Adolor Corporation (Nasdaq:ADLR) today reported financial
results for the fourth quarter and year ended December 31,
2008.
Net product sales of ENTEREG� (alvimopan) recognized for the
quarter and year ended December 31, 2008 were approximately $1.1
million and $1.2 million, respectively. Under Adolor�s current
revenue recognition policy, revenue related to a customer shipment
is deferred until subsequent re-orders by that customer. For the
year ended December 31, 2008, net product sales were recognized
based on re-orders from approximately 185 hospitals. Total net
shipments for the quarter and year ended December 31, 2008 were
approximately $1.6 million and $2.2 million, respectively.
For the three months ended December 31, 2008, the company
reported a net loss of approximately $15.3 million, or $0.33 per
basic and diluted share, compared to a net loss of $10.1 million,
or $0.22 per basic and diluted share, in the three months ended
December 31, 2007. For the year ended December 31, 2008, the
company reported a net loss of approximately $30.1 million, or
$0.65 per basic and diluted share, compared to a net loss of $48.4
million, or $1.05 per basic and diluted share, for the same period
in 2007.
�With the approval and launch of our first product, 2008 was a
year of transformation for Adolor,� said Michael R. Dougherty,
President and Chief Executive Officer. �We enter 2009 energized by
the opportunity to bring ENTEREG forward to an increasing number of
patients and healthcare providers. We also remain focused on our
developing pipeline, and look ahead to Phase 2 proof of concept
studies in our delta opioid receptor agonist program with our
partner Pfizer and the filing of an IND for ADL7445 for opioid
bowel dysfunction later in 2009.�
Contract revenues were approximately $7.3 million and $3.7
million for the three months ended December 31, 2008 and 2007,
respectively, and were approximately $48.2 million and $9.1 million
for the years ended December 31, 2008 and 2007, respectively. The
increase in contract revenues in 2008 over 2007 principally
reflects a $20.0 million milestone payment received from
GlaxoSmithKline (GSK) in conjunction with the U.S. Food and Drug
Administration (FDA) approval of ENTEREG for the management of
postoperative ileus (POI) following bowel resection surgery and
contract revenues associated with the Pfizer collaboration.
Research and development expenses were approximately $13.8
million and $8.7 million for the three months ended December 31,
2008 and 2007, respectively, and approximately $52.7 million and
$41.6 million for the years ended December 31, 2008 and 2007,
respectively. The increase in expenses for the three months and
year ended December 31, 2008 was related principally to increased
activity in the company�s preclinical and clinical programs.
Selling, general and administrative expenses were approximately
$10.5 million and $6.8 million for the three months ended December
31, 2008 and 2007, respectively, and approximately $31.1 million
and $24.0 million for the years ended December 31, 2008 and 2007,
respectively. The increases in 2008 were driven primarily by
increased marketing and selling expenses associated with the launch
of ENTEREG.
As of December 31, 2008, Adolor had approximately $131.9 million
in cash, cash equivalents and short-term investments.
Conference Call Information
Adolor's management will discuss the company's fourth quarter
and full year 2008 results in a conference call with investors
beginning at 5:00 p.m. EST today, February 25, 2009. To participate
in the conference call, dial 1-866-394-4329 for domestic callers
and 1-706-902-1952 for international callers, and refer to
conference code number 85748128. Investors can listen to the call
live by logging on to the company's website at www.adolor.com and
clicking on "Investor Insights," then "Calendar of Events.� The
conference call will be archived and available to investors for one
week after the call.
About Adolor Corporation
Adolor Corporation is a biopharmaceutical company specializing
in the discovery, development and commercialization of novel
prescription pain management products.
Adolor�s first approved product in the United States is ENTEREG,
which is indicated to accelerate the time to upper and lower
gastrointestinal recovery following partial large or small bowel
resection surgery with primary anastomosis. ENTEREG is available
for short-term use in hospitals registered under the ENTEREG Access
Support and Education (E.A.S.E.�) Program. For more information on
ENTEREG, including its full prescribing information, visit
www.ENTEREG.com. In collaboration with GlaxoSmithKline (GSK), the
company launched ENTEREG in mid-2008.
For more information, visit www.adolor.com.
Forward-Looking Statements
This press release, and oral statements made with respect to
information contained in this release, may contain forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements provide Adolor�s
current expectations or forecasts of future events. These may
include statements regarding market prospects for ENTEREG,
including whether registered hospitals will order (or continue to
re-order) ENTEREG in the future, and whether growth in net
shipments and/or recognized net product sales will continue;
anticipated scientific progress on its research programs, including
the company�s plans to file an IND for ADL7445 in 2009; development
of potential pharmaceutical products, including the delta opioid
receptor agonist program and whether the company will commence
future Phase 2 proof of concept studies in such program;
interpretation of clinical results; prospects for regulatory
approvals; and other statements regarding matters that are not
historical facts. You may identify some of these forward-looking
statements by the use of words in the statements such as
�anticipate,� �estimate,� �expect,� �project,� �intend,� �plan,�
�believe� or other words and terms of similar meaning or that
otherwise express contingencies, goals, targets or future
development. These statements are based upon management�s current
expectations and are subject to risks and uncertainties, known and
unknown, that could cause actual results and developments to differ
materially from those expressed or implied in such statements due
to general financial, economic, regulatory and political conditions
affecting the biotechnology and pharmaceutical industries, as well
as more specific risks and uncertainties facing Adolor such as
those set forth in its reports on Forms�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 at www.sec.gov and from Adolor at
www.adolor.com. Given the uncertainties affecting pharmaceutical
companies such as Adolor, any or all of these forward-looking
statements may prove to be incorrect. Therefore, you should not
rely on any such factors or forward-looking statements. Adolor
undertakes no 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, except as may be required by law.
This press release is available on the website
http://www.adolor.com.
[Financial information follows]
�
ADOLOR CORPORATION
STATEMENTS OF OPERATIONS DATA (Unaudited) � �
For
the Three Months For the Years Ended December 31,
Ended December 31,
2008
�
2007
2008
�
2007
� Revenues: Product sales, net $ 1,079,391 $ - $ 1,247,271 $ -
Contract revenues � 7,330,631 � � 3,673,291 � � 48,208,224 � �
9,119,991 � Total revenues, net 8,410,022 3,673,291 49,455,495
9,119,991 � Operating expenses incurred: Cost of product sales
190,541 - 203,972 - Research and development 13,847,462 8,660,977
52,664,213 41,609,722 Selling, general and administrative �
10,452,291 � � 6,827,949 � � 31,114,718 � � 23,970,339 � Total
operating expenses � 24,490,294 � � 15,488,926 � � 83,982,903 � �
65,580,061 � � Loss from operations (16,080,272 ) (11,815,635 )
(34,527,408 ) (56,460,070 ) Interest income and other, net �
783,357 � � 1,715,087 � � 4,405,148 � � 8,017,095 � Net loss $
(15,296,915 ) $ (10,100,548 ) $ (30,122,260 ) $ (48,442,975 ) �
Basic and diluted net loss per share $ (0.33 ) $ (0.22 ) $ (0.65 )
$ (1.05 ) �
Shares used in computing basic and
diluted net loss per share
� 46,296,235 � � 45,940,460 � � 46,158,458 � � 45,932,981 � � �
BALANCE SHEET DATA
(Unaudited)
�
December 31, 2008 2007 �
Cash, cash equivalents and
short-term investments
$ 131,910,206 $ 167,189,499
Working capital
112,250,025 147,543,363
Total assets
144,426,567 178,676,652
Total stockholders' equity
88,618,562 112,353,478 �
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