Adolor Corporation (Nasdaq:ADLR) today reported financial
results for the three months ended March 31, 2009.
Net product sales of ENTEREG� (alvimopan) recognized for the
three months ended March 31, 2009 were approximately $1.4 million
on total net shipments of approximately $2.0 million. Under
Adolor's current revenue recognition policy, revenue related to a
customer shipment is deferred until subsequent re-orders by that
customer. Since the Company's launch of ENTEREG in June 2008,
approximately 300 hospitals have re-ordered the product.
Hospitals registered under the ENTEREG Access Support and
Education (E.A.S.E.�) Program increased by 175 to approximately
1,275 hospitals at the end of the quarter. More importantly,
acceptance of ENTEREG on hospital formularies increased during the
quarter by 125 to approximately 425 hospitals as of March 31, 2009,
including 275 of the 1,400 hospitals that perform approximately 80%
of the bowel resection surgeries in the United States.
�We continue to advance the acceptance and utilization of
ENTEREG in the hospital market,� said Michael R. Dougherty,
President and Chief Executive Officer. �In the first quarter, we
saw continued growth in the number of hospitals including ENTEREG
on their formularies, which we believe will translate into
increased usage. We also saw an increase in the number of both
first-time and repeat users of ENTEREG. Over the next several
months, we will continue to focus our efforts on driving awareness
of the clinical and economic benefits of ENTEREG to further
increase adoption and utilization.�
For the three months ended March 31, 2009, the Company reported
a net loss of approximately $13.2 million, or $0.28 per basic and
diluted share, compared to a net loss of $9.1 million, or $0.20 per
basic and diluted share, in the three months ended March 31,
2008.
As of March 31, 2009, Adolor had approximately $124.7 million in
cash, cash equivalents and short-term investments, a decrease of
$7.2 million since December 31, 2008. During the quarter, the
Company received a payment of approximately $8.4 million resulting
from a modification to the Company's collaboration agreement with
GlaxoSmithKline (GSK).
Contract revenues were approximately $5.2 million and $6.2
million for the three months ended March 31, 2009 and 2008,
respectively. The decrease in 2009 compared to 2008 was primarily
due to decreased amortization of deferred licensing fees relating
to the Company's agreement with Pfizer.
For the three months ended March 31, 2009 and 2008, research and
development expenses were approximately $12.3 million and $11.4
million, respectively. The increase in expenses for the three
months ended March 31, 2009 was due to expenses related to the
development of ADL7445 for opioid bowel dysfunction (OBD) and
higher personnel costs, partially offset by lower levels of
activity in the delta agonist program and preclinical programs and
the reduced development expenses for ENTEREG.
Selling, general and administrative expenses were approximately
$7.9 million and $5.5 million for the three months ended March 31,
2009 and 2008, respectively. The increase in 2009 was driven
primarily by increased marketing and selling expenses associated
with the commercialization of ENTEREG.
Conference Call Information
Adolor's management will discuss the Company's first quarter
2009 results in a conference call with investors beginning at 9:00
a.m. EDT today, April 29, 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
96507883. 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
(alvimopan), 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
E.A.S.E. Program. In collaboration with GSK, the Company launched
ENTEREG in mid-2008.
The Company's research and development pipeline includes: two
novel delta opioid receptor agonists, currently in mid-stage
clinical development in collaboration with Pfizer Inc. for chronic
pain; a mu opioid receptor antagonist entering development for
chronic OBD; and several opioid and non-opioid discovery
programs.
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 hospitals that have placed ENTEREG on formulary
will order (or continue to re-order) ENTEREG in the future, and
whether growth in formulary approvals, acceptance, utilization, net
shipments and/or recognized net product sales will occur;
anticipated scientific progress on its research programs, including
with respect to ADL7445; development of potential pharmaceutical
products, including the delta opioid receptor agonist 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
(Unaudited) �
For the Three Months Ended March
31,
2009
�
2008
� Revenues: Product sales, net $ 1,432,183 $ - Contract revenues �
5,247,477 � � 6,211,024 � Total revenues, net � 6,679,660 � �
6,211,024 � � Operating expenses incurred: Cost of product sales
153,304 - Research and development 12,322,623 11,421,072 Selling,
general and administrative � 7,877,674 � � 5,548,530 � Total
operating expenses � 20,353,601 � � 16,969,602 � � Loss from
operations (13,673,941 ) (10,758,578 ) Interest income, net �
486,601 � � 1,703,019 � Net loss $ (13,187,340 ) $ (9,055,559 ) �
Basic and diluted net loss per share $ (0.28 ) $ (0.20 ) � Shares
used in computing basic and diluted net loss per share � 46,296,235
� � 45,948,066 � � �
BALANCE SHEET DATA
(Unaudited)
�
March 31, December 31, �
2009 � �
2008 � Cash, cash equivalents and short-term investments $
124,672,129 $ 131,910,206 Working capital $ 105,697,227 $
112,250,025 Total assets $ 134,711,349 $ 144,426,567
Total stockholders' equity
$
76,151,609 $ 88,618,562 �
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