TARRYTOWN, N.Y., Aug. 5, 2021 /PRNewswire/ --
- Second quarter 2021 revenues increased 163% to $5.14 billion versus second quarter 2020
including $2.76 billion attributable
to REGEN-COVTM(2); revenues excluding
REGEN-COV(1)(2) increased 22%
- Second quarter 2021 EYLEA® U.S. net sales
increased 28% versus second quarter 2020 to a record $1.42 billion
- Second quarter 2021 Dupixent® global net
sales(3), which are recorded by Sanofi,
increased 59% to $1.50 billion versus
second quarter 2020
- Second quarter 2021 GAAP diluted EPS was $27.97 and non-GAAP diluted
EPS(1) was $25.80
- FDA updated REGEN-COV Emergency Use Authorization (EUA) with
lower dose, subcutaneous administration, and post-exposure
prophylaxis
- REGEN-COV Phase 3 RECOVERY trial in hospitalized patients
with severe COVID-19 met primary outcome
- Reported that Dupixent significantly improved itch and hives
in patients with chronic spontaneous urticaria, marking the fifth
disease to show positive pivotal results
- Phase 3 trial of Libtayo® combined with
chemotherapy stopped early due to significant improvement in
overall survival in patients with first-line advanced non-small
cell lung cancer
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced financial results for the second quarter of 2021 and
provided a business update.
"Regeneron had outstanding performance in the second quarter
during which we delivered to the U.S. government the entire order
for our COVID-19 antibody cocktail and recognized record global
sales from our EYLEA and Dupixent franchises," said Leonard S. Schleifer, M.D., Ph.D., President and
Chief Executive Officer of Regeneron. "We continue to advance
Dupixent's potential to help new patient groups, with recent
positive Phase 3 data in chronic spontaneous urticaria and
additional late-stage read-outs expected later this year in prurigo
nodularis, eosinophilic esophagitis, and pediatric atopic
dermatitis. With today's positive Phase 3 results in combination
with chemotherapy in non-small cell lung cancer, Libtayo yet again
demonstrates its potential to be a leading checkpoint inhibitor. We
also progressed our genetics medicines platform, with landmark
clinical data alongside our collaborator Intellia using a CRISPR
therapeutic and the discovery of a promising new obesity target
from the Regeneron Genetics Center."
Financial Highlights
($ in millions,
except per share data)
|
|
Q2
2021
|
|
Q2
2020
|
|
%
Change
|
Total
revenues
|
|
$
|
5,139
|
|
|
$
|
1,952
|
|
|
163%
|
GAAP net
income
|
|
$
|
3,099
|
|
|
$
|
897
|
|
|
245%
|
GAAP net income per
share - diluted
|
|
$
|
27.97
|
|
|
$
|
7.61
|
|
|
268%
|
Non-GAAP net
income(1)
|
|
$
|
2,895
|
|
|
$
|
854
|
|
|
239%
|
Non-GAAP net income
per share - diluted(1)
|
|
$
|
25.80
|
|
|
$
|
7.16
|
|
|
260%
|
"Regeneron performed exceptionally well in the second quarter
with the core business on a strong growth trajectory as we invest
in our diverse and differentiated pipeline for long-term and
sustainable growth," said Robert E.
Landry, Executive Vice President, Finance and Chief
Financial Officer of Regeneron.
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
- Enrollment in the Phase 3 studies for high-dose formulation in
diabetic macular edema (DME) and neovascular age-related macular
degeneration (wet AMD) was completed.
- Enrollment in the Phase 3 study for retinopathy of prematurity
(ROP) was also completed.
Dupixent® (dupilumab)
- The Company and Sanofi announced 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. The trial
showed that adding Dupixent to standard-of-care antihistamines
significantly reduced itch and hives for biologic-naive patients,
compared to antihistamines alone in the first of two trials of this
clinical program.
- In June 2021, the U.S. Food and
Drug Administration (FDA) approved a 200 mg single-dose pre-filled
pen for Dupixent.
REGEN-COVTM (casirivimab and
imdevimab)(2), a dual antibody cocktail to SARS-CoV-2
virus
- In the second quarter of 2021, the Company fulfilled its second
agreement with the U.S. government to manufacture and deliver 1.25
million doses of REGEN-COV at the lowest treatment dose authorized
by the FDA, and recognized $2.59
billion of REGEN-COV sales.
- In June 2021, the FDA updated the
REGEN-COV EUA by lowering the dose to 1,200 mg and permitting
administration by subcutaneous injection when intravenous infusion
is not feasible.
- In July 2021, based on positive
Phase 3 data announced in April 2021
which were recently published in the New England Journal of
Medicine, the FDA also expanded the EUA to include
post-exposure prophylaxis in people at high risk for progression to
severe COVID-19, who are not fully vaccinated or are not expected
to mount an adequate response to vaccination, and who have been
exposed to a SARS-CoV-2 infected individual or are at high risk of
exposure to an infected individual because of infection occurring
in the same institutional setting (such as in nursing homes or
prisons). For people who are not expected to mount an adequate
immune response to vaccination, REGEN-COV can also now be
administered monthly for the duration of ongoing exposure to
SARS-CoV-2.
- In July 2021, Japan's Ministry of Health, Labour and Welfare
(MHLW) approved the casirivimab and imdevimab antibody cocktail to
treat patients with mild to moderate COVID-19, making Japan the first country to grant a full
approval for the antibody cocktail.
- Positive results were announced from the Phase 3 UK-based
RECOVERY trial in hospitalized COVID-19 patients, demonstrating
that adding REGEN-COV to usual care reduced the risk of death by
20% in seronegative patients (patients who had not mounted a
natural antibody response on their own against SARS-CoV-2),
compared to seronegative patients receiving usual care alone. The
Company has requested that the EUA be further expanded to include
appropriate hospitalized patients.
Libtayo® (cemiplimab)
- In June 2021, the European
Commission (EC) approved Libtayo for the first-line treatment of
patients with advanced non-small cell lung cancer (NSCLC).
- In June 2021, the EC also
approved Libtayo for the treatment of metastatic or locally
advanced basal cell carcinoma (BCC).
- In August 2021, the Company and
Sanofi announced that the Phase 3 trial of Libtayo in combination
with platinum-doublet chemotherapy was stopped early after meeting
its overall survival primary endpoint in patients with advanced
NSCLC. These data are planned to form the basis of regulatory
submissions in the United States
and European Union (EU).
Odronextamab, a CD20xCD3 bispecific antibody
- The Company is resuming enrollment of patients with follicular
lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL), following
amendment of trial protocols and the FDA's lifting of the partial
clinical hold, in its monotherapy trials of odronextamab.
Fianlimab, an antibody to LAG-3
- Positive data from the Phase 1 trial in combination with
Libtayo in advanced melanoma were presented at the American Society
of Clinical Oncology (ASCO) Annual Meeting; the Company intends to
initiate a Phase 3 study in 2022.
REGN1908-1909, a multi-antibody therapy to Fel d 1
- The Company initiated a Phase 3 study in cat allergic
asthmatics.
Genetics Medicines
- Intellia Therapeutics, Inc. and the Company announced positive
interim data from the Phase 1 study of NTLA-2001, a CRISPR/Cas9
therapeutic for TTR gene knockout in people living with
hereditary transthyretin amyloidosis with polyneuropathy
(ATTRv-PN). These are the first-ever clinical data supporting
safety and efficacy of in vivo CRISPR genome editing in
humans and provide proof of concept for the ongoing multi-target
collaboration between the companies.
- The Regeneron Genetics Center published their discovery of
GPR75 gene mutations that protect against obesity. This
target is the focus of a small molecule collaboration agreement
with AstraZeneca announced in July
2021, under which the companies will equally share research
and development costs and any potential future profits.
Corporate Updates
The Company intends to invest approximately $1.8 billion over six years to expand its
research, preclinical manufacturing, and support facilities at the
Company's Tarrytown, New York
campus.
Second Quarter 2021 Financial Results
Revenues
Total revenues increased by 163% to $5.139 billion in the second quarter of 2021,
compared to $1.952 billion in the
second 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 Roche's sales of casirivimab
and imdevimab outside the United
States, increased by 22% to $2.379
billion in the second quarter of 2021, compared to the
second quarter of 2020(1).
Net product sales recorded by the Company consist of the
following:
($ in
millions)
|
|
Q2
2021
|
|
Q2
2020
|
EYLEA
|
|
$
|
1,425
|
|
|
$
|
1,114
|
|
Libtayo
|
|
78
|
|
|
63
|
|
Praluent®
|
|
42
|
|
|
47
|
|
REGEN-COV
|
|
2,591
|
|
|
—
|
|
Evkeeza®
|
|
2
|
|
|
—
|
|
ARCALYST®
|
|
—
|
*
|
|
3
|
|
Total net product
sales in the U.S.
|
|
$
|
4,138
|
|
|
$
|
1,227
|
|
|
* 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.
|
Net product sales of EYLEA in the
United States increased in the second quarter of 2021,
compared to the second quarter of 2020, primarily due to higher
sales volume as well as a favorable comparison given the adverse
impact of the COVID-19 pandemic on U.S. EYLEA demand during the
second quarter of 2020.
The Company fulfilled its second agreement with the U.S.
government and delivered 1.25 million doses of REGEN-COV. Other
than $34 million of expected
REGEN-COV net product sales in the third quarter of 2021 related to
this agreement, the Company does not anticipate recording any
additional net product sales of REGEN-COV in the United States during the third quarter of
2021. U.S. net product sales of REGEN-COV in the fourth quarter of
2021 will be dependent upon acceleration of COVID-19 cases and
related drug utilization.
Total revenues also include collaboration
revenues(3) of $955 million in the second quarter of 2021,
compared to $513 million in the
second quarter of 2020. Sanofi collaboration revenue increased
primarily due to the Company's share of profits from
commercialization of antibodies, which were $328 million in the second quarter of 2021,
compared to $172 million in the
second quarter of 2020. The change in the Company's share of
profits from commercialization of antibodies was driven by higher
Dupixent profits. In the second quarter of 2021, the Company also
recorded Roche collaboration revenue of $168
million in connection with the Company's share of gross
profits from Roche's sales of the casirivimab and imdevimab
antibody cocktail outside the United
States.
Refer to Table 4 for a summary of collaboration revenue.
Other revenue decreased in the second quarter of 2021, compared
to the second quarter of 2020, primarily due to lower amounts
recognized in connection with the Company's agreements with the
Biomedical Advanced Research Development Authority (BARDA) related
to funding of certain development activities for antibodies for the
treatment of COVID-19.
Operating Expenses
|
|
GAAP
|
|
%
Change
|
|
Non-GAAP(1)
|
|
%
Change
|
($ in
millions)
|
|
Q2
2021
|
|
Q2
2020
|
|
|
Q2
2021
|
|
Q2
2020
|
|
Research and
development (R&D)
|
|
$
|
714
|
|
|
$
|
722
|
|
|
(1%)
|
|
$
|
643
|
|
|
$
|
580
|
|
|
11%
|
Selling, general, and
administrative (SG&A)
|
|
$
|
415
|
|
|
$
|
348
|
|
|
19%
|
|
$
|
365
|
|
|
$
|
301
|
|
|
21%
|
Cost of goods sold
(COGS)
|
|
$
|
539
|
|
|
$
|
103
|
|
|
423%
|
|
$
|
514
|
|
|
$
|
93
|
|
|
453%
|
Cost of collaboration
and contract manufacturing (COCM)
|
|
$
|
154
|
|
|
$
|
173
|
|
|
(11%)
|
|
*
|
|
|
*
|
|
|
n/a
|
Other operating
(income) expense, net
|
|
$
|
(31)
|
|
|
$
|
(50)
|
|
|
(38%)
|
|
*
|
|
|
*
|
|
|
n/a
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* GAAP and
non-GAAP amounts are equivalent as no non-GAAP adjustments have
been recorded
|
- GAAP R&D expenses in the second quarter of 2020 included
$85 million in up-front payments in
connection with the collaboration agreement with Intellia. The
decrease in GAAP R&D expenses in the second quarter of 2021 was
offset primarily by higher costs incurred in connection with
development activities related to REGEN-COV, which also drove the
increase in non-GAAP R&D expenses.
- The increase in GAAP and non-GAAP SG&A expenses in the
second quarter of 2021 was primarily due to higher
headcount-related costs, an increase in commercialization-related
expenses for EYLEA and Libtayo, and costs associated with
educational campaigns related to COVID-19.
- The increase in COGS in the second quarter of 2021 was
primarily due to the recognition of manufacturing costs in
connection with product sales of REGEN-COV in the United States. In addition, the Company
recognized higher inventory write-offs and reserves in the second
quarter of 2021, compared to the second quarter of 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 unrealized and realized gains on equity securities of
$409 million in the second
quarter of 2021, compared to $228
million in the second quarter of 2020.
In the second quarter of 2021, the Company's GAAP effective tax
rate was 17.4%, compared to 2.4% in the second quarter of 2020. The
increase in the second quarter 2021 GAAP effective tax rate,
compared to the second quarter of 2020, was primarily due to the
significant positive impact of stock-based compensation in the
second quarter of 2020. In the second quarter of 2021, the non-GAAP
effective tax rate was 17.0%, compared to 0.9% in the second
quarter of 2020.
GAAP net income per diluted share was $27.97 in the second quarter of 2021, compared to
GAAP net income per diluted share of $7.61 in the second quarter of 2020. Non-GAAP net
income per diluted share was $25.80
in the second quarter of 2021, compared to non-GAAP net income per
diluted share of $7.16 in the second
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 half of
2021 was $1.295 billion, compared to
$1.641 billion in the first half of
2020, resulting in $1.031 billion in
free cash flow for the first half of 2021, compared to $1.341 billion for the first half of 2020. The
Company expects a significant increase in free cash flow in the
third quarter of 2021 as the Company collected all amounts due from
the U.S. government in connection with second quarter 2021
REGEN-COV sales in July 2021.
2021 Financial
Guidance(4)
The Company's full year 2021 financial guidance consists of the
following components:
|
|
GAAP
|
|
Non-GAAP(1)
|
R&D
|
|
$2.950 billion–$3.075
billion
(previously $3.000
billion–
$3.175 billion)
|
|
$2.650 billion–$2.750
billion
(previously $2.700
billion–
$2.850 billion)
|
SG&A
|
|
$1.730 billion–$1.830
billion
(previously $1.690 billion–
$1.840 billion)
|
|
$1.540 billion–$1.620
billion
(previously $1.500
billion–
$1.630 billion)
|
Gross margin on net
product sales(5)
|
|
87–88%
(previously
86–88%)
|
|
88–89%
(previously
87–89%)
|
COCM(6)
|
|
$630 million–$680
million
(previously $660 million–
$730 million)
|
|
*
|
Other operating
(income) expense, net
|
|
($135) million–($155)
million
(previously ($150)
million–
($175) million)
|
|
*
|
Capital
expenditures
|
|
$590 million–$640
million
(previously $585 million–
$650 million)
|
|
*
|
Effective tax rate
(ETR)
|
|
14–16%
(previously
12–14%)
|
|
14–16%
(previously
13–15%)
|
|
|
|
|
|
* GAAP and
non-GAAP amounts are equivalent as no non-GAAP adjustments have
been or are expected to be recorded.
|
A reconciliation of full year 2021 GAAP to Non-GAAP financial
guidance is included below:
|
|
Projected
Range
|
($ in
millions)
|
|
Low
|
|
High
|
GAAP
R&D
|
|
$
|
2,950
|
|
|
$
|
3,075
|
|
R&D: Non-cash
share-based compensation expense
|
|
(300)
|
|
|
(325)
|
|
Non-GAAP
R&D
|
|
$
|
2,650
|
|
|
$
|
2,750
|
|
|
|
|
|
|
GAAP
SG&A
|
|
$
|
1,730
|
|
|
$
|
1,830
|
|
SG&A: Non-cash
share-based compensation expense
|
|
(190)
|
|
|
(210)
|
|
Non-GAAP
SG&A
|
|
$
|
1,540
|
|
|
$
|
1,620
|
|
|
|
|
|
|
GAAP gross margin on
net product sales
|
|
87%
|
|
|
88%
|
|
Non-cash share-based
compensation expense
|
|
1%
|
|
|
1%
|
|
Non-GAAP gross margin
on net product sales
|
|
88%
|
|
|
89%
|
|
|
|
|
|
|
GAAP ETR
|
|
14%
|
|
|
16%
|
|
Income tax effect of
GAAP to non-GAAP reconciling items and other
|
|
< 1%
|
|
|
< 1%
|
|
Non-GAAP
ETR
|
|
14%
|
|
|
16%
|
|
|
(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)
|
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. The Company records its share of gross
profits from global sales within collaboration revenue.
|
|
|
(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 second quarter 2021 financial and operating results
on Thursday, August 5, 2021, at 8:30 AM
Eastern Time. To access this call, dial (888) 660-6127
(U.S.) or (973) 890-8355 (International), conference ID 9098036. 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), Evkeeza®
(evinacumab), InmazebTM (atoltivimab, maftivimab,
and odesivimab-ebgn), fasinumab,
REGEN-COVTM (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), 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 June 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
|
|
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)
|
|
|
|
June
30,
|
|
December
31,
|
|
|
2021
|
|
2020
|
Assets:
|
|
|
|
|
Cash and marketable
securities
|
|
$
|
7,811.1
|
|
|
$
|
6,722.6
|
|
Accounts receivable,
net
|
|
6,998.6
|
|
|
4,114.7
|
|
Inventories
|
|
1,983.9
|
|
|
1,916.6
|
|
Property, plant, and
equipment, net
|
|
3,358.5
|
|
|
3,221.6
|
|
Deferred tax
assets
|
|
746.6
|
|
|
858.9
|
|
Other
assets
|
|
587.2
|
|
|
328.9
|
|
Total
assets
|
|
$
|
21,485.9
|
|
|
$
|
17,163.3
|
|
|
|
|
|
|
Liabilities and
stockholders' equity:
|
|
|
|
|
Accounts payable,
accrued expenses, and other liabilities
|
|
$
|
3,090.3
|
|
|
$
|
2,806.8
|
|
Finance lease
liabilities
|
|
718.4
|
|
|
717.2
|
|
Deferred
revenue
|
|
570.7
|
|
|
635.5
|
|
Long-term
debt
|
|
1,979.2
|
|
|
1,978.5
|
|
Stockholders'
equity
|
|
15,127.3
|
|
|
11,025.3
|
|
Total liabilities and
stockholders' equity
|
|
$
|
21,485.9
|
|
|
$
|
17,163.3
|
|
TABLE 2
REGENERON
PHARMACEUTICALS, INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
|
(In millions,
except per share data)
|
|
|
|
Three Months
Ended
June
30,
|
|
Six Months
Ended
June
30,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product
sales
|
|
$
|
4,137.8
|
|
|
$
|
1,226.9
|
|
|
$
|
5,862.1
|
|
|
$
|
2,463.6
|
|
Collaboration
revenue
|
|
954.7
|
|
|
513.3
|
|
|
1,709.1
|
|
|
1,041.6
|
|
Other
revenue
|
|
46.0
|
|
|
211.8
|
|
|
96.0
|
|
|
275.0
|
|
|
|
5,138.5
|
|
|
1,952.0
|
|
|
7,667.2
|
|
|
3,780.2
|
|
Expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
714.2
|
|
|
722.0
|
|
|
1,457.1
|
|
|
1,305.9
|
|
Selling, general, and
administrative
|
|
414.7
|
|
|
348.3
|
|
|
820.3
|
|
|
715.6
|
|
Cost of goods
sold
|
|
539.4
|
|
|
102.5
|
|
|
722.6
|
|
|
181.3
|
|
Cost of collaboration
and contract manufacturing
|
|
154.3
|
|
|
173.0
|
|
|
279.1
|
|
|
311.5
|
|
Other operating
(income) expense, net
|
|
(31.3)
|
|
|
(50.2)
|
|
|
(71.8)
|
|
|
(90.6)
|
|
|
|
1,791.3
|
|
|
1,295.6
|
|
|
3,207.3
|
|
|
2,423.7
|
|
|
|
|
|
|
|
|
|
|
Income from
operations
|
|
3,347.2
|
|
|
656.4
|
|
|
4,459.9
|
|
|
1,356.5
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Other income
(expense), net
|
|
420.0
|
|
|
272.2
|
|
|
574.9
|
|
|
246.8
|
|
Interest
expense
|
|
(14.4)
|
|
|
(9.7)
|
|
|
(29.0)
|
|
|
(15.8)
|
|
|
|
405.6
|
|
|
262.5
|
|
|
545.9
|
|
|
231.0
|
|
|
|
|
|
|
|
|
|
|
Income before income
taxes
|
|
3,752.8
|
|
|
918.9
|
|
|
5,005.8
|
|
|
1,587.5
|
|
|
|
|
|
|
|
|
|
|
Income tax
expense
|
|
653.9
|
|
|
21.6
|
|
|
791.7
|
|
|
65.6
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
3,098.9
|
|
|
$
|
897.3
|
|
|
$
|
4,214.1
|
|
|
$
|
1,521.9
|
|
|
|
|
|
|
|
|
|
|
Net income per share
- basic
|
|
$
|
29.51
|
|
|
$
|
8.19
|
|
|
$
|
40.06
|
|
|
$
|
13.87
|
|
Net income per share
- diluted
|
|
$
|
27.97
|
|
|
$
|
7.61
|
|
|
$
|
38.07
|
|
|
$
|
13.03
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding - basic
|
|
105.0
|
|
|
109.6
|
|
|
105.2
|
|
|
109.7
|
|
Weighted average
shares outstanding - diluted
|
|
110.8
|
|
|
117.9
|
|
|
110.7
|
|
|
116.8
|
|
TABLE 3
REGENERON
PHARMACEUTICALS, INC.
|
RECONCILIATION OF
GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited)
|
(In millions,
except per share data)
|
|
|
|
Three Months
Ended
June
30,
|
|
Six Months
Ended
June
30,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
GAAP
R&D
|
|
$
|
714.2
|
|
|
$
|
722.0
|
|
|
$
|
1,457.1
|
|
|
$
|
1,305.9
|
|
R&D: Non-cash
share-based compensation expense
|
|
70.9
|
|
|
56.9
|
|
|
140.6
|
|
|
113.6
|
|
R&D: Up-front
payments related to license and collaboration agreements
|
|
—
|
|
|
85.0
|
|
|
—
|
|
|
85.0
|
|
Non-GAAP
R&D
|
|
$
|
643.3
|
|
|
$
|
580.1
|
|
|
$
|
1,316.5
|
|
|
$
|
1,107.3
|
|
|
|
|
|
|
|
|
|
|
GAAP
SG&A
|
|
$
|
414.7
|
|
|
$
|
348.3
|
|
|
$
|
820.3
|
|
|
$
|
715.6
|
|
SG&A: Non-cash
share-based compensation expense
|
|
49.6
|
|
|
38.2
|
|
|
100.4
|
|
|
78.5
|
|
SG&A: Litigation
contingencies and other
|
|
—
|
|
|
8.7
|
|
|
—
|
|
|
28.9
|
|
Non-GAAP
SG&A
|
|
$
|
365.1
|
|
|
$
|
301.4
|
|
|
$
|
719.9
|
|
|
$
|
608.2
|
|
|
|
|
|
|
|
|
|
|
GAAP COGS
|
|
$
|
539.4
|
|
|
$
|
102.5
|
|
|
$
|
722.6
|
|
|
$
|
181.3
|
|
COGS: Non-cash
share-based compensation expense
|
|
25.0
|
|
|
8.4
|
|
|
35.4
|
|
|
17.2
|
|
COGS: Other
|
|
—
|
|
|
0.9
|
|
|
—
|
|
|
0.9
|
|
Non-GAAP
COGS
|
|
$
|
514.4
|
|
|
$
|
93.2
|
|
|
$
|
687.2
|
|
|
$
|
163.2
|
|
|
|
|
|
|
|
|
|
|
GAAP other income
(expense), net
|
|
$
|
405.6
|
|
|
$
|
262.5
|
|
|
$
|
545.9
|
|
|
$
|
231.0
|
|
Other income/expense:
Gains on investments
|
|
(409.6)
|
|
|
(256.1)
|
|
|
(553.9)
|
|
|
(199.3)
|
|
Interest expense:
Other
|
|
—
|
|
|
1.5
|
|
|
—
|
|
|
1.5
|
|
Non-GAAP other income
(expense), net
|
|
$
|
(4.0)
|
|
|
$
|
7.9
|
|
|
$
|
(8.0)
|
|
|
$
|
33.2
|
|
|
|
|
|
|
|
|
|
|
GAAP net
income
|
|
$
|
3,098.9
|
|
|
$
|
897.3
|
|
|
$
|
4,214.1
|
|
|
$
|
1,521.9
|
|
Total of GAAP to
non-GAAP reconciling items above
|
|
(264.1)
|
|
|
(56.5)
|
|
|
(277.5)
|
|
|
126.3
|
|
Income tax effect of
GAAP to non-GAAP reconciling items
|
|
60.2
|
|
|
13.6
|
|
|
67.6
|
|
|
(23.2)
|
|
Non-GAAP net
income
|
|
$
|
2,895.0
|
|
|
$
|
854.4
|
|
|
$
|
4,004.2
|
|
|
$
|
1,625.0
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
$
|
27.57
|
|
|
$
|
7.80
|
|
|
$
|
38.06
|
|
|
$
|
14.81
|
|
Non-GAAP net income
per share - diluted
|
|
$
|
25.80
|
|
|
$
|
7.16
|
|
|
$
|
35.72
|
|
|
$
|
13.70
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating:
|
|
|
|
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
105.0
|
|
|
109.6
|
|
|
105.2
|
|
|
109.7
|
|
Non-GAAP net income
per share - diluted
|
|
112.2
|
|
|
119.3
|
|
|
112.1
|
|
|
118.6
|
|
|
|
|
|
|
|
|
|
|
Effective tax rate
reconciliation:
|
|
|
|
|
|
|
|
|
GAAP effective tax
rate
|
|
17.4%
|
|
|
2.4%
|
|
|
15.8%
|
|
|
4.1%
|
|
Income tax effect of
GAAP to non-GAAP reconciling items
|
|
(0.4%)
|
|
|
(1.5%)
|
|
|
(0.5%)
|
|
|
1.1%
|
|
Non-GAAP effective
tax rate
|
|
17.0%
|
|
|
0.9%
|
|
|
15.3%
|
|
|
5.2%
|
|
|
|
|
|
|
|
|
|
|
|
Free cash flow
reconciliation:
|
|
|
|
|
|
|
|
|
Net cash provided by
operating activities
|
|
$
|
626.7
|
|
|
$
|
943.4
|
|
|
$
|
1,295.2
|
|
|
$
|
1,641.4
|
|
Capital
expenditures
|
|
(148.5)
|
|
|
(129.9)
|
|
|
(263.8)
|
|
|
(300.0)
|
|
Free cash
flow
|
|
$
|
478.2
|
|
|
$
|
813.5
|
|
|
$
|
1,031.4
|
|
|
$
|
1,341.4
|
|
TABLE 4
REGENERON
PHARMACEUTICALS, INC.
|
COLLABORATION
REVENUE (Unaudited)
|
(In
millions)
|
|
|
|
Three Months
Ended
June
30,
|
|
Six Months
Ended
June
30,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Sanofi
collaboration revenue:
|
|
|
|
|
|
|
|
|
Antibody:
|
|
|
|
|
|
|
|
|
Regeneron's share of
profits in connection with commercialization of
antibodies
|
|
$
|
327.6
|
|
|
$
|
171.9
|
|
|
$
|
588.2
|
|
|
$
|
342.8
|
|
Reimbursement for
manufacturing of commercial supplies
|
|
110.9
|
|
|
100.6
|
|
|
216.5
|
|
|
180.7
|
|
Immuno-oncology:
|
|
|
|
|
|
|
|
|
Regeneron's share of
losses in connection with commercialization of Libtayo outside the
United States
|
|
(3.5)
|
|
|
(6.4)
|
|
|
(9.6)
|
|
|
(12.6)
|
|
Reimbursement for
manufacturing of commercial supplies
|
|
2.7
|
|
|
3.0
|
|
|
7.4
|
|
|
5.1
|
|
Total Sanofi
collaboration revenue
|
|
437.7
|
|
|
269.1
|
|
|
802.5
|
|
|
516.0
|
|
|
|
|
|
|
|
|
|
|
Bayer
collaboration revenue:
|
|
|
|
|
|
|
|
|
Regeneron's net profit
in connection with commercialization of EYLEA outside the United
States
|
|
335.4
|
|
|
230.9
|
|
|
644.3
|
|
|
484.7
|
|
Reimbursement for
manufacturing of commercial supplies
|
|
13.7
|
|
|
13.3
|
|
|
27.6
|
|
|
40.9
|
|
Total Bayer
collaboration revenue
|
|
349.1
|
|
|
244.2
|
|
|
671.9
|
|
|
525.6
|
|
|
|
|
|
|
|
|
|
|
Roche
collaboration revenue:
|
|
|
|
|
|
|
|
|
Regeneron's share of
gross profits in connection with sales of casirivimab and
imdevimab
|
|
167.9
|
|
|
—
|
|
|
234.7
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
Total collaboration
revenue
|
|
$
|
954.7
|
|
|
$
|
513.3
|
|
|
$
|
1,709.1
|
|
|
$
|
1,041.6
|
|
TABLE 5
REGENERON
PHARMACEUTICALS, INC.
|
NET PRODUCT SALES
OF REGENERON-DISCOVERED PRODUCTS (Unaudited)
|
(In
millions)
|
|
|
|
Three Months
Ended
June
30,
|
|
|
|
|
2021
|
|
2020
|
|
%
Change
|
|
|
U.S.
|
|
ROW
|
|
Total
|
|
U.S.
|
|
ROW
|
|
Total
|
|
(Total
Sales)
|
EYLEA(a)
|
|
$
|
1,424.7
|
|
|
$
|
903.8
|
|
|
$
|
2,328.5
|
|
|
$
|
1,113.7
|
|
|
$
|
641.0
|
|
|
$
|
1,754.7
|
|
|
33
|
%
|
Dupixent(b)
|
|
$
|
1,146.6
|
|
|
$
|
352.4
|
|
|
$
|
1,499.0
|
|
|
$
|
770.4
|
|
|
$
|
174.6
|
|
|
$
|
945.0
|
|
|
59
|
%
|
Libtayo(c)
|
|
$
|
78.0
|
|
|
$
|
38.9
|
|
|
$
|
116.9
|
|
|
$
|
63.3
|
|
|
$
|
16.7
|
|
|
$
|
80.0
|
|
|
46
|
%
|
Praluent(d)
|
|
$
|
41.9
|
|
|
$
|
57.5
|
|
|
$
|
99.4
|
|
|
$
|
47.2
|
|
|
$
|
39.4
|
|
|
$
|
86.6
|
|
|
15
|
%
|
REGEN-COV(e)
|
|
$
|
2,591.2
|
|
|
$
|
470.2
|
|
|
$
|
3,061.4
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(h)
|
Kevzara(b)
|
|
$
|
30.7
|
|
|
$
|
36.0
|
|
|
$
|
66.7
|
|
|
$
|
36.5
|
|
|
$
|
31.8
|
|
|
$
|
68.3
|
|
|
(2)
|
%
|
Evkeeza(f)
|
|
$
|
2.0
|
|
|
—
|
|
|
$
|
2.0
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(h)
|
ARCALYST(g)
|
|
$
|
7.7
|
|
|
—
|
|
|
$
|
7.7
|
|
|
$
|
2.7
|
|
|
—
|
|
|
$
|
2.7
|
|
|
185
|
%
|
ZALTRAP(b)
|
|
$
|
1.3
|
|
|
$
|
22.2
|
|
|
$
|
23.5
|
|
|
$
|
1.7
|
|
|
$
|
25.0
|
|
|
$
|
26.7
|
|
|
(12)
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months
Ended
June
30,
|
|
|
|
|
2021
|
|
2020
|
|
%
Change
|
|
|
U.S.
|
|
ROW
|
|
Total
|
|
U.S.
|
|
ROW
|
|
Total
|
|
(Total
Sales)
|
EYLEA(a)
|
|
$
|
2,771.7
|
|
|
$
|
1,728.1
|
|
|
$
|
4,499.8
|
|
|
$
|
2,285.7
|
|
|
$
|
1,322.7
|
|
|
$
|
3,608.4
|
|
|
25
|
%
|
Dupixent(b)
|
|
$
|
2,108.1
|
|
|
$
|
653.8
|
|
|
$
|
2,761.9
|
|
|
$
|
1,449.4
|
|
|
$
|
350.8
|
|
|
$
|
1,800.2
|
|
|
53
|
%
|
Libtayo(c)
|
|
$
|
147.1
|
|
|
$
|
70.6
|
|
|
$
|
217.7
|
|
|
$
|
125.0
|
|
|
$
|
29.8
|
|
|
$
|
154.8
|
|
|
41
|
%
|
Praluent(d)
|
|
$
|
85.2
|
|
|
$
|
118.8
|
|
|
$
|
204.0
|
|
|
$
|
82.3
|
|
|
$
|
84.1
|
|
|
$
|
166.4
|
|
|
23
|
%
|
REGEN-COV(e)
|
|
$
|
2,853.4
|
|
|
$
|
654.4
|
|
|
$
|
3,507.8
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(h)
|
Kevzara(b)
|
|
$
|
61.4
|
|
|
$
|
74.4
|
|
|
$
|
135.8
|
|
|
$
|
71.8
|
|
|
$
|
56.6
|
|
|
$
|
128.4
|
|
|
6
|
%
|
Evkeeza(f)
|
|
$
|
2.5
|
|
|
—
|
|
|
$
|
2.5
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(h)
|
ARCALYST(g)
|
|
$
|
9.9
|
|
|
—
|
|
|
$
|
9.9
|
|
|
$
|
5.7
|
|
|
—
|
|
|
$
|
5.7
|
|
|
74
|
%
|
ZALTRAP(b)
|
|
$
|
2.7
|
|
|
$
|
45.2
|
|
|
$
|
47.9
|
|
|
$
|
3.2
|
|
|
$
|
51.5
|
|
|
$
|
54.7
|
|
|
(12)
|
%
|
|
(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-second-quarter-2021-financial-and-operating-results-301348930.html
SOURCE Regeneron Pharmaceuticals