REGENERON PHARMACEUTICALS INC
For the period ended Mar 31, 2025. Filed Apr 29, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed Apr 29, 2025
REGN$904.35+0.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-10-31.
0001804220-24-000040
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-04-29.
0001804220-25-000022
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 142 previous paragraphs and 123 current paragraphs.
74 unchanged; 28 reworded; 21 added; 40 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 24 previous and 23 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (21)
Current report
•changes in laws, regulations, and policies affecting the healthcare industry;
Current report
(p) Used priority review voucher in connection with this regulatory review
Current report
EYLEA HD
Current report
On April 18, 2025, the FDA issued a CRL regarding the sBLA for the addition of extended dosing intervals. The FDA indicated that the submitted data did not support extended dosing intervals greater than every 16 weeks. The Company is evaluating the FDA's decision.
Current report
The FDA issued a CRL for the EYLEA HD pre-filled syringe on April 23, 2025. The Company held several teleconferences with the FDA to better understand the contents of the CRL, and believes the key outstanding issue relates to a question posed by the FDA to a third-party component supplier. This component supplier has expeditiously responded to FDA requests for information. The CRL did not identify any issues with the safety or efficacy of EYLEA HD, the usability of the device, proposed labelling, or pre-approval inspection findings.
Current report
Fianlimab
Current report
In April 2025, a pre-planned interim analysis was conducted on two ongoing Phase 2/3 studies evaluating the combination of fianlimab and cemiplimab in first-line advanced NSCLC. Due to limited follow-up, the Phase 2 portion of the studies will continue unchanged until additional data are available. The next analyses for these studies are expected in the first quarter of 2026, at which time a decision whether to advance to Phase 3 is expected to be made. No new safety signals were observed in either study.
Current report
Under the terms of the collaboration, the parties perform discovery research until designation of lead candidates. Following designation of a lead candidate, the parties may further advance such lead candidate under either a co-development and co-commercialization agreement or a license agreement. The initial target nomination and discovery period of five years has been automatically extended until the earlier of seven years from the effective date of the collaboration or the achievement of certain milestones (the "Research Term"). In addition, we have an option to extend the Research Term for an additional five-year period for a research extension fee of $300.0 million.
Current report
Nex-z, which is in clinical development, is subject to a co-development and co-commercialization arrangement pursuant to which Intellia leads development activities and the parties share development expenses 75% (Intellia)/25% (us). If nex-z is commercialized, Intellia will lead commercialization activities and we will be entitled to 25% of any profits.
Current report
Net product sales of EYLEA HD increased for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to higher sales volumes.
Current report
Net product sales of EYLEA for the three months ended March 31, 2025, compared to the same period in 2024, were negatively impacted by (i) lower volume as a result of continued competitive pressures (as described below), loss in market share to compounded bevacizumab due to patient affordability constraints, and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price. In addition, total EYLEA and EYLEA HD net product sales were negatively impacted by lower wholesaler inventory levels at the end of the first quarter of 2025 compared to the end of the fourth quarter of 2024.
Current report
EYLEA net product sales have been, and are likely to continue to be, negatively impacted by increased competition from other anti-VEGF products, including biosimilars, as well as the transition of patients from EYLEA to EYLEA HD. The magnitude and duration of such impact is presently unknown. For more information, see Part I, Item 1A. "Risk Factors - Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products -We are substantially dependent on the success of EYLEA, EYLEA HD, and Dupixent" and "The commercial success of our products and product candidates is subject to significant competition -Marketed Products." In addition, if independent not-for-profit patient assistance funds that provide copay assistance are unable to support eligible patients, this will likely have a continued negative impact on patient affordability resulting in lower utilization of higher-cost anti-VEGF agents.
Current report
Other Revenue
Current report
Other revenue decreased for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to lower reimbursements for manufacturing commercial supplies as a result of timing of shipments, partially offset by higher royalties and share of profits earned in connection with license agreements. Other revenue for the three months ended March 31, 2025 and 2024 included $69.9 million and $47.4 million, respectively, of royalties and share of profits earned in connection with license agreements.
Current report
Operating Expenses
Current report
Selling, general, and administrative expenses decreased for the three months ended March 31, 2025, compared to the same period in 2024, due to lower charitable contributions to an independent not-for-profit patient assistance organization and lower costs associated with the estimated amount payable for the Branded Prescription Drug Fee. Selling, general, and administrative expenses also included stock-based compensation expense of $95.2 million and $86.2 million for the three months ended March 31, 2025 and 2024, respectively.
Current report
Gross margin on net product sales decreased for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to higher inventory write-offs and reserves.
Current report
Our 2017 and 2018 federal income tax returns are currently under audit by the IRS, and we expect to be effectively settled with the IRS during the second quarter of 2025. The unrecognized tax benefits for the years under examination exceed the expected payment amount; therefore, we expect to recognize a net tax benefit upon conclusion of such examinations.
Current report
Dividends
Current report
In February 2025, our board of directors declared our first quarterly cash dividend. In March 2025, we paid a dividend of $0.88 per share on our Common Stock and Class A Stock to our shareholders.
Current report
Additionally, in April 2025, our board of directors declared a cash dividend of $0.88 per share on our Common Stock and Class A Stock. The dividend will be payable on June 6, 2025 to shareholders of record as of May 20, 2025.
Removed paragraphs (40)
Previous report
(m) FDA granted Fast Track designation for follicular lymphoma and diffuse large B-cell lymphoma
Previous report
Linvoseltamab
Previous report
In August 2024, the FDA issued a CRL for the BLA for linvoseltamab in relapsed/refractory multiple myeloma that has progressed after at least three prior therapies. The sole approvability issue identified is related to findings from a pre-approval inspection at a third-party fill/finish manufacturer. Resolution of this issue will be required for both FDA and EC regulatory approvals.
Previous report
Dupixent
Previous report
In September 2024, the Company and Sanofi announced that the first Phase 3 trial (Study A) of Dupixent in adults with uncontrolled and severe CPUO did not achieve statistical significance in its primary itch responder endpoint (despite favorable numerical improvements), but showed nominally significant improvements in all other itch endpoints. The Dupixent Phase 3 program in CPUO consists of Study A and Study B. Study B is planned to initiate as a subsequent pivotal trial.
Previous report
Early-Stage Clinical Development Updates
Previous report
In 2024, a Phase 1 study of linvoseltamab, in combination with dupilumab, in severe food allergy was initiated.
Previous report
In 2024, a Phase 1 combination cohort of nezastomig and REGN4336 (bispecific antibody targeting PSMA and CD3) in metastatic castration-resistant prostate cancer was initiated.
Previous report
During the second quarter of 2024, we elected to no longer co-develop ALN-APP pursuant to a co-development/co-commercialization collaboration agreement; as a result, Alnylam retains the right to develop and commercialize such product and we will receive a royalty on sales (if any).
Previous report
In addition, in October 2023, we elected to extend the period for selecting targets under the license and collaboration agreement for an additional two years until April 2026; as a result, we made a $30.0 million extension payment to Intellia.
Previous report
In March 2024, Intellia elected to opt-out of further development activities pursuant to the Factor IX co-development and co-commercialization agreement; as a result, we retain the right to develop and commercialize products directed to Factor IX, and Intellia will be entitled to receive milestone payments and royalties on sales (if any).
Previous report
Decibel
Previous report
In 2017, we entered into an agreement with Decibel Therapeutics, Inc. to discover and develop new potential therapeutics to protect, repair and restore hearing (including DB-OTO, which is currently in clinical development, and preclinical programs for GJB2-related and stereocilin-related hearing loss).
Previous report
In August 2023, we acquired Decibel by paying $101.3 million in cash (or $4.00 per share of Decibel common stock). In addition, Decibel shareholders received one non-tradeable contingent value right ("CVR") per share of Decibel common stock, entitling them to receive up to an additional $3.50 per share in cash upon achievement of certain development milestones for DB-OTO within specified time periods.
Previous report
During the third quarter of 2024, a development milestone contemplated by the CVRs was achieved, and, as a result, we paid $55.1 million to the holders of the CVRs. The holders of the CVRs will be entitled to receive an additional $42.0 million if an additional milestone contemplated by the CVRs is achieved.
Previous report
2seventy bio
Previous report
In 2018, we entered into a collaboration agreement with bluebird bio, Inc. (which subsequently spun out 2seventy bio, Inc. in 2021) to research, develop, and commercialize novel cell therapy approaches to address cancer.
Previous report
In April 2024, we acquired full development and commercialization rights to 2seventy bio's oncology and autoimmune preclinical and clinical stage cell therapy pipeline. Under the terms of the agreement, we made a $5.0 million up-front payment, and have assumed ongoing program, infrastructure, and personnel costs related to the product candidates acquired. We are obligated to pay 2seventy bio a regulatory milestone upon the first major market approval of the first approved product; and, with respect to any approved product, a low single-digit percent royalty on sales. In addition, we separately entered into sublease agreements for a portion of 2seventy bio's facilities.
Previous report
Corporate Information
Previous report
We were incorporated in the State of New York in 1988 and publicly listed in 1991. Our principal executive offices are located at 777 Old Saw Mill River Road, Tarrytown, New York 10591, and our telephone number at that address is (914) 847-7000.
Previous report
We make available free of charge on or through our Internet website (http://www.regeneron.com) our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and, if applicable, amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), as soon as reasonably practicable after we electronically file such material with, or furnish it to, the Securities and Exchange Commission ("SEC").
Previous report
Investors and other interested parties should note that we use our media and investor relations website (http://investor.regeneron.com) and our social media channels to publish important information about Regeneron, including information that may be deemed material to investors. We encourage investors and other interested parties to review the information we may publish through our media and investor relations website and the social media channels listed on our media and investor relations website, in addition to our SEC filings, press releases, conference calls, and webcasts.
Previous report
The information contained on our websites and social media channels is not included as a part of, or incorporated by reference into, this report.
Previous report
Total EYLEA HD and EYLEA net product sales in the U.S. increased for the three and nine months ended September 30, 2024 compared to the same periods in 2023. EYLEA HD was approved by the FDA in August 2023 andnet product sales for the three and nine months ended September 30, 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 EYLEAfor the three and nine months ended September 30, 2024 were adversely impacted by a lower net selling price compared to the same periods in 2023. In addition, for the three months ended September 30, 2024 total EYLEA HD and EYLEA net product sales were favorably impacted by approximately $40 million as a result of higher wholesaler inventory levels for EYLEA HD at the end of the third quarter of 2024 compared to the end of the second quarter of 2024, partially offset by lower wholesaler inventory levels for EYLEA.
Previous report
During the three months ended September 30, 2023, the Company earned the final $50.0 million sales-based milestone from Sanofi upon aggregate annual sales of antibodies outside the United States exceeding $3.0 billion on a rolling twelve-month basis.
Previous report
Roche Collaboration Revenue
Previous report
Roche distributes and records net product sales of Ronapreve outside the United States, and the parties share gross profits from sales. Net product sales of Ronapreve outside the United States declined as a result of new variants of the SARS-CoV-2 virus emerging that are not susceptible to the treatment.
Previous report
Expenses
Previous report
Acquired In-process Research and Development ("IPR&D")
Previous report
Acquired IPR&D for the three and nine months ended September 30, 2024 included a $45.0 million development milestone in connection with our collaboration agreement with Sonoma Biotherapeutics, Inc.
Previous report
Acquired IPR&D for the three and nine months ended September 30, 2023 included a $100.0 million development milestone in connection with our collaboration agreement with Alnylam Pharmaceuticals, Inc. The nine months ended September 30, 2023 also included a $45.0 million up-front payment in connection with our collaboration agreement with Sonoma.
Previous report
Selling, general, and administrative expenses increased for the three and nine months ended September 30, 2024, compared to the same periods in 2023, due to higher commercialization-related expenses to support our launch of EYLEA HD and higher headcount and headcount-related costs partly related to our international commercial expansion. Selling, general, and administrative expenses also included stock-based compensation expense of $83.1 million and $74.4 million for the three months ended September 30, 2024 and 2023, respectively, and $251.9 million and $224.5 million for the nine months ended September 30, 2024 and 2023, respectively.
Previous report
Cost of goods sold increased for the three and nine months ended September 30, 2024, compared to the same periods in 2023, primarily due to higher start-up costs for our Rensselaer, New York fill/finish facility.
Previous report
Other income (expense) consists of the following:
Previous report
Certain countries in which we have operations, including Ireland, have adopted legislation influenced by the Organization for Economic Co-operation and Development ("OECD") Global Anti-Base Erosion Model Rules ("Pillar Two") framework, including a minimum tax rate of 15%. The adoption of the Pillar Two framework did not have a material impact on our effective tax rate for the three and nine months ended September 30, 2024. It is uncertain whether the United States will enact legislation to adopt the Pillar Two framework. We continue to evaluate additional guidance released by the OECD, along with the pending legislative adoption by additional individual countries.
Previous report
Payments for the Libtayo intangible asset of $58.3 million and $145.7 million for the nine months ended September 30, 2024 and 2023, respectively, were related to contingent consideration in connection with our acquisition of the exclusive right to develop, commercialize, and manufacture Libtayo worldwide.
Previous report
Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $1.374 billion for the nine months ended September 30, 2024, compared to $844.5 million for the nine months ended September 30, 2023. In addition, payments in connection with Common Stock tendered for employee tax obligations were $775.7 million for the nine months ended September 30, 2024, compared to $242.5 million for the nine months ended September 30, 2023. For information related to repurchases of Common Stock, see "Share Repurchase Programs" section below.
Previous report
In January 2023, our board of directors authorized a share repurchase program to repurchase up to $3.0 billion of our Common Stock. As of September 30, 2024, the Company had repurchased the entire $3.0 billion of its Common Stock it was authorized to repurchase under the program.
Previous report
In April 2024, our board of directors authorized a share repurchase program to repurchase up to an additional $3.0 billion of our Common Stock. The share repurchase program permits the Company to make repurchases through a variety of methods, including open-market transactions (including pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Exchange Act), privately negotiated transactions, accelerated share repurchases, block trades, and other transactions in compliance with Rule 10b-18 of the Exchange Act. Repurchases may be made from time to time at management's discretion, and the timing and amount of any such repurchases will be determined based on share price, market conditions, legal requirements, and other relevant factors. The program has no time limit and can be discontinued at any time. There can be no assurance as to the timing or number of shares of any repurchases in the future.
Previous report
The table below summarizes the shares of our Common Stock that we repurchased and the cost of such shares, which were recorded as Treasury Stock.
Reworded paragraphs (28)
Previous wording
•competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates (including biosimilar versions of Regeneron's Products);
Current wording
•competing drugs and product candidates that may be superior to, or more cost effective than, 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") (including biosimilar versions of Regeneron's Products);
Previous wording
•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;
Current wording
•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 or other factors beyond Regeneron's control on the commercial success of Regeneron's Products and Regeneron's Product Candidates;
Previous wording
•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 those discussed or referenced in this report, Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs;
Current wording
•the nature, timing, and possible success and therapeutic applications of Regeneron's Products and Regeneron's Product Candidates and research and clinical programs now underway or planned, including without limitation those discussed or referenced in this report, Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs;
Previous wording
•our ability to manufacture and manage supply chains for multiple products and product candidates;
Current wording
•our ability to manufacture and manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions;
Previous wording
•the availability and extent of reimbursement of Regeneron's Products from third-party payors, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid;
Current wording
•the availability and extent of reimbursement or copay assistance for Regeneron's Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid;
Previous wording
•coverage and reimbursement determinations by such payors and new policies and procedures adopted by such payors;
Current wording
•coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties;
Previous wording
•the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on our business; and
Current wording
•the impact of public health outbreaks, epidemics, or pandemics on our business; and
Previous wording
•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 described further in Note 11 to our Condensed Consolidated Financial Statements included in this report), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those described in Note 11 to our Condensed Consolidated Financial Statements included in this report), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition.
Current wording
•risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those described in Note 12 to our Condensed Consolidated Financial Statements included in this report), 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 described further in Note 12 to our Condensed Consolidated Financial Statements included in this report), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition.
Previous wording
Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company that invents, develops, manufactures, and commercializes medicines for people with serious diseases. Our products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases, and rare diseases.
Current wording
Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company that invents, develops, manufactures, and commercializes medicines for people with serious diseases. Our products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
Previous wording
Our core business strategy is to maintain a strong foundation in basic scientific research and discovery-enabling technologies, and to build on that foundation with our clinical development, manufacturing, and commercial capabilities. Our objective is to continue to advance as an integrated, multi-product biotechnology company that provides patients and medical professionals with important medicines for preventing and treating human diseases.
Current wording
Our core business strategy is to maintain a strong foundation in scientific research and drug development using our proprietary technologies, and to build on that foundation with our clinical development, manufacturing, and commercial capabilities. Our objective is to continue to advance as an integrated, multi-product biotechnology company that provides patients and medical professionals with important medicines for preventing and treating human diseases.
Previous wording
For purposes of this report, references to our products encompass products marketed or otherwise commercialized by us and/or our collaborators or licensees and references to our product candidates encompass product candidates in development by us and/or our collaborators or licensees (in the case of collaborated or licensed products or product candidates under the terms of the applicable collaboration or license agreements), unless otherwise stated or required by the context.
Current wording
For purposes of this report, references to our products encompass products commercialized by us and/or our collaborators or licensees and references to our product candidates encompass product candidates in development by us and/or our collaborators or licensees (in the case of collaborated or licensed products or product candidates under the terms of the applicable collaboration or license agreements), unless otherwise stated or required by the context.
Previous wording
(h) Information in this column relates to U.S., EU, and Japan regulatory submissions only
Current wording
(h) Information in this column captures submissions to U.S., EU, and Japan regulatory authorities
Previous wording
A Phase 1/2 study of DB-OTO, an AAV-based gene therapy, in children with profound genetic hearing loss due to mutations of the otoferlin gene is ongoing. In May 2024, we presented updated data from the Phase 1/2 trial at the American Society of Gene and Cell Therapy ("ASGCT") annual conference and announced that DB-OTO improved hearing to normal levels in one child and that initial hearing improvements were observed in a second child. Additionally, the FDA granted DB-OTO Regenerative Medicine Advanced Therapy ("RMAT") designation.
Current wording
(m) FDA granted Regenerative Medicine Advanced Therapy ("RMAT") designation
Previous wording
We are collaborating with Sanofi on the global development and commercialization of Dupixent, Kevzara, and itepekimab (the "Antibody Collaboration"). Under the terms of the Antibody Collaboration, Sanofi is generally responsible for funding 80% to 100% of agreed-upon development costs. We are obligated to reimburse Sanofi for 30% to 50% of worldwide development expenses that were funded by Sanofi based on our share of collaboration profits; however, we are only required to apply 20% of our share of profits from the collaboration each calendar quarter to reimburse Sanofi for these development expenses. As of September 30, 2024, the total amount of our contingent reimbursement obligation to Sanofi (i.e., "development balance") in connection with such development expenses was approximately $1.810 billion.
Current wording
We are collaborating with Sanofi on the global development and commercialization of Dupixent, Kevzara, and itepekimab (the "Antibody Collaboration"). Under the terms of the Antibody Collaboration, Sanofi is generally responsible for funding 80% to 100% of agreed-upon development costs. We are obligated to reimburse Sanofi for 30% to 50% of development expenses that were funded by Sanofi based on our share of collaboration profits; however, we are only required to apply 20% of our share of profits from the collaboration each calendar quarter to reimburse Sanofi for these development expenses. As of March 31, 2025, the total amount of our contingent reimbursement obligation to Sanofi (i.e., "development balance") in connection with such development expenses was approximately $1.453 billion.
Previous wording
We and Alnylam Pharmaceuticals, Inc. are parties to a collaboration to discover, develop, and commercialize RNAi therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system ("CNS"), in addition to a select number of targets expressed in the liver.
Current wording
We and Alnylam Pharmaceuticals, Inc. are parties to a collaboration to discover, develop, and commercialize RNAi therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system, in addition to a select number of targets expressed in the liver.
Previous wording
We and Intellia Therapeutics, Inc. are parties to a license and collaboration agreement to advance CRISPR/Cas9 gene-editing technology forin vivo therapeutic development. NTLA-2001, which is in clinical development, is subject to a co-development and co-commercialization arrangement pursuant to which Intellia will lead development and commercialization activities and the parties share an agreed-upon percentage of development expenses and profits (if commercialized). In addition, we also have non-exclusive rights to independently develop and commercializeex vivo gene edited products.
Current wording
We and Intellia Therapeutics, Inc. are parties to a license and collaboration agreement to advance CRISPR/Cas9 gene-editing technology forin vivo therapeutic development, including therapies focused on neurological and muscular diseases. We have the right to select targets under the license and collaboration agreement until April 2026.
Previous wording
In September 2023, we expanded the license and collaboration agreement to develop additionalin vivo CRISPR-based gene editing therapies focused on neurological and muscular diseases. Intellia will lead the design of the editing methodology, we will lead the design of the targeted viral vector delivery approach, and the parties share costs equally. Each company will have the opportunity to lead potential development and commercialization of product candidates for one target, and the company that is not leading development and commercialization will have the option to enter into a co-development and co-commercialization agreement for the target.
Current wording
Intellia leads the design of the editing methodology, we lead the design of the targeted viral vector delivery approach, and the parties share costs equally. Each company has the opportunity to lead potential development and commercialization of product candidates for a target, and the company that is not leading development and commercialization will have the option to enter into a co-development and co-commercialization agreement for the target.
Previous wording
Our ability to generate profits and to generate positive cash flow from operations over the next several years depends significantly on the success in commercializing EYLEA HD, EYLEA, and Dupixent. We expect to continue to incur substantial expenses related to our research and development activities, and our research and development activities and related costs which are not reimbursed by collaborators are expected to expand and require additional resources. We also expect to incur substantial costs related to the commercialization of our marketed products. Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net sales of our products; the scope and progress of our research and development efforts; the timing of certain expenses; the continuation of our collaborations, in particular with Sanofi and Bayer, including our share of collaboration profits from sales of commercialized products and the amount of reimbursement of our research and development expenses that we receive from collaborators; and the amount of income tax expense we incur, which is partly dependent on the profits or losses we earn in each of the countries in which we operate. We cannot predict whether or when new products or new indications for marketed products will receive regulatory approval or, if any such approval is received, whether we will be able to successfully commercialize such products and whether or when they may become profitable.
Current wording
Our ability to generate profits and to generate positive cash flow from operations over the next several years depends significantly on the success in commercializing EYLEA HD, EYLEA, and Dupixent. We expect to continue to incur substantial expenses related to our research and development activities, and our research and development activities and related costs which are not reimbursed by collaborators are expected to expand and require additional resources. We also expect to incur substantial costs related to the commercialization of our marketed products. Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net sales of our products; the scope and progress of our research and development efforts; the timing of certain expenses; the continuation of our collaborations, in particular with Sanofi and Bayer, including our share of collaboration profits from sales of commercialized products and the amount of reimbursement of our research and development expenses that we receive from collaborators; and the amount of income tax expense we incur, which is partly dependent on the profits or losses we earn in each of the countries in which we operate. There is uncertainty surrounding whether or when new products or new indications for marketed products will receive regulatory approval or, if any such approval is received, whether we will be able to successfully commercialize such products and whether or when they may become profitable.
Previous wording
The increase in our share of profits for the three and nine months ended September 30, 2024, compared to the same periods in 2023, was driven by higher profits associated with Dupixent sales.
Current wording
The increase in our share of profits for the three months ended March 31, 2025, compared to the same period in 2024, was driven by higher profits associated with Dupixent sales.
Previous wording
Operating expenses included stock-based compensation of $225.1 million and $203.9 million for the three months ended September 30, 2024 and 2023, respectively, and $678.4 million and $644.6 million for the nine months ended September 30, 2024 and 2023, respectively. Stock-based compensation expense relates to equity awards granted under our long-term incentive plans.
Current wording
Operating expenses for the three months ended March 31, 2025 and 2024 included $255.7 million and $230.1 million, respectively, of stock-based compensation expense related to equity awards granted under our long-term incentive plans.
Previous wording
Research and development expenses included stock-based compensation expense of $123.7 million and $107.4 million for the three months ended September 30, 2024 and 2023, respectively, and $369.1 million and $356.0 million for the nine months ended September 30, 2024 and 2023, respectively.
Current wording
Research and development expenses included stock-based compensation expense of $141.0 million and $123.0 million for the three months ended March 31, 2025 and 2024, respectively.
Previous wording
Other operating expense (income), net, reflected charges of $8.0 million and $37.9 millionfor the three and nine months ended September 30, 2024, respectively, related to the increase in the estimated fair value of the contingent consideration liability recognized in connection with our 2023 acquisition of Decibel Therapeutics, Inc.
Current wording
Other operating expense (income), net, for the three months ended March 31, 2024 reflected a charge of $15.3 million related to the increase in the estimated fair value of the contingent consideration liability recognized in connection with our 2023 acquisition of Decibel Therapeutics, Inc.
Previous wording
Our effective tax rate for the three and nine months ended September 30, 2024 was positively impacted, compared to the U.S. federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate and stock-based compensation. Our effective tax rate for the nine months ended September 30, 2024 was negatively impacted by the remeasurement of existing uncertain tax positions.
Current wording
Our effective tax rate for the three months ended March 31, 2025 was positively impacted, compared to the U.S. federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate and federal tax credits for research activities. Our effective tax rate increased for the three months ended March 31, 2025, compared to the same period in 2024, due to lower tax benefits from less stock option exercises.
Previous wording
Sources and Uses of Cash for the Nine Months Ended September 30, 2024 and 2023
Current wording
Sources and Uses of Cash for the Three Months Ended March 31, 2025 and 2024
Previous wording
Capital expenditures for the nine months ended September 30, 2024 included costs incurred in connection with the expansion of our research, preclinical manufacturing, and support facilities at our Tarrytown, New York location, as well as costs associated with the expansion of our manufacturing facilities in Rensselaer, New York (including the fill/finish facility). In addition, in September 2024, we acquired a 1,100,000 square foot facility in Saratoga Springs, New York. We expect to incur capital expenditures of $700 million to $740 million for the full year of 2024 primarily in connection with the continued expansion of our facilities in Tarrytown and Rensselaer (including the fill/finish facility).
Current wording
Capital expenditures for the three months ended March 31, 2025 included costs incurred in connection with the expansion of our research, preclinical manufacturing, and support facilities at our Tarrytown, New York corporate headquarters. We expect to incur capital expenditures of $850 million to $950 million for the full year of 2025, including in connection with the continued expansion of our facilities in Tarrytown, New York.
Previous wording
As of September 30, 2024, $2.893 billion remained available for share repurchases under the April 2024 program.
Current wording
In each of April 2024 and February 2025, our board of directors authorized an additional share repurchase program for up to $3.0 billion of our Common Stock (up to $6.0 billion in the aggregate). The programs have no time limit and can be discontinued at any time. As of March 31, 2025, an aggregate of $3.874 billion remained available for share repurchases under the programs.
Previous wording
A summary of critical accounting estimates is presented in Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (filed February 5, 2024). There have been no material changes to critical accounting estimates during the nine months ended September 30, 2024.
Current wording
A summary of critical accounting estimates is presented in Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (filed February 5, 2025). There have been no material changes to critical accounting estimates during the three months ended March 31, 2025.
Previous wording
See Note 1 to our Condensed Consolidated Financial Statements for a summary of recently issued accounting standards.
Current wording
See Note 1 to our Condensed Consolidated Financial Statements included in this report for a description of recently issued accounting standards.