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
|
|
September
30, 2007 and December 31,
2006
|
1
|
Condensed
Statements of Operations
|
|
Three
and nine months ended September 30, 2007 and
2006
|
2
|
Condensed
Statements of Cash Flows
|
|
Nine
months ended September 30, 2007 and
2006
|
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
|
14
|
Item
4. Controls and
Procedures
|
15
|
PART
II. OTHER INFORMATION
|
|
Item 1A. Risk Factors |
15
|
Item
6. Exhibits
|
15
|
SIGNATURES
|
16
|
September
30,
|
December
31,
|
|||||
2007
|
2006
|
|||||
Assets
|
||||||
Current
assets:
|
||||||
Cash
and cash
equivalents
|
$ |
82,214,256
|
$ |
87,846,079
|
||
Short-term
investments
|
19,201,522
|
63,964,860
|
||||
Accounts
receivable
|
7,482,973
|
6,537,892
|
||||
Prepaid
expenses
|
3,434,112
|
4,038,419
|
||||
Interest
receivable
|
232,671
|
643,097
|
||||
Total
current
assets
|
112,565,534
|
163,030,347
|
||||
Equipment
and leasehold improvements, net of accumulated
depreciation
|
||||||
and
amortization
|
2,563,729
|
9,684,965
|
||||
Debt
issuance costs and other
assets
|
4,286,145
|
5,624,352
|
||||
Total
assets
|
$ |
119,415,408
|
$ |
178,339,664
|
||
Liabilities
and Shareholders' Deficit
|
||||||
Current
liabilities:
|
||||||
Accounts
payable
|
$ |
5,069,085
|
$ |
3,183,511
|
||
Accrued
research and
development
|
3,503,704
|
11,263,164
|
||||
Accrued
interest
|
906,538
|
2,540,000
|
||||
Accrued
compensation
|
1,525,287
|
1,465,644
|
||||
Accrued
and other
liabilities
|
607,632
|
791,661
|
||||
Current
portion of deferred
revenue
|
1,554,369
|
25,000,000
|
||||
Current
portion of convertible notes
payable
|
48,000,000
|
—
|
||||
Total
current
liabilities
|
61,166,615
|
44,243,980
|
||||
Convertible
notes payable, net of current
portion
|
238,980,424
|
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 —
|
||||||
39,518,492
and 39,452,927 shares at September 30, 2007
|
||||||
and
December 31, 2006,
respectively
|
214,108,950
|
207,388,894
|
||||
Warrants
|
613,021
|
613,021
|
||||
Accumulated
deficit
|
(395,464,018 | ) | (361,997,246 | ) | ||
Accumulated
other comprehensive
gain
|
10,416
|
7,682
|
||||
Total
shareholders'
deficit
|
(180,731,631 | ) | (153,987,649 | ) | ||
Total
liabilities and shareholders'
deficit
|
$ |
119,415,408
|
$ |
178,339,664
|
||
Three
months ended
|
Nine
months ended
|
|||||||||||||||
September
30,
|
September
30,
|
|||||||||||||||
2007
|
2006
|
2007
|
2006
|
|||||||||||||
Revenues:
|
||||||||||||||||
License
fees
|
$ |
—
|
$ |
6,250,000
|
$ |
27,083,333
|
$ |
16,666,667
|
||||||||
Research
and
development
|
7,438,867
|
4,042,683
|
22,075,490
|
4,042,683
|
||||||||||||
Total
revenues
|
7,438,867
|
10,292,683
|
49,158,823
|
20,709,350
|
||||||||||||
Operating
expenses:
|
||||||||||||||||
Research
and
development
|
16,818,119
|
21,806,971
|
59,112,592
|
54,514,773
|
||||||||||||
Marketing,
general and administrative
|
3,086,868
|
3,111,042
|
10,619,566
|
9,990,244
|
||||||||||||
Restructuring
and impairment costs
|
—
|
—
|
9,996,332
|
—
|
||||||||||||
Total
operating
expenses
|
19,904,987
|
24,918,013
|
79,728,490
|
64,505,017
|
||||||||||||
Operating
loss
|
(12,466,120 | ) | (14,625,330 | ) | (30,569,667 | ) | (43,795,667 | ) | ||||||||
Interest
income
|
1,310,322
|
2,391,460
|
4,798,125
|
6,998,118
|
||||||||||||
Interest
expense
|
(3,519,669 | ) | (2,139,450 | ) | (7,695,230 | ) | (6,335,565 | ) | ||||||||
Other
expense
|
—
|
—
|
—
|
(3,521,236 | ) | |||||||||||
Net
loss
|
$ | (14,675,467 | ) | $ | (14,373,320 | ) | $ | (33,466,772 | ) | $ | (46,654,350 | ) | ||||
Net
loss per share –
|
||||||||||||||||
basic
and
diluted
|
$ | (0.37 | ) | $ | (0.36 | ) | $ | (0.85 | ) | $ | (1.19 | ) | ||||
Weighted
average shares
|
||||||||||||||||
outstanding
– basic and diluted
|
39,515,014
|
39,451,933
|
39,493,974
|
39,359,938
|
||||||||||||
Nine
months ended
|
||||||||
September
30,
|
||||||||
2007
|
2006
|
|||||||
Operating
activities
|
||||||||
Net
loss
|
$ | (33,466,772 | ) | $ | (46,654,350 | ) | ||
Adjustments
to reconcile net loss to net cash
|
||||||||
used
in operating activities:
|
||||||||
Asset
impairment
costs
|
9,005,153
|
—
|
||||||
Amortization
of deferred
revenue
|
(27,083,333 | ) | (16,666,667 | ) | ||||
Stock-based
compensation
|
6,696,982
|
6,724,633
|
||||||
Amortization
of debt issuance
costs
|
1,338,207
|
1,112,888
|
||||||
Amortization
of discount on 4.5% convertible notes due 2011
|
980,424
|
—
|
||||||
Depreciation
and
amortization
|
710,357
|
688,295
|
||||||
Loss
on debt
conversion
|
—
|
3,521,236
|
||||||
Changes
in operating assets and liabilities:
|
||||||||
Accounts
receivable
|
(945,081 | ) | (6,795,305 | ) | ||||
Prepaid
expenses
|
604,307
|
(2,579,841 | ) | |||||
Interest
receivable
|
410,426
|
171,989
|
||||||
Accounts
payable
|
1,885,574
|
1,072,796
|
||||||
Accrued
research and
development
|
(7,759,460 | ) |
3,191,959
|
|||||
Accrued
interest
|
(1,633,462 | ) | (1,649,250 | ) | ||||
Accrued
compensation
|
59,643
|
(1,372,127 | ) | |||||
Accrued
and other
liabilities
|
(184,029 | ) | (570,750 | ) | ||||
Deferred
revenue
|
1,554,369
|
50,000,000
|
||||||
Net
cash used in operating
activities
|
(47,826,695 | ) | (9,804,494 | ) | ||||
Investing
activities
|
||||||||
Sales
and maturities of short-term
investments
|
104,729,736
|
105,425,992
|
||||||
Purchases
of short-term
investments
|
(59,963,664 | ) | (76,895,985 | ) | ||||
Purchases
of equipment and leasehold improvements
|
(2,594,274 | ) | (2,502,930 | ) | ||||
Net
cash provided by investing activities
|
42,171,798
|
26,027,077
|
||||||
Financing
activities
|
||||||||
Proceeds
from the exercise of common stock options
|
23,074
|
1,762,357
|
||||||
Payments
on equipment loan
facility
|
—
|
(87,580 | ) | |||||
Net
cash provided by financing activities
|
23,074
|
1,674,777
|
||||||
(Decrease)
increase in cash and cash equivalents
|
(5,631,823 | ) |
17,897,360
|
|||||
Cash
and cash equivalents at beginning of period
|
87,846,079
|
82,831,679
|
||||||
Cash
and cash equivalents at end of
period
|
$ |
82,214,256
|
$ |
100,729,039
|
||||
Supplemental
disclosures
|
||||||||
Interest
paid
|
$ |
7,010,062
|
$ |
6,871,927
|
Three
months ended
|
Nine
months ended
|
||||||
September
30,
|
September
30,
|
||||||
2007
|
2006
|
2007
|
2006
|
||||
Expected
volatility
|
76.45%
|
|
66.37%
|
82.86%
|
69.62%
|
||
Expected
term
|
5
years
|
5
years
|
3.5
years
|
5
years
|
|||
Risk
free interest
rate
|
4.54%
|
4.67%
|
4.91%
|
4.70%
|
|||
Fair
value of
grants
|
$1.10
|
$7.98
|
$1.41
|
$9.26
|
2008
Notes
|
$ 48,000,000
|
|
2011
Notes
|
60,410,000
|
|
2012
Notes
|
200,000,000
|
|
Face
value of convertible
notes
|
260,410,000
|
|
Discount
on the 2011
Notes
|
(21,429,576
|
) |
Total
2011 Notes and 2012
Notes
|
$ 238,980,424
|
Three
months ended
|
Nine
months ended
|
|||||||||||||||
September
30,
|
September
30,
|
|||||||||||||||
2007
|
2006
|
2007
|
2006
|
|||||||||||||
Direct
external AGI-1067 costs
|
$ |
14,106,187
|
$ |
12,256,126
|
$ |
44,351,188
|
$ |
31,930,434
|
||||||||
Unallocated
internal costs and other programs
|
2,711,932
|
9,550,845
|
14,761,404
|
22,584,339
|
||||||||||||
Total
research and development
|
$ |
16,818,119
|
$ |
21,806,971
|
$ |
59,112,592
|
$ |
54,514,773
|
·
|
announced
the focus on diabetes as the next step in the development of AGI-1067
and
commenced a new Phase III clinical trial, called ANDES, studying
the
effect of AGI-1067 in patients with
diabetes;
|
·
|
reduced
AtheroGenics’ near term cash requirements by exchanging $38.0 million of
the 4.5% convertible notes due September 2008 (2008 Notes) for $60.4
million of 4.5% convertible notes that will be due in March 2011
(2011
Notes);
|
·
|
reduced
the workforce by approximately 50%, resulting in a staff of 67 employees;
and
|
·
|
implemented
a retention/incentive program for key executive officers and
employees.
|
Payments
Due by Period
|
||||||||||||||||||||
Total
|
2007
|
2008-2009
|
2010-2011
|
Thereafter
|
||||||||||||||||
Contractual
obligations
|
||||||||||||||||||||
Operating
leases
|
$ |
1,790,093
|
$ |
341,837
|
$ |
1,446,501
|
$ |
1,755
|
$ |
—
|
||||||||||
Convertible
notes
|
308,410,000
|
—
|
48,000,000
|
60,410,000
|
200,000,000
|
|||||||||||||||
Interest
on convertible notes
|
25,174,175
|
—
|
13,596,900
|
10,077,675
|
1,500,000
|
|||||||||||||||
Total
contractual obligations
|
$ |
335,374,668
|
$ |
341,837
|
$ |
63,043,401
|
$ |
70,489,430
|
$ |
201,500,000
|
·
|
the
scope and results of our research, preclinical and clinical development
activities;
|
·
|
the
evolving requirements for, timing of, and the costs involved in,
obtaining
regulatory approvals;
|
·
|
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;
|
·
|
if
our common stock is no longer traded on a national securities exchange
or
system of automated quotations, the holders of our convertible notes
have
the right to require us to immediately repay amounts outstanding
under such notes, together with accrued interest up to such date;
and
|
·
|
the
extent to which we acquire or invest in businesses, products and
technologies.
|
·
|
our
inability to successfully develop and commercialize
AGI-1067;
|
·
|
the
actual results of clinical studies of AGI-1067 to treat diabetes
and
related regulatory judgments concerning AGI-1067 for use in diabetes
management;
|
·
|
if
our common stock is no longer traded on a national securities exchange
or
system of automated quotations, the holders of our convertible notes
have
the right to require us to immediately repay amounts outstanding
under
such notes, together with accrued interest up to such
date;
|
·
|
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;
|
|
·
|
generally
evolving regulatory requirements for drug product approval and
marketing;
|
·
|
our
ability to successfully develop AGI-1096 or 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;
|
|
·
|
regulatory
authorities may require that we conduct additional clinical trials
or
modify existing clinical trials
|
·
|
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 $48 million principal amount on the 4.5% convertible
notes due September 1, 2008;
|
and
our other notes as they become due; 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: November
9, 2007
|
/s/MARK P. COLONNESE |
Mark
P. Colonnese
|
|
Executive
Vice President, Commercial Operations and
|
|
Chief
Financial Officer
|
|