UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_________________
FORM 10-Q
___________
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2004
Commission File No. 0-31261
ATHEROGENICS, INC.
(Exact name of registrant as specified in its
charter)
Georgia |
58-2108232 |
(State of incorporation) |
(I.R.S. Employer Identification Number) |
8995 Westside Parkway,
Alpharetta,
Georgia30004
(Address of registrant's principal
executive offices, including zip code)
_______________________
(Registrant's telephone number, including area code):
(678) 336-2500
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [ X ] No [ ]
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Act). Yes [ X ] No [ ]
As of May 7, 2004 there were 37,010,252 shares of the registrant's common stock outstanding.
_________________________
ATHEROGENICS, INC.
FORM 10-Q
INDEX
PART I. FINANCIAL INFORMATION |
Page No. |
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Item 1. Financial Statements (unaudited) |
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Condensed Balance Sheets |
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March 31, 2004 and December 31, 2003 |
3 |
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Condensed Statements of Operations |
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Three months ended March 31, 2004 and 2003 |
4 |
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Condensed Statements of Cash Flows |
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Three months ended March 31, 2004 and 2003 |
5 |
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Notes to Condensed Financial Statements |
6 |
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Item 2. Management's Discussion and Analysis of Financial Condition |
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and Results of Operations |
8 |
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Item 3. Quantitative and Qualitative Disclosures About Market Risk |
13 |
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Item 4. Controls and Procedures |
13 |
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PART II. OTHER INFORMATION |
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Item 6. Exhibits and Reports on Form 8-K |
14 |
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SIGNATURES |
15 |
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2
PART I - FINANCIAL INFORMATION
ATHEROGENICS, INC.
CONDENSED BALANCE SHEETS
The accompanying notes are an integral part of these
condensed financial statements.
3
ATHEROGENICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
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Three months ended |
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March 31, |
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2004 |
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2003 |
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Revenues |
$ -- |
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$ -- |
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Operating expenses: |
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Research and development |
13,999,531 |
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10,338,278 |
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General and administrative |
1,681,316 |
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1,334,085 |
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Total operating expenses |
15,680,847 |
|
11,672,363 |
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Operating loss |
(15,680,847 |
) |
(11,672,363 |
) |
Interest income |
370,988 |
|
196,293 |
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Interest expense |
(1,292,841 |
) |
(18,631 |
) |
Net loss |
$(16,602,700 |
) |
$(11,494,701 |
) |
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Net loss per share - |
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basic and diluted |
$ (0.45 |
) |
$ (0.35 |
) |
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Weighted average shares |
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outstanding - basic and diluted |
36,866,673 |
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33,293,017 |
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The accompanying notes are an integral part of these
condensed financial statements.
4
ATHEROGENICS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
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Three months ended |
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March 31, |
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2004 |
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2003 |
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Operating activities: |
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Net loss |
$(16,602,700 |
) |
$(11,494,701 |
) |
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Adjustments to reconcile net loss to net cash used in |
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operating activities: |
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Depreciation and amortization |
223,669 |
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198,484 |
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Amortization of debt issuance costs |
163,245 |
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-- |
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Amortization of deferred stock compensation |
121,364 |
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320,670 |
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Changes in operating assets and liabilities: |
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Prepaid expenses |
(768,140 |
) |
(210,696 |
) |
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Notes receivable and other current assets |
(37,547 |
) |
(18,344 |
) |
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Accounts payable |
1,986,761 |
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692,471 |
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Accrued research and development |
(779,212 |
) |
1,138,668 |
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Accrued liabilities and compensation |
(1,596,890 |
) |
(486,953 |
) |
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Net cash used in operating activities |
(17,289,450 |
) |
(9,860,401 |
) |
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Investing activities: |
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Purchases of short-term investments |
(336,934 |
) |
(15,597,969 |
) |
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Purchases of equipment and leasehold improvements |
(76,149 |
) |
(74,824 |
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Net cash used in investing activities |
(413,083 |
) |
(15,672,793 |
) |
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Financing activities: |
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Proceeds from the issuance of common stock |
-- |
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48,395,000 |
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Proceeds from the exercise of common stock options |
1,406,856 |
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26,074 |
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Payments on equipment loan facility |
(116,437 |
) |
(107,847 |
) |
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Net cash provided by financing activities |
1,290,419 |
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48,313,227 |
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(Decrease) increase in cash and cash equivalents |
(16,412,114 |
) |
22,780,033 |
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Cash and cash equivalents at beginning of period |
72,058,249 |
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32,132,329 |
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Cash and cash equivalents at end of period |
$ 55,646,135 |
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$ 54,912,362 |
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Supplemental disclosures of cash flow information: |
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Interest paid |
$ 2,410,051 |
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$ 18,631 |
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Re-measurement adjustment for variable options and warrants issued |
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for technology license agreements and consulting agreements |
$ 252,580 |
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$ 223,570 |
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The accompanying notes are an integral part of these condensed financial statements.
5
ATHEROGENICS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(Unaudited)
1. Organization and Nature of Operations
AtheroGenics, Inc. (“AtheroGenics”) was
incorporated on November 23, 1993 (date of inception) in
the State of Georgia to focus on the discovery, development
and commercialization of novel therapeutics for the
treatment of chronic inflammatory diseases, such as heart
disease (atherosclerosis), rheumatoid arthritis and
asthma.
2. Basis of Presentation
The accompanying unaudited condensed financial statements
reflect all adjustments (consisting solely of normal
recurring adjustments) which management considers necessary
for a fair presentation of the financial position, results
of operations and cash flows of AtheroGenics for the
interim periods presented. Certain footnote
disclosures normally included in financial statements
prepared in accordance with accounting principles generally
accepted in the United States have been condensed or
omitted from the interim financial statements as permitted
by the rules and regulations of the Securities and Exchange
Commission. Interim results are not necessarily
indicative of results for the full year.
The interim results should be read in conjunction with the
financial statements and notes thereto included in
AtheroGenics' Annual Report on Form 10-K for the year
ended December 31, 2003. Shareholders are encouraged
to review the Form 10-K for a broader discussion of
AtheroGenics' opportunities and risks inherent in the
business. Copies of the Form 10-K are available on
request.
3. Net Loss per Share
The Financial Accounting Standards Board’s SFAS No.
128, Earnings per Share, requires presentation of
both basic and diluted earnings per share. Basic
earnings per share is computed by dividing net income
(loss) by the weighted average number of shares of common
stock outstanding during the period. Diluted earnings
per share is computed in the same manner as basic earnings
per share except that diluted earnings per share reflects
the potential dilution that would occur if outstanding
options, warrants and convertible notes were
exercised. Because AtheroGenics reported a net loss
for all periods presented, shares associated with stock
options, warrants and convertible note are not included
because they are antidilutive. Basic and diluted net
loss per share amounts are the same for the periods
presented.
4. Stock‑Based Compensation
AtheroGenics has elected to follow Accounting Principles
Board ("APB") Opinion No. 25, Accounting for
Stock Issued to Employees ("APB 25"), in
accounting for its stock‑based employee compensation
plans, rather than the alternative fair value accounting
method provided for under SFAS No. 123, Accounting for
Stock-Based Compensation (“SFAS 123”), as
SFAS 123 requires the use of option valuation models that
were not developed for use in valuing employee stock
options. AtheroGenics accounts for transactions in
which services are received in exchange for equity
instruments based on the fair value of such services
received from non‑employees, in accordance with SFAS
123 and Emerging Issues Task Force (“EITF”)
Issue No. 96‑18, Accounting for Equity
Instruments that are Issued to Other than Employees for
Acquiring, or in Conjunction with Selling, Goods or
Services. SFAS No. 148, Accounting for
Stock-Based Compensation – Transition and
Disclosure (“SFAS 148”), an amendment to
SFAS 123, requires disclosure in the summary of significant
accounting policies of the effects of the fair value
of stock-based employee compensation on reported net income
and earnings per share in annual and interim financial
statements.
6
The following table illustrates the effect on net loss and net loss per share if the fair value based method had been applied to all outstanding and unvested options in each period, based on the provisions of SFAS 123 and SFAS 148.
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Three months ended |
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March 31, |
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2004 |
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2003 |
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Net loss, as reported |
$(16,602,700 |
) |
$(11,494,701 |
) |
Add: Stock-based employee compensation |
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expense included in reported net loss |
12,035 |
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140,793 |
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Deduct: Total stock-based employee |
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compensation expense determined under |
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fair value based method for all awards |
(1,190,629 |
) |
(895,320 |
) |
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Pro forma net loss |
$(17,781,294 |
) |
$(12,249,228 |
) |
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Net loss per share: |
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Basic and diluted, as reported |
$ (0.45 |
) |
$ (0.35 |
) |
Basic and diluted, pro forma |
$ (0.48 |
) |
$ (0.37 |
) |
5. Convertible Notes Payable
In August 2003, AtheroGenics issued $100 million in
aggregate principal amount of 4.5% convertible notes due
September 1, 2008 with interest payable semi-annually
in March and September. Net proceeds to AtheroGenics
were approximately $96.7 million, after deducting expenses
and underwriter’s discounts and commissions.
AtheroGenics recorded issuance costs related to the notes
of approximately $3.3 million. These costs are
recorded as other assets and are being amortized to
interest expense over the five-year life of the notes.
The notes may be converted at the option of the holder into
shares of AtheroGenics’ common stock prior to the
close of business on September 1, 2008 at a conversion rate
of 65.1890 shares per $1,000 principal amount of notes,
representing a conversion price of approximately $15.34,
subject to adjustment. Under certain circumstances,
AtheroGenics may be obligated to redeem all or part of the
notes prior to their maturity at a redemption price equal
to 100% of their principal amount, plus accrued and unpaid
interest and liquidated damages, if any, up to but
excluding the maturity date.
AtheroGenics filed a shelf registration statement with the
Securities and Exchange Commission (“SEC”) that
was declared effective on December 22, 2003 covering the
resale of the notes and the common stock issuable upon
conversion of the notes. AtheroGenics has agreed to
use its reasonable best efforts to keep the shelf
registration statement effective until the earlier of:
(1) the date that all of the registrable securities
have been sold pursuant to the shelf registration statement
or pursuant to Rule 144 under the Securities Act or any
similar provision then in force; or (2) the expiration of
the holding period with respect to the registrable
securities under Rule 144(k) under the Securities Act of
1933, or any successor provision.
As of March 31, 2004, AtheroGenics had reserved 6,518,900
shares of common stock for future issuance in connection
with the convertible notes. In addition, as of March
31, 2004, accrued liabilities included approximately
$375,000 of accrued interest related to the convertible
notes.
7
6. Bank Credit Agreements
In March 2002, AtheroGenics entered into a revolving credit
facility with Silicon Valley Bank for up to a maximum
amount of $5,000,000 to be used for working capital
requirements. In December 2003, AtheroGenics canceled
the line of credit, which was unused during the entire
period.
In addition, in March 2002, AtheroGenics entered into an
equipment loan facility with Silicon Valley Bank for up to
a maximum amount of $2,500,000 to be used to finance
existing and new equipment purchases. Amounts
borrowed under the equipment loan facility are repaid in 33
equal installments of principal and interest beginning on
the first business day of the month following an
advance. As of March 31, 2004, there was an
outstanding balance of $446,624 under the equipment loan
facility and the weighted average interest rate was 7.7%
per year. The borrowing period for the equipment loan
facility expired in September 2003.
In connection with the revolving credit facility and the
equipment loan facility, AtheroGenics has granted to
Silicon Valley Bank a negative pledge on its intellectual
property and on deposits with Silicon Valley Bank and its
affiliates.
7. Reclassifications
Certain prior year balances have been reclassified to
conform to the current year presentation. These
reclassifications had no effect on previously reported net
loss or shareholders’ equity.
Item 2. Management's Discussion and
Analysis of Financial Condition and Results of Operations
The following should be read with the financial
statements and related footnotes and Management's
Discussion and Analysis of Financial Condition and Results
of Operations included in AtheroGenics' Annual Report
on Form 10-K for the fiscal year ended December 31,
2003. The results discussed below are not necessarily
indicative of the results to be expected in any future
periods. The following discussion contains
forward-looking statements that are subject to risks and
uncertainties which could cause actual results to differ
from the statements made. These risks are set forth
in more detail in our Annual Report on Form 10-K.
OVERVIEW
Since our operations began in 1994, we have focused on the
discovery, development and commercialization of novel drugs
for the treatment of chronic inflammatory diseases,
including heart disease (atherosclerosis), rheumatoid
arthritis and asthma. Based on our proprietary
vascular protectant, or v-protectant™, technology
platform, we have four drug programs in the clinic, and are
pursuing a number of other preclinical programs.
AGI-1067 is our v-protectant™ candidate that is most
advanced in clinical development, and is designed to
benefit patients with heart disease. AGI-1067 is
currently in a Phase III clinical trial, referred to as
ARISE, or Aggressive Reduction of Inflammation Stops
Events, to evaluate the impact of AGI-1067 on important
outcome measures such as death due to heart disease,
myocardial infarction, stroke, coronary revascularization
and unstable angina in patients who have coronary heart
disease. ARISE, which began enrollment in June 2003, will
enroll 4,000 patients who will be followed for an average
of 18 months or until a minimum of 1,160 primary events, or
outcome measures, have occurred. We are currently
conducting a Phase IIb clinical trial called CART-2, which
is a 500-patient study that examines the effect of 12
months of AGI-1067 therapy on atherosclerosis and
post-angioplasty restenosis. We completed enrollment
in CART-2 in August 2003 and expect to complete the
treatment phase in mid-2004, after which we will proceed
with data analysis and disclosure of the results.
8
Our second clinical compound, AGIX-4207, is a novel oral
agent being developed for the treatment of the signs and
symptoms of rheumatoid arthritis. We have completed a
Phase II clinical trial that evaluated safety, tolerability
and the effect of orally administered AGIX-4207 on
biological markers of inflammation in rheumatoid
arthritis patients. Data from the trial demonstrated
that treatment with AGIX-4207 was safe and well tolerated
by patients and also inhibited an increase in the
inflammatory biomarker known as the erythrocyte
sedimentation rate, or ESR, by more than 90 percent.
We have completed the treatment phase of a 275 patient
Phase II trial of AGIX-4207, called OSCAR, or Oral
Suppression of Cellular Inflammation Attenuates Rheumatoid
Arthritis. OSCAR will evaluate the impact of various
doses of AGIX-4207 versus placebo on clinical efficacy,
biomarkers and safety in patients with rheumatoid
arthritis. We expect to announce results from the
trial in the third quarter.
AGIX-4207 I.V., our third v-protectant™ candidate, is
an intravenous drug designed to treat rheumatoid arthritis
patients in whom the rapid attainment of target drug levels
in the blood is desirable. We have completed a Phase
I clinical trial that assessed the safety and tolerability
of AGIX-4207 I.V. in healthy volunteers. The results
from this trial demonstrated that single infusions of
AGIX-4207 I.V. were well tolerated and adverse events were
generally mild and not considered clinically
significant.
Our fourth v-protectant™ drug, AGI-1096, is a novel
antioxidant and selective anti-inflammatory agent that is
being developed to address the accelerated inflammation of
grafted blood vessels common in chronic organ transplant
rejection and known as transplant arteritis. We have
completed a Phase I clinical trial that assessed safety and
tolerability of AGI-1096 in healthy volunteers. The
results of AGI-1096 clinical trial data demonstrated the
drug was well tolerated at all oral doses, with no
drug-related adverse events. We are currently in
collaboration with Fujisawa Pharmaceutical Co., Ltd to
further develop AGI-1096.
To date, we have devoted substantially all of our resources
to research and development. We have not received any
commercial revenues from product sales. We expect to
incur significant losses in most years prior to deriving
any product revenue as we continue to increase research and
development costs. We have incurred significant
losses since we began operations in 1994 and as of March
31, 2004, we had an accumulated deficit of $159.1
million. We cannot assure you that we will become
profitable. We expect that losses will fluctuate from
quarter to quarter and that these fluctuations may be
substantial. Our ability to achieve profitability
depends upon a variety of factors, including our ability,
alone or with others, to complete the successful
development of our product candidates, to obtain required
regulatory clearances, and to manufacture and market our
future products.
CRITICAL ACCOUNTING POLICIES
AtheroGenics considers certain accounting policies related
to use of estimates, research and development accruals,
revenue recognition and stock based compensation to be
critical policies. There have been no material
changes in the critical accounting policies from what was
previously disclosed in AtheroGenics’ Annual Report
on Form 10-K for the year ended December 31, 2003 filed
with the Securities and Exchange Commission on March 15,
2004.
RESULTS OF OPERATIONS
Comparison of the Three Month Periods Ended March 31, 2004
and 2003
Revenues
There were no revenues during the three months ended March
31, 2004 and 2003.
9
Expenses
Research and Development. Research and
development expenses increased 35% to $14.0 million for the
three months ended March 31, 2004 from $10.3 million for
the comparable period in 2003. The increase in
research and development expenses for the three months
ended March 31, 2004 was primarily due to expenditures
related to ongoing patient recruitment and new clinical
development staff hires to support the AGI-1067 ARISE
clinical trial. In addition, there were increased expenditures for
the ongoing AGIX-4207 OSCAR Phase II clinical trial and the
ongoing AGI-1067 CART-2 Phase IIb clinical trial.
General and Administrative. General and
administrative expenses increased 26% to $1.7 million for
the three months ended March 31, 2004 from $1.3 million for
the comparable period in 2003. The increase in
general and administrative expenses for the three months
ended March 31, 2004 was primarily due to higher insurance
premiums and business development expenses related to
potential partnership activities.
Interest Income
Interest income was $370,988 for the three months ended
March 31, 2004 and $196,293 for the comparable period in
2003. The increase in interest income in the three
month period ended March 31, 2004 is due to the increased
amount of invested funds received from the $100.0 million
convertible debt offering in August 2003.
Interest Expense
Interest expense was $1.3 million for the three months
ended March 31, 2004 and $18,631 for the comparable period
in 2003. The increase in interest expense is due to
our $100.0 million convertible debt.
LIQUIDITY AND CAPITAL RESOURCES
Since inception, we have financed our operations primarily
through sales of equity securities and convertible
notes. At March 31, 2004, we had cash, cash
equivalents and short-term investments of $115.5 million,
compared with $131.6 million at December 31, 2003.
Working capital at March 31, 2004 was $110.1 million,
compared to $124.8 million at December 31, 2003. The
decrease in cash, cash equivalents, short-term investments
and working capital is primarily due to use of funds for
operating purposes.
Net cash used in operating activities was $17.3 million for
the three months ended March 31, 2004, compared to $9.9
million for the comparable period in 2003. The
increase in the use of cash in operating activities is
principally due to funding a net loss of $16.6
million. The increase in cash to fund the net loss is
primarily attributable to the expenditures for our ARISE
Phase III clinical trial, our CART-2 Phase IIb clinical
trial for AGI-1067 and our OSCAR Phase II clinical trial
for AGIX-4207, as well as other ongoing product development
activities. Prepaid expenses will continue to
fluctuate as pre-payments are made to contractors for the
ARISE clinical trial and are then expensed as services are
performed. We anticipate net cash usage in 2004 for
ARISE and our other ongoing clinical programs, as well as
our other operating activities, to be in a range of $63.0
million to $67.0 million, subject to the impact of a
potential corporate partnering arrangement for
AGI-1067.
Net cash used in investing activities was $413,083 for the
three months ended March 31, 2004, compared to $15.7
million for the comparable period in 2003. Net cash
used in investing activities during the three months ended
March 31, 2004 and 2003 consisted primarily of the
purchases of available-for-sale securities and equipment
and leasehold improvements.
Net cash provided by financing activities was $1.3 million
for the three months ended March 31, 2004, and $48.3
million for the comparable period in 2003. Net cash
provided by financing activities in the three months ended
March 31, 2004 consisted primarily of proceeds from the
exercise of common stock options. Net cash
10
provided by financing activities for the comparable
period in 2003 was primarily from the follow-on public
offering of 8.3 million shares of our common stock.
This was partially offset by payments on our equipment loan
facility.
In March 2002, we entered into a revolving credit facility
with Silicon Valley Bank (the “Bank") for up to
a maximum amount of $5.0 million to be used for working
capital requirements. The revolving credit facility
was not used, and as such, we terminated it in December
2003. We also entered into an equipment loan
facility, as modified in June 2003, with the Bank for up to
a maximum amount of $2.5 million to be used to finance
existing and new equipment purchases. The borrowing
period under the equipment loan facility, as modified,
expired on September 30, 2003. At March 31,
2004, there was an outstanding balance of approximately
$446,624 on the equipment loan facility and the weighted
average interest rate was 7.7% per year.
In August 2003, AtheroGenics issued $100 million in
aggregate principal amount of 4.5% convertible notes due in
2008 through a Rule 144A private placement to qualified
institutional buyers. These notes initially are
convertible into our common stock at a conversion rate of
65.1890 shares per $1,000 principal amount of notes, or
approximately $15.34 per share. Net proceeds were
approximately $96.7 million. We are using the net
proceeds from the sale of the notes for research and
development activities, including clinical trials, process
development and manufacturing support, and for general
corporate purposes, including working capital.
Pending these uses, the net proceeds have been invested in
interest-bearing, investment grade securities.
The following table summarizes our long-term contractual
obligations as of March 31, 2004.
|
Payments Due by Period |
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Total |
|
2004 |
|
2005-2006 |
|
2007-2008 |
|
Thereafter |
|
Contractual obligations |
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|
|
|
Operating leases, net of |
|
|
|
|
|
|
|
|
|
|
sublease income |
$ 5,464,710 |
|
$ 805,274 |
|
$2,152,011 |
|
$ 2,314,723 |
|
$192,702 |
|
Long-term debt |
100,446,624 |
|
393,873 |
|
52,751 |
|
100,000,000 |
|
-- |
|
Total contractual |
|
|
|
|
|
|
|
|
|
|
obligations |
$105,911,334 |
|
$1,199,147 |
|
$2,204,762 |
|
$102,314,723 |
|
$192,702 |
|
Based upon the current status of our product development
and commercialization plans, we believe that our existing
cash and cash equivalents and short-term investments will
be adequate to satisfy our capital needs for at least the
next 12 months. However, our actual capital
requirements will depend on many factors, including:
- |
the status of product development; |
|
|
- |
the time and cost involved in conducting clinical trials and obtaining regulatory approvals; |
|
|
- |
the costs of filing, prosecuting and enforcing patent and other intellectual property claims; |
|
|
- |
competing technological and market developments; and |
|
|
- |
our ability to establish new licensing and partnering agreements. |
We have historically accessed the capital markets from time
to time to raise adequate funds for operating needs and
cash reserves. Although we believe we have adequate
cash for at least the next 12 months, we may access capital
markets when we believe market conditions or company needs
merit doing so.
11
FORWARD-LOOKING STATEMENTS
The Private Securities Litigation Reform Act of 1995 (the
"Reform Act") provides a safe harbor for
forward-looking statements made by or on behalf of
AtheroGenics. AtheroGenics and its representatives
may from time to time make written or oral forward-looking
statements, including statements contained in this report
and our other filings with the Securities and Exchange
Commission and in our reports to our shareholders.
Generally, the words "believe,"
"expect," "intend,"
"estimate," "anticipate,"
"will" and similar expressions identify
forward-looking statements. All statements which
address operating performance, events or developments that
we expect or anticipate will occur in the future, such as
projections about our future results of operations or our
financial condition, research, development and
commercialization of our product candidates and anticipated
trends in our business, are forward-looking statements
within the meaning of the Reform Act. The
forward-looking statements are and will be based on
management's then current views and assumptions
regarding future events and operating performance, and
speak only as of their dates. AtheroGenics undertakes
no obligation to publicly update or revise any
forward-looking statements, whether as a result of new
information, future events or otherwise.
The following are some of the factors that could affect our
financial performance or could cause actual results to
differ materially from those expressed or implied in our
forward-looking statements:
- |
AGI-1067, AGIX-4207, AGIX-4207 I.V. 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; |
|
|
- |
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; |
|
|
12
- |
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; |
|
|
- |
if plaintiffs bring product liability lawsuits against us, we may incur substantial financial loss or 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 |
|
|
- |
conversion of our $100 million principal amount, 4.5% convertible notes will dilute the ownership |
|
interest of existing shareholders and could adversely affect the market price of our common stock. |
The foregoing list of important factors is discussed in
more detail in our Annual Report on Form 10-K for the
fiscal year ended December 31, 2003 and is not exclusive.
Item 3. Quantitative And Qualitative
Disclosures About Market Risk
Market risk represents the risk of loss that may impact our
financial position, operating results or cash flows due to
changes in U.S. interest rates. This exposure is
directly related to our normal operating activities.
Our cash, cash equivalents and short-term investments are
invested with high quality issuers and are generally of a
short-term nature. Interest rates payable on our
lease obligations are generally fixed. As a result,
we do not believe that near-term changes in interest rates
will have a material effect on our future results of
operations.
The following table summarizes information on our equipment
loan facility and convertible notes. The table
presents maturity of the debt and projected annual average
interest rates as of March 31, 2004.
|
|
|
|
|
|
|
|
|
Value as of |
|
2004 |
|
2005-2006 |
|
2007-2008 |
|
Total |
|
March 31, 2004 |
|
|
|
|
|
|
|
|
|
|
Long-term debt-fixed rate |
|
|
|
|
|
|
|
|
|
Maturity |
$393,873 |
|
$52,751 |
|
$100,000,000 |
|
$100,446,624 |
|
$173,446,624 |
Average interest rate |
7.7% |
|
7.7% |
|
4.5% |
|
|
|
|
Item 4. Controls and Procedures
Evaluation of disclosure controls and procedures.
Our chief executive officer and chief financial officer are
responsible for establishing and maintaining
"disclosure controls and procedures" (as defined
in the Securities Exchange Act of 1934 Rules 13a-15(e) and
15d-15(e)) for AtheroGenics. Our chief executive
officer and chief financial officer, after evaluating the
effectiveness of our disclosure controls and procedures as
of the end of the period covered by this quarterly report,
have concluded that our disclosure controls and procedures
are adequate and effective in timely alerting them to
material information relating to us required to be included
in our periodic SEC filings.
Changes in internal control over financial
reporting. There were no material changes in our
internal control over financial reporting that occurred
during our most recent fiscal quarter that have materially
affected, or are reasonably likely to materially affect,
our internal control over financial reporting.
13
PART II - OTHER INFORMATION
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits
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. |
(b) Reports on Form 8-K
On February 11, 2004, we furnished a Current Report on Form
8-K under Item 12, reporting the issuance of our press
release announcing our financial results for the quarter
and year ended December 31, 2003.
14
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
ATHEROGENICS, INC. |
|
|
Date: May 10, 2004 |
/s/ MARK P. COLONNESE |
|
Mark P. Colonnese |
|
Senior Vice President of Finance and |
|
Administration and Chief Financial Officer |
15