TARRYTOWN, N.Y., Feb. 5, 2021
/PRNewswire/ --
- Fourth quarter 2020 revenues increased 30% to $2.42 billion versus fourth quarter
2019(4)
- Fourth quarter 2020 EYLEA® U.S. net sales
increased 10% to $1.34 billion versus
fourth quarter 2019 and full year 2020 EYLEA U.S. net sales
increased 7% versus 2019
- Fourth quarter 2020 Dupixent® global net
sales(2), which are recorded by Sanofi,
increased 56% to $1.17 billion versus
fourth quarter 2019 and full year 2020 Dupixent global net sales
increased 75% versus 2019
- Fourth quarter 2020 GAAP diluted EPS was $10.24 and non-GAAP diluted
EPS(1) was $9.53
- REGEN-COV™ antibody cocktail for
COVID-19 received FDA Emergency Use Authorization; new agreement
signed with U.S. government to purchase up to 1.25 million
additional doses
- Positive interim data reported from Phase 3 trial with
REGEN-COV used as passive vaccine to prevent COVID-19
Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) today announced financial results
for the fourth quarter and full year 2020 and provided a business
update.
"In 2020, the Regeneron team rapidly mobilized our significant
scientific, development, manufacturing, and operational
capabilities to bring our monoclonal antibody cocktail, REGEN-COV,
to patients with COVID-19 through an Emergency Use Authorization,"
said Leonard S. Schleifer, M.D.,
Ph.D., President and Chief Executive Officer of Regeneron. "In
2021, in addition to our ongoing work on COVID-19, we expect
further diversified growth driven by continued EYLEA momentum,
expanded approvals and increased market penetration for Dupixent,
and new launches for Libtayo in oncology. We anticipate U.S.
regulatory action for Libtayo in both non-small cell lung cancer
and basal cell carcinoma within the next month – and anticipate
additional readouts later this year from across our oncology
pipeline, including the bispecific platform."
Financial Highlights
|
|
Three Months
Ended
December 31,
|
|
|
|
Year Ended
December 31,
|
|
|
($ in millions,
except per share data)
|
|
2020
|
|
2019
|
|
%
Change
|
|
2020
|
|
2019
|
|
%
Change
|
Total
revenues(4)
|
|
$
|
2,423
|
|
|
$
|
1,864
|
|
|
30%
|
|
$
|
8,497
|
|
|
$
|
6,558
|
|
|
30%
|
GAAP net
income
|
|
$
|
1,149
|
|
|
$
|
792
|
|
|
45%
|
|
$
|
3,513
|
|
|
$
|
2,116
|
|
|
66%
|
GAAP net income per
share -
diluted
|
|
$
|
10.24
|
|
|
$
|
6.93
|
|
|
48%
|
|
$
|
30.52
|
|
|
$
|
18.46
|
|
|
65%
|
Non-GAAP net
income(1)
|
|
$
|
1,080
|
|
|
$
|
858
|
|
|
26%
|
|
$
|
3,666
|
|
|
$
|
2,827
|
|
|
30%
|
Non-GAAP net income
per
share - diluted(1)
|
|
$
|
9.53
|
|
|
$
|
7.50
|
|
|
27%
|
|
$
|
31.47
|
|
|
$
|
24.67
|
|
|
28%
|
"In 2020, Regeneron delivered double-digit top- and bottom-line
growth and significant shareholder value despite the unprecedented
circumstances of a global pandemic," said Robert E. Landry, Executive Vice President,
Finance and Chief Financial Officer of Regeneron. "As we look ahead
into 2021 and beyond, our business momentum and strong balance
sheet give us confidence as we invest in R&D for long-term
growth and execute on our capital allocation priorities."
Business Highlights
Key Pipeline Progress
Regeneron has approximately 30
product candidates in clinical development, including five marketed
products for which it is investigating additional indications.
Updates from the clinical pipeline include:
Dupixent® (dupilumab)
- In November 2020, the European
Commission (EC) extended the marketing authorization in the
European Union (EU) to include children 6 to 11 years of age with
severe atopic dermatitis who are candidates for systemic
therapy.
- In October 2020, the Company and
Sanofi announced that a Phase 3 trial met its primary and all key
secondary endpoints in children aged 6 to 11 years with
uncontrolled moderate-to-severe asthma. A supplemental Biologics
License Application (sBLA) was subsequently submitted and a
submission in the EU is planned by the end of the first quarter of
2021.
- Phase 3 studies in chronic inducible urticaria, chronic
sinusitis without nasal polyposis, and allergic fungal
rhinosinusitis were initiated.
REGEN-COV™ (casirivimab and imdevimab), a dual
antibody cocktail to SARS-CoV-2 virus
- In November 2020, REGEN-COV
received Emergency Use Authorization (EUA) from the U.S. Food and
Drug Administration (FDA). REGEN-COV is authorized for the
treatment of mild to moderate COVID-19 in certain patients at high
risk for progressing to severe COVID-19 and/or
hospitalization.
- In January 2021, the Company
announced a second agreement with the U.S. government to
manufacture and deliver REGEN-COV. The U.S. government has agreed
to acquire up to 1.25 million additional doses at the lowest
treatment dose authorized or approved by the FDA for the indication
authorized under the EUA, resulting in payments to the Company of
up to $2.625 billion in the
aggregate. The U.S. government is obligated to purchase all filled
and finished doses of drug product delivered by June 30, 2021, and may accept doses through
September 30, 2021 at its discretion.
A number of factors may impact available filled and finished supply
by June 30, 2021, including
manufacturing considerations and authorized dose levels. The
agreement is in addition to the July
2020 agreement with the U.S. government for approximately
300,000 doses.
- In February 2021, the European
Medicines Agency (EMA) announced it had commenced a Rolling Review
of data for the casirivimab and imdevimab antibody cocktail. Data
on the safety, tolerability, and efficacy of the antibody cocktail
will be shared with the EMA as they become available in the coming
months.
- In October 2020, the Company
announced additional positive results from an ongoing Phase 2/3
seamless trial in the COVID-19 outpatient setting showing that
REGEN-COV significantly reduced viral load and COVID-19 medical
visits (hospitalizations, emergency room, urgent care visits,
and/or physician office/telemedicine visits). Initial clinical data
from this trial were published in the New England Journal of
Medicine (NEJM) in December
2020.
- A Phase 2 dose-ranging treatment study in non-hospitalized
patients with COVID-19 was initiated and a lower 1,200 mg dose is
being evaluated in the ongoing outpatient trial.
- In December 2020, the Company
announced initial encouraging data from an ongoing Phase 1/2/3
trial in seronegative hospitalized COVID-19 patients requiring
low-flow oxygen. The Phase 3 program in hospitalized patients will
continue based on passing a futility analysis evaluating the risk
of death or receiving mechanical ventilation and demonstrating
positive reductions in viral load. In October 2020, the Independent Data Monitoring
Committee (IDMC) for this trial recommended that, based on a
potential safety signal and an unfavorable risk/benefit profile at
this time, further enrollment of patients requiring high-flow
oxygen or mechanical ventilation be placed on hold.
- The United Kingdom-based
RECOVERY trial continues to evaluate REGEN-COV in hospitalized
patients and has enrolled more than 6,000 patients in the cohort
randomizing patients 1:1 to receive REGEN-COV or placebo.
- In January 2021, the Company
announced positive initial results from an ongoing Phase 3 trial
evaluating REGEN-COV used as a passive vaccine for the prevention
of COVID-19 in people at high risk of infection (due to household
exposure to a COVID-19 patient). An exploratory analysis was
conducted on the first approximately 400 evaluable individuals
enrolled in the trial, who were randomized to receive passive
vaccination with REGEN-COV (1,200 mg via subcutaneous injections)
or placebo.
- In January 2021, the Company
announced that preclinical studies showed that the REGEN-COV
antibody cocktail retains its potent neutralizing ability against
circulating SARS-CoV-2 variants identified in the United Kingdom, South Africa, and Brazil. Both antibodies in the cocktail
retained their potency against the UK variant (B.1.1.7); imdevimab
retained its potency against the South African variant (B.1.351),
while casirivimab potency was reduced but still comparable to that
of other single antibodies in development against the original
virus. The REGEN-COV antibody cocktail was prospectively designed
so that if variants arose affecting one component, the other
component could compensate and still allow for potent neutralizing
activity. In fact, as reported in Science in June 2020, Regeneron scientists predicted the key
mutation that has since appeared in the South African and
Brazil variants, and further
showed that this mutation would lower potency of the casirivimab
component, but be compensated for by the imdevimab component.
Libtayo® (cemiplimab)
- The FDA accepted for priority review, with a target action date
of February 28, 2021, the sBLA for
Libtayo as monotherapy to treat patients with first-line locally
advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50%
PD-L1 expression. A regulatory application for Libtayo as
monotherapy in first-line NSCLC was also submitted in the EU.
- The FDA accepted for priority review, with a target action date
of March 3, 2021, the sBLA for
Libtayo for the treatment of patients with locally advanced or
metastatic basal cell carcinoma (BCC). A regulatory application for
Libtayo in advanced BCC was also submitted in the EU.
Inmazeb™ (atoltivimab, maftivimab,
and odesivimab-ebgn)
- In October 2020, the FDA approved
Inmazeb (REGN-EB3) for the treatment of infection caused by
Zaire ebolavirus in adult
and pediatric patients, including newborns of mothers who have
tested positive for the infection.
REGN5458, a bispecific antibody targeting BCMA and CD3
- In December 2020, the Company
announced updated data from the Phase 1 portion of a Phase 1/2
trial in patients with relapsed or refractory (R/R) multiple
myeloma. The results continued to show deep and durable responses
in patients with heavily-pretreated multiple myeloma and were
shared in an oral presentation at the virtual 2020 American Society
of Hematology (ASH) Annual Meeting.
Odronextamab, a CD20xCD3 bispecific antibody
- In December 2020, updated results
from the Phase 1 trial in R/R follicular lymphoma, diffuse large
B-cell lymphoma, and other B-cell non-Hodgkin lymphomas were shared
in an oral presentation at ASH and included patient follow-up data
of up to 3 years.
- In December 2020, the Company
announced it was pausing new enrollment of patients with B-cell
non-Hodgkin lymphomas (B-NHL) in its trials in compliance with an
FDA partial clinical hold. The FDA requested that the Company amend
the trial protocols in order to further reduce the incidence of
≥Grade 3 cytokine release syndrome (CRS) during step-up dosing. The
Company is working with the FDA to amend the protocol, with the
goal of resuming patient enrollment within the first half of
2021.
Additional Bispecific Antibodies
- In addition to REGN5458 and odronextamab, the Company has
advanced two CD3 bispecifics into clinical trials including
MUC16xCD3 (REGN4018), which is being studied in ovarian
cancer.
- Three costimulatory CD28 bispecifics are now in clinical trials
targeting prostate cancer, ovarian cancer, and other solid
tumors.
- Also in clinical development is the first of a third class of
bispecifics, METxMET (REGN5093), in non-small cell lung cancer
driven by MET mutations and/or amplifications.
Itepekimab, an antibody to IL-33
- The Company and Sanofi have initiated a Phase 3 program in
chronic obstructive pulmonary disease (COPD).
REGN5713-5714-5715, a multi-antibody therapy to Betv1
- A Phase 3 study in birch allergy was recently initiated.
REGN5713-5714-5715 is designed to treat allergic inflammatory
conditions caused by the allergen Betv1, which is the main allergen
responsible for birch pollen allergies. Birch pollen allergy is one
of the most common causes of seasonal allergies that occur in the
spring, and is also believed to trigger "oral allergy syndrome"
food reactions to related allergens found in fruits and nuts such
as apples, pears, and cherries.
Select 2021 Milestones
Programs
|
|
|
Milestones
|
EYLEA
|
|
-
|
Report results from
Phase 2 study for high-dose formulation in neovascular age-related
macular degeneration (wet AMD)
|
Dupixent
|
|
-
|
FDA decision on sBLA
and MAA submission for asthma in pediatrics (6–11 years of
age)
|
|
|
-
|
Report results from
Part B of the Phase 3 study in adults and adolescents with
eosinophilic esophagitis (EoE)
|
|
|
-
|
Report results from
Phase 3 study in prurigo nodularis
|
REGEN-COV
(casirivimab and imdevimab)
|
|
-
|
Report additonal data
from Phase 3 portion of COVID-19 study in non-hospitalized
patients
|
|
|
-
|
Report results for
lower 1,200 mg dose in Phase 3 portion of COVID-19 study in
non-hospitalized patients
|
|
|
-
|
Report additional
data from Phase 3 portion of COVID-19 prevention study in household
contacts
|
|
|
-
|
Data to be reported
from Phase 3 United Kingdom-based RECOVERY trial in hospitalized
patients
|
|
|
-
|
Report data from
Phase 2 dose-ranging virology study in non-hospitalized
patients
|
|
|
-
|
Submit BLA and MAA
for COVID-19
|
Libtayo
|
|
-
|
FDA decision on sBLA
(target action date of February 28, 2021) and EC decision on
regulatory submission for first-line NSCLC, monotherapy
|
|
|
-
|
Interim analysis from
Phase 3 study in first-line NSCLC, chemotherapy
combination
|
|
|
-
|
FDA decision on sBLA
(target action date of March 3, 2021) and EC decision on regulatory
submission for advanced BCC
|
|
|
-
|
Interim analysis from
Phase 3 study in cervical cancer
|
REGN5458 (BCMA and
CD3 Bispecific Antibody)
|
|
-
|
Complete patient
enrollment in potentially pivotal Phase 2 study in multiple
myeloma
|
|
|
-
|
Initiate pivotal
trials in earlier lines of multiple myeloma therapy
|
Odronextamab (CD20
and CD3 Bispecific Antibody)
|
|
-
|
Complete patient
enrollment in potentially pivotal Phase 2 study in B-NHL
|
|
|
-
|
Initiate Phase 3
program
|
Praluent
|
|
-
|
FDA decision on sBLA
for homozygous familial hypercholesterolemia (HoFH) in adults
(target action date of April 4, 2021)
|
Evkeeza™ (evinacumab) (ANGPTL3
Antibody)
|
|
-
|
FDA decision on BLA
(target action date of February 11, 2021) and EC decision on MAA
for HoFH
|
Fasinumab (NGF
Antibody)
|
|
-
|
Report additional
longer-term safety results from Phase 3 studies in osteoarthritis
pain of the knee or hip
|
|
|
-
|
Continue discussions
with regulatory authorities and determine next steps for the
program
|
Fourth Quarter and Full Year 2020 Financial Results
Effective January 1, 2020, Regeneron implemented changes in
the presentation of its financial statements related to certain
reimbursements and other payments for products developed and
commercialized with collaborators. The Company made these
changes in presentation to better reflect the nature of the
Company's costs incurred and revenues earned pursuant to
arrangements with collaborators and to enhance the comparability of
Regeneron's financial statements with industry peers. The change in
presentation has been applied retrospectively. See note (4) below
for further information.
Revenues
Total revenues increased by 30% to $2.423
billion in the fourth quarter of 2020, compared to
$1.864 billion in the fourth quarter
of 2019. Full year 2020 total revenues increased 30% to
$8.497 billion, compared to
$6.558 billion for the full year
2019.
EYLEA® net product sales in the United States increased to $1.343 billion in the fourth quarter of 2020,
compared to $1.222 billion in the
fourth quarter of 2019. Full year 2020 EYLEA net product sales in
the United States increased to
$4.947 billion, compared to
$4.644 billion for the full year
2019. Overall distributor inventory levels for EYLEA in
the United States remained within
the Company's one-to-two-week targeted range.
Net product sales of REGEN-COV were $146
million in the fourth quarter of 2020 and $186 million for the full year of 2020.
Total revenues also include Sanofi and Bayer collaboration
revenues(2) of $678
million in the fourth quarter and $2.373 billion for the full year 2020, compared
to $482 million in the fourth quarter
and $1.549 billion for the full year
2019. Sanofi collaboration revenue increased primarily due to the
Company's share of profits from commercialization of antibodies,
which were $230 million and
$785 million in the fourth quarter
and full year 2020, respectively, compared to $104 million and $209
million in the fourth quarter and full year 2019,
respectively. The change in the Company's share of profits from
commercialization of antibodies was primarily driven by higher
Dupixent profits. In addition, in the third quarter of 2020, the
Company earned the first $50 million sales-based milestone
from Sanofi, upon annual sales of antibodies outside the United States exceeding $1.0 billion on a rolling twelve-month basis.
Refer to Table 4 for a summary of collaboration revenue.
Other revenues in the fourth quarter and full year of 2020,
compared to the same periods in the prior year, increased primarily
due to recognition of revenue of $43 million and
$187 million, respectively, in connection with the Company's
agreement with the Biomedical Advanced Research Development
Authority (BARDA) related to funding of certain development
activities for antibodies related to the treatment of COVID-19.
Other revenues for the full year of 2020 also increased due to
recognition of revenue in connection with the Company's agreement
with BARDA related to funding of certain Inmazeb development
activities and Sanofi's reimbursement for manufacturing commercial
supplies of Praluent.
Operating Expenses
|
|
GAAP
|
|
%
Change
|
|
Non-GAAP(1)
|
|
%
Change
|
($ in
millions)
|
|
Q4
2020
|
|
Q4
2019
|
|
|
Q4
2020
|
|
Q4
2019
|
|
Research and
development (R&D)
|
|
$
|
745
|
|
|
$
|
552
|
|
|
35%
|
|
$
|
675
|
|
|
$
|
450
|
|
|
50%
|
Selling, general, and
administrative
(SG&A)
|
|
$
|
304
|
|
|
$
|
452
|
|
|
(33%)
|
|
$
|
381
|
|
|
$
|
311
|
|
|
23%
|
Cost of goods sold
(COGS)
|
|
$
|
180
|
|
|
$
|
109
|
|
|
65%
|
|
$
|
166
|
|
|
$
|
93
|
|
|
78%
|
Cost of collaboration
and contract
manufacturing (COCM)
|
|
$
|
174
|
|
|
$
|
113
|
|
|
54%
|
|
*
|
|
|
*
|
|
|
n/a
|
Other operating
(income) expense,
net
|
|
$
|
(145)
|
|
|
$
|
(38)
|
|
|
282%
|
|
*
|
|
|
*
|
|
|
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)
|
|
2020
|
|
2019
|
|
|
2020
|
|
2019
|
|
Research and
development
|
|
$
|
2,735
|
|
|
$
|
2,450
|
|
|
12%
|
|
$
|
2,411
|
|
|
$
|
1,770
|
|
|
36%
|
Selling, general, and
administrative
|
|
$
|
1,346
|
|
|
$
|
1,342
|
|
|
—%
|
|
$
|
1,280
|
|
|
$
|
1,069
|
|
|
20%
|
Cost of goods
sold
|
|
$
|
492
|
|
|
$
|
362
|
|
|
36%
|
|
$
|
451
|
|
|
$
|
316
|
|
|
43%
|
Cost of collaboration
and contract
manufacturing
|
|
$
|
628
|
|
|
$
|
403
|
|
|
56%
|
|
*
|
|
|
*
|
|
|
n/a
|
Other operating
(income) expense,
net
|
|
$
|
(280)
|
|
|
$
|
(209)
|
|
|
34%
|
|
*
|
|
|
*
|
|
|
n/a
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* GAAP and non-GAAP
amounts are equivalent as no non-GAAP adjustments have been
recorded
|
- The higher GAAP and non-GAAP R&D expenses in the fourth
quarter and full year 2020, compared to the same periods in the
prior year, were primarily due to additional costs incurred in
connection with COVID-19 related development activities. The higher
GAAP and non-GAAP R&D expenses for full year 2020 were also due
to 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. GAAP
R&D expenses for full year 2020 included $85 million of up-front payments in connection
with the Intellia collaboration agreement, and GAAP R&D
expenses for full year 2019 included a $400
million up-front payment in connection with the Alnylam
collaboration agreement.
- The change in GAAP and non-GAAP SG&A expenses in the fourth
quarter and full year 2020, compared to the same periods in the
prior year, was primarily due to an increase in
commercialization-related costs for EYLEA and Libtayo, higher
headcount-related costs, and, effective April 1, 2020, no longer receiving
Praluent-related cost reimbursements from Sanofi for
Regeneron-incurred expenses. GAAP SG&A expenses for the fourth
quarter and full year 2020 were also positively impacted by a
reversal of $121 million in accruals
for litigation-related loss contingencies in the fourth quarter of
2020 as a result of the October 2020
ruling by the Technical Board of Appeal of the European Patent
Office and its impact on certain patent infringement actions in
Europe relating to Praluent. In
addition, in the fourth quarter of 2019, the Company recorded a
$35 million GAAP SG&A charge
related to employee separation costs, as the Company eliminated
certain commercialization activities and related headcount in
connection with the restructuring of the antibody agreement with
Sanofi.
- The increase in COGS in the fourth quarter and full year 2020,
compared to the same periods in the prior year, was primarily due
to the recognition of manufacturing costs in connection with the
initiation of product sales of REGEN-COV (which commenced in the
third quarter of 2020) and Praluent in the United States (which were recorded by
Sanofi prior to April 1, 2020), as
well as higher product sales of Libtayo and EYLEA in the United States. These increases were partly
offset by lower period costs for the Company's Limerick commercial
manufacturing facility and lower inventory write-downs and
reserves.
- The increase in COCM in the fourth quarter and full year 2020,
compared to the same periods in the prior year, was primarily due
to the recognition of manufacturing costs associated with Dupixent
and recognition of costs in connection with manufacturing ex-U.S.
commercial supplies of Praluent for Sanofi. In addition, COCM
increased for full year 2020 due to process validation costs in
connection with manufacturing Inmazeb under our BARDA
agreement.
- 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. The increase in other operating income in the fourth
quarter and full year 2020 was primarily due to the recognition of
cumulative catch-up adjustments of $100
million, net, arising from an update to the estimate of the
stage of completion for certain collaboration programs.
Other Financial Information
GAAP other income (expense), net, includes the recognition
of net gains on equity securities of $60 million in the fourth quarter and
$222 million for the full year 2020,
compared to net gains of $189 million
in the fourth quarter and $118
million for the full year 2019. In August 2020, the Company issued and sold
$1.250 billion aggregate principal
amount of 1.750% senior unsecured notes due 2030 and $750 million aggregate principal amount of 2.800%
senior unsecured notes due 2050, for which the associated interest
expense is included in GAAP and non-GAAP other income (expense),
net.
GAAP income tax expense was $75
million and the effective tax rate was 6.2% in the fourth
quarter of 2020, compared to $98
million and 11.0% in the fourth quarter of 2019. GAAP income
tax expense was $297 million and the
effective tax rate was 7.8% for the full year 2020, compared to
$313 million and 12.9% for the full
year 2019. The GAAP effective tax rate for the fourth quarter and
full year 2020 was positively impacted, compared to the U.S.
federal statutory rate, primarily by stock-based compensation,
federal tax credits for research activities, and income earned in
foreign jurisdictions with tax rates lower than the U.S. federal
statutory rate. In the fourth quarter and full year 2020, the
non-GAAP effective tax rate was 7.7% and 9.1%, respectively,
compared to 10.6% and 14.6% in the fourth quarter and full year
2019, respectively.
GAAP net income per diluted share was $10.24 in the fourth quarter of 2020, compared to
GAAP net income per diluted share of $6.93 in the fourth quarter of 2019. GAAP net
income per diluted share was $30.52
for the full year 2020, compared to GAAP net income per diluted
share of $18.46 for full year 2019.
Non-GAAP net income per diluted share was $9.53 in the fourth quarter of 2020, compared to
non-GAAP net income per diluted share of $7.50 in the fourth quarter of 2019. Non-GAAP net
income per diluted share was $31.47
for the full year 2020, compared to non-GAAP net income per diluted
share of $24.67 for the full year
2019. A reconciliation of the Company's GAAP to non-GAAP results is
included in Table 3 of this press release.
During 2020, the Company repurchased 1.6 million shares of its
common stock under the Company's share repurchase program. As of
December 31, 2020, the Company had
repurchased the entire $1.0 billion
it was authorized to repurchase under the program.
In January 2021, the Company's
board of directors authorized a new share repurchase program to
repurchase up to $1.5 billion of the
Company's common stock. Repurchases may be made from time to time
at management's discretion through a variety of methods. The
program has no time limit and can be discontinued at any time.
Net cash provided by operating activities in the fourth quarter
of 2020 was $1.231 billion, compared
to $787 million in the fourth quarter
of 2019, resulting in $1.070 billion
in free cash flow for the fourth quarter of 2020, compared to
$648 million for the fourth quarter
of 2019. Net cash provided by operating activities for the full
year 2020 was $2.618 billion,
compared to $2.430 billion in net
cash provided by operating activities for the full year 2019,
resulting in $2.004 billion in free
cash flow for the full year 2020, compared to $2.000 billion for the full year 2019.
2021 Financial
Guidance(3)
The Company's full year 2021 financial guidance consists of the
following components:
|
|
GAAP
|
|
Non-GAAP(1)
|
R&D
|
|
$3.000 billion–$3.175
billion
|
|
$2.700 billion–$2.850
billion
|
SG&A
|
|
$1.700 billion–$1.850
billion
|
|
$1.500 billion–$1.630
billion
|
Gross margin on net
product sales(5)
|
|
86%–88%
|
|
87%–89%
|
COCM(6)
|
|
$670 million–$750
million
|
|
*
|
Other operating
(income) expense, net
|
|
($150) million–($175)
million
|
|
*
|
Capital
expenditures
|
|
$600 million–$680
million
|
|
*
|
Effective tax rate
(ETR)
|
|
11–13%
|
|
12–14%
|
|
|
|
|
|
* GAAP and non-GAAP
amounts are equivalent as no non-GAAP adjustments have been or are
expected to be recorded.
|
A reconciliation of full year 2021 GAAP to Non-GAAP financial
guidance is included below:
|
|
Projected
Range
|
($ in
millions)
|
|
Low
|
|
High
|
GAAP
R&D
|
|
$
|
3,000
|
|
|
$
|
3,175
|
|
R&D: Non-cash
share-based compensation
expense
|
|
(300)
|
|
|
(325)
|
|
Non-GAAP
R&D
|
|
$
|
2,700
|
|
|
$
|
2,850
|
|
|
|
|
|
|
GAAP
SG&A
|
|
$
|
1,700
|
|
|
$
|
1,850
|
|
SG&A: Non-cash
share-based compensation
expense
|
|
(200)
|
|
|
(220)
|
|
Non-GAAP
SG&A
|
|
$
|
1,500
|
|
|
$
|
1,630
|
|
|
|
|
|
|
GAAP gross margin on
net product sales
|
|
86%
|
|
|
88%
|
|
Non-cash share-based
compensation
expense
|
|
1%
|
|
|
1%
|
|
Non-GAAP gross margin
on net product sales
|
|
87%
|
|
|
89%
|
|
|
|
|
|
|
GAAP ETR
|
|
11%
|
|
|
13%
|
|
Income tax effect of
GAAP to non-GAAP
reconciling items and other
|
|
1%
|
|
|
1%
|
|
Non-GAAP
ETR
|
|
12%
|
|
|
14%
|
|
|
(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, and free cash flow, which are financial measures that are
not calculated in accordance with U.S. Generally Accepted
Accounting Principles (GAAP). These non-GAAP financial measures are
computed by excluding certain non-cash and/or other items from the
related GAAP financial measure. The Company also includes a
non-GAAP adjustment for the estimated income tax effect of
reconciling items.
The Company makes
such adjustments for items the Company does not view as useful in
evaluating its operating performance. For example, adjustments may
be made for items that fluctuate from period to period based on
factors that are not within the Company's control (such as the
Company's stock price on the dates share-based grants are issued or
changes in the fair value of the Company's investments in equity
securities) or items that are not associated with normal, recurring
operations (such as restructuring-related expenses, including
employee separation costs). Management uses these non-GAAP measures
for planning, budgeting, forecasting, assessing historical
performance, and making financial and operational decisions, and
also provides forecasts to investors on this basis. With respect to
free cash flows, the Company believes that this non-GAAP measure
provides a further measure of the Company's operations' ability to
generate cash flows. Additionally, such non-GAAP measures provide
investors with an enhanced understanding of the financial
performance of the Company's core business operations. However,
there are limitations in the use of these and other non-GAAP
financial measures as they exclude certain expenses that are
recurring in nature. Furthermore, the Company's non-GAAP financial
measures may not be comparable with non-GAAP information provided
by other companies. Any non-GAAP financial measure presented by
Regeneron should be considered supplemental to, and not a
substitute for, measures of financial performance prepared in
accordance with GAAP. A reconciliation of the Company's historical
GAAP to non-GAAP results is included in Table 3 of this press
release.
|
|
|
(2)
|
The Company's
collaborators provide it with estimates of the collaborators'
respective sales and the Company's share of the profits or losses
from commercialization of products for the most recent fiscal
quarter. The Company's estimates for such quarter are reconciled to
actual results in the subsequent fiscal quarter, and the Company's
share of the profit or loss is adjusted on a prospective basis
accordingly, if necessary.
|
|
|
(3)
|
The Company's 2021
financial guidance does not assume the completion of any
significant business development transactions not completed as of
the date of this press release.
|
|
|
(4)
|
Applicable amounts
previously reported for the three months and year ended December
31, 2019 and as of December 31, 2019 have been revised to reflect a
change in presentation of cost reimbursements from collaborators
who are not deemed to be the Company's customers from collaboration
revenue to a reduction of the corresponding operating expense. The
Company also changed the presentation of amounts recognized in
connection with up-front and development milestone payments
received from collaboration revenue to other operating income, as
well as the presentation of the corresponding balance sheet
accounts. The revisions were reclassifications only and had no
impact on the Company's previously reported GAAP and non-GAAP net
income and net income per share. Refer to the Company's Form 10-Q
for the quarterly period ended September 30, 2020 (Note 1 of the
Notes to Condensed Consolidated Financial Statements) for further
details.
|
|
|
(5)
|
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 2020 financial and
operating results on Friday, February 5, 2021, at 8:30 AM. To access this call, dial (888) 660-6127
(U.S.) or (973) 890-8355 (International), conference ID 1580376. A
link to the webcast may be accessed from the "Investors and Media"
page of Regeneron's website at www.regeneron.com. A replay of the
conference call and webcast will be archived on the Company's
website and will be available for at least 30 days.
About Regeneron Pharmaceuticals, Inc.
Regeneron is a leading biotechnology company that invents
life-transforming medicines for people with serious
diseases. Founded and led for over 30 years by
physician-scientists, Regeneron's unique ability to repeatedly and
consistently translate science into medicine has led to eight
FDA-approved treatments and numerous product candidates in
development, 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,
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),
Inmazeb™ (atoltivimab, maftivimab, and
odesivimab-ebgn), fasinumab,
Evkeeza™ (evinacumab),
REGEN-COV™ (casirivimab and imdevimab),
garetosmab, pozelimab, odronextamab, itepekimab, REGN5458,
REGN5713-5714-5715, Regeneron's other oncology programs (including
its costimulatory bispecific portfolio), Regeneron's and its
collaborators' earlier-stage programs, and the use of human
genetics in Regeneron's research programs; the likelihood and
timing of achieving any of the anticipated milestones described in
this press release; safety issues resulting from the administration
of Regeneron's Products and Regeneron's Product Candidates in
patients, including serious complications or side effects in
connection with the use of Regeneron's Products and Regeneron's
Product Candidates in clinical trials; the likelihood, timing, and
scope of possible regulatory approval and commercial launch of
Regeneron's Product Candidates and new indications for Regeneron's
Products, including without limitation EYLEA, Dupixent, Libtayo,
Praluent, Kevzara, Inmazeb, Evkeeza, fasinumab, REGEN-COV,
garetosmab, pozelimab, odronextamab, itepekimab, REGN5458, and
REGN5713-5714-5715; the extent to which the results from the
research and development programs conducted by Regeneron and/or its
collaborators may be replicated in other studies and/or lead to
advancement of product candidates to clinical trials, therapeutic
applications, or regulatory approval; ongoing regulatory
obligations and oversight impacting Regeneron's Products (such as
EYLEA, Dupixent, Libtayo, Praluent, Kevzara, and Inmazeb), research
and clinical programs, and business, including those relating to
patient privacy; determinations by regulatory and administrative
governmental authorities which may delay or restrict Regeneron's
ability to continue to develop or commercialize Regeneron's
Products and 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 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), 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 (including the impact of the recently issued
"most-favored-nation" interim final rule); 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 REGEN-COV, 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:
|
|
|
|
|
|
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)
|
|
|
|
December
31,
|
|
|
2020
|
|
2019*
|
Assets:
|
|
|
|
|
Cash and marketable
securities
|
|
$
|
6,722.6
|
|
|
$
|
6,471.1
|
|
Accounts receivable -
trade, net
|
|
3,111.5
|
|
|
2,100.0
|
|
Accounts receivable -
Sanofi and other, net
|
|
1,003.2
|
|
|
685.6
|
|
Inventories
|
|
1,916.6
|
|
|
1,415.5
|
|
Property, plant, and
equipment, net
|
|
3,221.6
|
|
|
2,890.4
|
|
Deferred tax
assets
|
|
858.9
|
|
|
824.2
|
|
Other
assets
|
|
328.9
|
|
|
418.4
|
|
Total
assets
|
|
$
|
17,163.3
|
|
|
$
|
14,805.2
|
|
|
|
|
|
|
Liabilities and
stockholders' equity:
|
|
|
|
|
Accounts payable,
accrued expenses, and other liabilities
|
|
$
|
2,806.8
|
|
|
$
|
2,514.2
|
|
Long-term
debt
|
|
1,978.5
|
|
|
—
|
|
Deferred
revenue
|
|
635.5
|
|
|
487.4
|
|
Finance lease
liabilities
|
|
717.2
|
|
|
713.9
|
|
Stockholders'
equity
|
|
11,025.3
|
|
|
11,089.7
|
|
Total liabilities and
stockholders' equity
|
|
$
|
17,163.3
|
|
|
$
|
14,805.2
|
|
|
* Certain revisions
have been made to the previously reported December 31, 2019
amounts. See note (4) above.
|
TABLE 2
|
REGENERON
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
(In millions,
except per share data)
|
|
|
|
Three Months
Ended
December 31,
|
|
Year Ended
December 31,
|
|
|
2020
|
|
2019*
|
|
2020
|
|
2019*
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product
sales
|
|
$
|
1,621.8
|
|
|
$
|
1,286.4
|
|
|
$
|
5,567.6
|
|
|
$
|
4,834.4
|
|
Sanofi collaboration
revenue
|
|
317.1
|
|
|
170.8
|
|
|
1,186.4
|
|
|
403.6
|
|
Bayer collaboration
revenue
|
|
360.6
|
|
|
310.8
|
|
|
1,186.1
|
|
|
1,145.6
|
|
Other
revenue
|
|
123.4
|
|
|
95.5
|
|
|
557.0
|
|
|
174.0
|
|
|
|
2,422.9
|
|
|
1,863.5
|
|
|
8,497.1
|
|
|
6,557.6
|
|
Expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
744.5
|
|
|
552.4
|
|
|
2,735.0
|
|
|
2,450.0
|
|
Selling, general, and
administrative
|
|
303.5
|
|
|
451.8
|
|
|
1,346.0
|
|
|
1,341.9
|
|
Cost of goods
sold
|
|
179.6
|
|
|
108.5
|
|
|
491.9
|
|
|
362.3
|
|
Cost of collaboration
and contract manufacturing
|
|
173.5
|
|
|
113.2
|
|
|
628.0
|
|
|
402.8
|
|
Other operating
(income) expense, net
|
|
(145.2)
|
|
|
(38.1)
|
|
|
(280.4)
|
|
|
(209.2)
|
|
|
|
1,255.9
|
|
|
1,187.8
|
|
|
4,920.5
|
|
|
4,347.8
|
|
|
|
|
|
|
|
|
|
|
Income from
operations
|
|
1,167.0
|
|
|
675.7
|
|
|
3,576.6
|
|
|
2,209.8
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Other income
(expense), net
|
|
72.4
|
|
|
220.8
|
|
|
290.7
|
|
|
249.5
|
|
Interest
expense
|
|
(14.8)
|
|
|
(6.7)
|
|
|
(56.9)
|
|
|
(30.2)
|
|
|
|
57.6
|
|
|
214.1
|
|
|
233.8
|
|
|
219.3
|
|
|
|
|
|
|
|
|
|
|
Income before income
taxes
|
|
1,224.6
|
|
|
889.8
|
|
|
3,810.4
|
|
|
2,429.1
|
|
|
|
|
|
|
|
|
|
|
Income tax
expense
|
|
75.4
|
|
|
97.8
|
|
|
297.2
|
|
|
313.3
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
1,149.2
|
|
|
$
|
792.0
|
|
|
$
|
3,513.2
|
|
|
$
|
2,115.8
|
|
|
|
|
|
|
|
|
|
|
Net income per share
- basic
|
|
$
|
10.90
|
|
|
$
|
7.25
|
|
|
$
|
32.65
|
|
|
$
|
19.38
|
|
Net income per share
- diluted
|
|
$
|
10.24
|
|
|
$
|
6.93
|
|
|
$
|
30.52
|
|
|
$
|
18.46
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding - basic
|
|
105.4
|
|
|
109.2
|
|
|
107.6
|
|
|
109.2
|
|
Weighted average
shares outstanding - diluted
|
|
112.2
|
|
|
114.3
|
|
|
115.1
|
|
|
114.6
|
|
|
|
|
|
|
* Certain revisions
have been made to the previously reported December 31, 2019
amounts. See note (4) above.
|
TABLE 3
|
REGENERON
PHARMACEUTICALS, INC.
RECONCILIATION OF
GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited)
(In millions,
except per share data)
|
|
|
|
Three Months
Ended
December 31,
|
|
Year Ended
December 31,
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
GAAP
R&D
|
|
$
|
744.5
|
|
$
|
552.4
|
|
$
|
2,735.0
|
|
$
|
2,450.0
|
R&D: Non-cash
share-based compensation expense
|
|
69.1
|
|
72.4
|
|
238.6
|
|
250.4
|
R&D: Up-front
payments related to license and collaboration
agreements
|
|
—
|
|
30.0
|
|
85.0
|
|
430.0
|
Non-GAAP
R&D
|
|
$
|
675.4
|
|
$
|
450.0
|
|
$
|
2,411.4
|
|
$
|
1,769.6
|
|
|
|
|
|
|
|
|
|
GAAP
SG&A
|
|
$
|
303.5
|
|
$
|
451.8
|
|
$
|
1,346.0
|
|
$
|
1,341.9
|
SG&A: Non-cash
share-based compensation expense
|
|
38.6
|
|
45.4
|
|
153.0
|
|
167.7
|
SG&A: Litigation
contingencies
|
|
(121.0)
|
|
60.0
|
|
(95.0)
|
|
70.0
|
SG&A:
Restructuring-related expenses
|
|
5.2
|
|
35.2
|
|
8.1
|
|
35.2
|
Non-GAAP
SG&A
|
|
$
|
380.7
|
|
$
|
311.2
|
|
$
|
1,279.9
|
|
$
|
1,069.0
|
|
|
|
|
|
|
|
|
|
GAAP COGS
|
|
$
|
179.6
|
|
$
|
108.5
|
|
$
|
491.9
|
|
$
|
362.3
|
COGS: Non-cash
share-based compensation expense
|
|
13.8
|
|
15.7
|
|
40.4
|
|
46.2
|
COGS: Other
|
|
—
|
|
—
|
|
0.9
|
|
—
|
Non-GAAP
COGS
|
|
$
|
165.8
|
|
$
|
92.8
|
|
$
|
450.6
|
|
$
|
316.1
|
|
|
|
|
|
|
|
|
|
GAAP other income
(expense), net
|
|
$
|
57.6
|
|
$
|
214.1
|
|
$
|
233.8
|
|
$
|
219.3
|
Other income/expense:
Gains on investments
|
|
(59.5)
|
|
(189.0)
|
|
(221.6)
|
|
(118.3)
|
Interest expense:
Other
|
|
—
|
|
—
|
|
12.7
|
|
—
|
Non-GAAP other income
(expense), net
|
|
$
|
(1.9)
|
|
$
|
25.1
|
|
$
|
24.9
|
|
$
|
101.0
|
|
|
|
|
|
|
|
|
|
GAAP net
income
|
|
$
|
1,149.2
|
|
$
|
792.0
|
|
$
|
3,513.2
|
|
$
|
2,115.8
|
Total of GAAP to
non-GAAP reconciling items above
|
|
(53.8)
|
|
69.7
|
|
222.1
|
|
881.2
|
Income tax effect of
GAAP to non-GAAP reconciling items
|
|
14.8
|
|
(4.1)
|
|
(38.9)
|
|
(169.9)
|
Income tax
expense: Impact of sale of assets between foreign
subsidiaries
|
|
(30.0)
|
|
—
|
|
|
(30.0)
|
|
—
|
|
Non-GAAP net
income
|
|
$
|
1,080.2
|
|
$
|
857.6
|
|
$
|
3,666.4
|
|
$
|
2,827.1
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
$
|
10.25
|
|
$
|
7.85
|
|
$
|
34.07
|
|
$
|
25.89
|
Non-GAAP net income
per share - diluted
|
|
$
|
9.53
|
|
$
|
7.50
|
|
$
|
31.47
|
|
$
|
24.67
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating:
|
|
|
|
|
|
|
|
|
Non-GAAP net income
per share - basic
|
|
105.4
|
|
109.2
|
|
107.6
|
|
109.2
|
Non-GAAP net income
per share - diluted
|
|
113.4
|
|
114.3
|
|
116.5
|
|
114.6
|
|
|
|
|
|
|
|
|
|
Effective tax rate
reconciliation:
|
|
|
|
|
|
|
|
|
GAAP effective tax
rate
|
|
6.2
|
%
|
|
11.0
|
%
|
|
7.8
|
%
|
|
12.9
|
%
|
Income tax effect of
GAAP to non-GAAP reconciling items
|
|
1.5
|
%
|
|
(0.4)
|
%
|
|
1.3
|
%
|
|
1.7
|
%
|
Non-GAAP effective
tax rate
|
|
7.7
|
%
|
|
10.6
|
%
|
|
9.1
|
%
|
|
14.6
|
%
|
|
|
|
|
|
|
|
|
|
Free cash flow
reconciliation:
|
|
|
|
|
|
|
|
|
Net cash provided by
operating activities
|
|
$
|
1,231.0
|
|
$
|
787.4
|
|
$
|
2,618.1
|
|
$
|
2,430.0
|
Capital
expenditures
|
|
(161.4)
|
|
(139.0)
|
|
(614.6)
|
|
(429.6)
|
Free cash
flow
|
|
$
|
1,069.6
|
|
$
|
648.4
|
|
$
|
2,003.5
|
|
$
|
2,000.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TABLE 4
|
REGENERON
PHARMACEUTICALS, INC.
COLLABORATION
REVENUE (Unaudited)
(In
millions)
|
|
|
|
Three Months
Ended
December 31,
|
|
Year Ended
December 31,
|
|
|
2020
|
|
2019*
|
|
2020
|
|
2019*
|
Sanofi
collaboration revenue:
|
|
|
|
|
|
|
|
|
Antibody:
|
|
|
|
|
|
|
|
|
Regeneron's share of
profits in connection with
commercialization of antibodies
|
|
$
|
229.6
|
|
|
$
|
104.1
|
|
|
$
|
785.2
|
|
|
$
|
209.3
|
|
Sales-based milestone
earned
|
|
—
|
|
|
—
|
|
|
50.0
|
|
|
—
|
|
Reimbursement for
manufacturing of commercial supplies
|
|
93.0
|
|
|
72.2
|
|
|
368.0
|
|
|
216.0
|
|
Immuno-oncology:
|
|
|
|
|
|
|
|
|
Regeneron's share of
losses in connection with
commercialization of Libtayo outside the United
States
|
|
(8.4)
|
|
|
(5.5)
|
|
|
(25.7)
|
|
|
(21.7)
|
|
Reimbursement for
manufacturing of commercial supplies
|
|
2.9
|
|
|
—
|
|
|
8.9
|
|
|
—
|
|
Total Sanofi
collaboration revenue
|
|
$
|
317.1
|
|
|
$
|
170.8
|
|
|
$
|
1,186.4
|
|
|
$
|
403.6
|
|
|
|
|
|
|
|
|
|
|
Bayer
collaboration revenue:
|
|
|
|
|
|
|
|
|
Regeneron's net profit
in connection with commercialization of
EYLEA outside the United States
|
|
$
|
335.3
|
|
|
$
|
298.1
|
|
|
$
|
1,107.9
|
|
|
$
|
1,091.4
|
|
Reimbursement for
manufacturing of commercial supplies
|
|
25.3
|
|
|
12.7
|
|
|
78.2
|
|
|
54.2
|
|
Total Bayer
collaboration revenue
|
|
$
|
360.6
|
|
|
$
|
310.8
|
|
|
$
|
1,186.1
|
|
|
$
|
1,145.6
|
|
|
|
|
|
|
* Certain revisions
have been made to the previously reported December 31, 2019
amounts. See note (4) above.
|
TABLE 5
|
REGENERON
PHARMACEUTICALS, INC.
NET PRODUCT SALES
OF REGENERON-DISCOVERED PRODUCTS (Unaudited)
(In
millions)
|
|
|
|
Net Product
Sales
Recorded by
Regeneron
|
|
Three Months
Ended
December 31,
|
|
|
|
|
|
2020
|
|
2019
|
|
%
Change
|
|
|
|
U.S.
|
|
ROW
|
|
Total
|
|
U.S.
|
|
ROW
|
|
Total
|
|
(Total
Sales)
|
EYLEA(a)
|
|
U.S.
|
|
$
|
1,343.2
|
|
|
$
|
858.8
|
|
|
$
|
2,202.0
|
|
|
$
|
1,222.1
|
|
|
$
|
782.5
|
|
|
$
|
2,004.6
|
|
|
10
|
%
|
Dupixent
|
|
(b)
|
|
$
|
925.6
|
|
|
$
|
246.4
|
|
|
$
|
1,172.0
|
|
|
$
|
605.2
|
|
|
$
|
146.3
|
|
|
$
|
751.5
|
|
|
56
|
%
|
Libtayo(b)
|
|
U.S.
|
|
$
|
74.1
|
|
|
$
|
23.2
|
|
|
$
|
97.3
|
|
|
$
|
60.5
|
|
|
$
|
14.2
|
|
|
$
|
74.7
|
|
|
30
|
%
|
Praluent(c)
|
|
U.S.
|
|
$
|
55.2
|
|
|
$
|
45.7
|
|
|
$
|
100.9
|
|
|
$
|
43.1
|
|
|
$
|
38.3
|
|
|
$
|
81.4
|
|
|
24
|
%
|
Kevzara
|
|
(b)
|
|
$
|
36.6
|
|
|
$
|
34.9
|
|
|
$
|
71.5
|
|
|
$
|
37.6
|
|
|
$
|
22.1
|
|
|
$
|
59.7
|
|
|
20
|
%
|
REGEN-COV(d)
|
|
U.S.
|
|
$
|
145.5
|
|
|
—
|
|
|
$
|
145.5
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(e)
|
ZALTRAP
|
|
(b)
|
|
$
|
0.9
|
|
|
$
|
23.9
|
|
|
$
|
24.8
|
|
|
$
|
2.4
|
|
|
$
|
26.5
|
|
|
$
|
28.9
|
|
|
(14)
|
%
|
ARCALYST
|
|
U.S.
|
|
$
|
3.8
|
|
|
—
|
|
|
$
|
3.8
|
|
|
$
|
3.8
|
|
|
—
|
|
|
$
|
3.8
|
|
|
—
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Product
Sales
Recorded by
Regeneron
|
|
Year Ended
December 31,
|
|
|
|
|
|
2020
|
|
2019
|
|
%
Change
|
|
|
|
U.S.
|
|
ROW
|
|
Total
|
|
U.S.
|
|
ROW
|
|
Total
|
|
(Total
Sales)
|
EYLEA(a)
|
|
U.S.
|
|
$
|
4,947.2
|
|
|
$
|
2,961.5
|
|
|
$
|
7,908.7
|
|
|
$
|
4,644.2
|
|
|
$
|
2,897.4
|
|
|
$
|
7,541.6
|
|
|
5
|
%
|
Dupixent
|
|
(b)
|
|
$
|
3,226.2
|
|
|
$
|
818.6
|
|
|
$
|
4,044.8
|
|
|
$
|
1,871.2
|
|
|
$
|
444.4
|
|
|
$
|
2,315.6
|
|
|
75
|
%
|
Libtayo(b)
|
|
U.S.
|
|
$
|
270.7
|
|
|
$
|
77.5
|
|
|
$
|
348.2
|
|
|
$
|
175.7
|
|
|
$
|
18.1
|
|
|
$
|
193.8
|
|
|
80
|
%
|
Praluent(c)
|
|
U.S.
|
|
$
|
186.0
|
|
|
$
|
172.8
|
|
|
$
|
358.8
|
|
|
$
|
126.0
|
|
|
$
|
162.7
|
|
|
$
|
288.7
|
|
|
24
|
%
|
Kevzara
|
|
(b)
|
|
$
|
141.6
|
|
|
$
|
128.3
|
|
|
$
|
269.9
|
|
|
$
|
129.0
|
|
|
$
|
77.7
|
|
|
$
|
206.7
|
|
|
31
|
%
|
REGEN-COV(d)
|
|
U.S.
|
|
$
|
185.7
|
|
|
—
|
|
|
$
|
185.7
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(e)
|
ZALTRAP
|
|
(b)
|
|
$
|
5.8
|
|
|
$
|
97.9
|
|
|
$
|
103.7
|
|
|
$
|
7.3
|
|
|
$
|
101.1
|
|
|
$
|
108.4
|
|
|
(4)
|
%
|
ARCALYST
|
|
U.S.
|
|
$
|
13.1
|
|
|
—
|
|
|
$
|
13.1
|
|
|
$
|
14.5
|
|
|
—
|
|
|
$
|
14.5
|
|
|
(10)
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) Regeneron records net product
sales of EYLEA in the United States. Bayer records net product
sales of EYLEA outside the United States. The Company records its
share of profits/losses in connection with sales of EYLEA outside
the United States.
|
(b) Regeneron records net product
sales of Libtayo in the United States. Sanofi records net product
sales of Libtayo outside the United States and global net product
sales of Dupixent, Kevzara, and ZALTRAP. The Company records its
share of profits/losses in connection with (i) sales of Libtayo
outside the United States, and (ii) global sales of Dupixent and
Kevzara, within collaboration revenue (see Table 4). Sanofi pays
the Company a percentage of net sales of ZALTRAP.
|
(c) Effective April 1, 2020,
Regeneron records net product sales of Praluent in the United
States. Also effective April 1, 2020, Sanofi records net product
sales of Praluent outside the United States and pays the Company a
royalty on such sales. Previously, Sanofi recorded global net
product sales of Praluent and the Company recorded its share of
profits/losses in connection with such sales.
|
(d) Regeneron records net product
sales of REGEN-COV in connection with its agreements with the U.S.
government.
|
(e) Percentage not
meaningful
|
View original
content:http://www.prnewswire.com/news-releases/regeneron-reports-fourth-quarter-and-full-year-2020-financial-and-operating-results-301222814.html
SOURCE Regeneron Pharmaceuticals, Inc.