TARRYTOWN, N.Y., Nov. 5, 2020 /PRNewswire/ --
- Third quarter 2020 revenues increased 32% to $2.29 billion versus third quarter
2019(4)
- Third quarter 2020 EYLEA® U.S. net sales
increased 11% to $1.32 billion versus
third quarter 2019
- Third quarter 2020 Dupixent® global net
sales(2), which are recorded by Sanofi,
increased 69% to $1.07 billion versus
third quarter 2019
- Third quarter 2020 GAAP diluted EPS was $7.39 and non-GAAP diluted
EPS(1) was $8.36
- REGN-COV2 trial in the COVID-19 outpatient setting met
primary and key secondary endpoints
- FDA accepted for priority review Libtayo®
(cemiplimab-rwlc) for both advanced non-small cell lung cancer and
basal cell carcinoma
- FDA approved Inmazeb™ for Ebola
(Zaire ebolavirus)
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced financial results for the third quarter of 2020 and
provided a business update.
"Last week, Regeneron achieved an important milestone in the
fight against COVID-19 with prospective Phase 2/3 results showing
REGN-COV2 significantly reduced virus levels and the need for
further medical attention in non-hospitalized patients; we have
shared these important data with regulatory authorities," said
Leonard S. Schleifer, M.D., Ph.D.,
President and Chief Executive Officer of Regeneron. "Even with our
intense commitment to fighting COVID-19, Regeneron continues to
deliver across all aspects of our business. This quarter we had
robust top- and bottom-line growth driven by EYLEA in retinal
diseases and Dupixent in atopic dermatitis and asthma. In 2021, we
look forward to important potential launches including for our PD-1
inhibitor Libtayo in non-small cell lung cancer and advanced basal
cell carcinoma. Lastly, we are proud that our novel antibody
cocktail REGN-EB3 recently became the first FDA-approved treatment
for Ebola, underscoring the potential of antibody therapies to
address deadly infectious diseases."
"We continue to invest in our promising pipeline while
delivering meaningful revenue and earnings growth. Our revenue base
is becoming more diversified with increasing contribution from
Dupixent and Libtayo," said Robert E.
Landry, Executive Vice President, Finance and Chief
Financial Officer of Regeneron. "This is evidenced by Dupixent
achieving in excess of $1 billion in
global net sales this quarter."
Financial Highlights
($ in millions,
except per share data)
|
|
Q3
2020
|
|
Q3
2019
|
|
%
Change
|
Total
revenues(4)
|
|
$
|
2,294
|
|
|
$
|
1,744
|
|
|
32
|
%
|
GAAP net
income
|
|
$
|
842
|
|
|
$
|
670
|
|
|
26
|
%
|
GAAP net income per
share -
diluted
|
|
$
|
7.39
|
|
|
$
|
5.86
|
|
|
26
|
%
|
Non-GAAP net
income(1)
|
|
$
|
961
|
|
|
$
|
762
|
|
|
26
|
%
|
Non-GAAP net income
per
share -
diluted(1)
|
|
$
|
8.36
|
|
|
$
|
6.67
|
|
|
25
|
%
|
Business Highlights
Key Pipeline Progress
Regeneron has more than 20
product candidates in clinical development, including five marketed
products for which it is investigating additional indications.
Updates from the clinical pipeline include:
Dupixent® (dupilumab)
- In October 2020, the Company and
Sanofi announced that a Phase 3 trial met its primary and all key
secondary endpoints in children aged 6 to 11 years with
uncontrolled moderate-to-severe asthma. Regulatory submissions in
the United States and European
Union (EU) are planned by the first quarter of 2021.
- The European Medicines Agency's Committee for Medicinal
Products for Human Use (CHMP) adopted a positive opinion for
Dupixent, recommending to extend the approval in the EU to include
children aged 6 to 11 years with severe atopic dermatitis who are
candidates for systemic therapy.
- The U.S. Food and Drug Administration (FDA) granted
Breakthrough Therapy designation for the treatment of patients 12
years and older with eosinophilic esophagitis (EoE).
REGN-COV2, a dual antibody therapy to SARS-CoV-2 virus
- In October 2020, the Company
submitted a request to the FDA for an Emergency Use Authorization
(EUA) for REGN-COV2 in patients with mild-to-moderate COVID-19 who
are at risk for poor outcomes.
- In October 2020, the Company
announced positive results from an ongoing Phase 2/3 seamless trial
in the COVID-19 outpatient setting showing REGN-COV2 met the
primary and key secondary endpoints. REGN-COV2 significantly
reduced viral load and patient medical visits (hospitalizations,
emergency room, urgent care visits, and/or physician
office/telemedicine visits). In September
2020, the Company also reported the first data from a
descriptive analysis in this trial.
- In October 2020, the Independent
Data Monitoring Committee (IDMC) for the REGN-COV2 treatment trials
for COVID-19 recommended that the current hospitalized patient
trial be modified. Specifically, based on a potential safety signal
and an unfavorable risk/benefit profile at this time, the IDMC
recommended that further enrollment of patients requiring high-flow
oxygen or mechanical ventilation be placed on hold pending
collection and analysis of further data on patients already
enrolled. The IDMC also recommended continuing enrollment of
hospitalized patients requiring either no or low-flow oxygen as the
risk/benefit remains acceptable in these cohorts. Finally, the IDMC
recommended continuation of the outpatient trial (described further
above) without modification.
- In September 2020, the Company
and the University of Oxford announced
that the RECOVERY Phase 3 open-label trial in the United Kingdom will evaluate REGN-COV2. This
trial, which is being coordinated by researchers at the
University of Oxford, is in patients
hospitalized with COVID-19 and will compare the effects of adding
REGN-COV2 to the usual standard-of-care versus standard-of-care on
its own. The RECOVERY IDMC is aware of the IDMC recommendations
made in connection with the REGN-COV2 treatment trials (described
above), and will be discussing the impact, if any, on the RECOVERY
trial.
Oncology Program
- The FDA accepted for priority review, with a target action date
of February 28, 2021, the
supplemental Biologics License Application (sBLA) for
Libtayo® (cemiplimab) as monotherapy to treat patients
with first-line locally advanced or metastatic non-small cell lung
cancer (NSCLC) with ≥50% PD-L1 expression. A regulatory application
for Libtayo as monotherapy in first-line NSCLC was also submitted
in the EU.
- The FDA accepted for priority review, with a target action date
of March 3, 2021, the sBLA for
Libtayo for the treatment of patients with locally advanced or
metastatic basal cell carcinoma (BCC). A regulatory application for
Libtayo in advanced BCC was also submitted in the EU.
- Patient enrollment in the Libtayo Phase 3 first-line NSCLC
chemotherapy combination study was completed.
- The Company and Sanofi presented positive data from pivotal
trials for Libtayo monotherapy in first-line NSCLC and Libtayo
monotherapy in BCC at the European Society for Medical Oncology
(ESMO) Virtual Congress 2020.
- A Phase 2 study of REGN5458, a bispecific antibody targeting
BCMA and CD3, was initiated in multiple myeloma.
Inmazeb™ (atoltivimab, maftivimab,
and odesivimab-ebgn)
- In October 2020, the FDA approved
Inmazeb (REGN-EB3) for the treatment of infection caused by
Zaire ebolavirus in adult
and pediatric patients, including newborns of mothers who have
tested positive for the infection.
Praluent® (alirocumab)
- The FDA accepted for review the sBLA for homozygous familial
hypercholesterolemia (HoFH) in adults, with a target action date of
April 4, 2021.
Evinacumab, an antibody to ANGPTL3
- The FDA accepted for priority review the BLA for HoFH, with a
target action date of February 11,
2021. An MAA for HoFH has also been submitted in the
EU.
- The New England Journal of Medicine (NEJM) published
positive results from the Phase 3 trial in HoFH, showing that
adding evinacumab to other lipid-lowering therapies cut bad
cholesterol levels in half in patients with HoFH, including the
most difficult to treat patients who had nearly non-existent
LDL-receptor activity.
Corporate and Business Development Update
- In July 2020, the Company
announced an agreement whereby the Company was awarded a
$450 million contract to manufacture
and supply REGN-COV2 to the U.S. government. The Company commenced
delivery of REGN-COV2 drug product under the agreement during the
third quarter of 2020. The Company continues to ramp up production
for REGN-COV2 and now expects to have approximately 80,000 doses
available by the end of November, approximately 200,000 total doses
ready by the first week of January
2021, and approximately 300,000 total doses ready by the end
of January 2021.
- In August 2020, the Company
entered into a collaboration agreement with Roche to develop,
manufacture, and distribute REGN-COV2. Each company has committed
to dedicate a certain amount of manufacturing capacity to REGN-COV2
each year, and the collaboration is expected to substantially
increase supply of REGN-COV2. Under the terms of the agreement,
Regeneron will distribute and record sales for REGN-COV2 in
the United States and Roche will
be responsible for distribution outside the United States.
- In July 2020, the U.S. Department
of Health and Human Services (HHS) exercised its option under the
existing agreement for the treatment of Ebola virus infection to
provide additional funding for the manufacture and supply of
Inmazeb, pursuant to which Regeneron expects to deliver a
pre-specified number of treatment doses over the course of
approximately six years.
- In August 2020, the Company
issued and sold $2.0 billion
aggregate principal amount of senior unsecured notes. See further
details in the "Other Financial Information" section
below.
Third Quarter 2020 Financial Results
Effective January 1, 2020, Regeneron implemented changes in
the presentation of its financial statements related to certain
reimbursements and other payments for products developed and
commercialized with collaborators. The Company made these
changes in presentation to better reflect the nature of the
Company's costs incurred and revenues earned pursuant to
arrangements with collaborators and to enhance the comparability of
Regeneron's financial statements with industry peers. The change in
presentation has been applied retrospectively. See note (4) below
for further information.
Revenues
Total revenues increased by 32% to $2.294
billion in the third quarter of 2020, compared to
$1.744 billion in the third quarter
of 2019.
EYLEA® net product sales in the United States increased to $1.318 billion in the third quarter of 2020,
compared to $1.188 billion in the
third quarter of 2019. 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 $653
million in the third quarter of 2020, compared to
$469 million in the third quarter of
2019. Sanofi collaboration revenue increased primarily due to the
Company's share of profits from commercialization of antibodies,
which increased to $213 million in
the third quarter of 2020 from $94
million in the third quarter of 2019. The change in the
Company's share of profits from commercialization of
antibodies was primarily driven by higher Dupixent profits. In
addition, in the third quarter of 2020, the Company earned the
first $50 million sales-based milestone from Sanofi, upon
annual sales of antibodies outside the
United States exceeding $1.0
billion on a rolling twelve-month basis.
Refer to Table 4 for a summary of collaboration revenue.
Other revenues in the third quarter of 2020 include recognition
of revenue in connection with the Company's agreements with BARDA
related to funding of certain REGN-COV2 and Inmazeb development
activities.
Operating Expenses
|
|
GAAP
|
|
%
Change
|
|
Non-GAAP(1)
|
|
%
Change
|
($ in
millions)
|
|
Q3
2020
|
|
Q3
2019
|
|
|
Q3
2020
|
|
Q3
2019
|
|
Research and
development (R&D)
|
|
$
|
685
|
|
|
$
|
526
|
|
|
30%
|
|
$
|
629
|
|
|
$
|
466
|
|
|
35%
|
Selling, general, and
administrative
(SG&A)
|
|
$
|
327
|
|
|
$
|
304
|
|
|
8%
|
|
$
|
291
|
|
|
$
|
264
|
|
|
10%
|
Cost of goods sold
(COGS)
|
|
$
|
131
|
|
|
$
|
116
|
|
|
13%
|
|
$
|
122
|
|
|
$
|
100
|
|
|
22%
|
Cost of collaboration
and contract
manufacturing (COCM)
|
|
$
|
143
|
|
|
$
|
110
|
|
|
30%
|
|
*
|
|
|
|
*
|
|
|
n/a
|
Other operating
(income) expense,
net
|
|
$
|
(45)
|
|
|
$
|
(51)
|
|
|
(12%)
|
|
*
|
|
|
*
|
|
|
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 third
quarter of 2020 were primarily due to additional costs incurred in
connection with COVID-19 related development activities, higher
headcount and headcount-related costs, and an increase in clinical
manufacturing activities.
- The higher GAAP and non-GAAP SG&A expenses in the third
quarter of 2020 were primarily due to commercialization-related
costs for EYLEA and Praluent, and higher headcount-related
costs.
- The increase in cost of collaboration and contract
manufacturing in the third quarter of 2020 was primarily due to the
recognition of manufacturing costs associated with higher sales of
Dupixent and recognition of costs in connection with manufacturing
ex-U.S. commercial supplies of Praluent for Sanofi.
- 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 losses on equity securities of $37 million in the third quarter of 2020,
compared to net gains of $3 million
in the third quarter of 2019.
In the third quarter of 2020, the Company's GAAP effective tax
rate was 15.6%, compared to 12.9% in the third quarter of 2019. The
GAAP effective tax rate for the third quarter of 2020 was
positively impacted, compared to the U.S. federal statutory rate,
primarily by stock-based compensation, and, to a lesser extent,
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 third quarter of 2020, the non-GAAP
effective tax rate was 16.3%, compared to 13.6% in the third
quarter of 2019.
GAAP net income per diluted share was $7.39 in the third quarter of 2020, compared to
GAAP net income per diluted share of $5.86 in the third quarter of 2019. Non-GAAP net
income per diluted share was $8.36 in
the third quarter of 2020, compared to non-GAAP net income per
diluted share of $6.67 in the third
quarter of 2019. A reconciliation of the Company's GAAP to non-GAAP
results is included in Table 3 of this press release.
In August 2020, the Company issued
and sold $1.250 billion aggregate
principal amount of 1.750% senior unsecured notes due 2030 and
$750 million aggregate principal
amount of 2.800% senior unsecured notes due 2050. Net proceeds to
the Company from the issuance and sale of the notes were used in
part to repay the $1.5 billion bridge
loan facility, which was previously entered into in May 2020 in connection with the Company's
purchase of shares of its common stock held by Sanofi.
Net cash used in operating activities in the third quarter of
2020 was $254 million, compared to
$557 million in net cash provided by
operating activities in the third quarter of 2019, which led to
$(408) million in free cash flow for
the third quarter of 2020, compared to $436
million for the third quarter of 2019. The decrease in cash
from operating activities primarily resulted from an increase in
trade accounts receivable in connection with extending payment
terms to certain of the Company's EYLEA customers due to the
COVID-19 pandemic.
2020 Financial
Guidance(3)
The Company's full year 2020 financial guidance consists of the
following components:
|
|
GAAP
|
|
Non-GAAP(1)
|
R&D
|
|
$2.750 billion–$2.820
billion
(previously $2.605 billion–
$2.725 billion)
|
|
$2.420 billion–$2.470
billion
(previously $2.270 billion–
$2.370 billion)
|
SG&A
|
|
$1.425 billion–$1.475
billion
(previously $1.400 billion–
$1.480 billion)
|
|
$1.235 billion–$1.265
billion
(previously $1.210 billion–
$1.270 billion)
|
COGS
|
|
$485 million–$525
million
(previously $490 million–
$540 million)
|
|
$440 million–$470
million
(previously $445 million–
$485 million)
|
COCM(5)
|
|
$595 million–$625
million
(previously $600 million–
$660 million)
|
|
*
|
Other operating
(income)
expense, net
|
|
($180) million–($200)
million
(previously ($180) million–
($205) million)
|
|
*
|
Capital
expenditures
|
|
$570 million–$600
million
(previously $540 million–
$590 million)
|
|
*
|
Effective tax rate
(ETR)
|
|
9–11%
|
|
10–12%
|
|
|
|
|
|
* 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 2020 GAAP to Non-GAAP financial
guidance is included below:
|
|
Projected
Range
|
(In
millions)
|
|
Low
|
|
High
|
GAAP
R&D
|
|
$
|
2,750
|
|
|
$
|
2,820
|
|
R&D: Non-cash
share-based compensation expense
|
|
(245)
|
|
|
(265)
|
|
R&D: Up-front
payments related to license and collaboration agreements
|
|
(85)
|
|
|
(85)
|
|
Non-GAAP
R&D
|
|
$
|
2,420
|
|
|
$
|
2,470
|
|
|
|
|
|
|
GAAP
SG&A
|
|
$
|
1,425
|
|
|
$
|
1,475
|
|
SG&A: Non-cash
share-based compensation expense
|
|
(160)
|
|
|
(180)
|
|
SG&A: Litigation
contingencies and restructuring-related expenses
|
|
(30)
|
|
|
(30)
|
|
Non-GAAP
SG&A
|
|
$
|
1,235
|
|
|
$
|
1,265
|
|
|
|
|
|
|
GAAP COGS
|
|
$
|
485
|
|
|
$
|
525
|
|
COGS: Non-cash
share-based compensation expense
|
|
(44)
|
|
|
(54)
|
|
COGS: Other
|
|
(1)
|
|
|
(1)
|
|
Non-GAAP
COGS
|
|
$
|
440
|
|
|
$
|
470
|
|
|
|
|
|
|
GAAP ETR
|
|
9%
|
|
|
11%
|
|
Income tax effect of
GAAP to non-GAAP reconciling items and other
|
|
1%
|
|
|
1%
|
|
Non-GAAP
ETR
|
|
10%
|
|
|
12%
|
|
|
|
(1)
|
This press release
uses non-GAAP R&D, non-GAAP SG&A, non-GAAP COGS, non-GAAP
other income (expense) net, non-GAAP effective tax rate, non-GAAP
net income, non-GAAP net income per share, 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 2020
financial guidance does not assume the completion of any
significant business development transactions not completed as of
the date of this press release.
|
|
|
(4)
|
Applicable amounts
previously reported for the three and nine months ended September
30, 2019 and as of December 31, 2019 have been revised to reflect a
change in presentation of cost reimbursements from collaborators
who are not deemed to be the Company's customers from collaboration
revenue to a reduction of the corresponding operating expense. The
Company also changed the presentation of amounts recognized in
connection with up-front and development milestone payments
received from collaboration revenue to other operating income, as
well as the presentation of the corresponding balance sheet
accounts. The revisions were reclassifications only and had no
impact on the Company's previously reported GAAP and non-GAAP net
income and net income per share. Refer to the Company's Form 10-Q
for the quarterly period ended September 30, 2020 (Note 1 of the
Notes to Condensed Consolidated Financial Statements) for further
details.
|
|
|
(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 third quarter 2020 financial and operating results
on Thursday, November 5, 2020, at 8:30
AM. To access this call, dial (888) 660-6127 (U.S.) or (973)
890-8355 (International), conference ID 1535889. 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 eight
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 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 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),
Inmazeb™ (atoltivimab, maftivimab, and
odesivimab-ebgn), fasinumab, evinacumab, REGN-COV2, Regeneron's
oncology programs (including its costimulatory bispecific
portfolio), Regeneron's 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 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, timing, and scope of possible regulatory
approval and commercial launch of Regeneron's product candidates
and new indications for Regeneron's Products, including without
limitation EYLEA, Dupixent, Libtayo, Praluent, Kevzara, Inmazeb,
evinacumab, fasinumab, REGN-COV2, REGN5458, and REGN6569; 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, 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
product candidates; competing drugs and product candidates that may
be superior to, or more cost effective than, 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; 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 COGS, 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 REGN-COV2, 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, and Praluent), 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, 2019 and its Form 10-Q
for the quarterly period ended September 30,
2020. 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)
|
|
|
|
September
30,
|
|
December
31,
|
|
|
2020
|
|
2019*
|
Assets:
|
|
|
|
|
Cash and marketable
securities
|
|
$
|
5,901.0
|
|
|
$
|
6,471.1
|
|
Accounts receivable -
trade, net
|
|
3,092.5
|
|
|
2,100.0
|
|
Accounts receivable -
Sanofi and other
|
|
947.0
|
|
|
685.6
|
|
Inventories
|
|
1,801.6
|
|
|
1,415.5
|
|
Property, plant, and
equipment, net
|
|
3,138.3
|
|
|
2,890.4
|
|
Deferred tax
assets
|
|
804.2
|
|
|
824.2
|
|
Other
assets
|
|
399.4
|
|
|
418.4
|
|
Total
assets
|
|
$
|
16,084.0
|
|
|
$
|
14,805.2
|
|
|
|
|
|
|
Liabilities and
stockholders' equity:
|
|
|
|
|
Accounts payable,
accrued expenses, and other liabilities
|
|
$
|
2,664.0
|
|
|
$
|
2,514.2
|
|
Long-term
debt
|
|
1,978.3
|
|
|
—
|
|
Deferred
revenue
|
|
599.7
|
|
|
487.4
|
|
Finance lease
liabilities
|
|
716.5
|
|
|
713.9
|
|
Stockholders'
equity
|
|
10,125.5
|
|
|
11,089.7
|
|
Total liabilities and
stockholders' equity
|
|
$
|
16,084.0
|
|
|
$
|
14,805.2
|
|
|
* Certain revisions
have been made to the previously reported December 31, 2019
amounts. See note (4) above.
|
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,
|
|
|
2020
|
|
2019*
|
|
2020
|
|
2019*
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product
sales
|
|
$
|
1,482.2
|
|
|
$
|
1,238.3
|
|
|
$
|
3,945.8
|
|
|
$
|
3,548.0
|
|
Sanofi collaboration
revenue
|
|
353.3
|
|
|
175.0
|
|
|
869.3
|
|
|
232.8
|
|
Bayer collaboration
revenue
|
|
299.9
|
|
|
293.6
|
|
|
825.5
|
|
|
834.8
|
|
Other
revenue
|
|
158.6
|
|
|
36.8
|
|
|
433.6
|
|
|
78.5
|
|
|
|
2,294.0
|
|
|
1,743.7
|
|
|
6,074.2
|
|
|
4,694.1
|
|
Expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
684.6
|
|
|
526.0
|
|
|
1,990.5
|
|
|
1,897.6
|
|
Selling, general, and
administrative
|
|
326.9
|
|
|
304.4
|
|
|
1,042.5
|
|
|
890.1
|
|
Cost of goods
sold
|
|
131.0
|
|
|
115.9
|
|
|
312.3
|
|
|
253.8
|
|
Cost of collaboration
and contract manufacturing
|
|
143.0
|
|
|
109.6
|
|
|
454.5
|
|
|
289.6
|
|
Other operating
(income) expense, net
|
|
(44.6)
|
|
|
(50.7)
|
|
|
(135.2)
|
|
|
(171.1)
|
|
|
|
1,240.9
|
|
|
1,005.2
|
|
|
3,664.6
|
|
|
3,160.0
|
|
|
|
|
|
|
|
|
|
|
Income from
operations
|
|
1,053.1
|
|
|
738.5
|
|
|
2,409.6
|
|
|
1,534.1
|
|
|
|
|
|
|
|
|
|
|
Other (expense)
income, net
|
|
(54.8)
|
|
|
30.0
|
|
|
176.2
|
|
|
5.2
|
|
|
|
|
|
|
|
|
|
|
Income before income
taxes
|
|
998.3
|
|
|
768.5
|
|
|
2,585.8
|
|
|
1,539.3
|
|
|
|
|
|
|
|
|
|
|
Income tax
expense
|
|
156.2
|
|
|
98.9
|
|
|
221.8
|
|
|
215.5
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
842.1
|
|
|
$
|
669.6
|
|
|
$
|
2,364.0
|
|
|
$
|
1,323.8
|
|
|
|
|
|
|
|
|
|
|
Net income per share
- basic
|
|
$
|
7.98
|
|
|
$
|
6.12
|
|
|
$
|
21.83
|
|
|
$
|
12.12
|
|
Net income per share
- diluted
|
|
$
|
7.39
|
|
|
$
|
5.86
|
|
|
$
|
20.36
|
|
|
$
|
11.54
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding - basic
|
|
105.5
|
|
|
109.4
|
|
|
108.3
|
|
|
109.2
|
|
Weighted average
shares outstanding - diluted
|
|
113.9
|
|
|
114.2
|
|
|
116.1
|
|
|
114.7
|
|
|
|
|
|
|
* Certain revisions
have been made to the previously reported September 30, 2019
amounts. See note (4) above.
|
TABLE 3
|
|
REGENERON
PHARMACEUTICALS, INC.
|
RECONCILIATION OF
GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited)
|
(In millions,
except per share data)
|
|
|
|
Three Months
Ended
September 30,
|
|
Nine Months
Ended
September 30,
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
GAAP
R&D
|
|
$
|
684.6
|
|
$
|
526.0
|
|
$
|
1,990.5
|
|
$
|
1,897.6
|
R&D: Non-cash
share-based compensation expense
|
|
55.9
|
|
60.0
|
|
169.5
|
|
178.0
|
R&D: Up-front
payments related to license and collaboration
agreements
|
|
—
|
|
—
|
|
85.0
|
|
400.0
|
Non-GAAP
R&D
|
|
$
|
628.7
|
|
$
|
466.0
|
|
$
|
1,736.0
|
|
$
|
1,319.6
|
|
|
|
|
|
|
|
|
|
GAAP
SG&A
|
|
$
|
326.9
|
|
$
|
304.4
|
|
$
|
1,042.5
|
|
$
|
890.1
|
SG&A: Non-cash
share-based compensation expense
|
|
35.9
|
|
40.8
|
|
114.4
|
|
122.3
|
SG&A: Litigation
contingencies and restructuring-related
expenses
|
|
—
|
|
—
|
|
28.9
|
|
10.0
|
Non-GAAP
SG&A
|
|
$
|
291.0
|
|
$
|
263.6
|
|
$
|
899.2
|
|
$
|
757.8
|
|
|
|
|
|
|
|
|
|
GAAP COGS
|
|
$
|
131.0
|
|
$
|
115.9
|
|
$
|
312.3
|
|
$
|
253.8
|
COGS: Non-cash
share-based compensation expense
|
|
9.4
|
|
16.3
|
|
26.6
|
|
30.5
|
COGS: Other
|
|
—
|
|
—
|
|
0.9
|
|
—
|
Non-GAAP
COGS
|
|
$
|
121.6
|
|
$
|
99.6
|
|
$
|
284.8
|
|
$
|
223.3
|
|
|
|
|
|
|
|
|
|
GAAP other income
(expense), net
|
|
$
|
(54.8)
|
|
$
|
30.0
|
|
$
|
176.2
|
|
$
|
5.2
|
Other income/expense:
Losses (gains) on investments
|
|
37.2
|
|
(3.4)
|
|
(162.1)
|
|
70.7
|
Interest expense:
Other
|
|
11.2
|
|
—
|
|
12.7
|
|
—
|
Non-GAAP other income
(expense), net
|
|
$
|
(6.4)
|
|
$
|
26.6
|
|
$
|
26.8
|
|
$
|
75.9
|
|
|
|
|
|
|
|
|
|
GAAP net
income
|
|
$
|
842.1
|
|
$
|
669.6
|
|
$
|
2,364.0
|
|
$
|
1,323.8
|
Total of GAAP to
non-GAAP reconciling items above
|
|
149.6
|
|
113.7
|
|
275.9
|
|
811.5
|
Income tax effect of
GAAP to non-GAAP reconciling items
|
|
(30.5)
|
|
(21.5)
|
|
(53.7)
|
|
(165.8)
|
Non-GAAP net
income
|
|
$
|
961.2
|
|
$
|
761.8
|
|
$
|
2,586.2
|
|
$
|
1,969.5
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
$
|
9.11
|
|
$
|
6.96
|
|
$
|
23.88
|
|
$
|
18.04
|
Non-GAAP net income
per share - diluted
|
|
$
|
8.36
|
|
$
|
6.67
|
|
$
|
22.01
|
|
$
|
17.16
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating:
|
|
|
|
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
105.5
|
|
109.4
|
|
108.3
|
|
109.2
|
Non-GAAP net income
per share - diluted
|
|
115.0
|
|
114.2
|
|
117.5
|
|
114.8
|
|
|
|
|
|
|
|
|
|
Effective tax rate
reconciliation:
|
|
|
|
|
|
|
|
|
GAAP effective tax
rate
|
|
15.6
|
%
|
|
12.9
|
%
|
|
8.6
|
%
|
|
14.0
|
%
|
Income tax effect of
GAAP to non-GAAP reconciling items
|
|
0.7
|
%
|
|
0.7
|
%
|
|
1.0
|
%
|
|
2.2
|
%
|
Non-GAAP effective
tax rate
|
|
16.3
|
%
|
|
13.6
|
%
|
|
9.6
|
%
|
|
16.2
|
%
|
|
|
|
|
|
|
|
|
|
Free cash flow
reconciliation:
|
|
|
|
|
|
|
|
|
Net cash (used in)
provided by operating activities
|
|
$
|
(254.3)
|
|
$
|
557.3
|
|
$
|
1,387.1
|
|
$
|
1,642.6
|
Capital
expenditures
|
|
(153.2)
|
|
(121.7)
|
|
(453.2)
|
|
(290.6)
|
Free cash
flow
|
|
$
|
(407.5)
|
|
$
|
435.6
|
|
$
|
933.9
|
|
$
|
1,352.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TABLE 4
|
|
REGENERON
PHARMACEUTICALS, INC.
|
COLLABORATION
REVENUE (Unaudited)
|
(In
millions)
|
|
|
|
Three Months
Ended
September 30,
|
|
Nine Months
Ended
September 30,
|
|
|
2020
|
|
2019*
|
|
2020
|
|
2019*
|
Sanofi
collaboration revenue:
|
|
|
|
|
|
|
|
|
Antibody:
|
|
|
|
|
|
|
|
|
Regeneron's share of
profits in connection with
commercialization of
antibodies
|
|
$
|
212.8
|
|
|
$
|
94.2
|
|
|
$
|
555.6
|
|
|
$
|
105.2
|
|
Sales-based milestone
earned
|
|
50.0
|
|
|
—
|
|
|
50.0
|
|
|
—
|
|
Reimbursement for
manufacturing of commercial supplies
|
|
94.3
|
|
|
85.4
|
|
|
275.0
|
|
|
143.8
|
|
Immuno-oncology:
|
|
|
|
|
|
|
|
|
Regeneron's share of
losses in connection with
commercialization of Libtayo outside
the United States
|
|
(4.7)
|
|
|
(4.6)
|
|
|
(17.3)
|
|
|
(16.2)
|
|
Reimbursement for
manufacturing of commercial supplies
|
|
0.9
|
|
|
—
|
|
|
6.0
|
|
|
—
|
|
Total Sanofi
collaboration revenue
|
|
$
|
353.3
|
|
|
$
|
175.0
|
|
|
$
|
869.3
|
|
|
$
|
232.8
|
|
|
|
|
|
|
|
|
|
|
Bayer
collaboration revenue:
|
|
|
|
|
|
|
|
|
Regeneron's net profit
in connection with commercialization of
EYLEA outside the United
States
|
|
$
|
287.9
|
|
|
$
|
275.0
|
|
|
$
|
772.6
|
|
|
$
|
793.3
|
|
Reimbursement for
manufacturing of commercial supplies
|
|
12.0
|
|
|
18.6
|
|
|
52.9
|
|
|
41.5
|
|
Total Bayer
collaboration revenue
|
|
$
|
299.9
|
|
|
$
|
293.6
|
|
|
$
|
825.5
|
|
|
$
|
834.8
|
|
|
|
|
|
|
* Certain revisions
have been made to the previously reported September 30, 2019
amounts. See note (4) above.
|
TABLE 5
|
|
REGENERON
PHARMACEUTICALS, INC.
|
NET PRODUCT SALES
OF REGENERON-DISCOVERED PRODUCTS (Unaudited)
|
(In
millions)
|
|
|
|
Net Product
Sales
Recorded by
Regeneron
|
|
Three Months
Ended
September 30,
|
|
|
|
|
|
2020
|
|
2019
|
|
%
Change
|
|
|
|
U.S.
|
|
ROW
|
|
Total
|
|
U.S.
|
|
ROW
|
|
Total
|
|
(Total
Sales)
|
EYLEA(a)
|
|
U.S.
|
|
$
|
1,318.3
|
|
|
$
|
780.0
|
|
|
$
|
2,098.3
|
|
|
$
|
1,187.7
|
|
|
$
|
730.2
|
|
|
$
|
1,917.9
|
|
|
9
|
%
|
Dupixent
|
|
(b)
|
|
$
|
851.2
|
|
|
$
|
221.4
|
|
|
$
|
1,072.6
|
|
|
$
|
508.3
|
|
|
$
|
124.8
|
|
|
$
|
633.1
|
|
|
69
|
%
|
Libtayo(b)
|
|
U.S.
|
|
$
|
71.6
|
|
|
$
|
24.5
|
|
|
$
|
96.1
|
|
|
$
|
47.6
|
|
|
$
|
3.9
|
|
|
$
|
51.5
|
|
|
87
|
%
|
Praluent(c)
|
|
U.S.
|
|
$
|
48.5
|
|
|
$
|
43.0
|
|
|
$
|
91.5
|
|
|
$
|
33.5
|
|
|
$
|
36.2
|
|
|
$
|
69.7
|
|
|
31
|
%
|
Kevzara
|
|
(b)
|
|
$
|
33.2
|
|
|
$
|
36.8
|
|
|
$
|
70.0
|
|
|
$
|
36.5
|
|
|
$
|
18.3
|
|
|
$
|
54.8
|
|
|
28
|
%
|
REGN-COV2(d)
|
|
U.S.
|
|
$
|
40.2
|
|
|
—
|
|
|
$
|
40.2
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(e)
|
|
ZALTRAP
|
|
(b)
|
|
$
|
1.7
|
|
|
$
|
22.5
|
|
|
$
|
24.2
|
|
|
$
|
3.1
|
|
|
$
|
25.3
|
|
|
$
|
28.4
|
|
|
(15)
|
%
|
ARCALYST
|
|
U.S.
|
|
$
|
3.6
|
|
|
—
|
|
|
$
|
3.6
|
|
|
$
|
3.0
|
|
|
—
|
|
|
$
|
3.0
|
|
|
20
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Product
Sales
Recorded by
Regeneron
|
|
Nine Months
Ended
September 30,
|
|
|
|
|
|
2020
|
|
2019
|
|
%
Change
|
|
|
|
U.S.
|
|
ROW
|
|
Total
|
|
U.S.
|
|
ROW
|
|
Total
|
|
(Total
Sales)
|
EYLEA(a)
|
|
U.S.
|
|
$
|
3,604.0
|
|
|
$
|
2,102.7
|
|
|
$
|
5,706.7
|
|
|
$
|
3,422.1
|
|
|
$
|
2,114.9
|
|
|
$
|
5,537.0
|
|
|
3
|
%
|
Dupixent
|
|
(b)
|
|
$
|
2,300.6
|
|
|
$
|
572.2
|
|
|
$
|
2,872.8
|
|
|
$
|
1,266.0
|
|
|
$
|
298.1
|
|
|
$
|
1,564.1
|
|
|
84
|
%
|
Libtayo(b)
|
|
U.S.
|
|
$
|
196.6
|
|
|
$
|
54.3
|
|
|
$
|
250.9
|
|
|
$
|
115.2
|
|
|
$
|
3.9
|
|
|
$
|
119.1
|
|
|
111
|
%
|
Praluent(c)
|
|
U.S.
|
|
$
|
130.8
|
|
|
$
|
127.1
|
|
|
$
|
257.9
|
|
|
$
|
82.9
|
|
|
$
|
124.4
|
|
|
$
|
207.3
|
|
|
24
|
%
|
Kevzara
|
|
(b)
|
|
$
|
105.0
|
|
|
$
|
93.4
|
|
|
$
|
198.4
|
|
|
$
|
91.4
|
|
|
$
|
55.6
|
|
|
$
|
147.0
|
|
|
35
|
%
|
REGN-COV2(d)
|
|
U.S.
|
|
$
|
40.2
|
|
|
—
|
|
|
$
|
40.2
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(e)
|
|
ZALTRAP
|
|
(b)
|
|
$
|
4.9
|
|
|
$
|
74.0
|
|
|
$
|
78.9
|
|
|
$
|
4.9
|
|
|
$
|
74.6
|
|
|
$
|
79.5
|
|
|
(1)
|
%
|
ARCALYST
|
|
U.S.
|
|
$
|
9.3
|
|
|
—
|
|
|
$
|
9.3
|
|
|
$
|
10.7
|
|
|
—
|
|
|
$
|
10.7
|
|
|
(13)
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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) Regeneron records net product
sales of Libtayo in the United States. Sanofi records net product
sales of Libtayo outside the United States
and global net product sales of Dupixent, Kevzara, and ZALTRAP. The
Company records its share of profits/losses in connection with (i)
sales
of Libtayo outside the United States, and (ii) global sales of
Dupixent and Kevzara, within collaboration revenue (see Table 4).
Sanofi pays
the Company a percentage of net sales of ZALTRAP.
|
(c) 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.
|
(d) Regeneron records net product
sales of REGN-COV2 in connection with our agreement with the U.S.
government
|
(e) Percentage not
meaningful
|
View original
content:http://www.prnewswire.com/news-releases/regeneron-reports-third-quarter-2020-financial-and-operating-results-301166803.html
SOURCE Regeneron Pharmaceuticals, Inc.