Adolor Corporation Reports Second Quarter 2009 Financial Results
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ADLR | Quote | Chart | News | PowerRating -- --- Delta Phase 2a Proof of Concept Studies to Begin in Fourth Quarter 2009 -
Adolor Corporation (NasdaqGM: ADLR | Quote | Chart | News | PowerRating) today reported net product sales of
ENTEREG(R) (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.(TM)) 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(R)
(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.(TM) 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 Six Months Ended
June 30, 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
SOURCE: Adolor Corporation
Adolor Corporation
Stephen W. Webster
Senior Vice President, Finance and CFO
484-595-1500
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