Adolor Corporation Reports First Quarter 2007 Financial Results.EXTON, Pa. -- Adolor Corporation (Nasdaq:ADLR) today reported financial results for the three months ended March 31, 2007. For the three months ended March 31, 2007, the company reported a net loss of $13.2 million or $(0.29) per basic and diluted share, compared to a net loss of $17.4 million or $(0.42) per basic and diluted share for the same period in 2006. Contract revenues for the quarter ended March 31, 2007 were $1.8 million, compared to $2.6 million in the same period of 2006. This decrease was primarily due to a decrease in co-promotion revenues of $0.7 million from our Arixtra[R] co-promotion agreement with Glaxo, which expired in 2006. Research and development expenses in the first quarter of 2007 were $11.6 million, compared to $14.6 million for the same period in 2006. This decrease was principally related to decreased expenses relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc our Entererg[R] (alvimopan) program and sterile lidocaine lidocaine /li·do·caine/ (li´do-kan) an anesthetic with sedative, analgesic, and cardiac depressant properties, applied topically in the form of the base or hydrochloride salt as a local anesthetic; also used in the latter form as a patch program which was discontinued dis·con·tin·ue v. dis·con·tin·ued, dis·con·tin·u·ing, dis·con·tin·ues v.tr. 1. To stop doing or providing (something); end or abandon: in 2006. These decreases were partially offset by the increase in expenses related to our Delta program. Marketing, general and administrative expenses decreased to $5.8 million in the first quarter of 2007 from $7.5 million in the first quarter of 2006, as a result of decreased personnel expenses, including stock-based compensation expenses associated with Statement of Financial Accounting Standards 123R, combined with lower marketing and sales expenses. As of March 31, 2007, the Company had $169.3 million in cash, cash equivalents and short-term investments. About Adolor Corporation Adolor Corporation (Nasdaq:ADLR) is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain management products. Entereg[R] (alvimopan) is Adolor's lead product candidate under development for the management of the gastrointestinal side effects Side effects Effects of a proposed project on other parts of the firm. associated with 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. use. Adolor and GlaxoSmithKline (GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) ) are collaborating in the worldwide development and commercialization of Entereg[R] in multiple indications. Adolor also has a number of discovery research programs focused on the identification of novel compounds for the treatment of pain. By applying its knowledge and expertise in pain management, along with ingenuity, Adolor is seeking to make a positive difference for patients, caregivers and the medical community. For more information, visit www.adolor.com. Arixtra[R] is a registered trademark of GlaxoSmithKline. This release, and oral statements made with respect to information contained in this release, may constitute forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. 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. Such forward-looking statements include those which express plan, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Such known risks and uncertainties relate to, among other factors: the risk that the 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 development program remains on hold indefinitely; the risk that Adolor may not receive regulatory approval of Entereg [R] (alvimopan) for POI, OBD, or any other indication; the risk that Adolor may not be able to adequately address the deficiencies in the November 2006 FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approvable letter; the risk that a risk management plan could materially adversely affect the commercial prospects for Entereg, if regulatory approval is achieved; the risk that Adolor may not obtain FDA approval for Entereg in POI, whether due to Adolor's inability to provide additional data satisfactory to the FDA to obtain approval for the NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any , the adequacy of the safety and efficacy data from all of the Entereg studies, changing regulatory requirements Regulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. , the risk that the FDA may not agree with Adolor's and GSK's analyses of the Entereg studies (including Study 014) and may evaluate the results of these studies by different methods or conclude that the results from the studies, whether or not statistically significant, do not support safety, efficacy, a favorable risk/benefit profile, or there were human errors in the conduct of the studies, or otherwise; adverse safety findings in any Entereg studies; the risk that regulatory approvals for the use of Entereg in OBD are not achieved; the risk that filing targets for regulatory submissions or user fee goal dates are not met; the risk that the results of other clinical trials of Adolor's drug product candidates, including Entereg, are not positive; the risk of product liability claims; reliance on third party manufacturers; the costs, delays and uncertainties inherent in scientific research, drug development, clinical trials and the regulatory approval process; Adolor's history of operating losses operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. since inception and its need for additional funds to operate its business; Adolor's reliance on its collaborators, including GSK, in connection with the development and commercialization of Entereg; market acceptance of Adolor's products, if regulatory approval is achieved; competition; and securities litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. . Further information about these and other relevant risks and uncertainties may be found in Adolor's Reports on Form 8-K Form 8-K The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock. Form 8-K See 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 in the SEC EDGAR Edgar or Eadgar (both: ĕd`gər), 943?–975, king of the English (959–75), son of Edmund, king of Wessex. In 957 the Mercians and Northumbrians rebelled against Edgar's brother Edwy and chose Edgar as their king. database at http://www.sec.gov and from Adolor at http://www.adolor.com. Given the uncertainties affecting pharmaceutical companies in the development stage, you are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. Adolor undertakes no obligation to (and expressly disclaims any such 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. This press release is available on the website http://www.adolor.com. [TABLE OMITTED] |
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