Q1 2024 Incyte Corp Earnings Call

Operator: - question and answer session will follow the formal presentation. You may be placed into the question queue at any time by pressing Star 1 on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Ben Strain, Associate Vice President, Investor Relations. Please go ahead, Ben.

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

Ben Strain: Thank you, Kevin. Good morning and welcome to Incyte's First Quarter 2024 Earnings Conference Call. Before I 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 call. On today's call, I'm joined by Hervé, Pablo, 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 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 hand the call over to Hervé.

Ben Strain: 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 hand the call over to Herve.

Hervé Hoppenot: Thank you, Ben and good morning everyone. Before I get into the quarterly results, I'm pleased to share that Matteo Trotta has recently joined Incyte as General Manager of our U.S. Dermatology Business Unit reporting to me. Matteo comes to us from Novartis where he was responsible for the immunology business in the U.S. and he will be leading the US dermatology team at Incyte to continue to grow OPZELURA, prepared for the launches of povorcitinib and other promising IAI pipeline products in the coming years. Now turning to our Q1 results. Total revenue grew 9% in Q1 versus last year. And I will discuss in the next slide the details of the underlying demand growth for Jakafi and OPZELURA to clarify the performance of both brands in Q1. Starting with JAKAFI on Slide 6. In the first quarter, JAKAFI net product revenue of $572 million does not fully reflect the demand growth as total patients increased 5% in the first quarter versus the same quarter last year, with growth driven by PV and GVHD. Sequential growth versus Q4 was also strong in all indications, as you see on the graph on the right.

Herve Hoppenot: Now turning to our Q1 results. Total revenue grew 9% in Q1 versus last year, and I will discuss on the next slide the details of the underlying demand growth for Jaka Fye and Obseroa to clarify the performance of both brands in Q1, starting with Jessica Fye on slide 6. In the first quarter, Jakafi's net product revenue of $572 million does not fully reflect the demand growth as total patients increased 5% in the first quarter versus the same quarter last year, with growth driven by PV and GVH. However, sequential growth versus Q4 was also strong in all indications, as you can see on the graph on the right.

Herve Hoppenot: In the first quarter, Jakafi's net product revenue of $572 million does not fully reflect the demand growth as total patients increased 5% in the first quarter versus the same quarter last year, with growth driven by PV and GVH. However, sequential growth versus Q4 was also strong in all indications, as you can see on the graph on the right. Jessica Fye's channel inventory reduction in the first quarter had a negative impact on net revenues of approximately $55 million.

In the first quarter, Jakafi's net product revenue of $572 million does not fully reflect the demand growth as total patients increased 5% in the first quarter versus the same quarter last year, with growth driven by PV and GVH. However, sequential growth versus Q4 was also strong in all indications, as you can see on the graph on the right.

Hervé Hoppenot: JAKAFI channel inventory reduction in the first quarter had a negative impact on net revenues of approximately $55 million. Based on the strong patient demand since this quarter and anticipated growth for the balance of the year, we are reiterating our full year 2024 JAKAFI net revenue guidance of $2.69 billion to $2.75 billion. Turning to Slide 7 and looking at JAKAFI, total paid demand by indication during the first quarter of '22, '23 and 2024. As you can see, total paid demand growth in the top left corner continues to be strong. MF in the top right is consistent year-after-year, and the largest growth is coming from PV and GVHD. Additionally, JAKAFI continues to maintain its leadership and market share in myelofibrosis. Based on market research, total patient market share and discontinuation rate have remained stable in the first-line setting over the past several months with virtually no impact from competitors, which has been consistent with our expectations.

Herve Hoppenot: Based on the strong patient demand since this quarter and anticipated growth for the balance of the year, we are reiterating our full-year 2024 JCAFI Net Revenue Guidance of $2.69 to $2.75. Turning to slide 7 and looking at Jacka Fye's total paid demand by indication during the first quarter of 2022-2023 and 2023-2024, as you can see, total pay demand growth in the top left corner continues to MF in the top right is consistent year after year, and the largest growth is coming from PV and GVS. Additionally, Jakafi continues to maintain its leadership and market share in myelofibrosis. Based on market research, total patient market share and discontinuations rate have remained stable in first-line selling over the past several months with virtually no impact from competitors, which has been consistent with our expectations.

Herve Hoppenot: Additionally, Jakafi continues to maintain its leadership and market share in myelofibrosis. Based on market research, total patient market share and discontinuations rate have remained stable in first-line selling over the past several months with virtually no impact from competitors, which has been consistent with our expectations. Moving to Obstetrics and Gynecology.

Additionally, Jakafi continues to maintain its leadership and market share in myelofibrosis. Based on market research, total patient market share and discontinuations rate have remained stable in first-line selling over the past several months with virtually no impact from competitors, which has been consistent with our expectations.

Hervé Hoppenot: Moving to OPZELURA. Total OPZELURA net product revenues in the first quarter were $86 million, up 52% when compared to the same quarter last year. The weekly prescription trend, as shown on the right of Slide 8, reflects continued growth of OPZELURA in both atopic dermatitis and vitiligo, with typical Q1 seasonality. U.S. total prescriptions for Opzelura grew 41% year-over-year, outpacing the total AD market, which grew 23%. The AD market, including OPZELURA, was impacted by the Change Healthcare Cyber Attack, particularly in March. Importantly, we are beginning to see in April a rebound in filled prescription to level seen before the cyber-attack. From an access perspective, we have seen early encouraging results since OPZELURA moved in January to preferred position in the CVS network, as TRX growth within the CVS network outpaced growth seen in other plants.

Herve Hoppenot: Total obstetrics and gynecology network revenues in the first quarter were 86 million, up 52% when compared to the same quarter last year. The weekly prescription trend, as shown on the right of slide 8, reflects continued growth of Obsteroar in both atopic dermatitis and vitiligo. Typical Q1 seasonally, U.S. total prescriptions for Obstellura grew 41% year-over-year, outpacing the total AD market, which grew 23%. The crowded market, including Opselora, was impacted by the Chinese healthcare cyber-attack. Particularly in the mouth. Importantly, we are beginning to see in April a rebound in field prescriptions to levels seen before the cyberattack. From an access perspective, we have seen early and encouraging results since Obselora moved in January to a preferred position in the CVS network, as TRX growth within the CVS network outpaced growth seen in other.

Herve Hoppenot: Importantly, we are beginning to see in April a rebound in field prescriptions to levels seen before the cyberattack. From an access perspective, we have seen early and encouraging results since Obselora moved in January to a preferred position in the CVS network, as TRX growth within the CVS network outpaced growth seen in other. Moving to slide 9, as discussed in the past, we are on track to provide 10 high-impact launches by 2030. Importantly, many of the programs highlighted on this slide are de-risked, as they are post-proof of concept, including Axa-Telimab, which has been submitted to the FDA for approval, Roxolitinib cream in Pediatric AD to be submitted to the FDA in Q3, and Povositinib, where we are in phase three, in HS and DT-LIGO, and initiating a phase three

Importantly, we are beginning to see in April a rebound in field prescriptions to levels seen before the cyberattack. From an access perspective, we have seen early and encouraging results since Obselora moved in January to a preferred position in the CVS network, as TRX growth within the CVS network outpaced growth seen in other.

Hervé Hoppenot: Moving to Slide 9, as discussed in the past, we are on track to provide 10 high-impact launches by 2030. Importantly, many of the programs highlighted on this slide are de-risked as they are post-proof-of-concept, including Axatilimab, which has been submitted to the FDA for approval, Ruxolitinib Cream in Pediatric AD to be submitted to the FDA in Q3, and povorcitinib where we are in Phase III in HS and Vitiligo and initiating a Phase III study in prurigo nodularis later this year. Moving to slide 10, In addition to our internal efforts to deliver multiple launches by 2030, we recently announced an agreement to acquire Escient Pharmaceuticals for $750 million with cash on hand. This acquisition further strengthens our pipeline with two novel first-in-class medicines, EP262 and EP547, which have the potential to treat a broad range of inflammatory disorders. I will now turn the call over to Pablo.

Herve Hoppenot: We're probably going to do our list later this year. Moving to slide 10. In addition to our internal efforts to deliver multiple launches by 2030, we recently announced an agreement to acquire Essient Pharmaceuticals for $750 million with cash on hand. This acquisition further strengthens our pipeline with two novel first-in-class medicines, EP-262 and EP-547, which have the potential to treat a broad range of inflammatory disorders. I will now turn the call over to Pablo.

Pablo J. Cagnoni: Thank you, Hervé. And good morning, everyone. In the first quarter, we continue to make solid progress across our pipeline, which is focused on three areas, MPNs and graft-versus-host disease, oncology, and inflammatory diseases. In MPNs and graft-versus-host disease, we initiated a Phase I study earlier this quarter with a JAK2V617F inhibitor. As a reminder, the JAK2V617F mutation is the most common somatic mutation in myeloproliferative neoplasms 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, 058 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. Together with our anti-mutant CALR program, these two potentially disease-modifying programs represent a fundamentally new approach to addressing MF, ET, and PV and could help to solidify our leadership in MPNs.

Pablo J. Cagnoni: Together with our Anti-Mutant Call Out Program, these two potentially disease-modifying programs represent a fundamentally new approach to addressing MF, ET, and PV and could help to solidify our leadership in MPN. As previously disclosed, we submitted BLA-4-axetilimab for the treatment of third-line chronic rafferty's hose disease late last year. In February, the filing was accepted for prior review, and we anticipate a decision by the FDA in the second half of 2024. We are excited by the possibility of bringing new treatment options to patients with this devastating complication of hematopoietic stem cell transplantation.

Together with our Anti-Mutant Call Out Program, these two potentially disease-modifying programs represent a fundamentally new approach to addressing MF, ET, and PV and could help to solidify our leadership in MPN.

Pablo J. Cagnoni: As previously disclosed, we submitted the BLA for AXATILIMAB for the treatment in third-line chronic graft-versus-host disease late last year. In February, the filing was accepted for prior review, and we anticipate a decision by the FDA in the second half of 2024. We are excited by the possibility of bringing a new treatment options to patients with this devastating complication of hematopoietic stem cell transplant. In oncology, we continue to build out a robust pipeline with the potential to deliver meaningful innovation for patients. This quarter, we initiated a Phase I study with our KRASG12D inhibitor, INCB161734. INCB161734 is a potent, selective, and orally bioavailable KRASG12D inhibitor. And as highlighted at AACR earlier this month, it has shown excellent efficacy in several preclinical models. With no currently approved G12D targeting agents, 734 could address an important patient need as a KRASG12D mutation is found in 40% of pancreatic ductal adenocarcinoma, 15% of colorectal cancers, and 5% of non-small cell lung cancers. In dermatology, we continue to maximize the potential of RUXOLITINIB Cream and POVORCITINIB and believe the acquisition of Escient Pharmaceuticals, will substantially expand our II pipeline by adding 2 first-in-class medicines with the potential to address a number of medical needs.

Pablo J. Cagnoni: In oncology, we continue to build out a robust pipeline with the potential to deliver meaningful innovation for patients. This quarter, we initiated a phase one study with our KRAS G12D inhibitor, INCB161734. 734 is a potent, selective, and orally bioavailable KRAS D12T inhibitor, and as highlighted at ACR earlier this month, it has shown excellent efficacy in several preclinical models. With no currently approved G12D targeting agents, 734 could address an important patient need as a KRAS G12D mutation is found in 40% of pancreatic ductal adenocarcinoma, 15% of colorectal cancers, and 5% of non-small cell lung cancer. In dermatology, we continue to maximize the potential of roxalidinib cream and povresidinib and believe the acquisition of MRGPRx2 is a specific novel mechanism for blocking mast cell activation independent from IGE and has been a high priority target to add to our IAI pipeline.

Pablo J. Cagnoni: EP262 is a first-in-class medicine which entered the clinic in January 2023 and has been evaluated in Phase 2 studies. In a Phase 1, healthy volunteer study, AP262 was well tolerated, had low interpatient PK variability, and achieved exposures well above predicted efficacious levels. AP262 is currently in a Phase 1B open-label study in Sindhu and in two randomized Phase 2 studies in CSU and atopic dermatitis, with data for all three studies expected by early 2025. EP547 is a potent and highly selective antagonist of MRGPRX4. MRGPRx4 is expressed on neurons in the dorsal root ganglia and specifically activated by bile acids that are increased in cholestatic patients.

EP262 is a first-in-class medicine

Pablo J. Cagnoni: The key driver of our interest in Escient is our MRGPRX2 program. MRGPRX2 is a specific novel mechanism for blocking mast cell activation independent from IgE, and has been a high priority target to add to our IAI pipeline. EP262 is a first-in-class medicine, which entered the clinic in January of 2023, and has been evaluated in Phase II studies. In the Phase I healthy volunteer study, EP262 was well-tolerated, had low interpatient PK variability, and achieved exposures well above predicted efficacious levels. EP262 is currently in a Phase I-B open-label study in CIndU, and in two randomized Phase II studies in CSU and atopic dermatitis with data for all three studies expected by early 2025. EP547 is a potent and highly selective antagonist of MRGPRX4. MRGPRX4 is expressed on neurons in the dorsal root ganglia and specifically activated by bile acids that are increased in cholestatic patients.

Pablo J. Cagnoni: Initial evaluation is being conducted in cholestatic pruritus with clinical proof-of-concept for cholestatic pruritus associated with PBC and PSC anticipated by early 2025. A number of exciting readouts are expected by early 2025 with the potential first launch in CSU by 2029. At AAD earlier this quarter, we presented additional data from the randomized Phase II study of RUXOLITINIB Cream in patients with mild-to-moderate Hidradenitis Suppurativa, reinforcing the potential RUXOLITINIB Cream in the syndication. The study met its primary endpoint, demonstrated a significantly greater reduction in abscess and inflammatory nodule count compared to control at week 16, and further reinforces the efficacy and safety profile of RUXOLITINIB Cream. We are currently engaging with the FDA to obtain agreement on a potential Phase III design. We also presented positive data at AAD from the randomized Phase II study evaluating POVORCITINIB in patients with prurigo nodularis and are on track to initiate a Phase III study in the coming months.

Christiana Stamoulis: The study met its primary endpoint, demonstrated a significantly greater reduction in abscess and inflammatory nodule count compared to control at week 16, and further reinforced the efficacy and safety profile of ruxolitinib cream. We are currently engaging with the FDA to obtain agreement on a potential Phase III design. We also presented positive data at AAD from the randomized phase 2 study evaluating poversitinib in patients with prurigal nodularis and are on track to initiate a phase 3 study in the coming months, highlighted on slide 21.

The study met its primary endpoint, demonstrated a significantly greater reduction in abscess and inflammatory nodule count compared to control at week 16, and further reinforced the efficacy and safety profile of ruxolitinib cream. We are currently engaging with the FDA to obtain agreement on a potential Phase III design. We also presented positive data at AAD from the randomized phase 2 study evaluating poversitinib in patients with prurigal nodularis and are on track to initiate a phase 3 study in the coming months,

Pablo J. Cagnoni: As highlighted on Slide 21, the study made its primary endpoint of a four-greater-point improvement in the itch Numerical Rating Scale score, which was achieved by significantly more patients who received POVORCITINIB across all dosing groups at week 16 versus placebo. We believe that with RUXOLITINIB Cream and POVORCITINIB, we will be the only company with the ability to potentially provide both a topical and oral option for a number of indications including prurigo nodularis, Hidradenitis Suppurativa, and vitiligo. We continue to make important progress in the first quarter by achieving several clinical and regulatory milestones. Within our oncology pipeline, we believe that our potentially best-in-class CDK2 inhibitor is an active agent, and we look forward to sharing data as well as our development plan later this year. In addition, the pivotal trial of tafasitamab in patients with follicular and marginal zone lymphoma, also known as inMIND, we'll read out later this year, and we look forward to sharing those results.

Christiana Stamoulis: The study made its primary endpoint of a four-graded point improvement in the itch numerical rating scale score, which was achieved by significantly more patients who received poversitinib across all dosing groups at week 16 versus plus. We believe that with ruxolitinib cream and poversitinib, we will be the only company with the ability to potentially provide both a topical and oral option for a number of indication We continue to make important progress in the first quarter by achieving several clinical and regulatory milestones. Within our oncology pipeline, we believe that our potentially best-in-class CDK2 inhibitor is an active agent, and we look forward to sharing data as well as our development plan later this year. In addition, the pivotal trial of tafacitamab in patients with follicular and marginal zone lymphoma, also known as NMIND, will read out later this year, and we look forward to sharing those results.

Christiana Stamoulis: Within our oncology pipeline, we believe that our potentially best-in-class CDK2 inhibitor is an active agent, and we look forward to sharing data as well as our development plan later this year. In addition, the pivotal trial of tafacitamab in patients with follicular and marginal zone lymphoma, also known as NMIND, will read out later this year, and we look forward to sharing those results. With the BLA for oxytelumab submitted late last year, we look forward to working with the FDA to make oxytelumab available to patients with chronic raft-versus-host disease later this year and to initiate additional combination studies in patients with less pre-treated chronic raft-versus-host disease.

Within our oncology pipeline, we believe that our potentially best-in-class CDK2 inhibitor is an active agent, and we look forward to sharing data as well as our development plan later this year. In addition, the pivotal trial of tafacitamab in patients with follicular and marginal zone lymphoma, also known as NMIND, will read out later this year, and we look forward to sharing those results.

Pablo J. Cagnoni: With the BLA for AXATILIMAB submitted late last year, we look forward to working with the FDA to make AXATILIMAB available to patients with chronic graft-versus-host disease later this year and to initiate additional combination studies in patients with less pretreated chronic graft-versus-host. Within our dermatology portfolio, we expect to submit the sNDA for OPZELURA for pediatric atopic dermatitis and expect multiple data readouts throughout the year. With that, I would like to turn the call over to Christiana for the financial update.

Christiana Stamoulis: Within our dermatology portfolio, we expect to submit the SNDA for obsalura for pediatric atopic dermatitis and expect multiple data readouts throughout the year. 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 first quarter results reflect continued strong growth with total revenues of $881 million, up 9% versus the same period last year. Total product revenues of $730 million in Q1 were driven by demand growth for JAKAFI and OPZELURA and increased revenue contribution from MONJUVI following the acquisition in February of the global exclusive rights to tafasitamab. The product demand growth was partially offset by an anticipated reduction in channel inventory for JAKAFI and the typical Q1 dynamics for JAKAFI and OPZELURA. Total royalty revenues, which are primarily comprised of royalties from Novartis for JAKAFI and TABRECTA, royalties from Lilly for OLUMIANT were $126 million, up 9% compared to the first quarter of 2023, driven by strong demand for JAKAFI.

Christiana Stamoulis: Total royalty revenues, which are primarily comprised of royalties from Novartis for Jacobi and Tabrecta and royalties from Lilly for Olumient, were $126 million, up 9% compared to the first quarter of 2023, driven by strong demand for Jacobi. Total revenues also include the $25 million upfront payment received under our collaboration and license agreement with CMS for the development and commercialization of Positinib in China and select other Asian countries.

Total royalty revenues, which are primarily comprised of royalties from Novartis for Jacobi and Tabrecta and royalties from Lilly for Olumient, were $126 million, up 9% compared to the first quarter of 2023, driven by strong demand for Jacobi.

Christiana Stamoulis: Total revenues included $25 million upfront payment received under our collaboration and license agreement with CMS, for the development and commercialization of POVORCITINIB in China and select other Asian countries. Turning to JAKAFI on Slide 26. JAKAFI net product revenues were $572 million for the first quarter. Net product revenues reflect continued demand growth with total patients up 5% year-over-year, driven by growth in PV and GVHD and continued stable demand in MF. As a result, we experienced the highest quarter paid demand for JAKAFI since launch. As expected in Q1, we saw patients that were on free drug in the fourth quarter of 2023 returned to paid demand and a related decrease in channel inventory levels. As you may recall, channel inventory levels increased by $46 million in the fourth quarter of 2023. In the first quarter of this year, we saw a drawdown in channel inventory, which had $55 million negative impact on net sales versus the fourth quarter of 2023.

Christiana Stamoulis: Turning to Jakafi on slide 26, Jakafi Net Product Revenues were $572 million for the first quarter. Net product revenues reflect continued demand growth with total patients up 5% year-over-year driven by growth in PV and GVHD and continued stable demand in MS. As a result, we experienced the highest quarterly pay demand for Jaka Fye since launch. As expected, in Q1, we saw patients that were on free drugs in the fourth quarter of 2023 return to pay demand and a related decrease in channel inventory levels. As you may recall, channel inventory levels increased by $46 million in the fourth quarter of 2026. In the first quarter of this year, we saw a drawdown in channel inventory, which had a $55 million negative impact on net sales versus the fourth quarter of 2020.

Christiana Stamoulis: As you may recall, channel inventory levels increased by $46 million in the fourth quarter of 2026. In the first quarter of this year, we saw a drawdown in channel inventory, which had a $55 million negative impact on net sales versus the fourth quarter of 2020. While we expect Channel Inventory to remain around the levels we ended in Q1, buying decisions of our customers can not always be predictable. In addition, net sales in the first quarter were impacted by the typical Q1 higher gross net deductions as a result of both contributions to close the Medicare gap and commercial co-payments. Turning now to Opselura on slide 27.

As you may recall, channel inventory levels increased by $46 million in the fourth quarter of 2026. In the first quarter of this year, we saw a drawdown in channel inventory, which had a $55 million negative impact on net sales versus the fourth quarter of 2020.

Christiana Stamoulis: While we expect channel inventory to remain around the levels we ended in Q1, buying decisions of our customers can't always be predicted. In addition, net sales in the first quarter were impacted by the typical Q1 higher gross net deductions as a result of both contributions to close the Medicare gap and commercial copay assistance. Turning now to OPZELURA on Slide 27. Net product revenues for the first quarter were $86 million, representing a 52% increase year-over-year, driven by growth in net new patient starts and refills across both AD and vitiligo, as well as early contribution from the commercialization of OPZELURA for vitiligo in Germany, Austria and France. As expected, OPZELURA net product revenues in the first quarter reflected the typical Q1 seasonality and the reset of deductibles and copays at the beginning of the year. Beyond the typical Q1 dynamics OPZELURA product revenues were impacted by the cyber-attack on UnitedHealth Change Healthcare unit.

Christiana Stamoulis: Net product revenues for the first quarter were $86 million, representing a 52% increase year over year, driven by growth in new patient starts and refills across both AD and vitiligo, as well as early contribution from the commercialization of Opselura for vitiligo in Germany, Austria, and France. As expected, Opsalura Net Product revenues in the first quarter reflected the typical Q1 seasonality and the reset of deductibles and co-pays at the beginning of the year. Beyond the typical Q1 dynamics of Cellura product revenues, revenues were impacted by the Saber attack on UnitedHealth's Change Healthcare.

Christiana Stamoulis: Beyond the typical Q1 dynamics of Cellura product revenues, revenues were impacted by the Saber attack on UnitedHealth's Change Healthcare. Moving on to slide 28 and our operating expenses on a gap basis, total R&D expenses were $429 million for the first quarter, representing a 6% year-over-year increase, which was primarily as a result of the progression of our pipeline. Total SG&A expenses were $300 million for the first quarter, representing a 5% year-over-year decrease driven by the timing of direct-to-consumer marketing activities and certain other expenses.

Beyond the typical Q1 dynamics of Cellura product revenues, revenues were impacted by the Saber attack on UnitedHealth's Change Healthcare.

Christiana Stamoulis: Moving on to Slide 28 and our operating expenses on a GAAP basis. Total R&D expenses were $429 million for the first quarter, representing a 6% year-over-year increase, which was primarily as a result of the progression of our pipeline. Total SG&A expenses were $300 million for the first quarter, representing a 5% year-over-year decrease, driven by the timing of direct-to-consumer marketing activities and certain other expenses. Now turning to the acquisition of Escient Pharmaceuticals. Under the terms of the agreement, we will acquire Escient for $750 million in an all-cash transaction. We believe Escient’s two lead programs offer a multibillion-dollar potential commercial opportunity across multiple indications and have the potential to contribute to our revenue by 2029. In addition, we expect to be able to realize synergies by leveraging our current development and commercial capabilities and infrastructure.

Christiana Stamoulis: Now turning to the acquisition of Asient Pharmaceuticals, under the terms of the agreement, we will acquire Asient for $750 million in an all-cash transaction. We believe Asient's two lead programs offer a multi-billion dollar potential commercial opportunity across multiple indications and have the potential to contribute to our revenue by 2029. In addition, we expect to be able to realize synergies by leveraging our current development and commercial capabilities and infrastructure. We anticipate the acquisition to become effective by the third quarter of 2024 and add approximately $5 million per month in incremental R&D expenses.

Now turning to the acquisition of Asient Pharmaceuticals, under the terms of the agreement, we will acquire Asient for $750 million in an all-cash transaction. We believe Asient's two lead programs offer a multi-billion dollar potential commercial opportunity across multiple indications and have the potential to contribute to our revenue by 2029. In addition, we expect to be able to realize synergies by leveraging our current development and commercial capabilities and infrastructure.

Christiana Stamoulis: We anticipate the acquisition to become effective by the third quarter of 2024, and add approximately $5 million per month in incremental R&D expense. Depending on the timing of the close, we expect the acquisition to add $20 million to $30 million to the full year 2024 R&D expenses. Finally, following this acquisition, we'll continue to have a strong balance sheet, which will allows us to consider additional opportunities. As of the end of the first quarter, we have $3.9 billion in cash and no debt. Moving to our guidance for 2024. Excluding the impact of the acquisition of Escient, we are reiterating our full year 2024 guidance for JAKAFI, our other hematology/oncology products, COGS, R&D and SG&A. Operator, that concludes our prepared remarks. Please give your instructions and open the call for Q&A.

Christiana Stamoulis: Depending on the timing of the close, we expect the acquisition to add $20 to $30 million to the full year 2024 R&D expenses. Finally, following this acquisition, we'll continue to have a strong balance sheet, which allows us to consider additional opportunities. As of the end of the first quarter, we have $3.9 billion in cash and not debt. Moving to our guidance for 2024, excluding the impact of the acquisition of Haitian, we are reiterating our full year 2024 guidance for JakaPy, our other Hematology Oncology products, COGS, R&D, and SG&A. Operator, that concludes our prepared remarks. Please give your instructions and open the call for Q&A.

Operator: Certainly. We will now be conducting a question and answer session. If you would like to be placed in the question queue, please press Star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. To remove your question from the queue, you may press Star 2. Once again, that's Star 1 to be placed in the question queue. One moment, please, while we poll for questions.  Our first question is coming from Kelly Shi from Jefferies. Your line is now live.

Operator: Once again, that's Star 1 to be placed in the question queue. One moment, please, while we poll for questions. Our first question is coming from Kelly Shee from Jeffries. Your line is now live.

Kelly Shi: Thank you for taking my questions. So, for OPZELURA, could you give us some more color on the go-to net for the rest of the year? And what is the latest review and do you see in both AD and vitiligo? Thank you. And I also have a follow-up.

Christiana Stamoulis: Hi, Kelly, it's Christiana. Let me take the first part of the question, and then I will turn it to Matteo to comment on the second part. So, in terms of the gross to net in the first quarter, it was at the same level as last year Q1, so at around 60%. Going forward, as we have previously discussed, we will not be making forward-looking comments on gross to net. Our focus is on maximizing the potential of OPZELURA, and by this, I mean the maximizing net sales versus looking at gross to net in isolation.

Christiana Stamoulis: So in terms of gross to net in the first quarter, it was at the same level as last year's Q1, so around 60 percent. Going forward, as we have previously discussed, we will not be making forward-looking comments about gross to net. Our focus is on maximizing the potential of OBSELURA, and by this, I mean maximizing net sales versus looking at gross to net in isolation.

Matteo Trotta: And on the split of business between the two indications, when we look at the IQVIA data, triangulated with external and internal sources, we see a 40-60 split consistent over time, where 40% is non-segment of Vitiligo and 60% is atopic dermatitis. And we're very happy to see that both indications are growing at quite a healthy pace.

Kelly Shi: Thank you. And also at AAD dermatology conference, we saw the data of topical ruxo cream in both Hurley Stage 1 and the 2 HS patients. Could you share what kind of physician feedback this year? And also, how do they see the unmet needs in both cardiac Stage 1 and 2 patients for novel topical drug like OPZELURA needed to manage disease in this specific population? Thank you.

Steven H. Stein: Yes. Thank you for the question. It's Steven. So, the milder type of HS still represents about 100,000, 150,000 patients in the United States. It still has morbidity and unmet need, and these patients have absences and nodules that cause them discomfort and morbidity and lends itself to a topical treatment because it's not as extensive as the moderate and severe, which has fistulas, et cetera. So, we conducted this POC study and saw this data, which is extremely encouraging in the mild stage of HS in terms of abscess and nodule decreases. And as Pablo said in his prepared remarks, we are now working with regulators to get an appropriate endpoint in this entity for which no drug is approved and has this unmet need I spoke about. To the specifics of your question, the physician and KOL feedback is excellent. I mean they were surprised by the efficacy seen with a topical agent in this entity. So, we are excited about it as well.

Steven H. Stein: So the milder type of HS still represents about 100, 150,000 patients in the United States. It still has morbidity and unmet need, and these patients have abscesses and nodules that cause them, you know, discomfort and morbidity and lend themselves to a topical treatment because it's not as extensive as the moderate and severe, which have fistulas, etc. So, you know, we conducted this POC study and saw this data, which is extremely encouraging in this milder stage of HS in terms of abscess and nodule decreases. And as Pablo said in his prepared remarks, we're now working with regulators to get an appropriate endpoint for this entity for which no drug is approved and has this unmet need I spoke about. To the specifics of your question, the physician and KOL feedback is excellent. I mean, they were, you know, surprised by the efficacy seen with a topical agent. I'm so excited about it.

Steven H. Stein: And as Pablo said in his prepared remarks, we're now working with regulators to get an appropriate endpoint for this entity for which no drug is approved and has this unmet need I spoke about. To the specifics of your question, the physician and KOL feedback is excellent. I mean, they were, you know, surprised by the efficacy seen with a topical agent. I'm so excited about it.

Steven H. Stein: I'm so excited about it. Thank you very much. Thank you. Next question is coming from David Lebowitz from...

I'm so excited about it.

Thank you very much. Thank you. Next question is coming from David Lebowitz from...

Kelly Shi: Thank you very much. Thank you.

Kelly Shi: Thank you very much.

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

Next question is coming from David Lebowitz from...

David Neil Lebowitz: Thank you very much for taking my question. Could you comment on JAKAFI growth dynamics going forward given IRA and shift to the out-of-pocket expenses for patients?

Steven H. Stein: Sure. As you saw from our guidance, $2.69 billion, $2.75 billion, we're very optimistic about the continued growth of JAKAFI. Obviously, we benefit in the IRA because as we talked about before, we have the small biotech exemption. So, beginning in 2025, for example, with the reduced out-of-pockets for patients, it really just helps the patients, of course but we don't have to contribute that 20% to catastrophic that other oral drugs will. So, we think there is a benefit in 2024 for the reduced out-of-pocket in Medicare Part D being around 3,250 for patients for the entire year and then next year, being 2,000 all patients who are taking oral oncology drugs, I believe, will benefit, but we continue to see our growth, as Hervé pointed out, coming from PV, GVHD and in myofibrosis were very stable and remain the market leader in that setting.

Barry P. Flannelly: So we think there's a benefit in 2024 for the reduced out-of-pocket cost of Medicare Part D being around $3,250 for patients for the entire year, and then next year, being 2,000. All patients who are taking oral oncology drugs, I believe, will benefit. But we continue to see our growth, as Herve pointed out, coming from PV, GVHD, and in mild fibrosis. We're very stable and Would you be able to comment further on how growth in 2025 might look vis-a-vis 2024 given these dynamics? No, we obviously said we're still confident about $3 billion-plus by the time we hit 2028. So that's what we're still confident in, and so we think that $24 and $25 should be just fine.

So we think there's a benefit in 2024 for the reduced out-of-pocket cost of Medicare Part D being around $3,250 for patients for the entire year, and then next year, being 2,000. All patients who are taking oral oncology drugs, I believe, will benefit. But we continue to see our growth, as Herve pointed out, coming from PV, GVHD, and in mild fibrosis. We're very stable and

Would you be able to comment further on how growth in 2025 might look vis-a-vis 2024 given these dynamics? No, we obviously said we're still confident about $3 billion-plus by the time we hit 2028. So that's what we're still confident in, and so we think that $24 and $25 should be just fine.

David Neil Lebowitz: Would you be able to comment further on whether - how growth in 2025 might look vis-a-vis 2024 given these dynamics?

Steven H. Stein: No. We obviously said we are still confident about $3 billion plus by the time we hit 2028, so that's what we are still confident in. And so, we think that '24 and '25 should be just fine.

Operator: Thank you. Next question is coming from Kripa Devarakonda from Truist. Your line is now live.

Kripa Devarakinda: Hi guys. Thank you so much for taking my question. On JAKAFI, Hervé, you mentioned that you see very little impact on Jakafi's share from competitors. Can you talk a little bit about whether the competition has changed the average duration on JAKAFI? They do go on to JAKAFI in the frontline, but is there any - are you observing people getting off of JAKAFI sooner? And also for the BET inhibitor combination, there was a recent report of increased AML incidents in patients on the JAKAFI/BET combo for a competitor. I just wanted to get your insights into how this may or may not impact your internal BET program?  Thank you.

Hervé Hoppenot: So Kripa, I'll take your first call, and then I'll hand it over to Pablo for the second part of your question. So, for JAKAFI share from competitors. There really hasn't been any impact on our duration of therapy or discontinuation rates at all, certainly in myelofibrosis. So, we are very confident. We remain the market leader. Other JAK inhibitors may be used in the second-line, third-line setting. If anything, the market size itself is growing because now patients will go on 1, 2, 3 therapies, and I'll hand it over to Pablo for the second part of your question.

Pablo J. Cagnoni: Yes, thank you for the question. So, I mean, obviously, I'm not going to comment on data from other companies. Our BET inhibitor program, as we've discussed is going very well, and we'll discuss additional data over the course of the year, and we are planning a potential pivotal trial going forward, which we'll unveil later this year. Reviewing the data from our internal program, we have, at this point no concerns over the safety when it comes to AML transformation. Now you - I'm sure you know that if you follow a number of patients with MF for long enough, some of them will have transformation to AML as part of the natural history of the disease. But at this point, we have no concerns with our program.

Pablo J. Cagnoni: Well, at this point, we have no concerns with our Thank you. Next question is coming from Michael Schmidt from Guggenheim. Your line is now live. Hey guys, good morning. I had a question for Sidney. And, you know, again, comment.

Well, at this point, we have no concerns with our

Thank you. Next question is coming from Michael Schmidt from Guggenheim. Your line is now live. Hey guys, good morning. I had a question for Sidney. And, you know, again, comment.

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

Michael Schmidt: Hey, guys. Good morning. I had a question on POVORCITINIB and again, commenting about another data set. But I just wanted to get your insight on the reasons RINVOQ head-to-head study against DUPIXENT and AV and whether or how that impacts perhaps your view on the potential of POVORCITINIB across various dermatology indications?

Michael Schmidt: Thank you. The next question is coming from Michael Schmidt from Guggenheim. Your line is now live. Hey guys, good morning.

Steven H. Stein: Yes, Michael, thank you for the question. Now we have seen the data. Obviously, it is an impressive data set. At this point, as you know we have a number of studies ongoing POVORCITINIB. We have had internal discussions about the potential to extending the trials of povo to atopic dermatitis. What I can say right now is we are encouraged by the data from RINVOQ. I think that it's an indication that povo could work very well in this disease. We have not made an internal decision that yet as to whether to develop povorcitinib and atopic dermatitis yet, but it's certainly something we are contemplating.

Marc Frahm: Thank you. The next question is coming from Marc Frahm from TD Cal, and your line is now live.

Marc Frahm: Hi, thanks for taking my questions. Maybe just start. One, just following up on the prior BET question. Can you - were your comments just based on the clinical data you are seeing in those - concern of AML? Or maybe can you speak to preclinically - because I believe that BET inhibitor from a competitor has shown genotoxicity in some preclinical assays. Has your's shown genotoxicity?

Marc Frahm: Thank you. The next question is coming from Marc Frahm from TD Cal when your line is out live. Hi, thanks for taking my questions.

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

Steven H. Stein: Yes. It's Steven answering your question. So, just to reiterate Pablo's remarks and remind you that our BET program was in the clinic a while ago in solid tumors. And then we have obviously pivoted to study myeloproliferative neoplasms. We've treated close to 200 patients to-date. And in the clinical data set, which is the most powerful, as Pablo said we have no concern as regards AML transformation or any concerns that we've seen in that regard. From a prior preclinical work on things like AMs assay and genotoxicity, et cetera, we also have no issue, and we are aware of the issue with the competitor drug that was seen in preclinical work.

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

Brian Abrahams: Hi, guys. Good morning. Thank you so much for taking my questions. I wanted to drill down a little bit more on the JAKAFI dynamics. What's your explanation - or I guess what do you think is the best explanation for the sequential downtick in total JAKAFI demand? Was that something that's just seasonally related that you typically see in first quarter? And then I guess, on the competitive front, I am curious why you think you're not seeing any impact at this point to market share or patient persistence? Is this something you might expect to change going forward? Or would you expect market share and persistence to remain stable based on sort of what you're hearing in terms of market research and on the ground KOLs discussions? Thanks.

Herve Hoppenot: I wanted to drill down a little bit more on the Jackify dynamics. What's your explanation, or, more specifically, what do you think is the best explanation for the sequential downtick in total Jackify demand? Was that something that's just seasonally related that you typically see in the first quarter? And then, on the competitive front, I'm curious why you think you're not seeing any impact at this point on market share or patient persistence. Is this something you might expect to change going forward, or would you expect market share and persistence to remain stable based on sort of what you're hearing in terms of market research and on the ground KOL discussions?

Herve Hoppenot: Is this something you might expect to change going forward, or would you expect market share and persistence to remain stable based on sort of what you're hearing in terms of market research and on the ground KOL discussions?

Hervé Hoppenot: Maybe I can start on the uptick. I mean what we said, and you can see on the slide is that, in fact, there is an increase in the number of patients treated across all three indications in Q1 versus Q4, and there is a growth that you can see on the so-called paid demand graph also that shows that versus last year there is a lot of growth in PV and GVHD. So, the unit growth of JAKAFI sequential to Q4 and versus Q1 of last year is there and fairly visible. The reason for the sequential growth versus Q4 is what we discussed when we discussed Q4 a few months ago is that there was an abnormal free drug ratio in Q4 that has been completely fixed in Q1. So, we are back to normal rates of free drug in Q1. Now on the competitive side, maybe Barry, if you want to speak of why we don't see the impact of the new competitors.

Barry P. Flannelly: Sure. I think, in fact, the new competitors, let us take an [inaudible] and momelotinib as examples, there - as far as we can tell from all of our market research, from all of our experience working with hematologists, they are all being used in the second-line setting or maybe in patients that have very, very low platelets, for example. So, we anticipate because of really the overall survival benefit of JAKAFI, because of the tolerability of JAKAFI, because of the symptom release of JAKAFI, it's a great drug, and it will continue to be very useful to patients who have myelofibrosis going forward.

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

Vikram Purohit: Hi, good morning. Thanks for taking our questions. So, we had two, one on LIMBER and then one on OPZELURA. So on LIMBER, for the ALK2 POC data set we're expecting to see by the middle of the year, could you just frame for us kind of what the scope and size of the data set is going to be? And what you would define as sufficient for continued development for that program based on what we see for that POC data set? And then secondly, on OPZELURA, I just wanted to revisit the topic of potential guidance and see when you think might be a good potential time to provide revenue guidance for OPZELURA since you mentioned that it seems like the script shared seem stable between AD and vitiligo? Thanks.

Steven H. Stein: Hi, Vikram, it's Steven. So, on your first question, just a reminder, ALK2's mechanism felt to work through hepcidin inhibition and then ameliorate anemia by releasing iron and make it available for hemoglobin production. As we've already shown in multiple presentations, we can decrease subsiding levels. The question you get into does this translate to some sort of clinical benefit? Just to remind you of the study, it has 3 groups, treatment group A, B and C. A was monotherapy, B was in combination with RUX, but those were in later line patients. And the real focus right now, as you can see on clintrials.gov is treatment Group C, which is the treatment-naive group of patients to see in combination with RUX, will help make an effect that will be of clinical benefit to patients, either by raising hemoglobin or preventing the decrease that sometimes occurs with JAK2 inhibition.

Steven H. Stein: The real focus right now, as you can see on clintrials.gov, is treatment group C, which is a treatment-naive group of patients, to see if RUX, in combination with RUX, will help make an effect that will be of clinical benefit to patients, either by raising hemoglobin or preventing the decrease that sometimes occurs with JAK2 inhibition. Then, if we're able to demonstrate that as we increase the doses in the second half of this year, then we'll have a clinical proof of concept that we can then potentially take forward to the regulatory environment.

The real focus right now, as you can see on clintrials.gov, is treatment group C, which is a treatment-naive group of patients, to see if RUX, in combination with RUX, will help make an effect that will be of clinical benefit to patients, either by raising hemoglobin or preventing the decrease that sometimes occurs with JAK2 inhibition.

Steven H. Stein: And then if we're able to demonstrate that as we dose increase in the second half of this year, then we'll have a clinical proof-of-concept that we can then potentially take forward to a regulatory environment, but we'll have to be clear that we are benefiting patients from a clinical benefit point of view in that treatment-naive group, and we'll have that data set second half of this year. I'll turn it over for the second question.

Steven H. Stein: But we'll have to be clear that we are benefiting patients from a clinical benefit point of view in that treatment naive group, and we'll have that data set in the second half. Hi, Vikram. It's Christina. I'll take a second.

Christiana Stamoulis: Vikram, it's Christiana. I'll take the second part. As we discussed on our last call, before we provide guidance for OPZELURA, we’re looking to have more real world data on utilization, especially for vitiligo. And data that goes beyond that first initial phase of therapy, which may represent a phase of experimentation by patients. So, we are still early into the launch. We are still going through that initial phase of patients on therapy. So, we are waiting for more real-world data before we are in a position to give you guidance.

Derek Christian Archila: Thank you. The next question today is coming from Derek Archila from Wells Fargo. Your line is now live.

Derek Archila: Hi, good morning. Thanks for taking the questions. Just two quick ones from us. I guess, first, just on JAKAFI. As you noted, the JAKAFI growth coming from GBHD and PV. So I guess, what does this mean for future assumptions around myelofibrosis? I know you said stable but how should we be thinking about that for the rest of this year? And then in terms of CDK2, I guess, where do you think the bar is right now, I guess, from a PPP? And I guess what do you intend to show this year for proof-of-concept? Thanks.

Derek Christian Archila: Thank you. The next question today is coming from Derek Archila from Wells Fargo. Your line is now live. Hey, good morning. Thanks for taking the questions. Just two quick ones from us. I guess, you know, first on Jackify.

Operator: Thank you. Next question today is coming from Derek Archila from Wells Fargo. Your line is now live.

Barry P. Flannelly: I'll take the first part of your question, it's Barry. So for JAKAFI, we continue to see myelofibrosis - the way I look at the myelofibrosis patient population, there is about 18,000 patients, prevalent patients with myelofibrosis. And because we are the market leader because of the overall survival and symptom benefit that JAKAFI provides, we will continue to think of patients as either being on JAKAFI, which is most of the myelofibrosis patients or they have been on JAKAFI or they will be on JAKAFI. When they progress on JAKAFI, then there is other options, fortunately, that are available to them. But going forward for 2024 and beyond, we continue to expect to be the market leader in first-line myelofibrosis. And I'll turn the call over to Pablo.

Barry P. Flannelly: Or they will be on Jackify. When they progress on Jackify, then there are other options, fortunately, that are available to them. But going forward for 2024 and beyond, we continue to expect to be the market leader in first-line myelofibrosis. And I'll turn the call over to Pablo. Yes, thank you.

Or they will be on Jackify. When they progress on Jackify, then there are other options, fortunately, that are available to them. But going forward for 2024 and beyond, we continue to expect to be the market leader in first-line myelofibrosis. And I'll turn the call over to Pablo.

Pablo J. Cagnoni: Yes. Thank you for the question. So, in our CDK2 inhibitor program, we continue to be encouraged by the data that we have seen. And regarding the part of your question about what data we're going to review later this year, we are in the final stages of optimizing the dose for the CDK2 inhibitor program. Our idea will be later this year to provide a substantial clinical data set, including the dose selection for patients. Initially, the focus will be ovarian cancer, but not necessarily only over the longer-term, as well as we are starting combination trials in ovarian cancer, and we are continuing to enroll patients with breast cancer. So, later this year, you will see the dose selection, as well as the data for ovarian cancer, as well as the development plan in ovarian cancer. When it comes to the bar for efficacy, if you look at the CDK2 inhibitor landscape today, most of our competitors have decided to focus on breast cancer or other areas.

Pablo J. Cagnoni: Yes, thank you for the question. In our CDK2 inhibitor program, we continue to be encouraged by the data that we've seen. And regarding a part of your question about what data we're going to reveal later this year, we're in the final stages of optimizing the dose for the CDK2 inhibitor program. Our idea will be later this year to provide a substantial clinical data set, including the dose selection. For patients initially, the focus will be ovarian cancer, but not necessarily only over the longer term. As well as, we are starting combination trials in ovarian cancer, and we continue to enroll patients with breast cancer. So, later this year, you will see the dose selection, as well as data for ovarian cancer, as well as a development plan for ovarian cancer. When it comes to the bar for efficacy, if you look at the CDK2 inhibitor landscape today, most of our competitors have decided to focus on breast cancer or other areas.

Pablo J. Cagnoni: For patients initially, the focus will be ovarian cancer, but not necessarily only over the longer term. As well as, we are starting combination trials in ovarian cancer, and we continue to enroll patients with breast cancer. So, later this year, you will see the dose selection, as well as data for ovarian cancer, as well as a development plan for ovarian cancer. When it comes to the bar for efficacy, if you look at the CDK2 inhibitor landscape today, most of our competitors have decided to focus on breast cancer or other areas.

Pablo J. Cagnoni: We continue to believe that ovarian cancer is an important opportunity. Other competitors in the space like ADCs are coming into play. We are tracking those closely to figure it out what is the overlap between the different patient populations in different - with different molecular markers. But basically, in the second part of the year, later this year we'll provide clarity on dose, schedule and the development plan in ovarian cancer patients.

Jessica Fye: Thank you. The next question today is coming from Jessica Fye from JP Morgan. Your line is now live. Hey guys, good morning.

Operator: Thank you. Next question today is coming from Jessica Fye from JPMorgan. Your line is now live.

Jessica Fye: Hi, guys. Good morning. Thanks for taking my questions. First, on OPZELURA, is it possible to quantify the impact of the changed healthcare issue for that product? And what about for JAKAFI, was that impacted at all by the Change Healthcare issue in the quarter? And then on POVORCITINIB, the Phase III studies in vitiligo. I noticed on clinicaltrials.gov, it looks like there is a single primary endpoint of F-VASI 75 for the Phase III trials, whereas RINVOQ, I think, has two primary endpoints of F-VASI 75 and T-VASI T50. So, what's the rationale for only having a single primary endpoint here relative to the competition? And how do you expect that to kind of play out based on the end points you are studying? Thank you.

Christiana Stamoulis: Was that impacted at all by the change in health care issues in the quarter? And then on Pobrecitinib, the phase 3 studies in vitiligo, I noticed on clinicaltrials.gov, it looks like there's a single primary endpoint of FFASC-75 for the phase 3 trials, whereas RINVOC, I think, has two primary endpoints of FFASC-75 and TBASC-50 So what's the rationale for only having a single primary endpoint here relative to the competition, and how do you expect that to kind of play out based on the, you know, endpoints you're studying? Thank you.

Christiana Stamoulis: Hey guys, good morning. Thanks for taking my questions. First, on Opsalura, is it possible to quantify the impact of the change in health care issues for that product? And what about for Jackify?

Pablo J. Cagnoni: Hi, Jessica. I'll take the Change Healthcare on OPZELURA. What we see at the end of February that there was this cyber-attack reported pretty much caused the network interruption for a few weeks. So as a result, the Change Healthcare was unable to process the claim for a few weeks. When we looked at - when we deep dive in the data, we saw a softer March when you look at the entire atopic dermatitis market  that we monitor, and that caused an estimate of $4 million to $5 million negative impact from OPZELURA in Q1. The good news for us is that we are monitoring April, and we demand - weekly demand back on track to the levels we saw pre-cyber attack and the more recently.

Christiana Stamoulis: And that caused an estimate of 4 or 5 million negative impact from Obsalura in Q1. The good news for us is that we're monitoring April, and we see demand, weekly demand, back on track to the levels we saw pre-cyber attack and a little more.

Barry P. Flannelly: And Jessica, just on JAKAFI, we may have actually had an impact from Change Health, but we don't know. We did have when it first happened some request from specialty pharmacies that wanted extended terms for payment. But we really can't see a big impact because most of the specialty pharmacies were able to switch over to the other system that provides the service for the specialty pharmacies.

Steven H. Stein: And then, just to address your question on POVORCITINIB in vitiligo, we have two identical Phase III studies ongoing STOP V1 and STOP V2 in patients 18 years or older with 5% or greater body surface area involvement of non-segmental vitiligo. It's a little tricky on the endpoints. But just to tell you, our primary end point for the FDA in the United States is actually identical. It's Facial-VASI 75, and total VASI 50. For other parts of the world, there may be a different primary endpoint. For example, in Europe, they're interested most in the total VASI 50. So, that leads to some of the confusion. But for our study for the FDA, it's both Facial-VASI 75 and total VASI 50, together measured at week 52. Thanks.

Steven H. Stein: But for our study, for the FDA, it's both. Facial VASI 75 and total VASI 50, you know, together measured at week 50. Thank you. The next question today is coming from Tazeen Ahmad from Bank of America. Your line is now live. Hi, good morning, guys. Thanks for taking my question. On Opsalura, can you, and I'm sorry if I missed this in your prepared remarks, but could you talk about?

But for our study, for the FDA, it's both. Facial VASI 75 and total VASI 50, you know, together measured at week 50.

Thank you. The next question today is coming from Tazeen Ahmad from Bank of America. Your line is now live. Hi, good morning, guys. Thanks for taking my question. On Opsalura, can you, and I'm sorry if I missed this in your prepared remarks, but could you talk about?

Operator: Thank you. Next question today is coming from Tazeen Ahmad from Bank of America. Your line is now live.

Tazeen Ahmad: Hi, good morning guys. Thanks for taking my question. On OPZELURA, can you - and I'm sorry if I missed this in your prepared remarks, but can you talk about refill rates for patients maybe now that have been on therapy for a few quarters? Can you talk about how you are seeing their use of tubes with the average use of tubes is? I'm just curious that if patients are having good results with the claim, whether they are taking many drug holidays in between when they don't have as much itch, for example? Thanks.

Tazeen Ahmad: Thank you. The next question today is coming from Tazeen Ahmad from Bank of America.

Hervé Hoppenot: Matteo can add to the comment. I mean the picture in terms of refill rate has been the following is that, in atopic dermatitis, we have observed a refill that is slightly north of two tubes per patient. And that is relatively stable. Now it is still increasing a little bit, but it is relatively stable. In vitiligo, it's moving very quickly, and we are not yet at the steady state. It is a situation where we see, unfortunately that there are patients who are not complying with the treatment as it was prescribed, and we’re obviously working with physicians and patients directly to improve it. And as you know, I mean from the experience we had in the clinical trial, we are estimating that if we are successful, it will be around 10 tube per patient, but we are still at the number that is lower than that today when you try to look at patients who have enough history. So, do you want to speak about what we are doing on the marketing side.

Matt Phipps: In vitiligo, it's moving very quickly, and we are not yet at a steady state. It is a situation where we see, unfortunately, that there are patients who are not complying with the treatment as it was prescribed, and we are obviously working with physicians and patients directly to improve it. And as you know, from the experience we had in the clinical trial, we are estimating that if we are successful, it will be around 10 to per patient, but we are still at a number that is lower than that today when you try to look at patients who have enough history. So do you want to speak about what we are doing on the marketing side?

Matt Phipps: So do you want to speak about what we are doing on the marketing side? Yeah, the only comment that I can add is that just this quarter, we're launching a very promising adherence program that we're confident will impact and continue to impact the refill rate growth that we see across both indications, AD and vitiligo. Thank you. The next question today is coming from Salveen Richter from Goldman Sachs. Your line is now live. Good morning. Thanks for taking my question. Could you just give us an update on how the XUS launch of Opsalura is going?

So do you want to speak about what we are doing on the marketing side?

Yeah, the only comment that I can add is that just this quarter, we're launching a very promising adherence program that we're confident will impact and continue to impact the refill rate growth that we see across both indications, AD and vitiligo. Thank you. The next question today is coming from Salveen Richter from Goldman Sachs. Your line is now live. Good morning. Thanks for taking my question. Could you just give us an update on how the XUS launch of Opsalura is going?

Matteo Trotta: Yes. The only comment that I can add is on - just in this quarter, we are launching a very promising adherence program that we – we are confident will impact - continue to impact the refill rate growth that we see across both indications, AD and Vitiligo.

Thank you. The next question today is coming from Salveen Richter from Goldman Sachs. Your line is now live. Good morning. Thanks for taking my question. Could you just give us an update on how the XUS launch of Opsalura is going?

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

Salveen Richter: Good morning. Thanks for taking my question. Could you just give us an update on how the ex-U.S. launch of OPZELURA is progressing with the addition of France at this point? And how you are thinking about the pediatric uptake in 2025? And if I could also just ask one on business development. Post the recent acquisition, you still have significant balance sheet capacity. Could we see you do meaningful M&A in the near term on top of patient?

Hervé Hoppenot: Okay. So, maybe Salveen, I'll take the first part about the European launch because, in fact there is a lot of activities going on there. As you know, we launched in Germany, Austria. So, that is the base that we have. Recently, we’re part of AXA Direct, which is a French process where you can commercialize your product while you are negotiating the price. So, what you see in the numbers today is that there are around $2 million that are recognized sales from France. And it's a sort of an estimate with a conservative price per tube that we are using to do that. But the process there is moving very well, and we anticipate by the second half of the year to be fully reimbursed and paid for at a good price in France.

Salveen Richter: Thank you. The next question today is coming from Salveen Richter from Goldman Sachs. Your line is now live.

Herve Hoppenot: But the process there is moving very well, and we anticipate that by the second half of the year it will be fully reimbursed and paid for at a good price in France. And we have now agreements in Italy and Spain on the price at which we will be launching between mid-year and the second half of the year in both countries. So Germany, Italy, Spain, and France will be fully operational by Q3. And we'll be contributing to the top line.

But the process there is moving very well, and we anticipate that by the second half of the year it will be fully reimbursed and paid for at a good price in France.

Hervé Hoppenot: And we have now in Italy and Spain agreement on the price where we will be launching between mid-year and the second half of the year in both countries. So Germany, Italy, Spain and France will be fully operational by Q3 and will be contributing to the top-line. There is also some smaller countries in Europe where the process is ongoing, and there is always the big question mark of the United Kingdom, England, where as you know, the pricing discussion can take more time, and we are in the process there. So, it is a very positive outcome for Opzelura in Europe because we got reimbursement now in many countries and most of the large countries. And we see a very good uptake of the demand in terms of volume in the countries where it is available, specifically in France. Now the second part of your question was about the pediatric uptake in the U.S., when we get approval. So maybe, Matteo if you want to speak about that?

Herve Hoppenot: There are also some smaller countries in Europe where the process is ongoing. And there is always the big question mark of the United Kingdom, England, where, as you know, the pricing discussion can take more time. And we are in the process there. So it's a very positive outcome for Obstellura in Europe because we have got reimbursement now in many countries and most of the big countries. And we see a very good uptake of the demand in terms of volume in the countries where it's available specifically. The second part of your question was about the pediatric uptake in the U.S. when we get approval, so maybe, Matteo... Yeah, sure. Thanks.

There are also some smaller countries in Europe where the process is ongoing. And there is always the big question mark of the United Kingdom, England, where, as you know, the pricing discussion can take more time. And we are in the process there. So it's a very positive outcome for Obstellura in Europe because we have got reimbursement now in many countries and most of the big countries. And we see a very good uptake of the demand in terms of volume in the countries where it's available specifically. The second part of your question was about the pediatric uptake in the U.S. when we get approval, so maybe, Matteo...

Yeah, sure. Thanks.

Matt Phipps: And we're very excited by the potential opportunity to help two, three million children in the U.S., and we see data consistent with what we would expect. So, pending FDA approval, we are excited by another contribution and tailwind to our top line. This is a patient population that maybe the parents will be a little more sensitive to our box warning, but at the same time, it's two, three million patients and children that we potentially have the opportunity to help going forward.

Matteo Trotta: Yes, sure. Thanks for the question. And we are very excited by the potential opportunity to help 2 million, 3 million children in the U.S. And we see data consistent with what we would expect. So, pending FDA approval, we are excited by another contribution and tailwind to our top-line. This is a patient population that maybe the parents will be a little more sensitive to our box warning, but at the same time, it's 2 million, 3 million patients and children that we potentially have the opportunity to help going forward.

Hervé Hoppenot: On the busy side, maybe, Christiana, you can -

Christiana Stamoulis: Yes. Sure. So Salveen, as you commented on, we have a strong balance sheet, and we'll continue to have a strong balance sheet following the Escient acquisition. So, as of the end of this quarter, we have $3.9 billion of cash. We don't have any debt, which obviously that could give us additional firepower. So, that puts us in a position to be able to look at additional opportunities. And that's something that we are continuing to explore.

Eric Schmidt: Thank you. Our next question today is coming from Eric Schmidt from Cancer Fitzgerald. Your line is now live. Thanks for taking my question. Maybe just following on.

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

Thanks for taking my question. Maybe just following on.

Eric Schmidt: Thanks for taking my question. Maybe just following on Salveen's question on capital redeployment. Can you talk about your broader strategy there about also whether you consider returning cash to shareholders in the form of a dividend or a share buyback in addition to potentially using cash to expand your business?

Hervé Hoppenot: I can take that. I mean it's - we have been speaking about acquisition and external opportunities, which is obviously one very clear goal for the corporation is to diversify our revenue in the future and to increase to the growth coming from the current portfolio that we have. So, that's one option. And obviously, as we are doing with our Board, there are discussions about alternatives to that. But today, as you have seen with Escient, I mean there are opportunities that are very much in the range of what we are looking for in terms of timing and in terms of therapeutic areas, and that would be an interest. So, we are basically looking at both.

Jay Olson: Thank you. The next question is coming from Jay Olson from Oppenheimer. Your line is now live. Oh, hey, congrats on the progress of your KRAS G-12D. It seems like Incyte is increasing.

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

Jay Olson: Hi, congrats on the progress of your KRASG12D. It seems like Incyte is increasingly focused on targeted oncology versus immuno-oncology. Can you describe your strategy in oncology? And also, how are you planning to leverage your oral PD-L1 for your targeted oncology programs, in combination with your KRASG12D, or do you plan to develop additional KRAS inhibitors? Thank you.

Jay Olson: Thank you. The next question is coming from Jay Olson from Oppenheimer. Your line is now live.

Steven H. Stein: Yes. So, thank you for the question. So, your observation is correct. We are moving more aggressively into targeted oncology and trying to shift away from immuno-oncology. And that's a journey that has started a little bit over a year ago, and we intend to accelerate in the future. The idea here is well-defined patient populations, large treatment effect ideally single-agent activity with early proof-of-concept, and that will allow us to have much more efficient drug development process to accelerate some of these programs. We are very excited about the G12D program. We think it has the potential to be best-in-class. And as you point out, one of the things that we can leverage is we have access to what we believe is the most advanced for sure, oral PD-L1 inhibitor, and that will allow us to do oral-oral combinations in patients with a range of indications. And that applies also to the rest of the pipeline. And as I mentioned that journey will continue to accelerate in the future.

Pablo J. Cagnoni: We are moving more aggressively into targeted oncology and trying to shift away from immune oncology. And that's a journey that started over a year ago, and we intend to accelerate in the future. The idea here is well-defined patient populations, large treatment effects, ideally single agent activity with early proof of concept, and that will allow us to have a much more efficient drug development process to accelerate some of these programs. We're very excited about the G12D program. We think it has the potential to be the best in class. And as you point out, one of the things that we can leverage is we have access to what we believe is the most advanced oral PD-L1 inhibitor, and that will allow us to do oral-oral combinations in patients with a range of indications. And that applies also to the rest of the pipeline. And as I mentioned, that journey will continue to accelerate. Thank you. Next question is coming from Matt Phipps from William Blair. Your line is now live. Alright, thanks for taking my questions. Um, I guess I'll ask about the Cal R mutant antibody and data in early 2025. Will that be?

Pablo J. Cagnoni: And as you point out, one of the things that we can leverage is we have access to what we believe is the most advanced oral PD-L1 inhibitor, and that will allow us to do oral-oral combinations in patients with a range of indications. And that applies also to the rest of the pipeline. And as I mentioned, that journey will continue to accelerate. Thank you. Next question is coming from Matt Phipps from William Blair. Your line is now live. Alright, thanks for taking my questions. Um, I guess I'll ask about the Cal R mutant antibody and data in early 2025. Will that be?

Matt Phipps: And as I mentioned, that journey will continue to accelerate. Thank you. Next question is coming from Matt Phipps from William Blair. Your line is now live. Alright, thanks for taking my questions. Um, I guess I'll ask about the Cal R mutant antibody and data in early 2025. Will that be?

Operator: Thank you. Your next question is coming from Matt Phipps from William Blair. Your line is now live. Hi there.

Operator: Thank you. Your next question is coming from Matt Phipps from William Blair. Your line is now live.

Matt Phipps: Hi, thanks for taking my questions. I guess I'll ask about the CALR-mutant antibody and data in early 2025, will that be monotherapy or mono and JAKAFI combo and also myelofibrosis only or also including essential thrombocytopenia? And I guess just from a high level, the combination with JAKAFI, is that primarily to provide faster symptom relief? Or do you think, it is just kind of necessary to achieve efficacy for the antibody?

Pablo J. Cagnoni: So, we haven't decided exactly the scope of the data disclosure for the mutant-CALR antibody later this year. What I can tell you is that plan is to combine the mutant-CALR antibody with JAKAFI. And the idea there is, as you know, and we pointed out many times, Jakafi has a profound effect on symptom relief in these patients, which we believe, early in the management of the disease, could be very important even in the presence of a mutant-CALR antibody. The idea of mutant-CALR antibody here, as you know, is to transform - is to change the treatment objective to really eradicate the malignant clone. But still a potential early treatment or induction with JAKAFI could be very, very helpful for patients. And regarding the other part of your question, yes, we will have data in MF and ET as well.

Pablo J. Cagnoni: The idea of the mutant callar antibody here, as you know, is to transform and change the treatment objective to really eradicate the malignant clone. But still, a potential early treatment or induction with Jackify could be very, very helpful for patients. And regarding the other part of your question, yes, we will have data in MF and ET as well.

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

Evan Seigerman: Hi guys. Thank you so much for taking the question. Two from me. One, just taking a step back looking at P&L management. How do you think about being most efficient with your OpEx? And then, kind of a follow-up there. Would you ever consider using some of your balance sheet to, say, do buybacks, especially with the stock in the $50s? And then just as you think about your positioning in the derm space, a lot of focus on OPZELURA. Where do you want to win over the next five years when it comes to derm? Where do you think Incyte is best-suited to really take share? Maybe you can walk me through some of the most exciting parts of your pipeline in your view. Thank you.

Herve Hoppenot: One, just taking a step back, looking at P&L management, you know, how do you think about being most efficient with your OpEx? And then, kind of a follow up there, would you ever consider using some of your balance sheets to do buybacks, especially with the stock in the 50s? And then just, as you think about your positioning in the DERM space, a lot of focus on Opsalura. Where do you want to win over the next five years when it comes to DERM? Where do you think Incyte is best suited to really take share? Maybe walk me through some of the most exciting parts of your pipeline, in your view. Thank you.

Hervé Hoppenot: Okay. So, I think the first question was about the efficiency of the spending. So, as you see, I mean, we have in our P&L, we had a relatively - this quarter, we had a very flat SG&A and a relatively slower growing R&D. And that is what we have been speaking about for years now is basically growing the top-line at a faster rate than we are growing both components of the expenses and increasing leverage. So, that's sort of happening. They are depending on the event on the quarterly, it is not always at the same rate, but it is clearly the direction that we are taking. Concerning the buyback, I spoke about it. What I'm basically saying is that nothing is excluded from discussions, and that is something that is certainly part of the current dialogue. And now in the dermatology, maybe Pablo, if you want to speak about, or Steven, on the -

Pablo J. Cagnoni: ISGlobal.org, Concerning the buyback, I spoke about it, what I'm basically saying is that nothing is excluded from discussions, and that's something that you know is certainly part of the current dialogue. And now, on terminology, maybe Pablo, if you want to, I'm happy to comment.

Pablo J. Cagnoni: I'm happy to comment. Look, I think what we are building is an important portfolio of first-in-class or best-in-class in some cases, best-in-disease medicines in the - I would expand the questions in the inflammation space. And I think, that was a key driver of the acquisition of Escient to complement that with two first-in-class medicines, 262 and 547, that can really address a range of indications. We believe that that added to the portfolio that we have with POVORCITINIB, which is [inaudible] pipeline within a drug, we can win across a range of indications by providing patients and payers with a portfolio approach to some of these diseases, including prurigo nodularis, atopic dermatitis and now the new inflammatory diseases.

Operator: Thank you. Our next question is coming from Ren Benjamin from Citizens JMP. Your line is now live.

Ren Benjamin: Hi, great. Thanks for taking the question. Just a couple of quick ones. One on JAKAFI XR. Can you provide any sort of an update as to how that's progressing? And as you think about the strategy going forward, is this something that you are already starting to evaluate in combinations? Or do you only start doing that after an approval? And then, just as a follow-up, tafasitamab, just wanted to get your thoughts on the FL-MCL data that's coming out. Is this - is really going to be meaningful from a commercial perspective as the real opportunity in first-line DLBCL, which is expected in 2025? Thanks.

Steven H. Stein: One, on Jackify XR, can you provide any sort of an update as to how that's progressing? And as you think about the strategy going forward, is this something that you're already starting to evaluate in combinations, or do you only start doing that after an approval? And then just as a follow-up, TAP Acidimat, just wanted to get your thoughts on the FL-MCL data that's coming out. Is this really going to be meaningful from a commercial perspective, or is it the real opportunity in first-line DL-BCL, which is expected in 2025?

Steven H. Stein: So Ren, it's Steven answering your question. So, as Pablo said in remarks earlier this year, the XR process is underway with the regulators in terms of doing bioavailability and then followed by BE work. That will include stability it's about a two-year process, which we expect to complete in a way in time for the LOE. And the idea there is obviously to have the once daily available in time. It doesn't change any of our FDC work. We can still do fixed-dose combination work with BET and ALKs as we need to do, and we continue to progress those. In terms of tafasitamab, the studies are complete, both in mind and front mine. So, the low-grade follicular and marginal zone lymphoma study will be in the second half of this year. And in the first-line diffuse large B-cell lymphoma probably in Q1 2025. And we await that data. We know we have an active - very active and well-tolerated regimen in lymphomas, and we look forward to that data.

Steven H. Stein: It doesn't change any of our FTC work; we can still do fix those combination work with BETT and ELK as we need to do. And we continue to progress. In terms of Tapacitamab, you know, the studies are complete both in mind and in front of the mind. So the low-grade follicular and marginal zone lymphoma study will be in the second half of this year and in the first line of future B-cell lymphoma, probably in Q1 2025. And we, you know, we await that data. We know we have an active, very active, and well-tolerated regimen in lymphomas, and we look forward to that data.

Steven H. Stein: And we, you know, we await that data. We know we have an active, very active, and well-tolerated regimen in lymphomas, and we look forward to that data. Someone also mentioned earlier there, and Pablo said, you know, there's also interest now potentially in autoimmune work with CD19 antibodies, and that's something we're just looking at. To the meat of your question, yes, we very much expect the data to be meaningful with a well-tolerated active regimen, and we look forward to those data. Thank you. Our final question today is coming from Gavin Clark Gardner from Evercore ISI.

And we, you know, we await that data. We know we have an active, very active, and well-tolerated regimen in lymphomas, and we look forward to that data.

We know we have an active, very active, and well-tolerated regimen in lymphomas, and we look forward to that data. Someone also mentioned earlier there, and Pablo said, you know, there's also interest now potentially in autoimmune work with CD19 antibodies, and that's something we're just looking at. To the meat of your question, yes, we very much expect the data to be meaningful with a well-tolerated active regimen, and we look forward to those data. Thank you. Our final question today is coming from Gavin Clark Gardner from Evercore ISI.

We know we have an active, very active, and well-tolerated regimen in lymphomas, and we look forward to that data.

Steven H. Stein: Someone also mentioned earlier there, and Pablo said, you know, there's also interest now potentially in autoimmune work with CD19 antibodies, and that's something we're just looking at. To the meat of your question, yes, we very much expect the data to be meaningful with a well-tolerated active regimen, and we look forward to those data. Thank you. Our final question today is coming from Gavin Clark Gardner from Evercore ISI.

Steven H. Stein: As someone also brought up earlier there, and Pablo said, there is also interest now potentially in autoimmune work with CD19 antibodies, and that's something we're just looking at, at the moment. To the meat of your question, yes, we very much expect the data to be meaningful with a well-tolerated active regimen, and we look forward to those data sets. Thanks.

Steven H. Stein: Thank you. Our final question today is coming from Gavin Clark Gardner from Evercore ISI.

Operator: Thank you. Our final question today is coming from Gavin Clark-Gartner from Evercore ISI. Your line is now live. Hi guys.

Operator: Thank you. Our final question today is coming from Gavin Clark-Gartner from Evercore ISI. Your line is now live.

Gavin Clark-Gartner: Hi, thanks for fitting me in. Just wanted to ask one quick clarification on the CALR data. Did you note that you're planning to show some of that data later this year? Or could that still be a 2025 event?

Pablo J. Cagnoni: We haven't provided specific guidance. I think we said 2025. So, if I imply 2024, I apologize for misunderstanding but it’s - 2025 is the goal.

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

Hervé Hoppenot: Thank you all for participating in the call today and for your questions. The IR team will be available for questions throughout the day. Thank you and goodbye.

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

Presentation.

You may be placed in the question queue at any time by pressing star one on your telephone keypad. As a reminder, this conference is being recorded its now my pleasure to turn the call over to Ben strain Associate Vice President of Investor Relations. Please go ahead Ben.

Thank you Kevin Good morning, and welcome to insights first quarter 'twenty 'twenty four earnings conference call.

Before I 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 call on today's call I'm joined by array Pablo 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.

Looking statements, which are based on 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 hand, the call over to Irving.

Thank you Ben.

Good morning, everyone.

Before I get into the quarterly results I'm pleased to share that <unk> has recently joined insight.

Manager of our U S dermatology business unit reporting to me.

<unk> comes to us from Novartis, where he was responsible for the immunology business in the U S.

And he will be leading the U S. Dermatology team at insight to continue to grow up here a while.

Prepare for the launches of <unk> and was up from promising pipeline product in the coming years.

Now turning to our Q1 results.

When you grew 9% in Q1 versus last year and I will discuss in the next slide the details of the underlying demand growth for Jakafi and up to us to clarify the performance of both brands in Q1.

Starting with <unk> on slide six.

In the first quarter of Jakafi net product revenue of 572 million does not fully reflect the demand growth as total patients increased 5% in the first quarter versus the same quarter last year.

Gross driven by PV and Gvhd.

<unk> growth versus Q4, which was also strong in all indication as you see on the graph on the right.

Jakafi channel inventory reduction in the first quarter had a negative impact on net revenues of approximately $55 million.

Operator: A question and answer session will follow the formal presentation. You may be placed in the 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 call over to Ben Strain, Associate Vice President, Investor Relations. Please go ahead, Ben.

Operator: A question and answer session will follow the formal presentation. You may be placed in the 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 call over to Ben Strain, Associate Vice President, Investor Relations. Please go ahead, Ben.

Our Q1 results total revenue grew 9% in Q1 versus last year and I will discuss in the next slide the details of the underlying demand growth for jakafi in up to ought to clarify the performance of both brands in Q1.

Based on the strong patient demand since this quarter and anticipated growth for the balance of the year. We are reiterating our full year 2020 for Jakafi net revenue guidance of $2 69 to $2 75 billion.

Starting with Jakafi on slide six.

Ben Strain: Thank you, Kevin. Good morning, and welcome to Incyte's Q1 2024 earnings conference call. Before I 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 call. 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, 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 hand the call over to Hervé.

Ben Strain: Thank you, Kevin. Good morning, and welcome to Incyte's Q1 2024 earnings conference call. Before I 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 call. 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, 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 hand the call over to Hervé.

In the first quarter Jakafi net product revenue of $572 million does not fully reflect the demand growth as total patients increased 5% in the first quarter versus the same quarter of last year with growth driven by PV and gvhd.

Turning to slide seven and looking at Jakafi total paid demand by indication during the first quarter of 'twenty, two 'twenty, three and 'twenty 'twenty four.

You can see total paid demand growth in the top left corner continues to be strong.

F. In the top right is consistent year after year and the largest growth is coming from PV and gvhd.

Sequential growth versus Q4, which was also strong in all indication as you see on the graph on the right.

Jakafi channel inventory reduction in the first quarter had a negative impact on net revenues of approximately $55 million.

Additionally, the Jakafi continues to maintain its leadership in market share in myelofibrosis.

Market research total patient market share on discontinuation rates have remained stable in the first line setting across the past several months with virtually no impact from competitor, which has been consistent with our expectations.

Based on the strong patient demand since this quarter and anticipated growth for the balance of the year. We are reiterating our full year 2020 for Jakafi net revenue guidance of $2 69 to $2 75 billion.

Hervé Hoppenot: Thank you, Ben, and good morning, everyone. Before I get into the quarterly results, I'm pleased to share that Matteo Trotta has recently joined Incyte as General Manager of our US Dermatology Business Unit, reporting to me. Matteo comes to us from Novartis, where he was responsible for the immunology business in the US, and he will be leading the US dermatology team at Incyte to continue to grow Opzelura, prepare for the launches of povorcitinib and other promising derm pipeline product in the coming years. Now turning to our Q1 result. Total revenue grew 9% in Q1 versus last year, and I will discuss in the next slide the details of the underlying demand growth for Jakafi and Opzelura to clarify the performance of both brands in Q1. Starting with Jakafi on Slide six.

Herve Hoppenot: Thank you, Ben, and good morning, everyone. Before I get into the quarterly results, I'm pleased to share that Matteo Trotta has recently joined Incyte as General Manager of our US Dermatology Business Unit, reporting to me. Matteo comes to us from Novartis, where he was responsible for the immunology business in the US, and he will be leading the US dermatology team at Incyte to continue to grow Opzelura, prepare for the launches of povorcitinib and other promising derm pipeline product in the coming years. Now turning to our Q1 result. Total revenue grew 9% in Q1 versus last year, and I will discuss in the next slide the details of the underlying demand growth for Jakafi and Opzelura to clarify the performance of both brands in Q1. Starting with Jakafi on Slide six.

Yeah.

Moving to obscura total opposite of our network revenues in the first quarter were 86 million up 52% when compared to the same quarter last year.

Turning to slide seven and looking at Jakafi total paid demand by indication during the first quarter of 'twenty, two 'twenty, three and 'twenty 'twenty four.

The weekly prescription trends as shown on the right of slide eight reflects continued growth of <unk> in both atopic dermatitis and vitiligo with typical Q1 seasonality.

As you can see total paid demand growth in the top left corner continues to be strong MF in the top right is consistent year after year and the largest growth is coming from PV and gvhd.

U S total prescriptions for <unk> grew 41% year over year outpacing the total AG market, which grew 23%.

Additionally, the Jakafi continues to maintain its leadership in market share in myelofibrosis.

The AG market, including <unk> was impacted by the change has gifts I brought back.

On market research total patient market share on discontinuation rates have remained stable in the first line setting.

Particularly in March importantly, we are beginning to see a rebound in filled prescription to levels seen before the cyberattack.

The past several months with virtually no impact from competitor.

Which has been consistent with our expectations.

From an access perspective, we have seen early encouraging results in subzero unmoved and generate to preferred position in the CBS network.

Moving.

To obscura total opposite of our network revenues in the first quarter were $86 million up 52% when compared to the same quarter last year.

Hervé Hoppenot: In the first quarter, Jakafi net product revenue of $572 million does not fully reflect the demand growth, as total patients increased 5% in the first quarter versus the same quarter last year, with growth driven by PV and GVHD. Sequential growth versus Q4 was also strong in all indications, as you see on the graph on the right. Jakafi channel inventory reduction in the first quarter had a negative impact on net revenues of approximately $55 million. Based on the strong patient demand seen this quarter and anticipated growth for the balance of the year, we are reiterating our full year 2024 Jakafi net revenue guidance of $2.69 to 2.75 billion. Turning to Slide 7, looking at Jakafi, total paid demand by indication during the first quarter of 2022, 2023, and 2024.

In the first quarter, Jakafi net product revenue of $572 million does not fully reflect the demand growth, as total patients increased 5% in the first quarter versus the same quarter last year, with growth driven by PV and GVHD. Sequential growth versus Q4 was also strong in all indications, as you see on the graph on the right. Jakafi channel inventory reduction in the first quarter had a negative impact on net revenues of approximately $55 million. Based on the strong patient demand seen this quarter and anticipated growth for the balance of the year, we are reiterating our full year 2024 Jakafi net revenue guidance of $2.69 to 2.75 billion. Turning to Slide 7, looking at Jakafi, total paid demand by indication during the first quarter of 2022, 2023, and 2024.

<unk> growth within the CBS network outpaced growth seen in other plants.

The weekly prescription trends as shown on the right of slide eight reflects continued growth of <unk> in both atopic dermatitis and vitiligo with typical Q1 seasonality.

Moving to slide nine as discussed in the past we are on track to provide 10 high impact launches by 'twenty Saudi.

Importantly, many of the programs highlighted on this slide our derisked as they are post proof of concept, including exited demob, which has been submitted to the FDA for approval or solitary premium pediatric it need to be submitted to the FDA in Q3, and porosity need where we are in phase III in Hs in vitiligo and <unk>.

U S total prescriptions for <unk> grew 41% year over year outpacing the total AG market, which grew 23%.

The AG market, including <unk> was impacted by the change healthcare cyber attack.

Particularly in March importantly, we are beginning to see in April a rebound in filled prescription to levels seen before the cyber attack.

Shifting a phase III study in.

And probably gonna deliveries later this year.

Moving to slide 10 in addition to our internal efforts to deliver multiple launches by 2030.

From an access perspective, we have seen early encouraging results in subzero unmoved and generate to preferred position in the CBS network.

We recently announced an agreement to acquire <unk> pharmaceutical for $750 million with cash on hand.

<unk> growth within the CBS network outpaced growth seen in other plants.

This acquisition further strengthens our pipeline with two novel first in class medicines, EP 262 in EP 547, which has the potential to treat a broad range of inflammatory disorder.

Hervé Hoppenot: As you can see, total paid demand growth in the top left corner continues to be strong. MF, in the top right, is consistent year after year, and the largest growth is coming from PV and GVHD. Additionally, Jakafi continues to maintain its leadership and market share in myelofibrosis. Based on market research, total patient market share and discontinuation rate have remained stable in the first line setting over the past several months, with virtually no impact from competitors, which has been consistent with our expectations. Moving to Opzelura. Total Opzelura net product revenues in the first quarter were $86 million, up 52% when compared to the same quarter last year. The weekly prescription trend, as shown on the right of Slide eight, reflects continued growth of Opzelura in both atopic dermatitis and vitiligo, with typical Q1 seasonality.

As you can see, total paid demand growth in the top left corner continues to be strong. MF, in the top right, is consistent year after year, and the largest growth is coming from PV and GVHD. Additionally, Jakafi continues to maintain its leadership and market share in myelofibrosis. Based on market research, total patient market share and discontinuation rate have remained stable in the first line setting over the past several months, with virtually no impact from competitors, which has been consistent with our expectations. Moving to Opzelura. Total Opzelura net product revenues in the first quarter were $86 million, up 52% when compared to the same quarter last year. The weekly prescription trend, as shown on the right of Slide eight, reflects continued growth of Opzelura in both atopic dermatitis and vitiligo, with typical Q1 seasonality.

Moving to slide nine as discussed in the past we are on track to provide 10 high impact launches by 2030.

Importantly, many of the programs highlighted on this slide our derisked as they are post proof of concept, including exited them up which has been submitted to the FDA for approval of <unk> cream in pediatric indeed to be submitted to the FDA in Q3, and <unk>, where we are in phase III in Hs in vitiligo and <unk>.

I would now turn the call over to Pablo.

Thank you, Rob and good morning, everyone.

In the first quarter, we continued to make solid progress across our pipeline, which is focused on three areas and piceance and graft versus host disease oncology and inflammatory diseases.

Shifting a phase III study in.

And M P Anson graft versus host disease, we initiated a phase one study earlier this quarter, where Jack to vs 6007 F inhibitor.

And probably gonna deliveries later this year.

Moving to slide 10 in addition to our internal efforts to deliver multiple launches by 2030, we recently announced an agreement to acquire <unk> pharmaceutical for $750 million with cash on hand.

As a reminder, objectively six months, having that mutation is the most common somatic mutation in myeloproliferative neoplasms and is present in 50, 560, and 95% of patients with MF and PV respectively.

This acquisition further strengthens our pipeline with two novel first in class medicines, EP 262 in EP, five folks, Iran, which have the potential to treat a broad range of inflammatory disorders.

Unlike <unk>, which inhibits both wild type and with six months, having that mutation positive cells. All five eight selectively binds to the JAK two J H two site disrupting their historic trends have an F induced confirmation and thus, allowing selective inhibition immune activity and the JAK two receptor whilst.

Hervé Hoppenot: US total prescriptions for Opzelura grew 41% year over year, outpacing the total AD market, which grew 23%. The AD market, including Opzelura, was impacted by the Change Healthcare cyberattack, particularly in March. Importantly, we are beginning to see in April a rebound in field prescription to levels seen before the cyberattack. From an access perspective, we have seen early encouraging results since Opzelura moved in January to preferred position in the CVS network, as TRX growth within the CVS network outpaced growth seen in other plans. Moving to Slide 9. As discussed in the past, we are on track to provide 10 high-impact launches by 2030.

US total prescriptions for Opzelura grew 41% year over year, outpacing the total AD market, which grew 23%. The AD market, including Opzelura, was impacted by the Change Healthcare cyberattack, particularly in March. Importantly, we are beginning to see in April a rebound in field prescription to levels seen before the cyberattack. From an access perspective, we have seen early encouraging results since Opzelura moved in January to preferred position in the CVS network, as TRX growth within the CVS network outpaced growth seen in other plans. Moving to Slide 9. As discussed in the past, we are on track to provide 10 high-impact launches by 2030.

I would now turn the call over to Pablo.

Pablo: Thank you, Rob and good morning, everyone.

Pablo: The first quarter, we continued to make solid progress across our pipeline, which is focused on three areas and piceance and graft versus host disease oncology and inflammatory diseases.

Bearing wall type.

Together with our anti mutant Callout program, there's two potentially disease modifying programs represent a fundamentally new approach to addressing MF and PV and could help to solidify our leadership in M. P M.

Pablo: And mpls and graft versus host disease, we initiated a phase one study earlier this quarter, where Jack to vs 6007 F inhibitor.

Pablo: As a reminder, objectively six months, having that mutation is the most common somatic mutation in myeloproliferative neoplasms and is present in 50, 560, and 95% of patients with MF and PV respectively.

As previously disclosed we submitted the BLA for <unk> for the treatment in third line chronic graft versus host disease late last year.

In February the filing was accepted for priority review and we anticipate a decision by the FDA in the second half of 2024.

Pablo: Unlike <unk>, which inhibits both wild type and with six months, having that mutation positive cells. All five eight selectively binds to the JAK two J H two site disrupting their six months have an F induced confirmation and thus, allowing selective inhibition of immune activity and the JAK two receptor while sparing.

Hervé Hoppenot: Importantly, many of the programs highlighted on this slide are de-risked, as they are post-proof of concept, including axatilimab, which has been submitted to the FDA for approval, ruxolitinib cream in pediatric AD to be submitted to the FDA in Q3, and povorcitinib, where we are in phase III in HS and vitiligo, and initiating a phase III study in prurigo nodularis later this year. Moving to Slide 10. In addition to our internal efforts to deliver multiple launches by 2030, we recently announced an agreement to acquire Escient Pharmaceuticals for $750 million with cash on hand. This acquisition further strengthens our pipeline with two novel first-in-class medicines, EP262 and EP547, which have the potential to treat a broad range of inflammatory disorders. I will now turn the call over to Pablo.

Importantly, many of the programs highlighted on this slide are de-risked, as they are post-proof of concept, including axatilimab, which has been submitted to the FDA for approval, ruxolitinib cream in pediatric AD to be submitted to the FDA in Q3, and povorcitinib, where we are in phase III in HS and vitiligo, and initiating a phase III study in prurigo nodularis later this year. Moving to Slide 10. In addition to our internal efforts to deliver multiple launches by 2030, we recently announced an agreement to acquire Escient Pharmaceuticals for $750 million with cash on hand. This acquisition further strengthens our pipeline with two novel first-in-class medicines, EP262 and EP547, which have the potential to treat a broad range of inflammatory disorders. I will now turn the call over to Pablo.

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

In oncology, we continue to build out a robust pipeline with the potential to deliver meaningful innovation for patients.

Pablo: I'll type.

Pablo: Together with our anti mutant Callout program, there's two potentially disease modifying programs represent a fundamentally new approach to addressing MF and PV and could help to solidify our leadership in M. P ads.

This quarter, we initiated a phase one study with R. K Ras G 12 D inhibitor Incb 161 734.

734 is a potent selective and orally by available <unk> inhibitor and as highlighted at ACR earlier. This month and has shown excellent efficacy in several preclinical models.

Pablo: As previously disclosed we submitted the BLA for <unk> for the treatment in third line chronic graft versus host disease late last year and.

With no currently approved <unk> targeting agent 734 could address an important patient need as a K Ras G. <unk> mutation is found in 40% of pancreatic ductal adenocarcinoma.

Pablo: In February the filing was accepted for priority review and we anticipate a decision by the FDA in the second half of 2024.

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

15% of colorectal cancers, and 5% of non small cell lung cancers.

Operator: Thank you, Hervé, and good morning, everyone. In the first quarter, we continued to make solid progress across our pipeline, which is focused on three areas: MPNs and graft-versus-host disease, oncology, and inflammatory diseases. In MPNs and graft-versus-host disease, we initiated a phase I study earlier this quarter with a JAK2 V617F inhibitor.

Pablo Cagnoni: Thank you, Hervé, and good morning, everyone. In the first quarter, we continued to make solid progress across our pipeline, which is focused on three areas: MPNs and graft-versus-host disease, oncology, and inflammatory diseases. In MPNs and graft-versus-host disease, we initiated a phase I study earlier this quarter with a JAK2 V617F inhibitor.

In dermatology, we continue to maximize the potential of rux cream and power Sydney and believe the acquisition of <unk> Pharmaceuticals will substantially expand our pipeline by adding two first in class medicines with the potential to address a number of medical needs.

Pablo: In oncology, we continue to build out a robust pipeline with the potential to deliver meaningful innovation for patients.

Pablo: This quarter, we initiated a phase one study with R. K Ras <unk> 12 D inhibitor ICP 161, 700 347.

Pablo Cagnoni: ... As a reminder, the JAK2 V617F mutation is the most common somatic mutation in myeloproliferative neoplasms, 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 conformation, and thus allowing selective inhibition of mutant activity in the JAK2 receptor while sparing wild type. Together with our anti-mutant collar program, these two potentially disease-modifying programs represent a fundamentally new approach to addressing MF, ET, and PV, and could help to solidify our leadership in MPNs. As previously disclosed, we submitted a BLA for axatilimab for the treatment in third-line chronic graft-versus-host disease late last year. In February, the filing was accepted for prior review, and we anticipate a decision by the FDA in H2 2024.

As a reminder, the JAK2 V617F mutation is the most common somatic mutation in myeloproliferative neoplasms, 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 conformation, and thus allowing selective inhibition of mutant activity in the JAK2 receptor while sparing wild type.

Pablo: 734 is a potent selective and orally by available <unk> inhibitor and as highlighted at ACR. Early this month and has shown excellent efficacy in several preclinical models.

The key driver of our interest in <unk> is our <unk> two program.

And Mark your parents to specific novel mechanism for blocking mast cell activation independent from GE and has been a high priority target to add to our pipeline.

Pablo: With no currently approved <unk> targeting agent 734 could address an important patient need as a K Ras G talked in mutation is found in 40% of pancreatic ductal adenocarcinoma, 15% of colorectal cancers, and 5% of non small cell lung cancers.

<unk> is a first in class medicine, which entered the clinic in January 2023, and has been evaluated in phase III studies.

And the phase one healthy volunteer study <unk> was well tolerated had low inter patient PK variability and achieved exposures well above predicted efficacious levels.

Pablo: In dermatology, we continue to maximize the potential of rux cream and power sitting at and believe the acquisition of <unk> Pharmaceuticals will substantially expand our pipeline by adding two first in class medicines with the potential to address a number of medical needs.

Together with our anti-mutant collar program, these two potentially disease-modifying programs represent a fundamentally new approach to addressing MF, ET, and PV, and could help to solidify our leadership in MPNs. As previously disclosed, we submitted a BLA for axatilimab for the treatment in third-line chronic graft-versus-host disease late last year. In February, the filing was accepted for prior review, and we anticipate a decision by the FDA in H2 2024.

<unk> is currently in a phase <unk> open label study in center and in two randomized phase II studies in CSU in atopic dermatitis with data for all three study is expected by early 2025.

Pablo: The key driver of our interest in <unk> is our <unk> two program.

It would be 547 is a potent and highly selective antagonist of <unk> four.

Pablo: And Mark your parents to specific novel mechanism for blocking mast cell activation independent from GE and has been a high priority target to add to our pipeline.

<unk> four is expressed on neurons in the dorsal root ganglia, and specifically activated by bile acid that our increase in college static patients.

Pablo: <unk> is a first in class medicine, which entered the clinic in January 2023, and has been evaluated in phase III studies.

Pablo Cagnoni: We are excited by the possibility of bringing a new treatment options to patients with this devastating complication of hematopoietic stem cell transplant. In oncology, we continue to build out a robust pipeline with the potential to deliver meaningful innovation for patients. This quarter, we initiated a phase 1 study with our KRAS G12D inhibitor, INCB161734. Seven three four is a potent, selective, and orally bioavailable KRAS G12D inhibitor, and as highlighted at ACR earlier this month, it has shown excellent efficacy in several preclinical models. With no currently approved G12D targeting agents, seven three four could address an important patient need, as a KRAS G12D mutation is found in 40% of pancreatic ductal adenocarcinoma, 15% of colorectal cancers, and 5% of non-small cell lung cancers.

We are excited by the possibility of bringing a new treatment options to patients with this devastating complication of hematopoietic stem cell transplant. In oncology, we continue to build out a robust pipeline with the potential to deliver meaningful innovation for patients. This quarter, we initiated a phase 1 study with our KRAS G12D inhibitor, INCB161734. Seven three four is a potent, selective, and orally bioavailable KRAS G12D inhibitor, and as highlighted at ACR earlier this month, it has shown excellent efficacy in several preclinical models. With no currently approved G12D targeting agents, seven three four could address an important patient need, as a KRAS G12D mutation is found in 40% of pancreatic ductal adenocarcinoma, 15% of colorectal cancers, and 5% of non-small cell lung cancers.

Initial evaluation has been conducted in Cala static pruritus with clinical proof of concept for college static pruritus associated with PBC and PSC anticipated by early 2025.

Pablo: And the phase one healthy volunteer study <unk> was well tolerated had low inter patient PK variability and achieved exposures well above predicted efficacious levels.

A number of exciting Readouts are expected by early 2025 with a potential first launch in CSU by 2029.

Pablo: <unk> is currently in a phase <unk> open label study in center and in two randomized phase II studies in CSU in atopic dermatitis with data for all three study is expected by early 2025.

At AAD earlier this quarter, we presented additional data from the randomized phase II study of rux cream in patients with mild to moderate hidradenitis suppurativa reinforcing the potential rux cream in this indication.

<unk> seven is a potent and highly selective antagonist of <unk> four.

Study met its primary endpoint demonstrated significantly greater reduction in absence, any inflammatory nodule count compared to control at week 16, and further reinforces the efficacy and safety profile of rux cream.

Pablo: <unk> four is expressed on neurons in the dorsal root ganglia, and specifically activated by bile acid that our increase in cost static patients.

Pablo: Initial evaluation is being conducted in college static pruritus with clinical proof of concept for college static pruritus associated with PBC and PSC anticipated by early 2025.

We are currently engaging with the FDA to obtain agreement on a potential phase III design.

We also presented positive data at AAD from the randomized phase II study evaluating <unk> in patients with Perrigo nodule areas and are on track to initiate a phase III study in the coming months.

Pablo Cagnoni: In dermatology, we continue to maximize the potential of ruxolitinib cream and povorcitinib, and believe the acquisition of Escient Pharmaceuticals will substantially expand our I&I pipeline by adding two first-in-class medicines with the potential to address a number of medical needs. The key driver of our interest in Escient is our MRGPRX2 program. MRGPRX2 is a specific novel mechanism for blocking mast cell activation independent from IgE, and has been a high-priority target to add to our I&I pipeline. EP262 is a first-in-class medicine, which entered the clinic in January 2023 and has been evaluated in phase 2 studies. In the phase 1 healthy volunteer study, EP262 was well-tolerated, had low interpatient PK variability, and achieved exposures well above predicted efficacious levels.

In dermatology, we continue to maximize the potential of ruxolitinib cream and povorcitinib, and believe the acquisition of Escient Pharmaceuticals will substantially expand our I&I pipeline by adding two first-in-class medicines with the potential to address a number of medical needs. The key driver of our interest in Escient is our MRGPRX2 program. MRGPRX2 is a specific novel mechanism for blocking mast cell activation independent from IgE, and has been a high-priority target to add to our I&I pipeline. EP262 is a first-in-class medicine, which entered the clinic in January 2023 and has been evaluated in phase 2 studies. In the phase 1 healthy volunteer study, EP262 was well-tolerated, had low interpatient PK variability, and achieved exposures well above predicted efficacious levels.

Pablo: A number of exciting Readouts are expected by early 2025 with a potential first launch in CSU by 2029.

Highlights on slide 21, the study met its primary endpoint of a far greater point improvement in the itch numerical rating scale score, which was achieved by significantly more patients who received public sitting here across all dosing groups at week 16 versus placebo.

At AAD earlier this quarter, we presented additional data from the randomized phase II study of <unk> cream in patients with mild to moderate hidradenitis suppurativa reinforcing the potential rux cream in this indication.

Pablo: The study met its primary endpoint demonstrated a significantly greater reduction in absence, any inflammatory nodule count compared to control at week 16, and further reinforces the efficacy and safety profile of rux cream.

We believe our rux cream and polar sitting there we will be the only company with the ability to potentially provide both had topical and oral option for a number of indications, including Perrigo and all your Larry's Hunter out as Super Tivo and vitiligo.

We are currently engaging with the FDA to obtain agreement on a potential phase III design.

We continued to make important progress in the first quarter by achieving several clinical and regulatory milestones.

Pablo: We also presented positive data at AAD from the randomized phase II study evaluating <unk> in patients with Perrigo nodule Arris and are on track to initiate a phase III study in the coming months.

Our oncology pipeline, we believe that our potentially best in class CDK <unk> inhibitor is an active agent and we look forward to sharing data as well as our development plan later this year.

Pablo Cagnoni: EP262 is currently in a phase 1b open label study in SINDO and in two randomized phase 2 studies in CSU, and atopic dermatitis, with data for all three studies expected by early 2025. EP547 is a potent and highly selective antagonist of MRGPRX4. MRGPRX4 is expressed on neurons in the dorsal root ganglia and specifically activated by bile acids that are increased in cholestatic patients. Initial evaluation is being conducted in cholestatic pruritus, with clinical proof of concept for cholestatic pruritus associated with PBC and PSC anticipated by early 2025. A number of exciting readouts are expected by early 2025, with a potential first launch in CSU by 2029. At AAD, earlier this quarter, we presented additional data from the randomized phase 2 study of ruxolitinib cream in patients with mild to moderate hidradenitis suppurativa, reinforcing the potential ruxolitinib cream in this indication.

EP262 is currently in a phase 1b open label study in SINDO and in two randomized phase 2 studies in CSU, and atopic dermatitis, with data for all three studies expected by early 2025. EP547 is a potent and highly selective antagonist of MRGPRX4. MRGPRX4 is expressed on neurons in the dorsal root ganglia and specifically activated by bile acids that are increased in cholestatic patients.

Highlights on slide 21, the study met its primary endpoint of a far greater point improvement in the itch numerical rating scale score, which was achieved by significantly more patients who receive public sitting here across all dosing groups at week 16 versus placebo.

In addition, the pivotal trial, a tougher set them up in patients with Follicular and marginal zone lymphoma also known as N mind will read out later this year and we look forward to sharing those results.

The BLA for <unk> submitted late last year, we look forward to working with the FDA to make extra tell them are available to patients with chronic graft versus host disease. Later this year and to initiate additional combination studies in patients with less pretreated chronic graft versus host disease.

Pablo: We believe that with rux cream and polar sitting there we will be the only company with the ability to potentially provide both had topical and oral option for a number of indications, including Perrigo nausea, Lares Hunter I know Super Tivo and vitiligo.

Initial evaluation is being conducted in cholestatic pruritus, with clinical proof of concept for cholestatic pruritus associated with PBC and PSC anticipated by early 2025. A number of exciting readouts are expected by early 2025, with a potential first launch in CSU by 2029. At AAD, earlier this quarter, we presented additional data from the randomized phase 2 study of ruxolitinib cream in patients with mild to moderate hidradenitis suppurativa, reinforcing the potential ruxolitinib cream in this indication.

Within our dermatology portfolio, we expect to submit the NDA for <unk> for pediatric atopic dermatitis and expect multiple data readouts throughout the year.

Pablo: We continued to make important progress in the first quarter by achieving several clinical and regulatory milestones.

Pablo: In our oncology pipeline, we believe that our potentially best in class CDK <unk> inhibitor is an active agent and we look forward to sharing data as well as our development plan later this year.

With that I would like to turn the call over to Christiana for the financial update.

Thank you Pablo and good morning, everyone.

Our first quarter results reflect continued strong growth with total revenues of $881 million up 9% versus the same period last year.

Pablo: In addition, the pivotal trial of <unk> in patients with Follicular and marginal zone lymphoma also known as N mind will read out later this year and we look forward to sharing those results.

<unk> product revenues of $730 million in Q1 were driven by demand growth for Jakafi and upsell Lula and increased contribution from <unk>. Following the acquisition in February of the global exclusive rights to the deficit that month.

Pablo Cagnoni: The study met its primary endpoint, demonstrated a significantly greater reduction in abscess and inflammatory nodule count compared to control at week 16, and further reinforces the efficacy and safety profile of ruxolitinib cream. We are currently engaging with the FDA to obtain agreement on a potential phase 3 design. We also presented positive data at AAD from the randomized phase 2 study evaluating povorcitinib in patients with prurigo nodularis, and are on track to initiate a phase 3 study in the coming months. Highlighted on slide 21, the study met its primary endpoint of a four-grade point improvement in the itch numerical rating scale score, which was achieved by significantly more patients who received povorcitinib across all dosing groups at week 16 versus placebo.

The study met its primary endpoint, demonstrated a significantly greater reduction in abscess and inflammatory nodule count compared to control at week 16, and further reinforces the efficacy and safety profile of ruxolitinib cream. We are currently engaging with the FDA to obtain agreement on a potential phase 3 design. We also presented positive data at AAD from the randomized phase 2 study evaluating povorcitinib in patients with prurigo nodularis, and are on track to initiate a phase 3 study in the coming months. Highlighted on slide 21, the study met its primary endpoint of a four-grade point improvement in the itch numerical rating scale score, which was achieved by significantly more patients who received povorcitinib across all dosing groups at week 16 versus placebo.

Pablo: The BLA for <unk> submitted late last year, we look forward to working with the FDA to make extra tell them are available to patients with chronic graft versus host disease. Later this year and to initiate additional combination studies in patients with less pretreated chronic graft versus host disease.

The product demand growth was partially offset by an anticipated reduction in channel inventory for Jakafi in the typical Q1 dynamics for Jakafi in a pillow.

Pablo: Within our dermatology portfolio, we expect to submit the NDA for <unk> for pediatric atopic dermatitis and expect multiple data readouts throughout the year.

Total royalty revenues, which are primarily comprised of royalties from novartis and Jack for Jackup, the entoprocta and royalties from Lilly for <unk> $126 million up 9% compared to the first quarter of 2023, driven by strong demand for Jack Lee.

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

Christiana: Thank you Pablo and good morning, everyone.

Christiana: Our first quarter results reflect continued strong growth with total revenues of $881 million up 9% versus the same period last year.

Total revenues included $25 million upfront payment received under our collaboration and license agreement with CMS or the development and commercialization of policy in China and select other Asian countries.

Christiana: Product revenues of $730 million in Q1 were driven by demand growth for Jakafi and upsell Lula and increased contribution from one choosy. Following the acquisition in February of the global exclusive rights to the deficit that month.

Pablo Cagnoni: We believe that with ruxolitinib cream and povorcitinib, we will be the only company with the ability to potentially provide both a topical and oral option for a number of indications, including prurigo nodularis, hidradenitis suppurativa, and vitiligo. We continued to make important progress in the first quarter by achieving several clinical and regulatory milestones. Within our oncology pipeline, we believe that our potentially best-in-class CDK2 inhibitor is an active agent, and we look forward to sharing data as well as our development plan later this year. In addition, the pivotal trial of tafasitamab in patients with follicular and marginal zone lymphoma, also known as INMIND, will read out later this year, and we look forward to sharing those results.

We believe that with ruxolitinib cream and povorcitinib, we will be the only company with the ability to potentially provide both a topical and oral option for a number of indications, including prurigo nodularis, hidradenitis suppurativa, and vitiligo. We continued to make important progress in the first quarter by achieving several clinical and regulatory milestones. Within our oncology pipeline, we believe that our potentially best-in-class CDK2 inhibitor is an active agent, and we look forward to sharing data as well as our development plan later this year. In addition, the pivotal trial of tafasitamab in patients with follicular and marginal zone lymphoma, also known as INMIND, will read out later this year, and we look forward to sharing those results.

Turning to Jakafi on slide 26, Jakafi net product revenues were $572 million for the first quarter.

Christiana: The product demand growth was partially offset by an anticipated reduction in channel inventory for Jakafi in the typical Q1 dynamics for Jakafi and <unk>.

Net product revenues reflect continued demand growth with total patients up 5% year over year, driven by growth in PV and Gvhd and continued stable demand in EMEA.

Total royalty revenues, which are primarily comprised of royalties from novartis and Jack for Jacobean breakdown and royalties from Lilly for <unk> $126 million up 9% compared to the first quarter of 2023, driven by strong demand for Jack Lee.

As a result, we experienced the highest quarter paid demand for Jakafi since launch.

As expected in Q1, we saw patients that were on free drug in the first quarter of 2023 return to pay demand and the related degrees decrease in channel inventory levels.

Christiana: Total revenues included $25 million upfront payment received under our collaboration and license agreement with Tms for the development and commercialization of policy in China and select other Asian countries.

As you May recall, chador limitary levels increased by $46 million in the fourth quarter of 2023.

Pablo Cagnoni: With the BLA for axatilimab submitted late last year, we look forward to working with the FDA to make axatilimab available to patients with chronic graft-versus-host disease later this year, and to initiate additional combination studies in patients with less pretreated chronic graft-versus-host disease.

With the BLA for axatilimab submitted late last year, we look forward to working with the FDA to make axatilimab available to patients with chronic graft-versus-host disease later this year, and to initiate additional combination studies in patients with less pretreated chronic graft-versus-host disease.

In the first quarter of the here, we said a drawdown in channel inventory, which had $55 million negative impact on net sales versus the first fourth quarter of 2023.

Christiana: Turning to Jakafi on slide 26, Jakafi net product revenues were $572 million for the first quarter.

Christiana: Net product revenues reflect continued demand growth with total patients up 5% year over year, driven by growth in PV and Gvhd and continued stable demand in EMEA.

Operator: ... Within our dermatology portfolio, we expect to submit the sNDA for Opzelura for pediatric atopic dermatitis and expect multiple data readouts throughout the year. With that, I would like to turn the call over to Christiana for the financial update.

Within our dermatology portfolio, we expect to submit the sNDA for Opzelura for pediatric atopic dermatitis and expect multiple data readouts throughout the year. With that, I would like to turn the call over to Christiana for the financial update.

While we expect channel inventory to remain around the levels. We ended in Q1 buying decisions of our customers cannot always be predicted.

In addition, net sales in the first quarter were impacted by the typical Q1 higher gross to net deductions as a result of both contributions to close the Medicare gap and commercial copay assistance.

Christiana: As a result, we experienced the highest quarter paid demand for Jakafi since launch.

Christiana Stamoulis: Thank you, Pablo, and good morning, everyone. Our first quarter results reflect continued strong growth, with total revenues of $881 million, up 9% versus the same period last year. Total product revenues of $730 million in Q1 were driven by demand growth for Jakafi and Opzelura, and increased revenue contribution from Monjuvi, following the acquisition in February of the global exclusive rights to tafasitamab. The product demand growth was partially offset by an anticipated reduction in channel inventory for Jakafi and the typical Q1 dynamics for Jakafi and Opzelura. Total royalty revenues, which are primarily comprised of royalties from Novartis for Jakavi and Tabrecta, and royalties from Lilly for Olumiant, were $126 million, up 9% compared to the first quarter of 2023, driven by strong demand for Jakavi.

Christiana Stamoulis: Thank you, Pablo, and good morning, everyone. Our first quarter results reflect continued strong growth, with total revenues of $881 million, up 9% versus the same period last year. Total product revenues of $730 million in Q1 were driven by demand growth for Jakafi and Opzelura, and increased revenue contribution from Monjuvi, following the acquisition in February of the global exclusive rights to tafasitamab. The product demand growth was partially offset by an anticipated reduction in channel inventory for Jakafi and the typical Q1 dynamics for Jakafi and Opzelura. Total royalty revenues, which are primarily comprised of royalties from Novartis for Jakavi and Tabrecta, and royalties from Lilly for Olumiant, were $126 million, up 9% compared to the first quarter of 2023, driven by strong demand for Jakavi.

As expected in Q1, we saw patients that were on three drag in the first quarter of 2023 return to pay demand and the related degrees decrease in channel inventory levels.

Turning now to our pillar on slide 27, net product revenues for the first quarter were $86 million, representing a 52% increase year over year driven by growth in net new patient starts and refills across both of the in vitiligo as well as early contribution from the commercialization.

Christiana: As you May recall channel inventory levels increased by $46 million in the fourth quarter of 2023.

Christiana: In the first quarter of the here, we saw a drawdown in channel inventory, which had $55 million negative impact on net sales versus the first fourth quarter of 2023.

Okay, Laura for Vitiligo in Germany, Austria and France.

As expected <unk> net product revenues in the first quarter reflected the typical Q1 seasonality and the reset of deductibles and co pays at the beginning of the year.

Christiana: While we expect channel inventory to remain around the levels. We ended in Q1 buying decisions of our customers cannot always be predicted.

Beyond the typical Q1 dynamics up say Lora product revenues were impacted by this amount attack on United has changed healthcare unit.

Christiana: In addition, net sales in the first quarter were impacted by the typical Q1 higher gross to net deductions as a result of both contributions to close the Medicare gap and commercial copay assistance.

Moving on to slide 28 in our operating expenses on a GAAP basis total R&D expenses were $429 million for the first quarter, representing a 6% year over year increase which was primarily as a result of the progression of our pipeline.

Christiana Stamoulis: Total revenues include a $25 million upfront payment received under our collaboration and license agreement with CMS for the development and commercialization of povorcitinib in China and select other Asian countries. Turning to Jakafi on slide 26. Jakafi net product revenues were $572 million for the first quarter. Net product revenues reflect continued demand growth, with total patients up 5% year over year, driven by growth in PV and GVHD and continued stable demand in MF. As a result, we experienced the highest quarter paid demand for Jakafi since launch. As expected, in Q1, we saw patients that were on free drug in the fourth quarter of 2023 return to paid demand and a related decrease in channel inventory levels. As you may recall, channel inventory levels increased by $46 million in the fourth quarter of 2023.

Total revenues include a $25 million upfront payment received under our collaboration and license agreement with CMS for the development and commercialization of povorcitinib in China and select other Asian countries. Turning to Jakafi on slide 26. Jakafi net product revenues were $572 million for the first quarter. Net product revenues reflect continued demand growth, with total patients up 5% year over year, driven by growth in PV and GVHD and continued stable demand in MF. As a result, we experienced the highest quarter paid demand for Jakafi since launch. As expected, in Q1, we saw patients that were on free drug in the fourth quarter of 2023 return to paid demand and a related decrease in channel inventory levels. As you may recall, channel inventory levels increased by $46 million in the fourth quarter of 2023.

Christiana: Turning now to our pillar on slide 27, net product revenues for the first quarter were $86 million, representing a 52% increase year over year driven by growth in net new patient starts and refills across both ADN vitiligo as well as early contribution from the commercialization.

Total SG&A expenses were $300 million for the first quarter, representing a 5% year over year decrease driven by the timing of direct to consumer marketing activities and certain other expenses.

Christiana: Okay, Laura for Vitiligo in Germany, Austria and France.

As expected <unk> net product revenues in the first quarter reflected the typical Q1 seasonality and the reset of deductibles and co pays at the beginning of the year.

Now turning to the acquisition of <unk> Pharmaceuticals under the terms of the agreement we will acquire <unk> for $750 million in an all cash transaction.

Christiana: Beyond the typical Q1 dynamics up say Lora product revenues were impacted by this amount attack on United has changed healthcare unit.

We believe that chance to lead programs offered a multibillion dollar potential commercial opportunity across multiple indications and have the potential to contribute to our revenue by 2029.

Christiana: Moving on to slide 28 in our operating expenses on a GAAP basis total R&D expenses were $429 million for the first quarter, representing a 6% year over year increase which was primarily as a result of the progression of our pipeline.

In addition, we expect to be able to realize synergies by leveraging our current development and commercial capabilities and infrastructure.

We anticipate the acquisition to become effective by the third quarter of 2020 for another approximately $5 million per month in incremental R&D expense.

Christiana Stamoulis: In the first quarter of this year, we saw a drawdown in channel inventory, which had $55 million negative impact on net sales versus the fourth quarter of 2023. While we expect channel inventory to remain around the levels we ended in Q1, buying decisions of our customers cannot always be predicted. In addition, net sales in the first quarter were impacted by the typical Q1 higher gross-to-net deductions as a result of both contributions to close the Medicare gap and commercial copay assistance. Turning now to Opzelura on slide 27. Net product revenues for the first quarter were $86 million, representing a 52% increase year over year, driven by growth in net new patient starts and refills across both AD and vitiligo, as well as early contribution from the commercialization of Opzelura for vitiligo in Germany, Austria, and France.

In the first quarter of this year, we saw a drawdown in channel inventory, which had $55 million negative impact on net sales versus the fourth quarter of 2023. While we expect channel inventory to remain around the levels we ended in Q1, buying decisions of our customers cannot always be predicted. In addition, net sales in the first quarter were impacted by the typical Q1 higher gross-to-net deductions as a result of both contributions to close the Medicare gap and commercial copay assistance. Turning now to Opzelura on slide 27. Net product revenues for the first quarter were $86 million, representing a 52% increase year over year, driven by growth in net new patient starts and refills across both AD and vitiligo, as well as early contribution from the commercialization of Opzelura for vitiligo in Germany, Austria, and France.

Christiana: Total SG&A expenses were $300 million for the first quarter, representing a 5% year over year decrease driven by the timing of direct to consumer marketing activities and certain other expenses.

Depending on the timing of the close we expect the acquisition to add $20 million to $30 million through the fall.

Year 2020 for R&D expenses.

Christiana: Now turning to the acquisition of <unk> Pharmaceuticals under the terms of the agreement we will acquire <unk> for $750 million in an all cash transaction.

Finally, following this acquisition, we will continue to have a strong balance sheet.

Which will allows us to consider additional opportunities as of the end of the first quarter, we had $3 $9 billion in cash and no debt.

Christiana: We believe a chance to lead programs offered a multibillion dollar potential commercial opportunity across multiple indications and have the potential to contribute to our revenue by 2029.

Moving to our guidance for 2024, excluding the impact of the acquisition of patient we are reiterating our full year 2020 guidance for jakafi or other dermatology oncology products Cogs R&D and SG&A.

Christiana: In addition, we expect to be able to realize synergies by leveraging our current development and commercial capabilities and infrastructure.

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

Christiana: We anticipate the acquisition to become effective by the third quarter of 2020 for another approximately $5 million per month in incremental R&D expense.

Certainly, we'll now be conducting a question and answer session if you'd like to be placed in the question queue. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.

Christiana: Depending on the timing of the close we expect the acquisition to add $20 million to $30 million through the fall.

Christiana Stamoulis: As expected, Opzelura net product revenues in the first quarter reflected the typical Q1 seasonality and the reset of deductibles and copays at the beginning of the year. Beyond the typical Q1 dynamics, Opzelura product revenues were impacted by the cyberattack on UnitedHealth's Change Healthcare unit. Moving on to slide 28 and our operating expenses on a GAAP basis. Total R&D expenses were $429 million for the first quarter, representing a 6% year-over-year increase, which was primarily as a result of the progression of our pipeline. Total SG&A expenses were $300 million for the first quarter, representing a 5% year-over-year decrease, driven by the timing of direct-to-consumer marketing activities and certain other expenses. Now, turning to the acquisition of Ascend Pharmaceuticals. Under the terms of the agreement, we will acquire Ascend for $750 million in an all-cash transaction.

As expected, Opzelura net product revenues in the first quarter reflected the typical Q1 seasonality and the reset of deductibles and copays at the beginning of the year. Beyond the typical Q1 dynamics, Opzelura product revenues were impacted by the cyberattack on UnitedHealth's Change Healthcare unit. Moving on to slide 28 and our operating expenses on a GAAP basis. Total R&D expenses were $429 million for the first quarter, representing a 6% year-over-year increase, which was primarily as a result of the progression of our pipeline. Total SG&A expenses were $300 million for the first quarter, representing a 5% year-over-year decrease, driven by the timing of direct-to-consumer marketing activities and certain other expenses. Now, turning to the acquisition of Ascend Pharmaceuticals. Under the terms of the agreement, we will acquire Ascend for $750 million in an all-cash transaction.

Christiana: Year 2020 for R&D expenses.

If you'd like to remove your question from the queue. You May press star two once again Thats star one to be placed into question Q1 moment. Please while we poll for questions.

Christiana: Finally, following this acquisition, we will continue to have a strong balance sheet.

Christiana: Which will allows us to consider additional opportunities as of the end of the first quarter, we have $3 $9 billion in cash and no debt.

Our first question is coming from Kelly <unk> from Jefferies. Your line is now live.

Christiana: Moving to our guidance for 2024, excluding the impact of the acquisition of patient we are reiterating our full year 2020 guidance for jakafi or other dermatology oncology products Cogs R&D and SG&A.

Hi, Thank you for taking my questions.

So fall.

Can you give us some more color.

The gross to net for the rest of the year.

Ladies.

Ladies there with you guys.

Speaker Change: Operator that concludes our prepared remarks, please give your instructions and open the call for Q&A.

Wally.

Thank you Michael Thank you and I also have a follow up.

Yeah.

Speaker Change: Certainly, we'll now be conducting a question and answer session if you'd like to be placed in the question queue. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.

Hi, Kelly is Christiana, let me take the first part of the question and then I will tell you what they are able to comment on the second part.

In terms of the gross to net in the first quarter. It was at the same level as last.

Operator: People like to remove your question from the queue. You May press Star two once again Thats star one to be placed into question Q1 moment. Please while we poll for questions.

Q1, so at around 60%.

Going forward as we have previously discussed we will not be making forward looking comments of gross to net our focus is on maximizing the potential of absolute.

Christiana Stamoulis: We believe Escient's two lead programs offer a multibillion-dollar potential commercial opportunity across multiple indications and have the potential to contribute to our revenue by 2029. In addition, we expect to be able to realize synergies by leveraging our current development and commercial capabilities and infrastructure. We anticipate the acquisition to become effective by Q3 2024 and add approximately $5 million per month in incremental R&D expense. Depending on the timing of the close, we expect the acquisition to add $20 to 30 million to the full year 2024 R&D expenses. Finally, following this acquisition, we'll continue to have a strong balance sheet, which will allow us to consider additional opportunities. As of the end of Q1, we have $3.9 billion in cash and no debt.

We believe Escient's two lead programs offer a multibillion-dollar potential commercial opportunity across multiple indications and have the potential to contribute to our revenue by 2029. In addition, we expect to be able to realize synergies by leveraging our current development and commercial capabilities and infrastructure. We anticipate the acquisition to become effective by Q3 2024 and add approximately $5 million per month in incremental R&D expense. Depending on the timing of the close, we expect the acquisition to add $20 to 30 million to the full year 2024 R&D expenses. Finally, following this acquisition, we'll continue to have a strong balance sheet, which will allow us to consider additional opportunities. As of the end of Q1, we have $3.9 billion in cash and no debt.

Operator: Our first question is coming from Kelly <unk> from Jefferies. Your line is now live.

Kelly: Thank you for taking my questions.

I mean, they are maximizing net sales versus looking at gross to net in isolation.

Kelly: So fall.

Kelly: Can you give us some more color.

Kelly: The gross to net for the rest of the year.

And on the split of business between the two indications when we look at the IQ via data Triangulated with external and internal sources, we see a 40 60 split consistent overtime with 40% is non.

Kelly: Ladies.

Speaker Change: Ladies and gentlemen, thank you.

Speaker Change: Bose.

Speaker Change: Thank you Michael Thank you and I also have a follow up.

Speaker Change: Yeah.

Speaker Change: Hi, Kelly Christiana I'll, let me take the first part of the question and then I'll return to comment on the second part.

Non segmental vitiligo and 60% is our atopic dermatitis and we're very happy to see that both indications are growing at quite a healthy pace.

Speaker Change: In terms of the gross to net in the first quarter. It was at the same level as last.

Thank you and also at <unk>.

Speaker Change: <unk> Q1, so at around 60%.

The metallurgy conference we saw the data.

Speaker Change: Going forward as we have previously discussed we will not be making forward looking comments of gross to net our focus is on maximizing the potential of absolute.

Topical Rockville Clean Inc.

Holly stage, one and two Hs patients.

Could you share what kind of feedback since year.

Christiana Stamoulis: Moving to our guidance for 2024, excluding the impact of the acquisition of Ascend, we are reiterating our full year 2024 guidance for Jakafi, our other hematology oncology products, COGS, R&D, and SG&A. Operator, that concludes our prepared remarks. Please, give your instructions and open the call for Q&A.

Moving to our guidance for 2024, excluding the impact of the acquisition of Ascend, we are reiterating our full year 2024 guidance for Jakafi, our other hematology oncology products, COGS, R&D, and SG&A. Operator, that concludes our prepared remarks. Please, give your instructions and open the call for Q&A.

And also how do they see it.

I mean, they are maximizing net sales versus looking at the gross to net in isolation.

How do you think what in there too.

<unk> saw a novel topical drug like also rod needed to manage disease is expected to be a population. Thank you.

Speaker Change: And on the split of business between the two indications when we look at the IQ via data Triangulated with external and internal sources, we see a 40 60 split consistent overtime with 40% is non.

Yes. Thank you for the question, it's Steven So the mildest type of Hs still represents about 100 150000 patients in the United States is still has mobility and unmet need in these patients have abscess and nodules that caused them no discomfort and morbidity and lends itself.

Operator: Certainly. We'll now be conducting a question-and-answer session. If you'd like to be placed into question queue, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. If you'd like to remove your question from the queue, you may press star two. Once again, that's star one to be placed into question queue. One moment, please, while we poll for questions. Our first question is coming from Kelly Shih from Jefferies. Your line is now live.

Operator: Certainly. We'll now be conducting a question-and-answer session. If you'd like to be placed into question queue, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. If you'd like to remove your question from the queue, you may press star two. Once again, that's star one to be placed into question queue. One moment, please, while we poll for questions. Our first question is coming from Kelly Shih from Jefferies. Your line is now live.

Speaker Change: Non segmental vitiligo and 60% is a hot topic dermatitis, and we're very happy to see that both indications are growing at quite a healthy pace.

Speaker Change: Thank you and also.

Self to a topical treatment because it's not as extensive as the moderate and severe which has fistulas et cetera. So.

Speaker Change: Mccollough, Jake Humphrey, we saw the data.

Speaker Change: A copy call Rockville claim in both.

We conducted this POC study in so this data which is extremely encouraging in this smiled at stage of Hs in terms of abscess and nodules decreases and as Pablo said in his prepared remarks, we are now working with regulators to get an appropriate endpoint in this entity for which no drug is approved and has the sudden.

Speaker Change: Holly stage, one and two Hs patients could.

Speaker Change: Could you share what kind of utilization feedbacks teams here and also how do they see it.

Kelly Shih: ... Thank you for taking my questions. So for Opzelura, could you give us some more color on the gross-to-net for the rest of the year? And what is the latest refill trends you see in both AD and vitiligo? Thank you, and I also have a follow-up.

Kelly Shi: Thank you for taking my questions. So for Opzelura, could you give us some more color on the gross-to-net for the rest of the year? And what is the latest refill trends you see in both AD and vitiligo? Thank you, and I also have a follow-up.

Speaker Change: How do you think one or two patients.

Speaker Change: Novel topical drug like also rod needed to manage disease and is expected to be a population. Thank you.

Met need I spoke about.

To the specifics of your question the physicians and Kols feedback is excellent I mean they were.

Speaker Change: Yes. Thank you for the question, it's Steven So the mildest type of Hs still represents about 100 150000 patients in the United States is still has mobility and unmet need in these patients have abscess and nodules that cause them, no discomfort and morbidity and lend.

Christiana Stamoulis: Hi, Jessica, Christiana. Let me take the first part of the question, and then I will turn it to Matteo to comment on the second part. So in terms of the gross-to-net, in Q1, it was at the same level as last year Q1, so at around 60%. Going forward, as we have previously discussed, we will not be making forward-looking comments on gross-to-net. Our focus is on maximizing the potential of Opzelura, and by this, I mean the maximizing net sales versus looking at gross-to-net in isolation.

Christiana Stamoulis: Hi, Jessica, Christiana. Let me take the first part of the question, and then I will turn it to Matteo to comment on the second part. So in terms of the gross-to-net, in Q1, it was at the same level as last year Q1, so at around 60%. Going forward, as we have previously discussed, we will not be making forward-looking comments on gross-to-net. Our focus is on maximizing the potential of Opzelura, and by this, I mean the maximizing net sales versus looking at gross-to-net in isolation.

Sure.

Surprised by the efficacy seen with the topical agent in this entity. So we excited about it as well.

Thank you very much.

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

Steven: <unk> itself to a topical treatment because theres not as extensive as the moderate and severe which has fistulas et cetera. So we conducted this POC study and so this data which is extremely encouraging in this smiled at stage of Hs in terms of abscess nodule decreases and as Pablo said in his prepared remarks, we now.

Thank you very much for taking my question.

Comment on Jakafi growth demand dynamics going forward given I R. A.

And shifting the out of pocket expenses for patients.

Sure.

He is a shot from our guidance $2 69 to 75, we're very optimistic about the continued growth of our jakafi.

Steven: Working with regulators to get an appropriate endpoint in this entity for which no drug is approved and has this unmet need I spoke about the to the specifics of your question the physicians and Kols feedback is excellent I mean, they were surprised by the efficacy seen with the topical agent.

Matteo Trotta: On the split of business between the two indications, when we look at the IQVIA data, triangulated with external and internal sources, we see a 40/60 split consistent over time, where 40% is non-segmental vitiligo and 60% is atopic dermatitis. We're very happy to see that both indications are growing at quite a healthy pace.

Matteo Trotta: On the split of business between the two indications, when we look at the IQVIA data, triangulated with external and internal sources, we see a 40/60 split consistent over time, where 40% is non-segmental vitiligo and 60% is atopic dermatitis. We're very happy to see that both indications are growing at quite a healthy pace.

Jakafi.

Obviously, we benefit in the IRA because we as we talked about before we have the small biotech exemption.

So beginning in 2025 for example, with the reduced out of pocket for patients who really just <unk>.

In this entity so we excited about it as well.

Helps the.

Speaker Change: Thank you very much.

Patients of course, but we don't have to contribute 20% of catastrophic that other oral drugs will.

Kelly Shih: Thank you. And also, at AAD Dermatology Conference, we saw the data of topical ruxolitinib cream in both early stage one and the two HS patients. Could you share what kind of physician feedback do you hear? And also, how do they see the unmet needs in both early stage one and the two patients for normal topical drug like Opzelura are needed to manage disease in this specific population? Thank you.

Kelly Shi: Thank you. And also, at AAD Dermatology Conference, we saw the data of topical ruxolitinib cream in both early stage one and the two HS patients. Could you share what kind of physician feedback do you hear? And also, how do they see the unmet needs in both early stage one and the two patients for normal topical drug like Opzelura are needed to manage disease in this specific population? Thank you.

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.

So we think there is a benefit in 2024 for the reduced out of pocket in Medicare part D being around 30 to 50 for patients for the entire year and then next year being.

David Neil Lebowitz: <unk>.

David Neil Lebowitz: Jack if I close demand dynamics going forward, given IRA and shifting the out of pocket expenses.

David Neil Lebowitz: <unk>.

Being 2000, Oh Ah patients, who are taking oral oncology drugs I believe will benefit them, but we continue to see our growth as <unk> pointed out are coming from PV Gvhd and in myelofibrosis, we're very stable and remain.

David Neil Lebowitz: Sure.

Jack: As we show up from our guidance $2 69 to 75, we're very optimistic about the continued growth of our jakafi.

Steven Stein: Yeah, thank you for the question. It's Steven. So, the milder type of HS still represents about 150,000 patients in the United States. It still has morbidity and unmet need, and these patients have abscesses and nodules that cause them, you know, discomfort and morbidity, and lends itself to a topical treatment because it's not as extensive as the moderate and severe, which has fistulas, et cetera. So, you know, we conducted this POC study and saw this data, which is extremely encouraging in this milder stage of HS in terms of abscess and nodule decreases. And as Pablo said in his prepared remarks, we're now working with regulators to get an appropriate endpoint in this entity for which no drug is approved and has this unmet need I spoke about.

Steven Stein: Yeah, thank you for the question. It's Steven. So, the milder type of HS still represents about 150,000 patients in the United States. It still has morbidity and unmet need, and these patients have abscesses and nodules that cause them, you know, discomfort and morbidity, and lends itself to a topical treatment because it's not as extensive as the moderate and severe, which has fistulas, et cetera. So, you know, we conducted this POC study and saw this data, which is extremely encouraging in this milder stage of HS in terms of abscess and nodule decreases. And as Pablo said in his prepared remarks, we're now working with regulators to get an appropriate endpoint in this entity for which no drug is approved and has this unmet need I spoke about.

Speaker Change: Obviously, we benefit in the IRR, because we as we talked about before we have the small biotech exemption.

It remains the market leader in that setup setting.

Speaker Change: So beginning in 2025 for example, with the reduced out of pocket for patients who really just <unk>.

Would you be able to comment further on.

Whether how growth in 2025 might look.

Speaker Change: Helps the.

Speaker Change: Patients of course, but we don't have to contribute 20% of catastrophic that other oral drugs will.

These are the 2024 and given these dynamics.

No. We obviously said, we're still confident about $3 billion plus by the time we.

So we think there is a benefit in 2024 for the reduced out of pocket in Medicare part D being around 30 to 50 for patients for the entire year and then next year being.

Hit 2028.

So that's why we're still confident in and so we think that the 'twenty four and 'twenty five should be just fine.

Speaker Change: Being 2000, Oh Ah patients, who are taking oral oncology drugs I believe will benefit, but we continue to see our growth are as <unk> pointed out are coming from PV gvhd and in myelofibrosis, we're very stable and remain.

Thank you next question is coming from <unk> condo from Truest. Your line is now live.

Okay.

Hey, guys. Thank you so much for taking my question.

On Jakafi are the you mentioned that you see very little impact on Jakafi.

Steven Stein: To the specifics of your question, the physician and KOL feedback is excellent. I mean, they were, you know, surprised by the efficacy seen with a topical agent in this entity, so we're excited about it as well.

To the specifics of your question, the physician and KOL feedback is excellent. I mean, they were, you know, surprised by the efficacy seen with a topical agent in this entity, so we're excited about it as well.

Okay.

Can you talk a little bit about.

We remain the market leader in that setup setting.

The competition has changed.

Nation on Jakafi, we do go on to talk about the frontline, but is there any are you observing people getting off of Jakafi.

Speaker Change: Would you be able to comment further on.

Speaker Change: Whether how growth in 2025 might look.

Kelly Shih: Thank you very much.

Kelly Shi: Thank you very much.

Speaker Change: These are the 2024 and given these dynamics.

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

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

And also go.

The buttons EBITDA combination.

Speaker Change: No. We obviously said, we're still confident about $3 billion plus by the time we.

Christiana Stamoulis: Thank you very much for taking my question. Could you comment on Jakafi growth dynamics going forward, given IRA and shifts in the out-of-pocket expenses for patients?

David Lebowitz: Thank you very much for taking my question. Could you comment on Jakafi growth dynamics going forward, given IRA and shifts in the out-of-pocket expenses for patients?

In support of increased incidents in patients on the Jakafi that commvault for a competitor talks I just wanted to get your insights into how this may or may not impact your internal bet. Okay. Thank you.

Hit 2028.

Speaker Change: So that's what we're still confident in and so we think that the 24 and 25 should be just fine.

So Chris I'll take the first call and then I'll hand, it over to Pablo for the second part of your question so for Jakafi.

Steven Stein: Sure. You know, I, as you saw from our guidance, $2.69 to $2.75, we're very optimistic about the continued growth of Jakafi. Obviously, you know, we benefit in the IRA because we, as we talked about before, we have the small biotech exemption. So beginning in 2025, for example, with the reduced out-of-pockets for patients, it really just helps the patients, of course, but we don't have to contribute that 20% of to catastrophic that other oral drugs will.

Steven Stein: Sure. You know, I, as you saw from our guidance, $2.69 to $2.75, we're very optimistic about the continued growth of Jakafi. Obviously, you know, we benefit in the IRA because we, as we talked about before, we have the small biotech exemption. So beginning in 2025, for example, with the reduced out-of-pockets for patients, it really just helps the patients, of course, but we don't have to contribute that 20% of to catastrophic that other oral drugs will.

Ankur Tandon: Thank you. Your next question is coming from <unk> Tandon from Truest. Your line is now live.

Sure from competitors, there really hasnt been.

Ankur Tandon: Okay.

Vikram Tandon: Hey, guys. Thank you so much for taking my question.

Any impact on or duration of therapy or discontinuation rates at all certainly in myelofibrosis. So we're very confident that we remain the market leader.

Vikram Tandon: Jakafi are the you mentioned that you see very little impact on Jakafi.

Vikram Tandon: Okay.

Vikram Tandon: Can you talk a little bit about that.

Vikram Tandon: The competition has changed.

Other JAK inhibitors may be used in second line third line setting if anything.

Vikram Tandon: Elevation on Jakafi, we do go on to talk about the frontline, but is there any are you observing people getting off of Jakafi.

The market size itself is growing because now patients will go on 123 therapies and I'll hand, it over to Pablo for the second part of your question.

Vikram Tandon: And also for.

Oh, yes. Thank you for the question so.

The buttons EBITDA combination.

I'm not going to comment on data from from other from other companies.

Steven Stein: So we think there's a benefit in 2024 for the reduced out-of-pocket Medicare Part D, being around $3,250 for patients for the entire year, and then next year, being $2,000, all patients who are taking oral oncology drugs, I believe, will benefit. But we continue to see our growth, as Hervé pointed out, coming from PV, GVHD, and myelofibrosis, we're very stable and remain the market leader in that setting.

Vikram Tandon: In support of NK AML incidence in patients on the Jakafi <unk> combo for a capital I just wanted to get your insights into how this may or may not impact your internal program. Thank you.

So we think there's a benefit in 2024 for the reduced out-of-pocket Medicare Part D, being around $3,250 for patients for the entire year, and then next year, being $2,000, all patients who are taking oral oncology drugs, I believe, will benefit. But we continue to see our growth, as Hervé pointed out, coming from PV, GVHD, and myelofibrosis, we're very stable and remain the market leader in that setting.

Our bet inhibitor program as we've discussed is going very well and will will describe additional data over the course of the year and we're planning a potential pivotal trial.

Speaker Change: So Chris I'll take the first call and then I'll hand, it over to Pablo for the second part of your question so for Jakafi.

Going forward, which will unveil later this year.

Reviewing the data from our <unk> program, we have at this point or concerns over the safety when it comes to AML transformation now you I'm sure you know that.

Chris: Sure from competitors, there really hasnt been.

Chris: Any impact on or duration of therapy or discontinuation rates at all.

If you follow a number of patients with MF for long enough. Some of them will have transformation two ml as part of the natural history of the disease, but at this point, we have no concerns with our program.

Chris: Certainly in myelofibrosis. So we're very confident we remain the market leader other JAK inhibitors may be used in the second line third line setting if anything.

Christiana Stamoulis: Would you be able to comment further on whether how growth in 2025 might look, vis-a-vis 2024, given these dynamics?

David Lebowitz: Would you be able to comment further on whether how growth in 2025 might look, vis-a-vis 2024, given these dynamics?

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

Chris: The market size itself is growing because now patients will go on 123 therapies and I'll hand, it over to Pablo for the second part of your question.

Hey, guys good morning.

Had a question on <unk>.

Steven Stein: No. We obviously said we're still confident about $3 billion plus by the time we hit 2028. So that's what we're still confident in, and so we think that 2024 and 2025 should be just fine.

And again, commenting about another another dataset, but I just wanted to get your insights on the reasons or invoke head to head study against to pick send an ADM, whether or how that impacts perhaps your view on the potential for since nib across various dermatology indications.

Steven Stein: No. We obviously said we're still confident about $3 billion plus by the time we hit 2028. So that's what we're still confident in, and so we think that 2024 and 2025 should be just fine.

Pablo: Yes. Thank you for the question so.

Pablo: Obviously, I'm not going to comment on data from from other from other companies.

Pablo: Our bet inhibitor program as we've discussed is going very well and will will describe additional data over the course of the year and we're planning a potential pivotal trial.

Operator: Thank you. Next question is coming from Kripa Devarakonda from Truist. Your line is now live.

Operator: Thank you. Next question is coming from Kripa Devarakonda from Truist. Your line is now live.

Pablo: Going forward, which will unveil later this year.

Yes, Michael Thank you for the question and now we've seen the data I'm. Obviously, obviously, that's an impressive data set at this point as you know we have a number of studies ongoing with <unk>, we've had internal discussions about the potential to extending.

Pablo: Reviewing the data from our <unk> program, we have at this point or concerns over the safety when it comes to AML transformation now you I'm sure you know that.

Kelly Shih: Hey, guys. Thank you so much for taking my question. On Jakafi, Hervé, you mentioned that you see very little impact on Jakafi share from competitors. Can you talk a little bit about whether the competition has changed the average duration on Jakafi? They do go on to Jakafi as the frontline, but are you observing people getting off of Jakafi sooner? And also, for the BET inhibitor combination, there was a recent report of increased AML incidents in patients on the Jakafi BET combo for a competitor. I just wanted to get your insights into how this may or may not impact your internal BET program. Thank you.

Kripa Devarakonda: Hey, guys. Thank you so much for taking my question. On Jakafi, Hervé, you mentioned that you see very little impact on Jakafi share from competitors. Can you talk a little bit about whether the competition has changed the average duration on Jakafi? They do go on to Jakafi as the frontline, but are you observing people getting off of Jakafi sooner? And also, for the BET inhibitor combination, there was a recent report of increased AML incidents in patients on the Jakafi BET combo for a competitor. I just wanted to get your insights into how this may or may not impact your internal BET program. Thank you.

Pablo: If you follow a number of patients with MF for long enough. Some of them will have transformation two ml as part of the natural history of the disease, but at this point, we have no concerns with our program.

The trial is a puzzle to atopic dermatitis, what I can say right. Now is we're encouraged by the data from Marine book I think that it's an indication that people could work very well in this disease. We have not made an internal decision that yet as to whether to develop over Sidney <unk> and atopic dermatitis, yet, but it's certainly something we're contemplating.

Pablo: Thank you next question is coming from Michael Schmidt from Guggenheim. Your line is now live.

Michael Schmidt: Hey, guys good morning.

Michael Schmidt: Had a question on <unk>.

Michael Schmidt: And again, commenting about another another dataset, but I just wanted to get your insights on the reasons or invoke head to head study against to pick send an ADM, whether or how that impacts perhaps your view on the potential for since nib across various dermatology indications.

Thank you next question is coming from Mark Frost from TD Cowen. Your line is now live.

Hi, Thanks for taking my questions, maybe just start.

Steven Stein: So Kripa, I'll take your first call, and then I'll hand it over to Pablo for the second part of your question. For Jakafi, share from competitors, there really hasn't been any impact on your duration of therapy or discontinuation rates at all, certainly in myelofibrosis. We're very confident; we remain the market leader. Other JAK inhibitors may be used in the second line, third line setting. If anything, the market size itself is growing because now patients will go on one, two, three therapies. I'll hand it over to Pablo for the second part of your question.

Steven Stein: So Kripa, I'll take your first call, and then I'll hand it over to Pablo for the second part of your question. For Jakafi, share from competitors, there really hasn't been any impact on your duration of therapy or discontinuation rates at all, certainly in myelofibrosis. We're very confident; we remain the market leader. Other JAK inhibitors may be used in the second line, third line setting. If anything, the market size itself is growing because now patients will go on one, two, three therapies. I'll hand it over to Pablo for the second part of your question.

One just following up on the prior question.

Speaker Change: Yes, Michael Thank you for the question and now we've seen the data I'm. Obviously, obviously, that's an impressive data set at this point as you know we have a number of studies ongoing with <unk>, we've had internal discussions about the potential to extending.

What are your comments just based on the clinical data you are seeing in those concerns.

Or maybe can you speak to pretty quickly because I believe the bet inhibitor from our competitor has shown Gino toxicity and some preclinical assets has yours June Gino toxicity.

Michael Schmidt: The trial is a puzzle to atopic dermatitis, what I can say right. Now is we're encouraged by the data from Marine book I think that it's an indication that people could work very well in this disease. We have not made an internal decision that yet as to whether to develop over Sydney are in atopic dermatitis, yet, but it's certainly something we're contemplating.

Yeah, It's Steven answering your question. So just to reiterate Pablo's remarks, and remind you that our bet program was in the clinical while ago in solid tumors.

Pablo Cagnoni: Yes, thank you for the question. So, I mean, obviously, I'm not gonna comment on data from other companies. Our BET inhibitor program, as we've discussed, is going very well, and we'll discuss additional data over the course of the year, and we're planning a potential pivotal trial going forward, which we'll unveil later this year. Reviewing the data from our internal program, we have, at this point, no concerns over the safety when it comes to AML transformation. Now you-- I'm sure you know that, if you follow a number of patients with MF for long enough, some of them will have transformation to AML as part of the natural history of the disease. But at this point, we have no concerns with our program.

Pablo Cagnoni: Yes, thank you for the question. So, I mean, obviously, I'm not gonna comment on data from other companies. Our BET inhibitor program, as we've discussed, is going very well, and we'll discuss additional data over the course of the year, and we're planning a potential pivotal trial going forward, which we'll unveil later this year. Reviewing the data from our internal program, we have, at this point, no concerns over the safety when it comes to AML transformation. Now you-- I'm sure you know that, if you follow a number of patients with MF for long enough, some of them will have transformation to AML as part of the natural history of the disease. But at this point, we have no concerns with our program.

And then we've obviously pivoted to steady myeloproliferative neoplasms, we've treated you know close to 200 patients to date and in the clinical data set which is the most powerful as Pablo said, we have no concern as regards AML transformation or any concerns that we've seen in that regard from a prior preclinical work on things.

Michael Schmidt: Thank you next question is coming from Mark Frost from TD Cowen. Your line is now live.

Mark Frost: Hi, Thanks for taking my questions, maybe just start one just following up on the prior question.

Like Amy assay, and Gino toxicity et cetera. We also have no issue and we are aware of the issue with the competitor drug that was seen in preclinical work.

What are your comments just based on the clinical data you are seeing in those concerned vms or maybe can you speak to the pre clinically because I believe the bet inhibitor from our competitor has shown Gino toxicity and some preclinical assets has yours shown Gino toxicity.

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

Hey, guys. Good morning, Thanks, so much for taking my questions.

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

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

Speaker Change: Yeah, Steven answering your question. So just to reiterate Pablo's remarks, and remind you that our bet program was in the clinical while ago in solid tumors.

I wanted to drill down a little bit more on the Jakafi dynamics.

Michael Schmidt: Hey, guys. Good morning. I had a question on povorcitinib, and, you know, again, commenting about another data set. But I just wanted to get your insights on the recent Rinvoq head-to-head study against Dupixent in AD, and whether or how that impacts perhaps your view on the potential of povorcitinib across various dermatology indications.

Michael Schmidt: Hey, guys. Good morning. I had a question on povorcitinib, and, you know, again, commenting about another data set. But I just wanted to get your insights on the recent Rinvoq head-to-head study against Dupixent in AD, and whether or how that impacts perhaps your view on the potential of povorcitinib across various dermatology indications.

Whats your explanation or I guess, what do you think the best explanation for the sequential downtick in total Jakafi demand was that something that's just seasonally related that you typically see in first quarter and then I guess on the competitive front I am curious why do you think youre not seeing any impact at this point to market share patient persistence.

Speaker Change: And then we've obviously pivoted to study myeloproliferative neoplasms, we've treated you know close to 200 patients to date and in the clinical data set which is the most powerful as published said we have no concern as regards AML transformation or any concerns that we've seen in that regard from a prior preclinical work on things.

Is this something you might expect to change going forward or would you expect market share and persistence to remain stable based on sort of what youre hearing in terms of market research and on the ground Kols discussions. Thanks.

Pablo Cagnoni: Yeah, Michael, thank you for the question. Now, we've seen the data. Obviously, it's an impressive data set. At this point, as you know, we have a number of studies ongoing with povorcitinib. We've had internal discussions about the potential to extending the trials of povorcitinib to atopic dermatitis. What I can say right now is, we're encouraged by the data from Rinvoq. I think that it's an indication that povorcitinib could work very well in this disease. We have not made an internal decision that yet as to whether to develop povorcitinib in atopic dermatitis yet, but it's certainly something we're contemplating.

Pablo Cagnoni: Yeah, Michael, thank you for the question. Now, we've seen the data. Obviously, it's an impressive data set. At this point, as you know, we have a number of studies ongoing with povorcitinib. We've had internal discussions about the potential to extending the trials of povorcitinib to atopic dermatitis. What I can say right now is, we're encouraged by the data from Rinvoq. I think that it's an indication that povorcitinib could work very well in this disease. We have not made an internal decision that yet as to whether to develop povorcitinib in atopic dermatitis yet, but it's certainly something we're contemplating.

Speaker Change: <unk> aims assay and Gino toxicity et cetera. We also have no issue and we are aware of the issue with the competitor drug that was seen in preclinical work.

Maybe maybe I can start on the uptick I mean, what we first then you can see on the slide.

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

In fact, there is an increase in the number of patients treated across all three indications in Q1 versus Q4.

Hey, guys. Good morning, Thanks, so much for taking my questions.

Brian Corey Abrahams: I wanted to drill down a little bit more on the Jakafi dynamics.

There is a growth that you can see on the so called paid demand. The graph also shows that vessels, let Joe there is a lot of growth in PV gvhd. So the unit growth of Jakafi sequential to Q4 versus Q1 of last year is there on the unfairly visible so.

Brian Corey Abrahams: Whats your explanation or I guess, what do you think the best explanation for the sequential downtick in total Jakafi demand is that something that's just seasonally related that you typically see in first quarter and then I guess on the competitive front I am curious why do you think youre not seeing any impact at this point to market share patient persistence.

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

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

Marc Frahm: Hi, thanks for taking my questions. It-- maybe to start, one, just following up on the prior BET question, can, were your comments just based on the clinical data you're seeing in this concern of AML, or, maybe can you speak to preclinically? Because I believe that BET inhibitor from a competitor has shown genotoxicity in some preclinical assays. Has yours shown genotoxicity?

Marc Frahm: Hi, thanks for taking my questions. It-- maybe to start, one, just following up on the prior BET question, can, were your comments just based on the clinical data you're seeing in this concern of AML, or, maybe can you speak to preclinically? Because I believe that BET inhibitor from a competitor has shown genotoxicity in some preclinical assays. Has yours shown genotoxicity?

For the sequential growth versus Q4 is what we discussed when we discuss.

Brian Corey Abrahams: Is this something you might expect to change going forward or would you expect market share.

Q4, a few months ago is that there was abnormal free drug ratio in Q4 that has been completely.

Brian Corey Abrahams: And persistence to remain stable based on sort of what youre hearing in terms of market research and on the ground Kols discussions. Thanks.

Speaker Change: Maybe maybe I can start on the uptick I mean, what we first then you can see on the slide is that in fact, there is an increase in the number of patients treated across all three indications in Q1 versus Q4.

Fixed in Q1, so we are back to normal rates of free drug in Q1 now on the competitive side maybe.

Steven Stein: Yeah. It's Steven answering your question. So, you know, just to reiterate Pablo's remarks and remind you that our BET program was in the clinic a while ago in solid tumors. And then, you know, we've obviously pivoted to study myeloproliferative neoplasms. We've treated, you know, close to two hundred patients to date, and in the clinical data set, which is the most powerful, as Pablo said, we have no concern as regards AML transformation or any concerns that we've seen in that regard. From a, you know, prior preclinical work on things like Ames assay and genotoxicity, et cetera, we also have no issue, and we are aware of the issue with the competitive drug that was seen in preclinical work.

Steven Stein: Yeah. It's Steven answering your question. So, you know, just to reiterate Pablo's remarks and remind you that our BET program was in the clinic a while ago in solid tumors. And then, you know, we've obviously pivoted to study myeloproliferative neoplasms. We've treated, you know, close to two hundred patients to date, and in the clinical data set, which is the most powerful, as Pablo said, we have no concern as regards AML transformation or any concerns that we've seen in that regard. From a, you know, prior preclinical work on things like Ames assay and genotoxicity, et cetera, we also have no issue, and we are aware of the issue with the competitive drug that was seen in preclinical work.

If you want to speak of why we don't see the impact of the new competitor I'm sure I think in fact, the new competitors, let's take a banjo and Milan.

Speaker Change: There is a growth that you can see on the so called paid demand graph also shows that versus last Joe there is a lot of growth in PV gvhd. So the unit growth of Jakafi sequential to Q4 versus Q1 of last year is there and I'm fairly visible so.

As examples.

As far as we can tell from all of our market research from all of our experience working with Hematologists. They are all being used.

And the second line setting or or.

Maybe in patients that have very very low platelets. For example, so we anticipate because of really the overall survival benefit of Jakafi because of the tolerability of Jakafi because of the Sim.

Speaker Change: The reason for the sequential growth versus Q4 is what we discussed when we discuss Q.

Q4, a few months ago is that there was abnormal free drug ratio in Q4 that has been completely.

Symptom relief of Jakafi, it's a great drug and it will continue to be very useful to patients who have myelofibrosis going forward.

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

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

Speaker Change: Fixed in Q1, so we are back to normal rates of free drug in Q1 now on the competitive side maybe.

Thank you next question today is coming from Vikram <unk> from Morgan Stanley. Your line is my life.

Pablo Cagnoni: Hey, guys. Good morning. Thanks so much for taking my questions. I wanted to drill down a little bit more on the Jakafi dynamics. What's your explanation, or I guess, what do you think is the best explanation for the sequential downtick in total Jakafi demand? Was that something that's just seasonally related that you typically see in Q1? And then I guess on the competitive front, I'm curious why you think you're not seeing any impact at this point to market share or patient persistence. Is this something you might expect to change going forward, or would you expect market share and persistence to remain stable based on sort of what you're hearing in terms of market research and on the ground KOL discussions? Thanks.

Brian Abrahams: Hey, guys. Good morning. Thanks so much for taking my questions. I wanted to drill down a little bit more on the Jakafi dynamics. What's your explanation, or I guess, what do you think is the best explanation for the sequential downtick in total Jakafi demand? Was that something that's just seasonally related that you typically see in Q1? And then I guess on the competitive front, I'm curious why you think you're not seeing any impact at this point to market share or patient persistence. Is this something you might expect to change going forward, or would you expect market share and persistence to remain stable based on sort of what you're hearing in terms of market research and on the ground KOL discussions? Thanks.

Speaker Change: Barry if you want to speak of why we don't see the impact of the new competitor I'm sure I think in fact, the new competitors, let's take a banjo and Milan as.

Hi, good morning, Thanks for taking our questions. So we had two one on Libre and then one on ops and Lora.

On limber or the out too.

What the data said, we're expecting to see by the middle of the year could you just frame for us kind of what the scope and size of that dataset is going to be in.

Barry: As examples.

Barry: As far as we can tell from all of our market research from all of our experience working with Hematologists are all being used.

You know what you would define as.

Barry: And the second line setting or or.

Sufficient for continued development for that program based on what we see for that POC data set and then secondly on <unk>.

Barry: Maybe in patients that have very very low platelets. For example, so we anticipate because of really the overall survival benefit of Jakafi because of the tolerability of Jakafi because of the Sim.

Wanted to revisit the topic of potential guidance and see.

When you think might be.

Symptom relief of Jakafi, it's a great drug and it will continue to be very useful to patients who have myelofibrosis going forward.

A good potential time to provide revenue guidance for <unk> since you mentioned that it seems like the.

Hervé Hoppenot: Maybe I can start on the uptick. I mean, what we said, and you can see on the slide, is that in fact, there is an increase in the number of patients treated across all three indications in Q1 versus Q4. And there is a growth that you can see on the so-called paid demand graph also, that shows that versus last year, there is a lot of growth in PV and GVHD. So the unique growth of Jakafi, sequential to Q4 and versus Q1 of last year, is there and, and fairly visible. The reason for the sequential growth versus Q4 is what we discussed when we discussed, you know, Q4 a few months ago, is that there was an abnormal free drug ratio in Q4 that has been completely fixed in Q1.

Herve Hoppenot: Maybe I can start on the uptick. I mean, what we said, and you can see on the slide, is that in fact, there is an increase in the number of patients treated across all three indications in Q1 versus Q4. And there is a growth that you can see on the so-called paid demand graph also, that shows that versus last year, there is a lot of growth in PV and GVHD. So the unique growth of Jakafi, sequential to Q4 and versus Q1 of last year, is there and, and fairly visible. The reason for the sequential growth versus Q4 is what we discussed when we discussed, you know, Q4 a few months ago, is that there was an abnormal free drug ratio in Q4 that has been completely fixed in Q1.

Script chairs.

<unk>.

In stable between 80 and vitiligo.

Thank you next question today is coming from Vikram <unk> from Morgan Stanley. Your line is my life.

Yeah, Hi, Vikram, it's Steven so on your first question just reminding Elk two's mechanism that's felt to work through <unk> inhibition, and then ameliorate in EMEA by releasing on and make it available for hemoglobin production as we've already shown in multiple presentations, we can decrease.

Vikram Tandon: Hi, good morning, Thanks for taking our questions. So we had two one on Libre and then one on ops and Lora.

Vikram Tandon: On limber or the out to POC data said, we're expecting to see by the middle of the year could you just frame for us kind of what the scope and size of that data set is going to be in.

<unk> levels. The question you get into does this translate to some sort of clinical benefit just to remind you of the study. It has three groups treatment group a P&C <unk> monotherapy <unk> in combination with rux, but those were in later line patients in the real focus right now as you can see on print trials Dot Gov is treatment.

Vikram Tandon: And what you would define as.

Vikram Tandon: Sufficient for continued development for that program based on what we see for that POC data set and then secondly on <unk>.

Vikram Tandon: Just wanted to revisit the topic of potential guidance and see.

Vikram Tandon: When you think might be.

Vikram Tandon: Good potential timing.

<unk> C, which is a treatment naive group of patients to see in combination with rux will help make an effect that will be of clinical benefit to patients either by raising hemoglobin or preventing the decrease that sometimes occurs with JAK <unk> inhibition and then if we're able to demonstrate that as.

Provide revenue guidance for <unk> since you mentioned that it seems like the.

Vikram Tandon: Script chairs.

Hervé Hoppenot: So we are back to normal rate of free drug in Q1. Now, on the competitive side, maybe, Gary, if you want to speak of why we don't see the impact of the new competitor.

So we are back to normal rate of free drug in Q1. Now, on the competitive side, maybe, Gary, if you want to speak of why we don't see the impact of the new competitor.

Vikram Tandon: Seems stable between 80 and vitiligo. Thanks.

Yeah, Hi, Vikram, it's Steven so on your first question, just reminding Elk two's mechanism.

Steven Stein: Sure. I think in fact, the new competitors, you know, let's take Vonjo and momelotinib as examples. You know, they're as far as we can tell from all of our market research, from all of our experience working with hematologists, they're all being used in a second-line setting or you know, maybe in patients that have very, very low platelets, for example. So we anticipate, because of really the overall survival benefit of Jakafi, because of the tolerability of Jakafi, because of the symptom relief of Jakafi, it's a great drug, and it will continue to be very useful to patients who have myelofibrosis going forward.

Barry Flannelly: Sure. I think in fact, the new competitors, you know, let's take Vonjo and momelotinib as examples. You know, they're as far as we can tell from all of our market research, from all of our experience working with hematologists, they're all being used in a second-line setting or you know, maybe in patients that have very, very low platelets, for example. So we anticipate, because of really the overall survival benefit of Jakafi, because of the tolerability of Jakafi, because of the symptom relief of Jakafi, it's a great drug, and it will continue to be very useful to patients who have myelofibrosis going forward.

Steven: Felt to work through <unk> inhibition, and then ameliorate in EMEA by releasing on and make it available for hemoglobin production as we've already shown in multiple presentations. We can decrease <unk> levels. The question you get into does this translate to some sort of clinical benefit just to remind you of the study. It has three grew.

We dose increase in the second half of this year. They will have a clinical proof of concept that we can then potentially take forward to a regulatory environment, but we will have to be clear that we are benefiting patients from a clinical benefit point of view in their treatment naive group and we will have that dataset second half of this year.

Steven: <unk> treatment group, a P&C <unk> monotherapy <unk> in combination with rux, but those were in later line patients in the real focus right now as you can see on <unk> Gov is treatment group C, which is a treatment naive group of patients to see in combination with rux will help make an effect that will be.

I'll turn it over for the second question, Hi, Vikram, It's Chris and I'll take the second part.

As we discussed on our last call before we provide.

Guidance for upsell, we're at we're looking to have more real world data.

On utilization, especially for vitiligo and data that goes beyond that.

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

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

<unk> of clinical benefit to patients either by raising hemoglobin or preventing the decrease that sometimes occurs with JAK <unk> inhibition and then if we.

The initial phase of therapy, which may represent a face of experimentation by by patients. So we are still early into the launch we are still going through that initial phase of patients on therapy. So we're waiting for more.

Pablo Cagnoni: Hi, good morning. Thanks for taking our question. So we have two, one on Limber and then one on Opzelura.

Vikram Purohit: Hi, good morning. Thanks for taking our question. So we have two, one on Limber and then one on Opzelura.

Vikram Purohit: So on INCB, for the ALK2, POC data set we're expecting to see by the middle of the year, could you just frame for us kind of what the scope and size of that data set is going to be? And, you know, what you would define as sufficient for continued development for that program based on what we see for that POC data set. And then secondly, on Opzelura, I just wanted to revisit the topic of potential guidance and see when you think might be a good potential time to provide revenue guidance for Opzelura, since you mentioned that it seems like the script shares seem stable between AD and vitiligo. Thanks.

To demonstrate that as we dose increase in the second half of this year. Then we'll have a clinical proof of concept that we can then potentially take forward to a regulatory environment, but we will have to be clear that we are benefiting patients from a clinical benefit point of view in their treatment naive group and we'll have that data set second half of this year.

So on INCB, for the ALK2, POC data set we're expecting to see by the middle of the year, could you just frame for us kind of what the scope and size of that data set is going to be? And, you know, what you would define as sufficient for continued development for that program based on what we see for that POC data set. And then secondly, on Opzelura, I just wanted to revisit the topic of potential guidance and see when you think might be a good potential time to provide revenue guidance for Opzelura, since you mentioned that it seems like the script shares seem stable between AD and vitiligo. Thanks.

More real world data before we are in a position to give you guidance.

Thank you. Your next question today is coming from Derek our Chiller from Wells Fargo. Your line is now live.

Steven: I'll turn it over for the second question, Hi, Vikram, It's Chris again, I'll take the second part.

Hey, good morning, Thanks for taking the questions just two quick ones from US I guess first just on Jakafi as you noted the jakafi growth coming from Gvhd and Pvs. So I guess, what does this mean for future assumptions around myelofibrosis I know you said stable but.

Chris: As we discussed on our last call before we provide.

Chris: Guidance for up sell we're at we're looking to have more real world data.

Chris: On utilization, especially for vitiligo and data that goes beyond that.

Steven Stein: Yeah. Hi, Vikram, it's Steven. So on your first question, just remind you, you know, ALK2's mechanism is felt to work through hepcidin inhibition and then ameliorate, you know, anemia by releasing iron and make it available for hemoglobin production. As we've already shown in multiple presentations, we can decrease hepcidin levels. The question you get into, does this translate to some sort of clinical benefit? Just to remind you of the study, it has three groups: treatment group A, B, and C. A was monotherapy, B was in combination with RUX, but those were in later line patients.

Steven Stein: Yeah. Hi, Vikram, it's Steven. So on your first question, just remind you, you know, ALK2's mechanism is felt to work through hepcidin inhibition and then ameliorate, you know, anemia by releasing iron and make it available for hemoglobin production. As we've already shown in multiple presentations, we can decrease hepcidin levels. The question you get into, does this translate to some sort of clinical benefit? Just to remind you of the study, it has three groups: treatment group A, B, and C. A was monotherapy, B was in combination with RUX, but those were in later line patients.

Should we be thinking about that for the rest of this year and then in terms of CDK to I guess, where do you think the bar is right now I guess from us.

Chris: First the initial phase of therapy, which may represent a face of experimentation by by patients. So we are still early into the launch we are still going through that initial phase of patients on therapy. So we're waiting for.

TPP and I guess, what do you intend to show this year for proof of concept.

I'll take the first part of your question Barry So for Jakafi, we continue to see.

Chris: More real world data before we are in a position to give you guidance.

Myelofibrosis being the way I look at look at the Myelofibrosis patient population you know there was about 18000 patients prevalent patients with myelofibrosis and because we're the market leader because of the overall survival and symptom benefit that.

Chris: Thank you. Your next question today is coming from Derek our Chiller from Wells Fargo. Your line is now live.

Hey, good morning, Thanks for taking the questions just two quick ones from US I guess first just on Jakafi as you noted the jakafi growth coming from Gvhd and Pvs. So I guess, what does this mean for future assumptions around myelofibrosis I know you said stable, but how should we be thinking about that for the rest of this year and then in.

Steven Stein: The real focus right now, as you can see on ClinicalTrials.gov, is treatment group C, which is a treatment-naive group of patients to see in combination with RUX, will it make an effect that will be of clinical benefit to patients, either by raising hemoglobin or preventing the decrease that sometimes occurs with, you know, JAK2 inhibition. Then, you know, if we're able to demonstrate that as we dose increase in the second half of this year, then we'll have a clinical proof of concept that we can then potentially take forward to a regulatory environment. But we'll have to be clear that we are benefiting patients from a clinical benefit point of view in that treatment-naive group, and we'll have that data set second half of this year. I'll turn it over for the second question.

The real focus right now, as you can see on ClinicalTrials.gov, is treatment group C, which is a treatment-naive group of patients to see in combination with RUX, will it make an effect that will be of clinical benefit to patients, either by raising hemoglobin or preventing the decrease that sometimes occurs with, you know, JAK2 inhibition. Then, you know, if we're able to demonstrate that as we dose increase in the second half of this year, then we'll have a clinical proof of concept that we can then potentially take forward to a regulatory environment. But we'll have to be clear that we are benefiting patients from a clinical benefit point of view in that treatment-naive group, and we'll have that data set second half of this year. I'll turn it over for the second question.

<unk> provides.

We will continue to think a patient says either being on Jakafi, which is most of the myelofibrosis patients or they have been on jakafi or they will be on jakafi.

They are progressing on Jakafi then there is other options Fortunately that are available to them, but going forward for 2024.

Chris: Terms of CDK to I guess, where do you think the bar is right now I guess from us.

And beyond we continue to expect to be the market leader in first line myelofibrosis and I'll turn the call over to Pablo.

Speaker Change: TPP and I guess, what do you intend to show this year for proof of concept.

Yes. Thank you for the question so in our CDK inhibitor program, we continue to be encouraged by the data that we've seen and regarding.

Speaker Change: I'll take the first part of your question Barry So for Jakafi, we continue to see.

Speaker Change: Myelofibrosis being the way I look at look at the Myelofibrosis patient population you know there was about 18000 patients prevalent patients with myelofibrosis and because we're the market leader because of the overall survival and symptom benefit that.

Regarding your part of your question about what data we're going to reveal later this year. We're in the final stages of optimizing the dose for the CDK <unk> inhibitor program.

Christiana Stamoulis: Hi, Vikram, it's Christiana. I'll take the second part. As we discussed on our last call, before we provide guidance for Opzelura, we are looking to have more real-world data on utilization, especially for vitiligo, and data that goes beyond that first initial phase on therapy, which may represent a phase of experimentation by patients. So we are still early into the launch. We are still going through that initial phase of patients on therapy, so we're waiting for more real-world data before we are in a position to give you guidance.

Christiana Stamoulis: Hi, Vikram, it's Christiana. I'll take the second part. As we discussed on our last call, before we provide guidance for Opzelura, we are looking to have more real-world data on utilization, especially for vitiligo, and data that goes beyond that first initial phase on therapy, which may represent a phase of experimentation by patients. So we are still early into the launch. We are still going through that initial phase of patients on therapy, so we're waiting for more real-world data before we are in a position to give you guidance.

Our idea will be later this year to provide a substantial clinical dataset.

Speaker Change: <unk> provides.

<unk> the dose selection.

Speaker Change: We will continue to think a patient says either being on Jakafi, which is most of the myelofibrosis patients or they have been on jakafi or they will be on jakafi are when they are progressing on Jakafi. Then there is other options Fortunately that are available to them, but going forward for 2024.

For patient initial focus will be ovarian cancer, but not necessarily only over the longer term.

As well as we are starting combination trials in ovarian cancer and we're continuing to enroll patients with breast cancers are later this year you will see the dose selection as well as the data for ovarian cancer as well as the development plan in ovarian cancer.

Speaker Change: And beyond we continue to expect to be the market leader in first line myelofibrosis and I'll turn the call over to Pablo.

When it comes to the the bar for efficacy if you look at the CDK <unk> inhibitor of landscape today.

Thank you for the question so in our CDK inhibitor program, we continue to be encouraged by the data that we've seen and.

Most of our competitors have decided to focus on breast cancer or other areas.

Pablo: Regarding your part of your question about what data we're going to reveal later this year. We're in the final stages of optimizing the dose for the CDK <unk> inhibitor program.

Operator: Thank you. Next question today is coming from Derek Archilla from Wells Fargo. Your line is now live.

Operator: Thank you. Next question today is coming from Derek Archilla from Wells Fargo. Your line is now live.

We continue to believe that ovarian cancer is an important opportunity.

Other competitors in this space like Adcs are coming into play we're tracking those closely to figure it out what is the overlap between the different patient populations in different with different molecular markers, but basically in the in the second part of the year or later this year, we'll provide clarity on dose schedule under <unk>.

Derek Archilla: Hey, good morning. Thanks for taking the questions. Just two quick ones from us. I guess, you know, first, just on Jakafi, as you noted, you know, the Jakafi growth coming from GVHD and PV. So I guess, what does this mean for future assumptions around myelofibrosis? I know you said stable, but, you know, how should we be thinking about that for the rest of this year? And then in terms of CDK2, I guess, where do you think the bar is right now, you know, I guess from a TPP, and I guess, what do you intend to show this year for proof of concept? Thanks.

Derek Archila: Hey, good morning. Thanks for taking the questions. Just two quick ones from us. I guess, you know, first, just on Jakafi, as you noted, you know, the Jakafi growth coming from GVHD and PV. So I guess, what does this mean for future assumptions around myelofibrosis? I know you said stable, but, you know, how should we be thinking about that for the rest of this year? And then in terms of CDK2, I guess, where do you think the bar is right now, you know, I guess from a TPP, and I guess, what do you intend to show this year for proof of concept? Thanks.

Pablo: Our idea will be later this year to provide a substantial clinical dataset.

Pablo: Including the dose selection.

Pablo: For patients initially the focus will be ovarian cancer, but not necessarily only over the longer term.

As well as we are starting combination trials in ovarian cancer and we're continuing to enroll patients with breast cancers are later this year you will see the dose selection as well as the data for ovarian cancer as well as the development plan in ovarian cancer.

All of them in Atlanta in ovarian cancer patients.

Thank you next question today is coming from Jessica Fye from Jpmorgan. Your line is now live.

Hey, guys. Good morning, Thanks for taking my questions.

Pablo: When it comes to the the bar for efficacy if you look at the CDK <unk> inhibitor landscape today.

On <unk> is it possible to quantify the impact of the change healthcare issue for that product and what about for Jakafi was that impacted at all by the change healthcare.

Steven Stein: I'll take the first part of your questions, Barry. So for Jakafi, you know, we continue to see myelofibrosis being... The way I look at the myelofibrosis patient population, you know, there's about 18,000 patients, prevalent patients with myelofibrosis. And because we're the market leader, because of the overall survival and symptom benefit that Jakafi provides, we will continue to think of patients as either being on Jakafi, which is most of the myelofibrosis patients, or they have been on Jakafi, or they will be on Jakafi. When they progress on Jakafi, then there's other options, fortunately, that are available to them. But going forward for 2024, and beyond, we continue to expect to be the market leader in first-line myelofibrosis, and I'll turn the call over to Pablo.

Barry Flannelly: I'll take the first part of your questions, Barry. So for Jakafi, you know, we continue to see myelofibrosis being. The way I look at the myelofibrosis patient population, you know, there's about 18,000 patients, prevalent patients with myelofibrosis. And because we're the market leader, because of the overall survival and symptom benefit that Jakafi provides, we will continue to think of patients as either being on Jakafi, which is most of the myelofibrosis patients, or they have been on Jakafi, or they will be on Jakafi. When they progress on Jakafi, then there's other options, fortunately, that are available to them. But going forward for 2024, and beyond, we continue to expect to be the market leader in first-line myelofibrosis, and I'll turn the call over to Pablo.

Pablo: Most of our competitors have decided to focus on breast cancer or other areas. We continue to believe that ovarian cancer is an important opportunity.

And then on pulp are sitting in the phase III studies in vitiligo I noticed on clinical trials that does it looks like there was a single primary endpoint of <unk> 75 for the phase III trials, whereas that bring book I think has two primary endpoints of <unk> 75, and <unk> 50, so what's there.

Other competitors in this space like Adcs are coming into play we're tracking those closely to figure it out what is the overlap between the different patient populations in different with different molecular markers, but basically in the second part of the year or later this year, we'll provide clarity on dose schedule and a <unk>.

Now for only having a single primary endpoint here relative to the competitive competition and how do you expect that to kind of play out based on that.

Pablo: All of them and plan in ovarian cancer patients.

Pablo: Thank you next question today is coming from Jessica Fye from Jpmorgan. Your line is now live.

Endpoints you're studying thank you.

Okay.

Jessica Fye: Hey, guys. Good morning, Thanks for taking my questions.

I guess I'll take the J&J altogether.

Steven Stein: Yes, thank you for the question. So in our CDK2 inhibitor program, we continue to be encouraged by the data that we've seen. And, regarding a part of your question about what data we're gonna reveal later this year, we're in the final stages of optimizing the dose for the CDK2 inhibitor program. Our idea will be later this year to provide a substantial clinical data set, including the dose selection for patients. Initially, the focus will be ovarian cancer, but not necessarily only over the longer term. As well as we are starting combination trials in ovarian cancer, and we're continuing to enroll patients with breast cancer. So later this year, you will see the dose selection, as well as the data for ovarian cancer, as well as the development plan in ovarian cancer.

Pablo Cagnoni: Yes, thank you for the question. So in our CDK2 inhibitor program, we continue to be encouraged by the data that we've seen. And, regarding a part of your question about what data we're gonna reveal later this year, we're in the final stages of optimizing the dose for the CDK2 inhibitor program. Our idea will be later this year to provide a substantial clinical data set, including the dose selection for patients. Initially, the focus will be ovarian cancer, but not necessarily only over the longer term. As well as we are starting combination trials in ovarian cancer, and we're continuing to enroll patients with breast cancer. So later this year, you will see the dose selection, as well as the data for ovarian cancer, as well as the development plan in ovarian cancer.

On the obsolete.

Jessica Fye: On <unk> is it possible to quantify the impact of the change healthcare issue for that product and what about for Jakafi was that impacted at all by the change healthcare.

What we see at the end of February that there was the cyber attacks reported pretty much caused a naturally an interruption for a few weeks so as a result.

Change healthcare was unable to process the claim for a few weeks when we looked at when the deep dive in the data we still a softer March when you look at your entire atopic dermatitis market basket that we monitor and that caused an estimated four 5 million negative impact from <unk> in Q1, the good news for.

Jessica Fye: And then on the Phase III studies in Vitiligo I noticed on clinical trials that does it looks like there was a single primary endpoint of <unk> 75 for the phase III trials, whereas that bring book I think has two primary endpoints of FSC 75, and <unk> 50, so what's the.

It's just that we're monitoring April and we see demand weekly demand back on track to the levels. We saw pre cyber attack and ended up more recently.

Jessica Fye: Now for only having a single primary endpoint here relative to the competitive competition and how do you expect that to kind of play out based on that.

And Jessica just on Jakafi, we may have actually had an impact from change outs, but we don't know we did have when it first happened some request from specialty pharmacies that wanted to extended terms for payment, but we really can't see.

Speaker Change: Endpoints you're studying thank you.

Speaker Change: Yeah.

Steven Stein: When it comes to the bar for efficacy, if you look at the CDK2 inhibitor landscape today, most of our competitors have decided to focus on breast cancer or other areas. We continue to believe that ovarian cancer is an important opportunity. Other competitors in this space, like ADCs, are coming into play. We're tracking those closely to figure it out, what is the overlap between the different patient populations in different, with different molecular markers? But basically, in the second part of the year, later this year, we'll provide clarity on dose, schedule, and the development plan in ovarian cancer patients.

When it comes to the bar for efficacy, if you look at the CDK2 inhibitor landscape today, most of our competitors have decided to focus on breast cancer or other areas. We continue to believe that ovarian cancer is an important opportunity. Other competitors in this space, like ADCs, are coming into play. We're tracking those closely to figure it out, what is the overlap between the different patient populations in different, with different molecular markers? But basically, in the second part of the year, later this year, we'll provide clarity on dose, schedule, and the development plan in ovarian cancer patients.

Speaker Change: I guess I'll take the <unk>.

Speaker Change: On the obsolete.

Speaker Change: What we see at the end of February that there was the cyber attacks reported a pretty much caused a naturally an interruption for a few weeks so as a result.

Big impact because these most of these specialty pharmacies were able to switch over to the other.

Speaker Change: Change healthcare was unable to process the claim for a few weeks when we looked at when the deep dive in the data we still a softer March when you look at your entire atopic dermatitis market basket that we monitor and that caused an estimated 45 million negative impact from <unk> in Q1, the good news for.

The other.

Uh huh.

The other system that provides that.

This service for the specialty pharmacies.

And then just to address your question on <unk> in Vitiligo, we have two identical phase III studies ongoing stopped V. One and stop the two in patients 18 years or older with 5% or greater body surface area involvement of non Sigma until vitiligo, it's a little tricky on the endpoints, but just to tell you a prime.

Speaker Change: It's just that we're monitoring April and we see demand weekly demand back on track to the levels. We saw pre cyber attack and ended up more recently.

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

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

Speaker Change: And Jessica just on Jakafi, we may have actually had an impact from change outs, but we don't know we did have when it first happened some request from specialty pharmacies that wanted it extended terms for payment, but we really can't see.

Jessica Fahy: Hey, guys. Good morning. Thanks for taking my questions. First on Opzelura, is it possible to quantify the impact of the Change Healthcare issue for that product?

Jessica Fye: Hey, guys. Good morning. Thanks for taking my questions. First on Opzelura, is it possible to quantify the impact of the Change Healthcare issue for that product?

Barry endpoint for the FDA in the United States is actually identical it's facial <unk> 75, and total Vas 54 other parts of the world. There may be a different primary endpoint for example in Europe day interested most in the total <unk> 50, so that leads to some of the confusion, but for our study for the FDA.

David Lebowitz: ... What about for Jakafi? Was that impacted at all by the Change Healthcare issue in the quarter? And then on povorcitinib, the phase III studies in vitiligo, I noticed on clinicaltrials.gov, it looks like there's a single primary endpoint of F-VASI 75 for the phase III trials, whereas Rinvoq, I think, has two primary endpoints of F-VASI 75 and T-VASI 50. So what's the rationale for only having a single primary endpoint here relative to the competition, and how do you expect that to kind of play out based on the, you know, endpoints you're studying? Thank you.

What about for Jakafi? Was that impacted at all by the Change Healthcare issue in the quarter? And then on povorcitinib, the phase III studies in vitiligo, I noticed on clinicaltrials.gov, it looks like there's a single primary endpoint of F-VASI 75 for the phase III trials, whereas Rinvoq, I think, has two primary endpoints of F-VASI 75 and T-VASI 50. So what's the rationale for only having a single primary endpoint here relative to the competition, and how do you expect that to kind of play out based on the, you know, endpoints you're studying? Thank you.

Speaker Change: Big impact because these most of these specialty pharmacies were able to switch over to the other.

The other.

Speaker Change: Uh huh.

It's both facial <unk> 75 in total of <unk> 50, a cope together measured at week 52.

Speaker Change: The other system that provides the.

Speaker Change: This service for the specialty pharmacies.

<unk>.

Speaker Change: And then just to address your question on <unk> in Vitiligo, we have two identical phase III studies ongoing stopped V. One in stuffy two in patients 18 years or older with 5% or greater body surface area involvement of non <unk>, it's a little tricky on the endpoints, but just to tell you a prime.

Okay.

Your next question today is coming from <unk> <unk> from Bank of America. Your line is now live.

Hi, Good morning, guys. Thanks for taking my question.

And I'm sorry, if I missed this in your prepared remarks, but can you talk about refill rate.

For patients maybe now that had been on therapy for a few quarters can you talk about how youre seeing there as to.

Matteo Trotta: Hi, Jessica. I'll take the Change Healthcare on Opzelura. What we see at the end of February, that there was this cyberattack reported that pretty much caused a network interruption for a few weeks. So as a result, the Change Healthcare was unable to process the claim for a few weeks. When we looked at when we deep dive in the data, we saw a softer March when you look at the entire atopic dermatitis market basket that we monitor. And that caused an estimate of $4 or 5 million negative impact from Opzelura in Q1. The good news for us is that we're monitoring April, and we see demand, weekly demand back on track to the levels we saw pre-cyberattack and a little more recently.

Matteo Trotta: Hi, Jessica. I'll take the Change Healthcare on Opzelura. What we see at the end of February, that there was this cyberattack reported that pretty much caused a network interruption for a few weeks. So as a result, the Change Healthcare was unable to process the claim for a few weeks. When we looked at when we deep dive in the data, we saw a softer March when you look at the entire atopic dermatitis market basket that we monitor. And that caused an estimate of $4 or 5 million negative impact from Opzelura in Q1. The good news for us is that we're monitoring April, and we see demand, weekly demand back on track to the levels we saw pre-cyberattack and a little more recently.

Speaker Change: Barry endpoint for the FDA in the United States is actually identical it's it's facial <unk> 75, and total Vas 54 other parts of the world. There may be a different primary endpoint for example in Europe. They interested mostly in the total <unk> 50, so that leads to some of the confusion, but for our study for the FDA.

<unk>, what the average usage of tubes is I'm, just curious that if patients.

Are having good results with the claim whether theyre, taking many drug holidays in between when they don't have as much. It's for example, thanks.

Okay.

No matter, who kind of adds up to a comment I mean, the picture in terms of refill rate has been the following is that in atopic dermatitis.

Speaker Change: It's both <unk> 75 in total of <unk> 50, a cope together measured at week 52.

Speaker Change: <unk>.

We.

I've observed.

Speaker Change: Okay.

Speaker Change: Your next question today is coming from <unk> <unk> from Bank of America. Your line is now live.

The refuse that is slightly north of two tubes per patient.

Speaker Change: Hi, Good morning, guys. Thanks for taking my question.

And that's relatively stable now, it's still increasing a little bit but it is relatively stable in vitiligo, it's moving very quickly and we are not yet at the steady state.

Speaker Change: Sure I can you and I'm sorry, if I missed this in your prepared remarks, but can you talk about refill rate.

Christiana Stamoulis: Jessica, just on Jakafi, we may have actually had an impact from Change Healthcare, but we don't know. We did have, when it first happened, some requests from specialty pharmacies that wanted extended terms for payment, but we really can't see, you know, a big impact because most of the specialty pharmacies were able to switch over to the other system that provides this service for the specialty pharmacies.

Barry Flannelly: Jessica, just on Jakafi, we may have actually had an impact from Change Healthcare, but we don't know. We did have, when it first happened, some requests from specialty pharmacies that wanted extended terms for payment, but we really can't see, you know, a big impact because most of the specialty pharmacies were able to switch over to the other system that provides this service for the specialty pharmacies.

Speaker Change: For patients maybe now that had been on therapy for a few quarters can you talk about how youre seeing their use of tubes.

Yes.

A situation, where we see unfortunately adapt patients who are not complying with so treatment. It was prescribed and we obviously working.

Speaker Change: <unk>, what the average usage of tubes is I'm, just curious that if patients.

Speaker Change: Are having good results with the claim whether theyre, taking many drug holidays in between when they don't have as much. It's for example, thanks.

With physicians and patients directly to improve it.

As you know I mean from the experience we had in the clinical trial. We are estimating that if we are successful it will be around 10, two population, but we are still.

Okay.

Speaker Change: No matter, how can I go to a comment I mean, the picture in terms of repeat rates has been the following is that in atopic dermatitis.

At the number of loyal them today, when you try to look at patients who have enough history. So do you want to speak about what we are doing on the.

Pablo Cagnoni: Then just to address your question on povorcitinib in vitiligo, we have two identical phase III studies ongoing, STOP V1 and STOP V2, in patients eighteen years or older, with 5% or greater body surface area involvement of non-segmental vitiligo. It's a little tricky on the endpoints, but just to tell you, our primary endpoint for the FDA in the United States is actually identical. It's, it's facial VASI 75 and total VASI 50. For other parts of the world, there may be a different primary endpoint. For example, in Europe, they're interested mostly in the total VASI 50. So that leads to some of the confusion. But for our study, for the FDA, it's both facial VASI 75 and total VASI 50, you know, together measured at week 52. Thanks.

Pablo Cagnoni: Then just to address your question on povorcitinib in vitiligo, we have two identical phase III studies ongoing, STOP V1 and STOP V2, in patients eighteen years or older, with 5% or greater body surface area involvement of non-segmental vitiligo. It's a little tricky on the endpoints, but just to tell you, our primary endpoint for the FDA in the United States is actually identical. It's, it's facial VASI 75 and total VASI 50. For other parts of the world, there may be a different primary endpoint. For example, in Europe, they're interested mostly in the total VASI 50. So that leads to some of the confusion. But for our study, for the FDA, it's both facial VASI 75 and total VASI 50, you know, together measured at week 52. Thanks.

Speaker Change: We.

Speaker Change: I've observed.

The refuse that is slightly north of two tubes per patient.

Yeah, the only comment that I can add is on just in this quarter we're launching.

Speaker Change: And that's relatively stable now, it's still increasing a little bit but it is relatively stable in vitiligo, it's moving very quickly and we are not yet at the steady state.

Very promising adherence program that we were confident will impact are we continuing to impact the refill rate growth that we see across both indications a D in vitiligo.

Yes.

Speaker Change: A situation, where we see unfortunately adapt patients who are not complying with the treatment of it was prescribed and we obviously working.

Okay.

Thank you next question today is coming from Celgene Victor from Goldman Sachs. Your line is long life.

Speaker Change: With physicians and patients directly to improve it.

Good morning, Thanks for taking my question could you just give us an update on how the ex U S launch of <unk> progressing with the addition of France.

Speaker Change: As you know I mean from the experience we had in the clinical trial. We are estimating that if we are successful it will be around 10, two population, but we are still.

And how you're thinking about the pediatric uptake and in 2025.

Speaker Change: At the number of that is the loyal than today. When you try to look at patients who have enough for his story. So do you want to speak about what we are doing on the <unk> side.

Operator: Thank you. Next question today is coming from Tazeen Ahmad from Bank of America. Your line is now live.

Operator: Thank you. Next question today is coming from Tazeen Ahmad from Bank of America. Your line is now live.

I could also just ask one on business development.

The recent acquisition you still have significant balance sheet capacity could we see you do meaningful M&A in the near term on top of that Sean. Thank you.

Tazeen Ahmad: Hi, good morning, guys. Thanks for taking my question. On Opzelura, I'm sorry if I missed this in your prepared remarks, but can you talk about refill rates for patients maybe now that have been on therapy for a few quarters? Can you talk about how you're seeing their use of tubes, what the average use of tubes is? I'm just curious that if patients are having good results with the cream, whether they're taking mini drug holidays in between when they don't have as much itch, for example. Thanks.

Tazeen Ahmad: Hi, good morning, guys. Thanks for taking my question. On Opzelura, I'm sorry if I missed this in your prepared remarks, but can you talk about refill rates for patients maybe now that have been on therapy for a few quarters? Can you talk about how you're seeing their use of tubes, what the average use of tubes is? I'm just curious that if patients are having good results with the cream, whether they're taking mini drug holidays in between when they don't have as much itch, for example. Thanks.

Speaker Change: Yeah, the only comment that I can add is on just in this quarter we're launching.

Speaker Change: Very promising adherence program that we were confident will impact are we continuing to impact the refill rate growth that we see across both indications a D in vitiligo.

Okay. So maybe I'll start with I think the first.

For both the European launch because in fact, there is a lot of activities going on there as you know, we launched in Germany and Austria.

Good base that we have.

Speaker Change: Okay.

Recently, we have about of extra direct which is a French process, where you can commercialize your product. While you are negotiating the price. So what you see in the number of today is about around $2 million that are recognized sales from France and Italy.

Speaker Change: Thank you next question today is coming from Celgene Victor from Goldman Sachs. Your line is long life.

Reni John Benjamin: Good morning, Thanks for taking my question could you just give us an update on how the ex U S launch of <unk> progressing with the addition of France.

Hervé Hoppenot: Yeah, Matteo can add to the comment. I mean, the, the picture in term of refill rate has been the following, is that in atopic dermatitis, we have observed a refill that is slightly north of two tubes per patient. And that's relatively stable now. It's still increasing a little bit, but it is relatively stable. In vitiligo, it's moving very quickly, and we are not yet at the steady state. It is a situation where we see, unfortunately, that there are patients who are not complying with the treatment as it was prescribed, and we are obviously working with physicians and patients directly to improve it.

Herve Hoppenot: Yeah, Matteo can add to the comment. I mean, the, the picture in term of refill rate has been the following, is that in atopic dermatitis, we have observed a refill that is slightly north of two tubes per patient. And that's relatively stable now. It's still increasing a little bit, but it is relatively stable. In vitiligo, it's moving very quickly, and we are not yet at the steady state. It is a situation where we see, unfortunately, that there are patients who are not complying with the treatment as it was prescribed, and we are obviously working with physicians and patients directly to improve it.

Reni John Benjamin: And how you're thinking about the pediatric uptake and in 2025 and if I could also just ask.

Sort of an estimate with a conservative price book tubes that we are using to do that but the process. There is moving.

One on business development.

Reni John Benjamin: With the recent acquisition you still have significant balance sheet capacity could we see you do meaningful M&A in the near term on top of that Sean. Thank you.

Moving very well.

We anticipate by the Silicon Valley folks of Europe to be fully reimbursed and paid for at a good price in France, and we have now in Italy, and Spain agreement on the price, where we will be launching.

Sean: Okay. So maybe I'll start with my finger.

Sean: The part of both the European launch because in fact, there is a lot of activities going on there as you know we launched in Germany.

Between mid year understood unhelpful to Europe in the in both countries, So, Germany, Italy, Spain, and France will be fully operational by Q3.

Sean: So it's a good base that we have we recently were about of extra direct which is a French process, where you can commercialize your product. While you are negotiating the price. So what you see in the number of today's the Dow around 2 million that are recognized sales from France.

Hervé Hoppenot: As you know, I mean, from the experience we had in the clinical trial, we are estimating that if we are successful, it will be around 10 tubes per patient, but we are still at a number that is lower than that today. When you try to look at patients who have enough history. So do you want to speak about what we are doing on the marketing side?

As you know, I mean, from the experience we had in the clinical trial, we are estimating that if we are successful, it will be around 10 tubes per patient, but we are still at a number that is lower than that today. When you try to look at patients who have enough history. So do you want to speak about what we are doing on the marketing side?

And and we'd be contributing to the top line.

Also some smaller countries in Europe, where the process is ongoing and there is always a big question Mark go pursue United Kingdom of England, whereas who knows a pricing discussion can take time and we are we are in the process.

Sean: And it's a sort of an.

Sean: And we estimate with a conservative.

Sean: This book tubes that we are using to do that but the process. There is.

Sean: Moving very well.

It's a very positive outcome for <unk> in Europe, because we got reimbursement now in many countries and most of the large countries.

Matteo Trotta: Yeah, the only comment that I can add is on just in this quarter, we're launching very promising adherence program that we're confident will continue to impact the refill rate growth that we see across both indications, AD and vitiligo.

Matteo Trotta: Yeah, the only comment that I can add is on just in this quarter, we're launching very promising adherence program that we're confident will continue to impact the refill rate growth that we see across both indications, AD and vitiligo.

Sean: We anticipate by the second half of the Europe to be fully reimbursed and paid for at a good price in France, and we have now in Italy, and Spain agreement on the price, where we will be launching.

And we see a very good uptake of the demand in terms of volume.

Hum in the countries where it is.

But specifically in France.

Sean: Between mid year understood one hurtful to Europe in the in both countries, So, Germany, Italy, Spain, and France will be fully operational by Q3.

The second part of your question was about the pediatric uptake.

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

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

In the in the U S. When we get our products or maybe Matthew if you want to speak about that yes sure. Thanks for the question and look.

David Lebowitz: Good morning, thanks for taking my question. Could you just give us an update on how the ex-US launch of Opzelura is progressing with the addition of France at this point, and how you're thinking about the pediatric uptake in 2025? And if I could also just ask one on business development. You know, post the recent acquisition, you still have significant balance sheet capacity. Could we see you do meaningful M&A in the near term, on top of Escient? Thank you.

Salveen Richter: Good morning, thanks for taking my question. Could you just give us an update on how the ex-US launch of Opzelura is progressing with the addition of France at this point, and how you're thinking about the pediatric uptake in 2025? And if I could also just ask one on business development. You know, post the recent acquisition, you still have significant balance sheet capacity. Could we see you do meaningful M&A in the near term, on top of Escient? Thank you.

Sean: And it would be contributing to the top line.

We are very excited by the potential opportunity to help two 3 million children and in U S and we see data consistent.

Sean: Also some smaller countries in Europe, where the process is ongoing and there is always the big question Mark go pursue the United Kingdom, or England, whereas who knows a pricing discussion can take time and we are we are in the process.

Well, we would expect so pending FDA approval, we are excited by another contribution and tailwind to our top line. This.

This is a patient population that maybe the patents will be a little more sensitive to a box warning, but at the same time, it's two 3 million patients in children that we potentially MD opportunity to help going forward.

Sean: <unk> is a very positive outcome for <unk> in Europe, because we got reimbursement now in many countries and most of the large countries.

Hervé Hoppenot: Okay, so maybe, Salveen, I'll take the first part about the European launch, because in fact, there is a lot of activities going on there. As you know, we launched in Germany and Austria, so that's the base that we have. We recently were part of Accès Direct, which is a French process where you can commercialize your product while you are negotiating the price. So what you see in the numbers today is that there are around $2 million that are recognized sales from France. And it's a sort of an estimate of a co- with a conservative price per tube that we are using to do that. But the process there is moving very well, and we anticipate by the second half of the year to be fully reimbursed and paid for at a good price in France.

Herve Hoppenot: Okay, so maybe, Salveen, I'll take the first part about the European launch, because in fact, there is a lot of activities going on there. As you know, we launched in Germany and Austria, so that's the base that we have. We recently were part of Accès Direct, which is a French process where you can commercialize your product while you are negotiating the price. So what you see in the numbers today is that there are around $2 million that are recognized sales from France. And it's a sort of an estimate of a co- with a conservative price per tube that we are using to do that. But the process there is moving very well, and we anticipate by the second half of the year to be fully reimbursed and paid for at a good price in France.

Sean: And we see a very good uptake of the demand in terms of volume.

On the BD side medical reached around you can yes.

Sean: Hum in the countries, where it's available specifically in France.

Yes sure.

Sure. So Saturday NASDAQ you commented on we have a strong balance sheet that we will continue to have a strong balance sheet following nation.

Sean: The second part of your question was about the pediatric uptake.

Sean: In the in the U S. When we get a province, or maybe Matthew if you want to speak about that yes sure. Thanks for the question and look.

Acquisition, so as of the end of this quarter, we have $3 9 billion of cash we don't have any debt, which obviously that could give us additional firepower. So that puts us in a position to be able to look at additional opportunities and that's something that we are continuing to explore.

Matthew: We are very excited by the potential opportunity to help two 3 million children and in U S and we see data consistent.

Matthew: Well, we would expect so pending FDA approval, we are excited by another contribution and tailwind to our topline.

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

Matthew: This is a patient population that maybe the patents will be a little more sensitive to a box warning, but at the same time, it's two 3 million patients in children that we potentially have the opportunity to help going forward.

Well thanks for taking my question, maybe just following on <unk> question on capital redeployment.

Hervé Hoppenot: We have now, in Italy and Spain, agreement on the price where we will be launching between midyear and the second half of the year in both countries. So Germany, Italy, Spain, and France will be fully operational by Q3, and will be contributing to the top line. There is also some smaller countries in Europe where the process is ongoing, and there is always a big question mark of the United Kingdom, England, where, as you know, the pricing discussion can take more time, and we are in the process there. So it's a very positive outcome for Opzelura in Europe, because we got reimbursement now in many countries and most of the large countries.

We have now, in Italy and Spain, agreement on the price where we will be launching between midyear and the second half of the year in both countries. So Germany, Italy, Spain, and France will be fully operational by Q3, and will be contributing to the top line. There is also some smaller countries in Europe where the process is ongoing, and there is always a big question mark of the United Kingdom, England, where, as you know, the pricing discussion can take more time, and we are in the process there. So it's a very positive outcome for Opzelura in Europe, because we got reimbursement now in many countries and most of the large countries.

Can you talk about your broader strategy there about.

Matthew: On the BD side, maybe you could just set out and you can.

Also whether you would consider returning cash to shareholders in the form of a dividend or a share buyback potentially using cash to expand your business.

Speaker Change: Yes sure.

Speaker Change: Sure. So Saturday NASDAQ you commented on we have a strong balance sheet that we will continue to have a strong balance sheet following nation.

I guess I can figure out I mean, we are.

BD: Acquisition, so as of the end of this quarter, we have $3 9 billion of cash we don't have any debt, which obviously that could give us additional firepower. So that puts us in a position to be able to look at additional opportunities and that's something that we are continuing to explore.

I've been speaking about acquisition I'm external opportunities, which is obviously one very clear goal for the corporation is to diversify our world.

Revenue in the future and to increase through the growth coming from the current portfolio that we have so that's one.

And then obviously as we are doing with our board discussions about alternative forgot but today as you have seen with has jumped.

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

Well thanks for taking my question, maybe just following on <unk> question on capital redeployment.

Opportunities are very much in the range of what we are looking for in terms of timing and in terms of therapeutic areas and that would be in.

Hervé Hoppenot: We see a very good uptake of the demand in term of volume, in the countries where it's available, specifically in France. Now, the second part of your question was about the pediatric uptake, in the US when we get approval. So maybe, Matteo, if you want to speak about that?

We see a very good uptake of the demand in term of volume, in the countries where it's available, specifically in France. Now, the second part of your question was about the pediatric uptake, in the US when we get approval. So maybe, Matteo, if you want to speak about that?

Eric Schmidt: Can you talk about your broader strategy there about.

Eric Schmidt: Also whether you would consider returning cash to shareholders in the form of a dividend or a share buyback potentially using cash to expand your business.

So we are basically looking at both.

Thank you. Your next question is coming from Jay Olson from Oppenheimer. Your line is now live.

Eric Schmidt: Well I guess I can figure out I mean, we have been speaking about acquisition IMAX film all the opportunities, which is obviously one very clear goal for the corporation is to diversify our world.

Matteo Trotta: Yeah, sure. Thanks for the question. Well, we're very excited about the potential opportunity to help two, three million children in US. We see data consistent with what we would expect. So pending FDA approval, we are excited by another contribution and tailwind to our top line. This is a patient population that maybe the parents will be a little more sensitive to our box warning, but at the same time, it's two, three million patients and children that we potentially have the opportunity to help going forward.

Matteo Trotta: Yeah, sure. Thanks for the question. Well, we're very excited about the potential opportunity to help two, three million children in US. We see data consistent with what we would expect. So pending FDA approval, we are excited by another contribution and tailwind to our top line. This is a patient population that maybe the parents will be a little more sensitive to our box warning, but at the same time, it's two, three million patients and children that we potentially have the opportunity to help going forward.

Oh, Hey, congrats on the progress of your K Ras <unk> D. It seems like insight is increasingly focused on targeted oncology versus immuno oncology can you describe your strategy in oncology and also how are you planning to leverage your oral PDL one for your targeted oncology programs.

Eric Schmidt:

Revenue in the future and to increase through the growth coming from the current portfolio that we have so that's one.

Eric Schmidt: Some of them obviously.

In combination with your K Ras G 12, D or do you plan to develop additional K Ras inhibitors. Thank you.

Eric Schmidt: So we are doing with our board discussion I'm about alternative forgot but today.

Eric Schmidt: As you have seen with has jumped.

Yeah. So thank you for the question. So your observation is correct and we are moving more aggressively into targeted oncology and trying to shift away from immuno oncology and that that's a journey that has started to look at over a year ago, and we intend to accelerate in the future. The idea here is well defined.

Eric Schmidt: Opportunities are very much in the range of what we are looking for in terms of timing and in terms of therapeutic areas and that would be.

Hervé Hoppenot: On the busy side, maybe Christiana, you can-

Herve Hoppenot: On the busy side, maybe Christiana, you can-

Christiana Stamoulis: Yes, sure. So Salveen, as you commented on, we have a strong balance sheet, and we'll continue to have a strong balance sheet following the Asian acquisition. So as of the end of this quarter, we have $3.9 billion of cash. We don't have any debt, which obviously that could give us additional firepower. So that puts us in a position to be able to look at additional opportunities, and that's something that we are continuing to explore.

Christiana Stamoulis: Yes, sure. So Salveen, as you commented on, we have a strong balance sheet, and we'll continue to have a strong balance sheet following the Asian acquisition. So as of the end of this quarter, we have $3.9 billion of cash. We don't have any debt, which obviously that could give us additional firepower. So that puts us in a position to be able to look at additional opportunities, and that's something that we are continuing to explore.

Eric Schmidt: So we are basically looking at both.

Eric Schmidt: Thank you. Your next question is coming from Jay Olson from Oppenheimer. Your line is now live.

<unk> population is large treatment effect ideally single agent activity with early proof of concept and that will allow us to have much more efficient drug development process to accelerate some of those programs.

Jay Olson: Oh, Hey, congrats on the progress of your K Ras <unk> D. It seems like insight is increasingly focused on targeted oncology versus immuno oncology can you describe your strategy in oncology and also how are you planning to leverage your oral PDL one for your targeted oncology programs.

We're very excited about the <unk> program, we think it has the potential to be best in class.

And as you point out one of the things that we can leverage as we have access to what we believe is the most advanced for sure oral PDL, one inhibitor and that will allow us to do oral oral combinations.

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

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

Jay Olson: In combination with your <unk> 12, D or do you plan to develop additional K Ras inhibitors. Thank you.

Eric Schmidt: Well, thanks for taking my question. Maybe just following on Salveen's question on capital redeployment, can you talk about your broader strategy there, about also whether you'd consider returning cash to shareholders in the form of a dividend or share buyback, in addition to potentially using cash to expand your business?

Eric Schmidt: Well, thanks for taking my question. Maybe just following on Salveen's question on capital redeployment, can you talk about your broader strategy there, about also whether you'd consider returning cash to shareholders in the form of a dividend or share buyback, in addition to potentially using cash to expand your business?

In patients with a range of indications and dial applies also to the rest of the pipeline and as I mentioned that journey will continue to accelerate in the future.

Speaker Change: Yeah. So thank you for the question. So your observation is correct and we are moving more aggressively into targeted oncology and trying to shift away from immuno oncology and that that's a journey that has started to look at over a year ago, and we intend to accelerate in the future. The idea here is well defined.

Thank you next question is coming from that Phipps from William Blair. Your line is now live.

Alright, thanks for taking my questions.

Hervé Hoppenot: I can, I can take that. I mean, it's, we have been speaking about acquisition and external opportunities, which is obviously one very clear goal for the corporation, is to diversify our, revenue, in the future and to increase to the growth coming from the current portfolio that we have. So that's one option. And obviously, as we are doing with our board, there are discussion about alternatives to that. But today, as you have seen with the Escient, I mean, there are opportunities that are very much in the range of what we are looking for in term of timing and in term of therapeutic areas, and that would be an interest. So we are basically looking at both.

Herve Hoppenot: I can, I can take that. I mean, it's, we have been speaking about acquisition and external opportunities, which is obviously one very clear goal for the corporation, is to diversify our, revenue, in the future and to increase to the growth coming from the current portfolio that we have. So that's one option. And obviously, as we are doing with our board, there are discussion about alternatives to that. But today, as you have seen with the Escient, I mean, there are opportunities that are very much in the range of what we are looking for in term of timing and in term of therapeutic areas, and that would be an interest. So we are basically looking at both.

I guess I'll ask about the <unk> antibody and data in early 2025, well that'd be monotherapy or mono and Jakafi combo and also myelofibrosis, only or also including essential thrombocytopenia and I guess just from a high level. The combination with Jakafi is that primarily to provide faster symptom relief.

Speaker Change: Asian population is large treatment effect ideally single agent activity with early proof of concept and that will allow us to have much more efficient drug development process to accelerate some of those programs.

We're very excited about the <unk> program, we think it has the potential to be best in class.

Speaker Change: And as you point out one of the things that we can leverage as we have access to what we believe is the most advanced for sure oral PDL, one inhibitor and that will allow us to do oral oral combinations.

Or.

Do you think it is just kind of necessary to achieve that.

You can see for the antibody.

So we haven't decided exactly the scope of the data disclosure for the mutant Cal our antibody later this year what I can tell you is the plan is to combine them you can call our antibody with Jakafi and the idea. There is as you know and we pointed out many times that Jakafi has a profound effect on symptom relief in these patients, which we believe.

Speaker Change: In patients with a range of indications and dial applies also to the rest of the pipeline and as I mentioned that journey will continue to accelerate in the future.

Speaker Change: Thank you next question is coming from Matt Phipps from William Blair. Your line is now live.

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

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

Early in the management of the disease could be very important even in the presence of immune color antibody. The idea that you didn't call. Our antibody here as you know is to transform.

Alright, thanks for taking my questions.

Matt Phipps: I guess I'll ask about the catalog <unk> antibody data in early 2025, well that'd be monotherapy or mono and Jakafi combo and also myelofibrosis, only or also including essential thrombocytopenia and I guess just from a high level. The combination with Jakafi is that primarily to provide faster symptom relief.

Jay Olson: Oh, hey, congrats on the progress of your KRAS G12D. It seems like Incyte is increasingly focused on targeted oncology versus immuno-oncology. Can you describe your strategy in oncology? And also, how are you planning to leverage your oral PD-L1 for your targeted oncology programs in combination with your KRAS G12D, or do you plan to develop additional KRAS inhibitors? Thank you.

Jay Olson: Oh, hey, congrats on the progress of your KRAS G12D. It seems like Incyte is increasingly focused on targeted oncology versus immuno-oncology. Can you describe your strategy in oncology? And also, how are you planning to leverage your oral PD-L1 for your targeted oncology programs in combination with your KRAS G12D, or do you plan to develop additional KRAS inhibitors? Thank you.

Is to change the treatment objective to really eradicate the malignant clones, but still a potential early treatment or induction with jakafi could be very very helpful for patients and regarding the other part of your question. Yes, we will have data in MF and E T as well.

Matt Phipps: Or.

Matt Phipps: Do you think it is just kind of necessary to achieve that.

Matt Phipps: So the antibody.

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

Speaker Change: So we haven't decided exactly the scope of the data disclosure problem you can call. Our antibody later this year what I can tell you is the plan is to combine them you can call our antibody with Jakafi and the idea. There is as you know and we pointed out many times that Jakafi has a profound effect on symptom relief in this patient, which we believe.

Pablo Cagnoni: Yeah, so thank you for the question. So your observation is correct. We are moving more aggressively into targeted oncology and trying to shift away from immuno-oncology, and that's a journey that has started a little bit over a year ago, and we intend to accelerate in the future. The idea here is well-defined patient populations, large treatment effect, ideally single agent activity with early proof of concept, and that will allow us to have much more efficient drug development process to accelerate some of these programs. We're very excited about the G12D program. We think it has the potential to be best in class.

Pablo Cagnoni: Yeah, so thank you for the question. So your observation is correct. We are moving more aggressively into targeted oncology and trying to shift away from immuno-oncology, and that's a journey that has started a little bit over a year ago, and we intend to accelerate in the future. The idea here is well-defined patient populations, large treatment effect, ideally single agent activity with early proof of concept, and that will allow us to have much more efficient drug development process to accelerate some of these programs. We're very excited about the G12D program. We think it has the potential to be best in class.

Hey, guys. Thank you so much for taking the question.

Two for me one just taking a step back looking at P&L management, you know how do you think about being most efficient with your Opex and then kind of a follow up there would you ever consider.

Some of your balance sheet to say do buyback, especially with the stock in the fifties.

Speaker Change: Early in the management of the disease could be very important even in the presence of immune caller antibody. The idea that you didn't call. Our antibody here as you know is to transform.

And then just as you think about your positioning in the derm space a lot of focus on obsolete.

Speaker Change: Is to change the treatment objective to really eradicate the malignant clones, but still a potential early treatment or induction with jakafi. It could be very very helpful for patients and regarding the other part of your question. Yes, we will have data in MF and E T as well.

Where do you want to win over the next five years when it comes to term where do you think insight is best suited to really take share maybe you can walk me through some of the most exciting part of your pipeline in your view. Thank you.

Pablo Cagnoni: As you point out, one of the things that we can leverage is we have access to what we believe is the most advanced, for sure, oral PD-L1 inhibitor, and that will allow us to do oral-oral combinations, in patients with a range of indications. That applies also to the rest of the pipeline. As I mentioned, that journey will continue to accelerate in the future.

As you point out, one of the things that we can leverage is we have access to what we believe is the most advanced, for sure, oral PD-L1 inhibitor, and that will allow us to do oral-oral combinations, in patients with a range of indications. That applies also to the rest of the pipeline. As I mentioned, that journey will continue to accelerate in the future.

Okay. So I think the first question was about the.

Speaker Change: Thank you. Our next question is coming from having secreted from BMO capital markets. Your line is now live.

Efficiency of the of the spending so as you see I mean, we have in our P&L, we had a relatively this quarter, we had a very flat.

Hey, guys. Thank you so much for taking the question.

Haviv Segal: Two for me one just taking a step back looking at P&L management know, how do you think about being most efficient with your Opex and then kind of a follow up there would you ever consider using some of your balance sheet to say do buyback, especially with the stock in the fifties and.

SG&A.

Operator: Thank you. Next question is coming from Matt Phipps, from William Blair. Your line is now live.

Operator: Thank you. Next question is coming from Matt Phipps, from William Blair. Your line is now live.

Relatively slower growing R&D.

And that's what we have been speaking about for Europe, and I always basically growing the top line at a faster rate than we are growing well.

Matteo Trotta: Hi, thanks for taking my questions. I guess I'll ask about the CALR mutant antibody and data in early 2025. Will that be monotherapy or mono and Jakafi combo, and also myelofibrosis only, or also including essential thrombocythemia? And I guess just, from a high level, the combination with Jakafi, is that primarily to provide faster symptom relief? Or, do you think it is just kind of necessary to achieve full efficacy for the antibody?

Matt Phipps: Hi, thanks for taking my questions. I guess I'll ask about the CALR mutant antibody and data in early 2025. Will that be monotherapy or mono and Jakafi combo, and also myelofibrosis only, or also including essential thrombocythemia? And I guess just, from a high level, the combination with Jakafi, is that primarily to provide faster symptom relief? Or, do you think it is just kind of necessary to achieve full efficacy for the antibody?

Haviv Segal: Then just as you think about.

Both components of the of the expenses and the increasing leverage so that's sort of happening now.

Haviv Segal: Your positioning in the derm space a lot of focus on <unk>.

Haviv Segal: Where do you want to win over the next five years when it comes to term where do you think insight is best suited to really take share maybe you can walk me through some of the most exciting part of your pipeline in your view. Thank you.

Depending on the event on the quarterly burn.

It's not always at the same rate, but it is clearly the direction that we are taking.

Taking concerning the buyback I spoke about it what I'm basically saying is that nothing is excluded from discussions on.

Speaker Change: Okay. So I think the first question was about the <unk>.

Pablo Cagnoni: ... So, we haven't decided exactly the scope of the data disclosure for the mutant CALR antibody later this year. What I can tell you is the plan is to combine the mutant CALR antibody with Jakafi. And the idea there is, as you know, and we pointed out many times, Jakafi has a profound effect on symptom relief in these patients, which we believe early in dimension of the disease could be very important, even in the presence of a mutant CALR antibody. The idea of a mutant CALR antibody here, as you know, is to transform, is to change the treatment objective to really eradicate the malignant clone. But still, a potential early treatment or induction with Jakafi could be very, very helpful for patients. And regarding the other part of your question, yes, we will have data in MF and ET as well.

Pablo Cagnoni: So, we haven't decided exactly the scope of the data disclosure for the mutant CALR antibody later this year. What I can tell you is the plan is to combine the mutant CALR antibody with Jakafi. And the idea there is, as you know, and we pointed out many times, Jakafi has a profound effect on symptom relief in these patients, which we believe early in dimension of the disease could be very important, even in the presence of a mutant CALR antibody. The idea of a mutant CALR antibody here, as you know, is to transform, is to change the treatment objective to really eradicate the malignant clone. But still, a potential early treatment or induction with Jakafi could be very, very helpful for patients. And regarding the other part of your question, yes, we will have data in MF and ET as well.

That's something that the you know.

Speaker Change: Efficiency of the of the spending so as you see I mean, we have in our P&L, we had a relatively this quarter, we had a very flat.

Certainly a bulk.

South of the current dialogue I know in the dermatology, maybe Pablo if you want to.

To speak about.

Speaker Change: SG&A and relatively slower growing R&D and that's what we have been speaking about for Europe, and I always basically growing the topline at a faster rate than we are growing.

On the on the I'm happy I'm happy to comment.

Look I think what we're building is.

An important portfolio of first in class or best in class in some cases best in disease medicines in the I would expand the question Sandy flying in the inflammation space and I think that was a key driver of the acquisition of <unk> to complement that with two first in class.

Speaker Change: Both components of the of the expenses and the increasing so that's sort of happening.

Speaker Change: Depending on the event on the quarterly.

Speaker Change: It's not always at the same rate, but it's clearly the direction that we are.

Medicines, 262, and $5 seven that can really address a range of indications. We believe that that added to the portfolio that we have with polar Sydney, which is arguably a pipeline within a drug we can win across a range of indications by providing.

Speaker Change: Thinking concerning the buyback I spoke about it what I'm basically saying is that nothing is excluded from discussions and that's the that's the thing that.

Operator: Thank you. Our next question is coming from Evan Segerman, from BMO Capital Markets. Your line is now live.

Operator: Thank you. Our next question is coming from Evan Segerman, from BMO Capital Markets. Your line is now live.

Patients and payers with a portfolio approach to some of these diseases, including Perrigo note your Larry's atopic dermatitis and now they are newer inflammatory diseases.

Speaker Change: It is certainly a part of the current dialogue I know in the dermatology, maybe Pablo if you want to.

Evan Segerman: Hi, guys. Thank you so much for taking the question. Two from me. One, just taking a step back, looking at P&L management, you know, how do you think about being most efficient with your OpEx? And then kind of a follow-up there, would you ever consider, using some of your balance sheet to, say, do buybacks, especially with the stock in the fifties? And then just, you know, as you think about, your positioning in the derm space, a lot of focus on, Opzelura. Where, where do you wanna win over the next five years when it comes to derm? Where do you think Incyte is best suited to really take share? Maybe you could walk me through some of the most exciting parts of your pipeline in your view. Thank you.

Evan Seigerman (BMO Cap: Hi, guys. Thank you so much for taking the question. Two from me. One, just taking a step back, looking at P&L management, you know, how do you think about being most efficient with your OpEx? And then kind of a follow-up there, would you ever consider, using some of your balance sheet to, say, do buybacks, especially with the stock in the fifties? And then just, you know, as you think about, your positioning in the derm space, a lot of focus on, Opzelura. Where, where do you wanna win over the next five years when it comes to derm? Where do you think Incyte is best suited to really take share? Maybe you could walk me through some of the most exciting parts of your pipeline in your view. Thank you.

Pablo: Can you speak about the two of them on the on the I'm happy I'm happy to comment.

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

Pablo: Look I think what we're building is.

Okay, great. Thanks for taking the questions.

Pablo: An important portfolio of first in class or best in class in some cases best in disease medicines in the I would expand the questions, saying, they're flying in the inflammation space and I think that was a key driver of the acquisition of <unk> to complement that with two first in class.

Just a couple of quick ones one on Jakafi XR can you provide any sort of an update as to how that's progressing and as you think about the strategy going forward is this.

Something that you're already starting to evaluate combinations or do you only start doing that after the approval.

Pablo: Medicines, 262, and $5 seven that can really address a range of indications. We believe that that added to the portfolio that we have with polar Sydney, which is arguably a pipeline within a drug we can win across a range of indications by providing.

And then just as a follow up complicit or Matt just wanted to get your thoughts on DFL Mcl data. That's coming out is this just really going to be meaningful from a commercial perspective was the real opportunity in first line <unk>, which is expected in 2025.

Hervé Hoppenot: Okay. So I think the first question was about the efficiency of the spending. So as you see, I mean, we have in our P&L. We had a relatively flat quarter. We had a very flat SG&A and a relatively slower growing R&D. And that's what we have been speaking about for years now, is basically growing the top line at a faster rate than we are growing both components of the expenses and increasing leverage. So that's sort of happening. That depending on the event, on the quarterly, it's not always at the same rate, but it's clearly the direction that we are taking. Concerning the buyback, I spoke about it.

Herve Hoppenot: Okay. So I think the first question was about the efficiency of the spending. So as you see, I mean, we have in our P&L. We had a relatively flat quarter. We had a very flat SG&A and a relatively slower growing R&D. And that's what we have been speaking about for years now, is basically growing the top line at a faster rate than we are growing both components of the expenses and increasing leverage. So that's sort of happening. That depending on the event, on the quarterly, it's not always at the same rate, but it's clearly the direction that we are taking. Concerning the buyback, I spoke about it.

Pablo: Patients and payers with a portfolio approach to some of these diseases, including Perrigo knows your Larry's atopic dermatitis and now the new inflammatory diseases.

So Ren it's Steven answering your question.

As Pablo said in remarks earlier this year the XR a process is underway with the regulators in terms of doing a bioavailability and then followed by the work.

Pablo: Thank you. Our next question is coming from Ren Benjamin from citizens JMP. Your line is now live.

Ren Benjamin: Okay, great. Thanks for taking the questions.

Ren Benjamin: Just a couple of quick ones one on Jakafi XR can you provide any sort of an update as to how that's progressing and as you think about the strategy going forward is this.

That will include stability. So it's about a two year process, which we expect to complete in a way in time for the low <unk>.

And the idea there is obviously to have the once daily available in time it doesn't change any of our FTC work, we can still do fixed dose combination work with Burton Elk is we need to do and we continue to progress those in terms of our Tampa sit a mab.

Something that you're already starting to evaluate and in combinations or do you only start doing that after the approval.

Ren Benjamin: And then just as a follow up complicit or Matt just wanted to get your thoughts on DFL Mcl data. That's coming out is this just really going to be meaningful from a commercial perspective was the real opportunity in first line <unk>, which is expected in 2025.

Hervé Hoppenot: What I'm basically saying is that nothing is excluded from discussions, and that's, that's something that, you know, is, is certainly, part of the current dialogue. And now in the dermatology, maybe Pablo, if you want to, to speak about, or Steven on the, on the-

What I'm basically saying is that nothing is excluded from discussions, and that's, that's something that, you know, is, is certainly, part of the current dialogue. And now in the dermatology, maybe Pablo, if you want to, to speak about, or Steven on the, on the-

The studies are complete both in mind and frontline so the low grade Follicular and marginal zone lymphoma study will be in the second half of this year and in the first line diffuse large b cell lymphoma, probably in Q1 2025 and.

Ren Benjamin: So Ren it's Steven answering your question.

Pablo Cagnoni: I'm happy to comment. Look, I think what we're building is an important portfolio of first-in-class or best-in-class, in some cases, best-in-disease medicines. I would expand the question saying in the inflammation space. I think that was a key driver of the acquisition of Escient to complement that with two first-in-class medicines, EP262 and EP547, that can really address a range of indications. We believe that that added to the portfolio that we have with povorcitinib, which is arguably a pipeline within a drug. We can win across a range of indications by providing patients and payers with a portfolio approach to some of these diseases, including prurigo nodularis, atopic dermatitis, and other neuroinflammatory diseases.

Pablo Cagnoni: I'm happy to comment. Look, I think what we're building is an important portfolio of first-in-class or best-in-class, in some cases, best-in-disease medicines. I would expand the question saying in the inflammation space. I think that was a key driver of the acquisition of Escient to complement that with two first-in-class medicines, EP262 and EP547, that can really address a range of indications. We believe that that added to the portfolio that we have with povorcitinib, which is arguably a pipeline within a drug. We can win across a range of indications by providing patients and payers with a portfolio approach to some of these diseases, including prurigo nodularis, atopic dermatitis, and other neuroinflammatory diseases.

Ren Benjamin: As Pablo said in remarks earlier this year the XR a process is underway with the regulators in terms of doing a buy availability and then followed by <unk> work.

And we you know we await that data we know we have an active very active and well tolerated regimen in lymphomas, and we look forward to that data and someone who brought up earlier. The end Pablo said you know there's also interest now potentially in autoimmune work with CD 19 antibodies and that's something we just looking at at the moment.

Ren Benjamin: That will include stability. So it's about a two year process, which we expect to complete in a way in time for the low <unk>.

Ren Benjamin: And the idea there is obviously to have the once daily available in time it doesn't change any of our FTC work, we can still do fixed dose combination work with Burton Elk is we need to do and we continue to progress those in terms of our Tampa sit a mab.

You know to the meat of your question, Yes, we very much expect the data to be meaningful with a well tolerated active regimen and we look forward to those datasets.

Yes.

Thank you. Our final question today is coming from Gavin Clark Gardner from Evercore ISI. Your line is now live.

Ren Benjamin: The studies are complete both in mind and frontline so the low grade Follicular and marginal zone lymphoma study will be in the second half of this year and in the first line diffuse large b cell lymphoma, probably in Q1 2025, and we you know we await that data we know we have an active.

Hey, Thanks for fitting me in just wanted to ask one quick clarification on the caller data did you note that you're planning to show some of that data later this year or could that still be a 2025 of them.

Operator: Thank you. Our next question is coming from Ren Benjamin from Citizens JMP. Your line is now live.

Operator: Thank you. Our next question is coming from Ren Benjamin from Citizens JMP. Your line is now live.

We haven't provided specific guidance I think we said 20 to 25, sorry, five five implied 2024 and I apologize if I'm misunderstanding there was 20 to 25 years ago.

Ren Benjamin: Hey, great, thanks for taking the question. Just a couple of quick ones. One, on Jakafi XR, can you provide any sort of an update as to how that's progressing? And as you think about, you know, the strategy going forward, is this something that you're already starting to evaluate in combinations, or do you only start doing that after an approval? And then just as a follow-up, tafasitamab, just wanted to get your thoughts on the FL and CL data that's coming out. Is this really gonna be meaningful from a commercial perspective, or is the real opportunity in first line, you know, DLBCL, which is expected in 2025? Thanks.

Reni Benjamin: Hey, great, thanks for taking the question. Just a couple of quick ones. One, on Jakafi XR, can you provide any sort of an update as to how that's progressing? And as you think about, you know, the strategy going forward, is this something that you're already starting to evaluate in combinations, or do you only start doing that after an approval? And then just as a follow-up, tafasitamab, just wanted to get your thoughts on the FL and CL data that's coming out. Is this really gonna be meaningful from a commercial perspective, or is the real opportunity in first line, you know, DLBCL, which is expected in 2025? Thanks.

Ren Benjamin: Very active and well tolerated regimen in lymphomas, and we look forward to that data and someone who was brought up earlier. The end Pablo said you know there's also interest now potentially in autoimmune work with CD 19 antibodies and that's something we just looking at at the moment.

Okay.

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

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

Ren Benjamin: To the meat of your question, yes, we very much expect the data to be meaningful with a well tolerated active regimen and we look forward to those datasets.

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

Speaker Change: Thank you. Our final question today is coming from Gavin Clark Gardner from Evercore ISI. Your line is now live.

Speaker Change: Hey, Thanks for fitting me in I just wanted to ask one quick clarification on the caller data did you note that you're planning to show some of that data later this year or could that still be a 2025 of them.

Pablo Cagnoni: So, so Ren, it's Steven answering your question. So, you know, as Pablo said in, in remarks earlier this year, the XR process is underway with the regulators in terms of doing bioavailability and then followed by BE work. That'll include stability, so it's about a two-year process, which we expect to complete in a way in time for the LOE. And the idea there is obviously to have the once daily available in time. It doesn't change any of our FDC work. We can still do fixed dose combination work with BET and ALK2 as we need to do, and we continue to progress those.

Steven Stein: So, so Ren, it's Steven answering your question. So, you know, as Pablo said in, in remarks earlier this year, the XR process is underway with the regulators in terms of doing bioavailability and then followed by BE work. That'll include stability, so it's about a two-year process, which we expect to complete in a way in time for the LOE. And the idea there is obviously to have the once daily available in time. It doesn't change any of our FDC work. We can still do fixed dose combination work with BET and ALK2 as we need to do, and we continue to progress those.

Speaker Change: We haven't provided specific guidance I think we said 20 to 25, sorry, five five implied 2024 am I apologize for misunderstanding, but was 20 to $25 is the goal.

Speaker Change: Okay.

Speaker Change: Thank you we've reached end of our question and answer session I'd like to turn the floor back over for any further or closing comments.

Speaker Change: Thank you all for participating in the call today and for your questions. The IR team will be available for questions throughout the day, Thank you and goodbye.

Pablo Cagnoni: In terms of tafasitamab, you know, the studies are complete, both in relapsed and frontline, so the low-grade follicular and marginal zone lymphoma study will be in the second half of this year, and in the first line, diffuse large B-cell lymphoma, probably in Q1 2025. We await that data. We know we have an active, very active and well-tolerated regimen in lymphomas, and we look forward to that data. As someone also brought up earlier there and Pablo said, you know, there's also interest now potentially in autoimmune work with CD19 antibodies, and that's something we're just looking at at the moment.

In terms of tafasitamab, you know, the studies are complete, both in relapsed and frontline, so the low-grade follicular and marginal zone lymphoma study will be in the second half of this year, and in the first line, diffuse large B-cell lymphoma, probably in Q1 2025. We await that data. We know we have an active, very active and well-tolerated regimen in lymphomas, and we look forward to that data. As someone also brought up earlier there and Pablo said, you know, there's also interest now potentially in autoimmune work with CD19 antibodies, and that's something we're just looking at at the moment.

Speaker Change: Thank you that does conclude today's teleconference and webcast you may disconnect. Your line at this time and have a wonderful day, we thank you for your participation today.

Pablo Cagnoni: You know, to the meat of your question, yes, we very much expect the data to be meaningful with a, you know, well-tolerated, active regimen, and we look forward to those data sets. Thanks.

You know, to the meat of your question, yes, we very much expect the data to be meaningful with a, you know, well-tolerated, active regimen, and we look forward to those data sets. Thanks.

Operator: Thank you. Our final question today is coming from Gavin Clark-Gardner, from Evercore ISI. Your line is now live.

Operator: Thank you. Our final question today is coming from Gavin Clark-Gardner, from Evercore ISI. Your line is now live.

Hervé Hoppenot: Hey, thanks for fitting me in. Just wanted to ask one quick clarification on the CALR data. Did you note that you're planning to show some of that data later this year, or could that still be a 2025 event?

Gavin Clark-Gartner: Hey, thanks for fitting me in. Just wanted to ask one quick clarification on the CALR data. Did you note that you're planning to show some of that data later this year, or could that still be a 2025 event?

Pablo Cagnoni: We haven't provided specific guidance. I think we said 2025. So if, if I've implied 2024, I'm. I apologize for the misunderstanding, but 2025 is the goal.

Pablo Cagnoni: We haven't provided specific guidance. I think we said 2025. So if, if I've implied 2024, I'm. I apologize for the misunderstanding, but 2025 is the goal.

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

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

Ben Strain: Thank you all for participating in the call today and for your questions. The IR team will be available for questions throughout the day. Thank you and goodbye.

Ben Strain: Thank you all for participating in the call today and for your questions. The IR team will be available for questions throughout the day. Thank you and goodbye.

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

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