Regeneron Pharmaceuticals, Inc. (NASDAQ:
REGN)
today announced financial results for the third quarter of 2023 and
provided a business update.
"We have continued our momentum in the third quarter of 2023
with double-digit year-over-year revenue growth, driven by strong
Dupixent and Libtayo performance, as well as strong initial uptake
of EYLEA HD following its late August launch," said Leonard S.
Schleifer, M.D., Ph.D., Board Co-Chair, President and Chief
Executive Officer of Regeneron. "We are also making significant
progress across our diversified pipeline, with FDA priority review
designations for odronextamab in relapsed/refractory (R/R)
follicular lymphoma and R/R diffuse large B-cell lymphoma as well
as for Dupixent in pediatric eosinophilic esophagitis, while also
adding a promising gene therapy platform to our portfolio through
the recent acquisition of Decibel Therapeutics."
Financial
Highlights |
|
($ in millions, except per
share data) |
|
Q3 2023 |
|
Q3 2022 |
|
% Change |
|
Total revenues |
|
$ |
3,363 |
|
$ |
2,936 |
|
15 |
% |
|
GAAP net income |
|
$ |
1,008 |
|
$ |
1,316 |
|
(23 |
%) |
|
GAAP net income per share -
diluted |
|
$ |
8.89 |
|
$ |
11.66 |
|
(24 |
%) |
|
Non-GAAP net income(a) |
|
$ |
1,329 |
|
$ |
1,270 |
|
5 |
% |
|
Non-GAAP net income per share
- diluted(a) |
|
$ |
11.59 |
|
$ |
11.14 |
|
4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
"Our third quarter financial results reflect robust execution
across the enterprise, including notable pipeline advances and
strong commercial performance," said Robert E. Landry, Executive
Vice President, Finance and Chief Financial Officer of Regeneron.
"We also continued to deliver on our capital allocation priorities,
primarily investing in internal and external innovation coupled
with opportunistic share repurchases."
Business Highlights
Key Pipeline ProgressRegeneron 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 HD (aflibercept) 8 mg
- In August 2023, the U.S. Food and Drug Administration (FDA)
approved EYLEA HD for the treatment of patients with wAMD, DME, and
DR.
- The Company announced top-line, two-year (96 weeks) data from
the pivotal PULSAR trial in patients with wAMD. The longer-term
data follow the positive two-year results from the PHOTON trial in
DME, with PULSAR similarly demonstrating that the vast majority of
patients with wAMD were able to maintain or further extend the
dosing intervals. In addition, visual gains for EYLEA HD remained
largely consistent with those observed in the first year of the
trial. In PULSAR, the safety of EYLEA HD continued to be similar to
EYLEA through two years and remained consistent with the known
safety profile of EYLEA from previous clinical trials for wAMD.
These results were also presented at the 23rd EURETINA Congress in
October 2023.
Dupixent (dupilumab)
- In September 2023, the Ministry of Health, Labour and Welfare
(MHLW) in Japan approved Dupixent for the treatment of pediatric
and adolescent patients with atopic dermatitis.
- The FDA accepted for priority review the supplemental Biologics
License Application (sBLA) for the treatment of children aged 1 to
11 years with EoE, with a target action date of January 31, 2024.
The Company and Sanofi also presented, at the American College of
Gastroenterology (ACG) 2023 Annual Scientific Meeting, positive
results from a Phase 3 trial that showed consistent efficacy and
safety for up to one year (52 weeks) in children aged 1 to 11 years
with EoE.
- In October 2023, the FDA issued a Complete Response Letter
(CRL) for the sBLA for Dupixent in chronic spontaneous urticaria
(CSU). The CRL states that additional efficacy data are required to
support an approval; it did not identify any issues with safety or
manufacturing. An ongoing Phase 3 clinical trial (in biologic-naïve
patients) continues to enroll patients, with results expected in
late 2024.
- Based on recent feedback from the FDA, in addition to the
positive results of the Phase 3 BOREAS study, a positive interim
analysis of the replicate Phase 3 NOTUS study in chronic
obstructive pulmonary disease (COPD) would enable an sBLA
submission. The independent data monitoring committee will conduct
an interim analysis of the NOTUS study later this year.
Oncology Programs
- In September 2023, the FDA accepted for priority review the BLA
for odronextamab, a bispecific antibody targeting CD20 and CD3, to
treat adult patients with relapsed/refractory FL and
relapsed/refractory DLBCL who have progressed after at least two
prior systemic therapies, with a target action date of March 31,
2024. A regulatory application for odronextamab has also been
submitted in the European Union (EU).
- Phase 3 studies were initiated for odronextamab in earlier
lines of FL and DLBCL.
- The FDA granted Fast Track designation to fianlimab, an
antibody to LAG-3, in combination with Libtayo (cemiplimab) for the
first-line treatment of patients with metastatic melanoma (for
which a Phase 3 study is ongoing).
- A Phase 3 study was initiated for linvoseltamab, a bispecific
antibody targeting BCMA and CD3, in multiple myeloma.
- The Company presented key secondary endpoints, demonstrating
encouraging event-free survival, from a Phase 2 trial with Libtayo
as a neoadjuvant monotherapy in cutaneous squamous cell carcinoma
(CSCC) at the European Society for Medical Oncology (ESMO) Congress
2023. These results were also concurrently published in The Lancet
Oncology.
Other Programs
- The FDA approved Veopoz (pozelimab-bbfg), an antibody to C5,
for the treatment of adult and pediatric patients 1 year of age and
older with CHAPLE disease, also known as CD55-deficient
protein-losing enteropathy. CHAPLE is an ultra-rare hereditary
disease that can cause potentially life-threatening
gastrointestinal and cardiovascular symptoms.
- The Company announced preliminary, positive safety and efficacy
results from the first patient (<2 years of age) dosed in the
Phase 1/2 trial of DB-OTO, an AAV-based gene therapy, in children
with profound genetic hearing loss due to mutations of the
otoferlin gene.
Business Development Updates
- In September 2023, the Company completed its acquisition of
Decibel Therapeutics, Inc. and paid $101 million in cash, and
may also pay up to a maximum of approximately $97 million to
Decibel shareholders upon achievement of certain clinical
development and regulatory milestones for DB-OTO within specified
time periods. The acquisition builds upon a prior collaboration
between the companies and includes several ongoing gene therapy
programs targeting different forms of congenital, monogenic hearing
loss, including DB-OTO.
- In August 2023, the Company expanded its agreement with the
Biomedical Advanced Research and Development Authority (BARDA) of
the U.S. Department of Health and Human Services (HHS) to support
clinical development, clinical manufacturing, and the regulatory
licensure process of a next-generation COVID-19 monoclonal antibody
therapy for the prevention of SARS-CoV-2 infection. The new
contract has an estimated value of up to approximately
$326 million of government funding for certain development
activities.
- In September 2023, the Company and Intellia Therapeutics, Inc.
expanded their existing collaboration to develop additional in vivo
CRISPR-based gene editing therapies focused on neurological and
muscular diseases. The collaboration will leverage the Company's
proprietary antibody-targeted adeno-associated virus (AAV) vectors
and delivery systems and Intellia's proprietary Nme2 CRISPR/Cas9
(Nme2Cas9) systems adapted for viral vector delivery and designed
to precisely modify a target gene.
Corporate Updates
- The Company is participating in Together for CHANGE™, a
national health and education equity initiative established by
Nashville, Tennessee-based Meharry Medical College. The Together
for CHANGE initiative seeks to address inequities in science,
technology, engineering, and mathematics (STEM) careers and
research. In addition, the Company announced a five-year, $5
million strategic investment to bolster Nashville's STEM ecosystem
through high-quality, equitable engagement programs for students
and science teachers.
- The Company announced that Robert E. Landry, Executive Vice
President, Finance and Chief Financial Officer of Regeneron, will
retire in February 2024. Christopher Fenimore, current Senior Vice
President, Head of Accounting and Controller at Regeneron, will
succeed Mr. Landry as Chief Financial Officer upon his
retirement.
- The Company announced that Kathryn Guarini, Ph.D., and David P.
Schenkein, M.D., joined the Company's Board of Directors effective
September 8, 2023. Dr. Guarini recently retired as Chief
Information Officer of IBM. Dr. Schenkein is a General Partner and
Co-lead of the Life Sciences team at GV (Google Ventures).
Third
Quarter 2023 Financial Results |
|
Revenues |
|
($ in millions) |
|
Q3 2023 |
|
Q3 2022 |
|
% Change |
|
Net product sales: |
|
|
|
|
|
|
|
|
EYLEA - U.S. |
|
$ |
1,448 |
|
|
$ |
1,629 |
|
(11 |
%) |
|
EYLEA HD - U.S. |
|
|
43 |
|
|
|
— |
|
* |
|
|
Libtayo - Global** |
|
|
232 |
|
|
|
126 |
|
84 |
% |
|
Praluent® - U.S. |
|
|
40 |
|
|
|
30 |
|
33 |
% |
|
Evkeeza® - U.S. |
|
|
19 |
|
|
|
13 |
|
46 |
% |
|
Inmazeb® - U.S. |
|
|
4 |
|
|
|
3 |
|
33 |
% |
|
Total net product sales |
|
|
1,786 |
|
|
|
1,801 |
|
(1 |
%) |
|
|
|
|
|
|
|
|
|
|
Collaboration revenue: |
|
|
|
|
|
|
|
|
Sanofi |
|
|
1,065 |
|
|
|
711 |
|
50 |
% |
|
Bayer |
|
|
377 |
|
|
|
333 |
|
13 |
% |
|
Other |
|
|
(3 |
) |
|
|
6 |
|
* |
|
|
Other revenue |
|
|
138 |
|
|
|
85 |
|
62 |
% |
|
Total revenues |
|
$ |
3,363 |
|
|
$ |
2,936 |
|
15 |
% |
|
|
|
|
|
|
|
|
|
|
* Percentage not meaningful |
** Effective July 1, 2022, the Company began recording net product
sales of Libtayo outside the United States. Excluded from the third
quarter of 2022 is approximately $17 million of net product sales
recorded by Sanofi in connection with sales in certain markets
(Sanofi recorded net product sales in such markets during a
transition period). The percentage change shown would be 62% if
such sales were included (see Table 5). |
|
Net product sales of EYLEA in the U.S. decreased in the third
quarter of 2023, compared to the third quarter of 2022, primarily
due to a lower net selling price driven by changing market
dynamics, including increased competition. In August 2023, the FDA
approved EYLEA HD and the Company commenced recording sales in the
United States in the third quarter of 2023.
Sanofi collaboration revenue increased in the third quarter of
2023, compared to the third quarter of 2022, primarily due to the
Company's share of profits from commercialization of antibodies,
which were $863 million in the third quarter of 2023, compared
to $551 million in the third quarter of 2022. The change in
the Company's share of profits from commercialization of antibodies
was driven by higher profits associated with an increase in
Dupixent sales. In addition, during the third quarter of 2023, the
Company earned the final $50 million sales-based milestone from
Sanofi upon aggregate annual sales of antibodies outside the U.S.
exceeding $3.0 billion on a rolling twelve-month basis.
Refer to Table 4 for a summary of collaboration revenue.
Other revenue during the third quarter of 2023 included the
recognition of $34 million of revenue in connection with the
Company's agreement with BARDA to fund certain costs for a
next-generation COVID-19 monoclonal antibody therapy for the
prevention of SARS-CoV-2 infection.
Operating
Expenses |
|
|
|
GAAP |
|
%Change |
|
Non-GAAP(a) |
|
%Change |
($ in millions) |
|
Q3 2023 |
|
Q3 2022 |
|
|
Q3 2023 |
|
Q3 2022 |
|
Research and development (R&D) |
|
$ |
1,075 |
|
|
$ |
911 |
|
|
18 |
% |
|
$ |
954 |
|
$ |
817 |
|
17 |
% |
Acquired in-process research
and development (IPR&D) |
|
$ |
100 |
|
|
$ |
— |
|
|
** |
|
|
* |
|
* |
|
n/a |
Selling, general, and
administrative (SG&A) |
|
$ |
641 |
|
|
$ |
529 |
|
|
21 |
% |
|
$ |
534 |
|
$ |
467 |
|
14 |
% |
Cost of goods sold (COGS) |
|
$ |
225 |
|
|
$ |
141 |
|
|
60 |
% |
|
$ |
181 |
|
$ |
109 |
|
66 |
% |
Cost of collaboration and
contract manufacturing (COCM) |
|
$ |
212 |
|
|
$ |
177 |
|
|
20 |
% |
|
* |
|
* |
|
n/a |
Other operating (income)
expense, net |
|
$ |
(1 |
) |
|
$ |
(46 |
) |
|
(98 |
%) |
|
* |
|
* |
|
n/a |
|
|
|
|
|
|
|
|
|
|
|
|
|
* GAAP and non-GAAP amounts are equivalent as no non-GAAP
adjustments have been recorded. |
** Percentage not meaningful |
|
- GAAP and non-GAAP R&D expenses
increased in the third quarter of 2023, compared to the third
quarter of 2022, driven by additional costs incurred in connection
with higher headcount and headcount-related costs, the advancement
of the Company's late-stage pipeline, and increased manufacturing
activity associated with the Company's product candidates.
- Acquired IPR&D
expense in the third quarter of 2023 related to a $100 million
development milestone in connection with the Phase 1 ALN-APP
program, which is in collaboration with Alnylam Pharmaceuticals,
Inc.
- GAAP and non-GAAP
SG&A expenses increased in the third quarter of 2023, compared
to the third quarter of 2022, primarily due to higher headcount and
headcount-related costs and higher contributions to an independent
not-for-profit patient assistance organization.
- Other operating
(income) expense, net, decreased in the third quarter of 2023,
compared to the third quarter of 2022, due to the recognition of
$44 million of income in 2022 that did not recur during 2023 as a
result of discontinuing further clinical development of fasinumab
related to the Company's Teva and Mitsubishi Tanabe Pharma
collaborative arrangements.
Other Financial Information
GAAP other income (expense) included the recognition of net
unrealized losses on equity securities of $100 million in the third
quarter of 2023, compared to $254 million of net unrealized gains
in the third quarter of 2022. GAAP and Non-GAAP other income
(expense) also included interest income of $134 million in the
third quarter of 2023, compared to $43 million in the third
quarter of 2022.
In the third quarter of 2023, the Company's GAAP effective tax
rate (ETR) was 9.3%, compared to 12.9% in the third quarter of
2022. In the third quarter of 2023, the non-GAAP ETR was 11.9%,
compared to 12.1% in the third quarter of 2022.
GAAP net income per diluted share was $8.89 in the third quarter
of 2023, compared to $11.66 in the third quarter of 2022. Non-GAAP
net income per diluted share was $11.59 in the third quarter of
2023, compared to $11.14 in the third quarter of 2022. A
reconciliation of the Company's GAAP to non-GAAP results is
included in Table 3 of this press release.
During the third quarter of 2023, the Company repurchased shares
of its common stock and recorded the cost of the shares, or $507
million, as Treasury Stock. As of September 30, 2023,
$1.8 billion remained available for share repurchases under
the Company's share repurchase program.
2023 Financial Guidance(c)
The Company's full year 2023 financial guidance consists of the
following components:
|
|
2023 Guidance |
|
|
Prior |
|
Updated |
GAAP
R&D |
|
$4.315–$4.455 billion |
|
$4.370–$4.455 billion |
Non-GAAP
R&D(a) |
|
$3.825–$3.925 billion |
|
$3.875–$3.925 billion |
GAAP
SG&A |
|
$2.540–$2.680 billion |
|
$2.585–$2.685 billion |
Non-GAAP
SG&A(a) |
|
$2.180–$2.280 billion |
|
$2.210–$2.270 billion |
GAAP
gross margin on net product sales(d) |
|
87%–89% |
|
87%–88% |
Non-GAAP
gross margin on net product sales(a)(d) |
|
89%–91% |
|
89%–90% |
COCM(e)* |
|
$820–$880 million |
|
$840–$880 million |
Capital
expenditures* |
|
$760–$830 million |
|
$660–$700 million |
GAAP
effective tax rate |
|
8%–9% |
|
Unchanged |
Non-GAAP
effective tax rate(a) |
|
10%–11% |
|
Unchanged |
|
|
|
|
|
* GAAP and non-GAAP amounts are equivalent as no non-GAAP
adjustments have been or are expected to be recorded. |
|
A reconciliation of full year 2023 GAAP to non-GAAP financial
guidance is included below:
|
|
Projected Range |
($ in millions) |
|
Low |
|
High |
GAAP R&D |
|
$ |
4,370 |
|
|
$ |
4,455 |
|
Stock-based compensation expense |
|
|
475 |
|
|
|
500 |
|
Acquisition and integration costs |
|
|
20 |
|
|
|
30 |
|
Non-GAAP R&D |
|
$ |
3,875 |
|
|
$ |
3,925 |
|
|
|
|
|
|
GAAP SG&A |
|
$ |
2,585 |
|
|
$ |
2,685 |
|
Stock-based compensation expense |
|
|
300 |
|
|
|
320 |
|
Acquisition and integration costs |
|
|
75 |
|
|
|
95 |
|
Non-GAAP SG&A |
|
$ |
2,210 |
|
|
$ |
2,270 |
|
|
|
|
|
|
GAAP gross margin on net
product sales |
|
|
87 |
% |
|
|
88 |
% |
Stock-based compensation expense |
|
|
1 |
% |
|
|
1 |
% |
Intangible asset amortization expense |
|
|
1 |
% |
|
|
1 |
% |
Acquisition and integration costs |
|
|
<1 |
% |
|
|
<1 |
% |
Charges related to REGEN-COV |
|
|
<(1 |
%) |
|
|
<(1 |
%) |
Non-GAAP gross margin on net
product sales |
|
|
89 |
% |
|
|
90 |
% |
|
|
|
|
|
|
|
|
|
GAAP ETR |
|
|
8 |
% |
|
|
9 |
% |
Income tax effect of GAAP to non-GAAP reconciling items |
|
|
2 |
% |
|
|
2 |
% |
Non-GAAP ETR |
|
|
10 |
% |
|
|
11 |
% |
(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 ETR, non-GAAP net income,
non-GAAP net income per share, total revenues excluding
Ronapreve(b), 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 acquisition and
integration 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 the Company 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 for COVID-19 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 2023 financial
guidance does not assume the completion of any business development
transactions not completed as of the date of this press
release. |
|
|
(d) |
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. |
|
|
(e) |
Corresponding reimbursements from collaborators and others for
manufacturing of commercial supplies is recorded within
revenues. |
Conference Call
Information
Regeneron will host a conference call and simultaneous webcast
to discuss its third quarter 2023 financial and operating results
on Thursday, November 2, 2023, at 8:30 AM Eastern Time.
Participants may access the conference call live via webcast, or
register in advance and participate via telephone, on the
"Investors and Media" page of Regeneron's website at
www.regeneron.com. 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 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, 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 LinkedIn.
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 nature, timing, and
possible success and therapeutic applications of products marketed
or otherwise commercialized by Regeneron and/or its collaborators
or licensees (collectively, "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,
EYLEA® HD (aflibercept) Injection 8 mg, Dupixent®
(dupilumab), Libtayo® (cemiplimab),
Praluent® (alirocumab), Kevzara®
(sarilumab), Evkeeza® (evinacumab), Veopoz™
(pozelimab), odronextamab, itepekimab, fianlimab, garetosmab,
linvoseltamab, 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 those listed above and/or otherwise
discussed in this press release (such as any potential regulatory
approval of Dupixent in chronic obstructive pulmonary disease); 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, capital expenditures, and GAAP and non-GAAP ETR; the
potential for any license or collaboration agreement, including
Regeneron's agreements with Sanofi and Bayer (or their respective
affiliated companies, as applicable), to be cancelled or
terminated; the impact of public health outbreaks, epidemics, or
pandemics (such as the COVID-19 pandemic) on Regeneron's business;
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 and REGEN-COV®
(casirivimab and imdevimab)), 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, 2022 and its Form 10-Q for the
quarterly period ended September 30, 2023. 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 (https://investor.regeneron.com) and its
LinkedIn page
(https://www.linkedin.com/company/regeneron-pharmaceuticals).
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 Affairs |
|
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) |
|
|
|
September 30, |
|
December 31, |
|
|
2023 |
|
2022 |
Assets: |
|
|
|
|
Cash and marketable securities |
|
$ |
15,692.1 |
|
$ |
14,334.1 |
Accounts receivable, net |
|
|
5,584.5 |
|
|
5,328.7 |
Inventories |
|
|
2,562.0 |
|
|
2,401.9 |
Property, plant, and equipment, net |
|
|
4,006.1 |
|
|
3,763.0 |
Intangible assets, net |
|
|
1,017.2 |
|
|
915.5 |
Deferred tax assets |
|
|
2,316.8 |
|
|
1,723.7 |
Other assets |
|
|
984.6 |
|
|
747.6 |
Total assets |
|
$ |
32,163.3 |
|
$ |
29,214.5 |
|
|
|
|
|
Liabilities and stockholders'
equity: |
|
|
|
|
Accounts payable, accrued expenses, and other liabilities |
|
$ |
4,013.7 |
|
$ |
3,301.4 |
Finance lease liabilities |
|
|
720.0 |
|
|
720.0 |
Deferred revenue |
|
|
542.6 |
|
|
547.7 |
Long-term debt |
|
|
1,982.6 |
|
|
1,981.4 |
Stockholders' equity |
|
|
24,904.4 |
|
|
22,664.0 |
Total liabilities and
stockholders' equity |
|
$ |
32,163.3 |
|
$ |
29,214.5 |
|
|
|
|
|
|
|
TABLE 2
|
REGENERON PHARMACEUTICALS, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited) |
(In millions, except per share data) |
|
|
|
Three Months Ended September
30, |
|
Nine Months Ended September
30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
|
Net product sales |
|
$ |
1,786.1 |
|
|
$ |
1,801.4 |
|
|
$ |
5,226.2 |
|
|
$ |
5,194.4 |
|
Collaboration revenue |
|
|
1,438.3 |
|
|
|
1,050.6 |
|
|
|
4,133.1 |
|
|
|
3,326.7 |
|
Other revenue |
|
|
138.3 |
|
|
|
84.2 |
|
|
|
323.6 |
|
|
|
237.4 |
|
|
|
|
3,362.7 |
|
|
|
2,936.2 |
|
|
|
9,682.9 |
|
|
|
8,758.5 |
|
Expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
1,075.3 |
|
|
|
911.3 |
|
|
|
3,261.8 |
|
|
|
2,549.4 |
|
Acquired in-process research and development |
|
|
100.0 |
|
|
|
— |
|
|
|
156.1 |
|
|
|
225.1 |
|
Selling, general, and administrative |
|
|
640.5 |
|
|
|
529.1 |
|
|
|
1,893.6 |
|
|
|
1,455.4 |
|
Cost of goods sold |
|
|
224.5 |
|
|
|
141.3 |
|
|
|
625.3 |
|
|
|
497.8 |
|
Cost of collaboration and contract manufacturing |
|
|
211.9 |
|
|
|
176.5 |
|
|
|
673.5 |
|
|
|
522.0 |
|
Other operating (income) expense, net |
|
|
(0.5 |
) |
|
|
(45.7 |
) |
|
|
(1.6 |
) |
|
|
(83.3 |
) |
|
|
|
2,251.7 |
|
|
|
1,712.5 |
|
|
|
6,608.7 |
|
|
|
5,166.4 |
|
|
|
|
|
|
|
|
|
|
Income from operations |
|
|
1,111.0 |
|
|
|
1,223.7 |
|
|
|
3,074.2 |
|
|
|
3,592.1 |
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
17.6 |
|
|
|
301.4 |
|
|
|
32.2 |
|
|
|
(16.0 |
) |
Interest expense |
|
|
(17.8 |
) |
|
|
(15.3 |
) |
|
|
(54.7 |
) |
|
|
(42.0 |
) |
|
|
|
(0.2 |
) |
|
|
286.1 |
|
|
|
(22.5 |
) |
|
|
(58.0 |
) |
|
|
|
|
|
|
|
|
|
Income before income
taxes |
|
|
1,110.8 |
|
|
|
1,509.8 |
|
|
|
3,051.7 |
|
|
|
3,534.1 |
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
103.0 |
|
|
|
194.1 |
|
|
|
257.7 |
|
|
|
392.8 |
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
1,007.8 |
|
|
$ |
1,315.7 |
|
|
$ |
2,794.0 |
|
|
$ |
3,141.3 |
|
|
|
|
|
|
|
|
|
|
Net income per share -
basic |
|
$ |
9.48 |
|
|
$ |
12.31 |
|
|
$ |
26.16 |
|
|
$ |
29.30 |
|
Net income per share -
diluted |
|
$ |
8.89 |
|
|
$ |
11.66 |
|
|
$ |
24.57 |
|
|
$ |
27.73 |
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding - basic |
|
|
106.3 |
|
|
|
106.9 |
|
|
|
106.8 |
|
|
|
107.2 |
|
Weighted average shares
outstanding - diluted |
|
|
113.4 |
|
|
|
112.8 |
|
|
|
113.7 |
|
|
|
113.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TABLE 3
|
REGENERON PHARMACEUTICALS, INC. |
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION
(Unaudited) |
(In millions, except per share data) |
|
|
|
Three Months Ended September
30, |
|
Nine Months Ended September
30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
GAAP R&D |
|
$ |
1,075.3 |
|
|
$ |
911.3 |
|
|
$ |
3,261.8 |
|
|
$ |
2,549.4 |
|
Stock-based compensation expense |
|
|
107.4 |
|
|
|
93.7 |
|
|
|
356.0 |
|
|
|
275.8 |
|
Acquisition and integration costs |
|
|
13.5 |
|
|
|
1.0 |
|
|
|
17.7 |
|
|
|
15.6 |
|
Non-GAAP R&D |
|
$ |
954.4 |
|
|
$ |
816.6 |
|
|
$ |
2,888.1 |
|
|
$ |
2,258.0 |
|
|
|
|
|
|
|
|
|
|
GAAP SG&A |
|
$ |
640.5 |
|
|
$ |
529.1 |
|
|
$ |
1,893.6 |
|
|
$ |
1,455.4 |
|
Stock-based compensation expense |
|
|
74.4 |
|
|
|
59.8 |
|
|
|
224.5 |
|
|
|
178.0 |
|
Acquisition and integration costs |
|
|
32.4 |
|
|
|
2.0 |
|
|
|
58.5 |
|
|
|
3.1 |
|
Non-GAAP SG&A |
|
$ |
533.7 |
|
|
$ |
467.3 |
|
|
$ |
1,610.6 |
|
|
$ |
1,274.3 |
|
|
|
|
|
|
|
|
|
|
GAAP COGS |
|
$ |
224.5 |
|
|
$ |
141.3 |
|
|
$ |
625.3 |
|
|
$ |
497.8 |
|
Stock-based compensation expense |
|
|
22.1 |
|
|
|
12.8 |
|
|
|
64.1 |
|
|
|
39.2 |
|
Acquisition and integration costs |
|
|
0.9 |
|
|
|
— |
|
|
|
1.4 |
|
|
|
— |
|
Intangible asset amortization expense |
|
|
20.7 |
|
|
|
15.1 |
|
|
|
59.0 |
|
|
|
15.1 |
|
Charges related to REGEN-COV |
|
|
— |
|
|
|
4.9 |
|
|
|
(10.0 |
) |
|
|
62.9 |
|
Non-GAAP COGS |
|
$ |
180.8 |
|
|
$ |
108.5 |
|
|
$ |
510.8 |
|
|
$ |
380.6 |
|
|
|
|
|
|
|
|
|
|
GAAP other income (expense),
net |
|
$ |
(0.2 |
) |
|
$ |
286.1 |
|
|
$ |
(22.5 |
) |
|
$ |
(58.0 |
) |
Losses (gains) on investments, net |
|
|
127.0 |
|
|
|
(253.5 |
) |
|
|
324.5 |
|
|
|
117.3 |
|
Non-GAAP other income
(expense), net |
|
$ |
126.8 |
|
|
$ |
32.6 |
|
|
$ |
302.0 |
|
|
$ |
59.3 |
|
|
|
|
|
|
|
|
|
|
GAAP net income |
|
$ |
1,007.8 |
|
|
$ |
1,315.7 |
|
|
$ |
2,794.0 |
|
|
$ |
3,141.3 |
|
Total of GAAP to non-GAAP reconciling items above |
|
|
398.4 |
|
|
|
(64.2 |
) |
|
|
1,095.7 |
|
|
|
707.0 |
|
Income tax effect of GAAP to non-GAAP reconciling items |
|
|
(77.1 |
) |
|
|
18.9 |
|
|
|
(211.5 |
) |
|
|
(133.4 |
) |
Non-GAAP net income |
|
$ |
1,329.1 |
|
|
$ |
1,270.4 |
|
|
$ |
3,678.2 |
|
|
$ |
3,714.9 |
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income per share
- basic |
|
$ |
12.50 |
|
|
$ |
11.88 |
|
|
$ |
34.44 |
|
|
$ |
34.65 |
|
Non-GAAP net income per share
- diluted |
|
$ |
11.59 |
|
|
$ |
11.14 |
|
|
$ |
31.90 |
|
|
$ |
32.39 |
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating: |
|
|
|
|
|
|
|
|
Non-GAAP net income per share
- basic |
|
|
106.3 |
|
|
|
106.9 |
|
|
|
106.8 |
|
|
|
107.2 |
|
Non-GAAP net income per share
- diluted |
|
|
114.7 |
|
|
|
114.0 |
|
|
|
115.3 |
|
|
|
114.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION
(Unaudited) (continued) |
|
|
|
Three Months Ended September
30, |
|
Nine Months Ended September
30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenue reconciliation: |
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
3,362.7 |
|
|
$ |
2,936.2 |
|
|
$ |
9,682.9 |
|
|
$ |
8,758.5 |
|
Global gross profit payment from Roche in connection with sales of
Ronapreve |
|
|
— |
|
|
|
6.4 |
|
|
|
222.2 |
|
|
|
230.9 |
|
Other |
|
|
(5.7 |
) |
|
|
— |
|
|
|
(9.5 |
) |
|
|
— |
|
Total revenues excluding
Ronapreve |
|
$ |
3,368.4 |
|
|
$ |
2,929.8 |
|
|
$ |
9,470.2 |
|
|
$ |
8,527.6 |
|
|
|
|
|
|
|
|
|
|
Effective tax rate
reconciliation: |
|
|
|
|
|
|
|
|
GAAP ETR |
|
|
9.3 |
% |
|
|
12.9 |
% |
|
|
8.4 |
% |
|
|
11.1 |
% |
Income tax effect of GAAP to non-GAAP reconciling items |
|
|
2.6 |
% |
|
|
(0.8 |
%) |
|
|
2.9 |
% |
|
|
1.3 |
% |
Non-GAAP ETR |
|
|
11.9 |
% |
|
|
12.1 |
% |
|
|
11.3 |
% |
|
|
12.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September
30, |
|
|
|
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
Free cash flow
reconciliation: |
|
|
|
|
|
|
|
|
Net cash provided by operating
activities |
|
|
|
$ |
3,504.3 |
|
|
$ |
3,295.0 |
|
|
|
Capital expenditures |
|
|
|
|
(467.2 |
) |
|
|
(437.9 |
) |
|
|
Free cash flow |
|
|
|
$ |
3,037.1 |
|
|
$ |
2,857.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TABLE 4
|
REGENERON PHARMACEUTICALS, INC. |
COLLABORATION REVENUE (Unaudited) |
(In millions) |
|
|
|
Three Months Ended September
30, |
|
Nine Months Ended September
30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
Sanofi collaboration
revenue: |
|
|
|
|
|
|
|
|
Antibody: |
|
|
|
|
|
|
|
|
Regeneron's share of profits in connection with commercialization
of antibodies |
|
$ |
863.0 |
|
|
$ |
551.1 |
|
|
$ |
2,250.6 |
|
|
$ |
1,463.0 |
Sales-based milestones earned |
|
|
50.0 |
|
|
|
— |
|
|
|
50.0 |
|
|
|
50.0 |
Reimbursement for manufacturing of commercial supplies |
|
|
151.5 |
|
|
|
160.5 |
|
|
|
506.0 |
|
|
|
466.8 |
Other |
|
|
— |
|
|
|
(0.2 |
) |
|
|
— |
|
|
|
28.7 |
Immuno-oncology |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
11.3 |
Total Sanofi collaboration
revenue |
|
|
1,064.5 |
|
|
|
711.4 |
|
|
|
2,806.6 |
|
|
|
2,019.8 |
|
|
|
|
|
|
|
|
|
Bayer collaboration
revenue: |
|
|
|
|
|
|
|
|
Regeneron's share of profits in connection with commercialization
of EYLEA outside the United States |
|
|
349.9 |
|
|
|
315.3 |
|
|
|
1,031.0 |
|
|
|
993.4 |
Reimbursement for manufacturing of ex-U.S. commercial supplies |
|
|
27.2 |
|
|
|
17.5 |
|
|
|
79.7 |
|
|
|
60.3 |
One-time payment in connection with change in Japan
arrangement |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
21.9 |
Total Bayer collaboration
revenue |
|
|
377.1 |
|
|
|
332.8 |
|
|
|
1,110.7 |
|
|
|
1,075.6 |
|
|
|
|
|
|
|
|
|
Other collaboration
revenue: |
|
|
|
|
|
|
|
|
Global gross profit payment from Roche in connection with sales of
Ronapreve |
|
|
— |
|
|
|
6.4 |
|
|
|
222.2 |
|
|
|
230.9 |
Other |
|
|
(3.3 |
) |
|
|
— |
|
|
|
(6.4 |
) |
|
|
0.4 |
|
|
|
|
|
|
|
|
|
Total collaboration
revenue |
|
$ |
1,438.3 |
|
|
$ |
1,050.6 |
|
|
$ |
4,133.1 |
|
|
$ |
3,326.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TABLE 5
|
REGENERON PHARMACEUTICALS, INC. |
NET PRODUCT SALES OF REGENERON-DISCOVERED PRODUCTS
(Unaudited) |
(In millions) |
|
|
|
Three Months Ended September
30, |
|
|
|
|
2023 |
|
2022 |
|
% Change |
|
|
U.S. |
|
ROW(g) |
|
Total |
|
U.S. |
|
ROW |
|
Total |
|
(Total Sales) |
EYLEA(a) |
|
$ |
1,448.2 |
|
$ |
872.2 |
|
$ |
2,320.4 |
|
$ |
1,629.4 |
|
$ |
816.9 |
|
$ |
2,446.3 |
|
(5 |
%) |
EYLEA HD(a) |
|
$ |
42.7 |
|
$ |
— |
|
$ |
42.7 |
|
$ |
— |
|
$ |
— |
|
$ |
— |
|
(h) |
Dupixent(b) |
|
$ |
2,366.3 |
|
$ |
731.3 |
|
$ |
3,097.6 |
|
$ |
1,824.0 |
|
$ |
506.1 |
|
$ |
2,330.1 |
|
33 |
% |
Libtayo(c) |
|
$ |
144.1 |
|
$ |
88.3 |
|
$ |
232.4 |
|
$ |
94.7 |
|
$ |
48.5 |
|
$ |
143.2 |
|
62 |
% |
Praluent(d) |
|
$ |
40.4 |
|
$ |
125.1 |
|
$ |
165.5 |
|
$ |
29.7 |
|
$ |
84.0 |
|
$ |
113.7 |
|
46 |
% |
REGEN-COV(e) |
|
$ |
— |
|
$ |
— |
|
$ |
— |
|
$ |
— |
|
$ |
22.8 |
|
$ |
22.8 |
|
(100 |
%) |
Kevzara(b) |
|
$ |
52.4 |
|
$ |
43.3 |
|
$ |
95.7 |
|
$ |
53.1 |
|
$ |
35.0 |
|
$ |
88.1 |
|
9 |
% |
Other products(f) |
|
$ |
23.4 |
|
$ |
15.5 |
|
$ |
38.9 |
|
$ |
17.5 |
|
$ |
14.7 |
|
$ |
32.2 |
|
21 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September
30, |
|
|
|
|
2023 |
|
2022 |
|
% Change |
|
|
U.S. |
|
ROW |
|
Total |
|
U.S. |
|
ROW |
|
Total |
|
(Total Sales) |
EYLEA(a) |
|
$ |
4,382.1 |
|
$ |
2,605.6 |
|
$ |
6,987.7 |
|
$ |
4,768.2 |
|
$ |
2,544.2 |
|
$ |
7,312.4 |
|
(4 |
%) |
EYLEA HD(a) |
|
$ |
42.7 |
|
$ |
— |
|
$ |
42.7 |
|
$ |
— |
|
$ |
— |
|
$ |
— |
|
(h) |
Dupixent(b) |
|
$ |
6,369.6 |
|
$ |
2,002.4 |
|
$ |
8,372.0 |
|
$ |
4,731.7 |
|
$ |
1,500.6 |
|
$ |
6,232.3 |
|
34 |
% |
Libtayo(c) |
|
$ |
384.0 |
|
$ |
241.0 |
|
$ |
625.0 |
|
$ |
264.5 |
|
$ |
144.7 |
|
$ |
409.2 |
|
53 |
% |
Praluent(d) |
|
$ |
121.1 |
|
$ |
330.6 |
|
$ |
451.7 |
|
$ |
94.5 |
|
$ |
239.5 |
|
$ |
334.0 |
|
35 |
% |
REGEN-COV(e) |
|
$ |
— |
|
$ |
613.2 |
|
$ |
613.2 |
|
$ |
— |
|
$ |
681.2 |
|
$ |
681.2 |
|
(10 |
%) |
Kevzara(b) |
|
$ |
148.5 |
|
$ |
125.2 |
|
$ |
273.7 |
|
$ |
153.1 |
|
$ |
123.7 |
|
$ |
276.8 |
|
(1 |
%) |
Other products(f) |
|
$ |
64.0 |
|
$ |
48.9 |
|
$ |
112.9 |
|
$ |
39.5 |
|
$ |
54.1 |
|
$ |
93.6 |
|
21 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) Regeneron records net product sales of EYLEA and EYLEA HD 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) Prior to July 1, 2022, Regeneron recorded net product sales of
Libtayo in the United States and Sanofi recorded net product sales
of Libtayo outside the United States. The parties equally shared
profits/losses in connection with global sales of Libtayo.
Effective July 1, 2022, the Company began recording net product
sales of Libtayo outside the United States and pays Sanofi a
royalty on global sales. Included in this line item for the nine
months ended September 30, 2023 is $6 million of first quarter 2023
net product sales recorded by Sanofi in connection with sales in
certain markets outside the United States (Sanofi recorded net
product sales in such markets during a transition period until
inventory on hand as of July 1, 2022 had been sold through to the
end customers). |
(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 the United
States and Roche records net product sales of Ronapreve outside the
United States. The parties share gross profits from global sales of
REGEN-COV and Ronapreve based on a pre-specified formula. |
(f) Included in this line item are products which are sold by the
Company and others. Refer to "Third Quarter 2023 Financial Results"
section above for a complete listing of net product sales recorded
by the Company. Not included in this line item are net product
sales of ARCALYST®, which are recorded by Kiniksa; net product
sales of ARCALYST were $54 million for the second quarter of
2023. |
(g) Rest of world (ROW) |
(h) Percentage not meaningful |
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