Adolor Corporation (NasdaqGM: ADLR) today reported a net loss of
$9.6 million, or $(0.21) per basic and diluted share, for the three
months ended March 31, 2010, compared to a net loss of $13.2
million, or $(0.28) per basic and diluted share, for the three
months ended March 31, 2009.
Net product sales of ENTEREG® (alvimopan) for the three months
ended March 31, 2010 were $5.3 million compared to $1.4 million for
the three months ended March 31, 2009, primarily as a result of
growth in the number of ordering hospitals and increased usage at
ordering hospitals. Net product sales for the three months ended
March 31, 2010 were recognized at the time of shipment as compared
to net product sales for the three months ended March 31, 2009,
which were recognized on a reorder basis under our previous revenue
recognition policy. Net shipments of ENTEREG in the first quarter
of 2009 were $2.0 million.
“The first quarter saw steady progress across the board at
Adolor,” said Michael R. Dougherty, President and Chief Executive
Officer. “In our delta opioid receptor agonist program, we have
concluded enrollment in our Phase 2a proof-of-concept study of
ADL5859 and ADL5747 in osteoarthritis patients and expect to
present top line results from this study in mid-2010. We also were
pleased to initiate in the first quarter our Phase 2a
proof-of-concept study of ADL5747 in post-herpetic neuralgia and
enrollment is now well underway. In our opioid bowel dysfunction
(OBD) program, both ADL7445 and ADL5945 are now being evaluated in
patients with OBD. We are pleased with the results observed to date
in our Phase 1 program and anticipate initiating proof-of-concept
testing later this year.”
“Progress continues with ENTEREG as well,” added Mr. Dougherty.
“First quarter product sales were $5.3 million, with increases
in the number of hospitals including ENTEREG on formulary and in
re-ordering hospitals. We expect continued growth in product sales
as the benefits of this first-in-class drug become more widely
appreciated.”
Operating Highlights
As of March 31, 2010, the Company estimates that ENTEREG was
included on formulary of approximately 575 of the 1,400 hospitals
that collectively perform approximately 80% of the bowel resection
surgeries in the United States. In addition, approximately 925 of
the above-noted 1,400 hospitals, or 66%, are registered under the
ENTEREG Access Support and Education (E.A.S.E.™) Program as of
March 31, 2010.
Contract revenues were $5.4 million and $5.2 million for the
three months ended March 31, 2010 and 2009, respectively.
Research and development expenses were $10.5 million and $12.3
million for the three months ended March 31, 2010 and 2009,
respectively. This decrease was driven primarily by reductions in
expenses associated with our June 2009 restructuring, offset
partially by higher costs of clinical studies incurred during the
three months ended March 31, 2010 in our delta agonist program and
our OBD program.
Selling, general and administrative expenses were $9.2 million
and $7.9 million for the three months ended March 31, 2010 and
2009, respectively. The increase in the first quarter of 2010
compared to the same period in 2009 was primarily driven by higher
marketing expenses associated with ENTEREG, partially offset by
lower general and administrative expenses period-over-period.
As of March 31, 2010, the Company had $72.6 million in cash,
cash equivalents and short-term investments.
2010 Net Product Sales Guidance
The following guidance provided by Adolor is a projection, based
upon numerous assumptions, all of which are subject to certain
risks and uncertainties. For a discussion of the risks and
uncertainties associated with this forward-looking statement,
please see “Forward-Looking Statements” below.
The Company is reiterating its expectation for ENTEREG net
product sales of between $30 million and $35 million for the year
ending December 31, 2010.
Conference Call Information
Adolor's management will discuss the Company's first quarter
2010 results in a conference call with investors beginning at 8:45
a.m. ET today, April 28, 2010.
To participate in the conference call, dial (866) 272-9941 for
domestic callers and (617) 213-8895 for international callers, and
enter the conference passcode 38318251. Investors also 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.” A replay of the call will be available beginning
approximately two hours after the event. To listen to a replay of
the conference call, dial (888) 286-8010 (domestic) or (617)
801-6888 (international) and enter the conference passcode 20428470
or listen via Adolor’s website. The conference call replay will be
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. For more information on ENTEREG, including its
full prescribing information, visit www.ENTEREG.com. 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; two opioid receptor antagonists, ADL7445 and ADL5945,
entering development for chronic OBD; and several opioid and
non-opioid discovery programs.
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 ENTEREG net product sales guidance for
the year ending December 31, 2010, 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 Adolor’s research programs;
development of potential pharmaceutical products, including the
delta opioid receptor agonist and OBD programs and the timing and
results of any clinical studies of our compounds; 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.
ADOLOR CORPORATION AND
SUBSIDIARY
CONSOLIDATED STATEMENTS OF
OPERATIONS
(Unaudited)
Three Months EndedMarch
31,
2010 2009 Revenues: Product sales, net $
5,290,231 $ 1,432,183 Contract revenues 5,377,856
5,247,477 Total revenues, net
10,668,087 6,679,660 Operating expenses
incurred: Cost of product sales 589,952 153,304 Research and
development 10,518,140 12,322,623 Selling, general and
administrative 9,227,229 7,877,674
Total operating expenses 20,335,321
20,353,601 Loss from operations (9,667,234 )
(13,673,941 ) Interest income 67,695 486,601
Net loss $ (9,599,539 ) $ ( 13,187,340 ) Basic
and diluted net loss per share $ (0.21 ) $ (0.28 ) Shares
used in computing basic and diluted net loss per share
46,314,130 46,296,235
CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
March 31,
December 31,
2010 2009 Cash, cash equivalents and short-term
investments $ 72,567,872 $ 83,205,976 Working capital 57,139,980
66,989,322 Total assets 80,261,549 91,459,434 Total stockholders’
equity 35,247,147 44,053,673
Adolor Corp. (MM) (NASDAQ:ADLR)
Historical Stock Chart
From Jun 2024 to Jul 2024
Adolor Corp. (MM) (NASDAQ:ADLR)
Historical Stock Chart
From Jul 2023 to Jul 2024