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8-K - 8-K - Assertio Therapeutics, Inca17-18883_18k.htm

Exhibit 99.1

 

 

Depomed Announces Second Quarter 2017 Financial Results

 

- Updates Full-Year Financial Guidance -

- Second Quarter Revenues of $100 million -

- Increases Neurology Salesforce Effective September 1 -

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

 

NEWARK, California, August 7, 2017 - Depomed, Inc. (Nasdaq:DEPO) today reported financial results for the quarter ended June 30, 2017 and provided an update to the business.

 

“Our second quarter product revenue was broadly in line with our expectations,” said Arthur Higgins, President and CEO of Depomed. “We continue to operate in an environment that is challenging and rapidly evolving.  The increasing public focus on opioids as well as opioid manufacturers, including by government agencies and other industry stakeholders, will continue to disrupt the opioid markets.  While our flagship NUCYNTA franchise continues to outperform the long and short-acting markets, it is clearly not immune to these developments. Despite these challenges we continue to see opportunities to develop a leadership position in the treatment of pain by working with all stakeholders to encourage the appropriate prescribing and use of opioids. As a company, we remain committed to serving the pain management needs of patients and their physicians.”

 

Business and Financial Highlights

 

·                  Second quarter 2017 revenues were $100 million, broadly in line with our estimates

·                  Second quarter ending cash and marketable securities was $117 million, an increase of $26 million during the quarter after prepayment of $100 million of secured debt and an associated $4 million prepayment fee

·                  Quarterly GAAP net loss of ($27) million or ($0.43) per share

·                  Quarterly non-GAAP adjusted earnings of $5 million, or $0.08 per share

·                  Quarterly non-GAAP adjusted EBITDA of $28 million

·                  Instituted corporate governance updates to further align shareholder interests and corporate governance best practices

·                  Increasing Neurology salesforce effective September 1

 



 

REVENUES (GAAP BASIS)

(in thousands, unaudited)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2017

 

2016

 

2017

 

2016

 

 

 

 

 

 

 

 

 

 

 

Product sales, net:

 

 

 

 

 

 

 

 

 

Nucynta products

 

$

63,938

 

$

71,917

 

$

124,634

 

$

141,281

 

Gralise

 

18,122

 

23,788

 

36,674

 

42,811

 

Cambia

 

8,495

 

7,618

 

15,698

 

13,790

 

Lazanda

 

5,274

 

6,352

 

9,199

 

10,912

 

Zipsor

 

4,403

 

6,842

 

9,054

 

12,294

 

Managed care dispute reserve

 

 

 

(4,742

)

 

Total product sales, net

 

100,232

 

116,517

 

190,517

 

221,088

 

 

 

 

 

 

 

 

 

 

 

Royalties

 

225

 

165

 

387

 

374

 

 

 

 

 

 

 

 

 

 

 

Total revenues (GAAP Basis)

 

$

100,457

 

$

116,682

 

$

190,904

 

$

221,462

 

 

Increase in Neurology Salesforce

 

The Company is reinvesting in its neurology salesforce which is focused on Gralise and Cambia. The team is growing from 40 to 90 sales representatives effective September 1st. This investment, which will increase SG&A expense in the second half of the year, is designed to advance the Company’s initiative to strengthen its neurology platform and create a more diversified business.

 

Updated 2017 Financial Outlook

 

The Company is updating its 2017 financial guidance as a result of recent developments, including (a)  increased pressure on short-acting and long-acting opioid markets by federal and state governments, managed care and other stakeholders, (b) July shipment and prescription demand trends, (c) increased legal expenses associated with responding to recent government inquiries and subpoenas directed to opioid manufacturers and (d) expenses associated with the increase in the neurology salesforce:

 

 

 

Updated Guidance

 

Prior Guidance

 

Total Revenue (GAAP)

 

$395 to $410 million

 

$405-$425 million

 

Total Revenue (Non-GAAP)

 

$400 to $415 million

 

$410-$430 million

 

Non-GAAP SG&A Expense

 

$195 to $201 million

 

$187-$197 million

 

Non-GAAP R&D Expense

 

$18 to $23 million

 

$22-$29 million

 

Non-GAAP Adjusted EBITDA

 

$107 to $117 million

 

$120-$130 million

 

 

The decrease in non-GAAP R&D expense is related to lower post-marketing pediatric study expenses. The new Non-GAAP Adjusted EBITDA guidance reflects the reduction in the midpoint of the revenue guidance and the increased expenses.

 



 

The Company is not providing GAAP net loss or GAAP expense guidance, as the Company is not able to estimate its non-recurring expenses for 2017.

 

Non-GAAP Financial Measures

 

To supplement our financial results presented on a U.S. generally accepted accounting principles, or GAAP, basis, we have included 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. We believe that the presentation of these non-GAAP financial measures, when viewed with our results under GAAP and the accompanying reconciliation, provides supplementary information to analysts, investors, lenders, and our management in assessing the Company’s performance and results from period to period. We use these non-GAAP measures internally to understand, manage and evaluate the Company’s performance, and in part, in the determination of bonuses for executive officers and employees. 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 and non-GAAP adjusted earnings 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 amortization, IPR&D and non-cash adjustments related to product acquisitions, stock-based compensation expense, non-cash interest expense related to debt,  the special meeting requests made by an activist investor and CEO transition, restructuring costs, adjustments associated with non-recurring legal settlements and disputes, and to adjust for the tax effect related to each of the non-GAAP adjustments. Non-GAAP adjusted EBITDA is not based on any standardized methodology prescribed by GAAP and represents GAAP net income (loss) adjusted to exclude interest income, interest expense, amortization, IPR&D and non-cash adjustments related to product acquisitions, stock-based compensation expense, depreciation, taxes, restructuring costs, adjustments related to non-recurring legal settlements and disputes, the special meeting requests made by an activist investor, and CEO transition. Non-GAAP financial measures used by us may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.

 

Conference Call

 

Depomed will host a conference call today, Monday, August 7th beginning at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its results. Participants can access the call by dialing (866) 643-3010 (United States) or (857) 270-6032 (International) referencing Conference ID 61913049. 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 2017 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 achievement of 2017 financial guidance is significantly dependent upon the success of NUCYNTA ER and NUCYNTA, and the continuing public focus on the opioid markets and the decline in the short-acting and long-acting opioid markets present risk to achievement of financial guidance. 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 AND MEDIA CONTACT:

 

Christopher Keenan
VP, Investor Relations and Corporate Communications
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,

 

 

 

2017

 

2016

 

2017

 

2016

 

 

 

(unaudited)

 

(unaudited)

 

Revenues:

 

 

 

 

 

 

 

 

 

Product sales, net

 

$

100,232

 

$

116,517

 

$

190,517

 

$

221,088

 

Royalties

 

225

 

165

 

387

 

374

 

Total revenues

 

100,457

 

116,682

 

190,904

 

221,462

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of sales

 

19,725

 

20,965

 

37,499

 

44,514

 

Research and development expense

 

5,614

 

7,116

 

10,698

 

13,065

 

Selling, general and administrative expense

 

50,010

 

51,903

 

98,529

 

104,462

 

Amortization of intangible assets

 

25,735

 

27,037

 

51,470

 

54,074

 

Restructuring charges

 

3,441

 

 

3,441

 

 

Total costs and expenses

 

104,525

 

107,021

 

201,637

 

216,115

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(4,068

)

9,661

 

(10,733

)

5,347

 

Interest and other income

 

282

 

67

 

532

 

197

 

Loss on prepayment of senior notes

 

(5,364

)

(5,777

)

(5,364

)

(5,777

)

Interest expense

 

(17,758

)

(20,148

)

(37,882

)

(42,875

)

(Provision for)/Benefit from income taxes

 

249

 

5,656

 

47

 

11,650

 

Net loss

 

$

(26,659

)

$

(10,541

)

$

(53,400

)

$

(31,458

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.43

)

$

(0.17

)

$

(0.86

)

$

(0.52

)

Shares used in calculating basic and diluted net loss per share

 

62,532

 

61,166

 

62,331

 

61,032

 

 



 

CONSOLIDATED CONDENSED BALANCE SHEETS

(in thousands)

(unaudited)

 

 

 

June 30,

 

December 31,

 

 

 

2017

 

2016

 

 

 

 

 

 

 

Cash, cash equivalents and marketable securities

 

$

116,799

 

$

177,420

 

Accounts receivable

 

78,708

 

102,589

 

Inventories

 

10,433

 

13,033

 

Property and equipment, net

 

14,532

 

15,526

 

Intangible assets, net

 

850,679

 

902,149

 

Prepaid and other assets

 

14,449

 

14,620

 

Total assets

 

$

1,085,600

 

$

1,225,337

 

 

 

 

 

 

 

Accounts payable

 

12,408

 

14,855

 

Income tax payable

 

 

59

 

Interest payable

 

13,208

 

15,924

 

Accrued liabilities

 

53,052

 

59,398

 

Accrued rebates, returns and discounts

 

140,006

 

131,536

 

Senior notes

 

368,612

 

466,051

 

Convertible notes

 

260,938

 

252,725

 

Contingent consideration liability

 

7,356

 

14,825

 

Other liabilities

 

18,625

 

19,176

 

Shareholders’ equity

 

211,396

 

250,788

 

Total liabilities and shareholders’ equity

 

$

1,085,600

 

$

1,225,337

 

 



 

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,

 

 

 

2017

 

2016

 

2017

 

2016

 

 

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

GAAP net loss

 

$

(26,659

)

$

(10,541

)

$

(53,400

)

$

(31,458

)

Non-cash interest expense on debt

 

6,124

 

5,166

 

10,774

 

9,401

 

Managed care dispute reserve

 

 

 

4,742

 

 

Intangible amortization related to product acquisitions

 

25,735

 

27,037

 

51,470

 

54,074

 

Inventory step-up related to product acquisitions

 

 

5

 

 

16

 

Contingent consideration related to product acquisitions

 

(863

)

490

 

(5,332

)

907

 

Stock based compensation

 

3,403

 

4,328

 

6,959

 

8,238

 

Other costs (1)

 

253

 

743

 

2,529

 

927

 

Restructuring charges

 

3,441

 

 

3,441

 

 

Valuation allowance on deferred tax assets

 

7,534

 

 

15,102

 

 

Income tax effect of non-GAAP adjustments (3)

 

(13,519

)

(13,190

)

(26,403

)

(25,733

)

Non-GAAP adjusted earnings

 

$

5,449

 

$

14,038

 

$

9,882

 

$

16,372

 

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

 

1,348

 

1,348

 

2,695

 

2,695

 

Numerator

 

$

6,797

 

$

15,386

 

$

12,577

 

$

19,067

 

Shares used in calculation (2)

 

81,400

 

81,356

 

81,719

 

81,044

 

Non-GAAP adjusted earnings per share

 

$

0.08

 

$

0.19

 

$

0.15

 

$

0.24

 

 


(1) Other costs represents non-recurring costs associated with the special meeting requests of an activist investor, CEO transition 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.

 

(3) Calculated by taking the pre-tax non-GAAP adjustments and applying the statutory tax rate. Expected cash taxes were zero for the three months ended June 30, 2017 and $1,791 for the three months ended June 30, 2016. Expected cash taxes were $202 for the six months ended June 30, 2017 and $2,811 for the six months ended June 30, 2016.

 



 

RECONCILIATION OF GAAP NET LOSS TO NON-GAAP ADJUSTED EBITDA

(in thousands)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2017

 

2016

 

2017

 

2016

 

 

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

GAAP net loss

 

$

(26,659

)

$

(10,541

)

$

(53,400

)

$

(31,458

)

Pharmacy benefit manager dispute reserve

 

 

 

4,742

 

 

Intangible amortization related to product acquisitions

 

25,735

 

27,037

 

51,470

 

54,074

 

Inventory step-up related to product acquisitions

 

 

5

 

 

16

 

Contingent consideration related to product acquisitions

 

(863

)

490

 

(5,332

)

907

 

Stock based compensation

 

3,403

 

4,328

 

6,959

 

8,238

 

Interest income

 

(56

)

(67

)

(260

)

(197

)

Interest expense

 

22,673

 

25,320

 

42,245

 

47,336

 

Depreciation

 

608

 

632

 

1,234

 

1,262

 

Benefit from income taxes

 

(249

)

(5,656

)

(47

)

(11,650

)

Other costs (1)

 

253

 

743

 

2,529

 

927

 

Restructuring charges

 

3,441

 

 

3,441

 

 

Transaction costs

 

 

1

 

 

44

 

Non-GAAP adjusted EBITDA

 

$

28,286

 

$

42,292

 

$

53,581

 

$

69,499

 

 


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

 

RECONCILATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION

For the three months ended June 30, 2017

(in thousands)

(unaudited)

 

 

 

Cost of sales

 

Research and
development
expense

 

Selling,
general and
administrative
expense

 

Restructuring
Charges

 

Amortization
of intangible
assets

 

Interest
expense

 

Benefit from
(provision for)
income taxes

 

GAAP as reported

 

$

19,725

 

$

5,614

 

$

50,010

 

$

3,441

 

$

25,735

 

$

(17,758

)

$

249

 

Non-cash interest expense on debt

 

 

 

 

 

 

6,124

 

 

Intangible amortization related to product acquisitions

 

 

 

 

 

(25,735

)

 

 

Contingent consideration related to product acquisitions

 

 

 

1,128

 

 

 

(265

)

 

Stock based compensation

 

(39

)

(260

)

(3,104

)

 

 

 

 

Other costs

 

 

 

(253

)

 

 

 

 

Restructuring charges

 

 

 

 

(3,441

)

 

 

 

Valuation allowance on deferred tax assets

 

 

 

 

 

 

 

7,534

 

Income tax effect of non-GAAP adjustments

 

 

 

 

 

 

 

(13,519

)

Non-GAAP adjusted

 

$

19,686

 

$

5,354

 

$

47,781

 

$

 

$

 

$

(11,899

)

$

(5,736

)

 



 

RECONCILATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION

For the three months ended June 30, 2016

(in thousands)

(unaudited)

 

 

 

Cost of sales

 

Research and
development
expense

 

Selling,
general and
administrative
expense

 

Amortization
of intangible
assets

 

Interest
expense

 

Benefit from
(provision for)
income taxes

 

GAAP as reported

 

$

20,965

 

$

7,116

 

$

51,903

 

$

27,037

 

$

(20,148

)

$

5,656

 

Non-cash interest expense on debt

 

 

 

 

 

5,166

 

 

Intangible amortization related to product acquisitions

 

 

 

 

(27,037

)

 

 

Inventory step-up related to product acquisitions

 

(5

)

 

 

 

 

 

Contingent consideration related to product acquisitions

 

 

 

110

 

 

(600

)

 

Stock based compensation

 

(8

)

(131

)

(4,189

)

 

 

 

Other costs

 

 

 

(743

)

 

 

 

Income tax effect of non-GAAP adjustments

 

 

 

 

 

 

(13,190

)

Non-GAAP adjusted

 

$

20,952

 

$

6,985

 

$

47,081

 

$

 

$

(15,582

)

$

(7,534

)

 

RECONCILATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION

For the six months ended June 30, 2017

(in thousands)

(unaudited)

 

 

 

Product Sales

 

Cost of sales

 

Research and
development
expense

 

Selling,
general and
administrative
expense

 

Restructuring
Charges

 

Amortization
of intangible
assets

 

Interest
expense

 

Benefit from
(provision for)
income taxes

 

GAAP as reported

 

$

190,904

 

$

37,499

 

$

10,698

 

$

98,529

 

$

3,441

 

$

51,470

 

$

(37,882

)

$

47

 

Non-cash interest expense on debt

 

 

 

 

 

 

 

10,774

 

 

Managed care dispute reserve

 

4,742

 

 

 

 

 

 

 

 

Intangible amortization related to product acquisitions

 

 

 

 

 

 

(51,470

)

 

 

Contingent consideration related to product acquisitions

 

 

 

 

6,128

 

 

 

(796

)

 

Stock based compensation

 

 

(75

)

(607

)

(6,277

)

 

 

 

 

Other costs

 

 

 

 

(2,529

)

 

 

 

 

Restructuring charges

 

 

 

 

 

(3,441

)

 

 

 

Valuation allowance on deferred tax assets

 

 

 

 

 

 

 

 

15,102

 

Income tax effect of non-GAAP adjustments

 

 

 

 

 

 

 

 

(26,403

)

Non-GAAP adjusted

 

$

195,646

 

$

37,424

 

$

10,091

 

$

95,851

 

$

 

$

 

$

(27,904

)

$

(11,254

)

 

RECONCILATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION

For the six months ended June 30, 2016

(in thousands)

(unaudited)

 

 

 

Cost of sales

 

Research and
development
expense

 

Selling,
general and
administrative
expense

 

Amortization
of intangible
assets

 

Interest
expense

 

Benefit from
(provision for)
income taxes

 

GAAP as reported

 

$

44,514

 

$

13,065

 

$

104,462

 

$

54,074

 

$

(42,875

)

$

11,650

 

Non-cash interest expense on debt

 

 

 

 

 

9,401

 

 

Intangible amortization related to product acquisitions

 

 

 

 

(54,074

)

 

 

Inventory step-up related to product acquisitions

 

(16

)

 

 

 

 

 

Contingent consideration related to product acquisitions

 

 

 

287

 

 

(1,194

)

 

Stock based compensation

 

(16

)

(208

)

(8,014

)

 

 

 

Other costs

 

 

 

927

 

 

 

 

Income tax effect of non-GAAP adjustments

 

 

 

 

 

 

(25,733

)

Non-GAAP adjusted

 

$

44,482

 

$

12,857

 

$

97,662

 

$

 

$

(34,668

)

$

(14,083

)

 



 

RECONCILIATION OF GAAP NET LOSS PER SHARE TO NON-GAAP ADJUSTED EARNINGS PER SHARE

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2017

 

2016

 

2017

 

2016

 

 

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

GAAP net loss per share

 

$

(0.43

)

$

(0.17

)

$

(0.86

)

$

(0.52

)

Conversion from basic shares to diluted shares

 

0.10

 

0.04

 

0.20

 

0.13

 

Non-cash interest expense on debt

 

0.08

 

0.06

 

0.13

 

0.12

 

Managed care dispute reserve

 

 

 

0.06

 

 

Intangible amortization related to product acquisitions

 

0.32

 

0.33

 

0.63

 

0.67

 

Inventory step-up related to product acquisitions

 

 

0.00

 

 

0.00

 

Contingent consideration related to product acquisitions

 

(0.01

)

0.01

 

(0.07

)

0.01

 

Stock based compensation

 

0.04

 

0.05

 

0.09

 

0.10

 

Other costs

 

0.00

 

0.01

 

0.03

 

0.01

 

Restructuring charges

 

0.04

 

 

0.04

 

 

Valuation allowance on deferred tax assets

 

0.09

 

 

0.18

 

 

Income tax effect of non-GAAP adjustments

 

(0.17

)

(0.16

)

(0.32

)

(0.32

)

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

 

0.02

 

0.02

 

0.03

 

0.03

 

Non-GAAP adjusted earnings per share

 

$

0.08

 

$

0.19

 

$

0.15

 

$

0.24