TARRYTOWN, N.Y., May 7,
2019 /PRNewswire/ --
- First quarter 2019 revenues increased 13% to $1.71 billion versus first quarter 2018
- First quarter 2019 EYLEA® (aflibercept)
Injection U.S. net sales increased 9% to $1.07 billion versus first quarter 2018
- First quarter 2019 EYLEA net sales outside the United States, which are recorded by the
Company's collaborator Bayer(1), increased
7% to $669 million versus first
quarter 2018
- First quarter 2019 Dupixent® (dupilumab)
global net sales, which are recorded by the Company's collaborator
Sanofi, were $374 million
- First quarter 2019 Libtayo® (cemiplimab)
U.S. net sales were $27 million;
Libtayo was launched in October
2018
- First quarter 2019 GAAP diluted EPS was $3.99 and non-GAAP diluted EPS was $4.45
- FDA approved Dupixent for moderate-to-severe atopic
dermatitis in adolescents
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced financial results for the first quarter of 2019 and
provided a business update.
"In the first quarter, aggregate sales of all Regeneron-invented
products, recorded by the Company and its collaborators, were
$2.27 billion, an increase of 23%
over the same period last year. This was driven by an 8%
increase in EYLEA net sales, 185% increase in Dupixent net sales,
and a strong initial launch for Libtayo in advanced cutaneous
squamous cell carcinoma," said Leonard S.
Schleifer, M.D., Ph.D., President and Chief Executive
Officer of Regeneron. "We continue to unlock the full
potential of Dupixent, which is now FDA-approved in atopic
dermatitis and asthma in both adults and adolescents and is
currently under Priority Review by the FDA for chronic
rhinosinusitis with nasal polyps. Regeneron also continues to
invest in a broad immuno-oncology portfolio. At the June European
Hematology Association meeting, we look forward to presenting
updated promising results of the Phase 1 study of REGN1979 in
relapsed or refractory B-cell non-hodgkin lymphoma, including in
patients who have failed previous CAR-T therapy."
Financial
Highlights
|
|
|
|
|
|
|
|
($ in millions,
except per share data)
|
|
Three Months
Ended
March 31,
|
|
|
|
|
2019
|
|
2018
|
|
%
Change
|
Total
revenues
|
|
$
|
1,712
|
|
|
$
|
1,512
|
|
|
13
|
%
|
GAAP net
income
|
|
$
|
461
|
|
|
$
|
478
|
|
|
(4)
|
%
|
GAAP net income per
share - diluted
|
|
$
|
3.99
|
|
|
$
|
4.16
|
|
|
(4)
|
%
|
Non-GAAP net
income(2)
|
|
$
|
518
|
|
|
$
|
537
|
|
|
(4)
|
%
|
Non-GAAP net income
per share - diluted(2)
|
|
$
|
4.45
|
|
|
$
|
4.67
|
|
|
(5)
|
%
|
Business Highlights
Key Pipeline Progress
Regeneron has twenty product candidates in clinical development,
including five of the Company's U.S. Food and Drug Administration
(FDA) approved products for which it is investigating additional
indications. Updates from the clinical pipeline include:
EYLEA® (aflibercept) Injection
- In April 2019, the Company
resubmitted a supplemental Biologics License Application (sBLA) for
EYLEA in a pre-filled syringe.
- The EYLEA sBLA for the treatment of diabetic retinopathy has a
target action date of May 13,
2019.
Dupixent® (dupilumab)
- In March 2019, the FDA approved
Dupixent for adolescent patients 12 to 17 years of age with
moderate-to-severe atopic dermatitis whose disease is not
adequately controlled with topical prescription therapies or when
those therapies are not advisable.
- The FDA accepted for priority review the sBLA for Dupixent as
an add-on maintenance treatment for adults with inadequately
controlled severe chronic rhinosinusitis with nasal polyps
(CRSwNP), with a target action date of June
26, 2019. The Company and Sanofi have also submitted a
European Marketing Authorization Application (MAA) for CRSwNP.
- The European Medicines Agency's Committee for Medicinal
Products for Human Use (CHMP) adopted a positive opinion for
Dupixent, recommending it be approved for use in adults and
adolescents 12 years and older as add-on maintenance treatment for
severe asthma.
- Initiated a Phase 3 study in chronic obstructive pulmonary
disease (COPD).
Libtayo® (cemiplimab)
- The European Medicines Agency's CHMP recommended conditional
approval for Libtayo for the treatment of adult patients with
metastatic or locally advanced cutaneous squamous cell carcinoma
(CSCC) who are not candidates for curative surgery or curative
radiation.
REGN1979, a bispecific antibody against CD20 and CD3
- The Company expects to begin a potentially pivotal Phase 2
study in advanced follicular lymphoma this quarter, and a
potentially pivotal Phase 2 study in diffuse large B-cell lymphoma
(DLBCL) later this year.
- At the June European Hematology Association meeting, the
Company plans to present updated results of the Phase 1 study in
relapsed or refractory B-cell non-hodgkin lymphoma, including in
patients who have failed previous CAR-T therapy.
Praluent® (alirocumab)
- In March 2019, the European
Commission approved a new indication for Praluent to reduce
cardiovascular risk in adults with established atherosclerotic
cardiovascular disease (ASCVD) by lowering low-density lipoprotein
cholesterol (LDL-C) levels as an adjunct to correction of other
risk factors.
- In April 2019, the FDA approved a
new indication for Praluent to reduce the risk of heart attack,
stroke, and unstable angina requiring hospitalization in adults
with established cardiovascular disease.
- Beginning in March 2019, Praluent
was made available for both the 75 mg and 150 mg doses at a U.S.
list price of $5,850 annually, a 60%
reduction from the original price.
Business Development Update
- In April 2019, the Company
entered into a collaboration with Alnylam Pharmaceuticals, Inc. to
discover, develop, and commercialize new RNA interference (RNAi)
therapeutics for diseases of the eye and central nervous system, in
addition to a select number of targets expressed in the liver.
Under the terms of the agreement, the Company is obligated to make
an up-front payment of $400 million
and purchase $400 million of Alnylam
common stock. In addition, the Company will provide Alnylam with a
specified amount of funding at program initiation and at lead
candidate designation, and Alnylam is eligible to receive up to
$200 million in clinical
proof-of-principle milestones.
First Quarter 2019 Financial Results
Product Revenues: Net product sales were
$1.104 billion in the first quarter
of 2019, compared to $988 million in
the first quarter of 2018. EYLEA net product sales in
the United States were
$1.074 billion in the first quarter
of 2019, compared to $984 million in
the first quarter of 2018. Overall distributor inventory
levels for EYLEA in the United
States remained within the Company's one-to-two-week
targeted range.
Total Revenues: Total revenues, which include product
revenues described above, increased by 13% to $1.712 billion in the first quarter of 2019,
compared to $1.512 billion in the
first quarter of 2018. Total revenues include Sanofi and
Bayer collaboration revenues(6) of
$523 million in the first quarter of
2019, compared to $437 million in the
first quarter of 2018. The increase in Sanofi collaboration
revenue in the first quarter of 2019 was primarily due to the
Company's share of lower losses of collaboration antibodies,
primarily driven by higher net product sales of Dupixent.
This increase was partly offset by a decrease in reimbursement of
research and development costs under the Immuno-oncology Discovery
and Development Agreement with Sanofi, as the amended agreement
narrowed the scope of reimbursable activities to the BCMAxCD3 and
MUC16xCD3 programs.
Refer to Table 4 for a summary of collaboration and other
revenue.
Research and Development (R&D) Expenses: GAAP R&D
expenses were $642 million in the
first quarter of 2019, compared to $499
million in the first quarter of 2018. The higher
R&D expenses in the first quarter of 2019 were principally due
to additional costs incurred in connection with our earlier-stage
pipeline, an increase in Libtayo development expenses, higher
clinical manufacturing costs, and higher headcount and
headcount-related costs. In the first quarter of 2019,
R&D-related non-cash share-based compensation expense was
$59 million, compared to $41 million in the first quarter of 2018.
Selling, General, and Administrative (SG&A) Expenses:
GAAP SG&A expenses were $411
million in the first quarter of 2019, compared to
$331 million in the first quarter of
2018. The higher SG&A expenses in the first quarter of
2019 were primarily due to higher headcount and headcount-related
costs, higher contributions to independent not-for-profit patient
assistance organizations, and an increase in
commercialization-related expenses for Dupixent. In the first
quarter of 2019, SG&A-related non-cash share-based compensation
expense was $44 million, compared to
$35 million in the first quarter of
2018.
Cost of Collaboration and Contract Manufacturing (COCM):
GAAP COCM expenses were $108 million
in the first quarter of 2019, compared to $46 million in the first quarter of 2018.
The increase in COCM was primarily due to higher expenses in
connection with process validation at our Limerick manufacturing
facility, higher inventory write-offs and reserves, and the
recognition of manufacturing costs associated with higher sales of
Dupixent.
Other Income (Expense): GAAP other income (expense), net,
in the first quarter of 2019 and 2018 includes the recognition of
$43 million and $9 million, respectively, of net gains on equity
securities.
Income Taxes: In the first quarter of 2019, GAAP income
tax expense was $85 million and the
effective tax rate was 15.6%, compared to $107 million and 18.3% in the first quarter of
2018. The effective tax rate for the first quarter of 2019
was positively impacted, compared to the U.S. federal statutory
rate, primarily by the federal tax credit for research activities,
stock-based compensation, the foreign-derived intangible income
deduction, and income earned in foreign jurisdictions with tax
rates lower than the U.S. federal statutory rate.
GAAP and Non-GAAP Net Income(2):
GAAP net income was $461 million, or
$4.23 per basic share and
$3.99 per diluted share, in the first
quarter of 2019, compared to GAAP net income of $478 million, or $4.44 per basic share and $4.16 per diluted share, in the first quarter of
2018.
Non-GAAP net income was $518
million, or $4.75 per basic
share and $4.45 per diluted share, in
the first quarter of 2019, compared to non-GAAP net income of
$537 million, or $4.99 per basic share and $4.67 per diluted share, in the first quarter of
2018.
A reconciliation of the Company's GAAP to non-GAAP results is
included in Table 3 of this press release.
2019 Financial
Guidance(3)
The Company's updated full year 2019 financial guidance consists
of the following components:
GAAP Sanofi
collaboration revenue: Sanofi
reimbursement of Regeneron
commercialization-related expenses
|
$500 million–$535
million
(previously $510
million–$560 million)
|
GAAP Unreimbursed
R&D(5)
|
$1.880
billion–$2.000 billion
(previously $1.855
billion–$2.000 billion)
|
Non-GAAP Unreimbursed
R&D(2)(4)
|
$1.610
billion–$1.710 billion
(previously $1.590
billion–$1.710 billion)
|
GAAP
SG&A
|
$1.690
billion–$1.795 billion
(previously $1.700
billion–$1.830 billion)
|
Non-GAAP
SG&A(2)(4)
|
$1.500 billion–$1.580
billion
(previously $1.500
billion–$1.600 billion)
|
GAAP effective tax
rate
|
11%–13%
(previously
14%–16%)
|
Capital
expenditures
|
$410 million–$475
million
(previously $410 million–$490
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 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 changes in the fair value of the Company's equity
investments) 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 2019
financial guidance does not assume the completion of any
significant business development transactions not completed as of
the date of this press release (other than the collaboration with
Alnylam Pharmaceuticals, Inc. discussed above).
|
|
|
(4)
|
A reconciliation of
full year 2019 non-GAAP to GAAP financial guidance is included
below:
|
|
|
|
|
|
|
Projected
Range
|
|
|
(In
millions)
|
|
Low
|
|
High
|
|
|
GAAP unreimbursed
R&D (5)
|
|
$
|
1,880
|
|
|
$
|
2,000
|
|
|
|
R&D: Non-cash
share-based compensation expense
|
|
(270)
|
|
|
(290)
|
|
|
|
Non-GAAP unreimbursed
R&D
|
|
$
|
1,610
|
|
|
$
|
1,710
|
|
|
|
|
|
|
|
|
|
|
GAAP
SG&A
|
|
$
|
1,690
|
|
|
$
|
1,795
|
|
|
|
SG&A: Non-cash
share-based compensation expense
|
|
(190)
|
|
|
(215)
|
|
|
|
Non-GAAP
SG&A
|
|
$
|
1,500
|
|
|
$
|
1,580
|
|
|
|
(5)
|
Unreimbursed R&D
represents R&D expenses reduced by R&D expense
reimbursements from the Company's collaborators and/or
customers.
|
|
|
(6)
|
The Company's
collaborators provide it with estimates of the collaborators'
respective sales and the Company's share of the profits or losses
from commercialization of products for the most recent fiscal
quarter. The Company's estimates for such quarter are
reconciled to actual results in the subsequent fiscal quarter, and
the Company's share of the profit or loss is adjusted on a
prospective basis accordingly, if necessary.
|
Conference Call Information
Regeneron will host a conference call and simultaneous webcast
to discuss its first quarter 2019 financial and operating results
on Tuesday, May 7, 2019, 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 and Media" 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 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 seven 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 diseases, allergic and
inflammatory diseases, cancer, cardiovascular and metabolic
diseases, musculoskeletal diseases, 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 press release and
the impact of the recent and any potential future U.S. government
shutdowns on the anticipated timing of any FDA regulatory action
described in this press 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,
Libtayo® (cemiplimab) Injection, 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, Kevzara, and Libtayo), 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 (as applicable) to perform
manufacturing, 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, GAAP and non-GAAP unreimbursed
R&D, GAAP and 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 and other related proceedings relating to
EYLEA, Dupixent, and Praluent, the ultimate outcome of any such
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, including its Form 10-K for the
fiscal year ended December 31, 2018
and its Form 10-Q for the quarterly period ended March 31, 2019. 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 such non-GAAP financial
measures.
Contact
Information:
|
|
|
|
|
|
Mark
Hudson
|
|
Hala Mirza
|
Investor
Relations
|
|
Corporate
Communications
|
914-847-3482
|
|
914-847-3422
|
mark.hudson@regeneron.com
|
|
hala.mirza@regeneron.com
|
TABLE 1
|
REGENERON
PHARMACEUTICALS, INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS (Unaudited)
|
(In
millions)
|
|
|
|
March
31,
|
|
December
31,
|
|
|
2019
|
|
2018
|
Assets:
|
|
|
|
|
Cash and marketable
securities
|
|
$
|
5,572.2
|
|
|
$
|
4,564.9
|
|
Accounts receivable -
trade, net
|
|
1,728.4
|
|
|
1,723.7
|
|
Accounts receivable
from Sanofi and Bayer
|
|
576.8
|
|
|
519.5
|
|
Inventories
|
|
1,208.8
|
|
|
1,151.2
|
|
Property, plant, and
equipment, net
|
|
2,612.8
|
|
|
2,575.8
|
|
Deferred tax
assets
|
|
829.3
|
|
|
828.7
|
|
Other
assets
|
|
326.5
|
|
|
370.7
|
|
Total
assets
|
|
$
|
12,854.8
|
|
|
$
|
11,734.5
|
|
|
|
|
|
|
Liabilities and
stockholders' equity:
|
|
|
|
|
Accounts payable,
accrued expenses, and other liabilities
|
|
$
|
1,357.0
|
|
|
$
|
1,352.0
|
|
Deferred
revenue
|
|
1,343.2
|
|
|
916.7
|
|
Finance lease
liabilities
|
|
709.9
|
|
|
708.5
|
|
Stockholders'
equity
|
|
9,444.7
|
|
|
8,757.3
|
|
Total liabilities and
stockholders' equity
|
|
$
|
12,854.8
|
|
|
$
|
11,734.5
|
|
TABLE 2
|
REGENERON
PHARMACEUTICALS, INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
|
(In millions,
except per share data)
|
|
|
|
Three Months
Ended
March 31,
|
|
|
2019
|
|
2018
|
Revenues:
|
|
|
|
|
Net product
sales
|
|
$
|
1,104.4
|
|
|
$
|
987.9
|
|
Sanofi collaboration
revenue
|
|
246.4
|
|
|
189.5
|
|
Bayer collaboration
revenue
|
|
276.2
|
|
|
247.9
|
|
Other
revenue
|
|
84.8
|
|
|
86.2
|
|
|
|
1,711.8
|
|
|
1,511.5
|
|
Expenses:
|
|
|
|
|
Research and
development
|
|
641.8
|
|
|
498.6
|
|
Selling, general, and
administrative
|
|
410.8
|
|
|
330.8
|
|
Cost of goods
sold
|
|
70.9
|
|
|
69.2
|
|
Cost of collaboration
and contract manufacturing
|
|
108.3
|
|
|
45.7
|
|
|
|
1,231.8
|
|
|
944.3
|
|
|
|
|
|
|
Income from
operations
|
|
480.0
|
|
|
567.2
|
|
|
|
|
|
|
Other income
(expense), net
|
|
66.1
|
|
|
18.2
|
|
|
|
|
|
|
Income before income
taxes
|
|
546.1
|
|
|
585.4
|
|
|
|
|
|
|
Income tax
expense
|
|
(85.0)
|
|
|
(107.4)
|
|
|
|
|
|
|
Net income
|
|
$
|
461.1
|
|
|
$
|
478.0
|
|
|
|
|
|
|
Net income per share
- basic
|
|
$
|
4.23
|
|
|
$
|
4.44
|
|
Net income per share
- diluted
|
|
$
|
3.99
|
|
|
$
|
4.16
|
|
|
|
|
|
|
Weighted average
shares outstanding - basic
|
|
108.9
|
|
|
107.6
|
|
Weighted average
shares outstanding - diluted
|
|
115.5
|
|
|
114.9
|
|
TABLE 3
|
REGENERON
PHARMACEUTICALS, INC.
|
RECONCILIATION OF
GAAP NET INCOME TO NON-GAAP NET INCOME (Unaudited)
|
(In millions,
except per share data)
|
|
|
|
Three Months
Ended
March 31,
|
|
|
2019
|
|
2018
|
GAAP net
income
|
|
$
|
461.1
|
|
|
$
|
478.0
|
|
Adjustments:
|
|
|
|
|
R&D: Non-cash
share-based compensation expense
|
|
58.7
|
|
|
40.8
|
|
SG&A: Non-cash
share-based compensation expense
|
|
43.8
|
|
|
35.0
|
|
SG&A: Litigation
contingencies
|
|
5.0
|
|
|
—
|
|
COGS and COCM:
Non-cash share-based compensation expense
|
|
5.4
|
|
|
6.6
|
|
Other income/expense:
Gains and losses on investments in equity securities
|
|
(42.8)
|
|
|
(9.4)
|
|
Income tax effect of
reconciling items above
|
|
(13.5)
|
|
|
(14.3)
|
|
Non-GAAP net
income
|
|
$
|
517.7
|
|
|
$
|
536.7
|
|
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
$
|
4.75
|
|
|
$
|
4.99
|
|
Non-GAAP net income
per share - diluted
|
|
$
|
4.45
|
|
|
$
|
4.67
|
|
|
|
|
|
|
Shares used in
calculating:
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
108.9
|
|
|
107.6
|
|
Non-GAAP net income
per share - diluted
|
|
116.3
|
|
|
114.9
|
|
TABLE 4
|
REGENERON
PHARMACEUTICALS, INC.
|
COLLABORATION AND
OTHER REVENUE (Unaudited)
|
(In
millions)
|
|
|
|
Three Months
Ended
March 31,
|
|
|
2019
|
|
2018
|
Sanofi
collaboration revenue:
|
|
|
|
|
Reimbursement of
Regeneron research and development expenses
|
|
$
|
120.9
|
|
|
$
|
134.2
|
|
Reimbursement of
Regeneron commercialization-related expenses
|
|
118.9
|
|
|
86.6
|
|
Regeneron's share of
losses in connection with commercialization of
antibodies
|
|
(27.8)
|
|
|
(74.8)
|
|
Other
|
|
34.4
|
|
|
43.5
|
|
Total Sanofi
collaboration revenue
|
|
246.4
|
|
|
189.5
|
|
|
|
|
|
|
Bayer
collaboration revenue:
|
|
|
|
|
Regeneron's net
profit in connection with commercialization of EYLEA outside
the
United States
|
|
249.3
|
|
|
232.1
|
|
Reimbursement of
Regeneron development expenses
|
|
2.6
|
|
|
4.0
|
|
Other
|
|
24.3
|
|
|
11.8
|
|
Total Bayer
collaboration revenue
|
|
276.2
|
|
|
247.9
|
|
|
|
|
|
|
Total Sanofi and
Bayer collaboration revenue
|
|
$
|
522.6
|
|
|
$
|
437.4
|
|
|
|
|
|
|
Other
revenue:
|
|
|
|
|
Reimbursement of
Regeneron research and development expenses - Teva
|
|
$
|
32.2
|
|
|
$
|
39.1
|
|
Reimbursement of
Regeneron research and development expenses - other
|
|
8.4
|
|
|
2.7
|
|
Other
|
|
44.2
|
|
|
44.4
|
|
Total other
revenue
|
|
$
|
84.8
|
|
|
$
|
86.2
|
|
TABLE 5
|
REGENERON
PHARMACEUTICALS, INC.
|
NET PRODUCT SALES
OF REGENERON-DISCOVERED PRODUCTS (Unaudited)
|
(In
millions)
|
|
|
|
Three Months
Ended
March 31,
|
|
|
2019
|
|
2018
|
|
|
U.S.
|
|
ROW
|
|
Total
|
|
U.S.
|
|
ROW
|
|
Total
|
EYLEA*
|
|
$
|
1,074.1
|
|
|
$
|
669.4
|
|
|
$
|
1,743.5
|
|
|
$
|
984.0
|
|
|
$
|
624.0
|
|
|
$
|
1,608.0
|
|
Libtayo
|
|
26.8
|
|
|
—
|
|
|
26.8
|
|
|
—
|
|
|
—
|
|
|
—
|
|
ARCALYST
|
|
3.5
|
|
|
—
|
|
|
3.5
|
|
|
3.9
|
|
|
—
|
|
|
3.9
|
|
Net product sales
recorded by
Regeneron
|
|
$
|
1,104.4
|
|
|
|
|
|
|
$
|
987.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales
recorded by Sanofi*:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dupixent
|
|
$
|
303.0
|
|
|
$
|
70.7
|
|
|
$
|
373.7
|
|
|
$
|
116.8
|
|
|
$
|
14.6
|
|
|
$
|
131.4
|
|
Praluent
|
|
$
|
22.9
|
|
|
$
|
41.0
|
|
|
$
|
63.9
|
|
|
$
|
31.7
|
|
|
$
|
28.2
|
|
|
$
|
59.9
|
|
Kevzara
|
|
$
|
20.7
|
|
|
$
|
13.0
|
|
|
$
|
33.7
|
|
|
$
|
9.3
|
|
|
$
|
3.1
|
|
|
$
|
12.4
|
|
ZALTRAP
|
|
$
|
0.5
|
|
|
$
|
24.0
|
|
|
$
|
24.5
|
|
|
$
|
2.4
|
|
|
$
|
23.9
|
|
|
$
|
26.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Bayer records net
product sales of EYLEA outside the United States and Sanofi records
global net product sales of Dupixent, Praluent, Kevzara, and
ZALTRAP. Refer to Table 4 for the Company's share of
profits/losses recorded in connection with sales of EYLEA outside
the United States and global sales of Dupixent, Praluent, and
Kevzara. Sanofi pays the Company a percentage of aggregate
net sales of ZALTRAP.
|
View original
content:http://www.prnewswire.com/news-releases/regeneron-reports-first-quarter-2019-financial-and-operating-results-300844718.html
SOURCE Regeneron Pharmaceuticals, Inc.