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, 2006 and December 31, 2005
|
1
|
||||
Condensed
Statements of Operations
|
|||||
Three
and six months ended June 30, 2006 and 2005
|
2
|
||||
Condensed
Statements of Cash Flows
|
|||||
Six
months ended June 30, 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
|
15
|
||||
Item
4. Submission of Matters to a Vote of Security Holders
|
15
|
||||
Item
6. Exhibits
|
16
|
||||
SIGNATURES
|
17
|
||||
June
30,
|
December
31,
|
||||||
2006
|
2005
|
||||||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
106,957,349
|
$
|
82,831,679
|
|||
Short-term
investments
|
86,859,737
|
99,672,844
|
|||||
Prepaid
expenses
|
3,550,423
|
2,639,900
|
|||||
Interest
and other receivables
|
2,091,275
|
900,192
|
|||||
Total
current assets
|
199,458,784
|
186,044,615
|
|||||
Equipment
and leasehold improvements, net of accumulated
depreciation
|
|||||||
and
amortization
|
4,816,528
|
4,108,462
|
|||||
Debt
issuance costs and other assets
|
6,364,083
|
7,344,450
|
|||||
Total
assets
|
$
|
210,639,395
|
$
|
197,497,527
|
|||
Liabilities
and Shareholders' Deficit
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
2,095,873
|
$
|
2,188,461
|
|||
Accrued
research and development
|
2,889,599
|
3,946,970
|
|||||
Accrued
interest
|
2,540,000
|
2,750,000
|
|||||
Accrued
compensation
|
916,836
|
2,649,640
|
|||||
Accrued
and other liabilities
|
687,925
|
1,344,876
|
|||||
Current
portion of deferred revenue
|
25,000,000
|
—
|
|||||
Total
current liabilities
|
34,130,233
|
12,879,947
|
|||||
Convertible
notes payable and equipment loan, net of current portion
|
286,000,000
|
300,053,796
|
|||||
Long-term
portion of deferred revenue
|
14,583,333
|
—
|
|||||
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 —
|
|||||||
39,450,874
and 38,143,678 shares at June 30, 2006
|
|||||||
and
December 31, 2005, respectively
|
202,381,163
|
178,771,376
|
|||||
Warrants
|
613,021
|
620,223
|
|||||
Accumulated
deficit
|
(326,955,904
|
)
|
(294,674,874
|
)
|
|||
Accumulated
other comprehensive loss
|
(112,451
|
)
|
(152,941
|
)
|
|||
Total
shareholders' deficit
|
(124,074,171
|
)
|
(115,436,216
|
)
|
|||
Total
liabilities and shareholders' deficit
|
$
|
210,639,395
|
$
|
197,497,527
|
|||
Three
months ended
|
Six
months ended
|
||||||||||||
June
30,
|
June
30,
|
||||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
License
fee revenue
|
$
|
6,250,000
|
$
|
—
|
$
|
10,416,667
|
$
|
—
|
|||||
Operating
expenses:
|
|||||||||||||
Research and development
|
16,447,180
|
19,380,868
|
32,707,802
|
35,535,938
|
|||||||||
Marketing, general and administrative
|
3,171,869
|
2,231,731
|
6,879,202
|
4,052,549
|
|||||||||
Total operating expenses
|
19,619,049
|
21,612,599
|
39,587,004
|
39,588,487
|
|||||||||
Operating
loss
|
(13,369,049
|
)
|
(21,612,599
|
)
|
(29,170,337
|
)
|
(39,588,487
|
)
|
|||||
Interest
and other income
|
2,401,424
|
1,677,608
|
4,606,658
|
3,125,512
|
|||||||||
Interest
expense
|
(2,088,598
|
)
|
(2,270,388
|
)
|
(4,196,115
|
)
|
(4,373,961
|
)
|
|||||
Other
expense
|
—
|
—
|
(3,521,236
|
)
|
—
|
||||||||
Net
loss
|
$
|
(13,056,223
|
)
|
$
|
(22,205,379
|
)
|
$
|
(32,281,030
|
)
|
$
|
(40,836,936
|
)
|
|
Net
loss per share -
|
|||||||||||||
basic and diluted
|
$
|
(0.33
|
)
|
$
|
(0.59
|
)
|
$
|
(0.82
|
)
|
$
|
(1.09
|
)
|
|
Weighted
average shares
|
|||||||||||||
outstanding - basic and diluted
|
39,423,059
|
37,716,509
|
39,313,178
|
37,625,069
|
|||||||||
Six
months ended
|
|||||||
June
30,
|
|||||||
2006
|
2005
|
||||||
Operating
activities
|
|||||||
Net
loss
|
$
|
(32,281,030
|
)
|
$
|
(40,836,936
|
)
|
|
Adjustments
to reconcile net loss to net cash provided by
|
|||||||
(used
in) operating activities:
|
|||||||
Amortization
of license fee
|
(10,416,667
|
)
|
—
|
||||
Loss
on debt conversion
|
3,536,962
|
—
|
|||||
Stock-based
compensation
|
4,341,492
|
81,632
|
|||||
Depreciation
and amortization
|
453,683
|
378,277
|
|||||
Amortization
of debt issuance costs
|
743,462
|
713,395
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Interest
and other receivables
|
(1,191,083
|
)
|
(599,913
|
)
|
|||
Prepaid
expenses
|
(910,523
|
)
|
189,862
|
||||
Accounts
payable
|
(92,588
|
)
|
174,715
|
||||
Accrued
compensation
|
(1,732,804
|
)
|
(484,691
|
)
|
|||
Accrued
research and development
|
(1,057,371
|
)
|
(2,008,275
|
)
|
|||
Accrued
and other liabilities
|
(623,167
|
)
|
(14,428
|
)
|
|||
Accrued
interest
|
—
|
1,408,333
|
|||||
Deferred
revenue
|
50,000,000
|
—
|
|||||
Net
cash provided by (used in) operating activities
|
10,770,366
|
(40,998,029
|
)
|
||||
Investing
activities
|
|||||||
Sales
and maturities of short-term investments
|
63,497,596
|
42,864,820
|
|||||
Purchases
of short-term investments
|
(50,643,999
|
)
|
(118,573,432
|
)
|
|||
Purchases
of equipment and leasehold improvements
|
(1,161,749
|
)
|
(1,153,735
|
)
|
|||
Net
cash provided by (used in) investing activities
|
11,691,848
|
(76,862,347
|
)
|
||||
Financing
activities
|
|||||||
Proceeds
from the exercise of common stock options
|
1,751,036
|
1,262,830
|
|||||
Payments
on equipment loan facility
|
(87,580
|
)
|
(83,622
|
)
|
|||
Proceeds
from the issuance of 1.5% convertible notes
|
—
|
193,566,977
|
|||||
Net
cash provided by financing activities
|
1,663,456
|
194,746,185
|
|||||
Increase
in cash and cash equivalents
|
24,125,670
|
76,885,809
|
|||||
Cash
and cash equivalents at beginning of period
|
82,831,679
|
15,888,919
|
|||||
Cash
and cash equivalents at end of period
|
$
|
106,957,349
|
$
|
92,774,728
|
|||
Supplemental
disclosures
|
|||||||
Interest
paid
|
$
|
3,435,000
|
$
|
2,252,233
|
|||
Three
months ended
|
Six
months ended
|
||
June
30, 2006
|
June
30, 2006
|
||
Expected
volatility
|
67.79%
|
69.99%
|
|
Expected
term
|
5
years
|
5
years
|
|
Risk
free interest rate
|
5.04%
|
4.70%
|
|
Fair
value of grants
|
$8.24
|
$9.40
|
Three
months ended
|
Six
months ended
|
||||||
June
30, 2005
|
June
30, 2005
|
||||||
Net
loss, as reported
|
$
|
(22,205,379
|
)
|
$
|
(40,
836,936
|
)
|
|
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
|
(2,247,990
|
)
|
(4,658,715
|
)
|
|||
Pro
forma net loss
|
$
|
(24,453,369
|
)
|
$
|
(45,495,651
|
)
|
|
Net
loss per share:
|
|||||||
Basic and diluted, as reported
|
$
|
(0.59
|
)
|
$
|
(1.09
|
)
|
|
Basic and diluted, pro forma
|
$
|
(0.65
|
)
|
$
|
(1.21
|
)
|
Three
months ended
|
Six
months ended
|
||
June
30, 2005
|
June
30, 2005
|
||
Expected
volatility
|
77.91%
|
78.10%
|
|
Expected
term
|
5
years
|
5
years
|
|
Risk
free interest rate
|
4.13%
|
4.18%
|
|
Fair
value of grants
|
$8.00
|
$8.61
|
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
|
1,256,609
|
15.28
|
||||||
Exercised
|
(222,196
|
)
|
7.88
|
|||||
Canceled
|
(169,628
|
)
|
18.79
|
|||||
Outstanding
at June 30, 2006
|
5,240,417
|
12.05
|
7.08
|
$
19,696,609
|
||||
Exercisable
at June 30, 2006
|
3,055,794
|
$ 8.60
|
5.73
|
$
19,228,267
|
Three
months ended
|
Six
months ended
|
|||||||
June
30,
|
June
30,
|
|||||||
2006
|
2005
|
2006
|
2005
|
|||||
Direct
external AGI-1067 costs
|
$
9,376,078
|
$
15,018,838
|
$
19,674,308
|
$
27,993,582
|
||||
Unallocated
internal costs and other programs
|
7,071,102
|
4,362,030
|
13,033,494
|
7,542,356
|
||||
Total
research and development
|
$
16,447,180
|
$
19,380,868
|
$
32,707,802
|
$
35,535,938
|
· |
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; 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 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
|
Michael
A. Henos
|
33,263,516
|
787,904
|
Russell
M. Medford
|
33,870,303
|
181,117
|
Arthur
M. Pappas
|
33,870,083
|
181,337
|
No.
of Votes For
|
No.
of Votes Against
|
Abstention
|
33,993,489
|
45,556
|
12,375
|
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 8, 2006
|
/s/MARK P. COLONNESE |
Mark
P. Colonnese
|
|
Executive
Vice President, Commercial Operations
|
|
and
Chief Financial Officer
|