NEW HAVEN, Conn., Nov. 6, 2009 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals,
Inc. (Nasdaq:ACHN), a leader in the discovery and development of small molecule
drugs to combat the most challenging infectious diseases, today reported
financial results for the three and nine months ended September 30, 2009. For
the third quarter of 2009, the Company reported a net loss of $6.4 million,
compared with a net loss of $6.7 million for the same period last year. Cash,
cash equivalents and marketable securities as of September 30, 2009 were $15.3
million.
"In September, we announced completion of the phase 1a segment of our on-going
clinical trial with ACH-1625, our protease inhibitor for the treatment of
hepatitis C virus (HCV) infection. We were pleased to announce that ACH-1625 was
shown to be safe and well tolerated in both single-ascending and
multiple-ascending dose segments," said Michael Kishbauch, President and CEO of
Achillion. "We are currently completing the phase 1b segment of this trial in
patients infected with HCV and plan to announce efficacy results in the first
quarter 2010. We look forward to obtaining proof-of-concept data in this
important therapeutic area."
"Based on the safety and tolerability data we have seen to date in clinical
studies of ACH-1625, and its potential for convenient once-daily dosing, we
would expect that positive efficacy data from the ongoing phase 1b clinical
trial could make ACH-1625 an attractive candidate for fixed dose combinations of
direct acting antivirals and an important future treatment option for HCV
patients. Coupled with progress in our other two HCV programs, we believe we are
at a pivotal point in the development of our pipeline," he added.
Third Quarter Results
For the three months ended September 30, 2009, the Company reported a net loss
of $6.4 million, compared with a net loss of $6.7 million for the three months
ended September 30, 2008. Total revenues were negative $54,000 for the third
quarter of 2009, compared with $25,000 for the third quarter of 2008. Revenues
relate to the Company's collaboration agreement with Gilead Sciences to develop
compounds for use in treating chronic hepatitis C. Revenues decreased and were
negative as the result of an excess of payments made to Gilead over amounts
received from Gilead, as the collaboration provides for an equal sharing of
externally incurred costs. In addition, during the quarter, Achillion did not
recognize any revenue related to amortization of its up-front, milestone and FTE
payments previously received under the agreement, as at this time the
collaboration does not have a lead compound upon which it can accurately
estimate its future performance obligations.
Research and development expenses were $4.5 million in the third quarter of
2009, compared with $5.0 million for the same period of 2008. The decline in
research and development expenses is related to a decrease in outsourced
research costs, specifically related to clinical trial costs for elvucitabine
and preclinical trial costs for ACH-1625 and ACH-702, each of which is now
completed but which were ongoing in 2008. Such decreases were partially offset
by clinical trial costs for ACH-1625.
For the three months ended September 30, 2009, general and administrative
expenses were $1.5 million, essentially equal to the $1.6 million incurring
during the same period in 2008.
In addition, the Company incurred $332,000 in restructuring costs during the
third quarter of 2009 related to a reduction in workforce that took place in
July. Non-cash stock compensation expense totaled $479,000 for the third quarter
of 2009, and is included in both research and development and general and
administrative expenses, and compares with $606,000 of non-cash stock
compensation expense in the third quarter of 2008.
Cash, cash equivalents and marketable securities as of September 30, 2009 were
$15.3 million. This does not include any amounts associated with the stand-by
equity distribution agreement entered into on July 1, 2009, which to date has
not been utilized by the Company.
Nine Month Results
For the nine months ended September 30, 2009, the Company reported a net loss of
$19.2 million, compared with a net loss of $19.5 million in the same period in
2008. Total revenues for the first nine months of 2009 were negative $355,000,
compared with $1.1 million in the prior year period. Revenues decreased
primarily as a result of not amortizing upfront, milestone and FTE payments made
to Achillion by Gilead.
For the nine months ended September 30, 2009, research and development expenses
totaled $13.7 million, compared with $15.5 million during the same period in
2008. Research and development expenses decreased primarily as the result of
lower outsourced research costs, including those costs noted above, as well as
expenses related to a collaboration with FOB Synthesis, which was not continued
in 2009, offset by costs related to initiating clinical testing of ACH-1625.
General and administrative expenses were $4.7 million for the nine months ended
September 30, 2009, compared with $4.9 million in the same period in 2008.
Non-cash stock compensation expense totaled $1.5 million for the nine months
ended September 30, 2009, and is included in both research and development and
general and administrative expenses, and compares with non-cash stock
compensation expense of $1.7 million for the first nine months of 2008
About Achillion
Achillion is an innovative pharmaceutical company dedicated to bringing
important new treatments to patients with infectious disease. The company's
proven discovery and development teams have advanced multiple product candidates
with novel mechanisms of action. Achillion is focused on solutions for the most
challenging problems in infectious disease - hepatitis, resistant bacterial
infections and HIV. For more information on Achillion Pharmaceuticals, please
visit the company's web site at www.achillion.com or call Achillion at
1-203-624-7000.
Forward-looking Statements
This press release includes forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 that are subject to risks,
uncertainties and other factors, including statements with respect to
Achillion's expectations regarding the timing and duration of clinical trials,
the Company's expectations regarding the release of data from ongoing clinical
trials, the Company's performance under its collaboration agreement, the
Company's ability to raise additional funding and the expected benefits of the
Company's expense reductions. Among the factors that could cause actual results
to differ materially from those indicated by such forward-looking statements
are: Achillion's ability to attract and develop potential collaboration
relationships; unexpected regulatory actions or delays; uncertainties relating
to results of clinical trials, including additional data relating to ongoing
clinical trials, and Achillion's ability to obtain additional funding required
to conduct its research, development and commercialization activities. These and
other risks are described in the reports filed by Achillion with the U.S.
Securities and Exchange Commission, including its Annual Report on Form 10-K for
the year ended December 31, 2008.
All forward-looking statements reflect Achillion's expectations only as of the
date of this release and should not be relied upon as reflecting Achillion's
views, expectations or beliefs at any date subsequent to the date of this
release. Achillion anticipates that subsequent events and developments may cause
these views, expectations and beliefs to change. However, while Achillion may
elect to update these forward-looking statements at some point in the future, it
specifically disclaims any obligation to do so.
ACHN-G
ACHILLION PHARMACEUTICALS INC. (ACHN)
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Statements of Operations
(Unaudited, in thousands, except per share amounts)
---------------------------------------------------------------------
Three Months Ended Nine Months Ended
September 30, September 30,
------------------------ ----------------------
2009 2008 2009 2008
--------- --------- --------- ---------
Revenue $ (54) $ 25 $ (355) $ 1,050
--------- --------- --------- ---------
Operating
expenses:
Research and
development 4,479 5,016 13,684 15,496
General and
administrative 1,459 1,614 4,660 4,911
Restructuring
charges 332 -- 332 --
--------- --------- --------- ---------
Total
operating
expenses 6,270 6,630 18,676 20,407
--------- --------- --------- ---------
Loss from
operations (6,324) (6,605) (19,031) (19,357)
--------- --------- --------- ---------
Other income
(expense):
Interest income 21 159 170 612
Interest expense (124) (269) (451) (828)
--------- --------- --------- ---------
Net loss
before tax
benefits (6,427) (6,715) (19,312) (19,573)
Tax benefit 36 50 106 122
--------- --------- --------- ---------
Net loss $ (6,391) $ (6,665) $ (19,206) $ (19,451)
========= ========= ========= =========
Net loss per
share - basic
and diluted $ (0.24) $ (0.31) $ (0.73) $ (1.11)
========= ========= ========= =========
Weighted
average
shares
outstanding
- basic and
diluted 26,655 21,432 26,492 17,586
========= ========= ========= =========
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Balance Sheets
(Unaudited, in thousands)
---------------------------------------------------------------------
Sept. 30, Dec. 31,
2009 2008
---------- ----------
Cash and cash equivalents and
marketable securities $ 15,292 $ 35,357
Working capital 8,300 24,359
Total assets 17,373 38,561
Long-term liabilities 2,489 1,361
Total liabilities 10,159 13,540
Total stockholders' equity 7,214 25,021
-0-
CONTACT: Achillion Pharmaceuticals, Inc.
Mary Kay Fenton
(203) 624-7000
mfenton@achillion.com
Lippert/Heilshorn & Associates, Inc.
Investors:
Anne Marie Fields
(212) 838-3777
afields@lhai.com
Bruce Voss
(310) 691-7100
bvoss@lhai.com
