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
|
|
June
30, 2007 and December 31,
2006
|
1
|
Condensed
Statements of Operations
|
|
Three
and six months ended June 30, 2007 and
2006
|
2
|
Condensed
Statements of Cash Flows
|
|
Six
months ended June 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
|
7
|
Item
3. Quantitative and Qualitative Disclosures About Market
Risk
|
14
|
Item
4. Controls and
Procedures
|
14
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PART
II. OTHER INFORMATION
|
|
Item
1A. Risk
Factors
|
14
|
Item
4. Submission of Matters to a Vote of Security
Holders
|
15
|
Item
6. Exhibits
|
15
|
SIGNATURES
|
16
|
June
30,
|
December
31,
|
|||||||
2007
|
2006
|
|||||||
Assets
|
||||||||
Current
assets:
|
||||||||
Cash
and cash
equivalents
|
$ |
77,750,204
|
$ |
87,846,079
|
||||
Short-term
investments
|
36,949,237
|
63,964,860
|
||||||
Accounts
receivable
|
16,546,591
|
6,537,892
|
||||||
Prepaid
expenses
|
2,811,277
|
4,038,419
|
||||||
Interest
receivable
|
281,258
|
643,097
|
||||||
Total
current
assets
|
134,338,567
|
163,030,347
|
||||||
Equipment
and leasehold improvements, net of accumulated
depreciation
|
||||||||
and
amortization
|
2,478,579
|
9,684,965
|
||||||
Debt
issuance costs and other
assets
|
4,883,790
|
5,624,352
|
||||||
Total
assets
|
$ |
141,700,936
|
$ |
178,339,664
|
||||
Liabilities
and Shareholders' Deficit
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ |
10,538,771
|
$ |
3,183,511
|
||||
Accrued
research and
development
|
8,091,803
|
11,263,164
|
||||||
Accrued
interest
|
2,540,000
|
2,540,000
|
||||||
Accrued
compensation
|
1,763,356
|
1,465,644
|
||||||
Accrued
and other
liabilities
|
709,734
|
791,661
|
||||||
Current
portion of deferred
revenue
|
—
|
25,000,000
|
||||||
Total
current
liabilities
|
23,643,664
|
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 —
|
||||||||
39,508,492
and 39,452,927 shares at June 30, 2007
|
||||||||
and
December 31, 2006,
respectively
|
212,251,743
|
207,388,894
|
||||||
Warrants
|
613,021
|
613,021
|
||||||
Accumulated
deficit
|
(380,788,551 | ) | (361,997,246 | ) | ||||
Accumulated
other comprehensive (loss)
gain
|
(18,941 | ) |
7,682
|
|||||
Total
shareholders'
deficit
|
(167,942,728 | ) | (153,987,649 | ) | ||||
Total
liabilities and shareholders'
deficit
|
$ |
141,700,936
|
$ |
178,339,664
|
||||
Three
months ended
|
Six
months ended
|
|||||||||||||||
June
30,
|
June
30,
|
|||||||||||||||
2007
|
2006
|
2007
|
2006
|
|||||||||||||
Revenues:
|
||||||||||||||||
License
fees
|
$ |
20,833,333
|
$ |
6,250,000
|
$ |
27,083,333
|
$ |
10,416,667
|
||||||||
Research
and
development
|
9,425,371
|
—
|
14,636,623
|
—
|
||||||||||||
Total
revenues
|
30,258,704
|
6,250,000
|
41,719,956
|
10,416,667
|
||||||||||||
Operating
expenses:
|
||||||||||||||||
Research
and
development
|
22,330,198
|
16,447,180
|
42,294,473
|
32,707,802
|
||||||||||||
Marketing,
general and administrative
|
3,587,195
|
3,171,869
|
7,532,698
|
6,879,202
|
||||||||||||
Restructuring
and impairment costs
|
9,996,332
|
—
|
9,996,332
|
—
|
||||||||||||
Total
operating
expenses
|
35,913,725
|
19,619,049
|
59,823,503
|
39,587,004
|
||||||||||||
Operating
loss
|
(5,655,021 | ) | (13,369,049 | ) | (18,103,547 | ) | (29,170,337 | ) | ||||||||
Interest
income
|
1,604,120
|
2,401,424
|
3,487,803
|
4,606,658
|
||||||||||||
Interest
expense
|
(2,087,780 | ) | (2,088,598 | ) | (4,175,561 | ) | (4,196,115 | ) | ||||||||
Other
expense
|
—
|
—
|
—
|
(3,521,236 | ) | |||||||||||
Net
loss
|
$ | (6,138,681 | ) | $ | (13,056,223 | ) | $ | (18,791,305 | ) | $ | (32,281,030 | ) | ||||
Net
loss per share –
|
||||||||||||||||
basic
and
diluted
|
$ | (0.16 | ) | $ | (0.33 | ) | $ | (0.48 | ) | $ | (0.82 | ) | ||||
Weighted
average shares
|
||||||||||||||||
outstanding
– basic and diluted
|
39,498,338
|
39,423,059
|
39,483,280
|
39,313,178
|
||||||||||||
Six
months ended
|
||||||||
June
30,
|
||||||||
2007
|
2006
|
|||||||
Operating
activities
|
||||||||
Net
loss
|
$ | (18,791,305 | ) | $ | (32,281,030 | ) | ||
Adjustments
to reconcile net loss to net cash
|
||||||||
(used
in) provided by operating activities:
|
||||||||
Asset
impairment
costs
|
9,005,153
|
—
|
||||||
Amortization
of deferred
revenue
|
(27,083,333 | ) | (10,416,667 | ) | ||||
Stock-based
compensation
|
4,842,775
|
4,341,492
|
||||||
Amortization
of debt issuance
costs
|
740,562
|
743,462
|
||||||
Depreciation
and
amortization
|
495,165
|
453,683
|
||||||
Loss
on debt
conversion
|
—
|
3,536,962
|
||||||
Changes
in operating assets and liabilities:
|
||||||||
Accounts
receivable
|
(10,008,699 | ) | (1,335,714 | ) | ||||
Prepaid
expenses
|
1,227,142
|
(910,523 | ) | |||||
Interest
receivable
|
361,839
|
144,631
|
||||||
Accounts
payable
|
7,355,260
|
(92,588 | ) | |||||
Accrued
research and
development
|
(4,804,600 | ) | (1,057,371 | ) | ||||
Accrued
compensation
|
297,712
|
(1,732,804 | ) | |||||
Accrued
and other
liabilities
|
(81,927 | ) | (623,167 | ) | ||||
Deferred
revenue
|
—
|
50,000,000
|
||||||
Net
cash (used in) provided by operating activities
|
(36,444,256 | ) |
10,770,366
|
|||||
Investing
activities
|
||||||||
Sales
and maturities of short-term
investments
|
71,295,574
|
63,497,596
|
||||||
Purchases
of short-term
investments
|
(44,306,574 | ) | (50,643,999 | ) | ||||
Purchases
of equipment and leasehold improvements
|
(660,693 | ) | (1,161,749 | ) | ||||
Net
cash provided by investing activities
|
26,328,307
|
11,691,848
|
||||||
Financing
activities
|
||||||||
Proceeds
from the exercise of common stock options
|
20,074
|
1,751,036
|
||||||
Payments
on equipment loan
facility
|
—
|
(87,580 | ) | |||||
Net
cash provided by financing activities
|
20,074
|
1,663,456
|
||||||
(Decrease)
increase in cash and cash equivalents
|
(10,095,875 | ) |
24,125,670
|
|||||
Cash
and cash equivalents at beginning of period
|
87,846,079
|
82,831,679
|
||||||
Cash
and cash equivalents at end of
period
|
$ |
77,750,204
|
$ |
106,957,349
|
||||
Supplemental
disclosures
|
||||||||
Interest
paid
|
$ |
3,435,000
|
$ |
3,435,000
|
Three
months ended
|
Six
months ended
|
||||||
June
30,
|
June
30,
|
||||||
2007
|
2006
|
2007
|
2006
|
||||
Expected
volatility
|
83.10%
|
67.79%
|
83.10%
|
69.99%
|
|||
Expected
term
|
3.48
years
|
5
years
|
3.48
years
|
5
years
|
|||
Risk
free interest
rate
|
4.92%
|
5.04%
|
4.92%
|
4.70%
|
|||
Fair
value of
grants
|
$1.42
|
$8.24
|
$1.42
|
$9.40
|
Three
months ended
|
Six
months ended
|
|||||||||||||||
June
30,
|
June
30,
|
|||||||||||||||
2007
|
2006
|
2007
|
2006
|
|||||||||||||
Direct
external AGI-1067 costs
|
$ |
15,168,587
|
$ |
9,239,454
|
$ |
25,611,487
|
$ |
18,626,936
|
||||||||
Unallocated
internal costs and other programs
|
7,161,611
|
7,207,726
|
16,682,986
|
14,080,866
|
||||||||||||
Total
research and development
|
$ |
22,330,198
|
$ |
16,447,180
|
$ |
42,294,473
|
$ |
32,707,802
|
·
|
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 for $60.4 million of
4.5%
convertible notes that will be due in March
2011;
|
·
|
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.
|
·
|
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;
|
·
|
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 commercialize AGI-1067 following the release of the
ARISE
Phase III clinical trial results;
|
·
|
the
ability of AGI-1067 to treat diabetes and other
diseases;
|
·
|
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;
|
·
|
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 $48 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.
|
Name
of Nominee
|
No.
of Votes For
|
No.
of Votes Withheld
|
David
Bearman
|
29,646,733
|
215,413
|
Vaughn
D. Bryson
|
29,323,810
|
538,336
|
T.
Forcht Dagi, M.D.
|
29,643,533
|
218,613
|
No.
of Votes For
|
No.
of Votes Against
|
Abstention
|
29,675,558
|
145,108
|
41,480
|
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: August
9, 2007
|
/s/MARK
P. COLONNESE
|
Mark
P. Colonnese
|
|
Executive
Vice President, Commercial Operations and
|
|
Chief
Financial Officer
|
|