TARRYTOWN, N.Y., May 6, 2021 /PRNewswire/ --
- First quarter 2021 revenues increased 38% to $2.53 billion versus first quarter 2020; revenues
excluding REGEN-COVTM(1) increased
20%
- First quarter 2021 EYLEA® U.S. net sales
increased 15% to $1.35 billion versus
first quarter 2020
- First quarter 2021 Dupixent® global net
sales(2), which are recorded by Sanofi,
increased 48% to $1.26 billion versus
first quarter 2020
- First quarter 2021 GAAP diluted EPS was $10.09 and non-GAAP diluted
EPS(1) was $9.89
- Three FDA approvals received: Libtayo® for
first-line advanced non-small cell lung cancer (NSCLC) and advanced
basal cell carcinoma (BCC), and EvkeezaTM
for homozygous familial hypercholesterolemia (HoFH)
- Positive data reported from Phase 3 trials with REGEN-COV
used to treat and prevent COVID-19
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced financial results for the first quarter of 2021 and
provided a business update.
"Regeneron had a strong first quarter highlighting our continued
evolution into a company with multiple durable product lines
helping people with a range of serious diseases including
COVID-19," said Leonard S.
Schleifer, M.D., Ph.D., President and Chief Executive
Officer of Regeneron. "We recently reported positive Phase 3
results for REGEN-COV in both the COVID-19 outpatient treatment and
prevention settings and are working with national and state
authorities to improve access. We expect continued growth with
EYLEA in retinal diseases, as well as with Dupixent through further
penetration in existing indications and a broad Phase 3 development
program. In oncology, we are in the early days of launching Libtayo
for advanced basal cell carcinoma and non-small cell lung cancer
and recently announced positive pivotal data in cervical cancer
with regulatory submissions planned for later this year."
Financial Highlights
($ in millions,
except per share data)
|
|
Q1
2021
|
|
Q1
2020
|
|
%
Change
|
Total
revenues
|
|
$
|
2,529
|
|
|
$
|
1,828
|
|
|
38%
|
GAAP net
income
|
|
$
|
1,115
|
|
|
$
|
625
|
|
|
78%
|
GAAP net income per
share - diluted
|
|
$
|
10.09
|
|
|
$
|
5.43
|
|
|
86%
|
Non-GAAP net
income(1)
|
|
$
|
1,109
|
|
|
$
|
771
|
|
|
44%
|
Non-GAAP net income
per share - diluted(1)
|
|
$
|
9.89
|
|
|
$
|
6.60
|
|
|
50%
|
"Our business is off to a strong start in 2021 with double-digit
top- and bottom-line growth," said Robert
E. Landry, Executive Vice President, Finance and Chief
Financial Officer of Regeneron. "Our financial strength and solid
execution across the business continue to position the Company for
sustainable long-term growth."
Business Highlights
Key Pipeline Progress
Regeneron has approximately 30 product candidates in clinical
development, including six marketed products for which it is
investigating additional indications. Updates from the clinical
pipeline include:
EYLEA® (aflibercept) Injection
- In March 2021, JAMA
Ophthalmology announced initial results from the National
Institutes of Health-sponsored Protocol W trial evaluating EYLEA in
patients with moderate to severe non-proliferative diabetic
retinopathy (NPDR). The two-year data confirmed results from the
Company-sponsored PANORAMA trial and demonstrated that EYLEA
significantly reduced the risk of developing vision-threatening
complications with an every-16-weeks dosing regimen. The Company
plans to submit a supplemental Biologics License Application (sBLA)
for an every-16-weeks dosing regimen in patients with NPDR later
this year.
Dupixent® (dupilumab)
- The U.S. Food and Drug Administration (FDA) accepted for
review, with a target action date of October
21, 2021, the sBLA for Dupixent for children aged 6 to 11
years with moderate-to-severe asthma. A regulatory application for
Dupixent for children aged 6 to 11 years with severe asthma was
also submitted in the European Union (EU).
REGEN-COVTM (casirivimab with imdevimab), a dual
antibody cocktail to SARS-CoV-2 virus
- In March 2021, the Company
announced positive top-line results from the Phase 3 treatment
trial in high-risk COVID-19 outpatients. The trial met its primary
endpoint, showing that REGEN-COV significantly reduced the risk of
hospitalization or death by approximately 70% with both REGEN-COV
doses (1,200 mg and 2,400 mg) compared to placebo. The trial also
met key secondary endpoints, including the ability to reduce
symptom duration. Based on these results, the Company submitted a
request to the FDA to update the Emergency Use Authorization (EUA)
to the lower 1,200 mg dose.
- In April 2021, the National
Institutes of Health (NIH) COVID-19 Treatment Guidelines were
updated to strongly recommended that REGEN-COV be used in
non-hospitalized COVID-19 patients at high risk of clinical
progression.
- In April 2021, the Company
announced positive results from the Phase 3 COVID-19 prevention
trial in uninfected household contacts of SARS-CoV-2 infected
individuals. The trial met its primary and key secondary endpoints,
showing that REGEN-COV 1,200 mg administered subcutaneously reduced
the risk of symptomatic infections by 81%. The Company has shared
this data with the FDA and requested that the EUA be expanded to
include COVID-19 prevention for appropriate populations.
- In April 2021, the Company also
announced positive data from a Phase 3 treatment trial in recently
infected asymptomatic COVID-19 patients. The trial met all primary
and key secondary endpoints, and demonstrated that the 1,200 mg
subcutaneous injection of REGEN-COV reduced the risk of progressing
to symptomatic COVID-19 by 31%, and by 76% after the third
day.
- In January 2021, the Company
announced a second agreement with the U.S. government to
manufacture and deliver REGEN-COV. The U.S. government has agreed
to acquire up to 1.25 million additional doses at the lowest
treatment dose authorized or approved by the FDA for the indication
authorized under the EUA, resulting in payments to the Company of
up to $2.625 billion in the
aggregate. The Company anticipates being able to provide at least 1
million doses by June 30, 2021 if the
EUA is updated to the lower 1,200 mg dose. The U.S. government is
obligated to purchase all filled and finished doses of drug product
delivered by June 30, 2021, and may
accept additional doses through September
30, 2021 at its discretion. A number of factors may impact
the quantity of filled and finished product supplied by
June 30, 2021, including
manufacturing considerations and authorized dose levels.
Libtayo® (cemiplimab)
- In February 2021, the FDA
approved Libtayo for the first-line treatment of patients with
advanced NSCLC.
- In February 2021, the FDA also
approved Libtayo for the treatment of metastatic or locally
advanced BCC.
- In March 2021, the Company and
Sanofi announced positive results from the Phase 3 trial in
cervical cancer, which was stopped early based on a recommendation
by the Independent Data Monitoring Committee (IDMC). The results
demonstrated an overall survival benefit compared to chemotherapy.
Regulatory submissions are planned for later this year.
Evkeeza™, an antibody to ANGPTL3
- In February 2021, the FDA
approved Evkeeza for the treatment of adults and adolescents with
HoFH.
Bispecific Antibodies
- The Company retained the exclusive rights to develop and
commercialize two bispecific antibodies targeting BCMAxCD3
(REGN5458 and REGN5459) and a bispecific antibody targeting
MUC16xCD3 (REGN4018) as Sanofi did not exercise its options to
license rights to these product candidates under the companies'
immuno-oncology collaboration. REGN5458 and REGN5459 are in
clinical development for multiple myeloma, and REGN4018 is being
studied in ovarian cancer.
REGN1908-1909, a multi-antibody therapy to Fel d 1
- In February 2021, the Company
announced that the Phase 2 study in cat allergic patients with mild
asthma met its primary and key secondary endpoints. The Company
plans to initiate a Phase 3 study in cat allergic asthmatics later
this year.
First Quarter 2021 Financial Results
Revenues
Total revenues increased by 38% to $2.529
billion in the first quarter of 2021, compared to
$1.828 billion in the first quarter
of 2020. Total revenues excluding REGEN-COV increased by 20% to
$2.200 billion in the first quarter
of 2021, compared to the first quarter of 2020.
Net product sales recorded by the Company consist of the
following:
($ in
millions)
|
|
Q1
2021
|
|
Q1
2020
|
EYLEA
|
|
$
|
1,347
|
|
|
$
|
1,172
|
|
Libtayo
|
|
69
|
|
|
62
|
|
Praluent®
|
|
43
|
|
|
*
|
|
REGEN-COV
|
|
262
|
|
|
—
|
|
Evkeeza
|
|
1
|
|
|
—
|
|
ARCALYST®
|
|
2
|
|
|
3
|
|
Total net product
sales in the U.S.
|
|
$
|
1,724
|
|
|
$
|
1,237
|
|
|
|
|
|
|
* Effective April 1,
2020, the Company became solely responsible for the development and
commercialization of Praluent in the United States and records net
product sales of Praluent in the United States.
|
Total revenues also include collaboration
revenues(2) of $754 million in the first quarter of 2021,
compared to $528 million in the first
quarter of 2020. Sanofi collaboration revenue increased primarily
due to the Company's share of profits from commercialization of
antibodies, which were $261 million
in the first quarter of 2021, compared to $171 million in the first quarter of 2020. The
change in the Company's share of profits from commercialization of
antibodies was primarily driven by higher Dupixent profits. In the
first quarter of 2021, the Company also recorded Roche
collaboration revenue of $67 million
in connection with the Company's share of gross profits from sales
of the casirivimab with imdevimab antibody cocktail (known as
REGEN-COV in the United
States).
Refer to Table 4 for a summary of collaboration revenue.
Operating Expenses
|
|
GAAP
|
|
%
Change
|
|
Non-GAAP(1)
|
|
%
Change
|
($ in
millions)
|
|
Q1
2021
|
|
Q1
2020
|
|
|
Q1
2021
|
|
Q1
2020
|
|
Research and
development (R&D)
|
|
$
|
743
|
|
|
$
|
584
|
|
|
27%
|
|
$
|
673
|
|
|
$
|
527
|
|
|
28%
|
Selling, general, and
administrative (SG&A)
|
|
$
|
406
|
|
|
$
|
367
|
|
|
11%
|
|
$
|
355
|
|
|
$
|
307
|
|
|
16%
|
Cost of goods sold
(COGS)
|
|
$
|
183
|
|
|
$
|
79
|
|
|
132%
|
|
$
|
173
|
|
|
$
|
70
|
|
|
147%
|
Cost of collaboration
and contract manufacturing (COCM)
|
|
$
|
125
|
|
|
$
|
139
|
|
|
(10%)
|
|
|
*
|
|
|
|
*
|
|
|
n/a
|
Other operating
(income) expense, net
|
|
$
|
(41)
|
|
|
$
|
(40)
|
|
|
3%
|
|
|
*
|
|
|
|
*
|
|
|
n/a
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* GAAP and non-GAAP
amounts are equivalent as no non-GAAP adjustments have been
recorded
|
- The higher GAAP and non-GAAP R&D expenses in the first
quarter of 2021 were primarily due to costs incurred in connection
with development activities related to REGEN-COV.
- The increase in GAAP and non-GAAP SG&A expenses in the
first quarter of 2021 was primarily due to an increase in product
launch-related costs and higher headcount-related costs.
- The increase in COGS in the first quarter of 2021 was primarily
due to the recognition of manufacturing costs in connection with
product sales of REGEN-COV in the United
States, as well as Praluent in the
United States (which were recorded by Sanofi prior to
April 1, 2020).
- Other operating (income) expense, net, includes recognition of
a portion of amounts previously deferred in connection with
up-front and development milestone payments, as applicable,
received in connection with the Company's collaborative
arrangements.
Other Financial Information
GAAP other income (expense), net, includes the recognition
of net gains on equity securities of $144 million in the first quarter of 2021,
compared to net losses of $57 million
in the first quarter of 2020.
In the first quarter of 2021, the Company's GAAP effective tax
rate was 11.0%, compared to 6.6% in the first quarter of 2020. The
GAAP effective tax rate for the first quarter 2021 was positively
impacted, compared to the U.S. federal statutory rate, primarily by
the reversal of liabilities related to uncertain tax positions,
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. In the first quarter
of 2021, the non-GAAP effective tax rate was 10.5%, compared to
9.5% in the first quarter of 2020.
GAAP net income per diluted share was $10.09 in the first quarter of 2021, compared to
GAAP net income per diluted share of $5.43 in the first quarter of 2020. Non-GAAP net
income per diluted share was $9.89 in
the first quarter of 2021, compared to non-GAAP net income per
diluted share of $6.60 in the first
quarter of 2020. A reconciliation of the Company's GAAP to non-GAAP
results is included in Table 3 of this press release.
In January 2021, the Company's
board of directors authorized a new share repurchase program to
repurchase up to $1.5 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.
During the first quarter of 2021, the Company repurchased shares of
common stock under the program, and recorded the cost of the shares
received, or $323 million, as
Treasury Stock. As of March 31, 2021, $1.177 billion remained available for share
repurchases under the program.
Net cash provided by operating activities in the first quarter
of 2021 was $669 million, compared to
$698 million in the first quarter of
2020, resulting in $553 million in
free cash flow for the first quarter of 2021, compared to
$528 million for the first quarter of
2020.
2021 Financial
Guidance(3)
The Company's full year 2021 financial guidance consists of the
following components:
|
|
GAAP
|
|
Non-GAAP(1)
|
R&D
|
|
$3.000 billion–$3.175
billion
|
|
$2.700 billion–$2.850
billion
|
SG&A
|
|
$1.690 billion–$1.840
billion
(previously $1.700 billion–
$1.850 billion)
|
|
$1.500 billion–$1.630
billion
|
Gross margin on net
product sales(4)
|
|
86%–88%
|
|
87%–89%
|
COCM(5)
|
|
$660 million–$730
million
(previously $670 million–
$750 million)
|
|
*
|
Other operating
(income) expense, net
|
|
($150) million–($175)
million
|
|
*
|
Capital
expenditures
|
|
$585 million–$650
million
(previously $600 million–
$680 million)
|
|
*
|
Effective tax rate
(ETR)
|
|
12–14%
(previously
11–13%)
|
|
13–15%
(previously
12–14%)
|
|
|
|
|
|
* GAAP and non-GAAP
amounts are equivalent as no non-GAAP adjustments have been or are
expected to be recorded.
|
A reconciliation of full year 2021 GAAP to Non-GAAP financial
guidance is included below:
|
|
Projected
Range
|
($ in
millions)
|
|
Low
|
|
High
|
GAAP
R&D
|
|
$
|
3,000
|
|
|
$
|
3,175
|
|
R&D: Non-cash
share-based compensation
expense
|
|
(300)
|
|
|
(325)
|
|
Non-GAAP
R&D
|
|
$
|
2,700
|
|
|
$
|
2,850
|
|
|
|
|
|
|
GAAP
SG&A
|
|
$
|
1,690
|
|
|
$
|
1,840
|
|
SG&A: Non-cash
share-based compensation
expense
|
|
(190)
|
|
|
(210)
|
|
Non-GAAP
SG&A
|
|
$
|
1,500
|
|
|
$
|
1,630
|
|
|
|
|
|
|
GAAP gross margin on
net product sales
|
|
86%
|
|
88%
|
Non-cash share-based
compensation
expense
|
|
1%
|
|
1%
|
Non-GAAP gross margin
on net product sales
|
|
87%
|
|
89%
|
|
|
|
|
|
GAAP ETR
|
|
12%
|
|
14%
|
Income tax effect of
GAAP to non-GAAP
reconciling items and other
|
|
1%
|
|
1%
|
Non-GAAP
ETR
|
|
13%
|
|
15%
|
(1)
|
This press release
uses non-GAAP R&D, non-GAAP SG&A, non-GAAP gross margin on
net product sales, non-GAAP other income (expense) net, non-GAAP
effective tax rate, non-GAAP net income, non-GAAP net income per
share, total revenues excluding REGEN-COV, and free cash flow,
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/or other items from the related GAAP financial
measure. The Company also includes a non-GAAP adjustment for 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 investments in equity
securities) 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. With respect to
free cash flows, the Company believes that this non-GAAP measure
provides a further measure of the Company's operations' ability to
generate cash flows. 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.
|
|
|
(3)
|
The Company's 2021
financial guidance does not assume the completion of any
significant business development transactions not completed as of
the date of this press release.
|
|
|
(4)
|
Gross margin on net
product sales represents gross profit expressed as a percentage of
total net product sales recorded by the Company. Gross profit is
calculated as net product sales less cost of goods sold.
|
|
|
(5)
|
Corresponding
reimbursements from collaborators and others for manufacturing of
commercial supplies is recorded within revenues.
|
Conference Call Information
Regeneron will host a conference call and simultaneous webcast
to discuss its first quarter 2021 financial and operating results
on Thursday, May 6, 2021, at 8:30 AM
Eastern Time. To access this call, dial (888) 660-6127
(U.S.) or (973) 890-8355 (International), conference ID 7794757. 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 nine
FDA-approved treatments and numerous product candidates in
development, almost 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,
hematologic conditions, 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 impact of SARS-CoV-2 (the
virus that has caused the COVID-19 pandemic) on Regeneron's
business and its employees, collaborators, and suppliers and other
third parties on which Regeneron relies, Regeneron's and its
collaborators' ability to continue to conduct research and clinical
programs, Regeneron's ability to manage its supply chain, net
product sales of products marketed or otherwise commercialized by
Regeneron and/or its collaborators (collectively, "Regeneron's
Products"), and the global economy; the nature, timing, and
possible success and therapeutic applications of Regeneron's
Products and product candidates being developed by Regeneron and/or
its collaborators (collectively, "Regeneron's Product Candidates")
and research and clinical programs now underway or planned,
including without limitation EYLEA® (aflibercept)
Injection, Dupixent® (dupilumab),
Libtayo® (cemiplimab),
Praluent® (alirocumab),
Kevzara® (sarilumab),
EvkeezaTM (evinacumab),
InmazebTM (atoltivimab, maftivimab, and
odesivimab-ebgn), fasinumab,
REGEN-COVTM (casirivimab with imdevimab),
garetosmab, pozelimab, odronextamab, itepekimab, REGN5458,
REGN5713-5714-5715, Regeneron's other oncology programs (including
its costimulatory bispecific portfolio), Regeneron's and its
collaborators' earlier-stage programs, and the use of human
genetics in Regeneron's research programs; the likelihood and
timing of achieving any of the anticipated milestones described in
this press release; safety issues resulting from the administration
of Regeneron's Products and Regeneron's Product Candidates in
patients, including serious complications or side effects in
connection with the use of Regeneron's Products and Regeneron's
Product Candidates in clinical trials; the likelihood, timing, and
scope of possible regulatory approval and commercial launch of
Regeneron's Product Candidates and new indications for Regeneron's
Products, including those listed above and/or otherwise discussed
in this press release; the extent to which the results from the
research and development programs conducted by Regeneron and/or its
collaborators may be replicated in other studies and/or lead to
advancement of product candidates to clinical trials, therapeutic
applications, or regulatory approval; ongoing regulatory
obligations and oversight impacting Regeneron's Products (such as
EYLEA, Dupixent, Libtayo, Praluent, Kevzara, Evkeeza, and Inmazeb),
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 Regeneron's Product Candidates; competing
drugs and product candidates that may be superior to, or more cost
effective than, Regeneron's Products and Regeneron's Product
Candidates; uncertainty of the utilization, market acceptance, and
commercial success of Regeneron's Products and Regeneron's Product
Candidates and the impact of studies (whether conducted by
Regeneron or others and whether mandated or voluntary) or
recommendations and guidelines from governmental authorities and
other third parties on the commercial success of Regeneron's
Products and Regeneron's 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
Regeneron's Product Candidates; the availability and extent of
reimbursement of Regeneron's Products from third-party payers,
including private payer healthcare and insurance programs, health
maintenance organizations, pharmacy benefit management companies,
and government programs such as Medicare and Medicaid; coverage and
reimbursement determinations by such payers and new policies and
procedures adopted by such payers; 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 GAAP and non-GAAP R&D, GAAP and non-GAAP
SG&A, GAAP and non-GAAP gross margin on net product sales,
COCM, other operating (income) expense, net, capital expenditures,
and GAAP and non-GAAP effective tax rate; 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), as
well as Regeneron's agreement with Roche relating to the
casirivimab with imdevimab antibody cocktail (known as REGEN-COV in
the United States), to be
cancelled or terminated; 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, Praluent,
and REGEN-COV), other litigation and other proceedings and
government investigations relating to the Company and/or its
operations (including the pending civil litigation initiated by the
U.S. Attorney's Office for the District of Massachusetts), 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, 2020 and its Form 10-Q for the
quarterly period ended March 31,
2021. 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 or otherwise) 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)
|
|
|
|
March
31,
|
|
December
31,
|
|
|
2021
|
|
2020
|
Assets:
|
|
|
|
|
Cash and marketable
securities
|
|
$
|
7,047.5
|
|
|
$
|
6,722.6
|
|
Accounts receivable,
net
|
|
4,173.0
|
|
|
4,114.7
|
|
Inventories
|
|
2,164.7
|
|
|
1,916.6
|
|
Property, plant, and
equipment, net
|
|
3,262.6
|
|
|
3,221.6
|
|
Deferred tax
assets
|
|
765.1
|
|
|
858.9
|
|
Other
assets
|
|
359.3
|
|
|
328.9
|
|
Total
assets
|
|
$
|
17,772.2
|
|
|
$
|
17,163.3
|
|
|
|
|
|
|
Liabilities and
stockholders' equity:
|
|
|
|
|
Accounts payable,
accrued expenses, and other liabilities
|
|
$
|
2,606.6
|
|
|
$
|
2,806.8
|
|
Finance lease
liabilities
|
|
717.8
|
|
|
717.2
|
|
Deferred
revenue
|
|
491.9
|
|
|
635.5
|
|
Long-term
debt
|
|
1,978.9
|
|
|
1,978.5
|
|
Stockholders'
equity
|
|
11,977.0
|
|
|
11,025.3
|
|
Total liabilities and
stockholders' equity
|
|
$
|
17,772.2
|
|
|
$
|
17,163.3
|
|
TABLE 2
|
|
REGENERON
PHARMACEUTICALS, INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
|
(In millions,
except per share data)
|
|
|
|
Three Months
Ended
March
31,
|
|
|
2021
|
|
2020
|
Revenues:
|
|
|
|
|
Net product
sales
|
|
$
|
1,724.3
|
|
|
$
|
1,236.7
|
|
Collaboration
revenue
|
|
754.4
|
|
|
528.3
|
|
Other
revenue
|
|
50.0
|
|
|
63.2
|
|
|
|
2,528.7
|
|
|
1,828.2
|
|
Expenses:
|
|
|
|
|
Research and
development
|
|
742.9
|
|
|
583.9
|
|
Selling, general, and
administrative
|
|
405.6
|
|
|
367.3
|
|
Cost of goods
sold
|
|
183.2
|
|
|
78.8
|
|
Cost of collaboration
and contract manufacturing
|
|
124.8
|
|
|
138.5
|
|
Other operating
(income) expense, net
|
|
(40.5)
|
|
|
(40.4)
|
|
|
|
1,416.0
|
|
|
1,128.1
|
|
|
|
|
|
|
Income from
operations
|
|
1,112.7
|
|
|
700.1
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
Other income
(expense), net
|
|
154.9
|
|
|
(25.4)
|
|
Interest
expense
|
|
(14.6)
|
|
|
(6.1)
|
|
|
|
140.3
|
|
|
(31.5)
|
|
|
|
|
|
|
Income before income
taxes
|
|
1,253.0
|
|
|
668.6
|
|
|
|
|
|
|
Income tax
expense
|
|
137.8
|
|
|
44.0
|
|
|
|
|
|
|
Net income
|
|
$
|
1,115.2
|
|
|
$
|
624.6
|
|
|
|
|
|
|
Net income per share
- basic
|
|
$
|
10.58
|
|
|
$
|
5.69
|
|
Net income per share
- diluted
|
|
$
|
10.09
|
|
|
$
|
5.43
|
|
|
|
|
|
|
Weighted average
shares outstanding - basic
|
|
105.4
|
|
|
109.8
|
|
Weighted average
shares outstanding - diluted
|
|
110.5
|
|
|
115.1
|
|
TABLE 3
|
|
REGENERON
PHARMACEUTICALS, INC.
|
RECONCILIATION OF
GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited)
|
(In millions,
except per share data)
|
|
|
|
Three Months
Ended
March
31,
|
|
|
2021
|
|
2020
|
GAAP
R&D
|
|
$
|
742.9
|
|
|
$
|
583.9
|
|
R&D: Non-cash
share-based compensation expense
|
|
69.7
|
|
|
56.7
|
|
Non-GAAP
R&D
|
|
$
|
673.2
|
|
|
$
|
527.2
|
|
|
|
|
|
|
GAAP
SG&A
|
|
$
|
405.6
|
|
|
$
|
367.3
|
|
SG&A: Non-cash
share-based compensation expense
|
|
50.8
|
|
|
40.3
|
|
SG&A: Litigation
contingencies and other
|
|
—
|
|
|
20.2
|
|
Non-GAAP
SG&A
|
|
$
|
354.8
|
|
|
$
|
306.8
|
|
|
|
|
|
|
GAAP COGS
|
|
$
|
183.2
|
|
|
$
|
78.8
|
|
COGS: Non-cash
share-based compensation expense
|
|
10.4
|
|
|
8.8
|
|
Non-GAAP
COGS
|
|
$
|
172.8
|
|
|
$
|
70.0
|
|
|
|
|
|
|
GAAP other income
(expense), net
|
|
$
|
140.3
|
|
|
$
|
(31.5)
|
|
Other income/expense:
(Gains) losses on investments
|
|
(144.3)
|
|
|
56.8
|
|
Non-GAAP other income
(expense), net
|
|
$
|
(4.0)
|
|
|
$
|
25.3
|
|
|
|
|
|
|
GAAP net
income
|
|
$
|
1,115.2
|
|
|
$
|
624.6
|
|
Total of GAAP to
non-GAAP reconciling items above
|
|
(13.4)
|
|
|
182.8
|
|
Income tax effect of
GAAP to non-GAAP reconciling items
|
|
7.4
|
|
|
(36.8)
|
|
Non-GAAP net
income
|
|
$
|
1,109.2
|
|
|
$
|
770.6
|
|
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
$
|
10.52
|
|
|
$
|
7.02
|
|
Non-GAAP net income
per share - diluted
|
|
$
|
9.89
|
|
|
$
|
6.60
|
|
|
|
|
|
|
Shares used in
calculating:
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
105.4
|
|
|
109.8
|
|
Non-GAAP net income
per share - diluted
|
|
112.1
|
|
|
116.7
|
|
|
|
|
|
|
Effective tax rate
reconciliation:
|
|
|
|
|
GAAP effective tax
rate
|
|
11.0%
|
|
|
6.6%
|
|
Income tax effect of
GAAP to non-GAAP reconciling items
|
|
(0.5%)
|
|
|
2.9%
|
|
Non-GAAP effective
tax rate
|
|
10.5%
|
|
|
9.5%
|
|
|
|
|
|
|
Free cash flow
reconciliation:
|
|
|
|
|
Net cash provided by
operating activities
|
|
$
|
668.5
|
|
|
$
|
698.0
|
|
Capital
expenditures
|
|
(115.3)
|
|
|
(170.1)
|
|
Free cash
flow
|
|
$
|
553.2
|
|
|
$
|
527.9
|
|
TABLE 4
|
|
REGENERON
PHARMACEUTICALS, INC.
|
COLLABORATION
REVENUE (Unaudited)
|
(In
millions)
|
|
|
|
Three Months
Ended
March
31,
|
|
|
2021
|
|
2020
|
Sanofi
collaboration revenue:
|
|
|
|
|
Antibody:
|
|
|
|
|
Regeneron's share of
profits in connection with commercialization of
antibodies
|
|
$
|
260.6
|
|
|
$
|
170.9
|
|
Reimbursement for
manufacturing of commercial supplies
|
|
105.6
|
|
|
80.1
|
|
Immuno-oncology:
|
|
|
|
|
Regeneron's share of
losses in connection with commercialization of Libtayo
outside the United States
|
|
(6.1)
|
|
|
(6.2)
|
|
Reimbursement for
manufacturing of commercial supplies
|
|
4.7
|
|
|
2.1
|
|
Total Sanofi
collaboration revenue
|
|
364.8
|
|
|
246.9
|
|
|
|
|
|
|
Bayer
collaboration revenue:
|
|
|
|
|
Regeneron's net profit
in connection with commercialization of EYLEA outside
the United States
|
|
308.9
|
|
|
253.8
|
|
Reimbursement for
manufacturing of commercial supplies
|
|
13.9
|
|
|
27.6
|
|
Total Bayer
collaboration revenue
|
|
322.8
|
|
|
281.4
|
|
|
|
|
|
|
Roche
collaboration revenue:
|
|
|
|
|
Regeneron's share of
gross profits in connection with sales of casirivimab with
imdevimab
|
|
66.8
|
|
|
—
|
|
|
|
|
|
|
Total collaboration
revenue
|
|
$
|
754.4
|
|
|
$
|
528.3
|
|
TABLE 5
|
|
REGENERON
PHARMACEUTICALS, INC.
|
NET PRODUCT SALES
OF REGENERON-DISCOVERED PRODUCTS (Unaudited)
|
(In
millions)
|
|
|
|
Three Months
Ended
March
31,
|
|
|
|
|
2021
|
|
2020
|
|
%
Change
|
|
|
U.S.
|
|
ROW
|
|
Total
|
|
U.S.
|
|
ROW
|
|
Total
|
|
(Total
Sales)
|
EYLEA(a)
|
|
$
|
1,347.0
|
|
|
$
|
824.3
|
|
|
$
|
2,171.3
|
|
|
$
|
1,172.0
|
|
|
$
|
681.7
|
|
|
$
|
1,853.7
|
|
|
17%
|
Dupixent(b)
|
|
$
|
961.5
|
|
|
$
|
301.4
|
|
|
$
|
1,262.9
|
|
|
$
|
679.0
|
|
|
$
|
176.2
|
|
|
$
|
855.2
|
|
|
48%
|
Libtayo(c)
|
|
$
|
69.1
|
|
|
$
|
31.7
|
|
|
$
|
100.8
|
|
|
$
|
61.7
|
|
|
$
|
13.1
|
|
|
$
|
74.8
|
|
|
35%
|
Praluent(d)
|
|
$
|
43.3
|
|
|
$
|
61.3
|
|
|
$
|
104.6
|
|
|
$
|
35.1
|
|
|
$
|
44.7
|
|
|
$
|
79.8
|
|
|
31%
|
Kevzara(b)
|
|
$
|
30.7
|
|
|
$
|
38.4
|
|
|
$
|
69.1
|
|
|
$
|
35.3
|
|
|
$
|
24.8
|
|
|
$
|
60.1
|
|
|
15%
|
REGEN-COV(e)
|
|
$
|
262.2
|
|
|
$
|
176.6
|
|
|
$
|
438.8
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(h)
|
Evkeeza(f)
|
|
$
|
0.5
|
|
|
—
|
|
|
$
|
0.5
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(h)
|
ZALTRAP(b)
|
|
$
|
1.4
|
|
|
$
|
23.0
|
|
|
$
|
24.4
|
|
|
$
|
1.5
|
|
|
$
|
26.5
|
|
|
$
|
28.0
|
|
|
(13)%
|
ARCALYST(g)
|
|
$
|
2.2
|
|
|
—
|
|
|
$
|
2.2
|
|
|
$
|
3.0
|
|
|
—
|
|
|
$
|
3.0
|
|
|
(27)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) Regeneron records net product
sales of EYLEA in the United States. Bayer records net product
sales of EYLEA outside the United States. The Company records its
share of profits/losses in connection with sales of EYLEA outside
the United States.
|
(b) Sanofi records global net product
sales of Dupixent, Kevzara, and ZALTRAP. The Company records its
share of profits/losses in connection with global sales of Dupixent
and Kevzara, and Sanofi pays the Company a percentage of net sales
of ZALTRAP.
|
(c) Regeneron records net product
sales of Libtayo in the United States and Sanofi records net
product sales of Libtayo outside the United States. The parties
equally share profits/losses in connection with global sales of
Libtayo.
|
(d) Effective April 1, 2020,
Regeneron records net product sales of Praluent in the United
States. Also effective April 1, 2020, Sanofi records net product
sales of Praluent outside the United States and pays the Company a
royalty on such sales. Previously, Sanofi recorded global net
product sales of Praluent and the Company recorded its share of
profits/losses in connection with such sales.
|
(e) Regeneron records net product
sales of REGEN-COV in connection with its agreements with the U.S.
government. Roche records net product sales of the antibody
cocktail outside the United States and the parties share gross
profits from global sales based on a pre-specified formula,
depending on the amount of manufactured product supplied by each
party to the market.
|
(f) Regeneron records net product
sales of Evkeeza in the United States.
|
(g) Effective April 1, 2021, Kiniksa
records net product sales of ARCALYST in the United States and pays
the Company a share of ARCALYST profits. Prior to April 1, 2021,
Regeneron recorded net product sales of ARCALYST in the United
States.
|
(h) Percentage not
meaningful
|
View original
content:http://www.prnewswire.com/news-releases/regeneron-reports-first-quarter-2021-financial-and-operating-results-301285144.html
SOURCE Regeneron Pharmaceuticals, Inc.