TARRYTOWN, N.Y., Nov. 4, 2021 /PRNewswire/ --
- Third quarter 2021 revenues increased 51% to $3.45 billion versus third quarter 2020 including
$804 million attributable to
REGEN-COV®(2)
- Third quarter 2021 EYLEA® U.S. net sales
increased 12% versus third quarter 2020 to $1.47 billion
- Third quarter 2021 Dupixent® global net
sales(3), which are recorded by Sanofi,
increased 55% to $1.66 billion versus
third quarter 2020
- Third quarter 2021 GAAP diluted EPS was $14.33 and non-GAAP diluted
EPS(1) was $15.37
- Positive results reported from four Phase 3 Dupixent
studies; FDA expanded approval of Dupixent to include children aged
6 to 11 years with asthma
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced financial results for the third quarter of 2021 and
provided a business update.
"Regeneron had another strong quarter of core business growth,
with EYLEA and Dupixent reaching more patients than ever and
progress made across our diverse pipeline," said Leonard S. Schleifer, M.D., Ph.D., President and
Chief Executive Officer of Regeneron. "We secured a new U.S.
government supply agreement and are delivering an additional 1.4
million doses of REGEN-COV. Our Biologics License Application for
REGEN-COV as treatment and prophylaxis was accepted by the FDA for
priority review, with a mid-April
2022 action date. During the third quarter, we announced
positive data from Phase 3 trials of Dupixent in chronic
spontaneous urticaria and pediatric atopic dermatitis. We also
recently announced positive data from Phase 3 trials of Dupixent in
eosinophilic esophagitis and prurigo nodularis, and that the FDA
approval in pediatric asthma was extended to children as young as
six. Finally, our abstracts that will be released today for the
American Society of Hematology (ASH) Annual Meeting highlight
programs across the hematology portfolio, including our BCMA and C5
antibodies."
Financial Highlights
($ in millions,
except per share data)
|
|
Q3
2021
|
|
Q3
2020
|
|
%
Change
|
Total
revenues
|
|
$
|
3,453
|
|
|
$
|
2,294
|
|
|
51%
|
GAAP net
income
|
|
$
|
1,632
|
|
|
$
|
842
|
|
|
94%
|
GAAP net income
per
share - diluted
|
|
$
|
14.33
|
|
|
$
|
7.39
|
|
|
94%
|
Non-GAAP net
income(1)
|
|
$
|
1,773
|
|
|
$
|
961
|
|
|
84%
|
Non-GAAP net income
per
share - diluted(1)
|
|
$
|
15.37
|
|
|
$
|
8.36
|
|
|
84%
|
"Regeneron performed extremely well in the third quarter with
strong top- and bottom-line growth driven by an increasingly
diversified core business," said Robert E.
Landry, Executive Vice President, Finance and Chief
Financial Officer of Regeneron. "We are approaching the end of 2021
with positive momentum as we continue to invest in our broad
pipeline to drive sustained long-term growth."
Business Highlights
Key Pipeline Progress
Regeneron has over 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 August 2021, the Company
announced that an ongoing Phase 2 trial evaluating an 8 mg dose of
aflibercept in patients with neovascular age-related macular
degeneration (wet AMD) met its primary safety and efficacy
endpoints. The high-dose aflibercept formulation is currently also
being evaluated in two large Phase 3 trials in wet AMD and diabetic
macular edema (DME), which are expected to report results in the
second half of 2022.
Dupixent® (dupilumab)
- In October 2021, the U.S. Food
and Drug Administration (FDA) approved Dupixent for children aged 6
to 11 years with moderate-to-severe asthma.
- In July 2021, the Company and
Sanofi announced that a Phase 3 trial in patients with
moderate-to-severe chronic spontaneous urticaria (CSU) met its
primary and all key secondary endpoints at 24 weeks.
- In October 2021, the Company and
Sanofi announced that a second Phase 3 trial in adults and
adolescents with eosinophilic esophagitis (EoE) met its co-primary
endpoints in patients taking Dupixent 300 mg weekly, showing
significant improvements in clinical (Dysphagia Symptom
Questionnaire) and histologic disease measures compared to placebo.
A rolling supplemental Biologics License Application (sBLA) has
been initiated for adults and adolescents with EoE.
- In October 2021, the Company and
Sanofi announced that a Phase 3 trial in adults with uncontrolled
prurigo nodularis met its primary and all key secondary endpoints,
showing that Dupixent significantly reduced itch and skin lesions
compared to placebo in this investigational setting. Results from
an additional Phase 3 trial in prurigo nodularis are expected to be
reported in the first half of 2022.
- In August 2021, the Company and
Sanofi announced that a Phase 3 trial in children aged 6 months to
5 years with moderate-to-severe atopic dermatitis met its primary
and all secondary endpoints, and the companies expect to complete
regulatory submissions in the United
States and European Union (EU) in the coming months.
REGEN-COV® (casirivimab and
imdevimab)(2), a dual antibody cocktail to SARS-CoV-2
virus
- In September 2021, the Company
announced an agreement to supply the U.S. government with an
additional 1.4 million doses of REGEN-COV (of which over 300,000
doses were delivered during the third quarter of 2021). Pursuant to
the agreement, the U.S. government is obligated to purchase
REGEN-COV doses delivered by January 31,
2022, resulting in aggregate payments to the Company of up
to $2.940 billion. Roche will supply
a portion of the doses to Regeneron to fulfill Regeneron's
agreement with the U.S. government.
- The FDA accepted for priority review the BLA for COVID-19
treatment in non-hospitalized patients and as prophylaxis in
certain individuals, with a target action date of April 13, 2022. A Marketing Authorization
Application (MAA) for COVID-19 treatment in infected
non-hospitalized patients or as prophylaxis was also submitted in
the EU.
- In September 2021, the Company
announced that a Phase 3 trial in patients hospitalized with
COVID-19 met its primary endpoint, showing REGEN-COV significantly
reduced viral load. The FDA is currently reviewing the Company's
request to expand the Emergency Use Authorization (EUA) to include
treatment in hospital settings, and the Company plans to submit a
BLA and MAA for this patient population in the coming months.
- The New England Journal of Medicine published positive
detailed results from the Phase 3 trial that assessed the ability
of REGEN-COV to treat COVID-19 in infected high-risk
non-hospitalized patients.
Oncology Programs
- The FDA accepted for priority review, with a target action date
of January 30, 2022, the sBLA for
Libtayo® (cemiplimab) to treat patients with recurrent
or metastatic cervical cancer whose disease progressed on or after
chemotherapy. The MAA in the EU is expected to be submitted by the
end of the year.
- Positive data from the Phase 3 trial of Libtayo, in combination
with chemotherapy, in patients with advanced non-small cell lung
cancer, were presented at the European Society for Medical Oncology
Virtual Congress 2021. These results will form the basis of
regulatory submissions, which are planned in the United States and EU in the coming
months.
- A Phase 1 study of REGN5093-M114, a bispecific antibody-drug
conjugate targeting two distinct MET epitopes, was initiated in
MET-altered advanced non-small cell lung cancer.
Pozelimab, an antibody to C5
- A Phase 3 study of pozelimab in combination with cemdisiran, a
siRNA therapeutic, in myasthenia gravis was initiated.
REGN5713-5714-5715, a multi-antibody therapy to Bet v 1
- The initial Phase 3 study in birch allergic patients with
allergic rhinoconjunctivitis met its primary endpoint with a
reduction in the combined allergic rhinitis symptom and medication
score. The Company is currently evaluating further development
plans, including an additional Phase 3 study during an upcoming
birch pollen season.
Third Quarter 2021 Financial Results
Revenues
Total revenues increased by 51% to $3.453
billion in the third quarter of 2021, compared to
$2.294 billion in the third quarter
of 2020. Total revenues excluding (i) REGEN-COV (casirivimab and
imdevimab) net product sales in the
United States and (ii) the Company's share of gross profits
in connection with sales of casirivimab and imdevimab pursuant to
the Roche collaboration agreement, increased by 18% to $2.649 billion in the third quarter of 2021,
compared to the third quarter of 2020(1).
Net product sales recorded by the Company consist of the
following:
($ in
millions)
|
|
Q3
2021
|
|
Q3
2020
|
|
%
Change
|
EYLEA
|
|
$
|
1,473
|
|
|
$
|
1,318
|
|
|
12
|
%
|
Libtayo
|
|
78
|
|
|
72
|
|
|
8
|
%
|
Praluent®
|
|
45
|
|
|
49
|
|
|
(8)
|
%
|
REGEN-COV
|
|
677
|
|
|
40
|
|
|
**
|
Evkeeza®
|
|
7
|
|
|
—
|
|
|
**
|
ARCALYST®
|
|
—
|
*
|
|
3
|
|
|
**
|
Total net product
sales in the U.S.
|
|
$
|
2,280
|
|
|
$
|
1,482
|
|
|
54
|
%
|
|
|
|
|
|
|
|
* Effective April
1, 2021, Kiniksa records net product sales of ARCALYST in the
United States. Previously, the Company recorded net product sales
of ARCALYST in the United States.
|
** Percentage not
meaningful
|
During the third quarter of 2021, the Company commenced
deliveries of REGEN-COV under its September
2021 supply agreement with the U.S. government (as described
above).
Total revenues also include collaboration
revenues(3) of $1.074 billion in the third quarter of 2021,
compared to $653 million in the third
quarter of 2020. Sanofi collaboration revenue increased primarily
due to the Company's share of profits from commercialization of
antibodies, which were $387 million
in the third quarter of 2021, compared to $213 million in the third quarter of 2020. The
change in the Company's share of profits from commercialization of
antibodies was driven by higher Dupixent profits. In addition, in
both the third quarter of 2021 and 2020, the Company earned
$50 million sales-based milestones from Sanofi based upon
sales of antibodies outside the United
States on a rolling twelve-month basis. In the third quarter
of 2021, the Company also recorded Roche collaboration revenue of
$127 million in connection with the
true-up payment owed from Roche in connection with global gross
profits from sales of the casirivimab and imdevimab antibody
cocktail.
Refer to Table 4 for a summary of collaboration revenue.
Other revenue decreased in the third quarter of 2021, compared
to the third quarter of 2020, primarily due to lower amounts
recognized in connection with the Company's agreements with the
Biomedical Advanced Research Development Authority (BARDA) related
to funding of certain development activities for COVID-19
antibodies, and, to a lesser extent, Inmazeb®.
Operating Expenses
|
|
GAAP
|
|
%
Change
|
|
Non-GAAP(1)
|
|
%
Change
|
($ in
millions)
|
|
Q3
2021
|
|
Q3
2020
|
|
|
Q3
2021
|
|
Q3
2020
|
|
Research and
development (R&D)
|
|
$
|
665
|
|
|
$
|
685
|
|
|
(3%)
|
|
$
|
592
|
|
|
$
|
629
|
|
|
(6%)
|
Selling, general, and
administrative
(SG&A)
|
|
$
|
445
|
|
|
$
|
327
|
|
|
36%
|
|
$
|
391
|
|
|
$
|
291
|
|
|
34%
|
Cost of goods sold
(COGS)
|
|
$
|
239
|
|
|
$
|
131
|
|
|
82%
|
|
$
|
224
|
|
|
$
|
122
|
|
|
84%
|
Cost of collaboration
and contract
manufacturing (COCM)
|
|
$
|
214
|
|
|
$
|
143
|
|
|
50%
|
|
*
|
|
|
*
|
|
|
n/a
|
Other operating
expense (income), net
|
|
$
|
42
|
|
|
$
|
(45)
|
|
|
(193%)
|
|
*
|
|
|
*
|
|
|
n/a
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* GAAP and
non-GAAP amounts are equivalent as no non-GAAP adjustments have
been recorded
|
- The increase in SG&A expenses in the third quarter of 2021
was primarily due to higher headcount-related costs and an increase
in commercialization-related expenses for EYLEA, including
direct-to-consumer advertising.
- The increase in COGS in the third quarter of 2021 was primarily
due to the recognition of manufacturing costs in connection with
product sales of REGEN-COV in the United
States.
- The increase in COCM in the third quarter of 2021 was primarily
due to the recognition of manufacturing costs associated with
higher sales of Dupixent.
- Other operating expense (income), 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. The decrease in other operating income in the third
quarter of 2021 was primarily due to the recognition of a
cumulative catch-up adjustment of $67
million arising from an update to the estimate of the total
R&D costs expected to be incurred under the Sanofi
Immuno-oncology collaboration agreement.
Other Financial Information
In the third quarter of 2021, the Company's GAAP effective tax
rate was 10.2%, compared to 15.6% in the third quarter of 2020. The
decrease in the third quarter 2021 GAAP effective tax rate,
compared to the third quarter of 2020, was due in part to the
positive impact of stock-based compensation in the third quarter of
2021. In the third quarter of 2021, the non-GAAP effective tax rate
was 10.8%, compared to 16.3% in the third quarter of 2020.
GAAP net income per diluted share was $14.33 in the third quarter of 2021, compared to
GAAP net income per diluted share of $7.39 in the third quarter of 2020. Non-GAAP net
income per diluted share was $15.37
in the third quarter of 2021, compared to non-GAAP net income per
diluted share of $8.36 in the third
quarter of 2020. A reconciliation of the Company's GAAP to non-GAAP
results is included in Table 3 of this press release.
Net cash provided by operating activities in the first nine
months of 2021 was $4.709 billion,
compared to $1.387 billion in the
first nine months of 2020, resulting in $4.312 billion in free cash flow(1)
for the first nine months of 2021, compared to $934 million for the first nine months of 2020.
The increase in free cash flow was primarily due to the Company's
collection of amounts due from the U.S. government in connection
with REGEN-COV sales in 2021.
2021 Financial
Guidance(4)
The Company's full year 2021 financial guidance consists of the
following components:
|
|
GAAP
|
|
Non-GAAP(1)
|
R&D
|
|
$2.845 billion–$2.915
billion
(previously $2.950
billion–$3.075 billion)
|
|
$2.550 billion–$2.600
billion
(previously $2.650
billion–$2.750 billion)
|
SG&A
|
|
$1.760 billion–$1.830
billion
(previously $1.730 billion–$1.830 billion)
|
|
$1.560 billion–$1.610
billion
(previously $1.540
billion–$1.620 billion)
|
Gross margin on net
product sales(5)
|
|
Approximately
87.5%
(previously
87–88%)
|
|
Approximately
88%
(previously
88–89%)
|
COCM(6)
|
|
$670 million–$700
million (previously $630 million–$680 million)
|
|
*
|
Other operating
(income) expense, net
|
|
($50) million–($60)
million
(previously ($135)
million–($155) million)
|
|
*
|
Capital
expenditures
|
|
$545 million–$575
million (previously $590 million–$640 million)
|
|
*
|
Effective tax rate
(ETR)
|
|
14–15%
(previously
14–16%)
|
|
14–15%
(previously
14–16%)
|
|
|
|
|
|
* GAAP and
non-GAAP amounts are equivalent as no non-GAAP adjustments have
been or are expected to be recorded
|
A reconciliation of full year 2021 GAAP to Non-GAAP financial
guidance is included below:
|
|
Projected
Range
|
($ in
millions)
|
|
Low
|
|
High
|
GAAP
R&D
|
|
$
|
2,845
|
|
|
$
|
2,915
|
|
R&D: Non-cash
share-based compensation
expense
|
|
(295)
|
|
|
(315)
|
|
Non-GAAP
R&D
|
|
$
|
2,550
|
|
|
$
|
2,600
|
|
|
|
|
|
|
GAAP
SG&A
|
|
$
|
1,760
|
|
|
$
|
1,830
|
|
SG&A: Non-cash
share-based compensation
expense
|
|
(194)
|
|
|
(214)
|
|
SG&A: Litigation
contingencies and other
|
|
(6)
|
|
|
(6)
|
|
Non-GAAP
SG&A
|
|
$
|
1,560
|
|
|
$
|
1,610
|
|
|
|
|
|
|
GAAP gross margin on
net product sales
|
|
Approximately
87.5%
|
|
Approximately
87.5%
|
Non-cash share-based
compensation
expense
|
|
< 1%
|
|
< 1%
|
Non-GAAP gross margin
on net product sales
|
|
Approximately
88%
|
|
Approximately
88%
|
|
|
|
|
|
GAAP ETR
|
|
14%
|
|
15%
|
Income tax effect of
GAAP to non-GAAP
reconciling items and other
|
|
< 1%
|
|
< 1%
|
Non-GAAP
ETR
|
|
14%
|
|
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). 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 casirivimab and
imdevimab antibody cocktail is known as REGEN-COV in the United
States and RonapreveTM in other countries. The
Company records net product sales of REGEN-COV in the United States
and Roche records net product sales of Ronapreve outside the United
States.
|
|
|
(3)
|
The Company's
collaborators provide it with estimates of the collaborators'
respective sales and the Company's share of the profits or losses
(if applicable) 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 (if applicable) is
adjusted on a prospective basis accordingly, if
necessary.
|
|
|
(4)
|
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.
|
|
|
(5)
|
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.
|
|
|
(6)
|
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 2021 financial and operating results
on Thursday, November 4, 2021, at 8:30
AM Eastern Time. Participants may access the conference call
live via webcast on the "Investors and Media" page of Regeneron's
website at www.regeneron.com. To participate via telephone, please
register in advance at
http://www.directeventreg.com/registration/event/4979976. Upon
registration, all telephone participants will receive a
confirmation email detailing how to join the conference call,
including the dial-in number along with a unique passcode and
registrant ID that can be used to access the call. A replay of the
conference call and webcast will be archived on the Company's
website 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 or licensees (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 or licensees (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), Evkeeza®
(evinacumab), Inmazeb® (atoltivimab, maftivimab,
and odesivimab-ebgn), fasinumab, REGEN-COV®
(casirivimab and imdevimab), garetosmab, pozelimab, odronextamab,
itepekimab, REGN5458, REGN5713-5714-5715, REGN1908-1909,
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, 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 and imdevimab antibody cocktail (known as REGEN-COV in
the United States and
RonapreveTM in other countries) and its REGEN-COV
supply agreement with the U.S. government, 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 September 30,
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
|
|
Christina
Chan
|
Investor
Relations
|
|
Corporate
Communications
|
914-847-7786
|
|
914-847-8827
|
justin.holko@regeneron.com
|
|
christina.chan@regeneron.com
|
TABLE 1
|
|
REGENERON
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS (Unaudited)
(In
millions)
|
|
|
|
September
30,
|
|
December
31,
|
|
|
2021
|
|
2020
|
Assets:
|
|
|
|
|
Cash and marketable
securities
|
|
$
|
11,418.9
|
|
|
$
|
6,722.6
|
|
Accounts receivable,
net
|
|
5,452.0
|
|
|
4,114.7
|
|
Inventories
|
|
2,053.8
|
|
|
1,916.6
|
|
Property, plant, and
equipment, net
|
|
3,395.7
|
|
|
3,221.6
|
|
Deferred tax
assets
|
|
723.2
|
|
|
858.9
|
|
Other
assets
|
|
627.9
|
|
|
328.9
|
|
Total
assets
|
|
$
|
23,671.5
|
|
|
$
|
17,163.3
|
|
|
|
|
|
|
Liabilities and
stockholders' equity:
|
|
|
|
|
Accounts payable,
accrued expenses, and other liabilities
|
|
$
|
3,150.6
|
|
|
$
|
2,806.8
|
|
Finance lease
liabilities
|
|
719.0
|
|
|
717.2
|
|
Deferred
revenue
|
|
564.3
|
|
|
635.5
|
|
Long-term
debt
|
|
1,979.6
|
|
|
1,978.5
|
|
Stockholders'
equity
|
|
17,258.0
|
|
|
11,025.3
|
|
Total liabilities and
stockholders' equity
|
|
$
|
23,671.5
|
|
|
$
|
17,163.3
|
|
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,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product
sales
|
|
$
|
2,279.9
|
|
|
$
|
1,482.2
|
|
|
$
|
8,142.0
|
|
|
$
|
3,945.8
|
|
Collaboration
revenue
|
|
1,073.9
|
|
|
653.2
|
|
|
2,783.0
|
|
|
1,694.8
|
|
Other
revenue
|
|
99.0
|
|
|
158.6
|
|
|
195.0
|
|
|
433.6
|
|
|
|
3,452.8
|
|
|
2,294.0
|
|
|
11,120.0
|
|
|
6,074.2
|
|
Expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
665.4
|
|
|
684.6
|
|
|
2,122.5
|
|
|
1,990.5
|
|
Selling, general, and
administrative
|
|
445.0
|
|
|
326.9
|
|
|
1,265.3
|
|
|
1,042.5
|
|
Cost of goods
sold
|
|
238.8
|
|
|
131.0
|
|
|
961.4
|
|
|
312.3
|
|
Cost of collaboration
and contract manufacturing
|
|
214.4
|
|
|
143.0
|
|
|
493.5
|
|
|
454.5
|
|
Other operating
expense (income), net
|
|
42.0
|
|
|
(44.6)
|
|
|
(29.8)
|
|
|
(135.2)
|
|
|
|
1,605.6
|
|
|
1,240.9
|
|
|
4,812.9
|
|
|
3,664.6
|
|
|
|
|
|
|
|
|
|
|
Income from
operations
|
|
1,847.2
|
|
|
1,053.1
|
|
|
6,307.1
|
|
|
2,409.6
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Other (expense)
income, net
|
|
(16.4)
|
|
|
(28.5)
|
|
|
558.5
|
|
|
218.3
|
|
Interest
expense
|
|
(14.2)
|
|
|
(26.3)
|
|
|
(43.2)
|
|
|
(42.1)
|
|
|
|
(30.6)
|
|
|
(54.8)
|
|
|
515.3
|
|
|
176.2
|
|
|
|
|
|
|
|
|
|
|
Income before income
taxes
|
|
1,816.6
|
|
|
998.3
|
|
|
6,822.4
|
|
|
2,585.8
|
|
|
|
|
|
|
|
|
|
|
Income tax
expense
|
|
184.4
|
|
|
156.2
|
|
|
976.1
|
|
|
221.8
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
1,632.2
|
|
|
$
|
842.1
|
|
|
$
|
5,846.3
|
|
|
$
|
2,364.0
|
|
|
|
|
|
|
|
|
|
|
Net income per share
- basic
|
|
$
|
15.37
|
|
|
$
|
7.98
|
|
|
$
|
55.42
|
|
|
$
|
21.83
|
|
Net income per share
- diluted
|
|
$
|
14.33
|
|
|
$
|
7.39
|
|
|
$
|
52.29
|
|
|
$
|
20.36
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding - basic
|
|
106.2
|
|
|
105.5
|
|
|
105.5
|
|
|
108.3
|
|
Weighted average
shares outstanding - diluted
|
|
113.9
|
|
|
113.9
|
|
|
111.8
|
|
|
116.1
|
|
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,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
GAAP
R&D
|
|
$
|
665.4
|
|
|
$
|
684.6
|
|
|
$
|
2,122.5
|
|
|
$
|
1,990.5
|
|
R&D: Non-cash
share-based compensation expense
|
|
73.1
|
|
|
55.9
|
|
|
213.7
|
|
|
169.5
|
|
R&D: Up-front
payments related to license and collaboration
agreements
|
|
—
|
|
|
—
|
|
|
—
|
|
|
85.0
|
|
Non-GAAP
R&D
|
|
$
|
592.3
|
|
|
$
|
628.7
|
|
|
$
|
1,908.8
|
|
|
$
|
1,736.0
|
|
|
|
|
|
|
|
|
|
|
GAAP
SG&A
|
|
$
|
445.0
|
|
|
$
|
326.9
|
|
|
$
|
1,265.3
|
|
|
$
|
1,042.5
|
|
SG&A: Non-cash
share-based compensation expense
|
|
48.7
|
|
|
35.9
|
|
|
149.1
|
|
|
114.4
|
|
SG&A: Litigation
contingencies and other
|
|
5.6
|
|
|
—
|
|
|
5.6
|
|
|
28.9
|
|
Non-GAAP
SG&A
|
|
$
|
390.7
|
|
|
$
|
291.0
|
|
|
$
|
1,110.6
|
|
|
$
|
899.2
|
|
|
|
|
|
|
|
|
|
|
GAAP COGS
|
|
$
|
238.8
|
|
|
$
|
131.0
|
|
|
$
|
961.4
|
|
|
$
|
312.3
|
|
COGS: Non-cash
share-based compensation expense
|
|
15.1
|
|
|
9.4
|
|
|
50.5
|
|
|
26.6
|
|
COGS: Other
|
|
—
|
|
|
—
|
|
|
—
|
|
|
0.9
|
|
Non-GAAP
COGS
|
|
$
|
223.7
|
|
|
$
|
121.6
|
|
|
$
|
910.9
|
|
|
$
|
284.8
|
|
|
|
|
|
|
|
|
|
|
GAAP other (expense)
income, net
|
|
$
|
(30.6)
|
|
|
$
|
(54.8)
|
|
|
$
|
515.3
|
|
|
$
|
176.2
|
|
Other income/expense:
Losses (gains) on investments
|
|
29.3
|
|
|
37.2
|
|
|
(524.6)
|
|
|
(162.1)
|
|
Interest expense:
Other
|
|
—
|
|
|
11.2
|
|
|
—
|
|
|
12.7
|
|
Non-GAAP other
(expense) income, net
|
|
$
|
(1.3)
|
|
|
$
|
(6.4)
|
|
|
$
|
(9.3)
|
|
|
$
|
26.8
|
|
|
|
|
|
|
|
|
|
|
GAAP net
income
|
|
$
|
1,632.2
|
|
|
$
|
842.1
|
|
|
$
|
5,846.3
|
|
|
$
|
2,364.0
|
|
Total of GAAP to
non-GAAP reconciling items above
|
|
171.8
|
|
|
149.6
|
|
|
(105.7)
|
|
|
275.9
|
|
Income tax effect of
GAAP to non-GAAP reconciling items
|
|
(31.3)
|
|
|
(30.5)
|
|
|
36.3
|
|
|
(53.7)
|
|
Non-GAAP net
income
|
|
$
|
1,772.7
|
|
|
$
|
961.2
|
|
|
$
|
5,776.9
|
|
|
$
|
2,586.2
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
$
|
16.69
|
|
|
$
|
9.11
|
|
|
$
|
54.76
|
|
|
$
|
23.88
|
|
Non-GAAP net income
per share - diluted
|
|
$
|
15.37
|
|
|
$
|
8.36
|
|
|
$
|
50.99
|
|
|
$
|
22.01
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating:
|
|
|
|
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
106.2
|
|
|
105.5
|
|
|
105.5
|
|
|
108.3
|
|
Non-GAAP net income
per share - diluted
|
|
115.3
|
|
|
115.0
|
|
|
113.3
|
|
|
117.5
|
|
|
|
|
|
|
|
|
|
|
Effective tax rate
reconciliation:
|
|
|
|
|
|
|
|
|
GAAP effective tax
rate
|
|
10.2%
|
|
15.6%
|
|
14.3%
|
|
8.6%
|
Income tax effect of
GAAP to non-GAAP reconciling items
|
|
0.6%
|
|
0.7%
|
|
(0.3%)
|
|
1.0%
|
Non-GAAP effective
tax rate
|
|
10.8%
|
|
16.3%
|
|
14.0%
|
|
9.6%
|
|
|
|
|
|
|
|
|
|
Free cash flow
reconciliation:
|
|
|
|
|
|
|
|
|
Net cash provided by
(used in) operating activities
|
|
$
|
3,413.6
|
|
|
$
|
(254.3)
|
|
|
$
|
4,708.8
|
|
|
$
|
1,387.1
|
|
Capital
expenditures
|
|
(133.2)
|
|
|
(153.2)
|
|
|
(397.0)
|
|
|
(453.2)
|
|
Free cash
flow
|
|
$
|
3,280.4
|
|
|
$
|
(407.5)
|
|
|
$
|
4,311.8
|
|
|
$
|
933.9
|
|
TABLE 4
|
|
REGENERON
PHARMACEUTICALS, INC.
COLLABORATION
REVENUE (Unaudited)
(In
millions)
|
|
|
|
Three Months
Ended
September
30,
|
|
Nine Months
Ended
September
30,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Sanofi
collaboration revenue:
|
|
|
|
|
|
|
|
|
Antibody:
|
|
|
|
|
|
|
|
|
Regeneron's share of
profits in connection with commercialization
of antibodies
|
|
$
|
387.0
|
|
|
$
|
212.8
|
|
|
$
|
975.2
|
|
|
$
|
555.6
|
|
Sales-based milestone
earned
|
|
50.0
|
|
|
50.0
|
|
|
50.0
|
|
|
50.0
|
|
Reimbursement for
manufacturing of commercial supplies
|
|
144.7
|
|
|
94.3
|
|
|
361.2
|
|
|
275.0
|
|
Immuno-oncology:
|
|
|
|
|
|
|
|
|
Regeneron's share of
losses in connection with commercialization
of Libtayo outside the United States
|
|
(3.0)
|
|
|
(4.7)
|
|
|
(12.6)
|
|
|
(17.3)
|
|
Reimbursement for
manufacturing of commercial supplies
|
|
3.1
|
|
|
0.9
|
|
|
10.5
|
|
|
6.0
|
|
Total Sanofi
collaboration revenue
|
|
581.8
|
|
|
353.3
|
|
|
1,384.3
|
|
|
869.3
|
|
|
|
|
|
|
|
|
|
|
Bayer
collaboration revenue:
|
|
|
|
|
|
|
|
|
Regeneron's net profit
in connection with commercialization of
EYLEA outside the United States
|
|
351.0
|
|
|
287.9
|
|
|
995.3
|
|
|
772.6
|
|
Reimbursement for
manufacturing of commercial supplies
|
|
14.0
|
|
|
12.0
|
|
|
41.6
|
|
|
52.9
|
|
Total Bayer
collaboration revenue
|
|
365.0
|
|
|
299.9
|
|
|
1,036.9
|
|
|
825.5
|
|
|
|
|
|
|
|
|
|
|
Roche
collaboration revenue:
|
|
|
|
|
|
|
|
|
Global gross profit
true-up payment owed from Roche in
connection with sales of casirivimab and
imdevimab
|
|
127.1
|
|
|
—
|
|
|
361.8
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
Total collaboration
revenue
|
|
$
|
1,073.9
|
|
|
$
|
653.2
|
|
|
$
|
2,783.0
|
|
|
$
|
1,694.8
|
|
TABLE 5
|
|
REGENERON
PHARMACEUTICALS, INC.
NET PRODUCT SALES
OF REGENERON-DISCOVERED PRODUCTS (Unaudited)
(In
millions)
|
|
|
|
Three Months
Ended
September
30,
|
|
|
|
|
2021
|
|
2020
|
|
%
Change
|
|
|
U.S.
|
|
ROW
|
|
Total
|
|
U.S.
|
|
ROW
|
|
Total
|
|
(Total
Sales)
|
EYLEA(a)
|
|
$
|
1,473.4
|
|
|
$
|
930.8
|
|
|
$
|
2,404.2
|
|
|
$
|
1,318.3
|
|
|
$
|
780.0
|
|
|
$
|
2,098.3
|
|
|
15
|
%
|
Dupixent(b)
|
|
$
|
1,256.7
|
|
|
$
|
406.2
|
|
|
$
|
1,662.9
|
|
|
$
|
851.2
|
|
|
$
|
221.4
|
|
|
$
|
1,072.6
|
|
|
55
|
%
|
Libtayo(c)
|
|
$
|
78.4
|
|
|
$
|
41.1
|
|
|
$
|
119.5
|
|
|
$
|
71.6
|
|
|
$
|
24.5
|
|
|
$
|
96.1
|
|
|
24
|
%
|
Praluent(d)
|
|
$
|
44.8
|
|
|
$
|
69.7
|
|
|
$
|
114.5
|
|
|
$
|
48.5
|
|
|
$
|
43.0
|
|
|
$
|
91.5
|
|
|
25
|
%
|
REGEN-COV(e)
|
|
$
|
676.7
|
|
|
$
|
518.8
|
|
|
$
|
1,195.5
|
|
|
$
|
40.2
|
|
|
—
|
|
|
$
|
40.2
|
|
|
(h)
|
Kevzara(b)
|
|
$
|
58.5
|
|
|
$
|
39.3
|
|
|
$
|
97.8
|
|
|
$
|
33.2
|
|
|
$
|
36.8
|
|
|
$
|
70.0
|
|
|
40
|
%
|
Evkeeza(f)
|
|
$
|
6.6
|
|
|
—
|
|
|
$
|
6.6
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(h)
|
ARCALYST(g)
|
|
$
|
12.1
|
|
|
—
|
|
|
$
|
12.1
|
|
|
$
|
3.6
|
|
|
—
|
|
|
$
|
3.6
|
|
|
236
|
%
|
ZALTRAP(b)
|
|
$
|
1.2
|
|
|
$
|
20.9
|
|
|
$
|
22.1
|
|
|
$
|
1.7
|
|
|
$
|
22.5
|
|
|
$
|
24.2
|
|
|
(9)
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months
Ended
September
30,
|
|
|
|
|
2021
|
|
2020
|
|
%
Change
|
|
|
U.S.
|
|
ROW
|
|
Total
|
|
U.S.
|
|
ROW
|
|
Total
|
|
(Total
Sales)
|
EYLEA(a)
|
|
$
|
4,245.1
|
|
|
$
|
2,658.9
|
|
|
$
|
6,904.0
|
|
|
$
|
3,604.0
|
|
|
$
|
2,102.7
|
|
|
$
|
5,706.7
|
|
|
21
|
%
|
Dupixent(b)
|
|
$
|
3,364.8
|
|
|
$
|
1,060.0
|
|
|
$
|
4,424.8
|
|
|
$
|
2,300.6
|
|
|
$
|
572.2
|
|
|
$
|
2,872.8
|
|
|
54
|
%
|
Libtayo(c)
|
|
$
|
225.5
|
|
|
$
|
111.7
|
|
|
$
|
337.2
|
|
|
$
|
196.6
|
|
|
$
|
54.3
|
|
|
$
|
250.9
|
|
|
34
|
%
|
Praluent(d)
|
|
$
|
130.0
|
|
|
$
|
188.5
|
|
|
$
|
318.5
|
|
|
$
|
130.8
|
|
|
$
|
127.1
|
|
|
$
|
257.9
|
|
|
23
|
%
|
REGEN-COV(e)
|
|
$
|
3,530.1
|
|
|
$
|
1,173.2
|
|
|
$
|
4,703.3
|
|
|
$
|
40.2
|
|
|
—
|
|
|
$
|
40.2
|
|
|
(h)
|
Kevzara(b)
|
|
$
|
119.9
|
|
|
$
|
113.7
|
|
|
$
|
233.6
|
|
|
$
|
105.0
|
|
|
$
|
93.4
|
|
|
$
|
198.4
|
|
|
18
|
%
|
Evkeeza(f)
|
|
$
|
9.1
|
|
|
—
|
|
|
$
|
9.1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(h)
|
ARCALYST(g)
|
|
$
|
22.0
|
|
|
—
|
|
|
$
|
22.0
|
|
|
$
|
9.3
|
|
|
—
|
|
|
$
|
9.3
|
|
|
137
|
%
|
ZALTRAP(b)
|
|
$
|
3.9
|
|
|
$
|
66.1
|
|
|
$
|
70.0
|
|
|
$
|
4.9
|
|
|
$
|
74.0
|
|
|
$
|
78.9
|
|
|
(11)
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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, if any. Prior to April 1,
2021, Regeneron recorded net product sales of ARCALYST in the
United States.
|
(h) Percentage not
meaningful
|
View original
content:https://www.prnewswire.com/news-releases/regeneron-reports-third-quarter-2021-financial-and-operating-results-301416042.html
SOURCE Regeneron Pharmaceuticals, Inc.