TARRYTOWN, N.Y., Nov. 5, 2019 /PRNewswire/ --
- Third quarter 2019 revenues increased 23% to $2.05 billion versus third quarter 2018
- Third quarter EYLEA® U.S. net sales
increased 16% to $1.19 billion versus
third quarter 2018
- Dupixent® global net
sales(5), which increased 141% to
$633 million versus third quarter
2018, drove higher profitability from antibody collaboration with
Sanofi
- Third quarter 2019 GAAP diluted EPS was $5.86 and third quarter non-GAAP diluted
EPS(1) was $6.67
- Company announces $1.0 billion
share repurchase program
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced financial results for the third quarter of 2019 and
provided a business update.
"Regeneron delivered positive financial and operational results
this quarter, marked by significant EYLEA and Dupixent sales growth
and progress across our pipeline," said Leonard S. Schleifer, M.D., Ph.D., President and
Chief Executive Officer of Regeneron. "We are broadening our
efforts in retinal and type 2 inflammatory diseases, including
initiating late-stage trials of Dupixent in additional type 2
diseases in the coming months. Oncology is a major focus of
our research and development efforts, and we are advancing
important new potential treatments for patients with a variety of
cancers. We currently have six bispecific antibodies in the
clinic, and multiple pivotal trials with Libtayo in non-small cell
lung, skin, and other cancers."
"This quarter, we realized improving profitability from the
Sanofi antibody collaboration, which is contributing to a more
diverse earnings base for the Company," said Robert E. Landry, Executive Vice President,
Finance and Chief Financial Officer of Regeneron. "Our
financial results, strength of our balance sheet, and confidence in
our business longer-term allow us to continue deploying capital by
investing in internal and external innovation to expand our
pipeline, while also returning cash to shareholders with the
initiation of a $1 billion share
repurchase program."
Financial
Highlights
|
|
|
|
Three Months
Ended
September 30,
|
|
|
($ in millions,
except per share data)
|
|
2019
|
|
2018
|
|
%
Change
|
Total
revenues
|
|
$
|
2,048
|
|
|
$
|
1,663
|
|
|
23
|
%
|
GAAP net
income
|
|
$
|
670
|
|
|
$
|
595
|
|
|
13
|
%
|
GAAP net income per
share - diluted
|
|
$
|
5.86
|
|
|
$
|
5.17
|
|
|
13
|
%
|
Non-GAAP net
income(1)
|
|
$
|
762
|
|
|
$
|
675
|
|
|
13
|
%
|
Non-GAAP net income
per share - diluted(1)
|
|
$
|
6.67
|
|
|
$
|
5.87
|
|
|
14
|
%
|
Business Highlights
Key Pipeline Progress
Regeneron has 24 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 August 2019, the FDA approved
the EYLEA pre-filled syringe, which is expected to be launched
before the end of this year.
- A Phase 2 study exploring less frequent dosing intervals using
a high-dose formulation of aflibercept in wet AMD was
initiated.
- A Phase 3 study in retinopathy of prematurity was
initiated.
Dupixent® (dupilumab)
- In August 2019, the European
Commission (EC) extended its approval of Dupixent in the European
Union to include adolescents 12 to 17 years of age with
moderate-to-severe atopic dermatitis who are candidates for
systemic therapy.
- In August 2019, the Company and
Sanofi announced that the Phase 3 trial to treat severe atopic
dermatitis in children 6 to 11 years of age met its primary and
secondary endpoints. Submissions for a supplemental Biologics
License Application (sBLA) and Marketing Authorization Application
(MAA) for this expanded atopic dermatitis indication in pediatric
patients are expected by the end of the year.
- In October 2019, the EC approved
Dupixent in chronic rhinosinusitis with nasal polyposis
(CRSwNP).
- The Company and Sanofi plan to initiate Phase 3 studies in
bullous pemphigoid, prurigo nodularis, chronic spontaneous
urticaria, and additional type 2 inflammatory diseases.
Praluent® (alirocumab)
- In August 2019, the Company and
Sanofi announced the U.S. District Court for the District of
Delaware ruled in their favor and
found as a matter of law that Amgen's asserted patent claims for
antibodies targeting PCSK9 are invalid based on lack of
enablement.
Evinacumab, an antibody to ANGPTL3
- In August 2019, the Company
announced positive top-line results from a Phase 3 trial of
evinacumab in patients with homozygous familial
hypercholesterolemia (HoFH). The Company plans to submit a BLA in
mid-2020.
REGN-EB3, a multi-antibody therapy to Ebola virus infection
- In August 2019, the Company
announced that a randomized, controlled trial evaluating four
investigational therapies for Ebola virus infection was stopped
early because REGN-EB3 was superior to ZMapp (the control arm of
the trial since it was considered standard-of-care) in preventing
death. REGN-EB3 and another investigational drug are being further
studied as part of the Extension Phase of this trial.
- The FDA granted Breakthrough Therapy designation for the
treatment of Ebola virus infection and the Company has initiated a
rolling BLA submission.
REGN5678, a bispecific antibody targeting PSMA and CD28
- A Phase 1 study evaluating this first-in-class co-stimulatory
bispecific antibody was initiated in prostate cancer.
REGN5093, a bispecific antibody targeting two distinct MET
epitopes
- A Phase 1 study evaluating this first-in-class bispecific
antibody was initiated in MET-altered advanced non-small cell lung
cancer.
Share Repurchase Program
In November 2019, the Company's board of directors
authorized a share repurchase program to repurchase up to
$1.0 billion of the Company's Common
Stock. Repurchases may be made from time to time at
management's discretion through a variety of methods. The
program has no time limit and can be discontinued at any
time. No shares have been repurchased under the program to
date.
Third Quarter 2019 Financial Results
Total Revenues: Total revenues increased by 23% to
$2.048 billion in the third quarter
of 2019, compared to $1.663 billion
in the third quarter of 2018.
Net product sales were $1.238
billion in the third quarter of 2019, compared to
$1.025 billion in the third quarter
of 2018. EYLEA net product sales in the United States were $1.188 billion in the third quarter of 2019,
compared to $1.022 billion in the
third 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 also include Sanofi and Bayer collaboration
revenues(5) of $707
million in the third quarter of 2019, compared to
$521 million in the third quarter of
2018. Sanofi collaboration revenue in the third quarter of
2019 included the Company's share of profits from collaboration
antibodies (Dupixent, Praluent, and Kevzara) of $94 million, while Sanofi collaboration revenue
in the third quarter of 2018 included the Company's share of losses
from collaboration antibodies of $39
million. The increase in the Company's share of
profits from collaboration antibodies was primarily driven by
higher Dupixent profits.
Refer to Table 4 for a summary of collaboration and other
revenue.
Research and Development (R&D) Expenses: GAAP R&D
expenses were $663 million in the
third quarter of 2019, compared to $557
million in the third quarter of 2018. The higher
R&D expenses in the third quarter of 2019 were principally due
to additional costs incurred in connection with fasinumab as well
as our earlier-stage pipeline, and higher headcount and
headcount-related costs. In each of the third quarters of
2019 and 2018, R&D-related non-cash share-based compensation
expense was $60 million.
Selling, General, and Administrative (SG&A) Expenses:
GAAP SG&A expenses were $420
million in the third quarter of 2019, compared to
$369 million in the third quarter of
2018. The higher SG&A expenses in the third quarter of
2019 were primarily due to higher headcount and related costs, as
well as an increase in commercialization-related expenses for
Dupixent and EYLEA. In the third quarter of 2019,
SG&A-related non-cash share-based compensation expense was
$41 million, compared to $43 million in the third quarter of 2018.
Cost of Goods Sold (COGS): GAAP COGS was $116 million in the third quarter of 2019,
compared to $31 million in the third
quarter of 2018. The increase in COGS was primarily due to
the Company's obligation to pay Sanofi its share of Libtayo U.S.
gross profits, higher period costs at the Company's Limerick
manufacturing facility, and higher inventory reserves and
write-offs.
Income Taxes: In the third quarter of 2019, GAAP income
tax expense was $99 million and the
effective tax rate was 12.9%, compared to $41 million and 6.5%, respectively, in the third
quarter of 2018. The effective tax rate for the third quarter
of 2019 was positively impacted, compared to the U.S. federal
statutory rate, primarily by federal tax credits for research
activities and the foreign-derived intangible income deduction,
partly offset by the taxation of certain global intangible
low-taxed income. The Company's effective tax rate for the
third quarter of 2018 was positively impacted, compared to the U.S.
federal statutory rate, primarily by the tax benefit associated
with the U.S. Tax Reform Act and the federal tax credit for
research activities.
GAAP and Non-GAAP Net Income(1):
GAAP net income was $670 million, or
$5.86 per diluted share, in the third
quarter of 2019, compared to GAAP net income of $595 million, or $5.17 per diluted share, in the third quarter of
2018.
Non-GAAP net income was $762
million, or $6.67 per diluted
share, in the third quarter of 2019, compared to non-GAAP net
income of $675 million, or
$5.87 per diluted share, in the third
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(2)
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
|
$490 million–$510
million
(previously $500 million–$530 million)
|
Unreimbursed
R&D(4)
|
$2.360
billion–$2.410 billion
(previously $2.300
billion–$2.380 billion)
|
Non-GAAP Unreimbursed
R&D(1)(3)
|
$1.680
billion–$1.710 billion
(previously $1.650 billion–$1.710 billion)
|
GAAP
SG&A
|
$1.730
billion–$1.780 billion
(previously $1.705
billion–$1.785 billion)
|
Non-GAAP
SG&A(1)(3)
|
$1.550 billion–$1.580
billion
(previously $1.530 billion–$1.580 billion)
|
GAAP effective tax
rate
|
12%–14%
(previously 11%–13%)
|
Capital
expenditures
|
$390 million–$420
million
(previously $380 million–$420 million)
|
(1)
|
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. 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.
|
|
|
(2)
|
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.
|
|
|
(3)
|
A reconciliation of
full year 2019 non-GAAP to GAAP financial guidance is included
below:
|
|
|
Projected
Range
|
(In
millions)
|
|
Low
|
|
High
|
Unreimbursed
R&D(4)
|
|
$
|
2,360
|
|
|
$
|
2,410
|
|
R&D: Non-cash
share-based compensation expense
|
|
(250)
|
|
|
(270)
|
|
R&D: Up-front
payments related to license and
collaboration agreements
|
|
(430)
|
|
|
(430)
|
|
Non-GAAP unreimbursed
R&D
|
|
$
|
1,680
|
|
|
$
|
1,710
|
|
|
|
|
|
|
GAAP
SG&A
|
|
$
|
1,730
|
|
|
$
|
1,780
|
|
SG&A: Non-cash
share-based compensation
expense
|
|
(160)
|
|
|
(180)
|
|
SG&A:
Other
|
|
(20)
|
|
|
(20)
|
|
Non-GAAP
SG&A
|
|
$
|
1,550
|
|
|
$
|
1,580
|
|
(4)
|
Unreimbursed R&D
represents GAAP R&D expenses reduced by GAAP R&D expense
reimbursements from the Company's collaborators and/or customers
(refer to Table 4).
|
|
|
(5)
|
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 third quarter 2019 financial and operating results
on Tuesday, November 5, 2019, at 8:30
AM. To access this call, dial (800) 708-4540 (U.S.) or
(847) 619-6397 (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 at least 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, infectious diseases, pain, and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through its proprietary
VelociSuite® technologies, such as
VelocImmune® which uses a unique
genetically-humanized mouse to produce optimized fully-human
antibodies and bispecific antibodies, and through 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;
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,
evinacumab, and REGN-EB3; 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, unreimbursed R&D, 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 Dupixent and Praluent), other litigation and other
proceedings and government investigations relating to the Company
and/or its operations, the ultimate outcome of any such proceedings
and investigations, 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 September 30, 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:
|
|
|
|
|
|
Justin
Holko
|
|
Hala Mirza
|
Investor
Relations
|
|
Corporate
Communications
|
914-847-7786
|
|
914-847-3422
|
justin.holko@regeneron.com
|
|
hala.mirza@regeneron.com
|
TABLE 1
|
|
REGENERON
PHARMACEUTICALS, INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS (Unaudited)
|
(In
millions)
|
|
|
|
September
30,
|
|
December
31,
|
|
|
2019
|
|
2018
|
Assets:
|
|
|
|
|
Cash and marketable
securities
|
|
$
|
5,990.5
|
|
|
$
|
4,564.9
|
|
Accounts receivable -
trade, net
|
|
2,027.7
|
|
|
1,723.7
|
|
Accounts receivable
from Sanofi and Bayer
|
|
632.3
|
|
|
519.5
|
|
Inventories
|
|
1,344.3
|
|
|
1,151.2
|
|
Property, plant, and
equipment, net
|
|
2,771.4
|
|
|
2,575.8
|
|
Deferred tax
assets
|
|
808.3
|
|
|
828.7
|
|
Other
assets
|
|
364.8
|
|
|
370.7
|
|
Total
assets
|
|
$
|
13,939.3
|
|
|
$
|
11,734.5
|
|
|
|
|
|
|
Liabilities and
stockholders' equity:
|
|
|
|
|
Accounts payable,
accrued expenses, and other liabilities
|
|
$
|
1,429.7
|
|
|
$
|
1,352.0
|
|
Deferred
revenue
|
|
1,292.5
|
|
|
916.7
|
|
Finance lease
liabilities
|
|
712.7
|
|
|
708.5
|
|
Stockholders'
equity
|
|
10,504.4
|
|
|
8,757.3
|
|
Total liabilities and
stockholders' equity
|
|
$
|
13,939.3
|
|
|
$
|
11,734.5
|
|
TABLE 2
|
|
REGENERON
PHARMACEUTICALS, INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
|
(In millions,
except per share data)
|
|
|
|
Three Months
Ended
September 30,
|
|
Nine Months
Ended
September 30,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product
sales
|
|
$
|
1,238.3
|
|
|
$
|
1,025.5
|
|
|
$
|
3,548.0
|
|
|
$
|
3,009.8
|
|
Sanofi collaboration
revenue
|
|
404.2
|
|
|
256.3
|
|
|
999.7
|
|
|
683.5
|
|
Bayer collaboration
revenue
|
|
302.8
|
|
|
264.4
|
|
|
868.0
|
|
|
775.2
|
|
Other
revenue
|
|
103.1
|
|
|
117.3
|
|
|
278.2
|
|
|
314.5
|
|
|
|
2,048.4
|
|
|
1,663.5
|
|
|
5,693.9
|
|
|
4,783.0
|
|
Expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
663.4
|
|
|
557.0
|
|
|
2,353.5
|
|
|
1,584.8
|
|
Selling, general, and
administrative
|
|
419.9
|
|
|
369.2
|
|
|
1,248.0
|
|
|
1,064.9
|
|
Cost of goods
sold
|
|
115.9
|
|
|
30.8
|
|
|
253.8
|
|
|
136.1
|
|
Cost of collaboration
and contract manufacturing
|
|
110.7
|
|
|
79.6
|
|
|
304.5
|
|
|
180.9
|
|
|
|
1,309.9
|
|
|
1,036.6
|
|
|
4,159.8
|
|
|
2,966.7
|
|
|
|
|
|
|
|
|
|
|
Income from
operations
|
|
738.5
|
|
|
626.9
|
|
|
1,534.1
|
|
|
1,816.3
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense), net
|
|
30.0
|
|
|
9.0
|
|
|
5.2
|
|
|
61.0
|
|
|
|
|
|
|
|
|
|
|
Income before income
taxes
|
|
768.5
|
|
|
635.9
|
|
|
1,539.3
|
|
|
1,877.3
|
|
|
|
|
|
|
|
|
|
|
Income tax
expense
|
|
(98.9)
|
|
|
(41.2)
|
|
|
(215.5)
|
|
|
(253.3)
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
669.6
|
|
|
$
|
594.7
|
|
|
$
|
1,323.8
|
|
|
$
|
1,624.0
|
|
|
|
|
|
|
|
|
|
|
Net income per share
- basic
|
|
$
|
6.12
|
|
|
$
|
5.50
|
|
|
$
|
12.12
|
|
|
$
|
15.06
|
|
Net income per share
- diluted
|
|
$
|
5.86
|
|
|
$
|
5.17
|
|
|
$
|
11.54
|
|
|
$
|
14.14
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding - basic
|
|
109.4
|
|
|
108.0
|
|
|
109.2
|
|
|
107.8
|
|
Weighted average
shares outstanding - diluted
|
|
114.2
|
|
|
115.1
|
|
|
114.7
|
|
|
114.8
|
|
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
September 30,
|
|
Nine Months
Ended
September 30,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
GAAP net
income
|
|
$
|
669.6
|
|
|
$
|
594.7
|
|
|
$
|
1,323.8
|
|
|
$
|
1,624.0
|
|
Adjustments:
|
|
|
|
|
|
|
|
|
R&D: Non-cash
share-based compensation expense
|
|
60.0
|
|
|
60.4
|
|
|
178.0
|
|
|
160.8
|
|
R&D: Up-front
payments related to license and
collaboration agreements
|
|
—
|
|
|
—
|
|
|
400.0
|
|
|
—
|
|
SG&A: Non-cash
share-based compensation expense
|
|
40.8
|
|
|
42.9
|
|
|
122.3
|
|
|
118.4
|
|
SG&A: Litigation
contingencies
|
|
—
|
|
|
—
|
|
|
10.0
|
|
|
—
|
|
COGS and COCM:
Non-cash share-based compensation
expense
|
|
16.3
|
|
|
8.1
|
|
|
30.5
|
|
|
21.4
|
|
Other income/expense:
(Gains) losses on investments in
equity securities
|
|
(3.4)
|
|
|
4.9
|
|
|
70.7
|
|
|
(21.0)
|
|
Income tax effect of
reconciling items above
|
|
(21.5)
|
|
|
(23.7)
|
|
|
(165.8)
|
|
|
(55.8)
|
|
Income tax expense:
Adjustment to previously recorded
charge related to enactment of U.S. Tax Reform
Act
|
|
—
|
|
|
(11.9)
|
|
|
—
|
|
|
(11.9)
|
|
Non-GAAP net
income
|
|
$
|
761.8
|
|
|
$
|
675.4
|
|
|
$
|
1,969.5
|
|
|
$
|
1,835.9
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
$
|
6.96
|
|
|
$
|
6.25
|
|
|
$
|
18.04
|
|
|
$
|
17.03
|
|
Non-GAAP net income
per share - diluted
|
|
$
|
6.67
|
|
|
$
|
5.87
|
|
|
$
|
17.16
|
|
|
$
|
15.98
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating:
|
|
|
|
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
109.4
|
|
|
108.0
|
|
|
109.2
|
|
|
107.8
|
|
Non-GAAP net income
per share - diluted
|
|
114.2
|
|
|
115.1
|
|
|
114.8
|
|
|
114.9
|
|
TABLE 4
|
|
REGENERON
PHARMACEUTICALS, INC.
|
COLLABORATION AND
OTHER REVENUE (Unaudited)
|
(In
millions)
|
|
|
|
Three Months
Ended
September 30,
|
|
Nine Months
Ended
September 30,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Sanofi
collaboration revenue:
|
|
|
|
|
|
|
|
|
Antibody:
|
|
|
|
|
|
|
|
|
Reimbursement of
Regeneron research and development expenses
|
|
$
|
60.2
|
|
|
$
|
76.2
|
|
|
$
|
216.5
|
|
|
$
|
201.0
|
|
Reimbursement of
Regeneron commercialization-related expenses
|
|
111.6
|
|
|
103.7
|
|
|
349.3
|
|
|
292.8
|
|
Reimbursement for
Regeneron's manufacturing of commercial
supplies
|
|
78.5
|
|
|
40.3
|
|
|
133.3
|
|
|
94.4
|
|
Regeneron's share of
profits (losses) in connection with
commercialization of antibodies
|
|
94.2
|
|
|
(38.9)
|
|
|
105.2
|
|
|
(182.6)
|
|
Other
|
|
4.8
|
|
|
(7.2)
|
|
|
(0.6)
|
|
|
(12.3)
|
|
Immuno-oncology:
|
|
|
|
|
|
|
|
|
Reimbursement of
Regeneron research and development expenses
|
|
38.0
|
|
|
74.8
|
|
|
120.9
|
|
|
225.7
|
|
Reimbursement of
Regeneron commercialization-related expenses
|
|
3.0
|
|
|
3.2
|
|
|
7.0
|
|
|
6.5
|
|
Amounts recognized in
connection with up-front payments
received
|
|
18.5
|
|
|
7.9
|
|
|
73.8
|
|
|
65.2
|
|
Other
|
|
(4.6)
|
|
|
(3.7)
|
|
|
(5.7)
|
|
|
(7.2)
|
|
Total Sanofi
collaboration revenue
|
|
404.2
|
|
|
256.3
|
|
|
999.7
|
|
|
683.5
|
|
|
|
|
|
|
|
|
|
|
Bayer
collaboration revenue:
|
|
|
|
|
|
|
|
|
Regeneron's net
profit in connection with commercialization of
EYLEA outside the United States
|
|
275.0
|
|
|
243.2
|
|
|
793.3
|
|
|
721.5
|
|
Reimbursement of
Regeneron development expenses
|
|
5.0
|
|
|
0.5
|
|
|
15.6
|
|
|
8.3
|
|
Other
|
|
22.8
|
|
|
20.7
|
|
|
59.1
|
|
|
45.4
|
|
Total Bayer
collaboration revenue
|
|
302.8
|
|
|
264.4
|
|
|
868.0
|
|
|
775.2
|
|
|
|
|
|
|
|
|
|
|
Other
revenue:
|
|
|
|
|
|
|
|
|
Reimbursement of
Regeneron research and development expenses
- Teva
|
|
34.2
|
|
|
27.6
|
|
|
102.9
|
|
|
101.1
|
|
Reimbursement of
Regeneron research and development expenses
- other
|
|
24.9
|
|
|
6.3
|
|
|
37.0
|
|
|
12.9
|
|
Other
|
|
44.0
|
|
|
83.4
|
|
|
138.3
|
|
|
200.5
|
|
Total other
revenue
|
|
$
|
103.1
|
|
|
$
|
117.3
|
|
|
$
|
278.2
|
|
|
$
|
314.5
|
|
TABLE 5
|
|
REGENERON
PHARMACEUTICALS, INC.
|
NET PRODUCT SALES
OF REGENERON-DISCOVERED PRODUCTS (Unaudited)
|
(In
millions)
|
|
|
|
Three Months
Ended
September 30,
|
|
|
2019
|
|
2018
|
|
%
Change
|
|
|
U.S.
|
|
ROW
|
|
Total
|
|
U.S.
|
|
ROW
|
|
Total
|
|
(Total
Sales)
|
EYLEA*
|
|
$
|
1,187.7
|
|
|
$
|
730.2
|
|
|
$
|
1,917.9
|
|
|
$
|
1,021.8
|
|
|
$
|
654.6
|
|
|
$
|
1,676.4
|
|
|
14
|
%
|
Libtayo*
|
|
47.6
|
|
|
3.9
|
|
|
51.5
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
**
|
ARCALYST
|
|
3.0
|
|
|
—
|
|
|
3.0
|
|
|
3.7
|
|
|
—
|
|
|
3.7
|
|
|
(19)
|
%
|
Net product sales
recorded by
Regeneron
|
|
$
|
1,238.3
|
|
|
|
|
|
|
$
|
1,025.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Global net product
sales recorded by Sanofi*:
|
|
|
|
|
|
|
|
|
|
|
Dupixent
|
|
$
|
508.3
|
|
|
$
|
124.8
|
|
|
$
|
633.1
|
|
|
$
|
219.6
|
|
|
$
|
43.0
|
|
|
$
|
262.6
|
|
|
141
|
%
|
Praluent
|
|
$
|
33.5
|
|
|
$
|
36.2
|
|
|
$
|
69.7
|
|
|
$
|
48.4
|
|
|
$
|
31.8
|
|
|
$
|
80.2
|
|
|
(13)
|
%
|
Kevzara
|
|
$
|
36.5
|
|
|
$
|
18.3
|
|
|
$
|
54.8
|
|
|
$
|
19.9
|
|
|
$
|
5.0
|
|
|
$
|
24.9
|
|
|
120
|
%
|
ZALTRAP
|
|
$
|
3.1
|
|
|
$
|
25.3
|
|
|
$
|
28.4
|
|
|
$
|
1.5
|
|
|
$
|
23.9
|
|
|
$
|
25.4
|
|
|
12
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months
Ended
September 30,
|
|
|
2019
|
|
2018
|
|
%
Change
|
|
|
U.S.
|
|
ROW
|
|
Total
|
|
U.S.
|
|
ROW
|
|
Total
|
|
(Total
Sales)
|
EYLEA*
|
|
$
|
3,422.1
|
|
|
$
|
2,114.9
|
|
|
$
|
5,537.0
|
|
|
$
|
2,997.8
|
|
|
$
|
1,944.5
|
|
|
$
|
4,942.3
|
|
|
12
|
%
|
Libtayo*
|
|
115.2
|
|
|
3.9
|
|
|
119.1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
**
|
ARCALYST
|
|
10.7
|
|
|
—
|
|
|
10.7
|
|
|
12.0
|
|
|
—
|
|
|
12.0
|
|
|
(11)
|
%
|
Net product sales
recorded by
Regeneron
|
|
$
|
3,548.0
|
|
|
|
|
|
|
$
|
3,009.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Global net product
sales recorded by Sanofi*:
|
|
|
|
|
|
|
|
|
|
|
Dupixent
|
|
$
|
1,266.0
|
|
|
$
|
298.1
|
|
|
$
|
1,564.1
|
|
|
$
|
517.7
|
|
|
$
|
85.4
|
|
|
$
|
603.1
|
|
|
159
|
%
|
Praluent
|
|
$
|
82.9
|
|
|
$
|
124.4
|
|
|
$
|
207.3
|
|
|
$
|
121.5
|
|
|
$
|
92.0
|
|
|
$
|
213.5
|
|
|
(3)
|
%
|
Kevzara
|
|
$
|
91.4
|
|
|
$
|
55.6
|
|
|
$
|
147.0
|
|
|
$
|
48.1
|
|
|
$
|
13.3
|
|
|
$
|
61.4
|
|
|
139
|
%
|
ZALTRAP
|
|
$
|
4.9
|
|
|
$
|
74.6
|
|
|
$
|
79.5
|
|
|
$
|
6.6
|
|
|
$
|
73.5
|
|
|
$
|
80.1
|
|
|
(1)
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Bayer records net product sales of
EYLEA outside the U.S., and Sanofi records net product sales of
Libtayo outside the U.S. and global net product sales of Dupixent,
Praluent, Kevzara, and ZALTRAP. The Company records its share
of profits/losses in connection with sales of EYLEA and Libtayo
outside the U.S., and global sales of Dupixent, Praluent, and
Kevzara, within collaboration revenue (see Table 4). Sanofi
pays the Company a percentage of aggregate net sales of
ZALTRAP.
|
** Percentage not
meaningful
|
View original
content:http://www.prnewswire.com/news-releases/regeneron-reports-third-quarter-2019-financial-and-operating-results-300951188.html
SOURCE Regeneron Pharmaceuticals, Inc.