Q2 2024 Incyte Corp Earnings Call

July 30, 2024

Operator: Good morning and welcome to the Incyte Second Quarter 2024 Earnings Conference Call. If anyone should require operator assistance, please press star-zero on your telephone keypad. A question and answer session will follow the formal presentation. In the interest of time, may I ask you to please limit yourselves to one question? You may be placed in the question queue at any time by pressing star-1 on your telephone keypad. As a reminder, this conference is being recorded.

Hello, and welcome to the insight second quarter 2024 earnings conference call. If anyone should require operator assistance. Please press star zero on your telephone keypad.

Operator: A question and answer session will follow the formal presentation. In the interest of time, may I ask you to please limit yourselves to one question? You may be placed into the question queue at any time by pressing star 1 on your telephone keypad.

A question and answer session will follow the formal presentation.

In the interest of time, we ask you. Please limit yourself to one question you may be placed into question queue at any time by pressing star one on your telephone keypad.

As a reminder, this conference is being recorded.

It's now my pleasure to turn the conference over to finish trained associate Vice President of Investor Relations. Please go ahead Ben.

Operator: As a reminder, this conference is being recorded. It's now my pleasure to turn the conference over to Ben Strain, Associate Vice President of Investor Relations. Please go ahead, Ben. Thank you, Kevin. Good morning, and welcome to Incyte's second quarter 2024 earnings conference call.

As a reminder, this conference is being recorded. It's now my pleasure to turn the conference over to Ben Strain, Associate Vice President of Investor Relations. Please go ahead, Ben.

As a reminder, this conference is being recorded.

It's now my pleasure to turn the conference over to Ben Strain, Associate Vice President of Investor Relations. Please go ahead, Ben.

Thank you Kevin Good morning, and welcome to insight second quarter 2024 earnings conference call before we begin I encourage everyone to go to the investors section of our website to find the press release related financial tables and slides that follow today's discussion on today's call I'm joined by Irving Pablo and Christiana, who will deliver our prepared remarks.

Ben Strain: Thank you, Kevin. Good morning, and welcome to Incyte's Second Quarter 2024 Earnings Conference Call. Before we begin, I encourage everyone to go to the investor section of our website to find the press release, related financial tables and slides that will follow today's discussion. On today's call, I'm joined by Hervé, Pablo and Christiana, who will deliver our prepared remarks. Barry, Steven and Matteo will also be available for Q&A. I would like to point out that we'll be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC files for additional details. I will now turn the call over to Herve. Thank you, Barry.

Ben Strain: Thank you, Kevin. Good morning and welcome to Incyte's Second Quarter 2024 Earnings Conference Call. Before we begin, I encourage everyone to go to the investor section of our website to find the press release, related financial tables and slides that follow today's discussion. On today's call, I'm joined by Hervé, Pablo and Christiana, who will deliver our prepared remarks. Barry, Steven and Matteo will also be available for Q&A.

Ben Strain: Before we begin, I encourage everyone to go to the investor section of our website to find the press release, related financial tables, and slides that will follow today's discussion.

Ben Strain: Before we begin, I encourage everyone to go to the investor section of our website to find the press release, related financial tables and slides that will follow today's discussion. On today's call, I'm joined by Hervé, Pablo and Christiana, who will deliver our prepared remarks. Barry, Steven and Matteo will also be available for Q&A. I would like to point out that we'll be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC files for additional details. I will now turn the call over to Herve. Thank you, Barry.

Ben Strain: Before we begin, I encourage everyone to go to the investor section of our website to find the press release, related financial tables and slides that follow today's discussion. On today's call, I'm joined by Hervé, Pablo and Christiana, who will deliver our prepared remarks. Barry, Steven and Matteo will also be available for Q&A.

Ben Strain: On today's call, I'm joined by Herve, Pablo, and Christiana, who will deliver our prepared remarks.

Ben Strain: will deliver our prepared remarks. Barry, Steven, and Matteo will also be available for Q&A.

Barry Steven and Matteo will also be available for Q&A.

Ben Strain: I would like to point out that we'll be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC files for additional detail.

Ben Strain: I would like to point out that we'll be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC files for additional details. I will now turn the call over to Herve. Thank you, Barry.

I would like to point out that we'll be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC files for additional details.

I would like to point out that we'll be making forward looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties and our actual results may differ materially I encourage you to consult the risk factors discussed in our SEC filings for additional detail I will now turn the call over to Irving.

Ben Strain: I will now turn the call over to Herve. Thank you, Barry.

Ben Strain: I will now turn the call over to Hervé.

I will now turn the call over to Herve. Thank you, Barry.

Ben Strain: Thank you, Barry.

Hervé Hoppenot: Thank you, Ben and good morning, everyone. So, during the second quarter of 2024, we made significant progress across the business; with strong performance on the commercial side, driven by JAKAFI and OPZELURA; transformation of our pipeline, where we made important decisions on our clinical program and capital allocation, where we closed the Escient acquisition and completed the large-share repurchase. Looking at Q2 revenue--total revenue grew 9% year-over-year, exceeding $1 billion, while net product revenue grew 10% driven by the continued success of JAKAFI and OPZELURA, which I will detail in the following slide.

Hervé Hoppenot: Thank you, Ben and good morning, everyone.

Thank you Ben and good morning, everyone.

Hervé Hoppenot: So, during the second quarter of 2024, we made significant progress across the business; with strong performance on the commercial side, driven by JAKAFI and OPZELURA; transformation of our pipeline, where we made important decisions on our clinical program and capital allocation, where we closed the Escient acquisition and completed the large-share repurchase. Looking at Q2 revenue--total revenue grew 9% year-over-year, exceeding $1 billion, while net product revenue grew 10% driven by the continued success of JAKAFI and OPZELURA, which I will detail in the following slide. We continue to make strategic decisions that are transforming our clinical pipeline, and during the second quarter, we closed the acquisition of H&M Pharmaceuticals, which added two first-in-class medicines to our IAI portfolio. Additionally, we are intensifying our focus on and concentrating resources on those highest potential programs that have the largest impact for patients and for individuals. We also recently completed a large $2 billion share return. Further highlighting our excitement and conviction in our clinical pipeline and commercial business while retaining a strong balance sheet for potential further business development activities. Over the last 12 months, our clinical pipeline has significantly advanced, and we are on track to deliver a number of best-in-class and or first-in-class differentiated medicines in areas where there are no or limited treatment options. When comparing our pipeline today, on slide six, to where we were just seven months ago, we have added potentially transformative clinical programs, including KRAS G12D, TGS-Beta PD-1, MRG PRX2 and X4, and we have deprioritized some of the immuno-oncology programs, including TIM-3 and LAC-3 antibodies, LAC-3 PD-1 bi-specific, and the oral PD- Pablo will describe this pipeline transformation in some detail and will provide clarity on the potential timing of data availability.

So during the second quarter of 'twenty 'twenty four we made significant progress across the business with strong performance on the commercial side driven by Jack if I understood well.

Transformation of our pipeline, where we made important decision on our clinical programs.

And capital allocation, where we closed it sounds acquisition and completed the lions share repurchase.

Looking at Q2 revenue total revenue grew 9% year over year exceeding Wednesday, then why isn't net product revenue grew 10% driven by the continued success of Jakafi, you end up sidra, which I will detail in the following slides.

Hervé Hoppenot: We continue to make strategic decisions that are transforming our clinical pipeline and during the second quarter, we closed the acquisition of Escient Pharmaceuticals--which added two first-in-class medicines to our IAI portfolio. Additionally, we are intensifying our focus on and concentrating resources on those highest potential program which have the largest impact for patients and for Incyte. We also recently completed a large, $2 billion share repurchase, further highlighting our excitement and conviction in our clinical pipeline and commercial business while retaining a strong balance sheet for potential further business development activities. Over the last 12 months, our clinical pipeline has significantly advanced and we are on track to deliver a number of best-in-class and/or first-in-class differentiated medicines in areas where there are no or limited treatment options. When comparing our pipeline today--on slide six--to where we were just seven months ago, we have added potentially transformative clinical programs--including KRASG12D, TGFß PD-1, MRGPRX2 and X4 and we have deprioritized some of the immuno-oncology programs, including TIM-3 and LAG-3 antibodies, LAG-3/PD-1 bispecific and the oral PD-1 program. Pablo will describe this pipeline transformation in some details and will provide clarity on the potential timing of data availability.

Herve Hoppenot: We continue to make strategic decisions that are transforming our clinical pipeline, and during the second quarter, we closed the acquisition of H&M Pharmaceuticals, which added two first-in-class medicines to our IAI portfolio. Additionally, we are intensifying our focus on and concentrating resources on those highest potential programs that have the largest impact for patients and for individuals. We also recently completed a large $2 billion share return. Further highlighting our excitement and conviction in our clinical pipeline and commercial business while retaining a strong balance sheet for potential further business development activities. Over the last 12 months, our clinical pipeline has significantly advanced, and we are on track to deliver a number of best-in-class and or first-in-class differentiated medicines in areas where there are no or limited treatment options. When comparing our pipeline today, on slide six, to where we were just seven months ago, we have added potentially transformative clinical programs, including KRAS G12D, TGS-Beta PD-1, MRG PRX2 and X4, and we have deprioritized some of the immuno-oncology programs, including TIM-3 and LAC-3 antibodies, LAC-3 PD-1 bi-specific, and the oral PD- Pablo will describe this pipeline transformation in some detail and will provide clarity on the potential timing of data availability.

We continue to make strategic decisions about transforming our clinical pipeline and during the second quarter. We closed the acquisition of ascend pharmaceutical which added two first in class medicine into a well portfolio.

Hervé Hoppenot: Pharmaceuticals, which added two first-in-class medicines to our IAI portfolio. Additionally, we are intensifying our focus on and concentrating resources on those highest potential programs that have the largest impact for patients and for individuals. We also recently completed a large $2 billion share return. Further highlighting our excitement and conviction in our clinical pipeline and commercial business while retaining a strong balance sheet for potential further business development activities. Over the last 12 months, our clinical pipeline has significantly advanced, and we are on track to deliver a number of best-in-class and or first-in-class differentiated medicines in areas where there are no or limited treatment options. When comparing our pipeline today, on slide six, to where we were just seven months ago, we have added potentially transformative clinical programs, including KRAS G12D, TGS-Beta PD-1, MRG PRX2 and X4, and we have deprioritized some of the immuno-oncology programs, including TIM-3 and LAC-3 antibodies, LAC-3 PD-1 bi-specific, and the oral PD- Pablo will describe this pipeline transformation in some detail and will provide clarity on the potential timing of data availability.

Additionally, we are intensifying our focus on and concentrating our resources on those high potential program, which has the largest impact felt based on Sunshine site.

We also recently completed a large $2 billion share repurchase further highlighting our excitement and conviction in our clinical pipeline and commercial business why to retaining a strong balance sheet for potential business development activities.

Herve Hoppenot: Further highlighting our excitement and conviction in our clinical pipeline and commercial business while retaining a strong balance sheet for potential further business development activities. Over the last 12 months, our clinical pipeline has significantly advanced, and we are on track to deliver a number of best-in-class and or first-in-class differentiated medicines in areas where there are no or limited treatment options. When comparing our pipeline today, on slide six, to where we were just seven months ago, we have added potentially transformative clinical programs, including KRAS G12D, TGS-Beta PD-1, MRG PRX2 and X4, and we have deprioritized some of the immuno-oncology programs, including TIM-3 and LAC-3 antibodies, LAC-3 PD-1 bi-specific, and the oral PD- Pablo will describe this pipeline transformation in some detail and will provide clarity on the potential timing of data availability.

Hervé Hoppenot: Over the last 12 months, our clinical pipeline has significantly advanced and we are on track to deliver a number of best-in-class and/or first-in-class differentiated medicines in areas where there are no or limited treatment options. When comparing our pipeline today--on slide six--to where we were just seven months ago, we have added potentially transformative clinical programs--including KRASG12D, TGFß PD-1, MRGPRX2 and X4 and we have deprioritized some of the immuno-oncology programs, including TIM-3 and LAG-3 antibodies, LAG-3/PD-1 bispecific and the oral PD-1 program. Pablo will describe this pipeline transformation in some details and will provide clarity on the potential timing of data availability. Moving to Sprite Fever, Jakarta's net product revenues were 706 million, 3% year-over-year, and page demand increased 9%. As a reminder, the second quarter of 2023 benefited by approximately 37 million from Channel Inventory, which explains the 3% growth of net sales versus the 9% growth of actual sales. Based on the strength in demand seen during the first half of the year and anticipated growth for the balance of the year, we are raising the bottom end of our full year 2024 Jakarta Inlet Revenue Guidance to a new range of $2.71 billion to $2.75 billion. As you can see, unit growth continues to be strong.

Well those are last 12 months, our clinical pipeline has significantly advanced and we are on track to deliver on a number of best in class and first in class differentiated medicines in areas, where there are no or limited treatment options.

Compelling pipeline today on slide six where we have just seven months ago.

We have added potentially transformative clinical programs, including <unk> 12 D to just bid a PD one.

<unk> GP, Alex two in explorer and we have de prioritized some of the immuno oncology programs, including Tim three and lag three antibodies luxury PD one by specific kinds of all the PDL one program.

Pablo would you describe the pipeline transformation and some details and we'll provide clarity on the potential timing of data availability.

Herve Hoppenot: Moving to Sprite Fever, Jakarta's net product revenues were 706 million, 3% year-over-year, and page demand increased 9%. As a reminder, the second quarter of 2023 benefited by approximately 37 million from Channel Inventory, which explains the 3% growth of net sales versus the 9% growth of actual sales. Based on the strength in demand seen during the first half of the year and anticipated growth for the balance of the year, we are raising the bottom end of our full year 2024 Jakarta Inlet Revenue Guidance to a new range of $2.71 billion to $2.75 billion. As you can see, unit growth continues to be strong.

Moving to slide seven.

Net product revenues were 706 million up 3% year over year.

Hervé Hoppenot: Moving to slide seven. JAKAFI net product revenues were $706 million, up 3% year-over-year. Paid demand increased 9%. As a reminder, the second quarter of 2023 benefited by approximately $37 million from channel inventory, which explains the 3% growth of net sales versus the 9% growth of actual demand. Based on the strength in demand seen during the first half of the year and anticipated growth for the balance of the year, we are raising the bottom end of our full year 2024 JAKAFI net revenue guidance to a new range of $2.71 billion to $2.75 billion. Turning to slide eight. As you can see, unit growth continues to be strong.

Speaker Change: Paid demand increased 9% as a reminder, the second quarter of 2023 benefited by approximately 37 million from channel inventory, which explains a 3% gross up net sales versus 9% growth.

Geordie Mark.

Geordie Mark: Based on the strength in demand seen during the first half of the year and anticipated growth for the balance of the year. We are raising the bottom end of our food Europe 2020 for Jakafi net revenue guidance to a new rounds of 2.7 do you 1 billion to $2 75 billion $2 71 to two.

75 billion.

Turning to slide eight and looking at Jakafi total paid demand by indication during the first quarter of 'twenty to 'twenty two 'twenty three 'twenty four as you can see unit growth continued to be strong and that is stable year over year with modest growth in this quarter and the largest growth coming from both.

Hervé Hoppenot: I'm looking at JAKAFI's total paid demand by indication during the first quarter of 2022, '23 and '24. As you can see, unit growth continues to be strong; MF is stable year-over-year, with modest growth in this quarter and the largest growth coming from both PV and GVHD. JAKAFI continues to maintain its leadership in MF. Based on market research, discontinuation rates have remained stable in the first-line setting over the past several months, with minimal impact on competitor. These trends have been consistent with our expectations. Moving to OPZELURA on slide nine. Total OPZELURA net product revenue in the second quarter were $122 million, up 52% when compared to the same quarter last year.

Herve Hoppenot: MS is stable year over year, with modest growth in this quarter, and the largest growth coming from both PV and GVA, and Jack Appiah continues to maintain its leadership in MS. Based on market research, discontinuation rates have remained stable in the first line selling over the past several months with minimal impacts on competitiveness. Transcribed by https://otter.ai, Moving to Obstetrics and Gynecology Total obstetrics and gynecology product revenues in the second quarter were $122 million, up 52% when compared to the same quarter last year.

PV and Gvhd.

Jakafi continues to maintain its leadership in MF based on market research discontinuation rates have remained stable in the first line setting although the past several months with minimal impact from competitors. These trends have been consistent with our expectations.

Moving to slide nine.

Hervé Hoppenot: Total OPZELURA net product revenue in the second quarter were $122 million, up 52% when compared to the same quarter last year. The weekly prescription trend, as shown on the right of slide 9, reflects continued growth of OPZELURA in both atopic dermatitis and vitiligo and U.S. total prescriptions for OPZELURA grew 34% year-over-year, while refills grew 50% year-over-year. From an access perspective, we continue to see encouraging results since OPZELURA moved to earlier positions in certain commercial plans, demonstrating a positive impact to net sales, following the improved access. Moving to slide 10. During the second quarter, we made continuous progress on the re-endorsement of Obstetrics and Gynecology in Europe. Observer is now reimbursed in Germany, France, Italy, and Spain, and the 11 million in net sales during the second quarter were mostly driven by Germany and France. We expect Spain and Italy to start contributing to revenue beginning in. As shown on slide 11, Obstetrics and Gynecology was the first therapy to gain full reimbursement in France through a new process called Accedia. This process has accelerated patients' ability to obtain Obidora while pricing negotiations were ongoing and were reflected in the increase in revenues seen in Q2, and I will now turn the call over to Pablo.

Zero.

Revenue in the second quarter were $122 million up 52% when compared to the same quarter last year.

Herve Hoppenot: The weekly prescription trend, as shown on the right of slide 9, reflects continued growth of Optera in both Atopic Dermatitis and BC Ligo, and U.S. total prescriptions for Oxygorax grew 34% year-over-year, while refills grew 50% year-over-year. From an access perspective, we continue to see encouraging results since Optera moved to earlier positions in certain commercial plans, demonstrating a positive impact on net Moving to slide 10.

The weekly prescription trends are shown on the right of slide nine reflects continued growth of observed in both atopic dermatitis and vitiligo.

In U S total prescriptions for upsell doggie solid 12% yoga, Yeah, why are we still grew 50% year over year.

From an access perspective, we continued to see encouraging results in subzero I'm moved to Oreo position in southern commercial plans, demonstrating a positive impact to net sales.

Hervé Hoppenot: During the second quarter, we made continuous progress on the re-endorsement of OPZELURA in Europe. OPZELURA is now reimbursed in Germany, France, in Italy and Spain and the $11 million net sales during the second quarter were mostly driven by Germany and France. We expect Spain and Italy to start contributing to revenue beginning in Q3. As shown on slide 11, OPZELURA was the first therapy to gain full reimbursement in France through a new process called Accès Direct. This process has accelerated patients' ability to obtain OPZELURA while pricing negotiations were ongoing and were reflected in the increase in revenues seen in Q2. And I will now turn the call over to Pablo.

Geordie Mark: Following the improved access.

Herve Hoppenot: During the second quarter, we made continuous progress on the re-endorsement of Obstetrics and Gynecology in Europe. Observer is now reimbursed in Germany, France, Italy, and Spain, and the 11 million in net sales during the second quarter were mostly driven by Germany and France. We expect Spain and Italy to start contributing to revenue beginning in. As shown on slide 11, Obstetrics and Gynecology was the first therapy to gain full reimbursement in France through a new process called Accedia. This process has accelerated patients' ability to obtain Obidora while pricing negotiations were ongoing and were reflected in the increase in revenues seen in Q2, and I will now turn the call over to Pablo.

Yeah.

Moving to slide 10 during the second quarter, we made continued progress on the reimbursement of absurd right in Europe.

Zero is no reimbursed in Germany, France, Italy, and Spain, and 11 million in net sales during the second quarter were mostly driven by Germany, and France, We explain we expect Spain, and Italy to start contributing to revenue beginning in Q3.

Hervé Hoppenot: As shown on slide 11, OPZELURA was the first therapy to gain full reimbursement in France through a new process called Accès Direct. This process has accelerated patients' ability to obtain OPZELURA while pricing negotiations were ongoing and were reflected in the increase in revenues seen in Q2.

As shown on slide 11, the Sidra was the first therapy to gain reimbursement in France through a new process called <unk>.

This process has accelerated patients' ability to obtain absurdly high wide pricing negotiations are ongoing and were reflected in the increase in revenues in Q2.

Hervé Hoppenot: And I will now turn the call over to Pablo.

And then we know that on the Columbia to Pablo.

Pablo J. Cagnoni: Thank you, Hervé and good morning, everyone. Since joining Incyte one year ago, the R&D organization and I have been centered on accelerating the transformation of our pipeline to expand our leadership in treating patients with inflammatory diseases, MPNs, cancer and graft-versus-host disease, By harnessing a culture of rigorous decision-making, intense focus and excellence in execution, we have made considerable progress in advancing our goal of delivering best-in-class and/or first-in-class differentiated medicines in areas where there are no or limited treatment options.

Pablo J. Cagnoni: Thank you, Hervé and good morning, everyone.

Thank you Laura and good morning, everyone.

Pablo J. Cagnoni: Since joining Incyte one year ago, the R&D organization and I have been centered on accelerating the transformation of our pipeline to expand our leadership in treating patients with inflammatory diseases, MPNs, cancer and graft-versus-host disease. By harnessing a culture of rigorous decision-making, intense focus and excellence in execution, we have made considerable progress in advancing our goal of delivering best-in-class and/or first-in-class differentiated medicines in areas where there are no or limited treatment options.

Since joining inside one year ago, the R&D organization and I have been centered on accelerating the transformation of our pipeline to expand our leadership in treating patients with inflammatory diseases N P and cancer and graft versus host disease.

By harnessing our culture rigorous decision, making intense focused and excellence in execution. We have made considerable progress in advancing our goal of delivering best in class and or first in class differentiated medicines in areas, where there are no or limited treatment options.

Pablo J. Cagnoni: As a result, we anticipate delivering more than 10 high-impact launches by 2030, several of which are new molecular entities. As Hervé mentioned, we recently completed a strategic review of our pipeline to focus resources on programs with novel biology that hold the highest potential impact for patients. Based on available data, the evolving treatment landscape and the evolution of our internal pipeline, we have decided to discontinue a number of programs, including our oral PD-L1 programs, our LAG-3 monoclonal antibody program, our TIM-3 monoclonal antibody program and our LAG-3xPD-1 bispecific program. These data-driven decisions will enable us to fully realize the potential of our pipeline by delivering significant value to patients and our shareholders. With a strong sense of urgency, we plan to achieve a number of important clinical milestones in the coming months. We will advance the development of 12 new molecular entities and we will achieve up to 7 pivotal readouts as well as 8 readouts that will provide proof of concept in new indications for existing programs or for new molecular entities. In the next few slides, I will highlight a number of these programs.

As a result, we anticipate delivering more than 10 high impact launches by 2030, several of which are new molecular entities.

As already mentioned, we recently completed a strategic review of our pipeline to focus resources on programs with novel Biology that holds the highest potential impact for patients.

Based on available data the evolving treatment landscape and the evolution of our internal pipeline, we have decided to discontinue a number of programs, including our oral PD L. One programs are like three monoclonal antibody program, our Tim three monoclonal antibody program and our luxury by PD one by specific.

Pablo J. Cagnoni: These data-driven decisions will enable us to fully realize the potential of our pipeline by delivering significant value to patients and our shareholders. With a strong sense of urgency, we plan to achieve a number of important clinical milestones in the coming months. We will advance the development of 12 new molecular entities and we will achieve up to 7 pivotal readouts as well as 8 readouts that will provide proof of concept in new indications for existing programs or for new molecular entities. In the next few slides, I will highlight a number of these programs. In inflammation and autoimmunity, we continue to expand the breadth and novelty of our pipeline and expect to deliver multiple data sets beginning this year and beyond. We continue to evaluate the potential of rexalutinase cream and poversitinase across several new indications, including Pediatric Atopic Dermatitis, Prurigal Nodularis, Hyperadenitis Suprativa, Chronic Spontaneous Urticaria, and Asthma, with a recent acquisition of Essien Pharmaceuticals, we have added two potential first-in-class that aims to address a number of debilitating conditions, including chronic spontaneous urticaria, chronic inducible urticaria, atropic dermatitis, and cholestatic pruritus.

Program.

This data driven decisions will enable us to fully realize the potential of our pipeline by delivering significant value to patients and our shareholders.

Pablo J. Cagnoni: With a strong sense of urgency, we plan to achieve a number of important clinical milestones in the coming months. We will advance the development of 12 new molecular entities and we will achieve up to 7 pivotal readouts as well as 8 readouts that will provide proof of concept in new indications for existing programs or for new molecular entities. In the next few slides, I will highlight a number of these programs.

With a strong sense of urgency we plan to achieve a number of important clinical milestones in the coming months.

We will advance the development of 12, new molecular entities, and we will achieve up to seven pivotal readouts as well as eight readouts that will provide proof of concept and new indications for existing programs or for new molecular entities.

In the next few slides I will highlight a number of these programs.

In inflammation and autoimmunity, we continued to expand the breadth and novelty of our pipeline and expect to deliver multiple datasets beginning this year and beyond.

Pablo J. Cagnoni: In inflammation and autoimmunity, we continue to expand the breadth and novelty of our pipeline and expect to deliver multiple data sets beginning this year and beyond. We continue to evaluate the potential of RUXOLITINIB cream and POVORCITINIB across several new indications, including pediatric atopic dermatitis, prurigio nodularis, hydradenitis suppurativa, chronic spontaneous urticaria and asthma. With the recent acquisition of Escient Pharmaceuticals, we have added two potential first-in-class medicines that aims to address a number of debilitating conditions, including chronic spontaneous urticaria, chronic inducible urticaria, atopic dermatitis and cholestatic pruritus. We believe that with the introduction of these new medicines for this condition, we will see a greater number of patients seeking treatment who are currently underserved with available therapies or who are currently not receiving treatment. On slide 16, we continue to advance the development of RUXOLITINIB cream beyond AD and vitiligo to additional indications where it can provide significant value as either the first-ever FDA-approved therapy or first-approved topical therapy for patients living with these dermatologic conditions.

We continue to evaluate the potential of rux cream and but we're sitting here across several new indications, including pediatric atopic dermatitis perrigo inaugural Arris, hidradenitis, suppurativa chronic spontaneous urticaria and asthma.

Pablo J. Cagnoni: With the recent acquisition of Escient Pharmaceuticals, we have added two potential first-in-class medicines that aim to address a number of debilitating conditions, including chronic spontaneous urticaria, chronic inducible urticaria, atopic dermatitis and cholestatic pruritus. We believe that with the introduction of these new medicines for this condition, we will see a greater number of patients seeking treatment who are currently underserved with available therapies or who are currently not receiving treatment.

With our recent acquisition of asking in Pharmaceuticals, we have added two potential first in class medicines that aim to address and number of debilitating conditions, including chronic spontaneous urticaria chronic inducible urticaria, atopic dermatitis and call a static pruritus.

Pablo J. Cagnoni: We believe that with the introduction of these new medicines for this condition, we will see a greater number of patients seeking treatment who are currently underserved with available therapies or who are currently not receiving treatment. On slide 16, we continue to advance the development of RUXOLITINIB cream beyond AD and vitiligo to additional indications where it can provide significant value as either the first-ever FDA-approved therapy or first-approved topical therapy for patients living with these dermatologic conditions. Based on the positive Phase III data in pediatric atopic dermatitis, the supplementary NDA submission is on track to be filed in the third quarter of this year with a potential approval in 2025, which could provide an effective, non-steroidal topical option for the 2 to 3 million pediatric patients with AD in the U.S. In the most severe cases of this inflammatory disorder, pediatric AD may interfere with development, emphasizing the importance of delivering this medicine to these children as soon as possible. Now, turning to slide 17.

We believe that with introduction of this new medicines for these conditions, we will see a greater number of patients seeking treatment for currently underserved with available therapies or currently not receiving treatment.

Pablo J. Cagnoni: On slide 16, we continue to advance the development of RUXOLITINIB cream beyond AD and vitiligo to additional indications where it can provide significant value as either the first-ever FDA-approved therapy or first-approved topical therapy for patients living with these dermatologic conditions. Based on the positive Phase III data in pediatric atopic dermatitis, the supplementary NDA submission is on track to be filed in the third quarter of this year with a potential approval in 2025, which could provide an effective, non-steroidal topical option for the 2 to 3 million pediatric patients with AD in the U.S. In the most severe cases of this inflammatory disorder, pediatric AD may interfere with development, emphasizing the importance of delivering this medicine to these children as soon as possible. Now, turning to slide 17.

Yeah.

On slide 16, we continue to advance the development of Rux cream beyond a D and vitiligo two additional indications where it can provide significant value as either the first ever FDA approved therapy or first approved topical therapy for patients living with this dermatological conditions.

Pablo J. Cagnoni: Based on the positive Phase III data in pediatric atopic dermatitis, the supplementary NDA submission is on track to be filed in the third quarter of this year with a potential approval in 2025, which could provide an effective, non-steroidal topical option for the 2 to 3 million pediatric patients with AD in the U.S. In the most severe cases of this inflammatory disorder, pediatric AD may interfere with development, emphasizing the importance of delivering this medicine to these children as soon as possible. Now, turning to slide 17. We're currently conducting a phase 3 study evaluating raclutinib cream in patients with parietal nodularis, a chronic skin disorder that presents as multiple firm nodules commonly located on the extensive surfaces of the extremities and that are intensely parietic. The studies are going well, and we're on track to report results from the PIVL study next year with a potential approval as early as 2026, with no topical therapies currently approved for PN and over 100,000 patients on treatment, this is an important additional option for patients and a significant opportunity for Rush Lisney Cream.

Pablo J. Cagnoni: Based on the positive phase 3 data in pediatric atopic dermatitis, the supplementary NDA submission is on track to be filed in the third quarter of this year with a potential approval in 2025, which could provide an effective, non-steroidal topical option for the 2 to 3 million pediatric patients with AD in the U.S. In the most severe cases of this inflammatory disorder, pediatric AD may interfere with development, emphasizing the importance of delivering this medicine to these children as soon as possible. Now turning to slide 17.

Based on the positive phase III data in pediatric atopic dermatitis there.

Supplementary NDA submission is on track to be filed in the third quarter. This year with a potential approval in 2025, which could provide an effective non steroidal topical options well there are two to 3 million pediatric patients with ADP in the U S.

And the most severe cases of this inflammatory disorder pediatric a D may interfere with development emphasizing the importance of delivering this medicine to this children as soon as possible.

Now turning to slide 17.

Pablo J. Cagnoni: We're currently conducting a Phase III study evaluating RUXOLITINIB cream in patients with prurigo nodularis, a chronic skin disorder that presents as multiple firm nodules commonly located on the extensive surfaces of the extremities and that are intensely pruritic. The studies are going well and we're on track to report results from the pivotal study next year, with a potential approval as early as 2026. With no topical therapies currently approved for PN and over 100,000 patients on treatment, [inaudible] is an important additional option for patients and a significant opportunity for RUXOLITINIB cream. As shown on slide 18, we're continuing to execute a broad development plan for Provacidinib, our oral, small molecule, highly selective, backbone inhibitor. Oversignif is currently being evaluated in Phase 3 studies in Heterogenesis Suprativa, Vitiligo, and Prurigonagularis, and in randomized Phase 2 proof-of-concept studies in Asthma and Chronic Spontaneous Vertec Oberstetting has already demonstrated outstanding efficacy and safety in a randomized phase 2 study in moderate to severe hyaluronidase luprativa, an extremely painful inflammatory disease. As a reminder, we reported that at week 52, up to 29% of patients experienced a high score of 100, which is complete resolution of all manifestations.

Pablo J. Cagnoni: We're currently conducting a phase 3 study evaluating raclutinib cream in patients with parietal nodularis, a chronic skin disorder that presents as multiple firm nodules commonly located on the extensive surfaces of the extremities and that are intensely parietic. The studies are going well, and we're on track to report results from the PIVL study next year with a potential approval as early as 2026, with no topical therapies currently approved for PN and over 100,000 patients on treatment, this is an important additional option for patients and a significant opportunity for Rush Lisney Cream.

We're currently conducting a phase III study evaluating <unk> cream in patients with Perrigo inaugural Arris, a chronic skin disorder that presents us multiple firm nodule is commonly located under extensive surfaces of the extremities and there are intensely paretic.

This study is enrolling well and we're on track to report results from the pivotal study next year with a potential approval as early as 2026.

With no topical therapies currently approved for Pn and over 100000 patients on treatment. We see this as an important additional option for patients and a significant opportunity for <unk> cream.

Pablo J. Cagnoni: As shown on slide 18, we're continuing to execute a broad development plan for Provacidinib, our oral, small molecule, highly selective, backbone inhibitor. Oversignif is currently being evaluated in Phase 3 studies in Heterogenesis Suprativa, Vitiligo, and Prurigonagularis, and in randomized Phase 2 proof-of-concept studies in Asthma and Chronic Spontaneous Vertec Oberstetting has already demonstrated outstanding efficacy and safety in a randomized phase 2 study in moderate to severe hyaluronidase luprativa, an extremely painful inflammatory disease. As a reminder, we reported that at week 52, up to 29% of patients experienced a high score of 100, which is complete resolution of all manifestations.

As shown on slide 18, we're continuing to execute a broad development plan for <unk>, our oral small molecule highly selective JAK one inhibitor.

Pablo J. Cagnoni: As shown on slide 18, we're continuing to execute a broad development plan for POVORCITINIB--our oral, small molecule, highly selective JAK1 inhibitor. POVORCITINIB is currently being evaluated in Phase III studies in hidradenitis suppurativa, vitiligo and prurigo nodularis and in randomized Phase II proof of concept studies in asthma and chronic spontaneous urticaria--with data in both expected in 2025. POVORCITINIB has already demonstrated outstanding efficacy and safety in a randomized Phase II study in moderate-to-severe hidradenitis suppurativa, an extremely painful inflammatory disease. As a reminder, we reported that at week 52, up to 29% of patients experienced a HiSCR100 response, which is complete resolution of all manifestations. POVORCITINIB also had rapid and profound impact on reducing pain--as highlighted in the chart on the bottom of slide 19--and represents the first potential oral therapy for the treatment of HS, with the opportunity to change the current standard of care. The two Phase III studies--STOP-HS1 and STOP-HS2--are enrolling quite well, given the strong Phase II data and the limited number of effective treatment options. We anticipate Phase III data in early 2025, with a potential launch in 2026.

<unk> is currently being evaluated in phase III studies, and hotter, United Super Tivo, Vitiligo, and Perrigo nodule Iris and in randomized phase II proof of concept studies in asthma and chronic spontaneous urticaria with data in both expected in 2025.

Pablo J. Cagnoni: POVORCITINIB has already demonstrated outstanding efficacy and safety in a randomized Phase II study in moderate-to-severe hidradenitis suppurativa, an extremely painful inflammatory disease. As a reminder, we reported that at week 52, up to 29% of patients experienced a HiSCR100 response, which is complete resolution of all manifestations.

But we're sitting here has already demonstrated outstanding efficacy and safety in a randomized phase II study in moderate to severe hidradenitis suppurativa and extremely painful inflammatory disease. As a reminder, we reported that at week 52, after 29% of patients experience a high score 100 response.

Pablo J. Cagnoni: As a reminder, we reported that at week 52, up to 29% of patients experienced a HiSCR100 response, which is complete resolution of all manifestations. POVORCITINIB also had rapid and profound impact on reducing pain--as highlighted in the chart on the bottom of slide 19--and represents the first potential oral therapy for the treatment of HS, with the opportunity to change the current standard of care. The two Phase III studies--STOP-HS1 and STOP-HS2--are enrolling quite well, given the strong Phase II data and the limited number of effective treatment options. We anticipate Phase III data in early 2025, with a potential launch in 2026. With Ross Levine Cream and Pover Sidney, we believe we will be the only company to potentially provide both a topical and oral option for a number of indications, expanding their momentarium of effective therapies for certain conditions, including HS, vitiligo, and corrigonodular. Moving to Site 20 and our two newest IAI programs. We are pleased to have closed the SIN transaction and now add two mass-related G-protein-coupled receptor antagonists, or MRGPRs, to our pipeline, with significant potential in multiple indications. MRGPR antagonism is a specific novel mechanism for blocking mass electivation, independent from IGE, and has been a high-priority target to us for the IAI pipeline, as a paradigm changing therapeutic approach. Mast cells play a central role in the initiation and perpetuation of inflammatory responses, and their dysregulation can contribute to the development and progression of many inflammatory diseases.

Pablo J. Cagnoni: As a reminder, we reported that at week 52, up to 29% of patients experienced a HiSCR100 response, which is complete resolution of all manifestations.

Which is complete resolution of all manifestations.

Pablo J. Cagnoni: POVORCITINIB also had rapid and profound impact on reducing pain--as highlighted in the chart on the bottom of slide 19--and represents the first potential oral therapy for the treatment of HS, with the opportunity to change the current standard of care. The two Phase III studies--STOP-HS1 and STOP-HS2--are enrolling quite well, given the strong Phase II data and the limited number of effective treatment options. We anticipate Phase III data in early 2025, with a potential launch in 2026. With RUXOLITINIB cream and POVORCITINIB, we believe we will be the only company to potentially provide both a topical and oral option for a number of indications, expanding their momentarium of effective therapies for certain conditions--including HS, vitiligo and prurigo nodularis.

Pablo J. Cagnoni: Poverty also has a rapid and profound impact on reducing pain, as highlighted in the chart on the bottom of slide 19, and represents the first potential oral therapy for the treatment of HS with the opportunity to change the current standard of care. The two Phase 3 studies, SCOPH-HS1 and SCOPH-HS2, are progressing quite well given the strong Phase 2 data and the limited number of effective treatment options. We anticipate Phase 3 data in early 2025 with a potential launch in 2020.

But we're sitting have always had rapid and profound impact on reducing pain as highlighted in the chart on the bottom of slide 19 and represents the first potential oral therapy for the treatment of Hs with the opportunity to change the current standard of care.

The two phase III studies stopped pages, one and stop Hs to enrolling quite well given the strong phase two data and the limited number of effective treatment options, we anticipate phase III data in early 2025 with a potential launch in 2026.

Pablo J. Cagnoni: With Ross Levine Cream and Pover Sidney, we believe we will be the only company to potentially provide both a topical and oral option for a number of indications, expanding their momentarium of effective therapies for certain conditions, including HS, vitiligo, and corrigonodular. Moving to Site 20 and our two newest IAI programs. We are pleased to have closed the SIN transaction and now add two mass-related G-protein-coupled receptor antagonists, or MRGPRs, to our pipeline, with significant potential in multiple indications. MRGPR antagonism is a specific novel mechanism for blocking mass electivation, independent from IGE, and has been a high-priority target to us for the IAI pipeline, as a paradigm changing therapeutic approach. Mast cells play a central role in the initiation and perpetuation of inflammatory responses, and their dysregulation can contribute to the development and progression of many inflammatory diseases.

We're rux cream and polar Sidney if we believe it will be the only company to potentially provide both a topical and oral option for a number of indications expanding their monetary them of effective therapies for certain conditions, including Hs vitiligo and Perrigo nodule Arris.

Pablo J. Cagnoni: With RUXOLITINIB cream and POVORCITINIB, we believe we will be the only company to potentially provide both a topical and oral option for a number of indications, expanding their momentarium of effective therapies for certain conditions--including HS, vitiligo and prurigo nodularis. Moving to slide 20 and our two newest IAI programs. We are pleased to have closed the SIN transaction and now add two mass-related G-protein-coupled receptor antagonists, or MRGPRs, to our pipeline, with significant potential in multiple indications. MRGPR antagonism is a specific novel mechanism for blocking mass electivation, independent from IGE, and has been a high-priority target to us for the IAI pipeline, as a paradigm changing therapeutic approach. Mast cells play a central role in the initiation and perpetuation of inflammatory responses, and their dysregulation can contribute to the development and progression of many inflammatory diseases.

Pablo J. Cagnoni: Moving to slide 20 and our two newest IAI programs. We are pleased to have closed the Escient transaction and now add two Mas-related G protein-coupled receptor antagonists--or MRGPRs--to our pipeline, with significant potential in multiple indications. MRGPR antagonism is a specific novel mechanism for blocking mast cell activation, independent from IgE and has been a high-priority target to us for IAI pipeline as a paradigm-changing therapeutic approach. Mast cells play a central role in initiation and perpetuation of inflammatory responses and their dysregulation can contribute to the development and progression of many inflammatory diseases. 262 is a first-in-class medicine that entered the clinic in January of 2023 and is currently being evaluated in three proof-of-concept clinical studies. By blocking the activation of mast cells, 262 holds great promise across a broad range of mast cell-mediated diseases as a once-daily oral treatment, potentially devoid of the side effects observed without therapy. As a reminder, in a phase one healthy volunteer study, 262 was well tolerated at low interpatient PK variability and achieved exposures well above predicted efficacious levels.

Moving to slide 20, and our two newest III programs.

Pablo J. Cagnoni: We are pleased to have closed the SIN transaction and now add two mass-related G-protein-coupled receptor antagonists, or MRGPRs, to our pipeline, with significant potential in multiple indications. MRGPR antagonism is a specific novel mechanism for blocking mass electivation, independent from IGE, and has been a high-priority target to us for the IAI pipeline, as a paradigm changing therapeutic approach. Mast cells play a central role in the initiation and perpetuation of inflammatory responses, and their dysregulation can contribute to the development and progression of many inflammatory diseases.

We are pleased to have closed the <unk> transaction and now add two mass related G protein coupled receptor antagonist RMR GP ours to our pipeline with significant potential in multiple indications and.

<unk> antagonism as a specific novel mechanism for blocking mast cell activation independent from Iga and has been a high priority target to add to our I O pipeline as a paradigm changing therapeutic approach.

Sales play a central role in initiation and perpetuation of inflammatory responses and their dysregulation can contribute to the development and progression of Magnum Flammer Tory diseases.

Pablo J. Cagnoni: 262 is a first-in-class medicine which entered the clinic in January of 2023 and is currently being evaluated in three proof of concept clinical studies. By blocking the activation of mast cells, 262 holds great promise across a broad range of mast cell-mediated diseases as a once-daily oral treatment, potentially devoid of the side effects observed with other therapies. As a reminder, in a Phase I healthy volunteer study, 262 was well-tolerated at low interpatient PK variability and achieved exposures well above predicted efficacious levels. We believe the excellent safety profile, along with the potential for compelling efficacy, could be a key differentiator for this program. 262 is currently in a Phase 1b open-label study in Chronic Inducible Urticaria or SINDU and in a randomized Phase 2 study in Chronic Spontaneous Urticaria or CSU with data for the studies expected during the first quarter of 2025. Marked by painful and pruritic eyes, CINDU and CSU are currently treated with antihistamines but nearly 50% of patients do not experience symptom control which can lead to anxiety, depression, and inability to work in social isolation underscoring the need for safe and effective oral therapeutic options, 262 results are currently being evaluated in a randomized Phase 2 study in atopic dermatitis and data for this study is also expected during the first quarter of 2025.

Pablo J. Cagnoni: 262 is a first-in-class medicine that entered the clinic in January of 2023 and is currently being evaluated in three proof-of-concept clinical studies. By blocking the activation of mast cells, 262 holds great promise across a broad range of mast cell-mediated diseases as a once-daily oral treatment, potentially devoid of the side effects observed without therapy. As a reminder, in a phase one healthy volunteer study, 262 was well tolerated at low interpatient PK variability and achieved exposures well above predicted efficacious levels.

<unk> is a first in class medicine, which entered the clinic in January of 2023 and is currently being evaluated in three proof of concept clinical studies.

By blocking the activation of mast cells 262 holds great promise across a broad range of mass cell mediated diseases as a once daily oral treatment potentially devoid of the side effects observed with other therapies.

As a reminder, in our phase one healthy volunteer study 206, two was well tolerated at low inter patient PK variability and achieved exposures well about predicted efficacious levels.

Pablo J. Cagnoni: We believe the excellent safety profile, along with the potential for compelling efficacy, could be a key differentiator for this program. 262 is currently in a Phase Ib open-label study in chronic inducible Urticaria--or CIndU--and in a randomized Phase II study in chronic spontaneous urticaria--or CSU--with data for the studies expected during the first quarter of 2025. Marked by painful and pruritic hives, CIndU and CSU are currently treated with antihistamines but nearly 50% of patients do not experience symptom control, which can lead to anxiety, depression and inability to work and social isolation--underscoring the need for safe and effective oral therapeutic options. 262 results are currently being evaluated in a randomized Phase II study in atopic dermatitis and data for this study is also expected during the first quarter of 2025.

Pablo J. Cagnoni: We believe the excellent safety profile, along with the potential for compelling efficacy, could be a key differentiator for this program. 262 is currently in a Phase 1b open-label study in Chronic Inducible Urticaria or SINDU and in a randomized Phase 2 study in Chronic Spontaneous Urticaria or CSU with data for the studies expected during the first quarter of 2025. Marked by painful and pruritic eyes, CINDU and CSU are currently treated with antihistamines but nearly 50% of patients do not experience symptom control which can lead to anxiety, depression, and inability to work in social isolation underscoring the need for safe and effective oral therapeutic options, 262 results are currently being evaluated in a randomized Phase 2 study in atopic dermatitis and data for this study is also expected during the first quarter of 2025.

We believe the excellent safety profile, along with the potential for a compelling efficacy could be a key differentiator for this program.

262 is currently in a phase <unk> open label study in chronic inducible urticaria or syndrome and in a randomized phase II study in chronic spontaneous urticaria or CSU with data for this study is expected during the first quarter of 2025.

Pablo J. Cagnoni: Marked by painful and pruritic hives, CIndU and CSU are currently treated with antihistamines but nearly 50% of patients do not experience symptom control, which can lead to anxiety, depression and inability to work and social isolation--underscoring the need for safe and effective oral therapeutic options. 262 results are currently being evaluated in a randomized Phase II study in atopic dermatitis and data for this study is also expected during the first quarter of 2025. There is continued need for additional safe and effective oral treatment options in AD and we believe success in this indication could further build on our leadership in AD.

Marked by painful in Paretic Hives centre in CSU are currently treated with anti histamines by nearly 50% of patients do not experience symptom control, which can lead to anxiety depression and inability to work and social isolation underscoring the need for safe and effective oral therapeutic options.

Pablo J. Cagnoni: 262 results are currently being evaluated in a randomized Phase II study in atopic dermatitis and data for this study is also expected during the first quarter of 2025. There is continued need for additional safe and effective oral treatment options in AD and we believe success in this indication could further build on our leadership in AD. 547 is a highly selective antagonist of MRDPRX4, a cell surface receptor expressed on neurons in the dorsal root ganglia that is activated by bile acids, bilirubin, and adenine metabolites, and thought to be a key mediator of the often intense, unrelenting pruritus experienced by patients with cholestatic liver, Y4-7 has the potential to become the first targeted therapy for cholestatic pruritus lacking the side effects observed with other approaches.

262 is also currently being evaluated in a randomized phase II study in atopic dermatitis and data for this study is also expected during the first quarter of 2025.

Pablo J. Cagnoni: There is continued need for additional safe and effective oral treatment options in AD and we believe success in this syndication could further build on our leadership in AD. 547 is a highly selective antagonist of MRDPRX4, a cell surface receptor expressed on neurons in the dorsal root ganglia that is activated by bile acids, bilirubin, and adenine metabolites, and thought to be a key mediator of the often intense, unrelenting pruritus experienced by patients with cholestatic liver, Y4-7 has the potential to become the first targeted therapy for cholestatic pruritus lacking the side effects observed with other approaches.

There is continued need for additional safe an effective oral treatment options and a D and we believe success in this indication could further build on our leadership in E D.

Okay.

Pablo J. Cagnoni: 547 is a highly selective antagonist of MRGPRX4, a cell-surface receptor expressed on neurons in the dorsal root ganglia that is activated by bile acids, bilirubin and [inaudible] metabolites and thought to be a key mediator of the often intense, unrelenting pruritus experienced by patients with cholestatic liver disease. 547 has the potential to become the first targeted therapy for cholestatic pruritus, lacking the side effects observed with other approaches. A randomized, double-blind study is being conducted in patients with cholestatic pruritis due to primary biliary cirrhosis--or PBC--or primary sclerosing cholangitis--or PSC--with clinical proof of concept anticipated also during the first quarter of 2025. Moving to MPNs and graft-versus-host disease on slide 24. We highlight there a number of ongoing programs where we have the goal of developing new transformative therapeutic options to build upon the significant impact Jacker-Fye has had on patients, for a best inhibitor, dose escalation is ongoing, puts monotherapy in combination with Ruxledin, and we have reported reductions in spring length and volume as well as improvements in both symptoms and hemoglobin suggesting this is an active compound, We plan to advance this program into Phase 3 development and expect to provide an update later this year.

<unk> seven is a highly selective antagonist are very margin P. Rx for a cell surface receptor expressed on neurons in the dorsal root ganglia that is activated by bile acids bilirubin and other human metabolite and thought to be a key mediator of the often intense unrelenting pruritus experienced by patients with <unk>.

Static liver disease.

547 has the potential to become the first targeted therapy for college static pruritus lacking decide effects observed with other approaches.

Pablo J. Cagnoni: A randomized, double-blind study is being conducted in patients with cholestatic sclerosis due to primary biliary cirrhosis, or PBC, or primary sclerosing cholangitis, or PSC, with clinical proof-of-concept anticipated also during the first quarter of 2025. Moving to NPNs and graft-versus-dose disease on slide 24, we highlight there a number of ongoing programs where we have the goal of developing new transformative therapeutic options to build upon the significant impact Jacker-Fye has had on patients, for a best inhibitor, dose escalation is ongoing, puts monotherapy in combination with Ruxledin, and we have reported reductions in spring length and volume as well as improvements in both symptoms and hemoglobin suggesting this is an active compound, We plan to advance this program into Phase 3 development and expect to provide an update later this year.

A randomized double blind study is being conducted in patients we would call a static providers to two primary biliary cirrhosis or PBC, our primary sclerosing cholangitis or PSC with clinical proof of concept of anticipated also during the first quarter of 2025.

Pablo J. Cagnoni: Moving to MPNs and graft-versus-host disease on slide 24. We highlight there a number of ongoing programs where we have the goal of developing new transformative therapeutic options to build upon the significant impact JAKAFI has had on patients. For our BET inhibitor, dose escalation is ongoing both as monotherapy and in combination with RUXOLITINIB and we have reported reductions in spleen length and volume, as well as improvements in both symptoms and hemoglobin, suggesting this is an active compound. We plan to advance this program into Phase III development and expect to provide an update later this year. Fosilio-deuterative, our R2 inhibitor, we have observed early signals of clinical activity in patients with mild fibrosis through hepcidin reduction in monotherapy and in combination with ruxolysin. Ziller Conservative was tolerated with a favorable safety profile and continues to be dosed escalation. We plan to provide an update later this year. As previously disclosed, we submitted a BLA-corrected bacillus map for the treatment of third-line chronic graft-versus-host disease late last year based on a positive randomized phase 2 study.

Moving to N P Ensign graphics as host disease on slide 24, we highlight there and number of ongoing programs, where we have the goal of developing new transformative therapeutic options to build upon the significant impact Jakafi has had on patients for.

For our bet inhibitor dose escalation is ongoing but as monotherapy and in combination with rux letting it and we have reported reductions since playing <unk> and volume as well as improvements in both symptoms and hemoglobin, suggesting this is an active compound.

We plan to advance this program into phase III development and expect to provide an update later this year.

Pablo J. Cagnoni: Fosilio-deuterative, our R2 inhibitor, we have observed early signals of clinical activity in patients with mild fibrosis through hepcidin reduction in monotherapy and in combination with ruxolysin. Ziller Conservative was tolerated with a favorable safety profile and continues to be dosed escalation. We plan to provide an update later this year. As previously disclosed, we submitted a BLA-corrected bacillus map for the treatment of third-line chronic graft-versus-host disease late last year based on a positive randomized phase 2 study.

Pablo J. Cagnoni: For ZILUGISERTIB, our ALK2 inhibitor, we have observed early signals of clinical activity in patients with myelofibrosis through hepcidin reduction in monotherapy and in combination with RUXOLITINIB. ZILUGISERTIB was well-tolerated, with a favorable safety profile and continues to dose escalation. We plan to provide an update later this year. As previously disclosed, we submitted a BLA for AXATILIMAB for the treatment of third-line chronic graft-versus-host disease late last year, based on a positive randomized Phase II study.

Ausiello Conservative our <unk> two inhibitor, we have observed early signals of clinical activity in patients with myelofibrosis through herbicide and a reduction in monotherapy and in combination with rux letting it.

Sorry, if it was well tolerated with a favorable safety profile and continues to dose escalation.

Geordie Mark: We plan to provide an update later this year.

Pablo J. Cagnoni: As previously disclosed, we submitted a BLA for AXATILIMAB for the treatment of third-line chronic graft-versus-host disease late last year, based on a positive randomized Phase II study. In February, the filing was accepted for priority review and we anticipate an FDA decision in late August. We are excited by the possibility of bringing a new treatment option to patients with this devastating complication of hematopoietic stem cell transplant. Additionally, we anticipate initiating a Phase III trial in combination with steroids and a Phase II study in combination with RUXOLITINIB later this year. [inaudible] on JAKAFI, which is the foundational therapy for MF and PV, we are concentrated on improving outcomes in the near term by combining JAKAFI with other therapies, as well as through approaches that have disease-modifying potential and that can significantly expand the addressable patient population to more than 200,000 patients. Our novel, first-in-class, anti-mutant CALR-targeted monoclonal antibody has the potential to eradicate the malignant clone in patients with mutant CALR-positive MPNs and to significantly modify disease outcomes.

As previously disclosed we submitted the BLA for <unk> for the treatment of third line chronic graft versus host disease late last year based on a positive randomized phase II study in.

Pablo J. Cagnoni: In February, the filing was accepted for priority review, and we anticipate an FDA decision in late August. We are excited by the possibility of bringing a new treatment option to patients with this devastating complication of hematopoietic stem cell transplant. Additionally, we anticipate initiating a Phase 3 trial in combination with steroids and a Phase 2 study in combination with Ruxolitinib later this year. Putting on Jackify, which is the foundational therapy for NF and PV, we are concentrated on improving outcomes in the near term by combining Jackify with other therapies, as well as through approaches that have disease-modifying potential and that can significantly expand the addressable patient population to more than 200,000 patients, are novel, first-in-class, anti-mutant cholera-targeted monoclonal antibody has the potential to eradicate the malignant clone in patients with mutant cholera-positive MPNs and to significantly modify disease outcomes.

In February the filing was accepted for priority review and we anticipate an FDA decision in late August.

We are excited by the possibility of bringing a new treatment option to patients with this devastating complication of hematopoietic stem cell transplant.

Additionally, we anticipate initiating a phase III trial in combination with steroids and a phase II study in combination with rux letting it later this year.

The thing on Jakafi, which is the foundational therapy for MF and PV, we are concentrated on improving outcomes in the near term by combining jakafi with other therapies as well as three approaches that have disease modifying potential and that can significantly expand the addressable patient population to more than 200.

Pablo J. Cagnoni: [inaudible] on JAKAFI, which is the foundational therapy for MF and PV, we are concentrated on improving outcomes in the near term by combining JAKAFI with other therapies, as well as through approaches that have disease-modifying potential and that can significantly expand the addressable patient population to more than 200,000 patients. Our novel, first-in-class, anti-mutant CALR-targeted monoclonal antibody has the potential to eradicate the malignant clone in patients with mutant CALR-positive MPNs and to significantly modify disease outcomes. NAD-A9 binds with high affinity to mutant CoL-R and inhibits oncogenesis in cells expressing this oncoprotein and antagonizes CoL-R oncogenic function, resulting in selective inhibition of JAK-STAT signaling only in CoL-R mutated cells with no effect on normal cells. This selectivity results in the specific killing of tumor cells harboring the mutation and is suggestive of the potential to alter the cause of the disease in patients with color-mutant MS and essential thrombocytosis.

Pablo J. Cagnoni: Moving on to JAKAFI, which is the foundational therapy for MF and PV, we are concentrated on improving outcomes in the near term by combining JAKAFI with other therapies, as well as through approaches that have disease-modifying potential and that can significantly expand the addressable patient population to more than 200,000 patients. Our novel, first-in-class, anti-mutant CALR-targeted monoclonal antibody has the potential to eradicate the malignant clone in patients with mutant CALR-positive MPNs and to significantly modify disease outcomes.

<unk> thousand patients.

Our novel first in class anti mutant call our targeted monoclonal antibody has the potential to eradicate the malignant clone in patients with mutant colored positive N P and and to significantly modify disease outcomes.

Pablo J. Cagnoni: 9A9 binds with high affinity to mutant CALR and inhibits oncogenesis in cells, expressing this oncoprotein and antagonizes CALR oncogenic function--resulting in selective inhibition of JAK-STAT signaling only in CALR-mutated cell, with no effect on normal cells. This selectivity results in the specific killing of tumor cells harboring the mutation and is suggestive of the potential to alter the cause of the disease in patients with CALR-mutant MS and essential thrombocythemia. Mutant CALR-mutations are present in approximately 25% to 35% of patients with MF and ET. The Phase I studies are currently enrolling and we are on track to share data in 2025. As a reminder, the JAK2V617F mutation is the most common somatic mutation in MPNs and is present in 55%, 60% and 95% of patients with MF, ET and PV, respectively. Unlike RUXOLITINIB--which inhibits both wild-type and V617F mutation-positive cells--O58 selectively binds to the JAK2 JH2 site, disrupting the V617F-induced confirmation and thus, allowing selective inhibition of mutant activity in the JAK2 receptor while sparing wild-type, making our JAK2V617F inhibitor a potentially transformative therapy for patients with PV, MF and ET. Data for this program is expected in 2025. Moving to oncology pipeline in slide 29.

Pablo J. Cagnoni: NAD-A9 binds with high affinity to mutant CoL-R and inhibits oncogenesis in cells expressing this oncoprotein and antagonizes CoL-R oncogenic function, resulting in selective inhibition of JAK-STAT signaling only in CoL-R mutated cells with no effect on normal cells. This selectivity results in the specific killing of tumor cells harboring the mutation and is suggestive of the potential to alter the cause of the disease in patients with color-mutant MS and essential thrombocytosis.

99 bind with high affinity to mute in Qatar and inhibits oncogenesis in cells expressing this oncoprotein and Antagonizes, Colorado <unk> function, resulting in selective inhibition of JAK stat signaling only call are mutated cells with no effect on normal cells.

Cell activity resulted in the specific killing of tumor cells harboring that mutation and is suggestive of the potential to alter the cause of the disease in patients with <unk> mutant MF and essential thrombocythemia.

Pablo J. Cagnoni: I'm going to be calling out mutations that are present in approximately 25 to 35% of patients who have been tested by an EKG. The Phase I studies are currently enrolling patients, and we are on track to share data in 2025. As a reminder, the JAK2V617F mutation is the most common somatic mutation in NPNs and is present in 55, 60, and 95% of patients with MF, ET, and PV, respectively. Unlike Ruxolizumib, which inhibits both wild-type and V617F mutation-positive cells, O5-8 selectively binds to the JAK2-JH2 site, disrupting the V617F-induced conformation and thus allowing selective inhibition of mutant activity in the JAK2 receptor while sparing wild-type, making a JAK2V617F inhibitor a potentially transformative therapy for patients with PD, MS Data for this program is expected in 2025. Movies are on the Columby Pipeline in slot 29.

You didn't call out mutations are present in approximately 25% to 35% of patients with MF and E T.

Their phase one studies are currently enrolling and we are on track to share data in 2025.

Pablo J. Cagnoni: The Phase I studies are currently enrolling and we are on track to share data in 2025. As a reminder, the JAK2V617F mutation is the most common somatic mutation in MPNs and is present in 55%, 60% and 95% of patients with MF, ET and PV, respectively. Unlike RUXOLITINIB--which inhibits both wild-type and V617F mutation-positive cells--O58 selectively binds to the JAK2 JH2 site, disrupting the V617F-induced confirmation and thus, allowing selective inhibition of mutant activity in the JAK2 receptor while sparing wild-type, making our JAK2V617F inhibitor a potentially transformative therapy for patients with PV, MF and ET. Data for this program is expected in 2025. Moving to oncology pipeline in slide 29. We continue to build a robust portfolio with increased emphasis on first-in-class and our best-in-class and novel immuno-oncology programs with the potential for a large treatment effect. Zafacitamab, currently approved in combination with zanolinamide for patients with relapsed or refractory DLDCL, is on track to deliver Phase III results in follicular lymphoma and marginal zone lymphoma later this year I'll save you data for first-line DLDCL in combination with our two jobs. It's expected next year.

As a reminder, the Jack to be six months, having half mutation is the most common somatic mutation and mpls and as president of 50, 560, and 95% of patients with MF and PV respectively.

Unlike <unk>, which inhibits both wild type and V. Six months seven eight mutation positive cells 058 selectively binds to the Jack to J D to site disrupting the VCX fans have been asking to confirmation and thus, allowing selective inhibition of immune activity and ejector receptor, while sparing wild type.

Geordie Mark: Making our Jack to be six months have an F inhibitor, a potentially transformative therapy for patients with PV MF and E T D.

Data for this program is expected in 2025.

Pablo J. Cagnoni: Moving to oncology pipeline in slide 29. We continue to build a robust portfolio with increased emphasis on first-in-class and our best-in-class and novel immuno-oncology programs, with the potential for a large treatment effect. TAFASITAMAB--currently approved in combination with LENALIDOMIDE for patients with relapsed or refractory DLBCL--is on track to deliver Phase III results in follicular lymphoma and marginal zone lymphoma later this year, with a potential approval in 2025; while Phase III data for first-line DLBCL in combination with R2CHOP is expected next year. Today we unveil positive top-line results from two Pivotal Phase III RET-KEY Funding Map programs. Ritchie family map met the primary endpoints in both the squamous cell anal carcinoma and non-small cell lung cancer phase 3 studies. In non-small cell lung cancer, we show a statistically significant and clinically meaningful improvement in overall survival. In squamous cell anal carcinoma, we observe a statistically significant and clinically meaningful improvement in progression-free survival.

Moving to our oncology pipeline on slide 29.

Pablo J. Cagnoni: We continue to build a robust portfolio with increased emphasis on first-in-class and our best-in-class and novel immuno-oncology programs with the potential for a large treatment effect. Zafacitamab, currently approved in combination with zanolinamide for patients with relapsed or refractory DLDCL, is on track to deliver Phase III results in follicular lymphoma and marginal zone lymphoma later this year I'll save you data for first-line DLDCL in combination with our two jobs. It's expected next year.

Well continue to build a robust portfolio with increased emphasis on first in class or best in class and novel immuno oncology programs with the potential for a large treatment effects.

Deficit Demov currently got proved in combination of window, they don't mind for patients with relapsed or refractory D. L. P. C. L is on track to deliver phase III result, in Follicular lymphoma, and marginal zone lymphoma later this year with a potential approval in 2025.

Phase III data for first line <unk> in combination with our to chop is expected next year.

Pablo J. Cagnoni: Today, we unveil positive top-line results from two pivotal Phase III RETIFANLIMAB programs. RETIFANLIMAB met the primary endpoints in both the squamous cell anal carcinoma and non-small cell lung cancer Phase III studies. In non-small cell lung cancer, we saw a statistically significant and clinically meaningful improvement in overall survival and squamous cell anal carcinoma, we observe a statistically significant and clinically meaningful improvement in progression-free survival. Both studies showed that the family map was generally well tolerated, and no new safety signals were detected, which, if I remember correctly, could represent the first ever PD-1 or PD-L1 antibody approved for the first line treatment of patients with SCH. We believe that RETI Family MEM also has substantial strategic value as a combination therapy without other programs in our pipeline, and we look forward to sharing the full results of this study at an upcoming medical meeting later this year.

Pablo J. Cagnoni: Today we unveil positive top-line results from two Pivotal Phase III RET-KEY Funding Map programs. Ritchie family map met the primary endpoints in both the squamous cell anal carcinoma and non-small cell lung cancer phase 3 studies. In non-small cell lung cancer, we show a statistically significant and clinically meaningful improvement in overall survival. In squamous cell anal carcinoma, we observe a statistically significant and clinically meaningful improvement in progression-free survival.

Speaker Change: Today, we unveiled positive topline results from two pivotal phase III ready finally, my programs really found them and met the primary endpoints in both the squamous cell anal carcinoma, and non small cell lung cancer phase III studies.

In non small cell lung cancer, we show a statistically significant and clinically meaningful improvement in overall survival and squamous cell anal carcinoma, we have service statistically significant and clinically meaningful improvement in progression free survival.

Pablo J. Cagnoni: Both studies showed RETIFANLIMAB was generally well-tolerated and no new safety signals were detected. RETIFANLIMAB could represent the first-ever PD-1--or PD-L1 antibody approved for the first-line treatment of patients with SCAC. We believe that RETIFANLIMAB also has substantial strategic value as a combination therapy with the other programs in our pipeline and we look forward to sharing the full results of this study at an upcoming medical meeting later this year. Additionally, we plan on meeting with regulatory agencies to determine next steps and look forward to providing additional clarity in the coming weeks and months. A potentially first-in-class small-molecule CDK2 inhibitor has shown evidence of clinical activity, demonstrating partial responses of stable disease in patients with CCNE1 overexpressing tumors. We expect to share this data as well as the development plan at ESMO in September. We believe our CDK2 inhibitor could be a foundational therapy for patients with ovarian cancer, as well as other CCMU1 overexpressing tumor types. KRS mutations are one of the most common genetic abnormalities in cancer, especially lung, colon, and pancreatic cancer.

Pablo J. Cagnoni: Both studies showed that the family map was generally well tolerated, and no new safety signals were detected, which, if I remember correctly, could represent the first ever PD-1 or PD-L1 antibody approved for the first line treatment of patients with SCH. We believe that RETI Family MEM also has substantial strategic value as a combination therapy without other programs in our pipeline, and we look forward to sharing the full results of this study at an upcoming medical meeting later this year.

Studies show ready finally map was generally well tolerated and no new safety signals were detected.

Where do you find them up could represent the first ever PD, one or PDL, one antibody approved for first line treatment of patients with FCA.

We believe that Ritchie family members also have substantial strategic value as a combination therapy with other programs in our pipeline and we look forward to sharing the full results of this study at an upcoming medical meeting later this year.

Pablo J. Cagnoni: Additionally, we plan on meeting with regulatory agencies to determine next steps and look forward to providing additional clarity in the coming weeks and months. A potentially first-in-class small-molecule CDK2 inhibitor has shown evidence of clinical activity, demonstrating partial responses of stable disease in patients with CCNE1 overexpressing tumors. We expect to share this data as well as the development plan at ESMO in September. We believe our CDK2 inhibitor could be a foundational therapy for patients with ovarian cancer, as well as other CCMU1 overexpressing tumor types. KRS mutations are one of the most common genetic abnormalities in cancer, especially lung, colon, and pancreatic cancer.

Additionally, we plan on meeting with regulatory agencies to determine next steps and look forward to providing additional clarity in the coming weeks and months.

Pablo J. Cagnoni: A potentially first-in-class small-molecule CDK2 inhibitor has shown evidence of clinical activity, demonstrating partial responses of stable disease in patients with CCNE1 overexpressing tumors. We expect to share this data as well as the development plan at ESMO in September. We believe our CDK2 inhibitor could be a foundational therapy for patients with ovarian cancer, as well as other CCNE1 overexpressing tumor types. KRAS mutations are one of the most common genetic abnormalities in cancer, especially lung, colon and pancreatic cancers. A potentially first-in-class, best-in-class KRASG12D small molecule inhibitor, 734 is a potent, selective and orally bioavailable KRASG12D inhibitor that has shown excellent efficacy in several preclinical models. With no currently approved G12D-targeting agents, 734 could address an important patient need as the KRASG12D mutation is found in 40% of pancreatic ductal adenocarcinoma, 15% of colorectal cancer and 5% of non-small cell lung cancers. Our Phase I clinical trial is enrolling well and we are on track to share initial data in 2025.

Our potentially first in class small molecule CDK <unk> inhibitor has shown evidence of clinical activity demonstrating partial responses or stable disease in patients with <unk> any one over expressing tumors, we expect to share this data as well as the development plan at ESMO in September we believe our CDK <unk> inhibitor could.

A foundational therapy for patients with ovarian cancer as well as other cc anyone over expressing tumor types.

K Ras mutations are one of the most common genetic abnormalities in cancer, especially lung colon and pancreatic cancers.

Pablo J. Cagnoni: KRAS mutations are one of the most common genetic abnormalities in cancer, especially lung, colon and pancreatic cancers. A potentially first-in-class, best-in-class KRASG12D small molecule inhibitor, 734, is a potent, selective and orally bioavailable KRASG12D inhibitor that has shown excellent efficacy in several preclinical models. With no currently approved G12D-targeting agents, 734 could address an important patient need as the KKRASG12D mutation is found in 40% of pancreatic ductal adenocarcinoma, 15% of colorectal cancer and 5% of non-small cell lung cancers. Our Phase I clinical trial is enrolling well and we are on track to share initial data in 2025. The TGF data signaling pathway plays a complex role in cancer biology and progression with different functions in early and late stage cancers. Early generation therapies have been unsuccessful due in large part to the toxicity associated with systemic plasma inhibition, with our bite-specific antibody inhibiting PD-1 and TGF-beta receptor 2 signaling on T-cells.

Pablo J. Cagnoni: A potentially first-in-class, best-in-class KRF-D12C small molecule inhibitor 734 is a potent, selective, and orally bioavailable KRF-D12C inhibitor that has shown excellent efficacy in several preclinical models. With no currently approved T-TILT targeting agents, 734 could address an important patient need as the KRF T-TILT mutation is found in 40% of pancreatic ductal a Our phase one clinical trial is enrolling well, and we are on track to share initial data in 2025.

Potentially first in class best in class <unk> small molecule inhibitor 734 is a potent selective and orally by available care Este <unk> inhibitor that has shown excellent efficacy and several preclinical models.

With no currently approved <unk> target and agents 734 could address an important patient need as the kers detailed the mutation is found in 40% of pancreatic ductal adenocarcinoma, 15% of colorectal cancers, and 5% of non small cell lung cancers.

Our phase one clinical trial is enrolling well and we are on track to share initial data in 2025.

Pablo J. Cagnoni: The TGF-beta signaling pathway plays a complex role in cancer biology and progression with different functions in early and late-stage cancer cells. Early generation therapies have been unsuccessful, due in large part to the toxicity associated with systemic plasma inhibition. With our bispecific antibody inhibiting PD-1 and TGF-beta receptor 2 signaling in T cells. We have precisely tuned the binding arms against PD-1 and TGF-beta receptor 2, which we believe will result in the complete inhibition of TGF-beta signaling without the unwanted on-target effect. A TGF-beta receptor 2xPD-1 bispecific antibody has the potential to target multiple immunosuppressive pathways across a number of cancers. And if successful, could represent a meaningful contributor to our growth. We expect to share data from the Phase I program in 2025. In closing, this slide summarizes the considerable number of milestones across 2024 and 2025 that will continue the transformation of our pipeline, with a strong focus on new molecular entities with the potential to make an indelible impact on patients. With that, I would like to turn the call over to Christiana for the financial update. Thank you, Pablo.

Pablo J. Cagnoni: The TGF data signaling pathway plays a complex role in cancer biology and progression with different functions in early and late stage cancers. Early generation therapies have been unsuccessful due in large part to the toxicity associated with systemic plasma inhibition, with our bite-specific antibody inhibiting PD-1 and TGF-beta receptor 2 signaling on T-cells.

The TGF beta signaling pathway at place at complex role in cancer biology, and progression with different functions in Oregon late stage cancer cells.

Our early generation therapies have been unsuccessful due in large part to the toxicity associated with systemic pathway inhibition.

With our bi specific antibody inhibiting PD, one and TGF beta receptor signaling on T cells. We are precisely tuned to binding arms against PD, one and TGF beta receptor to which we believe will result in a complete inhibition of TGF beta signaling without the unwanted on target effects.

Christiana Stamoulis: We have precisely tuned the binding arms against PD-1 and TGF-beta receptor 2, which we believe will result in the complete inhibition of TGF-beta signaling without the unwanted on-target effect. A TCA failure receptor 2 by PD-1 bispecific antibody has the potential to target multiple immunosuppressive pathways across a number of cancers, and if successful, could represent a meaningful contributor to our growth. We expect to share data from the In closing, this slide summarizes the considerable number of milestones across 2024 and 2025 that will continue the transformation of our pipeline, with a strong focus on new molecular entities with the potential to make an indelible impact on patients. With that, I would like to turn the call over to Christiana for the financials. Thank you, Pablo.

Pablo J. Cagnoni: A TGF-beta receptor 2xPD-1 bispecific antibody has the potential to target multiple immunosuppressive pathways across a number of cancers. And if successful, could represent a meaningful contributor to our growth. We expect to share data from the Phase I program in 2025. In closing, this slide summarizes the considerable number of milestones across 2024 and 2025 that will continue the transformation of our pipeline, with a strong focus on new molecular entities with the potential to make an indelible impact on patients. With that, I would like to turn the call over to Christiana for the financial update.

Speaker Change: Our TGF beta receptor two by PD, one bispecific antibody has the potential to target multiple immunosuppressive pathways across a number of cancers and if successful could represent a meaningful contributor to our growth.

We expect to share data from the phase one program in 2025.

Pablo J. Cagnoni: In closing, this slide summarizes the considerable number of milestones across 2024 and 2025 that will continue the transformation of our pipeline, with a strong focus on new molecular entities with the potential to make an indelible impact on patients.

Christina: In closing this slide summarizes the considerable number of milestones across 2024, and 2025 that will continue the transformation of our pipeline with a strong focus on new molecular entities with a potential to make an indelible impact on patients with that I would like to turn the call over to Christina.

Pablo J. Cagnoni: With that, I would like to turn the call over to Christiana for the financial update.

Christiana Stamoulis: Thank you, Pablo and good morning, everyone. Our second quarter results reflect strong commercial execution and continued growth with total revenues of $1.04 billion, up 9% versus the same period last year. Total product revenues of $907 million in Q2 were driven by demand growth for Jagathai and Oxelura and increased revenue contribution from Monjuvi following our acquisition in February of the Global Exclusive Rights to Tathagata. Total royalty revenues were $137 million, up 8% compared to the second quarter of 2023, driven by an acceleration in the demand for debt.

Christiana Stamoulis: Thank you, Pablo and good morning, everyone.

The financial update.

Christiana Stamoulis: And good morning, everyone. Our second quarter results reflect strong commercial execution and continued growth with total revenues of $1.04 billion, up 9% versus the same period last year. Total product revenues of $907 million in Q2 were driven by demand growth for Jagathai and Oxelura and increased revenue contribution from Monjuvi following our acquisition in February of the Global Exclusive Rights to Tathagata. Total royalty revenues were $137 million, up 8% compared to the second quarter of 2023, driven by an acceleration in the demand for debt.

Thank you Pablo and good morning, everyone.

Christiana Stamoulis: Our second quarter results reflect a strong commercial execution and continued growth with total revenues of $1.04 billion, up 9% versus the same period last year. Total product revenues of $907 million in Q2 were driven by demand growth for JAKAFI and OPZELURA and increased revenue contribution from MONJUVI following our acquisition in February of the global exclusive rights to TAFASITAMAB. Total royalty revenues were $137 million, up 8% compared to the second quarter of 2023, driven by an acceleration in the demand for JAKAFI. Turning to Jatafi on slide 38, Jatafi Net Product Revenues were $706 million for the second quarter. Net Product Revenues Reflect Continued Demand Growth With Pay Demand Up 9% Year-over-Year Driven by Growth in PV, GVHD, and Energy. However, year-over-year net sales growth was lower than the underlying demand growth due to higher channel inventory levels at the end of Q2 last year. At the end of Q2 2024, channel inventory was within the normal range. Turning now to Opthalura on slide 39, net product revenues for the second quarter were $122 million, representing a 52% increase year-over-year, driven by growth in new patient starts and refills across both AD and vitiligo in the U.S., as well as continuous contributions from the commercialization of Opthalura for vitiligo in use.

Our second quarter results reflect our strong commercial execution and continued growth with total revenues of one point of $4 billion up 9% versus the same period last year.

Total product revenues of $907 million in Q2 were driven by demand growth for Jakafi in oxo Lora and increase revenue contribution from one Julie following our acquisition in February of the global exclusive rights to that asset.

Total royalty revenues were $137 million up 8% compared to the second quarter of 2023, driven by an acceleration in the demand for Jack Henry.

Christiana Stamoulis: Turning to JAKAFI on slide 38. JAKAFI net product revenues were $706 million for the second quarter. Net product revenues reflect continued demand growth, with paid demand up 9% year-over-year, driven by growth in PV, GVHD and MF. Year-over-year net sales growth was lower than the underlying demand growth due to higher channel inventory levels at the end of Q2 last year. At the end of Q2 2024, channel inventory was within normal range. Turning now to OPZELURA on slide 39. Net product revenues for the second quarter were $122 million, representing a 52% increase year-over-year, driven by growth in new patient starts and refills across both AD and vitiligo in the U.S., as well as continuous contributions from the commercialization of OPZELURA for vitiligo in Europe.

Christiana Stamoulis: Turning to Jatafi on slide 38, Jatafi Net Product Revenues were $706 million for the second quarter. Net Product Revenues Reflect Continued Demand Growth With Pay Demand Up 9% Year-over-Year Driven by Growth in PV, GVHD, and Energy. However, year-over-year net sales growth was lower than the underlying demand growth due to higher channel inventory levels at the end of Q2 last year. At the end of Q2 2024, channel inventory was within the normal range. Turning now to Opthalura on slide 39, net product revenues for the second quarter were $122 million, representing a 52% increase year-over-year, driven by growth in new patient starts and refills across both AD and vitiligo in the U.S., as well as continuous contributions from the commercialization of Opthalura for vitiligo in use.

Turning to Jakafi on slide 38, Jakafi net product revenues were $706 million for the second quarter net product revenues reflect continued demand growth with demand up 9% year over year driven by growth in PV Gvhd enemy.

Christiana Stamoulis: With Pay Demand Up 9% Year-over-Year Driven by Growth in PV, GVHD, and Energy. However, year-over-year net sales growth was lower than the underlying demand growth due to higher channel inventory levels at the end of Q2 last year. At the end of Q2 2024, channel inventory was within the normal range. Turning now to Opthalura on slide 39, net product revenues for the second quarter were $122 million, representing a 52% increase year-over-year, driven by growth in new patient starts and refills across both AD and vitiligo in the U.S., as well as continuous contributions from the commercialization of Opthalura for vitiligo in use.

Year over year net sales growth was lower than the underlying demand growth due to higher channel inventory levels at the end of Q2 last year.

At the end of Q2 2024 channel inventory was within normal range.

Christiana Stamoulis: Turning now to OPZELURA on slide 39. Net product revenues for the second quarter were $122 million, representing a 52% increase year-over-year, driven by growth in new patient starts and refills across both AD and vitiligo in the U.S., as well as continuous contributions from the commercialization of OPZELURA for vitiligo in Europe. In the second quarter, Europe contributed $11 million of OPZELURA net product revenues, driven by continued uptake in Germany and France. We expect contribution from Spain and Italy to start in the Q3, with a modest contribution in that quarter due to the impact of summer vacation in Europe. Moving on to slide 14, our operating expenses in a graphic. Total R&D expenses were $1.14 billion for the second quarter, reflecting the upfront consideration paid for the acquisition of Haitian Pharmaceuticals. Excluding the impact of the up-front consideration related to ASIENT and other up-front and milestone payments, total R&D expenses were $692 million, representing a 13% increase year-over-year due to continued investment in late-stage development, The Assumption of Morphosis, Chair of the Hasidabad Development Corp., and The Timing of Death.

Turning now to absolute on slide 39, net product revenues for the second quarter were $122 million, representing a 52% increase year over year driven by growth in new patient starts and refills across both ABN vitiligo in the U S as well as continued contribution from the commercialization.

I'll first say Lauder total vitiligo in Europe.

Christiana Stamoulis: In the second quarter, Europe contributed $11 million of Auxilliary Net Product Revenues driven by continued uptake in Germany and France. We expect contribution from Spain and Italy to start in the second quarter with a modest contribution in that quarter due to the impact of summer vacation.

In the second quarter Europe contributed $11 million of absolute net product revenues driven by continued uptake in Germany and France.

We expect contribution from Spain, and Italy, starting Q3 with a modest contribution in that quarter due to the impact of summer vacation in Europe.

Christiana Stamoulis: Moving on to slide 14, our operating expenses in a graphic. Total R&D expenses were $1.14 billion for the second quarter, reflecting the upfront consideration paid for the acquisition of Haitian Pharmaceuticals. Excluding the impact of the up-front consideration related to ASIENT and other up-front and milestone payments, total R&D expenses were $692 million, representing a 13% increase year-over-year due to continued investment in late-stage development, The Assumption of Morphosis, Chair of the Hasidabad Development Corp., and The Timing of Death.

Moving on to slide 14, our operating expenses on a GAAP basis.

Christiana Stamoulis: Moving on to slide 14 and our operating expenses on a graph basis. Total R&D expenses were $1.14 billion for the second quarter, reflecting the upfront consideration paid for the acquisition of Escient Pharmaceuticals. Excluding the impact of the up-front consideration related to Escient and other up-front and milestone payments, total R&D expenses were $692 million--representing a 13% increase year-over-year due to continued investment in our late-stage development assets, the assumption of MorphoSys' share of TAFASITAMAB development cost and the timing of certain expenses. Total SG&A expenses were $306 million for the second quarter, representing an 8% year-over-year increase, primarily driven by $22 million of expense related to accelerated vesting for certain Asian stock awards and severance payments in connection with the acquisition of the company. Excluding the impact of the upfront consideration related to the acquisition of HACIEN, HACIEN expenses were flat year-over-year, excluding the impact of upfront In Q2N, in the first half of the year, total OPEC revenues grew 8% and 5%, respectively, which is below the 9% growth in total revenue.

Total R&D expenses were one point something billion dollars for the second quarter, reflecting the upfront consideration paid for the acquisition of patient pharmaceuticals.

Excluding the impact of the upfront consideration related to Asia, and other upfront and milestone payments total R&D expenses were $692 million, representing a 13% increase year over year due to continued investment in our late stage development assets the assumption of more classes share.

Speaker Change: Uh huh.

Element costs and the timing of certain expenses.

Christiana Stamoulis: Total SG&A expenses were $306 million for the second quarter, representing an 8% year-over-year increase, primarily driven by $22 million of expense related to accelerated vesting for certain Escient stock awards and severance payments in connection with the acquisition of the company. Excluding the impact of the upfront consideration related to the acquisition of Escient, SG&A expenses were flat year-over-year. Excluding the impact of upfront consideration and milestone payments in Q2 and in the first half of the year, total OpEx grew 8% and 5%, respectively--which is below the 9% growth in total revenues. indicating continued improvement in operating margin. Turning to slide 41. As previously discussed, in May, we completed the acquisition of Escient Pharmaceuticals for a total consideration of $783 million, including Escient's net cash on the balance sheet at close. The allocation of the total consideration resulted in a one-time expense of $691 million recorded under R&D expense and $20 million recorded under SG&A expense. The remaining balance was allocated to certain assets and liabilities on the balance sheet. During June, we completed a $2 billion share purchase program, reflecting our confidence in the future outlook of the business, the strengths of our commercial product portfolio and the clinical development pipeline. In total, we repurchased and cancelled approximately 33.3 million shares of our common stock--representing 14.8% of our total outstanding shares of common stock--for $60 per share. The share repurchase resulted in a reduction in our cash balance and corresponding decrease to shareholders equity.

Speaker Change: Total SG&A expenses were $306 million for the second quarter, representing an 8% year over year increase primarily driven by $22 million of expense related to accelerated vesting.

As the Nations stock awards and severance payments in connection with the acquisition of the company.

Excluding the impacts of that front consideration related to the acquisition of pace in SG&A expenses were flat year over year.

Excluding the impact of upfront consideration and milestone payments in Q2 and in the first half of the year total Opex grew 8% and 5%, respectively, which is below the 9% growth in total revenues, indicating continued improvement in operating margins.

Christiana Stamoulis: Indicating Continued Improvement in Operating, Turning to slide 41, as previously discussed, in May, we completed the acquisition of Haitian Pharmaceuticals for a total consideration of $783 million, including Haitian's net cash on the balance sheet at close. The allocation of the total consideration resulted in a one-time expense of $691,000,000 recorded under R&D expense and $20,000,000 recorded under SG&A. During June, we completed a $2 billion series purchase program, reflecting our confidence in the future outlook of The Strengths of Our Commercial Product Portfolio and the Clinical Development Pipeline. In total, we repurchased and cancelled approximately 33.3 million shares of our common stock, representing 14.8% of our total outstanding shares of common stock, for $60. The share repurchase resulted in a reduction in our cash balance and a corresponding decrease in our shareholding.

Christiana Stamoulis: Turning to slide 41. As previously discussed, in May, we completed the acquisition of Escient Pharmaceuticals for a total consideration of $783 million, including Escient's net cash on the balance sheet at close. The allocation of the total consideration resulted in a one-time expense of $691 million recorded under R&D expense and $20 million recorded under SG&A expense. The remaining balance was allocated to certain assets and liabilities on the balance sheet. During June, we completed a $2 billion share purchase program, reflecting our confidence in the future outlook of the business, the strengths of our commercial product portfolio and the clinical development pipeline. In total, we repurchased and cancelled approximately 33.3 million shares of our common stock--representing 14.8% of our total outstanding shares of common stock--for $60 per share. The share repurchase resulted in a reduction in our cash balance and corresponding decrease to shareholders equity.

Christiana Stamoulis: Turning to slide 41.

Christiana Stamoulis: As previously discussed, in May, we completed the acquisition of Escient Pharmaceuticals for a total consideration of $783 million, including Escient's net cash on the balance sheet at close. The allocation of the total consideration resulted in a one-time expense of $691 million recorded under R&D expense and $20 million recorded under SG&A expense. The remaining balance was allocated to certain assets and liabilities on the balance sheet. During June, we completed a $2 billion share purchase program, reflecting our confidence in the future outlook of the business, the strengths of our commercial product portfolio and the clinical development pipeline. In total, we repurchased and cancelled approximately 33.3 million shares of our common stock--representing 14.8% of our total outstanding shares of common stock--for $60 per share. The share repurchase resulted in a reduction in our cash balance and corresponding decrease to shareholders equity.

Turning to slide 21, as previously discussed in May we completed the acquisition of patient pharmaceuticals for total consideration of $783 million, including Asean's net cash on the balance sheet at close.

The allocation of the total consideration resulted in a one time expense of $691 million recorded under R&D expense and $20 million recorded under SG&A expense.

The remaining balance was allocated to certain assets and liabilities on the balance sheet.

Christiana Stamoulis: During June, we completed a $2 billion share purchase program, reflecting our confidence in the future outlook of the business, the strengths of our commercial product portfolio and the clinical development pipeline. In total, we repurchased and cancelled approximately 33.3 million shares of our common stock--representing 14.8% of our total outstanding shares of common stock--for $60 per share. The share repurchase resulted in a reduction in our cash balance and corresponding decrease to shareholders equity. Moving on, to our guidance for 2024. As a result of Jacka Fye's strong performance in the first half of the year, we are raising the low end of our Jacka Fye guidance from $2.69 billion to $2.71 billion. For Opselura, we expect continuous growth in the second half of the year with the typical dermatology product seasonality reflected in Q3 demand and next product sales as a result of a lower number of patient visits during the summer vacation months

During June we completed the $2 billion share repurchase program, reflecting our confidence in the future outlook of the business.

Strength of our commercial product portfolio and the clinical development pipeline.

In total, we repurchased and canceled approximately $33 3 million shares of our common stock representing 14.8% of our total outstanding shares of common stock for $60 per share.

This share repurchase resulted in a reduction in our cash balance and a corresponding decrease to shareholders' equity.

Christiana Stamoulis: Moving on to our guidance for 2024. As a result of JAKAFI's continued strong performance in the first half of the year, we are raising the low end of our JAKAFI guidance from $2.69 billion to $2.71 billion. For OPZELURA, we expect continuous growth in the second half of the year, with the typical dermatology product seasonality reflected in Q3 demand in net product sales as a result of a lower number of patient visits during the summer vacation months. Moving to R&D guidance. As a result of the acquisition of Escient, we are updating our guidance for R&D expense, excluding the impact of the upfront consideration paid, to a new range of $1.76 to $1.80 billion. While a strategic review of our clinical portfolio and decision to discontinue select programs does not have an impact on R&D expenses in 2024, it creates room to aggressively pursue and invest in the development of our priority assets and, at the same time, control the future growth of R&D expenses. Finally, we are reiterating our full year 2024 guidance for other hematology/oncology products, COGs and SG&A.

Operator: Moving on, to our guidance for 2024. As a result of Jacka Fye's strong performance in the first half of the year, we are raising the low end of our Jacka Fye guidance from $2.69 billion to $2.71 billion. For Opselura, we expect continuous growth in the second half of the year with the typical dermatology product seasonality reflected in Q3 demand and next product sales as a result of a lower number of patient visits during the summer vacation months

Moving onto our guidance for 2024 as a result of Jakafi as continued strong performance in the first half of the year. We are raising the low end of our Jackup had guidance from $2 $69 billion to two point.

$71 million.

For <unk>, we expect continued growth in the second half of the year with a typical dermatology product seasonality reflected in Q3 demand and net product sales as a result of a lower number of patient visits during the summer vacation months.

Operator: Moving to R&D guidance, as a result of the acquisition of ASIAN, we are updating our guidance for R&D expense, excluding the impact of their front consideration paid, to a new range of $1.76 to $1.80 billion. While a strategic review of our clinical portfolio and decision to discontinue select programs does not have an impact on R&D expenses in 2024, it creates room to aggressively pursue and invest in the development of our priority assets while, at the same time, controlling the future growth of R&D. Finally, we are reiterating our full year 2024 guidance for other hematology-oncology products, COGs, and SGMs.

Christiana Stamoulis: Moving to R&D guidance. As a result of the acquisition of Escient, we are updating our guidance for R&D expense, excluding the impact of the upfront consideration paid, to a new range of $1.76 to $1.80 billion. While a strategic review of our clinical portfolio and decision to discontinue select programs does not have an impact on R&D expenses in 2024, it creates room to aggressively pursue and invest in the development of our priority assets and, at the same time, control the future growth of R&D expenses. Finally, we are reiterating our full year 2024 guidance for other hematology/oncology products, COGs and SG&A. Operator, that concludes our prepared remarks. Please give your instructions and open the call's Q&A.

Moving to R&D guidance as a result of the acquisition of patient we are updating our guidance for R&D expense, excluding the impact of the upfront consideration paid to a new range of one point 76 to one point to $80 billion.

Speaker Change: Well, our strategic review of our clinical portfolio decision to discontinue the select program does not have an impact on R&D expenses in 2024, it creates room to aggressively pursue and invest in the development of our priority assets and at the same time controllers. The teacher growth also R&D expenses.

Finally, we are reiterating our full year 2020 guidance for other dermatology oncology products Cogs and SG&A.

Christiana Stamoulis: Operator, that concludes our prepared remarks. Please give your instructions and open the call's Q&A.

Operator: Operator, that concludes our prepared remarks. Please give your instructions and open the call's Q&A. We will now be conducting a question and answer session. As a reminder, we ask that you please limit yourself to one question and then return to the queue. If you would like to be placed in the question queue, please press star 1 on your telephone keypad. One moment, please, while we pull for questions. As a reminder, please limit yourself to one question and then return to the queue. Our first question today is from Kripa Devarakonda from Truist Securities. Your line is now active.

Operator, that concludes our prepared remarks. Please give your instructions and open the call's Q&A.

Operator that concludes our prepared remarks, please give your instructions and open the call to Q&A.

Operator: Certainly. We'll now be conducting a question and answer session. As a reminder, we ask you please limit yourself to one question and then return to the queue. If you would like to be placed in the question queue, please press star-1 on your telephone keypad. One moment, please, while we pull for questions. As a reminder, please limit yourself to one question and then return to the queue. Our first question today is from Kripa Devarakonda from Truist Securities. Your line is now active.

Operator: We will now be conducting a question and answer session. As a reminder, we ask that you please limit yourself to one question and then return to the queue. If you would like to be placed in the question queue, please press star 1 on your telephone keypad. One moment, please, while we pull for questions. As a reminder, please limit yourself to one question and then return to the queue.

Certainly, we'll now be conducting a question and answer session. As a reminder, we ask you. Please limit yourself to one question and then return to the queue if you'd like to be placed in the question queue. Please press star one on your telephone keypad. One moment. Please while we poll for questions. As a reminder, please limit yourself to one question and then return to the queue.

Operator: the queue. Our first question today is from Kripa Devarakonda from Truist Securities. Your line is now active.

Operator: the queue.

Our first question today is coming from cryptographic Honda come true as Securities. Your line is alive.

Operator: Our first question today is coming from Kripa Devarakonda from Truist Securities. Your line is now live.

Kripa Devarakonda: Hey, guys. Thank you so much for taking my question and congrats on the quarter. I have a question about the pipeline restructuring. Can you drill in a little bit more into the key determinants of the pipeline restructuring? For instance, you know--two questions. One is, the oral PD-L1--you had seen data, you had multiple candidates, how much did the RETIFANLIMAB data that you have from the Phase III files recently impact this decision? Thank you. I'll get back in queue.

Hey, guys. Thank you so much for taking my question and congrats on the quarter.

Have a question about the pipeline just chechnyan can you drill a little bit more into the key determinants of the pipeline restructuring.

For instance, two questions. One when is the old PDL. One you had seen data you had multiple candidates.

Speaker Change: How much did the read upon the mob.

Data that you have from the phase III trials recently impact. This decision. Thank you I'll get back in queue.

Pablo J. Cagnoni: Yes, thank you for the question. This is Pablo. The RETIFANLIMAB data did not have an impact on the pipeline restructuring. As I mentioned in my prepared remarks, the restructuring was driven primarily by two things. One, data review of existing programs--the programs that we terminated, PD-L1, TIM-3, LAG-3, and the bispecific LAG-3, as well as the continued progression and promising data that we're seeing from the early-stage pipeline that is now becoming mid-stage and will start delivering important milestones in the next 18 months. So, it was unrelated to the RETIFANLIMAB pivotal Phase results. We are excited about those results, particularly anal cancer data that we think, as I mentioned in my prepared remarks, could potentially represent the first PD-1 antibody, previously untreated squamous cell anal cancer.

Pablo J. Cagnoni: The redefining of data did not have an impact on the pipeline restructuring. As I mentioned in my prepared remarks, the restructuring was driven primarily by two things. One, Data review of existing programs, the programs that we terminated, PDOR, PDO1, TIM3, RAC3, and device-specific RAC3, as well as the continued progression and promising data that we're seeing from the early-stage pipeline that is now becoming mid-stage and will start delivering important milestones in the next 18 months.

Oh, yes. Thank you for the question. This is Pablo the they're ready finally, my data did not have an impact on the pipeline restructuring as I mentioned in my prepared remarks, the restructuring was driven primarily by two things one.

Data review of existing programs the programs that we terminated PDR of PDL, one Tim three lag three NDA by specific like three as well as a continued progression and promising data that we're seeing from the earlier stage pipeline that is now becoming mid stage and it will start delivering important milestones in the next 18 months. So he was unrelated to <unk>.

Pablo J. Cagnoni: So it was unrelated to the Retty Family Mob pivotal phase results. We are excited about those results, particularly the anal cancer data that we think, as I mentioned in my previous remarks, could potentially represent the first PD-1 antibody. Thank you. Our next question today is coming from Michael Smith from Guggenheim Partners. Or is that a lie?

So it was unrelated to the Retty Family Mob pivotal phase results. We are excited about those results, particularly the anal cancer data that we think, as I mentioned in my previous remarks, could potentially represent the first PD-1 antibody. Thank you.

Red profoundly mob pivotal phase results were.

Pablo J. Cagnoni: So, it was unrelated to the RETIFANLIMAB pivotal Phase results. We are excited about those results, particularly anal cancer data that we think, as I mentioned in my prepared remarks, could potentially represent the first PD-1 antibody, previously untreated squamous cell anal cancer.

We are excited about those results, particularly the anti cancer data that we think as I mentioned in my prepared remarks could potentially represent the first PD one antibody for previously untreated squamous cell anal cancer.

Thank you. Our next question today is coming from Michael Schmidt from Guggenheim Partners. Your line is now live.

Operator: Next question is coming from Michael Schmidt from Guggenheim Partners. Your line is now live.

And just on Jakafi and he can comment on some recent trends I know you mentioned TV in Gvhd as key drivers, but what are your go forward expectations for Jakafi in myelofibrosis, specifically in new patients in the frontline setting.

Paul Jeng: Hi, this is Paul Jeng, on for Michael. Thanks for taking our question. On [inaudible] JAKAFI--and if you could comment on some recent trends. I know you mentioned PV and GVHD as key drivers but what are your go-forward expectations for JAKAFI share in myelofibrosis, specifically in new patients in the front-line setting? You mentioned some minimal impact from competitors, would you expect that to remain the case going into the second half of the year and beyond? Thank you.

You mentioned some minimal impact from competitors would you expect that your main case going into the second half of the year end and beyond thank you.

Operator: Thank you.

Hi, Paul it's Barry Thanks for the question.

So our Triton so as everybody said in fact, we're growing.

Total patients for MF quarter quarter over quarter year over year were up 2% and in fact, new patients in the quarter for for MF.

More than that.

In fact.

We continue to see growth of MF, but PV and gvhd or really the the main growth drivers if you're asking about the competition in fact, we think those drugs.

Procrit NIM and mobile apps are being used in the second line setting for the most part.

Thank you. Your next question is coming from Brian Abrahams from RBC capital markets. Your line is now live.

Barry P. Flannelly: Hi, Paul. It's Barry. Thanks for the question. So as Hervé said, in fact, we're growing. Total patients for MF quarter-over-quarter, year over year were up 2%. And in fact, new patients in the quarter for MF were up more than that. In fact, we continue to see growth for MF but PV and GVHD are really the main growth drivers. If you're asking about competition, in fact, we think those drugs PACRITINIB and MOMELOTINIB are being used in the second-line setting for the most part.

Oh, Hey, guys. Good morning, Thanks for taking my question and congrats on the continued progress with both operationally and commercially with the pipeline.

Barry P. Flannelly: So, as Herve said, in fact, we're growing. Total patients for MS quarter over quarter, year over year, we're up 2%. And in fact, new patients in a quarter.

Barry P. Flannelly: In fact, new patients in a quarter for NF were up more than that. In fact, we continue to see growth for NF, but PV and GVHD are really the main growth drivers. If you're asking about competition, in fact, we think those drugs Procritinib and Momilotinib are being used in the second line setting for the most part.

I guess speaking of the pipeline as we look towards ESMO was in the CDK too I was wondering if you could talk a little bit more about I guess, what we should be looking for I guess, how definitive are a dataset you expect to have in terms of patient numbers of the go forward dose and what you're hoping to show to be optimally and over time to be at.

Operator: Thank you. Next question is coming from Brian Abrahams from RBC Capital Markets. Your line is now live.

Speaker Change: <unk> impactful and competitive in ovarian and also to potentially expand into breast cancer and other indications, which may be more competitive.

Brian Abrahams: Capital Markets provided by Lyon Hey guys, good morning. Thanks for taking my question and congrats on the continued progress both operationally and commercially with the pipeline. I guess, speaking of the pipeline, as we look towards ESMO and the CDK2, I was wondering if you could talk a little bit more about, I guess, what we should be looking for, I guess, how definitive a data set you expect to have in terms of patient numbers of the go-forward dose, and what you're hoping to show to be optimally impactful and competitive in ovarian and also in the

Capital Markets provided by Lyon

Brian Abrahams: Hey guys, good morning. Thanks for taking my question and congrats on the continued progress, both operationally and commercially with the pipeline. I guess, speaking of the pipeline, as we look towards ESMO in the CDK2, I was wondering if you could talk a little bit more about what we should be looking for, I guess, how definitive a data set you expect to have in terms of patient numbers of the go-forward dose? And what you're hoping to show to be optimally, over time, to be optimally impactful and competitive in ovarian and also, to potentially expand into breast cancer and other indications which may be more competitive. Thanks.

Speaker Change: Certainly so we look forward to updating you on the progress of our CDK to program at ESMO and in a couple of months.

Pablo J. Cagnoni: and also to potentially expand into breast cancer and other indications which may be more competitive. Thanks.

As I've mentioned in my.

Prepared remarks, our focus initially is ovarian cancer.

Pablo J. Cagnoni: Certainly. So, we look forward to updating you on the progress of our CDK2 program at ESMO in a couple of months. As I mentioned in my prepared remarks, our focus initially is ovarian cancer. That doesn't mean we're not doing work in other tumor types, other CCNE1 overexpressing tumor types but the focus of this initial update will be ovarian cancer. And what we expect to show during the ESMO presentation is a data set that captures the dose escalation, we just had a range of doses with a CDK2 inhibitor and different schedules as well. And we'll provide data that we believe supports the case to continue development of CDK2 inhibitors in patients with ovarian cancer and we'll provide--as well as the data update--a development path for this product, for this molecule, in patients with ovarian cancer going forward. So, it will be data updates, we have a range of doses, different schedules and the data support for the development and we'll show you a development plan as well.

Speaker Change: We're not doing work in other tumor types are another see anyone over expressing tumor types as part of that.

Focus of this initial update will.

Will it be ovarian cancer, and where we expect to show during the ESMO presentation is.

A dataset that captures the dose escalation, we tested a range of doses with our CDK <unk> inhibitor and different schedules as well and we will provide data that we believe supports the case to continue the development of CDK <unk> inhibitor in patients with ovarian cancer and will provide.

Pablo J. Cagnoni: And what we expect to show during the ESMO presentation is a data set that captures the dose escalation, we just had a range of doses with a CDK2 inhibitor and different schedules as well. And we'll provide data that we believe supports the case to continue development of CDK2 inhibitors in patients with ovarian cancer and we'll provide--as well as the data update--a development path for this product, for this molecule, in patients with ovarian cancer going forward. So, it will be data updates, we have a range of doses, different schedules and the data support for the development and we'll show you a development plan as well.

Pablo J. Cagnoni: And we'll provide data that we believe supports the case to continue the development of CDK2 inhibitors in patients with ovarian cancer, and we'll provide, as well as the data update, a development path for this product, for this molecule, in patients with ovarian cancer going forward. So there will be data updates. We have a range of doses, different schedules, and data support for the development, and we'll show you a development plan as well.

As well as the data update it development path for this product for this molecule in patients with ovarian cancer going forward. So it will be data update.

A range of doses different schedules and the data supports further development and we'll show you a development plan as well.

Operator: Thank you. Next question is coming from Vikram Purohit from Morgan Stanley. Your line is now live.

Speaker Change: Thank you. Your next question is coming from Vikram from Morgan Stanley. Your line is now live.

Unknown Caller: Hi, good morning. Thank you for taking our question. We had one on limber. So for the L2 inhibitor data expected in the second half of the year, could you walk us through what your expectations are in terms of the volume of data we may get, the amount of follow-up, and what you're setting as the threshold for deciding on next steps for the program. Yeah, Steven, I'm taking your question. So, you know, in terms of its mechanism of action, it inhibits hepcidin, which then helps in terms of iron release and hemoglobin production.

Vikram Purohit: Hi, good morning. Thank you for taking our question. We had one on LIMBER. So, for the ALK2 inhibitor data expected in the second half of the year, could you walk us through what your expectations are in terms of the volume of data we may get, the amount of follow-up and what you're setting as the threshold for deciding on next steps for the program? Thank you.

Hi, Good morning. Thank you for taking my question, we had one on limber. So for the <unk> two inhibitor data expected in the second half of the year could you walk us through what your expectations are in terms of.

Steven H. Stein: So for the L2 inhibitor data expected in the second half of the year, could you walk us through what your expectations are in terms of the volume of data we may get, the amount of follow-up, and what you're setting as the threshold for deciding on next steps for the program. Yeah, Steven, I'm taking your question. So, you know, in terms of its mechanism of action, it inhibits hepcidin, which then helps in terms of iron release and hemoglobin production.

The volume of data, we may get the amount of follow up and what youre setting as the thresholds for deciding on next steps for the program. Thank you.

Steven H. Stein: Yeah, hi. Steven, taking your question. So, in terms of its mechanism of action--it inhibits hepcidin, which then helps in terms of iron release and hemoglobin production. You know, we've shown in prior data sets that as we increase dose, we get increasing hepcidin inhibition with some variation in the hemoglobin response, which is why we've continued to dose escalate because we've had more room to do so. You know, in terms of treating myelofibrosis, there is both disease-related anemia as well as potentially drug-induced anemia from suppression of cytokines, like erythropoietin. So, the idea is to try and attend to both of those and improve patients getting anemia, either from the disease or from the drug and we'll continue to escalate. And we'll show more patients with more data at higher doses and then, potentially, look at are there development paths there that will be potentially addressable by the compound in those settings by alleviating anemia from the disease and the drug. So, it's just that it's an updated data set in higher doses.

Steven H. Stein: You know, we've shown in prior data sets that as we increase the dose, we get increasing hepcidin inhibition with some variation in the hemoglobin response, which is why we've continued to dose escalate because we've had more room to do so. You know, in terms of treating myelofibrosis, there is both disease-related anemia as well as potentially drug-induced anemia from suppression of cytokines like erythropoietin. So the idea is to try and attend to both of those and improve patients getting anemia either from the disease or from the drug. And this will continue to escalate, and we'll show you more patients with more data at higher doses and then potentially look at, you know, are there development paths there that will be potentially addressable by the compound in those settings by alleviating anemia from the disease and the drug. So it's just that it's an updated data set

Speaker Change: Yeah, Hi, it's Steven taking your question Sir.

In terms of its mechanism of action inhibits hip sodden, which then helps in terms of I N release and hemoglobin production. We've shown in prior datasets that as we increase dose we get increasing hip sodden inhibition with some variation in the hemoglobin response, which is why we've continued to dose escalate.

Because we've had more room to do so in terms of treating myelofibrosis theres, both disease related anemia, as well as potentially dragging Houston EMEA from suppression of cytokines like erythropoietin. So the idea is to try and attend to both of those and improve.

Steven H. Stein: So, the idea is to try and attend to both of those and improve patients getting anemia, either from the disease or from the drug and we'll continue to escalate. And we'll show more patients with more data at higher doses and then, potentially, look at are there development paths there that will be potentially addressable by the compound in those settings by alleviating anemia from the disease and the drug. So, it's just that it's an updated data set in higher doses.

Patients get an anemia, either from the disease from the Dragon will continue to escalate and we will show more patients with more data at higher doses and then potentially look at are there.

Development cost there that will be potentially addressable by the compounding those settings by alleviating anemia from the disease and the drug. So it's just a it's an updated data set at higher doses.

Operator: Thank you. Next question is coming from David Lebowitz from Citi. Your line is now live.

Speaker Change: Thank you next question is coming from David Lebowitz from Citi. Your line is now live.

David Neil Lebowitz: Thank you very much for taking my question. Could you comment on the demand for PV at this point going into next year? How much impact has IRA had on the numbers so far? Hi, thanks for your questions, Barry.

David Lebowitz: Hi, thank you very much for taking my question. Could you comment on the demand for PV at this point going into next year? How much impact has IRA had to this point in the numbers?

Thank you very much for taking my question could you comment on the.

Demand for PV.

Speaker Change: Going into next year and how.

How much impact because I already had to this point.

And in the numbers.

Barry P. Flannelly: Hi, thanks for your questions. It's Barry. So PV, we believe, actually is growing because of the efficacy of the product on the disease. And in fact, the most recent data from MAJIC-PV showed that the long-term efficacy for JAKAFI for those patients is quite good and we believe that that has spurred the uptake of PV and of JAKAFI in PV patients. Obviously, the IRA and the elimination of catastrophic--what patients have to pay in the catastrophic coverage area--helps all patients who are on particularly, oral chemotherapy drugs. So, we're excited about that. We're glad that that's finally happened and next year, 2025, will even be better when out-of-pocket for patients on Medicare Part D will only be $2,000. So, the growth really is coming from the efficacy of the product and we're glad that change has happened to Medicare Part D to make all oncology drugs more affordable for patients.

Yeah.

Speaker Change: Hi, Thanks for the questions Barry So PV, we believe actually is growing because of the efficacy of the product and the disease and in fact, the most recent data from Magic P. V showed that our long term efficacy.

Barry P. Flannelly: PV, we believe, is actually growing because of the efficacy of the product on the disease, and, in fact, the most recent data from Magic PV showed that the long-term efficacy of Jackify for those patients is quite good, and we believe that that has spurred the uptake of PV and of Jackify in PV patients.

For Jakafi for those patients is quite good and we believe that that has spurred the uptake of.

PV and <unk> of Jakafi in PV patients.

Barry P. Flannelly: Obviously, the IRA and the elimination of catastrophic--what patients have to pay in the catastrophic coverage area--helps all patients who are on particularly, oral chemotherapy drugs. So, we're excited about that. We're glad that that's finally happened and next year, 2025, will even be better when out-of-pocket for patients on Medicare Part D will only be $2,000. So, the growth really is coming from the efficacy of the product and we're glad that change has happened to Medicare Part D to make all oncology drugs more affordable for patients.

Obviously, the I R a and the elimination of catastrophic.

When patients have to pay any catastrophic coverage area helps all patients helps all patients who are on particularly oral <unk>.

Barry P. Flannelly: So, we're excited about that, we're glad that it's finally happened, and next year, 2025, will even be better when out-of-pocket for patients on Medicare Part D will only be $2,000. So, the growth is really coming from efficacy.

Speaker Change: Chemotherapy drugs. So we're.

We're excited about that we're glad that it's finally happened in next year 2025 will even be better when out of pocket for patients on Medicare part D will only be $2000. So the growth really is coming from the efficacy of the product and we're glad that changes happened to Medicare part D to make all oncology drugs more affordable for.

Barry P. Flannelly: Thank you for coming from the efficacy of the product, and we're glad that change has happened to Medicare Part D to make all oncology drugs more affordable for patients.

Patients.

Eric Schmidt: Thank you. The next question is coming from Eric Schmidt from Chancellor Fitzgerald. Your line is now live. Thanks for taking my question. It's on R&D spend in the portfolio prioritization. I guess on the one hand, you know, you've cut some programs.

Operator: Thank you. Next question is coming from Eric Schmidt from Cantor Fitzgerald. Your line is now live.

Thank you. Your next question is coming from Eric Schmidt from Cantor Fitzgerald. Your line is now live.

Eric Schmidt: Thanks for taking my question. It's on R&D spend and the portfolio prioritization. I guess on the one hand, you know, you've cut some programs and on the other hand, you're ticking up your R&D guidance for 2024. I presume that's in part because of the Escient acquisition. But when you think kind of big picture and strategically around how much a company like Incyte should be investing in R&D, I do think you're still the industry high in terms of R&D as percent of sales. What is your sort of solution to what a proper investment is in R&D at this stage? All right, thank you for having me here.

Thanks for taking my question it's on <unk>.

R&D spend than the portfolio prioritization I guess on the one hand, you have cut some programs.

Eric Schmidt: On the other hand, you're taking up your R&D guidance for 2024. I presume that's in part because of the Eshin acquisition. But when you think kind of big picture and strategically around how much a company like Incyte should be investing in R&D, I do think you're still the industry leader in terms of R&D.

Weather had you're ticking up your R&D R&D guidance for 2024, and I presume that's in part because of the <unk> acquisition, but when do you think kind of big picture, it's strategically around how much a company like insight should be investing in R&D do you think you're still be industry high in terms of R&D as a percent of sales.

Eric Schmidt: Of R&D's percent soils, what is your sort of solution to what a proper investment is in R&D at this stage?

What is your sort of solution to toward a proper investment is already at this stage.

Hervé Hoppenot: Eric, thank you for--Hervé here. Thank you for the question because it's obviously something that has been sort of driving a lot of our thinking in the past few months. I mean, our first approach to R&D spending is a project-specific financial rationale. So, if you take any of these projects that Pablo went through--and there are 12 [inaudible] there--you can look at, does it make sense to develop this? Is that an investment that is reasonable for a product of this type? And you can--you can go through the list from 12D to TGF-beta to, obviously, 617F and CALR and each of the projects is first submitted to that test, saying, 'does it make sense, independently from the rest of the portfolio, to develop this product?'. And obviously, we came to that conclusion for the projects that are moving forward and either because of certain data or because of the competitive situation, we came to the opposite conclusion for some of the projects that we listed today. So, that's the first thing. And then, the second one is, is that something that Incyte can do by ourselves or should we look for other sources of financing for this project or partnering, if we believe that it's something that we cannot do by ourselves? And that's why we came up with this list of projects where, by stopping some of them, we are creating room for the new projects. We are also seeing some of the historical projects coming to an end, like RETIFANLIMAB and like, we will see a decrease of the investment in TAFASITAMAB over the next few months, as we are finishing the follicular study and next year will be the end of the first-line study. So, there is a movement where some projects are decreasing and some projects are being stopped. And all of that is creating room to, as was described by Christiana, basically maintain a reasonable R&D spend with improving ratios. And what Christiana just said is, as you see the evolution of the P&L, we have been consistently improving the ratios with the decreasing percentage of revenue in R&D and in SG&A. So, that's the big picture. It's going to happen at a pace that is over the next few years, it's not like one-time events where suddenly there is a big change in the number but a lot of the spirit of what was described today is prioritize resources to high potential programs in the pipeline. And I hope you could see from Pablo's discussion that there are a number of them and at the same time, you know, stop programs where we are not in a good competitive position or the data is not confirming what we were expecting at the beginning of the program.

Herve Hoppenot: All right, thank you for having me here. Thank you for the question, because it's obviously something that has been sort of driving a lot of our thinking in the past few months. I mean, our first approach to, our understanding is the project-specific Financial Rational. So if you take any of these projects that Pablo went through, and there are 12 MCs there, you can look at, does it make sense to develop this? Is that an investment that is reasonable for a product of this type?

All right, thank you for having me here.

Alright. Thank you for everybody here. Thank you for the question because it folks you'll see some things that have been.

Thank you for the question, because it's obviously something that has been sort of driving a lot of our thinking in the past few months. I mean, our first approach to, our understanding is the project-specific Financial Rational. So if you take any of these projects that Pablo went through, and there are 12 MCs there, you can look at, does it make sense to develop this? Is that an investment that is reasonable for a product of this type? And you can, you can go through the list from 12B to TGS Paylar to, obviously, 617F and Calar, and each of the projects is first submitted to that test, saying, does it make sense, independently from the rest of the portfolio, to develop this product? And obviously, we came to that conclusion for the projects that are moving forward. And either because of certain data or because of the competitive situation, we came to the opposite conclusion for some of the projects that we listed. So that's the first thing. And then the second question is, is that something that Incyte can do by itself, or should we look for other sources of financing for this project or partners if we believe that it's something that we can do by ourselves? And that's why we came up with this list of projects where, by stopping some of them, we are creating room for new projects. We are also seeing some of the historical projects coming to an end, like Oetitandimab, and we will see a decrease in the investment in Tapasitamab over the next few months, as we are finishing the follicular study, and next year will be the end of the first-line study So there is a movement where some projects are being scaled back, and some projects are being stopped. And all of that is creating room to, as was described by Christophe, basically maintain a reasonable R&D span with improving ratios. What Kripa has just said is, as you see the evolution of the P&L, we have been consistently improving the ratios, with a decreasing percentage of revenue in R&D and in HCM. So that's the big picture. It's going to happen at... You know, a pace that is over the next few years, it's not like one-time events where suddenly there is a big change in the number, but a lot of the spirit of what was described today is prioritized resources to high potential programs in the pipeline, and I hope you could see from Pago's discussion that there are a number of them, and at the same time, you know, stop programs where we are not in a good competitive position, you know, the data is not confirming what we were expecting at the beginning.

So that's driving a lot of our thinking in the past few months I mean, well.

First approach to.

R&D spending is a project specific financing shuttle rational. So you should take any of these projects by Blue went through them that 12 and six there you can look at does it make sense to develop it is that the investment that is reasonable for a product of this type and you can you can go through.

Herve Hoppenot: And you can, you can go through the list from 12B to TGS Paylar to, obviously, 617F and Calar, and each of the projects is first submitted to that test, saying, does it make sense, independently from the rest of the portfolio, to develop this product? And obviously, we came to that conclusion for the projects that are moving forward. And either because of certain data or because of the competitive situation, we came to the opposite conclusion for some of the projects that we listed. So that's the first thing.

Leased from 12 D to TGF beta two obviously 60 70, nerf and color on each of the projects is first submitted to that.

I mean does it make sense independently from the rest of the portfolio to develop this product. Obviously, we came to the conclusion for the projects that are moving for a while and either because of some data or because of the competitive situation that we came to the opposite conclusion for some of the projects in that.

Hervé Hoppenot: And obviously, we came to that conclusion for the projects that are moving forward and either because of certain data or because of the competitive situation, we came to the opposite conclusion for some of the projects that we listed today. So, that's the first thing. And then, the second one is, is that something that Incyte can do by ourselves or should we look for other sources of financing for this project or partnering, if we believe that it's something that we cannot do by ourselves? And that's why we came up with this list of projects where, by stopping some of them, we are creating room for the new projects. We are also seeing some of the historical projects coming to an end, like RETIFANLIMAB and like, we will see a decrease of the investment in TAFASITAMAB over the next few months, as we are finishing the follicular study and next year will be the end of the first-line study. So, there is a movement where some projects are decreasing and some projects are being stopped. And all of that is creating room to, as was described by Christiana, basically maintain a reasonable R&D spend with improving ratios. And what Christiana just said is, as you see the evolution of the P&L, we have been consistently improving the ratios with the decreasing percentage of revenue in R&D and in SG&A. So, that's the big picture. It's going to happen at a pace that is over the next few years, it's not like one-time events where suddenly there is a big change in the number but a lot of the spirit of what was described today is prioritize resources to high potential programs in the pipeline. And I hope you could see from Pablo's discussion that there are a number of them and at the same time, you know, stop programs where we are not in a good competitive position or the data is not confirming what we were expecting at the beginning of the program.

Herve Hoppenot: And then the second question is, is that something that Incyte can do by itself, or should we look for other sources of financing for this project or partners if we believe that it's something that we can do by ourselves?

Listed today. So that's the first thing and then there's still going to one is is that something that insight can do.

Our self or should we look for other sources of of.

Financing for this project or partnering if we believe that it's something that we can do by yourself and that's where we came with this list of project where by stopping some of them. We are creating room for the new project. We are also seeing some of the.

Herve Hoppenot: And that's why we came up with this list of projects where, by stopping some of them, we are creating room for new projects. We are also seeing some of the historical projects coming to an end, like Oetitandimab, and we will see a decrease in the investment in Tapasitamab over the next few months, as we are finishing the follicular study, and next year will be the end of the first-line study So there is a movement where some projects are being scaled back, and some projects are being stopped.

Hervé Hoppenot: We are also seeing some of the historical projects coming to an end, like RETIFANLIMAB and like, we will see a decrease of the investment in TAFASITAMAB over the next few months, as we are finishing the follicular study and next year will be the end of the first-line study. So, there is a movement where some projects are decreasing and some projects are being stopped. And all of that is creating room to, as was described by Christiana, basically maintain a reasonable R&D spend with improving ratios. And what Christiana just said is, as you see the evolution of the P&L, we have been consistently improving the ratios with the decreasing percentage of revenue in R&D and in SG&A. So, that's the big picture. It's going to happen at a pace that is over the next few years, it's not like one-time events where suddenly there is a big change in the number but a lot of the spirit of what was described today is prioritize resources to high potential programs in the pipeline. And I hope you could see from Pablo's discussion that there are a number of them and at the same time, you know, stop programs where we are not in a good competitive position or the data is not confirming what we were expecting at the beginning of the program.

Historical project coming to M N liquidity from the mob and like we will see a decrease of the investment in tougher because tomorrow, but over the next few months as we are finishing the particular study in the next year would be the end of the first line study. So there is a movement, where some projects are decreasing some project not being stuck.

Speaker Change: And all of that is creating room to as was described by Chris.

Christina <unk>.

Herve Hoppenot: And all of that is creating room to, as was described by Christophe, basically maintain a reasonable R&D span with improving ratios. What Kripa has just said is, as you see the evolution of the P&L, we have been consistently improving the ratios, with a decreasing percentage of revenue in R&D and in HCM. So that's the big picture. It's going to happen at... You know, a pace that is over the next few years, it's not like one-time events where suddenly there is a big change in the number, but a lot of the spirit of what was described today is prioritized resources to high potential programs in the pipeline, and I hope you could see from Pago's discussion that there are a number of them, and at the same time, you know, stop programs where we are not in a good competitive position, you know, the data is not confirming what we were expecting at the beginning.

Basically maintain a reasonable R&D spend within the with the improving ratios with Christopher I. Just said is as you see the evolution of the P&L, we have been consistently improving the ratios with the decreasing.

Hervé Hoppenot: And what Christiana just said is, as you see the evolution of the P&L, we have been consistently improving the ratios with the decreasing percentage of revenue in R&D and in SG&A. So, that's the big picture. It's going to happen at a pace that is over the next few years, it's not like one-time events where suddenly there is a big change in the number but a lot of the spirit of what was described today is prioritize resources to high potential programs in the pipeline. And I hope you could see from Pablo's discussion that there are a number of them and at the same time, you know, stop programs where we are not in a good competitive position or the data is not confirming what we were expecting at the beginning of the program.

Some page of revenue in R&D.

SG&A.

So that's the big picture is going to happen.

You know a pace that is over the next few years, it's not like one time event, where southern visa is a big change in the number but a lot of this period of what was described today is prioritized resources to high but on shuttle program in the pipeline and I Hope you could see.

Speaker Change: Some fabulous discussions that there are a number of them and at the same time.

Stop programs, where we are not in a good competitive position or did I not confirming what we were expecting at the beginning of the program.

Operator: Thank you. The next question is coming from James Shin from Deutsche Bank. Your line is now live.

Thank you next question is coming from Jamie Shen from Deutsche Bank. Your line is now live.

James Shin: Hi, good morning. For the LAG-3 asset, was it lack of differentiation from an existing asset that led to this discontinuation? Any color on what you saw or did not see from the LAG-3 would be helpful. Thank you.

Jamie Shen: Hi, good morning.

The lag three assets was it lack of differentiation from existing assets.

Continuation any color on what you saw we did not see from the lack of it would be helpful. Thank you.

Pablo J. Cagnoni: Yes, thank you for the question. The most important point, I think, for the LAG-3 programs--both the monoclonal antibody and the bispecific--was the competitive landscape, quite honestly. You know, we are behind--in both cases--far behind our competitors. There's a LAG-3, obviously, approved in combination with PD-1 and there's at least one bispecific LAG-3 that is well ahead of us, already in randomized trials. So, that was the main determinant. When it comes to data, we'll decide what is the right time and setting is to disclose some of the data that we've seen with those programs.

Okay.

Yes. Thank you for the question.

They're the most important point I think for the lag three program supports the monoclonal antibody in the bi specific whereas the competitive landscape quite honestly.

You know we are behind in both cases far behind our competitors because of like three obviously approved in combination with PD, one and there's at least one by specific like three that is well ahead of us already randomized trials. So that was the main determinant. When it comes to data will decide what is the right time and setting to do this.

Close some of the data that we've seen with those programs.

Yeah.

Operator: Thank you. Next question today is coming from Jessica Fye from J.P. Morgan Chase. Your line is now live.

Jamie Shen: Thank you. Your next question today is coming from Jessica Fye from JP Morgan Chase. Your line is now live.

Jessica Fye: Supplied from J.P. Morgan Street, the line is now live.

Jessica Fye: Thanks for taking my question. Looking ahead to the proof of concept data for the MRGPRX4 antagonist in PBC and PSC coming up next year, should we think about the data shared by Mirum in PBC as a potential benchmark you would like to meet? I think they showed around a 2.3 point placebo-adjusted difference on the Adult daily ItchRO score in PBC. And then, if I could sneak in a bigger picture one just for Pablo. Now that he's been at Incyte for about a year and has had some time to get to know the pipeline better, where do you think investors should spend more time and what do you think will be the company's most important pipeline asset if we look at, say, three years from now? Thanks. I think we are excited about that program, particularly in the case of the continuous need for better provider control in patients with PVC and PSC, particularly PSC, there are really no good alternatives out there that have been approved. So the benchmark for MIRM is a reasonable place to start. One of the things we like about X2 and X4, by the way, about 262 and 547, is the great safety profile we've seen so far. So stay tuned; we'll provide an update early next year.

Thanks for taking my question.

I had two the proof of concept data for the emerging pure export antagonist in PBC and PSC coming up next year should we think about the data shared by near them in PBC is a potential benchmark you'd like to meet I think they showed around at 2.3 point placebo adjusted difference on the adult daily interest score in PBC.

Jessica Fye: And then if I could only think,

Jessica Fye: 3.3.3.3.3.3.3.3.3. And then I could sneak in a bigger picture one, just for Pablo.

And then if I could sneak in a bigger picture one for Pablo.

Pablo J. Cagnoni: Now that he's been at Incyte for about a year and has had, Transcribed by https://otter.ai and what do you think will be the company's most important pipeline assets if we look at... I think we are excited about that program, particularly in the case of the continuous need for better provider control in patients with PVC and PSC, particularly PSC, there are really no good alternatives out there that have been approved. So the benchmark for MIRM is a reasonable place to start. One of the things we like about X2 and X4, by the way, about 262 and 547, is the great safety profile we've seen so far. So stay tuned; we'll provide an update early next year.

Pablo: Any insight for about a year and have had some time to get to know the pipeline better where do you think investors should spend more time.

What do you think will be the company's most important pipeline assets. If we look out say three years from now.

Pablo J. Cagnoni: I think we are excited about that program, particularly the continuous need for better provider control in patients with PBC and PSC. Particularly PSC, there's really no good alternatives out there that have been approved. So, the benchmark from Mirum is a reasonable place to start. One of the things we like about both X2 and X4, by the way--about 262 and 547--is the great safety profile we've seen so far. So, stay tuned--we'll provide an update early next year. When it comes to the second part of your question, if you look at slide 14--and it's hard to pick favorites from that slide--I think that I am very excited about some of the programs that are in the pipeline. I think that if you go vertical by vertical, I think obviously the acquisition of Escient with both the X2 and the X4 antagonists--those are potential both first-in-class programs that address a number of potential indications. I think in oncology, the near-term CDK2 data reveal is something that we're very excited about. And I think that when you look at our TGF-beta receptor x PD-1 bispecific, we have taken a unique approach to those two pathways that we think could be a big differentiator. And MPNs, of course, I have to mention--I'm using CALR and 617F programs, both of which are not just first-in-class but they're a unique way to address patients with MPNs and potentially change disease outcomes by changing the natural history of the disease. So, I think those are the areas where I would say, today, we have the most excitement inside the company. And I would add, by investigators outside the company that is showing by how quickly some of the studies are occurring.

I think we are excited about that program, particularly in pace.

The continuous need for better pruritus control in patients with PBC and PSC, a particular PSC, there's there's really no good alternatives out there.

There have been approved so the benchmark premium is a reasonable place to start one of the things we like about both X two X four by the way about 262 and 547.

Pablo J. Cagnoni: When it comes to the second part of your question, if you look at slide 14--and it's hard to pick favorites from that slide--I think that I am very excited about some of the programs that are in the pipeline. I think that if you go vertical by vertical, I think obviously the acquisition of Escient with both the X2 and the X4 antagonists--those are potential both first-in-class programs that address a number of potential indications. I think in oncology, the near-term CDK2 data reveal is something that we're very excited about. And I think that when you look at our TGF-beta receptor x PD-1 bispecific, we have taken a unique approach to those two pathways that we think could be a big differentiator. And MPNs, of course, I have to mention--I'm using CALR and 617F programs, both of which are not just first-in-class but they're a unique way to address patients with MPNs and potentially change disease outcomes by changing the natural history of the disease. So, I think those are the areas where I would say, today, we have the most excitement inside the company. And I would add, by investigators outside the company that is showing by how quickly some of the studies are occurring.

Great safety profile, we've seen so far so stay tuned we'll provide an update early next year.

Pablo J. Cagnoni: When it comes to the second part of your question, if you look at slide 14, and it's hard to pick favorites from that slide, I think that I am very excited about some of the programs that are in your pipeline. I think that if you go vertical by vertical, I think obviously the acquisition of Essien with both the X2 and the X4 antagonists, those are potential first-in-class programs that address a number of potential indications.

When it comes to the second part of your question. If you look at slide 14, and it's hard to pick favorites from that slide.

I think that I am very excited about some of the programs are all your pipeline I think that if you go vertical by vertical I think obviously the acquisition.

Oh firsthand with both the X two X four antagonist those are potential both first in class programs that address a number of potential indications I think in oncology the near term CDK to data reveal it's something that we're very excited about and I think that when you look at our TGF beta receptor by PD one by <unk>.

Pablo J. Cagnoni: I think in oncology, the near-term CDK2 data reveal something that we're very excited about. And I think that when you look at a TGA failure receptor by PD-1 specifically, we have taken a unique approach to those two pathways that we think could be a big differentiator. And MPNs, of course, as you mentioned, I'm using COLAR and 617x programs, both of which are not just first-in-class, but they're a unique way to address patients with MPNs and potentially change disease outcomes by changing the natural history of the disease.

Pablo J. Cagnoni: And I think that when you look at our TGF-beta receptor x PD-1 bispecific, we have taken a unique approach to those two pathways that we think could be a big differentiator. And MPNs, of course, I have to mention--I'm using CALR and 617F programs, both of which are not just first-in-class but they're a unique way to address patients with MPNs and potentially change disease outcomes by changing the natural history of the disease. So, I think those are the areas where I would say, today, we have the most excitement inside the company. And I would add, by investigators outside the company that is showing by how quickly some of the studies are occurring.

<unk>.

We have taken a unique approach to those two pathways that we think could be a big differentiator and an M. P ends of course I have to mention our mutant color in six months have a nice programs both of which are not just first in class, but there are unique way to address patients with mpls and potentially change disease outcomes like changing the natural history of the disease. So.

Pablo J. Cagnoni: So I think those are the areas where I would say today we have the most excitement inside the company, and I would add by investigators outside the company that are showing by how quickly some of the studies are occurring.

I think those are the areas, where I would say today, we have the most excitement inside the company and I would I would add by investigators outside the company that is show in by how quickly. Some of these studies are a crime.

Yeah.

Operator: Thank you. Next question today is coming from Jay Olson from Oppenheimer & Company. Your line is now live.

Thank you next question today is coming from Jay Olson from Oppenheimer <unk> Company. Your line is now live.

Jay Olson: Oh, hey. Congrats on the quarter and thanks for taking the question. There are some recent publications showing synergistic efficacy from combining JAK inhibitors with PD-1 antibodies. Can you please share your takeaways from those publications and does Incyte have plans to develop a JAK inhibitor such as POVORCITINIB in combination with PD-1 antibodies for oncology? Thank you.

Oh, Hey, congrats on the quarter and thanks for taking the question.

Speaker Change: There were some recent publications showing synergistic efficacy from combining JAK inhibitors with PD. One antibodies can you. Please share your takeaways from those publications and.

It does inside have plans to develop a JAK inhibitors, such as <unk>, who are sitting there in combination with PD one antibodies for oncology. Thank you.

Steven H. Stein: Yes, Jay. It's Steven. Thanks for the question. There were two simultaneous publications that were intriguing, showing that potentially, JAK inhibition can modulate the T cell environment in a positive way and enhance checkpoint inhibition. However, our own experience in the past has not been as successful clinically. So, I don't know if you remember but years ago, we tried JAK inhibition on its own in several solid tumors based on an inflammatory hypothesis with C-reactive protein and unfortunately, those endeavors were negative. We also did some work in investigating initiated work in combination with PD-1 and JAK inhibitors. Although we didn't have clinical data, some of the translational data didn't show the right directional changes in T cells. But, you know, you are correct in that those two simultaneous papers re-ignited some interest and we'll re-look at it but there are no current R&D sponsored plans there. Thank you.

Speaker Change: Yeah, Jay it's Steven Thanks for the question. They were two simultaneous publication that was intriguing showing that potentially JAK inhibition can modulate the T cell environment in a positive way and enhance checkpoint inhibition. However, our own experience in the past has not been as successful clinically so.

I don't know if you remember but years ago, we tried JAK inhibition on its own in several solid tumors based on an inflammatory hypothesis with C reactive protein and unfortunately, those endeavors were negative we also did some work and.

Steven H. Stein: We also did some work in investigating initiated work in combination with PD-1 and JAK inhibitors. Although we didn't have clinical data, some of the translational data didn't show the right directional changes in T cells. But, you know, you are correct in that those two simultaneous papers re-ignited some interest and we'll re-look at it but there are no current R&D sponsored plans there.

Steven H. Stein: We also did some work, investigating initiated work in combination with PD-1 and JAK inhibitors. Although we didn't have clinical data, some of the translational data didn't show the right directional changes in T cells. But you know, you're correct in that those two simultaneous papers reignited some interest, and we'll re-look at it, but there are no current R&D sponsored plans there. Thank you.

An investigator initiated work in combination with PD, one with JAK inhibitors, although we didn't have clinical data some of the translational data didn't show the right directional changes in T cells, but you are correct in that those two simultaneous papers has reignited some interest and will relocate it but no current R&D sponsored plans.

Sure.

Thank you.

Jay Olson: Thank you.

Operator: Thank you. Next question is coming from Evan Seigerman from BMO Capital Markets. Your line is now live.

Thank you next question is coming from Evan <unk> from BMO capital markets. Your line is now live.

Christiana Stamoulis: Alright, thank you so much for taking my question today. You know, with your recently completed large-scale share repurchase, how much capacity do you have left for further business development? And could you walk us through some of the rationale for doing such a large-scale share repurchase versus, say, doing a larger acquisition to bolster the pipeline? Hi Evan, it's Christiana.

Evan Seigerman: Hey, guys. Thank you so much for taking my question today. You know, with your recently completed large-scale share repurchase, how much capacity do you have left for further business development? And could you walk us through some of the rationale of doing such a large-scale share repurchase versus, say, doing a larger acquisition to bolster the pipeline?

Hey, guys. Thank you so much for taking my questions today.

<unk> recently completed a large shareholder share repurchase how much capacity do you have left for further business development.

Speaker Change: Walk us through some of the rationale of doing such a large scale share repurchase versus say doing a larger acquisition to bolster the pipeline.

Christiana Stamoulis: Hi, Evan. It's Christiana. So, first of all, the share repurchase that we did reflect the confidence that we have in the outlook of the business, both driven by this progress on the commercial front but also very much so by the evolving pipeline and all the excitement behind the programs that Pablo discussed. So, we saw a very big disconnect between the long-term value that we see in the company versus what has been reflected in the stock price. Thus, the decision to do the share repurchase. The size of the share repurchase was enabled by the fact that we have a very strong balance sheet and we were in a position to both do a big share purchase and, at the same time, retain financial flexibility for more BD if we chose to do so. As you saw today, we have a very exciting pipeline so, there is a lot of focus on moving forward our internal programs but we are in a position to opportunistically bring in additional opportunities if we believe these are opportunities where we can add value.

Christiana Stamoulis: So first of all, this purchase that we did reflected the confidence that we have in the outlook of the business, both driven by progress on the commercial front, but also very much so by the evolving pipeline and all the excitement behind the programs that Pablo discussed. So we saw a very big disconnect between the long-term value that we see in the company versus what has been reflected in the stock price.

Hi, Evan it's Chris.

Yeah. So first of all the share repurchase that we did reflect the confidence that we have in the outlook of the business, but driven.

Driven by progress on the commercial front, but are also very much so by the evolving pipeline and all the.

The excitement behind the programs that tableau discussed so we saw a big disconnect between the long term value that we see in the company is actually the WAC has been reflected in the stock price is.

Christiana Stamoulis: That was the decision to do the share purchase. The size of the share purchase was enabled by the fact that we had a very strong balance sheet and we were in a position to both do a big share purchase and, at the same time, retain financial flexibility for more BD if we chose to do so. So we ended the quarter with $1.5 billion in cash. We don't have any debt, which gives us additional firepower to be able to pursue BD if we decide to do so.

Speaker Change: That is the decision to do the share repurchase the size of the share repurchase.

It's enabled by the fact that we have a very strong balance sheet and we're in a position to both do.

<unk> share repurchase and at the same time our.

Christiana Stamoulis: The size of the share repurchase was enabled by the fact that we have a very strong balance sheet and we were in a position to both do a big share purchase and, at the same time, retain financial flexibility for more BD if we chose to do so. As you saw today, we have a very exciting pipeline so, there is a lot of focus on moving forward our internal programs but we are in a position to opportunistically bring in additional opportunities if we believe these are opportunities where we can add value.

Retain financial flexibility for more BD, if we choose to do so.

Speaker Change: So we ended the quarter was $1 5 billion in cash we don't have any debt, which gives us additional firepower.

Speaker Change: To.

Be able to pursue BD equal if we decided to do so.

Christiana Stamoulis: As you saw today, we have a very exciting pipeline. So there is a lot of focus on moving forward our internal programs, but we are in a position to opportunistically bring in additional opportunities if we believe these are opportunities where we can add value.

As you saw today.

We have if they.

Exciting pipeline. So there is a lot of focus on moving forward are intact.

Speaker Change: Programs, but we are in a position to opportunistically, bringing.

Additional opportunities if we believe these are opportunities, where we can add value.

Speaker Change: Yeah.

Operator: Thank you. Next question is coming from Marc Frahm from TD Cowen. Your line is now live.

Thank you next question is coming from Mark <unk> from TD calendar. Your line is now live.

Unknown: Hi, this is Alex, on for Marc. Thanks so much for taking my question. For OPZELURA, could you quantify the impact of the preferred formulary placement you achieved for 2024? And do you view these contracts as having been successful so far and would you maybe expect to negotiate any additional deals for the 2025 prime year? Thanks.

Hi, This is Alex on for Mark. Thanks, So much for taking my question for obsolete or could you quantify the impact of the preferred formulary placements you see for 2024 and do you view these contracts and how they've been successful so far and would you maybe expect to negotiate any additional deals for the 2025 plan here. Thanks.

Unknown Caller: For Apsalura, could you quantify the impact of preferred formulary placement?

Unknown Caller: for 2024. Do you view these contracts as having been successful so far and

Unknown Caller: So far, and would you maybe expect to negotiate any additional deals for the 2025 prime Year?

Matteo Trotta: Hi, Alex. Matteo here. Yes. So, the preferred positions that we gained this year in CBS was one of the key contributors to the OPZELURA growth that we're experiencing this year. In addition to that, obviously, we're seeing patients on CBS benefit from an easier and improved accessibility to OPZELURA. And it gives us the insight, the opportunity to better execute the support programs that we have in place for all the commercial eligible patients. In terms of expecting for the future, we have a plan for 2025, which we are executing while we speak. We'll continue to bring up some new data that we have. Very interesting from a PBM and payer perspective, the real-world evidence of OPZELURA. And we expect that we continue to improve our access going forward and utilization management, wherever it's feasible and possible. With always keeping in mind that every step we take in that direction will have to be improving our net sales line.

I like my theory here, yes, so for the preferred position that.

Speaker Change: We gained DCF and and Cvs, who is one of the key contributors to the obsolete.

Expediency DCF in addition to that obviously, we're seeing patients.

Yes benefit from an easier and improved accessibility to obsolete.

Speaker Change: Andy gave <unk> the opportunity to better execute the support programs that we have in place for all the commercial eligible patients in terms of expecting for the future. We have a plan for 2025, which we are executing a while we speak will continue to bring up some.

Matteo Trotta: In terms of expectations for the future, we have a plan for 2025, which we are executing while we speak. We'll continue to bring up some new data that we have. Very interesting from a PBM and payer perspective, the real-world evidence of ObSaluta, and we expect that we will continue to improve our access going forward and utilization management wherever it's feasible and possible. With always keeping in mind that every step we take in that direction will have to improve our net sales line.

Matteo Trotta: In terms of expecting for the future, we have a plan for 2025, which we are executing while we speak. We'll continue to bring up some new data that we have. Very interesting from a PBM and payer perspective, the real-world evidence of OPZELURA. And we expect that we continue to improve our access going forward and utilization management, wherever it's feasible and possible. With always keeping in mind that every step we take in that direction will have to be improving our net sales line.

Speaker Change: New data that we have a very interesting from a P. B M. M. P. A perspective, the real world evidence of <unk> and we expect that we continue to improve our access going forward and utilization management wherever its feasible and possible with always keeping in mind it.

Every step we take in that that axiom will have to be.

Improving the net sales line.

Operator: Thank you. Next question is coming from Reni Benjamin from Citizens JMP. Your line is now live.

Thank you next question is coming from Ren Benjamin from citizens JMP. Your line is now Matt.

Reni Benjamin: Hey, guys. Thanks for taking the questions. I guess I'd love to get your latest thoughts on TAFASITAMAB now that you've acquired the rights to that asset; how you're thinking about it and what the market opportunity is for frontline, you know, as well as follicular in MCL, especially given everything that you've learned from the relapsed/refractory DLBCL market and kind of the challenges there. Thanks.

Hey, guys. Thanks for taking the questions I guess I'd love to get your latest thoughts on path to sit in that now.

Herve Hoppenot: Now that you've acquired the rights to that asset and how you're thinking about it and what the market opportunity is for frontline, you know, as well as follicular and MPL, especially given everything that you've learned from the relapsing of the grassroots DLPCL market and kind of the challenges there.

Speaker Change: You've acquired the rights to that asset.

Speaker Change: You know kind of how you're thinking about it and what the market opportunity is for frontline as well as Follicular and M. C L, especially given everything that you've learned from the relapsed refractory <unk> B C. All market and kind of the challenges there.

<unk>.

Hervé Hoppenot: I think I will--maybe I can start and Barry can speak in more detail. I mean, the picture on TAFASITAMAB, obviously, was--the financial picture of TAFASITAMAB was changed when we basically got for free the full rights of the product. I mean, that was the transaction at the beginning of the year. Where it puts us now is facing the two Phase III studies that we have ongoing. We will have very soon, in the next few weeks, the result of the follicular lymphoma--assuming, if it's positive, it would obviously give us an opportunity. It's not enormous in size, it's very competitive but there is a lot of upside for the brand. At the stage where we are on this new indication, it would be a large randomized study so, it will add to the clinical profile of the product across all indications. So, that's the first step. And then, there is a first-line coming in 2025, where if positive and depending on the size of the benefits that is observed, could have a larger potential for the brand. I think the positioning of MONJUVI and MINJUVI in Europe and the U.S. is really driven by the fact that the efficacy that you see is at a very low cost, in term of safety and side effects. So, that was the ratio of efficacy and safety that we observed with--MONJUVI is very unique compared to the rest of the competition. And it has space that I think will, depending on the data that we see, will be important. It's not going to be a brand that is in the multi-billion range but it's going to be a brand that can increase by a few hundred millions and I think it will be a good contribution to the portfolio.

We're thinking Oh, maybe I can stop and Barry can speak in more detail.

Two of them come up obviously with.

Speaker Change: The financial picture of Bevacizumab with challenged when Oh, we basically got.

For free.

Right. So good product I mean that was a transaction at the beginning of the year, where it lets us know is facing the two phase III studies that we have ongoing we will have very soon in the next few weeks. So a result of the $42 for MA assuming if it's positive it will obviously give us.

The opportunity is not it's not enormous in size.

Fairly competitive, but there is a lot of upside.

Hervé Hoppenot: At the stage where we are on this new indication, it would be a large randomized study so, it will add to the clinical profile of the product across all indications. So, that's the first step. And then, there is a first-line coming in 2025, where if positive and depending on the size of the benefits that is observed, could have a larger potential for the brand. I think the positioning of MONJUVI and MINJUVI in Europe and the U.S. is really driven by the fact that the efficacy that you see is at a very low cost, in term of safety and side effects. So, that was the ratio of efficacy and safety that we observed with--MONJUVI is very unique compared to the rest of the competition. And it has space that I think will, depending on the data that we see, will be important. It's not going to be a brand that is in the multi-billion range but it's going to be a brand that can increase by a few hundred millions and I think it will be a good contribution to the portfolio.

Herve Hoppenot: And then there is a first line coming in 2025, where if positive and depending on the size of the benefits that are observed, could have a larger potential for the I think the positioning of Monjuvi and Ninjuvi in Europe and the US is really driven by the fact that the efficacy that you see is at a very low cost in terms of safety and side effects. So that the ratio of efficacy and safety that we observe with Monjuvi is very unique compared to the rest of the competition.

For the brand.

The stage, where we are in this new indication it would be a large randomized study. So it will add to the clinical profile of the product across all indications. So that's the first step and then there is a first line coming in 2025 well.

It is depending on the size of the benefit that is observed.

Speaker Change: Have a larger potential photos.

I think the positioning of our module B I mean, Julien in Europe, and the U S.

It's really driven by the fact that the efficacy that you see is at the very low cost into almost 50.

Hervé Hoppenot: So, that was the ratio of efficacy and safety that we observed with--MONJUVI is very unique compared to the rest of the competition. And it has space that I think will, depending on the data that we see, will be important. It's not going to be a brand that is in the multi-billion range but it's going to be a brand that can increase by a few hundred millions and I think it will be a good contribution to the portfolio.

Speaker Change: Side effects, so that was a ratio of efficacy safety that we observed with <unk>.

Speaker Change: Module B is very unique compared to the rest of the competition.

Herve Hoppenot: And it has space that I think will, depending on the data that we see, will be important. It's not going to be a brand that is in the multi-billion range, but it's going to be a brand that can increase by a few hundred million, and I think it will be a good contribution to the portfolio.

Speaker Change: And it has a space that I think we lose.

Well, depending on the data that we see.

It will be important it's not going to be a brand that is in the multi billion around but it's going to be a bomb.

Speaker Change: <unk> increased by a few hundred millions and I think it would be a good contribution to the portfolio.

Barry P. Flannelly: Yeah. I mean, Hervé really said it all but, you know, we are excited about follicular and marginal zone. There's combined--there's about 12,500 patients that are treated in those settings, in the second-line plus setting so, yes, it's competitive but particularly for follicular lymphoma, R2 is currently the market leader in the second-line setting in follicular lymphoma and obviously, adding TAFA to it, we hope to improve the outcome for patients and in the first-line setting for diffuse large B-cell lymphoma when we have that data next year. And hopefully, the addition of TAFA to R-CHOP will actually improve the lives of patients. In fact, you know, we're hoping to, obviously, improve cure rates and there's 30,000 patients in our frontline diffuse large B-cell lymphoma patients. And then, our study is really concentrating on IPIs three and higher. So anyway, so the opportunity for us is there, as long as the data is what we hope it to be. I think we'll have success, as Hervé said but in both situations--diffuse large B-cell lymphoma and in indolent lymphoma--it's a very competitive market but we think we have a profile of a drug that physicians and patients will want to use.

Yeah, I mean, everybody really said it all but we are excited about the follicular and marginal zone.

Barry P. Flannelly: Unknown, you know there are about 12,500 patients that are treated in those settings in the second line plus setting. So yes, it's competitive, but particularly for flicker lymphoma, R Squared is currently the market leader in the second line setting for flicker lymphoma, and obviously, adding CAPA to it, we hope to improve the outcome for patients. And the first line setting for diffuse large base lymphoma when we have that data next year, and hopefully, the addition of CAPA to our job will actually improve the lives of patients.

Speaker Change: Combined is about 12500 patients that are treated in those settings in the second line plus.

Setting so yes, it's competitive but particularly for Follicular lymphoma R. Squared is currently.

Market leader in the second line setting in Follicular lymphoma, and obviously, adding pathway to it we hope to improve the outcome for patients and in the first line setting for diffuse large b cell lymphoma, when we have that data next year and hopefully.

Barry P. Flannelly: And hopefully, the addition of TAFA to R-CHOP will actually improve the lives of patients. In fact, you know, we're hoping to, obviously, improve cure rates and there's 30,000 patients in our frontline diffuse large B-cell lymphoma patients. And then, our study is really concentrating on IPIs three and higher. So anyway, so the opportunity for us is there, as long as the data is what we hope it to be. I think we'll have success, as Hervé said but in both situations--diffuse large B-cell lymphoma and in indolent lymphoma--it's a very competitive market but we think we have a profile of a drug that physicians and patients will want to use.

Barry P. Flannelly: In fact, you know, we're hoping to obviously improve cure rates, and there are 30,000 patients in our frontline diffuse large basal lymphoma patients, and then, you know, our study is really concentrating on IPIs three and higher. So anyway, so the opportunity for us is there, as long as the data is what we hope it to be. I think we'll have, you know, success, as Herve said, but in both situations, it's useful, like B-cell lymphoma and in indolent lymphoma. It's a very competitive market, but we think we have a profile of a drug that physicians and patients will want to use.

Speaker Change: The addition of a task.

Speaker Change: To our job will actually improve the lives of patients and in fact, you know, we're hoping to obviously improve cure rates and there's 30000 patients in frontline diffuse large b cell.

Home of patients in our study is really concentrating on.

<unk> three and higher.

So.

Speaker Change: So anyway, so the opportunity for US is there as long as the data is what we hope it to be I think it will have.

Speaker Change: Our successes are they said, but in both situations diffuse large b cell lymphoma and in.

Speaker Change: Indolent lymphoma, it's a very competitive market, but we think we have a profile of a drug that.

Physicians and patients will want to use.

Operator: Thank you. Next question is coming from Kelly Shi from Jefferies. Your line is now live.

Kelly Shi: Thank you. Your next question is coming from Kelly <unk> from Jefferies. Your line is now live.

Unknown: Hi, good morning. This is Claire, on for Kelly. Thanks for taking our question and congrats on the quarter. So, just a quick one on OPZELURA. Could you help us understand the growth in that trend during the quarter and how should we think about it in the upcoming quarter? And what is the kind of latest mix you're seeing between atopic derm and vitiligo and how are you thinking about the pediatric uptick in 2025? Thank you.

Kelly Shi: Hi, Good morning. This is Claire on for Kelly.

Claire: Our question congrats on the quarter.

Just a quick one on lobster.

Speaker Change: Could you help us understand the question.

And how should we think about it.

Speaker Change: Quarter.

And what would kind.

Speaker Change: Kind of latest mix, you're seeing between impossible.

Speaker Change: And how are you thinking about the pediatric uptake in 2025. Thank you.

Okay.

Christiana Stamoulis: Hi, Clare. It's Christiana. Let me take the first part of the question regarding OPZELURA and gross-to-net. So, gross-to-net in Q2 was broadly in line with where we were last Q2 so, the growth really was driven by demand here. In terms of going forward, as we have discussed in the past, we are not focusing on gross-to-net in isolation but on net sales and there is where the focus is. If there are situations where we believe that there is an opportunity to improve positioning, to improve access by giving some additional discount and that would lead to a disproportionate increase in demand and, therefore, net sales--we are going to pursue it. But looking at gross-to-net in isolation is not something that we will be doing and providing separate forward guidance for GTN--gross-to-net. Yes. And I can take the other two pieces, Matteo here. One is the split between atopic dermatitis and non-segmental beta-ligo, which is currently 60-40. And it's a great indication for us because when we see And then the third piece of your question, I believe, was about sizing, the potential for the pediatric indication. We definitely see that one, the potential label expansion of Obstellura for patients 12 to 11 years old with atopic dermatitis, a driver of continuous growth. The patient population is quite sizable. We see 2 million patients with AD in the age range, and they are mostly treated with PCIs and PCFs today. So this is a great opportunity for us. And in terms of sizing, we see the contribution to our total AD business in the future from pediatric indications in the range of 10-15% of their business, which is fairly in line with what we see from other therapies in the same space for the same age range.

Yeah, Hi, Klas Christiana, let me take the first part of the question regarding upsell around gross to net so gross to net in Q.

It was a broker.

Broadly in line with where we were last Q2. So the growth really was driven by by demand here and in terms of going forward task, we have discussed in the past that.

Christiana Stamoulis: But looking at Gross2Net in isolation is not something that we will be doing and providing separate forward guidance for GPA growth. Yes, and I can take the other two pieces, Matteo here. One is the split between atopic dermatitis and non-segmental beta-ligo, which is currently 60-40. And it's a great indication for us because when we see

Christiana Stamoulis: [inaudible]

Speaker Change: We are not focusing on the gross to net in isolation, but oh lets say so there is where the focus is.

If there are situations, where we believe that.

There is an opportunity to improve positioning to improve access by giving some additional discount and that would lead to this proportionate increase in demand and therefore net sales we are going to pursue it but oh.

Speaker Change: Looking at the rest of that in isolation is not something that we will be doing and are providing separate.

Matteo Trotta: Yes. And I can take the other two pieces, Matteo here. One is the split between atopic dermatitis and non-segmental vitiligo, which is currently 60-40. And it's a great indication for us because when we see the split being consistent, the growth is coming from both indications. And then, the third piece of your question, I believe was on the sizing--the potential of the pediatric indication. We see definitely that one, the potential label expansion of OPZELURA for patients 12 to 11 years old with atopic dermatitis, a driver of continuous growth. The patient population is quite sizable. We see 2 million patients with AD in the age range and mostly treated with TCIs and TCFs today. So, great opportunity for us. And in terms of sizing, we see the contribution to our total AD business in the future from pediatric indications in the range of 10%, 15% of their business, which is fairly in line with what we see from other therapies in the same space for the same age range.

Speaker Change: Guidance for GP.

Gross to net.

Matteo Trotta: And then the third piece of your question, I believe, was about sizing, the potential for the pediatric indication. We definitely see that one, the potential label expansion of Obstellura for patients 12 to 11 years old with atopic dermatitis, a driver of continuous growth. The patient population is quite sizable. We see 2 million patients with AD in the age range, and they are mostly treated with PCIs and PCFs today. So this is a great opportunity for us.

Samantha: Yes, I can take the attitude PC Samantha here one is the split between our atopic dermatitis and non segmental vitiligo, which is currently 60 40, and it's a great indication for us because when we see displays being consistent the growth is coming from both indication and then the.

Third piece of your question I believe was on the sizing that potential of the pediatric indication.

We see definitely that won the potential label expansion of them to Luna for patients to have to 11 years old in atopic dermatitis and drive of our continuous growth.

Matteo Trotta: The patient population is quite sizable. We see 2 million patients with AD in the age range and mostly treated with TCIs and TCFs today. So, great opportunity for us. And in terms of sizing, we see the contribution to our total AD business in the future from pediatric indications in the range of 10%, 15% of their business, which is fairly in line with what we see from other therapies in the same space for the same age range.

Matteo Trotta: patient population is quite sizable. We see 2 million patients with AD in the age range and mostly treated with TCIs and TCFs today. So, great opportunity for us. And in terms of sizing, we see the contribution to our total AD business in the future from pediatric indications in the range of 10%, 15% of their business, which is fairly in line with what we see from other therapies in the same space for the same age range.

Population is quite sizable we see 2 million patients with a D. In the age range and mostly mostly treated with TC I's and T's yesterday, so great opportunity for us and in terms of sizing are we.

Matteo Trotta: And in terms of sizing, we see the contribution to our total AD business in the future from pediatric indications in the range of 10-15% of their business, which is fairly in line with what we see from other therapies in the same space for the same age range.

We see the contribution to our total S. A D business in the future from a pediatric indication in the range of 10% 15% of their business, which is fairly in line with what we see from out of therapies aimed at same space for the same age range.

Andrew Berens: Thank you. Our next question today is coming from Andrew Berens from SBB Security, who is on the line. Hi, thanks, and it's very important to have news beyond that stage of our existence. But I have a couple of questions.

Operator: Thank you. Our next question today is coming from Andrew Berens from SVB Securities. Your line is now live.

Thank you. Our next question today is coming from Andrew Berens from SBB keep SBB Securities. Your line is now live.

Andrew Berens: Hi. Thanks and it's Leerink Partners. We're glad to have moved beyond that stage of our existence. But a couple of questions. I was wondering if you could give us some color on the JAKAFI XR program? It seems as if you could have the PK/PD data this year and should we plan on getting an update ahead of the stability data? And then, for the CALR and JAK2 selective programs, I know it's early but what do you think a pivotal program would look like? Would the endpoints be similar to JAKAFI with an SVR35 rate and would you have to compare JAKAFI head-to-head or would you start in later stages of the disease and move forward? Thanks for taking my questions.

Hi, Thanks.

Speaker Change: <unk> Leerink partners.

And beyond that.

Each of our existence, but a couple of questions.

Andrew Berens: I was wondering if you could give us some color on the Jackify XR program. It seems as if you could have the PK PD data this year, and should we plan on getting an update ahead of the stability data? And then for the Cal R and Jack T selected programs. I know it's early, but what do you think a pivotal program would look like? Would the endpoints be similar to JACA files with an SBR 35 rate? Would you have to compare Jacobite head-to-head, or would you start in later stages of the disease and move forward?

I'm wondering if you could give us some color on the Jakafi XR program. It seems as if you could have the PK PD data this year and should we plan on giving an update ahead of the stability data and then for the Cal or Jack to selective programs.

It's early but what do you think a pivotal program would look like with the endpoints to be similar to Jakafi with SVR thirty-five rates and would you have to compare to Jakafi head to head or would you start in later stages of the disease and move forward.

Steven H. Stein: Thanks for taking my questions.

Speaker Change: Thanks for taking my questions.

Steven H. Stein: And Steven, thanks for your question. On Jackify XR, as Pablo had pointed out in his slide, he pointed to the pivotal BE data, the bioequivalence data, coming in the early part of 2025, next year, and then as the stability delivers towards the sort of third quarter, that's when we would file that indication, should everything be directionally correct, and then get an approval in 2026. So that's, you know, within what we said we would deliver for XR, and we await that pivotal BE data for which the study's starting very soon. For CalR and G617F, again, to expand on Pablo's comments, you know, it's still early days for both programs, obviously, in dose escalation, with enormous promise, in terms of a totally new mindset around disease modification-potentially-cure because of eradication of the malignant clone. And in those entities, I mean, it's still early days; we'd have to discuss with regulators whether there is a completely different way of viewing the diseases and not look at the traditional Jack inhibition pathway for SVR35 and total symptom score in terms of, you know, eradicating the clone and removing the malignancy and the associated morbidity from it. There are potentially other regulatory pathways which we'll explore at that time. So thank you for bringing that up, because it could be a completely new way of thinking about it. Your next question is coming from Gavin Clark Gardner from Evercore ISI. Your line is now live.

Steven H. Stein: Hey, Andrew. It's Steven, thanks for your question. On JAKAFI XR, as Pablo had in his slides, he pointed to the pivotal BE data--the bioequivalence data--coming in the early part of 2025 next year. And then, as the stability delivers towards the sort of third quarter, that's when we would file that indication--should everything be directionally correct. And then, get an approval in 2026. So, that's within what we said we would deliver for XR and we await that pivotal BE data for which the study's starting very soon. For CALR and G617F, again, to expand on Pablo's comments, it's still early days for both programs, obviously, in dose escalation with enormous promise--in terms of a totally new mindset around disease modification-potentially cure because of eradication of the malignant clone. And in those entities, I mean, it's still early days; we'd have to discuss with regulators, is there is a completely another way of viewing the diseases and not look at the traditional JAK inhibition pathway for SVR35 and total symptom score in terms of eradicating the clone and removing the malignancy and the associated morbidity from it. There are potentially other regulatory pathways which we'll explore at that time. So, thank you for bringing that up because it could be a completely new way of thinking about those entities.

Yeah, Andy it's Steven Thanks for your question on Jakafi XR as Pablo had any slides he pointed to the pivotal <unk> data the bioequivalence data coming in the early part of 2025 next year and then as the stability delivers towards the sort of third quarter. That's when we would file that indication should ever.

Can be directly correct and then get a.

In 2026, so that's you know.

Within what we said we would deliver for XR and we await that pivotal <unk> data for which the study starting very soon for <unk> 600, <unk> again to expand on public comments.

Steven H. Stein: For CALR and G617F, again, to expand on Pablo's comments, it's still early days for both programs, obviously, in dose escalation with enormous promise--in terms of a totally new mindset around disease modification-potentially cure because of eradication of the malignant clone. And in those entities, I mean, it's still early days; we'd have to discuss with regulators, is there is a completely another way of viewing the diseases and not look at the traditional JAK inhibition pathway for SVR35 and total symptom score in terms of eradicating the clone and removing the malignancy and the associated morbidity from it. There are potentially other regulatory pathways which we'll explore at that time. So, thank you for bringing that up because it could be a completely new way of thinking about those entities.

Steven H. Stein: For CalR and G617F, again, to expand on Pablo's comments, you know, it's still early days for both programs, obviously, in dose escalation, with enormous promise, in terms of a totally new mindset around disease modification-potentially-cure because of eradication of the malignant clone. And in those entities, I mean, it's still early days; we'd have to discuss with regulators whether there is a completely different way of viewing the diseases and not look at the traditional Jack inhibition pathway for SVR35 and total symptom score in terms of, you know, eradicating the clone and removing the malignancy and the associated morbidity from it.

Speaker Change: It's still early days with both programs, obviously in dose escalation with enormous promise in terms of a totally new mindset around disease modification dash potentially cure because of eradication of the malignant clone and in those entities I mean, it's still early days, we would have to discuss with regulators is there a completely now.

The way of viewing the diseases and not look at the traditional JAK inhibition pathway for SVR 35 in total symptom score in terms of eradicating the clone and removing the malignancy and the associated morbidity from it there are potentially other regulatory pathways, which will explore at that time. So thank you for bringing it.

Steven H. Stein: There are potentially other regulatory pathways which we'll explore at that time. So thank you for bringing that up, because it could be a completely new way of thinking about it. Your next question is coming from Gavin Clark Gardner from Evercore ISI. Your line is now live.

Because it could be a completely new way of thinking about those entities.

Operator: Thank you very much. Next question is coming from Gavin Clark-Gartner from Evercore ISI. Your line is now live.

Thank you. Our next question is coming from gathering Clark Gardner from Evercore ISI. Your line is now live.

Gavin Clark: Hey guys, I just wanted to ask another question about tacocitamibs; what are your latest thoughts on developing autoimmune diseases and how are you doing? Yes, thank you for the question. So, look, as Everett mentioned, when we acquired full rights for TEPLA-Cyclamide early this year and knew that we had a near-term febrile readout as well as another one next year, that led us to rethink a little bit about whether the level of investment in that program is adequate. And quite honestly, we're in the middle of that process. We're obviously aware of all the data with TG19-targeted therapies and autoimmune disease.

Gavin Clark-Gartner: Hey, guys. I just wanted to ask another question about TAFASITAMAB. What are your latest thoughts on developing in autoimmune diseases and how are you making that position? Thanks.

Hey, guys I just wanted to ask another question about <unk> what are your latest thoughts on developing an autoimmune diseases and how are you making that decision.

Pablo J. Cagnoni: Yes, thank you for the question. So look, as Hervé mentioned, when we acquired full rights for TAFASITAMAB early this year and knowing that we have a near-term pivotal readout as well as another one next year, that led us to rethink a little bit about whether the level of investment in that program is adequate. And quite honestly, we're in the middle of that process. We're obviously aware of all the data with CD19-targeted therapies in autoimmune disease. We're conducting a full evaluation as well as interactions with external scientists to really understand, A, what's the opportunity for TAFA at this point in AI from the mechanistic point of view; what's the competitive landscape, what does it look like and what are the remaining opportunities that we can go after with a reasonable and prudent level of investment. So, we're doing that evaluation literally as we speak. We'll have an update, probably, on that later this year.

Yes. Thank you for the question. So look as I mentioned, when we acquired full rights for tough transit time I've already this year and knowing that we have a near term pivotal readouts as well as another one next year allowed us to rethink a little bit about whether the level of investment in that program is adequate.

And quite honestly, we're in the middle of that process. We're obviously aware of all the data we'd seen in 19 targeted therapies and autoimmune disease, we're conducting a full evaluation as well as our interactions with external scientists to really understand a what's your opportunity for tough at this point in AI from the mechanistic point of view what's the.

Pablo J. Cagnoni: We're obviously aware of all the data with CD19-targeted therapies in autoimmune disease. We're conducting a full evaluation as well as interactions with external scientists to really understand, A, what's the opportunity for TAFA at this point in AI from the mechanistic point of view; what's the competitive landscape, what does it look like and what are the remaining opportunities that we can go after with a reasonable and prudent level of investment. So, we're doing that evaluation literally as we speak. We'll have an update, probably, on that later this year.

Pablo J. Cagnoni: We're conducting a full evaluation as well as interactions with external scientists to really understand, A, what's the opportunity for TAPA at this point in AI from the mechanistic point of view? What's the competitive landscape? What does it look like?

Pablo J. Cagnoni: And what are the remaining opportunities that we can go after with a reasonable and prudent level of investment? So, we're doing that evaluation literally as we speak. We'll have an update on that later this year. Thank you. Our final question today is coming from Salveen Richter from Goldman Sachs. Your line is now live.

And what are the remaining opportunities that we can go after with a reasonable and prudent level of investment? So, we're doing that evaluation literally as we speak. We'll have an update on that later this year.

Competitive landscape, what does it look like and what are the remaining opportunities that we can go after with a reasonable and prudent level of investments. So we're doing that evaluation.

Really as we speak we'll have an update probably on that later this year.

Operator: Thank you. Our final question today is coming from Salveen Richter from Goldman Sachs. Your line is now live.

Yeah.

Thank you. Our final question today is coming from Celgene Rector from Goldman Sachs. Your line is alive.

Salveen Richter: Good morning, thank you for taking my question. On the back of the portfolio prioritization and the Escient acquisition, do you feel comfortable at the current time that you can offset JAKAFI LOEs and grow beyond as well? Thank you.

Good morning. Thank you for taking my question on the back of that portfolio prioritization and the <unk> acquisition do you feel comfortable at the current time that you can offset jakafi Louise and beyond as well. Thank you.

Salveen Richter: and on the back of the Portfolio Prioritization and the Estiant Acquisition, do you feel comfortable at the current time that you can offset Sacrify LOEs and grow beyond as well? Thank you.

Hervé Hoppenot: Thank you, Salveen. Maybe I'll take that. I mean, it's obviously the whole purpose of our investment in R&D is to more than compensate for what could be the expiration of the current product. So, you can look at the size--I mean, the guidance we have on JAKAFI that has been there for a number of years is around $3 billion by--at peak sales. So, we are way--very much on the way to get there. And when you look at the number of projects, we are speaking of 10 launches in the next few years, we are speaking of 12 NCEs that we have in development--I mean, that would be, each of them with a potential that is meaningful, that would be certainly way more than what we need to just compensate for JAKAFI. So, the view--and obviously, it will depend on the clinical success we have with this project--but the view is that today our portfolio is very much giving us a growth profile that goes beyond JAKAFI's patent expiration.

Thank you Fredrik, maybe I'll take that I mean, it's obviously the water.

Herve Hoppenot: I mean, it's obviously the world... The purpose of our investment in R&D is to more than compensate for what could be the expiration of the current product, so... You can look at, you know, the size, I mean, the guidance we have on Jessica Fye that has been there for a number of years is around 3 billion by, uh, at peak sales, so we are way, very much on the way to get there, and when you look at the number of projects, we are speaking of 10 launches in the next few years, we are speaking of 12, 12 NCs that we have in development, I mean, that would be, Each of them with a potential that is meaningful, that would be certainly way more than what we need to just compensate for Jessica Fye.

Well most of our investment in R&D is to more than compensate for what could be your exploration of the gum products. So you can look at the size I mean, the guidance. We havent Jakafi has been therefore, an umbrella of Europe is around 3 billion buy a stick sales so.

We're very much on the way to get there and when you look at the number of projects. We are speaking of 10 launches in the next few years. We are speaking of 12 12 and sees that we have in development I mean that would be each of them with the potential for this meeting.

Hervé Hoppenot: And when you look at the number of projects, we are speaking of 10 launches in the next few years, we are speaking of 12 NCEs that we have in development--I mean, that would be, each of them with a potential that is meaningful, that would be certainly way more than what we need to just compensate for JAKAFI. So, the view--and obviously, it will depend on the clinical success we have with this project--but the view is that today our portfolio is very much giving us a growth profile that goes beyond JAKAFI's patent expiration.

Speaker Change: Meaningful that would be certainly we're more than what we need to just compensate project. That's right. So the view and obviously it will depend on the clinical success, we have with this project, but the view is that today our portfolio is very much giving us gross profile that goes beyond the jakafi bathroom fixtures.

Herve Hoppenot: So the view, and obviously, it will depend on the clinical success we have with this project, but the view is that today our portfolio is very much giving us a growth profile that goes beyond Jessica Fye's patent exploration.

Okay.

Operator: Thank you. We've reached the end of our question and answer session. I'd like to turn the call back over for any further closing comments. Thank you all for participating in the call today.

Operator: Thank you. We've reached the end of our question and answer session. I'd like to turn the call back over for any further closing comments.

Thank you we reached end of our question and answer session I would like to turn the floor back over for any further or closing comments.

Ben Strain: Thank you all for participating in the call today. Any questions, the IR team will be available for the rest of the day. Thank you and goodbye.

Thank you all for participating in the call today and your questions. The IR team will be available for the rest of the day, Thank you and goodbye.

Operator: That's all today and for your questions; the IR team will be available for the rest of the day. Thank you and goodbye.

Operator: Thank you. That does conclude today's teleconference webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.

Thank you that does conclude today's teleconference and webcast you may disconnect. Your lines. After this time and have a wonderful day, we thank you for your participation today.

Q2 2024 Incyte Corp Earnings Call

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