On February 4, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the fourth quarter and full year 2024 and provided a business update (Press release, Regeneron, FEB 4, 2025, View Source [SID1234650031]).

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"Regeneron’s financial and commercial strength allows for continued investment in our industry-leading R&D pipeline, while simultaneously returning capital to our shareholders through our newly initiated dividend program and increased share repurchase capacity," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "In 2025, we will continue to focus on our four blockbuster medicines as we progress our approximately 40 investigational candidates covering dozens of disease states with expansive market potential."

Financial Highlights

($ in millions, except per share data) Q4 2024 Q4 2023 % Change FY 2024 FY 2023 % Change
Total revenues $ 3,789 $ 3,434 10 % $ 14,202 $ 13,117 8 %
GAAP net income $ 918 $ 1,160 (21 %) $ 4,413 $ 3,954 12 %
GAAP net income per share – diluted $ 8.06 $ 10.19 (21 %) $ 38.34 $ 34.77 10 %
Non-GAAP net income(a) $ 1,390 $ 1,366 2 % $ 5,319 $ 5,045 5 %
Non-GAAP net income per share – diluted(a) $ 12.07 $ 11.86 2 % $ 45.62 $ 43.79 4 %

"2024 was another year of top- and bottom-line growth for Regeneron. This strong financial performance, coupled with the strength of our balance sheet, allows us to initiate a quarterly cash dividend program as well as increase our current share repurchase capacity to approximately $4.5 billion," said Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer of Regeneron.

Business Highlights

Key Pipeline Progress
Regeneron has approximately 40 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

The Company announced that the primary endpoint was met in the Phase 3 QUASAR trial investigating EYLEA HD for the treatment of patients with macular edema following RVO, including those with central, branch, and hemiretinal vein occlusions. In the trial, patients treated with EYLEA HD every 8 weeks (after initial monthly doses) experienced non-inferior vision gains compared to those treated with the approved monthly dosing regimen of EYLEA, the current standard of care. The Company plans to submit a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) in the first quarter of 2025.
A regulatory application for a pre-filled syringe was submitted to the FDA, with an FDA decision expected by mid-2025.
Dupixent (dupilumab)

In November 2024, the European Commission (EC) approved Dupixent to treat eosinophilic esophagitis (EoE) in children aged 1 to 11 years, making Dupixent the first and only medicine indicated to treat these young patients.
The FDA accepted for review the resubmission of an sBLA for Dupixent to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment, with a target action date of April 18, 2025.
An sBLA for Dupixent in bullous pemphigoid was submitted to the FDA.
A Phase 3 study in lichen simplex chronicus was initiated.
Libtayo (cemiplimab)

The Company announced positive results from a Phase 3 trial of Libtayo, which demonstrated that adjuvant treatment with Libtayo was the first and only immunotherapy that led to a statistically significant and clinically meaningful improvement in the primary endpoint of disease-free survival (DFS) in patients with high-risk CSCC after surgery.
A Phase 3 study of Libtayo administered intralesionally in patients with early-stage CSCC was initiated.
Hematology Programs

In January 2025, the Company resubmitted to the FDA the BLA for linvoseltamab, a bispecific antibody targeting BCMA and CD3, in relapsed/refractory (R/R) multiple myeloma following resolution of third-party manufacturing issues.
In January 2025, the Company resubmitted to the FDA the BLA for odronextamab, a bispecific antibody targeting CD20 and CD3, in R/R follicular lymphoma.
The Company presented new and updated data for odronextamab spanning several B-cell non-Hodgkin lymphoma (B-NHL) subtypes across earlier lines of treatment at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.
The Company announced positive Phase 2 results for two antibodies targeting distinct domains of Factor XI. REGN7508 (catalytic domain) is designed to maximize anticoagulant activity while minimizing bleeding risk, and REGN9933 (A2 domain) is designed to provide an additional option for patients with the highest bleeding risk who would otherwise not be candidates for currently available anticoagulants. Per the Phase 2 results, there was a robust antithrombotic effect for each antibody, and no clinically relevant bleeding was observed.
The Company announced positive updated data from a Phase 3 study of pozelimab (C5 antibody), in combination with cemdisiran (siRNA therapy), against ravulizumab, a standard-of-care C5 inhibitor, in patients with paroxysmal nocturnal hemoglobinuria (PNH). The study showed that the combination treatment helped patients achieve and maintain greater disease control, compared to ravulizumab. These results were presented at the 66th ASH (Free ASH Whitepaper) Annual Meeting and Exposition.
Other Programs

The EC approved Kevzara (sarilumab) for the treatment of polymyalgia rheumatica (PMR) and polyarticular juvenile idiopathic arthritis (pJIA).
A Phase 3 study for mibavademab, an agonist antibody to leptin receptor (LEPR), in generalized lipodystrophy was initiated.
Enrollment was completed in a Phase 2 study in obesity 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 itepekimab, an antibody to IL-33, in chronic rhinosinusitis without nasal polyposis (CRSsNP) was initiated.
A Phase 2 study for REGN7544, an antagonist antibody to NPR1, in postural orthostatic tachycardia syndrome (POTS) was initiated.
The Company shared initial data from the first patient in a Phase 1 study of linvoseltamab, in combination with Dupixent, in severe food allergy at the 43rd Annual J.P. Morgan Healthcare Conference.
Corporate and Business Development Updates

In February 2025, the Company’s board of directors approved the initiation of a quarterly cash dividend program and declared a cash dividend of $0.88 per share on the Company’s common stock and Class A stock, payable on March 20, 2025 to shareholders of record as of February 20, 2025. The Company intends to pay a cash dividend on a quarterly basis going forward, subject to market conditions and approval by the Company’s board of directors in its sole discretion.
In February 2025, the Company’s board of directors also authorized an additional $3.0 billion share repurchase program, bringing the total current capacity to approximately $4.5 billion. Repurchases may be made from time to time at management’s discretion through a variety of methods. The program has no time limit and can be discontinued at any time.
In January 2025, the Company entered into an agreement with Truveta Inc. pursuant to which the Company will sequence exomes and conduct genotyping and imputation of up to ten million de-identified consented volunteers using biospecimens provided by Truveta health system members across the United States.
The Company announced its inclusion on the Dow Jones Sustainability World Index (DJSI World) for the sixth consecutive year, as well as its fifth consecutive inclusion on the Dow Jones Sustainability North America Index (DJSI North America).
Select Upcoming 2025 Milestones

Programs Milestones
EYLEA HD - Submit sBLA in RVO (first quarter 2025) and FDA decision on sBLA (second half 2025)
- FDA decision for pre-filled syringe (mid-2025)
- FDA decision on sBLA with two-year data for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) (target action date of April 20, 2025)
- Submit sBLA for every 4-week dosing regimen (first quarter 2025) and FDA decision on sBLA (second half 2025)
Immunology & Inflammation - Report results from Phase 3 study for itepekimab (IL-33 antibody) in chronic obstructive pulmonary disease (COPD) (second half 2025) and submit BLA (second half 2025)
- FDA decision on sBLA for Dupixent in CSU (target action date of April 18, 2025)
- sBLA acceptance for Dupixent in bullous pemphigoid (first half 2025) and FDA decision on sBLA (second half 2025); regulatory submission in European Union (EU) (first half 2025)
- Initiate additional Phase 3 studies for itepekimab (IL-33 antibody) (first half 2025)
- Report additional data from Phase 1 study for linvoseltamab (BCMA and CD3 bispecific antibody) in combination with Dupixent in severe food allergies
Solid Organ Oncology - Submit sBLA for Libtayo in adjuvant CSCC (first half 2025)
- Report results from Phase 3 study of fianlimab (LAG-3 antibody), in combination with Libtayo, versus pembrolizumab in first-line metastatic melanoma (second half 2025) and submit BLA (second half 2025)
- Report initial Phase 2 data for fianlimab (LAG-3 antibody) in combination with Libtayo in first-line advanced non-small cell lung cancer (NSCLC) (first half 2025)
- Report additional data for ubamatamab (MUC16 and CD3 bispecific antibody) in ovarian cancer
- Report additional data from solid tumor costimulatory bispecific antibody programs
Hematology - FDA decision on BLA for odronextamab (CD20 and CD3 bispecific antibody) in R/R follicular lymphoma (second half 2025)
- FDA decision on BLA for linvoseltamab (BCMA and CD3 bispecific antibody) in R/R multiple myeloma (mid-2025)
- Initiate Phase 3 program for Factor XI antibodies (REGN9933 and REGN7508)
Genetic Medicines - Report additional data from Phase 1/2 study for DB-OTO (AAV-based gene therapy) in patients with hearing deficit due to variants of the otoferlin gene (mid-2025)
- Report results from Phase 3 study for pozelimab (C5 antibody) in combination with cemdisiran in myasthenia gravis (second half 2025)
Internal Medicine - Report results from Phase 2 study for semaglutide in combination with trevogrumab (myostatin antibody) with and without garetosmab (Activin A antibody) in obesity (second half 2025)
- Report results from Phase 2 study for mibavademab (LEPR agonist antibody) in combination with tirzepatide in obesity (second half 2025)
- Report results from Phase 3 study for garetosmab (Activin A antibody) in fibrodysplasia ossificans progressiva (FOP) (second half 2025)

Fourth Quarter and Full Year 2024 Financial Results

Revenues

($ in millions) Q4 2024 Q4 2023 % Change FY 2024 FY 2023 % Change
Net product sales:
EYLEA HD – U.S. $ 305 $ 123 148 % $ 1,201 $ 166 *
EYLEA – U.S. 1,190 1,338 (11 %) 4,767 5,720 (17 %)
Total EYLEA HD and EYLEA – U.S. 1,495 1,461 2 % 5,968 5,886 1 %
Libtayo – Global 367 244 50 % 1,217 863 41 %
Praluent- U.S. 63 61 3 % 242 182 33 %
Evkeeza- U.S. 38 24 58 % 126 77 64 %
Inmazeb- U.S. 40 62 (35 %) 76 70 9 %
Total net product sales 2,003 1,852 8 % 7,629 7,078 8 %

Collaboration revenue:
Sanofi 1,213 993 22 % 4,531 3,800 19 %
Bayer 377 377 — % 1,499 1,487 1 %
Other 17 — * 28 216 (87 %)
Other revenue 179 212 (16 %) 515 536 (4 %)
Total revenues $ 3,789 $ 3,434 10 % $ 14,202 $ 13,117 8 %

Total revenues excluding Ronapreve(a) $ 3,789 $ 3,436 10 % $ 14,201 $ 12,906 10 %

* Percentage not meaningful

EYLEA HD was approved by the FDA in August 2023 and net product sales in 2024 were driven by the transition of patients from other anti-VEGF products, including EYLEA, as well as new patients naïve to anti-VEGF therapy. Net product sales of EYLEA HD and EYLEA in the fourth quarter and full year 2024 were adversely impacted by a lower net selling price compared to the same periods of 2023. In addition, fourth quarter 2024 total EYLEA HD and EYLEA net product sales were favorably impacted by approximately $85 million as a result of higher wholesaler inventory levels for EYLEA, partially offset by lower wholesaler inventory levels for EYLEA HD, at the end of the fourth quarter 2024 compared to the end of the third quarter 2024.

Sanofi collaboration revenue increased in the fourth quarter and full year 2024, compared to the same periods of 2023, due to an increase in the Company’s share of profits from the commercialization of antibodies, which were $1.043 billion and $886 million in the fourth quarter of 2024 and 2023, respectively, and $3.924 billion and $3.137 billion for full year 2024 and 2023, 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. Sanofi collaboration revenue in 2023 was positively impacted by the recognition of a $50 million sales-based milestone.

Collaboration revenue for full year 2023 included $224 million in connection with the Company’s share of global gross profits from sales of Ronapreve by Roche.

Refer to Table 4 for a summary of collaboration revenue.

Operating Expenses

GAAP %
Change
Non-GAAP(a) %
Change
($ in millions) Q4 2024 Q4 2023 Q4 2024 Q4 2023
Research and development (R&D) $ 1,412 $ 1,177 20 % $ 1,224 $ 1,031 19 %
Acquired in-process research and development (IPR&D) $ 14 $ 30 (53 %) * * n/a
Selling, general, and administrative (SG&A) $ 792 $ 738 7 % $ 681 $ 622 9 %
Cost of goods sold (COGS) $ 327 $ 307 7 % $ 271 $ 259 5 %
Cost of collaboration and contract manufacturing (COCM) $ 239 $ 210 14 % * * n/a
Other operating expense (income), net $ 16 $ (1 ) ** $ — * **

GAAP %
Change
Non-GAAP(a) %
Change
FY 2024 FY 2023 FY 2024 FY 2023
Research and development $ 5,132 $ 4,439 16 % $ 4,563 $ 3,919 16 %
Acquired in-process research and development $ 101 $ 186 (46 %) * * n/a
Selling, general, and administrative $ 2,954 $ 2,631 12 % $ 2,544 $ 2,232 14 %
Cost of goods sold $ 1,087 $ 932 17 % $ 898 $ 770 17 %
Cost of collaboration and contract manufacturing $ 883 $ 884 — % * * n/a
Other operating expense (income), net $ 53 $ (2 ) ** $ — * **

* 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 fourth quarter and full year 2024, compared to the same periods in the prior year, driven by the advancement of the Company’s mid- and late-stage clinical pipeline and higher headcount-related costs.
Acquired IPR&D expense for full year 2024 included a $45 million development milestone in connection with the Company’s collaboration agreement with Sonoma Biotherapeutics, Inc. Acquired IPR&D expense for full year 2023 included a $100 million development milestone in connection with the Company’s collaboration with Alnylam Pharmaceuticals, Inc.
GAAP and non-GAAP SG&A expenses increased for full year 2024, compared to full year 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 for full year 2024, compared to full year 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 fourth quarter and full year 2024 reflects charges 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), net included the recognition of net unrealized losses on equity securities of $213 million in the fourth quarter of 2024, compared to $58 million of net unrealized gains in the fourth quarter of 2023. GAAP other income (expense), net included the recognition of net unrealized gains on equity securities of $118 million for full year 2024, compared to net unrealized losses of $238 million for full year 2023. GAAP and non-GAAP other income (expense), net also included interest income of $711 million for full year 2024, compared to $496 million for full year 2023.

In the fourth quarter and full year 2024, the Company’s GAAP effective tax rate (ETR) was 4.2% and 7.7%, respectively, compared to (1.0%) and 5.9% in the fourth quarter and full year 2023, respectively. The GAAP ETR increased in the fourth quarter of 2024, compared to the same period in the prior year, due to a lower benefit from stock-based compensation. In the fourth quarter and full year 2024, the non-GAAP ETR was 9.9% and 9.6%, respectively, compared to 2.4% and 9.1% in the fourth quarter and full year 2023, respectively.

GAAP net income per diluted share was $8.06 in the fourth quarter of 2024, compared to $10.19 in the fourth quarter of 2023. GAAP net income per diluted share was $38.34 for the full year 2024, compared to $34.77 for the full year 2023. Non-GAAP net income per diluted share was $12.07 in the fourth quarter of 2024, compared to $11.86 in the fourth quarter of 2023. Non-GAAP net income per diluted share was $45.62 for the full year 2024, compared to $43.79 for the full year 2023. A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.

The Company repurchased $976 million and $2.6 billion of shares of its common stock during the fourth quarter and full year 2024, respectively, and recorded the cost of the shares as Treasury Stock.

2025 Financial Guidance(c)

The Company’s full year 2025 financial guidance consists of the following components:

2025 Guidance
GAAP R&D $5.560–$5.795 billion
Non-GAAP R&D(a) $5.000–$5.200 billion
GAAP SG&A $2.910–$3.095 billion
Non-GAAP SG&A(a) $2.550–$2.700 billion
GAAP gross margin on net product sales(d) 84%–85%
Non-GAAP gross margin on net product sales(a)(d) 87%–88%
COCM(e)* $1.000–$1.150 billion
Capital expenditures* $850–$975 million
GAAP effective tax rate 9%–11%
Non-GAAP effective tax rate(a) 11%–13%

* 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 2025 GAAP to non-GAAP financial guidance is included below:

Projected Range
($ in millions) Low High
GAAP R&D $ 5,560 $ 5,795
Stock-based compensation expense 560 590
Acquisition and integration costs — 5
Non-GAAP R&D $ 5,000 $ 5,200

GAAP SG&A $ 2,910 $ 3,095
Stock-based compensation expense 360 390
Acquisition and integration costs — 5
Non-GAAP SG&A $ 2,550 $ 2,700

GAAP gross margin on net product sales 84% 85%
Intangible asset amortization expense 2% 2%
Stock-based compensation expense 1% 1%
Non-GAAP gross margin on net product sales 87% 88%

GAAP ETR 9% 11%
Income tax effect of GAAP to non-GAAP reconciling items 2% 2%
Non-GAAP ETR 11% 13%

(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, 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 flow, 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, the non-GAAP measures presented are intended to 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 2025 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 fourth quarter and full year 2024 financial and operating results on Tuesday, February 4, 2025, 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.