SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_________________
FORM 10-Q
___________
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2002
Commission File No. 0-31261
ATHEROGENICS, INC.
(Exact name of registrant as specified in its charter)
Georgia |
58-210832 |
(State of incorporation) |
(I.R.S. Employer Identification Number) |
8995 Westside Parkway, Alpharetta, Georgia 30004
(Address of registrant's principal executive
offices, including zip code)
_______________________
(Registrant's telephone number, including area code):
(678) 336-2500
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. Yes [ X ]
No [ ]
As of November 12, 2002, there were
28,128,099 shares of the registrant's
common stock outstanding.
_________________________
ATHEROGENICS, INC.
FORM 10-Q
INDEX
PART I. FINANCIAL INFORMATION |
Page No. |
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Item 1. Financial Statements (unaudited) |
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Condensed Balance Sheets |
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September 30, 2002 and December 31, 2001 |
3 |
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Condensed Statements of Operations |
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Three and nine months ended September 30, 2002 and 2001 |
4 |
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Condensed Statements of Cash Flows |
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Nine months ended September 30, 2002 and 2001 |
5 |
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Notes to Condensed Financial Statements |
6 |
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Item 2. Management's Discussion and Analysis of Financial Condition |
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and Results of Operations |
7 |
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Item 3. Quantitative and Qualitative Disclosures About Market Risk |
10 |
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|
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Item 4. Controls and Procedures |
11 |
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PART II. OTHER INFORMATION |
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Item 2. Changes in Securities and Use of Proceeds |
11 |
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Item 6. Exhibits and Reports on Form 8-K |
11 |
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SIGNATURES |
12 |
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|
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CERTIFICATIONS |
13 |
2
PART I - FINANCIAL INFORMATION
ATHEROGENICS, INC.
CONDENSED BALANCE SHEETS
The accompanying notes are an integral part of these
condensed financial statements.
3
ATHEROGENICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
Three months ended |
Nine months ended |
||||||||||||
September 30, |
September 30, |
||||||||||||
2002 |
2001 |
2002 |
2001 |
||||||||||
Revenues: |
|||||||||||||
License fees |
$ -- |
$ -- |
$ -- |
$ 1,111,111 |
|||||||||
Research and development |
-- |
538,511 |
-- |
1,339,067 |
|||||||||
Total revenues |
-- |
538,511 |
-- |
2,450,178 |
|||||||||
|
|||||||||||||
Operating expenses: |
|||||||||||||
Research and development |
5,700,117 |
4,236,143 |
16,403,313 |
11,654,926 |
|||||||||
General and administrative |
989,292 |
942,574 |
2,997,487 |
2,837,846 |
|||||||||
Amortization of deferred stock |
|||||||||||||
compensation |
443,371 |
815,819 |
1,442,017 |
1,836,212 |
|||||||||
Total operating expenses |
7,132,780 |
5,994,536 |
20,842,817 |
16,328,984 |
|||||||||
|
|||||||||||||
Operating loss |
(7,132,780 |
) |
(5,456,025 |
) |
(20,842,817 |
) |
(13,878,806 |
) |
|||||
Net interest income |
206,057 |
593,806 |
779,885 |
1,966,682 |
|||||||||
Net loss |
$ (6,926,723 |
) |
$ (4,862,219 |
) |
$ (20,062,932 |
) |
$ (11,912,124 |
) |
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|
|||||||||||||
Net loss per share - |
|||||||||||||
basic and diluted |
$ (0.25 |
) |
$ (0.18 |
) |
$ (0.72 |
) |
$ (0.47 |
) |
|||||
|
|||||||||||||
Weighted average shares outstanding - |
|||||||||||||
basic and diluted |
27,979,930 |
27,763,830 |
27,927,575 |
25,409,593 |
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The accompanying notes are an integral part of these
condensed financial statements.
4
ATHEROGENICS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
Nine months ended |
|||||||||||||
September 30, |
|||||||||||||
2002 |
2001 |
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|
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Operating activities: |
|||||||||||||
Net loss |
$ (20,062,932 |
) |
$ (11,912,124 |
) |
|||||||||
Adjustments to reconcile net loss to net cash used in |
|||||||||||||
operating activities: |
|||||||||||||
Depreciation and amortization |
549,292 |
354,096 |
|||||||||||
Amortization of deferred stock compensation |
1,442,017 |
1,836,212 |
|||||||||||
Stock issued for services |
-- |
29,778 |
|||||||||||
Changes in operating assets and liabilities: |
|||||||||||||
Accounts receivable |
-- |
599,733 |
|||||||||||
Prepaid expenses, notes receivable and other assets |
67,359 |
(159,728 |
) |
||||||||||
Accounts payable |
403,144 |
(1,085 |
) |
||||||||||
Accrued liabilities |
(47,118 |
) |
655,356 |
||||||||||
Deferred revenues |
-- |
(1,111,111 |
) |
||||||||||
Net cash used in operating activities |
(17,648,238 |
) |
(9,708,873 |
) |
|||||||||
|
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Investing activities: |
|||||||||||||
Purchases of equipment and leasehold improvements |
(488,779 |
) |
(777,934 |
) |
|||||||||
Sales of short-term investments |
18,160,189 |
9,423,409 |
|||||||||||
Net cash provided by investing activities |
17,671,410 |
8,645,475 |
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|
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Financing activities: |
|||||||||||||
Proceeds from equipment loan facility |
936,851 |
-- |
|||||||||||
Payments on equipment loan facility and capital lease obligation |
(226,128 |
) |
(116,317 |
) |
|||||||||
Proceeds from the issuance of common stock in a private placement |
-- |
18,928,055 |
|||||||||||
Proceeds from the exercise of common stock options |
238,399 |
93,758 |
|||||||||||
Net cash provided by financing activities |
949,122 |
18,905,496 |
|||||||||||
|
|||||||||||||
Increase in cash and cash equivalents |
972,294 |
17,842,098 |
|||||||||||
Cash and cash equivalents at beginning of period |
28,682,050 |
26,463,070 |
|||||||||||
Cash and cash equivalents at end of period |
$ 29,654,344 |
$ 44,305,168 |
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|
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Supplemental disclosures of cash flow information: |
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Interest paid |
$ 34,986 |
$ 21,437 |
|||||||||||
Valuation adjustment for variable options and warrants issued |
|||||||||||||
for technology license agreement |
(30,200 |
) |
-- |
The accompanying notes are an integral part of these
condensed financial statements.
5
ATHEROGENICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(Unaudited)
1. Basis of Presentation
The accompanying unaudited condensed financial statements
reflect all adjustments (consisting solely of normal
recurring adjustments) which management considers necessary
for a fair presentation of the financial position, results of
operations and cash flows of AtheroGenics for the interim
periods presented. Certain footnote disclosures
normally included in financial statements prepared in
accordance with accounting principles generally accepted in
the United States have been condensed or omitted from the
interim financial statements as permitted by the rules and
regulations of the Securities and Exchange Commission.
Interim results are not necessarily indicative of results for
the full year.
The interim results should be read in conjunction with the
financial statements and notes thereto included in
AtheroGenics' Annual Report on Form 10-K for the year
ended December 31, 2001. Shareholders are encouraged to
review the Form 10-K for a broader discussion of
AtheroGenics' opportunities and risks inherent in the
business. Copies of the Form 10-K are available on
request.
2. Recently Issued Accounting Standards
In October 2001, the Financial Accounting Standards Board
("FASB") issued Statement of Financial Accounting
Standards ("SFAS") No. 144, Accounting for the
Impairment or Disposal of Long-lived Assets, ("SFAS
144") which is applicable to financial statements issued
for fiscal years beginning after December 15, 2001.
SFAS 144 establishes a new method of accounting and
reporting for the impairment of long-lived assets other than
goodwill and intangible assets. The statement provides
a single accounting model for long-lived assets to be
disposed of and changes the criteria required to classify an
asset as held-for-sale. The adoption of SFAS 144 has
had no impact on AtheroGenics' financial statements.
3. Net Loss per Share
SFAS No. 128, Earnings per Share, requires
presentation of both basic and diluted earnings per
share. Basic earnings per share is computed by dividing
net income (loss) by the weighted average number of shares of
common stock outstanding during the period. Diluted
earnings per share is computed in the same manner as basic
earnings per share except that diluted earnings per share
reflects the potential dilution that would occur if
outstanding options and warrants were exercised.
Because AtheroGenics reported a net loss for all periods
presented, shares associated with stock options and warrants
are not included because they are antidilutive. Basic
and diluted net loss per share amounts are the same for these
periods.
4. Deferred Stock
Compensation
Deferred compensation for options granted to employees
represents the difference between the exercise price and the
deemed fair value of AtheroGenics' common stock on the
dates these stock options were granted. The deferred
compensation is included as a reduction of shareholders'
equity and is amortized over the vesting periods of the
individual options, generally four years, using the graded
vesting method. The graded vesting method provides for
vesting of portions of the overall award at interim dates and
results in higher vesting in earlier years than straight-line
vesting.
Deferred compensation for options and warrants granted to
consultants is determined in accordance with SFAS No. 123,
Accounting for Stock-Based Compensation, and Emerging
Issues Task Force ("EITF") Issue No. 96-18,
Accounting for Equity Instruments That are Issued to Other
Than Employees for Acquiring or in Conjunction with Selling
Goods or Services, as the fair value of the equity
instruments issued. Deferred compensation for options
and warrants granted to consultants is adjusted to fair
market value on each balance sheet date.
At September 30, 2002, AtheroGenics had a total of $1,584,486
remaining to be amortized over the vesting periods of all
stock options and warrants.
6
The following should be read with the financial statements
and related footnotes and Management's Discussion and
Analysis of Financial Condition and Results of Operations
included in AtheroGenics' Annual Report on Form
10-K. The results discussed below are not necessarily
indicative of the results to be expected in any future
periods. The following discussion contains
forward-looking statements that are subject to risks and
uncertainties which could cause actual results to differ from
the statements made.
OVERVIEW
Since our operations began in 1994, we have focused on the
discovery, development and commercialization of novel drugs
for the treatment of chronic inflammatory diseases, including
heart disease (atherosclerosis), rheumatoid arthritis and
asthma. Based on our proprietary vascular protectant
technology platform, we have four drug programs in the
clinic, and are progressing on a number of other preclinical
programs. Our most advanced clinical compound,
AGI-1067, is in a Phase IIb clinical trial for
atherosclerosis and post-angioplasty restenosis. We are
currently working in cooperation with the Food and Drug
Administration to define the Phase III clinical development
program for AGI-1067 as an oral therapy for atherosclerosis
in patients with established coronary artery disease.
Our second clinical compound, AGIX-4207, is a novel oral
agent being tested in a Phase II clinical program for the
treatment of rheumatoid arthritis. AGIX-4207 I.V. is an
intravenous rheumatoid arthritis treatment that has completed
a Phase I clinical trial. AGI-1096 is a novel, oral
agent that has completed a Phase I clinical trial for the
prevention of transplant rejection.
7
8
- |
the status of product development; |
|
|
- |
the time and cost involved in conducting clinical trials and obtaining regulatory approvals; |
|
|
- |
the costs of filing, prosecuting and enforcing patent and other intellectual property claims; |
|
|
- |
competing technological and market developments; and |
|
|
- |
our ability to establish new licensing agreements. |
FORWARD-LOOKING STATEMENTS
The Private Securities Litigation Reform Act of 1995 (the
"Reform Act") provides a safe harbor for
forward-looking statements made by or on behalf of
AtheroGenics. AtheroGenics and its representatives may
from time to time make written or verbal forward-looking
statements, including statements contained in this report and
our other filings with the Securities and Exchange Commission
and in our reports to our shareholders. Generally, the
words "believe," "expect,"
"intend," "estimate,"
"anticipate," "will" and similar
expressions identify forward-looking statements. All
statements which address operating performance, events or
developments that we expect or anticipate will occur in the
future, such as projections about our future results of
operations or our financial condition, research, development
and commercialization of our product candidates and
anticipated trends in our business, are forward-looking
statements within the meaning of the Reform Act. The
forward-looking statements are and will be based on
9
management's then current views and assumptions regarding future events and operating performance, and speak only as of their dates. AtheroGenics undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
- |
AGI-1067, AGIX-4207, AGIX-4207 I.V. and AGI-1096 may fail in clinical trials; |
|
|
- |
our ability to generate positive cash flow in light of our history of operating losses; |
|
|
- |
our inability to obtain additional financing on satisfactory terms, which could preclude us from |
developing or marketing our products; |
|
|
|
- |
our ability to successfully develop our other product candidates; |
|
|
- |
our ability to commercialize our product candidates if we fail to demonstrate adequately their safety |
and efficacy; |
|
|
|
- |
possible delays in our clinical trials; |
|
|
- |
our inability to predict whether or when we will obtain regulatory approval to commercialize our |
product candidates or the timing of any future revenue from these product candidates; |
|
|
|
- |
our need to comply with applicable regulatory requirements in the manufacture and distribution of |
our products to avoid incurring penalties that may inhibit our ability to commercialize our products; |
|
|
|
- |
our ability to protect adequately or enforce our intellectual property rights or secure rights to third |
party patents; |
|
|
|
- |
the ability of our competitors to develop and market anti-inflammatory products that are more |
effective, have fewer side effects or are less expensive than our current or future product candidates; |
|
|
|
- |
third parties' failure to synthesize and manufacture our product candidates, which could delay our |
clinical trials or hinder our commercialization prospects; |
|
|
|
- |
our ability to create sales, marketing and distribution capabilities or enter into agreements with third |
parties to perform these functions; |
|
|
|
- |
our ability to attract, retain and motivate skilled personnel and cultivate key academic collaborations; |
|
|
- |
our ability to obtain an adequate level of reimbursement or acceptable prices for our products; and |
|
|
- |
if plaintiffs bring product liability lawsuits against us, we may incur substantial financial loss or may |
be unable to obtain future product liability insurance at reasonable prices, if at all, either of which |
|
could diminish our ability to commercialize our future products. |
The foregoing list of important factors is not exclusive.
Item 3. Quantitative And Qualitative Disclosures About
Market Risk
Market risk represents the risk of loss that may impact our
financial position, operating results or cash flows due to
changes in U.S. interest rates. This exposure is
directly related to our normal operating activities.
Our cash, cash equivalents and short-term investments are
invested with high quality issuers and are generally of a
short-term nature. Interest rates payable on our lease
obligations are generally fixed. As a result, we do not
believe that near-term changes in interest rates will have a
material effect on our future results of operations.
10
Evaluation of disclosure controls and procedures.
Our chief executive officer and chief financial officer are
responsible for establishing and maintaining "disclosure
controls and procedures" (as defined in the Securities
Exchange Act of 1934 Rules 13a-14(c) and 15d-14(c)) for
AtheroGenics. Our disclosure controls and procedures
include our "internal controls," as that term is
used in Section 302 of the Sarbenes-Oxley Act of 2002 and
described in the Security and Exchange Commission's
Release No. 34-46427 (August 29, 2002). Our chief
executive officer and chief financial officer, after
evaluating the effectiveness of our disclosure controls and
procedures as of a date within 90 days before the filing date
of this quarterly report, have concluded that our disclosure
controls and procedures are adequate and effective in timely
alerting them to material information relating to us required
to be included in our periodic SEC filings.
Changes in internal controls. There were no
significant changes in our internal controls or in other
factors that could significantly affect those controls
subsequent to the date of the evaluation. As a result,
there were no corrective actions to be taken.
PART II - OTHER INFORMATION
Item 2. Changes in Securities and Use of
Proceeds
The Securities and Exchange Commission declared our
Registration Statement on Form S-1 (File No. 333-31140)
effective August 8, 2000. The net proceeds from the
sale of the 6,900,000 shares of common stock registered
pursuant to the Registration Statement (including the
exercise of the underwriters’ over-allotment option)
were $49.4 million after deducting underwriting discounts of
$3.9 million and offering expenses of $1.9 million.
We expect to use the proceeds from our initial public
offering for research and development activities, including
clinical trials, process development and manufacturing
support, and for general corporate purposes, including
working capital. A portion of the proceeds may be used
to acquire or invest in complementary businesses, products or
technologies. As of September 30, 2002, the proceeds
have been applied toward:
- |
purchases of fixed assets and leasehold improvements, $2.1 million; |
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|
- |
operating activities, $30.4 million; and |
|
|
- |
investments in highly liquid, interest bearing, investment grade securities, $16.9 million. |
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits
Exhibit No. |
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10.22* |
Separation and Consulting Agreement and General Release dated as of October 3, 2002 between |
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AtheroGenics, Inc. and Mitchell Glass, M.D. |
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__________ |
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* Filed herewith. |
(b) Reports on Form 8-K
None.
11
SIGNATURES
Pursuant to the requirements 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.
|
ATHEROGENICS, INC. |
Date: November 14, 2002 |
By: /s/ MARK P. COLONNESE |
|
MARK P. COLONNESE |
|
Senior Vice President of Finance and Administration and |
|
Chief Financial Officer (Principal Financial and |
|
Chief Accounting Officer) |
12
CERTIFICATIONS
I, Russell M. Medford, President and Chief Executive Officer, certify that:
1. I have reviewed this quarterly report on Form 10-Q of AtheroGenics, Inc.;
2. Based on my knowledge, this
quarterly report does not contain any untrue statement of a
material fact or
omit to
state a material fact necessary to make the statements made,
in light of the circumstances under
which such
statements were made, not misleading with respect to the
period covered by this quarterly
report;
3. Based on my knowledge, the
financial statements, and other financial information
included in this
quarterly
report, fairly represent in all material respects the financial
condition, results of operations
and cash flows of the registrant as of, and for the periods
presented in this quarterly report;
4. The registrant's other
certifying officers and I are responsible for establishing
and maintaining disclosure
controls and
procedures (as defined in Exchange Act Rules 13a-14 and
15d-14) for the registrant and we
have:
a) designed such disclosure controls and
procedures to ensure that material information relating to
the
registrant, including its consolidated subsidiaries, is made
known to us by others within those
entities, particularly during the period in which this
quarterly report is being prepared;
b) evaluated the effectiveness of the
registrant's disclosure controls and procedures as of a
date within
90 days prior to the filing date of this quarterly report
(the "Evaluation Date"); and
c) presented in this quarterly report our
conclusions about the effectiveness of the disclosure
controls
and procedures based on our evaluation as of the Evaluation
Date;
5. The registrant's other
certifying officers and I have disclosed, based on our most
recent evaluation, to the
registrant's auditors and the audit committee of
registrant's board of directors (or persons performing
the
equivalent
function):
a)
all significant deficiencies in the design or operation of
internal controls which could adversely
affect the registrant's ability to record, process,
summarize and report financial data and have
identified for the registrant's auditors any material
weaknesses in internal controls; and
b) any fraud, whether or not material, that
involves management or other employees who have a
significant role in the registrant's internal controls;
and
6. The registrant's other
certifying officers and I have indicated in this quarterly
report whether or not there
were
significant changes in internal controls or in other factors
that could significantly affect internal
controls
subsequent to the date of our most recent evaluation,
including any corrective actions with regard
to significant
deficiencies and material weaknesses.
Date: November 14, 2002 |
/s/ RUSSELL M. MEDFORD |
|
Russell M. Medford |
|
President and Chief Executive Officer |
13
I, Mark Colonnese, Senior Vice President of Finance and Administration and Chief Financial Officer, certify that:
1. I have reviewed this quarterly report on Form 10-Q of AtheroGenics, Inc.;
2. Based on my knowledge, this
quarterly report does not contain any untrue statement of a
material fact or
omit to
state a material fact necessary to make the statements made,
in light of the circumstances under
which such
statements were made, not misleading with respect to the
period covered by this quarterly
report;
3. Based on my knowledge, the
financial statements, and other financial information
included in this
quarterly
report, fairly represent in all material respects the financial
condition, results of operations
and cash flows of the registrant as of, and for the periods
presented in this quarterly report;
4. The registrant's other
certifying officers and I are responsible for establishing
and maintaining disclosure
controls and
procedures (as defined in Exchange Act Rules 13a-14 and
15d-14) for the registrant and we
have:
a) designed such disclosure controls and
procedures to ensure that material information relating to
the
registrant, including its consolidated subsidiaries, is made
known to us by others within those
entities, particularly during the period in which this
quarterly report is being prepared;
b) evaluated the effectiveness of the
registrant's disclosure controls and procedures as of a
date within
90 days prior to the filing date of this quarterly report
(the "Evaluation Date"); and
c) presented in this quarterly report our
conclusions about the effectiveness of the disclosure
controls
and procedures based on our evaluation as of the Evaluation
Date;
5. The registrant's other
certifying officers and I have disclosed, based on our most
recent evaluation, to the
registrant's auditors and the audit committee of
registrant's board of directors (or persons performing
the
equivalent
function):
a)
all significant deficiencies in the design or operation of
internal controls which could adversely
affect the registrant's ability to record, process,
summarize and report financial data and have
identified for the registrant's auditors any material
weaknesses in internal controls; and
b) any fraud, whether or not material, that
involves management or other employees who have a
significant role in the registrant's internal controls;
and
6. The registrant's other
certifying officers and I have indicated in this quarterly
report whether or not there
were
significant changes in internal controls or in other factors
that could significantly affect internal
controls
subsequent to the date of our most recent evaluation,
including any corrective actions with regard
to significant
deficiencies and material weaknesses.
Date: November 14, 2002 |
/s/ MARK P. COLONNESE |
|
Mark P. Colonnese |
|
Senior Vice President of Finance and |
|
Administration and Chief Financial Officer |
14