Regeneron Pharmaceuticals, Inc. (NASDAQ:
REGN) today announced financial results for the
second quarter of 2024 and provided a business update.
"Regeneron had a strong quarter, with total revenue up 12%
driven by notable growth for EYLEA HD, Dupixent, and Libtayo," said
Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and
Chief Executive Officer of Regeneron. "Importantly, Dupixent was
granted its first regulatory approval for COPD by the European
Commission, with FDA action anticipated in the third quarter,
presenting an opportunity to help even more patients around the
globe. As always, we remain focused on driving forward our diverse
clinical pipeline, progressing late-stage trials for Dupixent in
chronic spontaneous urticaria and other dermatologic indications;
itepekimab, our IL-33 antibody in COPD; fianlimab, our LAG-3
antibody in metastatic melanoma; and Libtayo in adjuvant cutaneous
squamous cell carcinoma. Finally, we were excited to advance
several promising earlier-stage programs, including various
antibody and GLP-1 combinations for obesity and our gene therapy
DB-OTO for genetic hearing loss."
Financial
Highlights |
|
|
|
|
|
|
($ in millions, except per
share data) |
|
Q2 2024 |
|
Q2 2023 |
|
% Change |
Total revenues |
|
$ |
3,547 |
|
$ |
3,158 |
|
12 |
% |
GAAP net income |
|
$ |
1,432 |
|
$ |
968 |
|
48 |
% |
GAAP net income per share -
diluted |
|
$ |
12.41 |
|
$ |
8.50 |
|
46 |
% |
Non-GAAP net income(a) |
|
$ |
1,351 |
|
$ |
1,182 |
|
14 |
% |
Non-GAAP net income per share
- diluted(a) |
|
$ |
11.56 |
|
$ |
10.24 |
|
13 |
% |
"Our second quarter financial performance reflects continued
strong momentum across our business, highlighted by double-digit
revenue and earnings growth," said Christopher Fenimore, Senior
Vice President, Finance and Chief Financial Officer of Regeneron.
"In the second half of the year, we look forward to advancing our
pipeline with several important clinical data readouts as well as
continued commercial execution and prudent capital deployment to
drive long-term value creation."
Business Highlights
Key Pipeline ProgressRegeneron has over 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 June 2024, a supplemental Biologics License Application
(sBLA) with two-year data for wet age-related macular degeneration
(wAMD) and diabetic macular edema (DME) was submitted to the U.S.
Food and Drug Administration (FDA).
Dupixent (dupilumab)
- In May 2024, after requesting additional efficacy analyses, the
FDA extended by three months the target action date of its priority
review of the sBLA for Dupixent as an add-on maintenance treatment
in certain adult patients with uncontrolled COPD, with a revised
target action date of September 27, 2024. Regeneron and Sanofi
remain confident that the additional analyses strongly support the
approval of Dupixent in COPD with evidence of type 2 inflammation,
and are committed to working with the FDA to bring Dupixent to
patients living with uncontrolled COPD as quickly as possible.
- In June 2024, the European Commission (EC) approved Dupixent as
an add-on maintenance treatment for adults with uncontrolled COPD
characterized by raised blood eosinophils. The EC is the first
regulatory authority in the world to have approved Dupixent for
COPD patients. Additional submissions are under review with other
regulatory authorities outside the United States, including in
China and Japan.
- The Company and Sanofi presented at the 2024 American Thoracic
Society International Conference positive data from the NOTUS Phase
3 trial evaluating Dupixent as an add-on maintenance treatment in
adults with uncontrolled COPD on maximal standard-of-care inhaled
therapy (nearly all on triple therapy) and evidence of type 2
inflammation. The NOTUS trial confirmed the positive results
demonstrated in the Phase 3 BOREAS trial. The data from the NOTUS
trial were also published in the New England Journal of Medicine
(NEJM).
- The FDA accepted for priority review the sBLA for Dupixent as
an add-on maintenance treatment for adolescents aged 12 to 17 years
with inadequately controlled chronic rhinosinusitis with nasal
polyposis (CRSwNP), with a target action date of September 15,
2024.
- The NEJM published results from a positive Phase 3 trial for
Dupixent in children aged 1 to 11 years with eosinophilic
esophagitis (EoE). The trial showed a greater proportion of those
receiving weight-tiered higher dose Dupixent experienced
significant improvements in many key disease measures of EoE,
compared to placebo at week 16.
Oncology Programs
- The European Medicines Agency’s (EMA) Committee for Medicinal
Products for Human Use (CHMP) adopted a positive opinion
recommending conditional marketing authorization of odronextamab, a
bispecific antibody targeting CD20 and CD3, to treat adults with
relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse
large B-cell lymphoma (DLBCL), after two or more lines of systemic
therapy. The EC is expected to announce a final decision in the
coming months.
- In June 2024, the 14-month median follow-up data from the
pivotal Phase 1/2 trial of linvoseltamab, a bispecific antibody
targeting BCMA and CD3, in patients with R/R multiple myeloma were
presented at the European Hematology Association (EHA) Congress
2024 and published in the Journal of Clinical Oncology. These
longer-term results show a deepening of responses following the
11-month median follow-up data previously presented in April
2024.
- A Phase 2 study for fianlimab, an antibody to LAG-3, in
combination with Libtayo (cemiplimab) for perioperative non-small
cell lung cancer (NSCLC) was initiated. A Phase 2/3 study for
fianlimab, in combination with Libtayo, for perioperative melanoma
was also initiated.
- The Company announced positive updated results from an ongoing
Phase 1/2 trial evaluating REGN7075, a costimulatory bispecific
antibody targeting EGFR and CD28, in combination with Libtayo in
patients with advanced solid tumors. Data from the dose-escalation
portion of the trial showed the investigational combination led to
anti-tumor responses in certain patients with microsatellite stable
colorectal cancer. The results were shared during an oral
presentation at the American Society of Clinical Oncology (ASCO)
2024 Annual Meeting.
Other Programs
- In June 2024, the FDA approved Kevzara® (sarilumab) for the
treatment of patients weighing 63 kg or greater with active
polyarticular juvenile idiopathic arthritis (pJIA), a form of
arthritis that impacts multiple joints at a time.
- A Phase 2 study in obesity was initiated for trevogrumab, an
antibody to myostatin (GDF8), in combination with semaglutide with
and without garetosmab, an antibody to Activin A.
- A Phase 2 study for REGN7508, an antibody to Factor XI, was
initiated in patients with thrombosis.
- The Company presented updated data from the Phase 1/2 trial of
DB-OTO, an AAV-based gene therapy, at the American Society of Gene
and Cell Therapy (ASGCT) annual conference and announced that
DB-OTO improved hearing to normal levels in one child and that
initial hearing improvements were observed in a second child. In
addition, the FDA recently granted DB-OTO Regenerative Medicine
Advanced Therapy (RMAT) designation for the treatment of congenital
auditory neuropathy secondary to biallelic mutations of the
otoferlin gene.
Second
Quarter 2024 Financial
ResultsRevenues |
($ in millions) |
|
Q2 2024 |
|
Q2 2023 |
|
% Change |
Net product sales: |
|
|
|
|
|
|
EYLEA HD - U.S. |
|
$ |
304 |
|
$ |
— |
|
|
* |
|
EYLEA - U.S. |
|
|
1,231 |
|
|
1,500 |
|
|
(18 |
%) |
Total EYLEA HD and EYLEA - U.S. |
|
|
1,535 |
|
|
1,500 |
|
|
2 |
% |
Libtayo - Global |
|
|
297 |
|
|
210 |
|
|
41 |
% |
Praluent - U.S. |
|
|
56 |
|
|
41 |
|
|
37 |
% |
Evkeeza®- U.S. |
|
|
31 |
|
|
19 |
|
|
63 |
% |
Inmazeb®- Global |
|
|
— |
|
|
2 |
|
|
(100 |
%) |
Total net product sales |
|
|
1,919 |
|
|
1,772 |
|
|
8 |
% |
|
|
|
|
|
|
|
Collaboration revenue: |
|
|
|
|
|
|
Sanofi |
|
|
1,146 |
|
|
944 |
|
|
21 |
% |
Bayer |
|
|
375 |
|
|
377 |
|
|
(1 |
%) |
Other |
|
|
3 |
|
|
(4 |
) |
|
* |
|
Other revenue |
|
|
104 |
|
|
69 |
|
|
51 |
% |
Total revenues |
|
$ |
3,547 |
|
$ |
3,158 |
|
|
12 |
% |
|
|
|
|
|
|
|
* Percentage not meaningful |
Total EYLEA HD and EYLEA net product sales in the U.S. increased
2% in the second quarter of 2024 compared to the second quarter of
2023. EYLEA HD was approved by the FDA in August 2023 and EYLEA HD
net product sales in the second quarter of 2024 were driven by the
transition of patients from other anti-VEGF products, including
EYLEA, to EYLEA HD, as well as new patients naïve to anti-VEGF
therapy. Net product sales of EYLEA decreased in the second quarter
of 2024, compared to the second quarter of 2023, primarily due to
(i) the aforementioned approval and transition of certain patients
to EYLEA HD, and (ii) other market dynamics that resulted in lower
volumes and a lower net selling price.
Sanofi collaboration revenue increased in the second quarter of
2024, compared to the second quarter of 2023, due to the Company's
share of profits from commercialization of antibodies, which were
$988 million in the second quarter of 2024, compared to
$751 million in the second quarter of 2023. The change in the
Company's share of profits from commercialization of antibodies was
driven by higher profits associated with an increase in Dupixent
sales.
Refer to Table 4 for a summary of collaboration revenue.
Operating
Expenses |
|
|
GAAP |
|
% Change |
|
Non-GAAP(a) |
|
% Change |
($ in millions) |
|
Q2 2024 |
|
Q2 2023 |
|
|
Q2 2024 |
|
Q2 2023 |
|
Research and development
(R&D) |
|
$ |
1,200 |
|
$ |
1,085 |
|
|
11 |
% |
|
$ |
1,072 |
|
$ |
974 |
|
10 |
% |
Acquired in-process research
and development (IPR&D) |
|
$ |
24 |
|
$ |
— |
|
|
** |
|
* |
|
* |
|
n/a |
|
Selling, general, and
administrative (SG&A) |
|
$ |
759 |
|
$ |
652 |
|
|
16 |
% |
|
$ |
667 |
|
$ |
562 |
|
19 |
% |
Cost of goods sold (COGS) |
|
$ |
258 |
|
$ |
192 |
|
|
34 |
% |
|
$ |
214 |
|
$ |
163 |
|
31 |
% |
Cost of collaboration and
contract manufacturing (COCM) |
|
$ |
222 |
|
$ |
213 |
|
|
4 |
% |
|
* |
|
* |
|
n/a |
|
Other operating expense
(income), net |
|
$ |
15 |
|
$ |
(1 |
) |
|
** |
|
|
$ |
— |
|
* |
|
** |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* 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 second quarter of 2024, compared
to the second quarter of 2023, driven by the advancement of the
Company's late-stage oncology programs, and higher headcount and
headcount-related costs.
- Acquired IPR&D
for the second quarter of 2024 included up-front payments, as well
as a premium on equity securities purchased, in connection with
collaboration and licensing agreements.
- GAAP and non-GAAP
SG&A expenses increased in the second quarter of 2024, compared
to the second quarter of 2023, due to higher
commercialization-related expenses to support the Company's launch
of EYLEA HD and higher headcount and headcount-related costs partly
related to the Company's international commercial expansion.
- GAAP and non-GAAP
COGS increased in the second quarter of 2024, compared to the
second quarter of 2023, primarily due to higher start-up costs for
the Company's Rensselaer, New York fill/finish facility.
- GAAP other operating
expense (income), net, for the second quarter of 2024 reflects a
charge related to the increase in the estimated fair value of the
contingent consideration liability recognized in connection with
the Company's 2023 acquisition of Decibel Therapeutics, Inc.
Other Financial Information
GAAP other income (expense) included the recognition of net
unrealized gains on equity securities of $393 million in the second
quarter of 2024, compared to $31 million of net unrealized losses
in the second quarter of 2023. GAAP and Non-GAAP other income
(expense) also included interest income of $179 million in the
second quarter of 2024, compared to $118 million in the second
quarter of 2023.
In the second quarter of 2024, the Company's GAAP effective tax
rate (ETR) was 12.0%, compared to 10.6% in the second quarter of
2023. The GAAP ETR increased in the second quarter of 2024,
compared to the second quarter of 2023, due to the remeasurement of
existing uncertain tax positions, offset by a higher benefit from
stock-based compensation. In the second quarter of 2024, the
non-GAAP ETR was 10.8%, compared to 12.2% in the second quarter of
2023.
GAAP net income per diluted share was $12.41 in the second
quarter of 2024, compared to $8.50 in the second quarter of 2023.
Non-GAAP net income per diluted share was $11.56 in the second
quarter of 2024, compared to $10.24 in the second quarter of 2023.
A reconciliation of the Company's GAAP to non-GAAP results is
included in Table 3 of this press release.
In April 2024, the Company's board of directors authorized a new
share repurchase program to repurchase up to an additional $3.0
billion of the Company's common stock. During the second quarter of
2024, the Company repurchased shares of its common stock and
recorded the cost of the shares, or $601 million, as Treasury
Stock. As of June 30, 2024, an aggregate of $3.6 billion
remained available for share repurchases under the Company's share
repurchase programs.
2024 Financial Guidance(c)
The Company's full year 2024 financial guidance consists of the
following components:
|
|
2024 Guidance |
|
|
Prior |
|
Updated |
GAAP R&D |
|
$4.920–$5.170 billion |
|
$5.020–$5.170 billion |
Non-GAAP R&D(a) |
|
$4.400–$4.600 billion |
|
$4.500–$4.600 billion |
GAAP SG&A |
|
$2.940–$3.090 billion |
|
$2.920–$3.060 billion |
Non-GAAP SG&A(a) |
|
$2.550–$2.650 billion |
|
Unchanged |
GAAP gross margin on net product
sales(d) |
|
86%–88% |
|
Approximately 86% |
Non-GAAP gross margin on net
product sales(a)(d) |
|
89%–91% |
|
Approximately 89% |
COCM(e)* |
|
$850–$910 million |
|
Unchanged |
Capital expenditures* |
|
$780–$880 million |
|
$750–$820 million |
GAAP effective tax rate |
|
7%–9% |
|
8%–9% |
Non-GAAP effective tax
rate(a) |
|
10%–12% |
|
10%–11% |
|
|
|
|
|
* GAAP and non-GAAP amounts are equivalent as no non-GAAP
adjustments have been or are expected to be recorded. |
A reconciliation of full year 2024 GAAP to non-GAAP financial
guidance is included below:
|
|
Projected Range |
($ in millions) |
|
Low |
|
High |
GAAP R&D |
|
$ |
5,020 |
|
|
$ |
5,170 |
|
Stock-based compensation expense |
|
|
510 |
|
|
|
540 |
|
Acquisition and integration costs |
|
|
10 |
|
|
|
30 |
|
Non-GAAP R&D |
|
$ |
4,500 |
|
|
$ |
4,600 |
|
|
|
|
|
|
GAAP SG&A |
|
$ |
2,920 |
|
|
$ |
3,060 |
|
Stock-based compensation expense |
|
|
330 |
|
|
|
350 |
|
Acquisition and integration costs |
|
|
40 |
|
|
|
60 |
|
Non-GAAP SG&A |
|
$ |
2,550 |
|
|
$ |
2,650 |
|
|
|
|
|
|
GAAP gross margin on net
product sales |
|
Approximately 86% |
|
Approximately 86% |
Stock-based compensation expense |
|
|
1 |
% |
|
|
1 |
% |
Intangible asset amortization expense |
|
|
1 |
% |
|
|
1 |
% |
Acquisition and integration costs |
|
<1 |
$ |
|
<1 |
% |
Non-GAAP gross margin on net
product sales |
|
Approximately 89% |
|
Approximately 89% |
|
|
|
|
|
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 operating (income) expense, net, 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 ability to generate
cash flows from its operations. 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. Roche records net product
sales of Ronapreve outside the United States. |
|
|
(c) |
The Company's 2024 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 second quarter 2024 financial and operating results
on Thursday, August 1, 2024, 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 by
physician-scientists, Regeneron's unique ability to repeatedly and
consistently translate science into medicine has led to numerous
approved treatments and product candidates in development, most 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, neurological diseases,
hematologic conditions, infectious diseases, and rare diseases.
Regeneron pushes the boundaries of scientific discovery and
accelerates drug development using its proprietary technologies,
such as VelociSuite®, which produces optimized fully human
antibodies and new classes of bispecific antibodies. Regeneron is
shaping the next frontier of medicine with data-powered insights
from the Regeneron Genetics Center® and pioneering genetic medicine
platforms, enabling Regeneron to identify innovative targets and
complementary approaches to potentially treat or cure diseases.
For more information, please visit www.regeneron.com or follow
Regeneron on LinkedIn, Instagram, Facebook, or X.
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® HD (aflibercept) Injection 8 mg,
EYLEA® (aflibercept) Injection,
Dupixent® (dupilumab), Libtayo®
(cemiplimab), Praluent® (alirocumab),
Kevzara® (sarilumab), Evkeeza®
(evinacumab), Veopoz® (pozelimab), odronextamab,
itepekimab, fianlimab, garetosmab, linvoseltamab,
REGN5713-5714-5715, NTLA-2001, 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, 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), other litigation and other
proceedings and government investigations relating to the Company
and/or its operations (including the pending civil proceedings
initiated or joined by the U.S. Department of Justice and 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, 2023 and its Form 10-Q for the quarterly period ended
June 30, 2024. 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) |
|
|
June 30, |
|
December 31, |
|
|
|
2024 |
|
|
2023 |
Assets: |
|
|
|
|
Cash and marketable securities |
|
$ |
17,531.4 |
|
$ |
16,241.3 |
Accounts receivable, net |
|
|
5,717.1 |
|
|
5,667.3 |
Inventories |
|
|
2,873.6 |
|
|
2,580.5 |
Property, plant, and equipment, net |
|
|
4,305.9 |
|
|
4,146.4 |
Intangible assets, net |
|
|
1,102.2 |
|
|
1,038.6 |
Deferred tax assets |
|
|
2,880.9 |
|
|
2,575.4 |
Other assets |
|
|
1,675.7 |
|
|
830.7 |
Total assets |
|
$ |
36,086.8 |
|
$ |
33,080.2 |
|
|
|
|
|
Liabilities and stockholders'
equity: |
|
|
|
|
Accounts payable, accrued expenses, and other liabilities |
|
$ |
4,385.8 |
|
$ |
3,818.6 |
Finance lease liabilities |
|
|
720.0 |
|
|
720.0 |
Deferred revenue |
|
|
791.6 |
|
|
585.6 |
Long-term debt |
|
|
1,983.6 |
|
|
1,982.9 |
Stockholders' equity |
|
|
28,205.8 |
|
|
25,973.1 |
Total liabilities and
stockholders' equity |
|
$ |
36,086.8 |
|
$ |
33,080.2 |
TABLE 2
REGENERON PHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited)(In millions, except per
share data) |
|
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Revenues: |
|
|
|
|
|
|
|
|
Net product sales |
|
$ |
1,918.6 |
|
|
$ |
1,772.1 |
|
|
$ |
3,679.9 |
|
|
$ |
3,440.1 |
|
Collaboration revenue |
|
|
1,524.0 |
|
|
|
1,316.7 |
|
|
|
2,790.8 |
|
|
|
2,694.8 |
|
Other revenue |
|
|
104.5 |
|
|
|
69.3 |
|
|
|
221.4 |
|
|
|
185.3 |
|
|
|
|
3,547.1 |
|
|
|
3,158.1 |
|
|
|
6,692.1 |
|
|
|
6,320.2 |
|
Expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
1,200.0 |
|
|
|
1,085.3 |
|
|
|
2,448.4 |
|
|
|
2,186.5 |
|
Acquired in-process research and development |
|
|
23.9 |
|
|
|
— |
|
|
|
31.0 |
|
|
|
56.1 |
|
Selling, general, and administrative |
|
|
758.8 |
|
|
|
652.0 |
|
|
|
1,447.8 |
|
|
|
1,253.1 |
|
Cost of goods sold |
|
|
257.8 |
|
|
|
192.4 |
|
|
|
498.2 |
|
|
|
400.8 |
|
Cost of collaboration and contract manufacturing |
|
|
222.4 |
|
|
|
212.5 |
|
|
|
415.8 |
|
|
|
461.6 |
|
Other operating expense (income), net |
|
|
14.6 |
|
|
|
(0.6 |
) |
|
|
29.9 |
|
|
|
(1.1 |
) |
|
|
|
2,477.5 |
|
|
|
2,141.6 |
|
|
|
4,871.1 |
|
|
|
4,357.0 |
|
|
|
|
|
|
|
|
|
|
Income from operations |
|
|
1,069.6 |
|
|
|
1,016.5 |
|
|
|
1,821.0 |
|
|
|
1,963.2 |
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
573.3 |
|
|
|
85.3 |
|
|
|
538.7 |
|
|
|
14.6 |
|
Interest expense |
|
|
(14.8 |
) |
|
|
(18.9 |
) |
|
|
(30.9 |
) |
|
|
(36.9 |
) |
|
|
|
558.5 |
|
|
|
66.4 |
|
|
|
507.8 |
|
|
|
(22.3 |
) |
|
|
|
|
|
|
|
|
|
Income before income
taxes |
|
|
1,628.1 |
|
|
|
1,082.9 |
|
|
|
2,328.8 |
|
|
|
1,940.9 |
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
195.8 |
|
|
|
114.5 |
|
|
|
174.5 |
|
|
|
154.7 |
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
1,432.3 |
|
|
$ |
968.4 |
|
|
$ |
2,154.3 |
|
|
$ |
1,786.2 |
|
|
|
|
|
|
|
|
|
|
Net income per share -
basic |
|
$ |
13.25 |
|
|
$ |
9.05 |
|
|
$ |
19.95 |
|
|
$ |
16.69 |
|
Net income per share -
diluted |
|
$ |
12.41 |
|
|
$ |
8.50 |
|
|
$ |
18.68 |
|
|
$ |
15.68 |
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding - basic |
|
|
108.1 |
|
|
|
107.0 |
|
|
|
108.0 |
|
|
|
107.0 |
|
Weighted average shares
outstanding - diluted |
|
|
115.4 |
|
|
|
113.9 |
|
|
|
115.3 |
|
|
|
113.9 |
|
TABLE 3
REGENERON PHARMACEUTICALS, INC.RECONCILIATION OF
GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited)(In
millions, except per share data) |
|
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
GAAP R&D |
|
$ |
1,200.0 |
|
|
$ |
1,085.3 |
|
|
$ |
2,448.4 |
|
|
$ |
2,186.5 |
|
Stock-based compensation expense |
|
|
122.4 |
|
|
|
109.1 |
|
|
|
245.4 |
|
|
|
248.6 |
|
Acquisition and integration costs |
|
|
5.3 |
|
|
|
2.6 |
|
|
|
9.1 |
|
|
|
4.2 |
|
Non-GAAP R&D |
|
$ |
1,072.3 |
|
|
$ |
973.6 |
|
|
$ |
2,193.9 |
|
|
$ |
1,933.7 |
|
|
|
|
|
|
|
|
|
|
GAAP SG&A |
|
$ |
758.8 |
|
|
$ |
652.0 |
|
|
$ |
1,447.8 |
|
|
$ |
1,253.1 |
|
Stock-based compensation expense |
|
|
82.6 |
|
|
|
73.3 |
|
|
|
168.8 |
|
|
|
150.1 |
|
Acquisition and integration costs |
|
|
9.7 |
|
|
|
16.5 |
|
|
|
28.5 |
|
|
|
26.1 |
|
Non-GAAP SG&A |
|
$ |
666.5 |
|
|
$ |
562.2 |
|
|
$ |
1,250.5 |
|
|
$ |
1,076.9 |
|
|
|
|
|
|
|
|
|
|
GAAP COGS |
|
$ |
257.8 |
|
|
$ |
192.4 |
|
|
$ |
498.2 |
|
|
$ |
400.8 |
|
Stock-based compensation expense |
|
|
18.2 |
|
|
|
19.6 |
|
|
|
39.1 |
|
|
|
42.0 |
|
Acquisition and integration costs |
|
|
0.8 |
|
|
|
0.5 |
|
|
|
1.2 |
|
|
|
0.5 |
|
Intangible asset amortization expense |
|
|
25.1 |
|
|
|
19.8 |
|
|
|
48.3 |
|
|
|
38.3 |
|
Charges related to REGEN-COV |
|
|
— |
|
|
|
(10.0 |
) |
|
|
— |
|
|
|
(10.0 |
) |
Non-GAAP COGS |
|
$ |
213.7 |
|
|
$ |
162.5 |
|
|
$ |
409.6 |
|
|
$ |
330.0 |
|
|
|
|
|
|
|
|
|
|
GAAP other operating expense
(income), net |
|
$ |
14.6 |
|
|
$ |
(0.6 |
) |
|
$ |
29.9 |
|
|
$ |
(1.1 |
) |
Change in fair value of contingent consideration |
|
|
14.6 |
|
|
|
— |
|
|
|
29.9 |
|
|
|
— |
|
Non-GAAP other operating
expense (income), net |
|
$ |
— |
|
|
$ |
(0.6 |
) |
|
$ |
— |
|
|
$ |
(1.1 |
) |
|
|
|
|
|
|
|
|
|
GAAP other income (expense),
net |
|
$ |
558.5 |
|
|
$ |
66.4 |
|
|
$ |
507.8 |
|
|
$ |
(22.3 |
) |
(Gains) losses on investments, net |
|
|
(392.6 |
) |
|
|
30.9 |
|
|
|
(196.5 |
) |
|
|
197.5 |
|
Non-GAAP other income
(expense), net |
|
$ |
165.9 |
|
|
$ |
97.3 |
|
|
$ |
311.3 |
|
|
$ |
175.2 |
|
|
|
|
|
|
|
|
|
|
GAAP net income |
|
$ |
1,432.3 |
|
|
$ |
968.4 |
|
|
$ |
2,154.3 |
|
|
$ |
1,786.2 |
|
Total of GAAP to non-GAAP reconciling items above |
|
|
(113.9 |
) |
|
|
262.3 |
|
|
|
373.8 |
|
|
|
697.3 |
|
Income tax effect of GAAP to non-GAAP reconciling items |
|
|
32.8 |
|
|
|
(49.1 |
) |
|
|
(61.0 |
) |
|
|
(134.4 |
) |
Non-GAAP net income |
|
$ |
1,351.2 |
|
|
$ |
1,181.6 |
|
|
$ |
2,467.1 |
|
|
$ |
2,349.1 |
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income per share
- basic |
|
$ |
12.50 |
|
|
$ |
11.04 |
|
|
$ |
22.84 |
|
|
$ |
21.95 |
|
Non-GAAP net income per share
- diluted |
|
$ |
11.56 |
|
|
$ |
10.24 |
|
|
$ |
21.09 |
|
|
$ |
20.32 |
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating: |
|
|
|
|
|
|
|
|
Non-GAAP net income per share
- basic |
|
|
108.1 |
|
|
|
107.0 |
|
|
|
108.0 |
|
|
|
107.0 |
|
Non-GAAP net income per share
- diluted |
|
|
116.9 |
|
|
|
115.4 |
|
|
|
117.0 |
|
|
|
115.6 |
|
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION
(Unaudited)(continued) |
|
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Revenue reconciliation: |
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
3,547.1 |
|
|
$ |
3,158.1 |
|
|
$ |
6,692.1 |
|
|
$ |
6,320.2 |
|
Global gross profit payment from Roche in connection with
sales of Ronapreve |
|
|
0.4 |
|
|
|
— |
|
|
|
0.9 |
|
|
|
222.2 |
|
Other |
|
|
— |
|
|
|
(3.8 |
) |
|
|
— |
|
|
|
(3.8 |
) |
Total revenues excluding
Ronapreve |
|
$ |
3,546.7 |
|
|
$ |
3,161.9 |
|
|
$ |
6,691.2 |
|
|
$ |
6,101.8 |
|
|
|
|
|
|
|
|
|
|
Effective tax rate
reconciliation: |
|
|
|
|
|
|
|
|
GAAP ETR |
|
|
12.0 |
% |
|
|
10.6 |
% |
|
|
7.5 |
% |
|
|
8.0 |
% |
Income tax effect of GAAP to non-GAAP reconciling items |
|
|
(1.2 |
%) |
|
|
1.6 |
% |
|
|
1.2 |
% |
|
|
3.0 |
% |
Non-GAAP ETR |
|
|
10.8 |
% |
|
|
12.2 |
% |
|
|
8.7 |
% |
|
|
11.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months EndedJune 30, |
|
|
|
|
|
|
|
2024 |
|
|
|
2023 |
|
|
|
Free cash flow
reconciliation: |
|
|
|
|
|
|
|
|
Net cash provided by operating
activities |
|
|
|
$ |
1,866.5 |
|
|
$ |
2,390.0 |
|
|
|
Capital expenditures |
|
|
|
|
(314.4 |
) |
|
|
(291.2 |
) |
|
|
Free cash flow |
|
|
|
$ |
1,552.1 |
|
|
$ |
2,098.8 |
|
|
|
TABLE 4
REGENERON PHARMACEUTICALS, INC.COLLABORATION
REVENUE (Unaudited)(In millions) |
|
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
|
|
2024 |
|
|
2023 |
|
|
|
2024 |
|
|
2023 |
|
Sanofi collaboration
revenue: |
|
|
|
|
|
|
|
|
Regeneron's share of profits in connection with
commercialization of antibodies |
|
$ |
988.3 |
|
$ |
751.1 |
|
|
$ |
1,792.3 |
|
$ |
1,387.6 |
|
Reimbursement for manufacturing of commercial supplies |
|
|
157.3 |
|
|
192.6 |
|
|
|
263.1 |
|
|
354.5 |
|
Total Sanofi collaboration
revenue |
|
|
1,145.6 |
|
|
943.7 |
|
|
|
2,055.4 |
|
|
1,742.1 |
|
|
|
|
|
|
|
|
|
|
Bayer collaboration
revenue: |
|
|
|
|
|
|
|
|
Regeneron's share of profits in connection with
commercialization of EYLEA 8 mg and EYLEA outside the United
States |
|
|
353.0 |
|
|
349.5 |
|
|
|
686.9 |
|
|
681.1 |
|
Reimbursement for manufacturing of ex-U.S. commercial
supplies |
|
|
22.1 |
|
|
27.2 |
|
|
|
44.2 |
|
|
52.5 |
|
Total Bayer collaboration
revenue |
|
|
375.1 |
|
|
376.7 |
|
|
|
731.1 |
|
|
733.6 |
|
|
|
|
|
|
|
|
|
|
Other collaboration
revenue: |
|
|
|
|
|
|
|
|
Global gross profit payment from Roche in connection with
sales of Ronapreve |
|
|
0.4 |
|
|
— |
|
|
|
0.9 |
|
|
222.2 |
|
Other |
|
|
2.9 |
|
|
(3.7 |
) |
|
|
3.4 |
|
|
(3.1 |
) |
|
|
|
|
|
|
|
|
|
Total collaboration
revenue |
|
$ |
1,524.0 |
|
$ |
1,316.7 |
|
|
$ |
2,790.8 |
|
$ |
2,694.8 |
|
TABLE 5
REGENERON PHARMACEUTICALS, INC.NET PRODUCT SALES
OF REGENERON-DISCOVERED PRODUCTS (Unaudited)(In
millions) |
|
|
Three Months EndedJune 30, |
|
|
|
|
|
2024 |
|
|
2023 |
|
% Change |
|
|
U.S. |
|
ROW(g) |
|
Total |
|
U.S. |
|
ROW |
|
Total |
|
(Total Sales) |
EYLEA HD and EYLEA(a) |
|
$ |
1,534.7 |
|
$ |
907.8 |
|
$ |
2,442.5 |
|
$ |
1,500.1 |
|
$ |
886.3 |
|
$ |
2,386.4 |
|
2 |
% |
Dupixent(b) |
|
$ |
2,610.2 |
|
$ |
946.2 |
|
$ |
3,556.4 |
|
$ |
2,105.2 |
|
$ |
684.2 |
|
$ |
2,789.4 |
|
27 |
% |
Libtayo(c) |
|
$ |
182.4 |
|
$ |
115.0 |
|
$ |
297.4 |
|
$ |
130.2 |
|
$ |
79.8 |
|
$ |
210.0 |
|
42 |
% |
Praluent(d) |
|
$ |
56.1 |
|
$ |
135.8 |
|
$ |
191.9 |
|
$ |
40.5 |
|
$ |
99.8 |
|
$ |
140.3 |
|
37 |
% |
Kevzara(b) |
|
$ |
65.1 |
|
$ |
44.6 |
|
$ |
109.7 |
|
$ |
56.9 |
|
$ |
42.6 |
|
$ |
99.5 |
|
10 |
% |
REGEN-COV(e) |
|
$ |
— |
|
$ |
1.1 |
|
$ |
1.1 |
|
$ |
— |
|
$ |
— |
|
$ |
— |
|
* |
|
Other products(f) |
|
$ |
30.9 |
|
$ |
20.8 |
|
$ |
51.7 |
|
$ |
22.5 |
|
$ |
16.9 |
|
$ |
39.4 |
|
31 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months EndedJune 30, |
|
|
|
|
|
2024 |
|
|
2023 |
|
% Change |
|
|
U.S. |
|
ROW |
|
Total |
|
U.S. |
|
ROW |
|
Total |
|
(Total Sales) |
EYLEA HD and EYLEA(a) |
|
$ |
2,936.3 |
|
$ |
1,757.2 |
|
$ |
4,693.5 |
|
$ |
2,933.9 |
|
$ |
1,733.4 |
|
$ |
4,667.3 |
|
1 |
% |
Dupixent(b) |
|
$ |
4,828.2 |
|
$ |
1,805.0 |
|
$ |
6,633.2 |
|
$ |
4,003.3 |
|
$ |
1,271.1 |
|
$ |
5,274.4 |
|
26 |
% |
Libtayo(c) |
|
$ |
341.6 |
|
$ |
219.7 |
|
$ |
561.3 |
|
$ |
239.9 |
|
$ |
152.7 |
|
$ |
392.6 |
|
43 |
% |
Praluent(d) |
|
$ |
126.1 |
|
$ |
267.1 |
|
$ |
393.2 |
|
$ |
80.7 |
|
$ |
205.5 |
|
$ |
286.2 |
|
37 |
% |
Kevzara(b) |
|
$ |
115.1 |
|
$ |
88.7 |
|
$ |
203.8 |
|
$ |
96.1 |
|
$ |
81.9 |
|
$ |
178.0 |
|
14 |
% |
REGEN-COV(e) |
|
$ |
— |
|
$ |
2.3 |
|
$ |
2.3 |
|
$ |
— |
|
$ |
613.2 |
|
$ |
613.2 |
|
(100 |
%) |
Other products(f) |
|
$ |
56.2 |
|
$ |
38.5 |
|
$ |
94.7 |
|
$ |
40.6 |
|
$ |
33.4 |
|
$ |
74.0 |
|
28 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note: The table above includes net product sales of
Regeneron-discovered products. Such net product sales are recorded
by the Company or others, as further described in the footnotes
below. |
* Percentage not meaningful |
(a)The Company records net product sales of EYLEA HD and EYLEA in
the United States, and Bayer records net product sales outside the
United States. The Company records its share of profits in
connection with sales outside the United States within
Collaboration revenue. |
(b)Sanofi records global net product sales of Dupixent and Kevzara,
and the Company records its share of profits in connection with
global sales of such products within Collaboration revenue. |
(c)The Company records global net product sales of Libtayo and pays
Sanofi a royalty on such sales. Prior to July 1, 2022, Sanofi
recorded net product sales of Libtayo outside the United States.
Included in this line item for the six months ended June 30, 2023
is approximately $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). |
(d)The Company 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, which
is recorded within Other revenue. |
(e)Roche records net product sales outside the United States and
the Company records its share of gross profits from sales based on
a pre-specified formula, which is recorded within Collaboration
revenue. |
(f)Included in this line item are products which are sold by the
Company and others. Refer to "Second Quarter 2024 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 $79 million for the first quarter of
2024. |
(g)Rest of world (ROW) |
Regeneron Pharmaceuticals (NASDAQ:REGN)
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