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8-K - 8-K - Assertio Therapeutics, Inca17-4689_18k.htm

Exhibit 99.1

 

Depomed Reports Fourth Quarter and Full Year 2016 Financial Results

 

- Record Annual Revenue of $456 million in 2016 -

 

- Record Quarterly Revenue of $124 million in Fourth Quarter —

 

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

 

NEWARK, CA., February 21, 2017 — Depomed, Inc. (Nasdaq:DEPO) today reported financial results and highlighted operational achievements for the quarter and twelve months ended December 31, 2016 and provided 2017 guidance.

 

“In 2016, we achieved key milestones strengthening our portfolio and de-leveraging our balance sheet.  We ended the year with record annual and quarterly revenue and EBITDA. In addition, we posted all-time net sales highs for every one of our brands,” said Jim Schoeneck, President and Chief Executive Officer of Depomed. “Our full-year net revenue reached $456 million, representing a 33% increase over 2015, with quarterly revenue of $124 million, an 11% increase year over year.  In addition, we have been successful in growing EBITDA from $7 million in 2014 to $111 million in 2015 and $156 million in 2016.  This, along with the early pay down of $100 million of our debt, significantly improves our credit profile and positions us well to refinance. We also built future value into the business as legal victories provided us with 9 more years to grow our flagship NUCYNTA franchise and allowed us to advance our patent infringement case against Purdue.”

 

Continued Mr. Schoeneck, “With the clarity on NUCYNTA’s exclusivity until December 2025 and the insights gained since its relaunch, in February we began implementing a multi-faceted growth initiative to increase the appropriate use of NUCYNTA Extended Release and Immediate Release and to drive growth across the portfolio. We continue to focus on opportunities to further differentiate our product portfolio, all with the goal of delivering value to our shareholders and to those we serve.”

 

Business and Financial Highlights

 

·                                          Record full year net product sales for 2016 were $455 million, an increase of 33% compared to $342 million for full year 2015

 

·                                          Full year GAAP net loss of ($89) million or ($1.45) per share, which includes a non-cash tax reserve adjustment of ($43) million

 

·                                          Full year non-GAAP adjusted earnings of $86 million, or $1.15 per share. We are modifying our method of calculating non-GAAP income taxes for non-GAAP adjusted earnings and non-GAAP adjusted earnings per share to align with the guidance under the Non-GAAP Financial Measures Compliance and Disclosure Interpretations issued by the SEC on May 17, 2016.  The amounts above reflect the Company’s prior methodology of calculating its non-GAAP income taxes for comparability to prior periods and to the Company’s prior guidance for 2016. Please see the non-GAAP tax discussion below for further discussion of the new methodology.

 

·                                          Full year non-GAAP adjusted EBITDA of $156 million

 

·                                          Fourth quarter 2016 net product sales were a record $124 million, compared to $111 million for fourth quarter of 2015, an increase of 11%

 



 

·                                          NUCYNTA franchise reported fourth quarter record net sales of $75 million

 

·                                          Fourth quarter ending cash and marketable securities was $177 million, cash generated during the quarter was $40 million

 

·                                          Quarterly GAAP net loss of ($44) million or ($0.72) per share, which includes a non-cash tax reserve adjustment of ($43) million

 

·                                          Quarterly non-GAAP adjusted earnings of $37 million, or $0.48 per share under the Company’s prior method of calculating its non-GAAP income tax expense.

 

·                                          Quarterly non-GAAP adjusted EBITDA of $51 million

 

·                                          U.S. District Court rules in favor of two key NUCYNTA patents, providing market exclusivity until December 2025

 

·                                          U.S. Court of Appeals upheld patents asserted against Purdue Pharma

 

·                                          Early payment of $100 million of secured debt in April 2016

 

NUCYNTA® Franchise Highlights

 

·                                          Full year 2016 record net sales of $281 million

 

·                                          Fourth quarter 2016 record net sales of $75 million

 

·                                          Net sales of $471 million since acquisition on April 2, 2015

 

·                                          NUCYNTA ER® reached record all-time quarterly prescription volume of over 90,000 in fourth quarter(1)

 

·                                          NUCYNTA ER 2016 total prescriptions of over 344,000, an increase of 19% over 2015(1)

 

·                                          NUCYNTA ER reached record all-time quarterly market share of 2.08% of total long acting opioids in December(1)

 

·                                          NUCYNTA reached record all-time quarterly market share of 0.29% in fourth quarter(1)

 

Marking a continued commitment to unlock value from its portfolio, in February, the company launched the first of a series of initiatives aimed at driving NUCYNTA growth in 2017 which include:

 

·                  Salesforce Deployment: adds 75 reps to Pain sales force for a total of 257, an increase  of 41%; Neuro and Oncology sales forces reduced by 70 positions to offset increase; new physician targeting emphasizes reimbursement coverage along with prescription volume

 

·                  Primary Care Physician Expansion: new salesforce deployment targets more coverage of high decile primary care prescribers

 

·                  NUCYNTA ER Diabetic Peripheral Neuropathy (DPN) Indication: highlights indication in category unique to NUCYNTA ER

 

·                  NUCYNTA Immediate Release Promotion: introduces a focused, stand-alone promotional campaign for the first time since relaunch

 



 

·                  NUCYNTA Label Expansion Studies: initiating studies aimed at strengthening NUCYNTA’s respiratory depression and abuse profiles

 

Other Product Portfolio Highlights

 

·                  Gralise® full-year net sales were $88 million, an increase of 9% compared to $81 million in 2015, fourth quarter net sales were $25 million, an increase of 15% compared to $22 million in the same period last year

 

·                  Cambia® full-year net sales were $31 million, an increase of 14% compared to $27 million in 2015, fourth quarter 2016 net sales were $8.4 million, an increase of 3% compared to $8.2 million in the same period last year

 

·                  Introduction of an aspartame-free formulation of CAMBIA for the treatment of migraine

 

·                  Lazanda® full-year net sales were $27 million, an increase of 50% compared to $18 million in 2015, fourth quarter net sales were $7.5 million, an increase of 42% compared to $5.2 million in the same period last year and record all-time market share of 4.5% in December(1)

 

·                  Introduction of a 300 mcg dose strength of Lazanda for the treatment of breakthrough cancer pain

 

·                  Zipsor® full-year net sales were $28 million, an increase of 7% compared to $26 million in 2015, fourth quarter net sales were $8.2 million, an increase of 6% compared to $7.7 million in the same period last year

 


(1) Source: SHA IDV

 



 

REVENUES (GAAP BASIS)

(in thousands, unaudited)

 

 

 

Three Months Ended

 

Twelve Months Ended

 

 

 

December 31,

 

December 31,

 

 

 

2016

 

2015

 

2016

 

2015

 

 

 

 

 

 

 

 

 

 

 

Product sales, net:

 

 

 

 

 

 

 

 

 

Nucynta products (1)

 

$

74,693

 

$

68,260

 

$

281,261

 

$

189,854

 

Gralise

 

24,995

 

21,737

 

88,446

 

81,054

 

Cambia

 

8,373

 

8,157

 

31,273

 

27,426

 

Lazanda

 

7,454

 

5,236

 

26,547

 

17,711

 

Zipsor

 

8,160

 

7,669

 

27,539

 

25,705

 

Total product sales, net

 

123,675

 

111,059

 

455,066

 

341,750

 

 

 

 

 

 

 

 

 

 

 

Royalties

 

236

 

113

 

831

 

985

 

 

 

 

 

 

 

 

 

 

 

Total revenues (GAAP Basis)

 

$

123,911

 

$

111,172

 

$

455,897

 

$

342,735

 

 


(1)  Nucynta acquisition completed April 2015

 

Change in Non-GAAP taxes

 

We are modifying our method of calculating non-GAAP income tax expense for non-GAAP adjusted earnings and non-GAAP adjusted earnings per share to align with the guidance under the Non-GAAP Financial Measures Compliance and Disclosure Interpretations issued by the SEC on May 17, 2016. This new methodology, which the Company will use exclusively beginning in first quarter of 2017, calculates non-GAAP tax expense (benefit) by adjusting the GAAP tax expense (benefit) for the estimated tax impact of each non-GAAP adjustment.  The estimated tax impact is based on the statutory income tax rate for each non-GAAP adjustment.  Previously, we adjusted the non-GAAP tax expense (benefit) to reflect the estimated amount we expected to pay or receive in taxes for the period.

 

The following tables show the calculation of non-GAAP adjusted earnings and non-GAAP adjusted earnings per share under both the prior and new methodologies for each of the quarters of 2015 and 2016.

 



 

2016 NON-GAAP ADJUSTED EARNINGS AND NON-GAAP ADJUSTED EARNINGS PER SHARE (PRIOR METHODOLOGY)

(in thousands, except per share amounts)

 

 

 

Q1 2016

 

Q2 2016

 

Q3 2016

 

Q4 2016

 

FY 2016

 

As reported - GAAP net loss

 

$

(20,917

)

$

(10,541

)

$

(12,894

)

$

(44,368

)

$

(88,720

)

Non-GAAP adjustments

 

35,794

 

37,769

 

38,562

 

80,629

 

192,754

 

Non-cash tax adjustment (1)

 

(7,014

)

(7,447

)

(4,739

)

784

 

(18,416

)

Non-GAAP adjusted earnings (prior methodology)

 

$

7,863

 

$

19,781

 

$

20,929

 

$

37,045

 

$

85,618

 

Add interest expense of convertible debt, net of tax

 

2,156

 

2,156

 

2,156

 

2,156

 

8,624

 

Numerator

 

$

10,019

 

$

21,937

 

$

23,085

 

$

39,201

 

$

94,242

 

Shares used in calculation

 

80,693

 

81,356

 

81,940

 

82,258

 

81,597

 

Non-GAAP adjusted earnings per share (prior methodology)

 

$

0.12

 

$

0.27

 

$

0.28

 

$

0.48

 

$

1.15

 

 


(1) Adjusts the provision for income taxes to reflects the estimated amount we expected to pay or receive in taxes for the period.

 

2016 NON-GAAP ADJUSTED EARNINGS AND NON-GAAP ADJUSTED EARNINGS PER SHARE (NEW METHODOLOGY)

(in thousands, except per share amounts)

 

 

 

Q1 2016

 

Q2 2016

 

Q3 2016

 

Q4 2016

 

FY 2016

 

As reported - GAAP net loss

 

$

(20,917

)

$

(10,541

)

$

(12,894

)

$

(44,368

)

$

(88,720

)

Non-GAAP adjustments

 

35,794

 

37,769

 

38,562

 

80,629

 

192,754

 

Income tax effect of non-GAAP adjustments (1)

 

(12,543

)

(13,190

)

(13,479

)

(13,220

)

(52,431

)

Non-GAAP adjusted earnings (new methodology)

 

$

2,334

 

$

14,038

 

$

12,189

 

$

23,041

 

$

51,603

 

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

 

1,348

 

1,348

 

1,348

 

1,348

 

5,390

 

Numerator

 

$

3,682

 

$

15,386

 

$

13,537

 

$

24,389

 

$

56,993

 

Shares used in calculation

 

80,693

 

81,356

 

81,940

 

82,258

 

81,597

 

Non-GAAP adjusted earnings per share (new methodology)

 

$

0.05

 

$

0.19

 

$

0.17

 

$

0.30

 

$

0.70

 

 


(1) Calculated by taking the pre-tax non-GAAP adjustments and applying the statutory tax rate.

(2) Uses the statutory tax rate.

 

2015 NON-GAAP ADJUSTED EARNINGS AND NON-GAAP ADJUSTED EARNINGS PER SHARE (PRIOR METHODOLOGY)

(in thousands, except per share amounts)

 

 

 

Q1 2015

 

Q2 2015

 

Q3 2015

 

Q4 2015

 

FY 2015

 

As reported - GAAP net loss

 

$

(11,633

)

$

(21,653

)

$

(11,785

)

$

(30,667

)

$

(75,738

)

Non-GAAP adjustments

 

7,821

 

48,909

 

38,752

 

69,212

 

164,694

 

Non-cash tax adjustment (1)

 

(4,181

)

(7,036

)

(2,076

)

(27,845

)

(41,138

)

Non-GAAP adjusted earnings (prior methodology)

 

$

(7,993

)

$

20,220

 

$

24,891

 

$

10,700

 

$

47,818

 

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

 

 

2,156

 

2,156

 

2,156

 

8,624

 

Numerator

 

$

(7,993

)

$

22,376

 

$

27,047

 

$

12,856

 

$

56,442

 

Shares used in calculation

 

59,561

 

81,186

 

81,830

 

81,023

 

81,099

 

Non-GAAP adjusted earnings per share (prior methodology)

 

$

(0.13

)

$

0.28

 

$

0.33

 

$

0.16

 

$

0.70

 

 


(1) Adjusts the provision for income taxes to reflects the estimated amount we expected to pay or receive in taxes for the period.

(2) The Company did not use the if-converted method in Q1 2015 as the result would be anti-dilutive.

 

2015 NON-GAAP ADJUSTED EARNINGS AND NON-GAAP ADJUSTED EARNINGS PER SHARE (NEW METHODOLOGY)

(in thousands, except per share amounts)

 

 

 

Q1 2015

 

Q2 2015

 

Q3 2015

 

Q4 2015

 

FY 2015

 

As reported - GAAP net loss

 

$

(11,633

)

$

(21,653

)

$

(11,785

)

$

(30,667

)

$

(75,738

)

Non-GAAP adjustments

 

7,821

 

48,909

 

38,752

 

69,212

 

164,694

 

Income tax effect of non-GAAP adjustments (1)

 

(2,300

)

(17,609

)

(13,715

)

(24,935

)

(58,559

)

Non-GAAP adjusted earnings (new methodology)

 

$

(6,112

)

$

9,647

 

$

13,252

 

$

13,610

 

$

30,397

 

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

 

 

1,348

 

1,348

 

1,348

 

5,390

 

Numerator

 

$

(6,112

)

$

10,995

 

$

14,599

 

$

14,957

 

$

35,787

 

Shares used in calculation

 

59,561

 

81,186

 

81,830

 

81,023

 

81,099

 

Non-GAAP adjusted earnings per share (new methodology)

 

$

(0.10

)

$

0.14

 

$

0.18

 

$

0.18

 

$

0.44

 

 


(1) Calculated by taking the pre-tax non-GAAP adjustments and applying the statutory tax rate.

(2) Uses the statutory tax rate. The Company did not use the if-converted method in Q1 2015 as the result would be anti-dilutive.

 



 

Valuation Allowance on Deferred Tax Assets

 

The Company recorded a $43 million GAAP tax expense charge related to the establishment of a reserve against the Company’s deferred tax assets during the fourth quarter of 2016.   This charge has no effect on the Company’s cash flows or non-GAAP financial measures and could reverse in future periods.

 

2017 Financial Outlook

 

As of February 21, 2017, Depomed is providing its financial outlook for total revenue, non-GAAP adjusted EBITDA, non-GAAP SG&A expense, and non-GAAP R&D expense for the full year 2017:

 

 

 

2017 Guidance

Total Revenue

 

$

490 to $520 million

Non-GAAP Adjusted EBITDA

 

$

170 to $195 million

Non-GAAP SG&A Expense

 

$

192 to $202 million

Non-GAAP R&D Expense

 

$

30 to $38 million

 

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, costs associated with the Company’s defense against the Horizon Pharma hostile takeover bid in 2015 and the special meeting requests made by an activist investor in 2016, adjustments associated with legal settlements, and to adjust for the tax effect related to each of the non-GAAP adjustments (new methodology) or to adjust for the income tax provision to reflect the estimated amounts payable or receivable in cash (prior methodology). 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, adjustments related to legal settlements, costs associated with the our defense against the Horizon Pharma hostile takeover bid in 2015 and the special meeting requests made by an activist investor in 2016, and transaction costs associated with product acquisitions. 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, Tuesday, February 21st, beginning at 4:30 p.m. EST (1:30 p.m. PST) to discuss its results. Participants can access the call by dialing (866) 643-3010 (United States) or (857) 270-6032 (international) referencing Conference ID 71033060.  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. Please 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.

 

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

 

Twelve Months Ended

 

 

 

December 31,

 

December 31,

 

 

 

2016

 

2015

 

2016

 

2015

 

 

 

(unaudited)

 

(unaudited)

 

Revenues:

 

 

 

 

 

 

 

 

 

Product sales, net

 

$

123,675

 

$

111,059

 

$

455,066

 

$

341,750

 

Royalties

 

236

 

113

 

831

 

985

 

Total revenues

 

123,911

 

111,172

 

455,897

 

342,735

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of sales

 

22,657

 

21,007

 

87,414

 

67,898

 

Research and development expense

 

9,154

 

6,340

 

32,631

 

17,541

 

Acquired in-process research and development

 

 

54,900

 

 

54,900

 

Selling, general and administrative expense

 

48,462

 

58,337

 

204,498

 

199,352

 

Amortization of intangible assets

 

25,734

 

27,060

 

106,845

 

83,344

 

Gain on settlement agreement

 

 

(29,900

)

 

(29,900

)

Total costs and expenses

 

106,007

 

137,744

 

431,388

 

393,135

 

 

 

 

 

 

 

 

 

 

 

Income (loss) from operations

 

17,904

 

(26,572

)

24,509

 

(50,400

)

Interest and other income

 

175

 

417

 

485

 

599

 

Loss on prepayment of senior notes

 

 

 

(5,777

)

 

Interest expense

 

(20,537

)

(22,701

)

(83,719

)

(73,436

)

Benefit/(Provision) from income taxes

 

(41,910

)

18,189

 

(24,218

)

47,499

 

Net loss

 

$

(44,368

)

$

(30,667

)

$

(88,720

)

$

(75,738

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.72

)

$

(0.51

)

$

(1.45

)

$

(1.26

)

Shares used in calculating basic and diluted net loss per share

 

61,695

 

60,580

 

61,289

 

60,117

 

 



 

CONSOLIDATED CONDENSED BALANCE SHEETS

(in thousands)

(unaudited)

 

 

 

December 31,

 

December 31,

 

 

 

2016

 

2015

 

 

 

 

 

 

 

Cash, cash equivalents and marketable securities

 

$

177,420

 

$

209,768

 

Accounts receivable

 

102,589

 

71,687

 

Inventories

 

13,033

 

10,494

 

Income taxes receivable

 

 

6,358

 

Property and equipment, net

 

15,526

 

14,794

 

Intangible assets, net

 

902,149

 

1,008,994

 

Deferred tax assets

 

 

22,995

 

Prepaid and other assets

 

14,620

 

12,159

 

Total assets

 

$

1,225,337

 

$

1,357,249

 

 

 

 

 

 

 

Accounts payable

 

14,855

 

12,805

 

Income tax payable

 

59

 

 

Interest payable

 

15,924

 

18,672

 

Accrued liabilities

 

59,398

 

62,931

 

Accrued rebates, returns and discounts

 

131,536

 

121,058

 

Senior notes

 

466,051

 

563,012

 

Convertible notes

 

252,725

 

237,313

 

Contingent consideration liability

 

14,825

 

14,971

 

Other liabilities

 

19,176

 

11,432

 

Shareholders’ equity

 

250,788

 

315,055

 

Total liabilities and shareholders’ equity

 

$

1,225,337

 

$

1,357,249

 

 



 

RECONCILIATION OF GAAP NET LOSS TO NON-GAAP ADJUSTED EBITDA

(in thousands)

 

 

 

Three Months Ended 

 

Twelve Months Ended

 

 

 

December 31, 

 

December 31, 

 

 

 

2016

 

2015

 

2016

 

2015

 

 

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

GAAP net loss

 

$

(44,368

)

$

(30,667

)

$

(88,720

)

$

(75,738

)

Intangible amortization related to product acquisitions

 

25,734

 

27,060

 

106,845

 

83,344

 

Inventory step-up related to product acquisitions

 

 

35

 

15

 

6,023

 

Product sales benefit related to product acquisitions

 

 

(488

)

 

9,977

 

Contingent consideration related to product acquisitions

 

694

 

652

 

2,287

 

(1,377

)

Stock based compensation

 

4,570

 

4,531

 

17,172

 

14,228

 

Interest income

 

(137

)

(417

)

(447

)

(599

)

Interest expense

 

19,932

 

22,091

 

87,088

 

71,129

 

Depreciation

 

622

 

661

 

2,530

 

2,390

 

Income taxes

 

41,910

 

(18,189

)

24,218

 

(47,499

)

Other costs (1)

 

2,409

 

8,249

 

5,352

 

11,869

 

Gain on settlement agreement

 

 

(29,900

)

 

(29,900

)

Transaction costs

 

 

189

 

45

 

12,456

 

Non-GAAP adjusted EBITDA

 

$

51,367

 

$

38,707

 

$

156,385

 

$

111,203

 

 


(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

 



 

RECONCILIATION OF GAAP NET LOSS TO NON-GAAP ADJUSTED EARNINGS (PRIOR METHODOLOGY)

(in thousands, except per share amounts)

 

 

 

Three Months Ended 

 

Twelve Months Ended

 

 

 

December 31, 

 

December 31,

 

 

 

2016

 

2015

 

2016

 

2015

 

 

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

GAAP net loss

 

$

(44,368

)

$

(30,667

)

$

(88,720

)

$

(75,738

)

Non-cash interest expense on debt

 

4,588

 

4,173

 

18,449

 

15,630

 

Intangible amortization related to product acquisitions

 

25,734

 

27,060

 

106,845

 

83,344

 

Inventory step-up related to product acquisitions

 

 

35

 

15

 

6,023

 

Product sales benefit related to product acquisitions

 

 

(488

)

 

9,977

 

Contingent consideration related to product acquisitions

 

694

 

652

 

2,287

 

(1,377

)

Stock based compensation

 

4,570

 

4,531

 

17,172

 

14,228

 

Acquired in process research and development

 

 

54,900

 

 

54,900

 

Gain on settlement agreement

 

 

(29,900

)

 

(29,900

)

Other costs (1)

 

2,409

 

8,249

 

5,352

 

11,869

 

Valuation allowance on deferred tax assets

 

42,634

 

 

42,634

 

 

Non-cash income tax adjustment (3)

 

784

 

(27,845

)

(18,416

)

(41,138

)

Non-GAAP adjusted earnings (prior methology)

 

$

37,045

 

$

10,700

 

$

85,618

 

$

47,818

 

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

 

2,156

 

2,156

 

8,624

 

8,624

 

Numerator

 

$

39,201

 

$

12,856

 

$

94,242

 

$

56,442

 

Shares used in calculation (2)

 

82,258

 

81,023

 

81,597

 

81,099

 

Non-GAAP adjusted earnings per share (prior methodology)

 

$

0.48

 

$

0.16

 

$

1.15

 

$

0.70

 

 


(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.

(3) Prior methodology. Reflects the estimated amount we expected to pay or receive in taxes for the period.

 



 

RECONCILIATION OF GAAP NET LOSS TO NON-GAAP ADJUSTED EARNINGS (NEW METHODOLOGY)

(in thousands, except per share amounts)

 

 

 

Three Months Ended 

 

Twelve Months Ended

 

 

 

December 31, 

 

December 31, 

 

 

 

2016

 

2015

 

2016

 

2015

 

 

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

GAAP net loss

 

$

(44,368

)

$

(30,667

)

$

(88,720

)

$

(75,738

)

Non-cash interest expense on debt

 

4,588

 

4,173

 

18,449

 

15,630

 

Intangible amortization related to product acquisitions

 

25,734

 

27,060

 

106,845

 

83,344

 

Inventory step-up related to product acquisitions

 

 

35

 

15

 

6,023

 

Product sales benefit related to product acquisitions

 

 

(488

)

 

9,977

 

Contingent consideration related to product acquisitions

 

694

 

652

 

2,287

 

(1,377

)

Stock based compensation

 

4,570

 

4,531

 

17,172

 

14,228

 

Acquired in process research and development

 

 

54,900

 

 

54,900

 

Gain on settlement agreement

 

 

(29,900

)

 

(29,900

)

Other costs (1)

 

2,409

 

8,249

 

5,352

 

11,869

 

Valuation allowance on deferred tax assets

 

42,634

 

 

42,634

 

 

Income tax effect of non-GAAP adjustments (3)

 

(13,220

)

(24,935

)

(52,431

)

(58,559

)

Non-GAAP adjusted earnings (new methology)

 

$

23,041

 

$

13,610

 

$

51,603

 

$

30,397

 

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

 

1,348

 

1,348

 

5,390

 

5,390

 

Numerator

 

$

24,389

 

$

14,957

 

$

56,993

 

$

35,787

 

Shares used in calculation (2)

 

82,258

 

81,023

 

81,597

 

81,099

 

Non-GAAP adjusted earnings per share (new methodology)

 

$

0.30

 

$

0.18

 

$

0.70

 

$

0.44

 

 


(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.

(3) New methodology. Calculated by taking the pre-tax non-GAAP adjustments and applying the statutory tax rate. Expected cash taxes for the period was ($1,508) and zero for the three and twelve months ended December 31, 2016 and $9,656 and ($6,361) for the three and twelve months ended December 31, 2015.

 



 

RECONCILATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION (PRIOR METHODOLOGY)

For the three months ended December 31, 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

 

$

22,657

 

$

9,154

 

$

48,462

 

$

25,734

 

$

(20,537

)

$

(41,910

)

Non-cash interest expense on debt

 

 

 

 

 

4,588

 

 

Intangible amortization related to product acquisitions

 

 

 

 

(25,734

)

 

 

Inventory step-up related to product acquisitions

 

 

 

 

 

 

 

Contingent consideration related to product acquisitions

 

 

 

(89

)

 

605

 

 

Stock based compensation

 

(16

)

(167

)

(4,387

)

 

 

 

Other costs

 

 

 

(2,409

)

 

 

 

Valuation allowance on deferred tax assets

 

 

 

 

 

 

42,634

 

Non-cash income tax adjustment (prior methodology)

 

 

 

 

 

 

784

 

Non-GAAP adjusted (prior methodology)

 

$

22,641

 

$

8,987

 

$

41,577

 

$

 

$

(15,344

)

$

1,508

 

 

RECONCILATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION (PRIOR METHODOLOGY)

For the twelve months ended December 31, 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

 

$

87,414

 

$

32,631

 

$

204,498

 

$

106,845

 

$

(83,719

)

$

(24,218

)

Non-cash interest expense on debt

 

 

 

 

 

18,449

 

 

Intangible amortization related to product acquisitions

 

 

 

 

(106,845

)

 

 

Inventory step-up related to product acquisitions

 

(15

)

 

 

 

 

 

Contingent consideration related to product acquisitions

 

 

 

120

 

 

2,407

 

 

Stock based compensation

 

(43

)

(496

)

(16,633

)

 

 

 

Other costs

 

 

 

(5,352

)

 

 

 

Valuation allowance on deferred tax assets

 

 

 

 

 

 

42,634

 

Non-cash income tax adjustment (prior methodology)

 

 

 

 

 

 

(18,416

)

Non-GAAP adjusted (prior methodology)

 

$

87,356

 

$

32,135

 

$

182,633

 

$

 

$

(62,863

)

$

 

 



 

RECONCILATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION (PRIOR METHODOLOGY)

For the three months ended December 31, 2015

(in thousands)

(unaudited)

 

 

 

Product Sales

 

Cost of sales

 

Research and
development
expense

 

IPR&D

 

Selling, general
and
administrative
expense

 

Amortization
of intangible
assets

 

Gain on
Settlement

 

Interest
expense

 

Benefit from
(provision for)
income taxes

 

GAAP as reported

 

$

111,059

 

$

21,007

 

$

6,340

 

$

54,900

 

$

58,337

 

$

27,060

 

$

(29,900

)

$

(22,701

)

$

18,189

 

Non-cash interest expense on debt

 

 

 

 

 

 

 

 

4,173

 

 

Intangible amortization related to product acquisitions

 

 

 

 

 

 

(27,060

)

 

 

 

Inventory step-up related to product acquisitions

 

 

35

 

 

 

 

 

 

 

 

Product sales benefit related to product acquisitions

 

(488

)

 

 

 

 

 

 

 

 

Contingent consideration related to product acquisitions

 

 

 

 

 

(42

)

 

 

610

 

 

Stock based compensation

 

 

(12

)

(58

)

 

(4,461

)

 

 

 

 

Acquired in process research and development

 

 

 

 

(54,900

)

 

 

 

 

 

Gain on settlement agreement

 

 

 

 

 

 

 

29,900

 

 

 

Other costs

 

 

 

 

 

(8,249

)

 

 

 

 

Non-cash income tax adjustment (prior methodology)

 

 

 

 

 

 

 

 

 

(27,845

)

Non-GAAP adjusted (prior methodology)

 

$

110,571

 

$

21,030

 

$

6,282

 

$

 

$

45,585

 

$

 

$

 

$

(17,918

)

$

(9,656

)

 

RECONCILATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION (PRIOR METHODOLOGY)

For the twelve months ended December 31, 2015

(in thousands)

(unaudited)

 

 

 

Product Sales

 

Cost of sales

 

Research and
development
expense

 

IPR&D

 

Selling, general
and
administrative
expense

 

Amortization
of intangible
assets

 

Gain on
Settlement

 

Interest
expense

 

Benefit from
(provision for)
income taxes

 

GAAP as reported

 

$

341,750

 

$

67,898

 

$

17,541

 

$

54,900

 

$

199,352

 

$

83,344

 

$

(29,900

)

$

(73,436

)

$

47,499

 

Non-cash interest expense on debt

 

 

 

 

 

 

 

 

15,630

 

 

Intangible amortization related to product acquisitions

 

 

 

 

 

 

(83,344

)

 

 

 

Inventory step-up related to product acquisitions

 

 

(6,023

)

 

 

 

 

 

 

 

Product sales benefit related to product acquisitions

 

9,977

 

 

 

 

 

 

 

 

 

Contingent consideration related to product acquisitions

 

 

 

 

 

3,684

 

 

 

2,307

 

 

Stock based compensation

 

 

(21

)

(277

)

 

(13,930

)

 

 

 

 

Acquired in process research and development

 

 

 

 

(54,900

)

 

 

 

 

 

Gain on settlement agreement

 

 

 

 

 

 

 

29,900

 

 

 

Other costs

 

 

 

 

 

 

 

 

 

 

Non-cash income tax adjustment (prior methodology)

 

 

 

 

 

 

 

 

 

(41,138

)

Non-GAAP adjusted (prior methodology)

 

$

351,727

 

$

61,854

 

$

17,264

 

$

 

$

189,106

 

$

 

$

 

$

(55,499

)

$

6,361

 

 



 

RECONCILATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION (NEW METHODOLOGY)

For the three months ended December 31, 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

 

$

22,657

 

$

9,154

 

$

48,462

 

$

25,734

 

$

(20,537

)

$

(41,910

)

Non-cash interest expense on debt

 

 

 

 

 

4,588

 

 

Intangible amortization related to product acquisitions

 

 

 

 

(25,734

)

 

 

Inventory step-up related to product acquisitions

 

 

 

 

 

 

 

Contingent consideration related to product acquisitions

 

 

 

(89

)

 

605

 

 

Stock based compensation

 

(16

)

(167

)

(4,387

)

 

 

 

Other costs

 

 

 

(2,409

)

 

 

 

Valuation allowance on deferred tax assets

 

 

 

 

 

 

42,634

 

Income tax effect of non-GAAP adjustments (new methodology)

 

 

 

 

 

 

(13,220

)

Non-GAAP adjusted (new methodology)

 

$

22,641

 

$

8,987

 

$

41,577

 

$

 

$

(15,344

)

$

(12,496

)

 

RECONCILATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION (NEW METHODOLOGY)

For the twelve months ended December 31, 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

 

$

87,414

 

$

32,631

 

$

204,498

 

$

106,845

 

$

(83,719

)

$

(24,218

)

Non-cash interest expense on debt

 

 

 

 

 

18,449

 

 

Intangible amortization related to product acquisitions

 

 

 

 

(106,845

)

 

 

Inventory step-up related to product acquisitions

 

(15

)

 

 

 

 

 

Contingent consideration related to product acquisitions

 

 

 

120

 

 

2,407

 

 

Stock based compensation

 

(43

)

(496

)

(16,633

)

 

 

 

Other costs

 

 

 

(5,352

)

 

 

 

Valuation allowance on deferred tax assets

 

 

 

 

 

 

42,634

 

Income tax effect of non-GAAP adjustments (new methodology)

 

 

 

 

 

 

(52,431

)

Non-GAAP adjusted (new methodology)

 

$

87,356

 

$

32,135

 

$

182,633

 

$

 

$

(62,863

)

$

(34,015

)

 



 

RECONCILATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION (NEW METHODOLOGY)

For the three months ended December 31, 2015

(in thousands)

(unaudited)

 

 

 

Product Sales

 

Cost of sales

 

Research and
development
expense

 

IPR&D

 

Selling, general
and
administrative
expense

 

Amortization
of intangible
assets

 

Gain on
Settlement

 

Interest
expense

 

Benefit from
(provision for)
income taxes

 

GAAP as reported

 

$

111,059

 

$

21,007

 

$

6,340

 

$

54,900

 

$

58,337

 

$

27,060

 

$

(29,900

)

$

(22,701

)

$

18,189

 

Non-cash interest expense on debt

 

 

 

 

 

 

 

 

4,173

 

 

Intangible amortization related to product acquisitions

 

 

 

 

 

 

(27,060

)

 

 

 

Inventory step-up related to product acquisitions

 

 

35

 

 

 

 

 

 

 

 

Product sales benefit related to product acquisitions

 

(488

)

 

 

 

 

 

 

 

 

Contingent consideration related to product acquisitions

 

 

 

 

 

(42

)

 

 

610

 

 

Stock based compensation

 

 

(12

)

(58

)

 

(4,461

)

 

 

 

 

Acquired in process research and development

 

 

 

 

(54,900

)

 

 

 

 

 

Gain on settlement agreement

 

 

 

 

 

 

 

29,900

 

 

 

Other costs

 

 

 

 

 

(8,249

)

 

 

 

 

Income tax effect of non-GAAP adjustments (new methodology)

 

 

 

 

 

 

 

 

 

(24,935

)

Non-GAAP adjusted (new methodology)

 

$

110,571

 

$

21,030

 

$

6,282

 

$

 

$

45,585

 

$

 

$

 

$

(17,918

)

$

(6,746

)

 

RECONCILATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION (NEW METHODOLOGY)

For the twelve months ended December 31, 2015

(in thousands)

(unaudited)

 

 

 

Product Sales

 

Cost of sales

 

Research and
development
expense

 

IPR&D

 

Selling, general
and
administrative
expense

 

Amortization
of intangible
assets

 

Gain on
Settlement

 

Interest
expense

 

Benefit from
(provision for)
income taxes

 

GAAP as reported

 

$

341,750

 

$

67,898

 

$

17,541

 

$

54,900

 

$

199,352

 

$

83,344

 

$

(29,900

)

$

(73,436

)

$

47,499

 

Non-cash interest expense on debt

 

 

 

 

 

 

 

 

15,630

 

 

Intangible amortization related to product acquisitions

 

 

 

 

 

 

(83,344

)

 

 

 

Inventory step-up related to product acquisitions

 

 

(6,023

)

 

 

 

 

 

 

 

Product sales benefit related to product acquisitions

 

9,977

 

 

 

 

 

 

 

 

 

Contingent consideration related to product acquisitions

 

 

 

 

 

3,684

 

 

 

2,307

 

 

Stock based compensation

 

 

(21

)

(277

)

 

(13,930

)

 

 

 

 

Acquired in process research and development

 

 

 

 

(54,900

)

 

 

 

 

 

Gain on settlement agreement

 

 

 

 

 

 

 

29,900

 

 

 

Other costs

 

 

 

 

 

 

 

 

 

 

Income tax effect of non-GAAP adjustments (new methodology)

 

 

 

 

 

 

 

 

 

(58,559

)

Non-GAAP adjusted (new methodology)

 

$

351,727

 

$

61,854

 

$

17,264

 

$

 

$

189,106

 

$

 

$

 

$

(55,499

)

$

(11,060

)

 



 

RECONCILIATION OF GAAP NET LOSS PER SHARE TO NON-GAAP ADJUSTED EARNINGS PER SHARE (PRIOR METHODOLOGY)

 

 

 

Three Months Ended

 

Twelve Months Ended

 

 

 

December 31,

 

December 31,

 

 

 

2016

 

2015

 

2016

 

2015

 

 

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

GAAP net loss per share

 

$

(0.72

)

$

(0.51

)

$

(1.45

)

$

(1.26

)

Conversion from basic shares to if-converted diluted shares

 

0.18

 

0.13

 

0.36

 

0.32

 

Non-cash interest expense on debt

 

0.06

 

0.05

 

0.23

 

0.19

 

Intangible amortization related to product acquisitions

 

0.31

 

0.33

 

1.31

 

1.03

 

Inventory step-up related to product acquisitions

 

 

 

 

0.07

 

Product sales benefit related to product acquisitions

 

 

(0.01

)

 

0.12

 

Contingent consideration related to product acquisitions

 

0.01

 

0.01

 

0.03

 

(0.02

)

Stock based compensation

 

0.06

 

0.06

 

0.21

 

0.18

 

Acquired in process research and development

 

 

0.68

 

 

0.68

 

Gain on settlement agreement

 

 

(0.37

)

 

(0.37

)

Other costs (1)

 

0.03

 

0.10

 

0.07

 

0.15

 

Valuation allowance on deferred tax assets

 

0.52

 

 

0.52

 

 

Non-cash income tax adjustment (3)

 

0.01

 

(0.34

)

(0.23

)

(0.51

)

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

 

0.03

 

0.03

 

0.11

 

0.11

 

Non-GAAP adjusted earnings per share (prior methodology)

 

$

0.48

 

$

0.16

 

$

1.15

 

$

0.70

 

 


(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.

(3) Prior methodology. Reflects the estimated amount we expected to pay or receive in taxes for the period.

 



 

RECONCILIATION OF GAAP NET LOSS PER SHARE TO NON-GAAP ADJUSTED EARNINGS PER SHARE (NEW METHODOLOGY)

 

 

 

Three Months Ended

 

Twelve Months Ended

 

 

 

December 31,

 

December 31,

 

 

 

2016

 

2015

 

2016

 

2015

 

 

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

GAAP net loss per share

 

$

(0.72

)

$

(0.51

)

$

(1.45

)

$

(1.26

)

Conversion from basic shares to if-converted diluted shares

 

0.18

 

0.13

 

0.36

 

0.32

 

Non-cash interest expense on debt

 

0.06

 

0.05

 

0.23

 

0.19

 

Intangible amortization related to product acquisitions

 

0.31

 

0.33

 

1.31

 

1.03

 

Inventory step-up related to product acquisitions

 

 

 

 

0.07

 

Product sales benefit related to product acquisitions

 

 

(0.01

)

 

0.12

 

Contingent consideration related to product acquisitions

 

0.01

 

0.01

 

0.03

 

(0.02

)

Stock based compensation

 

0.06

 

0.06

 

0.21

 

0.18

 

Acquired in process research and development

 

 

0.68

 

 

0.68

 

Gain on settlement agreement

 

 

(0.37

)

 

(0.37

)

Other costs (1)

 

0.03

 

0.10

 

0.07

 

0.15

 

Valuation allowance on deferred tax assets

 

0.52

 

 

0.52

 

 

Income tax effect of non-GAAP adjustments (3)

 

(0.16

)

(0.31

)

(0.64

)

(0.72

)

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

 

0.02

 

0.02

 

0.07

 

0.07

 

Non-GAAP adjusted earnings per share (new methodology)

 

$

0.30

 

$

0.18

 

$

0.70

 

$

0.44

 

 


(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.

(3) New methodology. Calculated by taking the pre-tax non-GAAP adjustments and applying the statutory tax rate.