Adolor Corporation Reports Second Quarter 2008 Financial Results
* Reuters is not responsible for the content in this press release.
EXTON, Pa.--(Business Wire)--
Adolor Corporation (Nasdaq:ADLR) today reported financial results
for the three and six months ended June 30, 2008.
For the three-month period ended June 30, 2008, the company
reported net income of $7.5 million, or $0.16 per basic and diluted
share, compared to a net loss of $11.6 million, or $0.25 per basic and
diluted share, for the same period in 2007. For the six-month period
ended June 30, 2008, the company reported a net loss of $1.6 million,
or $0.03 per basic and diluted share, compared to a net loss of $24.8
million, or $0.54 per basic and diluted share, for the same period in
2007. Results for 2008 were favorably impacted by the receipt of a
$20.0 million milestone payment from Glaxo Group Limited (Glaxo),
which was earned upon approval of Entereg(R) (alvimopan) by the U. S.
Food and Drug Administration (FDA) in the second quarter of 2008.
"The second quarter was highlighted by the FDA approval of Entereg
for the management of postoperative ileus in bowel resection
patients," said Michael R. Dougherty, president and chief executive
officer of Adolor Corporation. "We are delighted with the initial
interest of the hospital community in Entereg, and the receptivity to
the E.A.S.E.(TM) Program, with over 600 hospitals registered to date."
Mr. Dougherty continued, "Following a productive meeting with the
FDA in June, we were pleased to announce that the FDA lifted the
clinical hold on the development of Entereg for opioid bowel
dysfunction. We await GSK's determination as to their continued
involvement in the program. There remains a large, unmet need in
treatment options for the many patients suffering from this
debilitating condition."
Contract revenues were $27.0 million and $1.8 million for the
three months ended June 30, 2008 and 2007, respectively, and were
$33.2 million and $3.6 million for the six months ended June 30, 2008
and 2007, respectively. The increase in contract revenues for the
three-month and six-month periods ended June 30, 2008 was due
primarily to the $20.0 million milestone payment upon FDA approval of
Entereg and the inclusion of contract revenues from our collaboration
with Pfizer, Inc.
Research and development expenses were $13.3 million and $9.9
million for the three months ended June 30, 2008 and 2007,
respectively, and were $24.7 million and $21.5 million for the six
months ended June 30, 2008 and 2007, respectively. The increase in
expenses for the three-month and six-month periods ended June 30, 2008
was principally related to increased development and clinical trial
expenses under the Delta program and other research programs.
Marketing, general and administrative expenses were $7.2 million
and $5.5 million for the three months ended June 30, 2008 and 2007,
respectively, and were $12.8 million and $11.3 million for the six
months ended June 30, 2008 and 2007, respectively. Marketing, general
and administrative expense increases were principally the result of
increased expenses associated with the launch of Entereg.
As of June 30, 2008, the Company had $161.3 million in cash, cash
equivalents and short-term investments.
About Adolor Corporation
Adolor Corporation (Nasdaq:ADLR) is a biopharmaceutical company
specializing in the discovery, development and commercialization of
novel prescription pain management products. By applying its knowledge
and expertise in pain management, along with ingenuity, Adolor is
seeking to make a positive difference for patients, caregivers and the
medical community. For more information, visit www.adolor.com.
This release and oral statements made with respect to information
contained in this release, may constitute forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of
1995. Such forward-looking statements include those which express
plan, anticipation, intent, contingency, goals, targets or future
development and/or otherwise are not statements of historical fact.
These statements are based upon management's current expectations and
are subject to risks and uncertainties, known and unknown, which could
cause actual results and developments to differ materially from those
expressed or implied in such statements. Such known risks and
uncertainties relate to, among other factors: the risk that hospitals
even though registered in the E.A.S.E. Program do not order ENTEREG;
the risk that ENTEREG may not be a commercial success; the uncertainty
of market acceptance of ENTEREG, including acceptance by hospitals,
physicians, payors or the medical community; the risk that the Risk
Evaluation and Mitigation Strategy or REMS, including the registration
of hospitals could materially adversely affect the commercial
prospects for ENTEREG or negatively impact the uptake of ENTEREG; the
risks associated with government regulations relating to marketing and
selling pharmaceutical products; the risk of product liability claims;
the risks of reliance on third party manufacturers; the risk of
competitive products; the risk that Glaxo terminates the collaboration
agreement with respect to OBD; the risk that a protocol in OBD is not
submitted to the FDA; the risk that clinical development of alvimopan
in OBD does not continue; the risk that ENTEREG may not be approved in
OBD or any indication other than the FDA approved indication in bowel
resection surgery; the risk that filing targets for regulatory
submissions are not met; the risk that the results of other clinical
trials of Adolor's drug products and drug product candidates,
including ENTEREG, are not positive or do not support safety or
efficacy; the costs, delays and uncertainties inherent in scientific
research, drug development, clinical trials and the regulatory
approval process; the changing regulatory environment; risks
associated with intellectual property protection for Adolor's products
and third party intellectual property; Adolor's history of operating
losses since inception and its need for additional funds to operate
its business; Adolor's reliance on its collaborators, including Glaxo,
in connection with the development and commercialization of ENTEREG;
market acceptance of Adolor's products, if regulatory approval is
achieved; competition; and securities litigation.
Further information about these and other relevant risks and
uncertainties may be found in Adolor's Reports on Form 8-K, 10-Q and
10-K filed with the U.S. Securities and Exchange Commission. Adolor
urges you to carefully review and consider the disclosures found in
its filings which are available in the SEC EDGAR database at
http://www.sec.gov and from Adolor at http://www.adolor.com. Given the
uncertainties affecting pharmaceutical companies in the development
stage, you are cautioned not to place undue reliance on any such
forward-looking statements, any of which may turn out to be wrong due
to inaccurate assumptions, unknown risks, uncertainties or other
factors. Adolor undertakes no obligation to (and expressly disclaims
any such obligation to) publicly update or revise the statements made
herein or the risk factors that may relate thereto whether as a result
of new information, future events, or otherwise.
This press release is available on the website
http://www.adolor.com.
(Financial data table follows)
-0-
*T
ADOLOR CORPORATION
STATEMENTS OF OPERATIONS DATA
(Unaudited)
THREE MONTHS SIX MONTHS
ENDED JUNE 30, ENDED JUNE 30,
------------------------- --------------------------
2008 2007 2008 2007
----------- ------------- ------------ -------------
REVENUES
Contract revenues $26,964,318 $1,805,619 $33,175,342 $3,626,622
OPERATING
EXPENSES
Research and
development 13,262,176 9,935,998 24,683,248 21,509,015
Marketing,
general and
administrative 7,224,664 5,524,812 12,773,194 11,342,114
----------- ------------- ------------ -------------
Total operating
expenses 20,486,840 15,460,810 37,456,442 32,851,129
----------- ------------- ------------ -------------
Income (loss)
from operations 6,477,478 (13,655,191) (4,281,100) (29,224,507)
Interest income
and other, net 1,008,015 2,060,521 2,711,034 4,421,386
----------- ------------- ------------ -------------
Net income (loss) $7,485,493 ($11,594,670) ($1,570,066) ($24,803,121)
=========== ============= ============ =============
Basic net income
(loss) per share $0.16 ($0.25) ($0.03) ($0.54)
=========== ============= ============ =============
Diluted net
income (loss)
per share $0.16 ($0.25) ($0.03) ($0.54)
=========== ============= ============ =============
BALANCE SHEET DATA
(Unaudited)
JUNE 30, DECEMBER 31,
2008 2007
--------------------------
Cash, cash
equivalents and
short-term
investments $161,312,665 $167,189,499
Working capital 141,366,954 147,543,363
Total assets 172,352,959 178,676,652
Total
stockholders'
equity 114,119,136 112,353,478
*T
Adolor Corporation
Stephen W. Webster
Senior Vice President, Finance and CFO
484-595-1500
or
Sam Brown, Inc. (media)
Mike Beyer, 773-463-4211
Copyright Business Wire 2008
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