TARRYTOWN, N.Y., May 4, 2022
/PRNewswire/ --
- First quarter 2022 revenues increased 17% to $2.97 billion versus first quarter 2021;
excluding REGEN-COV®(a)(b), revenues
increased 25%
- First quarter 2022 EYLEA® U.S. net sales
increased 13% to $1.52 billion versus
first quarter 2021
- First quarter 2022 Dupixent® global net
sales(c)(recorded by Sanofi) increased 43% to
$1.81 billion versus first quarter
2021
- First quarter 2022 GAAP diluted EPS of $8.61; non-GAAP diluted EPS(a) of
$11.49
- Dupixent approved in EU for children aged 6–11 years with
severe asthma; FDA priority review granted for atopic dermatitis in
children aged 6 months to 5 years and eosinophilic
esophagitis
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced financial results for the first quarter of 2022 and
provided a business update.
"Our strong first quarter performance was marked by top- and
bottom-line growth, accompanied by R&D progress and continued
investment in our pipeline," said Leonard
S. Schleifer, M.D., Ph.D., President and Chief Executive
Officer of Regeneron. "We continued to see substantial U.S. sales
growth for EYLEA and Dupixent worldwide. We are well-positioned to
reach even more patients with type 2 inflammatory disease through
FDA priority review designations for Dupixent in children with
atopic dermatitis and in adults and adolescents with eosinophilic
esophagitis."
Financial Highlights
($ in millions,
except per share data)
|
|
Q1
2022
|
|
Q1
2021
|
|
%
Change
|
Total
revenues
|
|
$ 2,965
|
|
$ 2,529
|
|
17%
|
GAAP net
income
|
|
$
974
|
|
$ 1,115
|
|
(13%)
|
GAAP net income per
share - diluted
|
|
$
8.61
|
|
$ 10.09
|
|
(15%)
|
Non-GAAP net
income(a)
|
|
$ 1,318
|
|
$ 1,109
|
|
19%
|
Non-GAAP net income per
share - diluted(a)
|
|
$ 11.49
|
|
$
9.89
|
|
16%
|
"Our business achieved strong revenue growth in the first
quarter of 2022 as we continue to realize the benefits of our
sustained R&D investment and our focus on commercial
execution," said Robert E. Landry,
Executive Vice President, Finance and Chief Financial Officer of
Regeneron. "We remain confident that our differentiated products
and significant pipeline opportunities position us well to deliver
strong results and provide sustainable value to patients and
shareholders."
Business Highlights
Key Pipeline Progress
Regeneron has approximately 35 product candidates in clinical
development, including a number of marketed products for which it
is investigating additional indications. Updates from the clinical
pipeline include:
EYLEA® (aflibercept) Injection
- A supplemental Biologics License Application (sBLA) for EYLEA
for an every-16-weeks dosing regimen in patients with
non-proliferative diabetic retinopathy (NPDR) was submitted.
Aflibercept 8 mg
- In February 2022, the Company
announced detailed results from its Phase 2 trial evaluating an
investigational 8 mg high dose of aflibercept compared to the
currently-approved 2 mg dose of EYLEA in patients with neovascular
age-related macular degeneration (wet AMD). The trial met its
primary endpoints for safety, and no new safety signals were
observed through week 44. Consistent with initial data announced
last year, aflibercept 8 mg continued to show numeric improvements
in anatomical and vision outcomes compared to EYLEA through 44
weeks.
Dupixent® (dupilumab)
- In April 2022, the European
Commission (EC) approved Dupixent for the treatment of severe
asthma in children aged 6 to 11 years.
- The U.S. Food and Drug Administration (FDA) accepted for
priority review the sBLA for Dupixent for children aged 6 months to
5 years with moderate-to-severe atopic dermatitis, with a target
action date of June 9, 2022. A
regulatory application was also submitted in the European Union
(EU).
- The FDA accepted for priority review the sBLA for Dupixent for
adults and adolescents aged 12 years and older with eosinophilic
esophagitis (EoE), with a target action date of August 3, 2022. A regulatory application was also
submitted in the EU.
- In January 2022, the Company and
Sanofi announced positive results from a second Phase 3 trial in
adults with uncontrolled prurigo nodularis. An sBLA and a
regulatory submission in the EU for Dupixent for adults with
uncontrolled prurigo nodularis were subsequently submitted.
- In February 2022, the Company and
Sanofi provided an update on Dupixent in patients with chronic
spontaneous urticaria (CSU), in which they had previously reported
positive results from the first trial in biologic-naïve patients
(i.e., not previously treated with omalizumab) that showed Dupixent
significantly reduced itch and hives compared to standard-of-care
antihistamines alone. The Company and Sanofi announced that they
stopped a second trial in patients refractory to omalizumab due to
futility.
Antibodies to SARS-CoV-2 virus
- In April 2022, the Company
announced that the FDA extended by three months its review of the
BLA for REGEN-COV® (casirivimab and imdevimab) to treat
COVID-19 in non-hospitalized patients and as prophylaxis in certain
individuals. The extension is due to ongoing discussions with the
FDA on pre-exposure prophylactic use, for which Regeneron has
submitted additional data from its completed prophylaxis trial that
the FDA has accepted for review. The FDA determined these
additional data constitute a Major Amendment to the BLA and
provided a new target action date of July
13, 2022.
- A regulatory application was submitted in the EU for
RonapreveTM(b) for the treatment of COVID-19
in hospitalized patients.
- 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 an
Omicron-lineage variant that is not susceptible to the treatment.
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.
- The Company is progressing investigational "next generation"
antibodies that are active against multiple variants including
those of Omicron-lineage, and has initiated a first-in-human
clinical trial.
Fianlimab, an antibody to LAG-3
- A Phase 3 study in first-line metastatic melanoma was
initiated.
Odronextamab, a CD20xCD3 bispecific antibody
- The FDA granted Fast Track designation for follicular lymphoma
and diffuse large B-cell lymphoma.
NTLA-2001, a CRISPR/Cas9 therapeutic for TTR gene knockout
- In February 2022, Intellia
Therapeutics, Inc. and the Company reported updated positive
interim data from the Phase 1 trial in transthyretin (ATTR)
amyloidosis.
Business Development Update
- In April 2022, the Company
entered into a definitive merger agreement to acquire Checkmate
Pharmaceuticals, Inc. at a total equity value of approximately
$250 million. On May 2, 2022, the Company initiated a tender offer
to acquire any and all outstanding shares of Checkmate common stock
at a price of $10.50 per share, to be
paid to each shareholder tendering Checkmate shares in cash,
without interest, subject to reduction for any applicable
withholding taxes. The transaction is expected to close, subject to
the satisfaction of customary closing conditions including
regulatory approvals, in mid-2022.
First Quarter 2022 Financial Results
Revenues
Total revenues increased by 17% to $2.965
billion in the first quarter of 2022, compared to
$2.529 billion in the first quarter
of 2021. Total revenues excluding REGEN-COV and
Ronapreve(b) revenues for both periods increased by 25%
to $2.749 billion in the first
quarter of 2022, compared to the first quarter of
2021(a).
Net product sales recorded by the Company consist of the
following:
($ in
millions)
|
|
Q1
2022
|
|
Q1
2021
|
|
%
Change
|
EYLEA
|
|
$ 1,518
|
|
$
1,347
|
|
13%
|
Libtayo
|
|
79
|
|
69
|
|
14%
|
Praluent®
|
|
34
|
|
43
|
|
(21%)
|
REGEN-COV
|
|
—
|
|
262
|
|
(100%)
|
Evkeeza
|
|
8
|
|
1
|
|
**
|
ARCALYST®
|
|
— *
|
|
2
|
|
**
|
Total net product sales in the U.S.
|
|
$ 1,639
|
|
$
1,724
|
|
(5%)
|
|
|
|
|
|
|
|
* 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
|
Total revenues also include collaboration
revenues(c) of $1.233 billion in the first
quarter of 2022, compared to $754 million in the first quarter
of 2021. Sanofi collaboration revenue increased primarily due to
the Company's share of profits from commercialization of
antibodies, which were $415 million in the first quarter of
2022, compared to $261 million in the first quarter of 2021.
The change in the Company's share of profits from commercialization
of antibodies was driven by higher Dupixent profits. In the first
quarter of 2022, the Company earned a $50 million sales-based
milestone from Sanofi, upon aggregate annual sales of antibodies
outside the United States exceeding $2.0 billion on a rolling
twelve-month basis.
Bayer collaboration revenue increased to $385 million in
the first quarter of 2022, compared to $323 million in the
first quarter of 2021.
The Company also recorded Roche collaboration revenue of
$216 million for the first quarter of 2022, compared to
$67 million in the first quarter of 2021, in connection with
payments from Roche attributable to global gross profits from sales
of Ronapreve.
Refer to Table 4 for a summary of collaboration revenue.
Other revenue in the first quarter of 2022 included a
$30 million up-front payment received
from Ultragenyx in connection with the Company's Evkeeza license
and collaboration agreement.
Operating Expenses
|
|
GAAP
|
|
%
Change
|
|
Non-GAAP(a)
|
|
%
Change
|
|
($ in
millions)
|
|
Q1
2022
|
|
Q1
2021
|
|
|
Q1
2022
|
|
Q1
2021
|
|
|
Research and
development (R&D)
|
|
$ 844
|
|
$ 743
|
|
14%
|
|
$ 751
|
|
$ 673
|
|
12%
|
|
Acquired in-process
research and
development (IPR&D)**
|
|
$
28
|
|
$
—
|
|
100%
|
|
*
|
|
*
|
|
n/a
|
|
Selling, general, and
administrative
(SG&A)
|
|
$ 450
|
|
$ 406
|
|
11%
|
|
$ 389
|
|
$ 355
|
|
10%
|
|
Cost of goods sold
(COGS)
|
|
$ 207
|
|
$ 183
|
|
13%
|
|
$ 136
|
|
$ 173
|
|
(21%)
|
|
Cost of collaboration
and contract
manufacturing (COCM)
|
|
$ 198
|
|
$ 125
|
|
58%
|
|
*
|
|
*
|
|
n/a
|
|
Other operating
(income) expense,
net
|
|
$ (20)
|
|
$ (41)
|
|
(51%)
|
|
*
|
|
*
|
|
n/a
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* GAAP and non-GAAP amounts are equivalent as no
non-GAAP adjustments have been recorded.
|
** Beginning with the first quarter of 2022, the Company
added this new line item to its Statements of Operations, which
includes in-process R&D acquired in connection with asset
acquisitions as well as up-front/opt-in payments related to license
and collaboration agreements. Amounts recorded in this line would
have historically been recorded to R&D. In addition, the
Company has modified its presentation of non-GAAP reporting and
will no longer exclude such expenses from its non-GAAP results.
This change does not affect previously reported first quarter 2021
non-GAAP results as the Company recorded no significant charges
related to such transactions during that period.
|
- GAAP and non-GAAP R&D expenses increased in the first
quarter of 2022, compared to the first quarter of 2021, primarily
due to higher headcount and headcount-related costs, an increase in
clinical manufacturing activities, and lower reimbursements from
Roche related to REGEN-COV. The increase was partly offset by lower
costs incurred in connection with REGEN-COV development
activities.
- Acquired IPR&D in the first quarter of 2022 included a
$20 million opt-in payment in
connection with a product candidate under the Company's
collaboration agreement with Adicet Bio, Inc.
- The increase in GAAP and non-GAAP SG&A expenses in the
first quarter of 2022, compared to the first quarter of 2021, was
primarily due to higher headcount and headcount-related costs and
an increase in commercialization-related expenses for EYLEA.
- GAAP COGS in the first quarter of 2022 included $58 million of costs related to REGEN-COV,
including inventory write-offs and reserves, as a result of the FDA
revision of the EUA for REGEN-COV (as described above). GAAP and
non-GAAP COGS in the first quarter of 2022 included lower REGEN-COV
manufacturing costs since there were no net product sales in
the United States.
- COCM increased in the first quarter of 2022, compared to the
first quarter of 2021, primarily due to the recognition of
manufacturing costs associated with higher sales of Dupixent and an
increase in shipments of commercial supplies of Praluent for Sanofi
outside the United States.
Other Financial Information
GAAP other income (expense) included the recognition of net
unrealized losses on equity securities of $211 million in the
first quarter of 2022, compared to $144
million of net unrealized gains in the first quarter of
2021.
In the first quarter of 2022, the Company's GAAP effective tax
rate was 8.3%, compared to 11.0% in the first quarter of 2021. The
decrease in the GAAP effective tax rate was due in part to the
impact of stock-based compensation. In the first quarter of 2022,
the non-GAAP effective tax rate was 11.6%, compared to 10.5% in the
first quarter of 2021.
GAAP net income per diluted share was $8.61 in the first quarter of 2022, compared to
$10.09 in the first quarter of 2021.
Non-GAAP net income per diluted share was $11.49 in the first quarter of 2022, compared to
$9.89 in the first quarter of 2021. A
reconciliation of the Company's GAAP to non-GAAP results is
included in Table 3 of this press release.
During the first quarter of 2022, the Company repurchased shares
of common stock under its share repurchase program, and recorded
the cost of the shares received, or $352 million, as Treasury
Stock. As of March 31, 2022,
$2.493 billion remained
available for share repurchases under the program.
Net cash provided by operating activities in the first quarter
of 2022 was $2.102 billion,
compared to $669 million in the first
quarter of 2021, resulting in $1.960 billion in free cash flow for the
first quarter of 2022, compared to $553
million for the first quarter of 2021. The increase in free
cash flow in the first quarter of 2022 was primarily due to the
Company's collection of amounts due from the U.S. government in
connection with REGEN-COV sales in the fourth quarter of 2021.
2022 Financial
Guidance(d)
The Company's full year 2022 financial guidance consists of the
following components:
|
|
GAAP
|
|
Non-GAAP(a)
|
R&D
|
|
$3.270 billion–$3.500
billion
(previously $3.170
billion–$3.400 billion)
|
|
$2.900 billion–$3.100
billion
(previously $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(e)
|
|
89%–91%
|
|
90%–92%
|
COCM(f)
|
|
$750 million–$830
million
|
|
*
|
Other operating
(income) expense, net
|
|
($60) million–($80)
million
|
|
*
|
Capital
expenditures
|
|
$630 million–$700
million
(previously $650
million–$730 million)
|
|
*
|
Effective tax rate
(ETR)
|
|
11%–13%**
(previously
12%–14%)
|
|
12%–14%**
(previously
13%–15%)
|
|
|
|
|
|
* GAAP and non-GAAP amounts are equivalent as no
non-GAAP adjustments have been or are expected to be
recorded.
|
** ETR guidance excludes the impact of the provision
requiring capitalization and amortization of R&D expenses
enacted as part of the Tax Cuts and Job Act (TCJA), as management's
current expectation is it will be deferred or repealed by Congress
in 2022. If this provision of the TCJA is not deferred or repealed,
the Company would expect its ETR to be lower than the guidance
disclosed herein.
|
A reconciliation of full year 2022 GAAP to non-GAAP financial
guidance is included below:
|
|
Projected
Range
|
($ in
millions)
|
|
Low
|
|
High
|
GAAP R&D
|
|
$
3,270
|
|
$
3,500
|
R&D: Stock-based compensation expense
|
|
(370)
|
|
(400)
|
Non-GAAP
R&D
|
|
$
2,900
|
|
$
3,100
|
|
|
|
|
|
GAAP
SG&A
|
|
$
1,890
|
|
$
2,030
|
SG&A: Stock-based compensation expense
|
|
(240)
|
|
(260)
|
Non-GAAP
SG&A
|
|
$
1,650
|
|
$
1,770
|
|
|
|
|
|
GAAP gross margin on
net product sales
|
|
89%
|
|
91%
|
Stock-based compensation expense
|
|
<1%
|
|
<1%
|
Charges related to REGEN-COV
|
|
<1%
|
|
<1%
|
Non-GAAP gross margin
on net product sales
|
|
90%
|
|
92%
|
|
|
|
|
|
GAAP ETR
|
|
11%
|
|
13%
|
Income tax effect of GAAP to non-GAAP
reconciling items and other
|
|
1%
|
|
1%
|
Non-GAAP ETR
|
|
12%
|
|
14%
|
(a)
|
This press release uses
non-GAAP R&D, non-GAAP SG&A, non-GAAP COGS, non-GAAP gross
margin on net product sales, non-GAAP other income (expense), net,
non-GAAP effective tax rate, non-GAAP net income, non-GAAP net
income per share, total revenues excluding REGEN-COV and Ronapreve,
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 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.
|
|
|
(b)
|
The casirivimab and
imdevimab antibody cocktail is known as REGEN-COV in the United
States and Ronapreve 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.
|
|
|
(c)
|
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.
|
|
|
(d)
|
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.
|
|
|
(e)
|
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.
|
|
|
(f)
|
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 first quarter 2022 financial and operating results
on Wednesday, May 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/7327199. 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,
develops, and commercializes life-transforming medicines for people
with serious diseases. Founded and led for nearly 35 years by
physician-scientists, Regeneron's unique ability to repeatedly and
consistently translate science into medicine has led to numerous
FDA-approved treatments and 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 Regeneron, 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, fianlimab, 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; the likelihood that any planned or future acquisitions,
business combinations, or other related transactions, such as
Regeneron's planned acquisition of Checkmate Pharmaceuticals, Inc.
discussed in this press release, will close within the expected
time period or at all and whether and to what extent Regeneron will
realize any anticipated benefits of any such transaction; and risks
associated with intellectual property of other parties and pending
or future litigation relating thereto (including without limitation
the patent litigation and other related proceedings relating to
EYLEA, Dupixent, Praluent, and REGEN-COV), other litigation and
other proceedings and government investigations relating to the
Company and/or its operations (including the pending civil
litigation initiated by the U.S. Attorney's Office for the District
of Massachusetts), the ultimate
outcome of any such proceedings and investigations, and the impact
any of the foregoing may have on Regeneron's business, prospects,
operating results, and financial condition. A more complete
description of these and other material risks can be found in
Regeneron's filings with the U.S. Securities and Exchange
Commission, including its Form 10-K for the fiscal year ended
December 31, 2021 and its Form 10-Q
for the quarterly period ended March 31,
2022. 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:
|
|
|
|
|
|
Ryan Crowe
|
|
Christina
Chan
|
Investor
Relations
|
|
Corporate
Communications
|
914-847-8790
|
|
914-847-8827
|
ryan.crowe@regeneron.com
|
|
christina.chan@regeneron.com
|
TABLE 1
|
|
REGENERON
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS (Unaudited)
(In
millions)
|
|
|
|
March 31,
|
|
December 31,
|
|
|
2022
|
|
2021
|
Assets:
|
|
|
|
|
Cash and marketable securities
|
|
$
14,134.6
|
|
$
12,532.7
|
Accounts receivable, net
|
|
4,839.0
|
|
6,036.5
|
Inventories
|
|
1,991.5
|
|
1,951.3
|
Property, plant, and equipment, net
|
|
3,556.4
|
|
3,482.2
|
Deferred tax assets
|
|
1,140.3
|
|
876.9
|
Other assets
|
|
686.9
|
|
555.2
|
Total assets
|
|
$
26,348.7
|
|
$
25,434.8
|
|
|
|
|
|
Liabilities and
stockholders' equity:
|
|
|
|
|
Accounts payable, accrued expenses, and other
liabilities
|
|
$
3,208.8
|
|
$
3,451.0
|
Finance lease liabilities
|
|
720.0
|
|
719.7
|
Deferred revenue
|
|
524.8
|
|
515.3
|
Long-term debt
|
|
1,980.4
|
|
1,980.0
|
Stockholders' equity
|
|
19,914.7
|
|
18,768.8
|
Total liabilities and
stockholders' equity
|
|
$
26,348.7
|
|
$
25,434.8
|
TABLE 2
|
|
REGENERON
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
(In millions,
except per share data)
|
|
|
|
Three Months Ended
March 31,
|
|
|
2022
|
|
2021
|
Revenues:
|
|
|
|
|
Net
product sales
|
|
$
1,638.6
|
|
$
1,724.3
|
Collaboration revenue
|
|
1,232.5
|
|
754.4
|
Other revenue
|
|
94.0
|
|
50.0
|
|
|
2,965.1
|
|
2,528.7
|
Expenses:
|
|
|
|
|
Research and development
|
|
843.8
|
|
742.9
|
Acquired in-process research and development
|
|
28.1
|
|
—
|
Selling, general, and administrative
|
|
450.0
|
|
405.6
|
Cost of goods sold
|
|
207.3
|
|
183.2
|
Cost of collaboration and contract manufacturing
|
|
197.6
|
|
124.8
|
Other operating (income) expense, net
|
|
(20.2)
|
|
(40.5)
|
|
|
1,706.6
|
|
1,416.0
|
|
|
|
|
|
Income from
operations
|
|
1,258.5
|
|
1,112.7
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
Other (expense) income, net
|
|
(183.8)
|
|
154.9
|
Interest expense
|
|
(13.6)
|
|
(14.6)
|
|
|
(197.4)
|
|
140.3
|
|
|
|
|
|
Income before income
taxes
|
|
1,061.1
|
|
1,253.0
|
|
|
|
|
|
Income tax
expense
|
|
87.6
|
|
137.8
|
|
|
|
|
|
Net income
|
|
$
973.5
|
|
$
1,115.2
|
|
|
|
|
|
Net income per share -
basic
|
|
$
9.12
|
|
$
10.58
|
Net income per share -
diluted
|
|
$
8.61
|
|
$
10.09
|
|
|
|
|
|
Weighted average shares
outstanding - basic
|
|
106.8
|
|
105.4
|
Weighted average shares
outstanding - diluted
|
|
113.1
|
|
110.5
|
TABLE 3
|
|
REGENERON
PHARMACEUTICALS, INC.
RECONCILIATION OF
GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited)
(In millions,
except per share data)
|
|
|
|
Three Months Ended
March 31,
|
|
|
2022
|
|
2021
|
GAAP R&D
|
|
$
843.8
|
|
$
742.9
|
R&D: Stock-based compensation expense
|
|
92.4
|
|
69.7
|
Non-GAAP
R&D
|
|
$
751.4
|
|
$
673.2
|
|
|
|
|
|
GAAP
SG&A
|
|
$
450.0
|
|
$
405.6
|
SG&A: Stock-based compensation expense
|
|
60.7
|
|
50.8
|
Non-GAAP
SG&A
|
|
$
389.3
|
|
$
354.8
|
|
|
|
|
|
GAAP COGS
|
|
$
207.3
|
|
$
183.2
|
COGS: Stock-based compensation expense
|
|
13.8
|
|
10.4
|
COGS: Charges related to REGEN-COV
|
|
58.0
|
|
—
|
Non-GAAP
COGS
|
|
$
135.5
|
|
$
172.8
|
|
|
|
|
|
GAAP other income
(expense), net
|
|
$ (197.4)
|
|
$
140.3
|
Other income/expense: Losses (gains) on
investments
|
|
204.5
|
|
(144.3)
|
Non-GAAP other income
(expense), net
|
|
$
7.1
|
|
$
(4.0)
|
|
|
|
|
|
GAAP net
income
|
|
$
973.5
|
|
$
1,115.2
|
Total of GAAP to non-GAAP reconciling items above
|
|
429.4
|
|
(13.4)
|
Income tax effect of GAAP to non-GAAP reconciling
items
|
|
(85.3)
|
|
7.4
|
Non-GAAP net
income
|
|
$
1,317.6
|
|
$
1,109.2
|
|
|
|
|
|
Non-GAAP net income per
share - basic
|
|
$
12.34
|
|
$
10.52
|
Non-GAAP net income per
share - diluted
|
|
$
11.49
|
|
$
9.89
|
|
|
|
|
|
Shares used in calculating:
|
|
|
|
|
Non-GAAP net income per
share - basic
|
|
106.8
|
|
105.4
|
Non-GAAP net income per
share - diluted
|
|
114.7
|
|
112.1
|
RECONCILIATION OF
GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited)
(continued)
|
|
|
|
Three Months Ended
March 31,
|
|
|
2022
|
|
2021
|
Revenue reconciliation:
|
|
|
|
|
Total
revenues
|
|
$
2,965.1
|
|
$
2,528.7
|
REGEN-COV net product
sales in the United States
|
|
—
|
|
262.2
|
Global gross profit
payment from Roche in connection with sales of
Ronapreve
|
|
216.3
|
|
66.8
|
Total revenues
excluding REGEN-COV and Ronapreve
|
|
$
2,748.8
|
|
$
2,199.7
|
|
|
|
|
|
Effective tax rate
reconciliation:
|
|
|
|
|
GAAP effective tax
rate
|
|
8.3 %
|
|
11.0 %
|
Income tax effect of GAAP to non-GAAP reconciling
items
|
|
3.3%
|
|
(0.5%)
|
Non-GAAP effective tax
rate
|
|
11.6 %
|
|
10.5 %
|
|
|
|
|
|
Free cash flow reconciliation:
|
|
|
|
|
Net cash provided by
operating activities
|
|
$
2,101.7
|
|
$
668.5
|
Capital
expenditures
|
|
(141.8)
|
|
(115.3)
|
Free cash
flow
|
|
$
1,959.9
|
|
$
553.2
|
TABLE 4
|
|
REGENERON
PHARMACEUTICALS, INC.
COLLABORATION
REVENUE (Unaudited)
(In
millions)
|
|
|
|
Three Months Ended
March 31,
|
|
|
2022
|
|
2021
|
Sanofi collaboration revenue:
|
|
|
|
|
Antibody:
|
|
|
|
|
Regeneron's share of profits in
connection with
commercialization of
antibodies
|
|
$
415.3
|
|
$
260.6
|
Sales-based milestone
earned
|
|
50.0
|
|
—
|
Reimbursement for manufacturing
of commercial supplies
|
|
160.8
|
|
105.6
|
Immuno-oncology:
|
|
|
|
|
Regeneron's share of profits
(losses) in connection with
commercialization of
Libtayo outside the United States
|
|
2.8
|
|
(6.1)
|
Reimbursement for manufacturing
of ex-U.S. commercial supplies
|
|
2.0
|
|
4.7
|
Total Sanofi
collaboration revenue
|
|
630.9
|
|
364.8
|
|
|
|
|
|
Bayer collaboration revenue:
|
|
|
|
|
Regeneron's share of profits in connection with
commercialization
of EYLEA outside the United
States
|
|
338.4
|
|
308.9
|
Reimbursement for manufacturing of ex-U.S. commercial
supplies
|
|
25.0
|
|
13.9
|
One-time payment in connection with change in Japan
arrangement
|
|
21.9
|
|
—
|
Total Bayer
collaboration revenue
|
|
385.3
|
|
322.8
|
|
|
|
|
|
Roche collaboration revenue:
|
|
|
|
|
Global gross profit payment from Roche in connection with
sales of
Ronapreve
|
|
216.3
|
|
66.8
|
|
|
|
|
|
Total collaboration
revenue
|
|
$
1,232.5
|
|
$
754.4
|
TABLE 5
|
|
REGENERON
PHARMACEUTICALS, INC.
NET PRODUCT SALES OF
REGENERON-DISCOVERED PRODUCTS (Unaudited)
(In
millions)
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
|
2022
|
|
2021
|
|
% Change
|
|
|
U.S.
|
|
ROW
|
|
Total
|
|
U.S.
|
|
ROW
|
|
Total
|
|
(Total Sales)
|
EYLEA(a)
|
|
$
1,517.6
|
|
$
868.5
|
|
$
2,386.1
|
|
$
1,347.0
|
|
$ 811.2 *
|
|
$
2,158.2
|
|
11%
|
Dupixent(b)
|
|
$
1,325.6
|
|
$
484.8
|
|
$
1,810.4
|
|
$
961.5
|
|
$
301.4
|
|
$
1,262.9
|
|
43%
|
Libtayo(c)
|
|
$
78.9
|
|
$
45.8
|
|
$
124.7
|
|
$
69.1
|
|
$
31.7
|
|
$
100.8
|
|
24%
|
Praluent(d)
|
|
$
33.6
|
|
$
77.8
|
|
$
111.4
|
|
$
43.3
|
|
$
61.3
|
|
$
104.6
|
|
7%
|
REGEN-COV(e)
|
|
$
—
|
|
$
635.6
|
|
$
635.6
|
|
$
262.2
|
|
$
176.6
|
|
$
438.8
|
|
45%
|
Kevzara(b)
|
|
$
57.0
|
|
$
49.4
|
|
$
106.4
|
|
$
30.7
|
|
$
38.4
|
|
$
69.1
|
|
54%
|
Other
products(f)
|
|
$
9.9
|
|
$
20.4
|
|
$
30.3
|
|
$
4.1
|
|
$
23.0
|
|
$
27.1
|
|
12%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Effective January 1, 2022, the
Company and Bayer commenced sharing equally in profits and losses
based on sales from Bayer to its distributor in Japan. Previously,
the Company received from Bayer a tiered percentage of sales based
on sales by Bayer's distributor in Japan. Consequently, the prior
year net product sales amount has been revised for comparability
purposes.
|
(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 and Kevzara. The Company records its share of
profits/losses in connection with global sales of Dupixent and
Kevzara.
|
(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) Regeneron records net product sales
of Praluent in the United States. Sanofi records net product sales
of Praluent outside the United States and pays the Company a
royalty on 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.
|
(f) Included in this line item are
products which are sold by the Company and others. Refer to
Financial Results section above for a complete listing of net
product sales recorded by the Company. In addition, not included in
this line item are net product sales of ARCALYST subsequent to the
first quarter of 2021, which are recorded by Kiniksa; net product
sales of ARCALYST were $18.7 million for the fourth quarter of
2021.
|
View original
content:https://www.prnewswire.com/news-releases/regeneron-reports-first-quarter-2022-financial-and-operating-results-301539104.html
SOURCE Regeneron Pharmaceuticals, Inc.