Q2 2025 Regeneron Pharmaceuticals Inc Earnings Call

August 1, 2025

It depends on a listen only mode. Later, we will conduct a question and answer session. Please note that this conference call is being recorded I will now turn the call over to Ryan Crow Senior Vice President Investor Relations you may begin.

So on a listen only mode. Later, we will conduct a question and answer session.

Note that this conference call is being recorded I will now turn the call over to Ryan Crow Senior Vice President Investor Relations you may begin.

Note that this conference call is being recorded I will now turn the call over to Ryan Crow Senior Vice President of Investor Relations you may begin.

Thank you Shannon good morning, good afternoon, and good evening to everyone listening around the world. Thank you for your interest in Regeneron and welcome to our second quarter 2025 earnings Conference call, an archive and transcript of this call will be available on the Regeneron Investor Relations website. Shortly after our call concludes.

Thank you Dan and good morning, good afternoon, and good evening to everyone listening around the world. Thank you for your interest in Regeneron and welcome to our second quarter 2025 earnings Conference call, an archive and transcript of this call will be available on the Regeneron Investor Relations website. Shortly after our call concludes.

Marion McCourt: To Marion, thank you, George. Our second quarter performance highlights the strength and resiliency of Regeneron's commercial portfolio, demonstrating our ability to deliver important medicines to patients. We are well positioned to drive growth, fully realizing the potential of our leading brands and capitalizing on emerging opportunities. Recent launches include Linvoseltamab, our first hematology product in the US as well as two DUPIXENT dermatology launches in chronic spontaneous urticaria and bullous pemphigoid, further expanding its therapeutic reach. Our robust pipeline also provides substantial opportunities to bring transformative treatments to even more patients, starting with EYLEA HD and EYLEA. In the second quarter, total combined US net sales were $1.15 billion, maintaining our leading position in the anti-VEGF category, notably EYLEA HD. US net sales grew to $393 million driven by strong unit demand which increased 16% sequentially, making EYLEA HD the fastest growing innovative brand in the category.

Joining me on today's call are Dr. Leonard Schleifer Board Codeshare co founder President and Chief Executive Officer.

Marion McCourt: Thank you, George. Our second quarter performance highlights the strength and resiliency of Regeneron's commercial portfolio, demonstrating our ability to deliver important medicines to patients. We are well positioned to drive growth, fully realizing the potential of our leading brands and capitalizing on emerging opportunities. Recent launches include Linvoseltamab, our first hematology product in the US as well as two DUPIXENT dermatology launches in chronic spontaneous urticaria and bullous pemphigoid, further expanding its therapeutic reach. Our robust pipeline also provides substantial opportunities to bring transformative treatments to even more patients, starting with EYLEA HD and EYLEA. In the second quarter, total combined US net sales were $1.15 billion, maintaining our leading position in the anti-VEGF category, notably EYLEA HD. US net sales grew to $393 million driven by strong unit demand which increased 16% sequentially, making EYLEA HD the fastest growing innovative brand in the category.

Joining me on today's call are Dr. Leonard Schleifer.

Joining me on today's call are Dr. Leonard Schleifer Board Co Chair co founder President and Chief Executive Officer.

Dr <unk>, Georgia Accomplice Board Codeshare co founder President and Chief Scientific Officer, Marion Mccourt Executive Vice President of commercial and Chris Fenimore Executive Vice President and Chief Financial Officer.

Co Chair co founder President and Chief Executive Officer Dr.

Welcome to Regeneron Pharmaceuticals' second quarter 2025 earnings conference call. My name is Shannon, and I will be your operator for today's call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session.

Dr. George <unk> Board Codeshare co founder President and Chief Scientific Officer, Marion Mccourt Executive Vice President of commercial and Chris spent a more executive Vice President and Chief Financial Officer.

Dr. George John accomplished Board Codeshare co founder President and Chief Scientific Officer, Marion Mccourt Executive Vice President of commercial and Chris Fenimore Executive Vice President and Chief Financial Officer.

Ryan Crowe: Thank you, Shannon. Good morning, good afternoon, and good evening to everyone listening around the world. Thank you for your interest in Regeneron Pharmaceuticals, and welcome to our second quarter 2025 earnings conference call. An archive and transcript of this call will be available on the Regeneron Pharmaceuticals 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 Chris 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 Pharmaceuticals.

Please note that this conference call is being recorded. I will now turn the call over to Ryan Crow, senior, vice president, investor relations. You may begin.

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 forecasts and guidance development programs and related anticipated milestones collaborations finances regulatory matters payer coverage and reimbursement intellectual.

After our prepared remarks, the remaining time will be available for Q&A.

Thank you Shannon. Good morning, good afternoon and good evening to everyone listening around the world. Thank you for your interest in regeneron and Welcome to our second quarter 2025 earnings conference call.

Can archive and transcript of this call will be available on the regeneron. Investor relations website shortly after our call. Concludes

The 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.

Joining me on today's call are Dr. Leonard Slifer, board co-chair, co-founder president and chief executive officer.

Pending litigation and other proceedings and competition.

Dr. George Yancopoulos, Young Couples Board, Co-Chair, Co-Founder, President, and Chief Scientific Officer.

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 <unk> filings with the United States Securities and Exchange Commission, including its Form 10-Q for the quarter ended June 32025, which was filed with the SEC. This morning.

Marion mccort Executive, Vice President of commercial and Chris fenmore, Executive Vice President and Chief Financial Officer.

Marion McCourt: EYLEA HD has a solid foundation for future growth and now contributes 1/3 of total combined US net sales of our retina products. Looking ahead, we expect stable demand and total potential inflection pending FDA approval of enhancement to EYLEA HD's profile. EYLEA's second quarter US net sales were $754 million, reflecting competitive dynamics from both branded and biosimilar competition as well as the ongoing conversion of patients to EYLEA HD. EYLEA unit demand declined 10% sequentially and we anticipate comparable demand decline in the second half of the year. Retina practices continue to report a negative impact on the branded anti-VEGF category due to ongoing funding gaps at not-for-profit patient assistance foundations that provide copay support for eligible patients with retina diseases. Next to DUPIXENT. In the second quarter.

EYLEA HD has a solid foundation for future growth and now contributes 1/3 of total combined US net sales of our retina products. Looking ahead, we expect stable demand and total potential inflection pending FDA approval of enhancement to EYLEA HD's profile. EYLEA's second quarter US net sales were $754 million, reflecting competitive dynamics from both branded and biosimilar competition as well as the ongoing conversion of patients to EYLEA HD. EYLEA unit demand declined 10% sequentially and we anticipate comparable demand decline in the second half of the year. Retina practices continue to report a negative impact on the branded anti-VEGF category due to ongoing funding gaps at not-for-profit patient assistance foundations that provide copay support for eligible patients with retina diseases. Next to DUPIXENT.

After our prepared remarks, the remaining time will be available for Q&A.

Ryan Crowe: Such statements may include but are not limited to those related to Regeneron Pharmaceuticals and its products and business, financial forecasting guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement, 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 Pharmaceuticals' filings with the United States Securities and Exchange Commission, including its Form 10-Q for the quarter ended June 30, 2025, which was filed with the SEC this morning. Regeneron Pharmaceuticals does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise.

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 information regarding our use of non-GAAP financial measures and a reconciliation of those measures to GAAP.

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 information regarding our use of non-GAAP financial measures and a reconciliation of those measures to GAAP is available in our quarterly results press release and our corporate presentation.

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 forecasting, guidance development programs and related, anticipated Milestones, collaborations finances regulatory matters, payer coverage and reimbursement, intellectual property pending litigation and other proceedings and competition.

<unk> is available in our quarterly results press release, and our corporate presentation, both of which can be found on the regeneron Investor Relations website.

Each forward-looking statement is subject to risk and uncertainty that could cause actual results and events to differ materially from those projected. In that statement,

<unk> is available in our quarterly results press release, and our 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.

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 Lend. Please go ahead. Thanks, Brian Thanks for you and everybody else who's joining todays call.

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 June 30th 2025 which was filed with the SEC this morning.

With that let me turn the call over to our President and Chief Executive Officer, Dr. Leonard Schleifer Lend. Please go ahead. Thanks, Ryan Thanks for you and everybody else who's joining todays call.

With that let me turn the call over to our President and Chief Executive Officer, Dr. Leonard Schleifer Lend. Please go ahead. Thanks.

In the second quarter, global net sales were $4.3 billion and grew 21% on a constant currency basis compared to the prior year. This growth was driven by broad demand across existing and recently launched indications, geographies, and age groups. In the US, DUPIXENT net sales were $3.2 billion, representing 23% year-over-year growth and continuing DUPIXENT's strong performance and market-leading position. DUPIXENT is a leader in new-to-brand and total prescriptions for seven of its eight FDA-approved indications, with our recently launched CSU indication being the only exception. In atopic dermatitis, DUPIXENT continues to strengthen its position as a standard of care. Competitor promotional spend has further accelerated overall market growth, and DUPIXENT remains the primary beneficiary of this expansion. Recent launches in chronic spontaneous urticaria and bullous pemphigoid are off to a fast start.

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 in our quarterly results press release and our corporate presentation, both of which can be found on the Regeneron Pharmaceuticals 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, please go ahead.

Marion McCourt: Global net sales were $4.3 billion and grew 21% on a constant currency basis compared to the prior year. This growth was driven by broad demand across existing and recently launched indications, geographies, and age groups. In the US, DUPIXENT net sales were $3.2 billion, representing 23% year-over-year growth and continuing DUPIXENT's strong performance and market-leading position. DUPIXENT is a leader in new-to-brand and total prescriptions for seven of its eight FDA-approved indications, with our recently launched CSU indication being the only exception. In atopic dermatitis, DUPIXENT continues to strengthen its position as a standard of care. Competitor promotional spend has further accelerated overall market growth, and DUPIXENT remains the primary beneficiary of this expansion. Recent launches in chronic spontaneous urticaria and bullous pemphigoid are off to a fast start.

Regeneron does not undertake any obligation to update, any forward-looking statements whether as a result of new information, future events or otherwise.

Ryan Thanks for you and everybody else who's joining today's call.

Kumar remarks today I will review some of our key performance drivers from the second quarter, then briefly discuss some pipeline advances we have made this year and close with some comments on our capital allocation principles.

In addition, please note that gaap and non-gaap financial measures will be discussed on today's call.

Kumar remarks today I will review some of our key performance drivers from the second quarter and then briefly discuss some pipeline advances we have made this year and close with some comments on our capital allocation principles.

I will then hand, the call over to George who will provide more details on our pipeline progress while also highlighting some exciting emerging data from leading cohorts for our pivotal programs in myeloma and lymphoma.

Information regarding our use of non-gaap financial measures and a Reconciliation of those measures to Gap is available in our quarterly results, press release. And our 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.

Leonard Schleifer: Thanks, Ryan. Thanks for you and everybody else who is joining today's call. For my remarks today, I will review some of our key performance drivers from the second quarter, then briefly discuss some pipeline advances we have made this year, and close with some comments on our capital allocation principles. I will then hand the call over to George Yancopoulos, who will provide more details on our pipeline progress while also highlighting some exciting emerging data from leading cohorts for our pivotal programs in myeloma and lymphoma. From there, Marion McCourt will review our commercial performance. Finally, Chris Fenimore will detail our quarterly financial results and provide an update on our 2025 financial guidance. Regeneron delivered a strong second quarter, driven by durable growth drivers across our commercial portfolio.

From their mailing will review, our commercial performance and finally, Chris will detail, our quarterly financial results and provide an update on our 2025 financial guidance.

From their marine will review, our commercial performance and finally, Chris will detail, our quarterly financial results and provide an update on our 2025 financial guidance.

Marine will review, our commercial performance and finally, Chris will detail, our quarterly financial results and provide an update on our 2025 financial guidance.

With that. Let me turn the call over to our president and chief executive officer, Dr. Leonard Schiffer Len, please go ahead. Thanks Ryan. Thanks for you and everybody else who's joining today's call.

<unk> delivered a strong second quarter, driven by durable growth drivers across our commercial portfolio.

General and delivered a strong second quarter, driven by durable growth drivers across our commercial portfolio worldwide net product sales have do picks it increased by 21% and lip tayo by 25% at constant exchange rates.

Marion McCourt: The CSU launch has gained significant traction with both dermatologists and allergists who are actively prescribing Dupixent and embracing it as a trusted and effective treatment option. The BP launch in late June has also provided another opportunity for Dupixent as the first and only FDA approved treatment for this debilitating disease. Early launch indicators have been positive with Dupixent as a critical therapeutic option for this previously underserved patient population. Dupixent's respiratory indications including COPD, asthma, and nasal polyps continue to drive growth. The COPD launch is progressing very well with rapid physician uptake turning to oncology and hematology. In the second quarter, LIBTAYO delivered global net sales of $377 million, growing 25% on constant currency basis compared to the prior year. In the US LIBTAYO net sales grew 36% year over year to $248 million, driven by growth across the non-melanoma skin and lung cancer indications.

The CSU launch has gained significant traction with both dermatologists and allergists who are actively prescribing Dupixent and embracing it as a trusted and effective treatment option. The BP launch in late June has also provided another opportunity for Dupixent as the first and only FDA approved treatment for this debilitating disease. Early launch indicators have been positive with Dupixent as a critical therapeutic option for this previously underserved patient population. Dupixent's respiratory indications including COPD, asthma, and nasal polyps continue to drive growth. The COPD launch is progressing very well with rapid physician uptake turning to oncology and hematology. In the second quarter, LIBTAYO delivered global net sales of $377 million, growing 25% on constant currency basis compared to the prior year. In the US LIBTAYO net sales grew 36% year over year to $248 million, driven by growth across the non-melanoma skin and lung cancer indications.

Worldwide net product sales have do picks it increased by 21% and lip tayo by 25% at constant exchange rates, while Eylea HD in the U S grew by 29% compared to the second quarter of last year.

Mops today, I will review some of our key performance drivers from the second quarter, then briefly discuss some pipeline advances. We have made this year and close with some comments on our Capital, allocation principles.

Worldwide net product sales had do picks it increased by 21% and lip tayo by 25% at constant exchange rates, while Eylea HD in the U S grew by 29% compared to the second quarter of last year.

Eylea HD in the U S grew by 29% compared to the second quarter of last year.

With respect to Eylea second quarter, 2025 U S. Net product sales were $754 million down 39% compared to the second quarter of last year sequentially compared to the first quarter of 2025 positioning unit demand declined by 10%, but net product sales were favorably impacted.

I will then hand the call over to George who will provide more details on our pipeline progress. While also highlighting some exciting emerging data, from leading cohorts for our pivotal programs in Myoma and Lymphoma,

Marion will review our commercial performance and, finally, Chris will detail our quarterly financial results and provide an update on our 2025 financial guidance.

Leonard Schleifer: Worldwide net product sales for DUPIXENT increased by 21% and LIBTAYO by 25% at constant exchange rates, while EYLEA HD in the U.S. grew by 29% compared to the second quarter of last year. With respect to EYLEA, second quarter 2025 U.S. net product sales were $754 million, down 39% compared to the second quarter of last year. Sequentially, compared to the first quarter of 2025, physician unit demand declined by 10%, but net product sales were favorably impacted by prior period inventory dynamics. We expect ongoing switches to EYLEA HD, competitive pressures, patient affordability issues, and pricing to continue to negatively impact EYLEA U.S. net product sales going forward. EYLEA HD had a very encouraging performance in the second quarter, with U.S. net product sales reaching $393 million, an all-time high, driven by a notable step up in physician unit demand.

By prior period inventory dynamics, we expect ongoing switches to eylea HD competitive pressures patient affordability issues and pricing to continue to negatively impact Eylea U S net product sales going forward.

We turned in a strong second quarter, driven by durable growth drivers across our commercial portfolio.

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Eylea H D had a very encouraging performance in the second quarter with U S. Net product sales, reaching $393 million, an all time high driven by a notable step up in physician unit demand.

Worldwide net product sales for Dupixent increased by 21% in liptil, and by 25% at constant exchange rates, while IA HD in the U.S. grew by 29% compared to the second quarter of last year.

Eylea H D had a very encouraging performance in the second quarter with U S. Net product sales, reaching $393 million, an all time high driven by a notable step up in physician unit.

Leah H D had a very encouraging performance in the second quarter with U S. Net product sales, reaching $393 million, an all time high driven by a notable step up in physician unit.

Marion McCourt: The quarter was also favorably impacted by the timing of customer shipments by approximately $20 million, which we expect to adversely impact Q3 US net product sales. We continue to see robust demand and market leadership LIBTAYO in non-melanoma skin cancer. We're encouraged by strong key opinion leader interest in the clinical results for our Adjuvant CSCC program. Regulatory applications were recently accepted in both the US and EU, and preparations are underway for a potential launch in the US later this year and in Europe in 2026.

The quarter was also favorably impacted by the timing of customer shipments by approximately $20 million, which we expect to adversely impact Q3 US net product sales. We continue to see robust demand and market leadership LIBTAYO in non-melanoma skin cancer. We're encouraged by strong key opinion leader interest in the clinical results for our Adjuvant CSCC program. Regulatory applications were recently accepted in both the US and EU, and preparations are underway for a potential launch in the US later this year and in Europe in 2026.

With respect to AIA, second quarter 2025 U.S. net product sales were $754 million, down 39% compared to the second quarter of last year.

Future product enhancements, including pre filled syringe administration and every four week dosing interval for approved indications and the addition of macular edema following retinal vein occlusion or RVO are expected to help further realized.

Future product enhancements, including pre filled syringe administration and every four week dosing interval for approved indications and the addition of macular edema. Following retinal vein occlusion or RVO are expected to help further realize eylea HD commercial opportunity.

Sequentially compared to the first quarter of 2025 position, unit demand declined by 10%. However, net product sales were favorably impacted by prior period inventory dynamics.

HD commercial opportunity. These early HD enhancement and so now likely to be delayed from the August 2025, <unk> date as a result of observations from an SDA General site inspection at the fill up for these regulatory applications cattle, Indiana LLC.

HD commercial opportunity. These earlier HD enhancements are now likely to be delayed from the August 2025, <unk> date as a result of observations from an SDA General site inspection at the filler for these regulatory applications cattle, Indiana LLC.

Ongoing switches to AIA HD, compellent, pressures patient, affordability issues and pricing, to continue to negatively impact aiyah us, net product sales going forward.

These early HD enhancement and so now likely to be delayed from the August 2025, <unk> date as a result of observations from an FDA General site inspection at the filler for these regulatory applications catalog, Indiana, LLC, which was recently acquired by Novo Nordisk.

Marion McCourt: If approved, LIBTAYO has the potential to help more than 10,000 patients and in the US and EU in this setting in lung cancer. LIBTAYO is steadily increasing new patient share in the US with more physicians prescribing LIBTAYO as a preferred treatment option for their patients and solidifying its position as the number two most prescribed IO treatment in newly diagnosed patients outside the US. LIBTAYO net sales reached $129 million, growing 8% year over year on a constant currency basis, supported by ongoing launches and sustained demand in international markets. Now to Linvoseltamab, which was FDA approved in July and relapsed refractory multiple myeloma, marking a significant milestone for Regeneron. Since then we've made early launch progress. Importantly, Linvoseltamab was already added to the NCCN treatment guidelines as a preferred product on par with other bispecifics in its class.

If approved, LIBTAYO has the potential to help more than 10,000 patients and in the US and EU in this setting in lung cancer. LIBTAYO is steadily increasing new patient share in the US with more physicians prescribing LIBTAYO as a preferred treatment option for their patients and solidifying its position as the number two most prescribed IO treatment in newly diagnosed patients outside the US. LIBTAYO net sales reached $129 million, growing 8% year over year on a constant currency basis, supported by ongoing launches and sustained demand in international markets. Now to Linvoseltamab, which was FDA approved in July and relapsed refractory multiple myeloma, marking a significant milestone for Regeneron. Since then we've made early launch progress. Importantly, Linvoseltamab was already added to the NCCN treatment guidelines as a preferred product on par with other bispecifics in its class.

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Leonard Schleifer: Future product enhancements, including prefilled syringe administration and every four-week dosing interval for approved indications, and the addition of macular edema following retinal vein occlusion, or RVO, are expected to help further realize the EYLEA HD commercial opportunity. These EYLEA HD enhancements are now likely to be delayed from their August 2025 PDUFA dates as a result of observations from an FDA general site inspection at the filler for these regulatory applications, Catalent Indiana LLC, which was recently acquired by Novo Nordisk AS. Prior to its acquisition, this site was owned and operated by Catalent Inc., a leading contract manufacturer that in their fiscal year 2024 produced nearly 70 billion unit doses and did business with the vast majority of the top biopharmaceutical companies in the world. This inspection was completed in mid-July and was not specific to EYLEA HD.

IA HD had a very encouraging performance in the second quarter, with net product sales reaching $393 million, an all-time high, driven by a notable step up in physician unit demand.

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Two its acquisition. This site was owned and operated by Cadillac, Inc. A leading contract manufacturer.

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Prior to its acquisition. This site was owned and operated by <unk>, Inc.

Two its acquisition. This site was owned and operated by catalyst Inc. A leading contract manufacturer that in the fiscal year 2024 produced nearly 70 billion unit doses and did business with the vast majority of the top biopharmaceutical companies in the world.

Fiscal year 2024 produced nearly 70 billion unit doses and did business with the vast majority of the top biopharmaceutical companies in the world.

Leaving contract manufacturer.

<unk> 2024 produced nearly 70 billion unit doses and did business with the vast majority of the top biopharmaceutical companies in the world.

Future product enhancements, including pre-filled syringe Administration and every 4 week dosing interval for Approved indications and the addition of macular edema filing retinal vein occlusion or rvo are expected to help further realize the Ia HD commercial opportunity.

This inspection was completed in mid July and was not specific to Eylea HD.

Novo has been in communication with the FDA and expect to file its comprehensive and robust response next week.

Based on our review of the observation and Novo's proposed response, along with the progress we have made with ultimate third party fillers.

These are Leah HD enhancements are now likely to be delayed from their August 2025 Purdue for dates as a result of observations from an FDA General site. Inspection at the filler for these regulatory applications Catalan Indiana, LLC, which was recently acquired by Novo Nordisk as

Marion McCourt: Key opinion leaders recognize Linvoseltamab's potential to be best-in-class BCMA bispecific based on its impressive clinical efficacy, safety, and convenient response-adapted dosing. At this stage, we expect modest revenue contributions in the second half of 2025 as physicians must satisfy REMS requirements before administering Linvoseltamab, and formulary and pathway decisions need to be made. As George highlighted, Regeneron is advancing Linvoseltamab into earlier lines of therapy through our differentiated development program, aiming to establish Linvoseltamab as a leading agent in the rapidly growing $30 billion market for multiple myeloma and precursor conditions. In summary, the quarter has been defined by growth across EYLEA HD, DUPIXENT, and LIBTAYO, as well as important progress in several launches including Linvoseltamab. Our commercial portfolio is well positioned to capitalize on many near-term growth opportunities enabling us to deliver treatments to more patients. And with that, I'll turn the call.

Key opinion leaders recognize Linvoseltamab's potential to be best-in-class BCMA bispecific based on its impressive clinical efficacy, safety, and convenient response-adapted dosing. At this stage, we expect modest revenue contributions in the second half of 2025 as physicians must satisfy REMS requirements before administering Linvoseltamab, and formulary and pathway decisions need to be made. As George highlighted, Regeneron is advancing Linvoseltamab into earlier lines of therapy through our differentiated development program, aiming to establish Linvoseltamab as a leading agent in the rapidly growing $30 billion market for multiple myeloma and precursor conditions. In summary, the quarter has been defined by growth across EYLEA HD, DUPIXENT, and LIBTAYO, as well as important progress in several launches including Linvoseltamab. Our commercial portfolio is well positioned to capitalize on many near-term growth opportunities enabling us to deliver treatments to more patients. And with that, I'll turn the call to Chris.

Based on our review of the observation and Novo has proposed response along with the progress we have made with ultimate third party fillers, we anticipate an expeditious resolution of filling issues for Eylea HD.

Based on our review of the observation and Novo's proposed response, along with the progress we have made with alternate third party fillers, we anticipate an expeditious resolution of filling issues for Eylea HD.

We anticipate an expeditious resolution of filling issues for Eylea HD.

The BLA for <unk> bi specific antibody targeting CB, <unk> and CB <unk> III for relapsed refractory Follicular lymphoma was also impacted by the catalog, Indiana LLC site inspection and resulted in the FDA issuing HCR route earlier this week.

The BLA for <unk>, a bi specific antibody targeting <unk> and <unk> for relapsed refractory Follicular lymphoma was also impacted by the catalog, Indiana LLC site inspection and resulted in the FDA issuing HCR route earlier this week.

The BLA for <unk>, a bi specific antibody targeting <unk> and <unk> for relapsed refractory Follicular lymphoma was also impacted by the Cadillac, Indiana LLC site inspection and resulted in the FDA issuing a CR route earlier this week.

Prior to its acquisition, this site was owned and operated by cattle and Inc, a leading contract manufacturer that in their fiscal year. 2024 produced nearly 70 billion unit Doses and did business with the vast majority of the top bio pharmaceutical companies in the world.

Leonard Schleifer: Regeneron has been in communication with the FDA and expects to file its comprehensive and robust response next week. Based on our review of the observation and Regeneron's proposed response, along with the progress we have made with alternate third-party fillers, we anticipate an expeditious resolution of our filling issues for EYLEA HD. The BLA for ojemarximab, a bispecific antibody targeting CD20 and CD3 for relapsed refractory follicular lymphoma, was also impacted by the Catalent Indiana LLC site inspection and resulted in the FDA issuing a CRL earlier this week. Moving to DUPIXENT, second quarter 2025 global net product sales were $4.3 billion, up 21% on a constant currency basis versus the second quarter of 2024. Now annualizing at over $17 billion, DUPIXENT global growth continues across all approved indications in all approved age groups and across geographic regions.

This inspection was completed in mid, in mid July and was not specific to Aliyah HD.

Moving to depicts at second quarter of 2025 global net product sales were $4 3 billion up 21% on a constant currency basis versus the second quarter of 2024.

Novo has been in communication with the FDA and expects to file. Its comprehensive and robust response next week.

Moving to depicts at second quarter of 2025 global net product sales were $4 3 billion up 21% on a constant currency basis versus the second quarter of 2024.

Depicts at second quarter of 2025 global net product sales were $4 3 billion up 21% on a constant currency basis versus the second quarter of 2024 now.

Now annualized at over $17 billion to pixel global growth continues across all approved indications in all approved age groups and across geographic regions.

Now annualized at over $17 billion to pick some global growth continues across all approved indications in all approved age groups and across geographic regions.

Based on our review of the observation and no votes proposed response, along with the progress we have made with alternate third-party fillers, we anticipate an expeditious resolution of our filling issues for Aliyah HD.

In the U S depicts net product sales grew 23% to the second quarter of last year and continues its leadership position in both new to brand prescription share and total prescription share across all indications approved prior to this year.

Chris Fenimore: 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. Regeneron's second quarter results demonstrate the strength of our commercial portfolio, which enables us to continue investing in our robust pipeline and returning capital to shareholders. Second quarter 2025 total revenues of $3.7 billion grew 4% compared to the prior year, reflecting higher Sanofi collaboration revenue primarily driven by DUPIXENT, higher US net sales of EYLEA HD, and growth in global net sales of LIBTAYO. Second quarter diluted net income per share grew 12% from the prior year to $12.89 on net income of $1.4 billion. Beginning with the Sanofi collaboration, revenues were approximately $1.4 billion, of which $1.3 billion related to our share of collaboration profits.

In the U S depicts the net product sales grew 23% to the second quarter of last year and continues its leadership position in both new to brand prescription share and total prescription share across all indications approved prior to this year.

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's second quarter results demonstrate the strength of our commercial portfolio, which enables us to continue investing in our robust pipeline and returning capital to shareholders. Second quarter 2025 total revenues of $3.7 billion grew 4% compared to the prior year, reflecting higher Sanofi collaboration revenue primarily driven by DUPIXENT, higher US net sales of EYLEA HD, and growth in global net sales of LIBTAYO. Second quarter diluted net income per share grew 12% from the prior year to $12.89 on net income of $1.4 billion. Beginning with the Sanofi collaboration, revenues were approximately $1.4 billion, of which $1.3 billion related to our share of collaboration profits.

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In the second quarter of 2025, global net product sales were $4.3 billion, up 21% on a constant currency basis compared to the second quarter of 2024.

Leonard Schleifer: In the U.S., DUPIXENT net product sales grew 23% to the second quarter of last year and continues its leadership position in both new-to-brand prescription share and total prescription share across all indications approved prior to this year. Over the past 10 months, three new indications, chronic obstructive pulmonary disease, or COPD, chronic spontaneous urticaria, or CSU, and bullous pemphigoid, or BP, were approved by the FDA, enabling DUPIXENT to potentially treat more than 600,000 additional biologic eligible patients. These approvals bring the total addressable population for DUPIXENT in the U.S. to over 4 million patients, of which only a small fraction are being actively treated, positioning DUPIXENT to remain a strong growth driver over the near, medium, and long term. Global LIBTAYO net product sales grew 25% on a constant currency basis compared to the second quarter of last year and are now annualizing at $1.5 billion.

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Chris Fenimore: Regeneron share of profits grew 30% versus the prior year, driven by volume growth through DUPIXENT and improving collaboration margins. The Sanofi development balance was approximately $1.2 billion at the end of the second quarter, reflecting a reduction of approximately $430 million since the start of the year. We continue to expect the balance to be fully reimbursed by the end of the year. Moving to Bayer, second quarter net sales of EYLEA and EYLEA HD outside the US were $978 million, up 4% versus the prior year on a constant currency basis and inclusive of $242 million of EYLEA HD sales. Total Bayer collaboration revenue grew 11% to $415 million, of which $383 million related to our share of net profits outside the US. Other revenue in the second quarter was $184 million.

Regeneron share of profits grew 30% versus the prior year, driven by volume growth through DUPIXENT and improving collaboration margins. The Sanofi development balance was approximately $1.2 billion at the end of the second quarter, reflecting a reduction of approximately $430 million since the start of the year. We continue to expect the balance to be fully reimbursed by the end of the year. Moving to Bayer, second quarter net sales of EYLEA and EYLEA HD outside the US were $978 million, up 4% versus the prior year on a constant currency basis and inclusive of $242 million of EYLEA HD sales. Total Bayer collaboration revenue grew 11% to $415 million, of which $383 million related to our share of net profits outside the US. Other revenue in the second quarter was $184 million.

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Leonard Schleifer: In the U.S., where net product sales grew 16%, LIBTAYO continues to be the market-leading immunotherapy for advanced non-melanoma skin cancers while building share in the lung cancer market. We are looking forward to the FDA decision and potential launch later this year of LIBTAYO in a high-risk adjuvant cutaneous squamous cell carcinoma, where LIBTAYO has the potential to become the standard of care. If approved, LIBTAYO will be the first and only PD-1 antibody for this setting and would represent a significant advance for the up to 10,000 addressable patients in the U.S. who could benefit from this treatment. Moving to our pipeline, which now includes approximately 45 product candidates in various stages of clinical development, we continue to make significant investments in R&D that have yielded notable progress across several key programs so far this year, which George Yancopoulos will discuss in just a moment.

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Global Lipton net product sales grew 25% on a constant currency basis compared to the second quarter of last year and are now annualizing at $1.5 billion in the U.S.

Chris Fenimore: This included $118 million of profit share and royalties associated with license agreements, which were up 70% from the prior year. This increase was driven by growth in our share of profits from ARCALYST and higher royalty income from EYLEA. Now to our operating expenses. R&D expense was $1.3 billion in the second quarter, reflecting continued investments to support Regeneron's innovative mid- to late-stage pipeline, including our obesity, hematology, and thrombosis efforts. Second quarter SG&A was $542 million, down 19% from the prior year. The decline was driven by lower general and administrative expenses. Second quarter 2025 gross margin on net product sales was 86%. The lower gross margin versus the prior year reflects ongoing investments to support our manufacturing operations and higher inventory write-offs in the second quarter of 2025.

This included $118 million of profit share and royalties associated with license agreements, which were up 70% from the prior year. This increase was driven by growth in our share of profits from ARCALYST and higher royalty income from EYLEA. Now to our operating expenses. R&D expense was $1.3 billion in the second quarter, reflecting continued investments to support Regeneron's innovative mid- to late-stage pipeline, including our obesity, hematology, and thrombosis efforts. Second quarter SG&A was $542 million, down 19% from the prior year. The decline was driven by lower general and administrative expenses. Second quarter 2025 gross margin on net product sales was 86%. The lower gross margin versus the prior year reflects ongoing investments to support our manufacturing operations and higher inventory write-offs in the second quarter of 2025.

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Chris Fenimore: Our effective tax rate in Q2 was 8.3% inclusive of a favorable settlement of an IRS audit which lowered our tax rate by approximately 4 percentage points. Regeneron generated $1.7 billion in free cash flow through H1 2025 and ended the quarter with cash and marketable securities of $17.5 billion and debt of approximately $2.7 billion. We repurchased approximately $1.1 billion worth of our shares in Q2 and approximately $2.2 billion so far in 2025, resulting in a net reduction in our common shares outstanding of 3.2 million shares from the end of 2024, with approximately $2.8 billion still available for share repurchases as of 30 June. We remain opportunistic buyers of our shares.

Our effective tax rate in Q2 was 8.3% inclusive of a favorable settlement of an IRS audit which lowered our tax rate by approximately 4 percentage points. Regeneron generated $1.7 billion in free cash flow through H1 2025 and ended the quarter with cash and marketable securities of $17.5 billion and debt of approximately $2.7 billion. We repurchased approximately $1.1 billion worth of our shares in Q2 and approximately $2.2 billion so far in 2025, resulting in a net reduction in our common shares outstanding of 3.2 million shares from the end of 2024, with approximately $2.8 billion still available for share repurchases as of 30 June. We remain opportunistic buyers of our shares.

We also expect to make a decision on next steps for a pet command and COPD.

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Several differentiated early clinical and preclinical programs spanning hematology genetic medicines ophthalmology oncology and immunology represent an exciting next wave of innovations at regeneron.

Leonard Schleifer: Over the next six months, we anticipate Phase 3 data for our C5 program in generalized myasthenia gravis. For friandlimab, our LAD3 antibody in combination with LIBTAYO in advanced melanoma. For garatozumab, our activin A antibody in fibrodysplasia ossificans progressiva, or FOP, and our programs for birch and cat allergies. We also expect to make a decision on next steps for iripecumab in COPD. Several differentiated early clinical and preclinical programs spanning hematology, genetic medicines, ophthalmology, oncology, and immunology represent an exciting next wave of innovations at REGENERON. Finally, I'd like to provide an update on how we think about allocating shareholder capital. At our core, we firmly believe that internal investment offers the greatest potential return for shareholders. Therefore, we plan to continue investing heavily in our internal R&D programs while also making significant capital investments in the United States to support anticipated future growth.

Several differentiated early clinical and preclinical programs spanning hematology genetic medicines ophthalmology oncology and immunology represent an exciting next wave of innovations at regeneron.

We continue to make significant investments in R&D. That have yielded notable progress across several Key Programs so far this year, which George will discuss in just a moment.

Finally, I'd like to provide an update and an update on how we think about allocating shareholder capital.

Over the next 6 months, we anticipate phase 3 data for our C5 program and generalize my estimate Grabber gravis, for free and onab. Our land 3 antibody in combination with lipio Advanced melanoma.

Finally, I'd like to provide an update and an update on how we think about allocating shareholder capital.

At our core we firmly believe that internal investment offers the greatest potential return for shareholders. Therefore, we plan to continue investing heavily in our internal R&D programs, while also making significant capital investments in the United States to support anticipated future growth.

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We're investing over $7 billion in the U S over the coming years to expand our research and development capabilities and our manufacturing network, including a brand new state of the art fill finish manufacturing facility in Rensselaer New York.

Chris Fenimore: We have made some updates to our 2025 financial guidance. Changes in guidance ranges for SG&A, R&D, and COGS expenses result in a combined net decrease of $125 million at the respective midpoints, partially offset by slightly lower gross margin guidance. Importantly, the change to our gross margin guidance is unrelated to recent tariff announcements. While many details from the US-EU trade agreement have yet to emerge, including when a tariff may go into effect, we do not currently expect a 15% tariff on non-generic pharmaceutical products to have a material impact on our financial results in 2025. As we gain clarity on important details from the trade agreement and other potential tariffs, we will be in a better position to evaluate the financial impact of tariffs in 2026 and over the longer term.

We have made some updates to our 2025 financial guidance. Changes in guidance ranges for SG&A, R&D, and COGS expenses result in a combined net decrease of $125 million at the respective midpoints, partially offset by slightly lower gross margin guidance. Importantly, the change to our gross margin guidance is unrelated to recent tariff announcements. While many details from the US-EU trade agreement have yet to emerge, including when a tariff may go into effect, we do not currently expect a 15% tariff on non-generic pharmaceutical products to have a material impact on our financial results in 2025. As we gain clarity on important details from the trade agreement and other potential tariffs, we will be in a better position to evaluate the financial impact of tariffs in 2026 and over the longer term.

Several differentiated early clinical and preclinical programs spanning hematology genetic medicines Opthalmology, oncology and Immunology represent an exciting next wave of Innovations at the regeneron.

We also believe that these critical investments should be complemented by direct returns of capital to shareholders through share repurchases and dividends.

Finally, I'd like to provide an update on H. An update on how we think about allocating shareholder capital,

We also believe that these critical investments should be complemented by direct returns of capital to shareholders through share repurchases and dividends.

At our core, we firmly believe that internal investment offers the greatest potential return for shareholders.

We remain committed to funding both for the foreseeable future.

Given the strength of our balance sheet. We also have the flexibility to engage in business development and our focus remains on opportunities that can accelerate or strengthen our existing R&D capabilities. We have historically focused mainly on early stage assets and innovative platform technologies with significant synergies to our internal R&D.

Leonard Schleifer: We're investing over $7 billion in the U.S. over the coming years to expand our research and development capabilities and our manufacturing network, including a brand new state-of-the-art fill finish manufacturing facility in Rensselaer, New York. We also believe that these critical investments should be complemented by direct returns of capital to shareholders through share repurchases and dividends, and we remain committed to funding both for the foreseeable future. Given the strength of our balance sheet, we also have the flexibility to engage in business development, and our focus remains on opportunities that can accelerate or strengthen our existing R&D capabilities. We have historically focused mainly on early-stage assets and innovative platform technologies with significant synergies to our internal R&D efforts, while also considering differentiated later-stage opportunities in areas with high unmet medical need that complement our R&D focus.

Therefore, we plan to continue investing heavily in our internal R&D programs while also making significant capital investments in the United States to support anticipated future growth.

Efforts, while also considering differentiated latest stage opportunities in areas with high unmet medical need that complement our R&D focus.

We're investing over $7 billion in the U.S. over the coming years to expand our research and development capabilities and our manufacturing network, including a brand new state-of-the-art fill-finish manufacturing facility in Rensselaer, New York.

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Efforts, while also considering differentiated latest stage opportunities in areas with high unmet medical need that complement our R&D focus.

Chris Fenimore: Finally, while we are continuing to evaluate the impact of recently enacted tax legislation, we currently anticipate limited impact to our effective tax rate in the long term and continue to expect this rate to trend towards the mid-teens over time. A full summary of our latest guidance can be found in our press release issued earlier this morning. In conclusion, Regeneron's second quarter results demonstrate the strength of our business and enable us to continue to invest in our differentiated pipeline to deliver breakthroughs for patients and long-term value for shareholders. With that, I'll pass the call back to Ryan.

Finally, while we are continuing to evaluate the impact of recently enacted tax legislation, we currently anticipate limited impact to our effective tax rate in the long term and continue to expect this rate to trend towards the mid-teens over time. A full summary of our latest guidance can be found in our press release issued earlier this morning. In conclusion, Regeneron's second quarter results demonstrate the strength of our business and enable us to continue to invest in our differentiated pipeline to deliver breakthroughs for patients and long-term value for shareholders. With that, I'll pass the call back to Ryan.

In closing, we generated business remains sound with impressive commercial execution and driving strong financial results in the second quarter.

In closing, we generalize business remains sound with impressive commercial execution driving strong financial results in the second quarter. Our pipeline is poised to deliver scientific breakthroughs that can potentially help treat millions of patients and translate into meaningful commercial opportunities.

In closing, we generated business remains sound with impressive commercial execution and driving strong financial results in the second quarter.

We also believe that these critical investments should be complemented by direct returns of capital to shareholders through share repurchases and dividends. And we remain committed to funding both for the foreseeable future.

Our pipeline is poised to deliver scientific breakthroughs that can potentially help treat millions of patients and translate into meaningful commercial opportunities. The commercial team remains focused on maximizing growth drivers from our inline brands, while successfully launching new products and indications.

Given the strength of our balance sheet, we also have the flexibility to engage in business development, and our focus remains on opportunities that can accelerate or strengthen our existing R&D capabilities.

The commercial team remains focused on maximizing growth drivers from our in line brands, while successfully launching new products and indications. Finally, we continue to prudently deploy capital with the goal of delivering long term value to shareholders with that I'll now turn the call over.

Finally, we continue to prudently deploy capital with the goal of delivering long term value to shareholders with that I'll now turn the call over to George.

Ryan Crowe: Thank you, Chris. Before we move to Q&A, I just wanted to make one correction on our remark that Chris made. We anticipate fully reimbursing the Sanofi development balance by the end of 2026, not this year, end of 2026. With that, let's move to Q&A to ensure we're able to address as many questions as possible. We will answer one question from each caller before moving to the next. Next, Shannon, can we go to the first question please?

Finally, we continue to prudently deploy capital with the goal of delivering long term value to shareholders with that I'll now turn the call over to George.

Leonard Schleifer: In closing, Regeneron's business remains sound with impressive commercial execution driving strong financial results in the second quarter. Our pipeline is poised to deliver scientific breakthroughs that can potentially help treat millions of patients and translate into meaningful commercial opportunities. The commercial team remains focused on maximizing growth drivers from our inline brands while successfully launching new products and indications. Finally, we continue to prudently deploy capital with the goal of delivering long-term value to shareholders. With that, I'll now turn the call over to George. Thanks, Len. I'll start with DUPIXENT, which continues to set a high bar across multiple type 2 allergic diseases. DUPIXENT achieved another recent milestone as the first and only FDA-approved targeted medicine for bullous pemphigoid, a chronic, debilitating, and relapsing rare skin disease.

We have historically focused mainly on early-stage assets and innovative platform technologies with significant synergies to our internal R&D efforts, while also considering differentiated later-stage opportunities in areas with high unmet medical needs that complement our R&D focus.

Thanks Lynn.

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George.

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Thanks Lynn.

I'll start with depiction.

In closing we generate business. Remains sound with impressive commercial execution, driving strong financial results in the second quarter.

I'll start with depiction.

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Who picks it achieved another recent milestone as the first and only FDA approved targeted medicine for bolus pemphigoid chronic debilitating and relapsing rare skin disease. <unk> is now approved in the United States to treat eight distinct diseases, driven by type two inflammation, including disease affecting this.

Picks it achieved another recent milestone as the first and only FDA approved targeted medicine for bolus pemphigoid chronic debilitating and relapsing rare skin disease. <unk> is now approved in the United States to treat eight distinct diseases, driven by type two inflammation, including disease affecting this.

Operator: Thank you. To ask the question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11. Again, our first question comes from the line of Tim Anderson with Bank of America. Your line is now open.

Our pipeline is poised to deliver scientific breakthroughs that can potentially help treat millions of patients and translate into meaningful commercial opportunities.

Skin and respiratory system that can impact a broad range of patients infants to elderly individuals and as Lynn highlighted two pixel is the leading biologic treatment in its first six approved indications. We also remain excited about the potential for depiction and the elimination and treatment of allergies.

[Analyst]: Thanks so much. Good Q2 results. But I have a policy question. It's on MFN and the 17 letters that were sent out. Three of those letters had the CEO names crossed out, replaced with first names that were kind of penciled over. That was Lilly, Pfizer, and Regeneron. And it makes me wonder, is there a closer relationship between those CEOs and Trump? I know Lilly and Pfizer have been to Mar-a-Lago a lot to influence policy. So my question is, Len, have you been down there frequently as well? I asked because a common assumption that MFN might play out through a CMMI demo project. Eylea is a big Part B drug. Could that get wrapped into it or not? Because there's a biosimilar. So perhaps you have some visibility. Any perspective on any of this would be appreciated.

Tim Anderson: Thanks so much. Good Q2 results. But I have a policy question. It's on MFN and the 17 letters that were sent out. Three of those letters had the CEO names crossed out, replaced with first names that were kind of penciled over. That was Lilly, Pfizer, and Regeneron. And it makes me wonder, is there a closer relationship between those CEOs and Trump? I know Lilly and Pfizer have been to Mar-a-Lago a lot to influence policy. So my question is, Len, have you been down there frequently as well? I asked because a common assumption that MFN might play out through a CMMI demo project. Eylea is a big Part B drug. Could that get wrapped into it or not? Because there's a biosimilar. So perhaps you have some visibility. Any perspective on any of this would be appreciated.

Skin, the gut and respiratory system that can impact a broad range of patients for infants to elderly individuals and as Lynn highlighted two pixel is the leading biologic treatment. Its first six approved indications. We also remain excited about the potential for depiction and the elimination and treatment of allergies.

Skin, the gut and respiratory system that can impact a broad range of patients for infants to elderly individuals and as Lynn highlighted depiction is the leading biologic treatment in its first six approved indications. We also remain excited about the potential for depiction and the elimination and treatment of allergies.

The commercial team remains focused on maximizing growth drivers from our inline brands while successfully launching new products and indications. Finally, we continue to prudently deploy capital with the goal of delivering long-term value to shareholders. I'm now going to turn the call over to George.

Thanks Lynn. I'll start with 2 pixon.

This continues to set a high bar across multiple Type 2 allergic diseases.

As well as a number of other approaches we are pursuing for allergies, such as our cat and very specific allergy programs with updates on these programs expected later this year.

As well as a number of other approaches we are pursuing for allergies, such as our cat and burst specific allergy programs with updates on these programs expected later this year.

Leonard Schleifer: DUPIXENT is now approved in the United States to treat eight distinct diseases driven by type 2 inflammation, including diseases affecting the skin, the gut, and respiratory system that can impact a broad range of patients from infants to elderly individuals. As Len highlighted, DUPIXENT is the leading biologic treatment in its first six approved indications. We also remain excited about the potential for DUPIXENT in the elimination and treatment of allergies, as well as a number of other approaches we are pursuing for allergies, such as our cat and bird-specific allergy programs, with updates on these programs expected later this year. As previously reported, iripecumab, our interleukin-33 antibody evaluated for COPD in former smokers, regardless of eosinophil levels, met the primary endpoint in only one of two replicate studies. Together with Sanofi, we continue to evaluate the data to inform next steps for potential future COPD development.

As previously reported it a pit demand our interleukin 33 antibody evaluated for COPD and former smokers, regardless of eosinophil levels met the primary endpoint and only one of two replicate studies together, we're seeing if you would continue to evaluate the data to inform next steps for potential future COPD.

As previously reported pigment.

Interleukin 33 antibody evaluated for COPD and former smokers, regardless of eosinophil levels met the primary endpoint and only one of two replicate studies together, we're seeing if you would continue to evaluate data to inform next steps for potential future COPD development.

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Leonard Schleifer: Yeah, thanks. I have not been down there frequently. I think the President probably knows Regeneron and my first name given that it was Regeneron's cocktail for COVID that may have saved his life. Beyond that, I don't have any great insights to the policies. I have been and the company has been outspoken that we agree with the President that the Europeans are not paying their fair share of innovation, and some way that needs to change. It's complicated, and it does have to be done at a trade and policy level because it can't be done at an individual company level. It's very difficult. But we certainly agree that it's not right that Americans, American consumers should not be paying for all of the innovation. The solution is simply not to lower cost prices in the US without some equilibrating in Europe because then there'll be no innovation.

Leonard S. Schleifer: Yeah, thanks. I have not been down there frequently. I think the President probably knows Regeneron and my first name given that it was Regeneron's cocktail for COVID that may have saved his life. Beyond that, I don't have any great insights to the policies. I have been and the company has been outspoken that we agree with the President that the Europeans are not paying their fair share of innovation, and some way that needs to change. It's complicated, and it does have to be done at a trade and policy level because it can't be done at an individual company level. It's very difficult. But we certainly agree that it's not right that Americans, American consumers should not be paying for all of the innovation. The solution is simply not to lower cost prices in the US without some equilibrating in Europe because then there'll be no innovation.

Dupixent achieved another recent Milestone as the first and only FDA approved targeted medicine for bullous pentagon, a chronic debilitating and relapsing rare skin disease to pixon is now approved in the United States to treat 8. Distinct diseases driven by type 2 inflammation, including diseases affecting the skin the gut and respiratory system that can impact a broad range of patients from infants to elderly individuals. And as llenn, highlighted to pixon is the leading biologic treatment in its first 6 approved indications.

Notably the ongoing phase III studies in chronic rhinosinusitis with nasal polyps as well as phase II proof of concept studies in less validated clinical settings.

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Notably the ongoing phase III studies in chronic rhinosinusitis with nasal polyps as well as phase two proof of concept studies in less validated clinical settings.

Turning to our oncology efforts in high risk adjuvant SEC reptile became the first immunotherapy to demonstrate a benefit where others had failed the FDA accepted our supplemental BLA with priority review and assigned a <unk> date in October of this.

We also remain excited about the potential for depiction in the elimination and treatment of allergies, as well as a number of other approaches, we are pursuing for allergies such as our cat and birth specific algae programs with updates on these programs expected later this year.

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Turning to our oncology efforts and high risk adjuvant CFCC reptile became the first immunotherapy to demonstrate a benefit where others had failed the FDA accepted our supplemental BLA with priority review and assigned a <unk> date in October of this.

Leonard Schleifer: Iripecumab development continues in other respiratory diseases, most notably the ongoing phase 3 studies in chronic rhinosinusitis with nasal polyps, as well as phase 2 proof of concept studies in less validated clinical settings. Turning to our oncology efforts, in high-risk adjuvant CSCC, where LIBTAYO became the first immunotherapy to demonstrate a benefit where others had failed, the FDA accepted our supplemental BLAs with priority review and assigned a PDUFA date in October of this year. This dataset, presented earlier this year at ASCO and published in the New England Journal of Medicine, reinforces our belief that LIBTAYO provides a best-in-class foundation for combination therapies with our other oncology assets. In this context, LIBTAYO is being tested in combination with Fianlimab, our LAG-3 antibody, in a pivotal trial in first-line advanced melanoma, a setting in which this combination has generated compelling preliminary efficacy data when compared cross-trial to PD-1 monotherapy.

Year.

This dataset presented earlier this year at <unk> and published in the New England Journal of Medicine reinforces our belief that <unk> will provide a best in class Foundation for combination therapies with our other oncology assets.

Year.

This dataset presented earlier this year at <unk> and published in the New England Journal of Medicine reinforces our belief that <unk> provides a best in class Foundation for combination therapies with our other oncology assets.

And in this context, the Tayo is being tested in combination with the element our lag three antibody in a pivotal trial in first line advanced melanoma setting in which this combination has generated compelling preliminary efficacy data when compared cross trial to PD one monotherapy.

Concept studies in less validated clinical settings.

And in this context, the tayo, it's being tested in combination with the element our lag three antibody in a pivotal trial in first line advanced melanoma setting in which this combination has generated compelling preliminary efficacy data when compared cross trial to PD one monotherapy.

Turning to our oncology efforts.

Leonard Schleifer: But the answer to your question, Tim, is don't have any unique insight because my first name was used.

But the answer to your question, Tim, is don't have any unique insight because my first name was used.

The primary endpoint for this study is progression free survival and Keytruda monotherapy is the control enrollment for the PFS cohort was completed in January as expected. The results are now anticipated in late 2025 or early 2026 as the blinded PFS event rate accrual has slowed in recent months.

The primary endpoint for this study is progression free survival and Keytruda monotherapy to control enrollment for the PFS cohort was completed in January as expected. The results are now anticipated in late 2025 or early 2026 as the blinded PFS event rate accrual has slowed in recent months.

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

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

Operator: Sean, our next question comes from Tyler Van Buren of TD Cowen. Your line is now open.

Operator: Our next question comes from Tyler Van Buren of TD Cowen. Your line is now open.

Chris Fenimore: Great.

Tyler Van Buren: Great. Thanks guys. Congratulations on a large fee. Great to see you this quarter. So there's a great quarter over quarter rebound in EYLEA HD. So curious to hear what you would attribute that to. Regarding the Catalent site inspection issue, can you provide additional color on the nature of the issue and if there's precedent for how long it might take to resolve it or how long the potential HD approvals will be pushed back by?

Leonard Schleifer: Thanks guys. Congratulations on a large fee. Great to see you this quarter.

Chris Fenimore: So there's a great quarter over quarter.

Leonard Schleifer: Rebound in EYLEA HD. So curious to hear what you would attribute that to.

Turning to our <unk> three bite specifics.

In high-risk, adjunct cscc grip tile became the first immunotherapy to demonstrate a benefit, where others had failed. The FDA accepted our supplemental bla with priority review and assigned to Padua date in October of this year. This data set presented earlier this year at ASCO and published in the New England Journal of Medicine, reinforces our beliefs that lip tile provides a best-in-class foundation from combination therapies with our other oncology assets.

Our beef PMA by <unk> Bispecific has now been approved in the United States for relapsed refractory multiple myeloma.

George Yancopoulos: Regarding the Catalent site inspection issue.

Turning to our CD three bi specifics.

Leonard Schleifer: Can you provide additional color on the nature of the issue and if there's precedent for how long it might take?

<unk>, our <unk> by <unk> Bispecific has now been approved in the United States for relapsed refractory multiple myeloma.

Our beef PMA by five three by specific has now been approved in the United States for relapsed refractory multiple myeloma.

George Yancopoulos: To resolve it or how long the potential HD approvals will be pushed back by?

<unk> label is differentiated compared to other FDA approved <unk> bi specifics with nearly double the complete response rates <unk> label also includes a more favorable profile decided kind of leasing Jerome shorter required hospitalization periods.

Leonard Schleifer: The primary endpoint for this study is progression-free survival and Keytruda monotherapy as a control. Enrollment for the PFS cohort was completed in January, as expected, but results are now anticipated in late 2025 or early 2026, as the blinded PFS event rate accrual has slowed in recent months. Turning to our CD3 bispecifics, Linvoseltamab, our BCMA by CD3 bispecific, has now been approved in the United States for relapsed refractory multiple myeloma. Linvoseltamab's label is differentiated compared to other FDA-approved BCMA bispecifics with nearly double the complete response rates. Linvoseltamab's label also includes a more favorable profile for cytokine release syndrome, shorter required hospitalization periods, and a more convenient dosing regimen, with longer intervals between doses for those patients that achieve at least very good partial responses after 24 weeks on therapy.

And in this context lepto is being tested in combination with family, man. Our lack of 3 antibodies in a pivotal trial. In first line Advanced melanoma, a setting in, which this combination has generated compelling. Preliminary efficacy data when compared cross trial to pd1 monotherapy.

<unk> label is differentiated compared to other FDA approved <unk> bi specifics with nearly double the complete response rates <unk> label also includes more favorable profile decided kind of leasing drome shorter required hospitalization periods.

Leonard Schleifer: I'll let Marion get into more details about what was driving the CRL for HD in terms of Catalent. Really need to direct those calls to Novo. What we can say in a broad sense that these were not structural changes that are being requested by the FDA. It's not like they have to rebuild something or something of that. They're mainly process procedural, those sorts of a thing. As we said in our remarks, we do think that they'll provide a robust response. Novo's CEO wrote directly to the FDA and said they're going to elevate all this to the standards of Novo. I believe that we may not be the only customer that's ensnared because they do, as I said, they do work for virtually all the biopharmaceutical companies. They fill. Catalent filled in its fiscal year 2024, something like 70 or 80 billion unit doses.

Leonard S. Schleifer: I'll let Marion get into more details about what was driving the CRL for HD in terms of Catalent. Really need to direct those calls to Novo. What we can say in a broad sense that these were not structural changes that are being requested by the FDA. It's not like they have to rebuild something or something of that. They're mainly process procedural, those sorts of a thing. As we said in our remarks, we do think that they'll provide a robust response. Novo's CEO wrote directly to the FDA and said they're going to elevate all this to the standards of Novo. I believe that we may not be the only customer that's ensnared because they do, as I said, they do work for virtually all the biopharmaceutical companies. They fill. Catalent filled in its fiscal year 2024, something like 70 or 80 billion unit doses.

And a more convenient dosing regimen with longer intervals between doses for those patients that achieved at least very good partial responses. After 24 weeks on therapy.

The primary endpoint for this study is progression-free survival and Katrina. Monotherapy is the control. Enrollment for the PFS cohort was completed in January as expected but results are now anticipated in late 2025 or early 2026 as the blinded. PFS event rate approval has slowed in recent months

More broadly we believe logistic has the potential to become the backbone for therapeutic approaches across the myeloma treatment landscape that is from pre malignant settings through advanced disease, using both monotherapy and limited novel combination approaches of already summary.

More broadly we believe lose epic has the potential to become the backbone for therapeutic approaches across the myeloma treatment landscape that is from pre malignant settings through advanced disease, using both monotherapy and limited novel combination approaches of already summary.

Turning to our CD3 buy specifics loic. Our bcma by C3 by specific has now been approved in the United States for relapse refractory multiple Myoma.

<unk>, how long does it take me a best in class activity in the most advanced myeloma patients where it was recently approved moving to the premalignant settings, starting with high risk smoldering myeloma.

<unk> be a best in class activity in the most advanced myeloma patients where it was recently approved moving to the pre malignant settings, starting with high risk smoldering myeloma.

The deficit label is differentiated compared to other FDA-approved BCMA therapies by specifics, with nearly double the complete response rates. The Linux label also includes a more favorable profile for cytokine release syndrome, including shorter required hospitalization periods.

Initial cohort of 19 Evaluable patients with limited monotherapy, we observed a 100% overall response rate with a favorable safety profile.

Leonard Schleifer: More broadly, we believe Linvoseltamab has the potential to become the backbone for therapeutic approaches across the myeloma treatment landscape, that is, from premalignant settings through advanced disease, using both monotherapy and limited novel combination approaches. I've already summarized how Linvoseltamab may have best-in-class activity in the most advanced myeloma patients where it was recently approved. Moving to the premalignant settings, starting with high-risk smoldering myeloma, an initial cohort of 19 evaluable patients with Linvoseltamab monotherapy, we observed a 100% overall response rate with a favorable safety profile. Among the first six patients achieving one-year follow-up, five were in complete response, and all six were MRD negative. In this regard, and recognizing the limitations of cross-trial comparisons, Darzalex was recently approved in the EU as a monotherapy with a complete response rate of only 8.8% in a similar setting.

And a more convenient dosing regimen with longer intervals between doses. For those patients, that achieve, at least very good, partial responses after 24 weeks on therapy.

Initial cohort of 19, evaluable patients with <unk> monotherapy, we observed a 100% overall response rate with a favorable safety profile.

Leonard Schleifer: So I think that this has a good chance of being done expeditiously. But more specifically than that, it's a little early. When we know a little more, we'll get that information out to you. Turn it over to Marion to comment on driving of the sales for HD.

So I think that this has a good chance of being done expeditiously. But more specifically than that, it's a little early. When we know a little more, we'll get that information out to you. Turn it over to Marion to comment on driving of the sales for HD.

Among.

The first six patients.

Achieving one year of follow up five were in complete response and all six were <unk> negative in this regard and recognizing the limitations of cross trial comparisons <unk> was recently approved in the EU as a monotherapy with a complete response rate of only eight 8% in a similar setting.

Among.

The first six patients.

Marion McCourt: Thanks, Len and Tyler, just going back to the numbers as you were kind of sharing, the demand growth in the quarter was impressive. It was a 16% increase which resulted in our Q2 $393 million in net sales for EYLEA HD in the quarter. We would attribute it to frankly physicians' appreciation for the product profile that EYLEA HD provides. The clinical efficacy, the safety that we've talked about repeatedly, and then also the durability that allows patients to have longer periods of time between dosing, and the experience with the product has been very, very favorable. As I summarized, when we do get those label enhancements, we'll be able to even have more of a trajectory of growth and demand, but certainly very solid performance. And I would attribute it to the product profile and our excellent commercial team.

More broadly, We Believe loic has the potential to become the backbone. For therapeutic, approaches across the Myoma treatment landscape that is from pre-malignant settings through advanced disease. Using both monotherapy and limited novel combination approaches. I've already summarized how Lyn is ific? May have best-in-class activity in the most advanced Myoma patients where it was recently approved.

Based on this early data in high risk smoldering myeloma patients, which suggests that lose if we could prevent progression to malignant disease. We plan to initiate a phase III head to head study against <unk> lift in the fourth quarter.

Based on this early data in high risk smoldering myeloma patients, which suggests the lose if we could prevent progression to malignant disease. We plan to initiate a phase III head to head study against doors lift in the fourth quarter.

In another pre malignant plasma cell disorder light chain amyloidosis exploratory data with <unk> monotherapy showed that the average light chain levels were normalized by two weeks in the first 11 treated patients all of whom had failed prior therapies for context.

Moving to the premalignant settings. Starting with high-risk smoldering Myoma an initial cohort of 19 evaluation with linak monotherapy. We observed a 100% overall response rate with a favorable safety profile.

Among.

The first 6 patients.

In another pre malignant plasma cell disorder light chain amyloidosis exploratory data with logistic monotherapy showed that the average light chain levels were normalized by two weeks in the first 11 treated patients all of whom had failed prior therapies for context.

While noting the limitations of cross trial comparisons patients taking a four drug combination standard of care containing <unk> as one of the four components in previously untreated light chain amyloidosis. It took more than five months for patients to approach without achieving normalization.

Leonard Schleifer: Based on this early data in high-risk smoldering myeloma patients, which suggests that Linodizific could prevent progression to malignant disease, we plan to initiate a Phase 3 head-to-head study against Darzalex in the fourth quarter. In another premalignant plasma cell disorder, light chain amyloidosis, exploratory data with Linodizific monotherapy showed that the average light chain levels were normalized by two weeks in the first 11 treated patients, all of whom had failed prior therapies. For context, while noting the limitations of cross-trial comparisons, patients taking a four-drug combination standard of care containing Darzalex as one of the four components in previously untreated light chain amyloidosis, it took more than five months for patients to approach without achieving normalization.

Uh, achieving 1 year of follow-up 5 were in complete response and all 6 were mrd negative in this regard and recognizing the limitations of cross trial comparisons darlac was recently approved in the EU as a monotherapy with a complete response rate of only 8.8% in a similar setting.

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

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

Operator: Sean, our next question comes from the line of Chris Schott of J.P. Morgan. Your line is now open.

Operator: Our next question comes from the line of Chris Schott of JPMorgan. Your line is now open.

[Analyst]: Great, thanks so much. Just a couple more EYLEA ones as well. Just on the PDUFAs. Beyond the manufacturing dynamics, is there anything else pending with these three filings based on your discussion with FDA or are you otherwise confident that once the manufacturing is addressed we'll be seeing approvals here? And just the second one, second part on EYLEA, just can you talk a little bit about this branded share erosion you're seeing in the category to AVASTIN? Is that starting to stabilize at all and how quickly do you expect to recapture some of that lost share once the affordability issues have been addressed? Thank you.

Christopher Schott: Great, thanks so much. Just a couple more EYLEA ones as well. Just on the PDUFAs. Beyond the manufacturing dynamics, is there anything else pending with these three filings based on your discussion with FDA or are you otherwise confident that once the manufacturing is addressed we'll be seeing approvals here? And just the second one, second part on EYLEA, just can you talk a little bit about this branded share erosion you're seeing in the category to AVASTIN? Is that starting to stabilize at all and how quickly do you expect to recapture some of that lost share once the affordability issues have been addressed? Thank you.

Based on this early data and high-risk smoldering and maloma patients which suggests that it is. If it could prevent progression to malignant disease, we plan to initiate a phase 3 head-to-head study against darzelis in the fourth quarter.

Now moving to the second line multiple myeloma setting for patients who have failed or progressed. After the initial triplet or quadruplet regiment, usually containing doors.

Now moving to the second line multiple myeloma setting for patients who have failed or progressed after the initial triplet or quadruplet regimen, usually containing doors.

Now moving to the second line multiple myeloma setting for patients who have failed or progressed after the initial tripling or quadrupling regiment, usually containing doors.

In two and three other agents.

We presented data at <unk> earlier, this year showing that limited compare combined with Carfilzomib showed strong responses in relapsed or refractory myeloma patients demonstrating a 90% response rate and a 76% complete response rate. We think this novel doublet regimen could potentially offer in <unk>.

In two and three other agents.

In another pre-malignant plasma cell disorder, light chain emmolo doses exploratory data with loic monotherapy. Showed that the average light chain levels were normalized by 2 weeks. In the first 11, treated patients, all of whom had failed, prior therapies for contacts.

Leonard Schleifer: Yes. So I'll comment on the PDUFAs and Marion, comment a little bit on the share issues. As far as the PDUFAs go. Based on our discussions, we believe that there's nothing significant left to be done. Obviously some details, but we are expecting once the resolution of the filling issues has occurred to receive favorable action, we hope from the FDA.

Leonard S. Schleifer: Yes. So I'll comment on the PDUFAs and Marion, comment a little bit on the share issues. As far as the PDUFAs go. Based on our discussions, we believe that there's nothing significant left to be done. Obviously some details, but we are expecting once the resolution of the filling issues has occurred to receive favorable action, we hope from the FDA.

Port New treatment options for second line patients, who have failed <unk> containing frontline regimens and anticipate initiating a registrational randomized phase III trial in the fourth quarter of this year to evaluate the literature Carfilzomib doublet against standard of care in the second line setting.

Leonard Schleifer: Moving to the second-line multiple myeloma setting, for patients who have failed or progressed after the initial triplet or quadruplet regimen, usually containing Darzalex and two and three other agents, we presented data at ASCO earlier this year showing that Linodizific combined with carfilzomib showed strong responses in relapsed or refractory myeloma patients, demonstrating a 90% response rate and a 76% complete response rate. We think this novel doublet regimen could potentially offer an important new treatment option for second-line patients who have failed their CD38-containing front-line regimens and anticipate initiating a registrational randomized Phase 3 trial in the fourth quarter of this year to evaluate the Linodizific carfilzomib doublet against standard of care in the second-line setting. Importantly, across all of these settings, no new or unexpected safety signals have emerged for Linodizific.

While noting the limitations of cross trial comparisons patients, taking a 4 drug combination standard of care containing darlex as 1 of the 4 components in previously, untreated light chain Elmo dosis. It took more than 5 months for patients to approach without achieving normalization.

now, moving to the second line, multiple Myoma setting for patients with a failed or progressed after the initial triplet or quadruplet regimen usually containing dorsal X and 2 and 3 other agents,

Importantly across.

<unk> doublet against standard of care in the second line setting.

All of these settings, no new or unexpected safety signals have emerged.

Importantly.

Across all of these settings, no new or unexpected safety signals have emerged from this effort.

Most all of these settings, no new or unexpected safety signals have emerged from this effort.

Marion McCourt: And then on overall branded dynamic and overall performance, I'll share that if you look at total Regeneron, Eylea HD and Eylea category share, branded share in the quarter was just over 60%. If you look then at growth and what happened in the overall category anti-VEGF, overall category volume did grow, but the branded anti-VEGF category volume actually decreased by 1.2%, and that would be attributed primarily to the uptick in Avastin based on affordability issues. I don't have lens into what potentially will happen in the future.

Based on these collective datasets, suggesting that <unk> may have unprecedented ability to address my alone and pre malignant disease and become a new backbone for myeloma therapies, we anticipate conducting as many as 10 registrational trials for <unk>, including a broad registrational.

Based on these collective datasets, suggesting that Louis if it may have unprecedented ability to address my alone and pre malignant disease and become a new backbone for myeloma therapies, we anticipate conducting as many as 10 registrational trials for Linzess.

Represent the data at ASCO earlier this year showing that Linda ific compare combined with caroso. Man, showed strong responses in relapse or refractory maloma patients, demonstrating a 90% response rate and a 76% complete response rate.

Program, and frontline myeloma for transplant eligible and ineligible patients.

Including a broad Registrational program in frontline myeloma for transplant eligible and ineligible patients.

In frontline myeloma for transplant eligible and ineligible patients.

Onto <unk> estimate our CD 20 by <unk> three by specific which once again as with <unk>. We are looking to advance <unk> <unk> into earlier lymphoma settings and enrollment in these trials is proceeding expeditiously.

Tablet against standard of care in the second line setting.

Onto our June estimate our CD 20 by CD three by specific which once again as with <unk>. We are looking to advance <unk> <unk> estimate into earlier lymphoma settings and enrollment in these trials is proceeding expeditiously.

Onto <unk> or CD 20 by <unk> three by specific which once again as with <unk>. We are looking to advance edginess gene estimate into earlier lymphoma settings and enrollment in these trials is proceeding expeditiously.

Importantly.

Leonard Schleifer: Based on these collective datasets suggesting that Linodizific may have unprecedented ability to address myeloma and premalignant disease and become a new backbone for myeloma therapies, we anticipate conducting as many as 10 registrational trials for Linodizific, including a broad registrational program in front-line myeloma for transplant-eligible and ineligible patients. Onto Odronextamab, our CD20 by CD3 bispecific, which once again, as with Linvoseltamab, we are looking to advance Odronextamab into earlier lymphoma settings, and enrollment in these trials is proceeding expeditiously. In first-line follicular lymphoma, the phase 3 OLYMPIA Odronextamab monotherapy study has already completed enrollment. As previously reported, in an FDA-mandated lead-in cohort, Odronextamab monotherapy demonstrated an encouraging 100% complete response rate in the first 12 available patients with a favorable safety profile. For reference, standard of care Rituximab plus CHOP and Rituximab plus lenalidomide are reported to demonstrate complete responses of approximately 65% on average in these populations.

Across all of these settings. No new or unexpected. Safety signals have emerged for Linux.

Ryan Crowe: All right, let's move to the next question please.

Ryan Crowe: All right, let's move to the next question please, Shannon.

Operator: Shannon, our next question comes from the line of Jeff Meacham with Citi. Your line is now open.

In first line Follicular lymphoma, the phase III Olympia <unk> monotherapy study has already completed enrollment.

Operator: Our next question comes from the line of Geoff Meacham with Citi. Your line is now open.

In first line Follicular lymphoma, the phase III Olympia <unk> monotherapy study has already completed enrollment.

[Analyst]: Morning guys. Longtime listener, first time caller. Thanks for the question. Len, you mentioned up front internal R&D is really the best use of capital. You got 45 assets already in development. So you know, what's the ROI calculus on how you guys are prioritizing? I wasn't sure if our licensing non-core assets is reasonable, especially given the innovation as a premium now. Thank you.

Geoff Meacham: Morning guys. Longtime listener, first time caller. Thanks for the question. Len, you mentioned up front internal R&D is really the best use of capital. You got 45 assets already in development. So you know, what's the ROI calculus on how you guys are prioritizing? I wasn't sure if our licensing non-core assets is reasonable, especially given the innovation as a premium now. Thank you.

Previously reported and an FDA mandated lead in cohort <unk> monotherapy.

Demonstrated an encouraging 100% complete response rate in the first 12, evaluable patients with a favorable safety profile for reference standard of care.

Demonstrated an encouraging 100% complete response rate in the first 12 evaluable patients with a favorable safety profile for reference standard of care with Rituximab, plus chop and Rituximab plus landler mud are reported to demonstrate complete responses are approximately 65% on average in these <unk>.

Based on these collective data sets suggesting that Linux IFIC may have unprecedented ability to address my own and premalignant disease and become a new backbone for my own therapies, we anticipate conducting as many as 10 registrational trials for in Pacific, including a broad registrational program in frontline myoma for transplant-eligible and ineligible patients.

Demand plus chop and Rituximab plus landler mud are reported to demonstrate complete responses are approximately 65% on average in these populations.

Leonard Schleifer: You know, Jeff, it is for a first-time caller; it's a good question. I think we certainly have a broad and big pipeline. We have discussed whether or not on occasion it makes sense to turn over some of those assets. We've done that with our IL1 blocker and seeing pretty good results from our partner who has driven results in pericarditis, which is going very well. We do think that is a potential. But there are some areas where you don't want to do one-offs like oncology. I think what you heard from George is that, you know, part of his original strategy was to have a menu of agents that might be useful to combine. So we probably wouldn't want to do something in that area. But it's a fair point, and we do spend a lot of money on internal R&D.

Leonard S. Schleifer: You know, Geoff, it is for a first-time caller; it's a good question. I think we certainly have a broad and big pipeline. We have discussed whether or not on occasion it makes sense to turn over some of those assets. We've done that with our IL1 blocker and seeing pretty good results from our partner who has driven results in pericarditis, which is going very well. We do think that is a potential. But there are some areas where you don't want to do one-offs like oncology. I think what you heard from George is that, you know, part of his original strategy was to have a menu of agents that might be useful to combine. So we probably wouldn't want to do something in that area. But it's a fair point, and we do spend a lot of money on internal R&D.

Additionally to the potential improved rate of complete responses, we believe a monotherapy chemo free approach could also provide a favorable safety profile in comparison to these other chemo based regimens.

On to Arjun next, to map, our cd20 by C3 by specific. Which once again, as with the specific, we are looking to advance adjunct map into earlier lymphoma settings and enrollment in these trials is proceeding expeditiously.

Populations.

In first line diffuse large b cell lymphoma, the phase III Olympia <unk> III study, comparing <unk>, plus chop or chop to Rituximab plus job. The current standard of care. That's completed enrollment in the FDA mandated leading cohort in the first 313 patients treated at the intended <unk>.

In first-line follicular lymphoma, the Phase 3 of the Olympia, or Gene, next to that monotherapy study has already completed enrollment, as previously reported in an FDA-mandated lead-in cohort. Oene next to them monotherapy.

In first line diffuse large b cell lymphoma, the phase III Olympia three study comparing <unk> plus chop.

Oh chop to Rituximab plus chop the current standard of care, that's completed enrollment in the FDA mandated leading cohorts in the first 313 patients treated at the intended <unk> dose <unk> demonstrated once again, a 100% complete response rate with a favorable safety profile.

Oh chop to Rituximab plus job the current standard of care, that's completed enrollment in the FDA mandated leading cohort in the first 313 patients treated at the intended <unk> dose <unk> demonstrated once again, a 100% complete response rate with a favorable safety profile.

<unk> dos <unk> demonstrated once again, a 100% complete response rate with a favorable safety profile for reference R. Chop in first line <unk> has historically demonstrated complete response rate of about 75% in this setting.

Leonard Schleifer: In addition to the potential improved rate of complete responses, we believe a monotherapy chemo-free approach could also provide a favorable safety profile in comparison to these other chemo-based regimens. In first-line diffuse large B-cell lymphoma, the phase 3 OLYMPIA III study comparing Odronextamab plus CHOP or OCHOP to Rituximab plus CHOP, the current standard of care, has completed enrollment in the FDA-mandated lead-in cohorts. In the first 13 patients treated at the intended Odronextamab dose, OCHOP demonstrated once again a 100% complete response rate with a favorable safety profile. For reference, RCHOP in first-line DLBCL has historically demonstrated a complete response rate of about 75% in this setting. Both Linvoseltamab and Odronextamab represent potential significant treatment advances in their respective disease areas, and we look forward to rapidly advancing these programs. We plan to present or publish many of these early datasets over the coming months.

For reference R. Chop in first line <unk> has historically demonstrated complete response rate of about 75% in this setting.

Both <unk> and <unk> estimate represent potential significant treatment advances in their respective disease areas and we look forward to rapidly advancing these programs we plan to present or publish many of these early data sets over the coming months.

Demonstrated an encouraging 100% complete response rate in the first 12 available patients, with a favorable safety profile compared to the reference standard of care: Retuen Plus, CHOP, and Rituximab plus Lenalidomide are reported to demonstrate complete responses of approximately 65% on average in these populations. In addition to the potential improved rate of complete responses, we believe a monotherapy chemotherapy approach could also provide a favorable safety profile in comparison to these other chemo-based regimens.

Both <unk> and <unk> estimate represents potential significant treatment advances in their respective disease areas and we look forward to rapidly advancing these programs we plan to present or publish many of these early data sets over the coming months.

Leonard Schleifer: If it makes sense to partner or out license, we're certainly not structurally adverse to that.

If it makes sense to partner or out license, we're certainly not structurally adverse to that.

Turning now to thrombosis or factor 11 program continues to advance rapidly. The first pivotal study in post operative venous thromboembolism fallen total knee replacement surgery valuing our factor 11 catalytic domain antibody.

Ryan Crowe: Okay, let's move to the next question please.

Ryan Crowe: Okay, let's move to the next question please, Shannon.

Operator: Shannon, our next question comes from the line of Carter Gould with Cantor Fitzgerald. Your line is now open.

Operator: Our next question comes from the line of Carter Gould with Cantor Fitzgerald. Your line is now open.

[Analyst]: Good morning. Thanks for taking the question. I know it's only been a month since you formally launched the matching program with Good Days, but can you help us think about if there's been yet if you don't, excuse me, if you've delivered any matching funds yet and the extent to which you expect this to, I guess, return as a tailwind to your commercial performance in the back half of the year? Thank you.

Carter Gould: Good morning. Thanks for taking the question. I know it's only been a month since you formally launched the matching program with Good Days, but can you help us think about if there's been yet if you don't, excuse me, if you've delivered any matching funds yet and the extent to which you expect this to, I guess, return as a tailwind to your commercial performance in the back half of the year? Thank you.

Your first line is diffuse, large B-cell lymphoma. The Phase 3 Olympia 3 study is comparing Argenx MAP plus CHOP or OH, CHOP to Rituximab plus CHOP, the current standard of care. Enrollment has completed in the FDA-mandated lead-in cohorts in the first three. A total of 13 patients were treated at the intended dose. OH, CHOP demonstrated once again a 100% complete response rate with a favorable safety profile.

Versus apixaban in the ex parent.

<unk> has begun enrollment we anticipate data from this short duration study in 2027, which could support a fast to market regulatory pathway.

Versus apixaban in the ex parent.

Versus apixaban and Exar parent.

For reference, our CHOP in the first line, DLBCL has historically demonstrated a complete response rate of about 75% in this setting.

Has begun enrollment we anticipate data from this short duration study in 2027, which could support a fast to market regulatory pathway.

Additional pivotal studies in thrombosis indications are set to launch but year end with more pivotal study starts expected early next year.

Leonard Schleifer: I think it's still early for the program since it's only been in place for about a month and therefore I don't think we have any useful information to share. We'll get that later this quarter or the end of the quarter, but we haven't heard through the grapevine of any major contributions yet. We're watching this space very closely. We really do hope that our contribution in a matching form will stimulate others to contribute, but thus far, we don't have a lot to report.

Leonard S. Schleifer: I think it's still early for the program since it's only been in place for about a month and therefore I don't think we have any useful information to share. We'll get that later this quarter or the end of the quarter, but we haven't heard through the grapevine of any major contributions yet. We're watching this space very closely. We really do hope that our contribution in a matching form will stimulate others to contribute, but thus far, we don't have a lot to report.

Additional pivotal studies in thrombosis indications are set to launch but year end with more pivotal study starts expected early next year.

Leonard Schleifer: Turning now to thrombosis, our Factor XI program continues to advance rapidly. The first pivotal study in postoperative venous thromboembolism following total knee replacement surgery, evaluating our Factor XI catalytic domain antibody versus apixaban and enoxaparin has begun enrollment. We anticipate data from this short-duration study in 2027, which could support a fast-to-market regulatory pathway. Additional pivotal studies in thrombosis indications are set to launch by year-end, with more pivotal study starts expected early next year. Moving now to our obesity efforts, our recently in-licensed GLP-1 GIP receptor agonist positions us well to expand into the growing obesity market. REGENERON has multiple opportunities in this large and growing therapeutic area, including GLP-1 GIP receptor agonist monotherapy, a longer-acting agent in preclinical development, as well as approaches to enhance the quality of GLP-1-based weight loss through combination therapies with lean mass-bearing agents.

Moving now to our obesity.

Both Lo and OGX map represent potential, significant treatment advances in their respective disease areas. And we look forward to rapidly advancing these programs. We plan to present or publish many of these early data sets over the coming months.

Recently in licensed <unk> gift receptor agonist positions us well to expand into the growing obesity market Regeneron has multiple opportunities in this large and growing therapeutic area, including <unk> receptor agonist monotherapy.

Moving now to our obesity efforts our recently in licensed <unk> gift receptor agonist positions us well to expand into the growing obesity market Regeneron has multiple opportunities in this large and growing therapeutic area, including GOP, one kip receptor agonist monotherapy <unk>.

Moving now to our obesity efforts our recently in licensed <unk> gift receptor agonist positions us well to expand into the growing obesity market to geron has multiple opportunities in this large and growing therapeutic area, including GOP, one kip receptor agonist monotherapy <unk>.

Turning now to thrombosis, our Factor 11 program continues to advance rapidly. The first pivotal study in post-operative venous thromboembolism following total knee replacement surgery involving our Factor 11 catalytic domain is underway.

Our longer acting agent in preclinical development as well as approaches to enhance the quality of the GOP.

Longer acting agent in preclinical development as well as approaches to enhance the quality of GOP.

One based weight loss through combination therapies with lean mass sparing agents. We also see an opportunity to address common obesity comorbidities with novel combinations.

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

Ryan Crowe: Thanks, Len. Next question, please, Shannon.

George Yancopoulos: Shannon.

Operator: Our next question comes from the line of Corey Kasimov with Evercore ISI. Your line is now open.

Operator: Our next question comes from the line of Cory Kasimov with Evercore ISI. Your line is now open.

Results from our ongoing phase II courage study, which is evaluating the combination of <unk> and myostatin antibody with or without the our Tulsa Mab and activin antibody and some good tight confirmed the potential to enhance <unk> mediated weight loss, while preserving lean mass at the interim analysis are trial confirm there.

Versus pixel band and xop parent and has begun enrollment. We anticipate data from the short duration study in 2027, which could support a fast to Market regulatory pathway additional pivotal studies, and thrombosis indications are set to launch by year, end with more pivotal studies starts expected early next year.

Results from our ongoing phase II courage study, which is evaluating the combination of <unk> and myostatin antibody with or without the our Tulsa Mab and activin antibody and some good tight confirmed the potential to enhance <unk> mediated weight loss, while preserving mean miss at the interim analysis, our trial to confirm that.

Results from our ongoing phase II courage study, which is evaluating the combination of <unk> and myostatin antibody with or without the our Tulsa, Mab and activin antibody and <unk> confirmed the potential to enhance <unk> mediated weight loss, while preserving lean mass at the interim analysis are trial confirm that.

[Analyst]: Hey, good morning, guys. Thanks for taking the question. Curious as to your thoughts on the competitive OX40 ligand data shared thus far and how you believe this potentially competes with DUPIXENT's overall profile? Thank you.

Cory Kasimov: Hey, good morning, guys. Thanks for taking the question. Curious as to your thoughts on the competitive OX40 ligand data shared thus far and how you believe this potentially competes with DUPIXENT's overall profile? Thank you.

Leonard Schleifer: George, you want to cover that?

Leonard S. Schleifer: George, you want to cover that?

Approximately 35% of <unk> induced weight loss was due to lean mass loss and the average loss of 7% to eight pounds of lean mass per patient once again, highlighting a well documented concern associated with this therapeutic class combining some glue tied with our muscle preserving antibodies.

George Yancopoulos: Well, the data is interesting right now. I don't think suggests that it's offering really any advantages, and certainly it'll be a long time before it can approach the comfort of the safety profile. Let me just remind you that DUPIXENT is one of the only, if not the only, immunomodulator in the world that we've shown largely attacks a vestigial pathway which is largely not necessary to people living in the developed world because it's part of the immune system that was designed to attack largely obsolete pathogens that we no longer have to fight in developed countries. Most other approaches, including the OX40 approaches and so forth, are much more general approaches that attack fundamental parts of the immune system that are required very broadly.

Approximately 35% of <unk> induced weight loss was due to lean mass loss and the average loss of seven to eight pounds of lean mass per patient once again, highlighting a well documented concern associated with this therapeutic class combining some grid tied with our muscle preserving antibodies rich.

Moving now to our obesity efforts. Our recently in-licensed GLP-1 and GIP receptor agonists position us well to expand into the growing obesity market. The general has multiple opportunities in this large and growing therapeutic area, including GLP-1 and GIP receptor agonist monotherapy, a longer-acting agent in preclinical development, as well as approaches to enhance the quality of GLP.

Leonard Schleifer: We also see an opportunity to address common obesity comorbidities with novel combinations. Results from our ongoing phase two CURAGE study, which is evaluating the combination of tirvogramab, a myostatin antibody with or without garatozumab, an activin A antibody, and semaglutide, confirm the potential to enhance GLP-1-mediated weight loss while preserving lean mass. At the interim analysis, our trial confirmed that approximately 35% of semaglutide-induced weight loss was due to lean mass loss, an average loss of seven to eight pounds of lean mass per patient, once again highlighting a well-documented concern associated with this therapeutic class. Combining semaglutide with our muscle-preserving antibodies reduced lean mass loss by 50% to 80% while also increasing fat mass loss at the 26-week time point. The combination of semaglutide with tirvogramab was generally well tolerated.

1 based weight loss through combination, therapies, with lean mass bearing agents. We also see an opportunity to address common obesity. Comorbidities with novel combinations.

<unk> lean mass loss by 50% to 80%, while also increasing fat mass loss at the 26 week time point the combination of <unk> with <unk> was generally well tolerated the triplet combination of <unk> with both of them had a higher rate of discontinuation due to tolerability issues and other.

<unk> lean mass loss by 50% to 80%, while also increasing fat mass loss at the 26 week time point the combination of <unk> with <unk> was generally well tolerated the triplet combination semgroup side with both of them at a higher rate of discontinuation due to tolerability issues and other.

Adverse events consistent with the safety profile previously observed with <unk> monotherapy in other disease settings.

<unk> data from across this class further validates our approach in this area final 26 week efficacy and safety results were consistent with the interim data will be presented in a late breaking session at the 60 <unk> annual meeting of the European Association for the study of diabetes in September of 2025.

<unk> data from across this class further validates our approach in this area final 26 week efficacy and safety results were consistent with the interim data.

George Yancopoulos: It's going to be a long time before you would feel comfortable that you have the safety profile that you have with DUPIXENT. One of the miracles of DUPIXENT is its incredible efficacy, which is so far relatively unmatched, but just as, if not more importantly, that is immunomodulated, that actually corrects the immune system and does not debilitate it by creating any profound immunosuppression. I think when you look at other agents, whether you're talking about OX40 or talking about the JAKs or anything else, they are much broader at attacking the immune system. It's going to take a long time, I think, to develop the sort of comfort that one has with the incredible safety profile of DUPIXENT, let alone its efficacy.

Will be presented in a late breaking session at the 60 <unk> annual meeting of the European Association for the study of diabetes in September of 2025.

It's going to be a long time before you would feel comfortable that you have the safety profile that you have with DUPIXENT. One of the miracles of DUPIXENT is its incredible efficacy, which is so far relatively unmatched, but just as, if not more importantly, that is immunomodulated, that actually corrects the immune system and does not debilitate it by creating any profound immunosuppression. I think when you look at other agents, whether you're talking about OX40 or talking about the JAKs or anything else, they are much broader at attacking the immune system. It's going to take a long time, I think, to develop the sort of comfort that one has with the incredible safety profile of DUPIXENT, let alone its efficacy.

Concluding with our regeneron genetic medicines pipeline.

Leonard Schleifer: The triplet combination of semaglutide with both antibodies had a higher rate of discontinuations due to tolerability issues and other adverse events, consistent with the safety profile previously observed with garatozumab monotherapy in other disease settings. Emerging data from across this class further validates our approach in this area. Final 26-week efficacy and safety results were consistent with the interim data and will be presented in the late breaking session at the 61st annual meeting of the European Association for the Study of Diabetes in September of 2025. Concluding with our REGENERON genetic medicines pipeline, our C5 siRNA and antibody combination has shown robust efficacy in patients with paroxysmal nocturnal hemoglobinuria, or PNH. These data and PNH support our confidence in this regimen's potential to improve outcomes and reduce treatment burden in generalized myasthenia gravis, where pivotal results from an ongoing phase three study are expected in the third quarter.

<unk> five <unk>, an antibody combination has shown robust efficacy in patients with paroxysmal nocturnal hemoglobinuria, where <unk>. These data and PVH support our confidence in this regimen has potential to improve outcomes and reduce treatment burden in generalized myasthenia gravis, where pivotal results from an ongoing phase.

Concluding with our regeneron genetic medicines pipeline.

<unk> five <unk>, an antibody combination has shown robust efficacy in patients with paroxysmal nocturnal hemoglobinuria, where pn H. These data and PVH support our confidence in this regimen has potential to improve outcomes and reduce treatment burden and generalized myasthenia gravis, where pivotal results from an ongoing phase.

Results from our ongoing Phase 2 card study, which is a valuing, the combination of trauma. A myosin antibody with, or without guar to map an active, and a antibody. And some glutide confirm the potential to enhance glp1 mediated weight loss, while preserving lean mass at the inter analysis. Our trial confirmed that approximately 35% of cemig glutide. Induced weight loss was due to lean mass loss. An average loss of 7 to 8 pounds of lean mass per patient. Once again, highlighting a well-documented concern associated with this therapeutic class combining some agide with our muscle preserving antibodies, reduce lean mass loss by 50 to 80% while also increasing fat M Mass loss at the 26 week time point. The combination of some glutide with trauma was generally. Well tolerated, the triplet combination of cemig glutide with both antibodies had a higher rate of discontinuation due to tolerability

III study are expected in the third quarter. This study will provide insights into the activity of both <unk> monotherapy and <unk> antibody combination.

<unk> III study are expected in the third quarter. This study will provide insights into the activity of both <unk> monotherapy and <unk> antibody combination.

III study are expected in the third quarter. This study will provide insights into the activity of both <unk> monotherapy and <unk> antibody combination.

Our ongoing phase III studies in geographic atrophy, and <unk> as well as preclinical efforts in this space further underscore our commitment to advancing this program.

To save your profile, previously observed with the article may have monotherapy and other diseases. Sex emerging data from across this class further validates our approach in this area. The final 26-week efficacy and safety results were consistent with the interim data and will be presented in the late-breaking session at the 61st Annual Meeting of the European Association for the Study of Diabetes in September 2025.

Our ongoing phase III studies in geographic atrophy, and <unk> as well as preclinical efforts in this space further underscore our commitment to advancing this program.

Including with our general and genetic medicine's pipeline.

In addition, we will also continue to advance our genetic medicine programs and mash neurodegenerative disorders, and hearing loss and expect to provide updates over the next few months.

Leonard Schleifer: The corollary, of course, of what George was saying about attacking broadly is that we will deal with patients who have comorbidities, and we can do that in a way that I don't think any other agent is suggested that we'll be able to do. There are so many people who have asthma with atopic dermatitis or asthma with nasal polyps or asthma with eosinophilic esophagitis and so on. And so that fundamental mechanism of attacking this type 2 pathway that George is referring to gives us this commercial advantage as well because it attacks so many common diseases that many people have. And doctors also don't need to get familiar with many different drugs in this allergy spectrum when one like Dupixent can cut across so many. Next question.

Leonard S. Schleifer: The corollary, of course, of what George was saying about attacking broadly is that we will deal with patients who have comorbidities, and we can do that in a way that I don't think any other agent is suggested that we'll be able to do. There are so many people who have asthma with atopic dermatitis or asthma with nasal polyps or asthma with eosinophilic esophagitis and so on. And so that fundamental mechanism of attacking this type 2 pathway that George is referring to gives us this commercial advantage as well because it attacks so many common diseases that many people have. And doctors also don't need to get familiar with many different drugs in this allergy spectrum when one like Dupixent can cut across so many. Next question.

In addition, we will also continue to advance our genetic medicines programs and mash neurodegenerative disorders, and hearing loss and expect to provide updates over the next few months.

In addition, we will also continue to advance our genetic medicine programs and mash neurodegenerative disorders, and hearing loss and expect to provide updates over the next few months.

In summary, Regeneron continues to lead in scientific innovation delivering results that redefine possibilities in medicine, our R&D expertise has enabled us to build one of the most dynamic and promising pipelines in the industry and we look forward to several important milestone in the coming months with that let me turn it over to Mary.

In summary, Regeneron continues to lead in scientific innovation delivering results that redefined possibilities in medicine, our R&D expertise has enabled us to build one of the most dynamic and promising pipelines in the industry and we look forward to several important milestone in the coming months with that let me turn it over to Mary.

Leonard Schleifer: This study will provide insights into the activity of both the C5 siRNA monotherapy and C5 siRNA antibody combinations. Our ongoing phase 3 studies in geographic atrophy and PNH, as well as preclinical efforts in this space, further underscore our commitment to advancing this program. In addition, we also continue to advance our genetic medicines programs in NASH, neurodegenerative disorders, and hearing loss and expect to provide updates over the next few months. In summary, Regeneron continues to lead in scientific innovation, delivering results that redefine possibilities in medicine. Our R&D expertise has enabled us to build one of the most dynamic and promising pipelines in the industry, and we look forward to several important milestones in the coming months. With that, let me turn it over to Marion.

George our second quarter performance highlights the strength and resiliency of refinance commercial portfolio, demonstrating our ability to deliver important medicines to patients we are well positioned to drive growth fully realizing the potential of our leading brands and capitalizing on emerging opportunities. Recent launches include Lindsay ethic, our first hematology.

Thank you George our second quarter performance highlights the strength and resiliency of Regeneron commercial portfolio, demonstrating our ability to deliver important medicines to patients.

George our second quarter performance highlights the strength and resiliency every journalist commercial portfolio, demonstrating our ability to deliver important medicines to patients we are well positioned to drive growth fully realizing the potential of our leading brands and capitalizing on emerging opportunities recent launches include lenders ethic, our first hematology.

All right. C5 s i RNA and antibiotic combination has shown robust efficacy in patients with paroxysmal, nocturnal hemoglobinuria, or pnh these data in P&H support. Our confidence in this regiment's potential to improve outcomes and reduce treatment. Burden in generalized myia gravis, your results from an ongoing phase 3 study are expected in the third quarter. This study will provide insights into the activity of both the C5, srna monotherapy, and C5 srna. Antibody combinations. Our ongoing phase 3 studies in Geographic, Galaxy and P&H, as well as preclinical efforts in this space. Further underscore our commitment to advancing this program.

Well positioned to drive growth fully realizing the potential of our leading brands and capitalizing on emerging opportunities. Recent launches include lenders ethic, our first hematology product in the U S. As well as two depicts <unk> dermatology launches in chronic spontaneous urticaria and bullous pemphigoid further expanding its therapeutic reach a robot.

In addition, we also continue to advance our genetic methods programs in Mash neurodegenerative disorders and hearing loss and expect to provide updates over the next few months.

In the U S as well as two depicts <unk> dermatology launches in chronic spontaneous urticaria and bullous pemphigoid further expanding its therapeutic reach a robust pipeline also provides substantial opportunities to bring transformative treatments to even more patients.

In the U S as well as two depicts in dermatology lunches and chronic spontaneous urticaria and bullous pemphigoid further expanding its therapeutic reach a robust pipeline also provides substantial opportunities to bring transformative treatments to even more patients.

Ryan Crowe: Shannon, let's go to the next caller, please.

Operator: Our next question comes from the line of Evan Segerman with BMO Capital Markets. Your line is now open.

[Analyst]: Hi guys. Thank you so much for taking my question. I want to touch on some thoughts on MFN. So with some of your key products marketed outside of the United States by partners, specifically European partners, what mechanisms or abilities do you have to impact pricing OUS? Is there anything you can really do to force a higher price from a partner?

Evan Seigerman (BMO Cap: Hi guys. Thank you so much for taking my question. I want to touch on some thoughts on MFN. So with some of your key products marketed outside of the United States by partners, specifically European partners, what mechanisms or abilities do you have to impact pricing OUS? Is there anything you can really do to force a higher price from a partner?

Pipeline also provides substantial opportunities to bring transformative treatments to even more patients.

Marion McCourt: Thank you, George. Our second quarter performance highlights the strength and resiliency of Regeneron's commercial portfolio, demonstrating our ability to deliver important medicines to patients. We are well positioned to drive growth, fully realizing the potential of our leading brands and capitalizing on emerging opportunities. Recent launches include LIBTAYO, our first hematology product in the U.S., as well as two DUPIXENT dermatology launches in chronic spontaneous urticaria and bullous pemphigoid, further expanding its therapeutic reach. Our robust pipeline also provides substantial opportunities to bring transformative treatments to even more patients. Starting with EYLEA HD and EYLEA, in the second quarter, total combined U.S. net sales were $1.15 billion, maintaining our leading position in the anti-VEGF category. Notably, EYLEA HD U.S. net sales grew to $393 million, driven by strong unit demand, which increased 16% sequentially, making EYLEA HD the fastest growing innovative brand in the category.

Starting with Eylea HD and <unk> in the second quarter total combined U S. Net sales were 115 billion, maintaining our leading position in the anti VEGF category, notably alia HD U S. Net sales grew to $393 million driven by strong unit demand, which increased 16%.

In summary, Regeneron continues to lead in scientific innovations, delivering results that redefine possibilities in medicine. Our R&D expertise has enabled us to build one of the most dynamic and promising pipelines in the industry. We look forward to several important milestones in the coming months. With that, let me turn it over to the mayor.

Starting with Eylea HD in EMEA in the second quarter total combined U S. Net sales were $1, one 5 billion, maintaining our leading position in the anti VEGF category, notably alia HD U S. Net sales grew to $393 million driven by strong unit demand, which increased 16%.

Starting with Eylea HD and mainly in the second quarter total combined U S. Net sales were 115 billion, maintaining our leading position in the anti VEGF category, notably Eylea HD U S. Net sales grew to $393 million driven by strong unit demand, which increased 16%.

Leonard Schleifer: Yeah, it's a great question. I think that's one of the issues and that new contracts will probably, since this is going to apply mainly to new drugs, according to the Dear Health Plan letter, as it's being known in the industry now. The Dear Health Plan letter suggested that you have to do this on new products, not on old products. And one of the reasons may be because of that complication. I suspect a lot of new contracts will have to deal with the contingency of what happens when if you license something to Europe. But Evan, it's really a great question because, for example, we don't control the pricing of EYLEA outside the United States. That's controlled by Bayer. So these are some of the wrinkles that are going to have to be figured out. Thanks for pointing that out.

Leonard S. Schleifer: Yeah, it's a great question. I think that's one of the issues and that new contracts will probably, since this is going to apply mainly to new drugs, according to the Dear Health Plan letter, as it's being known in the industry now. The Dear Health Plan letter suggested that you have to do this on new products, not on old products. And one of the reasons may be because of that complication. I suspect a lot of new contracts will have to deal with the contingency of what happens when if you license something to Europe. But Evan, it's really a great question because, for example, we don't control the pricing of EYLEA outside the United States. That's controlled by Bayer. So these are some of the wrinkles that are going to have to be figured out. Thanks for pointing that out.

<unk>, making eylea HD SaaS, just growing innovative brand in the category.

<unk>, making aliyah HD SaaS, just growing innovative brand in the category.

<unk>, making eylea HD SaaS, just growing innovative brand in the category.

HD is a solid foundation for future growth and now contributes one third of total combined U S. Net sales for our retina products. Looking ahead, we expect stable demand and co potential inflection pending FDA approval of enhancement 20 Ahd's profile.

H D as a solid foundation for future growth and now contributes one third of total combined U S. Net sales for our retina products. Looking ahead, we expect stable demand and co potential inflection pending FDA approval of enhancement 20 Ahd's profile.

HD is a solid foundation for future growth and now contributes one third of total combined U S. Net sales for our retina products. Looking ahead, we expect stable demand and total potential inflection pending FDA approval of enhancement 20 Ahd's profile.

Thank you, George. Our second quarter performance highlights the strength and resiliency of Regeneron's commercial portfolio, demonstrating our ability to deliver important medicines to patients. We are well-positioned to drive growth, fully realizing the potential of our leading brands and capitalizing on emerging opportunities. Recent launches include Libtayo, our first hematology product in the U.S., as well as Dupixent in dermatology, launched for chronic spontaneous urticaria and atopic dermatitis, further expanding its therapeutic reach. Our robust pipeline also provides substantial opportunities to bring transformative treatments to even more patients.

Second quarter U S. Net sales were $754 million, reflecting competitive dynamics from both branded and Biosimilar competition as well as the ongoing conversion of patients 20 HD.

<unk> unit demand declined 10% sequentially and we anticipate comparable demand decline in the second half of the year.

Starting with AA, HD, and IA, the second quarter total combined U.S. net sales were $1.15 billion, maintaining our leading position in the anti-vegetative category. Notably, IA and HD U.S. net sales grew to $393 million, driven by strong unit demand, which increased 16% sequentially, making it...

<unk> unit demand declined 10% sequentially and we anticipate comparable demand decline in the second half of the year retina practices continued to report a negative impact on the branded anti VEGF category.

Unit demand declined 10% sequentially and we anticipate comparable demand decline in the second half of the year retina practices continued to report a negative impact on the branded anti VEGF category.

Marion McCourt: EYLEA HD has a solid foundation for future growth and now contributes one-third of total combined U.S. net sales of our retina products. Looking ahead, we expect stable demand and total potential inflection pending FDA approval of enhancement to EYLEA HD's profile. EYLEA's second quarter U.S. net sales were $754 million, reflecting competitive dynamics from both branded and biosimilar competition, as well as the ongoing conversion of patients to EYLEA HD. EYLEA unit demand declined 10% sequentially, and we anticipate comparable demand decline in the second half of the year. Retina practices continue to report a negative impact on the branded anti-VEGF category due to ongoing funding gaps at not-for-profit patient assistance foundations that provide copay support for eligible patients with retina diseases. Next to DUPIXENT, in the second quarter, global net sales were $4.3 billion and grew 21% on a constant currency basis compared to the prior year.

<unk> practices continued to report a negative impact on the branded anti VEGF category.

Ryan Crowe: Let's go to the next question, please.

Ryan Crowe: Let's go to the next question, please, Shannon.

Operator: Shannon, our next question comes from the line of Akash Tiwari with Jefferies. Your line is now open.

The ongoing funding gaps not for profit patient assistance foundations that provide co pay support for eligible patients with retinal diseases next to detection in the second quarter Global net sales were $4 3 billion and grew 21% on a constant currency basis compared to the prior year. This growth was driven by broad demand across existing.

Operator: Our next question comes from the line of Akash Tiwari with Jefferies. Your line is now open.

Ongoing funding gaps not for profit patient assistance foundations that provide co pay support for eligible patients with retinal diseases.

[Analyst]: Hey, thanks so much on Pavblu. We were internally expecting to see the ASP decline to kind of reflect Amgen's volume-based discounts. We felt like that would then in turn drop physician demand like we've seen with Cimerli. Interestingly, the ASP actually hasn't declined that much, suggesting Amgen may be offering deferred discounts. For the Regeneron team, how does the prolonged run rate for Pavblu impact your outlook for EYLEA? You mentioned continued declines. Number two, are there any options you're exploring here to combat this strategy? Thank you.

Akash Tewari: Hey, thanks so much. On Pavblu, we were internally expecting to see the ASP decline to kind of reflect Amgen's volume-based discounts. We felt like that would then in turn drop physician demand like we've seen with Cimerli. Interestingly, the ASP actually hasn't declined that much, suggesting Amgen may be offering deferred discounts. For the Regeneron team, how does the prolonged run rate for Pavblu impact your outlook for EYLEA? You mentioned continued declines. Number two, are there any options you're exploring here to combat this strategy? Thank you.

Earlier HD the fastest growing Innovative brand in the category. I lead HD has a solid foundation for future growth and now contributes 1/3 of total combined us. Net sales of our retina products looking ahead. We expect stable, demand and toe potential inflection pending FDA approval of enhancement to Aliyah hd's profile.

Next to the picture in the second quarter Global net sales were $4 3 billion and grew 21% on a constant currency basis compared to the prior year. This growth was driven by broad demand across existing and recently launched indications geographies and age groups.

And recently launched indications geographies and age groups in the U S depicts the net sales were $3 2 billion, representing 23% year over year growth.

The U S. <unk> net sales were $3 2 billion, representing 23% year over year growth and continuing to pick some strong performance and market leading position.

U S. <unk> net sales were $3 2 billion, representing 23% year over year growth.

You mean to pick some strong performance and market leading position.

Alias second quarter us, net sales were 754 million, reflecting competitive Dynamics from both branded and biosimilar competition, as well as the ongoing conversion of patients to Aliyah HD aliia unit, demand declined, 10% sequentially. And we anticipate comparable demand decline in the second half of the year.

<unk> is a leader in new to brand and total prescriptions for seven to eight FTE print indications with our recently launched CSU indication being the only exception and topic dermatitis depicts and continues to strengthen its position as the standard of care competitor promotional spend has further accelerated overall.

You mean to pick some strong performance and market leading position.

Leonard Schleifer: Yeah, I don't want to get into practices that some might deem inappropriate in terms of deferring of rebates. But that's something we're sort of looking into, is whether that is driving some of their success. At the end of the day, you have a product that globally has probably had something like 100 million injections. It's not just the product, but it's also the purity of how you make it and how doctors trust it and so on and so forth. But Pavblu is a competitor and we're out there. We think that HD is the real answer to that. And as many people as get experience with it, we think that's going to be a much preferred drug than EYLEA or Pavblu.

Leonard S. Schleifer: Yeah, I don't want to get into practices that some might deem inappropriate in terms of deferring of rebates. But that's something we're sort of looking into, is whether that is driving some of their success. At the end of the day, you have a product that globally has probably had something like 100 million injections. It's not just the product, but it's also the purity of how you make it and how doctors trust it and so on and so forth. But Pavblu is a competitor and we're out there. We think that HD is the real answer to that. And as many people as get experience with it, we think that's going to be a much preferred drug than EYLEA or Pavblu.

It is a leader in new to brand and total prescriptions for seven to eight FTE print indications with our recently launched CSU indication in the only exception and topic dermatitis depicts <unk> continues to strengthen its position as a standard of care competitor promotional spend has further accelerated overall.

<unk> is a leader in new to brand and total prescriptions for seven to eight FTE approved indications with our recently launched CSU indication being the only exception and topic dermatitis depicts and continues to strengthen its position as the standard of care competitor promotional spend has further accelerated overall.

Marion McCourt: This growth was driven by broad demand across existing and recently launched indications, geographies, and age groups. In the U.S., DUPIXENT net sales were $3.2 billion, representing 23% year-over-year growth and continuing DUPIXENT's strong performance and market-leading position. DUPIXENT is a leader in new-to-brand and total prescriptions for seven of its eight FDA-approved indications, with our recently launched CSU indication being the only exception. In atopic dermatitis, DUPIXENT continues to strengthen its position as a standard of care. Competitor promotional spend has further accelerated overall market growth, and DUPIXENT remains the primary beneficiary of this expansion. Recent launches in chronic spontaneous urticaria and bullous pemphigoid are off to a fast start. The CSU launch has gained significant traction with both dermatologists and allergists who are actively prescribing DUPIXENT and embracing it as a trusted and effective treatment option.

Greg and it takes it remains the primary beneficiary of this expansion recent launches and chronic spontaneous urticaria and bullous pemphigoid are off to a fast start. This CSU launches gained significant traction with both dermatologists and allergists, who are actively prescribing to pixel and embracing it as a trusted and effective treatment option.

Growth and it takes it remains the primary beneficiary of this expansion recent launches and chronic spontaneous urticaria and bullous pemphigoid are off to a fast start. This CSU launches gained significant traction with both dermatologists and allergists, who are actively prescribing to pixel and embracing it as a trusted and effective treatment option.

Retina practices continue to report, a negative impact on the Branded anti veg of category due to the ongoing funding gaps at not for-profit patient assistance. Foundations that provide co-pay support for eligible patients with Retina diseases. Next to depict them in the second quarter. Global net sales were 4.3 billion and grew 21% on a constant currency basis. Compared to the prior year, this growth was driven by broad demand across existing and recently launched indications geographies and age groups in the US, depicts. A net sales were 3.2 billion representing 23% year-over-year growth and continuing to pick some strong performance and marketing leading positions.

The BP launch in late June and has also provided another opportunity for <unk> as the first and only FDA approved treatment for this debilitating disease early lunch indicators have been positive with the pixel is a critical therapeutic option for this previously underserved patient population to pyxis respiratory indications, including COPD.

The BP launch in late June has also provided another opportunity for <unk> as the first and only FDA approved treatment for this debilitating disease early launch indicators have been positive with detection as a critical therapeutic option for this previously underserved patient population depicts since respiratory indications, including COPD.

The BP launched in late June and has also provided another opportunity for <unk> as the first and only FDA approved treatment for this debilitating disease early lunch indicators have been positive with the pixel is a critical therapeutic option for this previously underserved patient population to pyxis respiratory indications, including COPD.

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

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

Operator: Shannon, our next question comes from the line of Terrence Flynn of Morgan Stanley. Your line is now open.

Operator: Our next question comes from the line of Terrence Flynn of Morgan Stanley. Your line is now open.

As my nasal polyps continue to drive growth. The COPD launch is progressing very well with rapid physician uptake.

[Analyst]: Great. Thanks for taking the question. You mentioned in the Fianlumab first-line melanoma study that the event rate is slowing. So, just wondering if you could speculate on reasons there and just speak to your confidence level in showing a positive readout here and remind us what the efficacy bar is that you're looking for and helping to show. Thank you.

Terence Flynn [Managing Director: Great. Thanks for taking the question. You mentioned in the Fianlumab first-line melanoma study that the event rate is slowing. So, just wondering if you could speculate on reasons there and just speak to your confidence level in showing a positive readout here and remind us what the efficacy bar is that you're looking for and helping to show. Thank you.

As my nasal polyps continue to drive growth. The COPD launch is progressing very well with rapid physician uptake.

Turning to oncology and hematology in the second quarter mid tier to leverage global net sales of 377 million growing 25% on constant currency basis compared to the prior year.

Turning to oncology and hematology in the second quarter mid tier to lead our global net sales of 377 million growing 25% on constant currency basis compared to the prior year.

Turning to oncology and hematology in the second quarter mid tier to limit global net sales of 377 million growing 25% on constant currency basis compared to the prior year.

Marion McCourt: The BP launch in late June has also provided another opportunity for DUPIXENT as the first and only FDA-approved treatment for this debilitating disease. Early launch indicators have been positive, with DUPIXENT as a critical therapeutic option for this previously underserved patient population. DUPIXENT's respiratory indications, including COPD, asthma, and nasal polyps, continue to drive growth. The COPD launch is progressing very well with rapid physician uptake. Turning to oncology and hematology, in the second quarter, LIBTAYO delivered global net sales of $377 million, growing 25% on a constant currency basis compared to the prior year. In the U.S., LIBTAYO net sales grew 36% year-over-year to $248 million, driven by growth across the non-melanoma skin and lung cancer indications. The quarter was also favorably impacted by the timing of customer shipments by approximately $20 million, which we expect to adversely impact third-quarter U.S. net product sales.

The U S mid tier net sales grew 36% year over year to $2 $48 million driven by growth across the non melanoma skin and lung cancer indications.

U S mid tier net sales grew 36% year over year to $248 million driven by growth across the non melanoma skin and lung cancer indications.

The U S mid tier net sales grew 36% year over year to $2 $48 million driven by growth across the non melanoma skin and lung cancer indications.

George Yancopoulos: Well, I think that you can make a lot of speculations on what it means when you have less events than you might have planned or powered for. That said, what we're powering for is having minimally the sort of effect that the competitors have shown. Of course, with room to show, perhaps even a better effect. And as we said, because of the slowing of the event rates, it has now delayed when we're going to get these results.

Quarter was also favorably impacted by the timing of customer shipments by approximately $20 million, which we expect to adversely impact third quarter U S net product sales.

Continue to see robust demand and market leadership with Tayo in non melanoma skin cancer. We are encouraged by strong key opinion leader interest in the clinical results for adjuvant CFCC program.

Disease early. Launch indicators have been positive, which depicts them as a critical therapeutic option for this previously underserved patient. Population depictions respiratory indications including COPD asthma nasal. Polyps continue to drive growth. The COPD launches progressing, very well with rapid physician. Uptake.

Continue to see robust demand and market leadership, Tayo and non melanoma skin cancer were encouraged by strong key opinion leader interest in the clinical results for adjuvant CFCC program.

Continue to see robust demand and market leadership with Tayo in non melanoma skin cancer were encouraged by strong key opinion leader interest in the clinical results for adjuvant CFCC program.

<unk> applications for recently accepted in both the U S and EU and preparations are underway for a potential launch in the US Later this year and in Europe. In 2026, if approved <unk> has the potential to help more than 10000 patients in the U S and EU in this setting in lung cancer with time is steadily increasing.

Turning to oncology and hematology in the second quarter lived to deliver global net sales of 377 million growing 25% on constant currency basis compared to the prior year.

Leonard Schleifer: You know, this is why you do a blinded study. We've looked at, you know, hundreds of studies over the years. We have engaged in speculations. George probably has the most insight of anybody. But the bottom line is you just have to wait till the unblinding.

Leonard S. Schleifer: You know, this is why you do a blinded study. We've looked at, you know, hundreds of studies over the years. We have engaged in speculations. George probably has the most insight of anybody. But the bottom line is you just have to wait till the unblinding.

Tori applications for recently accepted in both the U S and EU and preparations are underway for a potential launch in the US Later this year and in Europe. In 2026, if approved <unk> has the potential to help more than 10000 patients in the U S and EU in this setting in lung cancer with time is steadily increasing.

Batori applications for recently accepted in both the U S and EU and preparations are underway for a potential launch in the US Later this year and in Europe. In 2026, if approved <unk> has the potential to help more than 10000 patients in the U S and EU in this setting in lung cancer <unk> steadily.

Ryan Crowe: Move to the next question, please, Shannon.

Operator: Our next question comes from the line of David Risinger of Leerink Partners. Your line is now open.

Marion McCourt: We continue to see robust demand and market leadership of LIBTAYO in non-melanoma skin cancer. We are encouraged by strong key opinion leader interest in the clinical results for our adjuvant CSCC program. Regulatory applications were recently accepted in both the U.S. and EU, and preparations are underway for a potential launch in the U.S. later this year and in Europe in 2026. If approved, LIBTAYO has the potential to help more than 10,000 patients in the U.S. and EU in this setting. In lung cancer, LIBTAYO is steadily increasing new patient share in the U.S., with more physicians prescribing LIBTAYO as a preferred treatment option for their patients and solidifying its position as the number two most prescribed IO treatment in newly diagnosed patients.

Greasing, new patient share in the U S with more physicians prescribing the tayo as a preferred treatment option for their patients and solidifying its position as the number two most prescribed I O treatment in newly diagnosed patients.

Creasing, new patient share in the U S with more physicians prescribing the tayo as a preferred treatment option for their patients and solidifying its position as the number two most prescribed I O treatment in newly diagnosed patients outside the U S. <unk> net sales reached 129 million growing 8% year over year on a constant currency.

In the US Leto. Net sales grew, 36% year-over-year to 248 million driven by growth Across the non-melanoma Skin and lung cancer indications. The quarter was also favorably impacted by the timing of customer shipments by approximately 20 million dollars which we expect to adversely impact. Third quarter us, net product sales.

[Analyst]: Yes, thanks very much, and thanks for all the updates. So, I guess my question is for Len and George. So, there's a tremendous disconnect between Regeneron management's view of its pipeline and Wall Street's views. I think that the company spending about $5 billion a year R&D and 2032 consensus pipeline estimates are about $3.5 billion. So, maybe you could shed some light on the path ahead for Regeneron to shed better light on the commercial value of its pipeline. Thank you, David.

David Risinger: Yes, thanks very much, and thanks for all the updates. So, I guess my question is for Len and George. So, there's a tremendous disconnect between Regeneron management's view of its pipeline and Wall Street's views. I think that the company spending about $5 billion a year R&D and 2032 consensus pipeline estimates are about $3.5 billion. So, maybe you could shed some light on the path ahead for Regeneron to shed better light on the commercial value of its pipeline. Thank you.

Outside the U S. <unk> net sales reached 129 million growing 8% year over year on a constant currency basis supported by ongoing launches and sustained demand in international markets, Netherlands, which was FDA approved in July in relapsed refractory multiple myeloma, marking a significant milestone for again on since.

Basis supported by ongoing launches and sustained demand in international markets, Netherlands, which was FDA approved in July in relapsed refractory multiple myeloma, marking a significant milestone for <unk>. Since then we've made early launch progress importantly was already added to the NCC and treat.

And then we've made early launch progress importantly, when does this like was already added to the NCC and treatment guidelines as a preferred product on par with other bi specifics in its class.

And then we've made early launch progress importantly, witnesses was already added to the NCC and treatment guidelines as a preferred product on par with other bi specifics in its class.

We continue to see robust demand and Market leadership, latio in Nom melanoma, skin cancer, we're encouraged by strong key opinion leader interest in the clinical results for our agent. Cscc program regulatory applications where recently accepted in both, the US and EU in preparations are underway for a potential launch in the US later this year. And in Europe in 2026, if approved, libtayo has the potential to help more than 10,000 patients in the US and EU. In this setting in lung cancer, lipio is steadily increasing.

Leonard Schleifer: Thanks for your question. It's a fair question. I think I would say two things before turning it over to George. First, I would say that history frequently is a good indicator. Our research organization has produced two of the most important drugs in the history of the industry, including EYLEA and DUPIXENT. I think that that's the first thing I would say. The second thing I would say is that you should perhaps listen very carefully and maybe George can reiterate some of what he said on the call today. Just as an example of one area of our pipeline which was really new and exciting, these data in early stage myeloma, smoldering myeloma, and early stage DLBCL lymphoma are really quite, quite encouraging for us. We are going full steam ahead into myeloma.

Leonard S. Schleifer: David, thanks for your question. It's a fair question. I think I would say two things before turning it over to George. First, I would say that history frequently is a good indicator. Our research organization has produced two of the most important drugs in the history of the industry, including EYLEA and DUPIXENT. I think that that's the first thing I would say. The second thing I would say is that you should perhaps listen very carefully and maybe George can reiterate some of what he said on the call today. Just as an example of one area of our pipeline which was really new and exciting, these data in early stage myeloma, smoldering myeloma, and early stage DLBCL lymphoma are really quite, quite encouraging for us. We are going full steam ahead into myeloma.

<unk> guidelines as a preferred product on par with other bi specifics in its class.

Key opinion leaders recognize what is the potential to be best in class B CMA by specific based on its impressive clinical efficacy efficacy safety and convenience.

Marion McCourt: Outside the U.S., LIBTAYO net sales reached $129 million, growing 8% year-over-year on a constant currency basis, supported by ongoing launches and sustained demand in international markets. Now to LIBTAYO, which was FDA approved in July in relapsed refractory multiple myeloma, marking a significant milestone for Regeneron. Since then, we've made early launch progress. Importantly, LIBTAYO was already added to the NCCN treatment guidelines as a preferred product, on par with other bispecifics in its class. Key opinion leaders recognize LIBTAYO's potential to be best-in-class BCMA bispecific based on its impressive clinical efficacy, safety, and convenient response adapted dosing. At this stage, we expect modest revenue contributions in the second half of 2025, as physicians must satisfy REMS requirements before administering LIBTAYO, and formulary and pathway decisions need to be made.

Key opinion leaders recognize one has the potential to be best in class B CMA by specific based on its impressive clinical efficacy efficacy safety and convenience.

Key opinion leaders recognize what is the potential to be best in class B CMA by specific based on its impressive clinical efficacy efficacy safety and convenience.

Sponsor adapted dosing at this stage, we expect modest revenue contributions in the second half of 2025 as physicians must satisfy rems requiring requirements before administering limits epic and formulary and pathway decisions need to be made as George highlighted regeneron is advancing women's I think into earlier lines of therapy.

Sponsor adapted dosing at this stage, we expect modest revenue contributions in the second half of 2025 is physicians must satisfy rems requiring requirements before administering lenders epic and formulary and pathway decisions need to be made as George highlighted regeneron is advancing women's I think into earlier lines of therapy.

Through our differentiated development program aiming to establish lenders they think SMB eating Egypt and the rapidly growing 30 billion dollar market for multiple myeloma and precursor conditions.

Through our differentiated development program aiming to establish lenders ethic SMB eating agent in the rapidly growing 30 billion dollar market for multiple myeloma and precursor conditions.

Through our differentiated development program aiming to establish lenders they think SMB eating Egypt, and the rapidly growing $30 billion market for multiple myeloma and precursor conditions.

New patients here in the U.S. are seeing more physicians prescribing Lurio as a preferred treatment option for their patients, solidifying its position as the number 2 most prescribed IO treatment in newly diagnosed patients outside the U.S. Lurio net sales reached $129 million, growing 8% year-over-year on a constant currency basis, supported by ongoing launches and sustained demand in international markets. NATAL, which was FDA approved in July, is a treatment for relapsed refractory multiple myeloma, marking a significant milestone for Regeneron. Since then, we've made early launch progress. Importantly, Lurio has already been added to the NCCN treatment guidelines as a preferred product on par with other bispecifics in this class.

Summary, the quarter has been defined by growth across Eylea, HD depiction and look tayo as well as important progress in several launches, including women's epic our commercial portfolio is well positioned to capitalize on many near term growth opportunities, enabling us to deliver treatments to more patients and with that I'll turn the call to Chris.

Summary, the quarter has been defined by growth across Eylea, HD depiction and reptile as well as important progress in several launches including limits epic our commercial portfolio is well positioned to capitalize on many near term growth opportunities, enabling us to deliver treatment to more patients and with that I'll turn the call to Chris.

Summary, the quarter has been defined by growth across Eylea, HD depiction and look tayo as well as important progress in several launches including limits epic our commercial portfolio is well positioned to capitalize on many near term growth opportunities, enabling us to deliver treatments to more patients and with that I'll turn the call to Chris.

Leonard Schleifer: We're going to probably have somewhere in the neighborhood of eight different phase 3s going by next year. That's a $30 billion market and it will grow substantially as it moves into the pre-malignant stage. Big opportunities. George, you want to add anything to that?

We're going to probably have somewhere in the neighborhood of eight different phase 3s going by next year. That's a $30 billion market and it will grow substantially as it moves into the pre-malignant stage. Big opportunities. George, you want to add anything to that?

Marion McCourt: As George highlighted, Regeneron is advancing LIBTAYO into earlier lines of therapy through our differentiated development program, aiming to establish LIBTAYO as a leading agent in the rapidly growing $30 billion market for multiple myeloma and precursor conditions. In summary, the quarter has been defined by growth across EYLEA HD, DUPIXENT, and LIBTAYO, as well as important progress in several launches, including LIBTAYO. Our commercial portfolio is well positioned to capitalize on many near-term growth opportunities, enabling us to deliver treatments to more patients. With that, I'll turn the call to Chris.

Thank you Mara and my comments today on Regeneron financial results and outlook will be on a non-GAAP basis, unless otherwise noted.

Thank you Mary and my comments today on Regeneron financial results and outlook will be on a non-GAAP basis, unless otherwise noted.

Regeneron second quarter results demonstrate the strength of our commercial portfolio, which enables us to continue investing in our robust pipeline and returning capital to shareholders.

George Yancopoulos: Well, I think we all have to understand and acknowledge that probably the valuation review of the pipeline is in many ways being capped by concerns about what's going on with our existing mega products and whether they're going to show growth above and beyond what's going to be happening with those products. I think if one was independently looking at any one of these various new opportunities, like Len said, we believe that our BCMA bispecific, which right now has the best data in one of the most exciting new classes in the entire industry, has a chance to become another one of the most important drugs in the industry. Based on certainly a lot of the data that I described today in terms of running portions of many of our phase 3 programs with it, and we have several such programs.

Regeneron second quarter results demonstrate the strength of our commercial portfolio, which enables us to continue investing in our robust pipeline and returning capital to shareholders.

Key opinion leaders recognize. Well as if its potential to be best-in-class, bcma by specific based on its impressive clinical efficacy. Efficacy safety and convenient response adapted, dosing at this stage, we expect modest Revenue contributions in the second half of 2025 as Physicians must satisfy Rems requirements before administering, Linda zivic and formulary and pathway, decisions need to be made as George highlighted. Regeneron is advancing 1 as if into earlier lines of therapy. Through our differentiated development program, aiming to establish limits ific as a leading agent in the rapidly growing 30 billion dollar market for multiple myeloma and precursor conditions in some

Second quarter of 2025 total revenues of $3 7 billion grew 4% compared to the prior year, reflecting higher satisfy collaboration revenue, primarily driven by depiction higher U S. Net sales of Eylea HD and growth in global net sales of lip tayo.

Second quarter of 2025 total revenues of $3 7 billion grew 4% compared to the prior year, reflecting higher Safi collaboration revenue, primarily driven by depiction higher U S. Net sales of Eylea HD and growth in global net sales of La Tayo.

Second quarter 2025, total revenues of $3 7 billion grew 4% compared to the prior year, reflecting higher satisfy collaboration revenue, primarily driven by depiction higher U S. Net sales of Eylea HD and growth in global net sales of lip tayo.

Second quarter diluted net income per share grew 12% from the prior year to $12 89.

Chris Fenimore: Thank you, Marion McCourt. My comments today on Regeneron Pharmaceuticals' financial results and outlook will be on a non-GAAP basis unless otherwise noted. Regeneron Pharmaceuticals' second quarter results demonstrate the strength of our commercial portfolio, which enables us to continue investing in our robust pipeline and returning capital to shareholders. Second quarter 2025 total revenues of $3.7 billion grew 4% compared to the prior year, reflecting higher Sanofi collaboration revenue, primarily driven by DUPIXENT, higher U.S. net sales of EYLEA HD, and growth in global net sales of LIBTAYO. Second quarter diluted net income per share grew 12% from the prior year to $12.89 on net income of $1.4 billion.

The quarter has been defined by growth across AIA. Each day, we depict and leverage important progress in several launches, including Libilo. Our commercial portfolio is well positioned to capitalize on many near-term growth opportunities, enabling us to deliver treatments to more patients. And with that, I'll turn the call to Chris.

Second quarter diluted net income per share grew 12% from the prior year to $12 89.

Our net income of $1 4 billion.

Thank you Marian my comments today on regeneron's financial results and Outlook.

Beginning with this therapy collaboration revenues were approximately $1 4 billion of which $1 3 billion related to our share of collaboration profits.

will be on a non-GAAP basis, unless otherwise noted.

Our net income of $1 4 billion.

Beginning with this therapy collaboration revenues were approximately $1 4 billion of which $1 3 billion related to our share of collaboration profits.

Regenerative share of profits grew 30% versus the prior year, driven by volume growth with <unk> and improving collaboration margins.

General on second quarter, results demonstrate the strength of our commercial portfolio which enables us to continue investing in our robust Pipeline and returning Capital to shareholders.

Regeneron share of profits grew 30% versus the prior year, driven by volume growth through <unk> and improving collaboration margins.

Regenerative share of profits grew 30% versus the prior year, driven by volume growth with <unk> and improving collaboration margins.

The therapy development balance was approximately $1 2 billion at the end of the second quarter, reflecting a reduction of approximately $430 million since the start of the year. We continue to expect the balance to be fully reimbursed by the end of the year.

George Yancopoulos: But I think right now the excitement or enthusiasm of those is always being limited by people wanting to know, well, what's going to happen with EYLEA and so forth. So I think that our pipeline would be viewed very differently if it was viewed in isolation because of the incredible potential and opportunities. And as Len said, one of the best predictors of whether people can really do something important is whether they've repeatedly done that in the past.

But I think right now the excitement or enthusiasm of those is always being limited by people wanting to know, well, what's going to happen with EYLEA and so forth. So I think that our pipeline would be viewed very differently if it was viewed in isolation because of the incredible potential and opportunities. And as Len said, one of the best predictors of whether people can really do something important is whether they've repeatedly done that in the past.

Second quarter of 2025 total revenues of 3.7 billion, grew 4% compared to the prior year. Reflecting higher sanity collaboration Revenue, primarily driven by dupixent higher us, net sales of ahd and growth in global net sales of libtayo

Moving to buyer second.

Second quarter net sales of Eylea in Eylea eight Meg outside the U S were $978 million up 4% versus the prior year on a constant currency basis and inclusive of $242 million of Eylea eight makes sales total Bayer collaboration revenue grew 11% to 415 million of which.

Chris Fenimore: Beginning with the Sanofi collaboration, revenues were approximately $1.4 billion, of which $1.3 billion related to our share of collaboration profits. Regeneron Pharmaceuticals' share of profits grew 30% versus the prior year, driven by volume growth through DUPIXENT and improving collaboration margins. The Sanofi development balance was approximately $1.2 billion at the end of the second quarter, reflecting a reduction of approximately $430 million since the start of the year. We continue to expect the balance to be fully reimbursed by the end of the year. Moving to Bayer, second quarter net sales of EYLEA and EYLEA 8MIG outside the U.S. were $978 million, up 4% versus the prior year on a constant currency basis, and inclusive of $242 million of EYLEA 8MIG sales. Total Bayer collaboration revenue grew 11% to $415 million, of which $383 million related to our share of net profits outside the U.S.

second quarter diluted. Net income per share through 12% from the prior year to 12.89 on net income of 1.4 billion.

Moving to buyer SEC.

Moving to buyer second.

Second quarter net sales of Eylea in Eylea eight Meg outside the U S were $978 million up 4% versus the prior year on a constant currency basis, and inclusive of $242 million of Eylea eight mix sales total Bayer collaboration revenue grew 11% to $415 million of which.

Second quarter net sales of Eylea in Eylea eight Meg outside the U S were $978 million up 4% versus the prior year on a constant currency basis, and inclusive of $242 million of Eylea eight makes sales total Bayer collaboration revenue grew 11% to $450 million of which.

Beginning with the Santa, Fe collaboration revenues were approximately 1.4 billion of which 1.3 billion related to our share of collaboration profits.

Leonard Schleifer: Okay, yeah. So one other thing I would just add, David, that if you think about where the big opportunities are, lymphoma, myeloma, all the complement mediated diseases, geographic atrophy, myasthenia gravis, PNH, where we think we have best in class. Throw on top of that all of the thrombotic diseases with our two different offerings in that we've got a lot to do, but we've got a lot of exciting things. We're going to have some updates hopefully in the near future for our allergy program for birch and for cat allergy and our broad general allergy program. This is, I would say, investment that is really going to have strong returns.

Leonard S. Schleifer: Okay, yeah. So one other thing I would just add, David, that if you think about where the big opportunities are, lymphoma, myeloma, all the complement mediated diseases, geographic atrophy, myasthenia gravis, PNH, where we think we have best in class. Throw on top of that all of the thrombotic diseases with our two different offerings in that we've got a lot to do, but we've got a lot of exciting things. We're going to have some updates hopefully in the near future for our allergy program for birch and for cat allergy and our broad general allergy program. This is, I would say, investment that is really going to have strong returns.

$383 million related to our share of net profits outside the U S.

Regeneron. Share of profits grew 30% versus the prior year, driven by volume growth, through Dixon and improving collaboration margins.

$383 million related to our share of net profits outside the U S.

Other revenue in the second quarter was $184 million. This included a $118 million of profit share and royalties associated with license agreements, which were up 70% from the prior year. This increase was driven by growth in our share of profits from archivist and higher royalty income from <unk>.

The Sanity Development balance was approximately $1.2 billion at the end of the second quarter, reflecting a reduction of approximately $430 million since the start of the year. We continue to expect the balance to be fully reimbursed by the end of the year.

Moving to buyer.

Now to our operating expenses R&D expense was $1 3 billion in the second quarter, reflecting continued investments to support regeneron innovative mid to late stage pipeline, including our obesity hematology and thrombosis efforts.

Now to our operating expenses R&D expense was $1 3 billion in the second quarter, reflecting continued investments to support Regeneron is innovative mid to late stage pipeline, including our obesity hematology and thrombosis efforts.

Second quarter, SG&A was $542 million down 19% from the prior year. The decline was driven by lower general and administrative expenses second quarter 2025 gross margin on net product sales was 86%, but lower lower gross margin versus the prior year reflects ongoing investments to support.

Chris Fenimore: Other revenue in the second quarter was $184 million. This included $118 million of profit share and royalties associated with license agreements, which were up 70% from the prior year. This increase was driven by growth in our share of profits from Arcalyst and higher royalty income from Alaris. Now to our operating expenses. R&D expense was $1.3 billion in the second quarter, reflecting continued investments to support Regeneron Pharmaceuticals' innovative mid-to-late stage pipeline, including our obesity, hematology, and thrombosis efforts. Second quarter SG&A was $542 million, down 19% from the prior year. The decline was driven by lower general and administrative expenses. Second quarter 2025 gross margin on net product sales was 86%. The lower gross margin versus the prior year reflects ongoing investments to support our manufacturing operations and higher inventory write-offs in the second quarter of 2025.

Of 242 million of ailia. 8, Mig sales, total buyer collaboration Revenue, grew 11% to 415 million of which 383 million related to our share of net profits outside the US

Second quarter, SG&A was $542 million down 19% from the prior year. The decline was driven by lower general and administrative expenses.

Leonard Schleifer: It is hard for any one analyst or any one analyst team to look at 45 programs, or if you've got 10 different companies and the other nine have two programs each, you know, you could consume all the time. And that's maybe why it doesn't get as much attention as we would like. But we're really excited about it. And I would encourage you, all of you, to go back and listen very carefully to what George said today as a hint on what could happen in this mega megaspace of myeloma.

Leonard S. Schleifer: It is hard for any one analyst or any one analyst team to look at 45 programs, or if you've got 10 different companies and the other nine have two programs each, you know, you could consume all the time. And that's maybe why it doesn't get as much attention as we would like. But we're really excited about it. And I would encourage you, all of you, to go back and listen very carefully to what George said today as a hint on what could happen in this mega megaspace of myeloma.

Second quarter 2025 gross margin on net product sales was 86%, but lower lower gross margin versus the prior year reflects ongoing investments to support our manufacturing operations and higher inventory write offs in the second quarter of 2025.

Our manufacturing operations and higher inventory write offs in the second quarter of 2025.

Our manufacturing operations at higher inventory write offs in the second quarter of 2025.

Our effective tax rate in the second quarter was eight 3% inclusive of a favorable settlement of an IRS audit, which lowered our tax rate by approximately four percentage points.

Other revenue in the second quarter was $184 million. This included $118 million of profit share and royalties associated with license agreements, which were up 70% from the prior year. This increase was driven by growth in our share of profits from Arkansass and higher royalty income from Allarus. Now, to our operating expenses: R&D expense was $1.3 billion in the second quarter, reflecting continued investments to support Regeneron's innovative mid to late-stage pipeline.

Ryan Crowe: Okay, let's move to the next question, please.

Ryan Crowe: Okay, let's move to the next question, please, Shannon.

Operator: Shannon, our next question comes from the line of Alexandra Hammond of Wolfe Research. Your line is now open.

Regeneron generated $1 7 billion in free cash flow through the first six months of 2025 and ended the quarter with cash and marketable securities of $17 5 billion and debt of approximately $2 7 billion.

Including our obesity hematology and thrombosis efforts.

Operator: Our next question comes from the line of Alexandria Hammond of Wolfe Research. Your line is now open.

Marion McCourt: Thanks for taking the question. I kind of wanted to focus on the pipeline, to Len's point. So one of the lesser talked about programs is Regeneron's Pozelimab readout in gMG. So as that readout approaches, can you just remind us again of the bar for success? I guess. What do you think you need to be commercially successful there? Thank you.

Alexandria Hammond: Thanks for taking the question. I kind of wanted to focus on the pipeline, to Len's point. So one of the lesser talked about programs is Regeneron's Pozelimab readout in gMG. So as that readout approaches, can you just remind us again of the bar for success? I guess. What do you think you need to be commercially successful there? Thank you.

Second quarter sgna was 542 million down. 19% from the prior year. The decline was driven by lower General and administrative expenses.

We repurchased approximately $1 $1 billion worth of our shares in the second quarter at approximately $2 2 billion. So far in 2025, resulting in a net reduction in our common shares outstanding of $3 2 million shares from the end of 2024 with approximately $2 8 billion still available for share repurchases as of June.

We repurchased approximately $1 $1 billion worth of our shares in the second quarter at approximately $2 $2 billion. So far in 2025, resulting in a net reduction in our common shares outstanding of $3 2 million shares from the end of 2024 with approximately $2 8 billion still available for share repurchases as of June.

Chris Fenimore: Our effective tax rate in the second quarter was 8.3%, inclusive of a favorable settlement of an IRS audit, which lowered our tax rate by approximately four percentage points. Regeneron generated $1.7 billion in free cash flow through the first six months of 2025 and ended the quarter with cash and marketable securities of $17.5 billion and debt of approximately $2.7 billion. We repurchased approximately $1.1 billion worth of our shares in the second quarter and approximately $2.2 billion so far in 2025, resulting in a net reduction in our common shares outstanding of 3.2 million shares from the end of 2024. With approximately $2.8 billion still available for share repurchases as of June 30, we remain opportunistic buyers of our shares. We have made some updates to our 2025 financial guidance.

second quarter, 2025 gross margin on net product sales was 86% the glower, lower gross margin versus the prior year reflects ongoing Investments to support our manufacturing operations and higher inventory, write-offs and the second quarter of 2025

George Yancopoulos: Well, I can speak to what we need to be clinically successful, and maybe I'll leave it for Marion, or speculation about what we need to be commercially successful. We are setting the bar pretty much at the bar that has been achieved with all other agents that are now being utilized in this clinical class. What we think we may have to offer is one of the more convenient dosing regimens in myasthenia gravis. We don't necessarily think that the sort of extent of blockade and so forth is going to be as important as it is in other diseases in order to demonstrate better efficacy. So the play in myasthenia gravis is to show similar benefit but with a much more convenient dosing regimen.

<unk>, we remained opportunistic opportunistic buyers of our shares.

Our effective tax rate. In the second quarter was 8.3%. Inclusive of a favorable settlement of an IRS audit, which lowered our tax rate by approximately 4 percentage points.

<unk>, we remained opportunistic opportunistic buyers of our shares.

We have made some updates to our 2025 financial guidance changes and guidance ranges for SG&A R&D and <unk> expenses result in a combined net decrease of $125 million.

Regeneron generated 1.7 billion in free cash flow through the first 6 months of 20125 and ended. The quarter with cash and marketable securities of 17.5 billion and debt of approximately 2.7 billion.

At their respective mid points, partially offset by slightly lower gross margin guidance importantly, the change to our gross margin guidance is unrelated to recent tariff announcements.

Many details from the U S. EU trade agreement have yet to emerge, including winning tariff may go into effect. We do not currently expect a 15% tariff on non generic pharmaceutical products to have a material impact on our financial results in 2025, as we gain clarity on important details from a trade agreement and <unk>.

We repurchased the approximately 1.1 billion dollars worth of our shares in the second quarter and approximately 2.2 billion so far in 2025, resulting in a net reduction. In our common shares outstanding of 3.2 million shares from the end of 2024,

With approximately 2.8 billion. Still available for share repurchases, as of June 30th, we remain opportunist opportunistic buyers of our shares,

Chris Fenimore: Changes in guidance ranges for SG&A, R&D, and COCM expenses result in a combined net decrease of $125 million at the respective midpoints, partially offset by slightly lower gross margin guidance. Importantly, the change to our gross margin guidance is unrelated to recent tariff announcements. While many details from the U.S.-EU trade agreement have yet to emerge, including when a tariff may go into effect, we do not currently expect a 15% tariff on non-generic pharmaceutical products to have a material impact on our financial results in 2025. As we gain clarity on important details from the trade agreement and other potential tariffs, we will be in a better position to evaluate the financial impact of tariffs in 2026 and over the longer term.

George Yancopoulos: Let me just remind you we have a monthly self-administered subcutaneous regimen, which, compared to other dosing regimens which tend to be IV infusions often administered much more frequently, or even subcutaneous daily injections. We think that those could have a lot of advantages for patients if they demonstrated similar types of efficacy. But the approach also can better control complement activity, and in several other diseases that we're exploring, we think that that can translate to actually an efficacy improvement as well.

Let me just remind you we have a monthly self-administered subcutaneous regimen, which, compared to other dosing regimens which tend to be IV infusions often administered much more frequently, or even subcutaneous daily injections. We think that those could have a lot of advantages for patients if they demonstrated similar types of efficacy. But the approach also can better control complement activity, and in several other diseases that we're exploring, we think that that can translate to actually an efficacy improvement as well.

Other potential tariffs, we will be in a better position to evaluate the financial impact of tariffs in 2026 and over the longer term.

Finally, while we are continuing to evaluate the impact of recently enacted tax legislation. We currently anticipated limited impact to our effective tax rate in the long term and continue to expect this rate to trend towards the mid teens over time, a full summary of our latest guidance can be found in our press release issued earlier this morning.

We have made some updates to our 2025 Financial guidance changes and guidance ranges for sgna R&D and cocm expenses result in a combined net decrease of 125 million at the respective. Midpoints partially offset by slightly lower gross margin. Guidance importantly, the change to our gross margin guidance is unrelated to recent tariff announcements.

In conclusion with general on second quarter results demonstrate the strength of our business and enable us to continue to invest in our differentiated pipeline to deliver breakthroughs for patients and long term value for shareholders with that I will pass the call back to Ryan.

Marion McCourt: I would add to that to George's comments that, you know, this is a large indication, there's a lot of unmet need. Then on top of that, if we're able to have a differentiated product that offers the conveniences that George has mentioned, that will be very, very important. Any additional efficacy benefit is always meaningful. And to this point, the safety profile looks very good. So we look forward to participating in this market.

In conclusion, we're generally second quarter results demonstrate the strength of our business and enable us to continue to invest in our differentiated pipeline to deliver breakthroughs for patients and long term value for shareholders with that I'll pass the call back to Ryan.

In conclusion, we are generally second quarter results demonstrate the strength of our business and enable us to continue to invest in our differentiated pipeline to deliver breakthroughs for patients and long term value for shareholders with that I will pass the call back to Ryan.

Thank you Chris before we move to Q&A just wanted to make one correction on a remark that Chris may we anticipate fully reimbursing the Santa Fe development balance by the end of 2026, not this year end of 2026 with that let's move to 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 <unk>.

Chris Fenimore: Finally, while we are continuing to evaluate the impact of recently enacted tax legislation, we currently anticipate a limited impact to our effective tax rate in the long term and continue to expect this rate to trend towards the mid teens over time. A full summary of our latest guidance can be found in our press release issued earlier this morning. In conclusion, Regeneron's second quarter results demonstrate the strength of our business and enable us to continue to invest in our differentiated pipeline to deliver breakthroughs for patients and long-term value for shareholders. With that, I'll pass the call back to Ryan.

While many details from the US-EU Trade Agreement have yet to emerge, including tariffs that may go into effect, we do not currently expect a 15% tariff on non-generic pharmaceutical products to have a material impact on our financial results. In 2025, as we gain clarity on important details from the trade agreement and other potential tariffs, we will be in a better position to evaluate the financial impact of tariffs in 2026 and over the longer term.

Thank you Chris before we move to Q&A just wanted to make one correction on our remarks that Chris May we anticipate fully reimbursing the Santa Fe development balance by the end of 2026, not this year end of 2026 with that let's move to 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.

Ryan Crowe: We have time for two more questions, please.

Ryan Crowe: We have time for two more questions, please, Shannon.

Operator: Shannon, our next question comes from the line of Brian Abrahams with RBC Capital Markets. Your line is now open.

Operator: Our next question comes from the line of Brian Abrahams with RBC Capital Markets. Your line is now open.

Next <unk>.

[Analyst]: Hey, good morning. Thanks for taking my question and congrats on the quarter on itepekimab. Just wondering if you had any new insights on why the AERIFY 2 study hit its primary endpoint and the feasibility of mitigating that in future studies and then maybe any potential adjustments you may consider to the ongoing studies and other indications. Thanks.

Brian Abrahams: Hey, good morning. Thanks for taking my question and congrats on the quarter on itepekimab. Just wondering if you had any new insights on why the AERIFY 2 study hit its primary endpoint and the feasibility of mitigating that in future studies and then maybe any potential adjustments you may consider to the ongoing studies and other indications. Thanks.

<unk> can we go to the first question. Please.

Thank you to ask a question. Please press star one on your telephone and wait for your name to be announced.

Next <unk>.

<unk> can we go to the first question. Please.

Thank you to ask a question. Please press star one on your telephone and wait for your name to be announced.

Thank you to ask a question. Please press star one of your telephone and wait for your name to be announced.

Withdraw your question. Please press star one again.

Our first question comes from the line of Tim Anderson with Bank of America. Your line is now open.

Withdraw your question. Please press star one again.

Ryan Crowe: Thank you, Chris. Before we move to Q&A, I just wanted to make one correction on a remark that Chris made. We anticipate fully reimbursing the Sanofi development balance by the end of 2026, not this year, end of 2026. With that, let's move to 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. Shannon, can we go to the first question, please?

Our first question comes from the line of Tim Anderson with Bank of America. Your line is now open.

Finally, while we are continuing to evaluate the impact of recently enacted tax legislation, we currently anticipated limited impact to our effective tax rate in the long term and continue to expect this rate to Trend towards the mid teens over time. A full summary of our latest guidance can be found in our press release issued earlier this morning in conclusion, regener on second quarter results demonstrate the strength of our business and enable us to continue to invest in our differentiated pipeline to deliver. Breakthroughs for patience, and long-term value for shareholders with that. I'll pass the call back to Ryan.

Thanks, so much.

George Yancopoulos: Yeah, that's a great question. I mean, it's interesting that of course we just saw two studies from a competitor that in general, on average had lower efficacy than we saw. But the two studies were quite similar in what the two studies showed in contrast to what we saw. Let me remind you, our two studies looked quite similar at the six-month time point, and one of the studies just turned south at that point. We've been looking at it, trying to figure it out. We have some ideas. Of course, one of the major factors was the study was primarily carried out during a very unusual time in the world for clinical trials, in the height of the pandemic, and so forth. And there was a lot of things that happened at that time.

Good Q2 results, but I have a policy question Hassan MSN.

Oh, thanks, so much.

Thanks, so much.

<unk> letters that were sent out three of those letters had the CEO of names crossed out replace with first names that were kind of penciled over that was Lilly Pfizer and Regeneron and it makes me wonder is there a closer relationship between those Ceos from Trump.

Good Q2 results, but I have a policy question Hassan MSN 17 letters that were sent out three of those letters had the CEO of names crossed out replace with first names that were kind of penciled over that was Lilly Pfizer and Regeneron and it makes me wonder is there a closer relationship between those Ceos from Trump.

Could Q2 results, but I have a policy question, that's on MSN and the <unk>.

17 letters that were sent out three of those letters had the CEO of names crossed out replace with first names that were kind of penciled over that was Lilly Pfizer and Regeneron and it makes me wonder is there a closer relationship between those Ceos from Trump.

Thank you Chris before we move to q and I just wanted to make 1 correction on, on our remarked that Chris may we anticipate fully reimbursing the Santa Fe development balanced by the end of 2026, not this year, end of 2026 with that. Let's uh, move the Q&A to ensure we are able to address as many questions as possible. We will answer 1 question from each caller before moving to the next.

Shannon: Thank you. To ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Our first question comes from the line of Tim Anderson with Bank of America. Your line is now open.

Lilly and Pfizer have been tomorrow lager or a lot to influence policy. So my question is Glenn have you been down there frequently as well.

Shannon, can we go to the first question, please?

I know Lilly and Pfizer have been tomorrow log of a lot to influence policy. So my question is Glenn have you been down there frequently as well.

Lilly and Pfizer have been tomorrow log of a lot to influence policy. So my question is have you been down there frequently as well.

I asked because the common assumption because that MSM might play out for a CMI demo project.

Thank you to ask a question. Please press star 1, 1 on your telephone and wait for your name to be announced to withdraw your question. Please press star 1 1 again.

I asked because the common assumption because that MSM might play out for a CMI demo project.

I asked because the common assumption because that MSN might play out for a CMI demo project.

Tim Anderson: Oh, thanks so much. Good Q2 results, but I have a policy question that is on MSN and the 17 letters that were sent out. Three of those letters had the CEO names crossed out, replaced with first names, and were kind of penciled over. That was Lilly, Pfizer, and Regeneron Pharmaceuticals. It makes me wonder, is there a closer relationship between those CEOs and Trump? I know Lilly and Pfizer have been to Mar-a-Lago a lot to influence policy, so my question is.

Our first question comes from the line of Tim Anderson with Bank of America. Your line is now open

Big part B drug could that get wrapped into it.

Or not because there was a biosimilar. So perhaps you have some visibility any perspective on any of this would be I appreciate it.

He is a big part b drug could that get wrapped into it.

Big part B drug.

That get wrapped into it.

Or not because there was a biosimilar. So perhaps you have some visibility maybe perspective on any of this would be I appreciate it.

We're not because theres a biosimilar. So perhaps you have some visibility any perspective on any of this would be I appreciate it.

Yes. Thanks.

Sprint down there frequently I think press.

Yes.

Yes. Thanks.

President probably knows regeneron.

Thanks.

George Yancopoulos: The rates of exacerbations dropped precipitously because people avoided going outside and therefore there were less exacerbations as noted worldwide, let alone the study and so forth. There was a lot of other associated events and so we are trying to figure it out. As we said, we're discussing how to go forward and the possibility of carrying out an additional Phase 3. Thanks, George.

The rates of exacerbations dropped precipitously because people avoided going outside and therefore there were less exacerbations as noted worldwide, let alone the study and so forth. There was a lot of other associated events and so we are trying to figure it out. As we said, we're discussing how to go forward and the possibility of carrying out an additional Phase 3.

Sprint down there frequently I think.

Frequently I think.

My first name given that.

President of probably knows regeneron.

<unk> probably noticed regeneron.

Oh thanks so much, uh, good Q2 results. But I have a policy question that's on MSN. And the 17 letters that were sent out 3 of those letters. Had the CEO names crossed out replaced with first names that were kind of penciled over that was Lily, fiser and regeneron. And it makes me wonder is there a closer relationship between those CEOs and Trump?

It was for Regeneron cocktail for coverage that may have saved his life.

And my first name given that.

Shannon: Have you been down there frequently as well? I ask because a common assumption is that MSN might play out through a CMMI demo project. I lose a big part of the drug. Could that get wrapped into it, or not because there is a biosimilar? So perhaps you have some visibility. Any perspective on any of this would be appreciated.

It was for Regeneron cocktail covered that may have saved his life.

It was for Regeneron.

Matt I don't have any great insights.

<unk> covered that may have saved his life.

I know Lily and fizer have been tomorrow. Lago a lot to influence policy. So my question is len. Have you been down there frequently as well?

The policies.

Beyond that I don't have any great insights to.

Have been in the company has been outspoken that we agree with the president.

Two the policies.

The policies.

I have been in the company has been outspoken.

The Europeans are not paying their fair share.

Ryan Crowe: Thanks, George. Shannon, last question please.

Ryan Crowe: Shannon, last question please.

We agree with the president at <unk>.

Innovation.

Operator: Our last question comes from the line of Salveen Richter with Goldman Sachs. Your line is now open.

The Europeans are not paying their fair share of innovation.

And some way that needs to change it's complicated and it.

Ryan Crowe: Yeah, thanks. I have not been down there frequently. I think, the President probably knows REGENERON and my first name, given that, it was REGENERON's cocktail for COVID that may have saved his life. Beyond that, I do not have any great insights to the policies. I have been, and the company has been outspoken, that we agree with the President that the Europeans are not paying their fair share of innovation, and some way that needs to change. It is complicated, and it does have to be done at a trade and policy level, because it cannot be done at an individual company level. It is very difficult. We certainly agree that it is not right that Americans, American consumers, should not be paying for all of the innovation.

Hi Li is a big part of the drug. Could that get wrapped into it uh or not because there's about a similar. So perhaps you have some visibility any perspective on any of this would be appreciated.

And some way that needs to change it's complicated and it does have to be done at a trade in policy level.

In some way that needs to change it's complicated and it does have to be done in a trade in policy level.

Does have to be done at a trade in policy level.

Marion McCourt: Good morning. Thanks for taking my question. With regard to business development, you speak to the flexibility today and the fact that you're considering differentiated later stage opportunities in areas with high unmet need. Can you just help us understand how you think about that in the context of your overall business.

Salveen Richter: Good morning. Thanks for taking my question. With regard to business development, you speak to the flexibility today and the fact that you're considering differentiated later stage opportunities in areas with high unmet need. Can you just help us understand how you think about that in the context of your overall business.

Does it can't be done at an individual company level, it's very difficult, but we certainly agree that it's not right that Americans American consumers should not be paying for all of the innovation. The solution is simply not to lower cost prices in the U S without.

Because it can't be done at an individual company level, it's very difficult, but we certainly agree that it's not right that Americans consumers, but should not be paying for all of the innovation. The solution is simply not to lower cost prices in the U S without some equilibrating.

Leonard Schleifer: Yeah, we spend a lot of time looking at a lot of things. One of the metrics that we're developing, which we hope maybe some analysts will adopt and investors might adopt, is combining the money spent by a company in research and development and acquiring research and development through a variety of deals, transactions, acquisitions, licensing milestones, and so forth. I think you might find out that you might be surprised that we don't spend that much more, perhaps on overall acquisition of products through research. We just spend more of it internally because our research efforts are so productive. But once again, we want the best stuff for patients. So we go outside and look and look and look. Occasionally we do find stuff. If we have to do it, we have a lot of flexibility to do it. Salveen, but we don't.

Leonard S. Schleifer: Yeah, we spend a lot of time looking at a lot of things. One of the metrics that we're developing, which we hope maybe some analysts will adopt and investors might adopt, is combining the money spent by a company in research and development and acquiring research and development through a variety of deals, transactions, acquisitions, licensing milestones, and so forth. I think you might find out that you might be surprised that we don't spend that much more, perhaps on overall acquisition of products through research. We just spend more of it internally because our research efforts are so productive. But once again, we want the best stuff for patients. So we go outside and look and look and look. Occasionally we do find stuff. If we have to do it, we have a lot of flexibility to do it, Salveen, but we don't.

Calibrating in Europe, because then there'll be no innovation.

But the answer to your question Tim is don't have any unique insight because of my first name was used.

Europe, because then there'll be no innovation.

The answer to your question Tim is don't have any unique insight because of my first name was used.

The answer to your question Tim is don't have any unique insight because my first name was used.

Thanks, Lynn, let's move to the next question. Please Sharon.

Our next question comes from Tyler Van Buren of TD Cowen. Your line is now open.

Thanks, Glenn let's move to the next question. Please Sharon.

Our next question comes from Tyler Van Buren of TD Cowen. Your line is now open.

Great. Thanks, guys. Congratulations on the great to see this quarter. So there was a great quarter over quarter rebound in Eylea HD. So curious to hear what you would attribute that to and regarding the catalyst site inspection issue can you provide additional color on the nature of the issue and if there is precedent for how long it might take to resolve.

Great. Thanks, guys congratulations on the great.

Great. Thanks, guys. Congratulations on the award fees, great to see this quarter.

Great to see this quarter. So there was a great quarter over quarter rebound in Eylea HD. So curious to hear what you would attribute that to and regarding the catalyst site inspection issue can you provide additional color on the nature of the issue and if there's precedent for how long it might take to resolve it or how long the potential HD approvals will be pushed back.

There was a great quarter over quarter rebound in Eylea HD. So curious to hear what you would attribute that to and regarding the catalyst site inspection issue can you provide additional color on the nature of the issue and if there is precedent for how long it might take to resolve it or how long the potential Ht approvals will be pushed back right.

Ryan Crowe: The solution is simply not to lower cost prices in the U.S., without some equilibrating in Europe because then there will be no innovation. The answer to your question, Tim, is I do not have any unique insight because my first name was used.

Yeah. Uh thanks. Uh um, I have not been down there frequently. I think uh, president probably knows regeneron. Uh, uh and my first name, uh, given that, uh, it was the regeneron's cocktail for Co that may have saved his life, uh, beyond that, I don't have any great insights, uh, to the policies. Um, I have been in the company has been outspoken, uh, that we agree with the president that, um, the Europeans are not paying their fair share, uh, of innovation. Um, and some way that needs to change its complicated, and it does have to be done at a trade and policy level, uh, because it can't be done at an individual company level. It's very difficult, but we certainly agree that it's not right. That Americans American consumers should not be paying for all of the Innovation. The solution is simply not to lower cost.

All of it or how long the potential HD approvals will be pushed back right.

Prices in the US, uh, without, uh, some equilibrating in Europe, because then there'll be no innovation.

I'll, let maryann get into more details about the.

Shannon: Thanks, Lynn. Let's move to the next question, please, Sean.

Right.

<unk>.

I'll, let maryann get into more details about the.

um, but the answer to your question Tim is don't have any unique Insight because my first name was used

What was driving the quarter for HD.

I'll, let maryann get into more details about the what was driving the quarter for HD.

Leonard Schleifer: Our next question comes from Tyler Van Buren of TD Cowen. Your line is now open.

A catalyst.

Thanks, Len. Uh let's move to the next question, please. Sean.

<unk>.

What was driving the quarter for HD.

Really need to direct those calls to novo what we can say in a broad sense that these are not structural changes that are being requested by the FDA. It sounded like they have to rebuild something or something of that mainly process procedural those sorts of thing as we said in our remarks.

Marion McCourt: Great. Thanks, guys. Congratulations on the largest fee. Great to see you this quarter. There's a great quarter-over-quarter rebound in EYLEA HD. Curious to hear what you would attribute that to. Regarding the Catalan site inspection issue, can you provide additional color on the nature of the issue and if there's precedent for how long it might take to resolve it or how long the potential HD approvals will be pushed back by?

Terms of catalyst.

In terms of catalyst.

Our next question comes from Tyler van baren of TD Cowen. Your line is now open.

Really need to direct those calls to novo what we can say in a broad sense.

Not structural changes that are being requested by the FDA. It sounded like they have to rebuild something or something of that they're mainly process procedural those sorts of thing as we said in our remarks.

Leonard Schleifer: You know, to us, it's not our lifeline like it is to so many companies. Even though people think it's their lifeline, I think more often they're pulling on threads and it's not really pulling them up anywhere because it's very hard to be successful buying things from the outside where you really don't know all the nitty gritty warts and so forth. But having said all that, every day we approach it with an open mind and look at tons of stuff.

You know, to us, it's not our lifeline like it is to so many companies. Even though people think it's their lifeline, I think more often they're pulling on threads and it's not really pulling them up anywhere because it's very hard to be successful buying things from the outside where you really don't know all the nitty gritty warts and so forth. But having said all that, every day we approach it with an open mind and look at tons of stuff.

We do think that.

They will provide a robust response novo's.

We do think that.

Oh road directly to the FDA and said that kind of elevate all this to the standards of Novo.

Ryan Crowe: will let Marion get into more details about what was driving the quarter for EYLEA HD. As terms of Catalent, we really need to direct those calls to Novo. What we can say in a broad sense is that these were not structural changes that are being requested by the FDA. It is not like they have to rebuild something or something of that. They are mainly process procedural, those sorts of things. As we said in our remarks, we do think that they will provide a robust response. Novo's CEO wrote directly to the FDA and said they are going to elevate all this to the standards of Novo. I believe that we may not be the only doofus that is ensnared because they do, as I said, they do work for virtually all the biopharmaceutical companies.

They will provide a robust response novo's CEO road directly to the FDA and said that kind of elevated August to the standards of Novo.

They will provide a robust response novo's CEO road directly to the FDA and said that kind of elevate all this to the standards of Novo.

Uh, great thanks, guys. Congratulations on a large B, great to see this quarter. Uh, so there's a great quarter over quarter Rebound, in ailia HD. So, curious to hear what you would attribute that to and regarding the Catalan site inspection issue. Can you provide additional color on the nature of the issue and if there's press in for how long it might take to resolve it or how long the potential HD approvals will be pushed back by

I believe that.

We may not be the only.

I believe that.

Due for the snare because they do as I said, they do work for virtually all of the biopharmaceutical companies.

We may not be the only.

Do for that and snare because they do as I said, they do work for virtually all of the biopharmaceutical companies.

Do forget since snare because they do as I said, they do work for virtually all of the biopharmaceutical companies. They fill a catalog sales tailwind its fiscal year 'twenty for something like 70, or 80 billion unit doses, So I think that.

Catalog sales tailwind its fiscal year 'twenty for something like 70, or 80 billion unit doses, So I think that.

Ryan Crowe: Okay, thank you, Len, and thanks to everyone who joined today's call and for your interest in Regeneron. We apologize to those that are remaining in the Q and A queue. We simply ran out of time and did not have a chance to hear from you today. As always, the investor relations team is available to answer any remaining questions you may have. Thank you once again and have a great day and a great weekend.

Ryan Crowe: Okay, thank you, Len, and thanks to everyone who joined today's call and for your interest in Regeneron. We apologize to those that are remaining in the Q&A queue. We simply ran out of time and did not have a chance to hear from you today. As always, the investor relations team is available to answer any remaining questions you may have. Thank you once again and have a great day and a great weekend.

Hey, Phil catalog sales failed in its fiscal year 'twenty for something like 70, or 80 billion unit doses.

This has a good chance of being done expeditiously, but more specifically than that it's a little early but we know a little more.

So I think that.

This has a good chance of being done expeditiously, but more specifically than that it's a little early but we know a little more.

This has a good chance of being done expeditiously, but more specifically than that similarly, when we know a little more.

We will get that information out to you.

Turn it over to Mary to comment on the driving of.

Operator: This concludes today's conference call. Thank you for your participation. You may now disconnect.

We'll get that information out to you.

With sales for HD, Thanks, Lynn and then Tyler just going back to the numbers as you were kind of sharing the demand growth in the quarter was impressive there was a 16% increase which resulted in our change in the $393 million in net sales for Eylea HCA in the quarter.

Uh let Marion get into more details about uh the uh what was driving the quarter for HD. Uh as terms of Catalan, um, what really need to direct those calls to Novo, uh, what we can say in a broad sense that these were not structural changes that are being requested by the FDA. It's not like they have to rebuild something or something of that. They're mainly processed procedural. Those sorts of things. Um, as we said in our remarks, um, we do think that um they'll provide a robust response, novo's uh CEO wrote directly to the FDA and said that kind of elevate all this to the standards of Novo.

Turn it over to Mary to comment on the driving of Hu.

With sales for HD, Thanks, Lynn and then Tyler.

With sales for HD. Thanks Lynn.

Hello.

Going back to the numbers as you are kind of sharing the demand growth in the quarter was impressive there was a 16% increase which resulted in our change in the $393 million in net sales for our <unk> HD in the quarter, we were distributed to frankly physician depreciation for the product profile.

Going back to the numbers as you were kind of sharing the demand growth in the quarter was impressive there was a 16% increase which resulted in our change in the $393 million in net sales for HCA in the quarter, we would attributed to frankly physicians appreciation for the product profile.

Ryan Crowe: They fill, Catalent fills, filled in its fiscal year 2024 something like 70 or 80 billion unit doses. So, I think that this has a good chance of being done expeditiously. But more specifically than that, it is a little early. When we know a little more, we will get that information out to you. Turn it over to Marion to comment on the driving of the sales for EYLEA HD.

We distributed two frankly physicians appreciation for the product profile that Eylea HD provides the clinical efficacy or safety that we've talked about repeatedly and then also the durability that allows patients to have longer periods of time between dosing and the experience with the product has been very very favorable as a summary.

That Eylea HD provides.

Clinical efficacy the safety that we've talked about repeatedly and then also the durability that allows patients to have longer periods of time between dosing and the experience with the product has been very very favorable as I summarize when we do get those label enhancements will be able to even have more of a trajectory of growth in demand.

Clinical efficacy or safety that we've talked about repeatedly and then also the durability that allows patients to have longer periods of time between dosing and the experience with the product has been very very favorable as I summarize when we do get those label enhancements will be able to even.

Um, I believe that, um, we may not be the only, uh, uh, due for that some snare because they do, as I said, they they do work for virtually all the bio pharmaceutical companies. They, they fill Catalan fills, uh, filled in its fiscal year, 24 like 70 or 80 billion unit doses. Um, so, uh, I think that, um, this has a good chance of being done expeditiously, but more specifically than that, that's a little early when we know a little more. Um, we'll get that information out to you.

Chris Fenimore: Thanks, Lynn. Tyler, going back to the numbers, as you were sharing, the demand growth in the quarter was impressive. It was a 16% increase, which resulted in our achieving the $393 million in net sales for EYLEA HD in the quarter. We would attribute it to physicians' appreciation for the product profile that EYLEA HD provides, the clinical efficacy, the safety that we've talked about repeatedly, and the durability that allows patients to have longer periods of time between dosing. The experience with the product has been very, very favorable. As I summarized, when we do get those label enhancements, we will be able to have more of a trajectory of growth in demand, but certainly very solid performance. I would attribute it to the product profile and our excellent commercial team.

When we do get those label enhancements will be able to even have more of a trajectory of growth in demand, but I, certainly very solid performance and I would attribute it to the product profile and our excellent commercial team.

Have more of a trajectory of growth in demand, but I, certainly very solid performance and I would attribute it to the product profile and our excellent commercial team.

But I certainly very solid performance and I would attribute it to the product profile and our excellent commercial team.

Thank you Len and Marion, let's move to the next question. Please Sharon.

Thank you Lynn and Marion, let's move to the next question. Please Sharon.

Our next question comes from the line of Chris Schott with Jpmorgan. Your line is now open.

Thank you Lynn and Marion, let's move to the next question. Please Sharon.

Our next question comes from the line of Chris Schott from Jpmorgan. Your line is now open.

Great. Thanks, so much just a couple more eylea ones as well just on the producers beyond the manufacturing dynamics is there anything else pending with these three filings based on your discussion with FDA or are you otherwise confidence that once the manufacturing's addressed will be seeing approvals here in just a second one the second part on Eylea.

Great. Thanks, so much just a couple more eylea ones as well just on the producers.

Great. Thanks, so much just a couple more eylea once as well just on the producers.

Beyond the manufacturing dynamics is there anything else pending with these three filings based on your discussion with FDA or are you otherwise confidence that once the manufacturing's addressed will be seeing approvals here in just a second one the second part on Eylea.

Just could you talk a little bit about the branded share erosion you are seeing in the category to a vast and is that starting to stabilize at all and how quickly do you expect to recapture some of that loss share once the affordability issues have been addressed thank you.

Could you talk a little bit about the branded share erosion you are seeing in the category to Avastin is that starting to stabilize at all and how quickly do you expect to recapture some of that loss share once the affordability issues have been addressed thank you.

Could you talk a little bit about the <unk>.

Branded share erosion you are seeing in the category to Avastin is that starting to stabilize at all and how quickly do you expect to recapture some of that loss share once the affordability issues have been addressed thank you.

Uh, turn it over to Mary and to comment on driving of uh, the sales for each day. Thanks Lynn. And um, Tyler. I you know, I just going back to the numbers as you were kind of, uh, sharing the demand growth, uh, in the quarter was impressive. It was a 16% increase which resulted in our changing day, 393 million, in net sales for AA HD in the quarter. We would distribute it to frankly, Physicians appreciation for the product profile. That IA HD provides the clinical epoche, the safety that we've talked about repeatedly and then also the durability that allows patients to have longer periods of time between dosing and, uh, the experience with the product has been very, very favorable, as I summarize when we do get those label enhancements. Um, we'll be able to even, uh, you know, have more of a trajectory of growth and demand but, uh, certainly very solid performance and I would attribute it to the pro.

Shannon: Thank you, Lynn and Marion. Let's move to the next question, please, Sean.

Product profile and our excellent commercial team.

Leonard Schleifer: Our next question comes from the line of Chris Schott of JPMorgan. Your line is now open.

Thank you Len and Marion. Let's move to the next question, please. Sean.

Yes, so I'll comment on that <unk> comment a little bit on the share issues.

Marion McCourt: Great. Thanks so much. Just a couple more EYLEA ones as well. Just on the PDUFAs, beyond the manufacturing dynamics, is there anything else pending with these three filings based on your discussion with FDA, or are you otherwise confident that once the manufacturing is addressed, we will be seeing approvals here? Just the second one, the second part on EYLEA, can you talk a little bit about the branded share erosion you are seeing in the category to Avastin? Is that starting to stabilize at all? How quickly do you expect to recapture some of that lost share once the affordability issues have been addressed? Thank you.

Yes, so I'll comment on the producers and Mary can you comment a little bit on the share issues.

Yes, so I'll comment on the <unk> comment a little bit on the share issues.

Our next question comes from the line of Chris shot of JP Morgan. Your line is now open,

The producers go based on our discussions we believe that.

As far as the producers go based on our discussions we believe that.

There is nothing significant left to be done obviously, some details, but we are expecting once the.

Resolution of the selling issues has occurred.

Sure.

Resolution of the selling issues has occurred to receive favorable action, we hope from the FDA.

To receive favorable action, we hope from the FDA.

Resolution of the selling issues has occurred to receive favorable action, we hope from the FDA.

And then on overall branded dynamic and overall performance.

Ryan Crowe: Yeah. I will comment on the PDUFAs and Marion can comment a little bit on the share issues. As far as the PDUFAs go, based on our discussions, we believe that there is nothing significant left to be done. Obviously, some details, but we are expecting once the resolution of the filling issues has occurred to receive favorable action, we hope, from the FDA.

Sure that if.

If you look at total Regeneron eylea, each DNA Leah category share branded share in the quarter with just over 60%.

Share once the affordability issues have been addressed. Thank you.

I'll share that.

If you look at total Regeneron <unk> category share branded share in the quarter with just over 60%.

If you look at total Regeneron, Eylea, HD, and LD or category share branded share in the quarter with just over 60%.

If you look then at growth and what happened in the overall category anti VEGF overall category.

<unk> did grow but the branded anti VEGF category volume actually decreased by one 2% and that would be attributed primarily to the uptick in avastin based on affordability issues.

Volume did grow but the branded anti VEGF category volume actually decreased by one 2% and that would be attributed primarily to the uptick in avastin based on affordability issues.

Chris Fenimore: On overall branded dynamic and overall performance, I will share that if you look at total Regeneron EYLEA HD and EYLEA category share, branded share in the quarter was just over 60%. If you look then at growth and what happened in the overall category, anti-VEGF overall category volume did grow, but the branded anti-VEGF category volume actually decreased by 1.2%. That would be attributed primarily to the uptick in Avastin based on affordability issues. I do not have a lens into what potentially will happen in the future.

Don't have lend into and what potentially will happen in the future.

Yeah, so I'll comment on the doofus and Mary comment a little bit on the share issues. Um, as far as the doofus go based on our discussions, uh, we believe that, uh, um, there's nothing significant left to be done, uh, obviously, uh, some details. But we do, we are expecting once the, uh, um, resolution of the filling issues has occurred, um, to receive favorable action. We hope from the FDA,

and then, on overall,

Don't have lend into and what potentially will happen in the future.

And so the next question please Shannon.

Our next question comes from the line of Geoff Meacham with Citi. Your line is now open.

Um, I'll share that.

So the next question please Shannon.

Our next question comes from the line of Geoff Meacham with Citi. Your line is now open.

Good morning, guys long time listener first time caller. Thanks for the question.

Glenn you mentioned upfront.

Internal R&D is really the best use of capital.

Yeah.

Glenn you mentioned upfront.

You've got 45 assets already in development, so what's the ROI calculus.

Internal R&D is really the best use of capital.

You've got 45 assets already in development, so what's the ROI calculus.

How are you guys are prioritizing I wasn't sure if.

Out licensing noncore assets is reasonable, especially given the innovation as a premium now thank you.

How you guys are prioritizing I wasn't sure if you will.

Shannon: All right. Let's move to the next question, please, Shannon.

Our licensing noncore assets is reasonable, especially given the innovation as a premium now thank you.

If you look at total regeneron Aaliyah HD and Aaliyah category share branded share in the quarter was just over. 60%, um, if you look then at growth and what happened in the overall category anti vegf overall category volume did grow but the Branded anti veg of category volume actually decreased by 1.2% and that would be attributed. Primarily to the uptick in avastin based on affordability issues. I, I don't have, um, Blends into you know what potentially will happen in the future.

Jeff.

Leonard Schleifer: Our next question comes from the line of Jeff Meacham with Citi. Your line is now open.

As for our first time call its a good question.

All right, let's go to the next question. Please Shannon.

I think we certainly.

Oh, next question.

Jeff.

And as for our first time call Thats a good question.

As for our first time call Thats a good question.

Shannon: Hey. Morning, guys. A longtime listener, a first-time caller. Thanks for the question. Lynn, you mentioned upfront, internal R&D is really the best use of capital. You got 45 assets already in development. So, what's the ROI calculus on how you guys are prioritizing? I wasn't sure if out-licensing non-core assets is reasonable, especially given the innovation as a premium now. Thank you.

Have a broad and big pipeline, we have discussed whether or not on occasion. It makes sense to turn it over some of those assets we've done that.

Was from the line of Jeff Meacham with City, your line is now open.

I think we certainly have.

Have a broad and big pipeline, we have discussed whether or not on occasion. It makes sense to turn over some of those assets we've done that.

Have a broad and big.

<unk> pipeline, we have discussed whether or not on occasion, it makes sense to turn over some of those assets we've done that.

Time listener. First-time caller. Thanks for the question.

You mentioned up front.

<unk>.

One blocker.

<unk> seen pretty good results from our partner, who has driven our results and.

Um, internal R&D is is really the best use of capital.

With.

One blocker.

<unk> seen pretty good results from our partner, who has driven our results and.

Sure.

We see pretty good results from our partner, who has driven our results and.

Carditis, which is going very well.

We do think that is a potential.

Pericarditis, which is going very well.

But there are some areas, where you don't wanted to one offs like oncology I think what you heard from Georges Thats.

Ryan Crowe: Yeah. Jeff, it is for a first-time caller. It is a good question. I think, we certainly, have a broad and big pipeline. We have discussed whether or not on occasion it makes sense to turn over some of those assets. We have done that, with our IL-1 blocker and, have seen pretty good results from our partner who has driven, results in, pericarditis, which is going very well. We do think that is a potential. But there are some areas where you do not want to do one-offs like oncology. I think what you heard from George Yancopoulos is that, you know, part of his original strategy was to have a menu of agents that might be useful to combine. So we probably would not want to do something in that area. But it is a fair point. And, we do spend a lot of money on internal R&D.

We do think that is a potential.

You got 45 assets already in development. So you know, what's the ROI calculus on? You know how you guys are prioritizing? I wasn't sure. If, you know out licensing, non-core assets is is reasonable, especially given, you know, the Innovation as a premium now. Thank you.

But there are some areas, where you don't wanted to one offs like oncology I think what you heard from Georges Thats.

But there are some areas, where you don't wanted to one offs like oncology I think what you heard from Georges.

No.

Part of it is original strategy was to have a.

<unk>.

Yes.

Part of it is original strategy was to have a.

And menu of agents that might be useful to combined so we probably wouldn't want to do something in that area, but it's a fair point and we do spend a lot of money on internal R&D and if it makes sense to partner or out license.

Our menu of <unk>.

A menu of agents that might be useful to combine so it probably wouldn't want to do something in that area, but it's a fair point and we do spend a lot of money on internal R&D and if it makes sense to partner or out license.

Agents that might be useful to combined so we probably wouldn't want to do something in that area.

But it's a fair point and we do spend a lot of money on internal R&D and if it makes sense to partner or out license.

Certainly not structurally adverse to that.

Okay, let's move to the next question. Please Shannon.

Italy.

That's true.

Slightly adverse to that.

Our next question comes from the line of Carnivals with Cantor. Your line is now open.

Okay, let's move to the next question. Please Shannon.

Our next question comes from the line of Cargos with Cantor. Your line is now open.

Good morning, Thanks for taking the question I know, it's only been amongst since you formally launched the matching program with good days, but can you help us think about if their spin.

Excuse me.

Delivered any matching funds, yet and the extent to which you expect this to I guess return as a tailwind to your commercial.

And Jeff. It's it is for the first time call. It's a good question. Um, uh, I think uh, we certainly, um, have a, a broad and and big pipeline, we have discussed whether or not on occasion, it makes sense to turn over some of those assets. Uh, we've done that, um, uh, with our io1 blocker and uh, the and seen pretty good results from our partner, who is driven the results in, um, pericarditis, uh, which is going very well. Um, we we do think that is a potential. Um, but there are some areas where you don't want to do 1 off like oncology. I think what you heard from George is that, you know, uh, we're part of his original strategy was to have a uh, a a menu of

Could you excuse me, if you've delivered any matching funds, yet and the extent to which you expect this to I guess return as a tailwind to your commercial.

Performance in the back half of the year. Thank you.

Ryan Crowe: And if it makes sense to partner or out-license, we are certainly, not structurally averse to that.

I think it's still early for the program since it's only been in place for about a month.

Performance in the back half of the year. Thank you.

I think it's still early for the program since it's only been in place for about a month.

Shannon: Okay. Let's move to the next question, please, Shannon.

And therefore, I don't think we.

The agents that might be useful to combine so it probably wouldn't want to do something in that area. Uh, but it's a fair point. And uh, we do spend a lot of money on internal R&D and if it makes sense to partner or outlines some, we're certainly uh not structurally adverse to that.

Leonard Schleifer: Our next question comes from the line of Carter Gould with Cantor. Your line is now open.

Have any useful information to share.

And therefore, I don't think we.

Okay, let's move to the next question, please Shannon.

Get that later this quarter and ended the quarter.

Have any useful information to share we'll get that later this quarter and ended the quarter.

Marion McCourt: Good morning. Thanks for taking the question. I know it has only been a month since you formally launched the matching program with Good Days, but can you help us think about if there has been, yet if you do not, if you, excuse me, if you have delivered any matching funds yet and the extent to which you expect this to, I guess, return as a tailwind to your commercial, performance in the back half of the year? Thank you.

Our next question comes from the line of carter gold with caner, your line is now open.

But we haven't heard through the grapevine of any major contributions yet, but we're watching this space very closely we really do hope that our contribution.

But we haven't heard through the grapevine of any major contributions yet.

But we're watching this space very closely we really do hope that our contribution and a matching foremost stimulate others.

But we are watching this space very closely we really do hope that our contribution and a matching formal stimulate others.

Matching formal stimulate others.

To contribute.

But.

So far we don't have a lot to report.

To contribute.

Thanks, Glenn next question please Shannon.

Uh, good morning. Thanks for taking the question. I know it's only been a month since you finally launched the matching program with good days. But can you help us? Think about, if there's been, uh, yet? If you don't, if, excuse me, if you've delivered any matching funds yet and the extent to, which you expect this to, I guess return as a Tailwind to your commercial. Uh,

But thus far we don't have a lot to report.

Ryan Crowe: I think it is still early for the program since it has only been in place for about a month. Therefore, I don't think we have any useful information to share. We will get that later this quarter or at the end of the quarter, but we haven't heard through the grapevine of any major contributions yet. We are watching this space very closely. We really do hope that our contribution in a matching form will stimulate others to contribute, but thus far, we don't have a lot to report.

Our next question comes from the line of Cory <unk> with Evercore ISI. Your line is now open.

Performance in the back half of the Year. Thank you.

Thanks, Glenn next question please Shannon.

Our next question comes from the line of Cory <unk> with Evercore ISI. Your line is now open.

Our next question comes from the line of Cory CASM off with Evercore ISI. Your line is now open.

Hey, good morning, guys. Thanks for taking the question.

Curious as to your thoughts on the competitive ox 40 ligand data shared thus far and how you believe this potentially competes with depicts since overall profile. Thank you.

Hey, good morning, guys. Thanks for taking the question.

Curious as to your thoughts on the competitive ox 40 ligand data shared thus far and how you believe this potentially competes with two fixed since overall profile. Thank you.

George you want to cover that.

Well the data is interesting right now I don't think suggests that it's offering really any advantages.

George you want to cover that.

Well the data is interesting right now I don't think suggests that it's offering really any advantages.

Shannon: Thanks, Lynn. Next question, please, Shannon.

And certainly it will be a long time before it can approach.

Uh, I think it's still early for the program since it's only been in place for about a month. Um and therefore I don't think we uh have any useful information to share. We'll get that later this quarter or the end of the quarter, um but we haven't heard through the grapevine of any major contributions yet. Um, but we're watching this space very closely. We really do hope that our contribution, uh, in a matching form will stimulate others, um, to contribute. Um, but uh, thus far, we don't have a lot to report.

Leonard Schleifer: Our next question comes from the line of Cory Kasimov with Evercore ISI. Your line is now open.

Thanks Len. Next question. Please Shannon.

And certainly it will be a long time before it can approach.

The comfort of the safety profile, let me just remind you that picks it is.

Shannon: Hey. Good morning, guys. Thanks for taking the question. Curious as to your thoughts on the competitive OX40 ligand data shared thus far and how you believe this potentially competes with DUPIXENT's overall profile. Thank you.

The comfort of the safety profile.

Line of Corey kasimov with evercore isi. Your line is now open.

One of the only if not the only immuno modulator in the world.

Let me just remind you that picks it is one of the only if not the only immuno modulator in the world.

We've shown largely.

Attacks of this digital pathway, which is largely not necessary.

We've shown largely.

Ryan Crowe: George, you want to cover that? The data is interesting. Right now, I do not think it suggests that it is offering really any advantages. Certainly, it will be a long time before it can approach the comfort of the safety profile. Let me just remind you that DUPIXENT is one of the only, if not the only, immunomodulator in the world, that we have shown largely attacks a vestigial pathway, which is largely not necessary to people living in the developed world, because it is part of the immune system that was designed to attack largely obsolete pathogens that we no longer have to fight in developed countries. Most other approaches, including the OX40 approaches and so forth, are much more general approaches that attack fundamental parts of the immune system that are required very broadly.

Hey, good morning guys. Thanks for taking the question. Um curious as to your thoughts on the uh competitive Ox 40, Lan data shared, thus far. And how you believe this potentially competes with dupax since overall profile. Thank you.

Attacks of the digital pathway, which is largely not necessary.

Attacks of this digital pathway, which is largely not necessary.

Two people living.

George, you want to cover that?

In the developed world because it's part of the immune system that was designed to attack largely obsolete pathogens that we no longer have to fight in developed countries.

um,

Two people living.

In the developed world because it's part of the immune system that was designed to attack largely obsolete pathogens that we no longer have to fight in developed countries.

Most other approaches, including the ox 40 approaches and so forth are much more general approaches that attack fundamental parts of the immune system. The required very broadly and so it is going to be a long time before you would feel comfortable that you have the safety profile that you have.

Most other approaches, including the ox 40 approaches and so forth are much more general approaches that attack fundamental parts of the immune system. The required very broadly and so it's going to be a long time before you would feel comfortable that you have the safety profile that you have.

With two pixels. So one of the miracles a two pixel is its incredible efficacy.

The comfort of the, uh, safety profile. Uh, let me just remind you that you picked it as one of the only, if not the only, you know, modulators in the world. Uh, that we've shown largely.

With two pixels. So one of the miracles to pixel is its incredible efficacy.

With two pixels. So one of the miracles a two pixel is its incredible efficacy.

But which is so far relatively unmatched, but just as if not more importantly that is immuno modulator. It actually corrects the immune system and does not debilitated by creating any profound immuno suppression. So I think when you look at other agents, whether you're talking about that's 40 or.

But which is so far relatively unmatched, but just as if not more importantly that is immuno modulator actually corrects the immune system and does not debilitated by creating any profound immuno suppression. So I think when you look at other agents, whether you're talking about that's 40 or.

Talking about the jacks.

Thing else.

Ryan Crowe: It is going to be a long time before you would feel comfortable that you have the safety profile that you have with DUPIXENT. One of the miracles of DUPIXENT is its incredible efficacy, which is so far relatively unmatched, but just as, if not more importantly, that it is an immunomodulator that actually corrects the immune system and does not debilitate it by creating any profound immunosuppression. I think, when you look at other agents, whether you are talking about OX40 or talking about the JAKs or anything else, they are much broader at attacking the immune system. It is going to take a long time, I think, to develop the sort of comfort that one has with the incredible safety profile of DUPIXENT, let alone its efficacy.

They are much broader.

Talking about the jacks.

And attack the immune system and so it's going to take a long time I think for.

Thing else.

They are much broader.

The attack immune system and so it's going to take a long time I think for.

To develop the sort of comfort that one has with the incredible safety profile of depicts and let alone its efficacy.

Attacks of vestigial pathway, which is largely not necessary. Um to people living um, in the developed world. Uh, because it's part of the immune system that was designed to attack largely obsolete pathogens that, we no longer have to fight and develop countries. Um, most other approaches including the ox 40 approaches and so forth are much more General approaches that attack fundamental parts of the immune system that are required very broadly. And so it's going to be a long time before you would feel comfortable, uh, that you have the safety profile that you have um uh with Dixon. So 1 of The Miracles of Dixon is its incredible efficacy.

Currently.

Of course of what George was saying about attacking broadly.

Currently.

We will deal with patients who have comorbidities.

Of course of what George was saying about attacking broadly.

We will deal with patients who have comorbidities.

We will deal with patients who have comorbidities and we can do that in a way that I don't think any other agent and suggested that we will be able to do there is so many people who have.

We can do that in a way that I don't think any other agent has suggested that we will be able to do there is so many people who have.

We can do that in a way that I don't think any other agent and suggested that we will be able to do there is so many people who have.

I just met with atopic dermatitis asthma with nasal polyps are asthma eosinophilic esophagitis and so on and so that's fundamental mechanism of attacking the type two pathway that George was referring to gives.

But which is, so far, relatively unmatched. But just as, if not more importantly, that is immunomodulatory, that actually corrects the immune system and does not debilitate by creating, uh, any profound immunosuppression. So, I think, uh, when you look at other agents, whether you're talking about JAKs or talking about the AXA40,

I just met with atopic dermatitis asthma with nasal polyps are asthma, eosinophilic esophagitis, and so on and so but fundamental mechanism of attacking the type two pathway that George is referring to gives.

I, just met with atopic dermatitis, or asthma with nasal polyps or asthma eosinophilic esophagitis and so on and so that's fundamental mechanism of attacking the type two pathway that George was referring to gives.

It gives us this commercial advantage as well because of the tech. So many common diseases that many people have and that is also don't need to get familiar with many different drugs and this allergy spectrum when one like to pixel can cut across so many next question next.

Ryan Crowe: The corollary, of course, of what George was saying about attacking broadly is that we will deal with patients who have comorbidities. We can do that in a way that I do not think any other agent has suggested that we will be able to do. There are so many people who have asthma with atopic dermatitis or asthma with nasal polyps or asthma with eosinophilic esophagitis and so on. That fundamental mechanism of attacking this type 2 pathway that George is referring to, gives us this commercial advantage as well because it attacks so many common diseases that many people have. Doctors also do not need to get familiar with many different drugs in this allergy spectrum, when one like DUPIXENT can cut across so many. Next question.

It gives us this commercial advantage as well because of the tech. So many common diseases that many people have and doctors.

It gives us this commercial advantage as well because of the tech. So many common diseases that many people and doctors.

So don't need to get familiar with many different drugs in this allergy spectrum.

So don't need to get familiar with many different drugs.

Allergy spectrum.

Wed like to pixel can cut across so many next question.

But in general it's going to the next caller. Please.

We'd like to pixel can cut across so many next question.

Our next question comes from the line of Evan <unk> with BMO capital markets. Your line is now open.

Next Gen. Let's go to the next caller please.

But in general it's going to the next caller. Please.

Our next question comes from the line of Evan <unk> with BMO capital markets. Your line is now open.

Hi, guys. Thank you so much for taking my question I wanted to touch on some thoughts around MFN. So with some of your key products marketed outside of the United States by partners, specifically European partners. What mechanisms are abilities, you have to impact pricing or U S.

Is there anything you can really do to force the higher priced from a partner.

Yes.

Is there anything you can really do to force the higher priced from a partner.

Or anything else. Um, they are much broader, uh, at attacking the immune system. And so, uh, it's going to take a long time I think for, um, uh, uh, to develop the sort of comfort that 1 has with the incredible safety profile of dupixent, let alone its efficacy. Yeah and and the car car of course what George was saying about attacking broadly. The is that we will deal with patients who have comorbidities and um we can do that in a way that I don't think any other agent is suggested that we'll be able to do. There's so many people who have um asthma with atopic dermatitis or asthma with nasal polyps or asthma with eosinophilic esophagitis and so on and so that fundamental mechanism of attacking this type 2 pathway that George is referring to um gives us this commercial Advantage as well because it attacks so many common diseases that many people have and doctors also don't need

Is there anything you can really do to force the higher priced from a partner.

Great question.

That's one of the issues.

Yes.

And that new contracts with.

Great question I.

I think that's one of the issues.

Shannon: Next question. Shannon, let's go to the next caller, please.

I think that's one of the issues.

Since this is going to apply mainly to new drugs. According to the letter Dear land letter, it's being known in the industry now.

to get familiar with many different drugs. Um, in this allergy Spectrum, uh, when 1 like to pixon can cut across so many next question.

Our net new contracts with.

And that new contracts with <unk>.

Leonard Schleifer: Our next question comes from the line of Evan Seigerman with BMO Capital Markets. Your line is now open.

Next question, Channel. Let's go to the next caller, please.

This is going to apply mainly to new drugs. According to the latter the deere land leather, it's being known in the industry now.

This is going to apply mainly to new drugs. According to the latter the deere land leather as being known in the industry now.

Marion McCourt: Hi, guys. Thank you so much for taking my question. I want to touch on some thoughts around MSN. With some of your key products marketed outside of the United States by partners, specifically European partners, what mechanisms or abilities do you have to impact pricing OUS? Is there anything you can really do to force a higher price from a partner?

The deal and leather suggest that you have to do this on new products not on all products and one of the reasons may be because of that complication I suspect a lot of new contracts will have to deal with the contingency of what happens when if you license something to Europe, but evidenced really a great question.

Our next question comes from the line of Evan sermon with BMO Capital markets. Your line is now open.

The Atlanta letter suggest that you have to do this on new products not on all products and one of the reasons may be because of that complication I suspect a lot of new contracts will have to deal with the contingency of what happens.

And leather suggest that you have to do this on new products not on all products and one of the reasons may be because of that complication I suspect a lot of new contracts will have to deal with the contingency of what happens.

Ryan Crowe: Yeah, it's a great question. I think that's one of the issues, and that new contracts will probably, since this is going to apply mainly to new drugs, according to the letter, the Dear Len letter, as it's being known in the industry now, the Dear Len letter suggested that you have to do this on new products, not on old products. One of the reasons may be because of that complication. I suspect a lot of new contracts will have to deal with the contingency of what happens when if you license something to Europe. Evan's really a great question because, for example, we don't control the pricing of EYLEA outside the United States. That's controlled by Bayer. These are some of the wrinkles that are going to have to be figured out. Thanks for pointing that out.

Because for example, we don't control the pricing of Eylea outside the United States that is controlled by base. So.

Hi guys, thank you so much for taking my question. I want to touch on some thoughts around NFN. Um, so with some of your key products marketed outside of the United States, by partners specifically European partners, what mechanisms or abilities do you have to impact pricing? Is there anything you can really do to force a higher price from a partner?

Your license something to Europe, but evidence really a great question. Because for example, we don't control the pricing of Eylea outside the United States.

License something to Europe, but evidence really a great question. Because for example, we don't control the pricing of Eylea outside the United States.

These are some of the wrinkles.

Have to be figured out thanks for pointing that out.

It's controlled by base. So these are some of the wrinkles that are going to have to be figured out thanks for pointing that out.

It's controlled by bad. So these are some of the wrinkles that are going to have to be figured out thanks for pointing that out.

Let's go to the next question please Shannon.

Our next question comes from the line of <unk> <unk> with Jefferies. Your line is now open.

The next question please Shannon.

Our next question comes from the line of <unk> <unk> with Jefferies. Your line is now open.

Yes.

Hey, thanks, so much on tablet, we were internally expecting to see the ASP decline.

Okay. Thanks, so much on tablet, we were internally expecting to see the ASP decline.

Hey, thanks, so much on tablet, we were internally expecting to see the ASP decline.

Decline.

Reflect amgen volume based discounts.

We felt like that would then in turn drop physician demand like we've seen with some rally interestingly the ACP actually hasnt declined that much suggesting amgen may be offering deferred discounts. So for the regeneron team how does the prolong runway for Pablo impact your outlook for Eylea. You mentioned continued decline and number two are there any options you're exploring.

Decline to kind of reflect amgen's volume based discounts.

Decline.

Flagged Amgen volume based discounts.

We felt like that would then in turn drop physician demand like we've seen with some rally interestingly the ASB actually hasn't declined that much suggesting aimed at maybe offering deferred discounts. So further regeneron team how does the prolong run rate per pad will impact your outlook for Eylea. You mentioned continued decline and number two are there any options you're exploring here.

We felt like that would then in turn drop physician demand like we've seen with some really interestingly the ASB actually hasn't declined that much suggesting amgen may be offering deferred discounts. So further regeneron team how does the prolong run rate per Pablo impact your outlook for Eylea. You mentioned continued decline and number two are there any options you're exploring.

Shannon: Let's go to the next question, please, Shannon.

To combat this strategy. Thank you.

Yeah, it's a great question. Um I think that's 1 of the issues um and that new contracts will probably since this is going to apply mainly to new drugs, according to the letter, the dear land letter, as it's being known in the industry now. Um the deal landlord is suggested that you have to do this on new products, not on Old products and that 1 of the reasons may be. Because of that complication, I suspect a lot of new contracts will have to deal with the contingency of what happens. Uh when uh, think if you license something to Europe, but evidence really a great question uh because for example we don't control the pricing of aiyah outside the United States, uh, that's controlled by Bay. So, um, these are some of the wrinkles that are going to have to be figured out. Thanks for pointing that out.

Leonard Schleifer: Our next question comes from the line of Akash Tawari with Jefferies. Your line is now open.

Go to the next question, please Shannon.

Yeah.

I don't want to get into practices that might be.

To combat this strategy. Thank you.

Marion McCourt: Hey. Thanks so much. On Pavlu, we were internally expecting to see the ASP decline to kind of reflect Amgen's volume-based discounts. We felt like that would then, in turn, drop physician demand like we have seen with Cimreli. Interestingly, the ASP actually has not declined that much, suggesting Amgen may be offering deferred discounts. For the Regeneron team, how does the prolonged runway for Pavlu impact your outlook for EYLEA? You mentioned continued declines. Are there any options you are exploring here to combat this strategy? Thank you.

Some might deem inappropriate in terms of deferring of rebates, but.

Yeah.

Our next question comes from the line of Akash tewari with Jeffrey's your line is now open.

I don't want to get into practices that might be.

Some might deem inappropriate in terms of deferring of rebates, but.

That's something we're sort of looking into its whether that is driving some of their success at the end of the day.

Product that globally is probably something.

Something like $100 million injections, it's not just the product, but it's also the.

Product globally is probably had something like $100 million injections, it's not just the product, but it's also.

Product that globally is probably something.

Something like 100 million injections, it's not just the product, but it's also the.

Purity of how you make it and how doctors trusted and so on and so forth, but Pat blue.

Purity of how you make it and how doctors trusted and so on and so forth, but tableau as a competitor.

Surety of how you make it and how doctors trusted and so on and so forth, but tableau as a competitor.

<unk>.

We are out there we think that HD is the real answer to that and as many people as.

Ryan Crowe: Yeah. I do not want to get into practices that might be, some might deem inappropriate in terms of deferring of rebates. But that is something we are sort of looking into is whether that is driving some of their success. At the end of the day, you have a product that globally has probably had something like 100 million injections. It is not just the product, but it is also the purity of how you make it and how doctors trust it and so on and so forth. But EYLEA is a competitor, and we are out there. We think that EYLEA HD is the real answer to that. As many people as get experience with it, we think that is going to be a much preferred drug than EYLEA, or EYLEA.

We're out there we think that HD is the real answer to that and as many people as.

Hey, thanks so much. Um, on Pavlo we were internally expecting to see the ASP, uh, decline to kind of reflect amen's, uh, volume based discounts. And we felt like that would then in turn drop uh, physician demand like we've seen with some really, interestingly, the ASB actually hasn't declined that much suggesting. Amen. May be offering deferred discounts. So for the regeneron team, how does the prolonged run rate for Pavlo impact? Your outlook for Ilya, you mentioned continued, declines and number 2. Are there any options you're exploring here to combat this strategy? Thank you.

We're out there we think that HD is the real answer to that and as many people as.

Okay.

Spirits with it we think that's going to be much preferred drug than eylea.

Get experience with it we think that's going to be much preferred drug when I leave.

Okay.

Spirit with it we think that's going to be much preferred drug when I leave.

Uh huh.

Okay next question please Shannon.

Our next question comes from the line of Terence Flynn of Morgan Stanley. Your line is now open.

<unk>.

The next question please Shannon.

And the next question please Shannon.

Our next question comes from the line of Terence Flynn of Morgan Stanley. Your line is now open.

Great. Thanks for taking the question.

You mentioned in the CMO Mab first line melanoma study.

Great. Thanks for taking the question.

The slowing so just wondering if you could speculate on reasons, there and just speak to your confidence level and showing.

You mentioned in the CMO Mab first line melanoma study.

You mentioned in the CMO, Matt first line melanoma study that the event rate is slowing. So just wondering if you could speculate on reasons, there and just speak to your confidence level and showing.

The slowing so just wondering if you could speculate on reasons, there and just speak to your confidence level and showing.

A positive readout here and remind us what the efficacy bar is that youre looking for and hoping to show. Thank you.

A positive readout here and remind us what the efficacy bar is that you are looking for and hoping to show. Thank you.

Well.

I think that you can make a lot of speculation on what it means when you have.

Shannon: Let's move to the next question, please, Shannon.

Well.

Something like a 100 million injections. It's not just the product, but it's also um, the purity of how you make it and and how doctors trust it and so on and so forth. But Pablo is a competitor, uh, and we're out there. Um, we think that HD is the real answer to that and as many people as uh, uh, get experience with it, we think that's going to be much preferred drug. Then I live uh, or have

I think that you can make a lot of speculation on what it means when you have.

Leonard Schleifer: Our next question comes from the line of Terence Flynn of Morgan Stanley. Your line is now open.

Less events.

To the next question, please Shannon.

And then you might have planned or powered for.

Less events.

Shannon: Great. Thanks for taking the question. You mentioned in the Fianlamab first-line melanoma study that the event rate is slowing. Just wondering if you could speculate on reasons there and speak to your confidence level in showing a positive readout here and remind us what the efficacy bar is that you are looking for and hoping to show. Thank you.

That said we are.

Then you might have planned or powered for.

Our next question comes from the line of parents Flynn of Morgan Stanley. Your line is now open

And then you might have planned or powered for.

We're powering for us having minimally the sort of the effect that the competitors have shown.

That said we are.

We're powering for us having minimally the sort of effect that the competitors have shown.

We're powering for us having minimally this sort of effect that the competitors have shown.

Of course with room to show, perhaps even a better effect.

And as we said because of the slowing of the event rates.

Of course with room to show, perhaps even a better effect.

And as we said because of the slowing of the event rates.

It has now delayed when we're going to get these results.

It has now delayed when we're going to get.

It has now delayed when we're going to get these results. This way to do a blinded study we've looked at.

They do a blinded study we've looked at.

Ryan Crowe: I think that you can make a lot of speculations on what it means when you have less events than you might have planned or powered for. That said, what we are powering for is having minimally the sort of effect that the competitors have shown, of course, with room to show perhaps even a better effect. As we said, because of the slowing of the event rates, it has now delayed when we are going to get these results. This is why you do a blinded study. We have looked at hundreds of studies over the years. We have engaged in speculations. George probably has the most insight of anybody, but the bottom line is you just have to wait till the unblinding.

Great. Thanks for taking the question. Um, you mentioned in the Kanab first line melanoma study that the event rate is slowing. So just wondering if you could speculate on reasons there and just speak to your confidence level in uh showing a um a positive readout here and remind us, what the uh the efficacy bar is that you're looking for and helping to show. Thank you.

Hundreds of studies over the years.

These results this way to do a blinded study we've looked at.

We are engaged in speculations.

Hundreds of studies over the years, we've engaged and speculations.

Hundreds of studies over the years.

George probably has the most inside of antibody, but the bottom line is it just have to wait until the unblinded.

well, um, I think that you can make a lot of speculations on what it means when you have

We are engaged in speculations.

<unk> probably has the most inside of antibody, but the bottom line is it just have to wait until the unblinded.

George probably has the most inside of antibody, but the bottom line is it just have to wait until the unblinded.

Moving to the next question please Shannon.

Our next question comes from the line of David Risinger of Leerink Partners. Your line is now open.

Move to the next question please Shannon.

Moving to the next question please.

Our next question comes from the line of David Risinger of Leerink Partners. Your line is now open.

Next question comes from the line of David Risinger of Leerink Partners. Your line is now open.

Yes, thanks, very much and thanks for all the updates so.

I guess my question is for Atlantic George So there is a tremendous disconnect between regeneron management speak of its pipeline and wall Street's views I think that.

Yes, thanks, very much and thanks for all the updates so.

less events. Uh, then you might have planned or powered for uh, that said, uh, what we're powering for is having minimally, the sort of effect that the competitors have shown uh, of course, with room to show perhaps even a better effect. Um, and as we said

I guess my question is for Atlanta, Georgia. So there is a tremendous disconnect between regeneron management speak of its pipeline and wall Street's views I think that.

I guess my question is for Len and George So Theres a tremendous disconnect between regeneron managements view of its pipeline and wall Street's views I think that.

The company is spending about $5 billion a year.

On R&D.

<unk> thousand 32 consensus pipeline estimates.

The company is spending about $5 billion a year on R&D.

The company is spending about $5 billion a year on R&D in 2032 consensus pipeline estimates are about $3 5 billion. So maybe you could share some light on the event path ahead for regeneron.

There are about $3 5 billion. So maybe you could share some light on the event path ahead for regeneron to shine better light on the commercial value of its pipeline. Thank you.

<unk> thousand 32 consensus pipeline estimates.

Shannon: Let's move to the next question, please, Shannon.

There are about $3 5 billion. So maybe you could share some light on the event path ahead for regeneron to shine better light on the commercial value of its pipeline. Thank you.

Because of the slowing of the event rates. Um, it has now delayed when we're going to get uh, these results. Yeah, this is why you do a blinded study. We've looked at, you know, hundreds of studies over the years but we have engaged in the speculations. Uh George probably has the most Insight of anybody, but the bottom line is you just have to wait till the unlimited.

Leonard Schleifer: Our next question comes from the line of David Risinger of Leerink Partners. Your line is now open.

Go to the next question, please Shannon.

<unk> better light on the commercial value of its pipeline. Thank you.

David Thanks for your question, it's a fair question.

Tim Anderson: Yes. Thanks very much, and thanks for all the updates. My question is for Lynn and George Yancopoulos. There is a tremendous disconnect between Regeneron management's view of its pipeline and Wall Street's views. I think that the company is spending about $5 billion a year on R&D, and 2032 consensus pipeline estimates are about $3.5 billion. So maybe you could share some light on the event path ahead for Regeneron to shine better light on the commercial value of its pipeline. Thank you.

Our next question comes from the line of Dave Risinger of Ling Partners. Your line is now open.

I think I would say two things before turning it over to George Firstly, I would say that.

David Thanks for your question, it's a fair question.

Thanks very much and thanks for all the updates. So,

uh,

I think I would say two things before turning it over to George Firstly, I would say that.

History frequently is a good indicator.

Our research organization has produced two of the most important drugs in the <unk>.

History frequently is a good indicator.

History of injury in the Street.

Our research organization has produced two of the most important drugs in the history of injury industry, including Eylea.

Our research organization has produced two of the most important drugs in the history of injury industry.

Including Eylea.

<unk>.

And I think that's the first thing I would say.

Including Eylea.

I guess my question is for Lennon and George. So there's a tremendous disconnect between regeneron management speed. If it's Pipeline and wall Street's views, I think that the company spending about 5 billion a year on R&D and 2032 consensus pipeline estimates.

<unk>.

Depicts it.

Second thing I would say is that.

And I think that's the first thing I would say the second thing I would say is that.

And I think that's the first thing I would say.

You should perhaps listen very carefully and maybe George can reiterate some of what he said on the call today about just as an example of one area of our pipeline, which was really new and exciting. These data in early stage myeloma smoldering myeloma and early stage PCL lymphoma.

Thing I would say is that.

You should perhaps listen very carefully and maybe George can reiterate some of what he said on the call today.

Ryan Crowe: Sure. David, thanks for your question. It's a fair question. I think I would say two things before turning it over to George. First, I would say that history frequently is a good indicator. Our research organization has produced two of the most important drugs in the history of the industry, including EYLEA and DUPIXENT. I think that that's the first thing I would say. The second thing I would say is that you should perhaps listen very carefully, and maybe George can reiterate some of what he said on the call today about just as an example of one area of our pipeline, which was really new and exciting. These data in early-stage myeloma, smoldering myeloma, and early-stage DLBCL lymphoma are really quite encouraging for us.

Are about 3 and a half billion. So maybe you could share some light on the event. Path ahead for regeneron to shine better light on the commercial value of its pipeline. Thank you.

And as an example of one area of our pipeline, which was really new and exciting. These data in early stage myeloma smuggling in myeloma and early stage Desio lymphoma are really quite quite encouraging for us.

These data in early stage myeloma, smoldering myeloma and early stage Desio lymphoma are really quite quite encouraging for us.

A really quite quite encouraging for us.

And we are going full steam ahead into myeloma, and we're going to probably have somewhere in the neighborhood of eight different phase III is going by next year.

And we are going full steam ahead into myeloma, and we're going to probably have somewhere in the neighborhood of eight different phase threes going by next year.

David. Thanks for your question. It's fair question. Um, I, you know, I think, I would say 2 things before turning it over to George. Well, first, I would say that, um, history frequently is a good indicator. Uh, our research organization has produced 2 of the most important drugs in the history of the injury in Industry. Uh, including uh, ah.

That's a $30 billion market and it will grow substantially as it moves into the pre malignant stage big opportunities George.

Uh and do pixcent. Um, and I think that that's the first thing I would say. Uh, the second thing I would say is that

That's a $30 billion market and it will grow substantially as it moves into the pre malignant stage big opportunities George.

Well I think we all have to understand and acknowledge that probably the valuation your view of the pipeline is in many ways being capped by concerns about what's going on with our existing.

Well I think we all have to understand and acknowledge that probably the valuation your view of the pipeline is in many ways being capped by concerns about what's going on with our existing <unk>.

Mega products.

Ryan Crowe: We are going full steam ahead into myeloma. We are going to probably have somewhere in the neighborhood of eight different Phase IIIs going by next year. That's a $30 billion market, and it will grow substantially as it moves into the premalignant stage. Big opportunities. George, you want to add anything to that?

And whether they're going to show growth above and beyond.

Mega products.

Meg of products.

Well, what's going to be happening with those products I think if one was independently looking at any one of these various new opportunities like Lin said.

And whether they're going to show growth above and beyond.

What's going to be happening with those products I think if one was independently looking at any one of these various new opportunities like <unk>.

Well, what's going to be happening with those products I think if one was independently looking at any one of these various new opportunities like <unk> said, we believe that our <unk> bispecific, which right now.

We believe that our <unk> Bispecific, which right now has the best data in one of the most exciting new classes in the entire industry has a chance to become another one of the most important drugs in the industry based on certainly a lot of the data that I described today and.

George Yancopoulos: I think we all have to understand and acknowledge that probably the valuation or view of the pipeline is in many ways being capped by concerns about what is going on with our existing mega products, and whether they are going to show growth above and beyond what is going to be happening with those products. I think if one was independently looking at any one of these various new opportunities, as Lynn said, we believe that our BCMA-Bi-Specific, which right now has the best data in one of the most exciting new classes in the entire industry, has a chance to become another one of the most important drugs in the industry, based on certainly a lot of the data that I described today in terms of running portions of many of our Phase III programs with it. We have several such programs.

Has the best data in one of the most exciting new classes in the entire industry has a chance to become another one of the most important drugs in the industry.

In terms of running portions of many of our phase III programs with it and we have several such programs, but I think right now the excitement or enthusiasm of those is always been.

Based on certainly a lot of the data that I described today in terms of running portions of many of our phase III programs with it and we have several such programs, but I think right now the excitement or enthusiasm of those has always been.

You should perhaps, listen very carefully and maybe George can reiterate some of what he said on the call today about testing, as an example of 1 area of our pipeline which was really new and exciting. Um, these data, in early stage, Myoma smoldering Myoma in early stage, dlbcl lymphoma are really quite quite encouraging for us. Um, and we are going full steam ahead into myeloma and we're going to probably have somewhere in the neighborhood of of 8. Uh different phase 3s going by next year. Um that's a 30 billion dollar market and it will grow substantially as it moves into the pre-malignant stage big opportunities. So George you want to add anything is that? Well, I think we all have to understand and acknowledge it. Probably the valuation or view of the pipeline is in many ways, being capped by concerns about what's going on with our existing

In terms of run in portions of many of our phase III programs with it and we have several such programs, but I think right now the excitement or enthusiasm of those has always been.

Limited by people want to know what's going to happen with Eylea in southwest. So I think that our pipeline would be viewed very differently.

It was viewed in isolation.

Because of the incredible potential and opportunities and as Len said, one of the best predictors.

Mega products, um, and uh, whether they're going to show growth above and beyond, um, uh, what's going to be happening with those products. I think if 1 was independently, looking at any 1 of these various New Opportunities, like Lynn said, uh, we believe that our Visa made by specific, which right now has

It was viewed in isolation.

Because of the incredible potential and opportunities and as Len said, one of the best predictors.

Because of the incredible potential and opportunities.

Whether people can really do something important is whether they've repeatedly done that in the past. Okay. So one other thing I would just add David that.

Len said one of the best predictors.

Whether people can really do something important is whether they've repeatedly done that in the past. Okay. So one other thing I would just add David that.

If you think about where the big opportunities are.

George Yancopoulos: I think right now the excitement or enthusiasm of those is always being limited by people wanting to know what is going to happen with EYLEA and so forth. I think that our pipeline would be viewed very differently if it was viewed in isolation because of the incredible potential and opportunities. As Lynn said, one of the best predictors of whether people can really do something important is whether they have repeatedly done that in the past.

Lymphoma myeloma, all the complement mediated diseases geographic atrophy, myasthenia gravis, <unk>, where we think we have best in class.

If you think about where the big opportunities are.

Is.

Lymphoma myeloma, all the complement mediated diseases geographic atrophy, myasthenia gravis, <unk>, where we think we have best in class.

On top of that all of the economic biotic diseases with our two different offerings in that.

On top of that all of the thrombotic diseases with our two different offerings in that.

We've got a lot to do but we've got a lot of exciting things, we're going to have some updates.

Being you know, limited by people, wanting to know, well, what's going to happen with Eileen and so forth. So I think that our pipeline would be viewed very differently if it was viewed in isolation.

We've got a lot to do but we've got a lot of exciting things, we're going to have some updates hopefully.

We've got a lot to do but we've got a lot of exciting things, we're going to have some updates.

In the near future for our LNG program for Birch and four.

Ryan Crowe: Okay. Yeah. One other thing I would just add, David, if you think about where the big opportunities are, lymphoma, myeloma, all the complement-mediated diseases, geographic atrophy, myasthenia gravis, PNH, where we think we have best in class, throw on top of that all of the thrombotic diseases with our two different offerings in that. We have a lot to do, but we have a lot of exciting things. We are going to have some updates, hopefully, in the near future for our allergy program for Birch and for cat allergy and our broad general allergy program. This is not, this is an, I would say, investment that is really going to have strong returns. It is hard for any one analyst or any one analyst team to look at 45 programs if you have 10 different companies and the other 9 have 2 programs each.

In the near future for our LNG program for Birch and four.

Cat allergy.

Broad General LNG program.

Cat allergy and our <unk>.

Cat allergy.

This is not this is it.

Broad General LNG program.

I would say investment that is really going to have strong returns.

Because of the incredible uh, potential and opportunities. And as 1 said, uh, 1 of the best predictors of of, of whether people can really do something important is whether they've repeatedly done that in the past. Okay, yeah, so 1 of the things I would just say that David that um uh, if you think about where the big opportunities are

This is this is it.

This is not this is it.

Lymphoma myeloma.

I would say investment that is really going to have strong returns.

And it is hard for anyone analysts or anyone Atlas team to look at 45 programs or if you've got 10 different companies and the other nine are two programs each.

It is hard for anyone analysts or anyone Atlas team to look at 45 programs or if you've got 10 different companies in other nine are two programs each.

And it is hard for anyone analysts or anyone Atlas team to look at 45 programs or if you've got 10 different companies in other nine.

You can consume all the time and Thats, maybe why it doesn't get as much attention as we would like but we're really excited about it and I would encourage you to all of you to go back and listen very carefully to what George said today.

Our two programs each.

Anytime what could happen in this mega Mega Mega space of myeloma.

As the Amazon what could happen in this mega Mega Mega space of myeloma.

Okay, let's move to the next question. Please Shannon.

Our next question comes from the line of Alexandria, Hamman of Wolfe Research. Your line is now open.

All the compliment mediated diseases. Geographic ADM, gravis P&H, where we think we have best-in-class. So, on top of that, all of the thrombotic diseases with our 2, different offerings in that. Um, we've got a lot to do, uh, but we've got a lot of exciting things. We're going to have some updates, uh, hopefully, uh, in the near future for our allergy program for Birch, and for um um cat allergy uh and our broad General allergy program. Um, and this is not the this is a a

The next question please Shannon.

Okay, let's move to the next question. Please Shannon.

Our next question comes from the line of Alexandria, Hamman of Wolfe Research. Your line is now open.

Thanks for taking the question and I kind of like to focus on the pipeline Glenn's point I wanted to ask you talked about programs with regeneron.

Thanks for taking the question and I got really to focus on the pipeline Glenn's point I wanted to ask you talked about programs with regeneron.

Thanks for taking the question and I kind of like to focus on the pipeline Glenn's point I wanted to ask you talked about programs with regeneron.

Ryan Crowe: You know, you could consume all the time. That is maybe why it does not get as much attention as we would like. But we are really excited about it. I would encourage all of you to go back and listen very carefully to what George Yancopoulos said today as a hint on what could happen in this mega, mega space of myeloma.

Sandy readout in Gmg, so as that readout approaches can you just remind us again of the bar for success I guess, what do you think you need to be commercially successful there. Thank you.

Sandy readout in Gmg, so that readout approaches can you just remind us again of the bar for success I guess, what do you think you need to be commercially successful there. Thank you.

Sandy readout in Gmg, so as that readout approaches can you just remind us again of the bar for success I guess, what do you think you need to be commercially successful there. Thank you.

Well I can speak to what we need to be clinically successful and maybe I'll leave it for maryann or speculation about what we need to be commercially successful.

Well I can speak to what we need to be clinically successful and maybe I'll leave it for maryann or speculation about what you need to be commercially successful.

Shannon: Okay. Let's move to the next question, please, Shannon.

I would say investment that is really going to have strong returns, um, and it is hard for anyone else or anyone else to look at 45 programs or if you've got 10 different companies and the other 9 have 2 Programs each, you know, you, you could consume all the time. And that's maybe why it doesn't get as much attention as we would like. But we're really excited about it. And I would encourage you to all of you to go back and listen very carefully to what George said today. Um, as a hint on what could happen in in this mega mega mega space of Myoma

Leonard Schleifer: Our next question comes from the line of Alexandria Hammond of Wolf Research. Your line is now open.

We are setting the bar pretty much at the bar that has been achieved.

Okay, let's move to the next question, please, Shannon.

Speaker 9: Thanks for taking the question. I kind of wanted to focus on the pipeline to Lynn's point. One of the lesser talked-about programs is Regeneron's POSI-SEMD readout in GMG. As that readout approaches, can you just remind us again of the bar for success? I guess, what do you think you need to be commercially successful there? Thank you.

We are setting the bar pretty much at the bar that has been achieved.

With all other agents that are now being utilized in this class.

Our next question comes from the line of Alexandria Hammond of Wolf Research. Your line is now open.

With all other agents that are now being utilized in this class of what we think we may have to offer is one of the more convenient dosing.

With all other agents that are now being utilized in this class of what we think we may have to offer is one of the more convenient.

We think we may have to offer is one of the more convenient.

Dosing regimens.

In myasthenia gravis, we don't necessarily think that the sort of extensive blockade and so forth.

Dosing regimens.

In myasthenia gravis, we don't necessarily think that the sort of extensive blockade and so forth.

Going to be as important as it is in other diseases in order to demonstrate better efficacy.

Ryan Crowe: I can speak to what we need to be clinically successful. Maybe I will leave it for Marion or speculation about what we need to be commercially successful. We are setting the bar pretty much at the bar that has been achieved with all other agents that are now being utilized in this class. What we think we may have to offer is one of the more convenient dosing regimens. In myasthenia gravis, we do not necessarily think that the sort of extent of blockade and so forth is going to be as important as it is in other diseases in order to demonstrate better efficacy. The play in myasthenia gravis is to show similar benefit, but with a much more convenient dosing regimen.

Thanks for taking the question and I kind of wanted to focus on the pipeline to lens point. So 1 of the Lesser talked about programs is regeneron's um posy some debris out in GMG. So, as that readout approaches, can you just remind us again of the bar for success? I guess, what do you think you need to be commercially successful there. Thank you.

Going to be as important as it is in other diseases in order to demonstrate better efficacy.

Well.

The play in Myasthenia gravis is to show similar benefit, but with a much more convenient.

Dosing regimen, and let me just remind you we have a monthly self administered subcutaneous regimen.

Compared to other dosing regimens, which are tend to be IV infusions, often administered much more frequently or even subcutaneous daily injections. We think that those could have a lot of advantages for patients if they demonstrated.

Which compare to other dosing regimens, which are tend to be IV infusions, often administered much more frequently or even subcutaneous daily injections. We think that those could have a lot of advantages for patients. If they demonstrated similar types of efficacy, but the approach.

I can speak to what we need to be clinically successful. And uh maybe I'll I'll I'll leave it for Mary and or speculation about what you need to be commercially successful. Uh, we are setting the bar pretty much at the bar that has been achieved, um, with all other agents, that that are now being utilized in this class. Uh, what we think we may have to offer is 1,

1 of the more.

<unk> types of efficacy.

But the approach. We're also can better control complement activity and in several other diseases that we're exploring we think that that can translate to actually an efficacy improvement as well.

So can better control complement activity in several other diseases that were exploring we think that that can translate to actually an efficacy improvement as well.

So can better control complement activity and in several other diseases that were exploring we think that that can translate to actually an efficacy improvement as well.

And I would add to that to George's comments that this is a large indication there's a lot of unmet need and then on top of that if we're able to have a differentiated product that offers the conveniences that George just mentioned that would be very very important any additional efficacy benefit is always meaningful and to this point the safety profile.

Ryan Crowe: Let me just remind you, we have a monthly self-administered subcutaneous regimen, which compared to other dosing regimens, which tend to be IV infusions often administered much more frequently or even subcutaneous daily injections, we think that those could have a lot of advantages for patients if they demonstrated similar types of efficacy. The approach also can better control complement activity. In several other diseases that we are exploring, we think that that can translate to actually an efficacy improvement as well.

And I would add to that to George's comments that this is a large indication there's a lot of unmet need and then on top of that if we're able to have a differentiated product that offers the conveniences that George has mentioned that will be very very important any additional efficacy benefit is always meaningful and to this point to safety profile.

<unk> looks very good so we look forward to participating in this market.

We have time for two more questions. Please Shannon.

So we look forward to participating in this market.

Very good so we look forward to participating in this market.

Our next question comes from the line of Brian Abrahams with RBC capital markets. Your line is now open.

We have time for two more questions. Please Shannon.

Our next question comes from the line of Brian Abrahams with RBC capital markets. Your line is now open.

Hey, good morning, Thanks for taking my question and congrats on the quarter.

Chris Fenimore: I would add to that, to George's comments, that this is a large indication. There is a lot of unmet need. On top of that, if we are able to have a differentiated product that offers the conveniences that George has mentioned, that will be very, very important. Any additional efficacy benefit is always meaningful. To this point, the safety profile looks very good. So we look forward to participating in this market.

Convenient, uh, dosing regimens. Um, in my senior gravis, we don't necessarily think that the sort of extent of blockade and so forth is going to be as important as it is in other diseases in order to demonstrate better efficacy. Uh, so the play in my senior graph is, is to show similar benefits, but with a much more convenient, uh, uh, dosing regimen. Let me just remind you, we have a monthly self-administered subcutaneous regimen, um, which compared to other dosing regimens, which are, uh, tend to be IV. Infusions often administered much more frequently or even subcutaneous, daily injections. Uh, we think that those could have a lot of advantages for patients if they demonstrated, uh, similar types of efficacy. But the approach also can better control complement activity. And in several other diseases that we're exploring we think that that can translate to actually an effort

To see Improvement as well.

Hey, good morning, Thanks for taking my question and congrats on the quarter I'd like to take them out, but just wondering if you had any new insights on why the <unk>. Two study didn't hit its primary endpoint and the feasibility of mitigating that in future studies and then maybe any potential adjustments you may consider to the ongoing studies in other indications. Thanks.

To take them out, but just wondering if you had any new insights on why the <unk>. Two study didn't hit its primary endpoint and the feasibility of mitigating that in future studies and then maybe any potential adjustments you may consider to the ongoing.

Ongoing studies in other indications thanks.

Yes, that's a great question I mean, it's interesting that of course, we just saw too.

Ongoing studies in other indications thanks.

Yes, that's a great question I mean, it's interesting that of course, we just saw two studies from a competitor that in general on average had lower efficacy than we saw but the two studies.

Shannon: We have time for two more questions, please, Shannon.

Studies from a competitor that in general on average had lower efficacy than we saw but the two studies.

To George's comments that, you know, this is a a large indication, there's a lot of unmet need and then on top of that, if we're able to have a differentiated product that offers the conveniences, the George has mentioned that would be very, very important. Any additional efficacy benefit is always meaningful and, you know, to this point the safety profile looks very good. So we look forward to participating in this market.

Leonard Schleifer: Our next question comes from the line of Brian Abrahams with RBC Capital Markets. Your line is now open.

Hey, have time for 2 more questions. Please Shannon.

We are quite similar.

Marion McCourt: Hey. Good morning. Thanks for taking my question and congrats on the quarter. On iTopecumab, just wondering if you had any new insights on why the AREFI-2 study didn't hit its primary endpoint and the feasibility of mitigating that in future studies. Also, are there any potential adjustments you may consider to the ongoing studies and other indications? Thanks.

Our next question comes from the line of Brian Abrams with RBC Capital markets. Your line is now open.

What the two studies showed in contrast to what we saw let me remind you are.

We are quite similar.

Sure.

And what the two studies showed in contrast to what we saw let me remind you are.

What the <unk> study showed in contrast to what we saw let me remind you are.

Two studies look quite similar at the six month time point and one of the studies just turns out at that point, we've been looking at it.

Two studies look quite similar at the six month time point and one of the studies just turns out at that point, we've been looking at it trying to figure it out.

And figure it out.

We have some some ideas of course one of the major factors was the study was primarily carried out during a very unusual timing of world for clinical trials in the height of the pandemic and so forth and there was a lot of things that happened at that time.

Ryan Crowe: Yeah, that's a great question. I mean, it's interesting that, of course, we just saw two studies from a competitor that, in general, on average, had lower efficacy than we saw. But the two studies were quite similar in what the two studies showed in contrast to what we saw. Let me remind you, our two studies looked quite similar at the six-month time point. One of the studies just turned south at that point. We've been looking at it, trying to figure it out. We have some ideas. Of course, one of the major factors was the study was primarily carried out during a very unusual time in the world for clinical trials and the height of the pandemic and so forth. There were a lot of things that happened at that time. The rates of exacerbations dropped precipitously because people avoided going outside.

Um hey good morning. Uh thanks for taking my question and uh congrats on the quarter. Um I like to pack a map just wondering if you had any new insights on why the airfi 2 study didn't hit its primary endpoint and the feasibility of uh mitigating that in future studies and then maybe any potential adjustments uh you may consider to the uh, ongoing studies and other indications. Thanks.

We have some some ideas of course one of the major factors was the study was primarily carried out.

During a very unusual time in the world for clinical trials in the height of the pandemic and so forth and there was a lot of things that happened at that time the rates of exacerbations dropped precipitously because people avoided going outside and therefore, they were less exacerbations as noted worldwide.

Rates of exacerbations dropped precipitously, because people avoided going outside and therefore, there were less exacerbations as noted worldwide, let alone the study and so forth there was a long row there associated events.

we saw but uh the 2 studies um, were quite similar um, in in in what the 2 studies showed in contrast to what we saw, let me remind you are

And so we are trying to figure it out and as we said we're discussing how to go forward.

Loan the study and so forth.

Well in the study and so forth.

And all the associated events.

And so we are trying to figure it out and as we said we're discussing how to go forward.

And the possibility of carrying out an additional phase III.

Thanks, George Sharon last question. Please.

And the possibility of carrying out an additional phase III.

Our last question comes from the line of solving Richter with Goldman Sachs. Your line is now open.

Thanks, George Shannon last question. Please.

Thanks, George Sharon last question. Please.

Our last question comes from the line of solving Richter with Goldman Sachs. Your line is now open.

Good morning, Thanks for taking my question with regard to business development, you spoke to the flexibility today and.

Good morning, Thanks for taking my question with regard to business development.

Ryan Crowe: Therefore, there were less exacerbations, as noted worldwide, let alone in the study and so forth. There were a lot of other associated events. So we are trying to figure it out. As we said, we're discussing how to go forward and the possibility of carrying out an additional phase III.

Besides that you are considering differentiated later stage opportunities in areas with high unmet need can you just help us understand.

Flexibility today and.

The fact that you are considering differentiated later stage opportunities in areas with high unmet need can you just help us understand.

How you think about that in the context of your overall business.

How you think about that in the context of <unk>.

How you think about that in the context of.

Yes.

Your overall business.

We spend a lot of time looking at a lot of things.

Yes.

Yes, that's it.

Shannon: Thanks, George. Shannon, last question, please.

And.

We spend a lot of time.

2 studies, look, quite similar at the 6-month time point and 1 of the studies, just turned South at that point. We've been looking at it, uh, trying to figure it out. Um, we we have some, some ideas, uh, of course, 1 of the major factors was, uh, the study was primarily carried out during a very unusual, uh, time in the world, for clinical trials, and the height of the pandemic and so forth. And there was a lot of things that happened. Uh, at that time, the rates of exacerbations dropped precipitously because people avoided going outside and therefore, they were less exacerbations as noted worldwide, let alone in the study and so forth. There was a lot of other Associated events. Um, and so, we are trying to figure it out and as we said, we're discussing how to go forward. Um, uh and uh, the possibility of carrying out an additional phase 3,

One of the metrics that we're developing which we hope makes some analysts will adopt.

Leonard Schleifer: Our last question comes from the line of Salveen Richter with Goldman Sachs. Your line is now open.

Looking at a lot of things.

Thanks, George Shannon. Last question, please.

And.

One of the metrics that we're developing which we hope maybe some analysts will adopt.

One of the metrics that we're developing which we hope maybe with some analysts will adopt.

As investors might adopt is key.

Speaker 9: Good morning. Thanks for taking my question. With regard to business development, you spoke to the flexibility today and the fact that you're considering differentiated later-stage opportunities in areas with high unmet need. Can you just help us understand how you think about that in the context of your overall business?

Our last question comes from the line of Saline Richter with Goldman Sachs. Your line is now open.

Combining the money spent by our company.

As investors might adopt is.

Combining the money spent by our company.

Research and development and acquiring research and development through a variety of deals transactions acquisitions licensing milestones and so forth and I think you might find that that you might be surprised.

Research and development and acquiring research and development through a variety of deals transactions acquisitions licensing.

In research and development and acquiring research and development through a variety of deals transactions acquisitions licensing.

Stone and so forth and I think Mike that that you might be surprised.

Stones, and so forth and I think Mike Brian.

Ryan Crowe: Yeah, we spend a lot of time looking at a lot of things. One of the metrics that we're developing, which we hope maybe some analysts will adopt and investors might adopt, is combining the money spent by a company in research and development and acquiring research and development through a variety of deals, transactions, acquisitions, licensing, milestones, and so forth. I think you might find out that you might be surprised that we don't spend that much more, perhaps, on overall acquisition of products through research. We just spend more of it internally because our research efforts are so productive. Once again, we want the best stuff for patients. So we go outside and look and look and look. Occasionally, we do find stuff. If we have to do it, we have a lot of flexibility to do it, Salveen.

We don't spend.

Good morning. Thanks for taking my question with regard to Business Development, you spoke to the flexibility today and um, the fact that you're considering differentiated later stage opportunities in areas with high-end met need, can you just help us understand? Um, how you think about that, in the context of of your overall business?

That that you might be surprised.

That much more perhaps on overall.

We don't spend.

That much more perhaps on overall acquisition of products to search we just spent more of an internally because our research efforts are so productive.

That much more perhaps on overall.

The acquisition of products through search we've just been more of an internally because our research efforts are so productive.

Yeah, it's a we spend a lot of time looking at a lot of things. Um, and

Acquisition of products to search we just spent more of an internally because our research efforts are so productive.

But once again, we want the best stuff for patients.

It, it 1 of the metrics that we're developing, which we hope maybe some analysts will adopt. Um, and investors might adopt is

But once again, we want the best stuff for patients.

And so we go outside and look and look and look.

But once again, we want the best stuff for patients.

So we go outside and look and look and look.

So we go outside and look and look and look at.

And occasionally we do client stuff.

And if we have to do it we have a lot of flexibility to do it salary, but we don't.

And occasionally we do client stuff.

And occasionally we do find stuff.

And if we have to do it we have a lot of flexibility to do it salary, but we don't.

If we have to do it we have a lot of flexibility to do it salary, but we don't.

To us it's not a lifeline.

Like an instant so many companies and even though people think it's their lifeline I think more often they're pulling on threads and it's not really pulling them up anyways, because it's very hard.

To us it's not a lifeline like an instant so many companies and even though people think it's their lifeline I think.

To us it's not a lifeline like an instant so many companies and even though people think it's their lifeline I think more often they're pulling on threads and it's not really pulling them up anyways, because it's very hard.

Combining the money spent by a company, uh, in research and development and acquiring research and development through, um, variety of deals, transactions, Acquisitions licensing. Milestones and so forth. And I think you might find out that you might be surprised, um, that we don't spend, uh, that much more, perhaps on, uh, overall.

And they're pulling on threads and it's not really pulling them up anyways, because it's very hard.

To be successful buying things from the outside where you really don't know.

Nitty gritty works and so forth, but having said all that we.

Every day, we approach it is with an open mind and look at tons of stuff.

Nitty gritty work and so forth, but having said all that we.

Every day, we approach it is with an open mind and look at tons of stuff.

Everyday we approach it is with an open mind and look at tons of stuff.

Okay. Thank you Lynn and thanks to everyone, who joined today's call and for your interest in Regeneron.

Ryan Crowe: But we don't, to us, it's not our lifeline like it is to so many companies. Even though people think it's their lifeline, I think more often they're pulling on threads, and it's not really pulling them up anywhere because it's very hard to be successful buying things from the outside where you really don't know all the nitty-gritty warts and so forth. Having said all that, every day, we approach it with an open mind and look at tons of stuff.

Okay. Thank you Lynn and thanks to everyone, who joined today's call and for your interest in Regeneron.

We apologize to those that are remaining in the Q&A queue. We simply ran out of time and did not have a chance to hear from you today, but as always the investor Relations team is available to answer any remaining questions you may have.

Acquisition of products through research—we just spend more internally because our research efforts are so productive. Um, but once again, we want the best stuff for patients. Um, and so we go outside and look and look and look. Um, and occasionally we do find stuff. Uh, and if we have to do it, we have a lot of flexibility to do it. Saline, but we don't, you know, to us, it's not a lifeline.

Once again and have a great day and a great weekend.

This concludes today's conference call. Thank you for your participation you may now disconnect.

Shannon: Okay. Thank you, Lynn. Thanks to everyone who joined today's call and for your interest in Regeneron Pharmaceuticals. We apologize to those that are remaining in the Q&A queue. We simply ran out of time and did not have a chance to hear from you today. As always, the Investor Relations team is available to answer any remaining questions you may have. Thank you once again and have a great day and a great weekend.

Like, it is for so many companies, and even though people think it's their Lifeline, I think more often, they're pulling on threads, and it's not really pulling them up anywhere, because it's very hard, um, to be successful, buying things from the outside where you really don't know, all the nitty-gritty warts, and so forth. But having said all that, we every day, we approach it as an with an open mind and look at tons of stuff.

Okay, thank you Lynn and thanks to everyone who joined today's call and for your interest in regeneron.

Leonard Schleifer: This concludes today's conference call. Thank you for your participation. You may now disconnect.

We apologize to those that are remaining in the Q&A queue. We simply ran out of time and did not have a chance to hear from you today. But as always, the Investor Relations team is available to answer any remaining questions you may have. Thank you once again, and have a great day and a great weekend.

This concludes our conference call. Thank you for your participation. You may now disconnect.

Q2 2025 Regeneron Pharmaceuticals Inc Earnings Call

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