-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, K0EFp0/mj5abJaOMDow4tYWlHMo+sZOlttGVJfQO7Ttekh6nDLREnRE3C6Jrt7lX /SapKbLqOTypsORn6+T3eg== 0001104659-08-066967.txt : 20081030 0001104659-08-066967.hdr.sgml : 20081030 20081030161132 ACCESSION NUMBER: 0001104659-08-066967 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20081030 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20081030 DATE AS OF CHANGE: 20081030 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DEPOMED INC CENTRAL INDEX KEY: 0001005201 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943229046 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-13111 FILM NUMBER: 081151177 BUSINESS ADDRESS: STREET 1: 1360 O'BRIEN DRIVE CITY: MENLO PARK STATE: CA ZIP: 94025 BUSINESS PHONE: 6504625900 MAIL ADDRESS: STREET 1: 1360 O'BRIEN DRIVE CITY: MENLO PARK STATE: CA ZIP: 94025 8-K 1 a08-27257_18k.htm 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 8-K

 

Current Report

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported):  October 30, 2008

 

DEPOMED, INC.

(Exact name of registrant as specified in its charter)

 

001-13111

(Commission File Number)

 

California

 

94-3229046

(State or other jurisdiction of

 

(I.R.S. Employer Identification No.)

incorporation)

 

 

 

1360 O’Brien Drive, Menlo Park, California  94025

(Address of principal executive offices, with zip code)

 

(650) 462-5900

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

o            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



 

Item 2.02 Results of Operations and Financial Condition

 

On October 30, 2008, Depomed, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2008.  The press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.

 

Item 9.01 Financial Statements and Exhibits

 

(d)

 

Exhibits

 

 

 

 

 

 

 

99.1

 

Depomed, Inc. Press Release issued on October 30, 2008

 

2



 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

 

DEPOMED, INC.

 

 

 

 

 

 

 

 

Date: October 30, 2008

 

By:

/s/ Tammy L. Cameron

 

 

 

Tammy L. Cameron

 

 

 

Controller and Interim Principal Financial and
Accounting Officer

 

3



 

EXHIBIT INDEX

 

Exhibit

 

Description

99.1

 

Depomed, Inc. Press Release issued on October 30, 2008

 

4


 

EX-99.1 2 a08-27257_1ex99d1.htm EX-99.1

Exhibit 99.1

 

Contact:

 

Ina Cu

Investor Relations

650-462-5900

 

DEPOMED REPORTS THIRD QUARTER 2008 FINANCIAL RESULTS

 

MENLO PARK, Calif., Oct. 30, 2008 – Depomed, Inc. (NASDAQ: DEPO) today reported financial results for the third quarter ended September 30, 2008.

 

Depomed reported a net loss of $271,000, or $0.01 per share, for the third quarter of 2008 compared to net income of $44.3 million, or $0.92 per share, for the third quarter of 2007.  Net loss for the third quarter of 2008 included a one-time recognition of $6.3 million in product sales of GLUMETZA related to previously deferred revenue, which had the effect of reducing net loss by $5.3 million.  Net income for the 2007 third quarter was primarily attributable to the termination of the company’s license and supply agreements with Esprit Pharma for Proquin XR, which resulted in recognition of $46.1 million in license revenue, $2.5 million in royalty revenue, and a $5.0 million one-time termination gain.

 

Revenue for the three months ended September 30, 2008 was $14.1 million, and included a one-time recognition of $6.3 million in product sales of GLUMETZA related to previously deferred revenue, compared to $52.9 million for the three months ended September 30, 2007, which included a one-time recognition of $48.6 million in revenue associated with the termination of the company’s license and supply agreements with Esprit Pharma in July 2007.

 

Regarding the one-time recognition of $6.3 million in product sales of GLUMETZA related to previously deferred revenue, prior to the third quarter of 2008, the company was unable to reasonably estimate product returns of GLUMETZA at the time of shipment and deferred recognition of revenue on product shipments of GLUMETZA until the product was dispensed to the end user through patient prescriptions. After two years of selling GLUMETZA, the company determined it had the information needed during the third quarter of 2008 to reasonably estimate returns on product shipments and recognized previously deferred revenue, net of estimated returns, contractual allowances and discounts. Beginning in the third quarter and on a forward basis, the company will recognize revenue on product shipments of GLUMETZA when title transfers to the customer, providing for estimates of future product returns.

 

Operating expenses for the three months ended September 30, 2008 were $12.2 million compared to $8.2 million for the three months ended September 30, 2007.  Operating expenses for the three months ended September 30, 2007 included a one-time gain of $5.0 million related to the termination of the Esprit Pharma agreements, which had the effect of reducing operating expenses for that period.  Stock-based compensation expense for the third quarter of 2008 was $729,000.

 

Cash, cash equivalents and marketable securities were $85.5 million as of September 30, 2008 compared to $69.5 million as of December 31, 2007.

 

“In the third quarter, we fulfilled several of our key objectives for 2008 by commencing the Phase 3 program for DM-5689 in menopausal hot flashes (formerly referred to as Gabapentin GR®), signing a GLUMETZA promotion agreement with Santarus which generated $12 million in upfront fees, and by advancing our early-stage product pipeline through a grant from The Michael J. Fox Foundation to

 



 

develop DM-1992, a novel gastric retentive controlled-release dosage form of Levodopa/Carbidopa for the treatment of Parkinson’s Disease,” stated Carl A. Pelzel, president and chief executive officer of Depomed.

 

Third Quarter 2008 and Other Recent Highlights

 

·                  Began Breeze 1, the first of two randomized, double-blind, placebo-controlled, 540-patient trials in the Phase 3 registration program for DM-5689 for the treatment of menopausal hot flashes (September 2008).  The second Phase 3 trial, Breeze 2, started in October 2008.

 

·                  Granted Santarus exclusive rights to promote GLUMETZA in the United States.

 

·                  Awarded a preclinical grant by The Michael J. Fox Foundation for the development of DM-1992, novel gastric retentive controlled-release dosage forms of Levodopa/Carbidopa for the treatment of Parkinson’s Disease.

 

·                  Drew an additional $5.6 million in July 2008 under the credit facility with General Electric Credit Company and Oxford Finance Corporation.

 

Conference Call

 

Depomed will host a conference call and webcast to discuss second quarter 2008 financial results and other aspects of its business today, Thursday, October 30, at 5:00 p.m. ET.  The webcast can be accessed on the investor section of the Depomed website at www.depomedinc.com.

 

About Depomed

 

Depomed, Inc. is a specialty pharmaceutical company with two approved products on the market and other product candidates in its pipeline. The company utilizes its proven, proprietary AcuFormTM drug delivery technology to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract.  Benefits of AcuForm-enhanced pharmaceuticals include the convenience of once-daily administration, improved treatment tolerability and enhanced compliance and efficacy.  GLUMETZAÒ (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States.  ProquinÒ XR (ciprofloxacin hydrochloride) is approved in the United States for the once-daily treatment of uncomplicated urinary tract infections and is being marketed in the United States within the urology, Ob/Gyn and long-term care specialties by Watson Pharmaceuticals.  Product candidate DM-1796 (formerly referred to as Gabapentin GRÒ) is in Phase 3 clinical development for the treatment of neuropathic pain, and product candidate DM-5689 (formerly referred to as Gabapentin GRÒ) is in Phase 3 clinical development for menopausal hot flashes.  Additional information about Depomed may be found on its website, www.depomedinc.com.

 

 “Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995.  Statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. The inclusion of forward-looking statements, including those related to expectations regarding clinical programs, product development, and potential benefits of our products and product candidates, should not be regarded as a representation that any of our plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in our business, including, without limitation, risks and uncertainties related to: our research and development efforts, including pre-clinical and clinical testing; regulation by the FDA and other

 

2



 

government agencies; the timing of regulatory applications and product launches; our ability to successfully commercialize our products; the success of our collaborative arrangements with development and commercialization partners; and other risks detailed in our filings with the Securities and Exchange Commission filings, including our most recent Annual Report on Form 10-K and our most recent Quarterly Report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date hereof. We undertake no obligation to revise or update this release to reflect events or circumstances that occur after the date of this release.

 

-Financial Tables Follow-

 

3



 

DEPOMED, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 (in thousands, except share and per share amounts)

(Unaudited)

 

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

Revenues:

 

 

 

 

 

 

 

 

 

Product sales

 

$

13,011

 

$

3,832

 

$

23,756

 

$

7,666

 

Royalties

 

516

 

2,546

 

1,060

 

2,625

 

License revenue

 

584

 

46,481

 

1,311

 

50,003

 

Collaborative and other revenue

 

 

1

 

 

3

 

Total revenues

 

14,111

 

52,860

 

26,127

 

60,297

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of sales

 

2,396

 

724

 

4,567

 

1,598

 

Research and development

 

6,998

 

4,724

 

17,748

 

19,425

 

Selling, general and administrative

 

5,250

 

8,483

 

16,998

 

21,033

 

Gain on termination of Esprit Pharma agreement

 

 

(5,000

)

 

(5,000

)

Gain on litigation settlement

 

 

 

(7,500

)

 

Total costs and expenses

 

14,644

 

8,931

 

31,813

 

37,056

 

 

 

 

 

 

 

 

 

 

 

Income (loss) from operations

 

(533

)

43,929

 

(5,686

)

23,241

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest and other income

 

515

 

638

 

1,871

 

1,504

 

Interest expense

 

(249

)

 

(254

)

 

Total other income (expense)

 

266

 

638

 

1,617

 

1,504

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) before income taxes

 

(267

)

44,567

 

(4,069

)

24,745

 

 

 

 

 

 

 

 

 

 

 

Provision for income taxes

 

(4

)

(248

)

(4

)

(252

)

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

(271

)

44,319

 

(4,073

)

24,493

 

 

 

 

 

 

 

 

 

 

 

Deemed dividend on preferred stock

 

(183

)

(174

)

(538

)

(511

)

 

 

 

 

 

 

 

 

 

 

Net income (loss) applicable to common stock shareholders

 

$

(454

)

$

44,145

 

$

(4,611

)

$

23,982

 

 

 

 

 

 

 

 

 

 

 

Basic net income (loss) applicable to common stock shareholders per common share

 

$

(0.01

)

$

0.93

 

$

(0.10

)

$

0.53

 

Diluted net income (loss) applicable to common stock shareholders per common share

 

$

(0.01

)

$

0.92

 

$

(0.10

)

$

0.52

 

 

 

 

 

 

 

 

 

 

 

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

 

48,123,668

 

47,630,945

 

48,011,004

 

45,334,269

 

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

 

48,123,668

 

47,786,334

 

48,011,004

 

45,801,242

 

 

4



 

DEPOMED, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

 (in thousands, except share and per share amounts)

 

 

 

September 30,

 

December 31,

 

 

 

2008

 

2007

 

 

 

(Unaudited)

 

(1)

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

14,120

 

$

14,374

 

Marketable securities

 

71,332

 

39,091

 

Accounts receivable

 

3,612

 

3,390

 

Unbilled accounts receivable

 

510

 

233

 

Inventories

 

3,008

 

3,263

 

Prepaid and other current assets

 

3,111

 

2,418

 

Total current assets

 

95,693

 

62,769

 

Marketable securities

 

 

16,058

 

Property and equipment, net

 

1,116

 

1,621

 

Other assets

 

197

 

197

 

 

 

$

97,006

 

$

80,645

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

1,345

 

$

1,134

 

Accrued compensation

 

1,930

 

1,558

 

Accrued clinical trial expense

 

844

 

322

 

Other accrued liabilities

 

5,129

 

3,322

 

Deferred product sales

 

1,437

 

6,489

 

Deferred license revenue

 

2,529

 

1,453

 

Other current liabilities

 

302

 

56

 

Current portion of long-term debt

 

2,621

 

 

Total current liabilities

 

16,137

 

14,334

 

Deferred license revenue, non-current portion

 

30,376

 

20,763

 

Long-term debt, net of current portion

 

6,499

 

 

Other long-term liabilities

 

598

 

28

 

Commitments

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

Preferred stock, no par value, 5,000,000 shares authorized; Series A convertible preferred stock, 25,000 shares designated, 18,158 shares issued and outstanding at September 30, 2008 and December 31, 2007, with an aggregate liquidation preference of $18,159

 

12,015

 

12,015

 

Common stock, no par value, 100,000,000 shares authorized; 48,140,927 and 47,865,529 shares issued and outstanding at September 30, 2008 and December 31, 2007, respectively

 

170,527

 

168,287

 

Accumulated deficit

 

(138,965

)

(134,892

)

Accumulated other comprehensive gain (loss)

 

(181

)

110

 

Total shareholders’ equity

 

43,396

 

45,520

 

 

 

$

97,006

 

$

80,645

 

 


(1) Derived from the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2007.

 

5


-----END PRIVACY-ENHANCED MESSAGE-----