Adolor Corporation (Nasdaq:ADLR) today reported financial results
for the year and fourth quarter ended December 31, 2007 and
provided an update on its Delta Program. 2007 Financial Results For
the twelve months ended December 31, 2007, the company reported a
net loss of $48.4 million or $(1.05) per basic and diluted share,
compared to a net loss of $69.7 million, or $(1.56) per basic and
diluted share for the same period in 2006. For the three month
period ended December 31, 2007, the company reported a net loss of
$10.1 million or $(0.22) per basic and diluted share, compared to a
net loss of $18.4 million or $(0.40) per basic and diluted share in
the three months ended December 31, 2006. �We enter 2008 with two
strong lead development programs, increasing momentum in discovery
research, and a solid financial foundation,� said Michael R.
Dougherty, president and chief executive officer of Adolor
Corporation. �With our PDUFA date for Entereg on May 10, 2008, we
await the FDA�s completion of its review of our NDA for
postoperative ileus. We look ahead to realizing our objective of
making this important new product available to patients in the near
future.� �A highlight of the fourth quarter of 2007 was our
collaboration with Pfizer Inc for the Delta Program,� continued
Dougherty. �Pfizer shares our vision for this program, the
development of an entirely new class of opioid receptor agonists,
and our joint efforts are now well underway. Finally, we are
increasingly enthusiastic about our early discovery and research
programs, and believe our efforts here will lead to the
identification of new development candidates for our growing
pipeline.� Contract revenues were approximately $9.1 million and
$15.1 million for the twelve months ended December 31, 2007 and
2006, respectively. The decrease in revenues was primarily the
result of a reduction in expenses incurred by us relating to
Entereg and reimbursable by GlaxoSmithKline (Glaxo) under the
collaboration agreement of $4.0 million and a reduction in
co-promotion revenues of $2.4 million relating to our Arixtra�
co-promotion with Glaxo which is no longer in place. These
decreases were partially offset by an increase in amortization of
up-front fees and cost reimbursements associated with the Pfizer
collaboration of $1.3 million. Contract revenues were approximately
$3.7 million and $4.3 million for the three months ended December
31, 2007 and 2006, respectively. Research and development expenses
were $41.6 million and $56.7 million for the twelve months ended
December 31, 2007 and 2006, respectively. The decrease was
primarily related to a reduction in costs associated with our
Entereg� (alvimopan) program and discontinued sterile lidocane
patch program, partially offset by an increase in expenses related
to our Delta program. Research and development expenses in the
three months ended December 31, 2007 were $8.7 million, compared to
$13.6 million for the same period in 2006. Marketing, general and
administrative expenses were $24.0 million and $37.7 million for
the twelve months ended December 31, 2007 and 2006, respectively.
The expense decrease was principally related to decreased personnel
expenses, including expense primarily associated with disbanding of
the sales force in 2006, as well as lower marketing and sales
expenses. Marketing, general and administrative expenses in the
three months ended December 31, 2007 were $6.8 million, compared to
$11.6 million for the same period in 2006. As of December 31, 2007,
the company had approximately $167.2 million in cash, cash
equivalents and short-term investments. Delta Program Update
Top-line results from a recently completed Phase 2a exploratory
study in acute dental surgery pain, 33CL230 (Study 230), indicated
that ADL5859 was generally well tolerated, but showed no efficacy
signal in this model. �The novelty of our Delta compounds will
require a broad exploratory effort and we have designed a Phase 2a
development program to understand their role in treating various
types of pain,� commented David Jackson, M.D., senior vice
president and chief medical officer of Adolor. �We look forward to
seeing the results from our multi-dose chronic and neuropathic pain
studies.� Adolor is collaborating with Pfizer in conducting
additional Phase 2a studies of ADL5859 to explore its utility in
treating chronic pain associated with rheumatoid arthritis and
peripheral neuropathic pain associated with diabetes. The companies
are also planning to conduct an additional study of ADL5859 in
treating pain associated with osteoarthritis. Study 230 was a
randomized double-blind, single-dose, active and placebo controlled
parallel group study of ADL5859 for the treatment of acute pain
following surgical removal of impacted third molars. The active
control in Study 230 was ibuprofen, and the primary endpoint for
the study was a measure of pain relief. A total of 201 patients
were enrolled in the study. Further, Adolor and Pfizer have begun
Phase 1 clinical testing of ADL5747, a second Delta agonist, in
healthy volunteers to investigate its safety, tolerability and
pharmacokinetics. About Adolor Corporation Adolor Corporation
(Nasdaq:ADLR) is a biopharmaceutical company specializing in the
discovery, development and commercialization of novel prescription
pain management products. Adolor has two lead product candidates in
development: Entereg� (alvimopan) for the management of the
gastrointestinal side effects associated with opioid use; and,
novel Delta opioid receptor agonists for a variety of pain
indications. Adolor and GlaxoSmithKline are collaborating in the
worldwide development and commercialization of Entereg in multiple
indications. Adolor and Pfizer are collaborating in the worldwide
development and commercialization of two Delta agonists for pain.
Adolor also has a number of discovery research programs focused on
the identification of novel compounds for the treatment of pain. 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. Arixtra� is a registered
trademark of GlaxoSmithKline. 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 Adolor may not receive regulatory approval of ENTEREG �
(alvimopan) for POI, OBD, or any other indication; the risk that
the PDUFA date extended to May 10, 2008 is further extended or not
met; the risk that a risk management plan acceptable to the FDA
could materially adversely affect the commercial prospects for
ENTEREG, if regulatory approval is achieved; the risk that Adolor
may not be able to adequately address the deficiencies in the
November 2006 FDA approvable letter; the risk that Adolor may not
obtain FDA approval for ENTEREG in POI, whether due to Adolor's
inability to provide additional data satisfactory to the FDA to
obtain approval for the NDA, the adequacy of the safety and
efficacy data from all of the ENTEREG studies, changing regulatory
requirements, the risk that the FDA may not agree with Adolor's and
GSK's analyses of the ENTEREG studies (including Study 014) and may
evaluate the results of these studies by different methods or
conclude that the results from the studies, whether or not
statistically significant, do not support safety, efficacy, a
favorable risk/benefit profile, or there were human errors in the
conduct of the studies, or otherwise; adverse safety findings in
any ENTEREG studies; the risk that the alvimopan Investigational
New Drug Applications (INDs) remain on clinical hold indefinitely;
the risk that filing targets for regulatory submissions or user fee
goal dates are not met; the risk that the results of other clinical
trials of Adolor's drug product candidates, including our Delta
product candidates are not positive; the risk of product liability
claims; reliance on third party manufacturers; the costs, delays
and uncertainties inherent in scientific research, drug
development, clinical trials and the regulatory approval process;
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 GSK, 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] ADOLOR CORPORATION STATEMENTS OF OPERATIONS DATA
(Unaudited) � FOR THE TWELVE MONTHS FOR THE THREE MONTHS ENDED
DECEMBER 31, ENDED DECEMBER 31, � 2007 � 2006 2007 � 2006 �
REVENUES Contract revenues $ 9,119,991 $ 15,087,411 $ 3,673,291 $
4,285,728 � OPERATING EXPENSES Research and development 41,609,722
56,659,750 8,660,977 13,598,294 Marketing, general and
administrative � 23,970,339 � � 37,689,565 � � 6,827,949 � �
11,583,773 � � Total operating expenses � 65,580,061 � � 94,349,315
� � 15,488,926 � � 25,182,067 � � Loss from operations (56,460,070
) (79,261,904 ) (11,815,635 ) (20,896,339 ) Interest income and
other, net � 8,017,095 � � 9,523,526 � � 1,715,087 � � 2,481,396 �
Net loss $ (48,442,975 ) $ (69,738,378 ) $ (10,100,548 ) $
(18,414,943 ) � Basic and diluted net loss per share $ (1.05 ) $
(1.56 ) $ (0.22 ) $ (0.40 ) � Shares used in computing basic and
diluted net loss per share 45,932,981 44,731,350 45,940,460
45,915,827 � � BALANCE SHEET DATA (Unaudited) � DECEMBER 31,
DECEMBER 31, 2007 2006 � Cash, cash equivalents and short-term
investments $ 167,189,499 $ 185,562,009 Working capital 147,543,363
173,130,129 Total assets 178,676,652 200,597,580 Total
stockholders' equity 112,353,478 153,180,628
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