REGENERON PHARMACEUTICALS INC
For the period ended Jun 30, 2024. Filed Aug 1, 2024.
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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.
Jun 30, 2024 · Filed Aug 1, 2024
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-02.
0001804220-24-000017
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-01.
0001804220-24-000028
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 145 previous paragraphs and 143 current paragraphs.
96 unchanged; 35 reworded; 10 added; 14 removed; 0 previous and 2 current paragraphs rearranged.
Tables are not compared: 21 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 (10)
Current report
(o) Studied in combination with semaglutide with and without garetosmab
Current report
(p) A Phase 2 study, sponsored by Eli Lilly, is also ongoing and testing the combination of tirzepatide and mibavademab compared with tirzepatide alone in patients with obesity.
Current report
Dupixent (dupilumab)
Current report
In May 2024, the FDA extended by three months the target action date of its priority review of the sBLA for Dupixent as an add-on maintenance treatment in certain adult patients with uncontrolled COPD. The FDA had requested additional analyses on the efficacy of Dupixent in the BOREAS and NOTUS pivotal trials. Based on the submission of these analyses, the agency determined that this additional information constituted a major amendment to the sBLA and extended the target action date accordingly. The revised target action date is September 27, 2024.
Current report
Linvoseltamab
Current report
During its review of the linvoseltamab BLA for relapsed/refractory multiple myeloma, the FDA informed us that the third-party fill/finish provider for linvoseltamab had unresolved findings from a pre-approval inspection for another company's product candidate, which is to be filled on the same manufacturing line as linvoseltamab. Although this third-party fill/finish provider communicated to us and the FDA that they believe these findings have been successfully remediated, the FDA has indicated that a re-inspection will be required before these issues are considered resolved and any new products filled on this line can be approved, including linvoseltamab. Therefore, we believe that any potential FDA approval of the linvoseltamab BLA will be delayed beyond the August 22, 2024 target action date. The FDA has not informed us of any approvability issues for linvoseltamab related to safety, efficacy, or the status of our confirmatory trial.
Current report
Early-Stage Clinical Development Updates
Current 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.
Current 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).
Current report
In July 2024, a development milestone contemplated by the CVRs was achieved, and, as a result, we became obligated to pay $55.1 million to the holders of the CVRs. The holders of the CVRs may be entitled to receive an additional $42.0 million if an additional milestone contemplated by the CVRs is achieved.
Removed paragraphs (14)
Previous report
•unanticipated expenses;
Previous report
Note: Refer to table below (net product sales of Regeneron-discovered products) for information regarding whether net product sales for a particular product are recorded by us or others. In addition, unless otherwise noted, products in the table above are generally approved for use in adults in the above-referenced diseases.
Previous report
(a) In collaboration with Bayer outside the United States. Aflibercept 8 mg is known as EYLEA HD in the United States and EYLEA 8 mg in other countries.
Previous report
(c) The Company is solely responsible for the development and commercialization of Praluent in the United States and Sanofi is responsible for the development and commercialization of Praluent outside the United States.
Previous report
(d) In collaboration with Roche. Product is known as REGEN-COV in the United States and Ronapreve™ in other countries.
Previous report
(e) The Company is solely responsible for the development and commercialization of Evkeeza in the United States and Ultragenyx is responsible for the development and commercialization of Evkeeza outside the United States.
Previous report
(f) Kiniksa is solely responsible for the development and commercialization of ARCALYST.
Previous report
(g) Sanofi is solely responsible for the development and commercialization of ZALTRAP.
Previous report
(b) In collaboration with Sanofi
Previous report
(k) In collaboration with Alnylam
Previous 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/co-commercialization collaboration agreement ("Co-Co Collaboration Agreement") (under which the parties are advancing ALN-APP) or a license agreement structure. The initial target nomination and discovery period is five years (which may under certain situations automatically be extended for up to seven years in the aggregate) (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.
Previous report
For CNS programs and liver programs, under a Co-Co Collaboration Agreement, the party designated as the lead party will lead development and commercialization of the program and the parties will split profits and share costs equally, subject to certain co-funding opt-outs at specified clinical trial phases or under other conditions. Alnylam is the lead party for ALN-APP.
Previous report
Under a license agreement, the lead party is designated as the licensee and has the right to develop and commercialize the collaboration product under such program. The licensee will be responsible for its own costs and expenses incurred. The licensee will pay to the licensor certain development and/or commercialization milestone payments, as well as certain tiered royalty payments to the licensor based on the aggregate annual net sales of the collaboration product.
Previous report
In August 2023, the FDA approved EYLEA HD in the United States.
Reworded paragraphs (35)
Previous wording
•the costs of developing, producing, and selling products; our ability to meet any of our financial projections or guidance, including without limitation capital expenditures, and changes to the assumptions underlying those projections or guidance;
Current wording
•our ability to meet any of our financial projections or guidance, including without limitation capital expenditures, and changes to the assumptions underlying those projections or guidance;
Previous wording
Net product sales of Regeneron-discovered products consist of the following:
Current wording
The table below includes net product sales of Regeneron-discovered products. Such net product sales are recorded by us or others, as further described in the footnotes to the table. We believe the information in the table is useful to investors as it demonstrates our pipeline productivity and our ability to innovate, discover, and develop new products, and bring those products to market either alone or based on contractual arrangements with other parties, which has a direct impact on our results of operations and financial condition. The table also shows the degree to which we, a collaborator, and/or a licensee is currently commercializing the products discovered by Regeneron. In addition, this information allows management and investors to assess the commercial trends and developments impacting Regeneron-discovered products. In arrangements where our collaborator or licensee is currently commercializing such products and is recording net product sales as a result, the net product sales shown in the table also are an important metric for management's review and assessment of (i) the revenues we record for our share of profits and/or royalties from such sales and (ii) the impact of our obligation to supply commercial product to certain of these collaborators or licensees.
Previous wording
(l) Under the terms of our license agreement for the combination consisting of cemdisiran and pozelimab, Alnylam is entitled to receive royalties on sales of the combination (if any), as well as sales milestones.
Current wording
(l) Under the terms of our license agreement for cemdisiran, Alnylam is entitled to receive royalties on sales (if any), as well as sales milestones.
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 oteoferlin gene is ongoing. The Company will present updated data from the Phase 1/2 trial at the May 2024 American Society of Gene and Cell Therapy ("ASGCT") annual conference.
Current 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, the Company 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.
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 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 March 31, 2024, the total amount of our contingent reimbursement obligation to Sanofi (i.e., "development balance") in connection with such development expenses was approximately $2.200 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 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 June 30, 2024, the total amount of our contingent reimbursement obligation to Sanofi (i.e., "development balance") in connection with such development expenses was approximately $2.013 billion.
Previous wording
Under our collaboration agreement, Sanofi records product sales for commercialized products, and Regeneron has the right to co-commercialize such products on a country-by-country basis. We co-commercialize Dupixent in the United States and in certain countries outside the United States. We supply certain commercial bulk product to Sanofi. We and Sanofi equally share profits from sales within the United States. We and Sanofi share profits outside the United States on a sliding scale based on sales starting at 65% (Sanofi)/35% (us) and ending at 55% (Sanofi)/45% (us).
Current wording
Under our collaboration agreement, Sanofi records product sales for commercialized products, and Regeneron has the right to co-commercialize such products on a country-by-country basis. We co-commercialize Dupixent in the United States and in certain countries outside the United States. We supply certain commercial bulk product to Sanofi. We and Sanofi equally share profits from sales within the United States, and share profits outside the United States on a sliding scale based on sales starting at 65% (Sanofi)/35% (us) and ending at 55% (Sanofi)/45% (us).
Previous wording
In 2019, we and Alnylam Pharmaceuticals, Inc. entered into a global, strategic 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. During 2023, we paid a $100.0 million development milestone to Alnylam upon the achievement of specified proof-of-principle criteria for the ALN-APP program and Alnylam is eligible to receive an additional $100.0 million clinical proof-of-principle milestone in connection with an eye program.
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 ("CNS"), in addition to a select number of targets expressed in the liver. During 2023, we paid a $100.0 million development milestone to Alnylam upon the achievement of specified proof-of-principle criteria for a CNS program (ALN-APP) and Alnylam is eligible to receive an additional $100.0 million clinical proof-of-principle milestone in connection with an eye program.
Previous wording
The parties have entered into various license agreements, including for a combination consisting of cemdisiran (a small interfering RNA ("siRNA") therapeutic targeting the C5 component of the human complement pathway being developed by Alnylam) and pozelimab, with us as the licensee.
Current wording
We have also entered into various license agreements with Alnylam, with us as the licensee, including for cemdisiran (a small interfering RNA ("siRNA") therapeutic targeting the C5 component of the human complement pathway) as a monotherapy and for a combination consisting of cemdisiran and pozelimab.
Previous wording
In 2016, we entered into a license and collaboration agreement with Intellia Therapeutics, Inc. 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). The collaboration was expanded in 2020 to provide us with rights to develop products for additionalin vivo CRISPR/Cas9-based therapeutic targets and for the companies to jointly develop potential products for the treatment of hemophilia A and B, with Regeneron leading development and commercialization activities. In addition, we also received 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. 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.
Previous wording
In September 2023, we further expanded our existing collaboration 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
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.
Previous wording
In addition, in October 2023, we elected to extend the period for selecting targets under the 2016 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.
Current wording
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 wording
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 clinical development and regulatory milestones for DB-OTO within specified time periods. The maximum aggregate amount that holders of the CVRs may be entitled to receive if all the milestones contemplated by the CVRs are achieved is approximately $97 million.
Current wording
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 wording
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. In addition, 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.
Current wording
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 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, a portion of which we expect to be reimbursed by our collaborators. In addition, our research and development activities and related costs which are not reimbursed 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. 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.
Previous wording
Net product sales of EYLEA in the United States decreased for the three months ended March 31, 2024, compared to the same period in 2023, primarily due to changing market dynamics, resulting in lower volumes and a lower net selling price.
Current wording
Total EYLEA HD and EYLEA net product sales in the U.S. increased for the three and six months ended June 30, 2024, compared to the same periods in 2023. EYLEA HD was approved by the FDA in August 2023 and EYLEA HD net product sales for the three and six months ended June 30, 2024 were driven by the transition of patients from other anti-VEGF products, including EYLEA, to EYLEA HD, as well as new patients naïve to anti-VEGF therapy. Net product sales of EYLEA in the United States decreased for the three and six months ended June 30, 2024, compared to the same periods in 2023, primarily due to (i) the aforementioned approval and transition of certain patients to EYLEA HD, and (ii) other market dynamics that resulted in lower volumes and a lower net selling price.
Previous wording
Global net product sales of Dupixent and Kevzara are recorded by Sanofi in connection with the Antibody Collaboration, and we and Sanofi share profits on such sales.
Current wording
Global net product sales of Dupixent and Kevzara are recorded by Sanofi, and we and Sanofi share profits on such sales.
Previous wording
The increase in our share of profits in connection with commercialization of antibodies for the three months ended March 31, 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 and six months ended June 30, 2024, compared to the same periods in 2023, was driven by higher profits associated with Dupixent sales.
Previous wording
Roche distributes and records net product sales of Ronapreve outside the United States, and the parties share gross profits from sales. For the three months ended March 31, 2024 and 2023, our share of gross profits in connection with sales of Ronapreve outside the United States was $0.5 million and $222.2 million, respectively.
Current wording
Roche distributes and records net product sales of Ronapreve outside the United States, and the parties share gross profits from sales.
Previous wording
Operating expenses for the three months ended March 31, 2024 and 2023 included a total of $230.1 million and $238.7 million, respectively, of stock-based compensation expense related to equity awards granted under our long-term incentive plans.
Current wording
Operating expenses included stock-based compensation of $223.2 million and $202.0 million for the three months ended June 30, 2024 and 2023, respectively, and $453.3 million and $440.7 million for the six months ended June 30, 2024 and 2023, respectively. Stock-based compensation expense relates to equity awards granted under our long-term incentive plans.
Previous wording
The following table summarizes our direct research and development expenses by clinical development program and other significant categories of research and development expenses. Direct research and development expenses are comprised primarily of costs paid to third parties for clinical and product development activities, including costs related to preclinical research activities, clinical trials, and the portion of research and development expenses incurred by our collaborators that we are obligated to reimburse. Indirect research and development expenses have not been allocated directly to each program, and primarily consist of costs to compensate personnel, overhead and infrastructure costs to maintain our facilities, and other costs related to activities that benefit multiple projects. Clinical manufacturing costs primarily consist of costs to manufacture bulk drug product for clinical development purposes as well as related drug filling, packaging, and labeling costs. Clinical manufacturing costs also includes pre-launch commercial supplies which did not meet the criteria to be capitalized as inventory. The table below also includes reimbursements of research and development expenses by collaborators, as when we are entitled to reimbursement of all or a portion of such expenses that we incur under a collaboration, we record those reimbursable amounts in the period in which such costs are incurred.
Current wording
The following table summarizes our direct research and development expenses by clinical development program and other significant categories of research and development expenses. Direct research and development expenses are comprised primarily of costs paid to third parties for clinical and product development activities, including costs related to preclinical research activities, clinical trials, and the portion of research and development expenses incurred by our collaborators that we are obligated to reimburse. Indirect research and development expenses have not been allocated directly to each program, and primarily consist of costs to compensate personnel, overhead and infrastructure costs to maintain our facilities, and other costs related to activities that benefit multiple projects. Clinical manufacturing costs primarily consist of costs to manufacture bulk drug product for clinical development purposes as well as related drug filling, packaging, and labeling costs. Clinical manufacturing costs also include pre-launch commercial supplies which did not meet the criteria to be capitalized as inventory. The table below also includes reimbursements of research and development expenses by collaborators, as when we are entitled to reimbursement of all or a portion of such expenses that we incur under a collaboration, we record those reimbursable amounts in the period in which such costs are incurred.
Previous wording
Research and development expenses included stock-based compensation expense of $123.0 million and $139.5 million for the three months ended March 31, 2024 and 2023, respectively.
Current wording
Research and development expenses included stock-based compensation expense of $122.4 million and $109.1 million for the three months ended June 30, 2024 and 2023, respectively, and $245.4 million and $248.6 million for the six months ended June 30, 2024 and 2023, respectively.
Previous wording
Acquired IPR&D for the three months ended March 31, 2023 included a $45.0 million up-front payment in connection with our collaboration agreement with Sonoma Biotherapeutics, Inc.
Current wording
Acquired IPR&D for the three and six months ended June 30, 2024 primarily included up-front payments, as well as a premium on equity securities purchased, in connection with collaboration and licensing agreements. Acquired IPR&D for the six months ended June 30, 2023 included a $45.0 million up-front payment in connection with our collaboration agreement with Sonoma Biotherapeutics, Inc.
Previous wording
Selling, general, and administrative expenses increased for the three months ended March 31, 2024, compared to the same period in 2023, due to an increase in commercialization-related expenses to support our launch of EYLEA HD and higher headcount and headcount-related costs primarily related to the international expansion in support of Libtayo and hematology product launch preparations. Selling, general, and administrative expenses also included stock-based compensation expense of $86.2 million and $76.8 million for the three months ended March 31, 2024 and 2023, respectively.
Current wording
Selling, general, and administrative expenses increased for the three and six months ended June 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 $82.6 million and $73.3 million for the three months ended June 30, 2024 and 2023, respectively, and $168.8 million and $150.1 million for the six months ended June 30, 2024 and 2023, respectively.
Previous wording
Cost of goods sold increased for the three months ended March 31, 2024, compared to the same period in 2023, primarily due to higher start-up costs for our Rensselaer, New York fill/finish facility.
Current wording
Cost of goods sold increased for the three and six months ended June 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 wording
Cost of collaboration and contract manufacturing decreased for the three months ended March 31, 2024, compared to the same period in 2023, primarily due to the recognition of lower Dupixent manufacturing costs as a result of the transition to a higher-yielding manufacturing process.
Current wording
Cost of collaboration and contract manufacturing decreased for the six months ended June 30, 2024, compared to the same period in 2023, partly due to the recognition of lower Dupixent manufacturing costs as a result of the transition to a higher-yielding manufacturing process.
Previous wording
Other operating expense (income), net, for the three months ended March 31, 2024 reflects a $15.3 million charge 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, reflected charges of $14.6 million and $29.9 million, for the three and six months ended June 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.
Previous wording
The Company's effective tax rate for the three months ended March 31, 2024 was positively impacted, compared to the U.S. federal statutory rate, primarily by stock-based compensation and income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate. The effective tax rate for the three months ended March 31, 2024 was positively impacted, compared to the same period in 2023, primarily by additional stock-based compensation.
Current wording
Our effective tax rate for the three and six months ended June 30, 2024 was positively impacted, compared to the U.S. federal statutory rate, primarily by stock-based compensation and income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate, partly offset by the remeasurement of existing uncertain tax positions.
Previous wording
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 months ended March 31, 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.
Current wording
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 six months ended June 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 wording
Sources and Uses of Cash for the Three Months Ended March 31, 2024 and 2023
Current wording
Sources and Uses of Cash for the Six Months Ended June 30, 2024 and 2023
Previous wording
Capital expenditures for the three months ended March 31, 2024 included costs incurred in connection with the expansion of our research, preclinical manufacturing, and support facilities at our Tarry town, New York location, as well as costs associated with the expansion of our manufacturing facilities in Rensselaer, New York (including equipment related to the fill/finish facility). We expect to incur capital expenditures of $780 million to $880 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 six months ended June 30, 2024 included costs incurred in connection with the expansion of our research, preclinical manufacturing, and support facilities at our Tarry town, New York location, as well as costs associated with the expansion of our manufacturing facilities in Rensselaer, New York (including the fill/finish facility). We expect to incur capital expenditures of $750 million to $820 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).
Previous wording
Payments for the Libtayo intangible asset of $27.9 million and $100.9 million for the three months ended March 31, 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.
Current wording
Payments for the Libtayo intangible asset of $58.3 million and $121.8 million for the six months ended June 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 wording
Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $682.1 million for the three months ended March 31, 2024, compared to $485.2 million for the three months ended March 31, 2023. For information related to repurchases of Common Stock, see "Share Repurchase Programs" section below.
Current wording
Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $1.120 billion for the six months ended June 30, 2024, compared to $575.9 million for the six months ended June 30, 2023. In addition, payments in connection with Common Stock tendered for employee tax obligations were $655.5 million for the six months ended June 30, 2024, compared to $113.1 million for the six months ended June 30, 2023. For information related to repurchases of Common Stock, see "Share Repurchase Programs" section below.
Previous wording
In January 2023, our board of directors authorized a share repurchase program to repurchase up to $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. As of March 31, 2024,$1.233 billion remained available for share repurchases under the program.
Current wording
In January 2023, our board of directors authorized a share repurchase program to repurchase up to $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 wording
In April 2024, our board of directors authorized a new share repurchase program to repurchase up to an additional $3.0 billion of our Common Stock. The share repurchase program was approved under terms substantially similar to the share repurchase program described above.
Current wording
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 was approved under terms substantially similar to the share repurchase program described above.
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 three months ended March 31, 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, 2023 (filed February 5, 2024). There have been no material changes to critical accounting estimates during the six months ended June 30, 2024.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
•the costs of developing, producing, and selling products or unanticipated expenses;
Current report — wording carried from elsewhere
As of June 30, 2024, an aggregate of $3.631 billion remained available for share repurchases under the programs.