0001104659-15-036804.txt : 20150511 0001104659-15-036804.hdr.sgml : 20150511 20150511160542 ACCESSION NUMBER: 0001104659-15-036804 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20150511 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20150511 DATE AS OF CHANGE: 20150511 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: 15850681 BUSINESS ADDRESS: STREET 1: 7999 GATEWAY BLVD. STREET 2: SUITE 300 CITY: NEWARK STATE: CA ZIP: 94560 BUSINESS PHONE: 510-744-8000 MAIL ADDRESS: STREET 1: 7999 GATEWAY BLVD. STREET 2: SUITE 300 CITY: NEWARK STATE: CA ZIP: 94560 8-K 1 a15-11160_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):  May 11, 2015

 

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)

 

 

 

7999 Gateway Blvd, Suite 300, Newark, California 94560

(Address of principal executive offices, with zip code)

 

(510) 744-8000

 (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 May 11, 2015, Depomed, Inc. issued a press release announcing its financial results for the first quarter and fiscal year ended March 31, 2015.  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 May 11, 2015

 

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: May 11, 2015

By:

/s/ August J. Moretti

 

 

August J. Moretti

 

 

Chief Financial Officer

 

3



 

EXHIBIT INDEX

 

Exhibit

 

Description

99.1

 

Depomed, Inc. Press Release issued on May 11, 2015

 

4


EX-99.1 2 a15-11160_1ex99d1.htm EX-99.1

Exhibit 99.1

 

Depomed Reports First Quarter 2015 Financial Results

 

·                  First quarter 2015 product sales of $31.7 million, up 47% compared to the first quarter of 2014

·                  Completed $1.05 billion NUCYNTA® acquisition on April 2

·                  Updated 2015 product sales outlook of $310 to $335 million, nearly triple 2014 product sales

·                  Conference call scheduled for today at 4:30 PM EDT; Dial in information below

 

NEWARK, Calif., May 11, 2015 — Depomed, Inc. (Nasdaq: DEPO) today reported financial results and highlighted operational achievements for the quarter ended March 31, 2015.

 

“Depomed is in a period of tremendous growth, on track to become one of the top five companies selling branded pain pharmaceuticals in the US by 2016,” said Jim Schoeneck, President and CEO of Depomed. “The products we have acquired over the past three years continue to perform exceptionally well.  Gralise, Cambia and Lazanda delivered strong revenue and prescription growth in first quarter. Our experience integrating and growing products will be focused on the relaunch of NUCYNTA in June. With NUCYNTA, we are now expecting 2015 total product sales of $310-$335 million, which is nearly triple our 2014 product sales and over five times 2013 product sales.”

 

Business and Financial Highlights

 

·                  Quarterly product sales for the first quarter of 2015 were $31.7 million, an increase of 47% compared to $21.5 million for first quarter of 2014

·                  Completed the acquisition of U.S. rights to the NUCYNTA® franchise from Janssen Pharmaceuticals on April 2

·                  $575 million loan committed in March enabled the rapid close of NUCYNTA transaction:

·                  Avoided dilution to shareholders

·                  Enhanced sales force recruitment and relaunch preparation

·                  Provides financial flexibility to pursue additional acquisitions

·                  Quarterly net loss of ($11.6 million) or ($0.20) per share

·                  Quarterly non-GAAP adjusted loss of ($8.0 million) or ($0.13) per share; includes investment of approximately $5 million in the Nucynta deal and one time relaunch expenses during first quarter

·                  In April, Depomed settled Gralise® ANDA litigation with Actavis, confirming exclusivity to 2024; all ANDA litigation related to Gralise is now resolved

 

Product Highlights

 

NUCYNTA® and NUCYNTA® ER (tapentadol)

 

·                  Depomed began fulfilling orders and shipping April 6

·                  Quintiles, the contract sales organization that promoted the NUCYNTA franchise for Janssen, continues to support these products for Depomed until relaunch in June

·                  Recruitment  of Depomed’s expanded sales force on target for relaunch in June

 



 

Gralise® (gabapentin):

 

·                  First quarter 2015 net sales were $17.3 million, up 59% compared to $10.9 million in  first quarter 2014

·                  First quarter 2015 total prescriptions were 77k, up 18% compared to first quarter 2014

·                  ANDA litigation settlement reached with Actavis confirms Gralise market exclusivity to 2024 resolving all existing ANDA litigation

 

Cambia® (diclofenac potassium for oral solution):

 

·                  First quarter 2015 net sales were $5.4 million, up 16% compared to $4.6 million in first quarter 2014

·                  First quarter 2015 total prescriptions were over 30,000, up 34% compared to first quarter 2014 when Depomed relaunched the product

·                  American Headache Society assessment released in January upgraded Cambia to first line therapy for acute migraine treatment

 

Lazanda® (fentanyl) Nasal Spray:

 

·                  First quarter 2015 net sales of $3.2 million, up 369% compared to $680,000 in first quarter 2014

·                  Total quarterly sprays exceeded 100,000 for the first time during  first quarter 2015, up 44% from fourth quarter 2014

 

Zipsor® (diclofenac potassium):

 

·                  First quarter 2015 net sales of $5.8 million, up 9% compared to $5.3 million in first quarter 2014

 

Revenue Summary

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2015

 

2014

 

 

 

(in thousands, unaudited)

 

Product sales:

 

 

 

 

 

Gralise

 

$

17,274

 

$

10,860

 

CAMBIA

 

5,365

 

4,623

 

Lazanda

 

3,186

 

680

 

Zipsor

 

5,845

 

5,343

 

Total product sales

 

31,670

 

21,506

 

 

 

 

 

 

 

Royalties

 

$

533

 

$

494

 

 

 

 

 

 

 

License and other revenue:

 

 

 

 

 

Mallinckrodt

 

$

 

$

10,000

 

Other

 

 

1,760

 

Total license and other revenue

 

 

11,760

 

 

 

 

 

 

 

Non-cash PDL royalty revenue

 

$

 

$

42,784

 

 

 

 

 

 

 

Total revenues (GAAP Basis)

 

$

32,203

 

$

76,544

 

 



 

2015 Financial Outlook

 

As of May 11, 2015, Depomed is updating its financial outlook for full year 2015, to include the impact of the acquisition of the NUCYNTA franchise

 

·                  Total product sales of $310 to $335 million

·                  Total SG&A and R&D expenses of $195 to $210 million

·                  Includes approximately $21 million of one-time NUCYNTA deal and relaunch expenses

·                  Intangible asset amortization of $85 to $90 million

·                  Non-GAAP adjusted earnings of $16 to $28 million

·                  Adjusted EBITDA of $85 to $100 million

 

Non-GAAP Financial Measures

 

In this press release, Depomed includes information about non-GAAP adjusted earnings (loss), non-GAAP adjusted earnings (loss) per share and adjusted EBITDA, non-GAAP financial measures, as useful operating metrics for the three month periods ended March 31, 2015 and 2014 and its full year 2015 financial outlook. The Company believes that the presentation of these non-GAAP financial measures, when viewed with our results under GAAP and the accompanying reconciliations, provides supplementary information to investors. The Company uses these non-GAAP financial measures in connection with its own planning and forecasting purposes and for measuring the Company’s performance. These non-GAAP financial measures should be considered in addition to, and not a substitute for, or superior to, net income or other financial measures calculated in accordance with GAAP. Non-GAAP adjusted earnings (loss) and non-GAAP adjusted earnings (loss) per share are not based on any standardized methodology prescribed by GAAP and represent GAAP net income (loss) and GAAP earnings (loss) per share adjusted to exclude (1) non-cash PDL royalty revenue, net of related costs, (2) non-cash interest expense on the liability related to the sale of future royalties and milestones to PDL, (3) amortization related to product acquisitions, (4) stock-based compensation expense, (5) non-cash interest expense related to convertible debt,  and to adjust (6) the income tax provision to reflect the estimated amounts payable in cash. Adjusted EBTITDA is not based on any standardized methodology prescribed by GAAP and represents GAAP net income (loss) adjusted to exclude (1) non-cash PDL royalty revenue, net of related costs, (2) interest income (3) interest expense, (4) amortization related to product acquisitions, (5) stock-based compensation expense, (5) depreciation, (6) taxes and (7) transaction costs associated with product acquisitions. Non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.

 



 

The following table reconciles the Company’s GAAP net income (loss) to non-GAAP adjusted loss for the three months ended March 31, 2015 and 2014:

 

RECONCILIATION OF GAAP NET INCOME (LOSS) TO NON-GAAP ADJUSTED LOSS

(in thousands, except per share amounts)

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2015

 

2014

 

 

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

GAAP net income (loss)

 

$

(11,633

)

$

17,939

 

Non-cash PDL royalties, net of related costs

 

 

(42,344

)

Non-cash interest expense on PDL liability

 

 

5,379

 

Non-cash interest expense on convertible debt

 

3,421

 

 

Amortization related to product acquisitions

 

1,586

 

4,555

 

Stock based compensation

 

2,813

 

1,859

 

Non-cash income tax adjustment

 

(4,181

)

11,827

 

Non-GAAP adjusted loss

 

$

(7,994

)

$

(785

)

Non-GAAP adjusted loss per share

 

$

(0.13

)

$

(0.01

)

 

The following table reconciles the Company’s GAAP net income (loss) to adjusted EBITDA for the three months ended March 31, 2015 and 2014:

 

RECONCILIATION OF GAAP NET INCOME (LOSS) TO ADJUSTED EBITDA

(in thousands, except per share amounts)

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2015

 

2014

 

 

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

GAAP net income (loss)

 

$

(11,633

)

$

17,939

 

Non-cash PDL royalties, net of related costs

 

 

(42,344

)

Amortization related to product acquisitions

 

1,586

 

4,555

 

Stock based compensation

 

2,813

 

1,859

 

Interest income

 

(57

)

(27

)

Interest expense

 

5,577

 

5,387

 

Depreciation

 

420

 

505

 

Taxes

 

(4,181

)

11,827

 

Transaction costs

 

2,459

 

 

Adjusted EBITDA

 

$

(3,016

)

$

(299

)

 



 

Conference Call

 

Depomed will host a conference call today, Monday, May 11TH, beginning at 4:30 p.m. EDT (1:30 p.m. PDT) 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 is a specialty pharmaceutical company that commercializes products for pain and neurology related disorders.  Our NUCYNTA® franchise includes NUCYNTA® ER (tapentadol) extended release tablets indicated for the management of pain, including neuropathic pain associated with diabetic peripheral neuropathy (DPN), severe enough to require daily, around-the-clock, long-term opioid treatment, and NUCYNTA® (tapentadol), an immediate release version of tapentadol, for management of moderate to severe acute pain in adults.  Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia. CAMBIA® (diclofenac potassium for oral solution) is a non-steroidal anti-inflammatory drug indicated for acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Zipsor® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adults.  Lazanda® (fentanyl) Nasal Spray is an intranasal fentanyl drug used to manage breakthrough pain in adults (18 years of age or older) who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. Gralise and various partner product candidates are formulated with Depomed’s proven, proprietary Acuform® drug delivery technology.  Additional information about Depomed may be found at 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 commercialization of NUCYNTA ER, NUCYNTA, Gralise, CAMBIA, Zipsor and Lazanda, Depomed’s financial outlook for 2015 and expectations regarding financial results and potential business opportunities 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, 2014 and most recent Quarterly Report on Form 10-Q. 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 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.

 

INVESTOR CONTACT:

 

August J. Moretti
Depomed, Inc.
510-744-8000
amoretti@depomed.com

 

MEDIA CONTACT:

 

Mark Corbae
Canale Communications for Depomed
619-849-5375
mark@canalecomm.com

 



 

CONSOLIDATED STATEMENTS OF OPERATIONS (GAAP BASIS)

(in thousands, except per share amounts)

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2015

 

2014

 

 

 

(unaudited)

 

(unaudited)

 

Revenues:

 

 

 

 

 

Product sales

 

$

31,670

 

$

21,506

 

Royalties

 

533

 

494

 

License and other revenue

 

 

11,760

 

Non-cash PDL royalty revenue

 

 

42,784

 

Total revenues

 

32,203

 

76,544

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

Cost of sales

 

3,112

 

3,702

 

Research and development expense

 

1,858

 

2,042

 

Selling, general and administrative expense

 

34,542

 

32,517

 

Amortization of intangible assets

 

2,540

 

2,539

 

Total costs and expenses

 

42,052

 

40,800

 

 

 

 

 

 

 

Income from operations

 

(9,849

)

35,744

 

Interest income and other

 

57

 

27

 

Interest expense

 

(6,022

)

(626

)

Non-cash interest expense on PDL liability

 

 

(5,379

)

Benefit from (provision for) income taxes

 

4,181

 

(11,827

)

Net income (loss)

 

$

(11,633

)

$

17,939

 

 

 

 

 

 

 

Basic net income (loss) per share

 

$

(0.20

)

$

0.31

 

Diluted net income (loss) per share

 

$

(0.20

)

$

0.30

 

 

 

 

 

 

 

Shares used in calculating basic net income per share

 

59,561

 

57,546

 

Shares used in calculating diluted net income per share

 

59,561

 

59,923

 

 



 

DEPOMED, INC.

CONSOLIDATED BALANCE SHEETS

(in thousands)

 

 

 

March 31,

 

December 31,

 

 

 

2015

 

2014

 

 

 

(unaudited)

 

 

 

 

 

 

 

 

 

Cash, cash equivalents and marketable securities

 

$

67,734

 

$

566,402

 

Restricted cash

 

500,000

 

 

Accounts receivable

 

23,454

 

27,008

 

Receivables from collaborative partners

 

1,048

 

1,070

 

Inventories

 

6,455

 

8,456

 

Income taxes receivable

 

3,424

 

4,030

 

Property and equipment, net

 

7,170

 

7,055

 

Intangible assets, net

 

69,822

 

72,361

 

Deferred tax assets

 

9,601

 

9,601

 

Prepaid and other assets

 

15,716

 

15,082

 

Total assets

 

$

704,424

 

$

711,065

 

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

$

55,803

 

$

52,686

 

Convertible debt

 

233,057

 

229,891

 

Contingent consideration liability

 

14,720

 

14,252

 

Deferred tax liabilities

 

25,924

 

32,589

 

Other liabilities

 

14,852

 

17,200

 

Shareholders’ equity

 

360,068

 

364,447

 

Total liabilities and shareholders’ equity

 

$

704,424

 

$

711,065