Georgia
|
58-2108232
|
(State
of incorporation)
|
(I.R.S.
Employer Identification Number)
|
PART
I. FINANCIAL INFORMATION
|
Page
No.
|
||||
Item
1. Condensed Financial Statements (unaudited)
|
|||||
Condensed
Balance Sheets
|
|||||
March
31, 2006 and December 31, 2005
|
1
|
||||
Condensed
Statements of Operations
|
|||||
Three
months ended March 31, 2006 and 2005
|
2
|
||||
Condensed
Statements of Cash Flows
|
|||||
Three
months ended March 31, 2006 and 2005
|
3
|
||||
Notes
to Condensed Financial Statements
|
4
|
||||
Item
2. Management's Discussion and Analysis of Financial Condition
|
|||||
and Results of Operations
|
8
|
||||
Item
3. Quantitative and Qualitative Disclosures About Market
Risk
|
15
|
||||
Item
4. Controls and Procedures
|
15
|
||||
PART
II. OTHER INFORMATION
|
|||||
Item
1. Legal Proceedings
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15
|
||||
Item
6. Exhibits
|
15
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||||
SIGNATURES
|
16
|
||||
March
31,
|
December
31,
|
||||||
2006
|
2005
|
||||||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
81,934,748
|
$
|
82,831,679
|
|||
Short-term
investments
|
127,535,049
|
99,672,844
|
|||||
Prepaid
expenses
|
3,708,592
|
2,639,900
|
|||||
Interest
and other receivables
|
2,921,896
|
900,192
|
|||||
Total
current assets
|
216,100,285
|
186,044,615
|
|||||
Equipment
and leasehold improvements, net of accumulated
depreciation
|
|||||||
and
amortization
|
4,405,100
|
4,108,462
|
|||||
Debt
issuance costs and other assets
|
6,734,268
|
7,344,450
|
|||||
Total
assets
|
$
|
227,239,653
|
$
|
197,497,527
|
|||
Liabilities
and Shareholders' Deficit
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
3,479,290
|
$
|
2,188,461
|
|||
Accrued
research and development
|
3,036,223
|
3,946,970
|
|||||
Accrued
and other liabilities
|
1,368,492
|
1,344,876
|
|||||
Accrued
interest
|
770,000
|
2,750,000
|
|||||
Accrued
compensation
|
533,790
|
2,649,640
|
|||||
Current
portion of deferred revenue
|
25,000,000
|
—
|
|||||
Total
current liabilities
|
34,187,795
|
12,879,947
|
|||||
Convertible
notes payable and equipment loan, net of current portion
|
286,045,095
|
300,053,796
|
|||||
Long-term
portion of deferred revenue
|
20,833,333
|
—
|
|||||
Shareholders'
deficit:
|
|||||||
Preferred
stock, no par value: Authorized—5,000,000 shares
|
—
|
—
|
|||||
Common
stock, no par value:
|
|||||||
Authorized—100,000,000
shares; issued and outstanding —
|
|||||||
39,381,022
and 38,143,678 shares at March 31, 2006
|
|||||||
and
December 31, 2005, respectively
|
199,607,034
|
178,771,376
|
|||||
Warrants
|
613,021
|
620,223
|
|||||
Accumulated
deficit
|
(313,899,681
|
)
|
(294,674,874
|
)
|
|||
Accumulated
other comprehensive loss
|
(146,944
|
)
|
(152,941
|
)
|
|||
Total
shareholders' deficit
|
(113,826,570
|
)
|
(115,436,216
|
)
|
|||
Total
liabilities and shareholders' deficit
|
$
|
227,239,653
|
$
|
197,497,527
|
|||
Three
months ended
|
|||||||
March
31,
|
|||||||
2006
|
2005
|
||||||
License
fee revenue
|
$
|
4,166,667
|
$
|
—
|
|||
Operating
expenses:
|
|||||||
Research and development
|
16,260,622
|
16,155,070
|
|||||
General
and administrative
|
3,707,333
|
1,820,818
|
|||||
Total operating expenses
|
19,967,955
|
17,975,888
|
|||||
Operating
loss
|
(15,801,288
|
)
|
(17,975,888
|
)
|
|||
Interest
and other income
|
2,205,234
|
1,447,904
|
|||||
Interest
expense
|
(2,107,517
|
)
|
(2,103,573
|
)
|
|||
Other
expense
|
(3,521,236
|
)
|
—
|
||||
Net
loss
|
$
|
(19,224,807
|
)
|
$
|
(18,631,557
|
)
|
|
Net
loss per share - basic and diluted
|
$
|
(0.49
|
)
|
$
|
(0.50
|
)
|
|
Weighted
average shares outstanding - basic and diluted
|
39,202,076
|
37,532,613
|
|||||
Three
months ended
|
|||||||
March
31,
|
|||||||
2006
|
2005
|
||||||
Operating
activities
|
|||||||
Net
loss
|
$
|
(19,224,807
|
)
|
$
|
(18,631,557
|
)
|
|
Adjustments
to reconcile net loss to net cash provided by
|
|||||||
(used in) operating activities:
|
|||||||
Amortization of license fee
|
(4,166,667
|
)
|
—
|
||||
Loss on debt conversion
|
3,524,236
|
—
|
|||||
Stock-based compensation
|
2,039,090
|
43,393
|
|||||
Depreciation and amortization
|
221,393
|
189,872
|
|||||
Amortization of debt issuance costs
|
373,253
|
318,007
|
|||||
Changes in operating assets and liabilities:
|
|||||||
Interest and other receivables
|
(2,021,704
|
)
|
(475,566
|
)
|
|||
Prepaid expenses
|
(1,068,692
|
)
|
1,587,439
|
||||
Accounts payable
|
1,290,829
|
606,639
|
|||||
Accrued compensation
|
(2,115,850
|
)
|
(785,269
|
)
|
|||
Accrued interest
|
(1,704,750
|
)
|
(466,667
|
)
|
|||
Accrued research and development
|
(910,747
|
)
|
(1,638,953
|
)
|
|||
Accrued and other liabilities
|
23,211
|
54,998
|
|||||
Deferred revenue
|
50,000,000
|
—
|
|||||
Net cash provided by (used in) operating activities
|
26,258,795
|
(19,197,664
|
)
|
||||
Investing
activities
|
|||||||
Purchases
of short-term investments
|
(30,087,721
|
)
|
(80,437,505
|
)
|
|||
Sales
and maturities of short-term investments
|
2,231,513
|
2,890,272
|
|||||
Purchases
of equipment and leasehold improvements
|
(518,031
|
)
|
(86,114
|
)
|
|||
Net cash used in investing activities
|
(28,374,239
|
)
|
(77,633,347
|
)
|
|||
Financing
activities
|
|||||||
Proceeds
from the exercise of common stock options
|
1,226,809
|
816,002
|
|||||
Payments
on equipment loan facility
|
(8,296
|
)
|
(83,622
|
)
|
|||
Proceeds
from the issuance of 1.5% convertible notes
|
—
|
193,566,977
|
|||||
Net cash provided by financing activities
|
1,218,513
|
194,299,357
|
|||||
(Decrease)
increase in cash and cash equivalents
|
(896,931
|
)
|
97,468,346
|
||||
Cash
and cash equivalents at beginning of period
|
82,831,679
|
15,888,919
|
|||||
Cash
and cash equivalents at end of period
|
$
|
81,934,748
|
$
|
113,357,265
|
|||
Supplemental
disclosures
|
|||||||
Interest
paid
|
$
|
3,435,000
|
$
|
2,252,233
|
|||
Expected
volatility
|
70.70%
|
Expected
term
|
5
years
|
Risk
free interest rate
|
4.59%
|
Fair
value of grants
|
$9.78
|
Three
months ended
|
|||
March
31, 2005
|
|||
Net
loss, as reported
|
$
|
(18,631,557
|
)
|
Add:
Stock-based employee compensation expense
|
|||
included in reported net loss
|
—
|
||
Deduct:
Total stock-based employee compensation expense
|
|||
determined under fair value based method for all awards
|
(2,410,725
|
)
|
|
Pro
forma net loss
|
$
|
(21,042,282
|
)
|
Net
loss per share:
|
|||
Basic
and diluted, as reported
|
$
|
(0.50
|
)
|
Basic
and diluted, pro forma
|
$
|
(0.56
|
)
|
Expected
volatility
|
78.74%
|
Expected
term
|
5
years
|
Risk
free interest rate
|
4.33%
|
Fair
value of grants
|
$10.73
|
Weighted
|
||||||||||||
Weighted
|
Average
|
Aggregate
|
||||||||||
Number
of
|
Average
|
Remaining
|
Intrinsic
|
|||||||||
Shares
|
Exercise
Price
|
Contractual
Life
|
Value
|
|||||||||
Outstanding
at January 1, 2006
|
4,375,632
|
$
|
11.17
|
|||||||||
Granted
|
950,609
|
15.82
|
||||||||||
Exercised
|
(152,344
|
)
|
8.05
|
|||||||||
Canceled
|
(44,099
|
)
|
17.77
|
|||||||||
Outstanding
at March 31, 2006
|
5,129,798
|
12.06
|
7.19
|
$
|
29,179,218
|
|||||||
Exercisable
at March 31, 2006
|
2,952,514
|
$
|
8.29
|
5.88
|
$
|
26,745,450
|
Three
months ended
|
|||||||
March
31,
|
|||||||
2006
|
2005
|
||||||
Direct
external costs:
|
|||||||
AGI-1067
|
$
|
10,298,230
|
$
|
12,978,744
|
|||
Unallocated
costs and other programs
|
5,962,392
|
3,176,326
|
|||||
Total research and development
|
$
|
16,260,622
|
$
|
16,155,070
|
Payments
Due by Period
|
||||||||||||||||
Total
|
Remainder
of 2006
|
2007-2008
|
2009-2010
|
Thereafter
|
||||||||||||
Contractual
obligations:
|
||||||||||||||||
Operating
leases
|
$
|
3,848,374
|
$
|
1,038,503
|
$
|
2,602,834
|
$
|
207,037
|
$
|
—
|
||||||
Long-term
debt
|
286,079,284
|
25,489
|
86,053,795
|
—
|
200,000,000
|
|||||||||||
Interest
on long-term debt
|
27,679,496
|
3,437,438
|
13,742,058
|
6,000,000
|
4,500,000
|
|||||||||||
Total
contractual obligations
|
$
|
317,607,154
|
$
|
4,501,430
|
$
|
102,398,687
|
$
|
6,207,037
|
$
|
204,500,000
|
· |
the
scope and results of our research, preclinical and clinical development
activities;
|
· |
the
timing of, and the costs involved in, obtaining regulatory approvals;
|
· |
the
timing, receipt and amount of sales and royalties, if any, from our
potential product candidates;
|
· |
the
timing, receipt and amount of milestone and other payments, if any;
|
· |
our
ability to maintain our collaborations with AstraZeneca and Astellas
and
the financial terms of our collaborations;
|
· |
the
costs involved in preparing, filing, prosecuting, maintaining and
enforcing patent claims and other patent-related
costs;
|
· |
the
costs related to purported class action lawsuits filed against us;
and
|
· |
the
extent to which we acquire or invest in businesses, products and
technologies.
|
·
|
AGI-1067
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;
|
|
·
|
our
substantial dependence on our AstraZeneca collaboration, which may
ultimately be unsuccessful;
|
·
|
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;
|
·
|
we
may face product liability lawsuits which may cause us to incur
substantial financial loss or we 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;
and
|
|
·
|
the
conversion of our $86 million principal amount, 4.5% convertible
notes and
our $200 million
|
principal
amount, 1.5% convertible notes will dilute the ownership interest
of
existing shareholders
|
|
and
could adversely affect the market price of our common
stock.
|
Exhibit
31.1
|
-
|
Certifications
of Chief Executive Officer under Rule 13a-14(a).
|
Exhibit
31.2
|
-
|
Certifications
of Chief Financial Officer under Rule 13a-14(a).
|
Exhibit
32
|
-
|
Certifications
of Chief Executive Officer and Chief Financial Officer under Section
1350.
|
ATHEROGENICS,
INC.
|
|
Date:
May 8, 2006
|
/s/MARK
P. COLONNESE
|
Mark
P. Colonnese
|
|
Senior
Vice President of Finance and
|
|
Administration
and Chief Financial Officer
|