Georgia
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58-2108232
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(State
of incorporation)
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(I.R.S.
Employer Identification Number)
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PART
I. FINANCIAL INFORMATION
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Page
No.
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||||
Item
1. Condensed Financial Statements (unaudited)
|
|||||
Condensed
Balance Sheets
|
|||||
March
31, 2007 and December 31, 2006
|
1
|
||||
Condensed
Statements of Operations
|
|||||
Three
months ended March 31, 2007 and 2006
|
2
|
||||
Condensed
Statements of Cash Flows
|
|||||
Three
months ended March 31, 2007 and 2006
|
3
|
||||
Notes
to Condensed Financial Statements
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4
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||||
Item
2. Management’s Discussion and Analysis of Financial Condition
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|||||
and Results of Operations
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7
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||||
Item
3. Quantitative and Qualitative Disclosures About Market
Risk
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13
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||||
Item
4. Controls and Procedures
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13
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||||
PART
II. OTHER INFORMATION
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|||||
Item
1A. Risk Factors
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13
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||||
Item
6. Exhibits
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14
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||||
SIGNATURES
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15
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||||
March
31,
|
December
31,
|
||||||
2007
|
2006
|
||||||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
81,953,789
|
$
|
87,846,079
|
|||
Short-term
investments
|
48,361,027
|
63,964,860
|
|||||
Accounts
receivable
|
6,582,868
|
6,537,892
|
|||||
Prepaid
expenses
|
4,212,580
|
4,038,419
|
|||||
Interest
receivable
|
377,531
|
643,097
|
|||||
Total
current assets
|
141,487,795
|
163,030,347
|
|||||
Equipment
and leasehold improvements, net of accumulated
depreciation
|
|||||||
and
amortization
|
10,732,127
|
9,684,965
|
|||||
Debt
issuance costs and other assets
|
5,254,071
|
5,624,352
|
|||||
Total
assets
|
$
|
157,473,993
|
$
|
178,339,664
|
|||
Liabilities
and Shareholders' Deficit
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
1,881,538
|
$
|
3,183,511
|
|||
Accrued
research and development
|
10,155,472
|
11,263,164
|
|||||
Accrued
compensation
|
859,407
|
1,465,644
|
|||||
Accrued
interest
|
822,500
|
2,540,000
|
|||||
Accrued
and other liabilities
|
932,530
|
791,661
|
|||||
Current
portion of deferred revenue
|
20,857,750
|
25,000,000
|
|||||
Total
current liabilities
|
35,509,197
|
44,243,980
|
|||||
Convertible
notes payable
|
286,000,000
|
286,000,000
|
|||||
Long-term
portion of deferred revenue
|
—
|
2,083,333
|
|||||
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 —
|
|||||||
39,494,492
and 39,452,927 shares at March 31, 2007
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|||||||
and
December 31, 2006, respectively
|
210,001,453
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207,388,894
|
|||||
Warrants
|
613,021
|
613,021
|
|||||
Accumulated
deficit
|
(374,649,870
|
)
|
(361,997,246
|
)
|
|||
Accumulated
other comprehensive gain
|
192
|
7,682
|
|||||
Total
shareholders' deficit
|
(164,035,204
|
)
|
(153,987,649
|
)
|
|||
Total
liabilities and shareholders' deficit
|
$
|
157,473,993
|
$
|
178,339,664
|
|||
Three
months ended
|
|||||||
March
31,
|
|||||||
2007
|
2006
|
||||||
Revenues:
|
|||||||
License fees
|
$
|
6,250,000
|
$
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4,166,667
|
|||
Research and development
|
5,211,252
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—
|
|||||
Total revenues
|
11,461,252
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4,166,667
|
|||||
Operating
expenses:
|
|||||||
Research and development
|
19,964,275
|
16,260,622
|
|||||
Marketing, general and administrative
|
3,945,503
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3,707,333
|
|||||
Total operating expenses
|
23,909,778
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19,967,955
|
|||||
Operating
loss
|
(12,448,526
|
)
|
(15,801,288
|
)
|
|||
Interest
income
|
1,883,683
|
2,205,234
|
|||||
Interest
expense
|
(2,087,781
|
)
|
(2,107,517
|
)
|
|||
Other
expense
|
—
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(3,521,236
|
)
|
||||
Net
loss
|
$
|
(12,652,624
|
)
|
$
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(19,224,807
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)
|
|
Net
loss per share -
|
|||||||
basic and diluted
|
$
|
(0.32
|
)
|
$
|
(0.49
|
)
|
|
Weighted
average shares outstanding -
|
|||||||
basic and diluted
|
39,468,054
|
39,202,076
|
|||||
Three
months ended
|
|||||||
March
31,
|
|||||||
2007
|
2006
|
||||||
Operating
activities
|
|||||||
Net
loss
|
$
|
(12,652,624
|
)
|
$
|
(19,224,807
|
)
|
|
Adjustments
to reconcile net loss to net cash
|
|||||||
(used in) provided by operating activities:
|
|||||||
Amortization of deferred revenue
|
(6,225,583
|
)
|
(4,166,667
|
)
|
|||
Stock-based compensation
|
2,597,004
|
2,039,090
|
|||||
Loss on debt conversion
|
—
|
3,524,236
|
|||||
Amortization of debt issuance costs
|
370,281
|
373,253
|
|||||
Depreciation and amortization
|
265,233
|
221,393
|
|||||
Changes in operating assets and liabilities:
|
|||||||
Accounts receivable
|
(44,976
|
)
|
(1,719,998
|
)
|
|||
Prepaid expenses
|
(174,161
|
)
|
(1,068,692
|
)
|
|||
Interest receivable
|
265,566
|
(301,706
|
)
|
||||
Accounts payable
|
(1,301,973
|
)
|
1,290,829
|
||||
Accrued research and development
|
(2,256,073
|
)
|
(910,747
|
)
|
|||
Accrued interest
|
(1,717,500
|
)
|
(1,704,750
|
)
|
|||
Accrued compensation
|
(606,237
|
)
|
(2,115,850
|
)
|
|||
Accrued and other liabilities
|
140,869
|
23,211
|
|||||
Deferred revenue
|
—
|
50,000,000
|
|||||
Net cash (used in) provided by operating activities
|
(21,340,174
|
)
|
26,258,795
|
||||
Investing
activities
|
|||||||
Sales
and maturities of
short-term investments
|
34,408,824
|
2,231,513
|
|||||
Purchases
of short-term investments
|
(18,812,481
|
)
|
(30,087,721
|
)
|
|||
Purchases
of equipment and leasehold improvements
|
(164,014
|
)
|
(518,031
|
)
|
|||
Net
cash provided by (used in) investing activities
|
15,432,329
|
(28,374,239
|
)
|
||||
Financing
activities
|
|||||||
Proceeds
from the exercise of common stock options
|
15,555
|
1,226,809
|
|||||
Payments
on equipment loan facility
|
—
|
(8,296
|
)
|
||||
Net
cash provided by financing activities
|
15,555
|
1,218,513
|
|||||
Decrease
in cash and cash equivalents
|
(5,892,290
|
)
|
(896,931
|
)
|
|||
Cash
and cash equivalents at beginning of period
|
87,846,079
|
82,831,679
|
|||||
Cash
and cash equivalents at end of period
|
$
|
81,953,789
|
$
|
81,934,748
|
|||
Supplemental
disclosures
|
|||||||
Interest
paid
|
$
|
3,435,000
|
$
|
3,435,000
|
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,
|
|||||||
2007
|
2006
|
||||||
Direct
external AGI-1067 costs
|
$
|
11,701,833
|
$
|
10,298,230
|
|||
Unallocated
internal costs and other programs
|
8,262,442
|
5,962,392
|
|||||
Total
research and development
|
$
|
19,964,275
|
$
|
16,620,622
|
· |
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 Astellas and the financial
terms of our collaboration;
|
· |
the
timing of, and the costs involved in, transitioning the AstraZeneca
collaboration;
|
· |
the
costs involved in preparing, filing, prosecuting, maintaining and
enforcing patent claims and other patent-related
costs; and
|
· |
the
extent to which we acquire or invest in businesses, products and
technologies.
|
·
|
our
inability to commercialize AGI-1067 following the release of the
ARISE
Phase III clinical trial;
|
·
|
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 my inhibit our ability
to
commercialize our product;
|
|
·
|
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
|
|
·
|
our
ability to repay $86 million principal amount on the 4.5% convertible
notes due September 1, 2008;
|
and
|
|
·
|
the
conversion of our convertible notes would 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 10, 2007
|
/s/MARK P. COLONNESE |
Mark
P. Colonnese
|
|
Executive
Vice President, Commercial Operations and
|
|
Chief
Financial Officer
|