Q1 2026 Regeneron Pharmaceuticals Inc Earnings Call

April 29, 2026

Speaker #1: Participants are on a listen-only mode. Later, we will conduct a question-and-answer session. Please note this conference is being recorded. I will now turn the call over to Ryan Crowe, Senior Vice President, Investor Relations, who may begin.

Speaker #2: Thank you, Kevin. Good morning, good afternoon, and good evening to everyone listening around the world. Thank you for your interest in REGENERON and welcome to our first quarter 2026 earnings conference call.

Speaker #2: An archive and transcript of this call will be available on the REGENERON Investor Relations website, shortly after our call concludes. Joining me on today's call are Dr. Leonard Schleifer, board co-chair, co-founder, president, and chief executive officer; Dr. George Yancopoulos, board co-chair, co-founder, president, and chief scientific officer; Marian McCourt, executive vice president of commercial; and Chris Fenimore, executive vice president and chief financial officer.

Operator: Welcome to the Regeneron Pharmaceuticals Q1 2026 Earnings Conference Call. My name is Kevin, and I'll be your operator for today's call. At this time, all participants are on a listen only mode. Later, we will conduct a question and answer session. Please note this conference is being recorded. I will now turn the call over to Ryan Crowe, Senior Vice President, Investor Relations. You may begin.

Ryan Crowe: Thank you, Kevin. Good morning, good afternoon, and good evening to everyone listening around the world. Thank you for your interest in Regeneron. Welcome to our Q1 2026 Earnings Conference Call. An archive and transcript of this call will be available on the Regeneron Investor Relations website shortly after our call concludes. Joining me on today's call are Dr. Leonard Schleifer, Board Co-Chair, Co-Founder, President, and Chief Executive Officer; Dr. George Yancopoulos, Board Co-Chair, Co-Founder, President, and Chief Scientific Officer; Marion McCourt, Executive Vice President of Commercial; and Christopher Fenimore, Executive Vice President and Chief Financial Officer. After our prepared remarks, the remaining time will be available for Q&A. I would like to remind you that remarks made on today's call may include forward-looking statements about Regeneron.

Speaker #2: After our prepared remarks, the remaining time will be available for Q&A. I would like to remind you that remarks made on today's call may include forward-looking statements about REGENERON, such statements may include, but are not limited to, those related to REGENERON and its products and business, financial forecast and guidance, development programs, and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement, changes to drug pricing, regulations, and requirements, and our drug pricing strategy, intellectual property, pending litigation, and other proceedings and competition.

Speaker #2: Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement.

Speaker #2: A more complete description of these and other material risks can be found in REGENERON's filings with the United States Securities and Exchange Commission, including its Form 10Q for the quarter-ended March 31, 2026, which was filed with the SEC this morning.

Ryan Crowe: Such statements may include, but are not limited to, those related to Regeneron and its products and business, financial forecast and guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement, changes to drug pricing, regulations and requirements, and our drug pricing strategy, intellectual property, pending litigation and other proceedings, and competition. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-Q for the quarter ended 31 March 2026, which was filed with the SEC this morning. Regeneron does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise.

Speaker #2: REGENERON does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise. In addition, please note that GAAP and non-GAAP financial measures will be discussed on today's call.

Speaker #2: Information regarding our use of non-GAAP financial measures and a reconciliation of those measures to GAAP is available on our quarterly results press release and corporate presentation, both of which can be found on the REGENERON Investor Relations website.

Speaker #2: Once our call concludes, the IR team will be available to answer any further questions. With that, let me turn the call over to our president and chief executive officer, Dr. Leonard Schleifer.

Speaker #2: Len.

Ryan Crowe: In addition, please note that GAAP and non-GAAP financial measures will be discussed on today's call. Information regarding our use of non-GAAP financial measures and a reconciliation of those measures to GAAP is available on our quarterly results, press release, and corporate presentation, both of which can be found on the Regeneron Investor Relations website. Once our call concludes, the IR team will be available to answer any further questions. With that, let me turn the call over to our President and Chief Executive Officer, Dr. Leonard Schleifer. Len.

Speaker #3: Thanks, Ryan. Thanks to everyone for joining today's call. We were pleased with REGENERON's performance to start 2026, highlighted by strong commercial execution across our key growth products, continued pipeline progress, a disciplined approach, to capital allocation, and our agreement with the US government to lower drug prices for American patients while preserving innovation.

Speaker #3: Starting with the financials, we delivered double-digit growth across both revenues and earnings, total revenues increased 19% compared to the first quarter of 2025, and non-GAAP earnings per share increased 15%, demonstrating our ability to deliver strong operating performance while continuing to invest in our science and long-term growth opportunities.

Leonard Schleifer: Thanks, Ryan. Thanks to everyone for joining today's call. We were pleased with Regeneron's performance to start 2026, highlighted by strong commercial execution across our key growth products, continued pipeline progress, a disciplined approach to capital allocation, and our agreement with the US government to lower drug prices for American patients while preserving innovation. Starting with the financials, we delivered double-digit growth across both revenues and earnings. Total revenues increased 19% compared to the Q1 of 2025, and non-GAAP earnings per share increased 15%, demonstrating our ability to deliver strong operating performance while continuing to invest in our science and long-term growth opportunities. Global Dupixent net sales increased 31% on a constant currency basis to $4.9 billion in the quarter.

Leonard Schleifer: Thanks, Ryan. Thanks to everyone for joining today's call. We were pleased with Regeneron's performance to start 2026, highlighted by strong commercial execution across our key growth products, continued pipeline progress, a disciplined approach to capital allocation, and our agreement with the U.S. government to lower drug prices for American patients while preserving innovation. Starting with the financials, we delivered double-digit growth across both revenues and earnings. Total revenues increased 19% compared to the Q1 of 2025, and non-GAAP earnings per share increased 15%, demonstrating our ability to deliver strong operating performance while continuing to invest in our science and long-term growth opportunities. Global Dupixent net sales increased 31% on a constant currency basis to $4.9 billion in the quarter.

Speaker #3: Global depicts a net sales increase 31% on a constant currency basis to $4.9 billion in the quarter, growth was broad-based and driven by continued strong demand across multiple approved indications and geographies, reinforcing Dupixent's position as the foundation of our immunology franchise.

Speaker #3: We also continue to advance our efforts with next-generation therapeutic approaches to strengthen our leadership position in inflammation and immunology. ILEA HD US net product sales increased 52% year over year to $468 million.

Speaker #3: We continue to see encouraging physician adoption of ILEA HD, reflecting confidence in its clinical profile and dosing flexibility. We resubmitted an application seeking FDA approval for filing fulfilling of the ILEA HD prefilled syringe at Catalin, Indiana, where the FDA has recently conducted a site reinspection.

Leonard Schleifer: Growth was broad-based and driven by continued strong demand across multiple approved indications and geographies, reinforcing Dupixent's position as the foundation of our immunology franchise. We also continue to advance our efforts with next-generation therapeutic approaches to strengthen our leadership position in inflammation and immunology. EYLEA HD US net product sales increased 52% year over year to $468 million. We continue to see encouraging physician adoption of EYLEA HD, reflecting confidence in its clinical profile and dosing flexibility. We resubmitted an application seeking FDA approval for fulfilling of the EYLEA HD prefilled syringe at Catalent, Indiana, where the FDA has recently conducted a site re-inspection. In addition, the FDA did not act by the April 2026 PDUFA date for the company's regulatory application for a second contract manufacturer for the PFS. Therefore, this application remains pending.

Speaker #2: also continue to advance our efforts with next-generation therapeutic approaches to strengthen our leadership position in inflammation and immunology. ILEA HD US net product sales increased 52% year over year to $468 million.

Speaker #3: In addition, the FDA did not act by the April 2026 PDUFA date for the company's regulatory application for a second contract manufacturer for the PFS.

Speaker #3: Therefore, this application remains pending. REGENERON and both third-party filling manufacturers are working closely with the FDA to resolve all outstanding issues and we anticipate a regulatory decision on one or both applications during this quarter.

Speaker #3: In oncology, global entire net product sales grew 54% to $438 million, driven by continued uptake in advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer, as well as early contributions from the adjuvant CSCC indication which received FDA approval in the fourth quarter of 2025.

Leonard Schleifer: Regeneron and both third-party filling manufacturers are working closely with the FDA to resolve all outstanding issues. We anticipate a regulatory decision on one or both applications during this quarter. In oncology, global Libtayo net product sales grew 54% to $438 million, driven by continued uptake in advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer, as well as early contributions from the adjuvant CSCC indication, which received FDA approval in Q4 2025. Turning briefly to our pipeline before George provides more details in his remarks, we've continued to make meaningful progress across multiple therapeutic areas so far in 2026.

Speaker #3: Turning briefly to our pipeline before George provides more details in his remarks, we have continued to make meaningful progress across multiple therapeutic areas so far in 2026.

Speaker #3: Last week, we received FDA approval of Voltarmany for genetic hearing loss, marking an important milestone for patients with this ultra-rare condition, and we have committed to offering this product for free.

Speaker #3: While this may seem like an unconventional decision, we believe it's the right one for REGENERON and it reflects the ethos that we live by, pushing the boundaries of science to benefit humanity.

In oncology, global entire net product sales grew 54% to $438 million, driven by continued uptake in advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer, as well as early contributions from the Adgen CSCC indication, which received FDA approval in the fourth quarter of 2025.

Speaker #3: Moving to other advances in our pipeline, we presented positive phase three data for some disorient our investigational SIRNA that targets C5 in generalized myasthenia gravis, which demonstrated a differentiated efficacy, safety, and convenience profile relative to approved myasthenia gravis therapies.

Leonard Schleifer: Last week, we received FDA approval of Otarmeni for genetic hearing loss, marking an important milestone for patients with this ultra-rare condition. We have committed to offering this product for free. While this may seem like an unconventional decision, we believe it's the right one for Regeneron. It reflects the ethos that we live by, pushing the boundaries of science to benefit humanity. Moving to other advances in our pipeline, we presented positive phase 3 data for cemdisiran, our investigational siRNA that targets C5 in generalized myasthenia gravis, which demonstrated a differentiated efficacy, safety, and convenience profile relative to approved myasthenia gravis therapies. We submitted a new application utilizing a priority review voucher. We anticipate an FDA decision in Q4.

Speaker #3: We submitted a new application utilizing a priority review voucher and anticipate an FDA decision in the fourth quarter. In metabolic disease, we enhance or announce positive phase three data in China for oletoreptide, our in-license GLP/GIP receptor agonist, with full data expected to be presented by Hansel later this year.

Turning briefly to our pipeline before. George provides more details in his remarks. We've continued to make meaningful progress across multiple therapeutic areas so far in 2026 last week, we received FDA approval of otter for genetic hearing loss, marking an important milestone for patients with this ultra rare condition and we have committed to offering this product for free.

Well, this may seem like an unconventional decision. We believe it's the right one for General, and it reflects the ethos that we live by—pushing the boundaries of science to benefit humanity.

Speaker #3: Dupixent achieved multiple regulatory milestones, expanding the eligible patient population to younger age groups and to new diseases. In addition, the FDA accepted our biologics license application for keratosumab and granted priority review with a decision in August, representing another important step forward for a rare disease portfolio.

Moving to other advances in our pipeline. We presented positive phase 3 data for some disarm. Our investigational sirna that targets C5 in generalized mastini gravis, which demonstrated a differentiated efficacy safety and convenience, profile, relative to approved, mastini, Gravette Therapies.

Leonard Schleifer: In metabolic disease, we announce positive phase 3 data in China for Oloretercetide, our in-licensed GLP-1 receptor agonist, with full data expected to be presented by Hansoh later this year. Dupixent achieve multiple regulatory milestones, expanding the eligible patient population to younger age groups and to new diseases. In addition, the FDA accepted our biologics license application for garetosmab and granted priority review with a decision in August, representing another important step forward for our rare disease portfolio. Briefly on capital allocation, we continue to take an approach that balances internal investment, which we believe offers the greatest long-term return for shareholders, with direct return of capital through share repurchases and dividends, as well as business development. In support of that approach, our board authorized a new $3 billion share repurchase program reflecting confidence in our business and financial position.

We submitted a new application, utilizing a priority review, voucher and anticipated, an FDA decision in the fourth quarter.

Speaker #3: Briefly, on capital allocation. We continue to take an approach that balances internal investment, which we believe offers the greatest long-term return for shareholders, with direct return of capital through share repurchases and dividends as well as business development.

In metabolic disease we enhance or announced positive phase 3 data in China for all of our repetitive are in licensed clip. Gip receptor Agnes with full data expected to be presented by Hansel, later this year.

Speaker #3: In support of that approach, our board authorized a new $3 billion share repurchase program, reflecting confidence in our business and financial position. We also recently entered into strategic collaborations with Thelix and Trinetix.

To pick in achieve multiple regulatory Milestones expanding the eligible, patient population to younger age groups and to new diseases.

Speaker #3: Finally, last week, we entered into a most-favored nation pricing agreement with the United States government, achieving our shared goals of ensuring timely and affordable access to groundbreaking medical advancements for medical patients, maintaining the United States' leadership in biotechnology innovation and manufacturing, and addressing the imbalance in the distribution of costs for medical innovation, which we have long argued has placed a disproportionate burden on American patients.

In addition, the FDA, accepted our biologics license application for garossino.

Briefly on Capital, allocation.

We continue to take an approach that balances internal investment, which we believe offers the greatest long-term return for shareholders, with direct return of capital through share repurchases and dividends, as well as business development.

Leonard Schleifer: We also recently entered into strategic collaborations with Telix and TriNetX. Finally, last week, we entered into a most favored nation pricing agreement with the United States government, achieving our shared goals of ensuring timely and affordable access to groundbreaking medical advancements for medical patients, maintaining the United States leadership in biotechnology, innovation, and manufacturing, and addressing the imbalance in the distribution of cost for medical innovation, which we have long argued has placed a disproportionate burden on American patients. In closing, the progress we've made so far in 2026 reflects the strength of our science and execution and sets a solid foundation for an exciting remainder of the year. With that, I'll turn the call over to George to discuss our R&D progress in more detail.

Speaker #3: In closing, we've made so far in the progress we've made so far in 2026 reflects the strength of our science and execution and sets a solid foundation for an exciting remainder of the year.

In support of that approach are bought authorized a new 3 billion dollar. Share we purchase program reflecting confidence in our business and financial position. We also recently entered into strategic collaboration with Felix and trinetx

Speaker #3: With that, I'll turn the call over to George to discuss our R&D progress in more detail.

Speaker #4: Thanks, Len. I'll start with our differentiated approach to treating complement-mediated diseases. Which was highlighted last week at our latest REGENERON roundtable investor event. Our core strategy is to deploy customized approaches using an SIRNA and antibody or a combination approach depending on the level and durability of complement inhibition required for each disease.

Finally, last week we entered into a most favorite Nation pricing agreement with the United States government. Achieving our shared goals of ensuring timely and affordable access to groundbreaking medical advancements for medical patients. Maintaining the United States leadership in biotechnology, Innovation, and Manufacturing, and addressing the imbalance. In the distribution of costs for medical Innovation, which we have long argued has placed a disproportionate burden on American patients.

Speaker #4: For example, it appears that in generalized myasthenia gravis, where GMG, the partial blockade with the C5 SRNA alone delivers optimal efficacy, safety, and convenience, while in PNH, complete blockade requiring combination of the SRNA with our C5 antibody is required to optimize efficacy.

George Yancopoulos: Thanks, Len. I'll start with our differentiated approach to treating complement-mediated diseases, which was highlighted last week at our latest Regeneron Roundtable investor event. Our core strategy is to deploy customized approaches using an siRNA, an antibody, or a combination approach, depending on the level and durability of complement inhibition required for each disease. For example, it appears that in generalized myasthenia gravis, or GMG, that partial blockade with the C5 siRNA alone delivers optimal efficacy, safety, and convenience, while in PNH, complete blockade requiring combination of the siRNA with our C5 antibody is required to optimize efficacy. For myasthenia gravis, we presented results from the phase 3 NIMBLE trial at the American Academy of Neurology Conference, which were also simultaneously published in The Lancet.

Closing we've made so far in 20, the progress we've made so far in 2026 reflects the strength of our science and execution and sense of solid foundation for an exciting remainder of the year. With that, I'll turn the call over to George to discuss our R&D progress in more detail.

Thanks Len. I'll start with our differentiated approach to treating compliment mediated diseases.

Which was highlighted last week at our latest regeneron Roundtable investor event.

Speaker #4: For myasthenia gravis, we present the results from the phase three Nimble trial at the American Academy of Neurology Conference, which were also sometimes published in the Lancet.

Speaker #4: Some disorient our investigational C5 SRNA as monotherapy as monotherapy met the primary and all key secondary endpoints with subcutaneous delivery every 12 weeks delivering a 2.3-point placebo-adjusted improvement in the MGADL endpoint at week 24.

Our core strategy is to deploy customized approaches using an S iron a, an antibody or a combination approach depending on the level and durability of complement inhibition required for each disease.

Speaker #4: In registrational clinical trials for the leading approved C5 inhibitors, which are administered as large-volume intravenous infusions dosed every two weeks or every eight weeks, placebo-adjusted improvements in this same MGADL endpoints have ranged from 1.6 to 1.9 points at similar time points.

For example, it appears that in generalized myasthenia gravis, or GMG, that partial blockade with the C5 S RNA alone delivers optimal efficacy, safety, and convenience. While in P&H, complete blockade—requiring combination of the S RNA with our C5 antibody—is required to optimize efficacy.

George Yancopoulos: Cemdisiran, our investigational C5 siRNA as monotherapy met the primary and all key secondary endpoints with subcutaneous delivery every 12 weeks, delivering a 2.3 points placebo-adjusted improvement in the MGADL endpoint at week 24. In registrational clinical trials for the leading approved C5 inhibitors, which are administered as large-volume intravenous infusions dosed every 2 weeks or every 8 weeks, placebo-adjusted improvements in the same MGADL endpoints have ranged from 1.6 to 1.9 points at similar time points. For Cemdisiran, clinically meaningful efficacy was demonstrated by week 2. Moreover, these improvements deepened over in time and were sustained through week 24 with no indication of waning efficacy between doses. The totality of the data, including mostly mild to moderate adverse events, support a compelling profile for Cemdisiran as a standalone quarterly therapy for this disease.

Which were also some tendency published in the Lancet.

Speaker #4: For some disorient, clinically meaningful efficacy was demonstrated by week two, moreover, these improvements deepened over time and were sustained through week 24 with no indication of waning efficacy between doses.

Speaker #4: The totality of the data including mostly mild to moderate adverse events support a compelling profile for some different as a standalone quarterly therapy for this disease.

Speaker #4: These data have been submitted to the FDA and we expect a regulatory decision in the fourth quarter of this year. In PNH, our phase three lead-in results reinforced the requirement for the combination of some disorient plus pozelumab, our C5 antibody, to deliver complete and sustained disease control.

Some different are investigational, C5. Srna as monotherapy as monotherapy met the primary and all key. Secondary endpoints with subcutaneous delivery, every 12 weeks, delivering a 2.3 Point, Placebo, adjusted Improvement in the mg ADL endpoint. At week 24 in registrational. Clinical trials, for the leading approved, C5 Inhibitors, which are administered. As large volume intravenous infusions just every 2 weeks or every 8 weeks.

Placebo just to improvements in this. Same mgl, end points have ranged from 1.6 to 1.9 points at similar time points.

For some different.

Speaker #4: Lead-in results suggest that our combination will provide best-in-class control based on LDH measures and that patients who are uncontrolled on regolizumab can largely be controlled when switched to our combination.

Speaker #4: Enrollment in the registrational enabling cohort of the phase three study is now complete and results are expected late in the fourth quarter of this year.

George Yancopoulos: These data have been submitted to the FDA, and we expect a regulatory decision in Q4 of this year. In PNH, our phase 3 lead-in results reinforce the requirement for the combination of cemdisiran plus pozelimab, our C5 antibody, to deliver complete and sustained disease control. Lead-in results suggest that our combination will provide best-in-class control based on LDH measures and that patients who are uncontrolled on Ravulizumab can largely be controlled when switched to our combination. Enrollment in the registrational enabling cohort of the phase 3 study is now complete, and results are expected late in Q4 of this year. Additionally, in PNH, and as part of our ongoing complement strategy, we recently initiated a first-in-human study evaluating siRNA that targets complement factor B.

Clinically meaningful efficacy was demonstrated by week 2. Moreover, these improvements deepened over time and were sustained through weak 24 with no, indication of winning efficacy between doses. The totality of the data, including mostly mild to moderate Adverse Events, support a compelling profile for some different as a standalone quarterly therapy for this disease.

These data have been submitted to the FDA and we expect a regulatory decision in the fourth quarter of this year.

Speaker #4: Additionally, in PNH and as part of our ongoing complement strategy, we recently initiated a first-in-human study evaluating SRNA that targets complement factor B. This approach is initially intended for the 20 to 30 percent of patients who despite optimal C5 therapy remain anemic due to extravascular hemolysis.

Speaker #4: But also has the potential to expand to a broader PNH population. If successful, SIRNA targeting of CFB could overcome the limitations associated with current CFB inhibitors, which require daily dosing and carry the risk of catastrophic hemolysis if doses are missed.

In P&H our phase 3, leading results, reinforce the requirement for the combination of some different plus puzzle map or C5, antibody to deliver complete and sustained Disease Control, leading results. Suggest that our combination will provide best-in-class control, based on LDH measures and that patients who are uncontrolled on resmen. Can largely be controlled when switched to our combination enrollment in the registration. All enabling cohort of the phase 3 study is now complete and results are expected late in the fourth quarter of this year.

Speaker #4: In ophthalmology, our C5 approach and geographic atrophy is on track to deliver interim data from the exploratory cohort of our phase three study in the fourth quarter of this year, which will help inform our pivotal strategy.

George Yancopoulos: This approach is initially intended for the 20% to 30% of patients who, despite optimal C5 therapy, remain anemic due to extravascular hemolysis, but also has the potential to expand to a broader PNH population. If successful, siRNA targeting of CFB could overcome the limitations associated with current CFB inhibitors, which require daily dosing and carry the risk of catastrophic hemolysis if doses are missed. In ophthalmology, our C5 approach in geographic atrophy is on track to deliver interim data from the exploratory cohort of our phase 3 study in Q4 of this year, which will help inform our pivotal strategy. As a reminder, we are evaluating cemdisiran with or without pozelimab administered systemically with the goal of slowing the growth rate of GA lesions while avoiding ocular safety issues that have been observed with certain approved intravitreal therapies.

Speaker #4: As a reminder, we are evaluating some disorient, with or without pozelumab, administered systemically with the goal of slowing the growth rate of GA lesions while avoiding ocular safety issues that have been observed with certain approved intravitreal therapies.

Additionally in P&H and as part of our ongoing compliment strategy, we recently initiated a first inhuman study evaluating srna, that targets complement Factor B. This approach is initially intended. For the 20-30% of patients who despite optimal C5 therapy remain anemic, due to extravascular hemolysis, but also has the potential to expand to a broader P&H population.

Speaker #4: However, to ensure that we have optionality depending on what we learn clinically, we have also recently begun clinical development of an intravitreal formulation of pozelumab and will also follow up with a co-formulation of pozelumab with aflibrisept, since some of the patients also develop wet AMD while being treated for their GA.

If successful sirna targeting of CFB could overcome the limitations associated with currency of the Inhibitors, which require daily dosing, and carry the risk of catastrophic hemolysis. If doses are missed

Speaker #4: Now, turning to immunology and inflammation. And starting with Dupixent. In the United States, Dupixent was recently approved as the first and only medicine for allergic fungal rhinosinusitis, or AFRS.

George Yancopoulos: However, to ensure that we have optionality depending on what we learn clinically, we have also recently begun clinical development of an intravitreal formulation of Pozelimab, and we will also follow up with a co-formulation of Pozelimab with aflibercept since some of the patients also develop wet AMD while being treated for their GA. Now, turning to immunology and inflammation, and starting with Dupixent. In the United States, Dupixent was recently approved as the first and only medicine for allergic fungal rhinosinusitis, or AFRS, in adults and children 6 years and older. AFRS is a specific type of chronic rhinosinusitis with nasal polyps that more often require surgery and is associated with higher rates of postoperative recurrence.

Speaker #4: In adults and children six years and older. AFRS is a specific type of chronic rhinosinusitis with nasal polyps that more often require surgery and is associated with higher rates of postoperative recurrence.

Speaker #4: Dupixent was also approved in the United States and Europe as the first targeted medicine for children 2 to 11 years of age with chronic spontaneous urticaria, expanding the eligible patient population beyond adolescents and adults.

Inosmi our C5 approach and Geographic, atrophy is on track to deliver interim data from the exploratory cohort of our phase 3 study in the fourth quarter of this year, which will help inform our pivotal strategy as a reminder. We are evaluating some different with or without puzzlement administered, systemically with the goal of slowing. The growth rate of GA lesions while. Avoiding ocular safety issues that have been observed with certain approved intravitreal therapies. However, to ensure that we have optionality depending on what we learned clinically we have also recently begun, clinical development of an introvert formulation of puzzle man and will also follow up with a co-formulation and puzzle with the flip. Since some of the patients also develop wet AMD while being treated for their ga

Speaker #4: This approval reinforces the expanding role of Dupixent across diseases driven in large part by type 2 inflammation and across a broad range of ages.

Speaker #4: Regarding our efforts to develop next-generation approaches to Dupixent pathway, we have previously disclosed that we are developing innovative velocimune-derived fully human long-acting antibodies and bispecifics that target the IL-4 receptor itself, as does DUPI, as well as the IL-13 and IL-4 cytokines that act through this receptor.

George Yancopoulos: Dupixent was also approved in the United States and Europe as the first targeted medicine for children 2 to 11 years of age with chronic spontaneous urticaria, expanding the eligible patient population beyond adolescents and adults. This approval reinforces the expanding role of Dupixent across diseases driven in large part by type II inflammation and across a broad range of ages. Regarding our efforts to develop next-generation approaches to Dupixent pathway, we have previously disclosed that we are developing innovative, VelocImmune-derived, fully human, long-acting antibodies and bispecifics that target the IL-4 receptor itself, as does Dupi, as well as the IL-13 and IL-4 cytokines that act through this receptor. We are on track to initiate a first-in-human trial for our IL-13 antibody by the middle of this year, both in healthy volunteers and in patients with atopic dermatitis, with plans to execute an expedited path to regulatory approvals.

Now, turning to immunology and inflammation, and starting with Dupixent in the United States, Dupixent was recently approved as the first and only medicine for allergic fungal rhinosinusitis, or AFRS, in adults and children 6 years and older. AFRS is a specific type of chronic rhinosinusitis with nasal polyps that more often requires surgery and is associated with higher rates of post-operative recurrence.

Speaker #4: We are on track to initiate a first-in-human trial for IL-13 antibody by the middle of this year, both in healthy volunteers and in patients with atopic dermatitis.

Dixon was also approved in the United States and Europe as the first Target of medicine for children 2 to 11 years of age. With chronic spontaneous urticaria expanding the eligible, patient population Beyond adolescence and adults disapproval. Reinforces the expanding role of depixon across diseases, driven in large part by type 2 inflammation and across a broad range of Ages.

Speaker #4: With plans to execute an expedited path to regulatory approvals. Beyond Dupixent lifecycle opportunities, we continue to advance our next wave of immunology and inflammation programs.

Speaker #4: Our goal is to keep exploring genetically validated targets that have the potential to become future pipeline and product opportunities. We are initiating a first-in-human study of an antibody to a target identified by the Regeneron genetic center as being genetically linked to several diseases such as lupus, Sjögren's, and primary biliary cholangitis.

Regarding our efforts to develop Next Generation. Approaches to the pics and pathway. We have previously disclosed that we are developing Innovative velocity, immune derived fully human long-acting antibodies. And by specifics, that Target the aisle 4 receptor itself

Speaker #4: We're also continuing to evaluate the best path forward across respiratory and sinonasal diseases for idiopicamab, our interleukin-33 antibody. In chronic rhinosinusitis with nasal polyp, our phase three studies are ongoing with results expected in 2027.

George Yancopoulos: Beyond Dupixent lifecycle opportunities, we continue to advance our next wave of immunology and inflammation programs. Our goal is to keep exploring genetically validated targets that have the potential to become future pipeline and product opportunities. We're initiating a first-in-human study of an antibody to a target identified by the Regeneron Genetics Center as being genetically linked to several diseases such as lupus, Sjögren's, and primary biliary cholangitis. We're also continuing to evaluate the best path forward across respiratory and sinonasal diseases for itepekimab, our interleukin-33 antibody. In chronic rhinosinusitis with nasal polyp, our phase 3 studies are ongoing, with results expected in 2027. Regarding COPD, we, Sanofi, and global regulators continue to discuss a potential 3rd phase 3 study, though no decision has been made on whether to move forward. Turning to oncology. On fianlimab, our LAG-3 antibody in combination with Libtayo.

To regulatory approvals.

Speaker #4: Regarding COPD, we as Sanofi and Global Regulators continue to discuss the potential third phase three study, the no decision has been made on whether to move forward.

Speaker #4: Turning to oncology. On Fianumab, our leg three antibody in combination with Liptaya. Our phase three study in metastatic melanoma remains on track. With results expected later in the second quarter of this year.

Beyond to pixel life cycle opportunities, we continue to advance our next wave of immunology and inflammation programs. Our goal is to keep exploring genetically validated targets that have the potential to become future pipeline in a product opportunities. We're initiating a first in human study of an antibody to a Target identified by the regeneron genetic Center, as being genetically linked to several diseases, such as lupus Shoguns and primary ability colonies,

Speaker #4: The primary analysis of progression-free survival will now consider all patients enrolled in the study with a minimum follow-up of six months. In adjuvant melanoma, the study continues following the first interim analysis.

Speaker #4: With the second interim analysis, and if necessary, a final analysis both expected in the second half of this year. We also continue to advance pivotal studies for linozipic in multiple myeloma and premalignant conditions, and expect to have results by early 2027 from our study in multiple myeloma patients that have received at least one prior line of therapy.

We're also continuing to evaluate the best path forward across respiratory and canes for a man or into Lucan 33 antibody in, chronic rhinosinusitis with nasal polyp are phase. 3 studies are ongoing with results. Expected in 2027 regarding COPD weed sanofi, and Global regulatory is continue to discuss a potential third phase 3 study. The no decision has been made on whether to move forward.

Turning to oncology.

George Yancopoulos: Our phase 3 study in metastatic melanoma remains on track, with results expected later in the Q2 of this year. The primary analysis of progression-free survival will now consider all patients enrolled in the study with a minimum follow-up of 6 months. In adjuvant melanoma, the study continues following the first interim analysis, with the second interim analysis and, if necessary, a final analysis, both expected in the H2 of this year. We also continue to advance pivotal studies for linvoseltamab in multiple myeloma and pre-malignant conditions and expect to have results by early 2027 from our study in multiple myeloma patients that have received at least one prior line of therapy, as well as MRD negativity results in 2028 from our study in first-line myeloma patients who are ineligible for stem cell transplant. Our first-line study for odronextamab in first-line follicular lymphoma is fully enrolled.

On fiano men are legitimate antibiotic in combination with child our phase 3 study in metastatic melanoma remains on track.

Speaker #4: As well as MRD negativity results in 2028 from our study in first-line myeloma patients who are ineligible for stem cell transplant. Our first-line study for Otaneximab in first-line follicular lymphoma is fully enrolled.

With results expected later in the second quarter of this year, the primary analysis of progression-free survival will now consider all patients enrolled in the study.

Speaker #4: This is the only study exploring a bispecific as monotherapy versus the current standard of care which is ARCHA across this bispecific arena. Moving to anti-coagulation.

With a minimum, follow-up of 6 months in adant melanoma, the study continues following, the first interim analysis with the second interim term analysis. And if necessary, a final analysis, both expected

Speaker #4: We initiated additional factor XI registrational studies in stroke prevention in patients with atrial fibrillation who are not candidates for direct oral anticoagulants, as well as cancer-associated venous thromboembolism.

in the second half of this year. We also continue to advance pivotal studies for Leno zic in multiple Myoma and premalignant conditions and expect to have results by early 2027 from our study in multiple myeloma patients that have received at least 1 prior line of therapy as well as mrd negativity results in 2028 from our study. And first line Myoma patients who are ineligible for stem cell transplant.

Speaker #4: Additional studies in peripheral arterial disease, peripherally inserted central catheter-associated thrombosis, secondary stroke prevention, as well as SPAF and DOAC eligible patients are all expected to commence this year.

George Yancopoulos: This is the only study exploring a bispecific as monotherapy versus the current standard of care, which is R-CHOP across this bispecific arena. Moving to anticoagulation. We initiated additional factor 11 registrational studies in stroke prevention in patients with atrial fibrillation who are not candidates for direct oral anticoagulants, as well as cancer-associated venous thromboembolism. Additional studies in peripheral arterial disease, peripherally inserted central catheter-associated thrombosis, secondary stroke prevention, as well as SPAF and DOAC-eligible patients are all expected to commence this year. Initial registrational studies from studies in venous thromboembolism prevention following knee replacement surgery are expected in Q1 2027. Turning to obesity. In March, Hansoh reported positive phase 3 results for olatorepatide, our in-licensed GLP-GIP agonist in Chinese patients with obesity, which compared favorably cross-trial to a previous Chinese study of tirzepatide for obesity.

Our first-line study for OAN next toab in first-line follicular lymphoma is fully enrolled. This is the only study.

Speaker #4: Initial registrational studies from studies in venous thromboembolism prevention following knee replacement surgery are expected in the first quarter of 2027. Turning to obesity. In March, Hanzo reported positive phase three results for oletorepatide, our in-license GLP GYP agonist.

exploring a by specific as monotherapy versus the current standard of care, which is our chop across this by specific Arena.

Speaker #4: In Chinese patients, with obesity, which compared favorably cross-trial to a previous Chinese study of terzepatide for obesity. In this randomized double-blind placebo-controlled trial of 604 adults across 33 sites, oletorepatide met its co-primary endpoints and delivered up to 19% mean body weight loss at week 48.

Moving to anti-anc to anti-coagulation. We initiate additional Factor, 11 registrations and stroke prevention in patients with atrial fibrillation who are not candidates for direct oral anticoagulants, as well as cancer Associated. Venus thrombo, embolism additional studies. In Peripheral arterial disease for fully insured Central.

Speaker #4: We are also encouraged by the safety results in particular the gastrointestinal tolerability profile. Hanzo is planning on presenting these promising results at a medical meeting later this year.

Catheter Associated, thrombosis secondary stroke prevention, as well as spa and doac eligible patients are all expected to commence this year. The initial registration studies from studies in Venus, thrombo, embolism, prevention. Following knee replacement surgery are expected in the first quarter of 2027.

Speaker #4: Building on this momentum, our oletorepatide phase two study in obesity is enrolling rapidly and later this year we expect to initiate two global phase three programs.

Turning to obesity in March, hands are reported positive face and results for atar. Repetitive are in licensed, glp Gip Agonist.

George Yancopoulos: In this randomized double-blind placebo-controlled trial of 604 adults across 33 sites, olatorepatide met its co-primary endpoints and delivered up to 19% mean body weight loss at week 48. We are also encouraged by the safety results, in particular, the gastrointestinal tolerability profile. Hansoh is planning on presenting these promising results at a medical meeting later this year. Building on this momentum, our olatorepatide phase 2 study in obesity is enrolling rapidly. Later this year, we expect to initiate two global phase 3 programs, one in patients with obesity and another patients with obesity and type 2 diabetes. In parallel, our work on the olatorepatide Praluent combination continues, with our first clinical study of weekly Praluent initiating shortly. In rare diseases, Len already mentioned the FDA approval of Otarmeni, formerly known as DB-OTO.

Speaker #4: One in patients with obesity and another patients with obesity and type 2 diabetes. In parallel, our work on the oletorepatide priority in combination continues with our first clinical study of weekly priority initiating shortly.

Speaker #4: In rare diseases, Len already mentioned the FDA approval of Otarmini, formerly known as DBOTO. This was an incredibly meaningful moment for the company as it has not only our first gene therapy approval, but one of the most striking successes with gene therapy in history.

In Chinese patients with obesity. Which compared favourably cross trial to a previous Chinese study of tatin for obesity in this randomized, double blind, Placebo control, Trials of 604, adults across 33 sites, all of their repetitive met, its co-primary end points. And delivered up to 19% mean body weight loss at week 48. We are also encouraged by the safety results. In particular, the gastrointestinal tolerability profile.

Hanzo is planning on presenting these promising results and a medical meeting later this year.

Building on this momentum are all repetitive faced to study in obesity is enrolling rapidly.

Speaker #4: Restoring for this first time a sensory function in humans. As published in the New England Journal of Medicine, nearly half the children who are born profoundly deaf were able to regain hearing at normal levels within one year of treatment.

Speaker #4: The mother of one of these children recently told the president of the United States a heartwarming story of how her son was now able to hear her say that she loved him.

And later this year, we expect to initiate 2, Global phase 3 programs 1 in patients with obesity and another patients with obesity type 2 diabetes in parallel. Our work on the other repetitive prowling combination continues with our first clinical study of weekly Parliament, initiating shortly.

George Yancopoulos: This was an incredibly meaningful moment for the company, as it is not only our first gene therapy approval, but one of the most striking successes with gene therapy in history, restoring for the first time a sensory function in humans. As published in The New England Journal of Medicine, nearly half the children who were born profoundly deaf were able to regain hearing at normal levels within one year of treatment. The mother of one of these children recently told the President of the United States a heartwarming story of how her son was now able to hear her say that she loved him. We decided to make Otarmeni free in the United States because we believed it was the right thing to do for these families.

In rare diseases. Len already mentioned the FDA approval of otm formerly known, as DBI.

Speaker #4: We decided to make Otarmini free in the United States because we believed it was the right thing to do for these families. We hope this highlights and reminds the world that it is the biopharma industry, which is frequently viewed so negatively, that is often responsible for delivering such medical miracles to humanity.

The incredibly meaningful moment for the company as is not only our first gene therapy approval, but under the most striking successes with gene therapy in history. Restoring for the first time, a sensory function in humans,

Speaker #4: Regeneron is a different type of company that attracts the best and the brightest to join our fight against disease, because we have a heart and a soul as well as a mission and a willingness to play the long game.

Speaker #4: Another rare disease that we have been studying for many years is fibrodysplasia ossificans progressiva, or FOP. A devastating condition in which muscle and soft tissues are progressively invaded and replaced by abnormal bone formation.

Now able to hear her say that she loved him.

George Yancopoulos: We hope this highlights and reminds the world that it is the biopharma industry, which is frequently viewed so negatively, that is often responsible for delivering such medical miracles to humanity. Regeneron is a different type of company that attracts the best and the brightest to join our fight against disease because we have a heart and a soul, as well as a mission and a willingness to play the long game. Another rare disease that we have been studying for many years is fibrodysplasia ossificans progressiva, or FOP, a devastating condition in which muscle and soft tissues are progressively invaded and replaced by abnormal bone formation. The FDA has accepted for priority review the BLA for Garetosumab, our activin A blocking antibody, with a PDUFA date in August of 2026.

Speaker #4: This FDA has accepted for priority review the BLA for Gertosomab, our active innate blocking antibody with a PDUFA date in August of 2026. If approved, Gertosomab would become the first and only available treatment shown to prevent abnormal bone formation in FOP patients.

We decided to make a Harmony free in the United States because we believed it was the right thing to do for these families. We hope this highlights and reminds the world that it is the biofarm industry, which is frequently viewed so negatively, that is often responsible for delivering such medical miracles to humanity.

Regeneron is a different type of company that attracts the best and the brightest to join our fight against disease because we have a heart and a soul as well as a mission and a willingness to play the long game.

Speaker #4: In genetic medicines, our first in human trials testing siRNAs targeting superoxide dismutase, or SOD1, in amyotrophic lateral sclerosis, alpha-synuclein for Parkinson's disease, and MAPTAU for Alzheimer's disease on rolling patients, and our initial MASH siRNA program readings targeting SIB, PNPLA3, and HSD17B13 are expected by the end of this year.

Another rare disease that we have been studying for many years is fibrodysplasia ossificans progressiva, or FOP, a devastating condition in which muscle and soft tissues are progressively invaded and replaced by abnormal bone formation.

George Yancopoulos: If approved, garetosmab would become the first and only available treatment shown to prevent abnormal bone formation in FOP patients. In genetic medicines, our first-in-human trials testing siRNAs targeting superoxide dismutase, or SOD1, in amyotrophic lateral sclerosis, alpha-synuclein for Parkinson's disease, and MAP-tau for Alzheimer's disease are enrolling patients. Our initial MASH siRNA program readings targeting CIDEB, PNPLA3, and HSD17B13 are expected by the end of this year. Concluding with recent early-stage research updates, the Regeneron Genetics Center recently announced a collaboration with TriNetX to access de-identified electronic health record data from a global network representing 300 million patients, creating an opportunity to connect large-scale genomic and proteomic cohorts to real-world clinical data in ways that can accelerate drug discovery, translation, development, as well as providing new ways of addressing digital health issues.

Speaker #4: Concluding with recent early-stage research updates, the Regeneron Genetics Center recently announced a collaboration with Trinetix to access de-identified electronic health record data from a global network representing 300 million patients creating an opportunity to connect large-scale genomic and proteomic cohorts to real-world clinical data in ways that can accelerate drug discovery, translation, development, as well as providing new ways of addressing digital health issues.

This, the FDA has accepted for priority review. The bla for gertos. Man are active in a blocking antibody with the Padua date in August of 2026. If approved, Gary Johnson, Med will become the first and only available treatment shown to prevent abnormal bone formation in fop patients.

Speaker #4: Regeneron also announced a strategic collaboration with Telex to co-develop and co-commercialize next-generation radiopharmaceutical therapies combining Regeneron's antibody discovery and oncology capabilities with Telex's radiopharmaceutical development and manufacturing expertise.

In genetic medicines are first in human trials. Testing sirnas targeting, superoxide dismutase or sod1. In amyotrophic lateral sclerosis, Alpha nuclei for Parkinson's Disease and map towel for Alzheimer's disease on rolling patients and our initial Mash srna program readings targeting side, B, pnpla3 and hsd 17. B13, are expected by the end of this year.

Speaker #4: In summary, we remain focused on advancing our late-stage, mid-stage, and early-stage programs as well as innovative research, which we firmly believe has the potential to continue to change the practice of medicine.

Speaker #4: With that, let me turn it over to Mary.

Speaker #1: Thanks, George. Our first quarter results represent a strong start to 2026. Our market-leading brands Idea HD depicts an enliptio delivered ongoing growth based on their clinical profile and our ability to execute effectively in competitive markets.

Concluding with recent early stage research updates the RE Jones genetic Center recently announced a collaboration with trinetx to access deified, electronic health record data from a Global Network representing 300 million patients, creating an opportunity to connect large-scale genomic, and proteomic cohorts to real world. Clinical data in ways that can accelerate drug Discovery translation development, as well as providing new ways of addressing digital health.

George Yancopoulos: Regeneron also announced a strategic collaboration with Telix to co-develop and co-commercialize next-generation radiopharmaceutical therapies, combining Regeneron's antibody discovery and oncology capabilities with Telix's radiopharmaceutical development and manufacturing expertise. In summary, we remain focused on advancing our late-stage, mid-stage, and early-stage programs, as well as innovative research, which we firmly believe has the potential to continue to change the practice of medicine. With that, let me turn it over to Marion.

Speaker #1: We begin 2026 well-positioned to advance our portfolio and are excited by upcoming opportunities to change the lives of even more patients. Starting with Idea HD and Idea, which delivered combined US net sales of $942 million in the first quarter, Idea HD net sales were $468 million representing 52% year-over-year growth.

Uh issues regeneron. Also announced a strategic collaboration with Tex to co-develop and Co commercialize Next Generation. Radio pharmaceutical therapies, combining regeneron's antibody discovering oncology capabilities with T's radio pharmaceutical development and Manufacturing expertise in summary. We remain focused on advancing, our late stage, mid-stage and early stage programs, as well, as Innovative research, which we firmly believe has the potential to continue to change the practice of

Marion McCourt: Thanks, George. Our Q1 results represent a strong start to 2026. Our market-leading brands, EYLEA HD, Dupixent, and Libtayo, delivered ongoing growth based on their clinical profile and our ability to execute effectively in competitive markets. We begin 2026 well-positioned to advance our portfolio and are excited by upcoming opportunities to change the lives of even more patients. Starting with EYLEA HD and EYLEA, which delivered combined US net sales of $942 million in Q1, EYLEA HD net sales were $468 million, representing 52% year-over-year growth. During the quarter, physician demand for EYLEA HD increased sequentially by 10% despite typical Q1 seasonality. Additionally, in Q1, wholesaler inventory levels were reduced to the normal range.

Marion McCourt: Thanks, George. Our Q1 results represent a strong start to 2026. Our market-leading brands, EYLEA HD, Dupixent, and Libtayo, delivered ongoing growth based on their clinical profile and our ability to execute effectively in competitive markets. We begin 2026 well-positioned to advance our portfolio and are excited by upcoming opportunities to change the lives of even more patients. Starting with EYLEA HD and EYLEA, which delivered combined U.S. net sales of $942 million in Q1, EYLEA HD net sales were $468 million, representing 52% year-over-year growth. During the quarter, physician demand for EYLEA HD increased sequentially by 10% despite typical Q1 seasonality. Additionally, in Q1, wholesaler inventory levels were reduced to the normal range.

Medicine with that. Let me turn it over to Mary.

Speaker #1: During the quarter, physician demand for Idea HD increased sequentially by 10%. Despite typical first-quarter seasonality, additionally, in the first quarter, wholesaler inventory levels were reduced to the normal range.

Speaker #1: Idea HD now has the broadest label and greatest dosing flexibility of any anti-VEGF medicine following recent label enhancements to include retinal vein occlusion and additional dosing options that range from every four weeks through every 20 weeks.

Speaker #1: We are encouraged by physician adoption following these label enhancements importantly, we also look forward to the upcoming FDA decision for the Idea HD prefilled syringe which, if approved, would bring what we believe is a best-in-class device to retina specialists and help drive continued uptake for Idea HD.

Marion McCourt: EYLEA HD now has the broadest label and greatest dosing flexibility of any anti-VEGF medicine following recent label enhancements to include retinal vein occlusion and additional dosing options that range from every four weeks through every twenty weeks. We are encouraged by physician adoption following these label enhancements. Importantly, we also look forward to the upcoming FDA decision for the EYLEA HD prefilled syringe, which, if approved, would bring what we believe is a best-in-class device to retina specialists and help drive continued uptake for EYLEA HD. In Q1, EYLEA's US net sales were $473 million, representing a 36% year-over-year decline. This reflects ongoing conversion to EYLEA HD, competitive pressures, and patient affordability issues.

Marion McCourt: EYLEA HD now has the broadest label and greatest dosing flexibility of any anti-VEGF medicine following recent label enhancements to include retinal vein occlusion and additional dosing options that range from every four weeks through every twenty weeks. We are encouraged by physician adoption following these label enhancements. Importantly, we also look forward to the upcoming FDA decision for the EYLEA HD prefilled syringe, which, if approved, would bring what we believe is a best-in-class device to retina specialists and help drive continued uptake for EYLEA HD. In Q1, EYLEA's U.S. net sales were $473 million, representing a 36% year-over-year decline. This reflects ongoing conversion to EYLEA HD, competitive pressures, and patient affordability issues.

Speaker #1: In the first quarter, Idea's US net sales were $473 million representing a 36% year-over-year decline. This reflects ongoing conversion to Idea HD, competitive pressures, and patient affordability issues.

It's George. Our first quarter results. Represent a strong start to 2026. Our Market leading Brands IA. HD, depicts them in libtayo delivered ongoing growth based on their clinical profile and our ability to execute effectively in competitive markets, We Begin 2026. Well, positioned to advance our portfolio and are excited by upcoming opportunities, to change the lives of even more patients starting with EHD and IA, which delivered combined us, net sales of 942 million in the first quarter IA HD. Net sales were 468 million representing 52% year-over-year growth during the quarter physician demand for elite HD. Increase sequentially by 10%. Despite typical first quarter seasonality, additionally. And the first quarter wholesaler inventory levels were reduced to the normal range, AIA HD. Now, has the broadest label and greatest dosing flexibility of any anti veg of medicine following recent label enhancements to include retinal vein occlusion.

Speaker #1: Additionally, during the first quarter, there was only a modest reduction in Idea inventory and continued inventory absorption is expected to negatively impact net product sales in the second quarter by approximately 20 million.

Speaker #1: Looking ahead to the second quarter, we expect to achieve sequential unit demand growth for Idea HD that is consistent with the 10% sequential demand growth in the first quarter.

And additional dosing options that range from every 4 weeks through every 20 weeks. We are encouraged by physician adoption following these label enhancements. Importantly, we also look forward to the upcoming FDA decision for the EYLEA HD pre-filled syringe, which, if approved, would bring what we believe is a best-in-class device to retina specialists and help drive continued uptake for EYLEA HD.

Speaker #1: Conversely, for Idea, we anticipate that demand will decline in the mid to high teens in the second quarter ahead of the potential launch of additional biosimilars in the second half of the year coupled with the factors that I highlighted earlier.

Marion McCourt: Additionally, during Q1, there was only a modest reduction in EYLEA inventory, and continued inventory absorption is expected to negatively impact net product sales in Q2 by approximately $20 million. Looking ahead to Q2, we expect to achieve sequential unit demand growth for EYLEA HD that is consistent with the 10% sequential demand growth in Q1. Conversely, for EYLEA, we anticipate the demand will decline in the mid to high teens in Q2 ahead of the potential launch of additional biosimilars in H2 of the year, coupled with the factors that I highlighted earlier. Together, EYLEA HD and EYLEA lead the innovative branded anti-VEGF category with more than 100 million injections of EYLEA HD and EYLEA administered worldwide since launch. Additionally, in the US, EYLEA HD now contributes half of net sales for our retina franchise.

Marion McCourt: Additionally, during Q1, there was only a modest reduction in EYLEA inventory, and continued inventory absorption is expected to negatively impact net product sales in Q2 by approximately $20 million. Looking ahead to Q2, we expect to achieve sequential unit demand growth for EYLEA HD that is consistent with the 10% sequential demand growth in Q1. Conversely, for EYLEA, we anticipate the demand will decline in the mid to high teens in Q2 ahead of the potential launch of additional biosimilars in H2 of the year, coupled with the factors that I highlighted earlier. Together, EYLEA HD and EYLEA lead the innovative branded anti-VEGF category with more than 100 million injections of EYLEA HD and EYLEA administered worldwide since launch. Additionally, in the U.S., EYLEA HD now contributes half of net sales for our retina franchise.

Speaker #1: Together, Idea HD and Idea lead the innovative branded anti-VEGF category with more than 100 million injections of Idea HD and Idea administered worldwide since launch.

Speaker #1: Additionally, in the US, Idea HD now contributes half of net sales for a retina franchise. Turning to Dupixent, which continues to transform the lives of more than 1.4 million patients worldwide with type 2 inflammatory diseases that are currently on treatment.

Speaker #1: In the first quarter, Dupixent net sales were $4.9 billion representing 31% year-over-year growth on a constant currency basis. US net sales grew 35% year-over-year to $5.6 billion.

The head of the potential launch of additional biosimilars in the second half of the Year coupled with the factors that are highlighted earlier.

Speaker #1: We continue to see growth across all nine indications including recent launches making Dupixent the number one biologic medicine prescribed by dermatologists, pulmonologists, allergists, and ENTs.

Marion McCourt: Turning to Dupixent, which continues to transform the lives of more than 1.4 million patients worldwide with type 2 inflammatory diseases that are currently on treatment. In Q1, Dupixent net sales were $4.9 billion, representing 31% year-over-year growth on a constant currency basis. US net sales grew 35% year-over-year to $5.6 billion. We continue to see growth across all 9 indications, including recent launches, making Dupixent the number 1 biologic medicine prescribed by dermatologists, pulmonologists, allergists, and ENTs. Across the blockbuster indications of atopic dermatitis, asthma, nasal polyps, and eosinophilic esophagitis, Dupixent continues to drive strong growth based on its differentiated clinical efficacy, safety profile, and physicians' strong preference for this brand. Uptake is also strong across more recent launches, including chronic obstructive pulmonary disease, chronic spontaneous urticaria, bullous pemphigoid, and allergic fungal rhinosinusitis.

Marion McCourt: Turning to Dupixent, which continues to transform the lives of more than 1.4 million patients worldwide with type 2 inflammatory diseases that are currently on treatment. In Q1, Dupixent net sales were $4.9 billion, representing 31% year-over-year growth on a constant currency basis. U.S. net sales grew 35% year-over-year to $5.6 billion. We continue to see growth across all 9 indications, including recent launches, making Dupixent the number 1 biologic medicine prescribed by dermatologists, pulmonologists, allergists, and ENTs. Across the blockbuster indications of atopic dermatitis, asthma, nasal polyps, and eosinophilic esophagitis, Dupixent continues to drive strong growth based on its differentiated clinical efficacy, safety profile, and physicians' strong preference for this brand. Uptake is also strong across more recent launches, including chronic obstructive pulmonary disease, chronic spontaneous urticaria, bullous pemphigoid, and allergic fungal rhinosinusitis.

Speaker #1: Across the blockbuster indications of atopic dermatitis, asthma, nasal polyps, and eosinophilic esophagitis, Dupixent continues to drive strong growth based on its differentiated clinical efficacy, safety profile, and physician's strong preference for this brand.

Speaker #1: Uptake is also strong across more recent launches including chronic obstructive pulmonary disease, chronic spontaneous urticaria, bullous pemphigoid, and allergic fungal rhinosinusitis. These launches across a growing range of age groups provide a runway for even more patients to benefit from Dupixent.

Speaker #1: With annualized global net sales of nearly $20 billion and significant room for further market penetration across indications, Dupixent is well-positioned for sustained growth over the near and long term.

Together, IA, HD, and IA lead the innovative branded anti-VEGF category. With more than 100 million injections via HD and IA administered worldwide since launch. Additionally, in the US, IE HD now contributes half of net sales for our retina franchise. Turning to Dupixent, which continues to transform the lives of more than 1.4 million patients worldwide with type 2 inflammatory diseases that are currently on treatment. And the first quarter depicts net sales of $4.9 billion, representing 31% year-over-year growth on a constant currency basis. US net sales grew 35% year-over-year to $5.6 billion. We continue to see growth across all 9 indications, including recent launches, making Dupixent the number 1 biologic medicine prescribed by dermatologists, pulmonologists, allergists, and ENTs.

Speaker #1: Turning to enliptio, which delivered $438 million in global net sales in the first quarter, in the US net sales were $286 million, as enliptio continues its strong trajectory as the leading immunotherapy for advanced non-melanoma skin cancers.

across the Blockbuster indications of atopic dermatitis. Asthma nasal polyps in the cinefila strong across more recent launches including

Marion McCourt: These launches across a growing range of age groups provide a runway for even more patients to benefit from Dupixent. With annualized global net sales of nearly $20 billion and significant room for further market penetration across indications, Dupixent is well-positioned for sustained growth over the near and long term. Turning to Libtayo, which delivered $438 million in global net sales in the first quarter. In the US, net sales were $286 million as Libtayo continues its strong trajectory as the leading immunotherapy for advanced non-melanoma skin cancers. The recent launch of Libtayo in adjuvant CSCC is also an emerging growth driver with encouraging uptake and positive feedback on this paradigm change in treatment. Libtayo is the only NCCN Category one preferred immunotherapy option for eligible adjuvant CSCC patients.

Marion McCourt: These launches across a growing range of age groups provide a runway for even more patients to benefit from Dupixent. With annualized global net sales of nearly $20 billion and significant room for further market penetration across indications, Dupixent is well-positioned for sustained growth over the near and long term. Turning to Libtayo, which delivered $438 million in global net sales in the Q1. In the U.S., net sales were $286 million as Libtayo continues its strong trajectory as the leading immunotherapy for advanced non-melanoma skin cancers. The recent launch of Libtayo in adjuvant CSCC is also an emerging growth driver with encouraging uptake and positive feedback on this paradigm change in treatment. Libtayo is the only NCCN Category one preferred immunotherapy option for eligible adjuvant CSCC patients.

Speaker #1: The recent launch of enliptio in adjuvant CACC is also an emerging growth driver with encouraging uptake and positive feedback on this paradigm-changing treatment. Enliptio is the only NCCN category 1 preferred immunotherapy option for eligible adjuvant CACC patients.

Speaker #1: In non-small cell lung cancer, enliptio is established as the second most prescribed first-line immunotherapy treatment in the US and we expect continued growth through 2026 as we gain incremental share in lung cancer and drive uptake in adjuvant CACC.

Chronic obstructive pulmonary disease, chronic spontaneous urticaria, bulus, PMP, FOID, and allergic fungal rhinosinusitis—these launches are across a growing range of age groups. They provide a runway for even more patients to benefit from Dupixent, with annualized global net sales of nearly $20 billion and significant room for further market penetration across indications. Dupixent is well positioned for sustained growth over the near and long term.

Speaker #1: Onto Linezific, which is in its second full quarter on the market. Early launch momentum has been driven by positive physician experience, a differentiated clinical profile, lower hospitalization requirements, and convenient dosing continued gradual uptake as we work to advance our clinical program in earlier lines of therapy.

Marion McCourt: In non-small cell lung cancer, Libtayo is established as the second most prescribed first-line immunotherapy treatment in the US, and we expect continued growth through 2026 as we gain incremental share in lung cancer and drive uptake in adjuvant CSCC. Onto linvoseltamab, which is in its second full quarter on the market. Early launch momentum has been driven by positive physician experience, a differentiated clinical profile, lower hospitalization requirements, and convenient dosing schedule. We expect continued gradual uptake as we work to advance our clinical program in earlier lines of therapy. I also wanted to spend a moment highlighting our expanding rare disease portfolio. Evkeeza is now in its fifth year on market in the US and delivered net sales of $46 million for the quarter, representing 48% growth year-over-year.

Marion McCourt: In non-small cell lung cancer, Libtayo is established as the second most prescribed first-line immunotherapy treatment in the U.S., and we expect continued growth through 2026 as we gain incremental share in lung cancer and drive uptake in adjuvant CSCC. Onto linvoseltamab, which is in its second full quarter on the market. Early launch momentum has been driven by positive physician experience, a differentiated clinical profile, lower hospitalization requirements, and convenient dosing schedule. We expect continued gradual uptake as we work to advance our clinical program in earlier lines of therapy. I also wanted to spend a moment highlighting our expanding rare disease portfolio. Evkeeza is now in its fifth year on market in the U.S. and delivered net sales of $46 million for the quarter, representing 48% growth year-over-year.

Speaker #1: I also wanted to spend a moment highlighting our expanding rare disease portfolio. Avkiza is now in its fifth year on market in the US and delivered net sales of $46 million for the quarter representing 48% growth year-over-year.

Speaker #1: Avkiza is well-established as a leading treatment for homozygous familial hypercholesterolemia with more than half of all diagnosed US patients currently on Avkiza or in the process of starting Avkiza.

Turning to lipio, which delivered 438 million in global net sales in the first quarter in the US, net sales were 286 million as a libtayo continues, its strong trajectory, as the leading immunotherapy for Advanced non-melanoma Skin cancers, the recent launch of Libya and addivon. Cscc is also an emerging growth driver with encouraging, uptake and positive feedback on this Paradigm. Changing treatment, latio is the only nccn category, 1 for free, Demunn therapy option for eligible. Adien CSC patients in non small cell. Lung cancer, Leo is established as a second. Most prescribed first line immunotherapy treatment in the US and we expect continued growth through 2026. As we gain, incremental, share and lung, cancer, and drive. Uptake in addivon, cscc on to Len as ific, which is in its second full quarter on the market. Early launch momentum has been driven by positive, physician experience a differentiate clinical profile lower Hospital.

Speaker #1: As highlighted by Len, we are also launching Otarmini, which is the first and only gene therapy for children born with genetic hearing loss in addition, we look forward to the anticipated FDA decision on garitozumab in August.

Speaker #1: Garitozumab is our potential treatment for FOP and has been shown to prevent 99% of abnormal bone formation. In closing, our strong first quarter results demonstrate growth potential across our portfolio.

Marion McCourt: Evkeeza is well established as a leading treatment for homozygous familial hypercholesterolemia, with more than half of all diagnosed US patients currently on Evkeeza or in the process of starting Evkeeza. As highlighted by Len, we are also launching Otarmeni, which is the first and only gene therapy for children born with genetic hearing loss. We look forward to the anticipated FDA decision on garetosmab in August. Garetosmab is our potential treatment for FOP and has been shown to prevent 99% of abnormal bone formation. In closing, our strong Q1 results demonstrate growth potential across our portfolio. We continue to advance our in-line brands while also preparing for multiple potential indication and new product launches, including for cemdisiran for generalized myasthenia gravis, where there is significant commercial opportunity in this large and growing market.

Marion McCourt: Evkeeza is well established as a leading treatment for homozygous familial hypercholesterolemia, with more than half of all diagnosed U.S. patients currently on Evkeeza or in the process of starting Evkeeza. As highlighted by Len, we are also launching Otarmeni, which is the first and only gene therapy for children born with genetic hearing loss. We look forward to the anticipated FDA decision on garetosmab in August. Garetosmab is our potential treatment for FOP and has been shown to prevent 99% of abnormal bone formation. In closing, our strong Q1 results demonstrate growth potential across our portfolio. We continue to advance our in-line brands while also preparing for multiple potential indication and new product launches, including for cemdisiran for generalized myasthenia gravis, where there is significant commercial opportunity in this large and growing market.

Hospitalization requirements and convenient, dosing schedule. We expect continual continued, gradual uptake as we work to advance our clinical program in earlier lines of therapy. I also wanted to spend a moment highlighting our expanding rare disease. Portfolio of Kiesza is now, in its fifth year on Market in the US and delivered, net sales of 46 million. For the quarter representing 48% growth year-over-year.

Speaker #1: We continue to advance our inline brands while also preparing for multiple potential indication and new product launches including for some different for generalized myasthenia gravis where there is significant commercial opportunity in this large and growing market.

Speaker #1: We remain well-positioned to deliver meaningful benefits to patients worldwide across a growing number of diseases. And with that, I'll turn the call over to Chris.

Speaker #2: Thank you, Marian. My comments today on Regeneron's financial results and outlook will be on a non-gap basis unless otherwise noted. Regeneron performed well in the first quarter, highlighted by double-digit growth on both the top and bottom line.

Speaker #2: First quarter 2026 total revenues grew 19% from the prior year to $3.6 billion, driven by higher Sanofi collaboration revenue as well as strong growth in net sales of Idea HD in the US and enliptio globally.

Marion McCourt: We remain well-positioned to deliver meaningful benefits to patients worldwide across a growing number of diseases. With that, I'll turn the call over to Chris.

Speaker #2: First quarter diluted net income per share grew 15% to $9.47 on net income of $1 billion. Beginning with the Sanofi collaboration, first quarter total Sanofi collaboration revenues were $1.6 billion of which $1.5 billion related to our share of collaboration profits.

As is, well established as a leading treatment for homozygous familial. Hypo cholesterol Mia. With more than half of all diagnosed us. Patients, currently on Aza or in the process of starting of Tisa. As highlighted by Len. We're also in launching otarre which is the first and only gene therapy for children. Born with genetic hearing loss. In addition, we look forward to the anticipated FDA decision on Gatos in August Gatos is our potential treatment for fop and has been shown to prevent 99% of ab. Abnormal bone formation in closing our strong first quarter results, demonstrate growth potential across our portfolio. We continue to advance our inline Brands while also comparing for multiple potential indication and new product launches, including for some different for generalized, Mio gravis, where there are significant commercial opportunity in this large and growing Market, we remain, well, positioned to deliver meaningful benefits to patients worldwide.

Christopher Fenimore: Thank you, Marion. My comments today on Regeneron's financial results and outlook will be on a non-GAAP basis, unless otherwise noted. Regeneron performed well in Q1, highlighted by double-digit growth on both the top and bottom line. Q1 2026 total revenues grew 19% from the prior year to $3.6 billion, driven by higher Sanofi collaboration revenue, as well as strong growth in net sales of EYLEA HD in the US and Libtayo globally. Q1 diluted net income per share grew 15% to $9.47 on net income of $1 billion. Beginning with the Sanofi collaboration, Q1 total Sanofi collaboration revenues were $1.6 billion, of which $1.5 billion related to our share of collaboration profits.

Christopher Fenimore: Thank you, Marion. My comments today on Regeneron's financial results and outlook will be on a non-GAAP basis, unless otherwise noted. Regeneron performed well in Q1, highlighted by double-digit growth on both the top and bottom line. Q1 2026 total revenues grew 19% from the prior year to $3.6 billion, driven by higher Sanofi collaboration revenue, as well as strong growth in net sales of EYLEA HD in the U.S. and Libtayo globally. Q1 diluted net income per share grew 15% to $9.47 on net income of $1 billion. Beginning with the Sanofi collaboration, Q1 total Sanofi collaboration revenues were $1.6 billion, of which $1.5 billion related to our share of collaboration profits.

Across a growing number of diseases. And with that, I'll turn the call over to Chris.

Thank you, Marion. My comments today on Regeneron's financial results and outlook will be on a non-GAAP basis, unless otherwise noted.

Speaker #2: Regeneron share of profits grew 42% versus the prior year driven by Dupixent sales growth and improving collaboration margins. We now expect the Sanofi development balance to be fully repaid by the end of the second quarter.

regenerative foreign well on the first quarter highlighted by double digit growth on both the top and bottom line.

Speaker #2: As a result, we expect Sanofi collaboration revenue to step up to reflect our full share of collaboration profits starting in the third quarter. Moving to Baier, first quarter net sales of Idea and Idea 8 MIG outside the US were $729 million inclusive of $333 million of Idea 8 MIG sales.

First quarter 2026, total revenues grew 19%, from the prior year to 3.6 billion driven by higher sanofi collaboration Revenue, as well as strong growth in net sales of AA, HD in the US and lipio globally.

On net income of $1 billion.

Christopher Fenimore: Regeneron's share of profits grew 42% versus the prior year, driven by Dupixent sales growth and improving collaboration margins. We now expect the Sanofi development balance to be fully repaid by the end of Q2. As a result, we expect Sanofi collaboration revenue to step up to reflect our full share of collaboration profits starting in Q3. Moving to Bayer. Q1 net sales of EYLEA and EYLEA eight mg outside the US were $729 million, inclusive of $333 million of EYLEA eight mg sales. Total Bayer collaboration revenue was $287 million, of which $240 million related to our share of net profits outside the US. Other revenue grew 109% in Q1 to $171 million.

Christopher Fenimore: Regeneron's share of profits grew 42% versus the prior year, driven by Dupixent sales growth and improving collaboration margins. We now expect the Sanofi development balance to be fully repaid by the end of Q2. As a result, we expect Sanofi collaboration revenue to step up to reflect our full share of collaboration profits starting in Q3. Moving to Bayer. Q1 net sales of EYLEA and EYLEA eight mg outside the U.S. were $729 million, inclusive of $333 million of EYLEA eight mg sales. Total Bayer collaboration revenue was $287 million, of which $240 million related to our share of net profits outside the U.S. Other revenue grew 109% in Q1 to $171 million.

Beginning with the sanity collaboration first quarter total sanity. Collaboration revenues were 1.6 billion of which 1.5 billion related to our share of collaboration profits.

Speaker #2: Total Baier collaboration revenue was $287 million of which $240 million related to our share of net profits outside the US. Other revenue grew $109% in the first quarter to $171 million.

Regeneron share of profits grew 42% versus the prior year, driven by Dupixent sales growth and improving collaboration margins.

Speaker #2: This included $101 million related to our share of profits from Arcalyst and royalty income from Olaris. Now to our operating expenses. R&D expense was $1.4 billion in the first quarter reflecting continued investments to support Regeneron's innovative pipeline including pivotal programs across late-stage opportunities in hematology, oncology, complement-mediated diseases, and anticoagulation.

We now expect the sanofi development balance to be fully repaid by the end of the second quarter. As a result. We expect sanofi collaboration Revenue to step up to reflect our full share of collaboration profits starting in the third quarter.

Moving to buyer.

Speaker #2: First quarter SG&A was $560 million reflecting investments to support the launch of enliptio in adjuvant CACC and to drive continued growth of Idea HD.

First quarter, net sales of AA, and AA 8, Mig outside, the US where 729 million inclusive of 333 million of ailia, 8 MC Sales. Total buyer collaboration Revenue was 287 million of which 240 million related to our share of net profits outside the US

Christopher Fenimore: This included $101 million related to our share of profits from ARCALYST and royalty income from Alnylam. To our operating expenses. R&D expense was $1.4 billion in Q1, reflecting continued investments to support Regeneron's innovative pipeline, including pivotal programs across late-stage opportunities in hematology, oncology, complement-mediated diseases, and anticoagulation. Q1 SG&A was $560 million, reflecting investments to support the launch of Libtayo and adjuvant CSCC and to drive continued growth of EYLEA HD. Q1 matching contribution to Good Days, an independent nonprofit patient assistance foundation, were de minimis. We remain committed to matching up to $200 million in 2026 to support patient access and affordability. Non-GAAP gross margin on net product sales was 86% in Q1.

Speaker #2: First quarter matching contribution to Good Days and independent nonprofit patient assistance foundation were de minimis. We remain committed to matching up to $200 million in 2026 to support patient access and affordability.

Other Revenue grew 109% in the first quarter to 171 million, this included, 101 million related to our share of profits from arcalyst and royalty income from Eros.

Speaker #2: Non-gap gross margin on net product sales was 86% in the first quarter. Our gap gross margin was 76% which was negatively impacted by cost incurred due to a temporary interruption in bulk manufacturing at our Limerick, Ireland site.

Now, to our operating expenses R&D expense was 1.4 billion in the first quarter, reflecting continued Investments to support, regeneron's Innovative pipeline, including pivotal programs, across late stage opportunities, and Hematology Oncology compliment, mediated diseases and anti-coagulation.

Speaker #2: We have now resumed initial production in the facility and expect to resume full production by the end of the second quarter. As a result, we anticipate our gap gross margin will continue to be negatively impacted in the second quarter as production returns to normal levels.

First quarter SDA was 560 million, reflecting Investments, to support the launch of libtayo and aajivan cscc. And to drive continued growth of Leah HD.

First quarter matching contribution to good days and independent nonprofit. Patient assistance, Foundation were diminished.

Speaker #2: This interruption has not impacted and is not expected to impact the availability of any products. Regeneron generated $848 million of free cash flow in the first quarter of 2026 and ended the quarter with cash and marketable securities less debt of $15.8 billion.

We remain committed to matching up to $200 million in 2026 to support patient access and affordability.

Christopher Fenimore: Our GAAP gross margin was 76%, which was negatively impacted by costs incurred due to a temporary interruption in bulk manufacturing at our Limerick, Ireland site. We have now resumed initial production in the facility and expect to resume full production by the end of Q2. As a result, we anticipate our GAAP gross margin will continue to be negatively impacted in Q2 as production returns to normal levels. This interruption has not impacted and is not expected to impact the availability of any products. Regeneron generated $848 million of free cash flow in Q1 2026 and ended the quarter with cash and marketable securities less debt of $15.8 billion.

Non-gaap growth margin on net product sales was 86% in the first quarter, our gaap, gross margin was 76%, which was negatively impacted by cost, incurred due to a temporary Interruption and both manufacturing at our liar Ireland site.

Speaker #2: We repurchased $800 million of our shares in the first quarter and announced this morning that the board of directors has authorized a new $3 billion share repurchase program.

We have now resumed initial production in the facility and expect to resume full production by the end of the second quarter.

Speaker #2: With this new authorization, we have approximately $3.4 billion available for share repurchases as of today and we remain opportunistic buyers of our shares. We have made some minor changes to our 2026 financial guidance including updating our gap gross margin guidance to be in the range of 77% to 78%.

As a result, we anticipate our gaap gross margin will continue to be negatively impacted in the second quarter as production returns to normal levels.

This Interruption has not impacted and is not expected to impact the availability of any products.

Speaker #2: This reflects actual and expected cost incurred as a result of the aforementioned temporary manufacturing interruption. A full summary of our guidance can be found in our earnings press release published earlier this morning.

Christopher Fenimore: We repurchased $800 million of our shares in Q1 and announced this morning that the board of directors has authorized a new $3 billion share repurchase program. With this new authorization, we have approximately $3.4 billion available for share repurchases as of today, and we remain opportunistic buyers of our shares. We have made some minor changes to our 2026 financial guidance, including updating our GAAP gross margin guidance to be in the range of 77% to 78%. This reflects actual and expected costs incurred as a result of the aforementioned temporary manufacturing interruption. A full summary of our guidance can be found in our earnings press release published earlier this morning.

Regeneron generated 848, million of free cash flow in the first quarter of 2026 and ended. The quarter with cash and marketable, securities, less debt of 15.8 billion.

Speaker #2: In conclusion, Regeneron is off to a strong start in 2026 with financial results that position us well to continue investing in our pipeline delivering breakthroughs for patients and driving long-term value for shareholders.

We repurchased 800 million of our shares in the first quarter and announced this morning that the board of directors has authorized a new 3 billion, share repurchase program.

With this new authorization, we have approximately 3.4 billion available for share repurchases as of today. And we've remained opportunistic buyers of our shares.

Speaker #2: With that, I'll pass the call back to Ryan.

Speaker #3: Thank you, Chris. This concludes our prepared remarks. We will now open the call for Q&A. To ensure we are able to address as many questions as possible, we are we will answer one question from each caller before moving to the next.

Speaker #3: Kevin, can we go to the first question, please?

We have made some minor changes to our 2026 Financial guidance. Including updating, our Gap growth margin guidance to be in the range of 77 to 78% this reflects actual and expected costs incurred, as a result of the aforementioned, temporary. Manufacturing interruption

Speaker #4: Thank you, ladies and gentlemen. If you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered or you wish to move yourself from the queue, please press star 11 again.

Christopher Fenimore: In conclusion, Regeneron is off to a strong start in 2026, with financial results that position us well to continue investing in our pipeline, delivering breakthroughs for patients, and driving long-term value for shareholders. With that, I'll pass the call back to Ryan.

A full summary of our guidance can be found in our earnings press release published earlier this morning.

In conclusion.

Speaker #4: One moment for our first question. Our first question comes from Tyler Van Buren with TD Cowen. Your line is open.

Ryan Crowe: Thank you, Chris. This concludes our prepared remarks. We will now open the call for Q&A. To ensure we are able to address as many questions as possible, we will answer one question from each caller before moving to the next. Kevin, can we go to the first question, please?

Regeneron is off to a strong. Start in 2026 with financial results. That position us well to continue investing in our pipeline, delivering breakthroughs for patients, and driving long-term value for shareholders with that. I'll pass the call back to Ryan.

Speaker #5: Hey, guys. Good morning. Thanks for the question. So Dupixent continues to be a monster delivering strong performances quarter after quarter after quarter. And it now looks like it will well exceed $30 billion of global sales.

Thank you, Chris, this concludes our prepared remarks, we will now open the call for Q&A.

Speaker #5: So given that, we get a lot of questions from investors, not just on lifecycle expansion but the Sanofi collaboration. So can you discuss your willingness to work on lifecycle expansion efforts within the Sanofi collaboration or come to an agreement on commercializing these assets together in order to take advantage of the Dupixent rebate wall and the status of that as opposed to moving lifecycle expansion candidates forward yourself and potentially further building out the commercial infrastructure?

To ensure we are able to address as many questions as possible. We are. We will answer 1 question from each caller before moving to the next.

Operator: Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star one one on your telephone. If your question has been answered or you wish to remove yourself from the queue, please press star one one again. One moment for our first question. Our first question comes from Tyler Van Buren with TD Cowen. Your line is open.

Evan, can we go to the first question, please? Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 1, 1 1 on your telephone. If your question has been answered, or you wish to remove yourself from the queue, please press star 1 on 1 again. 1 moment for our first question.

Tyler Van Buren: Hey, guys. Good morning. Thanks for the question. Dupixent continues to be a monster, delivering strong performances quarter after quarter after quarter, and it now looks like it will well exceed $30 billion of global sales. Given that, we get a lot of questions from investors, not just on life cycle expansion, but the Sanofi collaboration. Can you discuss your willingness to work on life cycle expansion efforts within the Sanofi collaboration or come to an agreement on commercializing these assets together in order to take advantage of the Dupixent rebate wall and the status of that, as opposed to moving life cycle expansion candidates forward yourself and potentially further building out the commercial infrastructure?

Our first question comes from Tyler van beer and with TD cow and your line is open.

Speaker #3: Oh, Tyler, it's Lynn. Thanks for that very poignant question. Maybe it'll give me an opportunity to publicly thank Paul Hudson for all the work he did on Dupixent since 2019.

Speaker #3: Thank you, Paul. And we wish you good luck in your next chapter. Also, as of today, Sanofi's new CEO, Belen Garrijo, is officially, I think, the CEO today.

Speaker #3: So we want to welcome Belen and wish her luck. And we look forward to working with her. And the rest of her team. Tyler, you're right.

Speaker #3: Dupixent is a remarkable product. As Marian detailed and George outlined, it's helping so many different people with so many millions of people with different diseases and is a financial juggernaut for the company.

Sets together in order to take advantage of the dupixent rebate wall and the status of that, uh, as opposed to moving life, cycle expansion, candidates for yourself and potentially further building out the commercial infrastructure.

Leonard Schleifer: Oh, Tyler, it is Len. Thanks for that, very poignant question. Maybe to give me an opportunity to publicly thank Paul Hudson for all the work he did on Dupixent since 2019. Thank you, Paul. We wish you good luck in your next chapter. Also, as of today, Sanofi's new CEO, Belén Garijo, is officially, I think, the CEO today. We want to welcome Belén and wish her luck, and we look forward to working with her and the rest of her team. Tyler, you are right. Dupixent is a remarkable product. As Marion detailed and George outlined, it is helping so many different people with so many millions of people with different diseases, and it is a financial juggernaut for the company. We are always open-minded to transactions.

Speaker #3: We are always open-minded to transactions. Certainly, leveraging what we've built in terms of both development capabilities as well as commercial capabilities has merit to it.

Speaker #3: We can do these things ourselves. We've had interest from many different places to sort of take on some of the next opportunities with us.

Speaker #3: But we're open-minded. And I look forward to talking with Belen and her team in the coming weeks and months, etc.

Speaker #5: Thanks, Lynn. Let's move to the next question, please, Kevin.

Speaker #4: One moment for our next question. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open.

Christopher Fenimore: Certainly leveraging what we've built in terms of both development capabilities, as well as commercial capabilities, has merit to it. We can do these things ourselves. We've had interest from many different places to sort of take on some of the next opportunities with us. We're open-minded, and I look forward to talking with Belén and her team in the coming weeks and months, et cetera.

Leonard Schleifer: Certainly leveraging what we've built in terms of both development capabilities, as well as commercial capabilities, has merit to it. We can do these things ourselves. We've had interest from many different places to sort of take on some of the next opportunities with us. We're open-minded, and I look forward to talking with Belén and her team in the coming weeks and months, et cetera.

Speaker #6: Great. Thanks, this is Chris on for Terence. We have a question about Fianle-Mab in metastatic melanoma. Is the PFS differentiation enough you need OS as well?

Oh Tyler. It's Len. Thanks for that. Very, uh, poignant question. Maybe to give me an opportunity to publicly. Thank, uh, Paul Hudson, for all the work he did. Uh, under pixon since 2019. Thank you. Paul, we wish you good luck in your next chapter. Also, as of today, Saint if he's new CEO, Ben go is officially, I think the CEO today. So we want to welcome Ben and wish her luck and we look forward to working with her and the rest of her team. Uh, Tyler, you're right. Do pixon is a remarkable product, that is marrying details and George outlined. It's helping so many different, uh, people with so many millions of people with different diseases and is a financial Juggernaut for the company. Um, we are always open-minded to transactions. Uh, certainly leveraging what we've built in terms of both development capabilities, uh, as well as commercial capabilities. Uh,

Speaker #6: Thank you.

Speaker #5: Well, it obviously depends on the results. It depends on exactly what the PFS results are. But the study is also designed so that if we have a substantial OS benefit, we will see that as well.

Ryan Crowe: Thanks, Len. Let's move to the next question, please, Kevin.

Has married to it. We can do these things ourselves. We've had interest from many different places, uh, to sort of, uh, take on some of the the next opportunities with us but uh, we're open-minded and I look forward to talking with Ben and her team uh in the coming weeks and months Etc.

Operator: One moment for our next question. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open.

Thanks, Len. Uh let's move to the next question, please. Kevin, 1 moment for our next question.

Our next question comes from Terren Flynn with Morgan Stanley. Your line is open.

[Analyst] (Morgan Stanley): Great. Thanks. This is Chris on for Terence. We have a question about fianlimab in metastatic melanoma. Is the PFS differentiation enough to capture majority share, or do you think you need OS as well? Thank you.

Speaker #5: And so the hope, of course, is that the study will show both the PFS and an OS benefit. But the results remain to be seen.

Great thanks. Uh, this is Chris on for Terren. Uh, we have a question about fieni map in map test, static melanoma.

Speaker #4: Thanks, George. Let's move to the next question, please.

Speaker #7: One moment.

Uh, is the PFS differentiation enough to capture majority share, or do you think you need OS as well? Thank you.

George Yancopoulos: Well, it obviously depends on the results. It depends on exactly what the PFS results are. The study is also designed so that if we have a substantial OS benefit, we will see that as well. The hope, of course, is that the study will show both a PFS and an OS benefit, you know, the results remain to be seen.

Speaker #4: Our next question comes from Chris Raymond with Raymond James. Your line is open.

Speaker #8: Hey, this is Sam Leachon for Chris Raymond. Just one on the Eylea prefilled syringe. So any commentary on why FDA missed the April PDUFA?

Speaker #8: Was that a request for more information or a backlog issue? And then you noted there was a reinspection at Catalent, Indiana, and you've resubmitted.

Speaker #8: Can we read in between the lines and assume that means the site inspection was positive? And what's kind of your overall guidance on timing for either of these applications?

Ryan Crowe: Thanks, George. Let's move to the next question, please.

Well it obviously depends on the results. It depends on um exactly what the PFS results are. But the study is also, uh, designed so that um, if we have um, a substantial OS benefit, we will we will see that as well. And so the hope of course, is that the study will show uh, both the PFS and an OS benefit, but, you know, the the results remain to be seen.

Operator: One moment. Our next question comes from Chris Raymond with Raymond James. Your line is open.

Speaker #8: Thank you.

Thanks George. Let's move to the next question, please. 1 moment.

Speaker #5: Yeah. So thanks for the question. I think we've told you what we know. We don't if the inspection turns out to be positive, then I think they will approve the drug.

Stanley Chan: Hey, this is Stanley Chan for Chris Raymond. Just one on the EYLEA pre-filled syringe. Any commentary on why FDA missed the April PDUFA? Was that a request for more information or a backlog issue? You noted there was a re-inspection at Catalent Indiana, and you've resubmitted. Can we re-read in between the lines and assume that means the site inspection was positive? What's kind of your overall guidance on timing for either of these applications? Thank you.

Our next question comes from Chris. Raymond with Raymond James, your line is open.

Speaker #5: So we await and both applications are pending. And the only thing I can say is that based on our conversations and how hard everybody's working at this and the FDA I think desire to get these sites up to the standards they want as well as get the products out there that are waiting, that we anticipate action on one or both of these during this court.

Leonard Schleifer: Yeah. Thanks for the question. I think we've told you what we know. We don't. If the inspection turns out to be positive, then I think they will approve the drug, so we wait. Both applications are pending. The only thing I can say is that based on our conversations and how hard everybody's working at this and the FDA, I think, desire to, you know, get these sites up to the standards they want, as well as get the products out there that are waiting, that we anticipate action on one or both of these during this quarter.

Hey, this is Sam Lee. John for Chris Raymond. Uh, just 1 on the, a pre-filled syringe, so any commentary on why FDA missed the April Padua and was that a request for more information or a backlog issue? And then you noted there was a reinspection at Catalin Indiana and you've resubmitted can we read read in between the lines and assume? That means the site inspection was positive. And uh, what's kind of your overall guidance on timing for either of these applications? Thank you.

Speaker #4: Thanks, Lynn. Let's move to the next question, please.

Speaker #7: One moment.

Speaker #4: Our next question comes from Cory Kasimoff with Evercore ISI. Your line is open.

Speaker #9: Hey, good morning, guys. Thanks for taking the question. Wanted to ask about Linezific and kind of the outlook and the multiple myeloma spaces. When we talk with doctors, obviously, excitement about the potential of BCMA bispecifics.

Speaker #9: But the main pushback on widespread adoption is the infection risk they carry. Especially in earlier-stage patients. So curious what you make of the debate and how you're trying to mitigate this in your trials going forward.

Ryan Crowe: Thanks, Len. Let's move to the next question, please.

Speaker #9: Thank you.

Yeah, so thanks for the question. I think we've told you, what we know. Um, we don't, uh, if the inspection turns out to be positive, then I think they will approve the, uh, the drug. So we wait, um, and both applications are pending, uh, and the only thing I can say is that based on our conversations and and how hard everybody's working at this and the FDA. I think desire to um, you know, get these sites up to the standards they want as well as get them products out there that are waiting. Um, that we anticipate action on 1 of both of these during this call.

Operator: One moment. Our next question comes from Cory Kasimov with Evercore ISI. Your line is open.

Speaker #5: So the debate of their use compared to what?

Thanks Len. Let's move to the next question, please. 1 moment.

Speaker #3: Yes, existing standards of care like that.

Speaker #5: I see.

Speaker #3: Etc.

Cory Kasimov: Hey, good morning, guys. Thanks for taking the question. Wanted to ask about linvoseltamab and kind of the outlook in the multiple myeloma spaces. When we talk with docs, there's obviously excitement about the potential of BCMA bispecifics, the main pushback on widespread adoption is the infection risk they carry, especially in earlier stage patients. Curious what you make of the debate and how you're trying to mitigate this in your trials going forward. Thank you.

Speaker #5: So obviously, all of these approaches carry significant infectious risks. As we've shown in our study, the disease itself carries substantial infectious risk. And if you actually look at our detailed data and publications on the matter, it actually turns out that the longer you treat these patients, the more you control their disease, the more functional their bone marrow becomes actually infectious risk goes down over time.

Our next question comes from Corey kasoof with evercore, isi, your line is open.

Hey, good morning guys, thanks for taking the question. Wanted to ask about Linda ific and kind of the Outlook and the multiple Myoma spaces. When we talk with docs. There's a excitement about the potential of of bcma by specifics but the main push back on widespread adoption is the infection risk. They carry especially in earlier, stage patients. So curious what you make of the debate and and how you're trying to mitigate this in your trials going forward. Thank you.

George Yancopoulos: The debate of their use compared to what?

Speaker #5: Which is actually quite stunning. So I think that the profile, if you really look at it, of the bispecifics in general and our bispecific in particular are very, very promising.

Ryan Crowe: It's existing standards of care like DVRd, et cetera.

Cory Kasimov: It's existing standards of care like DVRd, et cetera.

So, the debate of their use compared to what?

Leonard Schleifer: I see. Obviously all of these approaches carry significant infectious risks. As we've shown in our study, the disease itself carries substantial infectious risk. If you actually look at our detailed data and publications on the matter, it actually turns out that the longer you treat these patients, the more you control their disease, the more functional their bone marrow becomes. Actually, infectious risk goes down over time, which is actually quite stunning. I think that the profile, if you really look at it, of the bispecifics in general and our bispecific in particular are very, very promising, not only in terms of their impressive efficacy, but in terms of their overall side effect and tolerability profile, including, of course, the infectious risk.

George Yancopoulos: I see. Obviously all of these approaches carry significant infectious risks. As we've shown in our study, the disease itself carries substantial infectious risk. If you actually look at our detailed data and publications on the matter, it actually turns out that the longer you treat these patients, the more you control their disease, the more functional their bone marrow becomes. Actually, infectious risk goes down over time, which is actually quite stunning. I think that the profile, if you really look at it, of the bispecifics in general and our bispecific in particular are very, very promising, not only in terms of their impressive efficacy, but in terms of their overall side effect and tolerability profile, including, of course, the infectious risk.

Speaker #5: Not only in terms of their impressive efficacy, but in terms of their overall side effect and tolerability profile, including of course the infectious risk.

Speaker #5: So we think that this is going to become the dominant class for the treatment of this disease as well as its precursors. And we believe that if you look at the data, that our agent is certainly competitive, if not indeed best in class across all parameters here.

The more you control their disease, uh the more functional their bone marrow becomes actually infectious risk goes down over time, uh which is actually quite stunning.

Speaker #4: Thanks, George. Let's move to the next question, please, Kevin.

Speaker #7: One moment.

Speaker #4: Our next question comes from Tazeen Ahmad with Bank of America. Your line is open.

Speaker #10: Hi, good morning. Thanks for taking my question. As we think about next-gen DUPI, how are you thinking about the importance of having a late-stage program clearly defined before the US IP for Dupixent goes away whenever that might be?

George Yancopoulos: We think that this is gonna become the dominant class for the treatment of this disease as well as its precursors. We believe that, if you look at the data, that our agent is certainly competitive, if not indeed best in class across all parameters here.

Speaker #10: Just given the increasing number of potential long-acting injectables and other oral agents that might come online? Thanks.

Ryan Crowe: Thanks, George. Let's move to the next question, please, Kevin.

So, um, so I think that the profile, if you really look at it of the 5 specific in general and our by specific in particular are very, very promising, not only in terms of their impressive efficacy, but in terms of their overall side effect and tolerability profile, including, of course, the Infectious risks. So we think that this is going to become the dominant class, um, for the treatment of this disease, as well as its precursors. And we believe that, uh, if you look at the data that our agent is certainly competitive, if not indeed best-in-class across all parameters here,

Operator: One moment. Our next question comes from Tahseen Abad with Bank of America. Your line is open.

Operator: One moment. Our next question comes from Tazeen Ahmad with Bank of America. Your line is open.

Speaker #5: Yeah. Look, the we don't know how long the patent life will be for DUPI because we have lots and lots of intellectual property out there, lots of different types of patents, used patents, formulation patents, in addition, obviously, to the composition patent.

Thanks George. Let's move on to the next question, please. Kevin 1 moment.

Tahseen Abad: Hi, good morning. Thanks for taking my question. As you think about next gen Dupixent, how are you thinking about the importance of having a late-stage program, you know, clearly defined before the US IP for Dupixent goes away, whenever that might be, just given the increasing number of potential long-acting injectables and other oral agents that might come online? Thanks.

Tazeen Ahmad: Hi, good morning. Thanks for taking my question. As you think about next gen Dupixent, how are you thinking about the importance of having a late-stage program, you know, clearly defined before the U.S. IP for Dupixent goes away, whenever that might be, just given the increasing number of potential long-acting injectables and other oral agents that might come online? Thanks.

Our next question comes from tazeen about with Bank of America, your line is open.

Speaker #5: In terms about this, to us, we want to leverage our knowledge and immunology. We don't necessarily think about having to exactly replace or work on.

Speaker #5: We have nearly 50 things in the pipeline and we're looking forward to bringing as many important ones forward as we can. But we do have a number of these that George, I think, talked about.

Leonard Schleifer: Yeah. Look, the we don't know how long the patent life will be for Dupixent because we have lots and lots of intellectual property out there, lots of different types of patents, use patents, formulation patents, in addition, obviously, to the composition patent. In terms of how we think about this, to us, we wanna leverage our knowledge in immunology. We don't necessarily think about having to exactly replace or work on. We have nearly 50 things in the pipeline, and we're looking forward to bringing as many important ones forward as we can.

Hi, good morning. Uh, thanks for taking my question. Um, as we think about NextGen dupy, how are you thinking about the importance of having, um, a late stage program, um, you know, clearly defined before the US IP for dupixent, um, goes away whenever that might be just given the increasing number of of potential long-acting, uh, injectables and other oral agents that might come online. Thanks.

Speaker #5: The extended interval Dupixent, going after long-acting IL-13, IL-4, other diseases that we haven't even covered with DUPI, such as allergic diseases. In general, food allergies and so forth.

Speaker #5: So I think there's a lot of opportunity and one shouldn't just focus on a simple replacement or what have you. And one shouldn't assume when the patent for DUPI will actually expire.

Leonard Schleifer: We do have a number of these that George, I think, talked about, the extended interval Dupixent, going after long-acting IL-13, IL-4, other diseases that we haven't even covered with Dupixent such as allergic diseases, in general, food allergies and so forth. I think there's a lot of opportunity, and one shouldn't just focus on a simple replacement or what have you, and one shouldn't assume when the patent for Dupixent will actually expire.

Speaker #4: Okay. Thanks, Glenn. Let's move to the next question, please.

Speaker #7: One moment.

Speaker #4: Our next question comes from Carter Gould with Canter. Your line is open.

Speaker #11: Great. Good morning. Thanks for taking the questions. Maybe change it up a bit. For George, as you spoke about the co-injection of C5 with the Flibricept, should we think about that as more of a convenience play?

Yeah, look, um, the uh, we don't know how long, the patent life will be for do be because we have lots and lots of intellectual property out there. Lots of different types of patents used patents, formulation patents, and addition, obviously, uh, till the, uh, to the composition patent, uh, in terms of, uh, how we think about this to us. Um, we want to leverage our knowledge in Immunology, we don't necessarily think about having to exactly replace or work on. Um, we have nearly 50 things in in the pipeline, uh, and we're looking forward to Bringing as many important ones forward as we can. But we do have a number of these, uh, that George I think talked about, uh, the extended interval dupixent going after long acting Aisle 13 Isle 4 other, uh, other diseases that we haven't even covered with 2 pies such as allergic diseases.

Speaker #11: Sort ort of with the co-administration? Or potentially more of a, I guess, a label expansion as you think about potentially preventing wet AMD, I guess, forming for lack of a better term?

Speaker #5: I think those are both interesting possibilities. It could be used to actually prevent the development of the way AMD and/or to treat the patients who develop it.

Ryan Crowe: Okay. Thanks, Glen. Let's move to the next question, please.

Um, in general, uh, food allergies and so forth. So I think there's a lot of opportunity uh, and 1 shouldn't just focus on a simple replacement or what have you and 1 shouldn't assume when the patent uh for dupy will actually expire.

Operator: One moment. Our next question comes from Carter Gould with Barclays. Your line is open.

Okay, thanks, Glenn. Let's move to the next question, please. 1 moment.

Carter Gould: Great. Good morning. Thanks for taking the questions. Maybe to change it up a bit, for George, as you spoke about the co-injection of C5 with aflibercept, should we think about that as more of a convenience play, sort of, with the co-administration or, potentially more of a, I guess, a label expansion as you think about potentially preventing wet AMD, I guess, forming, for lack of a better term?

Our next question comes from carter gold with Kerr. Your line is open.

Speaker #5: And very importantly, as you probably know, there's a lot of evidence and suggestions about the causes of the occlusive retinal vasculitis that is seen with the other agents that are, for example, totally different kinds of molecules and pegulated and so forth.

Speaker #5: And these some of the characteristics of those molecules are associated with this occlusive retinal vasculitis. We hope and we believe based on our experience with biologics, with Eylea, and with this particular antibody, that we may not only have these convenience benefits, but perhaps most importantly, we may also avoid the very tragic very horrific side effects that are seen with the existing agents, which would allow them to be much more broadly used.

George Yancopoulos: I think those are both interesting possibilities. It could be used to actually prevent the development of the AMD and/or to treat the patients who develop it. Very importantly, as you probably know, there's a lot of evidence and suggestions about the causes of the occlusive retinal vasculitis that is seen with the other agents that are, for example, totally different kinds of molecules, integrated and so forth. These, some of the characteristics of those molecules are associated with this occlusive retinal vasculitis.

Uh great, uh good morning. Thanks for for taking the questions. Uh maybe uh, change it up a bit uh, for George. Uh, if you spoke about the co- injection of uh C5 with the flip. Um, should we think about that as more of a convenience play sort of with the co-administration or uh potentially more of a I guess a label expansion as you think about potentially preventing uh, wedding, AMD, uh uh I guess forming for lack of a better term.

I, I think those are both interesting possibilities. Uh, it could be, uh, used to actually prevent the development of the way, MD Andor to treat the patients, who develop it and very importantly, as you probably know. Um, there's a lot of

Speaker #5: Moreover, we would think, once again, as our experience indicates the history with Eylea, that we could have much longer-acting versions and moreover, depending on how the data looks, with the systemic as well as the local, one could imagine even combining the two to allow for very long-acting injections in the eye.

George Yancopoulos: We hope and we believe, based on our experience with biologics, with EYLEA, and with this particular antibody, that we may not only have these convenience benefits, but perhaps most importantly, we may also avoid the very tragic, very horrific side effects that are seen with the existing agents, which would allow them to be much more broadly used. Moreover, we would think, once again, as our experience indicates in the history with EYLEA, that we could have much longer-acting versions. Moreover, depending on how the data looks, with the systemic as well as the local, one could imagine even combining the two to allow for very long-acting injections in the eye. There's a lot of possibilities that could address better safety profile, as well as convenience, as well as potentially even efficacy.

Uh, evidence and suggestions about the causes of the, uh, occluded, occlusive retinal vasculitis. That is seen with the other agents that are. For example, uh, totally different kinds of molecules, and pegal and so forth and these some of the characteristics of those molecules are associated, uh, with this exclusive retinal vasculitis. We hope. And we believe, um, based on our experience with biologics with a and with this particular, antibody that, um, we may not only have these convenience benefits but perhaps most

Speaker #5: So there's a lot of possibilities that could address better safety profile as well as convenience as well as potentially even efficacy.

Speaker #4: Thanks, George. Next question, please, Kevin.

Speaker #7: One moment.

Speaker #4: Our next question comes from Evan Seigerman with BMO Capital Markets. Your line is open.

Speaker #12: Hi there. Thank you for taking my question. I'd love for you to walk me through the commercial considerations for developing your combo GLP-1, GIP, plus Praluent.

Speaker #12: And how can you accelerate the development to remain competitive in this rapidly evolving market?

Speaker #5: Well, the way we look at it, and I think Len came up with this terminology, imagine if you invented a GLP that was as good as the currently best-in-class agent, let's say Terzepatide, and acted very much the same but also lowered your bad cholesterol by more than 50% and was shown to decrease your risk of cardiovascular outcomes like heart attacks, and death.

Ryan Crowe: Thanks, George. Next question please, Kevin.

Possibilities, that could address better safety profile as well as convenience. Um, uh, as well as potentially even efficacy.

Operator: One moment. Our next question comes from Evan Seigerman with BMO Capital Markets. Your line is open.

Thanks George next question, please. Kevin 1 moment.

Evan Seigerman: Hi there. Thank you for taking my question. I'd love for you to walk me through the commercial considerations for developing your combo GLP-1/GIP plus Praluent, and how can you accelerate the development to remain competitive in this rapidly evolving market?

Our next question comes from Evans with our BMO Capital markets, your line is open.

Speaker #5: That GLP would become the preferred GLP on the planet. Especially if you priced it at a very similar price. Why would anybody take any other GLP?

Hi there. Thank you for taking my question. I’d love for you to walk me through the commercial considerations for developing your combo GLP-1, GIP plus Polyant, and how you can accelerate the development to remain competitive in this rapidly evolving market?

George Yancopoulos: Well, the way we look at it, and I think Len came up with this terminology, imagine if you invented a GLP that was as good as the currently best-in-class agent, let's say tirzepatide, and acted very much the same, but also lowered your bad cholesterol by more than 50% and was shown to decrease your risk of cardiovascular outcomes like heart attacks, and death. That GLP would become the preferred GLP on the planet, especially if you priced it at a very similar price. Why would anybody take any other GLP? We are very buoyed by the data that we see coming from our collaborators in China, where the cross-trial comparisons show that as we predicted based on our due diligence of the molecule, that it behaves, if anything, as well as tirzepatide.

Well.

Speaker #5: We are very bowied by the data that we see coming from our collaborators in China where the cross-trial comparisons show that as we predicted based on our due diligence of the molecule, that it behaves if anything as well as Terzepatide.

The way we look at it and I think Glenn came up with this terminology. Imagine if you invented a glp that was as good as the currently best-in-class agent, let's say terzi.

um, uh, an active very much the same but also

Speaker #5: And of course, our folks in the lab have been busy working developing co-formulated forms of this GLP together with our Praluent, which we believe we can be delivering by a very similar convenient auto-injector approach using the same approach as the GLPs are delivered as well.

Speaker #5: And we believe that we can price it very competitively to the GLPs. And we would think that honestly, any physician prescribing it or any patient thinking about it would say that why would they ever take a GLP especially since we know of the profound comorbidities associated with cardiovascular risk and hyperlipidemia in the same population?

Lowered, your bad cholesterol by more than 50% and was shown to decrease your risk of cardiovascular outcomes like heart attacks, uh, and and death. Um, that glp would become the preferred glp on the planet. Especially if you priced it at a very similar price, why would anybody take any other glp? Um, we are very, um, voiced by the data that we see, uh, coming from our collaborators in China. Uh, where the cross trial comparisons show that as we predicted,

George Yancopoulos: Of course, our folks in the lab have been busy working, developing co-formulated forms of this GLP together with our Praluent, which we believe we can be delivering by a very similar convenient auto-injector approach, using the same approach as the GLPs are delivered as well. We believe that we can price it very competitively to the GLPs. We would think that honestly any physician prescribing it or any patient thinking about it would say that why would they ever take a GLP, especially since we know of the profound comorbidities associated with cardiovascular risk and the hyperlipidemia in the same population. Why would they ever take a GLP if they had the option of taking a GLP that also lowered their lipids and also decreased their risk of bad cardiovascular outcomes?

Based on our due diligence of the molecule that it behaves, if anything as well as tapete. Uh, and of course, um,

Speaker #5: Why would they ever take a GLP if they had an option of taking a GLP that also lowered their lipids and also decreased their risk of bad cardiovascular outcomes?

Speaker #5: So to us, honestly, it sort of seems like a no-brainer. Obviously, there will be competition. But we believe we have potentially a best-in-class GLP and a best-in-class PCSK9 and the convenience for many people of these auto-injectors is now becoming so pervasive that we think a large segment of the population will opt for them.

Speaker #5: Now, this is, of course, not even presuming that the side effect profile that we see in China more broadly pertains in our upcoming global studies.

George Yancopoulos: To us, honestly, it sort of seems like a no-brainer. Obviously, there will be competition, but we believe we have potentially a best-in-class GLP and a best-in-class PCSK9, and the convenience for many people of these auto-injectors is now becoming so pervasive that we think a large segment of the population will opt for them. Now, this is of course, not even presuming that the side effect profile that we see in China more broadly pertains in our upcoming global studies. We think that this is a very, very exciting and a very, very large opportunity.

Speaker #5: So we think this is a very, very exciting and a very, very large opportunity.

Speaker #4: George, could you just correct the misunderstanding about weight loss, not lowering lipids?

Our folks in the lab have been busy working developing co-formulated, forms of this. Glp together with our prowl unit, which we believe we can be delivering, uh, by a very similar convenient, auto injector approach using the same approaches. The glps are delivered, um, uh, as well, and we believe that we can price it very competitively to the glps. And we would think that, honestly, any physician prescribing it or any patient thinking about it would say that, why would they ever take a glp, uh, especially since we know of the profound Cobb's associated with cardiovascular risk and, and Hyper lipidemia in the same population? Why they would they ever take a glp if they had an option of taking a glp that also lowered their their lipids, uh, and also decreased their risk of bad cardiovascular outcomes. So, that us honestly, it sort of seems like a no-brainer. Obviously, there will be competition.

Speaker #5: Yeah. So it's thank you, Len. It's a great point. As many people obviously know, weight loss and the GLPs can provide cardiovascular outcome benefits.

Speaker #5: But they do this by creating benefits across a wide variety of different risk factors. And they only lower your bad cholesterol by a few points.

But we believe we have potentially a best-in-class glp, and a best-in-class pcsk9, and the convenience for many people of these Auto injectors, uh, is now becoming so pervasive that we think a large segment of the population will offer them. Now, this is the

Speaker #5: In contrast to the 50 to 60 percent lowering that we see with the PCSK9 blockers. So this will be a real add-on in terms of the cardiovascular benefit and the lipid benefit compared to just GLP alones, which by themselves, though, they benefit outcomes, they do very little in terms of your lipid profile.

Leonard Schleifer: George, could you just correct the misunderstanding about weight loss not lowering lipids?

Of course, not even presuming that, the side effect profile that we see in China uh, more broadly pertains uh in our upcoming Global Studies. Uh, so we think this is a very, very exciting and a very, very large opportunity to could you just correct. The misunderstanding about weight loss, not lowering

George Yancopoulos: Yeah. Thank you, Len. It's a great point. As many people obviously know, weight loss and the GLPs can provide cardiovascular outcome benefits, but they do this by creating benefits across a wide variety of different risk factors. They only lower your bad cholesterol by a few points, in contrast to the 50% to 60% lowering that we see with the PCSK9 blockers. This will be a real add-on in terms of the cardiovascular benefit and the lipid benefit compared to just GLP alone, which by themselves, though they benefit outcomes, they do very little in terms of your lipid profile.

Lipids.

Yeah. So

Thank you, Lynn. Uh, it's a great point. Uh, as

Speaker #5: So many patients are obviously left with still high-risk based on their lipid profile if they're either obese or especially obese with type 2 diabetes where dyslipidemia there is a very serious and common comorbidity concern.

Speaker #4: Finally, the use of cholesterol-lowering drugs is now finally catching up, I think, to the science where the recommendations are to start earlier and longer.

Speaker #4: So I think that your indicated population to lower cholesterol and lose weight is going to be even broader. So as George said, this is a really significant opportunity.

George Yancopoulos: Many patients are obviously left with still high risk based on their lipid profile if they're either obese or especially obese with type 2 diabetes, where dyslipidemia there is a very serious and common comorbidity concern.

Speaker #5: Well, and very importantly, from the public health perspective, though recommendations are all about how focus on your lipids, much earlier, widespread use of lipid-lowering medications, they are dramatically underutilized in the world.

Leonard Schleifer: Finally, the use of cholesterol-lowering drugs is now finally catching up, I think, to the science where the recommendations are to start earlier and longer. I think that your indicated population to lower cholesterol and lose weight is gonna be even broader. As George said, this is a really significant opportunity.

Many people as, you know, uh, weight loss, and the glp is can provide cardiovascular outcome benefits but they do this by creating benefits across a wide. Variety of different, uh, risk factors. Uh, and they only lower, uh, your bad cholesterol by a few points. Uh, in contrast to the 50 to 60% lowering that we see, uh, with the pcsk9 blockers. So this will be a real add-on in terms of the cardiovascular benefit and the lipid benefit compared to just glp loans. Which by themselves, though they benefit outcomes, they do very little in terms of your lipid profile. So many patients are obviously left with still high risk based on their lipid profile, if they're either obese, or especially obese with type 2 diabetes. Where just lipidemia there is a very serious and common comorbidity concern,

Speaker #5: Unfortunately, this causes incredible morbidity and death. Heart disease is still the leading cause of death in the United States in part because of the underutilization of these incredible weapons we have.

Speaker #5: We think in a Trojan horse sort of way, this will provide incredible public health benefit by having all the people who are really so worried about their weight loss also get the lipid benefit, which will have this dramatic benefit, which is unfortunately underutilized and underappreciated.

George Yancopoulos: Well, very importantly, from the public health perspective, though recommendations are all about how focus on your lipids much earlier, widespread use of lipid-lowering medications, they are dramatically underutilized in the world. Unfortunately, this causes incredible morbidity and death. Heart disease is still the leading cause of death in the United States, in part because of the underutilization of these incredible weapons we have. We think in a Trojan horse sort of way, this will provide incredible public health benefit by having all the people who are really so worried about their weight loss also get the lipid benefit, which will have this dramatic benefit, which is unfortunately underutilized and underappreciated.

Speaker #4: Okay. Thank you, Len and George. Let's move to the next question, please.

Speaker #7: One moment.

Speaker #4: Our next question comes from Alexandria Hammond with Wolf. Your line is open.

Speaker #13: Thanks for taking the question. Can you share a little bit more on your clinical strategy to expedite development of your next-gen INI assets, particularly SUPI/DUPI?

Speaker #13: How do you expect to be able to kind of leverage the changes within FDA to further speed this development up? And has there been an ongoing dialogue with the regulators?

Speaker #13: Thank you.

Speaker #5: Well, we've obviously we're world leaders in this field. We created the field. We did the first studies in atopic dermatitis in the field. And we are well-positioned, we believe, to expedite and accelerate the programs as rapidly as possible.

Ryan Crowe: Okay. Thank you, Len and George. Let's move to the next question, please.

Of lipid lowering medications. They are dramatically underutilized in the world. Unfortunately, this causes incredible morbidity and death heart disease is still the leading cause of death in the United States in part because of the underutilization of these incredible weapons. We have we think in a trojan horse, sort of way. This will provide incredible public health benefit by having all the people who are really so worried about their weight loss. Also get the lipid benefit, which will have this dramatic benefit, which is unfortunately, underutilized and underappreciated

Operator: One moment. Our next question comes from Alexandria Hammond with Wolfe. Your line is open.

Okay, thank you, Len and George. Let's move to the next question, please. One moment.

Alexandria Hammond: Thanks for taking the question. Can you share a little bit more on your clinical strategy to expedite development of your next-gen I&I assets, particularly Supy-Dupy? How do you expect to be able to kind of leverage the changes within FDA to further speed this development up? Has there been an ongoing dialogue with the regulators? Thank you.

Our next question comes from Alexandria, Hammond with wolf. Your line is open.

Speaker #5: And we feel very good about our position and our plans here.

Speaker #4: Okay. Thanks, George. Let's move to the next question, please.

Speaker #7: One moment.

Speaker #4: Our next question comes from Salveen en Richter with Goldman Sachs. Your line is open.

Speaker #14: Good morning. Thanks for taking my questions. Just regards to the lifecycle strategy for Dupixent, which is broad and multi-pronged, where do you feel you have the most line of sight?

George Yancopoulos: Well, we've obviously, we're world leaders in this field. We created the field. We did the first studies in atopic dermatitis in the field. We are well-positioned, we believe, to expedite and accelerate the programs as rapidly as possible. We feel very good about our position and our plans here.

Thanks for taking the question. Can you share a little bit more on your clinical strategy to expedite the development of your next-gen ini assets? Particularly, subie dupy—how do you expect to be able to kind of leverage the changes within the FDA to further speed this development up, and has there been an ongoing dialogue with regulators? Thank you.

Speaker #14: And how are you optimizing the IL-4 agent or SUPI/DUPI? Thank you.

Speaker #3: Yeah. I think what George said is that we have a lot of experience here. We don't need to give out all of our details to help any competition that might be out there.

Ryan Crowe: Okay, thanks, George. Let's move to the next question, please.

Well, we've obviously, we're world leaders in this field, we created the field, we did the first studies in atopic dermatitis in the field, uh, and we are, well, positioned. We Believe to expedite and accelerate um, the programs as rapidly as possible. Uh, and we feel very good about our position and our plans here.

Operator: One moment. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open.

Speaker #3: But the team knows what they're doing. SUPI/DUPI is one that Sanofi and Regeneron by mutual agreement can add to the collaboration. We have the knowledge, the capabilities, and the desire to do this as efficiently as possible.

Okay. Thanks George. Uh, let's move to the next question, please. 1 moment.

Salveen Richter: Good morning. Thanks for taking my questions. Just regards to the life cycle strategy for Dupixent, which is broad and multi-pronged, where do you feel you have the most line of sight, and how are you optimizing the IL-4 agent or Supy-Dupy? Thank you.

Our next question comes from Saline Richter with Goldman Sachs. Your line is open.

Speaker #4: Okay. Next question, please, Kevin.

Speaker #7: One moment.

Morning, thanks for taking my questions. Um, just regards to the life cycle strategy for Dixon which is Broad and multi-pronged. Um, where do you feel you have the most line of sight and and how are you optimizing? Um the aisle for agent or or subie doobie, thank you.

Speaker #4: Our next question comes from Christopher Schott with JP Morgan. Your line is open.

Leonard Schleifer: Yeah. I think what George said, is that we have a lot of experience here. We don't need to give out all of our details to help any competition that might be out there. The team knows what they're doing. Supy-Dupy is one that Sanofi and Regeneron, by mutual agreement, can add to the collaboration. We have the knowledge, the capabilities, and the desire to do this as efficiently as possible.

Speaker #15: Hi. This is Taylor Hanley on for Chris Schott. Thank you so much for taking our question. We were just wondering, on LibTIO, can you provide any color on the drivers of performance this quarter?

Speaker #15: Was there anything one-time in there? How much of this was driven by the new indication CSCC? And is this a good baseline to think about growing off of going forward?

Speaker #15: Thank you.

Ryan Crowe: Okay. Next question, please, Kevin.

Speaker #16: So sure. Very happy to take the question. And I think the LibTIO performance certainly is strong. I would characterize the strength based on certainly the advances that we've seen in our skin indications, now with adjuvant CSCC, very exciting to help this group of patients with LibTIO.

Yeah, I think what joint said I'm not is that we have a lot of experience here, we don't need to give out all of our details to help any competition. That might be out there but, uh, the team, uh, knows what they're doing. Um, super dupy is 1, uh, that Santa Fe and the General on by mutual agreement. Can add to the collaboration. Um, we we have, uh, the knowledge, the capabilities, uh, and the desire to do this is officially as possible.

Operator: One moment. Our next question comes from Christopher Schott with J.P. Morgan. Your line is open.

Okay. Next question. Please. Kevin 1 moment.

Taylor Hanlon: Hi, this is Taylor Hanlon for Chris Schott. Thank you so much for taking our question. We were just wondering, on Libtayo, can you provide any color on the drivers of performance this quarter? Was there anything one time in there? How much of this was driven by the new indication CSCC? Is this a good baseline to think about growing off of going forward? Thank you.

Our next question comes from Christopher shot with JP Morgan. Your line is open.

Taylor Handley on for Chris shot.

Speaker #16: There's been a lot of enthusiasm and certainly the clinical profile of LibTIO in this indication was highly distinguishing. We also see performance in our lung cancer indication.

Speaker #16: US and international performance are strong. I would characterize the quarter, though, by comparison to a year-over-year comparison in a quarter that had some movement in inventory.

Marion McCourt: Sure, very happy to take the question, and I think the Libtayo performance certainly is strong. I would characterize the strength based on certainly the advances that we've seen in our skin indications. Now with adjuvant CSCC, very exciting to help this group of patients with Libtayo. There's been a lot of enthusiasm and certainly the clinical profile of Libtayo in this indication was highly distinguishing. We also see performance in our lung cancer indication. US and international performance are strong. I would characterize the quarter though by comparison to a year-over-year comparison in a quarter that had some movement in inventory. We can certainly go back and share more of the details with you on that, but very strong quarter, but there is some comparison that favored this quarter.

Marion McCourt: Sure, very happy to take the question, and I think the Libtayo performance certainly is strong. I would characterize the strength based on certainly the advances that we've seen in our skin indications. Now with adjuvant CSCC, very exciting to help this group of patients with Libtayo. There's been a lot of enthusiasm and certainly the clinical profile of Libtayo in this indication was highly distinguishing. We also see performance in our lung cancer indication. U.S. and international performance are strong. I would characterize the quarter though by comparison to a year-over-year comparison in a quarter that had some movement in inventory. We can certainly go back and share more of the details with you on that, but very strong quarter, but there is some comparison that favored this quarter.

Um, thank you so much for taking our question. Uh, we were just wondering on lip tile. Can you provide any color on the drivers of performance this quarter? Um was there anything 1 time in there? Uh how much of this was driven by the new indication cscc? And is this a um a good Baseline to think about growing off of going forward. Thank you.

Speaker #16: We can certainly go back and share more of the details with you on that. But very strong quarter. But there is some comparison that favored this quarter.

Speaker #4: Thanks, Mary. And next question, please.

Speaker #7: One moment.

Speaker #4: Our next question comes from David Reisinger with Leering Partners. Your line is open.

Speaker #17: Yes. Excuse me. Thanks very much. So hi, Len and George. My question is for you. So Regeneron spends aggressively on R&D, but the investment community lacks confidence that the company's candidates will move the needle commercially, in particular versus established competitors.

So sure, very happy to take the question. And I think the libtayo performance certainly is strong. I would, um, characterize the strength based on. Certainly, the advances that we've seen in our our skin indications. Now, with addivon cscc, very exciting to help this group of patients, um, with libtayo. There's been a lot of enthusiasm and certainly the clinical profile of lipio. And this indication was was highly distinguishing. We also see performance, um, in our lung cancer indication. Um, us and international performance are strong. I would characterize the quarter, though, by comparison to a year-over-year comparison in a quarter that had, um, some movement in inventory, we can certainly go back and share more of the details with you on that, but um, it's very strong quarter. But there is some comparison in the favored this quarter

Marion McCourt: Thanks, Mary. Next question, please.

Ryan Crowe: Thanks, Mary. Next question, please.

Operator: One moment. Our next question comes from David Risinger with Leerink Partners. Your line is open.

Thanks, Mary. And next question, please. One moment.

Speaker #17: So could you please highlight the pipeline candidates in late-stage development that will have cards turning over in the near term or relative near term?

Our next question comes from David Risinger with the ring Partners. Your line is open.

David Risinger: Yes, excuse me. Thanks very much. Hi, Len and George. My question is for you. Regeneron spends aggressively on R&D, but the investment community lacks confidence that the company's candidates will move the needle commercially, in particular versus established competitors. Could you please highlight the pipeline candidates in late-stage development that will have cards turning over in the near term, or relative near term, i.e. in the next, I don't know, 18 months or so, that you have the greatest confidence in that can generate multi-billion dollar peak sales that investors will be able to see more clearly in the next 18 months or so? Thank you very much.

Yes. Uh,

Speaker #17: I.e., in the next - I don't know - 18 months or so that you have the greatest confidence in that can generate multibillion-dollar peak sales that investors will be able to see more clearly in the next 18 months or so?

Speaker #17: Thank you very much.

Speaker #3: It's perhaps the most penetrating in the 160-odd conference calls I've done. Penetrating in detailed question, but unfortunately, David, it'll probably take several hours to answer.

Excuse me. Uh, thanks very much. Uh so uh hi uh Lennon George. Uh my question is for you. So regeneron spends aggressively on R&D but the investment Community lacks confidence. That the company's candidates will move the needle, commercially in particular versus uh established competitors.

Speaker #3: We have a robust pipeline we do have obviously highlighting the C5 franchise. We'll have more data and an approval action. We will have 11, I think, phase three trials ongoing in our anticoagulation program, which is a massive opportunity.

so, could you, please highlight the pipeline candidates in late stage development that, uh, will have cards turning over in the near term um or relative near-term IE in the next

Speaker #3: We have our linezipic and our OGENextimab, our bispecifics in myeloma and lymphoma ongoing. I think George just talked about our OLA plus an OLA plus ALI as a near term.

Leonard Schleifer: That's perhaps the most penetrating in the 160 odd conference calls I've done, penetrating and detailed question. Unfortunately, David, it will probably take several hours to answer. We have a robust pipeline. We do have obviously, highlighting the C5 franchise, where we will have more data and an approval action. We will have 11, I think, phase 3 trials ongoing in our anticoagulation program, which is a massive opportunity. We have our linvoseltamab and our odronextamab, our bispecifics in myeloma and lymphoma ongoing. I think George just talked about our OlaPlus and OlaPlus Ali as a near term. Obviously even in this quarter we have fianlimab plus Libtayo in metastatic melanoma. Maybe that, I will leave that for openers. But we...

Generate multi-billion dollar Peak sales that investors will be able to uh see more clearly in the next 18 months or so. Thank you very much.

Speaker #3: And obviously, even in this quarter, we have phenylimab plus LibTIO and metastatic melanoma. So maybe that I'll leave that for openers. But we have more and more things.

Speaker #3: We've got some exciting data coming out that we haven't even talked about. And I didn't just mention. So lots going on when you have 48 exciting things in development.

Speaker #4: And Kevin, can I just say, I mean, I want to comment that past performance should be the strongest indicator of future performance. There's only one company in recent history that I have its own labs produce two $10 billion plus blockbusters.

It's uh, perhaps the most penetrating, uh, in the 160, odd conference calls I've done, uh, penetrating in in detailed question. But, unfortunately, David, it'll probably take several hours to answer. We have a robust pipeline. Um, we do have obviously highlighting the C5 franchise where we'll have more data and an approval action. We we will have 11. I think phase 3 trials, ongoing in our anti-coagulation program, which is a massive opportunity. We have our limited, uh, and our, uh, uh, OG next toab, or by specifics in myeloma and Lymphoma ongoing. Um, I think, uh, George just talked about, uh, our Ola plus, uh, an Ola plus Ali as a near-term. And obviously, even in this quarter, we have the the animal map plus with Tio and metastatic, uh, melanoma. So we maybe that I'll leave that for openers.

Leonard Schleifer: We have more and more things, but we've got some exciting data coming out that we haven't even talked about, and that I didn't just mention. Lots going on when you have 48 exciting things in development.

Speaker #4: And let me remind you that I think you and probably a lot of other investors never saw those coming. Or ignored what we were saying about them.

Speaker #4: So I think that investor confidence, I think, should in large part be reflecting historical performance. And the recognition that we're blockbusters come from sometimes for the investor community can't be directly anticipated.

George Yancopoulos: I mean, I wanna comment that past performance should be the strongest indicator of future performance. There's only one company in recent history that of its own labs produced two $10 billion plus blockbusters. Let me remind you that I think you and probably a lot of other investors never saw those coming or ignored, you know, what we were saying about them. I think that investor confidence, I think, should in large part be reflecting, you know, historical performance and the recognition that where blockbusters come from sometimes for the investor community can't be directly anticipated. The best way of producing very important big drugs is by having very exciting molecules across all stages of development that have enormous opportunity.

Uh, and—but we, and we have more and more things that—we've got some, some exciting data coming out, uh, that we haven't, uh, even talked about, um, and I didn't just mention. So, uh, lots going on. When you have 48 exciting things in development—can I, can I just say? I mean, I—I, uh,

Speaker #4: And the best way of producing very important big drugs is by having very exciting molecules across all stages of development that have enormous opportunity and, if you just look at our oncology programs, whether it's phenyl and LibTIO, whether you look at linezipic, whether you also look at OGENextimab in follicular lymphoma, these are all potential blockbusters.

Want to comment that past performance should be the strongest indicator of the future performance. There's only 1 company in uh recent history that I have its own Labs, produced 2 101. Let me remind you that I think you and and probably a lot of other investors never saw those coming uh or ignored, you know, uh, what we were saying about them. So so I think that um,

Speaker #4: The C5 franchise is a pipeline in a franchise multiple blockbuster opportunities there are factor 11 customized approaches are looking more and more exciting, especially based on competitor data, using, we think, inferior and less convenient approaches.

Speaker #4: And we just covered the obesity opportunity which arguably could become the preferred obesity approach that not only addresses obesity but more aggressively addresses cardiovascular morbidity.

George Yancopoulos: If you just look at our oncology programs, whether it's fianlimab, Libtayo, whether you look at linvoseltamab, whether you also look at odronextamab in follicular lymphoma, these are all potential blockbusters. The C5 franchise is a pipeline in a franchise. Multiple blockbuster opportunities there. Our factor eleven customized approaches are looking more and more exciting, especially based on competitor data, using, we think, inferior and less convenient approaches. We just covered the obesity opportunity, which arguably, you know, could become the preferred obesity approach that not only addresses obesity, but more aggressively addresses cardiovascular morbidity. I don't know, it's hard to think of a more exciting pipeline in the entire industry.

Investor confidence, I think uh should should in large part, be reflecting uh, you know, historical performance, and the recognition that. Uh, we're Blockbusters come from sometimes for the investor Community. Um, can't be directly anticipated. And the best way of producing very important, big drugs is by having very exciting molecules across all stages of development, uh, that have, uh, enormous opportunity. Uh, and if you just look at our oncology programs, whether it's the analytical, whether you can Leno ific, whether you also look at,

Speaker #4: So I don't know. It's hard to think of a more exciting pipeline in the entire industry. Thanks, Len and George. We have time for two more questions,

Speaker #7: One moment.

Speaker #4: Our next question comes from Jeff Meacham with City. Your line is open.

Speaker #18: Hey, guys. Good morning. Thanks for the question. On phenylimab and lung, I just wanted to see if you guys can give us a bit more context for not moving to phase three.

Speaker #18: Maybe what was observed in the data and from a tolerability perspective? Are there any read-through to melanoma or broader solid tumor in terms of strategy?

Speaker #18: Thank you. Yeah. I think that we've been talking about this for a long time. I mean, we never indicated that we were excited about this opportunity.

Ryan Crowe: Thanks, Len and George. We have time for two more questions, Kevin.

Ojo. Next toab in in follicular lymphoma. These are all potential Blockbusters. The C5 franchise is, is a pipeline. In a, in a, in a franchise, multiple Blockbuster opportunities, there are factor, 11, customized approaches, are looking more and more exciting especially based on competitive data, uh, using we think, uh, inferior and less convenient approaches and we just covered the Obesity opportunity. Which arguably, you know, um, could become the uh, the preferred. Um, obesity approach that not only addresses obesity but uh more aggressively addresses, uh, cardiovascular morbidity. So, I know it's hard to think of a more exciting pipeline in the entire industry.

Operator: One moment. Our next question comes from Geoffrey Meacham with Citi. Your line is open.

Thanks, Len and George. We have time for two more questions. Kevin, one moment.

Speaker #18: Our data from earlier stage studies was always pointing us to the melanoma opportunity, once we see that data, it'll certainly guide our thinking forward.

Geoffrey Meacham: Hey, guys. Good morning. Thanks for the question. On fianlimab and lung, I just wanted to see if you guys can give us a bit more context for not moving to phase three, maybe what was observed in the data and from a tolerability perspective, is there any read-through to melanoma or broader solid tumor in terms of strategy? Thank you.

Our next question comes from Jeff Mitchum with City, your line is open.

Speaker #18: And in terms of going into additional cancer settings as well. But as we've been saying for a while, we never had any reason to really believe that this was going to be a game changer in the lung cancer space.

Hey guys. Good morning. Uh, thanks for the question. Um, on uh, fee and lamb and and lung. I just wanted to see if you guys can give us a bit more context for for not moving to to phase 3, maybe what was observed in the data? And

Speaker #18: And Jeff, there's no negative read-through for any new side effects or anything unanticipated.

From a tolerability perspective. Is there any read through to melanoma or broader solid tumor? Uh, in terms of strategy? Thank you.

George Yancopoulos: Yeah, I think that we've been talking about this for a long time. I mean, we never indicated that we were excited about this opportunity. Our data from earlier stage studies was always pointing us to the melanoma opportunity. Once we see that data, it'll certainly guide our thinking forward and in terms of going into additional cancer settings as well. As we've been saying for a while, we never had any reason to really believe that this was gonna be a game changer in the lung cancer space.

Speaker #4: Great. Thanks, Len and George. Last question, please, Kevin.

Speaker #7: One moment.

Speaker #4: Our last question comes from Brian Abrams with RBC Capital Markets. Your line is open.

Speaker #19: Hey, good morning. Thanks for taking my question. We were intrigued by the inclusion of milder patients in your long-acting IL-13 study versus contemporary AD trials.

Leonard Schleifer: Jeff, there's no negative read-through for any, from any new side effects or anything unanticipated.

Speaker #19: So I was wondering if you could talk about the potential untapped opportunity for systemic biologics here and the degree to which you can broaden the market even beyond where Gupi is used now.

Leonard Schleifer: Jeff, there's no negative read-through for any, from any new side effects or anything unanticipated.

Ryan Crowe: Great. Thanks, Len and George. Last question please, Kevin.

Yeah, I think that we've been talking about this for a long time, I mean, we never indicated that we were excited about this opportunity. Our data from earlier stage studies was always pointing us to the melanoma opportunity once we see that data. It will certainly guide, um, our thinking, uh, forward, and in terms of going into additional cancer settings as well. But as we've been saying for a while, we never had any reason to really believe uh that this was going to be a GameChanger in the lung cancer space. And and and uh, and Jeff. There's no negative read through for any from any new side effects. Anything unanticipated.

Speaker #19: Thanks.

Speaker #20: Just certainly in patients with mild disease, there's a lot of unmet needs. This is a potential area for greater understanding and advance for treatment.

Operator: One moment. Our last question comes from Brian Abrahams with RBC Capital Markets. Your line is open.

Great thanks. Len and George. Uh last question please Kevin 1 moment.

Speaker #20: I think we'll have to wait and take a look at clinical profile and opportunities and determine from there. But it is a large population and when the patient or the parent of the child with mild disease, it really isn't mild.

Brian Abrahams: Hey, good morning. Thanks for taking my question. We were intrigued by the inclusion of milder patients in your long-acting IL-13 study versus contemporary AD trial. I was wondering if you could talk about the potential untapped opportunity for systemic biologics here and the degree to which you can broaden the market even beyond where Dupixent is used now. Thanks.

RBC Capital markets, your line is open.

Speaker #20: It's aggravating. It's difficult. And certainly, there's a lot of unmet need and potential.

Speaker #18: Yeah. And I have to say, there was certainly in the early days a bias by investigators and the agency against using "a powerful biologic".

Uh, hey, good morning. Thanks for taking my question. Um, we were intrigued by the inclusion of milder patients in your long-acting il13 study versus contemporary, uh, add trial. So, I was wondering if you could talk about the potential untapped opportunity for systemic biologics here, and the degree to, which you can broaden the market even Beyond where dupies use now. Thanks,

Marion McCourt: Certainly in patients with mild disease, there's a lot of unmet needs. This is a potential area for greater understanding and advance for treatment. I think we'll have to, you know, wait and take a look at clinical profile and opportunities and determine from there. It is a large population and, when the patient or the, you know, the parent of the child with mild disease, it really isn't mild. It's very aggravating, it's difficult, and certainly there's a lot of unmet need and potential.

Speaker #18: It could be immunosuppressive. Remember, we didn't find it to be immunosuppressive. In fact, in the moderate to severe cases of atopic dermatitis, we actually saw less infections in patients who had skin lesions healing.

Speaker #18: It is not immunosuppressive on the side of the immune access, which deals with the kind of infections that people were used to with biologics.

Leonard Schleifer: Yeah. I have to say there was certainly in the early days a bias, by investigators and the agency against using, quote-unquote, "a powerful biologic." It could be immunosuppressive. Remember, we didn't find it to be immunosuppressive. In fact, in the moderate to severe cases of atopic dermatitis, we actually saw less infections in patients who had skin lesions healing. It is not immunosuppressive on the side of the immune axis, which deals with the kind of infections that people are used to with biologics, or might be with some of the orals that suppress both arms of the immune system. As George has talked many times, the type two immunity is not something, we rely on to keep us healthy from infections.

Certainly in patients with mild disease, there's a lot of unmet needs. This is a potential area for greater understanding and advanced for, uh, for treatment. I think we'll have to, you know, wait and take a look at clinical profile and opportunities, and determine from there, but, um, it is a large population. And, um, when the patient or the, you know, the, the parent of the child with mild disease, it really isn't mild. It's very, it's aggravating, it's difficult. And certainly there's a lot of unmet need and potential.

Speaker #18: Or might be with some of the orals that suppress both arms of the immune system as George is talking many times. The type 2 immunity is not something we rely on to keep us healthy from infections.

Speaker #18: It might play some role in parasitic infections. But you've got so many people having been treated now. And now thinking about going earlier makes some sense.

Speaker #4: All right. That's all the time we have for today. Thanks to everyone who dialed in for your interest in REGENERON. We apologize to those folks remaining in the Q&A queue who did not have a chance to hear from today.

Yeah, and I, I have to say there was certainly in the early days of bias by investigators, and the agency against using quote unquote, a powerful biologic. Um, it could be immunosuppressive, remember we need to find it to be immunosuppressive. In fact, in the monitor to severe cases of of any type of dermatitis, we actually saw less infections in patients who had skin lesions healing. Um, it is not immunosuppressive on the, on the, on the side of the immune access, which deals with the kind of infections that people who used to it by,

Speaker #4: As always, the investor relations team here at REGENERON is available to answer any remaining questions you may have. Thank you once again and have a great day.

Speaker #7: Thank you, ladies and gentlemen. So let's conclude today's presentation. We thank you for your participation. You may now disconnect and have a wonderful day.

Leonard Schleifer: It might play some role in parasitic infections, but you've got so many people having been treated now, and now thinking about going earlier makes some sense.

Ryan Crowe: All right. That's all the time we have for today. Thanks to everyone who dialed in for your interest in Regeneron. We apologize to those folks remaining in the queue who we did not have a chance to hear from today. As always, the investor relations team here at Regeneron is available to answer any remaining questions you may have. Thank you once again, and have a great day.

Logics or it might be with some of the orals that suppress both arms of the immune system as George's talked. Many times, the type 2 immunity is not something. Uh, we rely on to keep us healthy from infections. Um, it might play some role in in parasitic infections or you've got so many people having been treated now. Uh, and now thinking about going earlier, makes some sense.

Operator: Thank you, ladies and gentlemen. This concludes today's presentation. We thank you for your participation. You may now disconnect and have a wonderful day.

All right, that's all the time we have for today. Thanks to everyone who dialed in for your interest in Regeneron. We apologize to those folks remaining in the Q&A queue who did not have a chance to hear from us today. As always, the Investor Relations team or general is available to answer any remaining questions you may have. Thank you once again and have a great day.

Thank you, ladies and gentlemen. This include today's presentation, we thank you for your participation. You may now disconnect and have a wonderful day.

Q1 2026 Regeneron Pharmaceuticals Inc Earnings Call

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