Adolor Corporation (NasdaqGM: ADLR) today reported a net loss of
$6.1 million, or $(0.13) per basic and diluted share, for the three
months ended September 30, 2010, compared to a net loss of $11.1
million, or $(0.24) per basic and diluted share, for the three
months ended September 30, 2009. For the nine months ended
September 30, 2010, Adolor reported a net loss of $23.9 million, or
$(0.52) per basic and diluted share, compared to a net loss of
$40.9 million, or $(0.88) per basic and diluted share, for the nine
months ended September 30, 2009.
Net product sales of ENTEREG® (alvimopan) were $6.5 million and
$3.3 million for the three months ended September 30, 2010 and
2009, respectively, and $18.1 million and $7.2 million for the nine
months ended September 30, 2010 and 2009, respectively. The
increase in net product sales during the three and nine months
ended September 30, 2010 as compared to the prior year periods
resulted from an increase in the number of hospitals ordering
ENTEREG and increased penetration within existing hospital
customers. In addition, net product sales for the three and nine
months ended September 30, 2010 were recognized at the time of
shipment as compared to net product sales for the three and nine
months ended September 30, 2009, which were recognized on a reorder
basis under the Company’s previous revenue recognition policy. Net
shipments of ENTEREG for the three and nine months ended September
30, 2009 were $4.0 million and $8.9 million, respectively.
Separately, the Company recently announced that it initiated a
Phase 2 study of ADL5945 in patients suffering from opioid-induced
constipation (OIC).
“The third quarter saw solid progress in our OIC clinical
program, where we completed single-ascending dose studies with
ADL5945 and ADL7445 in healthy volunteers and multiple-ascending
studies with both compounds in patients suffering with OIC,” said
Michael R. Dougherty, President and Chief Executive Officer. “Our
Phase 2 study of ADL5945 is now underway and we look forward to
completing this important trial in mid-2011,” continued Mr.
Dougherty. “Third quarter financial results reflect continued
modest growth in ENTEREG sales and a reduction in our cash burn
from operations.”
Cash, cash equivalents and short-term investments at September
30, 2010 were $53.6 million. Third quarter operating expenses
included a cash charge of $1.9 million relating to the July 2010
restructuring.
About Adolor
Adolor Corporation is a biopharmaceutical company specializing
in the discovery, development and commercialization of novel
prescription gastrointestinal and 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 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:
ADL5945 and ADL7445, novel mu opiate receptor antagonists
undergoing clinical development for chronic OIC; two novel delta
opioid receptor agonists, one of which currently is in mid-stage
clinical development in collaboration with Pfizer Inc. for
neuropathic pain; and several earlier-stage compounds under
development for the management of pain and CNS disorders.
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 growth in net product sales will continue;
anticipated scientific progress on Adolor’s research programs;
development of potential pharmaceutical products, including the OBD
and the delta opioid receptor agonist programs and the timing and
results of any clinical studies of Adolor’s 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 Ended Nine Months Ended
September 30, September 30, 2010
2009 2010
2009 Revenues: Product sales, net $ 6,528,496
$ 3,343,947 $ 18,077,998 $ 7,158,679 Contract revenues
4,145,113 5,318,994 14,209,991
17,247,860 Total revenues, net
10,673,609 8,662,941 32,287,989
24,406,539 Operating expenses incurred: Cost
of product sales 730,337 320,711 1,997,572 704,273 Research and
development 6,425,667 11,105,662 26,539,299 35,400,476 Selling,
general and administrative 7,750,777 8,673,482 25,980,032
26,056,422 Restructuring charge 1,918,701
(148,000 ) 1,918,701 4,058,521
Total operating expenses 16,825,482 19,951,855
56,435,604 66,219,692
Loss from operations (6,151,873 ) (11,288,914 ) (24,147,615 )
(41,813,153 ) Interest income 38,505 159,842 157,658 954,894 Other
income 51,517 — 51,517
— Net loss $ (6,061,851 ) $ (11,129,072 ) $
(23,938,440 ) $ (40,858,259 ) Basic and diluted net loss per
share $ (0.13 ) $ (0.24 ) $ (0.52 ) $ (0.88 ) Shares used in
computing basic and diluted net loss per share 46,351,148
46,296,235 46,332,662
46,296,235
CONSOLIDATED BALANCE SHEET
DATA
(Unaudited)
September 30, December 31, 2010
2009 Cash, cash equivalents and short-term investments $
53,591,496 $ 83,205,976 Working capital 42,046,651 66,989,322 Total
assets 59,247,407 91,459,434 Total stockholders’ equity 22,293,395
44,053,673
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