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From the Wires
Labopharm Reports Results for Third Quarter Fiscal 2008
By: PR Newswire
Nov. 7, 2008 07:00 AM
- Quarter Highlighted by Submission of NDA for Novel Antidepressant and
Steady Global Growth for Once-Daily Tramadol -
"We are very pleased with the progress of our business," said Financial Summary Revenue from product sales of Labopharm's once-daily tramadol for the third quarter of fiscal 2008 increased to Recent Developments Once-Daily Tramadol Global Commercialization Program Product Continues to Exhibit Steady Growth in Market Share and In-Market Sales Globally - Labopharm's once-daily tramadol product continues to exhibit steady growth in market(3) share and in-market sales in Product Launched in Received Regulatory Approval in DDS-04A Containing Trazodone for Treatment of Depression Submitted NDA to U.S. FDA - Labopharm submitted a New Drug Application (NDA) under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act to the U.S. Food and Drug Administration (FDA) for DDS-04A, a once-daily serotonin antagonist reuptake inhibitor (SARI) that provides an effective option in the treatment of major depression. In addition to the U.S., the Company plans to pursue regulatory approval for DDS-04A in Twice-Daily Tramadol-Acetaminophen Combination Product Phase III Clinical Trial Continues - Enrolment for the North American Phase III clinical trial (study 06CCL3-001) continues, as do discussions with potential marketing partners for distribution of the product. The Company expects to report the results of the study in the second quarter of 2009. Misuse and Abuse Deterrent Platform Preparing to Initiate Clinical Studies for a Widely Misused Pain Drug - Labopharm is preparing to enter the clinic in the first half of 2009 with the first of potentially several misuse and abuse deterrent formulations of widely prescribed pain drugs. The Company completed pre-clinical, proof-of-principle studies of its platform using once-daily tramadol as a safe representative of the controlled-release opioid class of drugs. The positive results of the pharmacokinetic study demonstrated controlled-release characteristics and bioequivalence to once-daily tramadol and the in vitro studies demonstrated misuse and abuse deterrent characteristics. Financial Results Three-Month Period Ending Revenue for the third quarter of fiscal 2008 increased to Adjusted gross margin (as a percentage of revenue from product sales) for the third quarter of fiscal 2008 increased to 60% from 56% for the third quarter of fiscal 2007. Adjusted gross margin for the third quarter of fiscal 2008 excludes a write down of inventory of Licensing revenue for the third quarter of fiscal 2008 was Research and development expenses, before research and development tax credits, for the third quarter of fiscal 2008 were Selling, general and administrative expenses for the third quarter of fiscal 2008 were During the third quarter, the Company made an additional adjustment to the estimated fair value of its asset backed commercial paper (ABCP) investment and took an additional impairment charge of Net loss for the third quarter of fiscal 2008 was Cash, cash equivalents and available-for-sale marketable securities at Nine-Month Period Ending For the first nine months of fiscal 2008, revenue was Adjusted gross margin (as a percentage of revenue from product sales) for the first nine months of fiscal 2008 increased to 58% from 50% in the corresponding period last year. Adjusted gross margin for the first nine months of fiscal 2008 excludes a write down of inventory of Licensing revenue for the first nine months of fiscal 2008 was Research and development expenses, before research and development tax credits, for the first nine months of fiscal 2008 were Selling, general and administrative expenses for the first nine months of fiscal 2008 were relatively unchanged from the first nine months of fiscal 2007 at 15.8 million. Lower non-cash stock-based compensation expense was partially offset by an increase in legal and compensation costs. Net loss for the first nine months of fiscal 2008 was Labopharm continues to expect global sales of its once-daily tramadol product to be variable from quarter to quarter as a result of pipeline fill and other supply chain and market dynamics associated with the early stages of product launches. Labopharm believes that the penetration of markets in which its product has already been launched, as well as additional product launches globally, will result in continued annual growth in product sales. Hercules Growth Technology Capital Agreement In accordance with the terms of the Warrant Agreement related to Labopharm's term loan facility with Hercules Technology Growth Capital, Inc. (Hercules), and as a result of the Company's additional drawdown of 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 being commercially launched in key markets globally and its second product, a novel SARI containing 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. 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.
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(1) Serotonin Antagonist Reuptake Inhibitor.
(2) Includes France, Germany, the United Kingdom, Spain and Italy.
(3) Labopharm's target market in Europe consists of the market for
immediate-release, twice-daily, once-daily and drop formulations of
tramadol.
(4) Includes France, Germany, the United Kingdom, Spain and Italy.
(5) Includes France, Germany, the United Kingdom, Spain and Italy.
Labopharm Inc.
CONSOLIDATED BALANCE SHEETS
(Unaudited)
As at As at
September 30, December 31,
2008 2007
(Thousands of Canadian dollars) $ $
-------------------------------------------------------------------------
ASSETS
Current
Cash and cash equivalents 15,728 17,173
Available-for-sale marketable securities 28,340 54,726
Accounts receivable 2,827 1,972
Research and development tax credits receivable 2,097 1,197
Income taxes receivable 334 161
Inventories 1,695 2,875
Prepaid expenses and other assets 678 1,460
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Total current assets 51,699 79,564
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Restricted long-term investments 128 1,277
Long-term investment 3,378 4,329
Property, plant and equipment 10,630 10,800
Intangible assets 3,663 3,453
Future income tax assets 123 116
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69,621 99,539
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LIABILITIES AND SHAREHOLDERS' EQUITY
Current
Accounts payable and accrued liabilities 8,075 8,719
Current portion of deferred revenue 4,689 4,325
Current portion of obligations under capital leases 265 203
Current portion of long-term debt 640 -
-------------------------------------------------------------------------
Total current liabilities 13,669 13,247
-------------------------------------------------------------------------
Deferred revenue 10,188 17,083
Obligations under capital leases 5,413 5,613
Long-term debt 14,187 13,647
-------------------------------------------------------------------------
Total liabilities 43,457 49,590
-------------------------------------------------------------------------
Shareholders' equity
Share capital
Unlimited authorization of common shares,
voting, without par value; issued and
outstanding 56,826,063 and 56,817,963
as at September 30, 2008 and
December 31, 2007, respectively 241,967 241,955
Warrants 541 541
Contributed surplus 14,504 12,527
Deficit (230,733) (205,024)
Accumulated other comprehensive loss on
available-for-sale marketable securities (115) (50)
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Total shareholders' equity 26,164 49,949
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69,621 99,539
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Labopharm Inc.
INTERIM CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
For the three months For the nine months
(Thousands of ended: ended:
Canadian dollars, Sept. 30, Sept. 30, Sept. 30, Sept. 30,
except share and 2008 2007 2008 2007
per share amounts) $ $ $ $
-------------------------------------------------------------------------
REVENUE
Product sales 3,863 2,818 9,880 10,359
Licensing 5,576 1,058 7,701 4,786
Research and development
collaborations - 1,217 - 1,217
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9,439 5,093 17,581 16,362
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EXPENSES
Cost of goods sold
(excluding depreciation) 1,755 1,012 4,389 6,716
Research and development, net 6,267 7,145 18,264 17,296
Selling, general and
administrative 4,888 4,622 15,766 15,840
Financial costs 733 434 2,153 1,474
Impairment loss on
long-term investment 400 874 1,091 874
Depreciation and amortization 536 510 1,585 1,482
Interest income (351) (810) (1,554) (2,707)
Foreign exchange loss (gain) 488 (107) 196 280
-------------------------------------------------------------------------
14,716 13,680 41,890 41,255
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Loss before income taxes (5,277) (8,587) (24,309) (24,893)
Provision for income taxes
Current 700 508 1,500 1,710
Future - (64) - (64)
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700 444 1,500 1,646
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Net loss for the period (5,977) (9,031) (25,809) (26,539)
-------------------------------------------------------------------------
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Net loss per share -
basic and diluted (0.11) (0.16) (0.45) (0.47)
-------------------------------------------------------------------------
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Weighted average number
of common shares
outstanding 56,824,106 56,817,963 56,821,325 56,795,545
-------------------------------------------------------------------------
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Labopharm Inc.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
For the three months For the nine months
ended: ended:
Sept. 30, Sept. 30, Sept. 30, Sept. 30,
(Thousands of 2008 2007 2008 2007
Canadian dollars) $ $ $ $
-------------------------------------------------------------------------
OPERATING ACTIVITIES
Net loss for the period (5,977) (9,031) (25,809) (26,539)
Items not affecting cash:
Depreciation of property,
plant and equipment 471 448 1,386 1,304
Amortization of
intangible assets 65 62 199 178
Amortization of premium
or discounts on
marketable securities 6 57 33 207
Impairment loss on
long-term investment 400 874 1,091 874
Non-cash financial costs 101 30 288 107
Unrealized foreign
exchange loss (gain) 647 (106) 386 282
Future income tax - (64) - (64)
Stock-based compensation 410 674 1,981 3,573
-------------------------------------------------------------------------
(3,877) (7,056) (20,445) (20,078)
Net change in non-cash
operating items (6,623) 1,008 (5,906) 1,116
-------------------------------------------------------------------------
(10,500) (6,048) (26,351) (18,962)
-------------------------------------------------------------------------
INVESTING ACTIVITIES
Acquisition of marketable
securities (16,962) (11,733) (40,515) (64,980)
Proceeds from maturities
of marketable securities 11,200 15,491 67,019 81,876
Proceeds from disposals
of marketable securities - 3,498 - 3,498
Acquisition of restricted
long-term investment - - (45) -
Acquisition of property,
plant and equipment (196) (454) (1,344) (1,600)
Acquisition of intangible
assets (132) (334) (409) (457)
-------------------------------------------------------------------------
(6,090) 6,468 24,706 18,337
-------------------------------------------------------------------------
FINANCING ACTIVITIES
Repayment of obligations
under capital leases (66) (24) (138) (71)
Repayment of long-term debt - (1,004) - (3,061)
Transaction costs - - (118) -
Proceeds from issuance
of common shares 3 - 8 225
-------------------------------------------------------------------------
(63) (1,028) (248) (2,907)
-------------------------------------------------------------------------
Foreign exchange gain (loss)
on cash and cash equivalents
held in foreign currencies (176) (207) 448 (1,121)
Net decrease in cash and
cash equivalents
during the period (16,829) (815) (1,445) (4,653)
Cash and cash equivalents,
beginning of period 32,557 9,884 17,173 13,722
-------------------------------------------------------------------------
Cash and cash equivalents,
end of period 15,728 9,069 15,728 9,069
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Cash flows include the
following items:
Interest paid 632 328 1,777 1,107
Income taxes paid (received) 224 (430) 267 (902)
-------------------------------------------------------------------------
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SOURCE Labopharm Inc.
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