Adolor Corporation Reports Second Quarter 2008 Financial Results
2008-08-05 15:43:00
Adolor Corporation Reports Second Quarter 2008 Financial Results
EXTON, Pa.–(EMWNews)–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® (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.™
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]
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ADOLOR CORPORATION
STATEMENTS OF OPERATIONS DATA
(Unaudited) |
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THREE MONTHS |
SIX MONTHS |
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2008 |
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2007 |
2008 |
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2007 |
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REVENUES |
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Contract revenues |
$ 26,964,318 |
$ 1,805,619 |
$ 33,175,342 |
$ 3,626,622 |
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OPERATING EXPENSES |
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Research and development |
13,262,176 |
9,935,998 |
24,683,248 |
21,509,015 |
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Marketing, general and administrative |
7,224,664 |
5,524,812 |
12,773,194 |
11,342,114 |
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Total operating expenses |
20,486,840 |
15,460,810 |
37,456,442 |
32,851,129 |
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Income (loss) from operations |
6,477,478 |
(13,655,191) |
(4,281,100) |
(29,224,507) |
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Interest income and other, net |
1,008,015 |
2,060,521 |
2,711,034 |
4,421,386 |
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Net income (loss) |
$7,485,493 |
($11,594,670) |
($1,570,066) |
($24,803,121) |
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Basic net income (loss) per share |
$0.16 |
($0.25) |
($0.03) |
($0.54) |
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Diluted net income (loss) per share |
$0.16 |
($0.25) |
($0.03) |
($0.54) |
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BALANCE SHEET DATA
(Unaudited) |
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JUNE 30, |
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DECEMBER 31, |
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Cash, cash equivalents and short-term investments |
$ 161,312,665 |
$ 167,189,499 |
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Working capital |
141,366,954 |
147,543,363 |
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Total assets |
172,352,959 |
178,676,652 |
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Total stockholders’ equity |
114,119,136 |
112,353,478 |
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Adolor Corporation Vice President, Finance and CFO Brown, Inc. (media) |
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