Regeneron Reports Fourth Quarter and Full Year 2023 Financial and Operating Results

• Fourth quarter 2023 revenues increased 1% to $3.43 billion versus fourth quarter 2022; excluding Ronapreve^TM(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

"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

Fourth Quarter 2023 Financial Results

Revenues

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 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:

A reconciliation of full year 2024 GAAP to non-GAAP financial guidance is included below:

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.

TABLE 1

REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
(In millions)

TABLE 2

REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
(In millions, except per share data)

TABLE 3

REGENERON PHARMACEUTICALS, INC.
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited)
(In millions, except per share data)

RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited) (continued)

TABLE 4

REGENERON PHARMACEUTICALS, INC.
COLLABORATION REVENUE (Unaudited)
(In millions)

TABLE 5

REGENERON PHARMACEUTICALS, INC.
NET PRODUCT SALES OF REGENERON-DISCOVERED PRODUCTS (Unaudited)
(In millions)