Regeneron today announced financial results for the fourth quarter and full year 2017 and provided a business update.
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TARRYTOWN, N.Y., Feb. 8, 2018 /PRNewswire/ --
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the fourth quarter and full year 2017 and provided a business update. "In 2017, Regeneron's core EYLEA business continued to grow and we diversified our revenue stream by bringing two new products to patients in need," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "We are anticipating additional pipeline progress in 2018, including regulatory decisions for dupilumab in uncontrolled asthma and cemiplimab in advanced cutaneous squamous cell carcinoma, cardiovascular outcomes data for Praluent, as well as Phase 3 data for EYLEA in diabetic retinopathy."
Financial Highlights
($ in millions, except per share data) Three Months Ended Year Ended
December 31,
December 31,
2017 2016 % 2017 2016 %
Change Change
------ ------
Total revenues $1,582 $1,227 29% $5,872 $4,860 21%
GAAP net income $174 $253 (31)% $1,199 $896 34%
GAAP net income per share - diluted $1.50 $2.19 (32)% $10.34 $7.70 34%
Non-GAAP net income(2) $607 $353 72% $1,901 $1,319 44%
Non-GAAP net income per share - $5.23 $3.04 72% $16.32 $11.32 44%
diluted(2)
Net Product Sales of Regeneron-Discovered Products*
($ in millions) Three Months Ended Year Ended
December 31,
December 31,
2017 2016 % Change 2017 2016 % Change
---- ---- -------- ---- ---- --------
EYLEA in the United States $975 $858 14% $3,702 $3,323 11%
ARCALYST 4 5 (20)% 16 15 7%
Net product sales recorded by $979 $863 13% $3,718 $3,338 11%
Regeneron
EYLEA outside of the United States* $637 $496 28% $2,227 $1,872 19%
EYLEA global $1,612 $1,354 19% $5,929 $5,195 14%
Global net product sales recorded by Sanofi*:
Praluent $63 $41 54% $195 $116 68%
Dupixent 139 - ** 256 - **
Kevzara 9 - ** 13 - **
ZALTRAP 25 16 56% 84 72 17%
---
Net product sales recorded by Sanofi $236 $57 ** $548 $188 **
==== === === ==== ==== ===
* Bayer records net product sales of EYLEA outside the United States and Sanofi records global net product sales of Praluent, Dupixent, Kevzara, and ZALTRAP. Dupixent and Kevzara sales in 2017 were primarily in the United States. Refer to Table 4 below for the Company's share of profits/losses recorded in connection with sales
of EYLEA outside the United States and sales of Praluent, Dupixent, and Kevzara. Sanofi pays the Company a percentage of aggregate net sales of ZALTRAP.
** Percentage not meaningful
Fourth Quarter 2017 Business Highlights Pipeline Progress Regeneron has fifteen product candidates in clinical development, which consist of EYLEA and fully human antibodies generated using the Company's VelocImmune® technology, including six in collaboration with Sanofi. Updates from the clinical pipeline include: EYLEA® (aflibercept) Injection for Intravitreal Injection
Dupixent® (dupilumab) Injection
Praluent® (alirocumab) Injection for the Treatment of Elevated Low-Density Lipoprotein (LDL) Cholesterol
Cemiplimab, an antibody to programmed cell death protein 1 (PD-1), is being studied in patients with cancer.
Fasinumab is an antibody targeting Nerve Growth Factor (NGF).
Evinacumab is an antibody to angiopoietin-like protein 3 (ANGPTL3).
Nesvacumab/aflibercept is an antibody to angiopoietin2 (Ang2) co-formulated with aflibercept.
Business Development Update
The Company has also agreed to grant a limited waiver of the "lock-up" in the Amended and Restated Investor Agreement between the companies, so that Sanofi may sell up to an aggregate of 1.4 million shares of Regeneron Common Stock, representing approximately 6% of the shares of Regeneron Common Stock Sanofi currently owns, through the end of 2020 to fund a portion of the cemiplimab and dupilumab development expansion. If Sanofi desires to sell shares of Regeneron Common Stock during the term of the agreement to satisfy a portion or all of its funding obligations noted above, the Company may elect to purchase, in whole or in part, such shares from Sanofi. If the Company does not elect to purchase such shares, Sanofi may sell the applicable number of shares (subject to certain daily and quarterly limits) in one or more open-market transactions. Select Upcoming 2018 Milestones Programs Milestones
-------- ----------
EYLEA • FDA decision on sBLA for every 12-week dosing interval in wet AMD
• Report data from Phase 3 PANORAMA study in non-proliferative diabetic retinopathy (NPDR)
in patients without DME, and submit sBLA
• Submit sBLA for pre-filled syringe
--- ----------------------------------
Dupilumab • FDA filing and decision on sBLA for asthma in adult/adolescent patients
• Submit for European Union (EU) and Japan regulatory approval in asthma in adult/
adolescent patients
• Report data from Phase 3 study in adolescent patients (12-17 years of age) with atopic
dermatitis
• Report data from Phase 3 studies in nasal polyps
• Initiate Phase 3 study in EoE
• Initiate Phase 2 study in peanut allergy
• Initiate Phase 2 study as an adjunct to immunotherapy for grass allergy
• Initiate clinical programs in chronic obstructive pulmonary disease (COPD) and co-morbid
allergic conditions
--- ----------------------------------------------------------------------------------------
Praluent • Report results from ODYSSEY OUTCOMES study
• FDA decision on sBLA for use with apheresis
• Initiate Phase 3 pediatric studies in HoFH and HeFH
--- ---------------------------------------------------
Kevzara • Initiate Phase 3 study in giant cell arteritis
• Initiate Phase 3 study in polymyalgia rheumatica
--- ------------------------------------------------
Cemiplimab (PD-1 Antibody) • Complete rolling submission of BLA for CSCC and FDA decision on BLA
• Submit for regulatory approval in CSCC in the EU
• Initiate additional studies in non-small cell lung cancer
--- ---------------------------------------------------------
Fasinumab (NGF Antibody) • Report data from first Phase 3 efficacy study in osteoarthritis
• Advance Phase 3 program in chronic low back pain
--- ------------------------------------------------
Evinacumab (Angptl-3 Antibody) • Initiate Phase 2 study in severe hypertriglyceridemia
----------------------------- --- -----------------------------------------------------
REGN2477 (Activin A Antibody) • Initiate Phase 2 study in patients with fibrodysplasia ossificans progressiva (FOP)
---------------------------- --- ----------------------------------------------------------------------------------
REGN3500 (IL-33 Antibody) • Initiate Phase 2 programs in asthma, COPD, and atopic dermatitis
------------------------ --- ----------------------------------------------------------------
Fourth Quarter and Full Year 2017 Financial Results Product Revenues: Net product sales were $979 million in the fourth quarter and $3.718 billion for the full year 2017, compared to $863 million in the fourth quarter and $3.338 billion for the full year 2016. EYLEA net product sales in the United States were $975 million in the fourth quarter and $3.702 billion for the full year 2017, compared to $858 million in the fourth quarter and $3.323 billion for the full year 2016. Overall distributor inventory levels remained within the Company's one- to two-week targeted range. Total Revenues: Total revenues, which include product revenues described above, increased by 29% to $1.582 billion in the fourth quarter of 2017, compared to $1.227 billion in the fourth quarter of 2016. Total revenues include Sanofi and Bayer collaboration revenues of $497 million in the fourth quarter of 2017, compared to $313 million in the fourth quarter of 2016. Full year 2017 total revenues increased by 21% to $5.872 billion, compared to $4.860 billion for the full year 2016. Total revenues include Sanofi and Bayer collaboration revenues of $1.815 billion for the full year 2017, compared to $1.403 billion for the full year 2016. Sanofi collaboration revenue in the fourth quarter and full year 2017 included higher reimbursements by Sanofi in connection with commercial manufacturing activities and the recognition of a higher amount of previously deferred revenue from up-front and other payments in connection with the Company's Antibody Discovery Agreement ending on December 31, 2017 without any extension. Bayer collaboration revenue increased in the fourth quarter and full year 2017 primarily due to an increase in the Company's share of net profits in connection with higher sales of EYLEA outside the United States. In addition, in the fourth quarter of 2017, the Company reported that results from two nesvacumab/aflibercept Phase 2 studies did not provide sufficient differentiation to warrant Phase 3 development (as described above); therefore, the Company accelerated the recognition of deferred revenue from the up-front payment previously received from Bayer. Other revenue in the fourth quarter and full year 2017 increased primarily due to higher reimbursements of the Company's research and development expenses in connection with the collaboration agreement the Company entered into with Teva in September 2016. In addition, in the fourth quarter and full year 2017, the Company earned, and recognized as revenue, development milestones from collaboration partners in connection with the Company's fasinumab clinical program. Refer to Table 4 for a summary of collaboration and other revenue. Research and Development (R&D) Expenses: GAAP R&D expenses were $528 million in the fourth quarter and $2.075 billion for the full year 2017, compared to $479 million in the fourth quarter and $2.052 billion for the full year 2016. The higher R&D expenses in the fourth quarter and full year 2017 were principally due to an increase in cemiplimab and fasinumab clinical trial costs and a $25 million up-front payment made in connection with the Decibel Therapeutics agreement described under "Business Development Update". GAAP R&D expenses for full year 2016 included $75 million and $25 million of up-front payments in connection with license and collaboration agreements with Intellia Therapeutics and Adicet Bio, respectively. R&D-related non-cash share-based compensation expense was $59 million in the fourth quarter and $272 million for the full year 2017, compared to $75 million in the fourth quarter and $313 million for the full year 2016. Selling, General, and Administrative (SG&A) Expenses: GAAP SG&A expenses were $410 million in the fourth quarter and $1.320 billion for the full year 2017, compared to $326 million in the fourth quarter and $1.178 billion for the full year 2016. The higher selling, general, and administrative expenses in the fourth quarter and full year 2017 were primarily due to the launches of Dupixent and Kevzara, an increase in commercialization-related expenses associated with EYLEA, as well as launch preparation for cemiplimab. In addition, for full year 2017, these increases were partly offset by lower commercialization-related expenses associated with Praluent. SG&A-related non-cash share-based compensation expense was $62 million in the fourth quarter and $208 million for the full year 2017, compared to $74 million in the fourth quarter and $231 million for the full year 2016. Cost of Goods Sold (COGS): GAAP COGS was $53 million in the fourth quarter and $203 million for the full year 2017, compared to $45 million in the fourth quarter and $195 million for the full year 2016. Cost of goods sold increased slightly for full year 2017, compared to 2016, principally due to an increase in start-up costs for the Company's Limerick manufacturing facility, partly offset due to the fact that, effective May 2016, the Company was no longer obligated to pay royalties to Genentech based on U.S. sales of EYLEA. Cost of Collaboration and Contract Manufacturing (COCM): GAAP COCM was $53 million in the fourth quarter and $195 million for the full year 2017, compared to $30 million in the fourth quarter and $105 million for the full year 2016. The higher COCM costs for full year 2017 were primarily due to validation activities at the Company's Limerick manufacturing facility related to products that are in collaboration with Sanofi, partly offset by the fact that 2016 included royalties payable to Genentech based on sales of EYLEA outside the United States (which ended in May 2016). GAAP COCM was also adversely impacted by inventory write-offs and reserves in 2017 primarily related to product that no longer met quality specifications. Income Tax Expense: GAAP income tax expense was $381 million and the effective tax rate was 68.7% in the fourth quarter of 2017, compared to $88 million and 25.9% in the fourth quarter of 2016. GAAP income tax expense was $880 million and the effective tax rate was 42.3% for the full year 2017, compared to $434 million and 32.7% for the full year 2016. The effective tax rate for both the fourth quarter and full year 2017 was negatively impacted by the provisional charge of $326.2 million related to the re-measurement of the Company's U.S. net deferred tax assets upon the December 2017 enactment of the bill known as the Tax Cuts and Jobs Act (the "U.S. Tax Reform Act"), partly offset by the tax benefit associated with stock-based compensation. The Company's effective tax rate forecast for 2018 includes the estimated impact of the U.S. Tax Reform Act, which significantly revises U.S. corporate income tax laws by, among other things, reducing the U.S. federal corporate income tax rate from 35% to 21% and changing the taxation of foreign earnings. GAAP and Non-GAAP Net Income(2): GAAP net income was $174 million, or $1.62 per basic share and $1.50 per diluted share, in the fourth quarter of 2017, compared to GAAP net income of $253 million, or $2.41 per basic share and $2.19 per diluted share, in the fourth quarter of 2016. GAAP net income was $1.199 billion, or $11.27 per basic share and $10.34 per diluted share, for the full year 2017, compared to GAAP net income of $896 million, or $8.55 per basic share and $7.70 per diluted share, for the full year 2016. Non-GAAP net income was $607 million, or $5.67 per basic share and $5.23 per diluted share, in the fourth quarter of 2017, compared to non-GAAP net income of $353 million, or $3.35 per basic share and $3.04 per diluted share, in the fourth quarter of 2016. Non-GAAP net income was $1.901 billion, or $17.88 per basic share and $16.32 per diluted share, for the full year 2017, compared to non-GAAP net income of $1.319 billion, or $12.60 per basic share and $11.32 per diluted share, for the full year 2016. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release. 2018 Financial Guidance(3) The Company's full year 2018 financial guidance consists of the following components: Sanofi collaboration revenue: Sanofi reimbursement of $450 million-$500 million
Regeneron commercialization-related expenses
--------------------------------------------
Non-GAAP unreimbursed R&D(2)(4) $1.230 billion-$1.330 billion
Non-GAAP SG&A(2)(4) $1.350 billion-$1.450 billion
Effective tax rate 15%-19%
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Capital expenditures $420 million-$500 million
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(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 estimated 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) or
items that are not associated with normal, recurring
operations (such as changes in applicable laws and
regulations). 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 2018 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 2018 non-GAAP to GAAP
financial guidance is included below:
Projected Range
(In millions) Low High
GAAP unreimbursed R&D (5) $1,460 $1,580
R&D: Non-cash share-based
compensation expense (230) (250)
Non-GAAP unreimbursed R&D $1,230 $1,330
GAAP SG&A $1,545 $1,675
SG&A: Non-cash share-based
compensation expense (195) (225)
Non-GAAP SG&A $1,350 $1,450
(5) Unreimbursed R&D represents R&D expenses reduced by
R&D expense reimbursements from the Company's
collaborators and/or customers.
Conference Call Information Regeneron will host a conference call and simultaneous webcast to discuss its fourth quarter and full year 2017 financial and operating results on Thursday, February 8, 2018, at 8:30 AM. To access this call, dial (800) 708-4539 (U.S.) or (847) 619-6396 (International). A link to the webcast may be accessed from the "Investors & Media" page of Regeneron's website at http://investor.regeneron.com/events.cfm. A replay of the conference call and webcast will be archived on the Company's website and will be available for 30 days. About Regeneron Pharmaceuticals, Inc. Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, Regeneron's unique ability to repeatedly and consistently translate science into medicine has led to six FDA-approved treatments and numerous product candidates in development, all of which were homegrown in Regeneron's laboratories. Regeneron's medicines and pipeline are designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, infectious diseases, and rare diseases. Regeneron is accelerating and improving the traditional drug development process through its proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center®, which is conducting one of the largest genetics sequencing efforts in the world. For additional information about the Company, please visit www.regeneron.com or follow @Regeneron on Twitter. Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's products, product candidates, and research and clinical programs now underway or planned; the likelihood and timing of achieving any of the anticipated milestones described in this news release; unforeseen safety issues resulting from the administration of products and product candidates in patients, including serious complications or side effects in connection with the use of Regeneron's product candidates in clinical trials; the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates and new indications for marketed products, including without limitation EYLEA® (aflibercept) Injection, Dupixent® (dupilumab) Injection, Praluent® (alirocumab) Injection, Kevzara® (sarilumab) Injection, cemiplimab, fasinumab, and evinacumab; the extent to which the results from the research and development programs conducted by Regeneron or its collaborators may be replicated in other studies and lead to therapeutic applications; ongoing regulatory obligations and oversight impacting Regeneron's marketed products (such as EYLEA, Dupixent, Praluent, and Kevzara), research and clinical programs, and business, including those relating to patient privacy; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's products and product candidates; competing drugs and product candidates that may be superior to Regeneron's products and product candidates; uncertainty of market acceptance and commercial success of Regeneron's products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), on the commercial success of Regeneron's products and product candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; the ability of Regeneron's collaborators, suppliers, or other third parties to perform filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's products and product candidates; coverage and reimbursement determinations by third-party payers, including Medicare and Medicaid; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance, including without limitation those relating to Sanofi reimbursement of Regeneron commercialization-related expenses, non-GAAP unreimbursed R&D, non-GAAP SG&A, effective tax rate, and capital expenditures; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto, including without limitation the patent litigation proceedings relating to Praluent, the ultimate outcome of any such litigation proceedings, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). 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. Contact Information:
Manisha Narasimhan, Ph.D. Hala Mirza
Investor Relations Corporate Communications
914-847-5126 914-847-3422
manisha.narasimhan@regeneron.com hala.mirza@regeneron.com
TABLE 1
REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
(In thousands)
December 31,
2017 2016
---- ----
Assets:
Cash and marketable securities $2,896,074 $1,902,944
Accounts receivable - trade, net 1,538,642 1,343,368
Accounts receivable from Sanofi and Bayer 435,698 268,252
Inventories 726,138 399,356
Property, plant, and equipment, net 2,358,605 2,083,421
Deferred tax assets 506,291 825,303
Other assets 302,838 150,822
------- -------
Total assets $8,764,286 $6,973,466
========== ==========
Liabilities and stockholders' equity:
Accounts payable, accrued expenses, and other liabilities $967,418 $980,659
Deferred revenue 949,337 1,062,436
Capital and facility lease obligations 703,453 481,126
Stockholders' equity 6,144,078 4,449,245
--------- ---------
Total liabilities and stockholders' equity $8,764,286 $6,973,466
========== ==========
TABLE 2
REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
(In thousands, except per share data)
Three Months Ended Year Ended
December 31, December 31,
2017 2016 2017 2016
---- ---- ---- ----
Revenues:
Net product sales $978,718 $862,521 $3,718,463 $3,338,390
Sanofi collaboration revenue 199,523 131,165 877,193 658,665
Bayer collaboration revenue 297,133 181,484 938,052 744,270
Other revenue 107,073 51,657 338,519 119,102
------- ------ ------- -------
1,582,447 1,226,827 5,872,227 4,860,427
--------- --------- --------- ---------
Expenses:
Research and development 527,983 479,206 2,075,142 2,052,295
Selling, general, and administrative 409,913 325,937 1,320,433 1,177,697
Cost of goods sold 52,733 44,534 202,507 194,624
Cost of collaboration and contract manufacturing 53,007 30,147 194,554 105,070
------ ------ ------- -------
1,043,636 879,824 3,792,636 3,529,686
--------- ------- --------- ---------
Income from operations 538,811 347,003 2,079,591 1,330,741
------- ------- --------- ---------
Other income (expense), net 15,956 (5,476) (1,080) (926)
------ ------ ------ ----
Income before income taxes 554,767 341,527 2,078,511 1,329,815
Income tax expense (381,248) (88,412) (880,000) (434,293)
-------- ------- -------- --------
Net income $173,519 $253,115 $1,198,511 $895,522
======== ======== ========== ========
Net income per share - basic $1.62 $2.41 $11.27 $8.55
Net income per share - diluted $1.50 $2.19 $10.34 $7.70
Weighted average shares outstanding - basic 107,022 105,113 106,338 104,719
Weighted average shares outstanding - diluted 115,876 115,788 115,954 116,367
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 Year Ended
December 31, December 31,
2017 2016 2017 2016
---- ---- ---- ----
GAAP net income $173,519 $253,115 $1,198,511 $895,522
Adjustments:
R&D: Non-cash share-based compensation 58,704 75,057 271,878 313,048
expense
R&D: Up-front payments related to license and 25,000 - 25,000 100,000
collaboration agreements
SG&A: Non-cash share-based compensation expense 62,203 74,002 208,395 231,183
COGS and COCM: Non-cash share-based 6,226 5,499 27,004 15,647
compensation expense
Other expense: Loss on extinguishment of debt - 1 30,100 467
Income tax effect of reconciling items above (44,581) (55,132) (186,039) (236,663)
Income tax expense: Charge related to enactment 326,202 - 326,202 -
of U.S. Tax Reform Act
Non-GAAP net income $607,273 $352,542 $1,901,051 $1,319,204
======== ======== ========== ==========
Non-GAAP net income per share - basic $5.67 $3.35 $17.88 $12.60
Non-GAAP net income per share - diluted $5.23 $3.04 $16.32 $11.32
Shares used in calculating:
Non-GAAP net income per share - basic 107,022 105,113 106,338 104,719
Non-GAAP net income per share - diluted 116,202 115,887 116,518 116,548
TABLE 4
REGENERON PHARMACEUTICALS, INC.
COLLABORATION AND OTHER REVENUE (Unaudited)
(In thousands)
Three Months Ended Year Ended
December 31, December 31,
2017 2016 2017 2016
---- ---- ---- ----
Sanofi collaboration revenue:
Reimbursement of Regeneron research and $138,881 $136,323 $748,345 $703,397
development expenses
Reimbursement of Regeneron 117,857 91,990 368,859 305,947
commercialization-related expenses
Regeneron's share of losses in connection with (113,612) (125,528) (442,610) (459,058)
commercialization of antibodies
Other 56,397 28,380 202,599 108,379
------ ------ ------- -------
Total Sanofi collaboration revenue 199,523 131,165 877,193 658,665
------- ------- ------- -------
Bayer collaboration revenue:
Regeneron's net profit in connection with 231,172 165,051 802,298 649,232
commercialization of EYLEA outside the
United States
Reimbursement of Regeneron development 4,719 5,986 31,166 27,337
expenses
Other 61,242 10,447 104,588 67,701
------ ------ ------- ------
Total Bayer collaboration revenue 297,133 181,484 938,052 744,270
------- ------- ------- -------
Total Sanofi and Bayer collaboration revenue $496,656 $312,649 $1,815,245 $1,402,935
======== ======== ========== ==========
Other revenue:
Reimbursement of Regeneron research and $33,057 $21,170 $115,125 $24,234
development expenses - Teva
Reimbursement of Regeneron research and 2,897 770 6,459 2,323
development expenses - other
Substantive development milestones 35,000 - 90,000 -
Other 36,119 29,717 126,935 92,545
Total other revenue $107,073 $51,657 $338,519 $119,102
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Company Codes: NASDAQ-NMS:REGN |
