Regeneron Pharmaceuticals, Inc. (NASDAQ:
REGN)
today announced financial results for the fourth quarter and full
year 2023 and provided a business update.
"2023 marked another year of exceptional accomplishments for
Regeneron as we further diversified our revenue base and made
important progress in our robust R&D pipeline," said Leonard S.
Schleifer, M.D., Ph.D., Board Co-Chair, President and Chief
Executive Officer of Regeneron. "In 2024, we plan to build on this
momentum with continued growth of our breakthrough products
Dupixent and EYLEA HD while we bring additional new therapies to
market and advance our growing pipeline. Lastly, I want to
congratulate our Chief Financial Officer, Bob Landry, on the
occasion of his retirement and thank him for his significant
contributions to Regeneron during his ten years with the
Company."
Financial Highlights
|
|
Three Months EndedDecember
31, |
|
|
|
Year EndedDecember 31, |
|
|
($ in millions, except per
share data) |
|
2023 |
|
2022 |
|
% Change |
|
2023 |
|
2022 |
|
% Change |
Total revenues |
|
$ |
3,434 |
|
$ |
3,414 |
|
1 |
% |
|
$ |
13,117 |
|
$ |
12,173 |
|
8 |
% |
Total revenues excluding
Ronapreve(a)(b) |
|
$ |
3,436 |
|
$ |
3,018 |
|
14 |
% |
|
$ |
12,906 |
|
$ |
11,546 |
|
12 |
% |
GAAP net income |
|
$ |
1,160 |
|
$ |
1,197 |
|
(3 |
%) |
|
$ |
3,954 |
|
$ |
4,338 |
|
(9 |
%) |
GAAP net income per share -
diluted |
|
$ |
10.19 |
|
$ |
10.50 |
|
(3 |
%) |
|
$ |
34.77 |
|
$ |
38.22 |
|
(9 |
%) |
Non-GAAP net income(a) |
|
$ |
1,366 |
|
$ |
1,449 |
|
(6 |
%) |
|
$ |
5,045 |
|
$ |
5,164 |
|
(2 |
%) |
Non-GAAP net income per share
- diluted(a) |
|
$ |
11.86 |
|
$ |
12.56 |
|
(6 |
%) |
|
$ |
43.79 |
|
$ |
44.98 |
|
(3 |
%) |
"We were pleased with our fourth-quarter and full-year 2023
financial performance, highlighted by revenue growth of 14% and
12%, respectively, when excluding contributions from Ronapreve,
reflecting continued strength across our business," said Robert E.
Landry, Executive Vice President, Finance and Chief Financial
Officer of Regeneron. "In 2024, we plan to continue investing
heavily in internal R&D, driving commercial execution with
targeted promotion, and prudently deploying capital to business
development and share repurchases, all of which is expected to
better position the Company to deliver sustainable growth and
long-term value to shareholders."
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 January 2024, the European Commission (EC) and Japan's
Ministry of Health, Labour and Welfare (MHLW) each approved EYLEA 8
mg (known as EYLEA HD in the United States) for the treatment of
patients with wet age-related macular degeneration (wAMD) and
diabetic macular edema (DME).
- In January 2024, the United States Centers for Medicare &
Medicaid Services (CMS) assigned a permanent and product-specific
J-code (J0177) for EYLEA HD. Under the Healthcare Common Procedure
Coding System (HCPCS) process, the EYLEA HD J-code will become
effective on April 1, 2024. J-codes are permanent reimbursement
codes used by government payers and commercial insurers in the
United States to facilitate billing for Medicare Part B treatments,
which must be administered by a healthcare professional. J-codes
simplify and streamline the billing and reimbursement processes,
allowing for efficient claims processing.
Dupixent (dupilumab)
- The Company and Sanofi announced that based on results from an
interim analysis, the second Phase 3 trial (NOTUS) in patients with
uncontrolled COPD and evidence of type 2 inflammation met its
primary endpoint and showed that Dupixent significantly reduced
exacerbations by 34% (confirming positive results from the
replicate Phase 3 BOREAS trial). The NOTUS trial also confirmed
that treatment with Dupixent led to rapid and significant
improvements in lung function by 12 weeks and were sustained at 52
weeks. In December 2023, a supplemental Biologics License
Application (sBLA) was submitted to the U.S. Food and Drug
Administration (FDA) based on the results of these two trials. A
regulatory application has also been submitted in the European
Union (EU).
- In January 2024, the FDA approved Dupixent for the treatment of
children aged 1 to 11 years (weighing at least 15 kg) with
eosinophilic esophagitis (EoE), making Dupixent the first and only
medicine specifically indicated to treat these patients. A
regulatory application has also been submitted in the EU.
Oncology Programs
- The Company presented updated positive data from the pivotal
trial of linvoseltamab, a bispecific antibody targeting BCMA and
CD3, in patients with relapsed/refractory multiple myeloma at the
65th American Society of Hematology (ASH) Annual Meeting and
Exposition.
- A BLA for linvoseltamab in relapsed/refractory multiple myeloma
was submitted to the FDA in December 2023 and a regulatory
application is also under review in the EU.
- The Company presented updated data for odronextamab, a
bispecific antibody targeting CD20 and CD3, in patients with
relapsed/refractory follicular lymphoma (FL) and diffuse large
B-cell lymphoma (DLBCL) at the 65th ASH Annual Meeting and
Exposition. A BLA for odronextamab in relapsed/refractory FL and
DLBCL is currently under review by the FDA, with a target action
date of March 31, 2024, and a regulatory application is also under
review in the EU.
- The Company presented, at European Society for Medical Oncology
Immuno-Oncology (ESMO IO) Congress 2023, initial Phase 1
dose-escalation data for REGN5668, a costimulatory bispecific
antibody targeting MUC16 and CD28, in combination with Libtayo
(cemiplimab) that showed encouraging initial activity in patients
with recurrent ovarian cancer.
Other Programs
- The EC approved Evkeeza® (evinacumab) as an adjunct to other
lipid-lowering therapies to treat children with homozygous familial
hypercholesterolemia (HoFH), which extended the approved indication
to children as young as 5 years of age.
- A Phase 3 study was initiated for NTLA-2001, a TTR gene
knockout using CRISPR/Cas9, in transthyretin (ATTR) amyloidosis
with cardiomyopathy (ATTR-CM).
- The FDA granted Breakthrough Therapy designation to
mibavademab, an agonist antibody to leptin receptor (LEPR), for
generalized lipodystrophy (for which a Phase 2 study is
ongoing).
Corporate and Business Development Updates
- In the Company’s ongoing patent infringement lawsuit against
Mylan Pharmaceuticals Inc., a wholly-owned subsidiary of Viatris
Inc., and Biocon Biologics Inc. concerning Mylan’s filing for FDA
approval of an aflibercept 2 mg biosimilar (now owned by Biocon),
the United States District Court for the Northern District of West
Virginia issued a decision finding that (i) the asserted claims of
one of the Company’s formulation patents (U.S. Patent No.
11,084,865) were valid and infringed by Mylan and (ii) the asserted
claims of two of the Company’s methods of treatment patents (U.S.
Patent Nos. 10,888,601 and 11,253,572) were infringed by Mylan but
were invalid as obvious.
- In January 2024, the Company entered into an agreement with
2seventy bio, Inc. to acquire full development and
commercialization rights to its preclinical and clinical stage cell
therapy pipeline and will assume ongoing program, infrastructure,
and personnel costs related to these programs. The transaction is
expected to close in the first half of 2024 subject to certain
customary closing conditions.
- The Company announced its inclusion on the Dow Jones
Sustainability World Index (DJSI World) for the fifth consecutive
year, alongside its fourth consecutive inclusion on the Dow Jones
Sustainability North America Index (DJSI North America).
Select Upcoming 2024 Milestones
Programs |
|
|
|
Milestones |
Ophthalmology |
|
- |
|
Initiate pivotal retinal vein occlusion (RVO) study of EYLEA HD
(mid-2024) to enable FDA submission |
|
|
- |
|
Initiate pivotal studies of pozelimab (C5 antibody) in combination
with cemdisiran (siRNA therapy) in geographic atrophy (second half
2024) |
Immunology & Inflammation |
|
- |
|
EC
decision on regulatory submission for Dupixent for EoE in children
(1–11 years of age) (second half 2024) |
|
|
- |
|
sBLA acceptance for Dupixent in
COPD with type 2 inflammatory phenotype (first quarter 2024) and
FDA decision on sBLA (mid/second half 2024); EC decision on
regulatory submission (second half 2024) |
|
|
- |
|
Report results from ongoing Phase
3 study for Dupixent in chronic spontaneous urticaria (CSU) in
biologic-naïve patients (fourth quarter 2024) |
|
|
- |
|
Initiate Phase 1 study in severe
food allergy following transient linvoseltamab treatment (in
combination with Dupixent) (2024) |
|
|
- |
|
Complete enrollment of Phase 3 studies of itepekimab (IL-33
antibody) in COPD (second half 2024) |
Solid Organ Oncology |
|
- |
|
Conduct interim analysis from Phase 3 study of Libtayo in adjuvant
cutaneous squamous cell carcinoma (CSCC) (second half 2024) |
|
|
- |
|
Report potentially pivotal
initial results from Phase 2/3 study of fianlimab (LAG-3 antibody)
in combination with Libtayo in first-line metastatic melanoma and
initial combination data in first-line advanced non-small cell lung
cancer (NSCLC) (second half 2024) |
|
|
- |
|
Initiate potentially pivotal
Phase 2 study for fianlimab (in combination with Libtayo) in
perioperative melanoma and Phase 2 study for fianlimab (in
combination with Libtayo) in perioperative NSCLC (first half
2024) |
|
|
- |
|
Initiate dose-expansion cohorts
of REGN7075 (EGFR and CD28 costimulatory bispecific antibody) in
combination with Libtayo in EGFR-high tumors (first half 2024) |
|
|
- |
|
Initiate cohorts combining REGN5678 (PSMA and CD28 costimulatory
bispecific antibody) and REGN4336 (PSMA and CD3 bispecific
antibody) in metastatic castration-resistant prostate cancer and
initiate REGN5678 monotherapy cohort in renal cell carcinoma (first
half 2024) |
Hematology |
|
- |
|
FDA
decision on BLA (target action date of March 31, 2024) and EC
decision on regulatory submission (second half 2024) for
odronextamab in relapsed/refractory FL and DLBCL |
|
|
- |
|
BLA acceptance for linvoseltamab
in relapsed/refractory multiple myeloma (first quarter 2024) and
FDA decision on BLA (second half 2024) |
|
|
- |
|
Initiate Phase 1 study of
linvoseltamab in combination with CD38 and CD28 costimulatory
bispecific antibody in multiple myeloma (2024) |
|
|
- |
|
Report Phase 2 results for REGN9933 (Factor XI antibody) in
thrombosis (second half 2024) |
Genetic Medicines |
|
- |
|
Initiate Phase 1 study of Factor 9 gene insertion in hemophilia B
(mid-2024) |
|
|
- |
|
Report additional data from Phase
1/2 study for DB-OTO (AAV-based gene therapy) in pediatrics with
hearing loss (2024) |
|
|
- |
|
Initiate Phase 1 study of ALN-SOD (SOD1 siRNA) in amyotrophic
lateral sclerosis (ALS) (2024) |
Obesity |
|
- |
|
Initiate Phase 2 study of semaglutide in combination with
trevogrumab (anti-myostatin) with and without garetosmab
(anti-Activin A) (mid-2024) |
Fourth Quarter 2023 Financial Results
Revenues
($ in millions) |
|
Q4 2023 |
|
Q4 2022 |
|
% Change |
|
FY 2023 |
|
FY 2022 |
|
% Change |
Net product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
EYLEA HD - U.S. |
|
$ |
123 |
|
$ |
— |
|
|
* |
|
$ |
166 |
|
$ |
— |
|
|
* |
EYLEA - U.S. |
|
|
1,338 |
|
|
1,496 |
|
(11 |
%) |
|
|
5,720 |
|
|
6,265 |
|
(9 |
%) |
Total EYLEA HD and EYLEA - U.S. |
|
|
1,461 |
|
|
1,496 |
|
(2 |
%) |
|
|
5,886 |
|
|
6,265 |
|
(6 |
%) |
Libtayo - Global** |
|
|
244 |
|
|
152 |
|
61 |
% |
|
|
863 |
|
|
448 |
|
93 |
% |
Praluent®- U.S. |
|
|
61 |
|
|
36 |
|
69 |
% |
|
|
182 |
|
|
130 |
|
40 |
% |
Evkeeza - U.S. |
|
|
24 |
|
|
15 |
|
60 |
% |
|
|
77 |
|
|
48 |
|
60 |
% |
Inmazeb®- U.S. |
|
|
62 |
|
|
— |
|
|
* |
|
|
70 |
|
|
3 |
|
|
* |
Total net product sales |
|
|
1,852 |
|
|
1,699 |
|
9 |
% |
|
|
7,078 |
|
|
6,894 |
|
3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration
revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
Sanofi |
|
|
993 |
|
|
836 |
|
19 |
% |
|
|
3,800 |
|
|
2,856 |
|
33 |
% |
Bayer |
|
|
377 |
|
|
355 |
|
6 |
% |
|
|
1,487 |
|
|
1,431 |
|
4 |
% |
Other |
|
|
— |
|
|
396 |
|
(100 |
%) |
|
|
216 |
|
|
627 |
|
(66 |
%) |
Other revenue |
|
|
212 |
|
|
128 |
|
66 |
% |
|
|
536 |
|
|
365 |
|
47 |
% |
Total revenues |
|
$ |
3,434 |
|
$ |
3,414 |
|
1 |
% |
|
$ |
13,117 |
|
$ |
12,173 |
|
8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
* Percentage not
meaningful |
|
|
|
|
|
|
** Effective July
1, 2022, the Company began recording net product sales of Libtayo
outside the United States. Excluded from the full year 2023 is
approximately $6 million of first quarter 2023 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). Similarly, excluded from the fourth quarter and
full year 2022 is approximately $17 million and $34 million,
respectively, of net product sales recorded by Sanofi (see Table
5). |
Net product sales of EYLEA in the U.S. decreased in the fourth
quarter and full year 2023, compared to the same periods of 2022,
primarily due to changing market dynamics, resulting in a lower net
selling price and lower volumes. EYLEA volumes in the fourth
quarter of 2023 were impacted by the August 2023 launch of EYLEA HD
and subsequent transition of EYLEA patients to EYLEA HD.
Sanofi collaboration revenue increased in the fourth quarter and
full year 2023, compared to the same periods of 2022, primarily due
to the Company's share of profits from commercialization of
antibodies, which were $886 million and $619 million in
the fourth quarter of 2023 and 2022, respectively, and
$3.137 billion and $2.082 billion for the full year 2023
and 2022, respectively. 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 2023 (third quarter) the Company earned the final $50
million sales-based milestone from Sanofi based upon aggregate
annual sales of antibodies outside the U.S., compared to earning
two $50 million sales-based milestones in 2022 (including one in
the fourth quarter of 2022).
The Company recorded collaboration revenue during 2023 and 2022
in connection with payments from Roche attributable to global gross
profits from sales of Ronapreve. The decrease in other
collaboration revenue was due to lower sales of Ronapreve.
Refer to Table 4 for a summary of collaboration revenue.
Other revenue for the fourth quarter and full year 2023 included
the recognition of $16 million and $50 million,
respectively, of revenue in connection with the Company's agreement
with BARDA to fund certain costs for a next-generation COVID-19
monoclonal antibody therapy for the prevention of SARS-CoV-2
infection. The increase in other revenue in 2023 was also due to
higher royalties earned in connection with sales of Novartis'
Ilaris® (canakinumab).
Operating Expenses
|
|
GAAP |
|
% Change |
|
Non-GAAP(a) |
|
% Change |
($ in millions) |
|
Q4 2023 |
|
Q4 2022 |
|
|
Q4 2023 |
|
Q4 2022 |
|
Research and development (R&D) |
|
$ |
1,177 |
|
|
$ |
1,043 |
|
|
13 |
% |
|
$ |
1,031 |
|
$ |
911 |
|
13 |
% |
Acquired in-process research
and development (IPR&D) |
|
$ |
30 |
|
|
$ |
30 |
|
|
— |
% |
|
* |
|
* |
|
n/a |
|
Selling, general, and
administrative (SG&A) |
|
$ |
738 |
|
|
$ |
661 |
|
|
12 |
% |
|
$ |
622 |
|
$ |
579 |
|
7 |
% |
Cost of goods sold (COGS) |
|
$ |
307 |
|
|
$ |
302 |
|
|
2 |
% |
|
$ |
259 |
|
$ |
126 |
|
106 |
% |
Cost of collaboration and
contract manufacturing (COCM) |
|
$ |
210 |
|
|
$ |
238 |
|
|
(12 |
%) |
|
* |
|
* |
|
n/a |
|
Other operating (income)
expense, net |
|
$ |
(1 |
) |
|
$ |
(7 |
) |
|
(86 |
%) |
|
* |
|
* |
|
n/a |
|
|
|
GAAP |
|
% Change |
|
Non-GAAP(a) |
|
% Change |
|
|
FY 2023 |
|
FY 2022 |
|
|
FY 2023 |
|
FY 2022 |
|
Research and development |
|
$ |
4,439 |
|
|
$ |
3,593 |
|
|
24 |
% |
|
$ |
3,919 |
|
$ |
3,169 |
|
24 |
% |
Acquired in-process research
and development |
|
$ |
186 |
|
|
$ |
255 |
|
|
(27 |
%) |
|
* |
|
* |
|
n/a |
|
Selling, general, and
administrative |
|
$ |
2,631 |
|
|
$ |
2,116 |
|
|
24 |
% |
|
$ |
2,232 |
|
$ |
1,853 |
|
20 |
% |
Cost of goods sold |
|
$ |
932 |
|
|
$ |
800 |
|
|
17 |
% |
|
$ |
770 |
|
$ |
507 |
|
52 |
% |
Cost of collaboration and
contract manufacturing |
|
$ |
884 |
|
|
$ |
760 |
|
|
16 |
% |
|
* |
|
* |
|
n/a |
|
Other operating (income)
expense, net |
|
$ |
(2 |
) |
|
$ |
(90 |
) |
|
(98 |
%) |
|
* |
|
* |
|
n/a |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* GAAP and
non-GAAP amounts are equivalent as no non-GAAP adjustments have
been recorded. |
- GAAP and non-GAAP
R&D expenses increased in the fourth quarter and full year
2023, compared to the same periods in the prior year, 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
for the full year 2023 included a $100 million development
milestone in connection with the Phase 1 ALN-APP program, which is
in collaboration with Alnylam Pharmaceuticals, Inc. Acquired
IPR&D for the full year 2022 included a $195 million charge
related to the Company's acquisition of Checkmate Pharmaceuticals,
Inc.
- GAAP and non-GAAP
SG&A expenses increased in the fourth quarter of 2023, compared
to the fourth quarter of 2022, primarily due to higher headcount
and headcount-related costs and higher commercialization-related
expenses for various products, including the Company's retinal
franchise, partly offset by lower contributions to an independent
not-for-profit patient assistance organization. GAAP and non-GAAP
SG&A expenses increased for the full year 2023, compared to
full year 2022, primarily due to higher headcount and
headcount-related costs, an increase in commercialization-related
expenses for Libtayo, and, to a lesser extent, various other
products, and higher contributions to an independent not-for-profit
patient assistance organization.Non-GAAP SG&A expenses excluded
certain charges related to acquisition and integration-related
activities primarily incurred in connection with the July 2022
acquisition of Libtayo worldwide rights.
- GAAP and non-GAAP
COGS for the fourth quarter and full year 2023, when compared to
the same periods in the prior year, included higher start-up costs
for the Company's Rensselaer, New York fill/finish facility and an
increase in period costs at the Company's manufacturing facilities
(resulting from lower production volumes). GAAP COGS for the fourth
quarter and full year 2023, when compared to the same periods in
the prior year, included lower inventory write-offs and reserves
(which were primarily related to REGEN-COV® in 2022).Non-GAAP COGS
excluded certain charges related to REGEN-COV (primarily inventory
write-offs and reserves) of $134 million and $197 million in the
fourth quarter and full year 2022, respectively.
- COCM decreased in
the fourth quarter of 2023, compared to the fourth quarter of 2022,
primarily due to lower Dupixent manufacturing costs as a result of
the transition to a higher-yielding manufacturing process. COCM
increased for the full year 2023, compared to full year 2022,
primarily due to the recognition of costs in connection with
manufacturing commercial supplies for Sanofi related to Praluent
outside the United States and for Bayer related to EYLEA outside
the United States.
- Other operating
(income) expense, net for the full year 2022 included the
recognition of amounts previously deferred in connection with
up-front and development milestone payments received in connection
with the Company's previous Sanofi Immuno-Oncology, Teva, and
Mitsubishi Tanabe Pharma Corporation collaborative
arrangements.
Other Financial Information
GAAP other income (expense) included the recognition of net
unrealized losses on equity securities of $238 million for full
year 2023, compared to $40 million for full year 2022. GAAP and
Non-GAAP other income (expense) also included interest income of
$496 million and $160 million for the full year 2023 and
2022, respectively.
In the fourth quarter and full year 2023, the Company's GAAP
effective tax rate (ETR) was (1.0%) and 5.9%, respectively,
compared to 9.6% and 10.7% in the fourth quarter and full year
2022, respectively. The GAAP ETR in the fourth quarter and full
year 2023, compared to the same periods in the prior year, included
a higher benefit from stock-based compensation, federal tax credits
for research activities, and the proportion of income earned in
foreign jurisdictions with tax rates lower than the U.S. federal
statutory rate. In the fourth quarter and full year 2023, the
non-GAAP ETR was 2.4% and 9.1%, respectively, compared to 11.3% and
12.1% in the fourth quarter and full year 2022, respectively.
GAAP net income per diluted share was $10.19 in the fourth
quarter of 2023, compared to $10.50 in the fourth quarter of 2022.
GAAP net income per diluted share was $34.77 for the full year
2023, compared to $38.22 for full year 2022. Non-GAAP net income
per diluted share was $11.86 in the fourth quarter of 2023,
compared to $12.56 in the fourth quarter of 2022. Non-GAAP net
income per diluted share was $43.79 for the full year 2023,
compared to $44.98 for full year 2022. A reconciliation of the
Company's GAAP to non-GAAP results is included in Table 3 of this
press release.
During the fourth quarter and full year 2023, the Company
repurchased shares of its common stock and recorded the cost of the
shares, or $295 million and $2.215 billion, respectively, as
Treasury Stock. As of December 31, 2023, $1.5 billion remained
available for share repurchases under the Company's share
repurchase program.
2024 Financial Guidance(c)
The Company's full year 2024 financial guidance consists of the
following components:
|
|
2024 Guidance |
GAAP R&D |
|
$4.820–$5.070 billion |
Non-GAAP R&D(a) |
|
$4.300–$4.500 billion |
GAAP SG&A |
|
$2.890–$3.090 billion |
Non-GAAP SG&A(a) |
|
$2.500–$2.650 billion |
GAAP gross margin on net product
sales(d) |
|
86%–88% |
Non-GAAP gross margin on net
product sales(a)(d) |
|
89%–91% |
COCM(e)* |
|
$850–$910 million |
Capital expenditures* |
|
$825–$950 million |
GAAP effective tax rate |
|
8%–10% |
Non-GAAP effective tax
rate(a) |
|
10%–12% |
|
|
|
* GAAP and non-GAAP amounts are equivalent as no non-GAAP
adjustments have been or are expected to be recorded. |
A reconciliation of full year 2024 GAAP to non-GAAP financial
guidance is included below:
|
|
Projected Range |
($ in millions) |
|
Low |
|
High |
GAAP R&D |
|
$ |
4,820 |
|
|
$ |
5,070 |
|
Stock-based compensation expense |
|
|
510 |
|
|
|
540 |
|
Acquisition and integration costs |
|
|
10 |
|
|
|
30 |
|
Non-GAAP
R&D |
|
$ |
4,300 |
|
|
$ |
4,500 |
|
|
|
|
|
|
GAAP
SG&A |
|
$ |
2,890 |
|
|
$ |
3,090 |
|
Stock-based compensation expense |
|
|
350 |
|
|
|
380 |
|
Acquisition and integration costs |
|
|
40 |
|
|
|
60 |
|
Non-GAAP
SG&A |
|
$ |
2,500 |
|
|
$ |
2,650 |
|
|
|
|
|
|
GAAP gross
margin on net product sales |
|
|
86% |
|
|
|
88% |
|
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 |
|
|
89% |
|
|
|
91% |
|
|
|
|
|
|
GAAP ETR |
|
|
8% |
|
|
|
10% |
|
Income tax effect of GAAP to non-GAAP reconciling items |
|
|
2% |
|
|
|
2% |
|
Non-GAAP
ETR |
|
|
10% |
|
|
|
12% |
|
(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,
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. 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. |
|
|
(f) |
Represents Libtayo global net sales, inclusive of sales outside the
United States which were recorded by Sanofi prior to July 1,
2022. |
Conference Call
Information
Regeneron will host a conference call and simultaneous webcast
to discuss its fourth quarter and full year 2023 financial and
operating results on Friday, February 2, 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 for over 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® 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 litigation
initiated by the U.S. Attorney's Office for the District of
Massachusetts), the ultimate outcome of any such proceedings and
investigations, and the impact any of the foregoing may have on
Regeneron’s business, prospects, operating results, and financial
condition. A more complete description of these and other
material risks can be found in Regeneron's filings with the U.S.
Securities and Exchange Commission. Any forward-looking statements
are made based on management's current beliefs and judgment, and
the reader is cautioned not to rely on any forward-looking
statements made by Regeneron. Regeneron does not undertake any
obligation to update (publicly or otherwise) any forward-looking
statement, including without limitation any financial projection or
guidance, whether as a result of new information, future events, or
otherwise.
Regeneron uses its media and investor relations website and
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
investor relations website (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)
|
|
December 31, |
|
|
2023 |
|
2022 |
Assets: |
|
|
|
|
Cash and marketable securities |
|
$ |
16,241.3 |
|
$ |
14,334.1 |
Accounts receivable, net |
|
|
5,667.3 |
|
|
5,328.7 |
Inventories |
|
|
2,580.5 |
|
|
2,401.9 |
Property, plant, and equipment, net |
|
|
4,146.4 |
|
|
3,763.0 |
Intangible assets, net |
|
|
1,038.6 |
|
|
915.5 |
Deferred tax assets |
|
|
2,575.4 |
|
|
1,723.7 |
Other assets |
|
|
830.7 |
|
|
747.6 |
Total assets |
|
$ |
33,080.2 |
|
$ |
29,214.5 |
|
|
|
|
|
Liabilities and stockholders'
equity: |
|
|
|
|
Accounts payable, accrued expenses, and other liabilities |
|
$ |
3,818.6 |
|
$ |
3,301.4 |
Finance lease liabilities |
|
|
720.0 |
|
|
720.0 |
Deferred revenue |
|
|
585.6 |
|
|
547.7 |
Long-term debt |
|
|
1,982.9 |
|
|
1,981.4 |
Stockholders' equity |
|
|
25,973.1 |
|
|
22,664.0 |
Total liabilities and
stockholders' equity |
|
$ |
33,080.2 |
|
$ |
29,214.5 |
TABLE 2
REGENERON PHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited)(In millions, except per
share data)
|
|
Three Months EndedDecember
31, |
|
Year EndedDecember 31, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Revenues: |
|
|
|
|
|
|
|
|
Net product sales |
|
$ |
1,851.8 |
|
|
$ |
1,699.3 |
|
|
$ |
7,078.0 |
|
|
$ |
6,893.7 |
|
Collaboration revenue |
|
|
1,370.0 |
|
|
|
1,587.4 |
|
|
|
5,503.1 |
|
|
|
4,914.1 |
|
Other revenue |
|
|
212.5 |
|
|
|
127.7 |
|
|
|
536.1 |
|
|
|
365.1 |
|
|
|
|
3,434.3 |
|
|
|
3,414.4 |
|
|
|
13,117.2 |
|
|
|
12,172.9 |
|
Expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
1,177.2 |
|
|
|
1,043.1 |
|
|
|
4,439.0 |
|
|
|
3,592.5 |
|
Acquired in-process research and development |
|
|
30.0 |
|
|
|
30.0 |
|
|
|
186.1 |
|
|
|
255.1 |
|
Selling, general, and administrative |
|
|
737.7 |
|
|
|
660.5 |
|
|
|
2,631.3 |
|
|
|
2,115.9 |
|
Cost of goods sold |
|
|
306.8 |
|
|
|
302.2 |
|
|
|
932.1 |
|
|
|
800.0 |
|
Cost of collaboration and contract manufacturing |
|
|
210.2 |
|
|
|
238.4 |
|
|
|
883.7 |
|
|
|
760.4 |
|
Other operating (income) expense, net |
|
|
(0.5 |
) |
|
|
(6.6 |
) |
|
|
(2.1 |
) |
|
|
(89.9 |
) |
|
|
|
2,461.4 |
|
|
|
2,267.6 |
|
|
|
9,070.1 |
|
|
|
7,434.0 |
|
|
|
|
|
|
|
|
|
|
Income from operations |
|
|
972.9 |
|
|
|
1,146.8 |
|
|
|
4,047.1 |
|
|
|
4,738.9 |
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
193.0 |
|
|
|
195.3 |
|
|
|
225.2 |
|
|
|
179.3 |
|
Interest expense |
|
|
(18.3 |
) |
|
|
(17.4 |
) |
|
|
(73.0 |
) |
|
|
(59.4 |
) |
|
|
|
174.7 |
|
|
|
177.9 |
|
|
|
152.2 |
|
|
|
119.9 |
|
|
|
|
|
|
|
|
|
|
Income before income
taxes |
|
|
1,147.6 |
|
|
|
1,324.7 |
|
|
|
4,199.3 |
|
|
|
4,858.8 |
|
|
|
|
|
|
|
|
|
|
Income tax (benefit)
expense |
|
|
(12.0 |
) |
|
|
127.6 |
|
|
|
245.7 |
|
|
|
520.4 |
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
1,159.6 |
|
|
$ |
1,197.1 |
|
|
$ |
3,953.6 |
|
|
$ |
4,338.4 |
|
|
|
|
|
|
|
|
|
|
Net income per share -
basic |
|
$ |
10.88 |
|
|
$ |
11.19 |
|
|
$ |
37.05 |
|
|
$ |
40.51 |
|
Net income per share -
diluted |
|
$ |
10.19 |
|
|
$ |
10.50 |
|
|
$ |
34.77 |
|
|
$ |
38.22 |
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding - basic |
|
|
106.6 |
|
|
|
107.0 |
|
|
|
106.7 |
|
|
|
107.1 |
|
Weighted average shares
outstanding - diluted |
|
|
113.8 |
|
|
|
114.0 |
|
|
|
113.7 |
|
|
|
113.5 |
|
TABLE 3
REGENERON PHARMACEUTICALS,
INC.RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL
INFORMATION (Unaudited)(In millions, except per
share data)
|
|
Three Months EndedDecember
31, |
|
Year EndedDecember 31, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
GAAP R&D |
|
$ |
1,177.2 |
|
|
$ |
1,043.1 |
|
|
$ |
4,439.0 |
|
|
$ |
3,592.5 |
|
Stock-based compensation expense |
|
|
132.7 |
|
|
|
131.0 |
|
|
|
488.7 |
|
|
|
406.8 |
|
Acquisition and integration costs |
|
|
13.6 |
|
|
|
1.4 |
|
|
|
31.3 |
|
|
|
17.0 |
|
Non-GAAP R&D |
|
$ |
1,030.9 |
|
|
$ |
910.7 |
|
|
$ |
3,919.0 |
|
|
$ |
3,168.7 |
|
|
|
|
|
|
|
|
|
|
GAAP SG&A |
|
$ |
737.7 |
|
|
$ |
660.5 |
|
|
$ |
2,631.3 |
|
|
$ |
2,115.9 |
|
Stock-based compensation expense |
|
|
82.6 |
|
|
|
78.4 |
|
|
|
307.1 |
|
|
|
256.4 |
|
Acquisition and integration costs |
|
|
33.3 |
|
|
|
3.5 |
|
|
|
91.8 |
|
|
|
6.6 |
|
Non-GAAP SG&A |
|
$ |
621.8 |
|
|
$ |
578.6 |
|
|
$ |
2,232.4 |
|
|
$ |
1,852.9 |
|
|
|
|
|
|
|
|
|
|
GAAP COGS |
|
$ |
306.8 |
|
|
$ |
302.2 |
|
|
$ |
932.1 |
|
|
$ |
800.0 |
|
Stock-based compensation expense |
|
|
25.1 |
|
|
|
22.6 |
|
|
|
89.2 |
|
|
|
61.8 |
|
Acquisition and integration costs |
|
|
0.9 |
|
|
|
— |
|
|
|
2.3 |
|
|
|
— |
|
Intangible asset amortization expense |
|
|
21.9 |
|
|
|
19.7 |
|
|
|
80.9 |
|
|
|
34.8 |
|
Charges related to REGEN-COV |
|
|
— |
|
|
|
133.7 |
|
|
|
(10.0 |
) |
|
|
196.6 |
|
Non-GAAP COGS |
|
$ |
258.9 |
|
|
$ |
126.2 |
|
|
$ |
769.7 |
|
|
$ |
506.8 |
|
|
|
|
|
|
|
|
|
|
GAAP other income (expense),
net |
|
$ |
174.7 |
|
|
$ |
177.9 |
|
|
$ |
152.2 |
|
|
$ |
119.9 |
|
(Gains) losses on investments, net |
|
|
(58.1 |
) |
|
|
(80.5 |
) |
|
|
266.4 |
|
|
|
36.8 |
|
Non-GAAP other income
(expense), net |
|
$ |
116.6 |
|
|
$ |
97.4 |
|
|
$ |
418.6 |
|
|
$ |
156.7 |
|
|
|
|
|
|
|
|
|
|
GAAP net
income |
|
$ |
1,159.6 |
|
|
$ |
1,197.1 |
|
|
$ |
3,953.6 |
|
|
$ |
4,338.4 |
|
Total of GAAP to non-GAAP reconciling items above |
|
|
252.0 |
|
|
|
309.8 |
|
|
|
1,347.7 |
|
|
|
1,016.8 |
|
Income tax effect of GAAP to non-GAAP reconciling items |
|
|
(45.3 |
) |
|
|
(57.9 |
) |
|
|
(256.8 |
) |
|
|
(191.3 |
) |
Non-GAAP net income |
|
$ |
1,366.3 |
|
|
$ |
1,449.0 |
|
|
$ |
5,044.5 |
|
|
$ |
5,163.9 |
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income per share
- basic |
|
$ |
12.82 |
|
|
$ |
13.54 |
|
|
$ |
47.28 |
|
|
$ |
48.22 |
|
Non-GAAP net income per share
- diluted |
|
$ |
11.86 |
|
|
$ |
12.56 |
|
|
$ |
43.79 |
|
|
$ |
44.98 |
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating: |
|
|
|
|
|
|
|
|
Non-GAAP net income per share
- basic |
|
|
106.6 |
|
|
|
107.0 |
|
|
|
106.7 |
|
|
|
107.1 |
|
Non-GAAP net income per share
- diluted |
|
|
115.2 |
|
|
|
115.4 |
|
|
|
115.2 |
|
|
|
114.8 |
|
RECONCILIATION OF GAAP TO NON-GAAP
FINANCIAL INFORMATION (Unaudited)
(continued)
|
|
Three Months EndedDecember
31, |
|
Year EndedDecember 31, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Revenue reconciliation: |
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
3,434.3 |
|
|
$ |
3,414.4 |
|
|
$ |
13,117.2 |
|
|
$ |
12,172.9 |
|
Global gross profit payment from Roche in connection with sales of
Ronapreve |
|
|
2.1 |
|
|
|
396.4 |
|
|
|
224.3 |
|
|
|
627.3 |
|
Other |
|
|
(3.8 |
) |
|
|
— |
|
|
|
(13.3 |
) |
|
|
— |
|
Total revenues excluding
Ronapreve |
|
$ |
3,436.0 |
|
|
$ |
3,018.0 |
|
|
$ |
12,906.2 |
|
|
$ |
11,545.6 |
|
|
|
|
|
|
|
|
|
|
Effective tax rate
reconciliation: |
|
|
|
|
|
|
|
|
GAAP ETR |
|
|
(1.0% |
) |
|
|
9.6% |
|
|
|
5.9% |
|
|
|
10.7% |
|
Income tax effect of GAAP to non-GAAP reconciling items |
|
|
3.4% |
|
|
|
1.7% |
|
|
|
3.2% |
|
|
|
1.4% |
|
Non-GAAP ETR |
|
|
2.4% |
|
|
|
11.3% |
|
|
|
9.1% |
|
|
|
12.1% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year EndedDecember 31, |
|
|
|
|
|
|
2023 |
|
2022 |
|
|
Free cash flow
reconciliation: |
|
|
|
|
|
|
|
|
Net cash provided by operating
activities |
|
|
|
$ |
4,594.0 |
|
|
$ |
5,014.9 |
|
|
|
Capital expenditures |
|
|
|
|
(718.6 |
) |
|
|
(590.1 |
) |
|
|
Free cash flow |
|
|
|
$ |
3,875.4 |
|
|
$ |
4,424.8 |
|
|
|
TABLE 4
REGENERON PHARMACEUTICALS,
INC.COLLABORATION REVENUE
(Unaudited)(In millions)
|
|
Three Months EndedDecember
31, |
|
Year EndedDecember 31, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Sanofi collaboration
revenue: |
|
|
|
|
|
|
|
|
Antibody: |
|
|
|
|
|
|
|
|
Regeneron's share of profits in connection with commercialization
of antibodies |
|
$ |
885.9 |
|
|
$ |
619.0 |
|
$ |
3,136.5 |
|
|
$ |
2,082.0 |
Sales-based milestones earned |
|
|
— |
|
|
|
50.0 |
|
|
50.0 |
|
|
|
100.0 |
Reimbursement for manufacturing of commercial supplies |
|
|
107.0 |
|
|
|
166.9 |
|
|
613.0 |
|
|
|
633.7 |
Other |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
28.7 |
Immuno-oncology |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
11.3 |
Total Sanofi collaboration
revenue |
|
|
992.9 |
|
|
|
835.9 |
|
|
3,799.5 |
|
|
|
2,855.7 |
|
|
|
|
|
|
|
|
|
Bayer collaboration
revenue: |
|
|
|
|
|
|
|
|
Regeneron's share of profits in connection with commercialization
of EYLEA outside the United States |
|
|
345.4 |
|
|
|
324.0 |
|
|
1,376.4 |
|
|
|
1,317.4 |
Reimbursement for manufacturing of ex-U.S. commercial supplies |
|
|
31.4 |
|
|
|
31.1 |
|
|
111.1 |
|
|
|
91.4 |
One-time payment in connection with change in Japan
arrangement |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
21.9 |
Total Bayer collaboration
revenue |
|
|
376.8 |
|
|
|
355.1 |
|
|
1,487.5 |
|
|
|
1,430.7 |
|
|
|
|
|
|
|
|
|
Other collaboration
revenue: |
|
|
|
|
|
|
|
|
Global gross profit payment from Roche in connection with sales of
Ronapreve |
|
|
2.1 |
|
|
|
396.4 |
|
|
224.3 |
|
|
|
627.3 |
Other |
|
|
(1.8 |
) |
|
|
— |
|
|
(8.2 |
) |
|
|
0.4 |
|
|
|
|
|
|
|
|
|
Total collaboration
revenue |
|
$ |
1,370.0 |
|
|
$ |
1,587.4 |
|
$ |
5,503.1 |
|
|
$ |
4,914.1 |
TABLE 5
REGENERON PHARMACEUTICALS,
INC.NET PRODUCT SALES OF REGENERON-DISCOVERED
PRODUCTS (Unaudited)(In millions)
|
|
Three Months EndedDecember
31, |
|
|
|
|
2023 |
|
2022 |
|
% Change |
|
|
U.S. |
|
ROW(g) |
|
Total |
|
U.S. |
|
ROW |
|
Total |
|
(Total Sales) |
EYLEA HD(a) |
|
$ |
123.1 |
|
$ |
— |
|
$ |
123.1 |
|
$ |
— |
|
$ |
— |
|
$ |
— |
|
|
* |
EYLEA(a) |
|
$ |
1,337.5 |
|
$ |
889.6 |
|
$ |
2,227.1 |
|
$ |
1,496.4 |
|
$ |
838.6 |
|
$ |
2,335.0 |
|
(5 |
%) |
Total EYLEA HD and EYLEA |
|
$ |
1,460.6 |
|
$ |
889.6 |
|
$ |
2,350.2 |
|
$ |
1,496.4 |
|
$ |
838.6 |
|
$ |
2,335.0 |
|
1 |
% |
Dupixent(b) |
|
$ |
2,486.0 |
|
$ |
730.1 |
|
$ |
3,216.1 |
|
$ |
1,936.3 |
|
$ |
512.6 |
|
$ |
2,448.9 |
|
31 |
% |
Libtayo(c) |
|
$ |
154.8 |
|
$ |
89.0 |
|
$ |
243.8 |
|
$ |
110.0 |
|
$ |
58.8 |
|
$ |
168.8 |
|
44 |
% |
Praluent(d) |
|
$ |
61.3 |
|
$ |
125.9 |
|
$ |
187.2 |
|
$ |
35.5 |
|
$ |
97.9 |
|
$ |
133.4 |
|
40 |
% |
REGEN-COV(e) |
|
$ |
— |
|
$ |
5.6 |
|
$ |
5.6 |
|
$ |
— |
|
$ |
1,088.4 |
|
$ |
1,088.4 |
|
(99 |
%) |
Kevzara(b) |
|
$ |
66.2 |
|
$ |
46.0 |
|
$ |
112.2 |
|
$ |
46.6 |
|
$ |
34.6 |
|
$ |
81.2 |
|
38 |
% |
Other products(f) |
|
$ |
86.5 |
|
$ |
18.5 |
|
$ |
105.0 |
|
$ |
16.6 |
|
$ |
15.0 |
|
$ |
31.6 |
|
232 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year EndedDecember 31, |
|
|
|
|
2023 |
|
2022 |
|
% Change |
|
|
U.S. |
|
ROW |
|
Total |
|
U.S. |
|
ROW |
|
Total |
|
(Total Sales) |
EYLEA HD(a) |
|
$ |
165.8 |
|
$ |
— |
|
$ |
165.8 |
|
$ |
— |
|
$ |
— |
|
$ |
— |
|
|
* |
EYLEA(a) |
|
$ |
5,719.6 |
|
$ |
3,495.2 |
|
$ |
9,214.8 |
|
$ |
6,264.6 |
|
$ |
3,382.8 |
|
$ |
9,647.4 |
|
(4 |
%) |
Total EYLEA HD and EYLEA |
|
$ |
5,885.4 |
|
$ |
3,495.2 |
|
$ |
9,380.6 |
|
$ |
6,264.6 |
|
$ |
3,382.8 |
|
$ |
9,647.4 |
|
(3 |
%) |
Dupixent(b) |
|
$ |
8,855.6 |
|
$ |
2,732.5 |
|
$ |
11,588.1 |
|
$ |
6,668.0 |
|
$ |
2,013.2 |
|
$ |
8,681.2 |
|
33 |
% |
Libtayo(c) |
|
$ |
538.8 |
|
$ |
330.0 |
|
$ |
868.8 |
|
$ |
374.5 |
|
$ |
203.5 |
|
$ |
578.0 |
|
50 |
% |
Praluent(d) |
|
$ |
182.4 |
|
$ |
456.5 |
|
$ |
638.9 |
|
$ |
130.0 |
|
$ |
337.4 |
|
$ |
467.4 |
|
37 |
% |
REGEN-COV(e) |
|
$ |
— |
|
$ |
618.8 |
|
$ |
618.8 |
|
$ |
— |
|
$ |
1,769.6 |
|
$ |
1,769.6 |
|
(65 |
%) |
Kevzara(b) |
|
$ |
214.7 |
|
$ |
171.2 |
|
$ |
385.9 |
|
$ |
199.7 |
|
$ |
158.3 |
|
$ |
358.0 |
|
8 |
% |
Other products(f) |
|
$ |
150.5 |
|
$ |
67.4 |
|
$ |
217.9 |
|
$ |
56.1 |
|
$ |
69.1 |
|
$ |
125.2 |
|
74 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Percentage not meaningful |
(a) Regeneron 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. |
(b) Sanofi records global net product sales of Dupixent and
Kevzara. The Company records its share of profits 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 years
ended December 31, 2023 and 2022 is approximately $6 million and
$34 million, respectively, and for the fourth quarter of 2022
approximately $17 million, of 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) Roche records net product sales outside the United States; the
parties share gross profits from 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 "Fourth Quarter 2023 Financial
Results" section above for a complete listing of net product sales
recorded by the Company. |
(g) Rest of world (ROW) |
Grafico Azioni Regeneron Pharmaceuticals (NASDAQ:REGN)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Regeneron Pharmaceuticals (NASDAQ:REGN)
Storico
Da Giu 2023 a Giu 2024