TARRYTOWN, N.Y., Feb. 4, 2022 /PRNewswire/ --
- Fourth quarter 2021 revenues increased 104% to $4.95 billion versus fourth quarter 2020
including $2.30 billion attributable
to REGEN-COV®(2);
revenues excluding REGEN-COV(1) increased
17%
- Full year 2021 revenues increased 89% to $16.07 billion compared to full year 2020
including $6.19 billion attributable
to REGEN-COV(2); revenues excluding
REGEN-COV(1) increased 19%
- Fourth quarter 2021 EYLEA® U.S. net sales
increased 15% to $1.55 billion versus
fourth quarter 2020 and full year 2021 EYLEA U.S. net sales
increased 17% versus 2020
- Fourth quarter 2021 Dupixent® global net
sales(3), which are recorded by Sanofi,
increased 51% to $1.77 billion versus
fourth quarter 2020 and full year 2021 Dupixent global net sales
increased 53% versus 2020
- Fourth quarter 2021 GAAP diluted EPS was $19.69 and non-GAAP diluted
EPS(1) was $23.72
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced financial results for the fourth quarter and full year
2021 and provided a business update.
"In 2021, Regeneron delivered strong results across our core
business with impressive EYLEA and Dupixent growth, while also
helping address the ongoing pandemic by delivering REGEN-COV to
millions of patients," said Leonard S.
Schleifer, M.D., Ph.D., President and Chief Executive
Officer of Regeneron. "For 2022, we remain focused on building on
EYLEA's success, expanding approvals and patient reach for
Dupixent, pursuing new indications for Libtayo, and reading out
data from our oncology pipeline – all while continuing to progress
our diversified earlier-stage pipeline. We also remain committed to
our efforts to fight the COVID-19 pandemic and address the
significant need for effective treatments and preventative
approaches to SARS-CoV-2. Given the lack of efficacy of REGEN-COV
against the Omicron variant, we are working hard to develop next
generation antibodies that are active against Omicron and all other
variants of concern."
Financial Highlights
|
|
Three Months
Ended
December
31,
|
|
|
|
Year
Ended
December
31,
|
|
|
($ in millions,
except per share data)
|
|
2021
|
|
2020
|
|
%
Change
|
|
2021
|
|
2020
|
|
%
Change
|
Total
revenues
|
|
$
4,952
|
|
$
2,423
|
|
104%
|
|
$
16,072
|
|
$
8,497
|
|
89%
|
GAAP net
income
|
|
$
2,229
|
|
$
1,149
|
|
94%
|
|
$
8,075
|
|
$
3,513
|
|
130%
|
GAAP net income per
share - diluted
|
|
$
19.69
|
|
$
10.24
|
|
92%
|
|
$
71.97
|
|
$
30.52
|
|
136%
|
Non-GAAP net
income(1)
|
|
$
2,712
|
|
$
1,080
|
|
151%
|
|
$
8,488
|
|
$
3,666
|
|
132%
|
Non-GAAP net income
per
share - diluted(1)
|
|
$
23.72
|
|
$
9.53
|
|
149%
|
|
$
74.66
|
|
$
31.47
|
|
137%
|
"In 2021, Regeneron delivered solid top- and bottom-line growth
driven by strong execution within our core business," said
Robert E. Landry, Executive Vice
President, Finance and Chief Financial Officer of Regeneron. "With
growth continuing across our existing portfolio and investments in
our R&D engine supported by our strong balance sheet, we are
well positioned for sustainable long-term growth."
Business Highlights
Key Pipeline Progress
Regeneron has over 30 product
candidates in clinical development, including a number of marketed
products for which it is investigating additional indications.
Updates from the clinical pipeline in the fourth quarter of 2021
and 2022 to date include:
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 January 2022, the European Medicines Agency's
Committee for Medicinal Products for Human Use (CHMP) adopted a
positive opinion, recommending to extend the approval of Dupixent
in the European Union (EU) for the treatment of severe asthma in
children aged 6 to 11 years old. A final decision from the European
Commission (EC) regarding the regulatory application is expected in
the coming months.
- The New England Journal of Medicine published positive
results from the Phase 3 trial in children aged 6 to 11 years with
moderate-to-severe asthma.
- A supplemental Biologics License Application (sBLA) for
Dupixent for children aged 6 months to 5 years with
moderate-to-severe atopic dermatitis was submitted. A regulatory
submission is also expected to be completed in the EU in the coming
months.
- In January 2022, the Company and
Sanofi announced positive results from a second Phase 3 trial in
adults with uncontrolled prurigo nodularis. The trial met its
primary and key secondary endpoints, showing that Dupixent
significantly reduced itch and skin lesions compared to placebo at
24 weeks. Regulatory submissions are expected to commence in the
first half of 2022.
Antibodies to SARS-CoV-2 virus
- In the fourth quarter of 2021, the Company completed its final
deliveries of drug product under its agreement with the U.S.
government, delivering an additional 1.1 million doses of
REGEN-COV®, and recognizing $2.30
billion of REGEN-COV sales.
- In November 2021, the European
Commission approved the casirivimab and imdevimab(2)
antibody cocktail for people aged 12 years and older for the
treatment of non-hospitalized patients with confirmed COVID-19 who
do not require oxygen supplementation and who are at increased risk
of progressing to severe COVID-19, and to prevent COVID-19.
- In November 2021, the Company
announced additional positive results from a Phase 3 COVID-19
prevention trial jointly run with the National Institute of Allergy
and Infectious Diseases (NIAID), showing that a single dose of
REGEN-COV reduced the risk of contracting COVID-19 by 81.6% during
the pre-specified follow-up period (months 2–8), maintaining the
previously reported 81.4% risk reduction during the first month
after administration (the primary endpoint).
- Based on laboratory data that showed markedly decreased binding
to the Omicron spike protein, REGEN-COV is highly unlikely to be
active against the Omicron variant. In January 2022, the FDA revised the Emergency Use
Authorization (EUA) for REGEN-COV to exclude its use in geographic
regions where, based on available information including variant
susceptibility and regional variant frequency, infection or
exposure is likely due to a variant such as Omicron (B.1.1.529)
that is not susceptible to the treatment. With this EUA revision,
REGEN-COV is not currently authorized for use in any U.S. states,
territories, or jurisdictions, since Omicron is currently the
dominant variant across the United
States. If, in the future, patients in certain geographic
regions are likely to be infected or exposed to a variant that is
susceptible to REGEN-COV, then the limitation on use may be revised
in these areas.
- The Company continues to progress "next generation" antibodies
that are active against Omicron, Delta (B.1.617.2), and other
variants of concern. Pending regulatory discussions, new
therapeutic candidates could enter clinical development in the
coming months.
Oncology Programs
- The FDA accepted the sBLA for Libtayo® (cemiplimab),
in combination with chemotherapy, to treat patients with advanced
non-small cell lung cancer (NSCLC), with a target action date of
September 19, 2022. A regulatory
application was also submitted in the EU.
- In January 2022, the Company and
Sanofi announced the voluntary withdrawal of the sBLA for Libtayo
as a second-line treatment for patients with advanced cervical
cancer. The decision was made after the companies and the FDA were
not able to align on certain post-marketing studies. Discussions
with regulatory authorities outside of the United States are ongoing.
- In December 2021, the Company
announced results for higher dose level cohorts from the Phase 1
portion of the REGN5458 Phase 1/2 trial in patients with multiple
myeloma, which were presented at the American Society of Hematology
(ASH) Annual Meeting. The results showed a 75% overall response
rate in patients treated with the highest dose levels studied.
REGN5458 is a bispecific antibody targeting BCMA and CD3. The
Company expects to complete enrollment in a potentially pivotal
Phase 2 trial in multiple myeloma in the first quarter of
2022.
- The Company has additional CD3 bispecifics in clinical
development, including a Phase 1 study of REGN4336, a bispecific
antibody targeting PSMA and CD3, which was recently initiated in
prostate cancer.
- The Company has ongoing clinical development for three
costimulatory CD28 bispecifics targeting prostate cancer, ovarian
cancer, and other solid tumors.
- In NSCLC, the Company is in dose expansion for REGN5093, which
is a METxMET bispecific targeting cancers driven by MET mutations
and/or amplifications. The Company is also studying REGN5093-M114,
its first bispecific antibody-drug conjugate, in MET-altered
advanced NSCLC.
Pozelimab
- A Phase 3 study of pozelimab, an antibody to C5, in combination
with Alnylam's cemdisiran, an siRNA therapeutic, in paroxysmal
nocturnal hemoglobinuria (PNH) was initiated.
Business Development Update
- In January 2022, the Company
entered into a license and collaboration agreement for Ultragenyx
Pharmaceutical Inc. to develop and commercialize
Evkeeza® in countries outside of the United States.
Select 2022 Milestones
Programs
|
|
|
|
Milestones
|
Aflibercept 8
mg
|
|
-
|
|
Report results from
Phase 3 studies in neovascular age-related macular degeneration
(wet AMD) and diabetic macular edema (DME)
|
Dupixent
(dupilumab)
|
|
-
|
|
Complete rolling sBLA
submission for eosinophilic esophagitis (EoE) in adults and
adolescents
|
|
|
-
|
|
Report results from
additional Phase 3 study for chronic spontaneous urticaria
(CSU)
|
|
|
-
|
|
FDA decision on sBLA
for children aged 6 months to 5 years with moderate-to-severe
atopic dermatitis
|
Antibodies to
SARS-CoV-2 virus
|
|
-
|
|
FDA decision on BLA
(target action date of April 13, 2022) for COVID-19 treatment
of non-hospitalized patients and prevention
|
|
|
-
|
|
Submit sBLA for
COVID-19 treatment of hospitalized patients
|
|
|
-
|
|
Initiate "next
generation" monoclonal antibody clinical study
|
Libtayo
(cemiplimab)
|
|
-
|
|
FDA decision on sBLA
(target action date of September 19, 2022) and EC decision on
regulatory submission for NSCLC, chemotherapy
combination
|
REGN5458 (BCMA and
CD3
Bispecific Antibody)
|
|
-
|
|
Report results from
potentially pivotal Phase 2 study in multiple
myeloma
|
|
|
-
|
|
Initiate Phase 1 and
Phase 3 studies exploring combinations with
standard of care and additional combination studies
|
Odronextamab (CD20
and CD3 Bispecific Antibody)
|
|
-
|
|
Report additional
results from potentially pivotal Phase 2 study in B-cell
non-Hodgkin lymphoma (B-NHL)
|
|
|
-
|
|
Initiate OLYMPIA
Phase 3 program and additional combination studies
|
Solid Tumor
Bispecific Antibodies
|
|
-
|
|
Report results from
REGN4018 (MUC16 and CD3 bispecific antibody) Phase 1 study in
platinum-resistant ovarian cancer
|
|
|
-
|
|
Report results from
REGN5678 (PSMA and CD28 bispecific antibody) Phase 1 study in
prostate cancer
|
|
|
-
|
|
Report results from
REGN5093 (bispecific antibody targeting two distinct MET epitopes)
Phase 1 study in MET-altered advanced NSCLC
|
Fourth Quarter and Full Year 2021 Financial Results
Revenues
Total revenues increased by 104% to $4.952 billion in the fourth quarter of 2021,
compared to $2.423 billion in the
fourth quarter of 2020. Full year 2021 total revenues increased 89%
to $16.072 billion, compared to
$8.497 billion for the full year
2020. Total revenues excluding (i) REGEN-COV (casirivimab and
imdevimab) net product sales in the
United States and (ii) true-up payments recorded to
collaboration revenue in connection with global gross profits from
sales of the casirivimab and imdevimab antibody cocktail pursuant
to the Roche collaboration agreement, increased by 17% to
$2.654 billion in the fourth quarter
of 2021, compared to the fourth quarter of 2020, and increased by
19% to $9.882 billion for the full
year 2021, compared to the full year 2020(1).
Net product sales recorded by the Company consist of the
following:
($ in
millions)
|
|
Q4
2021
|
|
Q4
2020
|
|
%
Change
|
|
FY
2021
|
|
FY
2020
|
|
%
Change
|
EYLEA®
|
|
$
1,547
|
|
$
1,343
|
|
15%
|
|
$
5,792
|
|
$
4,947
|
|
17%
|
Libtayo
|
|
81
|
|
74
|
|
9%
|
|
306
|
|
271
|
|
13%
|
Praluent®
|
|
40
|
|
55
|
|
(27%)
|
|
170
|
|
151
|
|
13%
|
REGEN-COV
|
|
2,298
|
|
146
|
|
**
|
|
5,828
|
|
186
|
|
**
|
Evkeeza
|
|
9
|
|
—
|
|
**
|
|
19
|
|
—
|
|
**
|
ARCALYST®
|
|
— *
|
|
4
|
|
**
|
|
2 *
|
|
13
|
|
**
|
Total net product
sales in
the U.S.
|
|
$
3,975
|
|
$
1,622
|
|
145%
|
|
$
12,117
|
|
$
5,568
|
|
118%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* 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 fourth quarter of 2021, the Company completed its
final deliveries of REGEN-COV under its agreement with the U.S.
government.
Total revenues also include collaboration
revenues(3) of $890 million in the fourth quarter and
$3.673 billion for the full year
2021, compared to $678 million in the
fourth quarter and $2.373 billion for
the full year 2020. Sanofi collaboration revenue increased
primarily due to the Company's share of profits from
commercialization of antibodies, which were $388 million and $1.363
billion in the fourth quarter and full year 2021,
respectively, compared to $230
million and $785 million in
the fourth quarter and full year 2020, respectively. The change in
the Company's share of profits from commercialization of antibodies
was driven by higher Dupixent profits. The Company also recorded
Roche collaboration revenue of $362
million for the full year 2021 in connection with the
true-up payment from Roche attributable to global gross profits
from sales of the casirivimab and imdevimab antibody
cocktail. No Roche collaboration revenue was recorded during
the fourth quarter of 2021, as the Company owed a true-up payment
to Roche in connection with global gross profits from sales of the
antibody cocktail, which was recorded to Cost of goods sold.
Refer to Table 4 for a summary of collaboration revenue.
Other revenue decreased in the fourth quarter and full year of
2021, compared to the same periods of 2020, primarily due to lower
amounts recognized in connection with the Company's agreement with
the Biomedical Advanced Research Development Authority (BARDA)
related to funding of certain development activities for COVID-19
antibodies.
Operating Expenses
|
|
GAAP
|
|
%
Change
|
|
Non-GAAP(1)
|
|
%
Change
|
($ in
millions)
|
|
Q4
2021
|
|
Q4
2020
|
|
|
Q4
2021
|
|
Q4
2020
|
|
Research and
development (R&D)
|
|
$
786
|
|
$
745
|
|
6%
|
|
$
639
|
|
$
675
|
|
(5%)
|
Selling, general, and
administrative
(SG&A)
|
|
$
560
|
|
$
304
|
|
84%
|
|
$
495
|
|
$
381
|
|
30%
|
Cost of goods sold
(COGS)
|
|
$
812
|
|
$
180
|
|
351%
|
|
$
559
|
|
$
166
|
|
237%
|
Cost of collaboration
and contract
manufacturing (COCM)
|
|
$
171
|
|
$
174
|
|
(2%)
|
|
*
|
|
*
|
|
n/a
|
Other operating
(income) expense, net
|
|
$
(16)
|
|
$
(145)
|
|
(89%)
|
|
*
|
|
*
|
|
n/a
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* GAAP and
non-GAAP amounts are equivalent as no non-GAAP adjustments have
been recorded.
|
|
|
GAAP
|
|
%
Change
|
|
Non-GAAP(1)
|
|
%
Change
|
($ in
millions)
|
|
FY
2021
|
|
FY
2020
|
|
|
FY
2021
|
|
FY
2020
|
|
Research and
development
|
|
$
2,908
|
|
$
2,735
|
|
6%
|
|
$
2,548
|
|
$
2,411
|
|
6%
|
Selling, general, and
administrative
|
|
$
1,825
|
|
$
1,346
|
|
36%
|
|
$
1,606
|
|
$
1,280
|
|
25%
|
Cost of goods
sold
|
|
$
1,773
|
|
$
492
|
|
260%
|
|
$
1,470
|
|
$
451
|
|
226%
|
Cost of collaboration
and contract
manufacturing
|
|
$
664
|
|
$
628
|
|
6%
|
|
*
|
|
*
|
|
n/a
|
Other operating
(income) expense,
net
|
|
$
(46)
|
|
$
(280)
|
|
(84%)
|
|
*
|
|
*
|
|
n/a
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* GAAP and
non-GAAP amounts are equivalent as no non-GAAP adjustments have
been recorded.
|
- GAAP and non-GAAP R&D expenses in the fourth quarter of
2021, compared to the fourth quarter of 2020, included lower costs
incurred in connection with REGEN-COV development activities,
additional costs incurred in connection with the Company's
earlier-stage pipeline, higher headcount and headcount-related
costs, and an increase in clinical manufacturing activities.
Non-GAAP R&D expenses in the fourth quarter of 2021 excluded
$44 million of aggregate up-front
payments, primarily in connection with the collaboration agreement
with Nykode Therapeutics.
- GAAP and non-GAAP R&D expenses for full year 2021, compared
to full year 2020, included higher headcount and headcount related
costs, an increase in facilities-related expenses, and lower costs
incurred in connection with development activities for fasinumab
and Kevzara (for the treatment of COVID-19). Non-GAAP R&D
expenses for full year 2020 excluded $85
million of up-front payments in connection with the Intellia
collaboration agreement.
- The increase in GAAP and non-GAAP SG&A expenses in the
fourth quarter and full year 2021, compared to the same periods in
the prior year, was primarily due to an increase in
commercialization-related expenses for EYLEA, including
direct-to-consumer advertising, educational campaigns related to
COVID-19, and higher headcount-related costs. Non-GAAP SG&A
expenses in the fourth quarter and full year 2020 excluded the
reversal of accruals for Praluent litigation-related loss
contingencies.
- The increase in GAAP and non-GAAP COGS in the fourth quarter
and full year 2021, compared to the same periods in the prior year,
was primarily due to the recognition of manufacturing costs in
connection with product sales of REGEN-COV in the United States, in addition to a
$260 million fourth quarter 2021
true-up payment owed to Roche in connection with global gross
profits under the Company's collaboration agreement described
above. Additionally, during the fourth quarter of 2021, the Company
recorded a $232 million charge to
write down its REGEN-COV inventory as a result of data that showed
REGEN-COV was highly unlikely to be active against the Omicron
variant and the FDA revision of the EUA for REGEN-COV, pursuant to
which REGEN-COV was no longer authorized for use in any U.S.
states, territories, or jurisdictions.
- Other operating (income) expense, net, for full year 2021
included the recognition of a cumulative catch-up adjustment of
$67 million, which was recorded as a
reduction to other operating income, 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 operating
(income) expense, net, in the fourth quarter and full year 2020
included the recognition of cumulative catch-up adjustments of
$100 million, which was recorded as
an increase to other operating income, arising from an update to
the estimate of total R&D costs expected to be incurred for
certain collaboration programs.
Other Financial Information
GAAP other income (expense) included the recognition of net
unrealized losses on equity securities of $138 million in the fourth quarter of 2021,
compared to $62 million of net unrealized gains in the fourth
quarter of 2020. GAAP other income (expense) included the
recognition of net unrealized gains on equity securities of
$386 million for full year 2021,
compared to $196 million for full
year 2020.
In the fourth quarter and full year 2021, the Company's GAAP
effective tax rate was 11.0% and 13.4%, respectively, compared to
6.2% and 7.8% in the fourth quarter and full year 2020,
respectively. The increase in the fourth quarter and full year 2021
GAAP effective tax rate, compared to the same periods in the prior
year, was due in part to the impact of higher REGEN-COV sales in
the United States. In the fourth
quarter and full year 2021, the non-GAAP effective tax rate was
12.7% and 13.6%, respectively, compared to 7.7% and 9.1% in the
fourth quarter and full year 2020, respectively.
GAAP net income per diluted share was $19.69 in the fourth quarter of 2021, compared to
$10.24 in the fourth quarter of 2020.
GAAP net income per diluted share was $71.97 for the full year 2021, compared to
$30.52 for full year 2020. Non-GAAP
net income per diluted share was $23.72 in the fourth quarter of 2021, compared to
$9.53 in the fourth quarter of 2020.
Non-GAAP net income per diluted share was $74.66 for the full year 2021, compared to
$31.47 for the full year 2020. A
reconciliation of the Company's GAAP to non-GAAP results is
included in Table 3 of this press release.
In November 2021, the Company's
board of directors authorized a new share repurchase program to
repurchase up to $3.0 billion of
the Company's common stock. Repurchases may be made from time to
time at management's discretion through a variety of methods. The
program has no time limit and can be discontinued at any time.
Net cash provided by operating activities for the full year 2021
was $7.081 billion, compared to
$2.618 billion for the full year
2020, resulting in $6.529 billion in
free cash flow for the full year 2021, compared to $2.004 billion for the full year 2020. The
increase in free cash flow for the full year 2021 was primarily due
to the Company's collection of amounts due from the U.S. government
in connection with REGEN-COV sales.
2022 Financial
Guidance(4)
The Company's full year 2022 financial guidance consists of the
following components:
|
|
GAAP
|
|
Non-GAAP(1)
|
R&D
|
|
$3.170 billion–$3.400
billion
|
|
$2.800 billion–$3.000
billion
|
SG&A
|
|
$1.890 billion–$2.030
billion
|
|
$1.650 billion–$1.770
billion
|
Gross margin on net
product sales(5)
|
|
89%–91%
|
|
90%–92%
|
COCM(6)
|
|
$750 million–$830
million
|
|
*
|
Other operating
(income) expense, net
|
|
($60) million–($80)
million
|
|
*
|
Capital
expenditures
|
|
$650 million–$730
million
|
|
*
|
Effective tax rate
(ETR)
|
|
12%–14%
|
|
13%–15%
|
|
|
|
|
|
* GAAP and
non-GAAP amounts are equivalent as no non-GAAP adjustments have
been or are expected to be recorded.
|
A reconciliation of full year 2022 GAAP to Non-GAAP financial
guidance is included below:
|
|
Projected
Range
|
($ in
millions)
|
|
Low
|
|
High
|
GAAP
R&D
|
|
$
3,170
|
|
$
3,400
|
R&D: Non-cash
share-based compensation
expense
|
|
(370)
|
|
(400)
|
Non-GAAP
R&D
|
|
$
2,800
|
|
$
3,000
|
|
|
|
|
|
GAAP
SG&A
|
|
$
1,890
|
|
$
2,030
|
SG&A: Non-cash
share-based
compensation expense
|
|
(240)
|
|
(260)
|
Non-GAAP
SG&A
|
|
$
1,650
|
|
$
1,770
|
|
|
|
|
|
GAAP gross margin on
net product sales
|
|
89%
|
|
91%
|
Non-cash share-based
compensation
expense
|
|
1%
|
|
1%
|
Non-GAAP gross margin
on net product sales
|
|
90%
|
|
92%
|
|
|
|
|
|
GAAP ETR
|
|
12%
|
|
14%
|
Income tax effect of
GAAP to non-GAAP
reconciling items and other
|
|
1%
|
|
1%
|
Non-GAAP
ETR
|
|
13%
|
|
15%
|
(1)
|
This press release
uses non-GAAP R&D, non-GAAP SG&A, non-GAAP gross margin on
net product sales, non-GAAP other income (expense), net, non-GAAP
effective tax rate, non-GAAP net income, non-GAAP net income per
share, total revenues excluding REGEN-COV (casirivimab and
imdevimab), 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. A reconciliation of the Company's historical
GAAP to non-GAAP results is included in Table 3 of this press
release.
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.
|
|
|
(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. These estimates are revised, if necessary,
in subsequent periods if the Company's actual share of the profits
or losses differ from those estimates.
|
|
|
(4)
|
The Company's 2022
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 fourth quarter and full year 2021 financial and
operating results on Friday, February 4, 2022, 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/8706689. 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), aflibercept 8 mg, 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. 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:
|
|
|
|
|
|
Mark
Hudson
|
|
Christina
Chan
|
Investor
Relations
|
|
Corporate
Communications
|
914-847-3482
|
|
914-847-8827
|
mark.hudson@regeneron.com
|
|
christina.chan@regeneron.com
|
TABLE 1
|
|
REGENERON
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS (Unaudited)
(In
millions)
|
|
|
|
December
31,
|
|
|
2021
|
|
2020
|
Assets:
|
|
|
|
|
Cash and marketable
securities
|
|
$
12,532.7
|
|
$
6,722.6
|
Accounts receivable,
net
|
|
6,036.5
|
|
4,114.7
|
Inventories
|
|
1,951.3
|
|
1,916.6
|
Property, plant, and
equipment, net
|
|
3,482.2
|
|
3,221.6
|
Deferred tax
assets
|
|
876.9
|
|
858.9
|
Other
assets
|
|
555.2
|
|
328.9
|
Total
assets
|
|
$
25,434.8
|
|
$
17,163.3
|
|
|
|
|
|
Liabilities and
stockholders' equity:
|
|
|
|
|
Accounts payable,
accrued expenses, and other liabilities
|
|
$
3,451.0
|
|
$
2,806.8
|
Finance lease
liabilities
|
|
719.7
|
|
717.2
|
Deferred
revenue
|
|
515.3
|
|
635.5
|
Long-term
debt
|
|
1,980.0
|
|
1,978.5
|
Stockholders'
equity
|
|
18,768.8
|
|
11,025.3
|
Total liabilities and
stockholders' equity
|
|
$
25,434.8
|
|
$
17,163.3
|
TABLE 2
|
|
REGENERON
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
(In millions,
except per share data)
|
|
|
|
Three Months
Ended
December
31,
|
|
Year
Ended
December
31,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product
sales
|
|
$
3,975.2
|
|
$
1,621.8
|
|
$
12,117.2
|
|
$
5,567.6
|
Collaboration
revenue
|
|
890.3
|
|
677.7
|
|
3,673.3
|
|
2,372.5
|
Other
revenue
|
|
86.2
|
|
123.4
|
|
281.2
|
|
557.0
|
|
|
4,951.7
|
|
2,422.9
|
|
16,071.7
|
|
8,497.1
|
Expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
785.6
|
|
744.5
|
|
2,908.1
|
|
2,735.0
|
Selling, general, and
administrative
|
|
559.6
|
|
303.5
|
|
1,824.9
|
|
1,346.0
|
Cost of goods
sold
|
|
811.7
|
|
179.6
|
|
1,773.1
|
|
491.9
|
Cost of collaboration
and contract manufacturing
|
|
170.9
|
|
173.5
|
|
664.4
|
|
628.0
|
Other operating
(income) expense, net
|
|
(15.8)
|
|
(145.2)
|
|
(45.6)
|
|
(280.4)
|
|
|
2,312.0
|
|
1,255.9
|
|
7,124.9
|
|
4,920.5
|
|
|
|
|
|
|
|
|
|
Income from
operations
|
|
2,639.7
|
|
1,167.0
|
|
8,946.8
|
|
3,576.6
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Other (expense)
income, net
|
|
(122.2)
|
|
72.4
|
|
436.3
|
|
290.7
|
Interest
expense
|
|
(14.1)
|
|
(14.8)
|
|
(57.3)
|
|
(56.9)
|
|
|
(136.3)
|
|
57.6
|
|
379.0
|
|
233.8
|
|
|
|
|
|
|
|
|
|
Income before income
taxes
|
|
2,503.4
|
|
1,224.6
|
|
9,325.8
|
|
3,810.4
|
|
|
|
|
|
|
|
|
|
Income tax
expense
|
|
274.4
|
|
75.4
|
|
1,250.5
|
|
297.2
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
2,229.0
|
|
$
1,149.2
|
|
$
8,075.3
|
|
$
3,513.2
|
|
|
|
|
|
|
|
|
|
Net income per share
- basic
|
|
$
20.99
|
|
$
10.90
|
|
$
76.40
|
|
$
32.65
|
Net income per share
- diluted
|
|
$
19.69
|
|
$
10.24
|
|
$
71.97
|
|
$
30.52
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding - basic
|
|
106.2
|
|
105.4
|
|
105.7
|
|
107.6
|
Weighted average
shares outstanding - diluted
|
|
113.2
|
|
112.2
|
|
112.2
|
|
115.1
|
TABLE 3
|
|
REGENERON
PHARMACEUTICALS, INC.
RECONCILIATION OF
GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited)
(In millions,
except per share data)
|
|
|
|
Three Months
Ended
December
31,
|
|
Year
Ended
December
31,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
GAAP
R&D
|
|
$
785.6
|
|
$
744.5
|
|
$
2,908.1
|
|
$
2,735.0
|
R&D: Non-cash
share-based compensation expense
|
|
102.9
|
|
69.1
|
|
316.6
|
|
238.6
|
R&D: Up-front
payments related to license and collaboration
agreements
|
|
44.0
|
|
—
|
|
44.0
|
|
85.0
|
Non-GAAP
R&D
|
|
$
638.7
|
|
$
675.4
|
|
$
2,547.5
|
|
$
2,411.4
|
|
|
|
|
|
|
|
|
|
GAAP
SG&A
|
|
$
559.6
|
|
$
303.5
|
|
$
1,824.9
|
|
$
1,346.0
|
SG&A: Non-cash
share-based compensation expense
|
|
64.2
|
|
38.6
|
|
213.3
|
|
153.0
|
SG&A: Litigation
contingencies and other
|
|
—
|
|
(115.8)
|
|
5.6
|
|
(86.9)
|
Non-GAAP
SG&A
|
|
$
495.4
|
|
$
380.7
|
|
$
1,606.0
|
|
$
1,279.9
|
|
|
|
|
|
|
|
|
|
GAAP COGS
|
|
$
811.7
|
|
$
179.6
|
|
$
1,773.1
|
|
$
491.9
|
COGS: Non-cash
share-based compensation expense
|
|
21.3
|
|
13.8
|
|
71.8
|
|
40.4
|
COGS: REGEN-COV
inventory reserve
|
|
231.7
|
|
—
|
|
231.7
|
|
—
|
COGS: Other
|
|
—
|
|
—
|
|
—
|
|
0.9
|
Non-GAAP
COGS
|
|
$
558.7
|
|
$
165.8
|
|
$
1,469.6
|
|
$
450.6
|
|
|
|
|
|
|
|
|
|
GAAP other income
(expense), net
|
|
$
(136.3)
|
|
$
57.6
|
|
$
379.0
|
|
$
233.8
|
Other income/expense:
Losses (gains) on investments
|
|
137.6
|
|
(59.5)
|
|
(387.0)
|
|
(221.6)
|
Interest expense:
Other
|
|
—
|
|
—
|
|
—
|
|
12.7
|
Non-GAAP other income
(expense), net
|
|
$
1.3
|
|
$
(1.9)
|
|
$
(8.0)
|
|
$
24.9
|
|
|
|
|
|
|
|
|
|
GAAP net
income
|
|
$
2,229.0
|
|
$
1,149.2
|
|
$
8,075.3
|
|
$
3,513.2
|
Total of GAAP to
non-GAAP reconciling items above
|
|
601.7
|
|
(53.8)
|
|
496.0
|
|
222.1
|
Income tax effect of
GAAP to non-GAAP reconciling items
|
|
(119.2)
|
|
14.8
|
|
(82.9)
|
|
(38.9)
|
Income tax expense:
Impact of sale of assets between foreign
subsidiaries
|
|
—
|
|
(30.0)
|
|
—
|
|
(30.0)
|
Non-GAAP net
income
|
|
$
2,711.5
|
|
$
1,080.2
|
|
$
8,488.4
|
|
$
3,666.4
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
$
25.53
|
|
$
10.25
|
|
$
80.31
|
|
$
34.07
|
Non-GAAP net income
per share - diluted
|
|
$
23.72
|
|
$
9.53
|
|
$
74.66
|
|
$
31.47
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating:
|
|
|
|
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
106.2
|
|
105.4
|
|
105.7
|
|
107.6
|
Non-GAAP net income
per share - diluted
|
|
114.3
|
|
113.4
|
|
113.7
|
|
116.5
|
RECONCILIATION OF
GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited)
(continued)
|
|
|
|
Three Months
Ended
December
31,
|
|
Year
Ended
December
31,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Revenue
reconciliation:
|
|
|
|
|
|
|
|
|
Total
revenues
|
|
$
4,951.7
|
|
$
2,422.9
|
|
$
16,071.7
|
|
$
8,497.1
|
REGEN-COV net product
sales in the United States
|
|
2,297.9
|
|
145.5
|
|
5,828.0
|
|
185.7
|
Global gross profit
true-up payment from Roche in connection with
sales of casirivimab and imdevimab
|
|
—
|
|
—
|
|
361.8
|
|
—
|
Total revenues
excluding REGEN-COV (casirivimab and imdevimab)
|
|
$
2,653.8
|
|
$
2,277.4
|
|
$
9,881.9
|
|
$
8,311.4
|
|
|
|
|
|
|
|
|
|
Effective tax rate
reconciliation:
|
|
|
|
|
|
|
|
|
GAAP effective tax
rate
|
|
11.0 %
|
|
6.2%
|
|
13.4%
|
|
7.8%
|
Income tax effect of
GAAP to non-GAAP reconciling items
|
|
1.7%
|
|
1.5%
|
|
0.2%
|
|
1.3%
|
Non-GAAP effective
tax rate
|
|
12.7%
|
|
7.7%
|
|
13.6%
|
|
9.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year
Ended
December
31,
|
|
|
|
|
|
|
2021
|
|
2020
|
|
|
Free cash flow
reconciliation:
|
|
|
|
|
|
|
|
|
Net cash provided by
operating activities
|
|
|
|
$
7,081.3
|
|
$
2,618.1
|
|
|
Capital
expenditures
|
|
|
|
(551.9)
|
|
(614.6)
|
|
|
Free cash
flow
|
|
|
|
$
6,529.4
|
|
$
2,003.5
|
|
|
TABLE 4
|
|
REGENERON
PHARMACEUTICALS, INC.
COLLABORATION
REVENUE (Unaudited)
(In
millions)
|
|
|
|
Three Months
Ended
December
31,
|
|
Year
Ended
December
31,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Sanofi
collaboration revenue:
|
|
|
|
|
|
|
|
|
Antibody:
|
|
|
|
|
|
|
|
|
Regeneron's share of
profits in connection with
commercialization of antibodies
|
|
$
387.8
|
|
$
229.6
|
|
$
1,363.0
|
|
$
785.2
|
Sales-based milestones
earned
|
|
—
|
|
—
|
|
50.0
|
|
50.0
|
Reimbursement for
manufacturing of commercial supplies
|
|
127.6
|
|
93.0
|
|
488.8
|
|
368.0
|
Immuno-oncology:
|
|
|
|
|
|
|
|
|
Regeneron's share of
losses in connection with commercialization
of Libtayo outside the United States
|
|
(1.0)
|
|
(8.4)
|
|
(13.6)
|
|
(25.7)
|
Reimbursement for
manufacturing of commercial supplies
|
|
3.5
|
|
2.9
|
|
14.0
|
|
8.9
|
Total Sanofi
collaboration revenue
|
|
517.9
|
|
317.1
|
|
1,902.2
|
|
1,186.4
|
|
|
|
|
|
|
|
|
|
Bayer
collaboration revenue:
|
|
|
|
|
|
|
|
|
Regeneron's net profit
in connection with commercialization of
EYLEA outside the United States
|
|
353.9
|
|
335.3
|
|
1,349.2
|
|
1,107.9
|
Reimbursement for
manufacturing of commercial supplies
|
|
18.5
|
|
25.3
|
|
60.1
|
|
78.2
|
Total Bayer
collaboration revenue
|
|
372.4
|
|
360.6
|
|
1,409.3
|
|
1,186.1
|
|
|
|
|
|
|
|
|
|
Roche
collaboration revenue:
|
|
|
|
|
|
|
|
|
Global gross profit
true-up payment from Roche in connection
with sales of casirivimab and imdevimab
|
|
—
|
|
—
|
|
361.8
|
|
—
|
|
|
|
|
|
|
|
|
|
Total collaboration
revenue
|
|
$
890.3
|
|
$
677.7
|
|
$
3,673.3
|
|
$
2,372.5
|
TABLE 5
|
|
REGENERON
PHARMACEUTICALS, INC.
NET PRODUCT SALES
OF REGENERON-DISCOVERED PRODUCTS (Unaudited)
(In
millions)
|
|
|
|
Three Months
Ended
December
31,
|
|
|
|
|
2021
|
|
2020
|
|
%
Change
|
|
|
U.S.
|
|
ROW
|
|
Total
|
|
U.S.
|
|
ROW
|
|
Total
|
|
(Total
Sales)
|
EYLEA(a)
|
|
$
1,547.2
|
|
$
933.5
|
|
$
2,480.7
|
|
$
1,343.2
|
|
$
858.8
|
|
$
2,202.0
|
|
13%
|
Dupixent(b)
|
|
$
1,348.2
|
|
$
425.6
|
|
$
1,773.8
|
|
$
925.6
|
|
$
246.4
|
|
$
1,172.0
|
|
51%
|
Libtayo(c)
|
|
$
80.8
|
|
$
40.2
|
|
$
121.0
|
|
$
74.1
|
|
$
23.2
|
|
$
97.3
|
|
24%
|
Praluent(d)
|
|
$
40.0
|
|
$
62.6
|
|
$
102.6
|
|
$
55.2
|
|
$
45.7
|
|
$
100.9
|
|
2%
|
REGEN-COV(e)
|
|
$
2,297.9
|
|
$
572.7
|
|
$
2,870.6
|
|
$
145.5
|
|
—
|
|
$
145.5
|
|
(h)
|
Kevzara(b)
|
|
$
42.0
|
|
$
61.9
|
|
$
103.9
|
|
$
36.6
|
|
$
34.9
|
|
$
71.5
|
|
45%
|
Evkeeza(f)
|
|
$
9.3
|
|
—
|
|
$
9.3
|
|
—
|
|
—
|
|
—
|
|
(h)
|
ARCALYST(g)
|
|
$
18.7
|
|
—
|
|
$
18.7
|
|
$
3.8
|
|
—
|
|
$
3.8
|
|
392%
|
ZALTRAP(b)
|
|
$
1.4
|
|
$
20.3
|
|
$
21.7
|
|
$
0.9
|
|
$
23.9
|
|
$
24.8
|
|
(13%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year
Ended
December
31,
|
|
|
|
|
2021
|
|
2020
|
|
%
Change
|
|
|
U.S.
|
|
ROW
|
|
Total
|
|
U.S.
|
|
ROW
|
|
Total
|
|
(Total
Sales)
|
EYLEA(a)
|
|
$
5,792.3
|
|
$
3,592.4
|
|
$
9,384.7
|
|
$
4,947.2
|
|
$
2,961.5
|
|
$
7,908.7
|
|
19%
|
Dupixent(b)
|
|
$
4,713.0
|
|
$
1,485.3
|
|
$
6,198.3
|
|
$
3,226.2
|
|
$
818.6
|
|
$
4,044.8
|
|
53%
|
Libtayo(c)
|
|
$
306.3
|
|
$
151.9
|
|
$
458.2
|
|
$
270.7
|
|
$
77.5
|
|
$
348.2
|
|
32%
|
Praluent(d)
|
|
$
170.0
|
|
$
251.1
|
|
$
421.1
|
|
$
186.0
|
|
$
172.8
|
|
$
358.8
|
|
17%
|
REGEN-COV(e)
|
|
$
5,828.0
|
|
$
1,745.9
|
|
$
7,573.9
|
|
$
185.7
|
|
—
|
|
$
185.7
|
|
(h)
|
Kevzara(b)
|
|
$
161.9
|
|
$
176.1
|
|
$
338.0
|
|
$
141.6
|
|
$
128.3
|
|
$
269.9
|
|
25%
|
Evkeeza(f)
|
|
$
18.4
|
|
—
|
|
$
18.4
|
|
—
|
|
—
|
|
—
|
|
(h)
|
ARCALYST(g)
|
|
$
40.7
|
|
—
|
|
$
40.7
|
|
$
13.1
|
|
—
|
|
$
13.1
|
|
211%
|
ZALTRAP(b)
|
|
$
5.3
|
|
$
86.4
|
|
$
91.7
|
|
$
5.8
|
|
$
97.9
|
|
$
103.7
|
|
(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. Pursuant to a January 2022
agreement, Ultragenyx will record net product sales of Evkeeza
outside of the United States and will pay the Company a percentage
of such sales.
|
(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-fourth-quarter-and-full-year-2021-financial-and-operating-results-301475382.html
SOURCE Regeneron Pharmaceuticals, Inc.