EX-99 2 ex991.htm ex991.htm

Exhibit 99.1

 
 
Press Release
 
 
 
FOR IMMEDIATE RELEASE

LABOPHARM REPORTS RESULTS FOR

FOURTH QUARTER AND FISCAL YEAR 2009

 

– Company Preparing for Q3 2010 U.S. Launch of OLEPTRO™ –

 

LAVAL, Quebec (February 25, 2010) – Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today reported its financial results for the fourth quarter and fiscal year ended December 31, 2009.  All figures are in Canadian dollars unless otherwise stated.

 

“On February 2, Labopharm realized an important milestone – the FDA’s approval of our once-daily antidepressant, OLEPTRO™, for the U.S. market ,” said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. 

 

Labopharm expects to launch OLEPTRO™ in the third quarter of 2010.  The Company is focused on securing a marketing partnership that would allow Labopharm to participate in OLEPTRO™’s marketing and sales effort.   Labopharm’s recently completed equity offering allows the Company to continue to prepare for the commercial launch of OLEPTRO™ in parallel with its partnering discussions.

 

“We have invested a considerable amount of time and effort to understand our physician, patient and payor audiences, are in the process of finalizing a commercial strategy, including positioning, market access and distribution, and are pleased with the preliminary indications regarding our payor status,” added Mr. Howard-Tripp.

 

Financial Summary

 

Revenue from sales of the Company’s once-daily tramadol product for the fourth quarter of fiscal 2009 increased to $4.7 million from $3.3 million for the fourth quarter of fiscal 2008 and was composed of product sales outside of the U.S. of $4.5 million and product sales in the U.S. of $0.2 million.  Total revenue for the fourth quarter of fiscal 2009 was $6.7 million compared with $4.4 million for the fourth quarter of fiscal 2008. 

 

Gross margin for sales outside of the U.S. for the fourth quarter of fiscal 2009 was 55% compared with 56% for the fourth quarter of fiscal 2008.  Research and development expenses, net of research and development tax credits, for the fourth quarter of fiscal 2009 were $2.6 million compared with $5.2 million for the fourth quarter of fiscal 2008.  Selling, general and administrative expenses for the fourth quarter of fiscal 2009 were $5.2 million compared with

 

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$10.6 million for the fourth quarter of fiscal 2008 and included an accrual of $1.2 million in 2009 compared to $4.8 million in 2008, for the Company’s share of litigation costs for patent enforcement related to its once-daily tramadol product in the U.S.  Net loss for the fourth quarter of fiscal 2009 was $6.4 million, or $0.11 per share, compared with $14.6 million, or $0.26 per share, for the fourth quarter of fiscal 2008.

 

Other Key Developments

 

OLEPTRO™ (Antidepressant)

 

Awaiting Canadian Regulatory Approval – Labopharm’s New Drug Submission for OLEPTRO™ is currently under regulatory review in Canada with an anticipated action date of August 4, 2010. 

 

Twice-Daily Tramadol-Acetaminophen Formulation

 

Initiated Regulatory Approval Process in Europe – Labopharm initiated the regulatory approval process for its twice-daily tramadol-acetaminophen formulation for a number of European countries under the Decentralized Procedure (DCP), which provides an efficient mechanism that allows a company to simultaneously pursue regulatory approval for a medicinal product in multiple jurisdictions in Europe.  The countries for which the DCP has been initiated represent more than 25% of the European market for tramadol-acetaminophen products.

 

Once-Daily Tramadol

 

Global In-Market Sales Continue to Grow – In-market sales (in U.S. dollars) of Labopharm’s product (that is, sales of Labopharm’s product by its licensing and distribution partners to end users) for the 12-months ended September 30, 2009 grew by 63% compared to the comparable period of 2008.

 

Tridural is Canada’s Best-Selling Once-Daily Tramadol Product for 2009 – Labopharm’s product (marketed under the brand name Tridural™ in Canada) was the best-selling once-daily tramadol product in Canada for 2009.

 

Abuse-Misuse-Deterrent Platform

 

Initiated Clinical Development Program – Labopharm initiated the clinical program for its first product, an abuse- and misuse-deterrent formulation of a widely prescribed combination opioid pain product.

 

Financial Results

 

Three-Month Period Ended December 31, 2009

 

Revenue from product sales in all territories for the fourth quarter of fiscal 2009 increased to $4.7 million from $3.3 million for the fourth quarter of fiscal 2008.  Revenue from product sales to territories other than the U.S. was $4.5 million compared with $3.3 million for the fourth quarter of fiscal 2008.  The increase was the result of both higher sales volumes and a higher average selling price in the fourth quarter of 2009.  Total revenue for the fourth quarter of fiscal 2009 was $6.7 million compared with $4.4 million for the fourth quarter of fiscal 2008.

 

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Under its licensing and distribution agreement with Purdue Pharma Products L.P. for RYZOLT™ in the United States, Labopharm is currently entitled to royalty payments of 20% of Purdue's net sales of the product. Royalty revenue recorded on sales of RYZOLT™ in the U.S., which is recognized for accounting purposes upon dispensing of the product to the patient based on third-party prescription data (the “sell-through” method), was $0.6 million for the fourth quarter of 2009.

 

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 fourth quarter of fiscal 2009 was 55% compared with 56% for the fourth quarter of fiscal 2008.

 

Licensing revenue for the fourth 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 its once-daily tramadol product and twice-daily tramadol-acetaminophen formulation.  Licensing revenue for the fourth quarter of fiscal 2008 was $1.2 million.

 

Research and development expenses, before research and development tax credits, for the fourth quarter of fiscal 2009 were $3.0 million compared with $4.2 million for the fourth quarter of fiscal 2008.  The decrease was primarily the result of lower clinical trial costs in the fourth quarter of fiscal 2009.  Research and development tax credits for the fourth quarter of fiscal 2009 were $0.4 million compared with negative $1.0 million in the fourth quarter of 2008.  Negative R&D tax credits for the fourth quarter of 2008 were the result of a reversal due to a change in tax planning strategy in 2008. 

 

Selling, general and administrative expenses for the fourth quarter of fiscal 2009 were $5.2 million compared with $10.6 million for the fourth quarter of fiscal 2008.  The decrease is primarily the result of lower accruals for the Company's share of litigation costs incurred by Purdue to enforce certain of Purdue's U.S. patents related to Labopharm's once-daily tramadol product, which were $1.2 million for the fourth quarter of 2009 compared with $4.8 million for the fourth quarter of 2008.  The Company also incurred a $0.9 million restructuring charge during the fourth quarter of 2009 as a result of the reduction in workforce announced in November 2009.

 

Net loss for the fourth quarter of fiscal 2009 was $6.4 million, or $0.11 per share, compared with $14.6 million, or $0.26 per share, for the fourth quarter of fiscal 2008.

 

Cash, cash equivalents and marketable securities as at December 31, 2009 were $24.5 million compared with $23.8 million as at September 30, 2009.  During the fourth quarter of fiscal 2009, the Company received a 4.0 million Euros (CAD$6.2 million) payment under its distribution and supply agreement with Gr ü nenthal GmbH.  Subsequent to quarter end, the Company completed a draw down under its standby equity distribution agreement ( SEDA) and an underwritten public offering of units that, combined, generated net proceeds of approximately US$21.9 million (CAD$22.9 million).

 

Twelve-Month Period Ended December 31, 2009

 

Revenue for fiscal 2009 was $24.6 million compared with $22.0 million for fiscal 2008.  Revenue from product sales in all territories for fiscal 2009 increased to $18.5 million from $13.2 million for fiscal 2008.  Revenue from product sales to territories other than the U.S. increased to $15.8

 

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million from $13.2 for fiscal 2008.  The increase in product sales to territories other than the U.S. is primarily the result of a higher average selling price per tablet in 2009 due to more favourable country and product dosage strength mixes.  Product sales to the U.S. were $2.7 million.  Royalty revenue recorded on U.S. sales was $1.0 million.

 

Gross margin (as a percentage of revenue from product sales) for territories outside the U.S. for fiscal 2009 was 62% compared with 56% for fiscal 2008.  The increase is primarily the result of higher average selling prices per tablet during fiscal 2009.

 

Licensing revenue for fiscal 2009 was $4.9 million and represented a portion of licensing payments received from the Company’s licensing and distribution partners for its once-daily tramadol product and twice-daily tramadol-acetaminophen formulation.  Licensing revenue for fiscal 2008 was $8.9 million, including the non-recurring licensing revenue of $4.4 million related to the Company’s reacquisition of the rights to its once-daily tramadol product for the United Kingdom.

 

Net loss for fiscal 2009 was $26.1 million, or $0.46 per share, compared with $40.6 million, or $0.72 per share, for fiscal 2008.  The decrease in net loss is primarily the result of lower research and development costs, a higher foreign exchange gain and the absence of an impairment loss, which were partially offset by lower interest income, higher financial expenses and the restructuring charge incurred in fiscal 2009.

 

Conference Call

 

Labopharm will host a conference call today (Thursday, February 25, 2010) at 8:30 a.m. ET to discuss its 2009 fourth quarter and year end results. To access the conference call by telephone, dial 647-427-7450 or 1-888-231-8191 .  Please connect approximately five minutes prior to the beginning of the call to ensure participation.  The conference call will be archived for replay until midnight on Thursday, March 4, 2010.  To access the archived conference call, dial 416-849-0833 or 1-800-642-1687 and enter the reservation number 54748406 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.

 

Headquartered in Laval, Canada with US offices in Princeton, New Jersey, 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., Canada, major European markets and Australia. Its second product, OLEPTRO™, a novel formulation of trazodone for the treatment of major depressive disorder in adults, has received regulatory approval in the U.S. and is under regulatory review in Canada. Labopharm has initiated the European regulatory approval process for its third product, a twice-daily formulation of tramadol-acetaminophen. The Company also has a 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.

 

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This press release contains forward-looking statements, including statements concerning the market opportunity for OLEPTRO™, statements concerning partnering discussions and commercialization plan for OLEPTRO™, and statements concerning the Company’s pipeline of product candidates, which reflect the Company's current expectations regarding future events. These forward-looking statements involve risks and uncertainties, many of which are beyond the Company’s control. Actual events could differ materially from those projected herein and depend on a number of risks and uncertainties, including risks related to the Company’s ability to complete a partnering transaction and the terms of any such collaboration, if any, risks related to the market acceptance of the Company’s products and the speed of adoption by clinicians, risks related to intellectual property protection and potential infringement of third-party rights, risks related to research and development of pharmaceutical products and regulatory approvals, and risks associated with intense competition in the pharmaceutical industry generally. For additional disclosure regarding these and other risks faced by Labopharm Inc., see the disclosure contained in its public filings in the U.S. with the Securities and Exchange Commission (SEC) and in Canada with the Canadian Securities Administrators (CSA), available on the Investor Relations section of the Company’s website at www.labopharm.com and on the SEC's website at www.sec.gov and on the CSA’s website at www.sedar.com. Investors are cautioned not to place undue reliance on these forward-looking statements.  Unless required by law, the Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events, or circumstances or otherwise.

 

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RYZOLT™ is a trademark of Purdue Pharma Products L.P.

 

OLEPTRO™ is a trademark of Labopharm Inc.

 

CONTRAMID® is a registered trademark of Labopharm Inc.

 

For more information, please contact:

 

At Labopharm Inc.

Mark D’Souza

Senior Vice-President and Chief Financial Officer

Tel: (450) 686-0207

At The Equicom Group

Lawrence Chamberlain

Media and Investor Relations

Tel:  (416) 815-0700 ext. 257

lchamberlain@equicomgroup.com

 

French:

Joe Racanelli

Tel:  (514) 844-7997

jracanelli@equicomgroup.com

 

 

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Labopharm Inc.

CONSOLIDATED BALANCE SHEETS

[Thousands of Canadian dollars]

 

 

 

As at December 31,

2009


$

2008
[Restated]

$

 

 

 

ASSETS

 

 

Current

 

 

Cash and cash equivalents

23,650

8,373

Marketable securities

854

36,520

Accounts receivable

4,736

3,277

Research and development tax credits receivable

2,584

1,274

Income taxes receivable

223

474

Inventories

2,637

1,760

Prepaid expenses and other assets

701

641

Total current assets

35,385

52,319

 

Restricted long-term investments

133

141

Long-term investment

2,885

3,178

Property, plant and equipment

8,575

9,741

Intangible assets

2,018

2,263

Future income tax assets

124

145

 

49,120

67,787

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY (DEFICIENCY)

 

 

Current

 

 

Accounts payable and accrued liabilities

18,124

13,134

Current portion of deferred revenue

2,938

4,768

Current portion of obligations under capital leases

309

271

Current portion of long-term debt

3,558

3,378

Total current liabilities

24,929

21,551

 

Deferred revenue

14,364

9,094

Obligations under capital leases

5,033

5,342

Long-term debt

18,939

20,265

Total liabilities

63,265

56,252

 

 

 

Shareholders’ equity (deficiency)

 

 

Capital stock

 

 

Common shares, no par value, unlimited authorized shares, 57,456,364 and 56,826,063 issued as at December 31, 2009 and 2008, respectively

242,316

241,967

Warrants

937

751

Contributed surplus

16,385

14,937

Deficit

(273,625)

(247,515)

Accumulated other comprehensive income (loss)

(158)

1,395

Total shareholders’ equity (deficiency)

(14,145)

11,535

 

49,120

67,787


 

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CONSOLIDATED STATEMENTS OF OPERATIONS

[Thousands of Canadian dollars, except share and per share amounts]

 

For periods of :

Three months ended:

Twelve months ended:

 

Dec. 31, 2009

Dec. 31, 2008
[Restated]

Dec. 31, 2009

 

Dec. 31, 2008
[Restated]

 

$

$

$

$

 

 

 

 

 

REVENUE

 

 

 

 

Product sales

4,664

3,278

18,480

13,158

Licensing

1,238

1,155

4,902

8,856

Royalties

637

962

Research and development collaborations

182

228

 

6,721

4,433

24,572

22,014

 

 

 

   

EXPENSES

 

 

   

Cost of goods sold (excluding amortization)

2,194

1,429

8,345

5,818

Research and development expenses, net

2,606

5,187

12,703

23,451

Selling, general and administrative expenses

5,241

10,604

26,274

26,683

Financial expenses

1,286

980

4,296

3,133

Impairment loss on long-term investment

200

1,291

Amortization of property, plant and equipment and intangible assets

 

464

 

499

 

1,822

 

1,975

Interest income

(39)

(320)

(417)

(1,874)

Foreign exchange loss (gain)

440

2,039

(3,239)

2,235

Restructuring costs

897

897

 

13,089

20,618

50,681

62,712

Loss before income taxes

(6,368)

(16,185)

(26,109)

(40,698)

Income tax expense (recovery)

(10)

(1,559)

1

(59)

Net loss for the period

(6,358)

(14,626)

(26,110)

(40,639)

 

       

Net loss per share – basic and diluted

(0,11)

(0,26)

(0,46)

(0,72)

 

 

 

   

Weighted average number of
common shares outstanding

57,428,695

56,826,063

57,123,105

56,822,506

 

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CONSOLIDATED STATEMENTS OF CASH FLOWS

[Thousands of Canadian dollars]

 

 

 

For periods of :

Three months ended:

Twelve months ended:

 

Dec. 31, 2009

Dec. 31, 2008
[Restated]

Dec. 31, 2009

 

Dec. 31, 2008
[Restated]

 

$

$

$

$

 

 

 

 

 

OPERATING ACTIVITIES

 

 

 

 

Net loss for the period

(6,358)

(14,626)

(26,110)

(40,639)

Items not affecting cash :

 

 

 

 

Amortization of property, plant and equipment

265

260

1,494

1,646

Amortization of intangible assets

199

239

328

329

Amortization of premiums and discounts

   on marketable securities


20


20


110


53

Loss on sale of property, plant and equipment

65

Impairment loss on long-term investment

200

1,291

Non-cash financial expenses

211

135

707

423

Unrealized foreign exchange (gain) loss

(636)

1,683

(2,648)

2,069

Stock-based compensation

140

433

1,479

2,414

 

(6,159)

(11,656)

(24,575)

(32,414)

Net change in other operating items

6,771

4,198

5,937

(1,708)

 

612

(7,458)

(18,638)

(34,122)

 

 

 

 

 

INVESTING ACTIVITIES

 

 

 

 

Acquisition of marketable securities

(9,728)

(8,466)

(50,243)

Proceeds from disposals of marketable securities

3,234

9,420

3,234

Proceeds from maturities of marketable securities

9,034

32,639

67,019

Acquisition of restricted long-term investment

(45)

Acquisition of property, plant and equipment

(15)

(34)

(334)

(1,300)

Acquisition of intangible assets

(26)

(333)

(83)

(507)

 

8,993

(6,861)

33,176

18,158

 

 

 

 

 

FINANCING ACTIVITIES

 

 

 

 

Repayment of obligations under capital leases

(72)

(65)

(271)

(203)

Proceeds from issuance of common shares

20

547

8

Payment of issuance costs of common shares

(83)

(118)

Proceeds from issuance of long-term debt

5,647

2,549

5,647

Proceeds from issuance of warrants

190

190

Financing costs incurred

(362)

(118)

 

(135)

5,772

2,345

5,524

 

   

 

 

Foreign exchange gain (loss) on cash held in

   foreign currencies

(348)

1,192

(1,606)

1,640

Net increase (decrease) in cash and cash
   equivalents during the period

9,122

(7,355)

15,277

(8,800)

Cash and cash equivalents, beginning of period

14,528

15,728

8,373

17,173

Cash and cash equivalents, end of period

23,650

8,373

23,650

8,373

 

Supplemental cash flow information:

 

 

   

Interest paid

764

696

3,281

2,473

Income taxes paid (received)

16

(200)

267

 

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