- Company's Once-Daily Tramadol Product Now Launched in U.S. -
LAVAL, QC, May 7 /PRNewswire-FirstCall/ - Labopharm Inc. today reported its results for the first quarter ended March 31, 2009. All figures are in Canadian dollars unless otherwise stated.
Once-Daily Tramadol Launched in the U.S.
Labopharm's once-daily tramadol is now available in the U.S. Marketed and distributed in the U.S. by Purdue Pharma Products L.P. under the brand name Ryzolt(TM), the product is the first and only analgesic that contains both immediate and extended release components of tramadol. Ryzolt(TM) is now stocked and available in more than 27,000 retail pharmacies across the U.S.
"We are pleased to announce a major milestone for Labopharm, the U.S. launch of Ryzolt(TM), our unique once-daily tramadol product," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "With Ryzolt(TM), U.S. physicians now have a new option in analgesia for the millions of American patients suffering from moderate to moderately severe pain who require continuous treatment."
Pain affects an estimated 76 million Americans and the annual cost of chronic pain in the U.S. is estimated at US$100 billion, including healthcare expenses, lost income, and lost productivity.
Labopharm's once-daily tramadol is based on Labopharm's proprietary Contramid(R) controlled-release technology and is composed of a dual-matrix delivery system with both immediate-release and extended-release characteristics. Once-daily tramadol is now available in 17 countries around the world, including the U.S., Canada, the United Kingdom, France, Spain, Italy, Germany and Australia, among others.
Financial Summary
Revenue for the first quarter of fiscal 2009 increased to $5.0 million from $3.2 million for the first quarter of fiscal 2008. Revenue from sales of the Company's once-daily tramadol product for the first quarter of fiscal 2009 increased to $3.8 million from $2.2 million for the first quarter of fiscal 2008. Adjusted gross margin for the first quarter of fiscal 2009 was 57% compared with 58% for the first quarter of fiscal 2008. Research and development expenses, before research and development tax credits, for the first quarter of fiscal 2009 were $4.3 million compared with $6.9 million for the first quarter of fiscal 2008. Selling, general and administrative expenses for the first quarter of fiscal 2009 were $6.7 million compared with $4.9 million for the first quarter of fiscal 2008 and included an accrual of $0.7 million for the Company's share of litigation costs related to patent enforcement following approval of its once-daily tramadol product in the U.S. Net loss for the first quarter of fiscal 2009 was $8.0 million, or $0.14 per share, compared with $9.7 million, or $0.17 per share, for the first quarter of fiscal 2008.
Product Ranked Number One in New-to-Brand Prescriptions in Canada - Labopharm's product (marketed under the brand name Tridural(TM) in Canada) ranked number one among tramadol products (excluding combination products) in terms of new-to-brand prescriptions in Canada for the first quarter of 2009. Market share for Labopharm's product among tramadol products (excluding combination products) in Canada for the same period was 36%. The number of prescriptions written for Labopharm's product in Canada for the first quarter of 2009 increased 19% compared to the fourth quarter of 2008.
In-Market Sales in Europe Continue to Grow - In-market sales of Labopharm's product in Europe(1) grew 9% for the first two months of 2009 compared to the same period of 2008. Sales to European marketing partners are continuing to provide a solid contribution to the Company's revenue.
Established Marketing Partnerships for Eleven Additional Countries - Labopharm signed an agreement with iNova Pharmaceuticals, its marketing partner for Australia and New Zealand, for distribution of the Company's product in Singapore, Hong Kong, Malaysia, Philippines, Thailand, Taiwan and Indonesia. iNova plans to submit regulatory applications in each of these jurisdictions. The Company also signed licensing and distribution agreements for Portugal, Brazil, Denmark and Sweden.
Novel Trazodone Formulation
NDA Under Review by FDA/Company in Ongoing Discussions for U.S. Marketing Partnership - Labopharm's New Drug Application (NDA) for its novel trazodone formulation is under review by the U.S. Food and Drug Administration (FDA) with an action date under the Prescription Drug User Fee Act (PDUFA) of July 18, 2009. The Company is in ongoing discussions with potential marketing partners towards establishing a licensing and distribution agreement for the United States.
Financial Results
Three-Month Period Ended March 31, 2009
Revenue for the first quarter of fiscal 2009 increased to $5.0 million from $3.2 million for the first quarter of fiscal 2008. Revenue from product sales increased to $3.8 million from $2.2 million for the first quarter of fiscal 2008. The increase in revenue from product sales was primarily the result of higher sales volumes and higher average selling prices in the first quarter of fiscal 2009.
Adjusted gross margin (as a percentage of revenue from product sales) for the first quarter of fiscal 2009 was 57% compared with 58% for the first quarter of fiscal 2008. Adjusted gross margin for the first quarter of fiscal 2009 excludes the reversal of $240,000 of previously recorded write downs while adjusted gross margin for the first quarter of fiscal 2008 excludes an inventory write-off of $152,000 and a favourable adjustment for a royalty expense over-accrual of $105,000. The slight decrease in adjusted gross margin was due primarily to a higher average royalty rate paid, which was partially offset by a higher average selling price per tablet.
Licensing revenue for the first quarter of fiscal 2009 was $1.2 million and represented a portion of licensing payments received from the Company's licensing and distribution partners for once-daily tramadol. Licensing revenue for the first quarter of fiscal 2008 was $1.1 million.
Research and development expenses, before research and development tax credits, for the first quarter of fiscal 2009 were $4.3 million compared with $6.9 million for the first quarter of fiscal 2008. The decrease was primarily the result of lower clinical trial costs in the first quarter of fiscal 2009. Research and development tax credits for the first quarter of fiscal 2009 were $0.3 million compared with $1.2 million for the first quarter of fiscal 2008, a decrease in non-refundable Canadian federal tax credits resulting from a change in tax planning.
Selling, general and administrative expenses for the first quarter of fiscal 2009 were $6.7 million compared with $4.9 million for the first quarter of fiscal 2008. The increase is primarily the result of the accrual of $0.7 million for the Company's share of litigation costs incurred by Purdue Pharma to enforce certain of Purdue's U.S. patents related to Labopharm's once-daily tramadol product, as well as higher sales and marketing expenses.
Net loss for the first quarter of fiscal 2009 was $8.0 million, or $0.14 per share, compared with $9.7 million, or $0.17 per share, for the first quarter of fiscal 2008.
Cash, cash equivalents and marketable securities at March 31, 2009 were $35.9 million compared with $44.9 million at December 31, 2008. The cash, cash equivalents and marketable securities position at March 31, 2009 does not include the Company's Long-Term Notes, received in exchange of the Montreal Proposal ABCP, that have an estimated fair value of $3.0 million and that are recorded as a long-term investment.
Conference Call
Labopharm will host a conference call today (Thursday, May 7, 2009) at 8:30 a.m. ET to discuss its first quarter results. To access the conference call by telephone, dial 416-644-3420 or 1-800-732-0232. Please connect approximately five minutes prior to the beginning of the call to ensure participation. The conference call will be archived for replay until Thursday, May 14, 2009 at midnight. To access the archived conference call, dial 416-640-1917 or 1-877-289-8525 and enter the reservation number 21303738 followed by the number sign. A live audio webcast of the conference call will be available at www.labopharm.com. Please connect at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to join the webcast. The webcast will be archived at the above web site for 30 days.
About Labopharm Inc.
Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is being commercially launched in key markets globally and its second product, a novel formulation of trazodone for the treatment of major depressive disorder, is under regulatory review by the FDA. The Company also has a robust pipeline of follow-on products in both pre-clinical and clinical development. Labopharm's vision is to become an integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize its own products. For more information, please visit www.labopharm.com.
Ryzolt(TM) is a trademark of Purdue Pharma Products L.P.
This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the uncertainties related to the regulatory process in various countries for the approval of the Company's products and the successful commercialization of the products throughout the world if they are approved. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.
CONTACT: At Labopharm: Mark D'Souza, Senior Vice-President and Chief
Financial Officer, Tel: (450) 686-0207; At The Equicom Group: Jason Hogan,
Media and Investor Relations, Tel: (416) 815-0700, jhogan@equicomgroup.com;
French: Joe Racanelli, Tel: (514) 844-7997, jracanelli@equicomgroup.com
