TARRYTOWN, N.Y., Feb. 6, 2020 /PRNewswire/ --
- Fourth quarter 2019 revenues increased 13% to $2.17 billion versus fourth quarter 2018
- Fourth quarter EYLEA® U.S. net sales increased
13% to $1.22 billion versus fourth
quarter 2018 and full year 2019 EYLEA U.S. net sales increased 14%
versus 2018
- Dupixent® global net
sales(2), which are recorded by Sanofi,
increased 136% to $752 million versus
fourth quarter 2018 and increased to $2.32
billion for full year 2019
- Fourth quarter 2019 GAAP diluted EPS was $6.93 and fourth quarter non-GAAP diluted
EPS(1) was $7.50
- The Company and Sanofi announced intent to restructure
antibody collaboration for Kevzara® and
Praluent®
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced financial results for the fourth quarter and full year
2019 and provided a business update.
"Regeneron had a very productive 2019 marked by strong
commercial growth for our core franchises, significant pipeline and
regulatory progress, and positive financial results," said
Leonard S. Schleifer, M.D., Ph.D.,
President and Chief Executive Officer of Regeneron. "In 2020,
we are focused on driving continued growth with EYLEA, Dupixent,
and Libtayo and anticipate several new regulatory approvals and
submissions across our portfolio. Our expanding pipeline of
innovative and complementary immuno-oncology therapies continues to
advance, and we feel confident that we are positioned to bring new
breakthroughs to cancer patients and be a leader in this rapidly
evolving field."
"We continue to work constructively with Sanofi to finalize our
modified antibody agreement for Praluent and Kevzara, which we
expect to be accretive in 2020," said Robert E. Landry, Executive Vice President,
Finance and Chief Financial Officer of Regeneron. "We will
provide financial guidance for full year 2020 by no later than the
end of the first quarter."
Financial
Highlights
|
|
|
|
Three Months
Ended
December
31,
|
|
%
Change
|
|
Year
Ended
December
31,
|
|
%
Change
|
($ in millions,
except per share data)
|
|
2019
|
|
2018
|
|
|
2019
|
|
2018
|
|
Total
revenues
|
|
$
|
2,170
|
|
|
$
|
1,928
|
|
|
13
|
%
|
|
$
|
7,863
|
|
|
$
|
6,711
|
|
|
17
|
%
|
GAAP net
income
|
|
$
|
792
|
|
|
$
|
820
|
|
|
(3)
|
%
|
|
$
|
2,116
|
|
|
$
|
2,444
|
|
|
(13)
|
%
|
GAAP net income per
share -
diluted
|
|
$
|
6.93
|
|
|
$
|
7.15
|
|
|
(3)
|
%
|
|
$
|
18.46
|
|
|
$
|
21.29
|
|
|
(13)
|
%
|
Non-GAAP net
income(1)
|
|
$
|
858
|
|
|
$
|
786
|
|
|
9
|
%
|
|
$
|
2,827
|
|
|
$
|
2,622
|
|
|
8
|
%
|
Non-GAAP net income
per
share - diluted(1)
|
|
$
|
7.50
|
|
|
$
|
6.84
|
|
|
10
|
%
|
|
$
|
24.67
|
|
|
$
|
22.84
|
|
|
8
|
%
|
Business Highlights
Key Pipeline Progress
Regeneron has 22 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 December 2019, the Company
launched the EYLEA pre-filled syringe in the United States.
Dupixent® (dupilumab)
- In October 2019, the European
Commission (EC) approved Dupixent in chronic rhinosinusitis with
nasal polyposis (CRSwNP).
- The FDA accepted for priority review the supplemental Biologics
License Application (sBLA) for children aged 6 to 11 years with
moderate-to-severe atopic dermatitis, with a target action date of
May 26, 2020. In addition, a
Marketing Authorization Application (MAA) for children aged 6 to 11
years with moderate-to-severe atopic dermatitis was recently
submitted in the European Union.
- A Phase 2/3 study in bullous pemphigoid and Phase 3 studies in
prurigo nodularis and chronic spontaneous urticaria were
initiated.
Libtayo® (cemiplimab)
- A Phase 2 neoadjuvant study in cutaneous squamous cell
carcinoma (CSCC) was initiated.
REGN1979, a bispecific antibody targeting CD20 and CD3
- In December 2019, the Company
reported updated results from the initial clinical trial in
patients with non-Hodgkin lymphoma.
- The potentially pivotal Phase 2 study has been expanded to
include patients with diffuse large B-cell lymphoma (DLBCL) and
other non-Hodgkin lymphomas.
REGN5458, a bispecific antibody targeting BCMA and CD3
- In December 2019, the Company
announced positive preliminary results from an initial clinical
trial in patients with relapsed or refractory multiple
myeloma.
Pozelimab, an antibody to C5
- In December 2019, the Company
announced positive top-line results from a Phase 2 trial in
paroxysmal nocturnal hemoglobinuria (PNH).
Garetosmab, an antibody to Activin A
- In January 2020, the Company
announced encouraging results from a Phase 2 trial in
fibrodysplasia ossificans progressiva (FOP).
REGN-EB3, a multi-antibody therapy to Ebola virus infection
- The New England Journal of Medicine published results
from the randomized, controlled PALM trial showing that Regeneron's
REGN-EB3 and another agent provided the highest overall survival
rates among four investigational treatments for Ebola.
Business Development Update
- The Company and Sanofi announced their intent to restructure
their antibody collaboration for Kevzara and Praluent and enter
into a royalty-based arrangement. Under the proposed terms of the
agreement, Sanofi is expected to gain sole global rights to Kevzara
and sole rights to Praluent outside of the United States. Regeneron is expected to
gain sole U.S. rights to Praluent. Under the proposed terms, each
party will be solely responsible for funding development and
commercialization expenses in their respective territories. The
proposed agreement, which is expected to be finalized in the first
quarter of 2020, will not impact the companies' existing
collaboration relating to Dupixent and REGN3500.
- The Company entered into a research collaboration and option
licensing agreement with Vyriad, Inc. to discover and develop new
oncolytic (cancer-killing) virus-based treatments for various forms
of cancer.
Select 2020 Milestones
Programs
|
|
Milestones
|
Dupixent
|
-
|
FDA decision (target
action date of May 26, 2020) on sBLA and EC decision for expanded
atopic dermatitis indication in pediatric patients (6–11 years of
age)
|
|
-
|
Report results from
Phase 3 study for asthma in pediatric patients (6–11 years of
age)
|
|
-
|
Report results from
Phase 2 portion of Phase 2/3 study in eosinophilic esophagitis
(EOE)
|
Libtayo
|
-
|
Interim analysis of
overall survival in Phase 3 non-small cell lung cancer (NSCLC)
monotherapy study in patients with high PD-L1 expression
|
|
-
|
Report results from
potentially pivotal Phase 2 study in basal cell carcinoma
(BCC)
|
REGN1979 (CD20 and
CD3 Antibody)
|
-
|
Report updated
results from initial study in certain B-cell
malignancies
|
|
-
|
Continue to expand
potentially pivotal Phase 2 study
|
REGN5458 (BCMA and
CD3 Antibody)
|
-
|
Report updated
results from initial study in multiple myeloma
|
Evinacumab (ANGPTL3
Antibody)
|
-
|
Submit BLA and MAA
for homozygous familial hypercholesterolemia (HoFH)
|
Pozelimab (C5
Antibody)
|
-
|
Initiate Phase 3
program in PNH
|
|
-
|
Initiate combination
program with Alnylam's cemdisiran
|
Garetosmab (Activin A
Antibody)
|
-
|
Discuss regulatory
submission for FOP with regulatory authorities
|
Fasinumab (NGF
Antibody)
|
-
|
Report results from
Phase 3 studies in osteoarthritis pain of the knee or
hip
|
REGN-EB3
(Multi-antibody therapy to Ebola)
|
-
|
Complete rolling BLA
submission for Ebola
|
Fourth Quarter and Full Year 2019 Financial Results
Total Revenues: Total revenues increased by 13% to
$2.170 billion in the fourth quarter
of 2019, compared to $1.928 billion
in the fourth quarter of 2018. Full year 2019 total revenues
increased 17% to $7.863 billion,
compared to $6.711 billion for the
full year 2018.
Net product sales were $1.286
billion in the fourth quarter and $4.834 billion for the full year 2019, compared
to $1.096 billion in the fourth
quarter and $4.106 billion for the
full year 2018. EYLEA net product sales in the United States were $1.222 billion in the fourth quarter and
$4.644 billion for the full year
2019, compared to $1.079 billion in
the fourth quarter and $4.077 billion
for the full year 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(2) of $748
million in the fourth quarter and $2.616 billion for the full year 2019, compared
to $729 million in the fourth quarter
and $2.188 billion for the full year
2018. Sanofi collaboration revenue in the fourth quarter and
full year 2019 included the Company's share of profits from
collaboration antibodies (Dupixent, Praluent, and Kevzara) of
$104 million and $209 million, respectively, while Sanofi
collaboration revenue in the fourth quarter and full year 2018
included the Company's share of losses from collaboration
antibodies of $(44) million and
$(227) million, respectively.
The increase in the Company's share of profits from collaboration
antibodies was primarily driven by higher Dupixent profits.
Sanofi collaboration revenue in the fourth quarter of 2018 also
included the recognition of a cumulative catch-up adjustment of
$149 million arising from a change in
the estimate of the stage of completion of the collaborations'
immuno-oncology programs primarily in connection with the Amended
IO Discovery Agreement.
Refer to Table 4 for a summary of collaboration and other
revenue.
Research and Development (R&D) Expenses: GAAP R&D
expenses were $683 million in the
fourth quarter and $3.037 billion for
the full year 2019, compared to $601
million in the fourth quarter and $2.186 billion for the full year 2018. The
higher R&D expenses in the fourth quarter of 2019 were
principally due to additional costs incurred in connection with our
earlier-stage pipeline and dupilumab, and higher headcount and
headcount-related costs. The higher R&D expenses for the
full year 2019 were principally due to a $400 million up-front payment to Alnylam,
additional costs incurred in connection with our earlier-stage
pipeline, and higher headcount and headcount-related costs.
R&D-related non-cash share-based compensation expense was
$72 million in the fourth
quarter and $250 million for the full year 2019, compared
to $68 million in the fourth quarter and $229
million for the full year 2018.
Selling, General, and Administrative (SG&A) Expenses:
GAAP SG&A expenses were $587
million in the fourth quarter and $1.835 billion for the full year 2019, compared
to $491 million in the fourth quarter
and $1.556 billion for the full year
2018. The higher SG&A expenses in the fourth quarter and
full year 2019 were primarily due to higher headcount and
headcount-related costs, an increase in commercialization-related
expenses for Dupixent and EYLEA, additional accruals for loss
contingencies associated with ongoing litigation, and higher
contributions to independent not-for-profit patient assistance
organizations. In addition, in the fourth quarter of 2019,
the Company recorded a charge for restructuring-related costs,
primarily related to employee separation costs, as the Company has
eliminated certain commercialization activities and related
headcount in connection with the proposed restructuring of the
antibody agreement with Sanofi (as described above).
SG&A-related non-cash share-based compensation expense was
$45 million in the fourth quarter and
$168 million for the full year 2019,
compared to $51 million in the fourth
quarter and $169 million for the full
year 2018.
Cost of Goods Sold (COGS): GAAP COGS was $109 million in the fourth quarter and
$362 million for the full year 2019,
compared to $44 million in the fourth
quarter and $180 million for the full
year 2018. The increase in COGS was primarily due to our
obligation to pay Sanofi its share of Libtayo U.S. gross profits,
third-party royalties on Libtayo U.S. sales, and higher inventory
write-downs and reserves.
Cost of Collaboration and Contract Manufacturing (COCM):
GAAP COCM was $115 million in the
fourth quarter and $420 million for
the full year 2019, compared to $73
million in the fourth quarter and $254 million for the full year 2018. The
increase in COCM for the full year 2019 was primarily due to the
recognition of manufacturing costs associated with higher sales of
Dupixent.
Other Income (Expense): GAAP other income (expense),
net, includes the recognition of net gains on equity
securities of $189 million in
the fourth quarter and $118 million
for the full year 2019, compared to net losses of $(63) million in the fourth quarter and
$(42) million for the full year
2018.
Income Taxes: GAAP income tax expense was $98 million and the effective tax rate was 11.0%
in the fourth quarter of 2019, compared to a GAAP income tax
benefit of $(144) million and (21.3%)
in the fourth quarter of 2018. GAAP income tax expense
was $313 million and the effective tax rate
was 12.9% for the full year 2019, compared to
$109 million and 4.3% for
the full year 2018. The effective tax rate for the
fourth quarter and full year 2019 was positively impacted, compared
to the U.S. federal statutory rate, primarily by stock-based
compensation, income earned in foreign jurisdictions with tax rates
lower than the U.S. federal statutory rate, and federal tax credits
for research activities. The Company's effective tax rate for
the fourth quarter and full year 2018 was positively impacted,
compared to the U.S. federal statutory rate, primarily by the
Company's fourth quarter sale of non-inventory related assets
between foreign subsidiaries, which had a net impact on the rate
by 24.0% and 6.3% for the fourth quarter and
full year 2018, respectively. During the fourth quarter and
full year 2018, the Company also recorded an income tax benefit of
$56 million and $68 million, respectively, as an adjustment to
the provisional amount recorded as of December 31, 2017 for the U.S. Tax Reform
Act.
GAAP and Non-GAAP Net Income(1):
GAAP net income was $792 million, or
$6.93 per diluted share, in the
fourth quarter of 2019, compared to GAAP net income of $820 million, or $7.15 per diluted share, in the fourth quarter of
2018. GAAP net income was $2.116
billion, or $18.46 per diluted
share, for the full year 2019, compared to GAAP net income of
$2.444 billion, or $21.29 per diluted share, for the full year
2018.
Non-GAAP net income was $858
million, or $7.50 per diluted
share, in the fourth quarter of 2019, compared to non-GAAP net
income of $786 million, or
$6.84 per diluted share, in the
fourth quarter of 2018. Non-GAAP net income was $2.827 billion, or $24.67 per diluted share, for the full year 2019,
compared to non-GAAP net income of $2.622
billion, or $22.84 per diluted
share, for the full year 2018.
A reconciliation of the Company's GAAP to non-GAAP results is
included in Table 3 of this press release.
2020 Financial Guidance
Given the announcement regarding the intent to restructure
the antibody collaboration for Kevzara and Praluent with Sanofi,
Regeneron will provide financial guidance for full year 2020 by the
end of the first quarter of 2020.
(1)
|
This press release
uses non-GAAP net income and non-GAAP net income per share, 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 restructuring-related expenses,
including employee separation costs). 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
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 fourth quarter and full year 2019 financial and
operating results on Thursday, February 6, 2020, at
8:00 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 over 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, pain, infectious diseases, and rare
diseases.
Regeneron is accelerating and improving the traditional drug
development process through its proprietary
VelociSuite® technologies, such as
VelocImmune® which uses unique
genetically-humanized mice 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 products marketed
by Regeneron and/or its collaborators (collectively, "Regeneron's
Products") and Regeneron's 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 Regeneron's Products and product candidates in
patients, including serious complications or side effects in
connection with the use of Regeneron's Products and 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 Regeneron's
Products, including without limitation
EYLEA® (aflibercept) Injection,
Dupixent® (dupilumab) Injection,
Libtayo® (cemiplimab) Injection,
Praluent® (alirocumab) Injection,
Kevzara® (sarilumab) Injection, fasinumab,
evinacumab, REGN-EB3, garetosmab, pozelimab, and REGN1979; 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
Products (such as EYLEA, Dupixent, Libtayo, Praluent, and Kevzara),
research and clinical programs, and business, including those
relating to patient privacy; determinations by regulatory and
administrative governmental authorities which may delay or restrict
Regeneron's ability to continue to develop or commercialize
Regeneron's Products and product candidates; competing drugs and
product candidates that may be superior to Regeneron's Products and
product candidates; uncertainty of market acceptance and commercial
success of Regeneron's Products and product candidates and the
impact of studies (whether conducted by Regeneron or others and
whether mandated or voluntary), on the commercial success of
Regeneron's Products and product candidates; the ability of
Regeneron to manufacture and manage supply chains for multiple
products and product candidates; the ability of Regeneron's
collaborators, suppliers, or other third parties (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 payors, 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; 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. 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)
|
|
|
|
December
31,
|
|
|
2019
|
|
2018
|
Assets:
|
|
|
|
|
Cash and marketable
securities
|
|
$
|
6,471.1
|
|
|
$
|
4,564.9
|
|
Accounts receivable -
trade, net
|
|
2,100.0
|
|
|
1,723.7
|
|
Accounts receivable
from Sanofi and Bayer
|
|
572.2
|
|
|
519.5
|
|
Inventories
|
|
1,415.5
|
|
|
1,151.2
|
|
Property, plant, and
equipment, net
|
|
2,890.4
|
|
|
2,575.8
|
|
Deferred tax
assets
|
|
824.2
|
|
|
828.7
|
|
Other
assets
|
|
531.8
|
|
|
370.7
|
|
Total
assets
|
|
$
|
14,805.2
|
|
|
$
|
11,734.5
|
|
|
|
|
|
|
Liabilities and
stockholders' equity:
|
|
|
|
|
Accounts payable,
accrued expenses, and other liabilities
|
|
$
|
1,790.9
|
|
|
$
|
1,352.0
|
|
Deferred
revenue
|
|
1,210.7
|
|
|
916.7
|
|
Finance lease
liabilities
|
|
713.9
|
|
|
708.5
|
|
Stockholders'
equity
|
|
11,089.7
|
|
|
8,757.3
|
|
Total liabilities and
stockholders' equity
|
|
$
|
14,805.2
|
|
|
$
|
11,734.5
|
|
TABLE 2
|
|
REGENERON
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
(In millions,
except per share data)
|
|
|
|
Three Months
Ended
December
31,
|
|
Year
Ended
December
31,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product
sales
|
|
$
|
1,286.4
|
|
|
$
|
1,096.4
|
|
|
$
|
4,834.4
|
|
|
$
|
4,106.2
|
|
Sanofi collaboration
revenue
|
|
427.1
|
|
|
427.6
|
|
|
1,426.8
|
|
|
1,111.1
|
|
Bayer collaboration
revenue
|
|
320.8
|
|
|
301.5
|
|
|
1,188.8
|
|
|
1,076.7
|
|
Other
revenue
|
|
135.2
|
|
|
102.3
|
|
|
413.4
|
|
|
416.8
|
|
|
|
2,169.5
|
|
|
1,927.8
|
|
|
7,863.4
|
|
|
6,710.8
|
|
Expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
683.1
|
|
|
601.2
|
|
|
3,036.6
|
|
|
2,186.1
|
|
Selling, general, and
administrative
|
|
586.8
|
|
|
491.3
|
|
|
1,834.8
|
|
|
1,556.2
|
|
Cost of goods
sold
|
|
108.5
|
|
|
44.0
|
|
|
362.3
|
|
|
180.0
|
|
Cost of collaboration
and contract manufacturing
|
|
115.4
|
|
|
73.2
|
|
|
419.9
|
|
|
254.1
|
|
|
|
1,493.8
|
|
|
1,209.7
|
|
|
5,653.6
|
|
|
4,176.4
|
|
|
|
|
|
|
|
|
|
|
Income from
operations
|
|
675.7
|
|
|
718.1
|
|
|
2,209.8
|
|
|
2,534.4
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense), net
|
|
214.1
|
|
|
(41.9)
|
|
|
219.3
|
|
|
19.1
|
|
|
|
|
|
|
|
|
|
|
Income before income
taxes
|
|
889.8
|
|
|
676.2
|
|
|
2,429.1
|
|
|
2,553.5
|
|
|
|
|
|
|
|
|
|
|
Income tax (expense)
benefit
|
|
(97.8)
|
|
|
144.2
|
|
|
(313.3)
|
|
|
(109.1)
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
792.0
|
|
|
$
|
820.4
|
|
|
$
|
2,115.8
|
|
|
$
|
2,444.4
|
|
|
|
|
|
|
|
|
|
|
Net income per share
- basic
|
|
$
|
7.25
|
|
|
$
|
7.58
|
|
|
$
|
19.38
|
|
|
$
|
22.65
|
|
Net income per share
- diluted
|
|
$
|
6.93
|
|
|
$
|
7.15
|
|
|
$
|
18.46
|
|
|
$
|
21.29
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding - basic
|
|
109.2
|
|
|
108.2
|
|
|
109.2
|
|
|
107.9
|
|
Weighted average
shares outstanding - diluted
|
|
114.3
|
|
|
114.8
|
|
|
114.6
|
|
|
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
December
31,
|
|
Year
Ended
December
31,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
GAAP net
income
|
|
$
|
792.0
|
|
|
$
|
820.4
|
|
|
$
|
2,115.8
|
|
|
$
|
2,444.4
|
|
Adjustments:
|
|
|
|
|
|
|
|
|
R&D: Non-cash
share-based compensation expense
|
|
72.4
|
|
|
68.2
|
|
|
250.4
|
|
|
229.0
|
|
R&D: Up-front
payments related to license and
collaboration agreements
|
|
30.0
|
|
|
—
|
|
|
430.0
|
|
|
—
|
|
SG&A: Non-cash
share-based compensation
expense
|
|
45.4
|
|
|
50.8
|
|
|
167.7
|
|
|
169.2
|
|
SG&A:
Restructuring-related expenses
|
|
35.2
|
|
|
—
|
|
|
35.2
|
|
|
—
|
|
SG&A: Litigation
contingencies
|
|
60.0
|
|
|
30.0
|
|
|
70.0
|
|
|
30.0
|
|
COGS and COCM:
Non-cash share-based
compensation expense
|
|
15.7
|
|
|
7.8
|
|
|
46.2
|
|
|
29.2
|
|
Other income/expense:
(Gains) losses on
investments in equity securities
|
|
(189.0)
|
|
|
62.9
|
|
|
(118.3)
|
|
|
41.9
|
|
Income tax effect of
reconciling items above
|
|
(4.1)
|
|
|
(36.2)
|
|
|
(169.9)
|
|
|
(92.1)
|
|
Income tax expense:
Impact of sale of assets
between foreign subsidiaries
|
|
—
|
|
|
(162.1)
|
|
|
—
|
|
|
(162.1)
|
|
Income tax expense:
Adjustment to previously
recorded charge related to enactment of
U.S. Tax
Reform Act
|
|
—
|
|
|
(56.1)
|
|
|
—
|
|
|
(68.0)
|
|
Non-GAAP net
income
|
|
$
|
857.6
|
|
|
$
|
785.7
|
|
|
$
|
2,827.1
|
|
|
$
|
2,621.5
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
$
|
7.85
|
|
|
$
|
7.26
|
|
|
$
|
25.89
|
|
|
$
|
24.30
|
|
Non-GAAP net income
per share - diluted
|
|
$
|
7.50
|
|
|
$
|
6.84
|
|
|
$
|
24.67
|
|
|
$
|
22.84
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating:
|
|
|
|
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
109.2
|
|
|
108.2
|
|
|
109.2
|
|
|
107.9
|
|
Non-GAAP net income
per share - diluted
|
|
114.3
|
|
|
114.9
|
|
|
114.6
|
|
|
114.8
|
|
TABLE 4
|
|
REGENERON
PHARMACEUTICALS, INC.
COLLABORATION AND
OTHER REVENUE (Unaudited)
(In
millions)
|
|
|
|
Three Months
Ended
December
31,
|
|
Year
Ended
December
31,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Sanofi
collaboration revenue:
|
|
|
|
|
|
|
|
|
Antibody:
|
|
|
|
|
|
|
|
|
Reimbursement of
research and development expenses
|
|
$
|
61.2
|
|
|
$
|
64.3
|
|
|
$
|
277.7
|
|
|
$
|
265.3
|
|
Reimbursement of
commercialization-related expenses
|
|
130.6
|
|
|
124.4
|
|
|
479.9
|
|
|
417.2
|
|
Reimbursement for
manufacturing of commercial supplies
|
|
73.4
|
|
|
33.2
|
|
|
206.7
|
|
|
127.6
|
|
Regeneron's share of
profits (losses) in connection with
commercialization of antibodies
|
|
104.1
|
|
|
(44.4)
|
|
|
209.3
|
|
|
(227.0)
|
|
Other
|
|
(0.9)
|
|
|
(11.8)
|
|
|
(1.5)
|
|
|
(24.1)
|
|
Immuno-oncology:
|
|
|
|
|
|
|
|
|
Reimbursement of
research and development expenses
|
|
42.1
|
|
|
86.1
|
|
|
163.0
|
|
|
311.8
|
|
Reimbursement of
commercialization-related expenses
|
|
3.3
|
|
|
2.4
|
|
|
10.3
|
|
|
8.9
|
|
Amounts recognized in
connection with up-front payments
received
|
|
18.9
|
|
|
178.6
|
|
|
92.7
|
|
|
243.8
|
|
Other
|
|
(5.6)
|
|
|
(5.2)
|
|
|
(11.3)
|
|
|
(12.4)
|
|
Total Sanofi
collaboration revenue
|
|
427.1
|
|
|
427.6
|
|
|
1,426.8
|
|
|
1,111.1
|
|
|
|
|
|
|
|
|
|
|
Bayer
collaboration revenue:
|
|
|
|
|
|
|
|
|
Regeneron's net
profit in connection with commercialization of
EYLEA outside the United States
|
|
298.1
|
|
|
270.8
|
|
|
1,091.4
|
|
|
992.3
|
|
Reimbursement of
development expenses
|
|
7.4
|
|
|
2.4
|
|
|
23.0
|
|
|
10.8
|
|
Other
|
|
15.3
|
|
|
28.3
|
|
|
74.4
|
|
|
73.6
|
|
Total Bayer
collaboration revenue
|
|
320.8
|
|
|
301.5
|
|
|
1,188.8
|
|
|
1,076.7
|
|
|
|
|
|
|
|
|
|
|
Other
revenue:
|
|
|
|
|
|
|
|
|
Reimbursement of
research and development expenses - Teva
|
|
20.0
|
|
|
28.4
|
|
|
122.9
|
|
|
129.5
|
|
Reimbursement of
research and development expenses - other
|
|
57.3
|
|
|
4.7
|
|
|
94.3
|
|
|
17.6
|
|
Other
|
|
57.9
|
|
|
69.2
|
|
|
196.2
|
|
|
269.7
|
|
Total other
revenue
|
|
$
|
135.2
|
|
|
$
|
102.3
|
|
|
$
|
413.4
|
|
|
$
|
416.8
|
|
TABLE 5
|
|
REGENERON
PHARMACEUTICALS, INC.
NET PRODUCT SALES
OF REGENERON-DISCOVERED PRODUCTS (Unaudited)
(In
millions)
|
|
|
|
Three Months
Ended
December
31,
|
|
|
|
|
2019
|
|
2018
|
|
%
Change
|
|
|
U.S.
|
|
ROW
|
|
Total
|
|
U.S.
|
|
ROW
|
|
Total
|
|
(Total
Sales)
|
EYLEA*
|
|
$
|
1,222.1
|
|
|
$
|
782.5
|
|
|
$
|
2,004.6
|
|
|
$
|
1,078.9
|
|
|
$
|
724.4
|
|
|
$
|
1,803.3
|
|
|
11
|
%
|
Libtayo*
|
|
60.5
|
|
|
14.2
|
|
|
74.7
|
|
|
14.8
|
|
|
—
|
|
|
14.8
|
|
|
405
|
%
|
ARCALYST
|
|
3.8
|
|
|
—
|
|
|
3.8
|
|
|
2.7
|
|
|
—
|
|
|
2.7
|
|
|
41
|
%
|
Net product sales
recorded by
Regeneron
|
|
$
|
1,286.4
|
|
|
|
|
|
|
$
|
1,096.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales
recorded by Sanofi*:
|
|
|
|
|
|
|
|
|
|
|
Dupixent
|
|
$
|
605.2
|
|
|
$
|
146.3
|
|
|
$
|
751.5
|
|
|
$
|
258.6
|
|
|
$
|
60.2
|
|
|
$
|
318.8
|
|
|
136
|
%
|
Praluent
|
|
$
|
43.1
|
|
|
$
|
38.3
|
|
|
$
|
81.4
|
|
|
$
|
59.7
|
|
|
$
|
33.5
|
|
|
$
|
93.2
|
|
|
(13)
|
%
|
Kevzara
|
|
$
|
37.6
|
|
|
$
|
22.1
|
|
|
$
|
59.7
|
|
|
$
|
26.6
|
|
|
$
|
8.6
|
|
|
$
|
35.2
|
|
|
70
|
%
|
ZALTRAP
|
|
$
|
2.4
|
|
|
$
|
26.5
|
|
|
$
|
28.9
|
|
|
$
|
2.4
|
|
|
$
|
25.4
|
|
|
$
|
27.8
|
|
|
4
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year
Ended
December
31,
|
|
|
|
|
2019
|
|
2018
|
|
%
Change
|
|
|
U.S.
|
|
ROW
|
|
Total
|
|
U.S.
|
|
ROW
|
|
Total
|
|
(Total
Sales)
|
EYLEA*
|
|
$
|
4,644.2
|
|
|
$
|
2,897.4
|
|
|
$
|
7,541.6
|
|
|
$
|
4,076.7
|
|
|
$
|
2,668.9
|
|
|
$
|
6,745.6
|
|
|
12
|
%
|
Libtayo*
|
|
175.7
|
|
|
18.1
|
|
|
193.8
|
|
|
14.8
|
|
|
—
|
|
|
14.8
|
|
|
**
|
|
ARCALYST
|
|
14.5
|
|
|
—
|
|
|
14.5
|
|
|
14.7
|
|
|
—
|
|
|
14.7
|
|
|
(1)
|
%
|
Net product sales
recorded by
Regeneron
|
|
$
|
4,834.4
|
|
|
|
|
|
|
$
|
4,106.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales
recorded by Sanofi*:
|
|
|
|
|
|
|
|
|
|
|
Dupixent
|
|
$
|
1,871.2
|
|
|
$
|
444.4
|
|
|
$
|
2,315.6
|
|
|
$
|
776.3
|
|
|
$
|
145.7
|
|
|
$
|
922.0
|
|
|
151
|
%
|
Praluent
|
|
$
|
126.0
|
|
|
$
|
162.7
|
|
|
$
|
288.7
|
|
|
$
|
181.3
|
|
|
$
|
125.5
|
|
|
$
|
306.8
|
|
|
(6)
|
%
|
Kevzara
|
|
$
|
129.0
|
|
|
$
|
77.7
|
|
|
$
|
206.7
|
|
|
$
|
74.7
|
|
|
$
|
21.9
|
|
|
$
|
96.6
|
|
|
114
|
%
|
ZALTRAP
|
|
$
|
7.3
|
|
|
$
|
101.1
|
|
|
$
|
108.4
|
|
|
$
|
9.0
|
|
|
$
|
98.8
|
|
|
$
|
107.8
|
|
|
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 (i) sales of EYLEA and Libtayo
outside the U.S., and (ii) 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-fourth-quarter-and-full-year-2019-financial-and-operating-results-300999889.html
SOURCE Regeneron Pharmaceuticals, Inc.