REGENERON PHARMACEUTICALS, INC. TARRYTOWN, N.Y., Feb. 9, 2016 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) today announced financial results for the fourth quarter and full year 2015 and provided an update on development programs.
Financial Highlights
--------------------
($ in millions, except per share data) Three Months Ended Year Ended
December 31, December 31,
------------ ------------
2015 2014* % Change 2015 2014* % Change
---- ---- -------- ---- ---- --------
EYLEA U.S. net product sales $746 $518 44% $2,676 $1,736 54%
Total revenues $1,098 $802 37% $4,104 $2,820 46%
Non-GAAP net income(2) $327 $328 - % $1,404 $1,175 19%
Non-GAAP net income per share - diluted(2) $2.83 $2.79 1% $12.07 $10.00 21%
GAAP net income $155 $90 72% $636 $338 88%
GAAP net income per share - diluted $1.34 $0.78 72% $5.52 $2.98 85%
* See note (4) below for an explanation of revisions made to certain amounts previously reported for the three months and year ended December 31, 2014.
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"Regeneron had a successful 2015, with strong growth in EYLEA sales for retinal diseases, the approval of Praluent for hypercholesterolemia, and important advances across all stages of our pipeline," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "In 2016, we look forward to driving increased physician education, patient access, and reimbursement for Praluent in the United States and to launching this important medicine in other countries around the world. We also anticipate significant pipeline progress including the U.S. FDA action on the sarilumab application for rheumatoid arthritis, the Phase 3 results and potential U.S. regulatory submission for dupilumab in atopic dermatitis, and the continued progress of our development programs for retinal diseases, asthma, pain, infectious diseases, and cancer. Realizing these important product and pipeline opportunities will require significant investments, which are essential to support our long-term growth and success."
Business Highlights
EYLEA(®) (aflibercept) Injection for Intravitreal Injection
-- In the fourth quarter of 2015, net sales of EYLEA in the United States
increased 44% to $746 million from $518 million in the fourth quarter of
2014. For the full year of 2015, net sales of EYLEA in the United
States increased 54% to $2.676 billion from $1.736 billion for the full
year 2014. Overall distributor inventory levels remained within the
Company's one- to two-week targeted range.
-- Bayer HealthCare commercializes EYLEA outside the United States. In the
fourth quarter of 2015, net sales of EYLEA outside of the United
States((1)) were $413 million, compared to $297 million in the fourth
quarter of 2014. In the fourth quarter of 2015, Regeneron recognized
$140 million from its share of net profit from EYLEA sales outside the
United States, compared to $88 million in the fourth quarter of 2014.
For the full year of 2015, net sales of EYLEA outside of the United
States((1)) were $1.413 billion, compared to $1.039 billion for the full
year 2014. For the full year of 2015, Regeneron recognized $467 million
from its share of net profit from EYLEA sales outside the United States,
compared to $301 million for the full year 2014.
-- In October 2015, the European Commission granted marketing authorization
of EYLEA for the treatment of visual impairment due to myopic choroidal
neovascularization.
Praluent(®) (alirocumab) Injection for the Treatment of High Low-Density Lipoprotein (LDL) Cholesterol
-- In the fourth quarter of 2015, net sales of Praluent were $7 million.
For the full year of 2015, net sales of Praluent were $11 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 in the fourth quarter of
2015.
-- The Phase 3 ODYSSEY OUTCOMES trial completed enrollment during the
fourth quarter of 2015.
Pipeline Progress
Regeneron has thirteen product candidates in clinical development. These consist of EYLEA and twelve 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 is the Company's antibody targeting IL-6R for rheumatoid arthritis. In December 2015, the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for sarilumab, with a target action date of October 30, 2016. Sarilumab is currently being studied in the global Phase 3 SARIL-RA program
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.
-- Multiple Phase 3 studies of dupilumab in atopic dermatitis are currently
underway. Phase 3 pivotal trials in atopic dermatitis are fully
enrolled.
-- A Phase 3 pivotal study of dupilumab in patients with uncontrolled
persistent asthma continues to enroll patients.
Fasinumab is an antibody targeting Nerve Growth Factor (NGF). A sixteen-week Phase 2b/3 clinical trial for pain due to osteoarthritis has completed enrollment. The FDA has confirmed that the Company may proceed with studies of longer than sixteen-week duration.
REGN2222, an antibody targeting the respiratory syncytial virus (RSV), is in Phase 3 clinical development. In October 2015, the FDA granted Fast Track designation to REGN2222 for the prevention of serious lower respiratory tract disease caused by RSV.
Select Upcoming 2016 Milestones
Clinical Programs Milestones
----------------- ----------
EYLEA - Initiate Phase 3 study for the
treatment of diabetic
retinopathy in patients without
diabetic macular edema (DME)
----- --- -------------------------------
REGN2176-3 (PDGFR-beta - Report results from Phase 2
study
Antibody co-formulated with
aflibercept)
-----------
Nesvacumab/aflibercept - Initiate Phase 2 study
(Ang2 Antibody co-formulated
with aflibercept)
----------------
Praluent - Independent Data Monitoring
Committee (IDMC) interim
analyses of ODYSSEY OUTCOMES
trial
--------
- Ongoing launch in the United
States as well as in additional
territories outside the United
States
--- --------------------------------
Sarilumab (IL-6R Antibody) - Regulatory decision in the
United States
--------------------------
- File for regulatory approvals
outside the United States
- Report results from Phase 3
SARIL-RA-MONARCH trial
evaluating sarilumab versus
adalimumab in monotherapy
--- ----------------------------
Dupilumab (IL-4R Antibody) - Report results from Phase 3
atopic dermatitis pivotal
trials
--------------------------
- Complete rolling BLA submission
for atopic dermatitis in the
United States
--- --------------------------------
Fasinumab (NGF Antibody) - Report results from Phase 2b/3
study in osteoarthritis
------------------------
- Initiate longer duration
(greater than 16 weeks) Phase 3
trial
--- --------------------------------
Immuno-oncology (PD-1 Antibody - Report data from Phase 1 studies
in patients with cancer
and bi-specific antibody against CD20
and CD3)
-------------------------------------
Fourth Quarter and Full Year 2015 Financial Results
Product Revenues: Net product sales were $750 million in the fourth quarter and $2.689 billion for the full year 2015, compared to $522 million in the fourth quarter and $1.751 billion for the full year 2014. EYLEA net product sales in the United States were $746 million in the fourth quarter and $2.676 billion for the full year 2015, compared to $518 million in the fourth quarter and $1.736 billion for the full year 2014.
Total Revenues: Total revenues, which include product revenues described above, increased by 37% to $1.098 billion in the fourth quarter of 2015, compared to $802 million in the fourth quarter of 2014. Total revenues also include collaboration revenues of $330 million in the fourth quarter of 2015, compared to $272 million in the fourth quarter of 2014. Full year 2015 total revenues increased by 46% to $4.104 billion, compared to $2.820 billion for the full year 2014, and included collaboration revenues of $1.339 billion for the full year 2015, compared to $1.037 billion for the full year 2014. Collaboration revenues in the fourth quarter and full year 2015 increased primarily due to higher reimbursement of the Company's research and development expenses under its antibody collaboration with Sanofi, 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 the Company's share of higher collaboration losses primarily in connection with commercialization of Praluent. Collaboration revenue for the full year 2015 and 2014 also included $15 million and $105 million, respectively, of sales milestone payments from Bayer HealthCare.
Refer to Table 4 for a summary of collaboration revenue.
Research and Development (R&D) Expenses: In 2015, GAAP R&D expenses were $461 million in the fourth quarter and $1.621 billion for the full year, compared to $352 million in the fourth quarter and $1.271 billion for full year 2014. The higher 2015 R&D expenses in the fourth quarter and full year were principally due to higher development costs primarily related to dupilumab and higher headcount to support the Company's increased R&D activities. In 2014, GAAP R&D expenses also included the Company's 50% share, or $34 million, of the cost of purchasing a FDA priority review voucher. In addition, in 2015, R&D-related non-cash share-based compensation expense was $73 million for the fourth quarter and $256 million for the full year, compared to $51 million in the fourth quarter and $184 million for the full year 2014.
Selling, General, and Administrative (SG&A) Expenses: In 2015, GAAP SG&A expenses were $295 million in the fourth quarter and $839 million for the full year, compared to $175 million in the fourth quarter and $519 million for full year 2014. The increases were primarily due to higher headcount and higher commercialization expenses related to EYLEA and Praluent. These increases were partly offset by a 2014 incremental charge related to the Branded Prescription Drug Fee, based on final regulations issued by the Internal Revenue Service (IRS) in July 2014. In 2015, SG&A-related non-cash share-based compensation expense was $82 million for the fourth quarter and $193 million for the full year, compared to $61 million in the fourth quarter and $135 million for the full year 2014.
Cost of Goods Sold (COGS): In 2015, GAAP COGS was $71 million in the fourth quarter and $242 million for the full year, compared to $38 million in the fourth quarter and $129 million for the full year 2014. 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 increased principally due to the increase in U.S. EYLEA net product sales, as well as an increase in Limerick start-up costs.
Cost of Collaboration and Contract Manufacturing (COCM): In 2015, GAAP COCM was $40 million in the fourth quarter and $151 million for the full year, compared to $22 million in the fourth quarter and $76 million for the full year 2014. COCM includes costs the Company incurs in connection with producing commercial drug supplies for Sanofi and Bayer HealthCare. COCM increased primarily due to royalties payable to Genentech in connection with sales of EYLEA outside the United States, as well as the recognition of costs associated with commercial supplies of EYLEA manufactured for Bayer HealthCare.
Other Income (Expense): In 2015 and 2014, GAAP other expense includes losses on extinguishment of debt related to conversions of a portion of the Company's 1.875% convertible senior notes. In addition, GAAP other expense includes interest expense on the Company's convertible senior notes, which decreased due to conversions of a substantial portion of these notes in 2014 and 2015.
Income Tax Expense: In the fourth quarter of 2015, GAAP income tax expense was $72 million and the effective tax rate was 31.8%, compared to $100 million and 52.5% in the fourth quarter of 2014. In 2015, GAAP income tax expense was $589 million and the effective tax rate was 48.1% for the full year, compared to $423 million and 55.6% for the full year 2014. The effective tax rates for the full year of both 2015 and 2014 were negatively impacted, compared to the U.S. federal statutory rate, by losses incurred in foreign jurisdictions with rates lower than the federal statutory rate and the non-tax deductible Branded Prescription Drug Fee, partly offset by the federal tax credit for increased research activities and, in 2015, a higher domestic manufacturing deduction. In the fourth quarter of 2015, the 2015 federal tax credit for increased research activities was enacted retroactive to the beginning of the year.
Non-GAAP and GAAP Net Income: The Company reported non-GAAP net income of $327 million, or $3.15 per basic share and $2.83 per diluted share, in the fourth quarter of 2015, compared to non-GAAP net income of $328 million, or $3.23 per basic share and $2.79 per diluted share, in the fourth quarter of 2014. The Company reported non-GAAP net income of $1.404 billion, or $13.62 per basic share and $12.07 per diluted share, for the full year 2015, compared to non-GAAP net income of $1.175 billion, or $11.68 per basic share and $10.00 per diluted share, for the full year 2014.
The Company reported GAAP net income of $155 million, or $1.49 per basic share and $1.34 per diluted share, in the fourth quarter of 2015, compared to GAAP net income of $90 million, or $0.89 per basic share and $0.78 per diluted share, in the fourth quarter of 2014. The Company reported GAAP net income of $636 million, or $6.17 per basic share and $5.52 per diluted share, for the full year 2015, compared to GAAP net income of $338 million, or $3.36 per basic share and $2.98 per diluted share, for the full year 2014.
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 full year 2016 financial guidance consists of the following components:
EYLEA
U.S.
net
product
sales Approximately 20% growth over 2015
Non-
GAAP
unreimbursed
R&D(2) $875 million - $950 million
Non-
GAAP
SG&A(2) $925 million - $1,000 million
Cash
tax
as
a
%
of
non-
GAAP
pre-
tax
income(2) 35% - 45%*
---------
Capital
expenditures $580 million - $680 million
------------ ---------------------------
* - Includes a non-recurring tax
payment of approximately $222
million related to the immuno-
oncology upfront payment from Sanofi
that the Company received in 2015.
(1) Regeneron records net product sales of
EYLEA in the United States. Outside
the United States, EYLEA net product
sales comprise sales by Bayer
HealthCare in countries other than
Japan and sales by Santen
Pharmaceutical Co., Ltd. in Japan
under a co-promotion agreement with
an affiliate of Bayer HealthCare.
The Company recognizes its share of
the profits (including a percentage
on sales in Japan) from EYLEA sales
outside the United States within
"Bayer HealthCare 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,
non-GAAP SG&A, and cash tax as a
percentage of non-GAAP pre-tax
income, which are financial measures
that are not calculated in accordance
with U.S. Generally Accepted
Accounting Principles ("GAAP"). The
Company believes that the
presentation of these non-GAAP
measures is useful to investors
because they exclude, as applicable:
(i) non-cash share-based
compensation expense, which
fluctuates 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; (ii)
the incremental charge recorded in
the third quarter of 2014 related to
the issuance of the final IRS
regulations that provide guidance on
the annual fee imposed by the Patient
Protection and Affordable Care Act
(the final IRS regulations differed
from the temporary regulations issued
in 2011 which resulted in the
recognition of a catch-up
adjustment); (iii) non-cash interest
expense related to the Company's
convertible senior notes, since this
is not deemed useful in evaluating
the Company's operating performance;
(iv) loss on extinguishment of debt,
since this non-cash charge is based
on factors that are not within the
Company's control; and (v) income tax
expense for 2014, which was
principally a non-cash expense due
primarily to utilization of net
operating loss and tax credit
carryforwards, and deductions related
to employee stock option exercises.
In 2015, income tax expense
adjustments consider the tax effect
of reconciling items and an
adjustment from GAAP tax expense to
the amount of taxes that are paid or
payable in cash in respect of the
current period. As there is a
significant difference between the
Company's effective tax rate and
actual cash income taxes paid or
payable, GAAP income tax expense is
not deemed useful in evaluating the
Company's operating performance.
Non-GAAP unreimbursed R&D represents
non-GAAP R&D expenses reduced by R&D
expense reimbursements from the
Company's collaboration partners.
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. 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) Applicable amounts originally reported
for the three months and year ended
December 31, 2014 and as of December
31, 2014 have been revised to reflect
certain revisions, including a
correction to the Company's
accounting for certain stock option
awards. These revisions consisted
entirely of non-cash adjustments and
had no impact on the Company's
previously reported non-GAAP
financial measures, including non-
GAAP net income and non-GAAP net
income per share. Refer to the
Company's Form 10-K for the year
ended December 31, 2015 (Notes 1 and
14 of the Notes to Consolidated
Financial Statements) for further
details.
--- --------------------------------------
Conference Call Information
Regeneron will host a conference call and simultaneous webcast to discuss its fourth quarter and full year 2015 financial and operating results on Tuesday, February 9, 2016, at 8:30 AM. To access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International). A link to the webcast may be accessed from the "Events and Presentations" page of Regeneron's website at www.regeneron.com. 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 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 high LDL-cholesterol, eye diseases, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases. 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 new 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 Praluent(®) (alirocumab) Injection, sarilumab, dupilumab, fasinumab and REGN2222; ongoing regulatory obligations and oversight impacting Regeneron's marketed products (such as EYLEA(®) (aflibercept) Injection and Praluent), 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; 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 sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance, including without limitation those relating to EYLEA U.S. net product sales, non-GAAP unreimbursed R&D, non-GAAP SG&A, cash tax as a percentage of non-GAAP pre-tax income, and capital expenditures; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and Bayer HealthCare LLC, 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. 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, including its Form 10-K for the fiscal year ended December 31, 2014 and its Form 10-Q for the quarterly period ended September 30, 2015. 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,
------------
2015 2014*
---- ----
Assets:
Cash and marketable securities $1,677,385 $1,360,634
Accounts receivable -trade,
net 1,152,489 739,379
Accounts receivable from Sanofi
and Bayer HealthCare 315,304 236,993
Inventories 238,578 128,861
Deferred tax assets 461,945 315,416
Property, plant, and equipment,
net 1,594,120 974,309
Other assets 169,311 82,080
Total assets $5,609,132 $3,837,672
========== ==========
Liabilities and stockholders'
equity:
Accounts payable, accrued
expenses, and other
liabilities $760,619 $619,083
Deferred revenue 818,166 209,274
Facility lease obligations 364,708 312,291
Convertible senior notes 10,802 146,773
Stockholders' equity 3,654,837 2,550,251
Total liabilities and
stockholders' equity $5,609,132 $3,837,672
========== ==========
* Certain revisions have been
made to the amounts
originally reported as of
December 31, 2014. See note
(4) above.
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,
------------ ------------
2015 2014* 2015 2014*
---- ---- ---- ----
Revenues:
Net product sales $749,524 $521,518 $2,689,478 $1,750,762
Sanofi collaboration revenue 165,672 135,271 758,873 541,299
Bayer HealthCare collaboration revenue 164,809 137,095 580,488 495,555
Other revenue 18,072 8,445 74,889 31,941
------ ------
1,098,077 802,329 4,103,728 2,819,557
--------- ------- --------- ---------
Expenses:
Research and development 461,210 351,745 1,620,577 1,271,353
Selling, general, and administrative 294,954 175,307 838,526 519,267
Cost of goods sold 71,078 37,957 241,702 129,030
Cost of collaboration and contract manufacturing 39,753 21,517 151,007 75,988
------- ------
866,995 586,526 2,851,812 1,995,638
------- ------- --------- ---------
Income from operations 231,082 215,803 1,251,916 823,919
------- ------- --------- -------
Other income (expense):
Investment and other income (expense) 1,750 2,952 6,283 8,157
Interest expense (3,609) (6,350) (14,241) (37,372)
Loss on extinguishment of debt (1,934) (22,682) (18,861) (33,469)
------ ------- -------
(3,793) (26,080) (26,819) (62,684)
------ ------- ------- -------
Income before income taxes 227,289 189,723 1,225,097 761,235
Income tax expense (72,295) (99,628) (589,041) (423,109)
------- ------- -------- --------
Net income $154,994 $90,095 $636,056 $338,126
======== ======= ======== ========
Net income per share - basic $1.49 $0.89 $6.17 $3.36
Net income per share - diluted $1.34 $0.78 $5.52 $2.98
Weighted average shares outstanding - basic 103,765 101,467 103,061 100,612
Weighted average shares outstanding - diluted 115,496 114,246 115,230 113,413
* Certain revisions have been
made to the amounts
originally reported for the
three months and year ended
December 31, 2014. See note
(4) above.
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,
------------ ------------
2015 2014* 2015 2014*
---- ---- ---- ----
GAAP net income $154,994 $90,095 $636,056 $338,126
Adjustments:
R&D: Non-cash share-based compensation expense 72,570 51,180 255,708 184,347
SG&A: Non-cash share-based compensation expense 82,212 61,095 193,026 134,715
SG&A: Branded Prescription Drug Fee incremental charge - - - 40,600
COGS and COCM: Non-cash share-based compensation expense 3,609 744 10,315 2,688
Interest expense: Non-cash interest related to convertible senior notes 41 2,375 2,818 17,821
Other expense: Loss on extinguishment of debt 1,934 22,682 18,861 33,469
Non-cash income taxes 11,433 99,628 287,110 423,109
------ -------
Non-GAAP net income $326,793 $327,799 $1,403,894 $1,174,875
======== ======== ========== ==========
Non-GAAP net income per share - basic $3.15 $3.23 $13.62 $11.68
Non-GAAP net income per share - diluted (a) $2.83 $2.79 $12.07 $10.00
Shares used in calculating:
Non-GAAP net income per share - basic 103,765 101,467 103,061 100,612
Non-GAAP net income per share - diluted (b) 115,639 117,825 116,355 117,966
* Certain revisions have been
made to the amounts
originally reported for the
three months and year ended
December 31, 2014. See note
(4) above.
(a) For diluted non-GAAP net
income per share calculation,
excludes $5.0 million of
interest expense for the year
ended December 31, 2014
related to the contractual
coupon interest rate on the
Company's 1.875% convertible
senior notes, since these
securities were dilutive.
Such amounts were not
material for the three months
ended December 31, 2015 and
2014, and for the year ended
December 31, 2015.
(b) Weighted average shares
outstanding includes the
dilutive effect, if any, of
employee stock options,
restricted stock awards,
convertible senior notes, and
warrants.
TABLE 4
REGENERON PHARMACEUTICALS, INC.
COLLABORATION REVENUE (Unaudited)
(In thousands)
Three Months Ended Year Ended
December 31, December 31,
------------ ------------
2015 2014 2015 2014
---- ---- ---- ----
Sanofi collaboration revenue:
Regeneron's share of losses in connection with commercialization of
antibodies $(96,459) $(24,253) $(240,042) $(41,378)
Reimbursement of Regeneron research and development expenses 171,366 143,664 776,086 552,567
Reimbursement of Regeneron commercialization-related expenses 68,205 12,417 157,350 19,480
Other 22,560 3,443 65,479 10,630
------ ----- ------ ------
Total Sanofi collaboration revenue 165,672 135,271 758,873 541,299
------- ------- ------- -------
Bayer HealthCare collaboration revenue:
Regeneron's net profit in connection with commercialization of EYLEA
outside the United States 140,100 88,011 466,667 301,302
Sales milestones - 30,000 15,000 105,000
Cost-sharing of Regeneron development expenses 3,326 (1,661) 18,962 26,231
Other 21,383 20,745 79,859 63,022
Total Bayer HealthCare collaboration revenue 164,809 137,095 580,488 495,555
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Total collaboration revenue $330,481 $272,366 $1,339,361 $1,036,854
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To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/regeneron-reports-fourth-quarter-and-full-year-2015-financial-and-operating-results-300216966.html
SOURCE Regeneron Pharmaceuticals, Inc.
