the Nasdaq Capital Market or the
Nasdaq Global Market, but we cannot assure you that our common
stock will be relisted within any particular time period, or at
all. As noted below, we may effectuate a reverse stock split in
order to qualify our stock for relisting.
21
In order
to qualify our stock for relisting, we may effectuate a reverse
stock split, which could adversely affect our
stockholders.
In order to qualify our stock for relisting, we may effectuate a
reverse stock split. AMEX requires a minimum bid price of $2.00,
the Nasdaq Capital Market requires a minimum bid price of $4.00
and the Nasdaq Global Market requires a minimum bid price of
$5.00. As of February 28, 2007, the closing price for our
common stock as reported on the Nasdaq OTC Bulletin Board
Market was $1.75 per share.
Any reverse stock split requires the prior approval of our
stockholders at a stockholders meeting, because our charter
prohibits stockholder action by written consent. Our
stockholders have authorized us to effectuate a reverse stock
split at any time until May 18, 2007. The authorization
allowed for the combination of any whole number of shares of
common stock between and including two and five into one share
of common stock, i.e., each of the following combination
ratios: one for two, one for three, one for four and one for
five. If our Board of Directors decides to proceed with the
reverse stock split, then the Board will determine the exact
ratio within the range described in the previous sentence. In
many instances historically the markets have reacted negatively
to the effectuation of a reverse stock split. The trading price
of our stock may be negatively affected if our Board decides to
proceed with a reverse stock split. If the Board of Directors
does not implement a reverse stock split prior to May 18,
2007, then stockholder approval again would be required prior to
implementing any reverse stock split. We expect to ask our
stockholders at our 2007 annual meeting to authorize a reverse
stock split for another two years.
We could
be difficult to acquire due to anti-takeover provisions in our
charter, our stockholders rights plan and Delaware
law.
Provisions of our certificate of incorporation and bylaws may
have the effect of making it more difficult for a third party to
acquire, or of discouraging a third party from attempting to
acquire control of our company. In addition, we have adopted a
stockholder rights plan in which preferred stock purchase rights
were distributed as a dividend. These provisions may make it
more difficult for stockholders to take corporate actions and
may have the effect of delaying or preventing a change in
control. These provisions also could deter or prevent
transactions that stockholders deem to be in their interests. In
addition, we are subject to the anti-takeover provisions of
Section 203 of the Delaware General Corporation Law.
Subject to specified exceptions, this section provides that a
corporation may not engage in any business combination with any
interested stockholder during the three-year period following
the time that such stockholder becomes an interested
stockholder. This provision could have the effect of delaying or
preventing a change of control of our company. The foregoing
factors could reduce the price that investors or an acquirer
might be willing to pay in the future for shares of our common
stock.
|
|
Item 1B.
|
Unresolved
Staff Comments
|
Not applicable.
Our executive offices, as well as our principal manufacturing
and research facilities, are located in a 28,000 square
foot facility in Irvine, California. The lease for this facility
expires in 2010, with an option to extend the lease for an
additional five years. We believe that our property and
equipment are generally well maintained, in good operating
condition and are sufficient to meet our current needs.
|
|
Item 3.
|
Legal
Proceedings
|
We are a party to lawsuits in the normal course of our business.
Litigation and governmental investigation can be expensive and
disruptive to normal business operations. Moreover, the results
of complex legal proceedings are difficult to predict.
Significant judgments or settlements in connection with the
legal proceedings described below may have a material adverse
effect on our business, financial condition, results of
operations and cash flows. Other than as described below, we are
not a party to any legal proceedings that we believe to be
material.
22
Governmental
Investigations
As reported in the
Form 8-K
that we filed on July 20, 2006, we executed a consent to
entry of judgment in favor of the Securities and Exchange
Commission (the SEC) on July 14, 2006 and
entered into a non-prosecution agreement with the Department of
Justice (the DOJ) on July 18, 2006. These two
agreements effectively resolve with respect to the Company the
investigations begun by the SEC and by the DOJ in January 2003.
The investigations and legal proceedings related to certain
former officers and former directors remain ongoing. We remain
contractually obligated to pay legal fees for and otherwise
indemnify these former officers and former directors. On
August 9, 2006, the SEC filed civil fraud charges in
federal district court against two former officers.
Given the recent announcements by numerous companies and the
SECs current focus on stock option plan administration,
our Audit Committee requested that management conduct an
internal review of our historical stock option practices, the
timing of stock option grants and related accounting and
documentation. Based on this review, management identified
several stock option grants made between 1997 and 2002 for which
the actual measurement dates appeared to differ from the
recorded grant dates. Management analyzed the potential
accounting impact, assuming that the measurement dates for these
option grants differ from the recorded grant dates, and
concluded that the financial impact did not necessitate
adjustment to or restatement of our previously-issued financial
reports. Management reported the results of its review to our
Audit Committee and Board of Directors at their regularly
scheduled meetings on July 26, 2006. Following these
meetings, we contacted the SEC and the DOJ and reported our
findings. On August 1, 2006, we met with the SEC staff to
discuss our findings and later received a subpoena from the SEC
requesting additional option-related information. We have
responded to this subpoena and will continue to fully cooperate
with the SEC and DOJ and with their ongoing investigations
related to certain of our former officers and former directors.
After receiving the subpoena from the SEC, management identified
certain stock option grants made in 2003 for which the actual
measurement dates may differ from the recorded grant dates.
However, similar to the grants between 1997 and 2002 previously
identified, management concluded that the financial impact,
individually and in the aggregate, of the 2003 grants did not
necessitate adjustment to or restatement of our
previously-issued financial reports.
Lawsuit
with KPMG LLP
On October 26, 2006, we filed a lawsuit with the Superior
Court of the State of California for the County of Orange
against our former independent auditor, KPMG LLP, for
professional negligence and breach of contract, seeking damages
in an amount to be determined at trial. Previously, we had
entered into a Mediation and Tolling Agreement with KPMG
pursuant to which KPMG agreed that the statute of limitations
would be tolled to provide an opportunity for mediation between
the parties. We engaged in mediation with KPMG on
September 27, 2006 but the parties were unable to reach
settlement. Accordingly, we proceeded with the filing of the
lawsuit. In response to our claims against KPMG, KPMG filed a
cross-complaint against the Company and certain former officers.
Under the cross-complaint, KPMG makes claims against the Company
for breach of contract, violations of the federal racketeering
statute and conspiracy to violate the federal racketeering
statute, seeking damages in an amount to be determined at trial.
We are not able to predict the outcome of this lawsuit.
|
|
Item 4.
|
Submission
of Matters to a Vote of Security Holders
|
Not applicable.
23
PART II
|
|
Item 5.
|
Market
for Registrants Common Equity, Related Stockholder Matters
and Issuer Purchases of Equity Securities
|
Market
Information
On January 16, 2003, our common stock was delisted from the
Nasdaq National Market and began to trade on the Pink Sheets. On
October 21, 2005, our stock began to trade on the Nasdaq
OTC Bulletin Board Market or OTCBB. The symbol
under which we trade on the OTCBB is ENDO.
The following table sets forth for the fiscal quarters
indicated, the high and low sales prices for our common stock as
reflected on the Pink Sheets or OTCBB, as applicable. Such
prices represent inter-dealer prices without retail mark up,
mark down or commission and may not necessarily represent actual
transactions.
|
|
|
|
|
|
|
|
|
|
|
High
|
|
|
Low
|
|
|
Year Ended December 31,
2006:
|
|
$
|
3.50
|
|
|
$
|
2.68
|
|
First Quarter
|
|
|
3.55
|
|
|
|
2.35
|
|
Second Quarter
|
|
|
2.80
|
|
|
|
1.50
|
|
Third Quarter
|
|
|
2.05
|
|
|
|
1.57
|
|
Fourth Quarter
|
|
|
|
|
|
|
|
|
Year Ended December 31,
2005:
|
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
3.70
|
|
|
$
|
2.25
|
|
Second Quarter
|
|
|
4.40
|
|
|
|
2.98
|
|
Third Quarter
|
|
|
5.15
|
|
|
|
2.89
|
|
Fourth Quarter
|
|
|
3.29
|
|
|
|
2.35
|
|
Holders
As of February 28, 2007, there were 239 holders of record
of our common stock. This number was derived from our
stockholder records and does not include beneficial owners of
our common stock whose shares are held in the names of various
dealers, clearing agencies, banks, brokers, and other
fiduciaries.
Dividends
We have never paid any cash dividends on our capital stock. We
anticipate that we will retain any future earnings to support
operations and to finance the growth and development of our
business. Therefore, we do not expect to pay cash dividends in
the foreseeable future. Any determination to pay dividends in
the future will be at the discretion of our Board of Directors
and will depend on existing conditions, including our financial
condition, contractual restrictions, capital requirements and
business prospects.
Recent
Sales of Unregistered Securities
None, except as previously reported in a Quarterly Report on
Form 10-Q
or Current Report on
Form 8-K.
Issuer
Purchases of Equity Securities
Not applicable.
|
|
Item 6.
|
Selected
Consolidated Financial Data
|
The selected financial data set forth below should be read in
conjunction with Part II, Item 7
Managements Discussion and Analysis of Financial
Condition and Results of Operations and our consolidated
financial statements and related notes included elsewhere in
this Annual Report on
Form 10-K.
The selected financial data as of and for the years ended
December 31, 2002, 2003 and 2004 were previously restated.
Detailed information regarding these restatements is disclosed
in Notes 3 and 16 to our consolidated financial statements
24
filed in our annual report on
Form 10-K
for the year ended December 31, 2002 and Note 2 to our
consolidated financial statements filed in our annual report on
Form 10-K
(as amended) for the year ended December 31, 2004. As
discussed below is Part II, Item 7
Managements Discussion and Analysis of Financial
Condition and Results of Operations effective
January 1, 2006 we adopted Statement of Financial
Accounting Standards No. 123 (revised 2004), Share Based
Payment, which changed the way we account for our
stock-based
compensation. Our historical results are not necessarily
indicative of operating results to be expected in the future.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2002
|
|
|
2003
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
Revenues from continuing operations
|
|
$
|
17,901
|
|
|
$
|
19,604
|
|
|
$
|
24,181
|
|
|
$
|
28,274
|
|
|
$
|
27,990
|
|
Loss from continuing operations
|
|
$
|
(26,492
|
)
|
|
$
|
(24,963
|
)
|
|
$
|
(31,901
|
)
|
|
$
|
(14,838
|
)
|
|
$
|
(11,076
|
)
|
Net loss per share of common
stock basic and diluted (continuing operations)
|
|
$
|
(1.11
|
)
|
|
$
|
(1.03
|
)
|
|
$
|
(1.31
|
)
|
|
$
|
(0.51
|
)
|
|
$
|
(0.37
|
)
|
Weighted-average shares of common
stock outstanding
|
|
|
23,822
|
|
|
|
24,162
|
|
|
|
24,263
|
|
|
|
28,978
|
|
|
|
30,253
|
|
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
92,628
|
|
|
$
|
71,997
|
|
|
$
|
34,374
|
|
|
$
|
32,237
|
|
|
$
|
16,246
|
|
Common stock warrants
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
5,023
|
|
|
$
|
1,307
|
|
|
|
Item 7.
|
Managements
Discussion and Analysis of Financial Condition and Results of
Operations
|
The following discussion should be read in conjunction with
Item 1 Business,
Item 1A Risk Factors,
Item 6 Selected Consolidated Financial
Data and Item 8 Financial
Statements and Supplementary Data, as well as our
consolidated financial statements and related notes contained
elsewhere in this Annual Report on
Form 10-K.
This discussion contains forward-looking statements based on our
current expectations. There are various factors many
beyond our control that could cause our actual
results or the occurrence or timing of expected events to differ
materially from those anticipated in these forward-looking
statements. Some of these factors are described below and other
factors are described elsewhere in this Annual Report on
Form 10-K,
including above under Risks Factors in Item 1A
of this Annual Report on
Form 10-K.
In addition, there are factors not described in this Annual
Report on
Form 10-K
that could cause our actual results or the occurrence or timing
of expected events to differ materially from those anticipated
in these forward-looking statements. All forward-looking
statements included in this Annual Report on
Form 10-K
are based on information available to us as of the date hereof,
and we assume no obligation to update any such forward-looking
statements.
Overview
We are an innovative medical device company focused on the
development of minimally invasive technologies for tissue and
tumor ablation through cryoablation, which is the use of ice to
destroy tissue, such as tumors, for therapeutic purposes. We
develop and manufacture devices for the treatment of prostate
and renal cancer and we believe that our proprietary
technologies have broad applications across a number of markets,
including the ablation of tumors in the lung and liver and
palliative intervention (treatment of pain associated with
metastases).
Today, our FDA-cleared Cryocare Surgical System occupies a
growing position in the urological market for treatment of
prostate and renal cancers. Because of our initial concentration
on prostate and renal cancers, the majority of our sales and
marketing resources are directed toward the promotion of our
technology to urologists. In addition to selling our
cryosurgical disposable products to hospitals and mobile service
companies, we contract directly with hospitals for the use of
our Cryocare Surgical System and disposable products on a
fee-for-service
basis. Since 2003, we maintain a dedicated sales team focused on
selling percutaneous cryoablation procedures related to liver
and lung cancer and palliative intervention (treatment of pain
associated with metastases) to interventional radiology
physicians throughout the United States. We intend to continue
to identify and develop new markets for our cryosurgical
products and technologies, particularly in the area of tumor
ablation.
We previously owned Timm Medical Technologies, Inc. (Timm
Medical), a company focused on erectile dysfunction
products. We sold Timm Medical to UK-based Plethora Solutions
Holdings plc on February 10, 2006.
25
Strategy
and Key Metrics
Our strategy is to achieve a dominant position in the prostate
and renal cancer markets, and further develop and increase the
acceptance of our technology in the interventional radiology and
oncology markets for treatment of liver and lung cancers and
palliative intervention (treatment of pain associated with
metastases). At the same time, we seek to achieve penetration
across additional markets with our proprietary cryosurgical
technology.
Our primary objective is to grow market share, currently
measured in terms of the number of procedures performed with our
Cryocare Surgical System, which we calculate using two primary
components. The first component is that we include the actual
number of cryoablation cases for which we are responsible for
performing the service element on behalf of the healthcare
facility. In the second, we compute a procedure case equivalent
based on sales of our cryoablation disposable products by using
the expected disposable product usage for a procedure for those
sales. Procedure growth has been an important metric to which we
have referred during the past several years in order to measure
the success of our strategy. In the past several years, we have
been successful in increasing the estimated number of domestic
cryoablation procedures on a
year-over-year
basis. Most recently, in 2006 estimated procedures increased
21.8 percent to 7,802 from 6,407 in 2005 which increased
35.9 percent from 4,713 in 2004.
In addition to being a key business metric, procedure growth is
an important driver of revenue growth, because a significant
percentage of our revenue consists of sales of the disposable
supplies used in procedures performed with the Cryocare Surgical
System, as shown below under Results of Operations.
In 2003 we redirected our strategy for our cryosurgical business
away from emphasizing sales of Cryocare Surgical Systems and
instead towards seeking to increase recurring sales of our
disposable products. Over the past several years, a significant
percentage of our revenue consists of sales of the disposable
supplies either separately or in conjunction with procedures
performed with the Cryocare Surgical System, as shown below
under Results of Operations. In addition, beginning
in 2004, we changed our business model to emphasize our strength
as a medical device manufacturer and strategically reduced the
amount of revenues attributable to the service model where we
are responsible for performing the service element of the
procedures on behalf of the healthcare facility for a procedure
fee. By the fourth quarter of 2006, we have achieved our goal of
having the substantial majority of our procedures comprised of
sale of cryoablation disposable products without the service
element. The percent of procedures for which we perform the
service element declined from 79.4% in the fourth quarter of
2004 to 19.5% in the fourth quarter of 2006. This change in
revenue mix between cases for which we provide the service
element and cases for which we merely sell disposable products
has impacted our gross margin. Revenues from a case for which we
merely sell disposable products are less than the revenue from a
case for which we are responsible for providing the service
element. As the percentage of cases from product sales increases
relative to procedure fees, our incremental revenues grow at a
slower rate than our overall procedures growth. However, the
gross profit realized is generally equivalent since we do not
incur fees to third party service providers for product sales.
For cases for which we are responsible for providing the service
element, we typically subcontract with a third party service
provider to provide the service element of a procedure on our
behalf and thereby incur services fees. As a result, our gross
margin (gross profit as a percent of revenues) increases as we
shift from procedure fees to sales of disposable products.
The factors driving interest in and utilization of cryoablation
by urologists include increased awareness and acceptance of
cryoablation by industry thought leaders, continued publication
of clinical follow up data on the effectiveness of cryoablation,
including
10-year data
published in 2005, increased awareness among patients of
cryoablation and its preferred outcomes as compared to other
modalities, the efforts of our dedicated cryoablation sales
force and our continued expenditure of funds on patient
education and advocacy.
26
Results
of Operations
Revenues and cost of revenues from continuing operations related
to the following products and services for the three-year period
ended December 31, 2006 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
|
(In thousands)
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cryoablation disposable products
|
|
$
|
4,584
|
|
|
$
|
6,790
|
|
|
$
|
13,948
|
|
Cryocare Surgical Systems
|
|
|
1,403
|
|
|
|
743
|
|
|
|
1,096
|
|
Other (Urohealth)
|
|
|
49
|
|
|
|
72
|
|
|
|
44
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,036
|
|
|
|
7,605
|
|
|
|
15,088
|
|
Cryoablation procedure fees
|
|
|
17,516
|
|
|
|
19,780
|
|
|
|
12,298
|
|
Cardiac royalties (CryoCath)
|
|
|
629
|
|
|
|
889
|
|
|
|
604
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
24,181
|
|
|
$
|
28,274
|
|
|
|
27,990
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cryoablation disposable products
and procedure fees
|
|
$
|
13,330
|
|
|
$
|
15,278
|
|
|
|
11,541
|
|
Cryocare Surgical Systems
|
|
|
255
|
|
|
|
460
|
|
|
|
802
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
13,585
|
|
|
$
|
15,738
|
|
|
$
|
12,343
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs of revenues for cryoablation disposable products and
procedure fees are combined for reporting purposes. Sales of
cryoablation disposable products and procedure fees incorporate
similar inventory when sold and we do not separately track the
cost of disposable products sold directly to customers and those
consumed in cryoablation procedures. Procedure fees relate to
services which are provided to medical facilities upon request
to facilitate the overall delivery of our technology into the
marketplace.
We recognize revenues from sales of Cryocare Surgical Systems
and disposable cryoprobes when persuasive evidence of an
arrangement exists, delivery has occurred, the fee is fixed and
determinable, and collectibility is reasonably assured. Revenues
are deferred when we have continuing obligations until those
obligations are fulfilled. We also contract with medical
facilities for the use of the Cryocare Surgical Systems in
cryoablation treatments for which we charge a per-procedure fee.
Cryoablation services generally consist of rental and transport
of a Cryocare Surgical System as well as the services of a
technician to assist the physician with the setup and monitoring
of the equipment.
Costs of revenues consist of fixed and variable costs incurred
in the manufacture of our products in addition to depreciation
of Cryocare Surgical Systems placed in the field with customers
under our placement program or with our sales and service
personnel. We incur an additional cost of revenues in the form
of a fee for equipment usage and other services when a procedure
is performed on a system owned by an unrelated service provider.
The fee paid to the third-party service provider is charged to
costs of revenues when the procedure is performed and billed.
Research and development expenses include expenses associated
with the design and development of new products as well as
enhancements to existing products. We expense research and
development costs when incurred. Our research and development
efforts are occasionally subject to significant non-recurring
expenses and fees that can cause some variability in our
quarterly research and development expenses.
Selling and marketing expenses primarily consist of salaries,
commissions and related benefits and overhead costs for
employees and activities in the areas of selling, marketing and
customer service. Expenses associated with advertising, trade
shows, promotional and training costs related to marketing our
products are also classified as selling and marketing expenses.
General and administrative expenses primarily consist of
salaries and related benefits and overhead costs for employees
and activities in the areas of legal affairs, finance,
information technology, human resources and
27
administration. Fees for attorneys, independent auditors and
certain other outside consultants are also included where their
services are related to general and administrative activities.
This category also includes reserves for bad debt, and
litigation losses less amounts recoverable under our insurance
policies. Litigation reserves and insurance recoveries are
recorded when such amounts are probable and can be reasonably
estimated.
Effective January 1, 2006, we adopted Statement of
Financial Accounting Standards No. 123 (revised 2004),
Share Based Payment (SFAS No. 123R) using the
modified-prospective transition method. Under that transition
method, compensation cost recognized in the year ended
December 31, 2006 includes (a) compensation cost for
all share-based payments granted prior to, but not yet vested as
of January 1, 2006 based on the grant-date fair value
estimated in accordance with the original provisions of
SFAS 123 Accounting for Stock-Based
Compensation and (b) compensation cost for all
share-based payments granted subsequent to January 1, 2006,
based on the
grant-date
fair value estimate in accordance with the provisions of
SFAS 123R. Results for prior periods have not been
restated. As a result of adopting SFAS No. 123R, our
net loss for the three month period and year ended
December 31, 2006 was $0.8 million and
$2.6 million, respectively, greater than if we had
continued to account for stock-based compensation under
Accounting Principles Board Opinion No. 25, Accounting
for Stock Issued to Employees, and its related
interpretations. As of December 31, 2006, there was
$3.4 million of total unrecognized compensation costs
related to unvested stock-based compensation arrangements
granted under the stock option plans. That cost is expected to
be amortized on a straight-line basis over a weighted average
period of 1.2 years less any stock options forfeited prior
to vesting.
Costs, expenses and other results of operations from continuing
operations for the three-year period ended December 31,
2006 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
|
(In thousands)
|
|
|
Cost of revenues
|
|
$
|
13,585
|
|
|
$
|
15,738
|
|
|
$
|
12,343
|
|
Research and development
|
|
|
1,856
|
|
|
|
2,283
|
|
|
|
2,781
|
|
Selling and marketing
|
|
|
13,354
|
|
|
|
13,001
|
|
|
|
15,195
|
|
General and administrative
|
|
|
16,379
|
|
|
|
13,858
|
|
|
|
13,107
|
|
Goodwill impairment and other
charges
|
|
|
9,900
|
|
|
|
26
|
|
|
|
|
|
Loss on divestitures, net
|
|
|
711
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
$
|
55,785
|
|
|
$
|
44,906
|
|
|
$
|
43,426
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
$
|
293
|
|
|
$
|
308
|
|
|
$
|
452
|
|
Interest expense
|
|
$
|
(7
|
)
|
|
$
|
657
|
|
|
$
|
3,716
|
|
Minority interests
|
|
$
|
(583
|
)
|
|
$
|
|
|
|
$
|
|
|
Year
Ended December 31, 2006 Compared to Year Ended
December 31, 2005
Revenues. Revenues for the year ended
December 31, 2006 decreased to $28.0 million compared
to $28.3 million in 2005. The revenue decrease resulted
from a rapid shift in mix from procedures for which we are
responsible for providing the service element to those for which
we solely sell our cryoablation disposable products. Total
procedures increased 21.8 percent to 7,802 for the year
ended December 31, 2006 from 6,407 in the comparable period
of 2005, while the related revenues decreased by
1.2 percent. Of the total procedures performed during the
year ended December 31, 2006, 31.7 percent were those
for which we provided cryoablation services and
68.3 percent were from the sale of cryoablation disposable
products. This compares to 62.7 percent for cryoablation
services and 37.3 percent for sales of cryoablation
disposable products during the year ended December 31,
2005. While our total procedures increased significantly, the
lower average sales price from selling direct disposable
products as compared to our average service price from providing
the service element had the effect of slightly decreasing our
revenues year over year. However, direct product sales also have
lower cost of revenues and produce much higher gross margins as
discussed above. The shift in our revenue mix was faster than
expected but in line with our overall strategy to shift our
business to become a more traditional medical device
manufacturer.
Cardiac royalty revenue decreased to $0.6 million for the
year ended December 31, 2006 from $0.9 million for the
same period in 2005 mainly because the contractual rate CryoCath
is obligated to pay us as percentage of related
28
revenues decreased from 9.0 percent to 5.0 percent in
2006. Revenue from the sale of Cryocare Surgical Systems
increased for the year ended December 31, 2006 from the
comparable period in 2005 to $1.1 million from
$0.7 million primarily due to increased sales of our
systems internationally.
Costs of Revenues. Costs of revenues for the
year ended December 31, 2006 decreased 21.6 percent to
$12.3 million compared to $15.7 million for the same
period in 2005. The decrease was driven mainly by the rapid
shift in revenue mix resulting in a decrease in the number of
cryoablation procedures for which we bear responsibility for
providing the service element of the procedure as opposed to
solely selling our cryoablation disposable products. This mix
shift led to a decrease in fees we paid to third party service
providers. Costs for materials, labor and overhead per
cryoablation case also decreased as we achieve manufacturing
efficiencies and improve product design. Fees to service
providers were $8.0 million in 2005 and $4.7 million
in 2006. This decrease was offset slightly by a
$0.3 million increase in cost related to Cryocare Surgical
Systems.
Gross Margins. Gross margins on revenues
increased to 55.9 percent for the year ended
December 31, 2006 compared to 44.3 percent for the
same period in 2005. The positive trend in our gross margins
relates primarily to the shift in our business model to a much
larger percentage of total procedures are from the sale of our
cryoablation disposable products as opposed to procedures where
we are responsible for providing the service element of the
procedure, which generates a lower gross margin as a percent of
revenues. Also contributing to the increase in gross margin were
continued reductions in manufacturing costs for our cryoablation
disposable products. Gross margins were negatively affected
during the year ended December 31, 2006 by transactions
where we allowed certain customers to upgrade to our Cryocare CS
System from a previous generation of our Cryocare Surgical
System with nominal additional payment, resulting in a net loss
of $0.5 million.
Research and Development Expenses. Research
and development expenses for the year ended December 31,
2006 increased 21.8 percent to $2.8 million compared to
$2.3 million for the comparable period in 2005. The
increase was primarily attributable to increased compensation
costs of $0.1 million and costs associated with several new
development projects we have undertaken to reduce the
manufacturing costs of Cryocare disposables and broaden the
application of cryoablation outside of our current markets in
urology and interventional radiology. Included in research and
development expenses for the year ended December 31, 2006
is $0.1 million in non-cash stock-based compensation
expense. As a percentage of revenues, research and development
expenses increased to 9.9 percent during the year ended
December 31, 2006, from 8.1 percent during the year
ended December 31, 2005.
Selling and Marketing Expenses. Selling and
marketing expenses for the year ended December 31, 2006
increased 16.9 percent or $2.2 million to
$15.2 million as compared to $13.0 million for the
same period in 2005. Driving the increases were proctor fees and
related cost increases of $0.4 million, increased travel
costs of $0.2 million, non-cash stock-based compensation
expenses relating to the implementation of
SFAS No. 123R in the amount of $0.6 million and
increased compensation related expenses in our sales
organization of $0.8 million.
General and Administrative Expenses. General
and administrative expenses for the year ended December 31,
2006 declined 5.4 percent or $0.8 million to
$13.1 million as compared to $13.9 million for the
same period in 2005. We had decreases in several areas including
legal and accounting costs of $1.7 million as a result of
establishing in house legal counsel and marked efforts to reduce
accounting and consulting fees, specifically those related to
compliance with section 404 of the Sarbanes-Oxley Act of
2002 (Sarbanes-Oxley). We had $0.5 million in
reductions in insurance premiums due to concerted efforts to
reduce premiums without compromising coverage. During the second
quarter of 2006 the statute of limitations expired on
$0.9 million of potential payroll tax liability pertaining
to employee loans forgiven and stock option exercises that
occurred in 2002 and prior, compared to $0.2 million of
similar reductions in 2005. In 2005 we paid $0.6 million in
liquidated damages related to our common stock warrants, which
did not recur in 2006.
These reductions were partially offset by $2.2 million in
additional compensation expense including $1.8 million of
non-cash stock-based compensation expenses relating to the
implementation of SFAS No. 123R. Additionally in the
fourth quarter of 2006, we reserved a total of $0.7 million
on notes receivable. Of this amount $0.4 million relates to
the write off of a note with a related party. The
$0.3 million remaining amount is related to a possible
arrangement with the purchaser of Timm Medical which we may
offer a payment discount in exchange for acceleration of payment
of the remaining balance of the purchase note.
29
Interest Income. Interest income for the year
ended December 31, 2006 increased to $0.5 million from
$0.3 million in 2005. This increase is due to interest
income on a note receivable for the 2003 sale of our urinary
incontinence product line and interest income earned from the
investment of our cash balances.
Interest Expense. Interest expense for the
year ended December 31, 2006 was a negative expense of
$(3.7) million compared to $(0.7) million in negative
expense for the same period in 2005. The negative interest
expense for the years ended December 31, 2006 and 2005 were
due to the decreases in the fair value of common stock warrants
issued in connection with our private placement in March 2005.
Loss from Continuing Operations. Loss from
continuing operations for the year ended December 31, 2006
was $11.1 million or $0.37 per basic and diluted share
on 30.3 million weighted average shares outstanding
compared to a loss from continuing operations of
$14.8 million or $0.51 per basic and diluted share on
29.0 million weighted average shares outstanding for the
same period in 2005. Included in the loss from continuing
operations during the year ended December 31, 2006 is an
aggregate of $2.8 million of non-cash stock-based
compensation expense in accordance with SFAS No. 123R,
a reduction in accrued payroll taxes of $0.9 million which
were no longer statutorily due and the reduction in interest
expense of $3.7 million from the change in the fair value
of common stock warrants.
Income from Discontinued Operations. Income
from discontinued operations for the year ended
December 31, 2006 represents the operating results of Timm
Medical through the date of sale on February 10, 2006.
Income for the 2006 period was $0.3 million, net of income
taxes or $0.01 per basic and diluted share on
30.3 million weighted average shares outstanding. The 2006
income included $0.5 million gain on sale of Timm Medical
and a tax provision of $0.2 million. Income from
discontinued operations for the year ended December 31,
2005 was $1.2 million, net of income taxes of
$0.8 million or $0.04 per basic and diluted share on
29.0 million weighted average shares outstanding. The 2005
period includes income of $0.6 million as a result of the
elimination of the estimated costs to sell, which was previously
reported as a component of a 2004 impairment charge when Timm
Medical was initially marketed for sale.
Net Loss. Net loss for the year ended
December 31, 2006 was $10.8 million or $0.36 per
basic and diluted share on 30.3 million weighted average
shares outstanding, compared to a net loss of
$13.7 million, or $0.47 per basic and diluted share on
29.0 million weighted average shares outstanding for the
same period in 2005.
Year
Ended December 31, 2005 Compared to Year Ended
December 31, 2004
Revenues. Revenues for the year ended
December 31, 2005 increased $4.1 million to
$28.3 million from $24.1 million in 2004 representing
an increase of 16.9 percent. The increase in revenues was
primarily attributable to growth in sales of disposables and
procedure fees.
The number of cryosurgical procedures performed, and related
sales of disposable products used in these procedures, increased
35.9 percent to 6,407 in 2005 from 4,713 in 2004, while the
related revenues increased 20.2 percent to
$26.6 million in 2005 from $22.1 million in 2004.
Contributing to growth in sales of cryosurgical products was an
increase in direct sales both in urology and interventional
radiology. Since the revenue for a sale of cryoablation
disposable products is less on average than a cryoablation
procedure fee, as the percentage of cases derived from sales of
cryosurgical disposable products increases relative to cases
derived from cryoablation procedure fees (where we are
responsible for providing the service element of the procedure),
our incremental revenues grow at a slower rate than our overall
procedure growth. However, the gross profit realized is
equivalent since we do not incur fees to third party service
providers for a sale of cryoablation disposable products.
CryoCath royalty revenues also increased 41.3 percent or
$0.3 million compared to 2004 while revenues from Cryocare
Surgical Systems decreased by 47.0 percent or
$0.7 million due to our strategy of promoting adoption of
our technology through emphasis on growth in cryoablation
procedures, rather than through sales of capital equipment.
Cost of Revenues. Cost of revenues for 2005
increased 15.9 percent to $15.7 million compared to
$13.6 million for 2004. Cost of revenues related to our
cryosurgical probes and procedures increased 14.7 percent
to $15.3 million for 2005 from $13.3 million in 2004.
The increase in cost of revenues resulted primarily from growth
in sales of cryosurgical probes and procedures. In addition,
this increase was driven by an increase in the
30
number of cryoablation procedures for which we bill a procedure
fee and subcontract the service to third party service providers
at an additional cost. While the frequency of fees paid to third
party service providers increased, the percentage of total
cryoablation procedures requiring these services declined and
the average service fee per procedure was reduced by
15.3 percent. Cost of revenues increases were also
partially offset by the continued reductions in manufacturing
costs for our cryoablation disposable products.
Gross Margins. Gross margins on revenues
increased to 44.2 percent for 2005 compared to
43.7 percent for 2004 as a result of the cost of revenues
factors outlined above.
Research and Development Expenses. Research
and development expenses for 2005 increased 23.0 percent to
$2.3 million compared to $1.9 million for 2004. The
increase was primarily attributable to increased costs
associated with several new development projects that we have
undertaken in our efforts to reduce the manufacturing costs of
the disposable components used in cryoablation surgical
procedures as well as efforts to broaden the application of
cryoablation outside of our current markets in urology and
interventional radiology. As a percentage of revenues, research
and development expenses increased to 8.1 percent in 2005
from 7.7 percent for 2004.
Selling and Marketing Expenses. Selling and
marketing expenses for 2005 decreased 2.6 percent to
$13.0 million compared to $13.4 million for 2004. The
decrease in sales and marketing expenses were primarily due to
improved management of our proctoring program which reduced
expenses by $0.3 million by being more selective in the
physicians we allow to be proctored as well as reducing the cost
of each individual proctoring event. The decrease in selling and
marketing expenses was also due to reduced severance expense in
the amount of $0.2 million, offset by an increase in
commissions expense of $0.2 million.
General and Administrative Expenses. General
and administrative expenses for 2005 decreased 15.4 percent
to $13.9 million compared to $16.4 million for 2004.
Legal and accounting costs incurred during 2005 in connection
with our historical accounting and financial reporting declined
to $3.6 million from $7.1 million. Included in the
$3.6 million were $1.3 million of costs related to our
efforts to comply with Section 404 of Sarbanes-Oxley. Included
in the $7.1 million from 2004 were $2.3 million of
costs related to our Sarbanes-Oxley compliance efforts. The
reductions in legal and accounting expenses were partially
offset by $0.6 million of liquidated damages related to the
delay in the SEC declaring effective our
Form S-2
registration statement related to our March 2005 private
placement.
Goodwill Impairment and Other Charges. During
the year ended 2005, we recorded $26,000 to write down a
partnership interest in the mobile prostate treatment business
to fair value. During 2004, we had recorded $9.9 million in
impairment charges to write down the goodwill and amortizable
intangibles in conjunction with our ownership interests in
certain mobile prostate treatment businesses. We also recorded a
charge of $5.9 million to write down the goodwill and
intangible assets of Timm Medical in 2004, which is included in
loss from discontinued operations.
Interest Income. Interest income for 2005 was
unchanged at $0.3 million compared to 2004, and represents
interest income on interest-bearing cash accounts as well as
interest received on the promissory note from SRS Medical Corp.
in connection with the sale of the urodynamics and urinary
incontinence products lines by Timm Medical in 2003.
Interest Expense. Interest expense was
negative for 2005 in the amount of ($0.7) million and
relates to the net decrease in the fair market value of common
stock warrants issued in connection with our March 2005 private
placement.
Loss from Continuing Operations. Loss from
continuing operations for 2005 was $14.8 million or
$0.51 per basic and diluted share on 29.0 million
weighted average shares outstanding, compared to a loss of
$31.9 million, or $1.31 per basic and diluted share on
24.3 million weighted average shares outstanding for 2004.
Income (Loss) from Discontinued Operations. On
February 10, 2006, we closed the sale of our wholly-owned
subsidiary, Timm Medical, to UK-based Plethora Solutions
Holdings plc. Proceeds from the sale were $9.5 million,
consisting of $8.1 million in cash and a
24-month
convertible promissory note of $1.4 million. Revenues for
Timm Medical for the year ended December 31, 2005 were
$9.3 million. Income before taxes was $2.0 million and
net income was $1.2 million for 2005. In 2004, Timm Medical
reported a loss of $5.7 million, after the
$5.9 million impairment charge.
31
Off
Balance Sheet Financing
Other than lease commitments, legal contingencies incurred in
the normal course of business, and employment contracts, we do
not have any off-balance sheet financing arrangements or
liabilities. In addition, our policy is not to enter into
derivative instruments, futures or forward contracts. Our
business is transacted solely in U.S. dollars and, while future
fluctuations of the U.S. dollar may affect the price
competitiveness of our products, there is no known significant
direct foreign currency exchange rate risk. Finally, we do not
have any majority-owned subsidiaries or any interests in, or
relationships with, any material special-purpose entities that
are not included in the consolidated financial statements.
Liquidity
and Capital Resources
Since inception, we have incurred losses from operations and
have reported negative cash flows. As of December 31, 2006,
we had an accumulated deficit of $176.4 million and cash
and cash equivalents of $1.8 million.
We do not expect to reach cash flow positive operations in 2007,
and we expect to continue to generate losses from operations for
the foreseeable future. These losses have resulted in part from
our continued investment to gain acceptance of our technology
and investments in initiatives that we believe should ultimately
result in cost reductions. In addition to these continued
investments, although we recently resolved the investigations by
the SEC and DOJ of our historical accounting and financial
reporting (see above under Part I, Item 3, Legal
Proceedings), we still have obligations to indemnify and
advance the legal fees for our former officers and former
directors in connection with the ongoing investigations and
legal proceedings related to those individuals. The amount of
those legal fees may exceed the reimbursement due to us from our
directors and officers liability insurance, and the
excess may have a material adverse effect on our business,
financial condition, results of operations and liquidity. We
also face large cash expenditures in the future related to past
due state and local taxes primarily, sales and use tax
obligations, which we estimate to be approximately
$2.8 million and which was accrued as of December 31,
2006. We are in the process of negotiating resolutions of the
past due state and local tax obligations with the applicable tax
authorities.
On October 25, 2006, we entered into an agreement with
Fusion Capital Fund II, LLC (Fusion Capital)
pursuant to which we have the right to sell to Fusion Capital up
to $16.0 million of common stock over a two year period at
prices determined based upon the market price of our common
stock at the time of each sale without any fixed discount (in
$100,000 increments every fourth business day, with additional
$150,000 increments available every third business day if the
market price of our common stock is $1.50 or higher), subject to
our ability to comply with certain on-going requirements. These
requirements include, among others, maintaining effectiveness of
the registration statement covering the sale of the shares
purchased by Fusion Capital, and maintenance of trading prices
at or above $1.00. The $150,000 increment can be increased if
the market price of our common stock increases. The SEC declared
the registration statement effective on December 1, 2006.
We will use existing cash reserves, as well as future proceeds
from sales, if any, of common stock to Fusion Capital, to
finance our projected operating and cash flow needs, along with
continued expense management efforts. In addition, we may borrow
funds under our line of credit with our bank as long as we
remain in compliance with the representations, warranties,
covenants and borrowing conditions set forth in the agreements
governing the line of credit. The funds we can borrow are based
on eligible trade receivables and inventory as defined. The
credit facility includes a subjective acceleration clause and a
requirement to maintain a lock box with the lender, the proceeds
from which will be applied to reduce the outstanding borrowings
upon our default or if other conditions are met. We were not in
compliance with the minimum tangible net worth covenant under
our bank line of credit for the months September to November
2006. On December 22, 2006, we signed an amendment to the
Loan and Security Agreement. Among other things, the amendment
(i) modifies the borrowing base to increase the eligible
accounts receivable from 80 percent to 85 percent and
modifies the definition of accounts that are ineligible under
the borrowing base calculation; (ii) modifies the loan
margin as defined to 1.50 percent, and (iii) waives
non-compliance with the minimum tangible net worth requirement
at September 30, 2006, October 31, 2006 and
November 30, 2006, as well as modifies the terms of the
covenant. At December 31, 2006, we were in compliance with
all covenants and had no borrowings outstanding under the line
of credit. On February 23, 2007, the credit agreement was
amended to further modify the minimum tangible net worth
provision and to extend the maturity date to February 27,
2008. As of February 28, 2007 we had $1.9 million
outstanding on the line of credit.
32
Our cash needs are not entirely predictable and the availability
of funds from Fusion Capital and our bank are subject to many
conditions, including certain subjective acceleration clauses
and other provisions, some of which are predicated on events
that are not within our control. Accordingly, we cannot
guarantee the availability of these capital resources or that
they will be sufficient to fund our ongoing operations to the
point where our operations will generate positive cash flows. In
assessing whether to enter into the Fusion Capital financing and
renew the bank line of credit, we considered these factors in
light of our circumstances and likely cash requirements. After
comparing the Fusion Capital financing and bank line of credit
to other financing alternatives potentially available to us, we
made a business decision that the Fusion Capital financing and
bank line of credit represented the best financing alternatives
then available to us.
We continue to believe that the Fusion Capital financing and
bank line of credit should provide us with the capital resources
that we need to reach the point where our operations will
generate positive cash flows. However, primarily because of the
subjective acceleration clauses and other conditions referred to
above, the audit report of our independent auditors contained in
this Annual Report on
Form 10-K
contains an unqualified opinion with an explanatory paragraph,
to the effect that there is substantial doubt about our ability
to continue as a going concern. This opinion could itself have a
material adverse effect on our business, financial condition,
results of operations and cash flows.
Contractual
Obligations
In the table below, we set forth our contractual obligations as
of December 31, 2006. Some of the figures we include in
this table are based on managements estimates and
assumptions about these obligations, including their duration,
the possibility of renewal, anticipated actions by third
parties, and other factors. Because these estimates and
assumptions are necessarily subjective, the contractual
obligations we will actually pay in future periods may vary from
those reflected in the table.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period [Update]
|
|
|
|
Total
|
|
|
2007
|
|
|
2008-2009
|
|
|
2010-2011
|
|
|
|
(In thousands)
|
|
|
Non-cancelable operating leases(1)
|
|
$
|
1,785
|
|
|
$
|
587
|
|
|
$
|
1,075
|
|
|
$
|
123
|
|
Purchase commitments(2)
|
|
|
620
|
|
|
|
620
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
2,405
|
|
|
$
|
1,207
|
|
|
$
|
1,075
|
|
|
$
|
123
|
|
|
|
|
(1) |
|
We enter into operating leases in the normal course of business.
We lease office space as well as other property and equipment
under operating leases. Some lease agreements provide us with
the option to renew the lease at the end of the original term.
Our future operating lease obligations would change if we
exercise these renewal options and if we enter into additional
operating lease agreements. For more information, see
Note 13 Commitments and Contingencies to
our Consolidated Financial Statements. |
|
(2) |
|
These purchase commitments relate to agreements to purchase
goods or services. These obligations are not recorded in our
consolidated financial statements until contract payment terms
take effect. We expect to fund these commitments with cash flows
from operations and from cash balances on hand. The obligations
shown in the above table are subject to change based on, among
other things, our manufacturing operations not operating in the
normal course of business, the demand for our products, and the
ability of our suppliers to deliver the products or services as
promised. |
Additionally, under a commercialization agreement, we are
obligated to make monthly advances of $42,500 to our
collaboration partner beginning the fourth quarter of 2005. This
obligation continues until either we or our partner enter into a
licensing agreement sufficient to reimburse us for all prior
payments and fund the partner going forward.
We are also obligated to indemnify certain former officers and
directors and advance legal fees to them in connection with
continuing investigations and legal proceedings involving these
individuals by the SEC and DOJ. Legal fees under these
obligations cannot be estimated.
33
Critical
Accounting Policies
The foregoing discussion and analysis of our financial condition
and results of operations are based on our consolidated
financial statements, which have been prepared in accordance
with U.S. generally accepted accounting principles. The
preparation of the financial statements requires management to
make estimates and assumptions in applying certain critical
accounting policies. Certain accounting estimates are
particularly sensitive because of their significance to our
consolidated financial statements and because of the possibility
that future events affecting the estimates could differ
significantly from current expectations. Factors that could
possibly cause actual amounts to differ from current estimates
relate to various risks and uncertainties inherent in our
business, including those set forth under Risks
Factors in Item 1A of this Annual Report on
Form 10-K.
Management believes that the following are some of the more
critical judgment areas in the application of accounting
policies that affect our financial statements.
Revenue Recognition. We follow the provisions
of Staff Accounting Bulletin 104, Revenue Recognition
in Financial Statements (SAB 104) and
Emerging Issues Task Force (EITF) Issue
No. 00-21,
Revenue Arrangements with Multiple Deliverables for
revenue recognition. Under SAB 104, four conditions must be
met before revenue can be recognized: (i) there is
persuasive evidence that an arrangement exists,
(ii) delivery has occurred or service has been rendered,
(iii) the price is fixed or determinable and
(iv) collection is reasonably assured.
We reduce our revenues for customer concessions, and defer
revenue recognition for minimum procedure guarantees, contingent
payment arrangements and when we have continuing performance
obligations until a future date when the contingencies are
resolved and obligations met.
Where we own the equipment used in the procedure, we bill the
medical facility and retain the entire procedure fee. In many
instances, however, the equipment is owned by a third-party who
contracts with us to perform the service component of the
procedure. Third-party service providers are at times entities
owned or controlled by urologists who perform cryosurgical
procedures. In the latter case, we still invoice the medical
facility but we pay a fee to the third-party service provider.
The procedure fee is recorded as revenue in the period when the
procedure is performed and, where applicable, the fee paid to a
third-party service provider is included in cost of revenues for
the same period.
From time to time we provide loaner equipment to customers as
part of a strategy aimed at promoting broader acceptance of our
technology and driving sales of disposable products faster than
would be possible if we restricted use of the device only to
customers willing to make a significant capital investment in a
Cryocare Surgical System. In these situations, we either loan a
mobile Cryocare Surgical System to a hospital or consign a
stationary Cryocare Surgical System with the hospital under our
placement program and charge a fee for each procedure in which
the equipment is used. Cost of revenues includes depreciation on
the Cryocare Surgical Systems we own over an estimated useful
life of three years. We have also reduced the selling price of
our Cryocare Surgical System to at or near cost to promote sales
of our cryoablation disposable products.
Under certain circumstances, we will upgrade our older model
Cryocare Surgical Systems for our new model with select
customers. The terms of the upgrade can include the trade-in of
an older system for a refurbished system at no additional cost
to the customer, or a trade-in for an older system plus cash for
a refurbished or new Cryocare Surgical System. These upgrades
are not part of a bundled arrangement conditioned upon past or
future purchases of our products. They are offered at our
election as a means to introduce our latest technology to the
market place. The older systems received in the trade are then
redeployed for interventional radiology procedures or sold in
secondary markets. When these upgrades take place, we invoice
the customer for the upgraded Cryocare Surgical System and
expense the cost of the system upon shipment. If we determine
that there will be a loss on the trade, we may record the loss
at the time the commitment is made. We recognize revenue to the
extent of the cash consideration upon shipment. We do not assign
a value to the older trade-in system since they generally have
exceeded our estimated useful life of three years
We routinely assess the financial strength of our customers and,
as a consequence, believe that our accounts receivable credit
risk exposure is limited. Accounts receivable are carried at
original invoice amount less all discounts and allowances, and
less an estimate for doubtful accounts and sales returns based
on a periodic review of outstanding receivables. Allowances are
provided for known and anticipated credit losses as determined
by management in the course of regularly evaluating individual
customer receivables. This evaluation takes into
34
consideration a customers financial condition and credit
history as well as current economic conditions. Accounts
receivable are written off when deemed uncollectible. Recoveries
of accounts receivable previously written off are recorded when
received.
Impairment of Long-Lived Assets. We have a
significant amount of property, equipment and amortizable
intangible assets primarily consisting of purchased patents and
acquired technology. In accordance with Statement of Financial
Accounting Standards (SFAS) No. 144, Accounting for the
Impairment or Disposal of Long Lived Assets, we review our
long-lived assets and certain identifiable intangibles for
impairment whenever events or changes in circumstances indicate
that the carrying amount of an asset or asset group may not be
recoverable. Recoverability of long-lived and amortizable
intangible assets to be held and used is measured by a
comparison of the carrying amount of an asset to the
undiscounted future operating cash flows expected to be
generated by the asset. If such assets are considered to be
impaired, the impairment to be recognized is measured as the
amount by which the carrying value of the assets exceeds their
fair value. In 2004, we recognized impairment charges of
$2.1 million and $80,000 to reduce the carrying value of
intangible assets acquired in the Timm Medical acquisition and
equity interests in the mobile prostate treatment businesses,
respectively.
Legal and Other Loss Contingencies. In the
normal course of business, we are subject to contingencies, such
as legal proceedings and claims arising out of our business that
cover a wide range of matters, including tax matters, product
liability and workers compensation. In accordance with
SFAS No. 5, Accounting for Contingencies, we
record accruals for such contingencies when it is probable that
a liability will be incurred and the amount of loss can be
reasonably estimated. A significant amount of management
estimation is required in determining when, or if, an accrual
should be recorded for a contingent matter and the amount of
such accrual, if any. Due to the uncertainty of determining the
likelihood of a future event occurring and the potential
financial statement impact of such an event, it is possible that
upon further development or resolution of a contingent matter, a
charge could be recorded in a future period that would be
material to our consolidated results of operations, financial
position or cash flows.
Other Investments. We review our equity
investments for impairment based on our determination of whether
a decline in the market value of the investment below our
carrying value is other than temporary. In making this
determination, we consider Accounting Principles Board Opinion
(APB) No. 18, The Equity Method of Accounting of
Investments in Common Stock, and EITF
00-31,
The Meaning of
Other-Than-Temporary
Impairment and Its Application to Certain Investments, which
set forth factors to be evaluated in determining whether a loss
in value should be recognized. Factors include the
investees operational performance, indicators of continued
viability, financing status, liquidity prospects and cash flow
forecasts. We also consider our ability to hold the investment
until we recover our cost, the market price and market price
fluctuations of the investments publicly traded shares and
the ability of the investee to sustain an earnings capacity
which would justify the carrying amount of the investment. In
addition, we assess if these equity investees constitute
variable interest entities and are required to be consolidated
under FASB Interpretation No. 46 (revised December 2003),
Consolidation of Variable Interest Entities, an
interpretation of ARB No. 51.
Income Taxes. In the preparation of our
consolidated financial statements, we are required to estimate
income taxes in each of the jurisdictions in which we operate,
including estimating both actual current tax exposure and
assessing temporary differences resulting from differing
treatment of items for tax and accounting purposes. Assessment
of actual current tax exposure includes assessing tax
strategies, the status of tax audits and open audit periods with
the taxing authorities. To the extent that we have deferred tax
assets, we must assess the likelihood that our deferred tax
assets will be recovered from taxable temporary differences, tax
strategies or future taxable income and to the extent that we
believe that recovery is not likely, we must establish a
valuation allowance. As of December 31, 2006 we have
established a valuation allowance of $66.4 million against
our deferred tax assets. In the future, we may adjust our
estimates of the amount of valuation allowance needed and such
adjustment would impact our provision for income taxes in the
period of such change. Effective January 1, 2007, we will
adopt the provisions of FASB Interpretation No. 48,
Accounting for Uncertainty in Income Taxes, an interpretation of
SFAS No. 109 (FIN 48). FIN 48 prescribes
a minimum recognition threshold a tax position is required to
meet before being recognized in the financial statements.
Stock based compensation. As a normal
practice, we compensate employees and non-employee directors
through stock-based compensation. Effective January 1,
2006, we account for our
stock-based
compensation under
35
the provisions of SFAS No. 123R, Share-Based
Payments. SFAS No. 123R eliminates the use of the
intrinsic value method of accounting under Accounting Principles
Board Opinion No. 25, Accounting for Stock Issued to
Employees (APB 25) and requires companies
to recognize in the financial statements the cost of employee
services received in exchange for awards of equity instruments
based on the grant date fair value of those awards. The
estimation of stock-based compensation requires the use of
complex option pricing models and application of judgment in
selecting the appropriate valuation assumptions, as such
volatility, forfeiture rates and expected term. We value our
stock-based
compensation using the Black-Scholes option pricing model and
the single option award approach, in accordance with the
requirements of SFAS No. 123R and Staff Accounting
Bulletin (SAB) No. 107, Share-Based Payment. We
reduce our compensation expense for estimated forfeitures based
on historical forfeiture behavior, excluding unusual events or
behavior that is not indicative of future expectations. We will
re-assess the appropriateness of the valuation assumptions,
including our calculated forfeiture rate, on a semi-annual basis
or when events or changes in circumstances warrant a
re-evaluation. In addition, we monitor equity instruments with
non-standard provisions, such as performance-based vesting
conditions, accelerated vesting based on achievement of
performance milestones and features that require instrument to
be accounted for as liabilities.
Inflation
The impact of inflation on our business has not been significant
to date.
|
|
Item 7A.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
The primary objective of our investment activities is to
preserve principal while at the same time maximizing the income
we receive from our invested cash without significantly
increasing risk of loss. Our financial instruments include cash,
cash equivalents, accounts and notes receivable, minority
investments, accounts payable and accrued liabilities and common
stock warrants. As of December 31, 2006, the carrying
values of these financial instruments approximated their fair
values.
Our policy is not to enter into derivative financial
instruments. In addition, we do not enter into any futures or
forward contracts and therefore, we do not have significant
market risk exposure with respect to commodity prices.
Although we transact our business in U.S. dollars, future
fluctuations in the value of the U.S. dollar may affect the
price competitiveness of our products. However, we do not
believe that we currently have any significant direct foreign
currency exchange rate risk and have not hedged exposures
denominated in foreign currencies or any other derivative
financial instruments.
|
|
Item 8.
|
Financial
Statements and Supplementary Data
|
Our financial statements and schedules, as listed under
Item 15, appear in a separate section of this Annual Report
on
Form 10-K
beginning on
page F-1.
|
|
Item 9.
|
Changes
in and Disagreements With Accountants on Accounting and
Financial Disclosure
|
Not applicable.
36
|
|
Item 9A.
|
Controls
and Procedures
|
(a) Evaluation of Disclosure Controls and
Procedures. We maintain disclosure controls and
procedures that are designed to ensure that information required
to be disclosed in our reports pursuant to the Securities
Exchange Act of 1934, as amended, is recorded, processed,
summarized and reported within the time periods specified in the
SECs rules and forms and that such information is
accumulated and communicated to our management, including our
chief executive officer and chief financial officer, as
appropriate, to allow for timely decisions regarding required
disclosure. In designing and evaluating the disclosure controls
and procedures, management recognizes that any controls and
procedures, no matter how well designed and operated, can
provide only reasonable assurance of achieving the desired
control objectives, and management is required to apply its
judgment in evaluating the cost-benefit relationship of possible
controls and procedures.
As required by
Rule 13a-15(b)
of the Securities Exchange Act of 1934, as amended, we carried
out an evaluation, under the supervision and with the
participation of our management, including our chief executive
officer and chief financial officer, of the effectiveness of the
design and operation of our disclosure controls and procedures
as of the end of the period covered by this report. Based on the
foregoing, our chief executive officer and chief financial
officer concluded that our disclosure controls and procedures
were effective at a reasonable assurance level.
(b) Managements Annual Report on Internal Control
Over Financial Reporting. Management of the
company is responsible for establishing and maintaining adequate
internal control over financial reporting as defined in
Rules 13a-15(f)
and
15d-15(f)
under the Securities Exchange Act of 1934. Our internal control
over financial reporting is designed to provide reasonable
assurance regarding the reliability of financial reporting and
the preparation of financial statements for external purposes in
accordance with generally accepted accounting principles. Our
internal control over financial reporting includes those
policies and procedures that:
(i) pertain to the maintenance of records that, in
reasonable detail, accurately and fairly reflect the
transactions and dispositions of the assets of the Company;
(ii) provide reasonable assurance that transactions are
recorded as necessary to permit preparation of financial
statements in accordance with generally accepted accounting
principles, and that receipts and expenditures of the Company
are being made only in accordance with authorizations of
management and directors of the Company; and
(iii) provide reasonable assurance regarding prevention or
timely detection of unauthorized acquisition, use or disposition
of the Companys assets that could have a material effect
on the financial statements.
Because of its inherent limitations, internal control over
financial reporting may not prevent or detect misstatements.
Also, projections of any evaluation of effectiveness to future
periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree
of compliance with the policies or procedures may deteriorate.
Management assessed the effectiveness of the Companys
internal control over financial reporting as of
December 31, 2006. In making this assessment, management
used the criteria set forth by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO) in Internal
Control Integrated Framework.
Based on our assessment and those criteria, management believes
that the Company maintained effective internal control over
financial reporting as of December 31, 2006.
The Companys independent registered public accounting firm
has issued an attestation report on managements assessment
of the Companys internal control over financial reporting.
That report appears below in this Item 9A.
(c) Changes in Internal Controls. There
was no change in our internal control over financial reporting
during our fourth fiscal quarter for 2006 that has materially
affected, or is reasonably likely to materially affect, our
internal control over financial reporting.
37
REPORT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
ON INTERNAL CONTROL OVER FINANCIAL REPORTING
To the Board of Directors
Endocare, Inc.
We have audited managements assessment, included in the
accompanying Managements Annual Report on Internal Control
Over Financial Reporting, that Endocare, Inc. (Endocare)
maintained effective internal control over financial reporting
as of December 31, 2006, based on criteria established in
Internal Control Integrated Framework issued
by the Committee of Sponsoring Organizations of the Treadway
Commission (the COSO criteria). Endocares management is
responsible for maintaining effective internal control over
financial reporting and for its assessment of the effectiveness
of internal control over financial reporting. Our responsibility
is to express an opinion on managements assessment and an
opinion on the effectiveness of Endocares internal control
over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether effective internal control
over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of
internal control over financial reporting, evaluating
managements assessment, testing and evaluating the design
and operating effectiveness of internal control, and performing
such other procedures as we considered necessary in the
circumstances. We believe that our audit provides a reasonable
basis for our opinion.
A companys internal control over financial reporting is a
process designed to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with
generally accepted accounting principles. A companys
internal control over financial reporting includes those
policies and procedures that (1) pertain to the maintenance
of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the
company; (2) provide reasonable assurance that transactions
are recorded as necessary to permit preparation of financial
statements in accordance with generally accepted accounting
principles, and that receipts and expenditures of the company
are being made only in accordance with authorizations of
management and directors of the company; and (3) provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use, or disposition of the
companys assets that could have a material effect on the
financial statements.
Because of its inherent limitations, internal control over
financial reporting may not prevent or detect misstatements.
Also, projections of any evaluation of effectiveness to future
periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree
of compliance with the policies or procedures may deteriorate.
In our opinion, managements assessment that Endocare
maintained effective internal control over financial reporting
as of December 31, 2006, is fairly stated, in all material
respects, based on the COSO criteria. Also, in our opinion,
Endocare maintained, in all material respects, effective
internal control over financial reporting as of
December 31, 2006, based on the COSO criteria.
We have also audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States), the
consolidated balance sheets of Endocare as of December 31,
2005 and 2006, and the related consolidated statements of
operations, stockholders equity, and cash flows for each
of the three years in the period ended December 31, 2006 of
Endocare, Inc. and our report dated March 8, 2007,
expressed an unqualified opinion thereon.
Los Angeles, California
March 8, 2007
38
|
|
Item 9B.
|
Other
Information
|
Not applicable.
PART III
|
|
Item 10.
|
Directors,
Executive Officers and Corporate Governance
|
The information required by this Item 10 is incorporated by
reference to the Definitive Proxy Statement relating to our 2007
Annual Meeting of Stockholders, which we expect to file within
120 days after the end of our fiscal year ended
December 31, 2006.
|
|
Item 11.
|
Executive
Compensation
|
The information required by this Item 11 is incorporated by
reference to the Definitive Proxy Statement relating to our 2007
Annual Meeting of Stockholders, which we expect to file within
120 days after the end of our fiscal year ended
December 31, 2006.
|
|
Item 12.
|
Security
Ownership of Certain Beneficial Owners and Management and
Related Stockholder Matters
|
The information required by this Item 12 is incorporated by
reference to the Definitive Proxy Statement relating to our 2007
Annual Meeting of Stockholders, which we expect to file within
120 days after the end of our fiscal year ended
December 31, 2006.
|
|
Item 13.
|
Certain
Relationships and Related Transactions, and director
independence
|
The information required by this Item 13 is incorporated by
reference to the Definitive Proxy Statement relating to our 2007
Annual Meeting of Stockholders, which we expect to file within
120 days after the end of our fiscal year ended
December 31, 2006.
|
|
Item 14.
|
Principal
Accountant Fees and Services
|
The information required by this Item 14 is incorporated by
reference to the Definitive Proxy Statement relating to our 2007
Annual Meeting of Stockholders, which we expect to file within
120 days after the end of our fiscal year ended
December 31, 2006.
39
PART IV
|
|
Item 15.
|
Exhibits
and Financial Statement Schedules
|
(a)(1) Financial Statements:
The Consolidated Financial Statements of the Company are
included in a separate section of this Annual Report on
Form 10-K
commencing on the pages referenced below:
|
|
|
|
|
Page
|
|
|
|
|
Consolidated Financial
Statements of the Company:
|
|
|
|
|
F-1
|
|
|
F-2
|
|
|
F-3
|
|
|
F-4
|
|
|
F-5
|
|
|
F-6 to F-37
|
(2) Financial Statement Schedules:
Schedule II Valuation and Qualifying Accounts
for the years ended December 31, 2004, 2005 and 2006 is
included in the Consolidated Financial Statements at
page F-38.
All other schedules have been omitted because they are not
applicable, not required or the information is included in the
consolidated financial statements or the notes thereto.
(3) Exhibits:
A list of exhibits to this
Form 10-K
is found in the Exhibit Index immediately following the
Signature Page of this
Form 10-K,
which is hereby incorporated by reference herein.
Supplemental
Information
We have not sent an annual report or proxy materials to our
stockholders as of the date of this Annual Report on
Form 10-K.
We intend to provide our stockholders with an annual report and
proxy materials after the filing of this Annual Report on
Form 10-K,
and we will furnish the annual report to the SEC at that time.
40
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the
Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned
thereunto duly authorized.
Endocare, Inc.
Date: March 16, 2007
|
|
|
|
By:
|
/s/ Craig
T. Davenport
|
Craig T. Davenport
Chairman, Chief Executive Officer and President
POWER OF
ATTORNEY
Know all men by these presents, that each person whose signature
appears below constitutes and appoints Craig T. Davenport and
Michael R. Rodriguez, and each or any one of them, his true and
lawful
attorney-in-fact
and agent, with full power of substitution, for him and in his
name, place and stead, in any and all capacities, to sign any
and all amendments to this Annual Report on
Form 10-K,
and to file the same, with all exhibits thereto, and other
documents in connection therewith, with the SEC, granting unto
said
attorneys-in-fact
and agents, and each of them, full power and authority to do and
perform each and every act and thing requisite and necessary to
be done in connection therewith, as fully to all intents and
purposes as he might or could do in person, hereby ratifying and
confirming all that said
attorneys-in-fact
and agents, or any of them, or their or his substitutes or
substitute, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of
1934, this report has been signed below by the following persons
on behalf of the registrant and in the capacities and on the
dates indicated.
|
|
|
|
|
|
|
Signature
|
|
Title
|
|
Date
|
|
/s/ Craig
T.
Davenport
Craig
T. Davenport
|
|
Chairman, Chief Executive Officer
and President (principal executive officer)
|
|
March 16, 2007
|
|
|
|
|
|
/s/ Michael
R.
Rodriguez
Michael
R. Rodriguez
|
|
Senior Vice President, Finance and
Chief Financial Officer (principal financial and accounting
officer)
|
|
March 16, 2007
|
|
|
|
|
|
/s/ John
R. Daniels,
M.D.
John
R. Daniels, M.D.
|
|
Director
|
|
March 16, 2007
|
|
|
|
|
|
/s/ David
L.
Goldsmith
David
L. Goldsmith
|
|
Director
|
|
March 16, 2007
|
|
|
|
|
|
/s/ Eric
S. Kentor
Eric
S. Kentor
|
|
Director
|
|
March 16, 2007
|
|
|
|
|
|
/s/ Terrence
A. Noonan
Terrence
A. Noonan
|
|
Director
|
|
March 16, 2007
|
|
|
|
|
|
/s/ Thomas
R. Testman
Thomas
R. Testman
|
|
Director
|
|
March 16, 2007
|
41
REPORT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors
Endocare, Inc.
We have audited the accompanying consolidated balance sheets of
Endocare, Inc. (the Company) and subsidiaries as of
December 31, 2005 and 2006, and the related consolidated
statements of operations, stockholders equity, and cash
flows for each of the three years in the period ended
December 31, 2006. Our audits also included the financial
statement schedule listed in the Index at Item 15(a)(2).
These financial statements and schedule are the responsibility
of the Companys management. Our responsibility is to
express an opinion on these financial statements and schedule
based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by
management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, the financial statements referred to above
present fairly, in all material respects, the consolidated
financial position of Endocare, Inc. and subsidiaries at
December 31, 2005 and 2006, and the consolidated results of
their operations and their cash flows for each of the three
years in the period ended December 31, 2006, in conformity
with U.S. generally accepted accounting principles. Also in
our opinion, the related financial statement schedule, when
considered in relation to the basic financial statements taken
as a whole, presents fairly in all material respects the
information set forth therein.
The accompanying financial statements have been prepared
assuming that Endocare, Inc. will continue as a going concern.
As more fully described in Note 2, Endocare, Inc. has
incurred recurring operating losses, cash flow deficits and has
a working capital deficiency. In addition, the Company did not
comply with a certain loan covenant during 2006 and may not be
able to comply with the convenant in future periods. These
conditions raise substantial doubt about the Companys
ability to continue as a going concern. Managements plans
in regard to these matters also are described in Note 2.
The financial statements do not include any adjustments to
reflect the possible future effects on the recoverability and
classification of assets or the amounts and classification of
liabilities that may result from the outcome of this uncertainty.
As discussed in Note 3 to the consolidated financial
statements, Endocare, Inc. changed its method of accounting for
Share-Based Payments in accordance with Statement of Financial
Accounting Standards No. 123 (revised 2004) on
January 1, 2006.
We also have audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States), the
effectiveness of Endocare, Inc.s internal control over
financial reporting as of December 31, 2006, based on
criteria established in Internal Control Integrated
Framework issued by the Committee of Sponsoring Organizations of
the Treadway Commission and our report dated March 8, 2007
expressed an unqualified opinion thereon.
/s/ Ernst &
Young llp
Los Angeles, California
March 8, 2007
F-1
ENDOCARE,
INC. AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31
|
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
|
(In thousands, except per share data)
|
|
|
Product sales
|
|
$
|
6,036
|
|
|
$
|
7,605
|
|
|
$
|
15,088
|
|
Service revenues
|
|
|
17,516
|
|
|
|
19,780
|
|
|
|
12,298
|
|
Other
|
|
|
629
|
|
|
|
889
|
|
|
|
604
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24,181
|
|
|
|
28,274
|
|
|
|
27,990
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues
|
|
|
13,585
|
|
|
|
15,738
|
|
|
|
12,343
|
|
Research and development
|
|
|
1,856
|
|
|
|
2,283
|
|
|
|
2,781
|
|
Selling and marketing
|
|
|
13,354
|
|
|
|
13,001
|
|
|
|
15,195
|
|
General and administrative
|
|
|
16,379
|
|
|
|
13,858
|
|
|
|
13,107
|
|
Goodwill impairment and other
charges
|
|
|
9,900
|
|
|
|
26
|
|
|
|
|
|
Loss on divestitures, net
|
|
|
711
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
55,785
|
|
|
|
44,906
|
|
|
|
43,426
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(31,604
|
)
|
|
|
(16,632
|
)
|
|
|
(15,436
|
)
|
Interest income
|
|
|
293
|
|
|
|
308
|
|
|
|
452
|
|
Interest expense
|
|
|
(7
|
)
|
|
|
657
|
|
|
|
3,716
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
before minority interests
|
|
|
(31,318
|
)
|
|
|
(15,667
|
)
|
|
|
(11,268
|
)
|
Minority interests
|
|
|
(583
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
before taxes
|
|
|
(31,901
|
)
|
|
|
(15,667
|
)
|
|
|
(11,268
|
)
|
Tax benefit on continuing
operations
|
|
|
|
|
|
|
829
|
|
|
|
192
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
|
(31,901
|
)
|
|
|
(14,838
|
)
|
|
|
(11,076
|
)
|
Income (loss) from discontinued
operations, net of taxes
|
|
|
(5,718
|
)
|
|
|
1,159
|
|
|
|
311
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(37,619
|
)
|
|
$
|
(13,679
|
)
|
|
$
|
(10,765
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share of
common stock basic and diluted Continuing operations
|
|
$
|
(1.31
|
)
|
|
$
|
(0.51
|
)
|
|
$
|
(0.37
|
)
|
Discontinued operations
|
|
$
|
(0.24
|
)
|
|
$
|
0.04
|
|
|
$
|
0.01
|
|
Weighted-average shares of common
stock outstanding
|
|
|
24,263
|
|
|
|
28,978
|
|
|
|
30,253
|
|
The accompanying notes are an integral part of these
Consolidated Financial Statements.
F-2
ENDOCARE,
INC. AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
|
|
December 31
|
|
|
|
2005
|
|
|
2006
|
|
|
|
(In thousands, except share and per share data)
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
8,108
|
|
|
$
|
1,811
|
|
Accounts receivable less
allowances for doubtful accounts and sales returns of $70 and
$84 at December 31, 2005 and 2006, respectively
|
|
|
3,549
|
|
|
|
4,161
|
|
Inventories
|
|
|
2,462
|
|
|
|
2,260
|
|
Prepaid expenses and other current
assets
|
|
|
1,213
|
|
|
|
1,284
|
|
Assets of discontinued operations
|
|
|
9,624
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
24,956
|
|
|
|
9,516
|
|
Property and equipment, net
|
|
|
1,794
|
|
|
|
1,040
|
|
Intangibles, net
|
|
|
4,167
|
|
|
|
3,613
|
|
Investments and other assets
|
|
|
1,320
|
|
|
|
2,077
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
32,237
|
|
|
$
|
16,246
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS EQUITY
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
4,384
|
|
|
$
|
3,393
|
|
Accrued compensation
|
|
|
3,614
|
|
|
|
3,000
|
|
Other accrued liabilities
|
|
|
4,925
|
|
|
|
3,594
|
|
Liabilities of discontinued
operations
|
|
|
1,461
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
14,384
|
|
|
|
9,987
|
|
Common stock warrants
|
|
|
5,023
|
|
|
|
1,307
|
|
Deferred compensation
|
|
|
|
|
|
|
74
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par
value; 1,000,000 shares authorized; none issued and
outstanding
|
|
|
|
|
|
|
|
|
Common stock, $0.001 par
value; 50,000,000 shares authorized; 30,089,144 and
30,679,176 shares issued and outstanding at
December 31, 2005 and 2006, respectively
|
|
|
30
|
|
|
|
31
|
|
Additional paid-in capital
|
|
|
178,477
|
|
|
|
181,289
|
|
Accumulated deficit
|
|
|
(165,677
|
)
|
|
|
(176,442
|
)
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
12,830
|
|
|
|
4,878
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders equity
|
|
$
|
32,237
|
|
|
$
|
16,246
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
Consolidated Financial Statements.
F-3
ENDOCARE,
INC. AND SUBSIDIARIES
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
Common Stock
|
|
|
Additional
|
|
|
Accumulated
|
|
|
Deferred
|
|
|
|
|
|
Stockholders
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Paid-In Capital
|
|
|
Deficit
|
|
|
Compensation
|
|
|
Treasury Stock
|
|
|
Equity
|
|
|
Balance at December 31,
2003
|
|
|
24,183
|
|
|
$
|
24
|
|
|
$
|
171,875
|
|
|
$
|
(114,379
|
)
|
|
$
|
(107
|
)
|
|
$
|
(2,092
|
)
|
|
$
|
55,321
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss and comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(37,619
|
)
|
|
|
|
|
|
|
|
|
|
|
(37,619
|
)
|
Stock options exercised
|
|
|
350
|
|
|
|
|
|
|
|
92
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
92
|
|
Compensation related to issuance
of options and warrants
|
|
|
|
|
|
|
|
|
|
|
123
|
|
|
|
|
|
|
|
13
|
|
|
|
|
|
|
|
136
|
|
Treasury stock retired
|
|
|
|
|
|
|
|
|
|
|
(2,596
|
)
|
|
|
|
|
|
|
|
|
|
|
2,596
|
|
|
|
|
|
Purchase of treasury stock
|
|
|
(191
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(504
|
)
|
|
|
(504
|
)
|
Deferred compensation on options
forfeited
|
|
|
|
|
|
|
|
|
|
|
(94
|
)
|
|
|
|
|
|
|
94
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2004
|
|
|
24,342
|
|
|
$
|
24
|
|
|
$
|
169,400
|
|
|
$
|
(151,998
|
)
|
|
$
|
|
|
|
$
|
|
|
|
$
|
17,426
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss and comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(13,679
|
)
|
|
|
|
|
|
|
|
|
|
|
(13,679
|
)
|
Stock options exercised
|
|
|
112
|
|
|
|
|
|
|
|
116
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
116
|
|
Compensation expense
|
|
|
|
|
|
|
|
|
|
|
51
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
51
|
|
Sale of common stock
|
|
|
5,635
|
|
|
|
6
|
|
|
|
8,910
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,916
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2005
|
|
|
30,089
|
|
|
$
|
30
|
|
|
$
|
178,477
|
|
|
$
|
(165,677
|
)
|
|
$
|
|
|
|
$
|
|
|
|
$
|
12,830
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss and comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,765
|
)
|
|
|
|
|
|
|
|
|
|
|
(10,765
|
)
|
Stock options exercised
|
|
|
86
|
|
|
|
|
|
|
|
108
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
108
|
|
Compensation expense
|
|
|
|
|
|
|
|
|
|
|
2,797
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,797
|
|
Sale of common stock
|
|
|
504
|
|
|
|
1
|
|
|
|
(93
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(92
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2006
|
|
|
30,679
|
|
|
$
|
31
|
|
|
$
|
181,289
|
|
|
$
|
(176,442
|
)
|
|
$
|
|
|
|
$
|
|
|
|
$
|
4,878
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
Consolidated Financial Statements.
F-4
ENDOCARE,
INC. AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Years Ended December 31,
|
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
|
(In thousands)
|
|
|
Cash flows from operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(37,619
|
)
|
|
$
|
(13,679
|
)
|
|
$
|
(10,765
|
)
|
Adjustments to reconcile net loss
to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
3,481
|
|
|
|
3,054
|
|
|
|
1,576
|
|
Reserve for uncollectible notes
|
|
|
|
|
|
|
|
|
|
|
695
|
|
(Gain) loss on divestitures, net
|
|
|
711
|
|
|
|
(609
|
)
|
|
|
(524
|
)
|
Compensation expense related to
issuance of options, warrants and restricted stock
|
|
|
136
|
|
|
|
51
|
|
|
|
2,845
|
|
Goodwill impairment and other
charges
|
|
|
15,810
|
|
|
|
26
|
|
|
|
|
|
Loss on sale of placement units and
other fixed assets
|
|
|
139
|
|
|
|
107
|
|
|
|
47
|
|
Minority interests
|
|
|
584
|
|
|
|
(214
|
)
|
|
|
|
|
Extinguishment of payroll tax
liabilities
|
|
|
(117
|
)
|
|
|
(182
|
)
|
|
|
(891
|
)
|
Interest expense on common stock
warrants
|
|
|
|
|
|
|
(657
|
)
|
|
|
(3,716
|
)
|
Changes in operating assets and
liabilities, net of effects from purchases and divestitures:
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(248
|
)
|
|
|
(354
|
)
|
|
|
(407
|
)
|
Inventories
|
|
|
(1,516
|
)
|
|
|
(318
|
)
|
|
|
112
|
|
Prepaid expenses and other current
assets
|
|
|
1,132
|
|
|
|
(454
|
)
|
|
|
(83
|
)
|
Accounts payable
|
|
|
(675
|
)
|
|
|
(337
|
)
|
|
|
(1,409
|
)
|
Accrued compensation
|
|
|
(33
|
)
|
|
|
429
|
|
|
|
281
|
|
Other accrued liabilities
|
|
|
1,127
|
|
|
|
(1,581
|
)
|
|
|
(1,364
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating
activities
|
|
|
(17,088
|
)
|
|
|
(14,718
|
)
|
|
|
(13,603
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property and equipment
|
|
|
(456
|
)
|
|
|
(423
|
)
|
|
|
(158
|
)
|
Purchases of intangibles
|
|
|
|
|
|
|
(330
|
)
|
|
|
|
|
Partnership distributions to
minority interests
|
|
|
(739
|
)
|
|
|
|
|
|
|
|
|
Proceeds from divestitures
|
|
|
2,388
|
|
|
|
850
|
|
|
|
7,480
|
|
Other assets
|
|
|
315
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by investing
activities
|
|
|
1,508
|
|
|
|
97
|
|
|
|
7,322
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options and warrants exercised
|
|
|
92
|
|
|
|
116
|
|
|
|
108
|
|
Borrowings on line of credit
|
|
|
|
|
|
|
|
|
|
|
250
|
|
Payments on line of credit
|
|
|
|
|
|
|
|
|
|
|
(250
|
)
|
Proceeds from sale of stock and
warrants, net
|
|
|
|
|
|
|
14,596
|
|
|
|
(92
|
)
|
Repurchase of treasury stock
|
|
|
(504
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in)
financing activities
|
|
|
(412
|
)
|
|
|
14,712
|
|
|
|
16
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase/(decrease) in cash and
cash equivalents
|
|
|
(15,992
|
)
|
|
|
91
|
|
|
|
(6,265
|
)
|
Cash and cash equivalents,
beginning of year
|
|
|
23,977
|
|
|
|
7,985
|
|
|
|
8,108
|
|
Less: Cash of discontinued
operations
|
|
|
(155
|
)
|
|
|
32
|
|
|
|
(32
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of
year
|
|
$
|
7,830
|
|
|
$
|
8,108
|
|
|
$
|
1,811
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non cash activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Transfer of inventory to property
and equipment for placement at customer sites
|
|
$
|
951
|
|
|
$
|
532
|
|
|
$
|
587
|
|
Transfer from property and
equipment to inventory for sale of Cryocare Surgical Systems
|
|
|
|
|
|
|
|
|
|
|
470
|
|
Other supplemental information:
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid
|
|
$
|
8
|
|
|
$
|
36
|
|
|
$
|
19
|
|
Income taxes paid
|
|
$
|
2
|
|
|
$
|
22
|
|
|
$
|
55
|
|
The accompanying notes are an integral part of these
Consolidated Financial Statements.
F-5
ENDOCARE,
INC. AND SUBSIDIARIES
(Tabular numbers in thousands, except per share data)
|
|
1.
|
Organization
and Operations of the Company
|
Endocare (we or Endocare) is a medical
device company focused on developing, manufacturing and selling
cryosurgical products with the potential to improve the
treatment of cancer and other tumors. We were formed in 1990 as
a research and development division of Medstone International,
Inc. (Medstone), a manufacturer of shockwave
lithotripsy equipment for the treatment of kidney stones.
Following our incorporation under the laws of the state of
Delaware in 1994, we became an independent, publicly-owned
corporation upon Medstones distribution of our stock to
the existing stockholders on January 1, 1996.
Through February 10, 2006 we also offered vacuum therapy
systems for non-pharmaceutical treatment of erectile dysfunction
through our wholly-owned subsidiary Timm Medical Technologies,
Inc. (Timm Medical), which was sold to a third party effective
February 2006 (see Note 7 Dispositions and
Discontinued Operations). The operating results of Timm Medical
are included in discontinued operations.
|
|
2.
|
Recent
Operating Results and Liquidity
|
Since inception, we have incurred losses from operations and
have reported negative cash flows. Losses from continuing
operations were $31.9 million, $14.8 million and
$11.1 million for the three years ended December 31,
2006. Operating cash flow deficits were $17.1 million,
$14.7 million and $13.6 million during this three year
period. As of December 31, 2006, we had an accumulated
deficit of $176.4 million and cash and cash equivalents of
$1.8 million.
We do not expect to reach cash flow positive operations in 2007,
and we expect to continue to generate losses from operations for
the foreseeable future. These losses have resulted in part from
our continued investment to gain acceptance of our technology
and investment in initiatives that we believe should ultimately
result in cost reductions. In addition to these continued
investments, although we recently resolved the investigations by
the Securities and Exchange Commission (SEC) and the
U.S. Department of Justice (DOJ) of our historical
accounting and financial reporting (see 12
Commitments and Contingencies
Government Investigations), we still have obligations to
indemnify and advance the legal fees for our former officers and
former directors in connection with the ongoing investigations
and legal proceedings related to those individuals. The amount
of those legal fees may exceed the reimbursement due to us from
our directors and officers liability insurance, and
the excess may have a material adverse effect on our business
financial condition, results of operations and liquidity. We
also face large cash expenditures in the future related to past
due state and local tax obligations primarily sales and use tax,
which we estimate to be approximately $2.8 million and was
accrued as of December 31, 2006. We are in the process of
negotiating resolutions of the past due state and local tax
obligations with the applicable tax authorities. However there
is no assurance that these obligations will be reduced as a
result of the negotiations or that we will be allowed to pay the
amounts due over an extended period of time.
We also intend to continue investing in our sales and marketing
efforts to physicians in order to raise awareness and gain
further acceptance of our technology. This investment is
required in order to increase physicians usage of our
technology in the treatment of prostate and renal cancers, lung
and liver cancers and palliative intervention (treatment of pain
associated with metastases). Such costs will be reported as
current period charges under generally accepted accounting
principles.
Since we do not currently have sufficient financial resources to
fund our ongoing needs, we will require additional equity
financing or borrowings in order to continue operations. Our
funding sources include a $16 million common stock purchase
agreement with Fusion Capital Fund II, LLC and our
$4 million credit agreement with Silicon Valley Bank. The
availability under both agreements is subject to many
conditions, some of which are predicated on events that are not
within our control. Accordingly, we cannot guarantee that these
capital resources will be available or will be sufficient.
F-6
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
As more fully described in Note 6
Private Placement of Common Stock and
Warrants, on October 25, 2006, we entered into an
agreement with Fusion Capital Fund II, LLC (Fusion
Capital) pursuant to which we have the right to sell to
Fusion Capital up to $16.0 million of common stock over a
two year period at prices determined based upon the market price
of our common stock at the time of each sale without any fixed
discount. However we only have the right to sell $100,000 every
fourth business day, with additional $150,000 increments
available every third business day if the market price of our
common stock is $1.50 or higher, subject to our ability to
comply with certain on going requirements. This $150,000
increment can be further increased at graduated levels up to
$1.0 million if the market price increases from $1.50 to
$6.00. Fusion Capitals obligation to buy shares from us is
automatically suspended if the trading share price decreases
below $1.00. We are also subject to certain on-going
requirements, which include maintaining effectiveness of a
registration statement filed in November 2006 covering the sale
of the shares purchased by Fusion Capital, listing of the shares
on the principal market on which they are traded, timely
issuance of purchased shares and maintenance of trading prices
at or above $1.00. Our inability to comply with these and other
requirements (an event of default) will allow Fusion Capital to
terminate the agreement. We sold $50,000 of shares to Fusion
Capital in December 2006 and an additional $1.0 million
through February 28, 2007. Although we are in compliance
with these requirements at December 31, 2006, there is no
assurance that we will continue to comply in future periods. In
addition, the extent to which we rely on Fusion Capital as a
source of funding will depend on a number of factors including
the prevailing market price of our common stock. Since we have
authorized 8,000,000 shares for sale under the stock
purchase agreement, the selling price of our common stock to
Fusion Capital will have to average at least $2.00 per
share for us to receive the maximum proceeds of
$16.0 million. Assuming a purchase price of $1.75 per
share (the closing sale price of the common stock on
February 28, 2007) and the purchase by Fusion Capital
of the full 8,000,000 shares under the common stock
purchase agreement, gross proceeds to us would be
$14.0 million.
Under our credit facility with Silicon Valley Bank, we can
borrow up to $4 million based on the amount of eligible
inventory and trade receivables as defined under the credit
agreement, but is ultimately subject to the good faith business
judgment of the lender. The agreement contains restrictive
covenants and subjective acceleration clauses that permit the
lender to accelerate payment of all outstanding balances and/or
cease to make further advances to us if an event of default
occurs or if the lender determines in its judgment that a
material adverse change has occurred. As more fully discussed in
Note 13 Line of Credit,
our tangible net worth decreased below the required level at
September 30, October 31 and November 30, 2006.
In December 2006, the lender amended the credit facility to
waive these defaults and to modify the minimum tangible net
worth provision. In February 2007, we further amended the
minimum net tangible net worth provision and extended the
expiration date of the credit facility. Although we are in
compliance with the modified covenants at December 31,
2006, there is no assurance that we will be able to comply with
all the requirements in future periods, that we can obtain a
waiver if another default occurs or that the lender will not
exercise the subjective acceleration clause to terminate the
agreement. We have no amounts outstanding under this line of
credit at December 31, 2006 though we had $1.9 million
in outstanding borrowings through February 28, 2007. As
amended, the credit facility expires on February 27, 2008.
Our continuing losses, cash flow deficits, and our obligations,
along with the contingencies in our funding sources, together
raise substantial doubt about our ability to continue as a going
concern. The accompanying financial statements have been
prepared assuming that we will continue as a going concern and
do not include any adjustments to reflect the possible future
effects on the recoverability and classification of assets or
the amounts and classification of liabilities that may result
from the outcome of this uncertainty.
We will use existing cash reserves, working capital through the
sale of our products, as well as future proceeds from sales, if
any, of common stock to Fusion Capital, to finance our projected
operating and cash flow needs, along with continued expense
management efforts. We have reduced operating cash use over the
past five years by streamlining our corporate structure,
focusing resources on our core products and strategic
initiatives,
re-engineering
our products to lower manufacturing costs, reducing use of
consultants and professional services and delaying or
eliminating non-essential spending. We have also instituted
additional equity incentive programs to reduce cash compensation
outlays.
F-7
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
We may borrow funds under our line of credit with our bank for
short term needs as long as we remain in compliance with the
representations, warranties, covenants and borrowing conditions.
We believe that the financing with Fusion Capital and our line
of credit with our bank should provide us with the capital
resources that we need to reach the point where our operations
will generate positive cash flows. We will continue to endeavor
to reduce expenses, defer or eliminate lower priority research,
clinical and marketing activities to conserve cash and garner
manufacturing efficiencies through product re-engineering and
sourcing our product components to overseas or to lower cost
suppliers. However, our cash needs are not entirely predictable
and the availability of funds from Fusion Capital and our bank
are subject to many conditions, including certain subjective
acceleration clauses and other provisions, some of which are
predicated on events that are not within our control. Even if we
are able to access the full $16.0 million under the common
stock purchase agreement with Fusion Capital, we may still need
additional capital to fully implement our business, operating
and development plans. In addition, if financing from Fusion
Capital were to prove unavailable or prohibitively dilutive and
if we are unable to sell enough of our products, we may need to
secure another source of funding in order to satisfy our working
capital needs. Accordingly, we cannot guarantee the availability
of these capital resources or that they will be sufficient to
fund our ongoing operations to the point where our operations
will generate positive cash flows. Should the financing we
require to sustain our working capital needs be unavailable or
prohibitively expensive when we require it, the consequences
would be a material adverse effect on our business, financial
condition, results of operations and cash flows.
In assessing whether to enter into the Fusion Capital financing
and renew the bank line of credit, we considered these factors
in light of our circumstances and likely cash requirements.
After comparing the Fusion Capital financing and bank line of
credit to other financing alternatives potentially available to
us, we made a business decision that the Fusion Capital
financing and bank line of credit represented the best financing
alternatives then available to us.
We continue to believe that the Fusion Capital financing and
bank line of credit should provide us with the capital resources
that we need to reach the point where our operations will
generate positive cash flows. However, primarily because of the
subjective acceleration clauses and other conditions referred to
above that may limit our access to these funding sources, the
audit report of our independent auditors contained in this
Annual Report on
Form 10-K
contains an unqualified opinion with an explanatory paragraph,
to the effect that there is substantial doubt about our ability
to continue as a going concern. This opinion could itself have a
material adverse effect on our business, financial condition,
results of operations and cash flows.
|
|
3.
|
Summary
of Significant Accounting Policies
|
Principles
of Consolidation
The consolidated financial statements include the accounts of
the parent and all majority owned and controlled subsidiaries.
All significant intercompany balances and transactions have been
eliminated in consolidation.
Comprehensive
Income
Statement of Financial Accounting Standard, or SFAS,
No. 130, Reporting Comprehensive Income, requires reporting
and displaying comprehensive income (loss) and its components,
which, for Endocare, is the same as the net loss reflected in
the consolidated statements of stockholders equity.
F-8
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Use of
Estimates
The preparation of consolidated financial statements in
conformity with U.S. generally accepted accounting
principles requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities as of the date
of the financial statements. Estimates also affect the reported
amounts of revenues and expenses during the reporting period.
Actual results could differ from these estimates. Principal
areas requiring the use of estimates include: determination of
allowances for uncollectible accounts and notes receivable and
sales returns, warranty obligations, reserves for excess and
obsolete inventory, valuation allowances for investments and
deferred tax assets, impairment of long-lived and intangible
assets, determination of stock-based compensation to employees
and consultants, valuation of the warrants and reserves for
litigation and other legal and regulatory matters, among others.
Revenue
Recognition
Revenues from sales of Cryocare Surgical Systems and
cryoablation disposable products are recognized when persuasive
evidence of an arrangement exists, delivery has occurred, the
fee is fixed and determinable, and collectibility is reasonably
assured. We also contract with medical facilities to provide
cryoablation disposable products and services for which we
charge a per-procedure fee. The cryoablation services provided
generally consist of rental and transport of a Cryocare Surgical
System, as well as the services of a technician to assist the
physician with the
set-up, use
and monitoring of the equipment and include the necessary
disposable products and supplies. The medical facilities are
billed for procedures performed using Cryocare Surgical Systems
owned either by us or by third parties who perform the service
component of the procedure. We receive procedure fee revenue
from the medical facility and, where a third-party service
provider is involved, pay a fee to the service provider. The fee
billed to the medical facility is recorded as revenue in the
period when the procedure is performed. Cost of revenues
includes the cost of the necessary disposable products and
supplies and, if applicable, third party service provider fees
which are recorded at the time of the procedure. Cost of
revenues also includes depreciation related to Endocare-owned
Cryocare Surgical Systems over an estimated useful life of three
years.
We have continued to experience year over year growth in
cryosurgical disposable product sales and procedure fee
revenues. In the past two years, we have placed increasing
emphasis on direct sale of our products rather than procedure
fee revenues. As a result of the shift in revenue mix from
cryoablation procedure fees to sales of cryoablation disposable
products, which have a lower average selling price and cost of
sales per procedure, we have experienced an increase in gross
margins as a percentage of revenues although the gross profit
dollars per case generally are the same. Our gross margin has
also increased due to reconfiguration of our products to reduce
manufacturing costs, sourcing products and components to lower
cost suppliers. We have also reduced operating expenses through
streamlining our corporate organization, elimination or deferral
of some longer-term research, development, clinical and
marketing activities, and in general better control of our
operating expenses.
F-9
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Revenues and the related cost of revenues from continuing
operations consist of the following for the three years ended
December 31, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cryoablation disposable products
|
|
$
|
4,584
|
|
|
$
|
6,790
|
|
|
$
|
13,948
|
|
Cryocare Surgical Systems
|
|
|
1,403
|
|
|
|
743
|
|
|
|
1,096
|
|
Other (Urohealth)
|
|
|
49
|
|
|
|
72
|
|
|
|
44
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,036
|
|
|
|
7,605
|
|
|
|
15,088
|
|
Cryoablation procedure fees
|
|
|
17,516
|
|
|
|
19,780
|
|
|
|
12,298
|
|
Cardiac royalties (CryoCath)
|
|
|
629
|
|
|
|
889
|
|
|
|
604
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
24,181
|
|
|
$
|
28,274
|
|
|
$
|
27,990
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cryoablation disposable products
and procedure fees
|
|
$
|
13,330
|
|
|
$
|
15,278
|
|
|
$
|
11,541
|
|
Cryocare Surgical Systems
|
|
|
255
|
|
|
|
460
|
|
|
|
802
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
13,585
|
|
|
$
|
15,738
|
|
|
$
|
12,343
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues for cryoablation disposable products and
procedure fees are combined for reporting purposes. Sales of
cryoablation disposable products and procedure fees incorporate
similar inventory when sold and we do not separately track the
cost of disposable products sold directly to customers and those
consumed in cryoablation procedures. Procedure fees relate to
services which are provided to medical facilities upon request
to facilitate the overall delivery of our technology into the
marketplace.
We provide customary sales incentives to customers and
distributors in the ordinary course of business. These
arrangements include volume discounts, equipment upgrades and
rent-to-own
programs. These transactions are accounted for in accordance
with Emerging Issues Task Force (EITF) Issue
No. 00-21,
Revenue Arrangements with Multiple Deliverables, when
applicable. We defer the recognition of certain Cryocare
Surgical System revenues where we have continuing performance
obligations. Deferred revenues are adjusted in future periods
when remaining obligations have been met. Deferred revenue as of
December 31, 2004, 2005, and 2006 is not significant and
were included in other accrued liabilities. From time to time,
we may agree to provide equipment upgrades for free or at
significant discounts to select customers who purchased Cryocare
Surgical Systems in the prior years. These offers to upgrade are
at our discretion and intended to facilitate the delivery of our
latest cryoablation technology into the market place. The loss
on equipment provided for upgrades is expensed at the earlier of
the commitment or shipment date. In 2006, we recorded net
expense of $525,000 for the cost of 18 Cryocare Surgical Systems
provided to customers as free or discounted upgrades pursuant to
commitments made in the current year. We have has also reduced
the selling price of Cryocare Surgical Systems to at or near
cost to promote the use of cryoablation as a preferred treatment
option. These initiatives have decreased the gross margin on
sale of Cryocare Surgical Systems.
No customer accounted for more than 10 percent of total
revenues in 2004 or 2005. In 2006 one customer accounted for
28.8 percent of total revenues. This customer accounted for
45.7 percent of our accounts receivable balance as of
December 31, 2006. We derived 91.9 percent,
93.1 percent and 94.2 percent of revenues from sales
in the United States during this three-year period.
We routinely assess the financial strength of our customers and
believe that our accounts receivable credit risk exposure is
limited. Accounts receivable are carried at original invoice
amount less an estimate for doubtful
F-10
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
accounts and sales returns based on a periodic review of
outstanding receivables. International shipments are billed and
collected by Endocare in U.S. dollars. Allowances are
provided for known and anticipated credit losses as determined
by management in the course of regularly evaluating individual
customer receivables. This evaluation takes into consideration a
customers financial condition and credit history as well
as current economic conditions. Accounts receivable are written
off when deemed uncollectible. Recoveries of accounts receivable
previously written off are recorded when received.
Inventories
Inventories, consisting of raw materials,
work-in-process
and finished goods, are stated at the lower of cost or market,
with cost determined by the
first-in,
first-out method. Reserves for slow-moving and obsolete
inventories are provided based on historical experience and
product demand. We evaluate the adequacy of these reserves
periodically.
The following is a summary of inventory (excluding assets of
discontinued operations):
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2005
|
|
|
2006
|
|
|
|
(In thousands)
|
|
|
Raw materials
|
|
$
|
1,646
|
|
|
$
|
1,750
|
|
Work in process
|
|
|
275
|
|
|
|
300
|
|
Finished goods
|
|
|
911
|
|
|
|
778
|
|
|
|
|
|
|
|
|
|
|
Total inventories
|
|
|
2,832
|
|
|
|
2,828
|
|
Less inventory reserve
|
|
|
(370
|
)
|
|
|
(568
|
)
|
|
|
|
|
|
|
|
|
|
Inventories, net
|
|
$
|
2,462
|
|
|
$
|
2,260
|
|
|
|
|
|
|
|
|
|
|
Property
and Equipment
Property and equipment are stated at cost and are depreciated on
a straight-line basis over the estimated useful lives of the
respective assets, which range from three to seven years.
Leasehold improvements are amortized over the shorter of the
estimated useful lives of the assets or the related lease term.
Cryosurgical equipment placed at customer sites for use with our
disposable cryoprobes is depreciated into cost of revenues over
estimated useful lives of three years. Repair and maintenance
costs are expensed as incurred. Depreciation expense from
continuing operations was $2.0 million, $1.7 million
and $1.0 million in 2004, 2005 and 2006, respectively.
The following is a summary of property and equipment (excluding
assets of discontinued operations):
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2005
|
|
|
2006
|
|
|
|
(In thousands)
|
|
|
Equipment and computers
|
|
$
|
1,697
|
|
|
$
|
1,825
|
|
Cryosurgical systems placed at
customer sites
|
|
|
5,746
|
|
|
|
5,019
|
|
Furniture and fixtures
|
|
|
905
|
|
|
|
908
|
|
Leasehold improvements
|
|
|
321
|
|
|
|
321
|
|
|
|
|
|
|
|
|
|
|
Total property and equipment, at
cost
|
|
|
8,669
|
|
|
|
8,073
|
|
Accumulated depreciation and
amortization
|
|
|
(6,875
|
)
|
|
|
(7,033
|
)
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
$
|
1,794
|
|
|
$
|
1,040
|
|
|
|
|
|
|
|
|
|
|
F-11
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Long-Lived
Assets, Goodwill and Intangible Assets Subject to
Amortization
We acquire goodwill and amortizable intangible assets in
business combinations and asset purchases. The excess of the
purchase price over the fair value of net assets acquired are
allocated to goodwill and identifiable intangibles. We do not
amortize goodwill which is consistent with the provisions of
Statement of Financial Accounting Standards (SFAS) No. 142,
Goodwill and other Intangible Assets as more fully
described in Note 5 Impairment of Goodwill and
Other Intangible Assets. Goodwill and indefinite lived
assets are reviewed annually for impairment and on an interim
basis if events or changes in circumstances indicate that the
asset might be impaired.
Intangible assets that are deemed to have finite useful lives
are recorded at cost and amortized using the straight-line
method over their estimated useful lives, as follows:
|
|
|
Trade names (discontinued
operations)
|
|
15 years
|
Domain names
|
|
5 years
|
Covenants not to compete
|
|
3 to 5 years
|
Developed technology (discontinued
operations)
|
|
15 years
|
Patents
|
|
3 to 15 years
|
In accordance with SFAS No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets, we review
long-lived assets for impairment whenever events or changes in
circumstances indicate that the carrying value of such assets
may not be recoverable. We consider assets to be impaired and
write them down to fair value if estimated undiscounted cash
flows associated with those assets are less than their carrying
amounts. Fair value is based upon the present value of the
associated cash flows. Changes in circumstances (for example,
changes in laws or regulations, technological advances or
changes in our strategies) may also reduce the useful lives from
initial estimates. Changes in the planned use of intangibles may
result from changes in customer base, contractual agreements, or
regulatory requirements. In such circumstances, we will revise
the useful life of the long-lived asset and amortize the
remaining net book value over the adjusted remaining useful
life. There were no changes in estimated useful lives during
2004, 2005 and 2006. In the third quarter of 2004, we recorded a
$9.9 million impairment charge relating to the mobile
prostate treatment partnerships (included in continuing
operations) and an impairment charge of $5.9 million
related to Timm Medical (included in discontinued operations)
(see Notes 5 Impairment of Goodwill
and other Intangible Assets and
Note 7 Dispositions and Discontinued
Operations). No impairment charge was recorded in 2005
or 2006.
Amortization expense for each of the years ending
December 31 will consist of the following amounts:
|
|
|
|
|
2007
|
|
$
|
489
|
|
2008
|
|
|
483
|
|
2009
|
|
|
483
|
|
2010
|
|
|
483
|
|
2011
|
|
|
483
|
|
Thereafter
|
|
|
1,192
|
|
|
|
|
|
|
|
|
$
|
3,613
|
|
|
|
|
|
|
Amortization expense from continuing operations totaled
$0.7 million, $0.6 million and $0.6 million in
2004, 2005 and 2006, respectively.
F-12
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following is a summary of intangible assets (excluding
discontinued operations):
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2005
|
|
|
2006
|
|
|
|
(In thousands)
|
|
|
Domain name
|
|
$
|
435
|
|
|
$
|
435
|
|
Covenant not to compete
|
|
|
352
|
|
|
|
352
|
|
Patents
|
|
|
6,205
|
|
|
|
6,205
|
|
|
|
|
|
|
|
|
|
|
Total intangibles
|
|
|
6,992
|
|
|
|
6,992
|
|
Accumulated amortization
|
|
|
(2,825
|
)
|
|
|
(3,379
|
)
|
|
|
|
|
|
|
|
|
|
Intangibles, net
|
|
$
|
4,167
|
|
|
$
|
3,613
|
|
|
|
|
|
|
|
|
|
|
Investments
We hold other investments which primarily consist of strategic
investments of less than 20 percent equity interest in
certain companies acquired in conjunction with various strategic
alliances. These represent minority interests in
start-up
technology companies. We do not have the ability to exercise
significant influence over the financial or operational policies
or administration of any of these companies; therefore, they are
accounted for under the cost method. Realized gains and losses
are recorded when related investments are sold. Investments in
privately-held companies are regularly assessed for impairment
through review of operations and indicators of continued
viability, including operating performance, financing status,
liquidity prospects and cash flow forecasts. Impairment losses
are recorded when events and circumstances indicate that such
assets might be impaired and the decline in value is
other-than-temporary.
These investments are included in investments and other assets.
Product
Warranties
Certain of our products are covered by warranties against
defects in material and workmanship for periods up to two years
after the sale date. The estimated warranty cost is recorded at
the time of sale and is adjusted periodically to reflect actual
experience. Factors that affect our warranty liability include
the number of units sold, historical and anticipated rates of
warranty claims, and cost per claim. Our warranty costs and
liability (included in other accrued liabilities) were not
significant for 2004, 2005 or 2006.
Research
and Development
Research and development activities are performed primarily
in-house. Expenditures primarily include personnel, clinical
studies, and material expenses incurred to design, create, and
test prototypes. These expenditures are charged to operations as
incurred until technological feasibility has been established.
Costs to maintain patents are included in general and
administrative expenses.
Advertising
Advertising costs are included in selling and marketing expenses
as incurred and totaled $0.5 million, $0.3 million and
$0.3 million for 2004, 2005 and 2006, respectively.
Shipping
and Handling Costs
We incurred shipping and handling costs in the normal course of
business. All shipping and handling costs related to our
products are charged to cost of sales as incurred.
F-13
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Cash and
Cash Equivalents
All highly liquid investments purchased with an original
maturity of three months or less are considered to be cash
equivalents. Cash and cash equivalents include money market
funds and various deposit accounts.
We have $0.2 million in restricted cash on a certificate of
deposit which collateralizes the outstanding premium balance on
our directors and officers liability insurance
policy. The required deposits steps down ratably throughout the
remaining policy period. The policy period ends April, 2007. We
classify this restricted cash in prepaids and other current
assets since the premiums due are included in current
liabilities.
Concentrations
of Credit Risk
Financial instruments, which potentially subject us to
concentrations of credit risk, primarily consist of cash and
cash equivalents, and accounts receivable and notes receivable.
We may be exposed from time to time to credit risk with our bank
deposits in excess of the FDIC insurance limits. We have not
experienced any losses in such accounts and believe we are not
exposed to any significant credit risk on cash and cash
equivalents. Our receivables are derived primarily from sales of
Cryocare Surgical Systems and cryoablation disposable products
to medical facilities, medical groups and urologists.
Cryoablation procedure fees are generated from medical
facilities. We have one customer that accounted for
28.8 percent of our revenues for the year ended
December 31, 2006. This same customer accounted for
39.8 percent of our fourth quarter 2006 revenues. Our
accounts receivable as of December 31, 2006 consisted of
45.7 percent of receivables from this customer. We have no
history of past due receivables from this customer. We perform
ongoing credit evaluations of our customers and generally do not
require collateral. Reserves are maintained for potential credit
losses. There are no significant concentrations of credit risk
with respect to trade receivables except for the customer
referenced above.
We also have a note receivable from the sale of a Timm Medical
product line in 2003 and from the divestiture of Timm Medical in
2006, which is secured. We also have a secured note receivable
from a shareholder consultant to Endocare. These are included in
investments and other assets. We evaluate the creditworthiness
of the debtors periodically and provide allowances for
uncollectible amounts. In the fourth quarter of 2006, we
recorded a $0.4 million charge to write off the shareholder
note and reduced the carrying value of the note from the sale of
Timm Medical by $0.3 million. See Note 7
Dispositions and Discontinued Operations and
Note 14 Related Party
Transactions, for further discussion.
Fair
Value of Financial Instruments
The primary objective of our investment activities is to
preserve principal while at the same time maximize the income we
receive from our invested cash without significantly increasing
the risk of loss. Our consolidated balance sheets include the
following financial instruments: cash and cash equivalents,
accounts and notes receivable, minority investments, accounts
payable, accrued liabilities and common stock warrants. The
carrying amounts of current assets and liabilities approximate
their fair values because of the relatively short period of time
between the origination of these instruments and their expected
realization. The interest rates on the notes receivable related
to Timm Medical generally approximate market rates for secured
obligations of similar terms and maturity. The fair value of
minority investments cannot be estimated since the investees are
privately held early stage companies. The common stock warrants
are recorded at fair value, which is adjusted each quarter using
a modified Black-Scholes pricing model.
Risks and
Uncertainties
Our profitability depends in large part on increasing our
revenue base and effectively managing costs of sales, customer
acquisition costs and administrative overhead. We continually
review our pricing and cost structure in an effort to select the
optimal revenue and distribution models. Several factors could
adversely affect revenues and costs, such as changes in health
care practices, payer reimbursement, inflation, new
technologies, competition and
F-14
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
product liability litigation, which are beyond our control and
could adversely affect our ability to accurately predict
revenues and effectively control costs. Many purchasers of our
products and services rely upon reimbursement from third-party
payers, including Medicare, Medicaid and other government or
private organizations. These factors could have a material
adverse effect on our financial condition, results of operations
or cash flows.
Reclassification
Certain previously reported amounts have been reclassified to
conform to the current presentation.
Off-Balance
Sheet Financings and Liabilities
Other than lease commitments, legal contingencies incurred in
the normal course of business, and employment contracts, we do
not have any off-balance sheet financing arrangements or
liabilities. In addition, our policy is not to enter into
derivative instruments, futures or forward contracts. Our
business is transacted solely in U.S. dollars and, while
future fluctuations of the U.S. dollar may affect the price
competitiveness of our products, there is no known significant
direct foreign currency exchange rate risk. Finally, we do not
have any majority-owned subsidiaries or any interests in, or
relationships with, any material special-purpose entities that
are not included in the consolidated financial statements.
Other
Accrued Liabilities
Other accrued liabilities as of December 31, 2005 and 2006
includes $3.4 million and $2.8 million in state and
local taxes, primarily sales and use taxes in various
jurisdictions in the United States.
Capital
Stock and Earnings Per Share
In February 2004, we retired 326,222 of our common shares held
in treasury, including 120,022 shares purchased from
BioLife Solutions, Inc. (BioLife) for approximately
$0.5 million, in connection with settlement of our
litigation with BioLife which was concluded in February 2004.
Basic net income or loss per share is computed by dividing net
income or loss by the weighted average number of common shares
outstanding for the respective periods. Diluted loss per share,
calculated using the treasury stock method, gives effect to the
potential dilution that could occur upon the exercise of certain
stock options and warrants that were outstanding during the
respective periods presented. For periods when we reported a net
loss from continuing operations, these potentially dilutive
common shares were excluded from the diluted income or loss per
share calculation because they were anti-dilutive.
Taxes
We recognize deferred tax assets and liabilities for temporary
differences between the financial reporting basis and the tax
basis of our assets and liabilities along with net operating
loss and credit carryforwards, if it is more likely than not
that the tax benefits will be realized. To the extent a deferred
tax asset cannot be recognized under the preceding criteria,
allowances must be established. The impact on deferred taxes of
changes in tax rates and laws, if any, are applied to the years
during which temporary differences are expected to be settled
and reflected in the financial statements in the period of
enactment.
Stock-Based
Compensation
As of December 31, 2006, we have five stock-based employee
compensation plans and one non-employee director stock-based
compensation plan. Prior to January 1, 2006, we accounted
for stock-based compensation for those plans under the
recognition and measurement provisions of Accounting Principles
Board Opinion No. 25, Accounting for Stock Issued to
Employees (APB 25) as permitted by
SFAS No. 123, Accounting for Stock Based
F-15
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Compensation. Compensation expense recorded under
APB 25 has not been significant since we generally grant
options with an exercise price equal to the fair value of our
common stock on the date of grant.
Effective January 1, 2006, we adopted
SFAS No. 123 (revised 2004), Share Based Payment
(SFAS No. 123R) using the modified
prospective transition method. Among other items,
SFAS No. 123R eliminates the use of the intrinsic
value method of accounting under APB 25 and requires
companies to recognize in the financial statements the cost of
employee services received in exchange for awards of equity
instruments based on the grant date fair value of those awards.
Under the modified prospective method, we recognize compensation
cost in the financial statements beginning with the effective
date based on the requirements of SFAS No. 123R for
all share-based payments granted, modified or settled after
January 1, 2006, and based on the requirements of
SFAS No. 123 for all unvested awards granted prior to
the effective date.
We will continue to use the Black-Scholes standard option
pricing model and the single option award approach to measure
the fair value of the stock options granted to employees. In
conjunction with the adoption of SFAS No. 123R, we
modified certain assumptions and estimation methodologies for
inputs to the Black-Scholes valuation calculations in accordance
with the requirements of SFAS No. 123R and Staff
Accounting Bulletin (SAB) No. 107, Share-Based
Payment. These changes primarily include the following:
a. We increased the expected term from five years to
6.25 years using the shortcut method under
SAB 107 (an expected term based on the mid point between
the vesting date and the end of the contractual term). The use
of the short cut method is permitted through December 31,
2007. We will convert to company-specific experience on or
before January 1, 2008. The options have a maximum
contractual term of 10 years and vest pro-rata over four
years, which is the requisite service period.
b. While we continue to use historical volatility (based on
daily trading prices) to estimate the fair value of options
granted, we have increased the period over which volatility is
measured from three years to 6.25 years. We have excluded
the period from October 24, 2002 to January 16, 2003
(inclusive) during which our common stock experienced unusually
high volatility as a result of announcement of our failure to
file the September 30, 2002
Form 10-Q,
temporary suspension of trading, delisting of our shares from
NASDAQ, and an investigation commenced by the SEC. These changes
resulted in a net decrease in volatility from previous
estimates. Average volatility for options granted in 2004, 2005
and during the year ended December 31, 2006 was
approximately 89.0 percent, 90.3 percent and
69.5 percent, respectively. We did not incorporate implied
volatility since there are no actively traded option contracts
on our common stock and sufficient data for an accurate measure
of implied volatility were not available.
c. Prior to January 1, 2006, we accounted for
forfeitures as they occurred. Compensation expense related to
unvested forfeited options was reversed in the period the
employee was terminated. Upon adoption of
SFAS No. 123R, we have estimated an average forfeiture
rate of approximately 25.0 percent based on historical
experience from 2001 through December 31, 2006. Stock-based
compensation expense recorded in the 2006 periods is net of
expected forfeitures. We will periodically assess the forfeiture
rate. Changes in estimates will be recorded in the period of
adjustment, if any.
We have no unamortized deferred compensation relating to
outstanding option grants since we generally award stock options
to our employees with exercise prices equal to the fair value of
the underlying common stock on the date of grant. Due to our
continuing losses, we do not recognize deferred tax assets
related to our stock-based compensation and we have not recorded
benefits for tax deductions in excess of recognized compensation
costs (required to be recorded as financing cash flows) due to
the uncertainty of when we will generate taxable income to
realize such benefits.
As a result of adopting SFAS No. 123R, our loss from
continuing operations and net loss for the year ended
December 31, 2006 was $2.6 million ($0.09 per
basic and diluted share) greater than if we had continued to
account for stock-based compensation under APB 25 and its
related interpretations. Of the $2.6 million recorded
during the year ended December 31, 2006 $56,000, was
expensed as cost of goods sold, $0.1 million was included
in research
F-16
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
and development expenses, $0.6 million in selling and
marketing expenses and $1.8 million in general and
administration expenses. As of December 31, 2006, there was
$3.4 million (net of estimated forfeitures) of total
unrecognized compensation costs related to unvested stock-based
compensation arrangements granted under the stock option plans.
That cost is expected to be amortized on a straight-line basis
over a weighted average period of 1.2 years less any stock
options forfeited prior to vesting. As of December 31,
2006, stock compensation cost capitalized as inventory was
insignificant.
Prior to January 1, 2006, we accounted for stock-based
employee compensation plans in accordance with APB 25 and
followed the pro forma disclosure requirements set forth in
SFAS No. 123. The following table illustrates the
effect on net loss and loss per share for the years ended
December 31, 2004 and 2005 as if we had applied the fair
value recognition provisions of SFAS No. 123 to
stock-based employee compensation. The amounts in the table
below include stock-based compensation expense related to Timm
Medical which was not significant (dollars in thousands, except
per share amounts):
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2004
|
|
|
2005
|
|
|
Net loss, as reported(a)
|
|
$
|
(37,619
|
)
|
|
$
|
(13,679
|
)
|
Add: Stock-based employee
compensation expense included in reported net loss for all
awards(b)
|
|
|
136
|
|
|
|
43
|
|
Less: Total stock-based employee
compensation expense determined under fair value based method
for all awards
|
|
|
(3,875
|
)
|
|
|
(3,696
|
)
|
|
|
|
|
|
|
|
|
|
Net loss, as adjusted
|
|
$
|
(41,358
|
)
|
|
$
|
(17,332
|
)
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share:
|
|
|
|
|
|
|
|
|
As reported
|
|
$
|
(1.55
|
)
|
|
$
|
(0.47
|
)
|
As adjusted
|
|
$
|
(1.70
|
)
|
|
$
|
(0.60
|
)
|
The fair value of each option grant is estimated on the date of
grant using the Black-Scholes option pricing model with the
following assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
Stock volatility
|
|
|
0.89
|
|
|
|
0.90
|
|
|
|
0.70
|
|
Risk-free interest rate
|
|
|
3.6
|
%
|
|
|
4.0
|
%
|
|
|
4.6
|
%
|
Expected life in years
|
|
|
5 years
|
|
|
|
5 years
|
|
|
|
6.25 years
|
|
Stock dividend yield
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
In the past, we had issued stock options and warrants to
consultants for services performed. Compensation expense for the
fair value of these options was determined by the Black-Scholes
option-pricing model and was charged to operations over the
service period or as performance goals were achieved. Such
expense was included in net loss as reported. |
|
(b) |
|
Since we issue options with exercise prices equal to or
exceeding the fair values of the underlying common stock, no
compensation expense was recorded for options issued to
employees. The recorded expense generally related to
compensation charges upon modification of vesting terms,
cashless exercises, and other non-routine transactions. |
Weighted average expected volatility for stock options granted
in 2004 and 2005 was based on daily trading prices from April
2003 and an expected term of five years. The risk free interest
rate reflects the yield on zero coupon U.S. treasuries at
the date of grant, based on the median time the options are
expected to be outstanding. No expected dividend yield is used
because we have not historically paid dividends and do not
intend to pay dividends in the foreseeable future.
F-17
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
4.
|
Recent
Accounting Pronouncements
|
In June 2006, the Financial Accounting Standards Board (FASB)
issued Interpretation No. 48, Accounting for Uncertainty
in Income Taxes, an interpretation of
SFAS No. 109, Accounting for Income Taxes
(FIN 48) to create a single model to address
accounting for uncertainty in tax positions. FIN 48
clarifies the accounting for income taxes, by prescribing a
minimum recognition threshold a tax position is required to meet
before being recognized in the financial statements. FIN 48
also provides guidance on de-recognition, measurement,
classification, interest and penalties, accounting in interim
periods, disclosure and transition. FIN 48 is effective for
fiscal years beginning after December 15, 2006. We will
adopt FIN 48 as of January 1, 2007, as required. The
cumulative effect of adopting FIN 48 will be recorded in
retained earnings. We are in the process of determining the
effect, if any, the adoption of FIN 48 will have on our
financial position and results of operations.
FASB Staff Position (FSP)
No. 00-19-2,
Accounting for Registration Payment Arrangements, was
issued in December 2006 to addresses an issuers accounting
for a registration payment arrangement. The FSP specifies that
the contingent obligation to make future payments or otherwise
transfer consideration under a registration payment arrangement
should be separately recognized and measured in accordance with
SFAS No. 5, Accounting for Contingencies. For
registration payment arrangements and financial instruments
subject to those arrangements that were entered into prior to
the issuance of this FSP and that continue to be outstanding at
the adoption date, this guidance is effective for fiscal years
beginning after December 15, 2006 and interim periods
within those fiscal years. As more fully described under
Note 6 Private Placement of Common
Stock and Warrants, we issued warrants in conjunction
with common shares in a March 2005 private placement. Under a
related registration rights agreement, we were required to file
a registration statement to cover the resale of the shares and
the shares underlying the warrants within 30 days of
closing and to have the registration statement declared
effective within 90 days of closing. We were subject to
liquidation damages when the filing and the effectiveness date
occurred after the required time period and incurred penalties
of $0.6 million in 2005. The registration obligation
remains outstanding until the warrants are exercised or expired
and additional liquidation damages may be incurred if the
effectiveness of the registration statement lapses. We currently
accounts for the registration payment arrangement and warrants
as one instrument classified as a derivative (a non-current
liability) under EITF
No. 00-19,
Accounting for Derivative Financial Instruments Indexed to,
and Potentially Settled in, a Companys Own Stock. Upon
adoption of this FSP on January 1, 2007, the warrants will
be reclassified to equity without regard to the contingent
obligation to transfer consideration under the registration
payment arrangement. The amount that would have been recognized
for the warrants at the original issuance date
($5.7 million) will be reclassified to equity. The
difference between the $5.7 million and the carrying value
of the warrant liability as of December 31, 2006
($1.3 million) will be recorded as a cumulative-effect
adjustment to reduce opening retained earnings on
January 1, 2007. Thereafter, accruals for liquidated
damages, if any, will be recorded when they are probable and
reasonably estimable.
Other recent accounting pronouncements issued by the FASB
(including its Emerging Issues Task Force), the AICPA, and the
SEC did not, or are not believed by management to, have a
material impact on our present or future consolidated financial
statements.
|
|
5.
|
Impairment
of Goodwill and Other Intangible Assets
|
Under SFAS No. 142, Goodwill and Other Intangible
Assets, goodwill and indefinite-lived intangible assets are
not amortized but instead are reviewed annually for impairment
and on an interim basis if events or changes in circumstances
between annual tests indicate that an asset might be impaired.
Goodwill is tested for impairment by comparing its fair value to
its carrying value under a two-step process. The first step
requires us to compare the fair value of its reporting units to
the carrying value of the net assets of the respective reporting
units, including goodwill. Our management is primarily
responsible for estimating fair value for impairment purposes.
Management may consider a number of factors, including
valuations or appraisals, when estimating fair value. If the
fair value of the reporting unit is less than the carrying
value, goodwill of the reporting unit is potentially impaired
and we then
F-18
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
complete step two to measure the impairment loss, if any. The
second step requires the calculation of the implied fair value
of goodwill by deducting the fair value of all tangible and
intangible net assets of the reporting unit from the fair value
of the reporting unit. If the implied fair value of goodwill is
less then the carrying amount of goodwill, an impairment loss is
recognized equaled to the difference.
In accordance with SFAS No. 142, we completed our
annual goodwill impairment test on October 1, 2004 and 2005
for all of our reporting units. We assessed the fair values of
each reporting unit based on a weighted combination of
(i) the guideline company method that utilizes revenue
multiples for comparable publicly-traded companies, and
(ii) a discounted cash flow model that utilizes future net
cash flows, the timing of these cash flows, and a discount rate
(or weighted average cost of capital which considers the cost of
equity and cost of debt financing expected by a typical market
participant) representing the time value of money and the
inherent risk and uncertainty of the future cash flows. We then
determined the implied fair value of the goodwill
and amortizable intangibles. Based on this analysis, we recorded:
a) A third quarter of 2004 impairment charge of
$5.9 million to reduce the carrying value of Timm
Medicals goodwill ($3.1 million) and developed
technology ($2.1 million) to fair value and an additional
charge of approximately $0.7 million for the estimated cost
to sell Timm Medical. The charge is included in the net loss
from discontinued operations. The interim impairment analysis in
the third quarter of 2004 was required based on our decision to
actively market Timm Medical to potential buyers in July 2004,
as well as declining revenues, turnover in sales force, and
below average growth as compared to general industry trends.
Based on the purchase price received by us from the sale of Timm
Medical completed in February 2006 (see Note 7
Dispositions and Discontinued Operations),
there was no further impairment as of December 31, 2005.
b) A third quarter of 2004 impairment charge of
$9.9 million to write-off the carrying value of goodwill
($9.8 million) and covenant not to compete
($0.1 million) with respect to the pending divestiture of
the mobile prostate treatment businesses (the Partnerships). We
originally acquired the Partnerships in September 2002. The
goodwill primarily related to the distribution network provided
by the Partnerships, which allowed us to further penetrate
desired markets. Since investors in the mobile treatment
businesses are comprised of urologists, the Partnerships
facilitated the continued promotion of cryosurgery as the
preferred treatment for prostate cancer. In addition, upon our
purchase of the Partnerships, the seller (USMD) exited the
cryosurgical operations and terminated its exclusive
distribution agreement with us, allowing us to access a
previously restricted market. After we sold the Partnerships in
December 2004, we still expected to, and did, retain access to
the service and distribution network through our existing
contracts and continue to benefit from the strategic value of a
non-exclusive distribution arrangement with the buyer. However,
since this economic benefit could not be quantified with
reasonable accuracy, we recorded the $9.9 million charge to
write off the excess of the carrying value of the
Partnerships net assets over the preliminary purchase
offer, less selling costs. See Note 7
Dispositions and Discontinued Operations for
the loss recorded upon final sale in the fourth quarter of 2004.
As of December 31, 2006, after Timm Medical was sold in
February 2006, there was no remaining goodwill or indefinite
life intangibles.
|
|
6.
|
Private
Placement of Common Stock and Warrants
|
Fusion
Capital Equity Purchase Agreement
On October 25, 2006, we entered into an agreement with
Fusion Capital Fund II, LLC (Fusion Capital)
pursuant to which we have the right to sell to Fusion Capital up
to $16.0 million worth of common stock, at our election,
over a two year period at prices determined based upon the
market price of our common stock at the time of each sale,
without any fixed discount. Common stock may be sold in $100,000
increments every fourth business day, with additional $150,000
increments available every third business day if the market
price of our common stock is $1.50 or higher. This $150,000
increment can be further increased at graduated levels up to
$1.0 million if
F-19
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
the market price increases from $1.50 to $6.00. If the price of
the stock is below $1.00 per share, the obligation for
Fusion Capital to buy any shares of stock is automatically
suspended. Under the terms of the agreement, we issued
437,957 shares of common stock to Fusion Capital for no
consideration as a commitment fee.
Under a related registration rights agreement, before Fusion
Capital is obligated to purchase shares, we were required to
file a registration statement covering the sale of up to
8,473,957 common shares within 20 days of signing the
agreement. The
Form S-1
was filed in November 2006 and declare effective on
December 1, 2006. We are required to maintain effectiveness
of the registration statement until the earlier of the date that
Fusion Capital may sell the shares without restriction pursuant
to Rule 144(k) or the date that Fusion Capital has sold all
purchased shares and no available unpurchased shares remain
under the agreement. Upon occurrence of certain events of
default as defined, including lapse of effectiveness of the
registration statement for 10 or more consecutive business days
or for 30 or more business days within a
365-day
period, suspension of trading for 3 business days, delisting of
the shares from the principal market on which they are traded,
failure by our stock transfer agent to issue shares within
5 business days, or other material breaches, Fusion Capital
may terminate the stock purchase agreement. We have the right to
terminate the agreement at any time.
In December 2006, we sold 30,242 shares for $50,000.
Through February 28, 2007, we sold an additional
536,736 shares for $1.0 million. We are obligated to
pay a transaction fee equal to 6.0 percent of the stock proceeds
to an investment advisory firm under a
pre-existing
capital advisory agreement.
March
2005 Private Placement
On March 11, 2005, we completed a private placement of
5,635,378 shares of our common stock and detachable
warrants to purchase 3,944,748 common shares at an offering
price of $2.77 per share, for aggregate gross proceeds of
$15.6 million. Transaction costs were $1.0 million,
resulting in net proceeds of $14.6 million. Of the total
warrants, 1,972,374 have an initial exercise price of $3.50
(Series A warrants) per share and 1,972,374 have an initial
exercise price of $4.00 (Series B warrants) per share.
The warrants have an anti-dilution clause that is triggered upon
issuance of a certain number of shares of our common stock that
reduces the effective exercise price of the warrants to preserve
the ownership of the warrant holders. As a result of the
issuance of 504,199 shares to Fusion capital in 2006,
described above, the exercise price of the Series A
Warrants decreased to $3.46 to effectively provide holders an
additional 24,967 shares. The Series B Warrants
exercise price decreased to $3.95 to effectively provide the
holders another 22,802 shares. Additionally, through
February 28, 2007 we issued an additional
536,736 shares to Fusion Capital, which decreased the
Series A Warrant exercise price to $3.41 to effectively
provide holders an additional 25,607 shares and the
Series B Warrant exercise price decreased to $3.90
effectively providing the Series B Warrant holders an
additional 29,255 shares.
The warrants initially are exercisable at any time until
March 11, 2010 for cash only. The warrants may be exercised
on a cashless exercise basis in limited circumstances after the
first anniversary of the closing date if there is not an
effective registration statement covering the resale of the
shares underlying the warrants. Each warrant is callable by us
at a price of $0.01 per share underlying such warrant if
our stock trades above certain dollar thresholds ($6.50 for the
Series A warrants and $7.50 for Series B warrants) for
20 consecutive days commencing on any date after the
effectiveness of the registration statement, provided that
(a) we provide
30-day
advanced written notice (Notice Period), (b) we
simultaneously call all warrants on the same terms and
(c) all common shares issuable are registered. Holders may
exercise their warrants during the Notice Period and warrants
which remain unexercised will be redeemed at $0.01 per
share.
Upon exercise we will pay transaction fees equal to six percent
of the warrant proceeds under an existing capital advisory
agreement.
Pursuant to the terms of the registration rights agreement, we
filed with the SEC a registration statement on
Form S-2
under the Securities Act of 1933, as amended, covering the
resale of all of the common stock purchased
F-20
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
and the common stock underlying the issued warrants. The
S-2
registration statement was declared effective September 28,
2005. We subsequently filed a post effective amendment on
Form S-3,
which was declared effective on March 28, 2006. As a result
of the delay in obtaining effectiveness of the original
registration statement the warrant expiration date was extended
to May 1, 2010, pursuant to the terms of the warrants.
The registration rights agreement further provides that if a
registration statement is not filed within 30 days of
closing or does not become effective within 90 days
thereafter, then in addition to any other rights the holders may
have, we will be required to pay each holder an amount in cash,
as liquidated damages, equal to one percent per month of the
aggregate purchase price paid by such holder. We incurred
$0.6 million of total liquidated damages through
September 28, 2005, when the
S-2
registration statement was declared effective. Liquidated
damages are included in general and administrative expenses. We
could incur similar liquidated damages in the future if holders
are unable to make sales of their shares under the registration
agreement if, for example, we fail to keep the registration
statement effective as required by SEC rules or if future
amendments to the registration statement are not declared
effective in a timely manner.
Since the liquidated damages under the registration rights
agreement could in some cases exceed a reasonable discount for
delivering unregistered shares, the warrants have been
classified as a liability until the earlier of the date the
warrants are exercised in full or expire. In accordance with
EITF 00-19,
Accounting for Derivative Financial Instruments Indexed To,
and Potentially Settled In, a Companys Own Stock, we
have allocated a portion of the offering proceeds to the
warrants based on their fair value. EITF
00-19 also
requires that we revalue the warrants as a derivative instrument
periodically to compute the value in connection with changes in
the underlying stock price and other assumptions, with the
change in value recorded as interest expense. We determined the
fair value of the warrants as follows as of December 31,
2006:
|
|
|
|
|
First, the Black-Scholes option-pricing model was used with the
following assumptions: an expected life equal to the remaining
contractual term of the warrants (3.25 years); no
dividends; a risk free rate of 4.73 percent, which equals
the yield on Treasury bonds at constant (or fixed) maturity
equal to the remaining contractual term of the warrants; and
volatility of 53.53 percent. Under these assumptions, the
Black-Scholes option-pricing model yielded a value of $0.38 for
each of the Series A warrants and $0.32 for each of the
Series B warrants, for an aggregate value of
$1.4 million;
|
|
|
|
Second, since the warrants are limited in the amount of
realizable profit to the holders as a result of the call
provision described above, we reduced the value of the warrants
to account for the probability that the stock price will reach
or exceed $6.50 and $7.50, respectively ( i.e., the
prices above which we have the right to call the Series A
and Series B warrants, effectively compelling the holders
to exercise their warrants). We used a statistical formula to
calculate the probability that our stock price will reach or
exceed $6.50 and $7.50, respectively. Based on this formula, we
calculated that, for the Series A warrants, the probability
that the stock price of $6.50 will be reached or exceeded is
approximately 0.28 percent. Similarly, we calculated that,
for the Series B warrants, the probability that the stock
price of $7.50 will be reached or exceeded is approximately
0.04 percent. Based on these probabilities, the valuation
of each of the Series A warrants is calculated at $0.38
(which equals one minus 0.28 percent, multiplied by $0.38)
and the valuation of each of the Series B warrants is
calculated at $0.32 (which equals one minus 0.04 percent,
multiplied by $0.32). This yields an aggregate value of the
warrants equal to $1.4 million; and
|
|
|
|
Third, we further reduced the value of the warrants on the
assumption that our stock price on the day that the warrants are
exercised will be affected by dilution as a result of the
additional stock introduced into the market. Given that there
are approximately 30.7 million shares outstanding, we
calculated that the exercise of the warrants will result in
dilution of approximately 6.2 percent. Using the dilution
figure of 6.2 percent, we reduced the value of each of the
Series A warrants to $0.36 and the Series B warrants
to $0.31. This yields an aggregate value of the warrants equal
to $1.3 million.
|
F-21
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
As a result of this fair value calculation, we recorded negative
interest expense of $3.7 million for the year ended
December 31, 2006 (as compared to a reduction of
$0.7 million in 2005), which represents the change in the
fair value of the warrants from December 31, 2005. The
decrease in the warranty liability is primarily a result of the
decrease in the share price from $2.74 at December 31, 2005
to $1.77 at December 31, 2006, decrease in the overall
volatility of our common shares and the continual lapse of the
remaining contractual term. The $3.7 million includes a
$0.8 million benefit ($0.03 per basic and diluted
share) benefit from the reduction in the fair value of the
warrants as previously calculated at December 31, 2005 due
to changes in the methodology we used to measure volatility in
conjunction with the adoption of SFAS No. 123R,
Share Based Payment as further discussed in
Note 3 Summary of Significant
Accounting Policies Stock-Based
Compensation above. This reduction was a change in estimate
and was recorded in 2006 first quarter operations.
Under EITF
00-19, the
warrant liability will not be classified into stockholders
equity until the earlier of the warrant exercise or expiration
date. Until that time, the warrant liability is recorded at fair
value based on the methodology described above. We do not expect
that the warrants will be exercised within the next
12 months based on the current trading prices of our common
stock and has classified the warrants as a non-current liability
at December 31, 2005 and 2006. Changes in fair value during
each period is recorded as interest expense. As discussed in
Note 4 Recent Accounting
Pronouncements, upon the adoption of FSP
No. 00-19-2,
Accounting for Registration Payment Arrangements, on
January 1, 2007, the warrant liability will be reclassified
to stockholders equity.
One current member and one former member of our management team
made personal investments totaling $0.7 million in the
aggregate, and a member of the board of directors invested
$0.3 million in the 2005 private placement.
|
|
7.
|
Dispositions
and Discontinued Operations
|
Timm
Medical 2005
We acquired Timm Medical in February 2002. During 2003 certain
non-core product lines of Timm Medical were divested (see
below). In July 2004, we began to actively market Timm Medical
for sale in conjunction with a fund-raising initiative. We
reported Timm Medical as an asset held for sale effective July
2004 and recorded an impairment charge totaling
$5.9 million to reduce the carrying value of Timm Medical
to fair value, less costs to sell. Following the completion of
the $15.6 million private placement in March 2005 (see
Note 6 Private Placement of Common
Stock and Warrants) we reclassified Timm Medical as
held and used in the first quarter of 2005 as we were no longer
seeking a buyer and had ceased all marketing efforts. As a
result of this change in plan, included in net income from
discontinued operations for the year ended December 31,
2005 is $0.4 million in depreciation and amortization
expense for fixed assets and intangibles for the period from
July 31, 2004 to March 31, 2005 and $0.6 million
income as a result of the elimination of the estimated costs to
sell, which were previously reported as a component of the 2004
impairment charge.
In late 2005 we received substantive expression of interest from
Plethora Solutions Holdings plc (Plethora), a company listed on
the London Stock Exchange, to acquire Timm Medical and the
parties entered into a Stock Purchase Agreement on
January 13, 2006. The transaction closed on
February 10, 2006. We have not received significant direct
cash flows from Timm Medical and have not had significant
continuing involvement in its operations since the sale. In
accordance with SFAS No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets, the assets and
liabilities of Timm Medical were classified as discontinued
operations in the consolidated financial statements for each
year presented. The assets and liabilities of Timm Medical as of
December 31, 2005 were classified as current. Sale proceeds
(net of $0.6 million of transaction costs) totaled
$8.9 million which resulted in a gain on sale of
$0.5 million recorded in the first quarter of 2006. The
gross proceeds of $9.5 million included cash of
$8.1 million and a two-year, five percent promissory note
secured by the assets of Timm Medical for $1.4 million. The
note is convertible into Plethoras ordinary shares at any
time. If Plethoras shares trade above a specified amount
for 20 consecutive days, Plethora has the option to require
conversion. We are currently in negotiations with Plethora to
accelerate the payment of the note by no later than June of 2007
for a lump
F-22
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
sum reduced amount. The final settlement is subject to approval
by the Board of Directors. Based on these negotiations we have
reserved $0.3 million of the note balance in the fourth
quarter of 2006. Net cash proceeds from the divestiture were
$7.5 million (after $0.6 million in transaction costs
and $0.04 million in cash of Timm Medical as of the
disposition date).
We agreed to retain certain assets and liabilities of Timm
Medical, including all tax liabilities totaling
$1.1 million, obligations and rights to a $2.7 million
note receivable from the sale of Timm Medicals urinary
incontinence product line in 2003, certain litigation to which
Timm Medical is a party and ownership of Urohealth BV (Timm
Medicals wholly-owned subsidiary with insignificant
operations). Assets and liabilities we retained and their
related revenues and expenses are excluded from discontinued
operations. The stock purchase agreement requires an
indemnification escrow of $1.4 million (proceeds from the
note receivable under certain circumstances in conjunction with
the notes payment terms) to indemnify Plethora against
certain claims and liabilities.
Assets and liabilities of discontinued operations as of
February 10, 2006 and December 31, 2005 included the
following:
|
|
|
|
|
|
|
|
|
|
|
Feb 10,
|
|
|
Dec 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
Cash, inventories and other
current assets
|
|
$
|
1,041
|
|
|
$
|
1,216
|
|
Property and equipment, net
|
|
|
71
|
|
|
|
75
|
|
Goodwill, net
|
|
|
4,552
|
|
|
|
4,552
|
|
Intangibles, net
|
|
|
3,680
|
|
|
|
3,716
|
|
Other assets
|
|
|
65
|
|
|
|
65
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
9,409
|
|
|
$
|
9,624
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities:
|
Accounts payable and other current
liabilities
|
|
|
502
|
|
|
$
|
942
|
|
Other accrued liabilities
|
|
|
486
|
|
|
|
519
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
988
|
|
|
|
1,461
|
|
|
|
|
|
|
|
|
|
|
Net assets
|
|
$
|
8,421
|
|
|
$
|
8,163
|
|
|
|
|
|
|
|
|
|
|
Revenues for Timm Medical were $8.5 million,
$9.3 million and $1.0 million in 2004, 2005 and 2006,
respectively. The operations of Timm Medical are classified as
discontinued operations as a result of the sale of Timm Medical
in 2006. The 2004 loss from Timm Medical included a
$5.9 million impairment charge to write down goodwill and
intangible assets. Income from discontinued operations for the
year ended December 31, 2006 includes a $0.5 million
gain on disposal and is net of $0.2 million in taxes.
Cryosurgical
Products for Cardiac Applications
On April 14, 2003, we sold our cardiac-related product
manufacturing operations and licensed the related intellectual
property to CryoCath Technologies, Inc. (CryoCath) for
$10.0 million. CryoCath was the exclusive distributor for
cryoprobes and consoles in connection with the
SurgiFrosttm
system, a cryoablation system designed to treat cardiac
arrhythmias. We transferred all of our manufacturing assets and
inventory related to the cardiac product line to CryoCath,
including technical know-how, vendor lists, production equipment
and inventory. In addition, CryoCath received an exclusive
worldwide perpetual license for cardiac uses to our proprietary
argon gas based technology associated with the product and makes
payments to us under a nine-year descending royalty stream based
on net sales of products incorporating the licensed technology.
We also agreed to a
12-year
worldwide covenant not to compete in the cardiac field. Upon the
consummation of the sale, we terminated our pre-existing
F-23
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
distribution agreement with CryoCath. We are required to attend
quarterly and annual technical update meetings through 2014.
Since the technology was internally developed and the tangible
assets sold had minimal value, the sale resulted in a 2003
second quarter gain of $10.0 million. The royalty stream
decreases from 10 percent to 3 percent of net sales
from the SurgiFrosttm system during the period 2004 to 2012. The
royalty payments are recorded in the periods earned. We have
collected $7.5 million of the total sale proceeds in 2003
and the remaining $2.5 million in January 2004. Royalty
income was $0.6 million, $0.9 million and
$0.6 million in 2004, 2005 and 2006, respectively.
Urinary
Incontinence and Urodynamics
On October 15, 2003, Timm Medical agreed to sell the
manufacturing assets related to its urodynamics and urinary
incontinence product lines to SRS Medical Corp.
(SRS) for a $2.7 million note. These assets
include certain patents and trademarks related to the
urodynamics and urinary incontinence products, inventory,
customer lists and technical know-how. The note bears interest
at 7.5 percent and is secured by the assets sold. As
amended in March 2004, the note requires quarterly payments of
$45,000 beginning March 31, 2004, increasing to $60,000 for
the quarter ended December 31, 2005. Amounts which remain
outstanding at December 31, 2005 are payable at least
$60,000 per quarter until the outstanding principal and
accrued interest are paid in full. The carrying values of the
urodynamics and urinary incontinence-related assets were
$1.3 million on the date of sale. Management concluded that
collection of the note from SRS was not reasonably assured. As a
result, a loss of $1.3 million was recorded in the fourth
quarter of 2003 equal to the carrying value of the assets sold
and collections on the note, if any, will be reported as gain in
the period received. Collections during 2004, 2005 and 2006 were
$0.2 million and $0.3 million and $0.2 million
respectively and have been applied to accrued interest. As of
December 31, 2005 the note was transferred from Timm
Medical to Endocare prior to the sale of Timm Medical.
The combined revenues, costs of revenues and gross profit
related to the divested product lines were $5.4 million,
$2.3 million and $3.1 million, respectively, for 2004
and are included in income (loss) from discontinued operations.
Incremental selling, general and administrative expenses
attributable to these product lines were not significant.
Mobile
Prostate Treatment Businesses (Partnerships)
On December 30, 2004, we entered into a
Partnership Interest Purchase Agreement (the Purchase
Agreement) with Advanced Medical Partners, Inc.
(AMPI), a customer of and third-party service
provider to us. Pursuant to the Purchase Agreement, we agreed to
sell to AMPI our interests in nine partnerships and our minority
investment in U.S. Therapies, LLC (a national urology
services company) acquired in June 2001 for $0.9 million.
As a result of the sale, we recorded a loss on divestiture of
$0.7 million in the 2004 fourth quarter. The loss comprises
$0.9 million in proceeds less selling costs of
approximately $63,000 and $1.5 million of the net tangible
assets sold. The proceeds were received in February 2005. After
the sale, we continue to pay the Partnerships, similar to other
service providers, the contracted fee for mobile support
services. As such, the Partnerships are not presented as
discontinued operations. The remaining mobile treatment
businesses retained by us have ceased operations or are pending
dissolution.
|
|
8.
|
Stock-Based
Compensation Plans
|
As of December 31, 2006, we have five stock-based employee
compensation plans and one non-employee director stock-based
compensation plan.
F-24
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following tables summarize our option activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
|
|
|
|
Weighted-Average
|
|
|
|
|
|
Weighted-Average
|
|
|
|
|
|
Weighted-Average
|
|
|
|
Number of
|
|
|
Exercise Price
|
|
|
Number of
|
|
|
Exercise Price
|
|
|
Number of
|
|
|
Exercise Price
|
|
|
|
Options
|
|
|
Per Option
|
|
|
Options
|
|
|
Per Option
|
|
|
Options
|
|
|
Per Option
|
|
|
Outstanding, beginning of year
|
|
|
5,118,752
|
|
|
$
|
5.06
|
|
|
|
5,361,682
|
|
|
$
|
4.72
|
|
|
|
5,621,240
|
|
|
$
|
4.27
|
|
Granted
|
|
|
1,397,500
|
|
|
|
2.94
|
|
|
|
1,549,250
|
|
|
|
3.19
|
|
|
|
1,116,250
|
|
|
|
2.84
|
|
Cancelled/forfeited
|
|
|
(804,570
|
)
|
|
|
5.32
|
|
|
|
(1,094,463
|
)
|
|
|
5.34
|
|
|
|
(742,459
|
)
|
|
|
3.69
|
|
Exercised
|
|
|
(350,000
|
)
|
|
|
0.26
|
|
|
|
(195,229
|
)
|
|
|
2.10
|
|
|
|
(85,833
|
)
|
|
|
1.26
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, end of year
|
|
|
5,361,682
|
|
|
|
4.72
|
|
|
|
5,621,240
|
|
|
|
4.27
|
|
|
|
5,909,198
|
|
|
|
4.13
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average
|
|
|
|
|
|
Options Exercisable
|
|
|
|
Number
|
|
|
Remaining
|
|
|
|
|
|
Number
|
|
|
Weighted-
|
|
Range Of
|
|
Outstanding at
|
|
|
Contractual Life
|
|
|
Weighted-Average
|
|
|
Exercisable at
|
|
|
Average
|
|
Exercise Price
|
|
December 31, 2006
|
|
|
(Number of Years)
|
|
|
Exercise Price
|
|
|
December 31, 2006
|
|
|
Exercise Price
|
|
|
$ 1.80 - 2.22
|
|
|
760,500
|
|
|
|
8.21
|
|
|
$
|
2.15
|
|
|
|
232,917
|
|
|
$
|
2.11
|
|
2.25 - 2.25
|
|
|
625,000
|
|
|
|
6.17
|
|
|
|
2.25
|
|
|
|
585,938
|
|
|
|
2.25
|
|
2.36 - 2.75
|
|
|
604,833
|
|
|
|
7.35
|
|
|
|
2.67
|
|
|
|
390,709
|
|
|
|
2.65
|
|
2.80 - 3.00
|
|
|
700,995
|
|
|
|
8.52
|
|
|
|
2.88
|
|
|
|
244,921
|
|
|
|
2.91
|
|
3.04 - 3.31
|
|
|
646,750
|
|
|
|
8.82
|
|
|
|
3.24
|
|
|
|
58,707
|
|
|
|
3.20
|
|
3.35 - 4.15
|
|
|
704,521
|
|
|
|
7.70
|
|
|
|
3.79
|
|
|
|
396,051
|
|
|
|
3.91
|
|
4.16 - 4.20
|
|
|
40,917
|
|
|
|
6.81
|
|
|
|
4.18
|
|
|
|
34,958
|
|
|
|
4.18
|
|
4.27 - 4.27
|
|
|
1,000,000
|
|
|
|
6.96
|
|
|
|
4.27
|
|
|
|
675,000
|
|
|
|
4.27
|
|
4.69 - 13.42
|
|
|
614,632
|
|
|
|
4.72
|
|
|
|
8.04
|
|
|
|
588,799
|
|
|
|
8.19
|
|
13.42 - 21.23
|
|
|
211,050
|
|
|
|
4.84
|
|
|
|
16.18
|
|
|
|
211,050
|
|
|
|
16.18
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,909,198
|
|
|
|
7.25
|
|
|
$
|
4.10
|
|
|
|
3,419,050
|
|
|
$
|
4.84
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted average fair value of our options at the grant date
was approximately $2.22 in 2004, $2.25 in 2005, and $1.90 in
2006. The aggregate intrinsic value is calculated as the
difference between the exercise price of the underlying awards
and the quoted price of our common stock for those awards that
have an exercise price currently below the quoted price. In each
of the years ended December 31, 2004, 2005 and 2006, the
aggregate intrinsic value of options exercised under the stock
option plans was $0.9 million, $0.3 million and
$0.1 million, respectively. Cash received from option
exercises under all stock-based payment arrangements for the
years ended December 31, 2004, 2005 and 2006 was $92,000,
$116,000 and $108,000, respectively.
The aggregate intrinsic value of options outstanding and
exercisable at December 31, 2006 was zero. The weighted
average remaining contractual life on options outstanding and
exercisable as of December 31, 2006 was 7.25 years and 6.33
years, respectively.
Employment related taxes payable associated with the exercise of
employee stock options and loan forgiveness at December 31,
2005 and 2006 were $1.0 million and $0.1 million,
respectively (included in accrued compensation).
F-25
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
9.
|
Equity
Incentive Plans
|
Share-based
payments
As of December 31, 2006, we had options and deferred stock
units outstanding under five employee and one non-employee
director stock-based compensation plans, as follows:
2004 Stock Incentive Plan. The 2004 Stock
Incentive Plan adopted in September 2004 authorizes the Board or
one or more committees designated by the Board (the Plan
Administrator) to grant options and rights to purchase
common stock to employees, directors and consultants. Options
may be either incentive stock options as defined in
Section 422 of the Internal Revenue Code of 1986, as
amended, non-statutory stock options or other equity
instruments. The 2004 Stock Incentive Plan replaced the 1995
Stock Plan and 1995 Director Plan described below. The
exercise price is equal to the fair market value of our common
stock on the date of grant (or 110 percent of such fair
market value, in the case of options granted to any participant
who owns stock representing more than 10 percent of our
combined voting power). Options generally vest 25 percent
on the one-year anniversary date, with the remaining
75 percent vesting monthly over the following three years
and are exercisable for 10 years. On the first trading day
of each calendar year beginning in 2005, shares available for
issuance will automatically increase by three percent of the
total number of outstanding common shares at the end of the
preceding calendar year, up to a maximum of
1,000,000 shares. In addition, the maximum aggregate number
of shares which may be issued under the 2004 Stock Incentive
Plan will be increased by any shares (up to a maximum of
2,800,000 shares) awarded under the 1995 Stock Plan and
1995 Director Plan that are forfeited, expire or are
cancelled. Options become fully vested if an employee is
terminated without cause within 12 months of a change in
control as defined. Upon a corporate transaction as defined,
options not assumed or replaced will vest immediately. Options
assumed or replaced will vest if the employee is terminated
without cause within 12 months. As of December 31,
2006, there were outstanding under the 2004 Stock Incentive Plan
options to purchase 2,704,833 shares of our common stock
and 2,051,079 options were available for grant.
1995 Stock Plan. The 1995 Stock Plan
authorized the Board or one or more committees designated by the
Board (such committee, the Committee) to grant
options and rights to purchase common stock to employees and
certain consultants and distributors. Options granted under the
1995 Stock Plan may be either incentive stock
options as defined in Section 422 of the Internal
Revenue Code of 1986, as amended, non-statutory stock options or
other equity instruments, as determined by the Board or the
Committee. The exercise price of options granted under the 1995
Stock Plan was required to equal the fair market value of our
common stock on the date of grant. Options generally vest
25 percent on the one-year anniversary date, with the
remaining 75 percent vesting monthly over the following
three years. Options are exercisable for 10 years. The 1995
Stock Plan was replaced by the 2004 Stock Incentive Plan on
September 10, 2004. As of December 31, 2006,
there were outstanding under the 1995 Stock Plan options to
purchase 1,494,504 shares of our common stock and no
options were available for grant.
1995 Director Option Plan. The
1995 Director Option Plan (the Director Plan)
provided automatic, non-discretionary grants of options to our
non-employee directors (Outside Directors). Upon
election, each director receives an initial option grant to
purchase 20,000 shares of common stock which vest over two
years and an annual option grant to purchase 5,000 common shares
which becomes exercisable after one year. The exercise price of
options granted to Outside Directors was required to be the fair
market value of our common stock on the date of grant. Options
granted to Outside Directors have
10-year
terms, subject to an Outside Directors continued service
as a director. The 1995 Director Option Plan was replaced
by the 2004 Stock Incentive Plan on September 10, 2004. As
of December 31, 2006, there were outstanding under the
1995 Director Option Plan options to purchase
65,000 shares of Endocares common stock and no
options were available for grant.
2002 Supplemental Stock Plan. We adopted the
2002 Supplemental Stock Plan (2002 Plan) effective
June 25, 2002. Under the 2002 Plan,
non-statutory
options may be granted to employees, consultants and outside
directors with an exercise price equal to at least 85 percent of
the fair market value per share of our common stock on the date
of grant. The 2002 Plan expires June 24, 2012, unless
earlier terminated in accordance with plan provisions.
F-26
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The 2002 Plan also terminates automatically upon certain
extraordinary events, such as the sale of substantially all or
our assets, a merger in which we are not the surviving entity or
acquisition of 50 percent or more of the beneficial ownership in
our common stock by other parties. Upon such an event, all
options become fully exercisable. Through December 31,
2006, there were options to purchase 140,000 shares of our
common stock outstanding under the 2002 Plan. On
February 22, 2007 our Board of Directors terminated the
2002 Plan. As a results, no additional options may be granted
under the 2002 Plan. The termination of the 2002 Plan does not
affect the 140,000 outstanding options referred to above.
Employee Deferred Stock Unit Program. On
May 18, 2006 we adopted the Employee Deferred Stock
Unit Program and the Non-employee Director Deferred
Stock Unit Program. Under the terms of the employee
program, certain eligible employees have the option to elect to
receive all or a portion of their annual incentive award (at a
minimum of 25 percent) in deferred stock units in lieu of
cash. In addition each participating employee will also receive
an additional premium in stock at a percentage determined by the
Compensation Committee of our Board. That percentage premium for
2006 is 20 percent. Each unit entitles the holder to
receive one common share at a specified future date. Irrevocable
deferral elections are made during a designated period no later
than June 30 of each year. The units vest upon the
determination of the incentive award achieved and the number of
stock units earned. This determination is made in the first
quarter of the following fiscal year. The stock price to
determine the number of shares to be issued is the fair market
value of the stock on the date on which the deferred stock units
are granted. In 2006, the date of grant was June 23, 2006,
on which date the closing stock price was $2.70. Compensation
expense related to the bonus incentive award program is recorded
pro rata during the performance year based on the estimated
incentives achieved, whether payable in cash or in stock units.
The portion of incentive award payable in stock units is
recorded as additional
paid-in-capital.
The estimated value of the incentives is periodically adjusted
based on current expectations regarding the levels of
achievement. As of December 31, 2006, 51,197 shares
were expected to be issued under the plan.
Non-employee Directors Deferred Stock Unit
Program. Under the directors plan, members of the
board of directors can choose to have all or a portion of their
director fees paid in fully vested deferred stock units (at a
minimum of 25 percent) commencing July 1, 2006. The
date of grant and share price used to determine the number of
deferred stock units is set on the fifth business day after the
end of the quarter in which the services are rendered.
Additionally, to cover taxes directors may choose to have up to
50 percent of their deferred stock units paid in cash at
the date the underlying common shares are to be issued based on
the share price at the time. During 2006, elections were made in
June. Future annual deferred elections will be made in December
for the following year. Deferred stock units are granted each
quarter based on the director fees earned in the prior quarter
and the fair market value of the stock on the date of grant. The
first grant was made in October 2006 for the September 30,
2006 quarter. Directors fees, whether payable in cash or
in stock units, are expensed when incurred. The maximum number
of deferred stock units that can be settled in cash at the
option of the holder is recorded as a liability (included in
deferred compensation) and adjusted each quarter to current fair
value until settlement occurs. The fair value of the portion of
the deferred stock units issuable in shares are fixed at the
date of grant and are expensed in the quarter the services are
received. At December 31, 2006, 84,647 fully vested
deferred stock units valued at $152,000 have been issued under
the plan, of which $74,000 was recorded as a liability.
Common shares underlying the vested stock units in the employee
and director plans are issued at the earlier of the payout date
specified by the participant (which is at least two years from
the applicable election deadline), a change in control event as
defined, or the month following the participants death.
Option Arrangements Outside of Plans. In
addition to the option plans described above, on March 3,
2003, we granted options to purchase 750,000 shares of
common stock to our then President and Chief Operating Officer.
The options were granted at $2.25 per share; 250,000 of the
options were available for accelerated vesting based on the
attainment of certain milestones and objectives or five years,
whichever came first. Twenty-five percent of the remaining
500,000 options vest on the first anniversary with the balance
ratably over three years. In September 2006, the former officer
forfeited 250,000 of unvested options upon separation from
Endocare. Pursuant to the
F-27
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
original terms of the grant, the former officer is entitled to
continue vesting in 62,500 options for one year. The expense
related to the unvested options retained by the former officer
(net of reversal of expenses on the forfeited options) was
included in the $0.3 million severance charge recorded in
the third quarter of 2006.
On December 15, 2003, we granted 1,000,000 options to
purchase common stock to our Chief Executive Officer. The
options were granted at $4.27 per share; 100,000 of these
options are available for accelerated vesting based on the
attainment of certain milestones and objectives or five years,
whichever comes first. Twenty-five percent of the remaining
options vest immediately with the balance vesting ratably over
three years. These milestones were not met as of
December 31, 2006.
As of December 31,2006 we also had 4,861 options issued and
outstanding under equity compensation plans assumed by us in
connections with mergers and acquisitions.
All options granted pursuant to our stock-based compensation
plans are subject to immediate vesting upon a change in control
as defined in the respective plan, except for special provisions
in the case of the 2004 Stock Incentive Plan as described above.
Stockholder
Rights Plan
In April 1999, we adopted a stockholder rights plan (the Plan)
in which preferred stock purchase rights were distributed as a
dividend at the rate of one right for each share of common stock
held as of the close of business on April 15, 1999. The
rights are designed to guard against partial tender offers and
other abusive and coercive tactics that might be used in an
attempt to gain control of us or to deprive our stockholders of
their interest in the long-term value of Endocare. The rights
will be exercisable only if a person or group acquires
15 percent or more of Endocares common stock (subject
to certain exceptions stated in the Plan) or announces a tender
offer the consummation of which would result in ownership by a
person or group of 15 percent or more of our common stock.
At any time on or prior to the close of business on the first
date of a public announcement that a person or group has
acquired beneficial ownership of 15 percent or more of our
common stock (subject to certain exceptions stated in the Plan),
the rights are redeemable for $0.01 per right at the option
of the Board of Directors. The rights will expire at the close
of business on April 15, 2009 (the Final Expiration
Date), unless the Final Expiration Date is extended or
unless we redeemed or exchanged the rights earlier.
The composition of the federal and state income tax provision
(benefit) from continuing operations is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
|
(In thousands)
|
|
|
Federal
|
|
$
|
|
|
|
$
|
(705
|
)
|
|
$
|
(163
|
)
|
State
|
|
|
|
|
|
|
(124
|
)
|
|
|
(29
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
|
|
|
$
|
(829
|
)
|
|
$
|
(192
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The 2005 tax benefit is the result of current year pre-tax book
losses being utilized against pre-tax book income from
discontinued operations. There is an offsetting tax provision
within discontinued operations.
F-28
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following table summarizes the tax effects of temporary
differences, which give rise to significant portions of the
deferred tax assets at December 31:
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2006
|
|
|
|
(In thousands)
|
|
|
Deferred tax assets (liabilities):
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
$
|
468
|
|
|
$
|
448
|
|
Nondeductible reserves and accruals
|
|
|
2,280
|
|
|
|
2,399
|
|
Investment in stock of
discontinued operation
|
|
|
10,468
|
|
|
|
|
|
Research and experimentation tax
credit carryforwards
|
|
|
1,000
|
|
|
|
1,153
|
|
Net operating loss carryforwards
|
|
|
42,578
|
|
|
|
45,430
|
|
Capital loss carryforwards
|
|
|
5,279
|
|
|
|
16,064
|
|
Stock-based compensation
|
|
|
|
|
|
|
724
|
|
Other
|
|
|
1,417
|
|
|
|
160
|
|
|
|
|
|
|
|
|
|
|
|
|
|
63,490
|
|
|
|
66,378
|
|
Valuation allowance
|
|
|
(63,490
|
)
|
|
|
(66,378
|
)
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
During 2005, in connection with the presentation of Timm Medical
Technologies, Inc. (Timm Medical) as a discontinued
operation (see Note 7 Dispositions and Discontinued
Operations), we recorded a deferred tax asset of
$10.5 million for the tax in excess of financial statement
basis in the stock of Timm Medical. As a result of continued
operating losses and, in 2005, the recording of a deferred tax
asset for the tax in excess of financial statement basis in the
stock of Timm Medical, the valuation allowance increased by
$15.1 million and $2.9 million during the years ended
December 31, 2005 and 2006, respectively. Due to our
history of operating losses, management has not determined that
it is more likely than not that the deferred tax assets will be
realized through future earnings. Accordingly, valuation
allowances have been recorded to fully reserve the deferred tax
assets as of December 31, 2005 and 2006.
Actual income tax expense differs from amounts computed by
applying the United States federal income tax rate of
34 percent to pretax loss as a result of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
|
(In thousands)
|
|
|
Computed expected tax benefit
|
|
$
|
(10,846
|
)
|
|
$
|
(5,327
|
)
|
|
$
|
(3,831
|
)
|
Nondeductible expenses
|
|
|
78
|
|
|
|
89
|
|
|
|
342
|
|
Increase in valuation allowance
|
|
|
12,950
|
|
|
|
4,490
|
|
|
|
4,296
|
|
State taxes
|
|
|
(1,861
|
)
|
|
|
(81
|
)
|
|
|
(19
|
)
|
Other
|
|
|
(321
|
)
|
|
|
|
|
|
|
(980
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Actual tax expense (benefit)
|
|
$
|
|
|
|
$
|
(829
|
)
|
|
$
|
(192
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2006, we have federal and California net
operating loss carryforwards of $120.1 million and
$38.0 million, respectively. We also have approximately
$26.5 million in net operating loss carryforwards in
various other states. The federal net operating loss
carryforwards begin to expire in 2011 and the state net
operating loss carryforwards begin to expire in 2006. We also
have federal and state capital loss carryforwards in the amount
of $40.2 million and $33.6 million, respectively. In
addition, we have federal and state research and experimentation
credit carryforwards of $0.8 million and $0.4 million,
respectively. The federal research and experimentation credit
carryforwards begin to expire in 2011 and the state research and
experimentation credit carryforwards do not expire.
F-29
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Internal Revenue Code (IRC) Sections 382 and 383 limit the
annual utilization of net operating loss and tax credit
carryforwards existing prior to a change in control. Based upon
prior equity transaction activity, some or all of our existing
net operating loss and tax credit carryforwards may be subject
to annual limitations under IRC Sections 382 and 383. We
have not performed an analysis to determine whether such change
in control has occurred for tax reporting purposes and if so,
the specific limitations that may result.
|
|
11.
|
Collaborative
and Other Agreements
|
Sanarus
Medical Inc.
In October 1999, we entered into a strategic alliance with
Sanarus Medical, Inc. (Sanarus), a privately held medical device
company. We received 200,041 Series A voting convertible
preferred shares for $0.3 million and a warrant to acquire
3,166,000 common shares for $0.01 per share in
consideration for entering into a manufacturing, supply and
license agreement (the 1999 Agreement). The 1999
Agreement provided Sanarus an exclusive, royalty-free, worldwide
non-sublicenseable right to develop, manufacture and sell
products using cryoablation technology developed by Endocare for
use in the field of gynecology and breast diseases. The warrant
is exercisable at any time through October 12, 2009. In
June 2001, the 1999 Agreement was amended (the 2001 Agreement)
to provide for (i) the termination of Sanaruss
exclusive, royalty-free, worldwide non-sublicenseable right
under the 1999 Agreement; (ii) Sanaruss grant us of
an exclusive (even as to Sanarus), worldwide, irrevocable, fully
paid-up
right to develop, manufacture and sell products using certain
Sanarus technology for use in the diagnosis, prevention and
treatment of prostate, kidney and liver diseases, disorders and
conditions; and (iii) our grant to Sanarus of an exclusive
(even as to Endocare), worldwide, irrevocable, fully
paid-up
right to develop, manufacture and sell products using certain of
our technology for use in the diagnosis, prevention and
treatment of gynecological and breast diseases, disorders and
conditions.
In June 2001, we provided a bridge loan to Sanarus in the amount
of $0.3 million and received a warrant to purchase
36,210 shares of Series B voting preferred stock. The
loan was repaid in July 2001. In April 2003, Endocare and other
investors entered into a second bridge loan financing in which
Sanarus issued to us a convertible promissory note in the
aggregate amount of $0.6 million and a warrant to purchase
equity shares in Sanarus with an aggregate exercise price of up
to $0.3 million. Upon completion of an equity financing by
Sanarus in October 2003, the bridge loan and warrant were
canceled in exchange for 908,025 shares of Series C
voting preferred stock and a warrant to purchase 308,823
Series C shares at $0.68 per share. As of
December 31, 2006 and 2005, our voting interest in Sanarus
was approximately 4.1 percent and 5.2 percent,
respectively, on an as-converted fully diluted basis.
Our former Chief Executive Officer and Chairman of the Board was
a member of Sanaruss Board of Directors through
October 22, 2003. The total investment in Sanarus of
$0.9 million as of December 31, 2005 and 2006 is
included in investments and other assets. The investment is
recorded at cost since we do not exercise significant influence
over the operations of Sanarus.
CryoFluor
Therapeutics
Effective December 21, 2004, Endocare and CryoFluor
Therapeutics, LLC (CryoFluor) entered into a
Services Agreement and First Amendment to CryoFluors
Operating Agreement. Under the Services Agreement, we will
provide to CryoFluor certain product design and development
services, which consist of both preclinical stage services and
clinical stage services , in exchange for 945,000 LLC units. In
2006, the agreement was amended to reduce the total number of
units issuable to Endocare from 945,000 to 898,500 units.
As amended in exchange for the preclinical stage services,
CryoFluor issued 500,000 ownership units to Endocare on
December 21, 2004, which are subject to vesting as
described below. In exchange for the clinical stage services,
the Services Agreement provides that CryoFluor shall issue to
Endocare an additional 398,500 ownership units on April 5,
2006 (the Second Tranche Date). Each ownership unit has an
ascribed value of $1.00.
F-30
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The ownership units are subject to vesting as follows:
(i) 50,000 of the units vested on December 21, 2004;
(ii) 39,850 units upon the Second Tranche Date;
(iii) 450,000 units upon completion of the preclinical
services and CryoFluors acceptance of our report relating
to the preclinical services; and (iv) the remaining
358,650 units upon completion of the clinical services and
CryoFluors acceptance of our report relating to the
clinical services. In the event of a termination of the Services
Agreement for any reason, all ownership units that have not
vested as of the termination date will be forfeited. As of
December 31, 2006, we completed the preclinical services
and have vested in 500,000 units. The vested and unvested
units held by Endocare constitute 18.8 percent of
CryoFluors outstanding ownership interests as of such date.
Pursuant to the First Amendment to the Operating Agreement, we
were admitted as a member of CryoFluor on December 21,
2004. Each other member of CryoFluor granted to us a limited
right of first negotiation with respect to the sale of ownership
units held by such member. In addition, CryoFluor granted to us
a limited right of first negotiation with respect to the sale,
assignment, license or other transfer of the technology owned by
CryoFluor that is the subject of the development program under
the Services Agreement.
Since CryoFluor is a development stage company and the fair
value of our contracted services could not be accurately
determined, we have recorded a valuation allowance against the
ascribed value of its minority interest investment in CryoFluor.
We accounted for our investment in CryoFluor using the equity
method.
CryoDynamics,
LLC Research & Development
Agreement
On November 8, 2005, we entered into a commercialization
agreement (the Agreement) with CryoDynamics, LLC to
design and develop a cryosurgical system utilizing nitrogen gas.
The parties will jointly own all inventions made or conceived by
CryoDynamics in performing the Agreement (Development
Inventions). To assist CryoDynamics in its research and
development efforts, we will advance CryoDynamics
$42,500 per month, effective October 1, 2005 until
such time as either party enters into a license agreement based
upon the nitrogen system with an independent third party that
results in CryoDynamics receiving an amount sufficient to repay
the advances and fund CryoDynamics monthly operating
expenses of $42,500.
Under the Agreement, CryoDynamics granted to us an exclusive,
worldwide license (with the right to sublicense) to the
Development Inventions and pre-existing technology in all
medical fields of use. We also have granted to CryoDynamics an
exclusive, worldwide license (with the right to sublicense) to
such Development Inventions in specified fields of use.
Royalties and license fees will be determined in accordance with
the Agreement. The Agreement also provides for a right of first
refusal should CryoDynamics intend to accept an offer from any
potential buyer for the sale of all or part of
CryoDynamicss business.
The Agreement will continue until the later of
(a) December 31, 2015, or (b) expiration of the
parties obligations to pay royalties or until the
Agreement is terminated because of breach, insolvency or
bankruptcy.
Since repayment of amounts advanced under the agreement is
contingent upon the successful development, commercialization
and licensing of the technology and is not reasonably assured,
these advances are expensed as incurred. We recorded
$0.1 million and $0.5 million of research and
development costs for the years ended December 31, 2005 and
2006, respectively in connection with the Agreement.
Patent,
Licensing, Royalty and Distribution Agreements
We have entered into other patent, licensing and royalty
agreements with third parties, some of whom also have consulting
agreements with us and are owners of or affiliated with entities
which have purchased products from us. These agreements
generally provide for purchase consideration in the form of
cash, common shares, warrants or options and royalties based on
a percentage of sales related to the licensed technology,
subject to minimum amounts per year. The patents and licensing
rights acquired are recorded based on the fair value of the
consideration paid. Options and warrants issued are valued using
the Black-Scholes option pricing model. These assets are
amortized over their respective estimated useful lives. Royalty
payments are expensed as incurred.
F-31
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
We have entered into additional distribution agreements with
third parties. These agreements govern all terms of sale,
including shipping terms, pricing, discounts and minimum
purchase quotas, if applicable. Pricing is fixed and
determinable and the distributors contractual obligation
to pay is not contingent on other events, such as final sale to
an end-user. We generally do not grant a right of return except
for defective products in accordance with our warranty policy,
and in some cases for unsold inventory within a limited time
period upon the termination of the distribution agreement.
|
|
12.
|
Commitments
and Contingencies
|
Leases
We lease office space and equipment under operating leases,
which expire at various dates through 2010. Some of these leases
contain renewal options and rent escalation clauses. Future
minimum lease payments by year and in the aggregate under all
non-cancelable operating leases consist of the following (in
thousands):
|
|
|
|
|
Year ending December 31, 2007
|
|
$
|
587
|
|
2008
|
|
|
529
|
|
2009
|
|
|
546
|
|
2010
|
|
|
123
|
|
2011
|
|
|
|
|
Thereafter
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,785
|
|
|
|
|
|
|
Employment
and Severance Agreements
We have has entered into employment agreements with certain
executives which provide for annual base salaries and cash
incentive payments of up to 85 percent of base salary
subject to attainment of corporate goals and objectives pursuant
to incentive compensation programs approved by our board of
directors, and stock options. The agreements provide for
severance payments if the executive is terminated other than for
cause or terminates for good reason as defined. The options vest
over specified time periods with accelerated vesting upon
attainment of performance targets in certain instances.
Former
Officers
As described in further detail below under Legal
Matters our former Chief Executive Officer and
Chairman of the Board (former CEO) and former Chief Financial
Officer and Chief Operating Officer (former CFO) both of whom
ceased to be employed by us in 2003, are defendents in a civil
lawsuit filed by the SEC and are being investigated by the DOJ
relating to our historical financial reporting issues and
related matters. The former CEO and the former CFO have each
agreed to repay us severance and related amounts ($800,000 in
the case of the former CEO and approximately $600,000 in
the case of the former CFO) upon either (i) his conviction
in a court of law, or entering into a plea of guilt or no
contest to, any crime directly relating to his activities on
behalf of Endocare during his employment, or
(ii) successful prosecution of an enforcement action by the
SEC against him.
On October 2, 2006, we executed a General Release of All
Claims with our then President and Chief Operating Officer (the
former President) upon his separation effective
October 2, 2006. We agreed to pay the former President his
base salary of $0.3 million per year via semi-monthly
salary continuation payments for a period of 12 months and
continuation of his health benefits pursuant to COBRA for one
year. The former President held 800,000 options from various
grants, of which 437,500 options had vested prior to the
separation date. He forfeited 300,000 unvested options upon
separation but is entitled to continue vesting in the remaining
62,500 unvested options for one year pursuant to the original
grant terms. These options will be fully vested by March 2007.
The expense related to the unvested options retained by the
employee (net of reversal of stock-based compensation
F-32
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
expense on the forfeited options) was included in the
$0.3 million severance charge recorded in the third quarter
of 2006. The 500,000 options remain outstanding at
December 31, 2006 and are exercisable at $2.25 per
share.
On August 27, 2004, we executed a General Release of All
Claims with our then Chief Financial Officer which was effective
as of August 10, 2004. Pursuant to the terms of the General
Release, we agreed to pay her current base salary of
$0.2 million per year via semi-monthly salary continuation
payments for a period of 12 months and continuation of her
health benefits pursuant to COBRA for one year. We also agreed
to permit our then Chief Financial Officer to continue to vest
in all stock options held at the separation date through
July 31, 2005. We recorded stock-based compensation expense
of $0.1 million. In 2004 and 2005, our then Chief Financial
Officer exercised options to purchase 15,625 and
130,208 shares, respectively. The remaining vested options
expired unexercised.
Employee
Benefit Plans
We have has a 401(k) savings plan covering substantially all
employees. The Plan currently provides for a discretionary match
of amounts contributed by each participant as approved by the
Compensation Committee of the Board of Directors. No matching
contributions were made in 2004, 2005 or 2006.
Legal
Matters
We are a party to lawsuits in the normal course of our business.
Litigation and governmental investigation can be expensive and
disruptive to normal business operations. Moreover, the results
of complex legal proceedings are difficult to predict.
Significant judgments or settlements in connection with the
legal proceedings described below may have a material adverse
effect on our business, financial condition, results of
operations and cash flows. Other than as described below, we are
not a party to any legal proceedings that we believe to be
material.
Governmental
Investigations
As reported in the
Form 8-K
that we filed on July 20, 2006, we executed a consent to
entry of judgment in favor of the Securities and Exchange
Commission (the SEC) on July 14, 2006 and
entered into a non-prosecution agreement with the Department of
Justice (the DOJ) on July 18, 2006. These two
agreements effectively resolve with respect to us the
investigations begun by the SEC and by the DOJ in January 2003,
regarding allegations that we and certain of our former officers
and former directors and one current employee issued, caused to
be issued, false and misleading statements regarding our
financial results for 2001 and 2002 and related matters. Under
the terms of the consent judgment with the SEC (i) we paid
a total of the $750,000 in civil penalties and disgorgement; and
(2) we agreed to a stipulated judgment enjoining future
violations of securities laws. On April 7, 2006, we entered
into an escrow agreement with Morrison & Foerster LLP,
our outside counsel, pursuant to which we placed the $750,000
anticipated settlement in escrow with Morrison &
Foerster LLP at the request of the SEC staff. The funds were
released from the escrow to the SEC in August 2006. A liability
for the monetary penalty was accrued in 2004. The investigations
and legal proceedings related to certain former officers and
former directors remain ongoing and are not affected by our
settlements with the SEC and DOJ. We remain contractually
obligated to pay legal fees for and otherwise indemnify these
former officers and former directors. On August 9, 2006 the
SEC filed civil fraud charges in federal district court against
two former officers. Our directors and officers
liability insurance may fund certain losses, including defense
costs, related to these matters. At December 31, 2006, we
have $1.0 million in remaining available coverage under the
applicable excess directors and officers liability policy.
This policy reimburses 75 percent of the first
$2.25 million in eligible costs to a maximum of
approximately $1.7 million, zero percent of the next
$500,000 and 57.5 percent of the next $1 million to a
maximum of $575,000. This coverage will be exhausted in its
entirety after we incur $2.0 million in additional costs.
F-33
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Historical
option granting practices
Given the recent announcements by numerous companies and the
SECs current focus on stock option plan administration,
our Audit Committee requested that management conduct an
internal review of our historical stock option practices, the
timing of stock option grants and related accounting and
documentation. Based on this review, management identified
several stock option grants made between 1997 and 2002 for which
the actual measurement dates appeared to differ from the
recorded grant dates. Management analyzed the potential
accounting impact, assuming that the measurement dates for these
option grants differ from the recorded grant dates, and
concluded that the financial impact did not necessitate
adjustment to or restatement of our previously-issued financial
reports in accordance with Staff Accounting
Bulletin No. 99, Materiality, and No. 108,
Considering the Effects of Prior Year Misstatements When
Quantifying Misstatements in Current Year Financial
Statements. Management reported the results of its review to
our Audit Committee and Board of Directors at their regularly
scheduled meetings on July 26, 2006. Following these
meetings, we contacted the SEC and the DOJ and reported our
findings. On August 1, 2006, we met with the SEC staff to
discuss our findings and later received a subpoena from the SEC
requesting additional option-related information. We have
responded to this subpoena and will continue to fully cooperate
with the SEC and DOJ and with their ongoing investigations
related to certain of our former officers and former directors.
After receiving the subpoena from the SEC, management identified
certain stock option grants made in 2003 for which the actual
measurement dates may differ from the recorded grant dates.
However, similar to the grants between 1997 and 2002 previously
identified, management concluded that the financial impact of
the 2003 grants, individually and in the aggregate, did not
necessitate adjustment to or restatement of our
previously-issued financial reports.
Shareholder
Class Action and Derivate Lawsuits
In November 2002, we were named as a defendant, together with
certain former officers, in a
class-action
lawsuit filed in the United States District Court for the
Central District of California. This action, which was
consolidated with other similar complaints on October 31,
2003, alleged that the defendants violated sections of the
Securities Exchange Act of 1934 by purportedly issuing false and
misleading statements regarding our revenues and expenses in
press releases and SEC filings. On November 8, 2004, we
executed a settlement agreement with the lead plaintiffs and
their counsel. In exchange for a release of all claims, Endocare
and certain individuals paid a total of $8.95 million in
cash, which was funded by our directors and officers
liability insurance carriers prior to December 31, 2004. On
February 7, 2005, the Court issued a final order approving
the agreement and dismissing the
class-action
lawsuit.
On December 6, 2002, Frederick Venables filed a purported
derivative action against us and certain former officers and a
former director in California based upon allegations that the
defendants issued false and misleading statements regarding
Endocares revenues and expenses in press releases and SEC
filings. On December 6, 2004, we executed a settlement
agreement with the plaintiff and his counsel and the derivative
lawsuit was dismissed on December 8, 2004. Under the
agreement, in exchange for the plaintiffs release of all
claims, we paid a total of $0.5 million in cash prior to
December 31, 2004. The agreement also required us to
maintain various corporate governance measures for a period of
at least two years, unless a modification is necessary in the
good faith business judgment of our Board of Directors.
The settlements referenced above, the related legal and defense
costs and cost under our ongoing indemnification obligations to
certain former officers and former directors were covered under
four directors and officers liability insurance
policies in effect at that time, with limits of $5 million
each and aggregate coverage of $20 million. The primary
carrier reimbursed our defense costs up to the limits of its
$5 million policy. The three excess carriers, representing
$15 million of the $20 million of coverage, filed
arbitration complaints seeking rescission of the policies. In
December 2004 and February 2005, we reached settlement with two
of the three excess carriers to reimburse us for current and
future legal defense and litigation settlement costs. On
December 1, 2005, we entered into a settlement agreement
with the remaining excess carrier pursuant to which we paid the
carrier $1.0 million in full settlement of any claims.
Under the settlement agreement, we also granted a mutual release
to
F-34
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
the carrier. As of December 31, 2006, we have
$1.0 million in remaining available coverage through the
third excess carrier for legal costs under our continuing
indemnification obligations to our former officers and former
directors who remain under investigation and subject to legal
proceedings by the SEC and DOJ.
Lawsuit
With KPMG LLP
On October 26, 2006, we filed a lawsuit with the Superior
Court of the State of California for the County of Orange
against our former independent auditor, KPMG LLP, for
professional negligence and breach of contract, seeking damages
in an amount to be determined at trial. Previously, we had
entered into a Mediation and Tolling Agreement with KPMG
pursuant to which KPMG agreed that the statute of limitations
would be tolled to provide an opportunity for mediation between
the parties. We engaged in mediation with KPMG on
September 27, 2006 but the parties were unable to
reach settlement. Accordingly, we proceeded with the filing of
the lawsuit. In response to our claims against KPMG, KPMG filed
a cross-complaint against us and certain former officers. Under
the cross-complaint, KPMG makes claims against us for breach of
contract, violations of the federal racketeering statute and
conspiracy to violate the federal racketeering statute, seeking
damages in an amount to be determined at trial. We are not able
to predict the outcome of this lawsuit.
Other
Litigation
In January 2006, we entered into a settlement and release
agreement with certain parties against whom we had a claim from
a judgment awarded to us in prior years. We received $162,500 in
the settlement of this claims, which was recorded as a reduction
of general and administrative expenses in the first quarter of
2006.
In addition, we are, in the normal course of business, subject
to various other legal matters, which management believes will
not individually or collectively have a material adverse effect
on our results of operations or cash flows of a future period.
The results of litigation and claims cannot be predicted with
certainty, and we cannot provide assurance that the outcome of
various legal matters will not have a material adverse effect on
our business, consolidated financial condition, results of
operations or cash flows. As of December 31, 2006 we have
not established a liability for contingencies in the
consolidated balance sheets since the likelihood of loss and the
potential liability cannot be reasonably estimated at this time.
Managements evaluation of the likelihood of an unfavorable
outcome with respect to these actions could change in the
future. We have purchased directors and officers
liability and other insurance which may fund certain losses,
including defense costs, related to the above litigation
matters. These recoveries will be recorded when the amounts are
determined to be recoverable from the insurance carriers.
From time to time, we have received correspondence alleging
infringement of proprietary rights of third parties. No
assurance can be given that any relevant claims of third parties
would not be upheld as valid and enforceable, and therefore that
we could be prevented from practicing the subject matter claimed
or would be required to obtain licenses from the owners of any
such proprietary rights to avoid infringement.
On October 26, 2005, we entered into a one-year credit
facility with Silicon Valley Bank (Bank), which provides up to
$4 million in borrowings in the form of term loans (not to
exceed $500,000) and a revolving line of credit for working
capital purposes. The agreement was amended in February, April
and December 2006 and was extended to February 28, 2007.
The credit facility permits the borrowings up to the lesser of
$4.0 million or amounts available under a borrowing base
formula based on eligible accounts receivable and inventory. As
amended, the borrowing base is (i) 85 percent of
eligible accounts receivable, plus (ii) the lesser of
30 percent of the value of eligible inventory or $500,000.
Borrowings are secured by all of our assets, including all
receivable collections which are held in trust for the Bank.
Interest is payable monthly at prime rate plus 1.5 percent. The
agreement requires a one-time commitment fee of $40,000 paid on
effective date and an annual facility fee equal to 0.5 percent
of the unused portion of the facility. A termination fee will
also be assessed if the credit facility is terminated prior to
F-35
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
expiration. We borrowed and repaid $250,000 on the line of
credit in 2006. As of February 28, 2007, we had
$1.9 million outstanding on the line of credit.
As a condition to each advance under the credit facility, all
representations and warranties by us must be materially true and
no event of default has occurred or is continuing. In addition,
the lender, in its good faith business judgment, must determine
that no material adverse change has occurred. A material adverse
change occurs when there is a material impairment in the
priority of the lenders lien in the collateral or its
value, a material adverse change in our business, operations or
condition, a material impairment of the prospect of repayment or
if the Bank determines, in its good faith reasonable judgment,
that there is a reasonable likelihood that we will fail to
comply with one or more financial covenant in the next financial
reporting period.
The Loan and Security Agreement contains various financial and
operating covenants that impose limitations on our ability,
among other things, to incur additional indebtedness, merge or
consolidate, sell assets except in the ordinary course of
business, make certain investments, enter into leases and pay
dividends without the consent of the Bank. The credit facility
also includes a subjective acceleration clause and a requirement
to maintain a lock box with the lender to which all collections
are deposited. Under the subjective acceleration clause, the
lender may declare default and terminate the credit facility if
it determines that a material adverse charge has occurred. If
the aggregate outstanding advances plus reserves placed by the
Bank against the loan availability exceeds 50 percent of
the receivable borrowing base component as defined, or if a
default occurs, all current and future lock box proceeds will be
applied against the outstanding borrowings. The credit facility
also contains cross-default provisions and a minimum tangible
net worth requirement measured on a monthly basis. Tangible net
worth must be equal or greater than the sum of a base amount
($2.5 million at December 31, 2006, $1.5 million
at January 31, 2007 and $1.0 million at
February 28, 2007) plus 25 percent of all
consideration received from issuing equity securities and
subordinated debt and 25 percent of positive consolidated
net income in each quarter.
We were not in compliance with the minimum tangible net worth
covenant for the months September to November 2006. On
December 22, 2006, we signed an amendment to the Loan and
Security Agreement. Among other things, the amendment
(i) modifies the borrowing base to increase the eligible
accounts receivable from 80 percent to 85 percent and
modifies the definition of accounts that are ineligible under
the borrowing base calculation; (ii) modifies the loan
margin as defined to 1.50 percent, and (iii) waives
non-compliance with the minimum tangible net worth requirement
at September 30, 2006, October 31, 2006 and
November 30, 2006, as well as modifies the terms of the
covenant. At December 31, 2006, we were in compliance with
all covenants and had no borrowings outstanding under the line
of credit.
On February 23, 2007, the credit agreement was amended to
further modify the minimum tangible net worth provision and to
extend the maturity date to February 27, 2008.
|
|
14.
|
Related
Party Transactions
|
In February 2002, we purchased the patents to certain
cryosurgical technologies and a covenant not to compete from a
cryosurgeon inventor for 100,000 shares of our common stock
valued at $1.4 million, of which $1.1 million
(75,000 shares) was allocated to the patent to be amortized
over 15 years and the remaining $0.3 million
(25,000 shares) was allocated to the covenant to be
amortized over five years.
The agreement also requires the seller to perform certain
consulting services over 15 years for the consideration
received. No consideration was allocated to the consulting
agreement since its value could not be accurately measured. In
January 2003, we extended a $344,000 loan to the seller to
assist with the payment of related federal income taxes arising
from the 2002 asset sale. The loan was secured by the shares
issued, bore interest at 1.8 percent and was originally due
in January 2005. In 2004 and 2006, we extended the maturity date
to January 2006 and January 2007, respectively. The outstanding
balance of the note has been charged to bad debt as of
December 31, 2006 and included in general and
administrative expenses. The accrued interest income in the
amount of $25,000 was reversed in the fourth quarter of 2006.
F-36
ENDOCARE,
INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
15.
|
Quarterly
Results of Operations (Unaudited)
|
The following is a summary of the quarterly results of
operations for the years ended December 31, 2006 and 2005
(in thousands, except per share data).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter Ended
|
|
|
Quarter Ended
|
|
|
Quarter Ended
|
|
|
Quarter Ended
|
|
|
|
March 31,
|
|
|
June 30,
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2006
|
|
|
2006
|
|
|
2006
|
|
|
2006
|
|
|
Revenues from continuing operations
|
|
$
|
7,262
|
|
|
$
|
6,908
|
|
|
$
|
6,700
|
|
|
$
|
7,120
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues from continuing
operations
|
|
$
|
3,766
|
|
|
$
|
3,256
|
|
|
$
|
2,677
|
|
|
$
|
2,644
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
$
|
(5,174
|
)
|
|
$
|
(708
|
)
|
|
$
|
(2,149
|
)
|
|
$
|
(3,045
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(4,929
|
)
|
|
$
|
(708
|
)
|
|
$
|
(2,149
|
)
|
|
$
|
(2,979
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
per share of common stock basic and diluted
|
|
$
|
(0.17
|
)
|
|
$
|
(0.02
|
)
|
|
$
|
(0.07
|
)
|
|
$
|
(0.10
|
)
|
Net loss per share of common
stock basic and diluted
|
|
$
|
(0.16
|
)
|
|
$
|
(0.02
|
)
|
|
$
|
(0.07
|
)
|
|
$
|
(0.10
|
)
|
Weighted average shares of common
stock outstanding basic and diluted
|
|
|
30,143
|
|
|
|
30,166
|
|
|
|
30,175
|
|
|
|
30,532
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter Ended
|
|
|
Quarter Ended
|
|
|
Quarter Ended
|
|
|
Quarter Ended
|
|
|
|
March 31,
|
|
|
June 30,
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2005
|
|
|
2005
|
|
|
2005
|
|
|
2005
|
|
|
Revenues from continuing operations
|
|
$
|
6,867
|
|
|
$
|
6,919
|
|
|
$
|
7,008
|
|
|
$
|
7,480
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues from continuing
operations
|
|
$
|
4,186
|
|
|
$
|
3,924
|
|
|
$
|
3,809
|
|
|
$
|
3,818
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
$
|
(5,219
|
)
|
|
$
|
(4,522
|
)
|
|
$
|
(2,997
|
)
|
|
$
|
(2,100
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(4,506
|
)
|
|
$
|
(4,196
|
)
|
|
$
|
(2,460
|
)
|
|
$
|
(2,517
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
per share of common stock basic and diluted
|
|
$
|
(0.17
|
)
|
|
$
|
(0.15
|
)
|
|
$
|
(0.10
|
)
|
|
$
|
(0.07
|
)
|
Net loss per share of common
stock basic and diluted
|
|
$
|
(0.15
|
)
|
|
$
|
(0.14
|
)
|
|
$
|
(0.08
|
)
|
|
$
|
(0.08
|
)
|
Weighted average shares of common
stock outstanding basic and diluted
|
|
|
29,988
|
|
|
|
30,044
|
|
|
|
30,069
|
|
|
|
30,081
|
|
F-37
ENDOCARE,
INC. AND SUBSIDIARIES
SCHEDULE II
VALUATION AND QUALIFYING ACCOUNTS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at the
|
|
|
Additions
|
|
|
|
|
|
Balance at
|
|
|
|
Beginning of
|
|
|
Charges to
|
|
|
|
|
|
|
|
|
the End of
|
|
|
|
the Period
|
|
|
Operations
|
|
|
Other
|
|
|
Deductions
|
|
|
the Period
|
|
|
|
(In thousands)
|
|
|
2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for Doubtful Accounts
and Sales Returns
|
|
$
|
1,986
|
|
|
$
|
(726
|
)
|
|
$
|
|
|
|
$
|
(1,186
|
)
|
|
$
|
74
|
|
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for Doubtful Accounts
and Sales Returns
|
|
$
|
74
|
|
|
$
|
10
|
|
|
$
|
|
|
|
$
|
(14
|
)
|
|
$
|
70
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for Doubtful Accounts
and Sales Returns
|
|
$
|
70
|
|
|
$
|
36
|
|
|
$
|
|
|
|
$
|
(22
|
)
|
|
$
|
84
|
|
Amounts exclude discontinued operations.
F-38
EXHIBIT INDEX
|
|
|
|
|
Exhibit No.
|
|
Description
|
|
|
2
|
.1(1)
|
|
Stock Purchase Agreement, dated as
of January 13, 2006, by and among Plethora Solutions
Holdings plc, Endocare, Inc. and Timm Medical Technologies, Inc.
The schedules and other attachments to this exhibit were
omitted. The Company agrees to furnish a copy of any omitted
schedules or attachments to the Securities and Exchange
Commission upon request.
|
|
2
|
.2(2)
|
|
$1,425,000 Secured Convertible
Promissory Note, dated as of February 10, 2006, from
Plethora Solutions Holdings plc to Endocare, Inc.
|
|
3
|
.1(3)
|
|
Certificate of Amendment of
Restated Certificate of Incorporation of the Company.
|
|
3
|
.2(3)
|
|
Certificate of Designation of
Series A Junior Participating Preferred Stock of the
Company.
|
|
3
|
.3(3)
|
|
Restated Certificate of
Incorporation.
|
|
3
|
.4(4)
|
|
Amended and Restated Bylaws of the
Company.
|
|
4
|
.1(5)
|
|
Form of Stock Certificate.
|
|
4
|
.2(6)
|
|
Form of Series A Warrant.
|
|
4
|
.3(6)
|
|
Form of Series B Warrant.
|
|
4
|
.4(7)
|
|
Rights Agreement, dated as of
March 31, 1999, between the Company and U.S. Stock
Transfer Corporation, which includes the form of Certificate of
Designation for the Series A Junior Participating Preferred
Stock as Exhibit A, the form of Rights Certificate as
Exhibit B and the Summary of Rights to Purchase
Series A Preferred Shares as Exhibit C.
|
|
4
|
.5(8)
|
|
Amendment No. 1 to Rights
Agreement, dated as of September 24, 2005, between the
Company and U.S. Stock Transfer Corporation.
|
|
10
|
.1(9)
|
|
Lease Agreement, dated as of
November 26, 2001, by and between the Company and The
Irvine Company.
|
|
10
|
.2(9)
|
|
Form of Indemnification Agreement
by and between the Company and its directors.
|
|
10
|
.3(9)
|
|
Form of Indemnification Agreement
by and between the Company and its executive officers.
|
|
10
|
.4(10)
|
|
1995 Director Option Plan (as
amended and restated through March 2, 1999).
|
|
10
|
.5(11)
|
|
1995 Stock Plan (as amended and
restated through December 30, 2003).
|
|
10
|
.6(13)
|
|
Employment Agreement, dated as of
December 15, 2003, by and between the Company and Craig T.
Davenport.
|
|
10
|
.7(14)
|
|
Employment Agreement, dated as of
August 11, 2004, by and between the Company and Michael R.
Rodriguez.
|
|
10
|
.8(15)
|
|
2004 Stock Incentive Plan.
|
|
10
|
.9(16)
|
|
2004 Non-Employee Director Option
Program under 2004 Stock Incentive Plan.
|
|
10
|
.10(16)
|
|
Form of Award Agreement Under 2004
Stock Incentive Plan.
|
|
10
|
.11(17)
|
|
Confidential Settlement Agreement
and Release, dated as of February 18, 2005, by and between
the Company and Great American E&S Insurance Company.
|
|
10
|
.12(6)
|
|
Purchase Agreement, dated as of
March 10, 2005, by and between the Company and the
Investors (as defined therein).
|
|
10
|
.13(6)
|
|
Registration Rights Agreement,
dated as of March 10, 2005, by and between the Company and
the Investors (as defined therein).
|
|
10
|
.14(18)
|
|
First Amendment to Employment
Agreement with Craig T. Davenport, dated as of April 28,
2005.
|
|
10
|
.15(2)
|
|
Loan and Security Agreement, dated
as of October 26, 2005, by and among the Company, Timm
Medical Technologies, Inc. and Silicon Valley Bank.
|
|
10
|
.16(2)
|
|
Commercialization Agreement, dated
as of November 8, 2005, by and between the Company and
CryoDynamics, LLC.
|
|
10
|
.17(19)
|
|
Employment Agreement, dated as of
January 17, 2006, by and between the Company and Clint B.
Davis.
|
|
10
|
.18(20)
|
|
Description of director
compensation, as amended on February 23, 2006.
|
F-39
|
|
|
|
|
Exhibit No.
|
|
Description
|
|
|
10
|
.19(21)
|
|
Description of 2006 Management
Incentive Compensation Program.
|
|
10
|
.20(22)
|
|
Amendment to Loan Documents, dated
as of April 24, 2006, by and between the Company and
Silicon Valley Bank.
|
|
10
|
.21(23)
|
|
Amendment to Loan Documents, dated
as of February 10, 2006, between the Company, Timm Medical
Technologies, Inc. and Silicon Valley Bank.
|
|
10
|
.22(24)
|
|
Employee Deferred Stock Unit
Program, effective as of May 18, 2006.
|
|
10
|
.23(24)
|
|
Non-Employee Director Deferred
Stock Unit Program, effective as of May 18, 2006.
|
|
10
|
.24(25)
|
|
First Amendment to Lease, dated as
of May 19, 2006, between the Company and The Irvine Company.
|
|
10
|
.25(25)*
|
|
Customer Quote, dated as of
January 9, 2006, to Advanced Medical Partners, Inc..
|
|
10
|
.26(25)*
|
|
Amended and Restated Endocare
Service Agreement, dated as of January 9, 2006, between the
Company and Advanced Medical Partners, Inc..
|
|
10
|
.27(26)
|
|
Common Stock Purchase Agreement,
dated as of October 25, 2006, by and between the Company
and Fusion Capital Fund II, LLC.
|
|
10
|
.28(26)
|
|
Registration Rights Agreement,
dated as of October 25, 2006, by and between the Company
and Fusion Capital Fund II, LLC.
|
|
10
|
.29(27)
|
|
Non-Prosecution Agreement, dated
as of July 18, 2006, by and between the Company and the
Department of Justice.
|
|
10
|
.30(27)
|
|
Consent to Entry of Judgment,
dated as of July 14, 2006, in favor of the Securities and
Exchange Commission.
|
|
10
|
.31(28)
|
|
Form of Retention Agreement.
|
|
10
|
.32(29)
|
|
Amendment to Loan Documents, dated
as of December 22, 2006, by and between Endocare, Inc. and
Silicon Valley Bank.
|
|
21
|
.1(30)
|
|
Subsidiaries of the Company.
|
|
23
|
.1
|
|
Consent of Independent Registered
Public Accounting Firm.
|
|
24
|
.1(31)
|
|
Power of Attorney.
|
|
31
|
.1
|
|
Certification under
Section 302 of the Sarbanes-Oxley Act of 2002 for Craig T.
Davenport.
|
|
31
|
.2
|
|
Certification under
Section 302 of the Sarbanes-Oxley Act of 2002 for Michael
R. Rodriguez.
|
|
32
|
.1
|
|
Certification under
Section 906 of the Sarbanes-Oxley Act of 2002 for Craig T.
Davenport.
|
|
32
|
.2
|
|
Certification under
Section 906 of the Sarbanes-Oxley Act of 2002 for Michael
R. Rodriguez.
|
|
|
|
|
|
Management contract or compensatory plan or arrangement. |
|
* |
|
Certain confidential portions of this exhibit were omitted and
provided separately to the SEC pursuant to a request for
confidential treatment. |
|
(1) |
|
Previously filed as an exhibit to our
Form 8-K
filed on January 18, 2006. |
|
(2) |
|
Previously filed as an exhibit to our
Form 10-K
filed on March 16, 2006. |
|
(3) |
|
Previously filed as an exhibit to our Registration Statement on
Form S-3
filed on September 20, 2001. |
|
(4) |
|
Previously filed as an exhibit to our
Form 10-K
filed on March 16, 2004. |
|
(5) |
|
Previously filed as an exhibit to our
Form 10-K
for the year ended December 31, 1995. |
|
(6) |
|
Previously filed as an exhibit to our
Form 8-K
filed on March 16, 2005. |
|
(7) |
|
Previously filed as an exhibit to our
Form 8-K
filed on June 3, 1999. |
|
(8) |
|
Previously filed as an exhibit to our
Form 8-K
filed on June 28, 2005. |
|
(9) |
|
Previously filed as an exhibit to our
Form 10-K
filed on March 29, 2002. |
|
|
|
(10) |
|
Previously filed as an exhibit to our Registration Statement on
Form S-8
filed on June 2, 1999. |
|
(11) |
|
Previously filed as an appendix to our Definitive Proxy
Statement filed on December 3, 2003. |
|
(12) |
|
Previously filed as an exhibit to our
Form 10-K
filed on December 3, 2003. |
F-40
|
|
|
(13) |
|
Previously filed as an exhibit to our
Form 8-K
filed on December 16, 2003. |
|
(14) |
|
Previously filed as an exhibit to our
Form 8-K
filed on August 12, 2004. |
|
(15) |
|
Previously filed as an appendix to our Definitive Proxy
Statement filed on August 6, 2004. |
|
(16) |
|
Previously filed as an exhibit to our
Form 10-K
filed on March 16, 2005. |
|
(17) |
|
Previously filed as an exhibit to our
Form 10-Q
filed on May 10, 2005. |
|
(18) |
|
Previously filed as an exhibit to our
Form 8-K
filed on May 3, 2005. |
|
(19) |
|
Previously filed as an exhibit to our
Form 8-K
filed on January 12, 2006. |
|
(20) |
|
Previously filed as an exhibit to our
Form 8-K
filed on March 1, 2006. |
|
(21) |
|
Previously filed as an exhibit to our
Form 8-K
filed on March 14, 2006. |
|
(22) |
|
Previously filed as an exhibit to our
Form 8-K
filed on April 25, 2006. |
|
(23) |
|
Previously filed as an exhibit to our
Form 10-Q
filed on May 10, 2006. |
|
(24) |
|
Previously filed as an exhibit to our
Form 8-K
filed on May 22, 2006. |
|
(25) |
|
Previously filed as an exhibit to our
Form 10-Q
filed on August 8, 2006. |
|
(26) |
|
Previously filed as an exhibit to our
Form 8-K
filed on October 30, 2006. |
|
(27) |
|
Previously filed as an exhibit to our
Form 10-Q
filed on November 9, 2006. |
|
(28) |
|
Previously filed as an exhibit to our
Form 8-K
filed on December 13, 2006. |
|
(29) |
|
Previously filed as an exhibit to our
Form 8-K
filed on December 22, 2006. |
|
(30) |
|
Not applicable because the Company does not have any
subsidiaries that constitute significant
subsidiaries under
Rule 1-02(w)
of
Regulation S-X. |
|
(31) |
|
Included on the signature page of this
Form 10-K. |
F-41