OREANDA-NEWS. Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the second quarter of 2016 and provided a business update.

Financial Highlights

        
     

($ in millions, except per share data)

  

Three Months Ended
June 30,
   

2016

  

2015*

  

% Change

EYLEA U.S. net product sales

  

$

831

    

$

655

    

27

%

Total revenues

  

$

1,213

    

$

999

    

21

%

GAAP net income

  

$

196

    

$

195

    

1

%

GAAP net income per share - diluted

  

$

1.69

    

$

1.69

    

—

%

Non-GAAP net income(2)

  

$

329

    

$

265

    

24

%

Non-GAAP net income per share - diluted(2)

  

$

2.82

    

$

2.27

    

24

%
             

* See Table 3 of this press release for an explanation of revisions made to 2015 non-GAAP amounts previously reported.

"In the first half of this year, EYLEA continued to demonstrate strong sales growth, and Praluent sales made steady progress as healthcare providers become more familiar with this new therapeutic class and learn to navigate payer utilization management criteria," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron.  "In the second half of the year, for sarilumab in rheumatoid arthritis, we look forward to the upcoming U.S. regulatory decision and potential launch.  We also recently completed a U.S. regulatory submission for dupilumab for the treatment of atopic dermatitis and are working to bring this breakthrough therapy to patients as soon as possible."

Business Highlights

Marketed Product Update

EYLEA® (aflibercept) Injection for Intravitreal Injection

  • In the second quarter of 2016, net sales of EYLEA in the United States increased 27% to $831 million from $655 million in the second quarter of 2015. Overall distributor inventory levels remained within the Company's one- to two-week targeted range.
  • Bayer commercializes EYLEA outside the United States. In the second quarter of 2016, net sales of EYLEA outside of the United States(1) were $486 million, compared to $338 million in the second quarter of 2015. In the second quarter of 2016, Regeneron recognized $167 million from its share of net profit from EYLEA sales outside the United States, compared to $107 million in the second quarter of 2015.

Praluent® (alirocumab) Injection for the Treatment of Elevated Low-Density Lipoprotein (LDL) Cholesterol

  • In the second quarter of 2016, global net sales of Praluent were $24 million. Product sales for Praluent are recorded by Sanofi, and the Company shares in any profits or losses from the commercialization of Praluent. Praluent was launched in the United States in the third quarter of 2015 and in certain countries in the European Union commencing in the fourth quarter of 2015.
  • In the second quarter of 2016, the U.S. Food and Drug Administration (FDA) accepted for review a supplemental Biologics License Application (sBLA) for a monthly dosing regimen of Praluent, with a target action date of January 24, 2017.
  • In July 2016, the Japanese Ministry of Health, Labour and Welfare granted marketing and manufacturing authorization for Praluent for the treatment of uncontrolled LDL cholesterol, in certain adult patients with hypercholesterolemia at high cardiovascular risk.
  • The ODYSSEY OUTCOMES trial remains ongoing, and is assessing the potential of Praluent to demonstrate cardiovascular benefit.

Pipeline Progress
Regeneron has fifteen product candidates in clinical development.  These consist of EYLEA and fourteen fully human monoclonal antibodies generated using the Company's VelocImmune® technology, including four in collaboration with Sanofi.  In addition to EYLEA and Praluent, highlights from the antibody pipeline include:

Sarilumab, the Company's antibody targeting IL-6R for rheumatoid arthritis, is currently being studied in the global Phase 3 SARIL-RA program.

  • In December 2015, the FDA accepted for review a Biologics License Application (BLA) for sarilumab, with a target action date of October 30, 2016.
  • In July 2016, the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for sarilumab.

Dupilumab, the Company's antibody that blocks signaling of IL-4 and IL-13, is currently being studied in atopic dermatitis, asthma, nasal polyps, and eosinophilic esophagitis.

  • A BLA for atopic dermatitis was recently submitted to the FDA.
  • In April 2016, the Company and Sanofi reported that the Phase 3 LIBERTY AD SOLO 1 and SOLO 2 trials evaluating dupilumab in adult patients with inadequately controlled moderate-to-severe atopic dermatitis met their primary endpoints.
  • In June 2016, the Company and Sanofi reported that the Phase 3 LIBERTY AD CHRONOS trial evaluating dupilumab with topical corticosteroids in adult patients with inadequately controlled moderate-to-severe atopic dermatitis met its primary and key secondary endpoints.

Fasinumab, the Company's antibody targeting Nerve Growth Factor (NGF), is currently being studied in patients with pain due to osteoarthritis (Phase 3) and chronic low back pain (Phase 2b/3).

  • In May 2016, the Company reported top-line results from a Phase 2/3 study evaluating fasinumab in patients with moderate-to-severe osteoarthritis pain of the hip or knee who have a history of inadequate pain relief or intolerance to current analgesic therapies. The study met its primary endpoint at 16 weeks.

REGN2810, an antibody to programmed cell death protein 1 (PD-1), entered a potentially pivotal clinical study for the treatment of advanced cutaneous squamous cell carcinoma in the second quarter of 2016.

Evinacumab is an antibody to Angptl-3.  In May 2016, the Company reported positive interim results from an ongoing proof-of-concept study in patients with homozygous familial hypercholesterolemia (HoFH).

REGN3470-3471-3479 is a combination of antibodies to Ebola virus.  A Phase 1 clinical study in healthy volunteers was initiated in the second quarter of 2016.  In addition, in the second quarter of 2016, the FDA granted orphan-drug designation to REGN3470-3471-3479 for the treatment of Ebola virus infection.

REGN2477 is an antibody to Activin A being developed for Fibrodysplasia Ossificans Progressiva (FOP).  A Phase 1 clinical study was initiated in the second quarter of 2016 in healthy volunteers.

Select Upcoming 2016 Milestones

Clinical Programs

Milestones

REGN2176-3 (PDGFR-beta Antibody co-formulated with aflibercept)
  • Report results from Phase 2 study

Praluent
  • Data Monitoring Committee interim analysis of ODYSSEY OUTCOMES trial
  • Ongoing launch in additional countries

Sarilumab (IL-6R Antibody)
  • FDA target action date of October 30, 2016
  • File for additional regulatory approvals outside the United States

Dupilumab (IL-4R Antibody)
  • FDA to provide target action date related to BLA submission for atopic dermatitis in the United States
  • Complete patient enrollment in Phase 3 asthma trial
  • Initiate Phase 3 study in pediatric patients in atopic dermatitis

Business Development Update

  • In April 2016, the Company and Intellia Therapeutics, Inc. entered into a license and collaboration agreement to advance CRISPR/Cas gene-editing technology for in vivo therapeutic development. In addition to the discovery, development and commercialization of new therapies, the companies will focus on technology development of the CRISPR/Cas platform. In May 2016, Intellia completed an initial public offering of its common stock and the Company purchased $50.0 million of Intellia common stock in a concurrent private placement.
  • In July 2016, the Company and Adicet Bio, Inc. entered into a license and collaboration agreement to develop next-generation engineered immune-cell therapeutics with fully human chimeric antigen receptors and T-cell receptors directed to disease-specific cell surface antigens in order to enable the precise engagement and killing of tumor cells.

Second Quarter 2016 Financial Results

Product Revenues: Net product sales were $834 million in the second quarter of 2016, compared to $658 million in the second quarter of 2015.  EYLEA net product sales in the United States were $831 million in the second quarter of 2016, compared to $655 million in the second quarter of 2015.

Total Revenues: Total revenues, which include product revenues described above, increased by 21% to $1,213 million in the second quarter of 2016, compared to $999 million in the second quarter of 2015.  Total revenues also include Sanofi and Bayer collaboration revenues of $355 million in the second quarter of 2016, compared to $329 million in the second quarter of 2015.  Collaboration revenues in the second quarter of 2016 increased primarily due to an increase in the Company's net profit from commercialization of EYLEA outside the United States and reimbursement of the Company's research and development expenses and amortization of up-front payments received in connection with the Company's July 2015 immuno-oncology collaboration with Sanofi, partly offset by lower reimbursement of the Company's research and development expenses and an increase in the Company's share of losses primarily from the commercialization of Praluent under the Company's antibody collaboration with Sanofi.

Refer to Table 4 for a summary of collaboration revenue.

Research and Development (R&D) Expenses: GAAP R&D expenses were $560 million in the second quarter of 2016, compared to $390 million in the second quarter of 2015.  The higher R&D expenses in the second quarter of 2016 were principally due to the $75 million up-front payment made in connection with the April 2016 license and collaboration agreement with Intellia, higher development costs primarily related to fasinumab and REGN2810, and higher headcount to support the Company's increased R&D activities, partly offset by lower development costs primarily related to dupilumab.  In addition, in the second quarter of 2016, R&D-related non-cash share-based compensation expense was $79 million, compared to $60 million in the second quarter of 2015.

Selling, General, and Administrative (SG&A) Expenses: GAAP SG&A expenses were $292 million in the second quarter of 2016, compared to $175 million in the second quarter of 2015.  The increase was primarily due to higher commercialization-related expenses in connection with EYLEA and Praluent, and higher headcount.  In addition, in the second quarter of 2016, SG&A-related non-cash share-based compensation expense was $48 million, compared to $32 million in the second quarter of 2015.

Cost of Goods Sold (COGS): GAAP COGS was $41 million in the second quarter of 2016, compared to $61 million in the second quarter of 2015.  COGS primarily consists of royalties as well as costs in connection with producing U.S. EYLEA commercial supplies, and various start-up costs in connection with the Company's Limerick, Ireland commercial manufacturing facility.  COGS decreased principally due to a decrease in royalties since the Company's obligation to pay Genentech based on sales of EYLEA ended in May 2016.

Income Tax Expense: In the second quarter of 2016, GAAP income tax expense was $96 million and the effective tax rate was 32.9%, compared to $133 million and 40.7% in the second quarter of 2015.  The effective tax rate for the second quarter of 2016 was positively impacted, compared to the U.S. federal statutory rate, by the tax benefit associated with stock-based compensation, the domestic manufacturing deduction, and the federal tax credit for increased research activities, partly offset by the negative impact of losses incurred in foreign jurisdictions with rates lower than the federal statutory rate and the non-tax deductible Branded Prescription Drug Fee.  As described in Table 3 of this press release, the Company adopted Accounting Standards Update 2016-09 (ASU 2016-09), Compensation - Stock Compensation, Improvements to Employee Share-Based Payment Accounting, during the second quarter of 2016.  ASU 2016-09 requires companies to recognize all excess tax benefits and tax deficiencies in connection with stock-based compensation as income tax expense or benefit in the income statement (previously, excess tax benefits were recognized in additional paid-in capital on the balance sheet).

GAAP and Non-GAAP Net Income: The Company reported GAAP net income of $196 million, or $1.88 per basic share and $1.69 per diluted share, in the second quarter of 2016, compared to GAAP net income of $195 million, or $1.89 per basic share and $1.69 per diluted share, in the second quarter of 2015.

The Company reported non-GAAP net income of $329 million, or $3.15 per basic share and $2.82 per diluted share, in the second quarter of 2016, compared to non-GAAP net income of $265 million, or $2.58 per basic share and $2.27 per diluted share, in the second quarter of 2015.

A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release.

2016 Financial Guidance(3)

The Company's updated full year 2016 financial guidance consists of the following components:

EYLEA U.S. net product sales

20% - 25% growth over 2015 (reaffirmed)

Sanofi reimbursement of Regeneron commercialization-related expenses

$310 million - $340 million

(previously $320 million - $370 million)

Non-GAAP unreimbursed R&D(2) (4)

$970 million - $1.01 billion

(previously $875 million - $950 million)

Non-GAAP SG&A(2) (4)

$980 million - $1.02 billion

(previously $925 million - $1.0 billion)

Effective tax rate

33% - 41%

Capital expenditures

$480 million - $530 million

(previously $550 million - $625 million)

(1)

Regeneron records net product sales of EYLEA in the United States.  Outside the United States, EYLEA net product sales comprise sales by Bayer in countries other than Japan and sales by Santen Pharmaceutical Co., Ltd. in Japan under a co-promotion agreement with an affiliate of Bayer.  The Company recognizes its share of the profits (including a percentage on sales in Japan) from EYLEA sales outside the United States within "Bayer collaboration revenue" in its Statements of Operations.
   

(2)

This press release uses non-GAAP net income, non-GAAP net income per share, non-GAAP unreimbursed R&D, and non-GAAP SG&A, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles ("GAAP").  These non-GAAP financial measures are computed by excluding certain non-cash and other items from the related GAAP financial measure.  Non-GAAP adjustments also include the income tax effect of reconciling items.

 

The Company makes such adjustments for items the Company does not view as useful in evaluating its operating performance.  For example, adjustments may be made for items that fluctuate from period to period based on factors that are not within the Company's control, such as the Company's stock price on the dates share-based grants are issued.  Management uses these non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis.  Additionally, such non-GAAP measures provide investors with an enhanced understanding of the financial performance of the Company's core business operations.  However, there are limitations in the use of these and other non-GAAP financial measures as they exclude certain expenses that are recurring in nature.  Furthermore, the Company's non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies.  Any non-GAAP financial measure presented by Regeneron should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP.  A reconciliation of the Company's historical GAAP to non-GAAP results is included in Table 3 of this press release.
   

(3)

The Company's 2016 financial guidance does not assume the completion of any significant business development transactions not completed as of the date of this press release.
   

(4)

A reconciliation of full year 2016 non-GAAP to GAAP financial guidance is included below:
   

Projected Range

(In millions)

  

Low

  

High

GAAP unreimbursed R&D (5)

  

$

1,390

    

$

1,450

  

R&D: Non-cash share-based compensation expense

  

(320)

    

(340)

  

R&D: Upfront payments related to license and
    collaboration agreements

  

(100)

    

(100)

  

Non-GAAP unreimbursed R&D

  

$

970

    

$

1,010

  
         

GAAP SG&A

  

$

1,205

    

$

1,275

  

SG&A: Non-cash share-based compensation expense

  

(225)

    

(255)

  

Non-GAAP SG&A

  

$

980

    

$

1,020

  

(5)

Unreimbursed R&D represents R&D expenses reduced by R&D expense reimbursements from the Company's collaborators and/or customers.
   

 

About Regeneron Pharmaceuticals, Inc.

Regeneron is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.  Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, atopic dermatitis, pain, cancer, and infectious diseases. 

Non-GAAP Financial Measures

This press release and/or the financial results attached to this press release include amounts that are considered "non-GAAP financial measures" under SEC rules.  As required, Regeneron has provided reconciliations of historical non-GAAP financial measures.

TABLE 1
 

REGENERON PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)

(In thousands)
 
   

June 30,

  

December 31,
   

2016

  

2015

Assets:

        

Cash and marketable securities

  

$

1,635,016

    

$

1,677,385

  

Accounts receivable - trade, net

  

1,431,966

    

1,152,489

  

Accounts receivable from Sanofi and Bayer

  

320,005

    

315,304

  

Inventories

  

316,073

    

238,578

  

Deferred tax assets

  

626,191

    

461,945

  

Property, plant, and equipment, net

  

1,772,923

    

1,594,120

  

Other assets

  

102,732

    

169,311

  

Total assets

  

$

6,204,906

    

$

5,609,132

  
         

Liabilities and stockholders' equity:

        

Accounts payable, accrued expenses, and other liabilities

  

$

880,357

    

$

760,619

  

Deferred revenue

  

884,016

    

818,166

  

Facility lease obligations

  

363,550

    

364,708

  

Convertible senior notes

  

477

    

10,802

  

Stockholders' equity

  

4,076,506

    

3,654,837

  

Total liabilities and stockholders' equity

  

$

6,204,906

    

$

5,609,132

  

TABLE 2
 

REGENERON PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)

(In thousands, except per share data)
 
   

Three Months Ended
June 30,

  

Six Months Ended
June 30,
   

2016

  

2015

  

2016

  

2015

Revenues:

                

Net product sales

  

$

834,219

    

$

657,819

    

$

1,618,401

    

$

1,202,392

  

Sanofi collaboration revenue

  

163,414

    

195,110

    

383,108

    

368,466

  

Bayer collaboration revenue

  

191,896

    

134,237

    

371,488

    

258,083

  

Other revenue

  

23,100

    

11,451

    

40,481

    

39,288

  
   

1,212,629

    

998,617

    

2,413,478

    

1,868,229

  

Expenses:

                

Research and development

  

559,930

    

390,330

    

1,030,042

    

733,443

  

Selling, general, and administrative

  

292,038

    

174,588

    

581,715

    

333,579

  

Cost of goods sold

  

41,247

    

60,855

    

120,189

    

103,425

  

Cost of collaboration and contract manufacturing (COCM)

  

27,786

    

27,985

    

60,596

    

69,370

  
   

921,001

    

653,758

    

1,792,542

    

1,239,817

  
                 

Income from operations

  

291,628

    

344,859

    

620,936

    

628,412

  
                 

Other income (expense), net

  

628

    

(16,863)

    

1,471

    

(23,893)

  
                 

Income before income taxes

  

292,256

    

327,996

    

622,407

    

604,519

  
                 

Income tax expense

  

(96,038)

    

(133,353)

    

(244,804)

    

(333,855)

  
                 

Net income

  

$

196,218

    

$

194,643

    

$

377,603

    

$

270,664

  
                 

Net income per share - basic

  

$

1.88

    

$

1.89

    

$

3.61

    

$

2.64

  

Net income per share - diluted

  

$

1.69

    

$

1.69

    

$

3.24

    

$

2.35

  
                 

Weighted average shares outstanding - basic

  

104,633

    

102,886

    

104,462

    

102,558

  

Weighted average shares outstanding - diluted

  

116,231

    

115,259

    

116,617

    

114,962

  

TABLE 3
 

REGENERON PHARMACEUTICALS, INC.

RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME (Unaudited)

(In thousands, except per share data)
 
   

Three Months Ended

June 30,

  

Six Months Ended

June 30,
   

2016

  

2015

  

2016

  

2015

GAAP net income

  

$

196,218

    

$

194,643

    

$

377,603

    

$

270,664

  

Adjustments:

                

R&D: Non-cash share-based compensation expense

  

79,317

    

60,045

    

157,419

    

119,547

  

R&D: Upfront payment related to license and
   collaboration agreement

  

75,000

    

—

    

75,000

    

—

  

SG&A: Non-cash share-based compensation expense

  

47,730

    

32,159

    

107,812

    

74,334

  

COGS and COCM: Non-cash share-based
   compensation expense

  

4,644

    

2,053

    

8,710

    

4,135

  

Other expense: Non-cash interest and loss on
   extinguishment related to convertible senior notes

  

494

    

16,299

    

578

    

19,489

  

Income tax effect of reconciling items above (c)

  

(74,287)

    

(39,734)

    

(125,014)

    

(78,222)

  

Non-GAAP net income (c)

  

$

329,116

    

$

265,465

    

$

602,108

    

$

409,947

  
                 

Non-GAAP net income per share - basic

  

$

3.15

    

$

2.58

    

$

5.76

    

$

4.00

  

Non-GAAP net income per share - diluted (a)

  

$

2.82

    

$

2.27

    

$

5.15

    

$

3.51

  
                 

Shares used in calculating:

                

Non-GAAP net income per share - basic

  

104,633

    

102,886

    

104,462

    

102,558

  

Non-GAAP net income per share - diluted (b)

  

116,523

    

116,977

    

116,836

    

116,778

  

(a)

For diluted non-GAAP net income per share calculations, interest expense related to the contractual coupon interest rate on the Company's 1.875% convertible senior notes were excluded since these securities were dilutive.  Such interest expense was not material for the three and six months ended June 30, 2016 and 2015.
   

(b)

Weighted average shares outstanding includes the dilutive effect, if any, of employee stock options, restricted stock awards, convertible senior notes, and warrants.
   

(c)

Prior to the quarter ended June 30, 2016, non-GAAP measures presented by the Company also included an income tax expense adjustment from GAAP tax expense to the amount of taxes that were paid or payable in cash in respect of the relevant period.  Historically, there had been a significant difference between the Company's GAAP effective tax rate and actual cash income taxes paid or payable primarily due to the utilization of excess tax benefits in connection with employee exercises of stock options (which were recorded to additional paid-in capital for GAAP reporting purposes).  In connection with the adoption of ASU 2016-09, Compensation - Stock Compensation, Improvements to Employee Share-Based Payment Accounting, during the second quarter of 2016, the Company chose to discontinue such non-GAAP adjustment as ASU 2016-09 requires entities to recognize excess tax benefits in connection with employee exercises of stock options in the income statement.  The Company adopted this aspect of ASU 2016-09 prospectively.  A reconciliation to the previously reported non-GAAP adjustment is presented below:
   

Three Months Ended

June 30, 2015

  

Six Months Ended

June 30, 2015

Non-GAAP net income - as revised (see above)

  

$

265,465

    

$

409,947

  

Income tax effect of reconciling items (see
  above)

  

39,734

    

78,222

  

Non-cash income taxes (as previously
  reported)

  

32,925

    

185,891

  

Non-GAAP net income - as previously reported

  

$

338,124

    

$

674,060

  
         

Note: As a result of the above revisions to non-GAAP net income, non-GAAP net income per share (basic and diluted) have also been revised accordingly.

TABLE 4
 

REGENERON PHARMACEUTICALS, INC.

COLLABORATION REVENUE (Unaudited)

(In thousands)
 
   

Three Months Ended
June 30,

  

Six Months Ended
June 30,
   

2016

  

2015

  

2016

  

2015

Sanofi collaboration revenue:

                

Reimbursement of Regeneron research and
   development expenses

  

$

176,582

    

$

211,516

    

$

399,459

    

$

381,022

  

Reimbursement of Regeneron commercialization-
   related expenses

  

85,885

    

27,346

    

159,159

    

35,804

  

Regeneron's share of losses in connection with
   commercialization of antibodies

  

(122,107)

    

(46,313)

    

(221,529)

    

(68,718)

  

Other

  

23,054

    

2,561

    

46,019

    

20,358

  

Total Sanofi collaboration revenue

  

163,414

    

195,110

    

383,108

    

368,466

  
                 

Bayer collaboration revenue:

                

Regeneron's net profit in connection with
   commercialization of EYLEA outside the United
   States

  

167,492

    

106,631

    

313,327

    

196,057

  

Sales milestones

  

—

    

—

    

—

    

15,000

  

Cost-sharing of Regeneron development expenses

  

7,060

    

8,390

    

11,699

    

12,301

  

Other

  

17,344

    

19,216

    

46,462

    

34,725

  

Total Bayer collaboration revenue

  

191,896

    

134,237

    

371,488

    

258,083

  
                 

Total Sanofi and Bayer collaboration revenue

  

$

355,310

    

$

329,347

    

$

754,596

    

$

626,549

  
                 

Note: In addition to amounts noted in the table above, the Company recorded $0.4 million and $0.6 million for the three and six months ended June 30, 2016, respectively, related to reimbursements of Regeneron research and development expenses by other entities.