Q1 2024 Regeneron Pharmaceuticals Inc Earnings Call

May 2, 2024

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Operator: Welcome to the Regeneron Pharmaceuticals Q1 2024 earnings conference call. My name is Josh, and I will be your operator for today's call. At this time, all participants are in 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 Crowe, Senior Vice President, Investor Relations. You may begin.

No.

Speaker Change: Thanks, a lot.

Okay.

Josh: Welcome to the Regeneron Pharmaceuticals 1st Quarter 2024 Earnings Conference Call. My name is Josh and I will be your operator for today's call. At this time, all participants are in 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.

Operator: Welcome to the Regeneron Pharmaceuticals 1st Quarter 2024 Earnings Conference Call. My name is Josh and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. Please note that this conference call is being recorded.

Speaker Change: Okay.

Josh: Welcome to the Regeneron Pharmaceuticals first quarter 2024 earnings Conference call. My name is Josh and I will be your operator for today's call. At this time all participants are in 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.

I will now turn the call over to Ryan Crowe, Senior Vice President, Investor Relations. You may begin.

Ryan: <unk> Senior Vice President Investor Relations you may begin.

Ryan Crowe: Thanks, Josh. Good morning, good afternoon, and good evening to everyone listening around the world. Thank you for your interest in Regeneron, and welcome to our first quarter 2024 earnings conference call. An archive and transcript of this call will be available on the Regeneron Investor Relations website shortly after the call ends. 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, Marianne McCourt, Executive Vice President of Commercial, and Chris Fenimore, Senior Vice President and Chief Financial Officer. After our prepared remarks, the remaining time will be available for your questions. We anticipate today's call will last approximately 60 minutes. I would like to remind you that remarks made on today's call may include forward-looking statements about Regeneron.

Ryan Crowe: Thanks, Josh. Good morning, good afternoon and good evening to everyone listening around the world. Thank you for your interest in Regeneron and welcome to our 1st Quarter 2024 Earnings Conference Call. An archive and transcript of this call will be available on the Regeneron Investor Relations website shortly after the call ends. 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, Senior Vice President and Chief Financial Officer.

Ryan: Thanks, Josh Good morning, good afternoon, and good evening to everyone listening around the world. Thank you for your interest in Regeneron and welcome to our first quarter 2024 earnings Conference call.

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, Senior Vice President and Chief Financial Officer.

Ryan Crowe: After our prepared remarks, the remaining time will be available for your questions. We anticipate today's call will last approximately 60 minutes. 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 issues, intellectual property, pending litigation and other proceedings and competition.

Ryan: An archive and transcript of this call will be available on the Regeneron Investor Relations website. Shortly after the call ends.

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

Speaker Change: Dr. George Young accomplished board Codeshare co founder President and Chief Scientific Officer.

Speaker Change: Marion Mccourt Executive Vice President of commercial and Chris Fenimore, Senior Vice President and Chief Financial Officer.

Speaker Change: After our prepared remarks, the remaining time will be available for your questions. We anticipate today's call will last approximately 60 minutes.

Ryan Crowe: Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2024, which was filed with the SEC this morning. Regeneron does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Speaker Change: Yes.

Speaker Change: I would like to remind you that remarks made on today's call may include forward looking statements about regeneron such statements may include but are not limited to those related to regeneron and its products and business financial forecast and guidance development programs and related anticipated milestones collaborations finances regulatory matters payer coverage and reimbursement issues.

Ryan Crowe: Such statements may include, but are not limited to, those related to Regeneron and its products and business, financial forecast and guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement issues, intellectual property, pending litigation and other proceedings, and competition. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2024, which was filed with the SEC this morning. Regeneron does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise.

Such statements may include, but are not limited to, those related to Regeneron and its products and business, financial forecast and guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement issues, intellectual property, pending litigation and other proceedings, and competition. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2024, which was filed with the SEC this morning. Regeneron does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise.

Speaker Change: Intellectual property pending litigation and other proceedings and competition.

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

Speaker Change: A more complete description of these and other material risks can be found in regeneron and <unk> filings with the United States Securities and Exchange Commission.

Speaker Change: Including its Form 10-Q for the quarter ended March 31, 2024, which was filed with the SEC. This morning rich.

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

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 accessed on the Regeneron Investor Relations website. Once our call concludes, Chris and 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?

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 accessed on the Regeneron Investor Relations website. Once our call concludes, Chris and the IR team will be available to answer any further questions. With that, let me turn the call over to our President and Chief Executive Officer, Dr. Leonard Schleifer. Len?

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

Speaker Change: Information 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 accessed on the regeneron Investor Relations website.

Speaker Change: Once our call concludes Chris and the IR team will be available to answer your answer any further questions.

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 the reconciliation of those measures to GAAP is available in our quarterly results press release and our corporate presentation, both of which can be accessed on the Regeneron Investor Relations website. Once our call concludes, Chris and 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?

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 the reconciliation of those measures to GAAP is available in our quarterly results press release and our corporate presentation, both of which can be accessed on the Regeneron Investor Relations website. Once our call concludes, Chris and the IR team will be available to answer any further questions.

Speaker Change: With that let me turn the call over to our President and Chief Executive Officer, Dr. Leonard Schleifer Len.

With that, let me turn the call over to our President and Chief Executive Officer, Dr. Leonard Schleifer. Len?

Leonard S. Schleifer: Thanks, Ryan. Thanks to everyone joining today's call. Regeneron is off to a strong start in 2024, reflected in our solid first quarter financial results, as well as the progress we've made across our pipeline in the first four months of the year. From my remarks today, I'd like to briefly review some of our key performance drivers and then discuss a few of our more differentiated development programs, which have the potential to drive sustainable long-term growth for the company and value for our shareholders. After my remarks, George will provide an update on our pipeline, Marion will then review our commercial performance and Chris will discuss our financial results.

Leonard S. Schleifer: Thanks, Ryan. Thanks to everyone joining today's call.

Leonard Schleifer: Thanks, Ryan. Thanks to everyone joining today's call. Regeneron's off to a strong start in 2024, reflected in our solid Q1 2024 financial results, as well as the progress we have made across our pipeline in the first four months of the year. For my remarks today, I'd like to briefly review some of our key performance drivers and then discuss a few of our more differentiated development programs, which have the potential to to drive sustainable long-term growth for the company and value for our shareholders. After my remarks, George will provide an update on our pipeline, Marion will then review our commercial performance, and Chris will discuss our financial results. Q1 2024 revenues grew 7% after excluding last year's revenue contribution from our COVID antibodies.

Leonard S. Schleifer: Thanks, Ryan and thanks to everyone. Joining today's call Regeneron is off to a strong start in 2024 reflected in our solid first quarter financial results as well as the progress we've made across our pipeline in the first four months of the year.

Regeneron is off to a strong start in 2024, reflected in our solid first quarter financial results, as well as the progress we've made across our pipeline in the first four months of the year. From my remarks today, I'd like to briefly review some of our key performance drivers and then discuss a few of our more differentiated development programs, which have the potential to drive sustainable long-term growth for the company and value for our shareholders. After my remarks, George will provide an update on our pipeline, Marion will then review our commercial performance and Chris will discuss our financial results.

Leonard S. Schleifer: For my remarks today I'd like to briefly review some of our key performance drivers and then discuss a few of our more differentiated development programs, which have the potential to drive sustainable long term growth for the company and value for our shareholders.

Leonard S. Schleifer: After my remarks, George will provide an update on our pipeline Marion will then review our commercial performance and Chris will discuss our financial results.

Leonard S. Schleifer: 1st quarter 2024 revenues grew 7% after excluding last year's revenue contribution from our COVID antibodies. Growth was primarily driven by Sanofi collaboration revenues and LIBTAYO global net product sales, which grew by 14% and 45%, respectively. DUPIXENT global net product sales worth 3.1 billion, up 24%, reflecting strong growth across all approved indications. EYLEA HD generated $200 million in its second full quarter on the U.S. market, outperforming recent launches in the anti-VEGF category. Now, with a permanent J-code in place, improving payer coverage, broad prescriber familiarity and satisfaction with the EYLEA HD clinical profile and direct-to-consumer TV promotion underway, we continue to position EYLEA HD as the new standard of care for retinal diseases.

Leonard S. Schleifer: First quarter 2024 revenues grew 7% after excluding last year's revenue contribution from our Covid antibodies growth was primarily driven by scientific collaboration revenues and lip Tayo global net product sales, which grew by 14% and 45% respectively to pick.

Leonard Schleifer: Growth was primarily driven by Sanofi collaboration revenues and Libtayo global net product sales, which grew by 14% and 45%, respectively. Dupixent global net product sales were $3.1 billion, up 24%, reflecting strong growth across all approved indications. Eylea HD generated $200 million in its second full quarter on the US market, outperforming recent launches in the anti-VEGF category. Now, with a permanent J-code in place, improving payer coverage, broad prescriber familiarity and satisfaction with the Eylea HD clinical profile, and direct-to-consumer TV promotion underway, we continue to position Eylea HD as the new standard of care for retinal diseases. Shifting to chronic obstructive pulmonary disease, or COPD, where Regeneron and Sanofi have two differentiated opportunities to transform the treatment paradigm for patients living with this debilitating disease.

Growth was primarily driven by Sanofi collaboration revenues and Libtayo global net product sales, which grew by 14% and 45%, respectively. Dupixent global net product sales were $3.1 billion, up 24%, reflecting strong growth across all approved indications. Eylea HD generated $200 million in its second full quarter on the US market, outperforming recent launches in the anti-VEGF category. Now, with a permanent J-code in place, improving payer coverage, broad prescriber familiarity and satisfaction with the Eylea HD clinical profile, and direct-to-consumer TV promotion underway, we continue to position Eylea HD as the new standard of care for retinal diseases. Shifting to chronic obstructive pulmonary disease, or COPD, where Regeneron and Sanofi have two differentiated opportunities to transform the treatment paradigm for patients living with this debilitating disease.

Leonard S. Schleifer: Global net product sales were $3 1 billion up 24%, reflecting strong growth across all approved indications.

Leonard S. Schleifer: Leah HD generated 200 million in its second full quarter on the U S market outperforming recent launches in the anti VEGF category.

Leonard S. Schleifer: Now, with a permanent J-code in place, improving payer coverage, broad prescriber familiarity and satisfaction with the EYLEA HD clinical profile and direct-to-consumer TV promotion underway, we continue to position EYLEA HD as the new standard of care for retinal diseases. Shifting to chronic obstructive pulmonary disease or COPD, where Regeneron and Sanofi have two differentiated opportunities to transform the treatment paradigm for patients living with this debilitating disease. As announced in February, our sBLA for DUPIXENT for the treatment of COPD with type 2 inflammation was accepted by the FDA for priority review with a June 27th PDUFA date.

Now, with a permanent J-code in place, improving payer coverage, broad prescriber familiarity and satisfaction with the EYLEA HD clinical profile and direct-to-consumer TV promotion underway, we continue to position EYLEA HD as the new standard of care for retinal diseases. Shifting to chronic obstructive pulmonary disease or COPD, where Regeneron and Sanofi have two differentiated opportunities to transform the treatment paradigm for patients living with this debilitating disease.

Leonard S. Schleifer: Now with the permanent J code in place improving payer coverage broad prescriber familiarity and satisfaction with the Eylea HD clinical profile and direct to consumer TV promotion underway, we continue to position Eylea HD as the new standard of care for retinal diseases.

Shifting to chronic obstructive pulmonary disease or COPD, where Regeneron and Sanofi have two differentiated opportunities to transform the treatment paradigm for patients living with this debilitating disease. As announced in February, our sBLA for DUPIXENT for the treatment of COPD with Type 2 inflammation was accepted by the FDA for priority review with a June 27th PDUFA date. During its review of our submission, the FDA has requested additional efficacy analyses, including an information request received earlier this week regarding sub-populations from the BOREAS and NOTUS pivotal studies. Our analyses across these requested patient subgroups indicate a consistent and clinically meaningful reduction in COPD exacerbations. While the FDA has requested these analyses be submitted by the end of May, we anticipate providing them substantially sooner. We and Sanofi are confident that these additional analyses strongly support the approval of DUPIXENT in eosinophilic COPD. If the FDA determines that they need additional time to review these analyses, a decision on the sBLA could be delayed for up to three months.

Leonard S. Schleifer: Shifting to chronic obstructive pulmonary disease, or COPD, where regeneron and Sanofi have two differentiated opportunities to transform the treatment paradigm for patients living with this debilitating disease.

As announced in February, our sBLA for DUPIXENT for the treatment of COPD with type 2 inflammation was accepted by the FDA for priority review with a June 27th PDUFA date. During its review of our submission, the FDA has requested additional efficacy analyses, including an information request received earlier this week regarding sub-populations from the BOREAS and NOTUS pivotal studies. Our analyses across these requested patient subgroups indicate a consistent and clinically meaningful reduction in COPD exacerbations. While the FDA has requested these analyses be submitted by the end of May, we anticipate providing them substantially sooner. We and Sanofi are confident that these additional analyses strongly support the approval of dupixan and eosinophilic COPD. If the FDA determines that they need additional time to review these analyses, a decision on the SPLA could be delayed for up to three months.

Leonard Schleifer: As announced in February, our sBLA for Dupixent for the treatment of COPD with Type 2 inflammation was accepted by the FDA for priority review, with a 27 June 2024 PDUFA date. During its review of our submission, the FDA has requested additional efficacy analyses, including an information request received earlier this week regarding subpopulations from the BORREAS and NODUS pivotal studies. Our analyses across these requested patient subgroups indicate a consistent and clinically meaningful reduction in COPD exacerbations. While the FDA has requested these analyses be submitted by the end of May, we anticipate providing them substantially sooner. We and Sanofi are confident that these additional analyses strongly support the approval of Dupixent in eosinophilic COPD. If the FDA determines that they need additional time to review these analyses, a decision on the sBLA could be delayed for up to three months.

As announced in February, our sBLA for Dupixent for the treatment of COPD with Type 2 inflammation was accepted by the FDA for priority review, with a 27 June 2024 PDUFA date. During its review of our submission, the FDA has requested additional efficacy analyses, including an information request received earlier this week regarding subpopulations from the BORREAS and NODUS pivotal studies. Our analyses across these requested patient subgroups indicate a consistent and clinically meaningful reduction in COPD exacerbations. While the FDA has requested these analyses be submitted by the end of May, we anticipate providing them substantially sooner. We and Sanofi are confident that these additional analyses strongly support the approval of Dupixent in eosinophilic COPD. If the FDA determines that they need additional time to review these analyses, a decision on the sBLA could be delayed for up to three months.

Leonard S. Schleifer: As announced in February our SPL, a for <unk> for the treatment of COPD with type two inflammation was accepted by the FDA for priority view, we view.

Leonard S. Schleifer: With a June 27th Paducah date.

Leonard S. Schleifer: During its review of our submission, the FDA has requested additional efficacy analyses, including an information request received earlier this week regarding subpopulations from the Boreas and Notice Pivotal Studies. Our analyses across these requested patient subgroups indicate a consistent and clinically meaningful reduction in COPD exacerbations. While the FDA has requested these analyses be submitted by the end of May, we anticipate providing them substantially sooner. We and Sanofi are confident that these additional analyses strongly support the approval of dupixan and eosinophilic COPD. If the FDA determines that they need additional time to review these analyses, a decision on the SPLA could be delayed for up to three months.

Leonard S. Schleifer: During its review of our submission the FDA has requested additional efficacy analyses, including an information request received earlier this week regarding subpopulations from the breweries and noticed pivotal studies or analyses across these requests.

Our analyses across these requested patient subgroups indicate a consistent and clinically meaningful reduction in COPD exacerbations. While the FDA has requested these analyses be submitted by the end of May, we anticipate providing them substantially sooner. We and Sanofi are confident that these additional analyses strongly support the approval of DUPIXENT in eosinophilic COPD. If the FDA determines that they need additional time to review these analyses, a decision on the sBLA could be delayed for up to three months.

Leonard S. Schleifer: <unk> patient subgroups indicated consistent and clinically meaningful reduction in COPD exacerbations, while the FDA has requested these analyses be submitted by the end of May we anticipate providing them substantially sooner.

Leonard S. Schleifer: We and Sanofi are confident that these additional analyses strongly support the approval of the pigs and eosinophilic COPD.

Leonard S. Schleifer: If the FDA determines that they need additional time to review these analyses.

Leonard S. Schleifer: On the S BLA could be delayed for up to three months.

Leonard S. Schleifer: We and our partner, Sanofi, are preparing for a launch that many pulmonologists, respiratory key opinion leaders and their patients are eagerly anticipating. If approved, DUPIXENT would be the only biologic therapy for COPD and the first new treatment approach for this disease in more than a decade. There is a high, unmet need for COPD with Type 2 inflammation, with approximately 300,000 eligible patients in the United States and another approximately 300,000 eligible patients in the EU and Japan, where we are also seeking regulatory approvals.

Leonard Schleifer: We and our partner, Sanofi, are preparing for a launch that many pulmonologists, respiratory key opinion leaders, and their patients are eagerly anticipating. If approved, Dupixent will be the only biologic therapy for COPD and the first new treatment approach for this disease in more than a decade. There is a high unmet need in COPD with type two inflammation, with approximately 300,000 eligible patients in the United States and another approximately 300,000 eligible patients in the EU and Japan, where we are also seeking regulatory approvals. Turning to Itopekimab, our IL-33 antibody, which is being evaluated in former smokers with COPD, regardless of eosinophilic phenotype, we remain on track to report results and enable potential global regulatory filings in the second half of next year.

We and our partner, Sanofi, are preparing for a launch that many pulmonologists, respiratory key opinion leaders, and their patients are eagerly anticipating. If approved, Dupixent will be the only biologic therapy for COPD and the first new treatment approach for this disease in more than a decade. There is a high unmet need in COPD with type two inflammation, with approximately 300,000 eligible patients in the United States and another approximately 300,000 eligible patients in the EU and Japan, where we are also seeking regulatory approvals. Turning to Itopekimab, our IL-33 antibody, which is being evaluated in former smokers with COPD, regardless of eosinophilic phenotype, we remain on track to report results and enable potential global regulatory filings in the second half of next year.

Leonard S. Schleifer: We and our partner <unk> are preparing for a launch that many pulmonologists respiratory key opinion leaders and their patients are eagerly anticipating if approved depicts and would be the only biologic therapy for COPD in the first new treatment approach for this disease in more than a decade.

Leonard S. Schleifer: There is a high unmet need in COPD with type two inflammation with approximately 300000 eligible patients in the United States and another approximately 300000 eligible patients in the U E EU and Japan.

Leonard S. Schleifer: We are also seeking regulatory approvals.

Leonard S. Schleifer: Turning to ITEPEKIMAB, our IL-33 antibody, which is being evaluated in former smokers with COPD regardless of the eosinophilic phenotype. We remain on track to report results and enable potential global regulatory filings in the second half of next year. ITEPEKIMAB can potentially address up to 1 million patients in the G7 countries, while China also represents a significant opportunity. We are very excited about potentially bringing these important new therapies to COPD patients while expanding our commercial respiratory franchise.

Leonard S. Schleifer: Turning to <unk>, our IL 33, antibody, which is being evaluated and former smokers with COPD, regardless of its independent phenotype. We remain on track to report results and enabled potential global regulatory filings in the second half of next year in a pack of Mab can potentially.

Leonard Schleifer: Itopekimab can potentially address up to one million patients in the G7 countries, while China also represents a significant opportunity. We are very excited about potentially bringing these important new therapies to COPD patients, while expanding our commercial respiratory franchise. In a moment, George will describe another key opportunity in our pipeline involving Dupixent, in combination with our BCMA by CD3 bispecific antibody, Linvoseltumab, which we believe has the potential to address any severe allergy and allow the millions of severe allergy sufferers to stop living in fear of an accidental exposure. Moving from Linvoseltumab to, in severe allergy, to its differentiated opportunity in multiple myeloma, where it is currently under FDA and EMA review in the relapsed refractory setting.

Itopekimab can potentially address up to one million patients in the G7 countries, while China also represents a significant opportunity. We are very excited about potentially bringing these important new therapies to COPD patients, while expanding our commercial respiratory franchise. In a moment, George will describe another key opportunity in our pipeline involving Dupixent, in combination with our BCMA by CD3 bispecific antibody, Linvoseltumab, which we believe has the potential to address any severe allergy and allow the millions of severe allergy sufferers to stop living in fear of an accidental exposure. Moving from Linvoseltumab to, in severe allergy, to its differentiated opportunity in multiple myeloma, where it is currently under FDA and EMA review in the relapsed refractory setting.

Leonard S. Schleifer: Address up to 1 million patients in the G. Seven countries, while China also represents a significant opportunity. We are very excited about potentially bringing these important new therapies with COPD patients, while expanding our commercial respiratory franchise.

Leonard S. Schleifer: In a moment, George will describe another key opportunity in our pipeline, involving DUPIXENT in combination with our BCMAxCD3 bispecific antibody, LINVOSELTAMAB -- which we believe has the potential to address any severe allergy and allow the millions of severe allergy sufferers to stop living in fear of an accidental exposure. Moving from LINVOSELTAMAB in severe allergy to its differentiated opportunity in multiple myeloma, where it is currently under FDA and EMA review in the relapsed refractory setting.

Leonard S. Schleifer: In a moment George will describe another key opportunity in our pipeline involving <unk> in combination with our be CMA by CD three by specific antibody Limburg South of Mab, which we believe has the potential to address any severe allergy and allow the millions of severe allergy saft.

Leonard S. Schleifer: To stop living in fear of an accidental exposure.

Leonard S. Schleifer: Moving from Linz, invokes ultimate and severe allergy to its differentiated opportunity in multiple myeloma, where it is currently under FDA and EMA review and the mill.

Leonard S. Schleifer: In our registration enabling dataset, while cost trial comparisons and caveats apply, we believe LINVOSELTAMAB represents a best-in-class opportunity because it has the highest objective response rates and complete response rates at similar follow-up observed across the BMA bispecific class to date, requires the least number of days in the hospital compared to other drugs in the category and is the only BCMAxCD3 agent currently under review or already approved by the FDA, that evaluated every four-week dosing. If approved,

In our registration enabling dataset, while cost trial comparisons and caveats apply, we believe LINVOSELTAMAB represents a best-in-class opportunity because it has the highest objective response rates and complete response rates at similar follow-up observed across the BMA bispecific class to date, requires the least number of days in the hospital compared to other drugs in the category and is the only BCMAxCD3 agent currently under review or already approved by the FDA, that evaluated every four-week dosing. If approved, we believe these are all important considerations for patients, caregivers, providers, and payers that could drive LINVOSELTAMAB adoption.

Leonard S. Schleifer: Lapsed refractory setting.

Leonard Schleifer: In our registration-enabling data set, while cross-trial comparisons caveats apply, we believe Linvoseltumab represents a best-in-class opportunity because it has the highest objective response rates and complete response rates at similar follow-up observed across the BCMA bispecific class to date, requires the least number of days in the hospital compared to other drugs in the category, and is the only BCMA xCD3 agent currently under review or already approved by the FDA that evaluated every four-week dosing. If approved, we believe these are all important considerations for patients, caregivers, providers, and payers that could drive Linvoseltumab adoption. In closing, I'm excited and energized by the differentiated opportunities in our pipeline, which now has over 35 programs in clinical development, spanning many distinct therapeutic areas.

In our registration-enabling data set, while cross-trial comparisons caveats apply, we believe Linvoseltumab represents a best-in-class opportunity because it has the highest objective response rates and complete response rates at similar follow-up observed across the BCMA bispecific class to date, requires the least number of days in the hospital compared to other drugs in the category, and is the only BCMA xCD3 agent currently under review or already approved by the FDA that evaluated every four-week dosing. If approved, we believe these are all important considerations for patients, caregivers, providers, and payers that could drive Linvoseltumab adoption. In closing, I'm excited and energized by the differentiated opportunities in our pipeline, which now has over 35 programs in clinical development, spanning many distinct therapeutic areas.

Leonard S. Schleifer: And our registration enabling dataset.

Leonard S. Schleifer: Cross trial comparisons caveats apply we believe limbo Salta Mab represents a best in class opportunity because it has the highest objective response rates and complete response rates at similar follow up observed across the BMA Bispecific class today requires the least number of days.

Leonard S. Schleifer: The hospital compared to other drugs in the category and it's the only be CMA by CD three agent currently under review or are already approved by the FDA that evaluated every four week dosing.

If approved, we believe these are all important considerations for patients, caregivers, providers, and payers that could drive LINVOSELTAMAB adoption. In closing, I am excited and energized by the differentiated opportunities in our pipeline, which now has over 35 programs in clinical development spanning many distinct therapeutic areas. Our commercial team continues to execute well and is building momentum in competitive categories and we continue to deploy capital with the goal of driving shareholder returns over time. With that, I'll turn the call over to George.

If approved, we believe these are all important considerations for patients, caregivers, providers, and payers that could drive LINVOSELTAMAB adoption.

Leonard S. Schleifer: We believe these are all important considerations for patients, caregivers, providers, and payers that could drive Limboseltamib adoption. In closing, I am excited and energized by the differentiated opportunities in our pipeline, which now has over 35 programs in clinical development spanning many distinct therapeutic areas. Our commercial team continues to execute well and is building momentum in competitive categories, and we continue to deploy capital with the goal of driving shareholder returns over the next. With that, I'll turn the call over to George.

Leonard S. Schleifer: If approved we believe these are all important considerations for patients caregivers providers and payers that could drive limbo sell them at adoption.

In closing, I am excited and energized by the differentiated opportunities in our pipeline, which now has over 35 programs in clinical development spanning many distinct therapeutic areas. Our commercial team continues to execute well and is building momentum in competitive categories and we continue to deploy capital with the goal of driving shareholder returns over time.

Leonard S. Schleifer: In closing I am excited and energized by the differentiated opportunities in our pipeline, which now has over 35 programs in clinical development spanning many distinct therapeutic areas.

Leonard Schleifer: Our commercial team continues to execute well and is building momentum in competitive categories, and we continue to deploy capital with the goal of driving shareholder returns over time. With that, I'll turn the call over to George.

Our commercial team continues to execute well and is building momentum in competitive categories, and we continue to deploy capital with the goal of driving shareholder returns over time. With that, I'll turn the call over to George.

Leonard S. Schleifer: Our commercial team continues to execute well and is building momentum in competitive categories and we continue to look to deploy capital with the goal of driving shareholder returns overtime.

With that, I'll turn the call over to George.

Leonard S. Schleifer: With that I'll turn the call over to George.

George Yancopoulos: Thanks, Len. Since Len covered the status of the Dupixent and Itopekimab programs in COPD in great detail, I'd like to start with a bit more about our innovative treatment approach for severe allergies, a first-ever combination of an immunomodulatory antibody, that is Dupixent, with a bispecific antibody. Despite the remarkable benefit demonstrated by Dupixent across multiple diseases characterized by allergic or Type 2 inflammation, Dupixent alone does not immediately reverse severe allergies by itself. These allergies are caused by high levels of an immunoglobulin class known as IgE, made by long-lived plasma cells. This has caused some to refer to the E in IgE as E for evil. Although Dupixent will prevent formation of new IgE plasma cells, it does not eliminate those that have already formed.

George D. Yancopoulos: Thanks, Len. Since Len covered the status of the DUPIXENT and ITEPEKIMAB programs in COPD in great detail, I'd like to start with a bit more about our innovative treatment approach for severe allergies. A first-ever combination of an immunomodulatory antibody, that is DUPIXENT, with a bispecific antibody. Despite the remarkable benefit demonstrated by DUPIXENT across multiple diseases characterized by allergic or Type 2 inflammation, DUPIXENT alone does not immediately reverse severe allergies by itself. These allergies are caused by high levels of an immunoglobulin class known as IgE, made by long-lived plasma cells. This has caused some to refer to the E in IGE, as E for evil.

George D. Yancopoulos: Thanks Lynn.

George D. Yancopoulos: <unk> covered the status of the <unk>.

George D. Yancopoulos: Pick a mab programs in COPD in great detail I would like to start with a bit more about our innovative treatment approach for severe allergies.

George D. Yancopoulos: First ever combination of immuno module Tory antibody that is <unk> with a bi specific antibody.

George D. Yancopoulos: Despite the remarkable benefit demonstrated by depiction across multiple diseases characterized by allergic where type two inflammation.

George D. Yancopoulos: <unk> alone does not immediately reverse severe allergies by itself.

These allergies are caused by high levels of an immunoglobulin class known as IgE, made by long-lived plasma cells. This has caused some to refer to the E in IGE, as E for evil. Although DUPIXENT will prevent formation of new IgE plasma cells, it does not eliminate those that have already formed. Regeneron scientists have shown that these allergy-causing IgE plasma cells can be rapidly eliminated with a short course of treatment with our bispecific antibody known as LINVOSELTAMAB. While DUPIXENT treatment will then prevent these cells from returning, as recently highlighted in our publication in Science Translational Medicine. We have commenced our proof-of-concept clinical trial to explore the potential for this combination approach to eliminate severe food allergy. We are hoping to see initial observations from this small study later this year, which will inform next steps.

George D. Yancopoulos: These allergies are caused by high levels of a new mirror Goblin class known as I G E.

George D. Yancopoulos: Made by long lived plasma cells. This has caused some to refer to the E GE.

George D. Yancopoulos: E S E for evil.

George D. Yancopoulos: Although DuPixin will prevent the formation of new IgE plasma cells, it does not eliminate those that have already formed. Regeneron scientists have shown that these algae-causing IgE plasma cells can be rapidly eliminated with a short course of treatment with our bi-specific antibody known as lymphoceltamide. [inaudible] Treatment will then prevent these cells from returning, as recently highlighted in our publication in Science Translational Medicine. We have commenced our proof-of-concept clinical trial to explore the potential for this combination approach to eliminate severe food allergy. We are hoping to see initial observations from this small study later this year, which will inform next steps.

George D. Yancopoulos: Although two pixel will prevent formation of new <unk> E plasma cells. It does not eliminate those that have already formed.

George Yancopoulos: Regeneron scientists have shown that these allergy-causing IgE plasma cells can be rapidly eliminated with a short course of treatment with our bispecific antibody, known as Linvoseltumab, while Dupixent treatment will then prevent these cells from returning, as recently highlighted in our publication in Science Translational Medicine. We have commenced our proof of concept clinical trial to explore the potential for this combination approach to eliminate severe food allergy. We are hoping to see initial observations from this small study later this year, which will inform next steps. Moving on to oncology and Libtayo combinations. Early clinical results of our LAG-3 antibody, Fianlimab, in combination with Libtayo, suggest that these antibodies represent one of the most promising checkpoint inhibitor combinations in clinical development.

Regeneron scientists have shown that these allergy-causing IgE plasma cells can be rapidly eliminated with a short course of treatment with our bispecific antibody, known as Linvoseltumab, while Dupixent treatment will then prevent these cells from returning, as recently highlighted in our publication in Science Translational Medicine. We have commenced our proof of concept clinical trial to explore the potential for this combination approach to eliminate severe food allergy. We are hoping to see initial observations from this small study later this year, which will inform next steps. Moving on to oncology and Libtayo combinations. Early clinical results of our LAG-3 antibody, Fianlimab, in combination with Libtayo, suggest that these antibodies represent one of the most promising checkpoint inhibitor combinations in clinical development.

George D. Yancopoulos: <unk> scientists have shown that these algae, causing.

George D. Yancopoulos: E plasma cells can be rapidly eliminated with a short course of treatment with our bi specific antibody known as limbus ultimate.

While DUPIXENT treatment will then prevent these cells from returning, as recently highlighted in our publication in Science Translational Medicine. We have commenced our proof-of-concept clinical trial to explore the potential for this combination approach to eliminate severe food allergy. We are hoping to see initial observations from this small study later this year, which will inform next steps.

George D. Yancopoulos: While two peaks.

George D. Yancopoulos: Treatment.

George D. Yancopoulos: We'll then prevent b cells from return as recently highlighted in a publication in science translational medicine we.

George D. Yancopoulos: We have commenced our proof of concept clinical trial to explore the potential to this combined combination approach to eliminate severe food allergy, we're hoping to see initial observations from this small study later this year, which will inform next steps.

George D. Yancopoulos: Moving on to oncology and LIBTAYO combinations. Early clinical results of our LAG-3 antibody, FIANLIMAB, in combination with LIBTAYO suggest that these antibodies represent one of the most promising checkpoint inhibitor combinations in clinical development. Recall, FIANLIMAB-LIBTAYO demonstrated potential for best-in-class efficacy in first-line metastatic melanoma, with objective response rates of approximately 60% across three independent cohorts from our first-in-human study, with a safety profile that is similar to that seen with anti-PD-1 monotherapy. With longer-term follow-up, these initial responses continue to deepen, including patients converting into complete responses.

Moving on to oncology and LIBTAYO combinations. Early clinical results of our LAG-3 antibody, FIANLIMAB, in combination with LIBTAYO suggest that these antibodies represent one of the most promising checkpoint inhibitor combinations in clinical development. Recall, FIANLIMAB-LIBTAYO demonstrated potential for best-in-class efficacy in first-line metastatic melanoma, with objective response rates of approximately 60% across three independent cohorts from our first-in-human study, with a safety profile that is similar to that seen with anti-PD-1 monotherapy.

George D. Yancopoulos: Moving on to oncology and the child combinations early clinical results of our luxury antibody for <unk> in combination with reptile suggest that these antibodies represent one of the most promising checkpoint inhibitor combinations in clinical development.

George Yancopoulos: Recall, Fianlimab Libtayo demonstrated potential for best-in-class efficacy in first-line metastatic melanoma, with objective response rates of approximately 60% across three independent cohorts from our first in-human study, with a safety profile that is similar to that seen with anti-PD-1 monotherapy. With longer-term follow-up, these initial responses continue to deepen, including patients converting into complete responses. We look forward to presenting updated results from these expansion cohorts in the second half of this year. Encouraged by these initial results, last year, we initiated a phase II/III study of the combination of Fianlimab and Libtayo in first-line metastatic melanoma. This study is enrolling faster than expected and will now be conducted solely as a phase III study, with the final analysis to be reported during 2025. These pivotal melanoma data will inform whether Fianlimab and Libtayo have the potential to emerge as a new standard of care in melanoma.

Recall, Fianlimab Libtayo demonstrated potential for best-in-class efficacy in first-line metastatic melanoma, with objective response rates of approximately 60% across three independent cohorts from our first in-human study, with a safety profile that is similar to that seen with anti-PD-1 monotherapy. With longer-term follow-up, these initial responses continue to deepen, including patients converting into complete responses. We look forward to presenting updated results from these expansion cohorts in the second half of this year. Encouraged by these initial results, last year, we initiated a phase II/III study of the combination of Fianlimab and Libtayo in first-line metastatic melanoma. This study is enrolling faster than expected and will now be conducted solely as a phase III study, with the final analysis to be reported during 2025. These pivotal melanoma data will inform whether Fianlimab and Libtayo have the potential to emerge as a new standard of care in melanoma.

George D. Yancopoulos: Recall, the <unk> demonstrated potential for best in class efficacy in first line metastatic melanoma with objective response rates of approximately 60% across three independent cohorts from our first in human study with a safety profile that is similar to that seen with anti PD one monotherapy.

With longer-term follow-up, these initial responses continue to deepen, including patients converting into complete responses. We look forward to presenting updated results from these expansion cohorts in the second half of this year. Encouraged by these initial results, last year, we initiated a Phase II/III study of the combination of FIANLIMAB and LIBTAYO in first-line metastatic melanoma. This study is enrolling faster than expected and will now be conducted solely as a Phase III study, with the final analysis to be reported during 2025. These pivotal melanoma data will inform whether FIANLIMAB and LIBTAYO have the potential to emerge as a new standard of care in melanoma.

George D. Yancopoulos: With longer term follow up these initial responses continue to deepen including patients converting into complete responses. We look forward to presenting updated results from these expansion cohorts in the second half of this year.

George D. Yancopoulos: We look forward to presenting updated results from these expansion cohorts in the second half of this year. Encouraged by these initial results, last year, we initiated a Phase 2-3 study of the combination of pheanlamab and leptile in first-line metastatic melanoma. This study is enrolling faster than expected and will now be conducted solely as a Phase 3 study, with the final analysis to be reported during 2025. These pivotal melanoma data will inform whether pheanlamab and leptile have the potential to emerge as a new standard of care in melanoma.

George D. Yancopoulos: Encouraged by these initial results last year, we initiated a phase two three study with the combination of <unk> and reptile in first line metastatic melanoma. This study is enrolling faster than expected and we will now be conducted solely as a phase III study with the final analysis to be reported during 2012.

George D. Yancopoulos: Five of these pivotal melanoma data will inform whether <unk> has the potential to emerge as a new standard of care in melanoma.

George Yancopoulos: Next, to our bispecifics for hematology/oncology. Regarding Odronextamab, our CD20xCD3 bispecific, as announced in March, we received complete response letters from the FDA for our BLA for relapse-refractory follicular lymphoma and relapse-refractory diffuse large B-cell lymphoma. The only approvability issue was related to the limited enrollment of these confirmatory trials, which we intend to address as we continue to enroll patients in these studies. The EU decision on Odronextamab application is expected in the second half of this year. Moving on to Linvoseltumab. As Len noted, this bispecific continues to demonstrate a potentially best-in-class profile in late-line myeloma in terms of efficacy, safety, dosing, and hospitalization burden. In an oral presentation at the recent AACR medical meeting, we presented results of an 11-month median follow-up of 117 patients. A 71% objective response rate, with 46% of patients achieving a complete response or better.

Next, to our bispecifics for hematology/oncology. Regarding Odronextamab, our CD20xCD3 bispecific, as announced in March, we received complete response letters from the FDA for our BLA for relapse-refractory follicular lymphoma and relapse-refractory diffuse large B-cell lymphoma. The only approvability issue was related to the limited enrollment of these confirmatory trials, which we intend to address as we continue to enroll patients in these studies. The EU decision on Odronextamab application is expected in the second half of this year. Moving on to Linvoseltumab. As Len noted, this bispecific continues to demonstrate a potentially best-in-class profile in late-line myeloma in terms of efficacy, safety, dosing, and hospitalization burden. In an oral presentation at the recent AACR medical meeting, we presented results of an 11-month median follow-up of 117 patients. A 71% objective response rate, with 46% of patients achieving a complete response or better.

George D. Yancopoulos: Next, to our bispecifics for hematology/oncology. Regarding ODRONEXTAMAB -- our CD20xCD3 bispecific -- as announced in March, we received complete response letters from the FDA for our BLA for relapsed refractory follicular lymphoma and relapsed refractory diffuse large B cell lymphoma. The only approvability issue was related to the limited enrollment of these confirmatory trials, which we intend to address as we continue to enroll patients in these studies. The EU decision on ODRONEXTAMAB application is expected in the second half of this year. Moving on, to Limbaugh-Selkman.

Next, to our bispecifics for hematology/oncology. Regarding ODRONEXTAMAB -- our CD20xCD3 bispecific -- as announced in March, we received complete response letters from the FDA for our BLA for relapsed refractory follicular lymphoma and relapsed refractory diffuse large B cell lymphoma. The only approvability issue was related to the limited enrollment of these confirmatory trials, which we intend to address as we continue to enroll patients in these studies. The EU decision on ODRONEXTAMAB application is expected in the second half of this year.

George D. Yancopoulos: Next.

George D. Yancopoulos: Two our bi specifics for hematology oncology rigs.

George D. Yancopoulos: Regarding <unk>, our CD 20 by CD three Bispecific as announced in March we received a complete response letters from the FDA for our BLA for relapsed refractory Follicular lymphoma, and relapsed refractory diffuse large b cell lymphoma. The only approved ability issue was related to the limited enrollment of these confirmatory trials, which we.

George D. Yancopoulos: We intend to address as we continue to enroll patients in these studies the EU decision on <unk> Mab applications is expected in the second half of this year.

Moving on to LINVOSELTAMAB. As Len noted, this bispecific continues to demonstrate a potentially best-in-class profile in late-line myeloma in terms of efficacy, safety, dosing and hospitalization burden. In an oral presentation at the recent AACR medical meeting, we presented results of an 11-month median follow-up of 117 patients, a 71% objective response rate with 46% of patients achieving a complete response or better. We are planning to present updated 14-month follow-up results at the upcoming EHA meeting, in which we anticipate observing a further deepening of responses. Regarding the ongoing FDA review, we believe that confirmatory study will be sufficiently enrolled to support approval. We're also evaluating LINVOSELTAMAB in earlier stages of myeloma and in precursor conditions, such as smoldering myeloma and monoclonal gammopathy of unknown significance or MGUS. Next, bispecifics for solid tumors. Our co-stimulatory bispecific antibodies are being tested in numerous studies, including as monotherapies as well as in combination with CD3 bispecifics and with LIBTAYO.

George D. Yancopoulos: As Len noted, this Bios-specific continues to demonstrate a potentially best-in-class profile in late-line myeloma in terms of efficacy, safety, dosing, and hospitalization burden. In an oral presentation at the recent AACR medical meeting, we presented results of an 11-month median follow-up of 117 patients, 71% objective response rate, with 46% of patients achieving a complete response or better.

George D. Yancopoulos: Moving on to Limbo cellcom out as.

George D. Yancopoulos: As Lynn noted this by specific continues to demonstrate a potentially best in class profile in late line myeloma in terms of efficacy safety dosing and hospitalization burden.

George D. Yancopoulos: In an oral presentation at the recent ACR medical meeting we presented results of an 11 month median follow up of 117 patients.

George D. Yancopoulos: 71% objective response rate with 46% of patients achieving a complete response or better we are planning to present updated 14 month follow up results at the upcoming EHS meeting, which we anticipate observing a further deepening of responses.

George D. Yancopoulos: We are planning to present updated 14-month follow-up results at the upcoming EHA meeting, where we anticipate observing a further deepening of response. Regarding the ongoing FDA review, we believe the confirmatory study will be sufficiently enrolled to support approval. We're also evaluating limosultumab in earlier stages of myeloma and in precursor conditions, such as smoldering myeloma and monoclonal gammopathy of unknown significance (MGUS). Next, bi-specifics for solid tumors. Our co-similatory bispecific antibodies are being tested in numerous studies, including as monotherapies, as well as in combination with CD3 Bios specifics and Liptia.

We are planning to present updated 14-month follow-up results at the upcoming EHA meeting, in which we anticipate observing a further deepening of responses. Regarding the ongoing FDA review, we believe that confirmatory study will be sufficiently enrolled to support approval. We're also evaluating LINVOSELTAMAB in earlier stages of myeloma and in precursor conditions, such as smoldering myeloma and monoclonal gammopathy of unknown significance or MGUS.

George Yancopoulos: We are planning to present updated fourteen-month follow-up results at the upcoming EHA meeting, in which we anticipate observing a further deepening of responses. Regarding the ongoing FDA review, we believe the confirmatory study will be sufficiently enrolled to support approval. We're also evaluating Linvoseltumab in earlier stages of myeloma and in precursor conditions such as smoldering myeloma, and monoclonal gammopathy of unknown significance or MGUS. Next, to bispecifics for solid tumors. Our costimulatory bispecific antibodies are being tested in numerous studies, including as monotherapies, as well as in combination with CD3 bispecifics and with Libtayo. Our EGFR by CD28 bispecific in combination with Libtayo, we are planning to present updated dose escalation results in an oral presentation at ASCO. Most notably, in microsatellite stable colorectal cancer, a tumor historically unresponsive to immunotherapy, EGFR by CD28 in combination with Libtayo demonstrated antitumor activity.

We are planning to present updated fourteen-month follow-up results at the upcoming EHA meeting, in which we anticipate observing a further deepening of responses. Regarding the ongoing FDA review, we believe the confirmatory study will be sufficiently enrolled to support approval. We're also evaluating Linvoseltumab in earlier stages of myeloma and in precursor conditions such as smoldering myeloma, and monoclonal gammopathy of unknown significance or MGUS. Next, to bispecifics for solid tumors. Our costimulatory bispecific antibodies are being tested in numerous studies, including as monotherapies, as well as in combination with CD3 bispecifics and with Libtayo. Our EGFR by CD28 bispecific in combination with Libtayo, we are planning to present updated dose escalation results in an oral presentation at ASCO. Most notably, in microsatellite stable colorectal cancer, a tumor historically unresponsive to immunotherapy, EGFR by CD28 in combination with Libtayo demonstrated antitumor activity.

Regarding the ongoing FDA review, we believe that confirmatory study will be sufficiently enrolled to support approval. We're also evaluating LINVOSELTAMAB in earlier stages of myeloma and in precursor conditions, such as smoldering myeloma and monoclonal gammopathy of unknown significance or MGUS. Next, bispecifics for solid tumors. Our co-stimulatory bispecific antibodies are being tested in numerous studies, including as monotherapies as well as in combination with CD3 bispecifics and with LIBTAYO.

George D. Yancopoulos: Regarding the ongoing FDA review, we believe the confirmatory study will be sufficiently enrolled to support approval. We're also evaluating <unk> in earlier stages myeloma and precursor conditions, such as smoldering myeloma and monoclonal gammopathy of unknown significance or M. Gus.

Next, bispecifics for solid tumors. Our co-stimulatory bispecific antibodies are being tested in numerous studies, including as monotherapies as well as in combination with CD3 bispecifics and with LIBTAYO. Our EGFRxCD28 bispecific in combination with LIBTAYO, we are planning to present updated dose escalation results in an oral presentation at ASCO. Most notably, in microsatellite stable colorectal cancer -- a tumor historically unresponsive to immunotherapy -- EGFRxCD28 in combination with LIBTAYO, demonstrated anti-tumor activity.

George D. Yancopoulos: Next to bi specifics for solid tumors.

George D. Yancopoulos: Co stimulatory Bispecific antibodies are being tested in numerous studies, including as monotherapy as well as in combination with <unk>, <unk> Bispecific and <unk> Chile.

George D. Yancopoulos: Our EGFR by CD28 bi-specific and combination of lip tile, we are planning to present updated dose escalation results in an oral presentation at Ask. Most notably, in microsatellite-stable colorectal cancer, a tumor historically unresponsive to immunotherapy, EGFR by CD28 in combination with lip tile demonstrated anti-tumor activity.

George D. Yancopoulos: <unk> Egfr by CD 28 by specific in combination will have tayo, we are planning to present updated dose escalation results in an oral presentation at <unk>.

George D. Yancopoulos: Most notably in microsatellite stable colorectal cancer, a tumor historically unresponsive to immunotherapy.

George D. Yancopoulos: GFR by <unk> 28 in combination with flip trial demonstrated anti tumor activity.

George D. Yancopoulos: Regarding safety, to date, we have not observed severe immune-related adverse events with this agent at our recommended Phase II dose. Based on these data, we're enrolling dose expansion cohorts, testing our EGFRxCD28 co-stim bispecific plus LIBTAYO in various cancers, including non-small cell lung cancer with or without EGF receptor mutations, microsatellite stable colorectal cancer, head and neck squamous cell carcinoma and others.

George Yancopoulos: Regarding safety, to date, we have not observed severe immune-related adverse events with this agent at our recommended phase II dose. Based on these data, we are enrolling dose expansion cohorts, testing our EGFR by CD28 costim bispecific plus Libtayo in various cancers, including non-small cell lung cancer, with or without EGF receptor mutations, microsatellite stable colorectal cancer, head and neck squamous cell carcinoma, and others. Onto our PSMA by CD28 costim bispecific, which is already demonstrating promising activity in prostate cancer in combination with Libtayo. We will soon initiate combination treatment of our PSMA by CD28 costim bispecific with our PSMA by CD3 bispecific, which, based on preclinical studies, may maintain efficacy but with better tolerability.

Regarding safety, to date, we have not observed severe immune-related adverse events with this agent at our recommended phase II dose. Based on these data, we are enrolling dose expansion cohorts, testing our EGFR by CD28 costim bispecific plus Libtayo in various cancers, including non-small cell lung cancer, with or without EGF receptor mutations, microsatellite stable colorectal cancer, head and neck squamous cell carcinoma, and others. Onto our PSMA by CD28 costim bispecific, which is already demonstrating promising activity in prostate cancer in combination with Libtayo. We will soon initiate combination treatment of our PSMA by CD28 costim bispecific with our PSMA by CD3 bispecific, which, based on preclinical studies, may maintain efficacy but with better tolerability.

George D. Yancopoulos: Regarding safety to date, we have not observed severe immune related adverse events with this agent at a recommended phase two dose based on these data we are enrolling dose expansion cohorts testing, our egfr by <unk> 28, co stim Bispecific cluster title in various cancers, including non small cell lung cancer with or without EGF.

George D. Yancopoulos: Receptor mutations.

George D. Yancopoulos: Microsatellite stable colorectal cancer head and neck squamous cell carcinoma and others.

George D. Yancopoulos: On to our PSMAxCD28 co-stimulatory bispecific, which is already demonstrating promising activity in prostate cancer in combination with LIBTAYO. We will soon initiate combination treatment of our PSMAxD28 co-stim bispecific with our PSMAxCD3 bispecific, which, based on preclinical studies, may maintain efficacy but with better tolerability. We're also evaluating our MUC16xCD28 co-stimulatory bispecific with UBAMATAMAB -- our MUC16xCD3 bispecific -- as well as with LIBTAYO; our CD3xCD28 co-stim with LINVOSELTAMAB for myeloma and our CD22xCD28 co-stim with ODRONEXTAMAB for lymphoma.

George D. Yancopoulos: Onto our SMA by <unk> 28, co stimulatory, Bispecific, which is already demonstrating promising activity in prostate cancer in combination with lip tile. We will soon initiate combination treatment of RP SMA by <unk> 28, co stim Bispecific with RP SMA by six three by specific which based on proof.

George D. Yancopoulos: Clinical studies may maintain efficacy, but with better Tolerability. We were also Valerie are amongst 16 by CD 28, co stimulatory Bispecific with Uber Madam App, our mercury team by three buses.

George Yancopoulos: We're also evaluating our MUC16 by CD28 costimulatory bispecific with Ubamatamab, our MUC16 by CD3 bispecific, as well as with Libtayo, our CD3 by CD28 costim with Linvoseltumab for myeloma, and our CD22 by CD28 costim with Odronextamab for lymphoma. Moving on to our classical hematology pipeline. Our C5 approach involves a first-in-class combination of an siRNA with an antibody for more complete target blockade, and our initial clinical data supports potential best-in-class efficacy in paroxysmal nocturnal hemoglobinuria, or PNH. Results from the preliminary cohort of the PNH phase 3 study will be presented at the EHA conference in June, with additional results expected later this year.

We're also evaluating our MUC16 by CD28 costimulatory bispecific with Ubamatamab, our MUC16 by CD3 bispecific, as well as with Libtayo, our CD3 by CD28 costim with Linvoseltumab for myeloma, and our CD22 by CD28 costim with Odronextamab for lymphoma. Moving on to our classical hematology pipeline. Our C5 approach involves a first-in-class combination of an siRNA with an antibody for more complete target blockade, and our initial clinical data supports potential best-in-class efficacy in paroxysmal nocturnal hemoglobinuria, or PNH. Results from the preliminary cohort of the PNH phase 3 study will be presented at the EHA conference in June, with additional results expected later this year.

George D. Yancopoulos: As well as with lip tower, our CD three.

George D. Yancopoulos: By <unk> 28 costume with Linda <unk> for myeloma, and our CD 22 by CD 28, co stim with <unk> for lymphoma.

George D. Yancopoulos: Moving on to our classical hematology pipeline. Our C5 approach involves a first-in-class combination of an sRNA with an antibody for a more complete target blockade and our initial clinical data supports potential best-in-class efficacy in paroxysmal nocturnal hemoglobinuria or PNH. Results from the preliminary cohort of the PNH Phase III study will be presented at the EHA conference in June, with additional results expected later this year. In addition to PNH and myasthenia gravis, which are already enrolling their respective pivotal trials, we are planning on extending the systemic combination approach to geographic atrophy in dry AMD, with the first pivotal study in GA expected to get underway this year. We are also anticipating proof-of-concept data later this year for two complementary factor XI antibodies in the setting of prevention of venous thromboembolism after knee replacement surgery. Depending on these data, one or both of these antibodies could remain on a rapid path to registrational studies, which could begin by late 2024 or early 2025.

Moving on to our classical hematology pipeline. Our C5 approach involves a first-in-class combination of an sRNA with an antibody for a more complete target blockade and our initial clinical data supports potential best-in-class efficacy in paroxysmal nocturnal hemoglobinuria or PNH. Results from the preliminary cohort of the PNH Phase III study will be presented at the EHA conference in June, with additional results expected later this year.

George D. Yancopoulos: Moving on to a classical hematology pipeline.

George D. Yancopoulos: Our C. Five approach involves a first in class combination of an S. RNA with an antibody for a more complete target blockade and our initial clinical data supports potential best in class efficacy in paroxysmal nocturnal hemoglobinuria or <unk>.

George D. Yancopoulos: Results from the preliminary cohort of the <unk> Phase III study will be presented at the conference in June with additional results expected. Later this year. In addition to <unk> and myasthenia gravis, which are already enrolling their respective pivotal trials. We are planning on extending the systemic combination approach to geographic atrophy in dry AMD.

George D. Yancopoulos: In addition to PNH and Mycenae Gravis, which are already enrolling their respective pivotal trials, we are planning on extending the systemic combination approach to geographic atrophy in dry AMD, with the first pivotal study in GA expected to get underway this year. We are also anticipating proof-of-concept data later this year for two complementary Factor XI antibodies in the setting of prevention of venous thromboembolism after knee Depending on these data, one or both of these antibodies could remain on a rapid path to registrational studies, which could begin by late 2024 or early 2025.

George Yancopoulos: In addition to PNH and myasthenia gravis, which are already enrolling their respective pivotal trials, we are planning on extending the systemic combination approach to geographic atrophy in dry AMD, with the first pivotal study in GA expected to get underway this year. We are also anticipating proof-of-concept data later this year for our two complementary Factor XI antibodies in the setting of prevention of venous thromboembolism after knee replacement surgery. Depending on these data, one or both of these antibodies could remain on a rapid path to registrational studies, which could begin by late 2024 or early 2025. Our first-in-class antibody to TMPRSS6, a genetically validated target for iron overload diseases such as beta thalassemia, is also making progress. This antibody has potential to meaningfully reduce toxic organ iron in patients for whom iron chelation is inadequate or intolerable.

In addition to PNH and myasthenia gravis, which are already enrolling their respective pivotal trials, we are planning on extending the systemic combination approach to geographic atrophy in dry AMD, with the first pivotal study in GA expected to get underway this year. We are also anticipating proof-of-concept data later this year for our two complementary Factor XI antibodies in the setting of prevention of venous thromboembolism after knee replacement surgery. Depending on these data, one or both of these antibodies could remain on a rapid path to registrational studies, which could begin by late 2024 or early 2025. Our first-in-class antibody to TMPRSS6, a genetically validated target for iron overload diseases such as beta thalassemia, is also making progress. This antibody has potential to meaningfully reduce toxic organ iron in patients for whom iron chelation is inadequate or intolerable.

George D. Yancopoulos: With the first pivotal study in <unk> expect it to get underway this year.

George D. Yancopoulos: We are also anticipating proof of concept data later this year for our two complementary factor 11 antibodies in the setting of prevention of venous thromboembolism after knee replacement surgery depending.

George D. Yancopoulos: Depending on these data one or both of these antibodies could remain on a rapid path to Registrational studies, which could begin by late 2024 or early 2025.

George D. Yancopoulos: Our first-in-class antibody, TMPRSS6, a genetically-validated target for iron-overload diseases such as beta-thalassemia, is also making progress. This antibody has potential to meaningfully reduce toxic organ iron in patients for whom iron chelation is inadequate or intolerable. Updated proof of mechanism data in healthy volunteers will be presented at the upcoming EHA conference. These results demonstrated deep, sustained reductions in serum iron and robust induction of the liver hormone hepcidin, supporting the potential to release iron from organs. We are on track to start a Phase II proof-of-concept study in beta-thalassemia patients in the second half of the year.

George D. Yancopoulos: Our first in class antibody to temper six a genetically validated target for iron overload diseases, such as beta Thalassemia is also making progress. This antibody has potential to meaningfully reduce toxic Oregon iron in patients for whom iron chelation is inadequate or intolerable.

George Yancopoulos: Updated proof of mechanism data in healthy volunteers will be presented at the upcoming EHA conference. These results demonstrated deep, sustained reductions in serum iron and robust induction of the liver hormone hepcidin, supporting the potential to release iron from organs. We are on track to start a phase II proof-of-concept study in beta thalassemia patients in the second half of the year. Moving to obesity. Our most advanced approach is designed to address potential negative consequences of widespread use of GLP-GIP receptor agonists. As has been widely reported, the profound weight loss caused by these agents, unfortunately, can also result in substantial loss of muscle, which is particularly concerning in older obese patients. Our antibodies to myostatin-related pathways may prevent this muscle loss.

Updated proof of mechanism data in healthy volunteers will be presented at the upcoming EHA conference. These results demonstrated deep, sustained reductions in serum iron and robust induction of the liver hormone hepcidin, supporting the potential to release iron from organs. We are on track to start a phase II proof-of-concept study in beta thalassemia patients in the second half of the year. Moving to obesity. Our most advanced approach is designed to address potential negative consequences of widespread use of GLP-GIP receptor agonists. As has been widely reported, the profound weight loss caused by these agents, unfortunately, can also result in substantial loss of muscle, which is particularly concerning in older obese patients. Our antibodies to myostatin-related pathways may prevent this muscle loss.

George D. Yancopoulos: Updated proof of mechanism data in healthy volunteers will be presented at the upcoming EHS conference.

George D. Yancopoulos: These results demonstrated deep sustained reductions in serum iron and robust induction of deliver hormone hip side supporting the potential to release iron from Oregon's we are on track to start a phase II proof of concept study in beta thalassemia patients in the second half of the year.

George D. Yancopoulos: We are on track to start a Phase II proof-of-concept study in beta-thalassemia patients in the second half of the year. Moving to obesity, our most advanced approach is designed to address potential negative consequences of widespread use of GLP-GIP receptor agonists. As has been widely reported, the profound weight loss caused by these agents can also result in substantial loss of muscle, which is particularly concerning in older obese patients.

We are on track to start a Phase II proof-of-concept study in beta-thalassemia patients in the second half of the year.

Moving to obesity. Our most advanced approach is designed to address potential negative consequences of widespread use of GLP-GIP receptor agonists. As has been widely reported, the profound weight loss caused by these agents, unfortunately, can also result in substantial loss of muscle, which is particularly concerning in older obese patients. Our antibodies to myostatin-related pathways may prevent this muscle loss. Indeed, our data in obese non-human primates show that combining semaglutide with TREVOGRUMAB -- our antibody-targeting myostatin -- with or without GARETOSMAB -- our antibody-targeting activin A or myostatin-2 -- demonstrated a comparable reduction in body weight at week 20 relative to semaglutide monotherapy but with improved quality weight loss, resulting in more fat loss while preserving or even increasing lean mass. Part A of our proof-of-concept study in healthy volunteers, intended to demonstrate safety of a higher dose of TREVOGRUMAB, has completed enrollment.

George D. Yancopoulos: Moving to obesity.

George D. Yancopoulos: Our most advanced approach is designed to address potential negative consequences of widespread use of G. L. P gift receptor agonists as has been widely reported the profound weight loss caused by these agents. Unfortunately can also result in substantial loss of muscle.

George D. Yancopoulos: Which is particularly concerning older obese patients are antibodies to myostatin related pathways may prevent this muscle loss. Indeed, our data in obese nonhuman primates showed that combining <unk> with <unk>, an antibody targeting <unk> with or without <unk>, our antibody tar.

George D. Yancopoulos: Our antibodies to myostatin-related pathways may prevent this muscle loss. Indeed, our data in obese non-human primates show that combining semaglutide with trevagrumab, or an antibody targeting myostatin, with or without gartizumab, our antibody targeting active NA, or myostatin 2, demonstrated a comparable reduction in body weight at week 20 relative to semaglutide monotherapy, but with improved quality of Part A of our proof-of-concept study in healthy volunteers intended to demonstrate the safety of a higher dose of trevogrumab has completed enrollment.

George Yancopoulos: Indeed, our data in obese non-human primates show that combining Semaglutide with Trevogrumab, or an antibody targeting myostatin, with or without Garetosmab, our antibody targeting Activin A or myostatin-2, demonstrated a comparable reduction in body weight at week 20 relative to Semaglutide monotherapy, but with improved quality of weight loss, resulting in more fat loss while preserving or even increasing lean mass. Part A of our proof-of-concept study in healthy volunteers, intended to demonstrate safety of a higher dose of Trevogrumab, has completed enrollment. Note that over 400 subjects, including healthy volunteers and sarcopenic patients, have been dosed with Trevogrumab throughout its clinical development, with no meaningful safety or tolerability concerns observed to date. Part B of the study, which will evaluate muscle preservation antibodies in combination with Semaglutide in obese participants, remains on track to start enrolling mid-year.

Indeed, our data in obese non-human primates show that combining Semaglutide with Trevogrumab, or an antibody targeting myostatin, with or without Garetosmab, our antibody targeting Activin A or myostatin-2, demonstrated a comparable reduction in body weight at week 20 relative to Semaglutide monotherapy, but with improved quality of weight loss, resulting in more fat loss while preserving or even increasing lean mass. Part A of our proof-of-concept study in healthy volunteers, intended to demonstrate safety of a higher dose of Trevogrumab, has completed enrollment. Note that over 400 subjects, including healthy volunteers and sarcopenic patients, have been dosed with Trevogrumab throughout its clinical development, with no meaningful safety or tolerability concerns observed to date. Part B of the study, which will evaluate muscle preservation antibodies in combination with Semaglutide in obese participants, remains on track to start enrolling mid-year.

Indeed, our data in obese non-human primates show that combining semaglutide with TREVOGRUMAB -- our antibody-targeting myostatin -- with or without GARETOSMAB -- our antibody-targeting activin A or myostatin-2 -- demonstrated a comparable reduction in body weight at week 20 relative to semaglutide monotherapy but with improved quality weight loss, resulting in more fat loss while preserving or even increasing lean mass. Part A of our proof-of-concept study in healthy volunteers, intended to demonstrate safety of a higher dose of TREVOGRUMAB, has completed enrollment.

George D. Yancopoulos: Getting active M&A or Myostatin, two demonstrated a comparable reduction in body weight at week 20 relative to <unk> monotherapy, but with improved quality of weight loss, resulting in more fat loss, while preserving or even increasing lean mass.

George D. Yancopoulos: Part a of our proof of concept study in healthy volunteers intended to demonstrate safety of a higher dosage. Trevor grew mab has completed enrollment note that over 400 subjects, including healthy volunteers and Cyclopedic patients had been dosed with <unk> throughout its clinical development.

George D. Yancopoulos: Note that over 400 subjects, including healthy volunteers and sarcopenic patients, have been dosed with TREVOGRUMAB throughout its clinical development, with no meaningful safety or tolerability concerns observed to date. Part B of the study, which will evaluate muscle preservation antibodies in combination with semaglutide in obese participants, remains on track to start enrolling mid-year. Assuming a reasonable pace of enrollment, we expect to report top-line results, including changes in body weight, fat mass and muscle mass, in the second half of 2025.

George D. Yancopoulos: With no meaningful safety or Tolerability concerns observed to date part b of the study, which will evaluate muscle preservation antibodies in combination with <unk>.

George D. Yancopoulos: Abuse participants remains on track to start enrolling midyear, assuming a reasonable pace of enrollment we expect to report top line results, including changes in body weight fat mass and muscle mass in second half of 2025.

George Yancopoulos: Assuming a reasonable pace of enrollment, we expect to report top-line results, including changes in body weight, fat mass, and muscle mass in H2 2025. I will conclude with our genetic medicines effort. At the upcoming ASGCT conference, we will present updated data from our DB-OTO gene therapy program for genetic hearing loss. The first patient treated with this therapy, a 10-month-old girl who was profoundly deaf at baseline, now at 24 weeks after treatment, had hearing in the normal range, and the second treated patient is following a similar trajectory of improvement through earlier stages of follow-up.

Assuming a reasonable pace of enrollment, we expect to report top-line results, including changes in body weight, fat mass, and muscle mass in H2 2025. I will conclude with our genetic medicines effort. At the upcoming ASGCT conference, we will present updated data from our DB-OTO gene therapy program for genetic hearing loss. The first patient treated with this therapy, a 10-month-old girl who was profoundly deaf at baseline, now at 24 weeks after treatment, had hearing in the normal range, and the second treated patient is following a similar trajectory of improvement through earlier stages of follow-up.

George D. Yancopoulos: I will conclude with our genetic medicines effort. At the upcoming ASGCT conference, we will present updated data from our DB-OTO gene therapy program for genetic hearing loss. The first patient treated with this therapy, a 10-month-old girl who was profoundly deaf at baseline, now at 24 weeks after treatment, has hearing in the normal range and the second treated patient is following a similar trajectory of improvement through earlier stages of follow-up. We are aiming to enroll several more patients this year, potentially enabling regulatory submissions by the end of next year. And we also look forward to bringing additional auditory gene therapy programs to the clinic in the coming years, with the potential to address more common forms of monogenic hearing loss. Our collaboration with Intellia on CRISPR gene editing continues to advance. We've begun to enroll patients in the Phase III MAGNITUDE study of Intellia 2001 for a lead indication of ATTR amyloidosis with cardiomyopathy, the first in vivo CRISPR program cleared to enter Phase III studies in the United States.

I will conclude with our genetic medicines effort. At the upcoming ASGCT conference, we will present updated data from our DB-OTO gene therapy program for genetic hearing loss. The first patient treated with this therapy, a 10-month-old girl who was profoundly deaf at baseline, now at 24 weeks after treatment, has hearing in the normal range and the second treated patient is following a similar trajectory of improvement through earlier stages of follow-up. We are aiming to enroll several more patients this year, potentially enabling regulatory submissions by the end of next year. And we also look forward to bringing additional auditory gene therapy programs to the clinic in the coming years, with the potential to address more common forms of monogenic hearing loss.

George D. Yancopoulos: I will conclude with our genetic medicines effort.

George D. Yancopoulos: The upcoming Aaas GCT conference, we will present updated data from our <unk> gene therapy program for genetic hearing loss. The first patient treated with this therapy, a 10 month old girl, who is profoundly deaf at baseline.

George D. Yancopoulos: Now at 24 weeks after treatment had hearing in the normal range in the second treated patient is following a similar trajectory of improvement through earlier stages of follow up.

Marion McCourt: We are aiming to enroll several more patients this year, potentially enabling regulatory submissions by the end of next year. And we also look forward to bringing additional auditory gene therapy programs to the clinic in the coming years, with the potential to address more common forms of monogenic hearing. Our collaboration with Intelia on CRISPR gene editing continues to advance. We've begun to enroll patients in the Phase III Magnitude Study of Intelia 2001 for a lead indication of TTR amyloidosis with cardiomyopathy, the first in vivo CRISPR program cleared to enter Phase III studies in the United States.

George Yancopoulos: We are aiming to enroll several more patients this year, potentially enabling regulatory submissions by the end of next year, and we also look forward to bringing additional auditory gene therapy programs to the clinic in the coming years, with the potential to address more common forms of monogenic hearing loss. Our collaboration with Intellia on CRISPR gene editing continues to advance. We've begun to enroll patients in the phase 3 Magnitude study of NTLA-2001 for a lead indication of TTR amyloidosis with cardiomyopathy, the first in vivo CRISPR program cleared to enter phase 3 studies in the United States. We're also on track to be the first to use CRISPR technology to insert a corrective gene in vivo for a deficiency disease.

We are aiming to enroll several more patients this year, potentially enabling regulatory submissions by the end of next year, and we also look forward to bringing additional auditory gene therapy programs to the clinic in the coming years, with the potential to address more common forms of monogenic hearing loss. Our collaboration with Intellia on CRISPR gene editing continues to advance. We've begun to enroll patients in the phase 3 Magnitude study of NTLA-2001 for a lead indication of TTR amyloidosis with cardiomyopathy, the first in vivo CRISPR program cleared to enter phase 3 studies in the United States. We're also on track to be the first to use CRISPR technology to insert a corrective gene in vivo for a deficiency disease.

George D. Yancopoulos: We are aiming to enroll several more patients this year potentially enabling regulatory submissions by the end of next year and we also look forward to bringing additional auditory gene therapy programs to the clinic in the coming years with the potential to address more common forms of monogenic hearing loss.

And we also look forward to bringing additional auditory gene therapy programs to the clinic in the coming years, with the potential to address more common forms of monogenic hearing loss. Our collaboration with Intellia on CRISPR gene editing continues to advance. We've begun to enroll patients in the Phase III MAGNITUDE study of Intellia 2001 for a lead indication of ATTR amyloidosis with cardiomyopathy, the first in vivo CRISPR program cleared to enter Phase III studies in the United States.

And we also look forward to bringing additional auditory gene therapy programs to the clinic in the coming years, with the potential to address more common forms of monogenic hearing loss.

Our collaboration with Intellia on CRISPR gene editing continues to advance. We've begun to enroll patients in the Phase III MAGNITUDE study of Intellia 2001 for a lead indication of ATTR amyloidosis with cardiomyopathy, the first in vivo CRISPR program cleared to enter Phase III studies in the United States. We are also on track to be the first to use CRISPR technology to insert a corrective gene in vivo for a deficiency disease. We have now achieved clearance from both the U.S. and EU authorities for our insertion program for factor IX and we have already enrolled initial patients into the leading portion of this program. Moving on to our sRNA collaboration with Alnylam, which has not only demonstrated successful silencing of genes in the liver but also, for the first time for siRNA, in the brain. Additionally, we're excited about potentially initiating later this year, a potentially pivotal study for ALN-SOD treatment in ALS patients with SOD-1 mutations. With that overview, I will turn the call over to Marion.

George D. Yancopoulos: Our collaboration with Intel you on CRISPR gene editing continues to advance we have begun to enroll patients in the phase III magnitude study of <unk> 2001 for our lead indication of GTR amyloidosis with cardiomyopathy. The first in vivo CRISPR program cleared to enter phase III studies in the United.

Marion McCourt: We are also on track to be the first to use CRISPR technology to insert a corrective gene in vivo for a deficiency disease. We have now achieved clearance from both the U.S. and EU authorities for our insertion program for Factor IX, and we have already enrolled initial patients into the leading portion of this program. Moving on to our siRNA collaboration with L-Nylam, which has not only demonstrated successful silencing of genes in the liver but also for the first time in the brain. Additionally, we're excited about potentially initiating later this year a potentially pivotal study for ALN-SOD treatment in ALS patients with SOD1 mutations. With that overview, I will turn the call over to Marion.

George D. Yancopoulos: States. We're also on track to be the first to use CRISPR technology to insert a corrective gene in vivo for a deficiency disease. We have now achieved clearance from both the U S and EU authorities for our in sourcing program for factor nine.

George Yancopoulos: We have now achieved clearance from both the US and EU authorities for our insertion program for Factor IX, and we have already enrolled initial patients into the lead-in portion of this program. Moving on to our siRNA collaboration with Alnylam, which has not only demonstrated successful silencing of genes in the liver, but also for the first time for siRNA in the brain. Additionally, we're excited about potentially initiating later this year, a potentially pivotal study for our ALN-SOD treatment in ALS patients with SOD1 mutations. With that overview, I will turn the call over to Mary.

We have now achieved clearance from both the US and EU authorities for our insertion program for Factor IX, and we have already enrolled initial patients into the lead-in portion of this program. Moving on to our siRNA collaboration with Alnylam, which has not only demonstrated successful silencing of genes in the liver, but also for the first time for siRNA in the brain. Additionally, we're excited about potentially initiating later this year, a potentially pivotal study for our ALN-SOD treatment in ALS patients with SOD1 mutations. With that overview, I will turn the call over to Mary.

George D. Yancopoulos: And we have already enrolled initial patients into the lead in portion of this program.

Moving on to our siRNA collaboration with Alnylam, which has not only demonstrated successful silencing of genes in the liver but also, for the first time for siRNA, in the brain. Additionally, we're excited about potentially initiating later this year, a potentially pivotal study for ALN-SOD treatment in ALS patients with SOD-1 mutations.

George D. Yancopoulos: Moving onto our <unk> collaboration with <unk>, which has not only demonstrating successful silencing of genes in the liver, but also for the first time for SA RNA in the brain. Additionally, we are excited about potentially initiating later this year or potentially pivotal study for <unk>.

George D. Yancopoulos: <unk> treatment in ALS patients with <unk> mutations.

With that overview, I will turn the call over to Marion.

George D. Yancopoulos: With that overview I will turn the call over to Mary Thanks, George our results in the first quarter demonstrated the strong performance of our commercial portfolio and future growth opportunity.

Marion McCourt: Thanks, George. Our results in the first quarter demonstrate the strong performance of our commercial portfolio and future growth opportunity. We continue to strengthen and expand our leadership positions across our in-line brands and we are preparing for potential upcoming launches. I'll start with our anti-VEGF franchise and the ongoing launch progress of EYLEA HD. First quarter U.S. net sales grew 63% sequentially to $200 million. As real-world experience with efficacy and safety continues to grow, EYLEA HD is delivering on its promise of extending the duration between treatments, with the majority of patients achieving this goal. Retina specialists are highly satisfied with EYLEA HD, as demonstrated by prescribing across a broad range of patients. To date, most EYLEA HD patients are being switched from existing medicines, most notably EYLEA and FARICIMAB and we are also seeing an increase in treatment-naive patients. For the quarter, EYLEA HD and EYLEA together, secured 45% of the anti-VEGF category share. Combined U.S. net sales were $1.4 billion, which includes a reduction in wholesaler inventory of approximately $40 million.

Marion McCourt: Thanks, George. Our results in the first quarter demonstrate the strong performance of our commercial portfolio and future growth opportunity. We continue to strengthen and expand our leadership positions across our in-line brands, and we are preparing for potential upcoming launches. I'll start with our anti-VEGF franchise and the ongoing launch progress of Eylea HD. First quarter US net sales grew 63% sequentially to $200 million. As real-world experience with efficacy and safety continues to grow, Eylea HD is delivering on its promise of extending the duration between treatments, with the majority of patients achieving this goal. Retina specialists are highly satisfied with Eylea HD, as demonstrated by prescribing across a broad range of patients. To date, most Eylea HD patients are being switched from existing medicines, most notably Eylea and Lucentis, and we are also seeing an increase in treatment-naive patients.

Mary: So we need to strengthen and expand our leadership positions across our inline brands and we are preparing for potential upcoming launches.

Marion McCourt: As real-world experience with efficacy and safety continues to grow, ILEA HD is delivering on its promise of extending the duration between treatments, with the majority of patients achieving this goal. Retina specialists are highly satisfied with ILEA HD, as demonstrated by prescribing it across a broad range of patients. To date, most ILEA HD patients are being switched from existing medicines, most notably ILEA and furosemab, and we are also seeing an increase in treatment-naive patients. For the quarter, ILEA HD and ILEA together secured 45% of the anti-veg category share. Combined U.S. net sales were $1.4 billion, which included a reduction in wholesaler inventory of approximately $40 million.

I'll start with our anti-VEGF franchise and the ongoing launch progress of EYLEA HD. First quarter U.S. net sales grew 63% sequentially to $200 million. As real-world experience with efficacy and safety continues to grow, EYLEA HD is delivering on its promise of extending the duration between treatments, with the majority of patients achieving this goal. Retina specialists are highly satisfied with EYLEA HD, as demonstrated by prescribing across a broad range of patients. To date, most EYLEA HD patients are being switched from existing medicines, most notably EYLEA and FARICIMAB and we are also seeing an increase in treatment-naive patients. For the quarter, EYLEA HD and EYLEA together, secured 45% of the anti-VEGF category share. Combined U.S. net sales were $1.4 billion, which includes a reduction in wholesaler inventory of approximately $40 million.

Mary: With our <unk> franchise.

Mary: <unk> launch progress of Eylea HD first quarter U S. Net sales grew 63% sequentially to 200 million as real world experience with the efficacy and safety continues to grow.

Mary: HD is delivering on its promise of extending the duration between treatments with the majority of patients achieving this goal retina specialists are highly satisfied with eylea HD as demonstrated by prescribing across a broad range of patients to date most.

Mary: Patients are being switched from existing medicines, most notably Eylea and <unk> and we are also seeing an increase in treatment nave patients for the quarter Eylea HD and India together secured 45% of the anti VEGF category share combined U S. Net sales were $1 4 billion.

Marion McCourt: For the quarter, Eylea HD and Eylea together secured 45% of the anti-VEGF category share. Combined US net sales were $1.4 billion, which includes a reduction in wholesaler inventory of approximately $40 million. This reflects a sequential drawdown of Eylea inventory that was partially offset by a modest increase in Eylea HD inventory ahead of the permanent J-code on 1 April. Since launch, our team has made significant progress to enhance reimbursement and market access for Eylea HD. The permanent J-code has increased prescribers' reimbursement confidence, reflected by increased use among existing customers, as well as a step-up in new customers ordering for the first time. We're very encouraged by Eylea HD uptake, despite a different payer market today compared to when Eylea was launched more than a decade ago.

For the quarter, Eylea HD and Eylea together secured 45% of the anti-VEGF category share. Combined US net sales were $1.4 billion, which includes a reduction in wholesaler inventory of approximately $40 million. This reflects a sequential drawdown of Eylea inventory that was partially offset by a modest increase in Eylea HD inventory ahead of the permanent J-code on 1 April. Since launch, our team has made significant progress to enhance reimbursement and market access for Eylea HD. The permanent J-code has increased prescribers' reimbursement confidence, reflected by increased use among existing customers, as well as a step-up in new customers ordering for the first time. We're very encouraged by Eylea HD uptake, despite a different payer market today compared to when Eylea was launched more than a decade ago.

For the quarter, EYLEA HD and EYLEA together, secured 45% of the anti-VEGF category share. Combined U.S. net sales were $1.4 billion, which includes a reduction in wholesaler inventory of approximately $40 million. This reflects the sequential drawdown of EYLEA inventory that was partially offset by a modest increase in EYLEA HD inventory, ahead of the permanent J-code on April 1st. Since launch, our team has made significant progress to enhance reimbursement and market access for EYLEA HD. The permanent J-code has increased prescribers' reimbursement confidence, reflected by increased use among existing customers, as well as a step up in new customers ordering for the first time.

Mary: Which includes a reduction in wholesaler inventory of approximately $40 million. This reflects a sequential drawdown of eylea inventory that was partially offset by a modest increase in eylea HD inventory ahead of the permanent J code on April 1st.

Marion McCourt: This reflects the sequential drawdown of ILEA inventory that was partially offset by a modest increase in ILEA HD inventory ahead of the permanent J code on April 1st. Since launch, our team has made significant progress to enhance reimbursement and market access for ILEA HD. The permanent J code has increased prescribers' reimbursement confidence, reflected by increased use among existing customers, as well as a step up in new customers ordering for the first time.

Mary: Since launch our team has made significant progress to enhance reimbursement and market access for Eylea. Each day. The permanent J code has increased prescribers reimbursement confidence reflected by increased usage among existing customers as well as a step up in new customers ordering for the first time.

Marion McCourt: We're very encouraged by EYLEA HD update, despite a different payer market today compared to when EYLEA was launched more than a decade ago. For example, while more than 80% of medical benefit lives are now covered for EYLEA HD, increases in utilization management or step edits are impacting all branded products. We are also highly focused on educating patients about the potential for EYLEA HD to deliver best-in-category vision and safety benefits with fewer injections. In mid-March, we began our direct-to-consumer TV campaign, designed to raise brand awareness among treatment-experienced and treatment-naive patients. Since initiating the DTC campaign, retina specialists have reported a significant increase in patients actively asking about and being prescribed EYLEA HD. In summary, the EYLEA HD launch outperformed expectations and we are on track to establish EYLEA HD as the new standard of care for retinal disease.

We're very encouraged by EYLEA HD update, despite a different payer market today compared to when EYLEA was launched more than a decade ago. For example, while more than 80% of medical benefit lives are now covered for EYLEA HD, increases in utilization management or step edits are impacting all branded products. We are also highly focused on educating patients about the potential for EYLEA HD to deliver best-in-category vision and safety benefits with fewer injections.

Mary: We're encouraged by NDA HD update despite a different payer market today compared to when I was.

Marion McCourt: For example, while more than 80% of medical benefit lives are now covered for Eylea HD, increases in utilization management or step edits are impacting all branded products. We are also highly focused on educating patients about the potential for Eylea HD to deliver best-in-category vision and safety benefits with fewer injections. In mid-March, we began our direct-to-consumer TV campaign, designed to raise brand awareness among treatment-experienced and treatment-naive patients. Since initiating the DTC campaign, retina specialists have reported a significant increase in patients actively asking about and being prescribed Eylea HD. In summary, the Eylea HD launch outperformed expectations, and we are on track to establish Eylea HD as the new standard of care for retinal disease. Turning now to Dupixent, where Q1 global net sales grew 25% on a constant currency basis to $3.1 billion.

For example, while more than 80% of medical benefit lives are now covered for Eylea HD, increases in utilization management or step edits are impacting all branded products. We are also highly focused on educating patients about the potential for Eylea HD to deliver best-in-category vision and safety benefits with fewer injections. In mid-March, we began our direct-to-consumer TV campaign, designed to raise brand awareness among treatment-experienced and treatment-naive patients. Since initiating the DTC campaign, retina specialists have reported a significant increase in patients actively asking about and being prescribed Eylea HD. In summary, the Eylea HD launch outperformed expectations, and we are on track to establish Eylea HD as the new standard of care for retinal disease. Turning now to Dupixent, where Q1 global net sales grew 25% on a constant currency basis to $3.1 billion.

Mary: Launched more than a decade ago for example, more than 80% of medical benefit lives are now covered finally, HD increases in utilization management or step edits are impacting all branded products.

Mary: Also highly focused on educating patients about the potential for Eylea HD.

Mary: Best in category, Jayson and safety benefits with fewer injections in mid March we began our direct to consumer TV sample designed to raise brand awareness among treatment experienced and treatment naive patients since.

In mid-March, we began our direct-to-consumer TV campaign, designed to raise brand awareness among treatment-experienced and treatment-naive patients. Since initiating the DTC campaign, retina specialists have reported a significant increase in patients actively asking about and being prescribed EYLEA HD. In summary, the EYLEA HD launch outperformed expectations and we are on track to establish EYLEA HD as the new standard of care for retinal disease.

Marion McCourt: Since initiating the DTC campaign, retina specialists have reported a significant increase in patients actively asking about and being prescribed EYLEA HD. In summary, the EYLEA HD launch outperformed expectations and we are on track to establish EYLEA HD as the new standard of care for retinal disease. Turning now to DUPIXENT, where first-quarter global net sales grew 25% on a constant currency basis to $3.1 billion. In the U.S., net sales grew 17% to $2.2 billion, driven by continued robust demand and the impact of customary 1st quarter seasonality dynamics, including annual resets of insurance plans.

Since initiating the DTC campaign, retina specialists have reported a significant increase in patients actively asking about and being prescribed EYLEA HD. In summary, the EYLEA HD launch outperformed expectations and we are on track to establish EYLEA HD as the new standard of care for retinal disease.

Mary: The DTC campaign retina specialists have reported a significant increase in patients actively asking about and being prescribed eylea each day and summary.

Mary: Steve launch outperformed expectations and we are on track to establish that EMEA HD as the new standard of care for retinal disease, turning now to depiction of our first quarter Global net sales grew 25% on a constant currency basis to $3 1 billion in the U S. Net sales grew 17% to $2.

Turning now to DUPIXENT, where first-quarter global net sales grew 25% on a constant currency basis to $3.1 billion. In the U.S., net sales grew 17% to $2.2 billion, driven by continued robust demand and the impact of customary 1st quarter seasonality dynamics, including annual resets of insurance plans. DUPIXENT is the clear leader in new-to-brand prescription share across all five FDA-approved indications and leads in total biologic prescriptions in four of its approved indications. More than 850,000 patients are currently on therapy worldwide and three DUPIXENT indications have achieved blockbuster status: atopic dermatitis, asthma and nasal polyps. Across all three of these indications, DUPIXENT is competitively differentiated based on its clinical profile, depth of clinical experience and potential to be prescribed to very young patients, as young as six months in the case of atopic dermatitis.

Marion McCourt: In the US, net sales grew 17% to $2.2 billion, driven by continued robust demand and the impact of customary Q1 seasonality dynamics, including annual resets of insurance plans. Dupixent is the clear leader in new-to-brand prescription share across all five FDA-approved indications and leads in total biologic prescriptions in four of its approved indications. More than 850,000 patients are currently on therapy worldwide, and three Dupixent indications have achieved blockbuster status: atopic dermatitis, asthma, and nasal polyps. Across all three of these indications, Dupixent is competitively differentiated based on its clinical profile, depth of clinical experience, and potential to be prescribed to very young patients, as young as six months in the case of atopic dermatitis. We continue to see great progress with our recent launches in EoE, Dupixent's GI indication, and prurigo nodularis in dermatology.

In the US, net sales grew 17% to $2.2 billion, driven by continued robust demand and the impact of customary Q1 seasonality dynamics, including annual resets of insurance plans. Dupixent is the clear leader in new-to-brand prescription share across all five FDA-approved indications and leads in total biologic prescriptions in four of its approved indications. More than 850,000 patients are currently on therapy worldwide, and three Dupixent indications have achieved blockbuster status: atopic dermatitis, asthma, and nasal polyps. Across all three of these indications, Dupixent is competitively differentiated based on its clinical profile, depth of clinical experience, and potential to be prescribed to very young patients, as young as six months in the case of atopic dermatitis. We continue to see great progress with our recent launches in EoE, Dupixent's GI indication, and prurigo nodularis in dermatology.

Mary: $2 billion, driven by continued robust demand and the impact of customary first quarter seasonality dynamics.

Mary: The annual reset of insurance plans.

Marion McCourt: Dupixent is the clear leader in new-to-brand prescription share across all five FDA-approved indications and leads in total biologic prescriptions in four of its approved indications. More than 850,000 patients are currently on therapy worldwide, and three Dupixen indications have achieved blockbuster status: atopic dermatitis, asthma, and nasal polyps. Across all three of these indications, Dupixen is competitively differentiated based on its clinical profile, depth of clinical experience, and potential to be prescribed to very young patients, as young as six months in the case of atopic dermatitis.

Mary: <unk> is the clear leader in new to brand prescription share across all sides FDA approved indications and leads and total biologic prescriptions and four of its approved indications.

More than 850,000 patients are currently on therapy worldwide and three DUPIXENT indications have achieved blockbuster status: atopic dermatitis, asthma and nasal polyps. Across all three of these indications, DUPIXENT is competitively differentiated based on its clinical profile, depth of clinical experience and potential to be prescribed to very young patients, as young as six months in the case of atopic dermatitis. We continue to see great progress with our recent launches in EoE, DUPIXENT's GI indication and prurigo nodularis in dermatology. Patient initiations across both indications continue to reach all-time highs and in late January, DUPIXENT was approved in pediatric EoE, the brand's fourth pediatric indication. Early launch indicators are positive, as DUPIXENT is transforming the standard of care for these children aged 1 to 11, as it has for adults and adolescents with EoE. In addition to its approved indications, there's great potential for DUPIXENT in an increasing list of additional Type 2 diseases, including COPD.

More than 850,000 patients are currently on therapy worldwide and three DUPIXENT indications have achieved blockbuster status: atopic dermatitis, asthma and nasal polyps.

Mary: More than 850000 patients are currently on therapy worldwide and three depicts and indications have achieved blockbuster status.

Across all three of these indications, DUPIXENT is competitively differentiated based on its clinical profile, depth of clinical experience and potential to be prescribed to very young patients, as young as six months in the case of atopic dermatitis. We continue to see great progress with our recent launches in EoE, DUPIXENT's GI indication and prurigo nodularis in dermatology. Patient initiations across both indications continue to reach all-time highs and in late January, DUPIXENT was approved in pediatric EoE, the brand's fourth pediatric indication. Early launch indicators are positive, as DUPIXENT is transforming the standard of care for these children aged 1 to 11, as it has for adults and adolescents with EoE.

Mary: Dermatitis asthma and nasal polyps across all three of these indications you pixel is competitively differentiated based on its clinical profile depth of clinical experience.

Mary: Potential to be prescribed to very young patients as young as six months in the case of atopic dermatitis.

Marion McCourt: We continue to see great progress with our recent launches in EOE, Dupixen's GI indication, and Progonodularis in dermatology. Patient initiations across both indications continue to reach all-time highs, and in late January, Dupixen was approved in pediatric EOE, the brand's fourth pediatric indication. Early launch indicators are positive, as Dupixent is transforming the standard of care for these children aged 1 to 11, as it has for adults and adolescents with EOE. In addition to its approved indications, there's great potential for Dupixent in an increasing list of additional type 2 diseases, including COPD.

Mary: We continue to see great progress with our recent launches.

Mary: Since Gi indication in <unk> in dermatology patient initiations across both indications continued reach all time highs and in late January to takes it was approved in pediatric.

Marion McCourt: Patient initiations across both indications continued to reach all-time highs, and in late January, Dupixent was approved in pediatric EoE, the brand's fourth pediatric indication. Early launch indicators are positive, as Dupixent is transforming the standard of care for these children aged one to 11, as it has for adults and adolescents with EoE. In addition to its approved indications, there's great potential for Dupixent in an increasing list of additional type 2 diseases, including COPD. If approved, Dupixent will achieve two important firsts: the first biologic medicine for COPD and also the first new treatment in more than a decade for this devastating disease. In the US, approximately 300,000 patients with uncontrolled COPD show evidence of type 2 inflammation.

Patient initiations across both indications continued to reach all-time highs, and in late January, Dupixent was approved in pediatric EoE, the brand's fourth pediatric indication. Early launch indicators are positive, as Dupixent is transforming the standard of care for these children aged one to 11, as it has for adults and adolescents with EoE. In addition to its approved indications, there's great potential for Dupixent in an increasing list of additional type 2 diseases, including COPD. If approved, Dupixent will achieve two important firsts: the first biologic medicine for COPD and also the first new treatment in more than a decade for this devastating disease. In the US, approximately 300,000 patients with uncontrolled COPD show evidence of type 2 inflammation.

Mary: The brand for the pediatric indication early launch indicators are positive as depiction is transforming the standard of care for these children, aged one to 11 as it has for adults and adolescents with Ely.

In addition to its approved indications, there's great potential for DUPIXENT in an increasing list of additional Type 2 diseases, including COPD. If approved, DUPIXENT will achieve two important firsts. The first biologic medicine for COPD and also, the first new treatment in more than a decade for this devastating disease. In the U.S., approximately 300,000 patients with uncontrolled COPD show evidence of Type 2 inflammation. If approved, we will work to rapidly establish the unique clinical benefits of DUPIXENT, activate physician adoption, motivate patients to seek treatment and also, advance access and affordability. We are confident that COPD will drive meaningful growth for DUPIXENT if approved in this indication and see an additional opportunity to address patient unmet need with ITEPEKIMAB, our investigational IL-33 antibody designed to help COPD patients who are former smokers. With significant runway for growth and existing and potential new indications, we are confident in DUPIXENT's ongoing growth trajectory.

Mary: In addition to its approved indications there is great potential for depictions in an increasing list of additional type two diseases, including COPD. If approved <unk> will achieve two important first the first biologic medicine for COPD and also the first new treatment in more than a decade for this devastating disease.

Marion McCourt: If approved, Dupixent will achieve two important firsts. The first biologic medicine for COPD and also the first new treatment in more than a decade for this devastating disease. In the U.S., approximately 300,000 patients with uncontrolled COPD show evidence of type 2 inflammation.

Mary: In the U S. Approximately 300000 patients with uncontrolled COPD show evidence of type two inflammation.

Marion McCourt: If approved, we will work to rapidly establish the unique clinical benefits of Dupixent, activate physician adoption, motivate patients to seek treatment, and also advance access and affordability. We are confident that COPD will drive meaningful growth for Dupixent if approved in this indication, and we see an additional opportunity to address patient unmet need with Idopecmeb, our investigational IL-33 antibody designed to help COPD patients who are former smokers. With significant runway for growth and existing and potential new indications, we are confident in Dupixent's ongoing growth trajectory.

Marion McCourt: If approved, we'll work to rapidly establish the unique clinical benefits of Dupixent, activate physician adoption, motivate patients to seek treatment, and also advance access and affordability. We are confident that COPD will drive meaningful growth for Dupixent if approved in this indication, and see an additional opportunity to address patient unmet need with Itopekimab, our investigational IL-33 antibody designed to help COPD patients who are former smokers. With significant runway for growth in existing and potential new indications, we are confident in Dupixent's ongoing growth trajectory. And finally, to Libtayo. In Q1, global net sales were $264 million, up 44% on a constant currency basis from the prior year, driven by our dual focus in skin and lung cancers. In non-melanoma skin cancer, Libtayo continues to lead the immunotherapy category in CSCC and BCC, with opportunity for continued market growth.

If approved, we'll work to rapidly establish the unique clinical benefits of Dupixent, activate physician adoption, motivate patients to seek treatment, and also advance access and affordability. We are confident that COPD will drive meaningful growth for Dupixent if approved in this indication, and see an additional opportunity to address patient unmet need with Itopekimab, our investigational IL-33 antibody designed to help COPD patients who are former smokers. With significant runway for growth in existing and potential new indications, we are confident in Dupixent's ongoing growth trajectory. And finally, to Libtayo. In Q1, global net sales were $264 million, up 44% on a constant currency basis from the prior year, driven by our dual focus in skin and lung cancers. In non-melanoma skin cancer, Libtayo continues to lead the immunotherapy category in CSCC and BCC, with opportunity for continued market growth.

Mary: We will rapidly award to rapidly establish unique clinical benefits of detection.

Mary: Physician adoption motivate patients to seek treatment and also advanced access and affordability. We are confident that COPD will drive meaningful growth for <unk>. If approved in this indication and see an additional opportunity to address patient unmet need with <unk>, our investigational IL 33 antibody designed to help.

We are confident that COPD will drive meaningful growth for DUPIXENT if approved in this indication and see an additional opportunity to address patient unmet need with ITEPEKIMAB, our investigational IL-33 antibody designed to help COPD patients who are former smokers. With significant runway for growth and existing and potential new indications, we are confident in DUPIXENT's ongoing growth trajectory.

Mary: COPD patients, who are former smokers with significant runway for growth in existing and potential new indications. We are confident in <unk> ongoing growth trajectory and finally to the tire in the first quarter Global net sales were 264 million up 44% on a constant currency basis from the prior year.

Marion McCourt: And finally, to LIBTAYO. In the first quarter, global net sales were $264 million, up 44% on a constant currency basis from the prior year, driven by our dual focus in skin and lung cancers. In non-melanoma skin cancer, LIBTAYO continues to lead the immunotherapy category in CSCC and BCC, with opportunity for continued market growth. In lung cancer, we are making steady progress in capturing category share in both monotherapy and chemotherapy combination patients. Our Oncology team is also preparing for the upcoming August 22nd LINVOSELTAMAB PDUFA data. Recent data reinforces that LINVOSELTAMAB has the potential to be best-in-class for late-stage myeloma patients and we look forward to its potential launch. In summary, our commercial team continues to bring important medicines to patients across an expanding range of diseases. We are focused on differentiating our medicines to increase category share and drive market growth. Potential upcoming launches across our portfolio provide the opportunity to extend the benefits of our medicines to even more patients. And with that, I'll pass the call to Chris.

And finally, to LIBTAYO. In the first quarter, global net sales were $264 million, up 44% on a constant currency basis from the prior year, driven by our dual focus in skin and lung cancers. In non-melanoma skin cancer, LIBTAYO continues to lead the immunotherapy category in CSCC and BCC, with opportunity for continued market growth. In lung cancer, we are making steady progress in capturing category share in both monotherapy and chemotherapy combination patients. Our Oncology team is also preparing for the upcoming August 22nd LINVOSELTAMAB PDUFA data. Recent data reinforces that LINVOSELTAMAB has the potential to be best-in-class for late-stage myeloma patients and we look forward to its potential launch. In summary, our commercial team continues to bring important medicines to patients across an expanding range of diseases. We are focused on differentiating our medicines to increase category share and drive market growth. Potential upcoming launches across our portfolio provide the opportunity to extend the benefits of our medicines to even more patients.

Mary: Year, driven by our dual focus in skin and lung cancers.

Mary: Non melanoma skin cancer with tire continues to lead immunotherapy category, and CSC and BCC with opportunity for continued market growth.

Marion McCourt: In lung cancer, we are making steady progress in capturing category share in both monotherapy and chemotherapy combination patients. Our oncology team is also preparing for the upcoming 22 August linvoseltumab PDUFA date. Recent data reinforces that linvoseltumab has the potential to be best in class for late-stage myeloma patients, and we look forward to its potential launch. In summary, our commercial team continues to bring important medicines to patients across an expanding range of diseases. We are focused on differentiating our medicines to increase category share and drive market growth. Potential upcoming launches across our portfolio provide the opportunity to extend the benefits of our medicines to even more patients. With that, I'll pass the call to Chris.

In lung cancer, we are making steady progress in capturing category share in both monotherapy and chemotherapy combination patients. Our oncology team is also preparing for the upcoming 22 August linvoseltumab PDUFA date. Recent data reinforces that linvoseltumab has the potential to be best in class for late-stage myeloma patients, and we look forward to its potential launch. In summary, our commercial team continues to bring important medicines to patients across an expanding range of diseases. We are focused on differentiating our medicines to increase category share and drive market growth. Potential upcoming launches across our portfolio provide the opportunity to extend the benefits of our medicines to even more patients. With that, I'll pass the call to Chris.

Mary: Lung cancer, we're making steady progress in capturing category share in both monotherapy and chemotherapy combination patients oncology team is also preparing for the upcoming August 22nd Linda Sultan that produce to date recent data reinforces that Linda Sultan that has the potential to be best in class for late stage myeloma.

Our Oncology team is also preparing for the upcoming August 22nd LINVOSELTAMAB PDUFA data. Recent data reinforces that LINVOSELTAMAB has the potential to be best-in-class for late-stage myeloma patients and we look forward to its potential launch. In summary, our commercial team continues to bring important medicines to patients across an expanding range of diseases. We are focused on differentiating our medicines to increase category share and drive market growth. Potential upcoming launches across our portfolio provide the opportunity to extend the benefits of our medicines to even more patients.

Marion McCourt: Our oncology team is also preparing for the upcoming August 22nd Limvaceltumab peducidate trial. Recent data reinforce that Limvaceltumab has the potential to be best in class for late-stage myeloma patients, and we look forward to its potential launch. In summary, our commercial team continues to bring important medicines to patients across an expanding range of diseases. We are focused on differentiating our medicines to increase category share and drive market growth. Potential upcoming launches across our portfolio provide the opportunity to extend the benefits of our medicines to even more patients. And with that, I'll pass the call to Chris.

Mary: On the patients and we look forward towards potential launch.

Mary: In summary, our commercial team continues to bring important medicines to patients across an expanding range of diseases. We have focused on differentiating our medicines to increase category share and drive market growth potential upcoming launches across our portfolio provide the opportunity to extend the benefits of our medicines to even more patients.

And with that, I'll pass the call to Chris.

Mary: And with that I'll pass the call to Chris.

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 delivered solid financial results in the first quarter of 2020. Excluding contributions from our COVID antibodies, total revenues increased 7% year over year to $3.1 billion, primarily driven by continued sales growth and margin expansion from Dupixent and strong global sales growth from Liptio. First quarter diluted net income per share was $9.55 on net income of $1.1 billion.

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

Chris 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 delivered solid financial results in Q1 2024. Excluding contributions from our COVID antibodies, total revenues increased 7% year over year to $3.1 billion, primarily driven by continued sales growth and margin expansion from Dupixent and strong global sales growth from Libtayo. First quarter diluted net income per share was $9.55 on net income of $1.1 billion. Moving to collaboration revenue. First quarter ex-US net sales of Eylea and Eylea HD, known as Eylea 8 mg outside the US, were $849 million, up 2% on a constant currency basis versus the prior year.

Christopher Thomas Schott: Thank you Marion my.

Christopher Thomas Schott: My comments today on Regeneron financial results and outlook will be on a non-GAAP basis, unless otherwise noted.

Regeneron delivered solid financial results in the first quarter of 2024. Excluding contributions from our COVID antibodies, total revenues increased 7% year-over-year to $3.1 billion, primarily driven by continued sales growth and margin expansion from DUPIXENT and strong global sales growth from LIBTAYO. 1st quarter diluted net income per share was $9.55 on net income of $1.1 billion.

Christopher Thomas Schott: Regeneron delivered solid financial results in the first quarter of 2024.

Christopher Thomas Schott: Excluding contributions from our Covid antibodies total revenues increased 7% year over year to $3 1 billion.

Christopher Thomas Schott: Primarily driven by continued sales growth and margin expansion from duplex and strong global sales growth from what Tayo.

Christopher Thomas Schott: First quarter diluted net income per share was $9 75.

Christopher Thomas Schott: On net income of $1 1 billion.

Chris: Moving to collaboration revenue. 1st quarter ex-U.S. net sales of EYLEA and EYLEA HD, known as EYLEA 8mg outside the U.S., were $849 million, up 2% on a constant currency basis versus the prior year. Total Bayer collaboration revenue was $356 million, of which $334 million related to our share of net profits outside the U.S. Total Sanofi collaboration revenue grew 14% in the 1st quarter to $910 million. Our share of collaboration profits was $804 million, an increase of 26% versus the prior year, driven by DUPIXENT's continued volume growth and improving margins.

Christopher Thomas Schott: Moving to collaboration revenue first quarter ex U S. Net sales of Eylea in Eylea HD known as Eylea eight Meg outside the U S were $849 million up 2% on a constant currency basis versus the prior year.

Chris Fenimore: Total Bayer collaboration revenue was $356 million, of which $334 million related to our share of net profits outside the US. Total Sanofi collaboration revenue grew 14% in Q1 to $910 million. Our share of collaboration profits was $804 million, an increase of 26% versus the prior year, driven by Dupixent's continued volume growth and improving margins. Reimbursement for manufacturing of commercial supply, a component of Sanofi collaboration revenue, was $106 million for the quarter, which is expected to be the lowest of the year. On a full-year basis, due to higher Dupixent volumes, we expect the amount of these reimbursements to be comparable to 2023. The Sanofi development balance was approximately $2.2 billion at the end of Q1.

Total Bayer collaboration revenue was $356 million, of which $334 million related to our share of net profits outside the US. Total Sanofi collaboration revenue grew 14% in Q1 to $910 million. Our share of collaboration profits was $804 million, an increase of 26% versus the prior year, driven by Dupixent's continued volume growth and improving margins. Reimbursement for manufacturing of commercial supply, a component of Sanofi collaboration revenue, was $106 million for the quarter, which is expected to be the lowest of the year. On a full-year basis, due to higher Dupixent volumes, we expect the amount of these reimbursements to be comparable to 2023. The Sanofi development balance was approximately $2.2 billion at the end of Q1.

Christopher Thomas Schott: Bayer collaboration revenue was $356 million of which $334 million related to our share of net profits outside the U S.

Christopher Thomas Schott: Total therapy collaboration revenue grew 14% in the first quarter to $910 million our share of collaboration profits was $804 million, an increase of 26% versus the prior year driven by two <unk> continued volume growth and improving margins.

Chris: Reimbursement for manufacturing of commercial supply, a component of Sanofi collaboration revenue, was $106 million for the quarter, which is expected to be the lowest of the year. On a full year basis, due to higher DUPIXENT volumes, we expect the amount of these reimbursements to be comparable to 2023. The Sanofi development balance was approximately $2.2 billion at the end of the 1st quarter. We anticipate this balance will be fully reimbursed by the end of 2026, which we expect will result in a significant step-up in our Sanofi collaboration profits thereafter. Before moving to expenses, I will mention that despite lower volumes, U.S. Praline sales in the 1st quarter reflected a gross-to-net adjustment, related to a true-up of rebates due to an adverse change in payer coverage. We now expect U.S. net sales of Praline to be modestly higher in 2024 as compared to 2023, primarily due to this adjustment. Now, to operating expenses.

Reimbursement for manufacturing of commercial supply, a component of Sanofi collaboration revenue, was $106 million for the quarter, which is expected to be the lowest of the year. On a full year basis, due to higher DUPIXENT volumes, we expect the amount of these reimbursements to be comparable to 2023. The Sanofi development balance was approximately $2.2 billion at the end of the 1st quarter. We anticipate this balance will be fully reimbursed by the end of 2026, which we expect will result in a significant step-up in our Sanofi collaboration profits thereafter.

Christopher Thomas Schott: Reimbursement for manufacturing of commercial supply a component of Sanofi collaboration revenue was $106 million for the quarter, which is expected to be the lowest of the year on a full year basis due to higher depicts and volumes. We expect the amount of these reimbursements to be comparable to 2023.

Christopher Thomas Schott: The <unk> development balance was approximately $2 2 billion at the end of the first quarter. We anticipate this balance will be fully reimbursed by the end of 2026, which we expect will result in a significant step up in our Saudi collaborations profits thereafter.

Chris: We anticipate this balance will be fully reimbursed by the end of 2026, which we expect will result in a significant step-up in our Sanofi collaboration profits thereafter. Before moving to expenses, I will mention that, despite lower volumes, U.S. Praline sales in the first quarter reflected a gross net adjustment related to a true-up of rebates due to an adverse change in payer coverage. We now expect U.S. net sales of Praline to be modestly higher in 2024 as compared to 2023, primarily due to this adjustment, not over-operating.

Chris Fenimore: We anticipate this balance will be fully reimbursed by the end of 2026, which we expect will result in a significant step-up in our Sanofi collaboration profits thereafter. Before moving to expenses, I will mention that despite lower volumes, US Praluent sales in Q1 reflected a gross to net adjustment related to a true-up of rebates due to an adverse change in payer coverage. We now expect US net sales of Praluent to be modestly higher in 2024 as compared to 2023, primarily due to this adjustment. Now to our operating expenses. Q1 R&D expense grew 17% year over year to $1.1 billion, reflecting continued investment in our robust pipeline.

We anticipate this balance will be fully reimbursed by the end of 2026, which we expect will result in a significant step-up in our Sanofi collaboration profits thereafter. Before moving to expenses, I will mention that despite lower volumes, US Praluent sales in Q1 reflected a gross to net adjustment related to a true-up of rebates due to an adverse change in payer coverage. We now expect US net sales of Praluent to be modestly higher in 2024 as compared to 2023, primarily due to this adjustment. Now to our operating expenses. Q1 R&D expense grew 17% year over year to $1.1 billion, reflecting continued investment in our robust pipeline.

Before moving to expenses, I will mention that despite lower volumes, U.S. PRALUENT sales in the 1st quarter reflected a gross-to-net adjustment, related to a true-up of rebates due to an adverse change in payer coverage. We now expect U.S. net sales of PRALUENT to be modestly higher in 2024 as compared to 2023, primarily due to this adjustment. Now, to operating expenses.

Christopher Thomas Schott: Moving to expenses I will mention that despite lower volumes U S. Praluent sales in the first quarter reflected a gross to net adjustment related to a true up of rebates due to an adverse change in payer coverage. We now expect U S. Net sales of probably went to be modestly higher in 2024 as compared to 2023, primarily due to this.

Christopher Thomas Schott: Adjustment.

Chris: 1st quarter R&D expense grew 17% year-over-year to $1.1 billion, reflecting continued investment in our robust pipeline. SG&A grew 13% from the prior year to $544 million in the 1st quarter, driven by investment to support the launcher by EYLEA HD, including direct-to-consumer promotion, as well as higher headcount and related costs primarily for our ongoing international commercial expansion. 1st quarter gross margin on net product sales was approximately 89%, which was impacted by ongoing startup costs for our fill-finish manufacturing facility. 1st quarter COCM was $193 million, reflecting a decline of 22% compared to the prior year, primarily due to lower DUPIXENT drug substance manufacturing cost. Now, to cash flow in the balance sheet.

1st quarter R&D expense grew 17% year-over-year to $1.1 billion, reflecting continued investment in our robust pipeline. SG&A grew 13% from the prior year to $544 million in the 1st quarter, driven by investment to support the launcher by EYLEA HD, including direct-to-consumer promotion, as well as higher headcount and related costs primarily for our ongoing international commercial expansion. 1st quarter gross margin on net product sales was approximately 89%, which was impacted by ongoing startup costs for our fill-finish manufacturing facility. 1st quarter COCM was $193 million, reflecting a decline of 22% compared to the prior year, primarily due to lower DUPIXENT drug substance manufacturing cost.

Christopher Thomas Schott: Now to our operating expenses first quarter R&D expense grew 17% year over year to $1 1 billion.

Christopher Thomas Schott: Reflecting continued investment in our robust pipeline.

Chris Fenimore: SG&A grew 13% from the prior year to $544 million in Q1, driven by investment to support the launch of EYLEA HD, including direct-to-consumer promotion, as well as higher headcount and related costs, primarily for our ongoing international commercial expansion. Q1 gross margin on net product sales was approximately 89%, which was impacted by ongoing start-up costs for our fill-finish manufacturing facility. Q1 COCM was $193 million, reflecting a decline of 22% compared to the prior year, primarily due to lower Dupixent drug substance manufacturing costs. Now to cash flow and the balance sheet. Regeneron generated $1.4 billion in free cash flow in Q1 and ended the quarter with cash and marketable securities less debt of approximately $14.8 billion.

SG&A grew 13% from the prior year to $544 million in Q1, driven by investment to support the launch of EYLEA HD, including direct-to-consumer promotion, as well as higher headcount and related costs, primarily for our ongoing international commercial expansion. Q1 gross margin on net product sales was approximately 89%, which was impacted by ongoing start-up costs for our fill-finish manufacturing facility. Q1 COCM was $193 million, reflecting a decline of 22% compared to the prior year, primarily due to lower Dupixent drug substance manufacturing costs. Now to cash flow and the balance sheet. Regeneron generated $1.4 billion in free cash flow in Q1 and ended the quarter with cash and marketable securities less debt of approximately $14.8 billion.

Christopher Thomas Schott: SG&A grew 13% from the prior year to $544 million in the first quarter driven by investments to support the launch of Eylea HD, including direct to consumer promotion as well as higher head count and related costs, primarily for our ongoing international commercial expansion.

Christopher Thomas Schott: First quarter gross margin on net product sales was approximately 89%, which was impacted by ongoing startup costs for our fill finish manufacturing facility.

Christopher Thomas Schott: First quarter <unk> was $193 million.

Christopher Thomas Schott: Reflecting a decline of 22% compared to the prior year, primarily due to lower <unk> drug substance manufacturing costs.

Now, to cash flow in the balance sheet. Regeneron generated $1.4 billion in free cash flow in the 1st quarter and ended the quarter with cash and marketable securities, less debt, of approximately $14.8 billion. We repurchased approximately $300 million of our shares in the 1st quarter and we had approximately $1.2 billion available for repurchases under our February 2023 authorization at the end of the 1st quarter. This morning, we also announced a new $3 billion share repurchase program, which provides us with additional flexibility to continue returning capital to shareholders over time and we remain buyers of our shares.

Chris: Regeneron generated $1.4 billion in free cash flow in the first quarter, and ended the quarter with cash and marketable securities less debt of approximately $14.8 billion. We repurchased approximately $300 million of our shares in the first quarter, and we had approximately $1.2 billion available for repurchases under our February 2023 authorization at the end of the first quarter. This morning, we also announced a new $3 billion share repurchase program, which provides us with additional flexibility to continue returning capital to shareholders over time, and we remain buyers of our shares.

Christopher Thomas Schott: Now to cash flow and the balance sheet.

Christopher Thomas Schott: Regeneron generated $1 4 billion in free cash flow in the first quarter and ended the quarter with cash and marketable securities less debt of approximately $14 8 billion.

George Yancopoulos: ... We repurchased approximately $300 million of our shares in Q1 and had approximately $1.2 billion available for repurchases under our February 2023 authorization at the end of Q1. This morning, we also announced a new $3 billion share repurchase program, which provides us with additional flexibility to continue returning capital to shareholders over time, and we remain buyers of our shares. Finally, we have made some minor changes to our full-year 2024 financial guidance. A complete summary of our latest full-year guidance is available in our press release issued earlier this morning. We now expect 2024 R&D expense to be in the range of $4.4 to 4.6 billion.

We repurchased approximately $300 million of our shares in Q1 and had approximately $1.2 billion available for repurchases under our February 2023 authorization at the end of Q1. This morning, we also announced a new $3 billion share repurchase program, which provides us with additional flexibility to continue returning capital to shareholders over time, and we remain buyers of our shares. Finally, we have made some minor changes to our full-year 2024 financial guidance. A complete summary of our latest full-year guidance is available in our press release issued earlier this morning. We now expect 2024 R&D expense to be in the range of $4.4 to 4.6 billion.

Christopher Thomas Schott: We repurchased approximately $300 million of our shares in the first quarter and had approximately $1 $2 billion available for repurchases under our February 2023 authorization at the end of the first quarter. This morning, We also announced a new $3 billion share repurchase program, which provides us with additional flexibility to continue.

Christopher Thomas Schott: Returning capital to shareholders over time, and we remain buyers of our shares.

Chris: Finally, we have made some minor changes to our full year 2024 financial guidance. A complete summary of our latest full year guidance is available in our press release issued earlier this morning. We now expect 2024 R&D expenses to be in the range of $4.4 to $4.6 billion. The change in R&D guidance is solely due to the inclusion of operating expenses associated with the acquisition of 2seventy bio's development programs, which closed on April 1st. In summary, Regeneron performed well in the 1st quarter and is positioned to continue to deliver strong results in 2024 and beyond. With that, I'll pass the call back to Ryan.

Finally, we have made some minor changes to our full year 2024 financial guidance. A complete summary of our latest full year guidance is available in our press release issued earlier this morning. We now expect 2024 R&D expenses to be in the range of $4.4 to $4.6 billion. The change in R&D guidance is solely due to the inclusion of operating expenses associated with the acquisition of 2seventy bio's development programs, which closed on April 1st. In summary, Regeneron performed well in the 1st quarter and is positioned to continue to deliver strong results in 2024 and beyond.

Christopher Thomas Schott: Finally, we have made some minor changes to our full year 2024 financial guidance, a complete summary of our latest full year guidance is available in our press release issued earlier. This morning, we now expect 2020 for R&D expense to be in the range of four 4% to $4 6 billion with.

George Yancopoulos: The change in R&D guidance is solely due to the inclusion of operating expenses associated with the acquisition of 2seventy bio's development programs, which closed on 1 April 2024. In summary, Regeneron performed well in Q1 and is positioned to continue to deliver strong results in 2024 and beyond. With that, I'll pass the call back to Ryan.

The change in R&D guidance is solely due to the inclusion of operating expenses associated with the acquisition of 2seventy bio's development programs, which closed on 1 April 2024. In summary, Regeneron performed well in Q1 and is positioned to continue to deliver strong results in 2024 and beyond. With that, I'll pass the call back to Ryan.

Christopher Thomas Schott: The change in R&D guidance is solely due to the inclusion of operating expenses associated with the acquisition of $2 70, Bio's development programs, which closed on April one.

Christopher Thomas Schott: In summary, we are general performed well in the first quarter and is positioned to continue to deliver strong results in 2024 and beyond with that I'll pass the call back to Ryan.

With that, I'll pass the call back to Ryan.

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

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

Thank you. As a reminder, to ask a question, please press

unknown: Thank you. As a reminder, 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. One moment for questions. And our first question comes from Colin Bristow with UBS. You may proceed.

Operator: Thank you. As a reminder, 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. One moment for questions.

Operator: Thank you. As a reminder, 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. One moment for questions. Our first question comes from Colin Bristow with UBS. You may proceed.

Speaker Change: Thank you as a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, one moment for questions.

Speaker Change: And our first question comes from Colin Bristow with UBS you May proceed.

Colin Bristow: Hey, good morning, and congrats on the quarter. Question for George. So George, there's a lot of interest, obviously, in your muscle-sparing obesity program. I was wondering if you could speak to how you think this will differentiate versus competitor muscle-sparing programs. And then within that, you know, what will you be specifically paying attention to whenever Lilly decides to disclose the Bemagromab phase two data? Thanks a lot.

Colin Nigel Bristow: Hey, good morning, and congrats on the quarter question for George George There's a lot of interest obviously in your muscle sparing of BCC program.

Colin Nigel Bristow: Wondering if you could speak to how you think this will differentiate <unk>.

And our first question comes from Colin Bristow with UBS. You may proceed.

Colin Nigel Bristow: Competitor muscles bearing programs and then within that what will you be specifically paying attention to whenever any decides the displays that the macro lab phase III data. Thanks Hello.

unknown: Hey, good morning and congrats on the quarter. Question for George. So, George, there's a lot of interest, obviously, in your muscle-sparing obesity program. I was wondering if you could speak to how you think this will differentiate versus competitor muscle-sparing programs? And then, within that, what will you be specifically paying attention to whenever Len decides to disclose the BIMAGRUMAB Phase II data? Thanks a lot. Thanks, great question. As you know, when you block with other approaches like Bimagramab, you're blocking over a dozen members of the so-called BMP GDF family, and so that raises concern because only A couple of those are actually involved in muscle preservation, so you may end up doing more harm than good. What we have identified over the years is that we have identified two members of this very large family of almost 20 factors, which two are specifically involved in muscle preservation.

Colin Bristow: Hey, good morning and congrats on the quarter. Question for George. So, George, there's a lot of interest, obviously, in your muscle-sparing obesity program. I was wondering if you could speak to how you think this will differentiate versus competitor muscle-sparing programs? And then, within that, what will you be specifically paying attention to whenever Len decides to disclose the BIMAGRUMAB Phase II data? Thanks a lot.

George Yancopoulos: Yeah, thanks. Great question. As you know, when you block with other approaches like Bemagromab, you're blocking over a dozen members of the so-called BMP GDF family and so forth. And that raises the concern, 'cause only a couple of those are actually involved in muscle preservation, that you may end up doing more harm than good. What we have identified over the years is, we identified the two members of this very large family of almost twenty factors, which two are specifically involved in muscle preservation. And we created antibodies to each of these two individually, and we're testing these antibodies individually as well as together. And obviously, in this field of obesity, safety matters almost as much as efficacy here.

Speaker Change: Yes, Thanks, Great question.

Speaker Change: As you know when you block with.

Speaker Change: Other approaches like the macro mab youre blocking.

George D. Yancopoulos: Thanks, great question. As you know, when you block with other approaches like BIMAGRUMAB, you're blocking over a dozen members of the so-called BMP/GDF family and so forth. And that raises the concern because only a couple of those are actually involved in muscle preservation, you may end up doing more harm than good. What we have identified over the years, is we identified two members of this very large family of almost 20 factors, which two are specifically involved in muscle preservation.

Speaker Change: Over a dozen members of the so called BNP GDS family and so forth and that raises the concern because only.

Speaker Change: A couple of those are actually involved in muscle preservation that you may end up doing more harm than good.

unknown: And we created antibodies to each of these two individually and we're testing these antibodies individually, as well as together. And obviously, in this field of obesity, safety matters almost as much as efficacy here. So, we believe we have the best program that is testing, specifically, just the specific members of this very large family that are involved in muscle preservation -- whether blocking either one or both together, is going to benefit the quality of the weight loss in terms of preserving muscle and maybe even causing more fat loss while creating, hopefully, the best possible safety profile.

Speaker Change: We have identified over the years as we identified two members of this very large family of almost 20 factors, which two are specifically involved in muscle preservation, we created antibodies to each of these two individually and were testing these antibodies.

Speaker Change: <unk> as well as together and obviously in this field of obesity.

Speaker Change: <unk> matters almost as much as as efficacy here. So we believe we have the best program that is testing specifically just the specific members of this very large family that are involved in muscle preservation with a blocking either one or both together.

George Yancopoulos: So we believe we have the best program that is testing specifically just the specific members of this very large family that are involved in muscle preservation, where they're blocking either one or both together, is going to benefit the quality of the weight loss in terms of preserving muscle and maybe even causing more fat loss, while creating, hopefully, the best possible safety profile. So we think that that's a big difference between our program and other programs that are blocking, as I said, almost 20 different members that are involved in all sorts of things, from, you know, you know, growth factors for the bone marrow, for red blood cells, controlling all sorts of things, from clotting to liver function and other things. So anyway, that's the major difference in our program.

So we believe we have the best program that is testing specifically just the specific members of this very large family that are involved in muscle preservation, where they're blocking either one or both together, is going to benefit the quality of the weight loss in terms of preserving muscle and maybe even causing more fat loss, while creating, hopefully, the best possible safety profile. So we think that that's a big difference between our program and other programs that are blocking, as I said, almost 20 different members that are involved in all sorts of things, from, you know, you know, growth factors for the bone marrow, for red blood cells, controlling all sorts of things, from clotting to liver function and other things. So anyway, that's the major difference in our program.

Speaker Change: Is going to benefit.

Speaker Change: The quality of the weight loss in terms of preserving muscle and may be even causing more fat loss, while creating hopefully the best possible safety profile. So we think that that's a big difference between our program and other programs that are blocking as I said almost 20 different members that are involved.

unknown: So, we think that that's a big difference between our program and other programs that are blocking, as I said, almost 20 different members that are involved in all sorts of things from, you know, growth factors for the bone marrow, for red blood cells; controlling all sorts of things from clotting to liver function and other things. And so, anyway, that's the major difference in our program.

Speaker Change: And all sorts of things from.

Speaker Change: <unk>.

Speaker Change: Growth factors for the bone marrow for Red blood cells.

Speaker Change: Trolling.

Speaker Change: All sorts of things from clotting to liver function and other things.

Speaker Change: And so anyway, that's the major difference.

Ryan Crowe: Thanks, George. Can we move to the next question, please, Josh?

George: George

Speaker Change: In our program.

Speaker Change: Thanks, George next question please Josh.

Operator: Thank you. One moment for questions. Our next question comes from Evan Segerman with BMO Capital Markets. You may proceed.

Operator: Thank you. One moment for questions. Our next question comes from Evan Seigerman with BMO Capital Markets. You may proceed.

Josh: Thank you.

Speaker Change: One moment for questions.

Speaker Change: Our next question comes from Evan <unk> with BMO capital markets. You May proceed.

Evan Seigerman: Hey, guys. Thank you so much for taking the question. Kind of a follow-up to Colin. When you think about endpoints in muscle-sparing kind of approaches in obesity, you know, what do you think FDA would accept? Right now, they're not really accepting DEXA scans. They're just looking at weight loss. Do you think that they would evolve to look at quality of weight loss as a key endpoint, as the space evolves?

Evan: Hey, guys. Thank you so much for taking the question kind of a follow up to Colorado.

Evan: What are you thinking about.

Evan: And muscle sparing kind of approaches in obesity.

Evan: What do you think FDA would accept right now youre not really existing Texas cancer, you're just looking at weight loss do you think that they would evolve to look at quality of weight loss as a key endpoint as the space.

George: Thank you so much for taking the question. Kind of a follow up to Colin. When you think about endpoints in muscle-sparing kind of approaches in obesity, Well, just to remind you, if you look at our paper where we did the non-human primate studies and so forth, the first thing we're going to be looking for is the very real possibility of increased weight loss, and that might be the simplest regulatory endpoint of all. After that, if we don't see that, but we see better quality weight loss, that could be manifested in a variety of ways, though we, of course, recognize that those would perhaps create more complicated ways of being regulated.

Evan Seigerman: Thank you so much for taking the question. Kind of a follow up to Colin. When you think about endpoints in muscle-sparing kind of approaches in obesity, what do you think the FDA would accept? Right now, they're not really accepting DEXA scans, they're just looking at weight loss -- do you think that they would evolve to look at quality of weight loss as a key endpoint as the space evolves?

Speaker Change: First of all.

George Yancopoulos: Well, just to remind you, if you look at our paper, where we did the non-human primate studies and so forth, the first thing we're gonna be looking for is the very real possibility of increased weight loss. And that might be the simplest regulatory endpoint of all. After that, if we don't see that, but we see better quality of weight loss, that could be manifested in a variety of ways, though we, of course, recognize that those would perhaps create a more complicated ways of being regulated. So obviously, if you increase the fat loss while preserving muscle, you should have dramatic benefits in metabolic parameters, which are often used in the field, particularly in people with diabetes and so forth.

Speaker Change: Well just to remind you if you look at our paper where.

Speaker Change: Where we did the nonhuman primate studies and so forth is the first thing we're going to be looking for is there is the very real possibly of increased weight loss.

George D. Yancopoulos: Well, just to remind you, if you look at our paper where we did the non-human primate studies and so forth, is the first thing we're going to be looking for is there is the very real possibility of increased weight loss. And that might be the simplest regulatory endpoint of all. After that, if we don't see that but we see better quality of weight loss, that could be manifested in a variety of ways -- though we, of course, recognize that those would, perhaps, create more complicated ways of being regulated. So, obviously, if you increase the fat loss while preserving muscle, you should have dramatic benefits in metabolic parameters -- which are often used in the field, particularly in people with diabetes and so forth. As well as, ultimately, in terms of function -- by having maintenance of function as opposed to losing function and maintaining those sort of functional endpoints. So, the simplest path might be simply weight loss. One could then move into metabolic parameters or muscle actual functional outcome measures but, to us, the most important thing in the Phase II study is to really just demonstrate the quality of the weight loss in terms of fat versus muscle because, ultimately, if you're preserving muscle and increasing the fat loss, it has to be much better for patients and it may avoid a lot of catastrophic long-term effects of widespread GLP-1 use. And, so if we see that, we think that we have a real opportunity to to turn that into real, widespread benefit for patients using this class of drugs.

Speaker Change: And that might be the simplest regulatory endpoint of all.

Speaker Change: After that.

Speaker Change: If we don't see that but we see better quality of weight loss that could be manifested in a variety of ways, though we of course recognize that those would perhaps create.

George: So obviously, if you increase the fat loss while preserving muscle, you should have dramatic benefits in metabolic parameters which are often used in the field, particularly in people with diabetes and so forth, as well as ultimately in terms of function by having maintenance of function as opposed to losing function and maintaining those sort of functional endpoints. So the simplest path might be simply weight loss. One could then move into metabolic parameters or muscle actual functional outcome measures, but to us, the most important thing in the phase 2 study is to really just demonstrate the quality of the weight loss in terms of fat versus muscle because, ultimately, if you're preserving muscle and increasing fat loss, it has to be much better for patients, and it may avoid a lot of catastrophic long-term effects of widespread GLP-1 use, and so if we see that, we Okay, thanks, George.

Speaker Change: More and more complicated ways of being regulated so obviously, if you increase the fat loss, while preserving muscle you should have dramatic benefits in metabolic parameters, which are often used in the field, particularly in people with diabetes and so forth.

So, obviously, if you increase the fat loss while preserving muscle, you should have dramatic benefits in metabolic parameters -- which are often used in the field, particularly in people with diabetes and so forth. As well as, ultimately, in terms of function -- by having maintenance of function as opposed to losing function and maintaining those sort of functional endpoints. So, the simplest path might be simply weight loss. One could then move into metabolic parameters or muscle actual functional outcome measures but, to us, the most important thing in the Phase II study is to really just demonstrate the quality of the weight loss in terms of fat versus muscle because, ultimately, if you're preserving muscle and increasing the fat loss, it has to be much better for patients and it may avoid a lot of catastrophic long-term effects of widespread GLP-1 use. And, so if we see that, we think that we have a real opportunity to to turn that into real, widespread benefit for patients using this class of drugs.

George Yancopoulos: As well as ultimately in terms of function, by having maintenance of function as opposed to losing function and maintaining those sort of functional endpoints. So the simplest path might be simply weight loss. One could then move into metabolic parameters or muscle, actual functional outcome measures. But to us, the most important thing in the phase two study is to really just demonstrate the quality of the weight loss in terms of fat versus muscle. Because ultimately, if you're preserving muscle and increasing the fat loss, it has to be much better for patients, and it may avoid a lot of catastrophic long-term effects of widespread GLP-1 use. And so if we see that, we think that we have a real opportunity to turn that into real widespread benefit for patients using this class of drugs.

As well as ultimately in terms of function, by having maintenance of function as opposed to losing function and maintaining those sort of functional endpoints. So the simplest path might be simply weight loss. One could then move into metabolic parameters or muscle, actual functional outcome measures. But to us, the most important thing in the phase two study is to really just demonstrate the quality of the weight loss in terms of fat versus muscle. Because ultimately, if you're preserving muscle and increasing the fat loss, it has to be much better for patients, and it may avoid a lot of catastrophic long-term effects of widespread GLP-1 use. And so if we see that, we think that we have a real opportunity to turn that into real widespread benefit for patients using this class of drugs.

Speaker Change: As well as ultimately in terms of function by having maintenance a function as opposed to losing function and maintaining those sort of functional endpoints. So the simple of path might be simply weight loss.

Speaker Change: One could then move into metabolic parameters or muscle actual functional outcome measures but to us.

One could then move into metabolic parameters or muscle actual functional outcome measures but, to us, the most important thing in the Phase II study is to really just demonstrate the quality of the weight loss in terms of fat versus muscle because, ultimately, if you're preserving muscle and increasing the fat loss, it has to be much better for patients and it may avoid a lot of catastrophic long-term effects of widespread GLP-1 use. And, so if we see that, we think that we have a real opportunity to to turn that into real, widespread benefit for patients using this class of drugs.

Speaker Change: Most important thing in the phase II study is to really just demonstrate the quality of the weight loss in terms of fat versus muscle because ultimately if youre preserving muscle and increasing the fat loss.

Speaker Change: Has to be much better for patients and it may avoid a lot of catastrophic long term effects of widespread <unk> one.

Speaker Change: Use and so if we see that we think that we have a real opportunity to turn that into real widespread benefit for patients using this class of drugs.

Ryan Crowe: Okay, thanks, George. Next question, please.

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

Speaker Change: Thanks, George next question please.

Operator: Thank you. One moment for questions. Our next question comes from Christopher Raymond with Piper Sandler. You may proceed.

Operator: Thank you. Our next question comes from Christopher Raymond with Piper Sandler. You may proceed.

Speaker Change: Thank you.

Speaker Change: One moment for questions.

Speaker Change: Our next question comes from Christopher Raymond with Piper Sandler You May proceed.

Christopher J. Raymond: Thanks. I have a question on the EYLEA franchise. I just noticed that McKesson bought one of the largest GPOs, USRetina, earlier this year and there's actually been, as you guys know, a relatively long march of retina practices being rolled up by various private equity firms over the last few years. So, yeah, I know this is something that's happening across a number of therapeutic specialty areas but maybe just talk about how you see this phenomenon impacting the practice of ophthalmology in the U.S. and any changes to your go-to-market strategy. And I guess, related -- the inventory drawdown, we didn't see that happen last year. Was there any effect from maybe some of these changes in your customer base that sort of drove that? Thanks.

Christopher Raymond: Thanks. I have a question on the EYLEA franchise. I just noticed that McKesson bought one of the largest GPOs, US Retina, earlier this year. And, you know, there's actually been a, as you guys know, a relatively long march of retina practices being rolled up by various private equity firms over the last few years. So, yeah, I know this is something that's happening across a number of therapeutic specialty areas, but maybe just talk about how you see this phenomenon impacting, you know, the practice of ophthalmology in the US, and, you know, any changes to your go-to-market strategy. And I guess, you know, related, the inventory drawdown, you know, we didn't see that happen last year.

Speaker Change: Thanks.

Christopher Joseph Raymond: On the Eylea franchise.

Christopher Joseph Raymond: Notice that Mckesson bought.

Christopher Joseph Raymond: One of the largest GPO is U S retina earlier this year.

Christopher Joseph Raymond: Yes, theres actually been a.

Christopher Joseph Raymond: You guys know a relatively long merger retina practices being rolled up by various private equity firms over the last few years. So I know this is something that's happening across a number of therapeutic specialty areas, but maybe just talk about how you see this phenomenon impacting.

Christopher Joseph Raymond: The practice of ophthalmology.

Christopher Joseph Raymond: Ophthalmology in the U S.

Christopher Joseph Raymond: Any changes to your go to market strategy and I guess related.

Speaker Change: The inventory drawdown.

Speaker Change: We didn't see that happened last year was there any effect from maybe some of these.

Christopher Raymond: Was there any effect from maybe some of these, you know, changes in your customer base that sort of drove that? Thanks.

Was there any effect from maybe some of these, you know, changes in your customer base that sort of drove that? Thanks.

Speaker Change: <unk> in your customer base that sort of drove that.

Marion McCourt: Sure. So, let me take the inventory item first and then I'll come back to the overall marketplace. But this was an aggregate, as I mentioned. In the quarter, we saw reduction in wholesaler inventory, broadly, of about $40 million. So, that reflects market-wide but that was a combination of two elements. It was a sequential drawdown of EYLEA inventory that was partially offset by a modest increase in EYLEA HD inventory ahead of the permanent J-code on April 1st.

Marion McCourt: Sure. So let me take the inventory item first, and then I'll come back to the overall marketplace. But this is, this was an aggregate. As I mentioned, in the quarter, we saw a reduction in wholesaler inventory broadly of about $40 million. So that reflects market-wide. But that was a combination of two elements. It was a sequential drawdown of EYLEA inventory that was partially offset by a modest increase in EYLEA HD inventory ahead of the permanent J-code on 1 April. And then I would share on the overall market, you know, in all the categories where we participate, we're always very conscious of the segmentation of the market, targeting the market, what's occurring in terms of, you know, customer base, and you know, certainly our strategies and our approach to the marketplace is reflective of that.

Speaker Change: <unk>.

Speaker Change: Sure. So let me take the <unk>.

Speaker Change: Inventory items first and then I'll come back to the overall marketplace. But this is this was in aggregate as I mentioned in the quarter, we saw a reduction.

Speaker Change: In wholesaler inventory broadly of about $40 million. So that reflects market wide, but that was a combination of two elements. It was a sequential drawdown of eylea inventory that was partially offset by a modest increase in eylea HD inventory ahead of the permanent J code.

unknown: And then, I would share on the overall market -- in all the categories where we participate, we're always very conscious of the segmentation of the market, targeting the market, what's occurring in terms of customer base. And certainly, our strategies and our approach to the marketplace is reflective of that. And the range of customers we have, as you point out, in retina and how that market has evolved over time. And I think our commercialization approach has been very effective in addressing that market evolution.

Speaker Change: On April 1st and then I would share on the overall market and all the categories, where we participate we're always very conscious of the segmentation of the market targeting in the market what's occurring in terms of customer base and certainly our strategies and our approach to the marketplace is reflective of <unk>.

Marion McCourt: You know, the range of customers we have, as you point out in retina and how that market has evolved over time, and I think our commercialization approach has been very effective in addressing that market evolution.

You know, the range of customers we have, as you point out in retina and how that market has evolved over time, and I think our commercialization approach has been very effective in addressing that market evolution.

Speaker Change: That and the range of customers, we have as you pointed out in retina and how that market has evolved over time and I think our commercialization approach has been very effective in addressing that market evolution.

Marion: Okay. Thanks, Marion. Next question, please, Josh. Thank you. One moment for questions. Our next question comes from Salveen Richter with Goldman Sachs. You may proceed. Good morning. Thanks for taking my question with you.

Ryan Crowe: Okay. Thanks, Marion. Next question, please, Josh.

Ryan Crowe: Okay, thanks, Mary. Next question, please, Josh.

Thank you. One moment for questions. Our next question comes from Salveen Richter with Goldman Sachs. You may proceed. Good morning. Thanks for taking my question with you.

Operator: Thank you. One moment for questions. Our next question comes from Salveen Richter with Goldman Sachs. You may proceed.

Speaker Change: Okay. Thanks, Marion next question please Josh.

Operator: Thank you. One moment for questions. Our next question comes from Salveen Richter with Goldman Sachs. You may proceed.

Salveen Richter: Good morning. Thanks for taking my question. With regard to the COPD program here, it doesn't seem like this is an approvability question. So, could you just speak to whether restrictions to specific sub-populations could be possible, albeit noting that you had a sub-population analysis that was consistent with the broader data. Thank you.

unknown: One moment for questions. Our next question comes from Salveen Richter of Goldman Sachs. Please proceed.

Josh: Thank you.

Speaker Change: One moment for questions.

unknown: Yeah. Salveen, thanks for the question. You're right. From our perspective, we think the data broadly supports the entire BLA and as well as all these analyses, the approval of the drug in eosinophilic COPD. As you might imagine, the FDA, when anticipating or looking at a new class of biologics, is very interested in checking it up and down and down and up and making sure that there's no sub-population of the study that might be driving the data. So, if one saw that, one might think about labeling it differently. But none of that has occurred. We've looked at all these analyses, we're going to submit them way ahead of the schedule that they've asked for and all of the analyses show a consistent and clinically meaningful reduction in COPD exacerbations across all of these subgroups that have been asked for.

Leonard S. Schleifer: Yeah. Salveen, thanks for the question. You're right. From our perspective, we think the data broadly supports the entire BLA and as well as all these analyses, the approval of the drug in eosinophilic COPD. As you might imagine, the FDA, when anticipating or looking at a new class of biologics, is very interested in checking it up and down and down and up and making sure that there's no sub-population of the study that might be driving the data.

Josh: Our next question comes from <unk> Richter with Goldman Sachs. You May proceed.

Len: From our perspective, we think the data broadly supports the entire BLA and as well as all these analyses. The approval of the drug in eosinophilic COPD. As you might imagine, the FDA, when anticipating or looking at a new class of biologics, is very interested in checking it up and down and down and up and making sure that there's no subpopulation of the study that might be driving the data. So if one saw that, one might think about labeling it differently, but none of that has occurred.

Salveen Richter: Good morning. Thanks for taking my question. With regard to the COPD program here, it doesn't seem like this is an approvability question, so could you just speak to whether restrictions to specific subpopulations could be possible, albeit noting that you had subpopulation analysis that was consistent with the broader data? Thank you.

Salveen Richter: Good morning, Thanks for taking my question with regard to the COPD program here.

Richter: It doesn't seem like this isn't a profitability question. So could you just speak to whether restrictions to specific subpopulations could be possible, albeit noting that you had.

Salveen Richter: Subpopulation analysis that was consistent with the broader data. Thank you.

George Yancopoulos: Yeah, Salveen, thanks for the question. You're right. From our perspective, we think the data broadly supports the entire BLA, and as well as all these analyses, the approval of the drug in eosinophilic COPD. As you might imagine, the FDA, when anticipating or looking at a new class of biologics, is very interested in checking it up and down and down and up, and making sure that there's no subpopulation of the study that might be driving the data. So they might, if one saw that, one might think about labeling it differently, but none of that has occurred. We've looked at all these analyses.

Leonard Schleifer: Yeah, Salveen, thanks for the question. You're right. From our perspective, we think the data broadly supports the entire BLA, and as well as all these analyses, the approval of the drug in eosinophilic COPD. As you might imagine, the FDA, when anticipating or looking at a new class of biologics, is very interested in checking it up and down and down and up, and making sure that there's no subpopulation of the study that might be driving the data. So they might, if one saw that, one might think about labeling it differently, but none of that has occurred. We've looked at all these analyses.

Savi: Yes, savi thanks for the question.

Savi: Right.

Savi: Our perspective, we think the data broadly supports the entire BLA and as well as all of these analysis the approval of the drug in eosinophilic COPD as you might imagine the SBA win.

Speaker Change: Anticipating or looking at a new class of biologics is very interested in and check.

So, if one saw that, one might think about labeling it differently. But none of that has occurred. We've looked at all these analyses, we're going to submit them way ahead of the schedule that they've asked for and all of the analyses show a consistent and clinically meaningful reduction in COPD exacerbations across all of these subgroups that have been asked for.

Savi: Checking it up and down and down and up and making sure that there is no sub population of the study that might.

Savi: Might be driving.

Savi: The data so they might be.

Savi: <unk> saw that one might think about labeling it differently, but none of that has occurred we've looked at all of these analyses were going to submit them way ahead of the schedule that they have asked for and all of the analysis show, a consistent and clinically meaningful reduction in <unk>.

Len: We've looked at all these analyses, and we're going to submit them way ahead of the schedule that they've asked for, and all of the analyses show a consistent and clinically meaningful reduction in COPD exacerbations across all of these subgroups that have been asked for.

George Yancopoulos: We're gonna submit them way ahead of the schedule that they've asked for, and all of the analyses show a consistent and clinically meaningful reduction in the COPD exacerbations across all of these subgroups that have been asked for.

We're gonna submit them way ahead of the schedule that they've asked for, and all of the analyses show a consistent and clinically meaningful reduction in the COPD exacerbations across all of these subgroups that have been asked for.

Savi: PD exacerbations across all of these subgroups rather than ask for.

unknown: Thanks, Len. Next question, please. Thank you. One moment for questions. Our next question comes from Tyler Van Buren with TD Cal, and you may proceed. Hey, guys. Good morning. Thanks for taking the question.

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

Thank you. One moment for questions. Our next question comes from Tyler Van Buren with TD Cal, and you may proceed. Hey, guys. Good morning. Thanks for taking the question.

Operator: Thank you. One moment for questions. Our next question comes from Tyler Van Buren with TD Cowen. You may proceed.

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

Speaker Change: Thanks, Glenn next question please.

Tyler Van Buren: Hey, guys. Good morning. Thanks for taking the question. For this initial severe food allergy study and the results by year-end, could you elaborate on exactly what will be reported and what you would hope to see to have early clinical proof-of-concept? And how long do you anticipate that these patients would stay on DUPIXENT in order to maintain low or no IgE levels?

unknown: Thank you. One moment for questions. Our next question comes from Tyler Van Buren with TD Cowen. You may proceed.

Operator: Thank you. One moment for questions. Our next question comes from Tyler Van Buren with TD Cowen. You may proceed.

Speaker Change: Thank you one moment for questions.

Speaker Change: Our next question comes from Tyler Van Buren with TD Cowen You May proceed.

Tyler Van Buren: Hey, guys. Good morning. Thanks for taking the question. For this initial severe food allergy study and the results by year-end, can you elaborate on exactly what will be reported and what you would hope to see to have early clinical proof of concept? And how long do you anticipate that these patients would stay on Dupixent, in order to maintain low or no IgE levels?

Speaker Change: Hey, guys. Good morning, Thanks for taking the question.

Speaker Change: Initial severe food allergy study and the results by year end could you elaborate on exactly what will be reported and what you would hope to see the early clinical proof of concept and how long do you anticipate that these patients would stay on <unk>.

Speaker Change: In order to maintain low or no GE levels.

George Yancopoulos: Yeah, these are great questions. We hope from the first few patients, if the results are as dramatic as they are in the preclinical studies, that we'll be seeing meaningful indicators that we are really reversing severe food allergy. Of course, the first thing and the most important biomarker, as I said, is this total immunoglobulin IgE, which you can both measure, but they are also routinely tested using these skin prick tests, which are how people are actually evaluated for allergy.

unknown: These are great questions. We hope, from the first few patients -- if the results are as dramatic as they are in the preclinical studies -- that we'll be seeing meaningful indicators that we are really reversing severe food allergy. Of course, the first thing and the most important biomarker, as I said, is this evil immunoglobulin, IgE -- which you can both measure but they are also routinely tested using these skin prick tests, which are how people are actually evaluated for allergies. So we expect, first of all, to be seeing that happening in the study in obvious ways. And then, we can follow that up. And it is allowed in the study, if we see dramatic responses in these markers of the actual allergy causing immunoglobulin, to then go on and do actual food challenge and so forth in the patients. So, it all depends on how obvious the reductions in this IgE are and if they're really dramatic, we can go on and do additional allergen challenge tests. But we hope, if the humans behave like the non-human primates, that we might be seeing something dramatic in the initial stages.

George D. Yancopoulos: These are great questions. We hope, from the first few patients -- if the results are as dramatic as they are in the preclinical studies -- that we'll be seeing meaningful indicators that we are really reversing severe food allergy. Of course, the first thing and the most important biomarker, as I said, is this evil immunoglobulin, IgE -- which you can both measure but they are also routinely tested using these skin prick tests, which are how people are actually evaluated for allergies.

Speaker Change: Yes. These are great questions.

Speaker Change: We hope from the first few patients if the results are as dramatic as they are in the preclinical studies that we'll be seeing meaningful meaningful indicators that we are really reversing severe food allergy of course, the first thing and the most important biomarker as I said.

Speaker Change: Is this evil immunoglobulin Iga, which you can both measure but they are also routinely tested using these skin prick tests, which are how people are actually evaluated.

unknown: So we expect, first of all, to be seeing that happening in the study in obvious ways. And then we can follow that up. And it is allowed in the study, if we see dramatic responses in these markers of the actual allergy causing immunoglobulin, to then go on and do actual food challenge and so forth in the patient. So it all depends on how obvious the reductions in this IGER are, and if they're really dramatic, we can go on and do additional allergen challenge. But we hope if humans behave like non-human primates, that we might be seeing something dramatic in the initial stages.

George Yancopoulos: So we expect, first of all, to be seeing that happening in the study in obvious ways, and then we can follow that up, and it is allowed in the study if we see dramatic responses in these markers of the actual allergy-causing immunoglobulin, to then go on and do actual food challenge and so forth in the patient. So it all depends on how obvious the reductions in this IgE are, and if they are really dramatic, we can go on and do additional allergen challenge tests. But we hope if the humans behave like the non-human primates that we might be seeing something dramatic in the initial patients.

So we expect, first of all, to be seeing that happening in the study in obvious ways, and then we can follow that up, and it is allowed in the study if we see dramatic responses in these markers of the actual allergy-causing immunoglobulin, to then go on and do actual food challenge and so forth in the patient. So it all depends on how obvious the reductions in this IgE are, and if they are really dramatic, we can go on and do additional allergen challenge tests. But we hope if the humans behave like the non-human primates that we might be seeing something dramatic in the initial patients.

So we expect, first of all, to be seeing that happening in the study in obvious ways. And then, we can follow that up. And it is allowed in the study, if we see dramatic responses in these markers of the actual allergy causing immunoglobulin, to then go on and do actual food challenge and so forth in the patients. So, it all depends on how obvious the reductions in this IgE are and if they're really dramatic, we can go on and do additional allergen challenge tests. But we hope, if the humans behave like the non-human primates, that we might be seeing something dramatic in the initial stages.

Speaker Change: For allergy. So we expect first of all to be seeing that happening.

Speaker Change: In this study in obvious ways and then we can follow that up and it is allowed in the study if we see dramatic responses in these markers of the actual allergy, causing immunoglobulin.

Speaker Change: Then go on and do actual food challenge and so forth and the patient so it all depends on.

Speaker Change: How.

Speaker Change: Obvious.

Speaker Change: The reductions in this Iga are and if they are really dramatic we can go on and do additional allergen challenge tests, but we hope if.

Speaker Change: The humans behave like the nonhuman primates that we might be seeing something.

Speaker Change: Dramatic in the initial patients George can you comment I think they also wanted to say how long you have to stay on.

Leonard S. Schleifer: George, can you comment? I think they also wanted to know how long you have to stay on DUPI.

Ryan Crowe: George, can you comment? I think they also wanted to know how long you have to stay on the Dupixent.

George D. Yancopoulos: Yeah. The interesting thing is, the animal studies suggest that the antibodies against the allergens come back as IgG -- G for good antibodies. The whole point of -- if you guys are familiar with so-called immunotherapy or desensitization therapy -- all of those therapies, what they're trying to do is induce the production of IgG to overwhelm the IgE. That's a much harder thing to do because they're not really getting rid of the IgE, they just have to overwhelm it with a lot more IgG. In the animal studies, it suggests that we get rid of the IgE and we replace it with IgG. We don't know, obviously.

George Yancopoulos: Yeah. The interesting thing is, the animal studies suggest that the antibodies against the allergens come back as IgG, G for good antibodies. The whole point of, if you guys are familiar with so-called immunotherapy or desensitization therapy, all of those therapies, what they're trying to do is induce production of IgG to overwhelm the IgE. That's a much harder thing to do because they're not really getting rid of the IgE. They just have to overwhelm with a lot more IgG. In the animal studies, it suggests that we get rid of the IgE and we replace it with IgG. We don't know, obviously, in the humans, it may be possible that short-term treatment, relatively short-term treatment, may allow patients who have replaced their IgE with IgG, and they will have long-term protection.

George D. Yancopoulos: Yes. The interesting thing is the animal studies suggest that the antibodies against the <unk> come back as I G. G. G for good antibodies.

George D. Yancopoulos: <unk> point of.

George D. Yancopoulos: If you guys are familiar with so called immunotherapy or desensitization therapy, all of those therapies. What they are trying to do is induced production of IAG G to overwhelm the GE. That's a much harder thing to do because they are not really getting rid of the IGT. They just have to overwhelm.

George D. Yancopoulos: Lot more agg.

George D. Yancopoulos: In the animal studies. It suggests that we get rid of the IAG and we replace it with IGT. We don't know obviously in the humans. It may be possible that short term treatment of relatively short term treatment.

unknown: In humans, it may be possible that short-term treatment -- relatively short-term treatment -- may allow patients who have replaced their IgE with IgG and they will have long-term protection. On the other hand, we may see that, to prevent these patients from making IgE and more IgGs in the future, that they may have to stay on DUPIXENT for substantial long periods of time. The good news about that, as we all know and as was highlighted in Marion's comments, DUPIXENT, compared to most other immunomodulatory agents, is not immunosuppressive.

George D. Yancopoulos: May allow patients who or replace their <unk> with ITG and they will have long term protection on the other hand, we may see that to prevent these patients from making IAG and more <unk> in the future that they may have to stay on the depiction for substantial long periods of time, the good news about that.

George Yancopoulos: On the other hand, we may see that to prevent these patients from making IgE and more IgGs in the future, that they may have to stay on the Dupixent for substantial long periods of time. The good news about that, as we all know, and as was highlighted, in Marianne's comments, Dupixent, compared to most other immunomodulatory agents, it's not immunosuppressive. It actually is corrective for the immune system, and as indicated by its labeling to very, very young patients, it's a very, very relatively safe immunomodulator and, and biologic. And since most people who have severe allergies also have a lot of other concomitant atopic diseases, it may be that it is best for these patients to keep their abnormal atopy or abnormal type 2 inflammation under control.

On the other hand, we may see that to prevent these patients from making IgE and more IgGs in the future, that they may have to stay on the Dupixent for substantial long periods of time. The good news about that, as we all know, and as was highlighted, in Marianne's comments, Dupixent, compared to most other immunomodulatory agents, it's not immunosuppressive. It actually is corrective for the immune system, and as indicated by its labeling to very, very young patients, it's a very, very relatively safe immunomodulator and, and biologic. And since most people who have severe allergies also have a lot of other concomitant atopic diseases, it may be that it is best for these patients to keep their abnormal atopy or abnormal type 2 inflammation under control.

George D. Yancopoulos: As we all know and as was highlighted.

George D. Yancopoulos: In Marion's comments.

Speaker Change: You're pixel.

George D. Yancopoulos: Compared to most other immuno modulator reagents, it's not immunosuppressive.

unknown: It actually is corrective for the immune system and, as indicated by its labeling, for very, very young patients, it's a very, very relatively safe immunomodulator and biologic. And since most people who have severe allergies also have a lot of other concomitant atopic diseases, it may be that it is best for these patients to keep their abnormal atopy or abnormal Type 2 inflammation under control. So, short answer is, there's a possibility it could be relatively short-term but there's also a possibility, at least for some or the majority of patients, it could be relatively long-term. But the good news is that they may actually have a long-term benefit for the patient because these patients are almost, by definition, what you call atopic patients who might need control of their Type 2 excess inflammation.

George D. Yancopoulos: It actually is corrective for the immune system.

George D. Yancopoulos: As indicated by its labeling to very very young patients. It's a very very comp relatively safe immuno modulator and biologic and since most people who have severe allergies will also have a lot of other concomitant atopic diseases. It may be that it is best for.

George D. Yancopoulos: These patients to keep their abnormal <unk> or abnormal type two inflammation under control. So short answer is it's there's a possibility it could be relatively short term, but theres also a possibility at least for some or the majority of patients it could be relatively long term, but the good news.

George Yancopoulos: So short answer is, there's a possibility it could be relatively short term, but there's also a possibility, at least for some or the majority of patients, it could be relatively long term. But the good news is that they may actually have a long-term benefit to the patient, because these patients are almost by definition, what you call atopic patients, who might need control of their Type 2 excess inflammation.

unknown: But the good news is that they may actually have a long-term benefit for the patient because these patients are, by definition, what you call atopic patients who might need control of their type 2 excess inflammation.

George D. Yancopoulos: Is that they may actually have a long term benefit for the patients because these patients are almost by definition, what you call atopic patients who might need control of their type two excess inflammation.

Ryan Crowe: All right, moving to the next question, please.

unknown: Moving to the next question, please. Thank you. One moment for questions. Our next question comes from Terence Flynn with Morgan Stanley. You may proceed. Great. Thanks for taking the question. I just had one.

Ryan Crowe: Alright. Moving to the next question, please.

Thank you. One moment for questions. Our next question comes from Terence Flynn with Morgan Stanley. You may proceed. Great. Thanks for taking the question. I just had one.

Operator: Thank you. One moment for questions. Our next question comes from Terence Flynn with Morgan Stanley. You may proceed.

Speaker Change: Alright, moving to the next question please.

Operator: Thank you. One moment for questions. Our next question comes from Terence Flynn with Morgan Stanley. You may proceed.

Terence Flynn: Great. Thanks for taking the question. Just had one, on your LAG-3 program. Obviously, you guys are aware that Bristol has discussed seeing a signal in a subset of lung cancer that benefits from a combination of PD-1 and LAG-3. So, i would just love your latest thoughts on how to think about that, in the context of both your program and then what you're hoping to see with this Phase II data later this year. Thank you.

unknown: One moment for questions. Our next question comes from Terence Flynn with Morgan Stanley. You may proceed.

Speaker Change: Thank you.

unknown: Right, that's a great question. Obviously, the thing that gets us excited about our program compared to the field is that we've seen levels of activity that haven't been seen in the other LAG-3 programs, particularly in melanoma. If that's true in melanoma, there would be hope that this would be seen broadly in other settings and indications. We are certainly excited to see the follow-up details on the BMS story, with potential activity in a specific sub-population. That will certainly help point us in our own studies to see what we're seeing within that sub-population that they're talking about, as well as more broadly. But of course, the hope, as I said, is that if it is indeed more active in one setting, such as melanoma, the hope is it will be broadly more active across other cancer settings as well. So, we are excited to see follow-up on their data, we're excited to see follow-up on our data, both in melanoma and in our lung studies.

George D. Yancopoulos: Right, that's a great question. Obviously, the thing that gets us excited about our program compared to the field is that we've seen levels of activity that haven't been seen in the other LAG-3 programs, particularly in melanoma. If that's true in melanoma, there would be hope that this would be seen broadly in other settings and indications.

Speaker Change: A moment for our questions.

Speaker Change: Our next question comes from Terence Flynn with Morgan Stanley You May proceed.

Terence Flynn: Great, thanks for taking the question. Just had one on your LAG-3 program. You know, obviously, you guys are aware that Bristol has discussed seeing a signal in a subset of lung cancer, that benefits from a combination of PD-1 and LAG-3. So would just love your latest thoughts on how to think about that in the context of, both your program and then, what you're hoping to see with this phase 2 data later this year. Thank you.

Terence C. Flynn: Great. Thanks for taking the question just had one of your lag three program.

Terence C. Flynn: Obviously, you guys are aware that Bristol has discussed seeing a signal in a subset of lung cancer that benefits from a combination of PD, one and lag three so would just love your latest thoughts on how to think about that in the context of both your program and then what you are hoping to see what this phase II data later this year. Thank you.

George: Obviously, the thing that gets us excited about our program compared to the field is that we've seen levels of activity that haven't been seen in the other leg three programs, particularly in melanoma. If that's true in melanoma, there would be hope that this would be seen broadly in other settings and indications. We are certainly excited to see the follow-up details on the BMS story with potential activity in a specific subpopulation.

George Yancopoulos: Right. That's, that's a great question. Obviously, the thing that gets us excited about our program compared to the field, is that we've seen levels of activity that haven't been seen in the other LAG-3 programs, particularly in melanoma. If that's true in melanoma, there would be hope that this would be seen broadly in other settings and indications. We are certainly excited to see the follow-up details on the BMS story with potential activity in a specific subpopulation. That will certainly help point us in our own studies to see what we're seeing within that subpopulation that they're talking about, as well as more broadly. But of course, the hope, as I said, is if it is indeed more active in one setting, such as melanoma, the hope is it'll be broadly more active across other cancer settings as well.

Speaker Change: Right. That's a great question, obviously the thing that gets us excited about our program compared to the field is that we've seen levels of activity that hasnt been seen in the other leg three programs.

We are certainly excited to see the follow-up details on the BMS story, with potential activity in a specific sub-population. That will certainly help point us in our own studies to see what we're seeing within that sub-population that they're talking about, as well as more broadly. But of course, the hope, as I said, is that if it is indeed more active in one setting, such as melanoma, the hope is it will be broadly more active across other cancer settings as well. So, we are excited to see follow-up on their data, we're excited to see follow-up on our data, both in melanoma and in our lung studies.

Speaker Change: Particularly in melanoma, if that's true in melanoma, there would be hope that this would be seen broadly in other settings and indications. We are certainly excited to see the follow up.

Terence C. Flynn: Details.

George: That will certainly help us in our own studies to see what we're seeing within that subpopulation that they're talking about, as well as more broadly. But of course, the hope, as I said, is that if it is indeed more active in one setting, such as melanoma, the hope is it will be more active across other cancer settings as well. So we are excited to see follow-up on their data. We're excited to see follow-up on our data, both in melanoma and in our lung studies.

Terence C. Flynn: John.

Terence C. Flynn: The BMS story.

Terence C. Flynn: With potential activity in a specific sub population that will certainly help point us in our own studies to see what we're seeing within that sub population that they are talking about as well as more broadly but of course the hope as I said is if it is indeed more active in one setting such as melanoma.

Terence C. Flynn: Hope is it will be broadly more active across other cancer settings as well. So so we are excited to see follow up on their data. We're excited to see follow up on our data both in melanoma and lung studies. Thanks. George next question. Please.

George Yancopoulos: So, we are excited to see follow-up on their data. We're excited to see follow-up on our data, both in melanoma and in our lung studies.

So, we are excited to see follow-up on their data. We're excited to see follow-up on our data, both in melanoma and in our lung studies.

George: Thanks, George. Next question, please. Thank you. One moment for questions. Our next question comes from William Pickering with Bernstein. You may proceed. Hi, good morning. Thank you so much for taking my question. I had a follow-up.

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

Thank you. One moment for questions. Our next question comes from William Pickering with Bernstein. You may proceed. Hi, good morning. Thank you so much for taking my question. I had a follow-up.

Operator: Thank you. One moment for questions. Our next question comes from William Pickering with Bernstein. You may proceed.

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

William Pickering: Hi, good morning. Thank you so much for taking my question. I had a follow-up on the food allergy program. Could you comment on the dose of LINVOSELTAMAB that you'll be testing as compared to the myeloma setting? What gives you confidence in the safety profile? And if a patient misses a DUPIXENT dose, would they then need to start over again with LINVO? Thank you.

unknown: Thank you. One moment for questions. Our next question comes from William Pickering with Bernstein. You may proceed.

Operator: Thank you. One moment for questions. Our next question comes from William Pickering with Bernstein. You may proceed.

George D. Yancopoulos: Thank you one moment for questions.

Terence C. Flynn: Our next question comes from William <unk> with Bernstein, You May proceed.

William Pickering: Hi, good morning. Thank you so much for taking my question. I had a follow-up on the food allergy program. Could you comment on the dose of Linvoseltumab that you'll be testing as compared to the myeloma setting? You know, what gives you confidence in the safety profile? And if a patient misses a Dupixent dose, would they then need to start over again with linvo? Thank you.

William: Hi, good morning. Thank you so much for taking my question I had a follow up on the food allergy program.

William: Could you comment on the dose of <unk> that you'll be testing as compared to the myeloma setting.

William: What gives you confidence in the safety profile.

Speaker Change: And if a patient misses that depicts and dose would then need to start over again with lindo. Thank you.

George D. Yancopoulos: Yeah. These are all great questions. So, what we've already actually shown, based on a variety of studies that we've done, is that normal, non-malignant, non-cancerous plasma cells -- the cells that are the immunoglobulin factory cells -- the normal versions of the cells are much more susceptible to bispecific than are malignant myeloma cells. So, in discussions and communications with the FDA, we're actually starting at much lower doses than the doses that are used in the myeloma programs, though there is an intrapatient dose escalation process.

George Yancopoulos: Yeah, these are all great questions. So what we've already actually shown, based on a variety of studies that we've done, is that normal, non-malignant, non-cancerous plasma cells, the cells that are the immunoglobulin factory cells, are the normal versions of the cells, are much more susceptible to the bispecific than our malignant myeloma cells. So in discussions and communications with the FDA, we're actually starting at much lower doses than the doses that are used in the myeloma programs, though there is an intra-patient dose escalation process. So we're literally watching. We're starting with low doses, and we're going up in the doses until we actually hopefully see elimination of the IgE.

Speaker Change: Yes. These are all great questions. So what we've already actually shown.

Speaker Change: Based on a variety of studies that we've done is that.

Speaker Change: Normal non malignant noncancerous plasma cells. The cells that are the immunoglobulin factory cells are the normal versions of the cells are much more susceptible to the bi specific than our malignant myeloma cells.

Speaker Change: So in discussions and communications with the FDA, we are actually starting at much lower doses and the doses that are used in the myeloma programs, though there is an intra patient dose escalation.

unknown: So, we're literally watching, we're starting with low doses and we're going up in doses until we actually, hopefully, see elimination of the IgE. That said, in terms of the safety, I just want to remind you that the much higher myeloma doses we came up with, as Len briefly summarized in this program, we believe that we have a differentiated program in terms of not only efficacy and hospitalization burden and so forth but also in safety. We have less than 1% grade 3 events at those high doses, in the much sicker myeloma patients. So, we hope and we expect that with lower doses in a much healthier population, that this will be a, hopefully, pretty well tolerated approach.

Speaker Change: Process. So we're literally watching we're starting with low doses and we are going up in the doses until we actually hopefully see elimination of the GE.

George Yancopoulos: That said, in terms of the safety, I just remind you that the much higher myeloma doses we came up as Len briefly summarized in this program, we believe that we have a differentiated program in terms of not only efficacy and hospitalization burden, so forth, but also in safety. We have less than 1% grade three events at those high doses in the much sicker myeloma patients. So we hope and we expect that with lower doses in a much healthier population, that this will be a hopefully pretty well-tolerated approach.

That said, in terms of the safety, I just remind you that the much higher myeloma doses we came up as Len briefly summarized in this program, we believe that we have a differentiated program in terms of not only efficacy and hospitalization burden, so forth, but also in safety. We have less than 1% grade three events at those high doses in the much sicker myeloma patients. So we hope and we expect that with lower doses in a much healthier population, that this will be a hopefully pretty well-tolerated approach.

Speaker Change: That said.

Speaker Change: In terms of the safety I, just remind you that the much higher myeloma doses, we came up as Len briefly summarizing this program, we believe that we have.

Speaker Change: Differentiated program in terms of not only efficacy and hospitalization burden and so forth, but also in safety, we have less than 1%.

Speaker Change: Great three events at those high doses in the much sicker myeloma patients. So we hope and we expect that with lower doses in a much healthier population that.

unknown: So, we hope and we expect that with lower doses in a much healthier population, that this will be a, hopefully, pretty well tolerated approach. And a much shorter -- treatment. Yeah, we think that ultimately we may get by with a single short course or a very short course of treatment. In terms of whether, you know, if somebody takes a holiday, whether one has to then start all over again with the elimination of the IgE cells, we think probably not because it takes a long time to get to those levels of IgE.

So, we hope and we expect that with lower doses in a much healthier population, that this will be a, hopefully, pretty well tolerated approach.

Speaker Change: This will be a hopefully pretty well tolerated approach.

And a much shorter -- treatment. Yeah, we think that ultimately we may get by with a single short course or a very short course of treatment. In terms of whether, you know, if somebody takes a holiday, whether one has to then start all over again with the elimination of the IgE cells, we think probably not because it takes a long time to get to those levels of IgE.

Leonard S. Schleifer: And a much shorter --

Ryan Crowe: A much shorter.

And a much shorter, yeah. We think that, ultimately, we may get by with a single, short course or a very short course of treatment. In terms of whether, you know, if somebody takes a holiday, whether one has to then start all over again with the elimination of the IgE cells, we think probably not because it takes a long time to get to those levels of IgE. So, you know, just delaying for a short period of time, you may not bounce back to those levels. As I said, you may have converted all of those cells to IgG or good cells by that point anyway. But of course, we have to be doing the studies and we have to be looking at these patients in the clinic to really understand. I should mention that the grade 3 events that I was talking about are reflected by cytokine release syndrome. A lot of that is also thought to be due to the load of the cancer cells. And obviously, these normal patients have much less of a load here. So, it's just another reason to expect, hopefully, better safety. We're going to be going with lower doses, more gentle treatment and they have much less load in there. So, you'd expect much less reason to be seeing things like cytokine release syndrome.

George D. Yancopoulos: And a much shorter, yeah. We think that, ultimately, we may get by with a single, short course or a very short course of treatment. In terms of whether, you know, if somebody takes a holiday, whether one has to then start all over again with the elimination of the IgE cells, we think probably not because it takes a long time to get to those levels of IgE. So, you know, just delaying for a short period of time, you may not bounce back to those levels. As I said, you may have converted all of those cells to IgG or good cells by that point anyway.

George Yancopoulos: A much shorter, yeah. We think that ultimately we may get by with a single short course or a very short course of treatment. In terms of whether, you know, if somebody takes a holiday, whether one has to then start all over again with the elimination of the IgE cells, we think probably not, because it takes a long time to get to those levels of IgE. So, you know, just delaying for a short period of time, it may not bounce back to those levels. As I said, you may have converted all of those cells to IgG or good cells by that point anyway. But of course, we have to be doing the studies, and we have to be looking at these patients in the clinic to really understand. When I...

Speaker Change: And a much shorter and a much shorter yes, we think that ultimately we may get by with a single short course, or very short course of treatment in terms of weather.

Speaker Change: If somebody takes a holiday whether one has to then start all over again with the elimination of the Iga cells.

Speaker Change: We think probably not because it takes a long time to get to those levels of Iga. So.

unknown: So, you know, just delaying for a short period of time, you may not bounce back to those levels. But, as I said, you may have converted all of those cells to IgG or good cells by that point anyway. But of course, we have to be doing the studies, and we have to be looking at these patients in the clinic to really understand. I should mention that the grade 3 events that I was talking about are reflected by cytokine release syndrome.

Speaker Change: Just delaying for.

Speaker Change: A short period of time, it may not bounce back to those levels as I said.

Speaker Change: You may have converted all of those cells to <unk> are good sales by that point anyway.

But of course, we have to be doing the studies and we have to be looking at these patients in the clinic to really understand. I should mention that the grade 3 events that I was talking about are reflected by cytokine release syndrome. A lot of that is also thought to be due to the load of the cancer cells. And obviously, these normal patients have much less of a load here. So, it's just another reason to expect, hopefully, better safety. We're going to be going with lower doses, more gentle treatment and they have much less load in there. So, you'd expect much less reason to be seeing things like cytokine release syndrome.

Speaker Change: But of course, we have to be doing the studies and we have to be looking at these patients in the clinic to really understand.

George Yancopoulos: I should mention that the grade three events that I was talking about are reflected by cytokine release syndrome. A lot of that is also thought to be due to the load of the cancer cells, and obviously, these normal patients have much less of a load here. So it's just another reason to expect, hopefully, better safety. We're gonna be going with lower doses, more gentle treatment, and they have much less load in there, so you'd expect much less reason to be seeing things like cytokine release syndrome.

I should mention that the grade three events that I was talking about are reflected by cytokine release syndrome. A lot of that is also thought to be due to the load of the cancer cells, and obviously, these normal patients have much less of a load here. So it's just another reason to expect, hopefully, better safety. We're gonna be going with lower doses, more gentle treatment, and they have much less load in there, so you'd expect much less reason to be seeing things like cytokine release syndrome.

Speaker Change: I should mention that the.

Speaker Change: The grade three events that I was talking about are reflected by cytokine release syndrome. A lot of that is also thought to be due to the the load of the cancer cells and honestly these normal patients have much less.

unknown: A lot of that is also thought to be due to the load of the cancer cells. And obviously, these normal patients have much less of a load here. So it's just another reason to expect hopefully better safety. We're going to be going with lower doses, more gentle treatment, and they have much less load in there. So you'd expect much less reason to be seeing things like cytokine release syndrome. Okay. Next question.

Speaker Change: Our load here. So it's just another reason to expect hopefully better safety, we're going to be going with lower doses.

Speaker Change: More gentle treatment and they have much less load in there. So you would expect much less reason to be seeing things like cytokine release syndrome. Okay. Next question. Please.

unknown: Okay, next question please. Thank you. One moment for questions. Our next question comes from Carter Gould with Barclays. Good morning. Thanks for taking the questions. Congratulations on all the progress. I wanted to ask another follow-up, sort of, on specifics in autoimmune, but I wanted to

Ryan Crowe: Okay. Next question, please.

Thank you. One moment for questions. Our next question comes from Carter Gould with Barclays. Good morning. Thanks for taking the questions. Congratulations on all the progress. I wanted to ask another follow-up, sort of, on specifics in autoimmune, but I wanted to

Operator: Thank you. One moment for questions. Our next question comes from Carter Gould with Barclays. You may proceed.

Carter Gould: Good morning. Thanks for taking the questions. Congrats on all the progress. I wanted to ask another follow-up, sort of, in bispecifics on autoimmune. But I wanted to go down a little bit of a different path, acknowledging the BCMA and DUPI effort. But we've seen CAR-T efforts and ADC approaches come to the rise in lupus and other autoimmune disorders and naturally, people then started talking about T cell engages. This seems like a natural place where Regeneron could leverage its bispecific capabilities, expertise. Are there efforts underway internally on this front? Has Regeneron looked at ways to leverage that expertise? Thank you.

Operator: Thank you. One moment for questions. Our next question comes from Carter Gold with Barclays. You may proceed.

unknown: One moment for questions. Our next question comes from Carter Gould with Barclays. You may proceed.

Speaker Change: Thank you.

Speaker Change: One moment for questions.

Speaker Change: Okay.

Speaker Change: Our next question comes from Carter Gould with Barclays. You May proceed.

Carter Gould: Good morning. Thanks for taking the questions. Congrats on all the progress. I wanted to ask another follow-up, sort of, in bispecifics and autoimmune, but wanted to go down a little bit of a different path, acknowledging the BCMA and Dupay effort. But we've seen sort of CAR-T efforts and ADC approaches sort of come to the rise in lupus and other autoimmune disorders, and naturally, people then started talking about T-cell engagers. This seems like a natural place where Regeneron could leverage its bispecific capabilities, expertise. Are there efforts underway internally on this front? Has Regeneron looked at ways to leverage that expertise? Thank you.

Carter Gould: Hi, good morning, Thanks for taking the question congrats on the progress I wanted to ask another follow up sort of.

Carter Gould: Bi specifics in autoimmune, but wanted to go down a little bit of a different path acknowledging the PCM Ain Dubai effort, but we're seeing sort of car T effort to an ADC approach has sort of come to the rise in lupus and other other autoimmune disorders are naturally people then sort of talking about T cell engaged this seems like a natural place where regeneron could leverage by specific capabilities expertise are there efforts.

Carter Gould: Underway internally on this front has regeneron looked at ways to leverage.

unknown: You know, that's a phenomenal question. And first of all, let me remind you that with our long-term collaboration and recent acquisition of 2seventy, 2seventy had exactly the sort of CAR-T programs that you're referring to in lupus and other autoimmune settings, which we are now obviously pursuing together with them. But that is one of the reasons why we were excited about turning the collaboration into a situation where we brought all the expertise and the scientists and leadership from 2seventy in-house. Because we're doing exactly what you suggested. We're hoping to actually

George D. Yancopoulos: You know, that's a phenomenal question. And first of all, let me remind you that with our long-term collaboration and recent acquisition of 2seventy, 2seventy had exactly the sort of CAR-T programs that you're referring to in lupus and other autoimmune settings, which we are now obviously pursuing together with them. But that is one of the reasons why we were excited about turning the collaboration into a situation where we brought all the expertise and the scientists and leadership from 2seventy in-house. Because we're doing exactly what you suggested.

George Yancopoulos: You know, that's a phenomenal question. And first of all, let me remind you that with a long-term collaboration and recent acquisition of 2seventy bio, 2seventy bio had exactly the sort of CAR-T programs that you're referring to, in lupus and other autoimmune settings, which we are now obviously pursuing together with them. But that is one of the reasons why we were excited about turning the collaboration into a situation where we brought all the expertise and the scientists and leadership, from 2seventy bio in-house, because we're doing exactly what you suggested. We're hoping to actually literally look in side-by-side studies, how CAR-T approaches in these settings of autoimmune, severe autoimmune diseases like lupus and so forth, compare directly head-to-head to our bispecifics.

Carter Gould: That expertise thank you.

George: And first of all, let me remind you that with our long-term collaboration and recent acquisition of 270, 270 had exactly the sort of CAR T programs that you're referring to in lupus and other autoimmune settings, which we are now obviously pursuing together with them. That is one of the reasons why we were excited about turning the collaboration into a situation where we brought all the expertise and the scientists and leadership from 270 in-house. Because we're doing exactly what you suggested. We're hoping to actually...

Speaker Change: A phenomenal question and first of all let me remind you that with our long term collaboration and recent acquisition of $2 $72 70 had exactly the sort of car T programs that youre, referring to in lupus and other autoimmune settings, which we are now on.

Speaker Change: Obviously pursuing together with them, but that is one of the reasons why we were excited about turning the collaboration into a situation, where we brought all the expertise and the scientist and leadership from $2 70 in house, because we're doing exactly what you suggested we are hoping to ask.

We're hoping to actually literally look at side-by-side studies how CAR-T approaches in these settings of autoimmune, severe autoimmune diseases like lupus and so forth, compare directly head-to-head to our bispecifics. And as you were sort of suggesting, you would think that there would be really little reason to think that the CAR-T solutions would be preferable in this setting, both in terms of off-the-shelfness and the ability to eliminate the normal cells. As I said, it's usually a lot easier to get rid of normal cells than it is malignant cells.

George: You literally look at side-by-side studies of CAR-T approaches in these settings of autoimmune, severe autoimmune diseases like lupus and so forth, and as you were sort of suggesting, you would think that there would be really little reason to think that CAR-T solutions would be preferable in this setting, both in terms of off-the-shelfness and the ability to eliminate normal cells. As I said, it's usually a lot easier to get rid of normal cells than it is malignant cells.

Carter Gould: <unk>.

Carter Gould: Literally look in side by sides studies, how car T approaches in these settings of autoimmune severe autoimmune diseases like lupus and self-worth compare directly head to head to our bi specifics and as you are sort of suggesting you would think.

George Yancopoulos: And as you were sort of suggesting, you would think that there would be really little reason to think that the CAR-T solutions would be preferable in this setting, both in terms of off-the-shelfness and the ability to eliminate the normal cells. As I said, it's usually a lot easier to get rid of normal cells than it is malignant cells. So whatever advantages you might have in certain settings of CAR-Ts, you would think in the normal disease settings, or at least normal cells in autoimmune disease settings, that bispecifics might be just as good, much more convenient, and much safer. So together with now our internal Regeneron Cell Medicines group that has involved a lot of the expertise and leadership of 2seventy bio, we're exploring that exact question.

And as you were sort of suggesting, you would think that there would be really little reason to think that the CAR-T solutions would be preferable in this setting, both in terms of off-the-shelfness and the ability to eliminate the normal cells. As I said, it's usually a lot easier to get rid of normal cells than it is malignant cells. So whatever advantages you might have in certain settings of CAR-Ts, you would think in the normal disease settings, or at least normal cells in autoimmune disease settings, that bispecifics might be just as good, much more convenient, and much safer. So together with now our internal Regeneron Cell Medicines group that has involved a lot of the expertise and leadership of 2seventy bio, we're exploring that exact question.

Carter Gould: That there would be really little reason to think that the car T solutions would be preferable in this setting both in terms of off the shelf newness and the ability to eliminate the normal cells. As I said, it's usually a lot easier to get rid of normal cells and it is malignant cells. So whatever advantages you might have.

George: So whatever advantages you might have in certain settings of CAR-Ts, you would think in the normal disease settings, or at least normal cells in autoimmune disease settings, that bispecifics might be just as good, much more convenient, and much safer. So, together with, now, our internal Regeneron cell medicines group that has involved a lot of the expertise and leadership of 2seventy, we're exploring that exact question. I should also say that, as clearly been announced by the company and is available in our public disclosures, we have already initiated separately, a variety of studies looking at our bispecifics to decrease autoantibodies and autoimmune diseases in other settings as well. So, we were already looking at this but, now, we're looking at these in direct comparison to our CAR-T approaches with our, now, internal Regeneron cell medicines efforts.

So whatever advantages you might have in certain settings of CAR-Ts, you would think in the normal disease settings, or at least normal cells in autoimmune disease settings, that bispecifics might be just as good, much more convenient, and much safer. So, together with, now, our internal Regeneron cell medicines group that has involved a lot of the expertise and leadership of 2seventy, we're exploring that exact question.

Carter Gould: Having certain settings of car Ts you would think in the normal disease setting or at least normal cells in autoimmune disease settings that bi specifics might be just as good much more convenient and much safer so together with now our internal.

I should also say that, as clearly been announced by the company and is available in our public disclosures, we have already initiated separately, a variety of studies looking at our bispecifics to decrease autoantibodies and autoimmune diseases in other settings as well. So, we were already looking at this but, now, we're looking at these in direct comparison to our CAR-T approaches with our, now, internal Regeneron cell medicines efforts.

Carter Gould: Regeneron cell medicines group that has involved a lot of the expertise leadership with $2 70 were exploring that exact question I should also say that as.

George Yancopoulos: I should also say that has clearly been announced by the company and is available in our public disclosures, we have already initiated separately a variety of studies looking at our bispecifics to decrease autoantibodies and autoimmune diseases in other settings as well. So we were already looking at this, but now we're looking at these in direct comparison to our CAR-T approaches with our now internal Regeneron Cell Medicines efforts.

I should also say that has clearly been announced by the company and is available in our public disclosures, we have already initiated separately a variety of studies looking at our bispecifics to decrease autoantibodies and autoimmune diseases in other settings as well. So we were already looking at this, but now we're looking at these in direct comparison to our CAR-T approaches with our now internal Regeneron Cell Medicines efforts.

George: So, we have clearly been announced by the company and is available in our public disclosures. We have already initiated separately a variety of studies looking at our bi-specifics to decrease autoantibodies and autoimmune diseases in other settings as well. So, we were already looking at this, but now we're looking at these in direct comparison.

Carter Gould: Clearly been announced by the company and is available in our public disclosures, we have already initiated separately.

Carter Gould: Alrighty of studies looking at our bi specifics to decrease auto antibodies in autoimmune diseases in other settings as well. So we were already looking at this but now we're looking at these in direct comparison to our car T approaches.

Speaker Change: With our now internal regeneron cell medicines efforts. Okay. Thank you George next question. Please.

Ryan Crowe: Okay. Thank you, George. Next question, please.

Ryan Crowe: Okay, thank you, George. Next question, please.

Operator: Thank you. One moment for questions. Our next question comes from Brian Abrahams with RBC Capital Markets. You may proceed.

Speaker Change: Thank you one moment for questions.

Brian Abrahams: Hi, good morning. Thanks for taking my question and congrats on all the progress. I know docs are really excited for DUPI in COPD but it is a new space for biologics. So, I'm curious the amount of education you think is going to be required and how this might affect the initial uptake trajectory? And then, how you're thinking the introduction of other biologics, which have also been showing promise, might impact the overall long-term market here and DUPI's positioning. Thanks.

Speaker Change: Our next question comes from Brian Abrahams with RBC capital markets. You May proceed.

Brian Abrahams: Hi, good morning. Thanks for taking my question, and congrats on all the progress. I know docs are really excited for Dupixent and COPD, but it is a new space for biologics. So I'm curious the amount of education you think is going to be required and how this might affect the initial uptake trajectory, and then how you're thinking the introduction of other biologics, which have also been showing promise, might impact the overall long-term market, here and Dupixent's positioning. Thanks.

Brian Corey Abrahams: Hi, Good morning, Thanks for taking my question and congrats on all the progress I know docs are really excited for <unk> in COPD, but is a new space for biologic. So I'm curious the amount of education, you think is going to be required and how this might affect the initial uptake trajectory and then how youre thinking the introduction of other biologics, which have also been showing promise might impact the overall long term.

Speaker Change: Market here and to be positioning thanks.

unknown: So, certainly, we look forward to the potential launch of DUPIXENT in COPD. There's such unmet need and such opportunity to help those patients with eosinophilic COPD. Our team, as you know, is very experienced with launches in DUPIXENT so, work is very much underway at Regeneron and also, obviously, in our collaboration with Sanofi to make sure that we apply the best practices in launch of new indications. I will share that many of these physicians have already experienced use of DUPIXENT with tremendous results. We've made great progress, as you know, in asthma, leading in new scripts and certainly making tremendous overall performance strides. But we will be very thoughtful on how best to reach physicians, how to make sure that we're aligned with reimbursement and affordability for patients, educating in the way we've come to understand is best for DUPIXENT and the various markets and indications that we've entered. So, we look forward to this opportunity.

Marion McCourt: So, certainly, we look forward to the potential launch of DUPIXENT in COPD. There's such unmet need and such opportunity to help those patients with eosinophilic COPD. Our team, as you know, is very experienced with launches in DUPIXENT so, work is very much underway at Regeneron and also, obviously, in our collaboration with Sanofi to make sure that we apply the best practices in launch of new indications. I will share that many of these physicians have already experienced use of DUPIXENT with tremendous results.

Marion McCourt: So certainly, you know, we look forward to the potential launch of Dupixent in COPD. There's such unmet need and such opportunity to help those patients with an eosinophilic COPD. Our team, as you know, is very experienced with launches in Dupixent, so work is very much underway at Regeneron and also with, obviously, under our collaboration with Sanofi, to make sure that, you know, we apply the best practices in launch of new indications. I will share that many of these physicians have already experienced use of Dupixent with tremendous results. We've made great progress, as you know, in asthma, leading in new scripts and certainly making tremendous overall performance strides.

Speaker Change: So certainly.

Speaker Change: We look forward to the potential launch of <unk> in COPD. There is such an unmet need in such opportunity to help those patients with <unk> and as soon as Delek.

Speaker Change: COPD our team as you know is very experienced with launches <unk>. So work is very much underway at regeneron and also with obviously under our collaboration with Sanofi to make sure that we apply the best practices and the launch of new indications I will share that many of these.

unknown: I will share that many of these physicians have already experienced the use of Dupixent with tremendous results. We've made great progress, as you know, in asthma, leading in new scripts, and certainly making tremendous overall performance strides. But we will be very thoughtful about how best to reach physicians, how to make sure that we're aligned with reimbursement and affordability for patients, and education in the way we've come to understand is best for Dupixent and the various markets and indications that we've entered. So we look forward to this opportunity. Okay.

We've made great progress, as you know, in asthma, leading in new scripts and certainly making tremendous overall performance strides. But we will be very thoughtful on how best to reach physicians, how to make sure that we're aligned with reimbursement and affordability for patients, educating in the way we've come to understand is best for DUPIXENT and the various markets and indications that we've entered. So, we look forward to this opportunity.

Speaker Change: <unk> have already experienced.

Speaker Change: Kicks in with tremendous results, we've made great progress as you know in asthma, leading in new scripts, and certainly making tremendous overall performance strides, but we will be very thoughtful on how best to reach physicians how to make sure that we're aligned with reimbursement and affordability for patients.

Marion McCourt: But we will be very thoughtful on how best to reach physicians, how to make sure that we're aligned with reimbursement and affordability for patients, educating in the way we've come to understand is best for Dupixent in the various markets and indications that we've entered. So we look forward to this opportunity.

Speaker Change: <unk> in the way we've come to understand his desk for detection in the various markets and indications that we've entered so we look forward to this opportunity.

Ryan Crowe: Okay. I think we have time for two more questions.

Speaker Change: Well I think we have time for two more questions.

Operator: Thank you. One moment for questions. Our next question comes from Mohit Bansal with Wells Fargo. You may proceed.

Speaker Change: Thank you.

Speaker Change: One moment for questions.

Speaker Change: Our next question comes from Mohit Bansal with Wells Fargo. You May proceed.

Mohit Bansal: Great. Thank you very much for taking my question. I have a question on Itopekimab. So in our conversation and literature search, it suggests that there may be a potential for disease modification with some kind of airway remodeling of this mechanism. Just wanted to see if you, you think that is possible, and what markers would you be looking forward to in the phase 3 trial beyond exacerbation, when the data comes? Thank you.

Mohit Bansal: Great. Thank you very much for taking my question I have a question on banking that so in our conversation and literature suggests that they may be.

Mohit Bansal: Potential for disease modification with some kind of <unk> modeling of this mechanism.

Mohit Bansal: Just wanted to see if you think that is possible and what markets would you be looking forward to the phase III trial beyond makes reservation when the data com. Thank you.

unknown: Great. Well, there's always the possibility of disease modification. We actually believe, for example, pixen and asthma may be doing exactly that sort of benefit. One of the best ways of actually looking at that is looking at overall loss of lung function over time. Because, as you know, in these lung diseases, as Marion said, in both asthma and COPD, these are diseases of the lungs followed largely by pulmonologists, the same sort of doctors.

Mohit Bansal: Great. Thank you very much for taking my question. I have a question on ITEPEKIMAB. So, in our conversation and literature search, it suggests that there may be a potential for disease modification with some kind of AAV modeling of this mechanism. Just wanted to see if you think that is possible? And what markers would you be looking forward to in the Phase III trial beyond exacerbation when the data comes? Thank you.

George Yancopoulos: Well, there's always the possibility of disease modification. We actually believe, for example, Dupixent and asthma may be doing exactly that, sort of benefit. One of the best ways of actually looking at that is looking at overall loss of lung function over time, because as you know, in these lung diseases, as Marianne said, in both asthma and COPD, these are diseases of the lungs followed largely by pulmonologists, the same sort of doctors. And it is well known that in both of these diseases, over time, patients start permanently losing lung capacity and lung function.

Well, there's always the possibility of disease modification. We actually believe, for example, DUPIXENT in asthma may be doing exactly that sort of benefit. One of the best ways of actually looking at that is looking at overall loss of lung function over time. Because as you know, in these lung diseases -- as Marion said -- in both asthma and COPD, these are diseases of the lungs followed largely by pulmonologists, the same sort of doctors. And it is well known that in both of these diseases, over time, patients start permanently losing lung capacity and lung function. We are and have been and have early data suggesting that DUPIXENT may prefer that in asthma and we'll certainly be looking at those sorts of things for, not only DUPIXENT but ITEPEKIMAB in COPD patients, in terms of modifying disease and long-term preservation and prevention of this otherwise unstoppable lung function loss.

George D. Yancopoulos: Well, there's always the possibility of disease modification. We actually believe, for example, DUPIXENT in asthma may be doing exactly that sort of benefit. One of the best ways of actually looking at that is looking at overall loss of lung function over time. Because as you know, in these lung diseases -- as Marion said -- in both asthma and COPD, these are diseases of the lungs followed largely by pulmonologists, the same sort of doctors. And it is well known that in both of these diseases, over time, patients start permanently losing lung capacity and lung function.

Speaker Change: Well, there's always the possibility of disease modification.

Speaker Change: We actually believe for example, do picks in an asthma may be doing exactly that sort of benefit.

Speaker Change: One of the best ways of actually looking at that is looking at overall loss of lung function over time, because as you know in these lung diseases.

Speaker Change: Marion said in both asthma and COPD. These are diseases lungs, followed largely by Pulmonologists, the same sort of doctors and it is well known that in both of these diseases overtime patients start permanently losing lung capacity in lung function, we are and have been and have early data suggesting.

unknown: And it is well known that in both of these diseases, over time, patients start permanently losing lung capacity and lung function. We are and have been and have early data suggesting that pixen may prefer that in asthma. And we'll certainly be looking at those sorts of things for not only pixen, but picumab in COPD patients in terms of modifying the disease and long-term preservation and prevention of this otherwise unstoppable lung function loss.

George Yancopoulos: We are, and have been, and have early data suggesting that Dupixent may prefer that in asthma, and we'll certainly be looking at those sorts of things for not only Dupixent, but Itopekimab, in the COPD patients in terms of modifying disease and long-term preservation and prevention of this otherwise, unstoppable lung function loss.

We are, and have been, and have early data suggesting that Dupixent may prefer that in asthma, and we'll certainly be looking at those sorts of things for not only Dupixent, but Itopekimab, in the COPD patients in terms of modifying disease and long-term preservation and prevention of this otherwise, unstoppable lung function loss.

We are and have been and have early data suggesting that DUPIXENT may prefer that in asthma and we'll certainly be looking at those sorts of things for, not only DUPIXENT but ITEPEKIMAB in COPD patients, in terms of modifying disease and long-term preservation and prevention of this otherwise unstoppable lung function loss.

Speaker Change: Two picks and may prefer that in asthma, and we'll certainly be looking at those sorts of things for not only do picks and put it to pick a mab.

Speaker Change: The COPD patients in terms of modifying disease, and long term preservation and prevention of this otherwise.

Speaker Change: Unstoppable lung function loss.

unknown: Okay. Last question, please, Josh. Thank you. One moment for our last question. And our last question comes from Chris Schott with J.P. Morgan. Hi, this is Taylor. I'm on behalf of Chris Schott. Thanks.

Ryan Crowe: Okay. Last question, please, Josh.

Ryan Crowe: Okay. Last question, please. Josh?

Thank you. One moment for our last question. And our last question comes from Chris Schott with J.P. Morgan. Hi, this is Taylor. I'm on behalf of Chris Schott. Thanks.

Operator: Thank you. One moment for our last question. And our last question comes from Chris Schott with J.P. Morgan. You may proceed.

Speaker Change: Okay last question please Josh.

Operator: Thank you. One moment for our last question. Our last question comes from Chris Schott with J.P. Morgan. You may proceed.

Unknown: Hi. This is Taylor, on for Chris Schott. Thanks for taking our question. So, we were wondering, would you be able to elaborate a little bit more about how you're thinking about the LINVOSELTAMAB launch as we approach the August PDUFA? And then, thinking about the field more broadly in myeloma, how are you thinking about MRD negativity as a surrogate? And thoughts on how you might be able to move into earlier lines in myeloma faster? Thank you.

unknown: One moment for our last question, and our last question comes from Chris Schott with J.P. Morgan. Please proceed.

Josh: Thank you.

Speaker Change: One moment for our last question.

Speaker Change: Okay.

Speaker Change: Last question comes from Chris Schott with Jpmorgan you May proceed.

[Analyst] (J.P. Morgan): Hi, this is Taylor on for Chris Schott. Thanks for taking our question. So we were wondering, would you be able to elaborate a little bit more about how you're thinking about the Linvoseltumab launch as we approach the August PDUFA? And then thinking about the field more broadly in myeloma, how are you thinking about MRD negativity as a surrogate, and thoughts on how you might be able to move into earlier lines in myeloma faster? Thank you.

[Analyst] (JPMorgan): Hi, this is Taylor on for Chris Schott. Thanks for taking our question. So we were wondering, would you be able to elaborate a little bit more about how you're thinking about the Linvoseltumab launch as we approach the August PDUFA? And then thinking about the field more broadly in myeloma, how are you thinking about MRD negativity as a surrogate, and thoughts on how you might be able to move into earlier lines in myeloma faster? Thank you.

Speaker Change: Hi, This is Taylor on for Chris Schott.

Taylor: Thanks for taking our question. So we were wondering would you be able to elaborate a little bit more about how youre thinking about the limbus allomap.

Taylor: Launch as we approach the August producer.

Taylor: And then thinking about the sales more broadly in myeloma, how are you thinking about embarking negativity as a surrogate.

Taylor: Thoughts on how you might be able to move into earlier lines in myeloma faster.

Leonard S. Schleifer: Marion can take the question on the launch and everything. I mean, obviously, the MRD negativity as endorsed by that panel, gives an opportunity to get these kinds of drugs to patients earlier in a variety of settings. So, we're looking forward to applying that approach in our future studies as we move towards earlier and different lines of therapy. Marion, on the launch?

George Yancopoulos: Marianne can, Marianne can take the question on the launch and everything. I mean, obviously the MRD negativity, as endorsed by that panel, it gives an opportunity to get these kinds of drugs to patients earlier in a variety of settings. So, we are looking forward to applying that approach in our future studies as we move towards earlier and different lines of therapy. Marianne, on the launch?

Taylor: Mary Mary can take the question on the launch and everything I mean, obviously, the <unk> negativity as endorsed by that panel.

Mary: It gives an opportunity to get.

Mary: These kinds of drugs to patients earlier in a variety of settings. So we're looking forward to applying that approach in our future studies as we move towards earlier in different lines of therapy Mariner launch sure. So.

Marion McCourt: Sure. So, we're certainly preparing for the potential launch with the August 22nd PDUFA date. And we're really excited because, as I've mentioned before, the recent data reinforces LINVOSELTAMAB as potentially a best-in-class product for late-stage myeloma patients. So, it's a wonderful opportunity to extend our oncology franchise in the new disease area.

Marion McCourt: Sure. So we, you know, we're certainly preparing for the potential launch with the 22 August PDUFA date, and we're really excited because, you know, as I'd mentioned before, the recent data reinforces Linvoseltumab as potentially a best-in-class product for late-stage myeloma patients. So it's a wonderful opportunity to extend our oncology franchise in a new disease area.

Mary: We're certainly preparing for the potential launch for August 22nd producer date, and we're really excited because as I had mentioned before the recent data reinforces Linda sells mab as potentially a best in class product.

Mary: For late stage myeloma patients.

Mary: As a wonderful opportunity to extend our oncology franchise and the new disease area.

unknown: Alright. Thanks, Lenn and Marion. And thanks to everyone who dialed in for your interest in Regeneron. We apologize to those remaining in the queue that we did not have a chance to hear from. As always, the IR team here at Regeneron is available to answer any remaining questions that you may have. Thank you once again and have a great day. Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.

Ryan Crowe: Alright. Thanks, Lenn and Marion. And thanks to everyone who dialed in for your interest in Regeneron. We apologize to those remaining in the queue that we did not have a chance to hear from. As always, the IR team here at Regeneron is available to answer any remaining questions that you may have. Thank you once again and have a great day.

Ryan Crowe: All right. Thanks, Len and Marion, and thanks to everyone who dialed in for your interest in Regeneron. We apologize to those remaining in the queue that we did not have a chance to hear from. As always, the IR team here at Regeneron is available to answer any remaining questions that you may have. Thank you once again, and have a great day.

Speaker Change: Alright, Thanks, a lot and Marion and thanks to everyone, who dialed in for your interest in Regeneron and we apologize to those remaining in the queue that we did not have a chance to hear from as always the IR team here at Regeneron is available to answer any remaining questions that you may have thank you once again and have a great day.

unknown: Thank you once again, and have a great day. Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.

Operator: Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.

unknown: Thank you. This concludes the conference. Thank you for your participation. You may now disconnect. And now the moon gets the biggest and brightest supernatural delight. Every photo is dancing in the moonlight. Everybody here is out of sight. But they don't bark, and they don't bite. They keep things loose, they keep things alight.

Operator: Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.

Speaker Change: Thank you this concludes.

Speaker Change: The conference. Thank you for your participation you may now disconnect.

Mary: [music].

Mary: Yes.

Mary: [music].

Operator: We get it almost every night. When that moon gets big and bright, it's a supernatural delight. Everybody was dancing in the moonlight. Everybody here is out of sight, but they don't bark, and they don't bite. They keep things loose, they keep things light. Every...

Mary: Got it.

unknown: And now the moon gets the biggest and brightest supernatural delight. Every photo is dancing in the moonlight. Everybody here is out of sight. But they don't bark, and they don't bite. They keep things loose, they keep things alight.

Mary: Fair enough.

Mary: And when that are moving against us.

Mary: And then thirdly.

Mary: Joe.

Mary: Auto was down.

Mary: Okay.

Mary: Yes.

Mary: [music], Yeah robotics is key.

Mary: Key here is that a side bar.

Mary: A R E.

Mary: Okay.

Mary: To keep things alive.

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