Attached files

file filename
8-K - 8-K - Assertio Therapeutics, Inca12-24336_28k.htm

Exhibit 99.1

 

Depomed Reports Third Quarter Financial Results

 

Conference Call Scheduled for today at 5:00PM EST

Updated dial in information included below

 

MENLO PARK, California, November 5, 2012 Depomed, Inc. (Nasdaq:DEPO) today reported financial results for the quarter and nine months ended September 30, 2012.

 

2012 Third Quarter and Recent Business Highlights

 

·                  Financial Highlights:

·                  Revenue of $33.3 million for the third quarter and $64.2 million for the nine months ended September 30

·                  Net loss of ($1.5) million or ($0.03) per share for the third quarter and ($26.1) million or ($0.47) per share for the nine months ended September 30

·                  $87.7 million of cash and marketable securities and no debt

·                  Gralise® (gabapentin) Highlights:

·                  Gralise product sales of $4.8 million for the third quarter

·                  Gralise prescription demand now over 3,500 per week

·                  Approximately 8,500 physicians have prescribed Gralise since launch

·                  Zipsor® (diclofenac potassium) Highlights:

·                  Zipsor product sales of $4.9 million for the third quarter

·                  Depomed promotion commenced end of July 2012

·                  Glumetza® (metformin hydrochloride extended release tablets) Highlights:

·                  Royalty of $11.6 million on third quarter Glumetza sales

·                  Technology and R&D Highlights:

·                  License agreement with Janssen Pharmaceuticals for Nucynta ER; $10 million upfront payment received in September; royalties started July 2, 2012 and continue through 2021

·                  Serada NDA accepted by FDA; Advisory Committee meeting tentatively scheduled for March 4, 2013; PDUFA date of May 31, 2013

 

“During the third quarter, Gralise prescriptions continued to grow, we relaunched Zipsor, Glumetza royalties for the quarter exceeded $11 million, we expanded our portfolio of license and development agreements with our license to Janssen for Nucynta ER and received a $10 million upfront payment. In October, the FDA

 

1



 

accepted our NDA for Serada and set a tentative date for an Advisory Committee. We believe that we are well on our way toward transforming Depomed into a sustainably profitable specialty pharmaceutical company.  We are developing a pain franchise with our two marketed products, Gralise and Zipsor.  We have a Glumetza royalty stream that should exceed $40 million for 2012, a broad base of six license and development agreements that should provide us significant milestones and royalties over the next several years, a pipeline of product candidates and a strong balance sheet,” said Jim Schoeneck, president and chief executive officer of Depomed.

 

Depomed Third Quarter Financial Highlights

 

Total revenue for the third quarter of 2012 was $33.3 million, consisting of $4.8 million of Gralise product sales, $4.9 million of Zipsor product sales, $12.2 million of royalties and $11.4 million of license and other revenue. License and other revenue includes recognition of the $10 million upfront payment received from Janssen under the license agreement for Nucynta ER.

 

This compares to revenues of $16.5 million in the third quarter of 2011. Third quarter 2011 revenues included $9.2 million of Glumetza product sales.  Revenues for third quarter 2012 do not reflect any Glumetza product sales as a result of the restructuring of the Santarus agreement in August 2011.  Prior to the restructuring of the agreement, Depomed recognized revenues and cost of goods from Glumetza sales and paid Santarus a promotion fee that was included in expenses.

 

Operating expenses were $33.1 million for the third quarter of 2012.  This compares with $24.7 million for third quarter 2011. Operating expenses increased primarily due to sales and marketing expenses associated with Gralise, which was launched in October 2011, and Zipsor which was acquired in June 2012. Operating expenses for the third quarter of 2012 also include $1.0 million of intangible amortization associated with the Zipsor acquisition and one-time research and development expenses of $1.8 million for the NDA filing fee for Serada and $0.6 million for the payment of a license milestone to a licensor of one of the Serada patents. Operating expenses for third quarter 2012 did not reflect any promotion fee expense, compared with $6.0 million in promotion fee expense for third quarter 2011.

 

Net loss for third quarter 2012 was ($1.5) million, or ($0.03) per share, compared to net loss of ($8.6) million, or ($0.15) per share for third quarter 2011.

 

2



 

Cash, cash equivalents and marketable securities were $87.7 million as of September 30, 2012 compared to $139.8 million as of December 31, 2011.

 

Conference Call

 

Depomed will host a conference call today, Monday November 5, beginning at 5:00 p.m. EST (2:00 p.m. PST) to discuss its results. Participants can access the call by dialing 877-317-6789 (United States) or 412-317-6789 (international). The conference call will also be available via a live webcast on the investor relations section of Depomed’s website at http://www.depomed.com. Access the website 15 minutes prior to the start of the call to download and install any necessary audio software. An archived webcast replay will be available on the Company’s website for three months.

 

About Depomed

 

Depomed, Inc. is a specialty pharmaceutical company with three approved and marketed products. Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN).  Zipsor ® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug (NSAID) indicated for relief of mild to moderate acute pain in adults.   Glumetza® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is commercialized by Santarus, Inc. in the United States. Depomed formulates its products and product candidates with its proven, proprietary Acuform® drug delivery technology, which is designed to improve existing oral medications, allowing for extended release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, www.depomed.com.

 

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to the commercial launch of Gralise, our ability to sell Zipsor; the efforts of our collaboration partners to commercialize products; and other risks detailed in the company’s Securities and Exchange Commission filings, including the company’s Annual Report on Form 10-K for the year ended December 31, 2011 and the Quarterly Reports on Form 10-Q for the quarters ended March 31 and June 30, 2012. The inclusion of forward-looking statements should not be regarded as a representation that any of the company’s plans or objectives will be achieved. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The

 

3



 

company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

 

CONTACT:
August J. Moretti
Depomed, Inc.
650-462-5900
amoretti@depomed.com

 

4



 

DEPOMED, INC.

CONDENSED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

(Unaudited)

 

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

 

2012

 

2011

 

2012

 

2011

 

Revenues:

 

 

 

 

 

 

 

 

 

Product sales

 

$

9,684

 

$

9,205

 

$

14,994

 

$

40,669

 

Royalties

 

12,201

 

2,179

 

31,199

 

2,412

 

License and other revenue

 

11,397

 

5,138

 

18,033

 

77,760

 

Total revenues

 

33,282

 

16,522

 

64,226

 

120,841

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of sales

 

1,763

 

1,150

 

3,723

 

4,925

 

Research and development expense

 

5,270

 

3,208

 

12,277

 

12,405

 

Selling, general and administrative expense:

 

 

 

 

 

 

 

 

 

Promotion fee expense

 

 

6,023

 

 

27,339

 

Other selling, general and administrative expense

 

26,832

 

15,451

 

73,625

 

32,667

 

Total selling, general and administrative expense

 

26,832

 

21,474

 

73,625

 

60,006

 

Gain on settlement agreement

 

 

 

 

(40,000

)

Amortization of intangible asset

 

958

 

 

1,063

 

 

Total costs and expenses

 

34,823

 

25,832

 

90,688

 

37,336

 

 

 

 

 

 

 

 

 

 

 

Income (loss) from operations

 

(1,541

)

(9,310

)

(26,462

)

83,505

 

Other income (expense)

 

57

 

386

 

405

 

713

 

Benefit from (provision for) income taxes

 

(11

)

348

 

(20

)

345

 

Net income (loss)

 

$

(1,495

)

$

(8,576

)

$

(26,077

)

$

84,563

 

 

 

 

 

 

 

 

 

 

 

Basic net income (loss) per common share

 

$

(0.03

)

$

(0.15

)

$

(0.47

)

$

1.56

 

Diluted net income (loss) per common share

 

$

(0.03

)

$

(0.15

)

$

(0.47

)

$

1.51

 

 

 

 

 

 

 

 

 

 

 

Shares used in computing basic net income (loss) per common share

 

56,039,186

 

55,371,954

 

55,794,357

 

54,267,829

 

Shares used in computing diluted net income (loss) per common share

 

56,039,186

 

55,371,954

 

55,794,357

 

56,071,870

 

 

5



 

DEPOMED, INC.

CONDENSED BALANCE SHEETS

(in thousands, except share amounts)

 

 

 

September 30,

 

December 31,

 

 

 

2012

 

2011

 

 

 

(Unaudited)

 

(1)

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

27,372

 

$

24,043

 

Marketable securities

 

52,537

 

62,106

 

Accounts receivable

 

4,848

 

4,420

 

Receivables from collaborative partners

 

10,054

 

8,135

 

Inventories

 

7,795

 

5,395

 

Prepaid and other current assets

 

2,748

 

5,390

 

Total current assets

 

105,354

 

109,489

 

Marketable securities, long-term

 

7,749

 

53,644

 

Property and equipment, net

 

5,250

 

1,070

 

Intangible assets, net

 

26,037

 

 

Other assets

 

526

 

169

 

 

 

$

144,916

 

$

164,372

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued liabilities

 

$

32,240

 

$

26,784

 

Deferred product sales

 

4,535

 

6,960

 

Deferred license revenue

 

5,781

 

6,032

 

Other current liabilities

 

332

 

64

 

Total current liabilities

 

42,888

 

39,840

 

Deferred license revenue, non-current portion

 

13,770

 

17,932

 

Other long-term liabilities

 

2,610

 

682

 

Shareholders’ equity:

 

 

 

 

 

Common stock

 

209,217

 

203,511

 

Accumulated deficit

 

(123,657

)

(97,580

)

Accumulated other comprehensive gain (loss)

 

88

 

(13

)

Total shareholders’ equity

 

85,648

 

105,918

 

 

 

$

144,916

 

$

164,372

 

 


(1) Derived from the audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2011.

 

6