-----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, ATddy+jelg0LHZ9c5FlxU9tfoownvui9JybEDFDDrnCsqeGdLPpUlly4tt+GcIpb B0xf3W4EIbIUNMtoAHR+2A== 0001104659-07-019119.txt : 20070314 0001104659-07-019119.hdr.sgml : 20070314 20070314160551 ACCESSION NUMBER: 0001104659-07-019119 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070314 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070314 DATE AS OF CHANGE: 20070314 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: 07693755 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 a07-7961_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):  March 14, 2007

 

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 Operation and Financial Condition

On March 14, 2007, Depomed, Inc. issued a press release announcing its financial results for the year ended December 31, 2006.  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 March 14, 2007

 

 

 




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:   March 14, 2007

By:

/s/ John F. Hamilton

 

 

John F. Hamilton

 

 

Vice President, Finance and

 

 

Chief Financial Officer

 




 

EXHIBIT INDEX

 

 

Exhibit

 

Description of Document

 

 

 

 

 

99.1

 

Depomed, Inc. Press Release issued on March 14, 2007

 



EX-99.1 2 a07-7961_1ex99d1.htm EX-99.1

Exhibit 99.1

 

Contacts:

Mohamad Tabrizi

Depomed, Inc.

650-462-5900

DEPOMED REPORTS 2006 YEAR END FINANCIAL RESULTS

Conference Call and Webcast to Be Held Today at 5:00 p.m. ET

 MENLO PARK, Calif., March 14, 2007 — Depomed, Inc. (NASDAQ:DEPO) today announced its financial results for the year ended December 31, 2006.  For the full year, revenues totaled $9.6 million, compared to $4.4 million reported for the full year 2005.  Cash, cash equivalents and marketable securities at December 31, 2006 were $33.6 million.

Of the total revenue recognized in 2006, $1.3 million was in product sales revenue from the commercial supply of ProQuin® XR (ciprofloxacin hydrochloride) to Esprit Pharma and $3.9 million related to royalties on ProQuin sales.  In addition, $526,000 was in product sales of Glumetza™ (metformin hydrochloride extended release tablets) through King Pharmaceuticals and $109,000 was attributed to royalties on sales of Glumetza in Canada through Biovail Corporation.  Amortization of license fees previously received from partner companies, including Esprit, Biovail and LG Life Sciences, totaled $3.6 million for the full year 2006.  Revenue for the full year 2006 does not include $4.8 million in deferred Glumetza revenue on product shipments to customers.

“In 2006 we continued to make significant progress throughout the business, successfully adding to and advancing our product pipeline and establishing partnerships to help further grow our commercial presence and leverage our AcuForm™ drug delivery technology,” said John W. Fara, Ph.D., president, chief executive officer and chairman of Depomed. “Looking ahead, we remain committed to supporting efforts to increase product sales. We look forward to the completion of the Phase 3 clinical trial of Gabapentin GR™ in postherpetic neuralgia in the coming months and to the initiation of a Phase 2 clinical trial of Gabapentin GR in menopausal hot flashes in the second quarter.”

For the full year ended December 31, 2006, a net loss of $39.7 million or $0.97 per share was reported, compared to a net loss of $24.5 million, or $0.64 per share for the year ended December 31, 2005.

Research and development expenses for the year ended December 31, 2006 were $26.9 million compared to $18.4 million for the year ended December 31, 2005. The increase was primarily due to expenses related to clinical development of Gabapentin GR for the treatment of postherpetic neuralgia (PHN) and diabetic peripheral neuropathy (DPN).

 Recent Events and 2006 Highlights

·                  Filed Investigational New Drug application for Gabapentin GR for the treatment of menopausal hot flashes; Phase 2 trial expected to begin in the second quarter of 2007 (March 2007);

·                  Completed enrollment in Phase 3 clinical trial of Gabapentin GR for the treatment of PHN (March 2007);




·                  License agreement entered into with Biovail for use of AcuForm drug delivery technology for the development of up to two Biovail products (February 2007);

·                  Announced positive results from Phase 2 clinical trial of Gabapentin GR for DPN that demonstrate a statistically significant reduction in pain, compared to placebo (December 2006);

·                  Secured exclusive rights to gabapentin for the treatment of menopausal hot flashes (October 2006);

·                  Initiated U.S.-commercial launch of Glumetza by partner, King Pharmaceutical (September 2006);

·                  Completed Phase 1 clinical trial in gastroesophageal reflux disease (August 2006);

·                  Formed strategic collaboration agreement with Patheon, Inc., facilitating partnering of AcuForm technology (August 2006).

 

Depomed will host a conference call and webcast to discuss full year 2006 financial results today, Wednesday, March 14, 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, Inc.

Depomed, Inc. is a specialty pharmaceutical company utilizing its innovative AcuFormTM drug delivery technology to develop novel oral products and improved, extended release formulations of existing oral drugs. AcuForm-based products are designed to provide once- daily administration and reduced side effects, improving patient convenience, compliance and pharmacokinetic profiles. ProQuin® XR (ciprofloxacin hydrochloride) extended-release tablets have been approved by the FDA for the once-daily treatment of uncomplicated urinary tract infections and are currently being marketed in the United States. In addition, once-daily GlumetzaTM (metformin hydrochloride extended release tablets) has been approved for use in adults with type 2 diabetes and is currently being marketed in the United States and Canada. The company is currently evaluating Gabapentin GRTM for the treatment of two pain indications, postherpetic neuralgia and diabetic peripheral neuropathy, and menopausal hot flashes. Additional information about Depomed may be found at its web site, www.depomedinc.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 our clinical programs and related research and development efforts; ; expectations regarding commercialization of our products; our research and development efforts, including pre-clinical and clinical testing; regulation by the FDA and other government agencies; the timing of regulatory applications and product launches; and other risks detailed in the company’s Securities and Exchange Commission filings, including the company’s Annual Report on Form 10-K. You are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date hereof. The 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.

# # #




DEPOMED, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS

 

 

Year Ended December 31,

 

 

 

2006

 

2005

 

2004

 

Revenues:

 

 

 

 

 

 

 

Product sales

 

$

1,790,834

 

$

930,624

 

$

 

Royalties

 

4,039,948

 

668,789

 

 

License revenue

 

3,610,468

 

575,291

 

31,250

 

Collaborative revenue

 

109,968

 

2,230,625

 

171,319

 

Total revenues

 

9,551,218

 

4,405,329

 

202,569

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

Cost of sales

 

1,600,744

 

908,521

 

 

Research and development

 

26,891,139

 

18,369,217

 

21,358,802

 

Selling, general and administrative

 

22,666,797

 

11,639,118

 

5,178,539

 

 

 

 

 

 

 

 

 

Total costs and expenses

 

51,158,680

 

30,916,856

 

26,537,341

 

 

 

 

 

 

 

 

 

Loss from operations

 

(41,607,462

)

(26,511,527

)

(26,334,772

)

 

 

 

 

 

 

 

 

Other income (expenses):

 

 

 

 

 

 

 

Gain from extinguishment of debt

 

 

1,058,935

 

 

Interest and other income

 

2,030,674

 

1,445,057

 

489,013

 

Interest expense

 

 

(459,737

)

(928,878

)

Total other income (expenses)

 

2,030,674

 

2,044,255

 

(439,865

)

 

 

 

 

 

 

 

 

Net loss before income taxes

 

(39,576,788

)

(24,467,272

)

(26,774,637

)

 

 

 

 

 

 

 

 

Provision for income taxes

 

(82,500

)

 

(99,000

)

 

 

 

 

 

 

 

 

Net loss

 

(39,659,288

)

(24,467,272

)

(26,873,637

)

 

 

 

 

 

 

 

 

Deemed dividend on preferred stock

 

(665,258

)

(842,202

)

 

 

 

 

 

 

 

 

 

Net loss applicable to common stock shareholders

 

$

(40,324,546

)

$

(25,309,474

)

$

(26,873,637

)

 

 

 

 

 

 

 

 

Basic and diluted net loss applicable to common stock shareholders per share

 

$

(0.97

)

$

(0.64

)

$

(0.78

)

 

 

 

 

 

 

 

 

Shares used in computing basic and diluted net loss per share

 

41,517,661

 

39,821,182

 

34,628,825

 

 




DEPOMED, INC.
CONSOLIDATED BALANCE SHEETS

 

 

December 31,

 

 

 

2006

 

2005

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

14,574,110

 

$

7,565,556

 

Marketable securities

 

16,984,503

 

51,507,509

 

Accounts receivable

 

7,126,895

 

1,094,840

 

Unbilled accounts receivable

 

1,954,904

 

861,576

 

Inventories

 

4,483,157

 

901,348

 

Prepaid and other current assets

 

2,756,174

 

1,107,710

 

Total current assets

 

47,879,743

 

63,038,539

 

Marketable securities

 

1,998,760

 

 

Property and equipment, net

 

2,541,463

 

3,146,611

 

Other assets

 

197,218

 

228,926

 

 

 

$

52,617,184

 

$

66,414,076

 

LIABILITIES AND SHAREHOLDERS’ EQUITY (DEFICIT)

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

4,886,222

 

$

1,588,999

 

Accrued compensation

 

1,817,418

 

1,989,606

 

Accrued clinical trial expense

 

726,379

 

63,005

 

Accrued promotion fee expense

 

2,339,925

 

 

Other accrued liabilities

 

3,087,998

 

718,788

 

Deferred product sales

 

4,825,099

 

82,048

 

Deferred license revenue

 

4,599,947

 

3,572,196

 

Other current liabilities

 

55,845

 

93,073

 

Total current liabilities

 

22,338,833

 

8,107,715

 

Deferred license revenue, non-current portion

 

57,483,045

 

51,421,263

 

Other long-term liabilities

 

83,766

 

124,099

 

Commitments

 

 

 

 

 

Shareholders’ equity (deficit):

 

 

 

 

 

Preferred stock, no par value, 5,000,000 shares authorized; Series A convertible preferred stock, 25,000 shares designated, 18,159 and 17,543 shares issued and outstanding at December 31, 2006 and 2005, respectively, with an aggregate liquidation preference of $18,158,848

 

12,015,000

 

12,015,000

 

Common stock, no par value, 100,000,000 shares authorized; 42,029,411 and 40,689,369 shares issued and outstanding at December 31, 2006 and 2005, respectively

 

144,820,534

 

139,640,599

 

Deferred compensation

 

 

(337,049

)

Accumulated deficit

 

(184,111,185

)

(144,451,897

)

Accumulated other comprehensive (loss)

 

(12,809

)

(105,654

)

Total shareholders’ equity (deficit)

 

(27,288,460

)

6,760,999

 

 

 

$

52,617,184

 

$

66,414,076

 

 



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