Adolor Corporation Reports Third Quarter 2009 Financial Results.EXTON, Pa. -- Adolor Corporation (NasdaqGM:ADLR) today reported a net loss of approximately $11.1 million, or ($0.24) per basic and diluted share, for the three months ended September 30, 2009 compared to a net loss of $13.3 million, or ($0.29) per basic and diluted share, for the three months ended September 30, 2008. For the nine months ended September 30, 2009, the Company reported a net loss of approximately $40.9 million, or ($0.88) per basic and diluted share, compared to a net loss of $14.8 million, or ($0.32) per basic and diluted share, for the nine months ended September 30, 2008. The prior year nine month period was favorably impacted by a $20.0 million milestone payment received from GlaxoSmithKline (GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) ) in the second quarter of 2008 upon the approval of ENTEREG[R] (alvimopan) by the U.S. Food and Drug Administration. The Company reported net shipments of ENTEREG for the three and nine months ended September 30, 2009 of approximately $4.0 million and $8.9 million, respectively, of which the Company recognized approximately $3.3 million and $7.2 million, respectively, as net product sales. Under Adolor's current revenue recognition policy, revenue related to a customer shipment is deferred until subsequent re-orders by that customer. As of September 30, 2009, there were approximately 625 repeat-order hospitals for ENTEREG, up from 450 at June 30, 2009. During the quarter, hospitals registered under the ENTEREG Access Support and Education (E.A.S.E.[TM]) Program increased by 125 to approximately 1,550 hospitals. Inclusion of ENTEREG on hospital formularies hospital formulary n. A compilation of pharmaceuticals and other information that reflects the current clinical judgment of a hospital's medical staff. also increased during the quarter by 125, or 21%, to approximately 725 hospitals as of September 30, 2009, which number includes approximately 435 of the 1,400 hospitals that perform approximately 80% of the bowel resection Bowel Resection Definition A bowel resection is a surgical procedure in which a part of the large or small intestine is removed. Purpose surgeries in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . Adolor also reported significant progress in its delta opioid receptor δ-Opioid receptors are a class of opioid receptor which have enkephalins as their endogenous ligands. Function Activation of the receptors produces analgesia. Some research suggests that they may also be related to seizures. agonist agonist /ag·o·nist/ (ag´ah-nist) 1. one involved in a struggle or competition. 2. agonistic muscle. 3. and opioid opioid /opi·oid/ (o´pe-oid) 1. any synthetic narcotic that has opiate-like activities but is not derived from opium. 2. any of a group of naturally occurring peptides, e.g. bowel dysfunction (OBD OBD On Board Diagnostics OBD On-Board Diagnosis OBD Organization of Black Designers OBD Overboard (Swedish punkrock band) OBD Opposed Blade Damper (mechanical) OBD Off-Board Diagnostics ) clinical development programs. Highlights from the quarter included: * Initiation with Pfizer, Inc. of a Phase 2a proof-of-concept study for the two delta compounds, ADL5859 and ADL5747, in patients suffering from osteoarthritis osteoarthritis or osteoarthrosis or degenerative joint disease Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first. ; * The filing of the Company's Investigational New Drug Application for ADL7445 in OBD and preparation for the initiation of a Phase 1 clinical trial phase 1 clinical trial Phase 1 study. See Phase study. ; and * The acquisition from Eli Lilly and Company Eli Lilly and Company (NYSE: LLY) is a global pharmaceutical company and one of the world's largest corporations. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States. of ADL5945, a clinical stage mu opioid receptor The μ opioid receptors (MOR) are a class of opioid receptors with high affinity for enkephalins and beta-endorphin but low affinity for dynorphins. The opiate alkaloids morphine and codeine are known to bind to this receptor. antagonist antagonist /an·tag·o·nist/ (an-tag´o-nist) 1. a substance that tends to nullify the action of another, as a drug that binds to a cell receptor without eliciting a biological response, blocking binding of substances that could with the potential to address gastrointestinal disorders such as OBD associated with the chronic use of opioid analgesics Analgesics, Opioid Definition Opioid analgesics, also known as narcotic analgesics, are pain relievers that act on the central nervous system. Like all narcotics, they may become habit-forming if used over long periods. . "The third quarter saw continued progress with ENTEREG, with net shipments increasing by nearly 40% from the second quarter of 2009 to $4.0 million and growth in hospital registrations and formulary formulary /for·mu·lary/ (for´mu-lar?e) a collection of recipes, formulas, and prescriptions. National Formulary see under N. for·mu·lar·y n. approvals," said Michael R. Dougherty, President and Chief Executive Officer. "We also continue to see validation of the benefits of ENTEREG as more hospitals report the results of their independent evaluations of ENTEREG. Finally, we are very pleased to report the progress in our clinical development pipeline, with multiple compounds now under development in both our delta and OBD programs." Contract revenues were approximately $5.3 million and $7.7 million for the three months ended September 30, 2009 and 2008, respectively, and were approximately $17.2 million and $40.9 million for the nine months ended September 30, 2009 and 2008, respectively. Contract revenues in the nine months ended September 30, 2008 included the $20.0 million milestone payment received from GSK. Research and development expenses were approximately $11.1 million and $14.1 million for the three months ended September 30, 2009 and 2008, respectively, and were approximately $35.4 million and $38.8 million for the nine months ended September 30, 2009 and 2008, respectively. Total research and development expenses decreased due to lower costs of clinical studies incurred during 2009 in our delta agonist program, lower expenses in our other programs and a reduction in headcount and depreciation expenses resulting from our June 2009 restructuring. These decreases were partially offset by higher expenses related to the development of our OBD program, including a $2.0 million payment to in-license ADL5945 as a clinical stage OBD candidate. Selling, general and administrative expenses were approximately $8.7 million and $7.9 million for the three months ended September 30, 2009 and 2008, respectively, and were approximately $26.1 million and $20.7 million for the nine months ended September 30, 2009 and 2008, respectively. The increase in 2009 was driven primarily by increased marketing and selling expenses associated with ENTEREG. As of September 30, 2009, the Company had approximately $94.4 million in cash, cash equivalents and short-term investments. Conference Call Information Adolor's management will discuss the Company's third quarter 2009 results in a conference call with investors beginning at 8:45 a.m. EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT today, October 29, 2009. To participate in the conference call, dial 866-314-5232 for domestic callers and 617-213-8052 for international callers, and refer to conference code number 38530562. 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 small bowel n. See small intestine. resection resection /re·sec·tion/ (-sek´shun) excision. root resection apicoectomy. transurethral resection of the prostate (TURP), transurethral prostatic resection surgery with primary anastomosis anastomosis /anas·to·mo·sis/ (ah-nas?tah-mo´sis) pl. anastomo´ses [Gr.] 1. communication between vessels by collateral channels. 2. . 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; two opioid receptor Opioid receptors are a group of G-protein coupled receptors with opioids as ligands. The endogenous opioids are dynorphins, enkephalins, endorphins, endomorphins and nociceptin/orphanin FQ. The opioid receptors are ~40% identical to somatostatin receptors (SSTRs). antagonists antagonists, n muscles that counterbalance agonists during specific movements. opioid Neurology A pain-attenuating peptide that occurs naturally in the brain, which induces analgesia by mimicking endogenous opioids at opioid , ADL7445 and ADL5945, 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 Adolor's research programs; development of potential pharmaceutical products, including the delta opioid receptor agonist and OBD programs, 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. [TABLE OMITTED] [TABLE OMITTED] |
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