ATLANTA, GA , a pharmaceutical company focused on the treatment
of chronic inflammatory diseases, today reported financial results
for the three months ended March 31, 2008.
During the first quarter of 2008, AtheroGenics recorded no
revenues, as compared to $11.5 million for the same period in 2007.
Revenues in 2007 were related to the Company's License Agreement
with AstraZeneca for AGI-1067, which was terminated last year.
Research and development expenses for the first quarter of 2008
decreased to $9.3 million as compared to $20.0 million for the same
period in 2007. This decline was primarily due to decreased
expenditures for the ARISE and FOCUS Phase 3 clinical trials, which
have since been concluded, and lower personnel costs resulting from
the Company's organizational restructuring in May of 2007,
partially offset by clinical trial expenditures for the ANDES Phase
3 clinical trial which commenced in 2007.
Marketing, general and administrative expenses for the first
quarter of 2008 decreased to $3.1 million from $3.9 million for the
same period in 2007. The decrease in the quarter primarily
reflected lower personnel costs.
Interest and other income decreased to $894 thousand in the
first quarter of 2008 from $1.9 million reported for the comparable
period in 2007. The decrease was due to reduced levels of invested
cash and lower interest rates.
Interest expense increased to $3.4 million in the first quarter
of 2008, from $2.1 million for the comparable period in 2007. The
increase in interest expense was primarily due to the additional
debt incurred as a result of an exchange, in the third quarter of
2007, of $38.0 million of 4.5 percent convertible notes due in 2008
for $60.4 million of 4.5 percent convertible notes due in 2011, as
well as the accretion of the discount recorded in connection with
the new notes.
AtheroGenics reported a net loss of $14.9 million, or $0.38 per
share, for the first quarter of 2008, as compared to $12.7 million,
or $0.32 per share, for the same period in 2007.
At March 31, 2008, cash, cash equivalents and short-term
investments totaled approximately $76 million.
"In the first quarter, we focused our efforts on achieving our
important clinical milestone, announcing the top-line interim
results of our ANDES Phase 3 study of AGI-1067 in Type 2 diabetes,
which will help guide further development of the drug candidate,"
stated Russell M. Medford, M.D., Ph.D., President and Chief
Executive Officer of AtheroGenics. "We are encouraged by the
statistically significant efficacy demonstrated by both doses of
AGI-1067 in the ANDES interim analysis at three months, and we now
expect to report the final results in the third quarter."
Clinical Highlight
On April 14, 2008, AtheroGenics released top-line results from a
planned interim analysis of its ongoing ANDES Phase 3 clinical
trial of AGI-1067 for the treatment of Type 2 diabetes. ANDES is
evaluating two dose levels of AGI-1067 given once daily over six
months. The primary efficacy endpoint is change in hemoglobin A1c
(A1c) from baseline compared to placebo in patients with Type 2
diabetes.
The interim analysis of 806 patients who completed three months
in the study showed dose-related, statistically significant
reductions in A1c. The mean changes for patients in the 150 mg, 75
mg, and placebo arms were 0.5 percent, 0.3 percent, and 0.1 percent
respectively, (p < 0.001 for 150 mg versus placebo, p=0.001 for
75 mg versus placebo).
About AtheroGenics
AtheroGenics is focused on the discovery, development and
commercialization of novel drugs for the treatment of chronic
inflammatory diseases, including diabetes and coronary heart
disease (atherosclerosis). The Company's lead antioxidant and
anti-inflammatory drug candidate, AGI-1067, is being studied in a
Phase III clinical trial known as ANDES (AGI-1067 as a Novel
Anti-Diabetic Agent Evaluation Study), for the treatment of
diabetes. In addition, the Company has other clinical and
preclinical anti-inflammatory compounds, including AGI-1096, an
oral agent for the prevention of organ transplant rejection. For
more information about AtheroGenics, please visit
http://www.atherogenics.com.
Conference Call and Webcast Information
AtheroGenics will be hosting a conference call and webcast on
Thursday, April 24, 2008, at 9:00 a.m. EDT to discuss first quarter
financial results and to provide a company update.
Conference Call Details:
(877) 407-8031 (U.S.)
(201) 689-8031 (International)
Replay Access:
(877) 660-6853 (U.S.)
(201) 612-7415 (International)
Conference ID: 281784 - Account #286
The conference call replay will be available until May 1, 2008.
Webcast Details:
To access the webcast, please go to
http://www.atherogenics.com/investor/index.html.
The webcast will be available until July 25, 2008 on AtheroGenics' website
www.atherogenics.com.
Disclosure Regarding Forward-Looking Statements
Statements contained in this press release that relate to events
or developments that we expect or anticipate will occur in the
future are deemed to be forward-looking statements, and can be
identified by words such as "believes," "intends," "expects" and
similar expressions. AtheroGenics cautions investors not to place
undue reliance on the forward-looking statements contained in this
release. An example of a forward looking statement in this press
release includes our expectation that we will announce the final
results from the ANDES clinical trial in the third quarter of 2008.
This and other such statements are subject to certain factors,
risks and uncertainties that may cause actual results, events and
performances to differ materially from those referred to in such
statements. For example, additional information relating to the
safety, efficacy or tolerability of AGI-1067, may be discovered
upon further analysis of trial data. The U.S. Food and Drug
Administration might not allow us to conduct further studies of the
efficacy of AGI-1067 for the same or new endpoints, and, to the
extent approved, additional clinical trial work may take a
significant period of time to complete or require significant
additional resources to complete. We cannot ensure that AGI-1067
will ever be approved or be proven safe and effective for use in
humans. These and other risks are discussed in AtheroGenics'
Securities and Exchange Commission filings, including, but not
limited to, the risks discussed in AtheroGenics' Annual Report on
Form 10-K for the fiscal year ended December 31, 2007 and are
specifically incorporated by reference into this press release. We
undertake no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events,
or otherwise.
AtheroGenics, Inc.
Statements of Operation
(Unaudited)
Three months ended
March 31,
----------------------------
2008 2007
------------- -------------
Revenues:
License fees $ -- $ 6,250,000
Research and development -- 5,211,252
------------- -------------
Total revenues -- 11,461,252
Operating expenses:
Research and development 9,250,062 19,964,275
Marketing, general and administrative 3,135,159 3,945,503
------------- -------------
Total operating expenses 12,385,221 23,909,778
------------- -------------
Operating loss (12,385,221) (12,448,526)
Interest and other income 893,637 1,883,683
Interest expense (3,400,310) (2,087,781)
------------- -------------
Net loss $ (14,891,894) $ (12,652,624)
============= =============
Net loss per share - basic and diluted $ (0.38) $ (0.32)
============= =============
Weighted average shares outstanding -
basic and diluted 39,518,492 39,468,054
============= =============
Balance Sheet Data
(Unaudited)
March 31, December 31,
2008 2007
------------- -------------
Cash, cash equivalents and short-term
investments $ 75,957,031 $ 92,875,420
Working capital 38,380,600 50,229,551
Total assets 82,538,876 103,139,028
Current portion of long-term debt 30,500,000 35,968,750
Long-term debt, less of current portion 253,330,804 252,163,102
Accumulated deficit (426,357,709) (411,465,815)
Total shareholders? deficit (209,155,293) (195,594,625)
CONTACTS: AtheroGenics, Inc. Mark P. Colonnese Executive Vice
President 678-336-2511 Email Contact Media Inquiries Jayme Maniatis
/ Dana Conti Schwartz Communications, Inc. 781-684-0770 Email
Contact Investor Inquiries Lilian Stern Stern Investor Relations,
Inc. 212-362-1200 Email Contact
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