Adolor Corporation (NasdaqGM: ADLR) today reported net product
sales of ENTEREG® (alvimopan) for the three and six months ended
June 30, 2009 of approximately $2.4 million and $3.8 million,
respectively, on total net shipments of approximately $2.9 million
and $4.9 million, respectively. Under Adolor’s current revenue
recognition policy, revenue related to a customer shipment is
deferred until subsequent re-orders by that customer. As of June
30, 2009, there were approximately 450 repeat-order hospitals for
ENTEREG, up from 300 at March 31, 2009.
During the quarter, hospitals registered under the ENTEREG
Access Support and Education (E.A.S.E.™) Program increased by 150
to approximately 1,425 hospitals. Inclusion of ENTEREG on hospital
formularies also increased during the quarter by 175, or 41%, to
approximately 600 hospitals as of June 30, 2009, which number
includes approximately 365 of the 1,400 hospitals that perform
approximately 80% of the bowel resection surgeries in the United
States.
“We continue to see growth in important metrics for ENTEREG,
including registrations and formulary approvals, and are now
beginning to see this translate into increased utilization of our
product,” said Michael R. Dougherty, President and Chief Executive
Officer. “Further, we are pleased to note that the first
independently conducted post-marketing case study of ENTEREG will
be presented to the medical community by Dr. Timothy L. Beard at
the Annual Meeting of the Northwest Society of Colon and Rectal
Surgeons in early August. We expect other case studies to follow
and believe that such ‘real world’ studies of ENTEREG should be
useful in fostering physician awareness of the potential benefits
ENTEREG may offer to bowel resection patients.”
Adolor also advanced its delta opioid receptor agonist program
with Pfizer Inc. In early 2009, the Company commenced a series of
studies to address the pharmacokinetic (PK) variability observed
with ADL5859 in previous Phase 2a trials.
“We recently completed the PK studies of the new formulations of
ADL5859 and ADL5747 and are encouraged that the results of these
studies explain the highly variable plasma levels previously seen,”
said Eliseo O. Salinas M.D., Senior Vice President, Research and
Development and Chief Medical Officer. “Based on these results,
Pfizer and we now expect to initiate Phase 2a proof-of-concept
studies in two chronic pain indications in the fourth quarter of
this year.”
For the three months ended June 30, 2009, the Company reported a
net loss of approximately $16.5 million, or ($0.36) per basic and
diluted share, compared to net income of $7.5 million, or $0.16 per
basic and diluted share, in the three months ended June 30, 2008.
For the six months ended June 30, 2009, the Company reported a net
loss of approximately $29.7 million, or ($0.64) per basic and
diluted share, compared to a net loss of $1.6 million, or ($0.03)
per basic and diluted share, in the six months ended June 30, 2008.
The year-ago periods were favorably impacted by a $20 million
milestone payment received from GlaxoSmithKline (GSK) in the second
quarter of 2008 upon the approval of ENTEREG by the U.S. Food and
Drug Administration.
Contract revenues were approximately $6.7 million and $27.0
million for the three months ended June 30, 2009 and 2008,
respectively, and were approximately $11.9 million and $33.2
million for the six months ended June 30, 2009 and 2008,
respectively. Contract revenues in the three and six months ended
June 30, 2008 were favorably impacted by the $20.0 million
milestone payment received from GSK.
In June 2009, the Company announced a reduction in force of
approximately 45 positions, or 28% of its workforce, as well as
other cost saving initiatives intended to lower its annualized net
cash used in operating activities. Once this reduction in force and
other cost savings initiatives are fully in place later in 2009,
the Company expects that annualized net cash used in operating
activities will be reduced by approximately $12 million. During the
three months ended June 30, 2009, the Company recorded total
restructuring charges of $4.2 million, consisting of $2.2 million
related to employee termination benefits and $2.0 million of
non-cash asset impairment charges.
As of June 30, 2009, the Company had approximately $108.6
million in cash, cash equivalents and short-term investments.
Conference Call Information
Adolor's management will discuss the Company's second quarter
2009 results in a conference call with investors beginning at 9:00
a.m. EDT today, July 29, 2009. To participate in the conference
call, dial (866) 394-4329 for domestic callers and (706) 902-1952
for international callers, and refer to conference code number
21182551. 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. 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.
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 peripheral mu opioid receptor antagonist entering
development for chronic opioid bowel dysfunction (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 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;
development of potential pharmaceutical products, including the
delta opioid receptor agonist program, the interpretation of the
results of the recently completed PK studies of ADL5859 and ADL5747
and the timing of and areas of focus for the planned Phase 2a
proof-of-concept studies with the delta 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.
[Financial information follows]
ADOLOR CORPORATION STATEMENTS OF
OPERATIONS (Unaudited) Three Months Ended
June 30,
Six Months Ended
June 30,
2009 2008 2009 2008
Revenues: Product sales, net $ 2,382,549 $ - $ 3,814,732 $ -
Contract revenues 6,681,389 26,964,318
11,928,866 33,175,342 Total revenues,
net 9,063,938 26,964,318 15,743,598
33,175,342 Operating expenses incurred:
Cost of product sales 230,258 - 383,562 - Research and development
11,972,191 13,262,176 24,294,814 24,683,248 Selling, general and
administrative 9,505,266 7,224,664 17,382,940 12,773,194
Restructuring charge 4,206,521 -
4,206,521 - Total operating expenses
25,914,236 20,486,840 46,267,837
37,456,442 Income (loss) from operations
(16,850,298 ) 6,477,478 (30,524,239 ) (4,281,100 ) Interest income,
net 308,451 1,008,015 795,052
2,711,034 Net income (loss) $ (16,541,847 ) $
7,485,493 $ (29,729,187 ) $ (1,570,066 ) Basic net income
(loss) per share $ (0.36 ) $ 0.16 $ (0.64 ) $ (0.03 )
Diluted net income (loss) per share $ (0.36 ) $ 0.16 $ (0.64 ) $
(0.03 ) Shares used in computing basic net income (loss) per
share 46,296,235 46,092,828 46,296,235
46,020,447 Shares used in computing
diluted net income (loss) per share 46,296,235
46,354,384 46,296,235 46,020,447
BALANCE SHEET DATA
(Unaudited)
June 30, December 31, 2009 2008
Cash, cash equivalents and short-term investments $ 108,592,396 $
131,910,206 Working capital $ 89,066,529 $ 112,250,025 Total assets
$ 116,852,529 $ 144,426,567 Total stockholders’ equity $ 60,456,016
$ 88,618,562
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