- Fourth quarter 2023 revenues increased 1% to $3.43 billion versus fourth quarter 2022; excluding RonapreveTM(a)(b), revenues increased 14%
- Full year 2023 revenues increased 8% to $13.12 billion versus full year 2022; excluding Ronapreve(a), revenues increased 12%
- Fourth quarter 2023 Dupixent® global net sales (recorded by Sanofi) increased 31% to $3.22 billion versus fourth quarter 2022; full year 2023 Dupixent global net sales increased 33% to $11.59 billion versus 2022
- Fourth quarter 2023 U.S. net sales for EYLEA® HD and EYLEA® were $1.46 billion, including $123 million from EYLEA HD; full year 2023 U.S. net sales for EYLEA HD and EYLEA were $5.89 billion, including $166 million from EYLEA HD following its August 2023 FDA approval
- Fourth quarter 2023 Libtayo® global net sales increased 44% to $244 million versus fourth quarter 2022; full year 2023 Libtayo global net sales increased 50% to $869 million versus 2022(f)
- Fourth quarter 2023 GAAP diluted EPS of $10.19 and non-GAAP diluted EPS(a) of $11.86; includes unfavorable $0.21 impact from acquired IPR&D charge
- Dupixent sBLA for chronic obstructive pulmonary disease (COPD) with type 2 inflammatory phenotype and linvoseltamab BLA for multiple myeloma submitted to FDA
TARRYTOWN, N.Y., Feb. 02, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the fourth quarter and full year 2023 and provided a business update. "2023 marked another year of exceptional accomplishments for Regeneron as we further diversified our revenue base and made important progress in our robust R&D pipeline," said Leonard S. Schleifer, M.D., Ph.D., Board Co-Chair, President and Chief Executive Officer of Regeneron. "In 2024, we plan to build on this momentum with continued growth of our breakthrough products Dupixent and EYLEA HD while we bring additional new therapies to market and advance our growing pipeline. Lastly, I want to congratulate our Chief Financial Officer, Bob Landry, on the occasion of his retirement and thank him for his significant contributions to Regeneron during his ten years with the Company." Financial Highlights | | | Three Months Ended
December 31, | | | | Year Ended
December 31, | | | | ($ 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 Progress
Regeneron has approximately 35 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include: EYLEA 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<
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