EX-99.1 2 a16-15985_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

Depomed Reports Second Quarter 2016 Financial Results

 

- Second Quarter Revenues of $117 million, 23% over 2Q 2015 -

- NUCYNTA® Franchise Second Quarter 2016 Record Net Sales of $72 million, 27% over 2Q 2015 -

- Conference Call Scheduled for Today at 4:30 PM EDT; Dial In Information Below -

 

NEWARK, CA. August 3, 2016 - Depomed, Inc. (Nasdaq: DEPO) today reported financial results and highlighted operational achievements for the quarter ended June 30, 2016.

 

“The second quarter marked the 1-year anniversary of the mid-June relaunch of our flagship NUCYNTA franchise,” said Jim Schoeneck, President and CEO of Depomed. “During the first full year after our relaunch, we delivered $274 million of total NUCYNTA net sales, an increase of 59% over the final year of sales under the previous owner.  NUCYNTA ER prescriptions continued to accelerate in June, up 26% over the prior year and achieving all-time high prescription volume and market share.  And this is against a backdrop of challenging opioid market conditions that see declining prescriptions for the overall market and other leading brands. We are also encouraged by the positive NUCYNTA IR trends, with May and June showing a 2% prescription volume increase year-over-year, reversing the 10% decline seen before our re-launch.  We believe that our flagship franchise is well-positioned for continued growth. The rest of our portfolio also performed well, delivering $45 million in combined revenues, with record quarterly revenues from both Gralise and Lazanda. Going forward we remain focused on growing our highly-differentiated portfolio and delivering value to all the groups we serve.”

 

Business and Financial Highlights

 

·                  Second quarter 2016 revenues were $117 million, compared to $95 million for second quarter of 2015, a 23% increase

·                  Second quarter NUCYNTA® franchise revenue $72 million, compared to $57 million for second quarter of 2015, a 27% increase

·                  Quarterly net loss of ($10.5) million or ($0.17) per share

·                  Quarterly non-GAAP adjusted earnings of $19.8 million, or $0.27 per share

·                  Quarterly non-GAAP adjusted EBITDA of $42.3 million

·                  Favorable Patent Office (PTAB) decision denying IPR patent challenge filed by Rosellini Scientific, LLC, ending the PTAB review relating to the NUCYNTA polymorph patent that expires in 2025

·                  Extension of stay by District Court in NUCYNTA ANDA Litigation with a decision expected no later than September 30, 2016

 

NUCYNTA Franchise Highlights

 

NUCYNTA and NUCYNTA ER

 

·                  Second quarter 2016 net sales of $72 million

·                  Net sales of $331 million since acquisition on April 2, 2015

·                  NUCYNTA ER record all-time monthly high prescription volume of over 29,000 reached in June(1)

 



 

·                  NUCYNTA ER record all-time monthly high market share of long acting opioid market of 1.91% reached in June(1)

·                  NUCYNTA ER June year-over-year prescription growth of 26%(1)

·                  First NUCYNTA IR year-over-year quarterly prescription growth since 2011(1)

·                  NUCYNTA IR May and June year-over-year prescription growth of 2%(1)

 

Product Portfolio Highlights

 

·                  Gralise® second quarter 2016 net sales were a record $23.8 million, an increase of 14% compared to $20.9 million in the same period last year

·                  Cambia® second quarter 2016 net sales were $7.6 million, an increase of 11% compared to $6.8 million in the same period last year

·                  Lazanda® second quarter 2016 net sales were a record $6.4 million, an increase of 65% compared to $3.9 million in the same period last year

 

REVENUES (GAAP BASIS)

(in thousands, unaudited)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2016

 

2015

 

2016

 

2015

 

 

 

 

 

 

 

 

 

 

 

Product sales, net:

 

 

 

 

 

 

 

 

 

Nucynta products (1)

 

$

71,917

 

$

56,653

 

$

141,281

 

$

56,653

 

Gralise

 

23,788

 

20,927

 

42,811

 

38,201

 

Cambia

 

7,618

 

6,848

 

13,790

 

12,213

 

Lazanda

 

6,352

 

3,853

 

10,912

 

7,038

 

Zipsor

 

6,842

 

6,014

 

12,294

 

11,861

 

Total product sales, net

 

116,517

 

94,295

 

221,088

 

125,966

 

 

 

 

 

 

 

 

 

 

 

Royalties

 

165

 

209

 

374

 

742

 

 

 

 

 

 

 

 

 

 

 

Total revenues (GAAP Basis)

 

$

116,682

 

$

94,504

 

$

221,462

 

$

126,708

 

 


(1) Nucynta acquisition closed in April 2015

 

Updated 2016 Financial Outlook

 

Depomed is updating its 2016 financial guidance as follows:

 

 

 

Updated Guidance

 

Prior Guidance

Total Revenue

 

$480 to $505 million

 

$490 to $520 million

Non-GAAP SG&A Expense

 

$185 to $190 million

 

$185 to $195 million

Non-GAAP R&D Expense

 

$28 to $35 million

 

$28 to $35 million

Non-GAAP Adjusted Earnings

 

$95 to $105 million

 

$95 to $115 million

Non-GAAP Adjusted EBITDA

 

$175 to $190 million

 

$175 to $205 million

 


(1) Source: SHA IDV

 



 

The Company is not providing GAAP net loss or GAAP expense guidance as the Company is not able to estimate its non-recurring costs for the remainder of 2016.

 

Non-GAAP Financial Measures

 

In this press release, Depomed includes information about non-GAAP adjusted earnings, non-GAAP adjusted earnings per share and non-GAAP adjusted EBITDA, non-GAAP financial measures, as useful operating metrics for the three month and six periods ended June 30, 2016 and 2015 and its full year 2016 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 relevant and useful supplementary information to analysts, investors, lenders, and our management in assessing the Company’s performance and liquidity. The Company uses these non-GAAP financial measures in connection with its own planning and forecasting purposes, and in part, in the determination of bonuses for executive officer and employees.

 

The Company uses non-GAAP adjusted earnings and non-GAAP adjusted earnings per share to evaluate its period-over-period operating performance because it provides supplementary information on the results of the primary operations of the Company that more consistently correlates with the Company’s underlying operating cash flows of the business by removing non-cash gains or losses and non-recurring cash gains or losses.  This measure may also be useful to investors and analysts in evaluating the underlying operating performance of the business.

 

Non-GAAP adjusted earnings and non-GAAP adjusted earnings per share are not based on any standardized methodology prescribed by GAAP and represent GAAP net loss and GAAP net loss per share adjusted to exclude (1) amortization and non-cash adjustments related to product acquisitions, (2) non-cash stock-based compensation expense, (3) non-cash interest expense related to debt, (4) non-recurring costs associated with the Company’s defense against the Horizon Pharma hostile takeover bid in 2015 and costs associated with the special meeting requests made by an activist investor in 2016, and by excluding (5) the non-cash portion of income tax benefit/expense related to the period.

 

The Company uses non-GAAP adjusted EBITDA to evaluate its period-over-period operating performance because it provides supplementary information on the results of the primary operations of the Company before investing and financing income and expense and taxes. This measure may be useful to lenders and other parties to evaluate our credit worthiness.  This measure may also be useful to investors and analysts in evaluating the underlying operating performance of the business.

 

Non-GAAP adjusted EBITDA is not based on any standardized methodology prescribed by GAAP and represents GAAP net loss adjusted to exclude (1) amortization and non-cash adjustments related to product acquisitions, (2) non-cash stock-based compensation expense, (3) depreciation, (4) taxes, (5) non-recurring costs associated with the Company’s defense against the Horizon Pharma hostile takeover bid in 2015 and costs associated with the special meeting requests made by an activist investor in 2016, (6) interest income and expense, and (7) non-recurring 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.

 

These non-GAAP financial measures should be considered in addition to, and not a substitute for, or superior to, net loss or other financial measures calculated in accordance with GAAP.

 

Conference Call

 

Depomed will host a conference call today, Wednesday, August 3rd, beginning at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its results. Participants can access the call by dialing (844) 839-0046 (United States) or (857) 270-6032 (International). The conference call will also be available via a live webcast under 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 leading specialty pharmaceutical company focused on enhancing the lives of the patients, families, physicians, providers and payors we serve through commercializing innovative products for pain and neurology related disorders. Depomed markets six medicines with areas of focus that include mild to severe acute pain, moderate to severe chronic pain, neuropathic pain, migraine and breakthrough cancer pain. Depomed is headquartered in Newark, California. To learn more about Depomed, visit 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 2016 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 most recent Annual Report on Form 10-K 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:
Christopher Keenan

VP, Investor Relations and Corporate Communications
Depomed, Inc.
510-744-8000
ckeenan@depomed.com

 



 

CONSOLIDATED STATEMENTS OF OPERATIONS (GAAP BASIS)

(in thousands, except per share amounts)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2016

 

2015

 

2016

 

2015

 

 

 

(unaudited)

 

(unaudited)

 

Revenues:

 

 

 

 

 

 

 

 

 

Product sales, net

 

$

116,517

 

$

94,295

 

$

221,088

 

$

125,966

 

Royalties

 

165

 

209

 

374

 

742

 

Total revenues

 

116,682

 

94,504

 

221,462

 

126,708

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of sales

 

20,965

 

22,865

 

44,514

 

25,977

 

Research and development expense

 

7,116

 

4,714

 

13,065

 

6,572

 

Selling, general and administrative expense

 

51,903

 

57,408

 

104,462

 

91,950

 

Amortization of intangible assets

 

27,037

 

26,731

 

54,074

 

29,271

 

Total costs and expenses

 

107,021

 

111,718

 

216,115

 

153,770

 

 

 

 

 

 

 

 

 

 

 

Income (Loss) from operations

 

9,661

 

(17,214

)

5,347

 

(27,062

)

Other income (expense)

 

67

 

61

 

197

 

118

 

Loss on prepayment of Senior Notes

 

(5,777

)

 

(5,777

)

 

Interest expense

 

(20,148

)

(22,078

)

(42,875

)

(28,100

)

Benefit from (provision for) income taxes

 

5,656

 

17,578

 

11,650

 

21,758

 

Net loss

 

$

(10,541

)

$

(21,653

)

$

(31,458

)

$

(33,286

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.17

)

$

(0.36

)

$

(0.52

)

$

(0.56

)

 

 

 

 

 

 

 

 

 

 

Shares used in calculating basic and diluted net loss per share

 

61,166,044

 

59,991,934

 

61,032,155

 

59,777,594

 

 



 

CONSOLIDATED CONDENSED BALANCE SHEETS

(in thousands)

(unaudited)

 

 

 

June 30,

 

December 31,

 

 

 

2016

 

2015

 

 

 

 

 

 

 

Cash, cash equivalents and marketable securities

 

$

118,930

 

$

209,768

 

Accounts receivable

 

79,974

 

71,687

 

Inventories

 

10,436

 

10,494

 

Income taxes receivable

 

6,362

 

6,358

 

Property and equipment, net

 

16,194

 

14,794

 

Intangible assets, net

 

954,920

 

1,008,994

 

Deferred tax assets

 

42,189

 

22,995

 

Prepaid and other assets

 

17,072

 

12,159

 

Total assets

 

$

1,246,077

 

$

1,357,249

 

 

 

 

 

 

 

Accounts payable

 

11,310

 

12,805

 

Income tax payable

 

6,528

 

 

Interest payable

 

15,782

 

18,672

 

Accrued liabilities

 

61,408

 

62,931

 

Accrued rebates, returns and discounts

 

117,807

 

121,058

 

Senior notes

 

464,872

 

563,012

 

Convertible notes

 

244,856

 

237,313

 

Contingent consideration liability

 

14,898

 

14,971

 

Other liabilities

 

11,514

 

11,432

 

Shareholders’ equity

 

297,102

 

315,055

 

Total liabilities and shareholders’ equity

 

$

1,246,077

 

$

1,357,249

 

 



 

RECONCILIATION OF GAAP NET LOSS TO NON-GAAP ADJUSTED EARNINGS

(in thousands, except per share amounts)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2016

 

2015

 

2016

 

2015

 

 

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

GAAP net loss

 

$

(10,541

)

$

(21,653

)

$

(31,458

)

$

(33,286

)

Non-cash interest expense on debt

 

5,166

 

3,984

 

9,401

 

7,405

 

Intangible amortization related to product acquisitions

 

27,037

 

26,731

 

54,074

 

29,271

 

Inventory step-up related to product acquisitions

 

5

 

5,057

 

16

 

5,202

 

Product sales benefit related to product acquisitions

 

 

10,466

 

 

10,466

 

Contingent consideration related to product acquisitions

 

490

 

(797

)

907

 

(1,895

)

Stock based compensation

 

4,328

 

3,253

 

8,238

 

6,066

 

Non-cash income tax adjustment

 

(7,447

)

(7,036

)

(14,461

)

(11,216

)

Other costs (1)

 

743

 

215

 

927

 

215

 

Non-GAAP adjusted earnings

 

$

19,781

 

$

20,220

 

$

27,644

 

$

12,228

 

Add interest expense of convertible debt, net of tax (2)

 

1,958

 

2,156

 

3,774

 

 

Numerator

 

$

21,739

 

$

22,376

 

$

31,418

 

$

12,228

 

Shares used in calculation (2)

 

81,356

 

81,186

 

81,044

 

62,955

 

Non-GAAP adjusted earnings per share (2)

 

$

0.27

 

$

0.28

 

$

0.39

 

$

0.19

 

 


(1) Other costs represents non-recurring costs associated with the special meeting requests of an activist investor and costs associated with the Company’s defense of Horizon Pharma’s hostile takeover attempt

 

(2) The Company uses the if-converted method to compute diluted earnings per share with respect to its convertible debt.  There was no add-back of interest expense or additional dilutive shares related to the convertible debt for the six months ending June 30, 2015 as the effect is anti-dilutive

 

RECONCILIATION OF GAAP NET LOSS TO NON-GAAP ADJUSTED EBITDA

(in thousands)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2016

 

2015

 

2016

 

2015

 

 

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

GAAP net loss

 

$

(10,541

)

$

(21,653

)

$

(31,458

)

$

(33,286

)

Intangible amortization related to product acquisitions

 

27,037

 

26,731

 

54,074

 

29,271

 

Inventory step-up related to product acquisitions

 

5

 

5,057

 

16

 

5,202

 

Product sales benefit related to product acquisitions

 

 

10,466

 

 

10,466

 

Contingent consideration related to product acquisitions

 

490

 

(797

)

907

 

(1,895

)

Stock based compensation

 

4,328

 

3,253

 

8,238

 

6,066

 

Interest and other income

 

(67

)

(61

)

(197

)

(118

)

Interest expense

 

25,320

 

21,433

 

47,336

 

27,010

 

Depreciation

 

632

 

627

 

1,262

 

1,048

 

Benefit from income taxes

 

(5,656

)

(17,578

)

(11,650

)

(21,758

)

Other costs (1)

 

743

 

215

 

927

 

215

 

Transaction costs

 

1

 

9,685

 

44

 

12,117

 

Non-GAAP adjusted EBITDA

 

$

42,292

 

$

37,378

 

$

69,499

 

$

34,338

 

 


(1) Other costs represents non-recurring costs associated with the special meeting requests of an activist investor and costs associated with the Company’s defense of Horizon Pharma’s hostile takeover attempt

 



 

RECONCILATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION

(in thousands)

(unaudited)

 

 

 

Three Months Ended

 

Three Months Ended

 

 

 

June 30, 2016

 

June 30, 2015

 

 

 

GAAP

 

 

 

Non-GAAP

 

GAAP

 

 

 

Non-GAAP

 

 

 

Reported

 

Adjustments

 

Adjusted

 

Reported

 

Adjustments

 

Adjusted

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

116,682

 

 

116,682

 

94,504

 

10,466

(a)

104,970

 

Cost of sales

 

20,965

 

(13

)(b)

20,952

 

22,865

 

(5,061

)(b)

17,804

 

Research and development expense

 

7,116

 

(131

)(c)

6,985

 

4,714

 

(46

)(c)

4,668

 

Selling, general and administrative expense

 

51,903

 

(4,822

)(d)

47,081

 

57,408

 

(1,976

)(d)

55,432

 

Amortization of intangible assets

 

27,037

 

(27,037

)(e)

 

26,731

 

(26,731

)(e)

 

Loss on prepayment of Senior Notes

 

5,777

 

(777

)(f)

5,000

 

 

 

 

Interest expense

 

(20,148

)

(4,989

)(g)

(15,159

)

(22,078

)

(4,629

)(g)

(17,449

)

Benefit from (provision for) income taxes

 

5,656

 

(7,447

)(h)

(1,791

)

17,578

 

(7,036

)(h)

10,542

 

Net (loss)/adjusted earnings

 

(10,541

)

30,322

(i)

19,781

 

(21,653

)

41,873

(i)

20,220

 

 


Explanation of adjustments:

(a) Product sales benefit related to product acquisition

(b) Inventory step-up related to product acquisitions and stock based compensation

(c) Stock-based compensation

(d) Non-recurring costs (Horizon Pharma and activist investor costs) of $743 and $215, stock-based compensation of $4,189 and $3,203, contingent consideration of ($110) and ($1,442) for the three months ended in June 30, 2016 and 2015, respectively

(e) Amortization of intangible assets

(f) Non-cash acceleration of debt discount

(g) Non-cash interest expense of $4,389 and $3,984, contingent consideration of $600 and $645 for the three months ended in June 30, 2016 and 2015, respectively

(h) Non-cash taxes

(i) Calculated by taking (a) plus (h) minus sum of (b) through (g)

 

 

 

Six Months Ended

 

Six Months Ended

 

 

 

June 30, 2016

 

June 30, 2015

 

 

 

GAAP

 

 

 

Non-GAAP

 

GAAP

 

 

 

Non-GAAP

 

 

 

Reported

 

Adjustments

 

Adjusted

 

Reported

 

Adjustments

 

Adjusted

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

221,462

 

 

221,462

 

126,708

 

10,466

(a)

137,174

 

Cost of sales

 

44,514

 

(32

)(b)

44,482

 

25,977

 

(5,207

)(b)

20,770

 

Research and development expense

 

13,065

 

(208

)(c)

12,857

 

6,572

 

(183

)(c)

6,389

 

Selling, general and administrative expense

 

104,462

 

(8,654

)(d)

95,808

 

91,950

 

(3,108

)(d)

88,842

 

Amortization of intangible assets

 

54,074

 

(54,074

)(e)

 

29,271

 

(29,271

)(e)

 

Loss on prepayment of Senior Notes

 

5,777

 

(777

)(f)

5,000

 

 

 

 

Interest expense

 

(42,875

)

(9,818

)(g)

(52,693

)

(28,100

)

(8,495

)(g)

(36,595

)

Benefit from (provision for) income taxes

 

11,650

 

(14,461

)(h)

(2,811

)

21,758

 

(11,216

)(h)

10,542

 

Net (loss)/adjusted earnings

 

(31,458

)

59,102

(i)

27,644

 

(33,286

)

45,514

(i)

12,228

 

 


Explanation of adjustments

(a) Product sales benefit related to product acquisition

(b) Inventory step-up related to product acquisitions and stock based compensation

(c) Stock-based compensation

(d) Non-recurring costs (Horizon Pharma and activist investor costs) of $927 and $215, stock-based compensation of $8,014 and $5,878, contingent consideration of ($287) and $(2,985) for the three months ended in June 30, 2016 and 2015, respectively

(e) Amortization of intangible assets

(f) Non-cash acceleration of debt discount

(g) Non-cash interest expense of $8,624 and $7,405, contingent consideration of $1,194 and $1,090 for the three months ended in June 30, 2016 and 2015, respectively

(h) Non-cash taxes

(i) Calculated by taking (a) plus (h) minus sum of (b) through (g)