- Company Advances Plans to Realize the Benefits of Commercialization: Streamlines Operations to Focus on Nearer-Term Commercial Opportunities -
LAVAL, QC,
"We have made strong progress in recent months towards the commercialization of our novel trazodone formulation in both the
Financial Summary
Revenue from sales of the Company's once-daily tramadol product for the third quarter of fiscal 2009 increased to
Gross margin for sales outside of the U.S. for the third quarter of fiscal 2009 increased to 65% from 55% for the third quarter of fiscal 2008. Research and development expenses, before research and development tax credits, for the third quarter of fiscal 2009 were
Corporate Streamlining
The Company announced it is streamlining its operations, eliminating 35 positions. Following the action, Labopharm will have 124 employees, approximately 75 of which will be in research and development positions. The reduction in workforce is expected to result in annual cost savings of approximately
"After careful consideration, Labopharm is today announcing measures that focus the organization to better support the full commercial potential of our products, our pipeline and our technologies," added Mr. Howard-Tripp.
The Company expects to incur a restructuring charge related to the reduction in workforce of approximately
Key Developments
Novel Trazodone Formulation
New PDUFA Action Date Assigned by FDA/API Manufacturing Issues Resolved - Labopharm's response to the FDA's complete response letter was accepted as complete and designated as a Class 2 resubmission. The FDA assigned the Company a new Prescription Drug User Fee Act (PDUFA) action date of
NDS Accepted for Review by Health
Twice-Daily Tramadol-Acetaminophen Formulation
Completed Distribution and Supply Agreement with Grünenthal - Labopharm completed a distribution and supply agreement with Grunenthal GmbH for its twice-daily tramadol acetaminophen formulation for a number of countries in
Once-Daily Tramadol
Product Maintained Number One Position in
Financial Results
Three-Month Period Ended
Revenue from product sales in all territories for the third quarter of fiscal 2009 increased to
Under its licensing and distribution agreement with Purdue Pharma Products L.P. for RYZOLT(TM) in the
Labopharm supplies finished packaged RYZOLT product at cost to Purdue, for which the Company records revenue from product sales that generate essentially no gross margin. As a result, gross margin figures discussed below exclude sales and cost of goods sold for product sold in the U.S. to provide a more meaningful understanding of those figures. Gross margin (as a percentage of revenue from product sales) for territories outside the U.S. for the third quarter of fiscal 2009 was 65% compared with 55% for the third quarter of fiscal 2008. The increase in gross margin was due to a more favourable product mix, certain cost reduction initiatives and manufacturing efficiencies, and lower inventory write-downs in the third quarter of 2009.
Licensing revenue for the third quarter of fiscal 2009 was
Research and development expenses, before research and development tax credits, for the third quarter of fiscal 2009 were
Selling, general and administrative expenses for the third quarter of fiscal 2009 were
Net loss for the third quarter of fiscal 2009 was
Cash, cash equivalents and marketable securities at
Nine-Month Period Ended
Revenue for the first nine months of fiscal 2009 was
Gross margin (as a percentage of revenue from product sales) for territories outside the U.S. for the first nine months of fiscal 2009 was 66% compared with 56% for the first nine months of fiscal 2008. Gross margin for territories outside the U.S. for the first nine months of fiscal 2009 includes the reversal of
Licensing revenue for the first nine months of fiscal 2009 was
Net loss for the first nine months of fiscal 2009 was
Conference Call
Labopharm will host a conference call today (
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 now available in 17 countries around the world, including the U.S.,
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. Except as required by law, the Company undertakes no obligation and does not intend to update these forward-looking statements.
Labopharm Inc. INTERIM CONSOLIDATED BALANCE SHEETS (Unaudited) As at As at September 30, December 31, 2009 2008 (Restated) (thousands of Canadian dollars) $ $ ------------------------------------------------------------------------- ASSETS Current Cash and cash equivalents 14,528 8,373 Marketable securities 9,229 36,520 Accounts receivable 4,063 3,277 Research and development tax credits receivable 2,174 1,274 Income taxes receivable 224 474 Inventories 2,460 1,760 Prepaid expenses and other assets 760 641 ------------------------------------------------------------------------- Total current assets 33,438 52,319 ------------------------------------------------------------------------- Restricted long-term investments 139 141 Long-term investment 2,885 3,178 Property, plant and equipment 9,238 10,213 Intangible assets 1,719 1,791 Future income tax assets 128 145 ------------------------------------------------------------------------- 47,547 67,787 ------------------------------------------------------------------------- ------------------------------------------------------------------------- LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIENCY) Current Accounts payable and accrued liabilities 16,264 13,134 Current portion of deferred revenue 5,143 4,768 Current portion of obligations under capital leases 299 271 Current portion of long-term debt 1,414 3,378 ------------------------------------------------------------------------- Total current liabilities 23,120 21,551 ------------------------------------------------------------------------- Deferred revenue 5,920 9,094 Obligations under capital leases 5,115 5,342 Long-term debt 21,611 20,265 ------------------------------------------------------------------------- Total liabilities 55,766 56,252 ------------------------------------------------------------------------- Shareholders' equity (deficiency) Share capital Common shares, no par value, unlimited authorized shares, 57,411,663 and 56,826,063 issued as at September 30, 2009 and December 31, 2008, respectively 242,979 241,967 Warrants 797 751 Contributed surplus 16,259 14,937 Deficit (267,267) (247,515) Accumulated other comprehensive income (loss) (987) 1,395 ------------------------------------------------------------------------- Total shareholders' equity (deficiency) (8,219) 11,535 ------------------------------------------------------------------------- 47,547 67,787 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Labopharm Inc. INTERIM CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) For the three months ended: For the nine months ended: September September September September 30, 30, 30, 30, (thousands of Canadian 2009 2008 2009 2008 dollars, except share (Restated) (Restated) and per share amounts) $ $ $ $ ------------------------------------------------------------------------- REVENUE Product sales 5,187 3,863 13,816 9,880 Licensing 1,191 5,576 3,664 7,701 Royalties 201 - 325 - Research and development collaboration 46 - 46 - ------------------------------------------------------------------------- 6,625 9,439 17,851 17,581 ------------------------------------------------------------------------- EXPENSES Cost of goods sold (excluding depreciation and amortization) 2,154 1,755 6,151 4,389 Research and development expenses, net 3,209 6,267 10,097 18,264 Selling, general and administrative expenses 7,999 4,963 21,033 16,079 Financial expenses 1,013 733 3,010 2,153 Impairment loss on long-term investment - 400 - 1,091 Depreciation and amortization 442 501 1,358 1,476 Interest income (84) (351) (378) (1,554) Foreign exchange loss (gain) (1,215) 488 (3,679) 196 ------------------------------------------------------------------------- 13,518 14,756 37,592 42,094 ------------------------------------------------------------------------- Loss before income taxes (6,893) (5,317) (19,741) (24,513) Provision for income taxes Current 11 700 11 1,500 ------------------------------------------------------------------------- Net loss for the period (6,904) (6,017) (19,752) (26,013) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Net loss per share - basic and diluted (0.12) (0.11) (0.35) (0.46) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Weighted average number of common shares outstanding 57,388,302 56,824,106 57,020,122 56,821,325 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Labopharm Inc. INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) For the three months ended: For the nine months ended: September September September September 30, 30, 30, 30, 2009 2008 2009 2008 (thousands of Canadian (Restated) (Restated) dollars) $ $ $ $ ------------------------------------------------------------------------- OPERATING ACTIVITIES Net loss for the period (6,904) (6,017) (19,752) (26,013) Items not affecting cash: Depreciation of property, plant and equipment 396 471 1,229 1,386 Amortization of intangible assets 46 30 129 90 Amortization of premiums and discounts on marketable securities 36 6 90 33 Loss on sale of property, plant and equipment 65 - 65 - Impairment loss on long-term investment - 400 - 1,091 Non-cash financial expenses 206 101 496 288 Unrealized foreign exchange loss (gain) (1,177) 647 (2,012) 386 Stock-based compensation 136 410 1,339 1,981 ------------------------------------------------------------------------- (7,196) (3,952) (18,416) (20,758) Net change in non-cash items 1,502 (6,623) (834) (5,906) ------------------------------------------------------------------------- (5,694) (10,575) (19,250) (26,664) ------------------------------------------------------------------------- INVESTING ACTIVITIES Acquisition of marketable securities - (16,962) (8,466) (40,515) Proceeds from maturities of marketable securities 595 - 23,605 - Proceeds from disposals of marketable securities 3,400 11,200 9,420 67,019 Acquisition of restricted long-term investment - - - (45) Acquisition of property, plant and equipment (251) (196) (319) (1,344) Acquisition of intangible assets (4) (57) (57) (96) ------------------------------------------------------------------------- 3,740 (6,015) 24,183 25,019 ------------------------------------------------------------------------- FINANCING ACTIVITIES Repayment of obligations under capital leases (68) (66) (199) (138) Proceeds from issuance of long-term debt 2,549 - 2,549 - Transaction costs (8) - (362) (118) Proceeds from issuance of share capital 366 3 527 8 Issuance costs of share capital (35) - (35) - ------------------------------------------------------------------------- 2,804 (63) 2,480 (248) ------------------------------------------------------------------------- Foreign exchange (loss) gain on cash held in foreign currencies (581) (176) (1,258) 448 Net increase (decrease) in cash and cash equivalents during the period 269 (16,829) 6,155 (1,445) Cash and cash equivalents, beginning of period 14,259 32,557 8,373 17,173 ------------------------------------------------------------------------- Cash and cash equivalents, end of period 14,528 15,728 14,528 15,728 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Supplemental cash flow information: Interest paid 802 632 2,294 1,777 Income taxes received 128 224 216 267 ------------------------------------------------------------------------- -------------------------------------------------------------------------
For further information: For further information: 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, [email protected]; French: Joe Racanelli, Tel: (514) 844-7997, [email protected]
Share this article