Q4 2023 Incyte Corp Earnings Call
Operator: --should you require operator assistance, please press star zero on your telephone keypad. 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 and we ask you to please ask one question and one follow-up. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Ben Strain, Associate Vice President of Investor Relations. Please go ahead Ben.
Ben Strain: Thank you Kevin. Good morning and welcome to Incyte's fourth quarter 2023 earnings conference call. Before we begin, I encourage everyone to go to the investors' section of our website to find the press release, related financial tables and slides to follow today's discussion. On today's call, I'm joined by Herve, Barry, Pablo, Steven and Christiana who will deliver our prepared remarks and will participate in the Q&A.
Ben Strain: Christiana, who will deliver our prepared remarks, and we will participate in the Q&A I.
Ben Strain: 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 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.
Herve Hoppenot: Thank you Ben and good morning everyone. So on slide five we achieved another strong year with 2023 with our royalty revenues growing 14% up from 2022 to reach $3.7 billion considering the strong performance we have delivered since 2018. We also achieved a [inaudible] milestone in the fourth quarter. Total product and royalty revenue reached 1 billion quarterly for the first time driven by the continued growth of JAKAFI and successful launch of OPZELURA.
Irving: So on slide five we achieved that in Australia with 2023. The royalty revenues growing 14% Augustus 2022 to reach $3 7 billion of them considering the strong performance we have developed since 2018. We also achieved if somebody can milestone in the fourth quarter total product and royalty revenue reached 1 billion quarterly for the first time driven by the continued growth of Jakafi and. And successful launch of ups at all.
Irving: The royalty revenues growing 14% Augustus 2022 to reach $3 7 billion of them considering the strong performance we have developed since 2018. We also achieved if somebody can milestone in the fourth quarter total product and royalty revenue reached 1 billion quarterly for the first time driven by the continued growth of Jakafi and. And successful launch of ups at all.
Irving: We also achieved if somebody can milestone in the fourth quarter total product and royalty revenue reached 1 billion quarterly for the first time driven by the continued growth of Jakafi and. And successful launch of ups at all.
Irving: And successful launch of ups at all.
Speaker Change: So moving to slide six, 2023 JAKAFI net sales were $2.6 billion growing 8% after the prior year with growth across all indications year over year. And OPZELURA saw strong momentum in 2023 growing 162% to $338 million, driven by new patients and repeat in both [inaudible] and vitiligo. We expect OPZELURA to continue to be a key contributor to growth in the next year.
Speaker Change: 2023, Jack ups right that says we have $2 6 billion growing 8%. This is a priority with growth across all indications yoga. And up to us. The momentum in 2023 growing 162% to 338 million driven by new patient on our risk teams in both <unk> and vitiligo. We expect to continue to be the chickens. Key contributors to growth in the next year. Okay.
And up to us. The momentum in 2023 growing 162% to 338 million driven by new patient on our risk teams in both <unk> and vitiligo. We expect to continue to be the chickens. Key contributors to growth in the next year. Okay.
Speaker Change: The momentum in 2023 growing 162% to 338 million driven by new patient on our risk teams in both <unk> and vitiligo. We expect to continue to be the chickens. Key contributors to growth in the next year. Okay.
Speaker Change: We expect to continue to be the chickens. Key contributors to growth in the next year. Okay.
Speaker Change: Key contributors to growth in the next year. Okay.
Okay.
Speaker Change: On slide seven, our clinical pipeline has the ability to deliver transformative therapies to patients across multiple programs and provides the opportunity for 10 high impact launches by 2030 as presented recently in San Francisco.
Speaker Change: Importantly, some of the programs highlighted on this slide [inaudible] proof of concept including [inaudible] which has been submitted to the FDA for approval, [inaudible] in pediatric atopic dermatitis to be submitted to the FDA by mid year, [inaudible] in HS where we have randomized phase two data and [inaudible] where we are in phase III in HS vitiligo and in PN, where we are on track to initiate the phase III studies this year. Each of these programs has the potential to address a significant market and provide an opportunity to contribute to the top line before the end of the decade.
Post proof of concept. <unk> exited the map, which has been submitted to the FDA for approval rux cream in pediatric atopic dermatitis to be submitted to the FDA by mid year Rux cream in the Hs, where we have randomized phase two data and porosity, but where we are in phase III in Hs vitiligo and. And in P. M, where we are on track to initiate the phase III studies this year. This program has put on. Sean to address a significant market and provide an opportunity to contribute to the top line before the end of the decade.
Speaker Change: <unk> exited the map, which has been submitted to the FDA for approval rux cream in pediatric atopic dermatitis to be submitted to the FDA by mid year Rux cream in the Hs, where we have randomized phase two data and porosity, but where we are in phase III in Hs vitiligo and. And in P. M, where we are on track to initiate the phase III studies this year. This program has put on. Sean to address a significant market and provide an opportunity to contribute to the top line before the end of the decade.
Speaker Change: And in P. M, where we are on track to initiate the phase III studies this year. This program has put on. Sean to address a significant market and provide an opportunity to contribute to the top line before the end of the decade.
Speaker Change: This program has put on. Sean to address a significant market and provide an opportunity to contribute to the top line before the end of the decade.
Speaker Change: Sean to address a significant market and provide an opportunity to contribute to the top line before the end of the decade.
Speaker Change: I would also like now to highlight the recent transaction with [inaudible] is on slide eight. As described in the press release we issued last week, we entered into an asset purchase agreement with [inaudible] which give us exclusive global rights for [inaudible] also known as [inaudible]. This acquisition provides a number of benefits to insight in the short term. First going forward we will now record all revenues from [inaudible] in the US while eliminating opposite shares of the royalties ex-US and all future milestones to [inaudible].
Speaker Change: As described in the press release, we issued last week. We entered into an asset purchase agreement with most of this would. Could you give us exclusive global rights for deficit them up for so long that Monrovia imagery. The acquisition provides a number of benefits to insight in the short term. It's going from Wild we will now record oil revenues for our modules in the U S. While eliminating shelves royalties ex U S and all future milestone too much with it.
Speaker Change: We entered into an asset purchase agreement with most of this would. Could you give us exclusive global rights for deficit them up for so long that Monrovia imagery. The acquisition provides a number of benefits to insight in the short term. It's going from Wild we will now record oil revenues for our modules in the U S. While eliminating shelves royalties ex U S and all future milestone too much with it.
Speaker Change: Could you give us exclusive global rights for deficit them up for so long that Monrovia imagery. The acquisition provides a number of benefits to insight in the short term. It's going from Wild we will now record oil revenues for our modules in the U S. While eliminating shelves royalties ex U S and all future milestone too much with it.
Speaker Change: The acquisition provides a number of benefits to insight in the short term. It's going from Wild we will now record oil revenues for our modules in the U S. While eliminating shelves royalties ex U S and all future milestone too much with it.
Speaker Change: It's going from Wild we will now record oil revenues for our modules in the U S. While eliminating shelves royalties ex U S and all future milestone too much with it.
Speaker Change: While eliminating shelves royalties ex U S and all future milestone too much with it.
Speaker Change: Secondly, we will realize significant operating efficiencies and cost synergies in US commercialization and in global development by removing redundant position or redundant external expenses and by simplifying the options. Therefore, in 2024, the deal will add to Incyte's revenue and will have a limited impact on operating income. For the future [inaudible] approved indication of relapse refractory [inaudible] represent a smaller opportunity for bevacizumab, we see upside potential in second line lollicular lymphoma and marginal zone lymphoma with phase III data expected later this year and in first line [inaudible] this year for which phase III data are expected in 2025. These programs have been co funded by [inaudible] Incyte will fully benefit from the upside from this indication. And this acquisition would be value accretive for Incyte in all scenarios. I will now turn the call over to Barry who will discuss our commercial performance in more detail.
Speaker Change: By removing redundant position, a redundant external expenses and by simplifying the op shops. For 2021st as deal will add to insights revenue and we'd have a limited impact on operating income.
Speaker Change: For 2021st as deal will add to insights revenue and we'd have a limited impact on operating income.
So the future why does the currently approved indication of relapsed relapse refractory there'll be Seattle represent a smaller opportunity for bevacizumab. We see upside, but I'm sure in second line Follicular lymphoma. Imagine marginal zone lymphoma with phase III data expected later this year. And in first line <unk> Michelle <unk>. For which phase III data are expected in 2025. These programs have been co funded by Morphoses, something now and if positive insight will fully benefit from the upside from this indication. And this acquisition would be value of credit for insight in all scenarios. I would now turn the call over to Barry will discuss our commercial performance in more detail. Thank.
Speaker Change: We see upside, but I'm sure in second line Follicular lymphoma. Imagine marginal zone lymphoma with phase III data expected later this year. And in first line <unk> Michelle <unk>. For which phase III data are expected in 2025. These programs have been co funded by Morphoses, something now and if positive insight will fully benefit from the upside from this indication. And this acquisition would be value of credit for insight in all scenarios. I would now turn the call over to Barry will discuss our commercial performance in more detail. Thank.
Speaker Change: Imagine marginal zone lymphoma with phase III data expected later this year. And in first line <unk> Michelle <unk>. For which phase III data are expected in 2025. These programs have been co funded by Morphoses, something now and if positive insight will fully benefit from the upside from this indication. And this acquisition would be value of credit for insight in all scenarios. I would now turn the call over to Barry will discuss our commercial performance in more detail. Thank.
Speaker Change: And in first line <unk> Michelle <unk>. For which phase III data are expected in 2025. These programs have been co funded by Morphoses, something now and if positive insight will fully benefit from the upside from this indication. And this acquisition would be value of credit for insight in all scenarios. I would now turn the call over to Barry will discuss our commercial performance in more detail. Thank.
Speaker Change: For which phase III data are expected in 2025. These programs have been co funded by Morphoses, something now and if positive insight will fully benefit from the upside from this indication. And this acquisition would be value of credit for insight in all scenarios. I would now turn the call over to Barry will discuss our commercial performance in more detail. Thank.
Speaker Change: These programs have been co funded by Morphoses, something now and if positive insight will fully benefit from the upside from this indication. And this acquisition would be value of credit for insight in all scenarios. I would now turn the call over to Barry will discuss our commercial performance in more detail. Thank.
Speaker Change: And this acquisition would be value of credit for insight in all scenarios. I would now turn the call over to Barry will discuss our commercial performance in more detail. Thank.
Speaker Change: I would now turn the call over to Barry will discuss our commercial performance in more detail. Thank.
Barry P. Flannelly: Thank you Herve and good morning everyone. Starting with JAKAFI on slide 10, in the fourth quarter, JAKAFI's net product revenue grew 7% year over year to $695 million and grew 8% for the full year to $2.6 billion. Total patients increased 6% in 2023 with growth being seen across all indications. We experienced some variation in JAKAFI dynamics during the fourth quarter, including an increase in patients on free drug as well as in inventory fluctuations. Recall inventory drew down modestly in Q3 and rebounded in the fourth quarter. Additionally, we anticipate the increase in patients on free drug seen at the end of 2023 to reverse and return to more normalized levels through '2024 supported by the lower out of pocket expenses under the part D redesign. Christiana will provide more details on these dynamics in her prepared remarks.
Barry: Starting with Jakafi in slide 10 in the fourth quarter Jakafi net product revenue grew 7% year over year to $695 million and grew 8% for the full year to $6 billion. Total patients increased 6% in 2023 with growth being seen across all indications. We experienced some variation in jakafi dynamics during the fourth quarter, including an increase in patients on free drug as well as an inventory fluctuations recall inventory drew down modestly in Q3 and rebounded in the fourth quarter. Additionally, we anticipate the increase in patients on free drug seen at the end of 2023% to reverse and returned to more normalized levels through 'twenty 'twenty four supported by the lower out of pocket expenses under the part D redesign. Kristina will provide more details on these dynamics in her prepared remarks.
Barry: Total patients increased 6% in 2023 with growth being seen across all indications. We experienced some variation in jakafi dynamics during the fourth quarter, including an increase in patients on free drug as well as an inventory fluctuations recall inventory drew down modestly in Q3 and rebounded in the fourth quarter. Additionally, we anticipate the increase in patients on free drug seen at the end of 2023% to reverse and returned to more normalized levels through 'twenty 'twenty four supported by the lower out of pocket expenses under the part D redesign. Kristina will provide more details on these dynamics in her prepared remarks.
Barry: We experienced some variation in jakafi dynamics during the fourth quarter, including an increase in patients on free drug as well as an inventory fluctuations recall inventory drew down modestly in Q3 and rebounded in the fourth quarter. Additionally, we anticipate the increase in patients on free drug seen at the end of 2023% to reverse and returned to more normalized levels through 'twenty 'twenty four supported by the lower out of pocket expenses under the part D redesign. Kristina will provide more details on these dynamics in her prepared remarks.
Barry: Additionally, we anticipate the increase in patients on free drug seen at the end of 2023% to reverse and returned to more normalized levels through 'twenty 'twenty four supported by the lower out of pocket expenses under the part D redesign. Kristina will provide more details on these dynamics in her prepared remarks.
Barry: Kristina will provide more details on these dynamics in her prepared remarks.
Barry: We continue and we expect continued growth of JAKAFI and have updated the full year net product revenue guidance for 2024 to a range of $2.69 to $2.75 billion. As highlighted on slide 11, JAKAFI continues to maintain its leadership and market share in MF driven by its unmatched product profile. Based on market research, other competitors have not had an impact on JAKAFI in regards to total patient market share or new patients and is consistent with our expectations. JAKAFI demand remained strong and we expect continued future growth driven by maintaining its leadership as standard of care in myelofibrosis, growth opportunities in polycythemia vera and chronic graft versus host disease as well as earlier use in chronic GVHD. Additionally, we anticipate the positive changes in out of pocket expenses for Medicare part D patients to contribute to the growth in the coming years with the biggest impact starting in 2025.
Barry: As highlighted on slide 11, Jakafi continues to maintain its leadership and market share in MF driven by its unmatched product profile. Based on market research other competitors have not had an impact on jakafi in regards to total patient market share or new patients and is consistent with our expectations. Jakafi demand remained strong and we expect continued future growth driven by maintaining its leadership as standard of care in myelofibrosis growth opportunities in polycythemia, Vera and chronic graft versus host disease as well as earlier use in chronic gvhd.
Barry: Based on market research other competitors have not had an impact on jakafi in regards to total patient market share or new patients and is consistent with our expectations. Jakafi demand remained strong and we expect continued future growth driven by maintaining its leadership as standard of care in myelofibrosis growth opportunities in polycythemia, Vera and chronic graft versus host disease as well as earlier use in chronic gvhd.
Barry: Jakafi demand remained strong and we expect continued future growth driven by maintaining its leadership as standard of care in myelofibrosis growth opportunities in polycythemia, Vera and chronic graft versus host disease as well as earlier use in chronic gvhd.
Barry: Italy, we anticipate the positive changes in out of pocket expenses for Medicare part D patients to contribute to the growth in the coming years with the big biggest impact starting in 2025.
Barry: Turning to slide 12 and OPZELURA's fourth quarter performance. OPZELURA net product revenues in the fourth quarter were $109 million, up 78% when compared to the same quarter last year. Total 2023 full year net sales grew 162% versus 2022 to reach $338 million. US patient demand increased during the quarter with total prescriptions growing 77% year over year and refills growing by 22% versus the prior quarter. The weekly prescription trend as shown on the right demonstrates typical end of Q4 dynamics as well as the continued growth of OPZELURA which is coming from both atopic dermatitis and vitiligo. In AD, growth was primarily driven by OPZELUA's efficacy and impact on inflammation and itch.
Turning to slide 12 and OPZELURA's fourth quarter performance. OPZELURA net product revenues in the fourth quarter were $109 million, up 78% when compared to the same quarter last year. Total 2023 full year net sales grew 162% versus 2022 to reach $338 million. US patient demand increased during the quarter with total prescriptions growing 77% year over year and refills growing by 22% versus the prior quarter.
Barry: <unk> net product revenues in the fourth quarter were $109 million up 78% when compared to the same quarter last year.
Barry: Total 2023 full year net sales grew 162% versus 2022 to reach $338 million U S patient demand increased during the quarter with total prescriptions growing 77% year over year and refill is growing by 22% versus the prior. Water. The weekly prescription trend as shown on the right demonstrates typical end of Q4 dynamics as well as the continued growth of <unk>, which is coming from both atopic dermatitis and the Lego and <unk> growth was primarily driven by <unk> efficacy and impact on inflammation and itch.
The weekly prescription trend as shown on the right demonstrates typical end of Q4 dynamics as well as the continued growth of OPZELURA which is coming from both atopic dermatitis and vitiligo. In AD, growth was primarily driven by OPZELURA's efficacy and impact on inflammation and itch. In vitiligo, where OPZELURA is the only approved treatment for re pigmentation growth was driven largely by refills improved access and our educational initiatives.
Barry: Water. The weekly prescription trend as shown on the right demonstrates typical end of Q4 dynamics as well as the continued growth of <unk>, which is coming from both atopic dermatitis and the Lego and <unk> growth was primarily driven by <unk> efficacy and impact on inflammation and itch.
Barry: The weekly prescription trend as shown on the right demonstrates typical end of Q4 dynamics as well as the continued growth of <unk>, which is coming from both atopic dermatitis and the Lego and <unk> growth was primarily driven by <unk> efficacy and impact on inflammation and itch.
Barry: In vitiligo, where OPZELURA is the only approved treatment for re pigmentation growth was driven largely by refills improved access and our educational initiatives.
Barry: We remain very optimistic about the long term potential of OPZELURA as we continue to see strong uptake. The launch continues to be strong indicating positive momentum with both physicians and patients as OPZELURA becomes established as one of the best recent dermatology launches. Looking at the first 27 months post FDA approval, OPZELURA continues to outperform other dermatology products on a launch aligned basis when measured by monthly dermatologist prescribed TRXs on the left and when comparing quarterly net revenues on the right, the successful launch of OPZELURA is driven by its compelling product profile, its ability to address significant unmet need in both atopic dermatitis and vitiligo and our strong market access relative to competition, where we continue to improve access and growing net sales.
We remain very optimistic about the long term potential of OPZELURA as we continue to see strong uptake. The launch continues to be strong indicating positive momentum with both physicians and patients as OPZELURA becomes established as one of the best recent dermatology launches.
Barry: The launch continues to be strong and indicating positive momentum with both physicians and patients is absolutely. It becomes established as one of the best recent dermatology launches looking at the first 27 months post FDA approval, absolutely continues to outperform other dermatology products on a launch aligned basis when <unk>. By monthly dermatologist prescribed <unk> on the left and when comparing quarterly net revenues on the right the. The successful launch of op to Lora is driven by its compelling product profile and its ability to address significant unmet need in both atopic dermatitis and did a lego and our strong market access relative to competition, where we continue to improve access and growing net sales.
Looking at the first 27 months post FDA approval, OPZELURA continues to outperform other dermatology products on a launch aligned basis when measured by monthly dermatologist prescribed TRXs on the left and when comparing quarterly net revenues on the right, the successful launch of OPZELURA is driven by its compelling product profile, its ability to address significant unmet need in both atopic dermatitis and vitiligo and our strong market access relative to competition, where we continue to improve access and growing net sales.
By monthly dermatologist prescribed <unk> on the left and when comparing quarterly net revenues on the right the. The successful launch of op to Lora is driven by its compelling product profile and its ability to address significant unmet need in both atopic dermatitis and did a lego and our strong market access relative to competition, where we continue to improve access and growing net sales.
Barry: The successful launch of op to Lora is driven by its compelling product profile and its ability to address significant unmet need in both atopic dermatitis and did a lego and our strong market access relative to competition, where we continue to improve access and growing net sales.
Barry: Turning to slide 14, we have a number of initiatives in place for OPZELURA to drive demand in 2024 in both AD and vitiligo. We know that based on OPZELURA's compelling efficacy and safety, health care professionals want to use OPZELURA sooner in the treatment algorithm. In addition to securing improved access for 2024, we are also continuing to look for ways to improve utilization management and we have an exceptional value proposition that supports these advancements. For vitiligo, we continue to drive patient awareness through consistent marketing campaigns with the goal of educating and inspiring these patients with positive, real world patient experiences. We believe this will drive further demand and activate patients to discuss treatment options with their dermatologist.
Barry: With care professionals want to use up slower sooner in the treatment algorithm. In addition to securing improved access for 2024. We are also continuing to look for ways to improve utilization management and we have an exceptional value proposition that supports these advancements for vitiligo, we continue to drive patient awareness through consistent marketing campaigns with the goal of educating and. Inspiring in these patients with positive real world patient experiences. We believe this will drive further demand and activate patients to discuss treatment options with their dermatologist.
Barry: In addition to securing improved access for 2024. We are also continuing to look for ways to improve utilization management and we have an exceptional value proposition that supports these advancements for vitiligo, we continue to drive patient awareness through consistent marketing campaigns with the goal of educating and. Inspiring in these patients with positive real world patient experiences. We believe this will drive further demand and activate patients to discuss treatment options with their dermatologist.
Barry: Inspiring in these patients with positive real world patient experiences. We believe this will drive further demand and activate patients to discuss treatment options with their dermatologist.
Barry: With that, I'll turn the call over to Pablo.
Pablo J. Cagnoni: Thank you Barry and good morning everyone. I want to highlight some of the key R&D milestones that we accomplished in 2023 and to provide a framework for how we are evolving our R&D focus with a near term goal to increase the rigor of our decision making, accelerate the progression of our pipeline and to optimize our resource allocation.
Pablo: As you can see on slide 16, we have three areas of focus where we're building a robust and diverse portfolio of medicines for the treatment of MP and [inaudible] host disease, oncology, and inflammatory diseases. We're advancing our pipeline to deliver impactful innovation with a focus on best-in-class and our first-in-class differentiated medicines in areas with large unmet medical need.
Pablo: We're advancing our pipeline to deliver impactful innovation with a focus on best in class and our first in class differentiated medicines in areas with large unmet medical need.
Pablo: Our discovery process is target and pathway centric and leverages cross program knowledge and deep biology expertise and our established disease areas of interest to identify and prosecute novel targets as well as disease in genotype specific dependencies with a modality agnostic approach.
Pablo: In addition to our established small molecule expertise, we have expanded our drug discovery capabilities to include monoclonal antibody discovery in house and have access to bi specific antibody discovery capabilities through our partnership with Maris.
Pablo: Turning now to slide 17, we made significant advancements across all three priority areas of focus in the R&D portfolio in 2023. In MPNs and graft versus host disease, we submitted the BLA for [inaudible] for the treatment in third line chronic graft versus host disease. We presented updates for our bet and out two inhibitors in MF and highlighted our new potentially transformative therapies for MF, PV, and ET, our mutant callout monoclonal antibody which is enrolling well in a phase one study and our Jack 2B 617F inhibitor for which we plan to initiate a phase one study in the next month.
Pablo: We've made significant advancements across all three priority areas of focus in the R&D portfolio in 2023 and. In Mpls and graft versus host disease, we submitted the BLA for <unk> until the map for the treatment in third line chronic graft versus host disease, we presented updates for our bet and out two inhibitors in MF and highlighted our new potentially transformative therapies for MF PV and E T. Our mutant callout, a monoclonal antibody which is.
In Mpls and graft versus host disease, we submitted the BLA for <unk> until the map for the treatment in third line chronic graft versus host disease, we presented updates for our bet and out two inhibitors in MF and highlighted our new potentially transformative therapies for MF PV and E T. Our mutant callout, a monoclonal antibody which is.
Pablo: Enrolling well in a phase one study and our Jack to be $6 seven F inhibitor for which we plan to initiate a phase one study in the next month.
Pablo: In oncology, we initiated several monotherapy and combination studies with our small molecule oral PDL-1 inhibitor and highlighted early signs of clinical activity with our small molecule CDK2 inhibitor. Additionally, we unveiled a new program in development, are KRS12D inhibitor, which entered the clinic earlier this year. Steven will provide more detail on the KRS12D program in his prepared remarks.
Pablo: Additionally, we unveiled a new program in development are <unk> 12, D inhibitor, which entered the clinic earlier this year Stephen will provide more detail on the <unk> program in his prepared remarks.
Pablo: In dermatology, we continue to maximize the potential of [inaudible] cream. In 2023, OPZELURA was approved in Europe for vitiligo as the first and only approved treatment for re pigmentation. We also presented positive phase III data in pediatric atopic dermatitis and announced that the primary endpoint was met in a randomized phase II study in patients with [inaudible]. For [inaudible], we presented positive randomized phase II data in vitiligo and initiated two phase III studies for patients with extensive vitiligo.
Pablo: We also presented positive phase III data in pediatric atopic dermatitis and announce the primary endpoint was met in a randomized phase II study in patients with HUD or Tonight is Super Achiever.
Pablo: For <unk>, we presented positive randomized phase II data in vitiligo and initiated two phase III studies for patients with extensive it'll IRA.
Pablo: We also announced that [inaudible] had met the primary endpoint in a randomized phase II study in patients with [inaudible] and we initiated two randomized phase two studies one for patients with asthma and another in patients with chronic spontaneous urticaria. We believe that with [inaudible] cream and [inaudible] we'll be the only company with the ability to address a broad spectrum of patients from mild to severe potentially providing both a topical and oral option for a number of indications, including [inaudible] Hidradenitis Suppurativa and vitiligo. But from an exhaustive list of all the R&D achievements in the past year, this demonstrates that 2023 was a very successful impactful year for Incyte and it serves as a foundation for a number of pivotal trials that will deliver results in the next few years.
Pablo: In patients with asthma and another in patients with chronic spontaneous urticaria. We believe that with rux cream and poorer sitting it will be the only company with the ability to address a broad spectrum of patients from mild to severe potentially providing both a topical and oral option for a number of indications, including perrigo inaugural areas Hidradenitis Suppurativa and.
Pablo: We believe that with rux cream and poorer sitting it will be the only company with the ability to address a broad spectrum of patients from mild to severe potentially providing both a topical and oral option for a number of indications, including perrigo inaugural areas Hidradenitis Suppurativa and.
Pablo: Vitiligo.
Pablo: But from an exhaustive list of all the R&D achievements in the past year. This demonstrates that 2023 was a very successful impactful year for insight and it serves as a foundation for a number of pivotal trials that will deliver results in the next few years.
Pablo: As you can see from slide 18, we anticipate that 2024 will be another very exciting year with multiple clinical and regulatory milestones. Steven will provide more details on these but I would like to highlight certain events. Within our oncology pipeline, we believe that our potentially best in class CDK-2 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 [inaudible] 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. We submitted the BLA for [inaudible] late last year, and we look forward to working with the FDA to make [inaudible] 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: Within our oncology pipeline, we believe that our potentially best in class CDK. Two inhibitor is an active agent and we look forward to sharing data as well as our development plan later this year in.
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.
Pablo: We submitted the BLA for <unk> until I'm up late last year, and we look forward to working with the F. D. A to make extra telemotor 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: Within our dermatology portfolio, we expect to submit the NDA for OPZELURA for pediatric atopic dermatitis and expect multiple data readouts throughout the year. With that, I would like to pass the call to Steven who will provide further details on our clinical development pipeline.
Steven H. Stein: Thank you Pablo. Starting on slide 20, in December, we presented more than 40 hematology and oncology abstracts, including a plenary presentation at the ASH annual meeting.
Stephen: Key highlights included a plenary scientific session, which featured the full data from AGAVE201 evaluating [inaudible], an anti CSF1R monoclonal antibody in patients with chronic graft versus host disease and additional data from the phase one two study of [inaudible] phase one data from our bet inhibitor and preclinical data of the JAK2B617F inhibitor.
Stephen: Inhibitor and preclinical data of the Jack <unk> $6 seven F inhibitor.
Stephen: For our bet inhibitor dose escalation is ongoing. In mono therapy and in combination therapy, we're seeing reductions in spleen lengths and volume as well as improvements in both symptoms and hemoglobin, suggesting that this is an active compound. We plan on advancing this program to phase III later this calendar year.
Stephen: In mono therapy and in combination therapy, we're seeing reductions in spleen lengths in volume as well as improvements in both symptoms and hemoglobin <unk>, suggesting that this is an active compound we plan on advancing this program to phase III later this calendar year.
Stephen: As we get closer, we will provide additional data details on study design and timing. Based on the efficacy and favorable safety profile seen in the phase II AGAVE 201 pivotal study, the BLA for [inaudible] was submitted to the FDA for approval for the treatment of patients with chronic graft versus host disease. We anticipate a decision by the FDA in the second half of 2024 and are excited by the possibility of bringing a new treatment option to these patients.
Stephen: Based on the efficacy and favorable safety profile seen in the phase III agave to zero one pivotal study the BLA for <unk> was submitted to the FDA for approval. The treatment of patients with chronic graft versus host disease. We anticipated decision by the FDA in the second half of 2024 and are excited by the possibility of bringing a new treatment option to these patients.
Stephen: The treatment of patients with chronic graft versus host disease. We anticipated decision by the FDA in the second half of 2024 and are excited by the possibility of bringing a new treatment option to these patients.
Stephen: We anticipated decision by the FDA in the second half of 2024 and are excited by the possibility of bringing a new treatment option to these patients.
Stephen: We continue to expand and advance our IAI dermatology portfolio as seen on slide 22. For [inaudible] cream, we recently presented positive phase III data in pediatric patients, where [inaudible] cream met its efficacy endpoints for both investigator global assessment treatment success and easy 75. We expect to submit the SNDA by the middle of 2024 with potential approval in 2025. We also disclosed that [inaudible] cream met the primary endpoint in the phase II study in mild to moderate hidradenitis suppurativa and we expect to present those results at a medical conference later this year, while a phase III study is being evaluated. [inaudible] cream is also currently being evaluated in two phase III studies in [inaudible] and two phase II studies in [inaudible] Sclerosis with data expected for both later this year.
Stephen: For both investigator global assessment treatment success, and easy 75, we expect to submit the NDA by the middle of 2024 with potential approval in 2025. We also disclosed that rux cream met the primary endpoint in the phase II study in mild to moderate hidradenitis Suppurativa and we expect to present those results at a medical conference later this year, while the phase III study has been evaluated. <unk> cream is also currently being evaluated in two phase III studies in <unk> and two phase II studies and lie can play in this and lack of Sclerosus with data expected for both later this year.
Stephen: We also disclosed that rux cream met the primary endpoint in the phase II study in mild to moderate hidradenitis Suppurativa and we expect to present those results at a medical conference later this year, while the phase III study has been evaluated. <unk> cream is also currently being evaluated in two phase III studies in <unk> and two phase II studies and lie can play in this and lack of Sclerosus with data expected for both later this year.
Stephen: <unk> cream is also currently being evaluated in two phase III studies in <unk> and two phase II studies and lie can play in this and lack of Sclerosus with data expected for both later this year.
[inaudible] our oral JAK 1 inhibitor is currently being evaluated in phase III studies in hidradenitis suppurativa and vitiligo and we recently announced that [inaudible] met the primary endpoint of a greater than or equal to a four point improvement in the HNRS across all three treatment groups in a phase II study in [inaudible]. We expect the full data set at a medical conference later this year and phase III planning is underway. Our earliest stage dermatology program, our IL-15 receptor beta antibody has begun evaluation in healthy volunteers.
Stephen: We expect the full data set at a medical conference later this year and phase III planning is underway. Our earliest stage dermatology program IL 15 receptor beta antibody has begun evaluation in healthy volunteers.
Stephen: Our earliest stage dermatology program IL 15 receptor beta antibody has begun evaluation in healthy volunteers.
Stephen: Moving to slide 23, last week at the European Hidradenitis Suppurativa Foundation Conference, we presented additional data from the open label extension of the phase II study of [inaudible] in HS. As a reminder, [inaudible] demonstrated dose dependent efficacy in patients with HS during the initial placebo controlled period at week 16. The data presented demonstrate that treatment with [inaudible] through week 52 resulted in a decrease in disease severity as classified by the international HS severity scoring system or IHS4. At week 52, the significant decrease in disease severity was observed with approximately 25% of patients achieving an IHS4 score of zero, which represents the complete resolution of abscess, nodule, and draining tunnels.
Stephen: Last week at the European here, not a Super Tivo Foundation Conference, we presented additional data from the open label extension of the Phase II study of <unk> in Hs. As a reminder, <unk> demonstrated dose dependent efficacy in patients with Hs during the initial placebo controlled period at week 16.
Stephen: As a reminder, <unk> demonstrated dose dependent efficacy in patients with Hs during the initial placebo controlled period at week 16.
Stephen: The data presented demonstrate that treatment with <unk> through week 52 resulted in a decrease in disease severity as classified by the international Hs severity scoring system. As for at week 52, the significant decrease in disease severity was observed with approximately 25% of patients achieving an IHS four score of zero, which represents the complete resolution of abscess nodule and draining tunnels.
Stephen: As for at week 52, the significant decrease in disease severity was observed with approximately 25% of patients achieving an IHS four score of zero, which represents the complete resolution of abscess nodule and draining tunnels.
Stephen: On slide 24, an additional analysis was maintenance response, which demonstrates that [inaudible] treated patients who achieved a response at week 16 were likely to maintain [inaudible] response through week 52. Both of these datasets build upon [inaudible] potential as a best-in-disease medicine for patients suffering from HS. As a reminder, two phase III studies evaluating [inaudible] in HS stop HS one and stop HS two are ongoing and enrolling very well.
Stephen: Both of these datasets build upon <unk> potential as a best in disease medicine for patients suffering from Hs. As a reminder, two phase III studies evaluating <unk> certainly been Hs stop Hs, one and stop ages, two are ongoing and enrolling very well.
Stephen: As a reminder, two phase III studies evaluating <unk> certainly been Hs stop Hs, one and stop ages, two are ongoing and enrolling very well.
Stephen: Our high potential oncology pipeline is currently focused on three advanced programs. The first is [inaudible], which is currently being evaluated in two phase III studies in patients with follicular and marginal zone lymphoma and in patients with previously untreated diffuse large b cell lymphoma. We're expecting phase III results from follicular and marginal zone lymphoma or the in line study in the second half of this year with the first line diffuse large B cell lymphoma frontline study readout in 2025.
Zone lymphoma or the in months study in the second half of this year with the first line diffuse large b cell lymphoma, a frontline study readout in 2025.
Stephen: The second is our small molecule oral PDL1 program. We have multiple ongoing studies as monotherapy or in combination with other agents such as [inaudible] and we expect to have combination data later this calendar year. And the third program is a small molecule CDK-2 inhibitor, where we recently announced early signs of clinical activity with multiple patients demonstrating partial responses. We expect to share data as well as the development plan later this calendar year.
Stephen: And the third program is a small molecule CDK <unk> inhibitor, where we recently announced early signs of clinical activity with multiple patients demonstrating partial responses, we expect to share data as well as the development plan later this calendar year.
Stephen: On slide 26, we recently announced that INCB 161734, a potent selective and orally available [inaudible] inhibitor recently entered the clinic in a phase one study. This program has shown encouraging preclinical antitumor activity in xenograft models with no currently approved G12B targeting agents could address a high unmet need. As a reminder, the KRSG12 mutation is found in approximately 40% of pancreatic ductal adenocarcinoma, 15% of colorectal cancer, and 5% of non small cell lung cancer and could thus represent a significant opportunity for Incyte if successful.
Stephen: This program has shown encouraging preclinical antitumor activity in xenograft models with no currently approved <unk> targeting agents could address a high unmet need as a reminder, the kers G. <unk> mutation is found in approximately 40% of pancreatic ductal adenocarcinoma, 15% of <unk>. Colorectal cancer, and 5% of non small cell lung cancer and could thus represent a significant opportunity for <unk> if successful.
Stephen: Colorectal cancer, and 5% of non small cell lung cancer and could thus represent a significant opportunity for <unk> if successful.
Stephen: In summary, we anticipate a number of upcoming pipeline updates in 2024, including sharing top line results from both the phase II studies in [inaudible] cream in HS and [inaudible] at a medical conference in the first half of this year. The second half of the year is looking to be a catalyst rich period as highlighted on slide 20 that we anticipate includes but is not limited to an approval with [inaudible] phase III results from [inaudible] and the initiation of a number of phase III studies, including with our bet inhibitor. With that, I would like to turn the call over to Christiana for the financial update.
Stephen: Second half of the year is looking to be catalyst rich period as highlighted on slide 20 that we anticipate. Includes but is not limited to an approval with the <unk> phase III results from <unk> and the initiation of a number of phase III studies, including without bet inhibitor with that I would like to turn the call over to Christiana for the financial update.
Stephen: Includes but is not limited to an approval with the <unk> phase III results from <unk> and the initiation of a number of phase III studies, including without bet inhibitor with that I would like to turn the call over to Christiana for the financial update.
Christiana Stamoulis: Thank you Steven and good morning everyone. 2023 was another year of strong financial performance with total product revenues of $862 million for the fourth quarter of the year and $3.2 billion for the full year, representing a 13 and 15% year over year increase respectively. Total royalty revenues, which are primarily comprised of royalties from Novartis for JAKAFI and [inaudible] and royalties from Lilly for [inaudible] were $150 million in the fourth quarter and $523 million for the full year, up 13 and 8% respectively compared to 2022. Total revenues grew 9% in the fourth quarter compared to the prior year period, reaching the $1 billion mark, an important milestone for Incyte. For the full year, total revenues were $3.7 billion.
Christiana: 2023 it was another year of strong financial performance with total product revenues of $862 million for the fourth quarter of the year and $3 $2 billion for the full year, representing a 13 and 15% year over year increase respectively. Total royalty revenues, which are primarily comprised of royalties from novartis for Jack IV antibiotic that and royalties from Lilly photo lumina $150 million in the fourth quarter and $523 million for the full year up.
Christiana: Total royalty revenues, which are primarily comprised of royalties from novartis for Jack IV antibiotic that and royalties from Lilly photo lumina $150 million in the fourth quarter and $523 million for the full year up.
Christiana: 13, and 8% respectively compared to 2022. Total revenues grew 9% in the fourth quarter compared to the prior year period, reaching the $1 billion. Mark an important milestone for insight. For the full year total revenues were $3 7 billion.
Christiana: Total revenues grew 9% in the fourth quarter compared to the prior year period, reaching the $1 billion. Mark an important milestone for insight. For the full year total revenues were $3 7 billion.
Christiana: Mark an important milestone for insight. For the full year total revenues were $3 7 billion.
Christiana: For the full year total revenues were $3 7 billion.
Christiana: Turning to JAKAFI on slide 30, JAKAFI net product revenues were $695 million for the fourth quarter and $2.6 billion for the full year 2023. In 2023, JAKAFI net sales grew 8% compared to the prior year. JAKAFI sales were negatively impacted by a significant increase in free drug in the fourth quarter of the year driven by an increase in the number of patients seeking support from Incyte's patient assistance program. The impact of the increase in [inaudible] was more than offset by an increase in channel inventory levels. This increase was in anticipation of patients moving into paid demand starting in Q1 of 2024. The increase in Q4 channel inventory levels represented $46 million in sales.
Christiana: In 2023, Jakafi net sales grew 8% compared to the prior year. Jakafi sales were negatively impacted by a significant increase in free drag in the fourth quarter of the year driven by an increase in the number of patients seeking support from insight patient assistance program. The impact of the increase in <unk> was more than offset by an increase in channel inventory levels. This increase was in anticipation of patients moving into paid demand starting in Q1 of 2024. The increase in Q4 channel inventory levels represented $46 million insane.
Christiana: Jakafi sales were negatively impacted by a significant increase in free drag in the fourth quarter of the year driven by an increase in the number of patients seeking support from insight patient assistance program. The impact of the increase in <unk> was more than offset by an increase in channel inventory levels. This increase was in anticipation of patients moving into paid demand starting in Q1 of 2024. The increase in Q4 channel inventory levels represented $46 million insane.
Christiana: The impact of the increase in <unk> was more than offset by an increase in channel inventory levels. This increase was in anticipation of patients moving into paid demand starting in Q1 of 2024. The increase in Q4 channel inventory levels represented $46 million insane.
Christiana: This increase was in anticipation of patients moving into paid demand starting in Q1 of 2024. The increase in Q4 channel inventory levels represented $46 million insane.
Christiana: The increase in Q4 channel inventory levels represented $46 million insane.
Christiana: Turning now to our OPZELURA, net product revenues for the fourth quarter were $109 million, representing a 78% increase year over year, driven primarily by increased patient demand. For the full year, total OPZELURA net product revenues were $338 million, representing a 162% increase compared to the prior year.
Christiana: For the full year <unk> net product revenues were $338 million, representing a 162% increase compared to the prior year.
Christiana: Moving on to slide 32 and our operating expenses on a GAAP basis, total R&D expenses were $444 million for the quarter, representing an 11% year over year decrease which was primarily as a result of the $70 million upfront payment made as part of the [inaudible] acquisition in Q4, 2022, and partially offset by the $20 million development milestone payments to former [inaudible] shareholders in the fourth quarter of 2023. For the full year 2023, total R&D expenses were $1.6 billion, representing a 3% year over year increase. This increase was primarily due to the progression of our pipeline and was mainly offset by lower upfront and milestone expenses in '23.
Moving on to slide 32 and our operating expenses on a GAAP basis, total R&D expenses were $444 million for the quarter, representing an 11% year over year decrease which was primarily as a result of the $70 million upfront payment made as part of the [inaudible] acquisition in Q4, 2022, and partially offset by the $20 million development milestone payments to former [inaudible] shareholders in the fourth quarter of 2023.
Christiana: In Q4, 2022, and partially offset by the 20. $20 million development milestone payments to former <unk> shareholders in the fourth quarter of 2023. For the full year 2023, total R&D expenses were $1 $6 billion, representing a 3% year over year increase. This increase was primarily due to the progression of our pipeline. It was mainly offset by lower upfront and milestone expenses in 'twenty three. Yeah.
Christiana: $20 million development milestone payments to former <unk> shareholders in the fourth quarter of 2023. For the full year 2023, total R&D expenses were $1 $6 billion, representing a 3% year over year increase. This increase was primarily due to the progression of our pipeline. It was mainly offset by lower upfront and milestone expenses in 'twenty three. Yeah.
Christiana: For the full year 2023, total R&D expenses were $1 $6 billion, representing a 3% year over year increase. This increase was primarily due to the progression of our pipeline. It was mainly offset by lower upfront and milestone expenses in 'twenty three. Yeah.
For the full year 2023, total R&D expenses were $1.6 billion, representing a 3% year over year increase. This increase was primarily due to the progression of our pipeline and was mainly offset by lower upfront and milestone expenses in '23.
Christiana: This increase was primarily due to the progression of our pipeline. It was mainly offset by lower upfront and milestone expenses in 'twenty three. Yeah.
Christiana: Yeah.
Christiana: Total SG&A expenses were $294 million for the fourth quarter, and $1.16 billion for the year. The year over year increase of 8% for the fourth quarter and 16% for the full year were mainly due to increased sales and marketing activities for OPZELURA in both the US and Europe, unfavorable effects and timing of certain G&A related expenses.
Christiana: The year over year increase of 8% for the fourth quarter and 16% for the full year were mainly due to increased sales and marketing activities for <unk> in both the U S and Europe unfavorable effects and timing of certain G&A related expenses.
Speaker Change: Moving onto 2024, I will now discuss the key components of our guidance on a GAAP basis, which includes revenues and expenses related to the recent acquisition of the exclusive global rights to [inaudible] but excludes any potential impact related to the accounting treatment of the $25 million purchase price paid.
Speaker Change: $5 million purchase price paid.
Speaker Change: For JAKAFI, we expect net product revenues to be in the range of $2.69 to $2.75 billion, on track to achieve our long term guidance of over $3 billion in net product revenues by 2028. We expect net product revenue growth to be driven exclusively by continued demand growth and be partially offset by lower net pricing as a result of IRA post price increase caps and continued growth in [inaudible] volumes.
Speaker Change: We expect net product revenue growth to be driven exclusively by continued demand growth and be partially offset by lower net pricing as a result of Iranian post price increase caps and continued growth in 340 <unk> volumes.
Speaker Change: As in previous years, we expect the gross to net adjustment to be higher in the first quarter of the year relative to the previous quarter and subsequent quarters due to the higher deductibles and our share of the donut hole for Medicare part D patients, which are primarily impacting the first quarter of the year.
While for OPZELURA we will not be providing full year guidance at this point, in the first quarter, we expect to see again the effect of typical Q1 dynamics of net sales, including higher patient out of pocket costs due to the plan deductibles resetting at the beginning of the year and the impact of holidays, medical conferences and other events on dermatology product sale. As a result, Q1 OPZELURA net product revenues are expected to be below the previous quarters and subsequent quarters and represent a smaller share of the full year net product revenues, consistent with what we saw in 2023. For other [inaudible] oncology products, which now include [inaudible], we expect total net product revenues to be in the range of $325 million to $360 million, which at the midpoint represents approximately 47% growth over '23.
Speaker Change: Plan deductibles resetting at the beginning of the year and the impact of holidays medical conferences and other events on dermatology product sale. As a result, Q1 absolute net product revenues are expected to be below the previous core tenants of the subsequent quarters and represent a smaller share of the full year net product revenues.
Speaker Change: As a result, Q1 absolute net product revenues are expected to be below the previous core tenants of the subsequent quarters and represent a smaller share of the full year net product revenues.
With what we saw in 2023.
Speaker Change: So rather than metallurgy oncology products, which now include.
Speaker Change: He iclusig atmosphere, one jewelry and MS. Julie we expect total net product revenues to be in the range of $325 million to $360 million, which at the midpoint represents approximately 47% silver 23.
Speaker Change: Turning to operating expenses on a GAAP basis, we expect Cogs to range from 7% to 8% of net product revenues, which is in line with 2023. R&D expense is expected to be in the range of $1.72 to $1.76 million, representing 7% growth at the midpoint versus 2023, primarily driven by the progression of our pipeline. We expect SG&A expense for the year to be in the range of $1.21 to $1.24 billion, representing 6% year over year growth at the midpoint, primarily driven by the inclusion of sales and marketing expenses associated with [inaudible] in the US under SG&A, whereas prior to the acquisition of full product rights they were included under the collaboration profit or loss share.
Speaker Change: With 2023. <unk> expense is expected to be in the range of $1 70 to $1 $76 million. Representing 7% growth at the midpoint versus 2023, primarily driven by the progression of our pipeline. We expect SG&A expense for the year to be in the range of one point to one to $1 billion to $4 billion, representing 6% year over year growth at the midpoint, primarily driven by the inclusion of sales and marketing expenses associated with one jewelry in the U S and the rest G&A, whereas prior.
Speaker Change: <unk> expense is expected to be in the range of $1 70 to $1 $76 million. Representing 7% growth at the midpoint versus 2023, primarily driven by the progression of our pipeline. We expect SG&A expense for the year to be in the range of one point to one to $1 billion to $4 billion, representing 6% year over year growth at the midpoint, primarily driven by the inclusion of sales and marketing expenses associated with one jewelry in the U S and the rest G&A, whereas prior.
Speaker Change: Representing 7% growth at the midpoint versus 2023, primarily driven by the progression of our pipeline. We expect SG&A expense for the year to be in the range of one point to one to $1 billion to $4 billion, representing 6% year over year growth at the midpoint, primarily driven by the inclusion of sales and marketing expenses associated with one jewelry in the U S and the rest G&A, whereas prior.
Speaker Change: We expect SG&A expense for the year to be in the range of one point to one to $1 billion to $4 billion, representing 6% year over year growth at the midpoint, primarily driven by the inclusion of sales and marketing expenses associated with one jewelry in the U S and the rest G&A, whereas prior.
Speaker Change: To the acquisition of full product right. They were included under the collaboration profit or loss share.
Speaker Change: 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'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. You may press star two if you'd like to move your question from the queue. As a reminder, we ask you please ask one question and one follow up then return to the queue. Our first question is coming from [inaudible] from Truist Securities. Your line is now live.
<unk> <unk>: And to the queue. Our first question is coming from <unk> <unk> from <unk> Securities. Your line is now live.
Unknown: Hey guys, thank you so much for taking my question. On JAKAFI myelofibrosis thank you so much for providing the market share details in all patients and new patients. I guess when do you anticipate stabilization of JAKAFI shares at these levels and if collaborative work can be approved in combination with [inaudible] assuming it happens sometime next year should we expect to see an inflection point? Thank you.
unknown: On Jakafi myelofibrosis. Thank you so much. The market share details in all patients in the Sham patients I guess when do you anticipate stabilization at these levels. And. Collaborative work can be approved in combination with rock. It happens sometime next year should we expect to see an inflection point.
<unk> <unk>: The market share details in all patients in the Sham patients I guess when do you anticipate stabilization at these levels. And. Collaborative work can be approved in combination with rock. It happens sometime next year should we expect to see an inflection point.
<unk> <unk>: And. Collaborative work can be approved in combination with rock. It happens sometime next year should we expect to see an inflection point.
<unk> <unk>: Collaborative work can be approved in combination with rock. It happens sometime next year should we expect to see an inflection point.
<unk> <unk>: It happens sometime next year should we expect to see an inflection point.
Barry P. Flannelly: So stabilization of market share in myelofibrosis, so JAKAFI as you know is the leader in myelofibrosis because of its safety, efficacy, overall survival and really tolerability, which is really a big advantage. We think that myelofibrosis will continue to be the largest proportion of our patient share until polycythemia vera patients ultimately take over because as you know those patients stay on for a long period of time.
Speaker Change: So stabilization of. Our market share in myelofibrosis so. Jakafi as you know is the leader in myelofibrosis because of its safety efficacy overall survival and really Tolerability, which is really. A big advantage. We think that myelofibrosis will continue to be titled largest proportion of our of our patient share until polycythemia Vera patients ultimately take over because as you know those patients stay on for a long period of time.
Speaker Change: Our market share in myelofibrosis so. Jakafi as you know is the leader in myelofibrosis because of its safety efficacy overall survival and really Tolerability, which is really. A big advantage. We think that myelofibrosis will continue to be titled largest proportion of our of our patient share until polycythemia Vera patients ultimately take over because as you know those patients stay on for a long period of time.
Speaker Change: Jakafi as you know is the leader in myelofibrosis because of its safety efficacy overall survival and really Tolerability, which is really. A big advantage. We think that myelofibrosis will continue to be titled largest proportion of our of our patient share until polycythemia Vera patients ultimately take over because as you know those patients stay on for a long period of time.
Speaker Change: A big advantage. We think that myelofibrosis will continue to be titled largest proportion of our of our patient share until polycythemia Vera patients ultimately take over because as you know those patients stay on for a long period of time.
Speaker Change: We think that myelofibrosis will continue to be titled largest proportion of our of our patient share until polycythemia Vera patients ultimately take over because as you know those patients stay on for a long period of time.
Speaker Change: Your question around [inaudible], if and when it gets approved in combination with JAKAFI of course, that's a good thing for us if in fact the profile of the drug as it appears or the combinations as it appears then many physicians may choose to use that combination and JAKAFI will only benefit, but we have to wait and see what happens with the approval process.
Speaker Change: The profile of the drug is as it appears are the combinations as it appears that many physicians may choose to use that combination. And of Jakafi will only benefit, but we have to wait and see. You know what happens with the approval process.
Speaker Change: And of Jakafi will only benefit, but we have to wait and see. You know what happens with the approval process.
Speaker Change: You know what happens with the approval process.
Unknown: Great. Thank you so much.
Operator: Thank you. Next question is coming from Andrew Berens from Leerink. Your line is now live.
Speaker Change: Thank you next question is coming from Andrew Berens from Leerink. Your line is that right.
Andrew Berens: Alright. I'm wondering if you guys could expand upon the development of JAKAFI XR in light of the recently announced spin off by Novartis for liver cirrhosis. Does Novartis' control of JAKAFI outside the US impact how you're thinking about developing your bet inhibitor? Do they have any direction or [inaudible] the directions of the XR version of JAKAFI? And then also I'm wondering if you think that an add on drug to JAKAFI that still require dramatic improvement as an endpoint for regulatory enforcement or do you think this has been a material change in [inaudible]?
Andrew Berens: I'm wondering if you guys could expand upon the development of Jakafi XR in light of the recently announced spin off. By Novartis liver cirrhosis, whose novartis has control of jakafi outside the U S impact how youre thinking about developing your bet inhibitor do they have any direction or saying they are the directions of the XR version of Jakafi and then also I'm wondering if you think that. Add on drug of Jakafi that balances still require dramatic improvement as an endpoint for regulatory enforcement or do you think this has been a material change in thinking that the agency.
Andrew Berens: By Novartis liver cirrhosis, whose novartis has control of jakafi outside the U S impact how youre thinking about developing your bet inhibitor do they have any direction or saying they are the directions of the XR version of Jakafi and then also I'm wondering if you think that.
Add on drug of Jakafi that balances still require dramatic improvement as an endpoint for regulatory enforcement or do you think this has been a material change in thinking that the agency.
Hervé Hoppenot: So let me take the piece about our agreement with Novartis on JAKAFI and Steven can speak about the development of XR. So the agreement is such that both parties can be co developing new formulations of [inaudible] in oncology, including the once a day. It has not been the case yet, but there is still an optionality from Novartis to co-develop XR if they wish and that would mean that they would be able to commercialize the XR formulation outside of the US, but not in the US, where obviously it would be commercialized by Incyte.
Andrew Berens: Our agreement with Novartis. So I guess I am Steven can speak about the development of XL. So the agreement is such that both parties can be. Uh huh. Co developing it. New formulations of <unk> in the oncology, including the once a day. It hasn't been the case, yet, but there is still a priority from novartis to <unk>.
Andrew Berens: So I guess I am Steven can speak about the development of XL. So the agreement is such that both parties can be. Uh huh. Co developing it. New formulations of <unk> in the oncology, including the once a day. It hasn't been the case, yet, but there is still a priority from novartis to <unk>.
Speaker Change: Uh huh. Co developing it. New formulations of <unk> in the oncology, including the once a day. It hasn't been the case, yet, but there is still a priority from novartis to <unk>.
Steven: Co developing it. New formulations of <unk> in the oncology, including the once a day. It hasn't been the case, yet, but there is still a priority from novartis to <unk>.
Steven: New formulations of <unk> in the oncology, including the once a day. It hasn't been the case, yet, but there is still a priority from novartis to <unk>.
Steven: It hasn't been the case, yet, but there is still a priority from novartis to <unk>.
Steven: Could develop extra if they wish and that would mean that they would be able to commercialize the XR formulation outside of the U S, but not in the U S, where obviously it would be commercialized by insight.
Steven H. Stein: And then Andy I'll take the other part of your question. So for [inaudible] XR as Pablo communicated at the ASH Investor event, we have now clear feedback from the FDA that we need to do a new formulation strength, which are already developed which are slightly higher and then demonstrate the EVA with those primarily around [inaudible] and AUC. That's the clear guidance from the FDA and we estimate this should be completed in a two year process, so well before the LOE. It doesn't affect our development of FTC's fixed dose combinations with any of our products so that continues.
Andy: Pablo communicated at the Ash Investor event, we have now clear feedback from the FDA that we need to do a.
Andy: New formulation strength.
Andy: Which are already developed which are slightly higher and then demonstrate the EPA with those primarily around cement and AUC. That's the clear guidance from the FDA and we estimate this should be completed in the two year process, so well before the low it.
Andy: It doesn't affect our development of FTC's fixed dose combinations with any of our products. So that continues.
Andy: For our bet inhibitor again, we showed data at ASH and alluded in my prepared remarks, we have clearly an active compound showing very good rates of spleen reduction both volume and length, very good symptom improvement and occasional hemoglobin increases just like we've seen with the other bet inhibitor. We have been operating like other companies under the assumption that at least in first line you need SCR thirty-five and symptoms to date to get approvals. I can't comment on where they are in their regulatory process or how the FDA may change in that regard, but that has been the standard to date.
Andy: <unk> like other companies under the assumption that at least in first line you need SCR thirty-five and symptoms to. To date to get approvals I can't comment on where they are in their regulatory process or how the FDA may change in that regard, but that has been the standard to date. <unk>.
Andy: To date to get approvals I can't comment on where they are in their regulatory process or how the FDA may change in that regard, but that has been the standard to date. <unk>.
<unk>.
Andrew Berens: Thank you very much.
Operator: Thank you. Our next question today is coming from Michael Schmidt from Guggenheim. Your line is now live.
Michael Schmidt: Hey, guys, thanks for taking my questions. I had one on [inaudible] as we think about the opportunity for this drug in multiple indications, I believe the HS Phase III trial is most advanced. Could you talk a bit about your expectations on how the drug may be positioned relative to some of the biologics in HS, humira or some of the IL-17 antibodies? And then also in PN where you had the positive topline data last year, [inaudible] is obviously approved here, again, could you talk a bit about how the drug might be fitting into that treatment paradigm relative to [inaudible]? Thanks so much.
Michael Schmidt: So as we think about the opportunity for this drug in multiple indications I believe the the H S Phase III trial is most advanced.
Michael Schmidt: Could you talk a bit about your expectations on how the drug may be position relative to some of the biologics and in H S. B, you know humira or some of the IL 17 antibodies. And then also in Pn, where you had the positive topline data allows us. <unk>, obviously approved here you know again could you talk a bit about how the drug might be fitting into that treatment paradigm relative to do connections. Thanks. So much.
Michael Schmidt: And then also in Pn, where you had the positive topline data allows us. <unk>, obviously approved here you know again could you talk a bit about how the drug might be fitting into that treatment paradigm relative to do connections. Thanks. So much.
Michael Schmidt: <unk>, obviously approved here you know again could you talk a bit about how the drug might be fitting into that treatment paradigm relative to do connections. Thanks. So much.
Steven H. Stein: Michael, hi, it's Steven. I'll start with your question. Thank you for the question. So [inaudible] in HS, we think we have outstanding efficacy data, which we've now updated with a 52-week data that shows prolonged effect that's maintained. And so remember this is a JAK-1 specific agent, about 50 folks selective for JAK-1 has a long half life and a very high volume of distribution, which may translate to more penetration in the skin, which is why we're seeing this degree of efficacy showing to date.
Steven: Prolonged effect that's maintained. And so remember this is a JAK one specific agent about 50 fold selective for JAK, one has a long half life and a very high volume of distribution, which may translate to more penetration in the skin, which is why are we seeing this degree of efficacy show in to date.
Steven: And so remember this is a JAK one specific agent about 50 fold selective for JAK, one has a long half life and a very high volume of distribution, which may translate to more penetration in the skin, which is why are we seeing this degree of efficacy show in to date.
Steven: Both phase III stop HS one and HS two are enrolling very, very well so it probably speaks to some of the belief out there in the agent and that is clearly our lead indication as you alluded to. It's hard to always cross compare with many caveats to other other studies where drugs aren't directly compared and you spoke about the IL seventeens here in the biologics. And clearly there's some variable activity there. You have to look at placebo corrected rates, but I think ours tackles multiple aspects of the disease pathophysiology, not just one interleukin and as I said, the drug profile with a long half life and high volume of distribution may lend itself to increase efficacy. Obviously time will tell with the phase III data. It'll be a once daily oral tablet which offers that sort of convenience.
The IL seventeens here in the biologics. And clearly there's some variable activity. There you have to look at placebo corrected rates, but I think you know ask tackles multiple aspects of the disease pathophysiology, not just one interleukin and as I said, the drug profile with a long half life and high volume of distribution may lend itself to increase efficacy, obviously time will tell with.
Steven: And clearly there's some variable activity. There you have to look at placebo corrected rates, but I think you know ask tackles multiple aspects of the disease pathophysiology, not just one interleukin and as I said, the drug profile with a long half life and high volume of distribution may lend itself to increase efficacy, obviously time will tell with.
Steven: the phase III data. It'll be a once daily oral tablet which offers that sort of convenience. In PN, what patients suffer from primarily is intense itching and again, our phase II proof of concept data is very strong in terms of the itch relief here and the ability to eliminate that symptom pretty quickly as well as over time disease resolution in the actual skin manifestations. There is, as you alluded to an approved agent in DUPIXENT but that has provided us the regulatory pathway on the way to go in terms of itch resolution and skin change resolution. And again, we'll offer the once daily oral convenience. We think we'll have a really good agents in terms of high efficacy there, so we're excited about this program as well. Thanks.
the phase III data. It'll be a once daily oral tablet which offers that sort of convenience.
Steven: Which offers that sort of convenience. In Pn. But patients suffer from primarily is intense itching and again you know our phase II proof of concept data is very strong in terms of the itch relief here and there and the ability to eliminate that symptom pretty quickly as well as over time. <unk> disease resolution in the actual skin manifestations there is as you allude to. Proved agent into pixel, but that has provided us the regulatory pathway on the way to go in terms of each resolution and skin change resolution and again, we'll offer the once daily oral convenience. We think we'll have a really good agents in terms of high high efficacy there so. Excited about this program as well thanks.
In PN, what patients suffer from primarily is intense itching and again, our phase II proof of concept data is very strong in terms of the itch relief here and the ability to eliminate that symptom pretty quickly as well as over time disease resolution in the actual skin manifestations. There is, as you alluded to an approved agent in DUPIXENT but that has provided us the regulatory pathway on the way to go in terms of itch resolution and skin change resolution. And again, we'll offer the once daily oral convenience. We think we'll have a really good agents in terms of high efficacy there, so we're excited about this program as well. Thanks.
Steven: In Pn. But patients suffer from primarily is intense itching and again you know our phase II proof of concept data is very strong in terms of the itch relief here and there and the ability to eliminate that symptom pretty quickly as well as over time. <unk> disease resolution in the actual skin manifestations there is as you allude to. Proved agent into pixel, but that has provided us the regulatory pathway on the way to go in terms of each resolution and skin change resolution and again, we'll offer the once daily oral convenience. We think we'll have a really good agents in terms of high high efficacy there so. Excited about this program as well thanks.
Steven: But patients suffer from primarily is intense itching and again you know our phase II proof of concept data is very strong in terms of the itch relief here and there and the ability to eliminate that symptom pretty quickly as well as over time. <unk> disease resolution in the actual skin manifestations there is as you allude to. Proved agent into pixel, but that has provided us the regulatory pathway on the way to go in terms of each resolution and skin change resolution and again, we'll offer the once daily oral convenience. We think we'll have a really good agents in terms of high high efficacy there so. Excited about this program as well thanks.
Steven: <unk> disease resolution in the actual skin manifestations there is as you allude to. Proved agent into pixel, but that has provided us the regulatory pathway on the way to go in terms of each resolution and skin change resolution and again, we'll offer the once daily oral convenience. We think we'll have a really good agents in terms of high high efficacy there so. Excited about this program as well thanks.
Steven: Proved agent into pixel, but that has provided us the regulatory pathway on the way to go in terms of each resolution and skin change resolution and again, we'll offer the once daily oral convenience. We think we'll have a really good agents in terms of high high efficacy there so. Excited about this program as well thanks.
Excited about this program as well thanks.
Operator: Thank you. Your next question today is coming from [inaudible] from Morgan Stanley. Your line is now live.
Unknown: Hi, good morning. Thanks for taking our questions. We have two on the pipeline. So first for the [inaudible] two program, you've guided to POC data by mid '24, we were just wondering what we can expect to learn with this update and what you will be reviewing specifically to decide what the next step of development could be for this program. And then secondly for the [inaudible] antibody, when can you expect to see initial phase one data there and what are you hoping to establish to get conviction that the program is headed in the right direction? Thank you.
Morgan Stanley: So first for the <unk> two program you've guided to POC data by mid 'twenty. Four we were just wondering what we can expect to learn with this update and what you will be reviewing specifically to decide what. What the next step of development could be for this program and then secondly exclude the teller antibody. Can you expect to see initial phase one data there and what are you hoping to establish to get conviction that the program is headed in the right direction. Thank you.
Morgan Stanley: What the next step of development could be for this program and then secondly exclude the teller antibody. Can you expect to see initial phase one data there and what are you hoping to establish to get conviction that the program is headed in the right direction. Thank you.
Morgan Stanley: Can you expect to see initial phase one data there and what are you hoping to establish to get conviction that the program is headed in the right direction. Thank you.
Pablo J. Cagnoni: Yes, thank you for the question. This is Pablo. So for the [inaudible] inhibitor program, what we're in the process of doing and what we need to establish is efficacy in a larger number of patients with newly diagnosed MF in combination with [inaudible] and that's what the team is focused on right now and as we mentioned at ASH last December. So we're continuing to push the dose, we need to get to doses of around 400 to 600 mg a day in order to get to maximum effect on [inaudible] 2, we need a longer duration of therapy in a larger group of patients in combination with rux. So that will happen over the course of the year. We haven't provided a specific timeline for when we're going to disclose the data, but as we mentioned at ASH last year, it would happen this year and we'll provide clarity on what the next steps for that program are.
Pablo: What we're in the process of doing and when interest Stablish is efficacy and a larger number of patients with newly diagnosed have mass in combination with <unk> and that's what the team is focused on right now and as we mentioned at Ash last December so we're continuing to push the dose we need to get to doses of a round four to 600 Meg.
Pablo: Times of day in order to get to maximum effect on Hep sighting to we need a longer duration of therapy in a larger group of patients in combination with rux. So that will happen over the course of the year. We haven't provided a specific timeline for when we're going to disclose the data, but as we mentioned at ash last year. It would happen this year.
Pablo: On the second question for the [inaudible] antibody program, we started dose escalation very recently as you know. That study is accruing very well. The initial our goals like for any first in human study are obviously to establish that the [inaudible] antibody is safe. We've got a good view of the pharmacokinetics in this first in human study and establish initial evidence of efficacy, which in this case will be by traditional endpoints in MPNs and also potentially a view on the [inaudible] monoclonal antibody [inaudible] real burden in some of those patients. That will happen over the course of the year. We haven't decided yet when we're gonna present data whether it's this year, whether at some point in 2025.
Pablo: The second question for them you didn't call our antibody program, we started dose escalation very recently as you know that. That that studies accruing very well the initial our goals like for any first in human study, obviously to establish that the smartwatch everybody's safe.
Pablo: That that studies accruing very well the initial our goals like for any first in human study, obviously to establish that the smartwatch everybody's safe.
Pablo: Got a good view of the pharmacokinetics in this first in human study and establish initial evidence of efficacy, which in this case will be by traditional endpoints in mpls and also potentially have you.
Pablo: You on their factor amusement Kellogg monoclonal antibody when a real burden and some of those patients that will happen over the course of the year, we haven't decided yet when we're gonna percent data whether it's this year, where they are at some point in 2025.
Pablo: Okay.
Unknown: Got it. Thank you.
Operator: Thank you. Next question is coming from Salveen Richter from Goldman Sachs. Your line is now live.
Unknown: Good morning. This is [inaudible] on for Salveen, thank you for taking our question. We had one question on OPZLURA. Outside of the 1Q dynamics that you spoke to, can you help us understand the forward launch trajectory in AVM vitiligo in the context of reimbursement and access and also gross to net in order to be fully able to capture the opportunity as you have additional indications coming in the coming years? Thank you.
Salveen Richter: We had one question on op similar outside of the one <unk> dynamics that you spoke to can you help us understand the forward launch trajectory and Atms that are like all in the context of reimbursement and access and also gross to net in order to be fully able to capture the opportunity as you have additional indications coming in.
Speaker Change: Thank you.
Barry P. Flannelly: Yeah, thanks for the question. So of course as far as launch trajectory, we're continuing to launch very well in both AD and vitiligo. We continue to expect growth in vitiligo just based upon our educational efforts directed both as patients and health care professionals. We know that the profile in AD in terms of its relief and clearance of the skin is unmatched for any topical therapy. We even believe that in AD for example, the profile is so good that as far as payers are concerned they are interested in the fact that more than 80% of the patients will be clear and have their itch relieved and can delay or not even go on to a biologic. So we think those dynamics are good for both AD and vitiligo going forward and we're looking forward to future growth. I'll turn the call over to Christiana to talk about gross to net.
Speaker Change: Expected growth in vitiligo, just based upon our educational efforts directed both types of patients and health care professionals are we know that the profile and a D. In terms of its relief and and clearance of the skin is unmatched for any therapy topical therapy, we even believe that.
Speaker Change: And a D. For example, the profile is so good that as far as payers are concerned. You know they are they are interested in the fact that more than 80% of the patients will be clear and have their itch relieved and.
Speaker Change: You know they are they are interested in the fact that more than 80% of the patients will be clear and have their itch relieved and.
Can delay or not even go on to a biologic so we. We think those dynamics are good for both <unk> and <unk> and vitiligo going forward and we can yeah. We're looking forward to future growth I'll turn the call over to Chris. Christianity to talk about gross to net.
We think those dynamics are good for both <unk> and <unk> and vitiligo going forward and we can yeah. We're looking forward to future growth I'll turn the call over to Chris. Christianity to talk about gross to net.
Chris: Christianity to talk about gross to net.
Christiana Stamoulis: So in terms of our gross to net, first of all, when you look at 2023, the average gross to net was around 55%. Our goal is to maximize the value of OPZELURA and maximize net sales. If going forward we make the decision to provide any additional discounts, it would be because we expect that these will improve access and will have a disproportionate impact on volume and that lead to higher net sales. As such, our comments they are going to be focused on net sales versus gross to net in isolation.
Chris: 2023, the average gross to net was around 55%. Our goal is to maximize the value of our <unk> and maximize net say. If going forward we make. Decision to provide any additional discounts it would be because we expect that these will improve access and that will have a disproportionate impact on volume and that lead to higher net sales. As such our comments they are going to be focused on net sales versus gross to net in isolation. Decision to provide any additional discounts it would be because we expect that these will improve access and that will have a disproportionate impact on volume and that lead to higher net sales. As such our comments they are going to be focused on net sales versus gross to net in isolation.
Chris: Our goal is to maximize the value of our <unk> and maximize net say. If going forward we make. Decision to provide any additional discounts it would be because we expect that these will improve access and that will have a disproportionate impact on volume and that lead to higher net sales. As such our comments they are going to be focused on net sales versus gross to net in isolation. Decision to provide any additional discounts it would be because we expect that these will improve access and that will have a disproportionate impact on volume and that lead to higher net sales. As such our comments they are going to be focused on net sales versus gross to net in isolation.
Chris: If going forward we make. Decision to provide any additional discounts it would be because we expect that these will improve access and that will have a disproportionate impact on volume and that lead to higher net sales. As such our comments they are going to be focused on net sales versus gross to net in isolation. Decision to provide any additional discounts it would be because we expect that these will improve access and that will have a disproportionate impact on volume and that lead to higher net sales. As such our comments they are going to be focused on net sales versus gross to net in isolation.
Chris: Decision to provide any additional discounts it would be because we expect that these will improve access and that will have a disproportionate impact on volume and that lead to higher net sales. As such our comments they are going to be focused on net sales versus gross to net in isolation.
Chris: As such our comments they are going to be focused on net sales versus gross to net in isolation.
Unknown: Thank you so much.
Chris: Okay. So much.
Speaker Change: So much.
Operator: Thank you. Your next question is coming from [inaudible] from Wells Fargo. Your line is now live.
Unknown: Hey, good morning, and thanks for taking the questions. Just wanted to piggyback on the last, just in terms of OPZELURA, is there one, any chance we get an update in terms of potential guidance for this year and then will you ever look to kind of breakout both kind of vitiligo and AD kind of scripts or sales if you can figure that out? And then secondly, just on [inaudible] can you quantify maybe the incremental growth opportunities you see for this asset in the follicular and marginal zone lymphoma indications? Thanks. So as far as breaking out AD versus vitiligo, I think we've said before, it's about 60% currently for AD, 40% currently for vitiligo. It could be changing a little bit. Ultimately, we expect vitiligo to perhaps surpass AD. AD patients are many new patients who have come on for atopic dermatitis and in vitiligo, it's about continued use and refills.
Unknown: Hey, good morning, and thanks for taking the questions. Just wanted to piggyback on the last, just in terms of OPZELURA, is there one, any chance we get an update in terms of potential guidance for this year and then will you ever look to kind of breakout both kind of vitiligo and AD kind of scripts or sales if you can figure that out? And then secondly, just on [inaudible] can you quantify maybe the incremental growth opportunities you see for this asset in the follicular and marginal zone lymphoma indications? Thanks.
Speaker Change: Just wanted to piggyback on the last just in terms of obsolete or is there. One you know any chance we get an update in terms of potential guidance for this year and then will you ever looked at kind of breakout. Both kind of is it a lie go and. A D kind of scripts or sales that you can figure that out and then secondly, just on top of it. I guess you know can you quantify maybe the integral incremental growth opportunities you see for this asset in the Follicular and marginal zone lymphoma indications. Thanks.
Speaker Change: Both kind of is it a lie go and. A D kind of scripts or sales that you can figure that out and then secondly, just on top of it. I guess you know can you quantify maybe the integral incremental growth opportunities you see for this asset in the Follicular and marginal zone lymphoma indications. Thanks.
Speaker Change: A D kind of scripts or sales that you can figure that out and then secondly, just on top of it. I guess you know can you quantify maybe the integral incremental growth opportunities you see for this asset in the Follicular and marginal zone lymphoma indications. Thanks.
Speaker Change: I guess you know can you quantify maybe the integral incremental growth opportunities you see for this asset in the Follicular and marginal zone lymphoma indications. Thanks.
Speaker Change: Okay. So. As far as breaking out <unk> versus <unk> I think we've said before. About 60% currently for a D 40% currently for vitiligo. It could be changing a little bit ultimately, we expect that a LIBOR totaling tubes, perhaps. Surpass a D. A D patients are many new patients so he's come on. For atopic dermatitis. And in Vitiligo, it's about continued use.
Speaker Change: So. As far as breaking out <unk> versus <unk> I think we've said before. About 60% currently for a D 40% currently for vitiligo. It could be changing a little bit ultimately, we expect that a LIBOR totaling tubes, perhaps.
Speaker Change: As far as breaking out <unk> versus <unk> I think we've said before. About 60% currently for a D 40% currently for vitiligo. It could be changing a little bit ultimately, we expect that a LIBOR totaling tubes, perhaps.
Steven H. Stein: So as far as breaking out AD versus vitiligo, I think we've said before, it's about 60% currently for AD, 40% currently for vitiligo. It could be changing a little bit. Ultimately, we expect vitiligo to perhaps surpass AD. AD patients are many new patients who have come on for atopic dermatitis and in vitiligo, it's about continued use and refills.
Speaker Change: About 60% currently for a D 40% currently for vitiligo. It could be changing a little bit ultimately, we expect that a LIBOR totaling tubes, perhaps.
Speaker Change: It could be changing a little bit ultimately, we expect that a LIBOR totaling tubes, perhaps.
Speaker Change: Surpass a D. A D patients are many new patients so he's come on. For atopic dermatitis. And in Vitiligo, it's about continued use.
Speaker Change: For atopic dermatitis. And in Vitiligo, it's about continued use.
Speaker Change: And in Vitiligo, it's about continued use.
Speaker Change: And refills.
Speaker Change: As far as [inaudible] goes, obviously, we're looking forward to hopefully positive data in follicular lymphoma, [inaudible] lymphoma and in first line diffuse large B cell lymphoma. So we think there are great opportunities ahead for these two indications. We think it's a great drug for lymphoma. Obviously, it's a crowded marketplace, but we think the profile of the drug and the trials we've put together for those two new indications are going to serve us well in the future. But in terms of calibration of follicular lymphoma we need to see the phase III data. So clearly it's a fairly competitive space. There are a lot of new products so we need to see the phase III data before we can give you a good calibration of that. I mean, the number of patients we are speaking about in the US is around--79,000 patients in first line diffuse large B cell lymphoma. There's about 13,000 patients in second line plus in follicular lymphoma in the United States.
As far as [inaudible] goes, obviously, we're looking forward to hopefully positive data in follicular lymphoma, [inaudible] lymphoma and in first line diffuse large B cell lymphoma. So we think there are great opportunities ahead for these two indications. We think it's a great drug for lymphoma. Obviously, it's a crowded marketplace, but we think the profile of the drug and the trials we've put together for those two new indications are going to serve us well in the future.
Speaker Change: Obviously, we're looking forward to hopefully positive data in Follicular lymphoma indolent lymphoma. And in first line diffuse large. B cell lymphoma. So we think there's great opportunities ahead for these two indications we think it's a great drug for lymphoma, obviously, it's quite. On a crowded marketplace, but we think the profile of the drug and the trials. We've put together for those two new indications are going to serve us well in the future. But in terms of calibration of a pretty. Where do you go up from where we need to see the phase III data. So clearly it's a fairly competitive. Players there are a lot of new products. So we need to see the phase III data before we can give you a good to. Calibration of that I mean, the number of patients. We are speaking about in the U S is a wrong. 79000 patients in. First line diffuse large b cell lymphoma, Theres about 13000 patients in second line plus in Follicular lymphoma in the United States. Calibration of that I mean, the number of patients. We are speaking about in the U S is a wrong. 79000 patients in. First line diffuse large b cell lymphoma, Theres about 13000 patients in second line plus in Follicular lymphoma in the United States.
Speaker Change: And in first line diffuse large. B cell lymphoma. So we think there's great opportunities ahead for these two indications we think it's a great drug for lymphoma, obviously, it's quite. On a crowded marketplace, but we think the profile of the drug and the trials. We've put together for those two new indications are going to serve us well in the future. But in terms of calibration of a pretty. Where do you go up from where we need to see the phase III data. So clearly it's a fairly competitive. Players there are a lot of new products. So we need to see the phase III data before we can give you a good to. Calibration of that I mean, the number of patients. We are speaking about in the U S is a wrong. 79000 patients in. First line diffuse large b cell lymphoma, Theres about 13000 patients in second line plus in Follicular lymphoma in the United States. Calibration of that I mean, the number of patients. We are speaking about in the U S is a wrong. 79000 patients in. First line diffuse large b cell lymphoma, Theres about 13000 patients in second line plus in Follicular lymphoma in the United States.
Speaker Change: B cell lymphoma. So we think there's great opportunities ahead for these two indications we think it's a great drug for lymphoma, obviously, it's quite. On a crowded marketplace, but we think the profile of the drug and the trials. We've put together for those two new indications are going to serve us well in the future. But in terms of calibration of a pretty. Where do you go up from where we need to see the phase III data. So clearly it's a fairly competitive. Players there are a lot of new products. So we need to see the phase III data before we can give you a good to. Calibration of that I mean, the number of patients. We are speaking about in the U S is a wrong. 79000 patients in. First line diffuse large b cell lymphoma, Theres about 13000 patients in second line plus in Follicular lymphoma in the United States. Calibration of that I mean, the number of patients. We are speaking about in the U S is a wrong. 79000 patients in. First line diffuse large b cell lymphoma, Theres about 13000 patients in second line plus in Follicular lymphoma in the United States.
Speaker Change: On a crowded marketplace, but we think the profile of the drug and the trials. We've put together for those two new indications are going to serve us well in the future. But in terms of calibration of a pretty. Where do you go up from where we need to see the phase III data. So clearly it's a fairly competitive. Players there are a lot of new products. So we need to see the phase III data before we can give you a good to. Calibration of that I mean, the number of patients. We are speaking about in the U S is a wrong. 79000 patients in. First line diffuse large b cell lymphoma, Theres about 13000 patients in second line plus in Follicular lymphoma in the United States. Calibration of that I mean, the number of patients. We are speaking about in the U S is a wrong. 79000 patients in. First line diffuse large b cell lymphoma, Theres about 13000 patients in second line plus in Follicular lymphoma in the United States.
But in terms of calibration of follicular lymphoma we need to see the phase III data. So clearly it's a fairly competitive space. There are a lot of new products so we need to see the phase III data before we can give you a good calibration of that. I mean, the number of patients we are speaking about in the US is around--79,000 patients in first line diffuse large B cell lymphoma. There's about 13,000 patients in second line plus in follicular lymphoma in the United States.
Hervé Hoppenot: But in terms of calibration of follicular lymphoma we need to see the phase III data. So clearly it's a fairly competitive space. There are a lot of new products so we need to see the phase III data before we can give you a good calibration of that. I mean, the number of patients we are speaking about in the US is around--
But in terms of calibration of a pretty. Where do you go up from where we need to see the phase III data. So clearly it's a fairly competitive. Players there are a lot of new products. So we need to see the phase III data before we can give you a good to. Calibration of that I mean, the number of patients. We are speaking about in the U S is a wrong. 79000 patients in. First line diffuse large b cell lymphoma, Theres about 13000 patients in second line plus in Follicular lymphoma in the United States. Calibration of that I mean, the number of patients. We are speaking about in the U S is a wrong. 79000 patients in. First line diffuse large b cell lymphoma, Theres about 13000 patients in second line plus in Follicular lymphoma in the United States.
Speaker Change: Where do you go up from where we need to see the phase III data. So clearly it's a fairly competitive. Players there are a lot of new products. So we need to see the phase III data before we can give you a good to. Calibration of that I mean, the number of patients. We are speaking about in the U S is a wrong. 79000 patients in. First line diffuse large b cell lymphoma, Theres about 13000 patients in second line plus in Follicular lymphoma in the United States. Calibration of that I mean, the number of patients. We are speaking about in the U S is a wrong. 79000 patients in. First line diffuse large b cell lymphoma, Theres about 13000 patients in second line plus in Follicular lymphoma in the United States.
Speaker Change: Players there are a lot of new products. So we need to see the phase III data before we can give you a good to. Calibration of that I mean, the number of patients. We are speaking about in the U S is a wrong. 79000 patients in. First line diffuse large b cell lymphoma, Theres about 13000 patients in second line plus in Follicular lymphoma in the United States.
Speaker Change: Calibration of that I mean, the number of patients. We are speaking about in the U S is a wrong. 79000 patients in. First line diffuse large b cell lymphoma, Theres about 13000 patients in second line plus in Follicular lymphoma in the United States.
Speaker Change: 79000 patients in. First line diffuse large b cell lymphoma, Theres about 13000 patients in second line plus in Follicular lymphoma in the United States.
Steven H. Stein: 79,000 patients in first line diffuse large B cell lymphoma. There's about 13,000 patients in second line plus in follicular lymphoma in the United States.
Speaker Change: First line diffuse large b cell lymphoma, Theres about 13000 patients in second line plus in Follicular lymphoma in the United States.
Unknown: Understood. Thank you.
Operator: Thank you. Your 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. [inaudible] the fourth quarter revenues were negatively impacted by the number of Medicare part D patients receiving free products, could you perhaps elaborate on this? And also looking ahead to 2024 and '25, you had spoken about how IRA dynamics could shift which will drive PV share, could you possibly give us some way to quantify the potential impacts of this shift over time? Thank you.
David Neil Lebowitz: Our use of it in the fourth quarter revenues were negatively impacted by the number of Medicare part D patients receiving <unk>. Free product could you perhaps elaborate on this and also looking ahead to 2024 and 'twenty five. You had. Spoken about how high are a dynamics could shifts which will drive PV share could you, possibly give us some way to quantify the potential impacts of this shift over time. Thank you.
David Neil Lebowitz: Free product could you perhaps elaborate on this and also looking ahead to 2024 and 'twenty five. You had. Spoken about how high are a dynamics could shifts which will drive PV share could you, possibly give us some way to quantify the potential impacts of this shift over time. Thank you.
David Neil Lebowitz: You had. Spoken about how high are a dynamics could shifts which will drive PV share could you, possibly give us some way to quantify the potential impacts of this shift over time. Thank you.
David Neil Lebowitz: Spoken about how high are a dynamics could shifts which will drive PV share could you, possibly give us some way to quantify the potential impacts of this shift over time. Thank you.
Barry P. Flannelly: So to answer the first question, in Q4, we saw a significant increase in patients seeking assistance from Incyte in the form of free drug of course. We know that these are paid patients who had Medicare part D and our assumption is these patients were receiving financial assistance from independent charitable foundations to cover their out of pocket expenses. This assistance was no longer valuable to them apparently towards the end of the year and of course, they came to us and they met our eligibility criteria for free drug. With the changes in Medicare in 2024, as you know, the out of pocket in 2024 for Medicare part D is greatly reduced therefore, we expect these patients to return to being paid patients. And in fact, we know already that many of these patients already have.
Speaker Change: In Q4, we saw a significant increase in patients seeking assistance from insight in the form of <unk>. Free drug of course. We know that these are paid patients who had Medicare part D and our assumption that these patients were receiving financial assistance from independent charitable foundations to cover their out of pocket expenses. This assistance was no longer a valuable to them apparently at the towards the end of the year and of course, they came to us and they met our eligibility criteria for free drug with the changes in Medicare in 2024, as you know the out of pocket in 2024 for Medicare part D is greatly reduced therefore, we expect these patients to return.
Speaker Change: Free drug of course. We know that these are paid patients who had Medicare part D and our assumption that these patients were receiving financial assistance from independent charitable foundations to cover their out of pocket expenses. This assistance was no longer a valuable to them apparently at the towards the end of the year and of course, they came to us and they met our eligibility criteria for free drug with the changes in Medicare in 2024, as you know the out of pocket in 2024 for Medicare part D is greatly reduced therefore, we expect these patients to return.
Speaker Change: We know that these are paid patients who had Medicare part D and our assumption that these patients were receiving financial assistance from independent charitable foundations to cover their out of pocket expenses. This assistance was no longer a valuable to them apparently at the towards the end of the year and of course, they came to us and they met our eligibility criteria for free drug with the changes in Medicare in 2024, as you know the out of pocket in 2024 for Medicare part D is greatly reduced therefore, we expect these patients to return.
Speaker Change: This assistance was no longer a valuable to them apparently at the towards the end of the year and of course, they came to us and they met our eligibility criteria for free drug with the changes in Medicare in 2024, as you know the out of pocket in 2024 for Medicare part D is greatly reduced therefore, we expect these patients to return.
Speaker Change: And in fact, we know already that many of these patients already have. In terms of 2024 and 2025 and the changes to Medicare part D, we think it's been very positive. We've been saying it for a long time that these co pays out of pocket cost for cancer patients who are on Medicare part D, it was very much too high and should be reduced and in fact they probably are still too high. But because of the way it happens in 2025, $2000 maximum out of pockets they can spread that out over throughout the year, so they pay about $167 per month for a 12 month period, we think that there's lots of patients perhaps over the years who have walked away, who abandoned the drug because they could not afford these out of pocket costs. We think that there's an opportunity at least for those patients who abandon drug or just thought they could not afford the drug now that the Medicare part D is greatly reduced, they could come back or opt into the drug therapy now.
And in fact, we know already that many of these patients already have.
In terms of 2024 and 2025 and the changes to Medicare part D, we think it's been very positive. We've been saying it for a long time that these co pays out of pocket cost for cancer patients who are on Medicare part D, it was very much too high and should be reduced and in fact they probably are still too high. But because of the way it happens in 2025, $2000 maximum out of pockets they can spread that out over throughout the year, so they pay about $167 per month for a 12 month period, we think that there's lots of patients perhaps over the years who have walked away, who abandoned the drug because they could not afford these out of pocket costs. We think that there's an opportunity at least for those patients who abandon drug or just thought they could not afford the drug now that the Medicare part D is greatly reduced, they could come back or opt into the drug therapy now.
Speaker Change: These co pays out of pocket cost for patients cancer patients who are on Medicare part D. You know it was very much too high and should be reduced and in fact. They probably are still too high but because of the way. It happens in 2025 $2000 maximum out of pockets they can spread that out over over throughout the year. So they pay about $167 per month for a 12 month period, we think that there's lots of patients perhaps over the years, who have walked away who are abandoned. Drug because they could not afford these out of pocket costs, we think that there's an opportunity at least for those patients who abandon drug or just thought they could not afford the drug now that the Medicare part D is greatly reduced. They could come back so a come back or are option into the drug therapy now so.
Speaker Change: You know it was very much too high and should be reduced and in fact. They probably are still too high but because of the way. It happens in 2025 $2000 maximum out of pockets they can spread that out over over throughout the year. So they pay about $167 per month for a 12 month period, we think that there's lots of patients perhaps over the years, who have walked away who are abandoned. Drug because they could not afford these out of pocket costs, we think that there's an opportunity at least for those patients who abandon drug or just thought they could not afford the drug now that the Medicare part D is greatly reduced. They could come back so a come back or are option into the drug therapy now so.
Speaker Change: They probably are still too high but because of the way. It happens in 2025 $2000 maximum out of pockets they can spread that out over over throughout the year. So they pay about $167 per month for a 12 month period, we think that there's lots of patients perhaps over the years, who have walked away who are abandoned. Drug because they could not afford these out of pocket costs, we think that there's an opportunity at least for those patients who abandon drug or just thought they could not afford the drug now that the Medicare part D is greatly reduced. They could come back so a come back or are option into the drug therapy now so.
Speaker Change: Drug because they could not afford these out of pocket costs, we think that there's an opportunity at least for those patients who abandon drug or just thought they could not afford the drug now that the Medicare part D is greatly reduced. They could come back so a come back or are option into the drug therapy now so.
Speaker Change: They could come back so a come back or are option into the drug therapy now so.
David Neil Lebowitz: Thanks for taking my question.
Operator: Thank you. Your next question is coming from Jessica Fye from JP Morgan. Your line is now live.
Jessica Fye: Hey, guys, good morning. Thanks for taking my questions and a couple of follow ups on some of the previous questions. What's your expectation for the proportion of JAKAFI patients receiving free drug in 2024? And then on OPZELURA for Europe, how are you expecting the average price to shake out for vitiligo and can you recap your latest thinking on pursuing AD there? And then in the US, I think you mentioned the recent script trends reflect kind of normal year end seasonality, is that to say you expect the volume reacceleration near term? I wasn't sure how to reconcile that with some of the other 1Q comments you made about OPZELURA. Thank you.
Jessica Fye: And then on obsolete or are for Europe, how are you expecting the average price to shake out. For vitiligo and can you recap your latest thinking on pursuing a D. There and then in the U S. I think you mentioned the recent scrip trends reflect kind of normal year end seasonality is that to say you expect the volume Reacceleration near term I wasn't sure how to reconcile that with some of the other <unk> comments you made about <unk>.
Jessica Fye: For vitiligo and can you recap your latest thinking on pursuing a D. There and then in the U S. I think you mentioned the recent scrip trends reflect kind of normal year end seasonality is that to say you expect the volume Reacceleration near term I wasn't sure how to reconcile that with some of the other <unk> comments you made about <unk>.
Barry P. Flannelly: Okay, I'll try to answer the first and third question and maybe ask Herve to talk about Europe. So the expectation for free drug is easy for JAKAFI. It's been 3% to 4% of our volume for years and years and years. We expect it to go back. We think this is a one time exceptional thing that happened because of the changes coming for Medicare part D. So again, no more than it has been historically, which is around three or 4% of our volume.
Speaker Change: Okay I'll try to answer the first and third question, maybe ask everybody to talk about Europe. So the expectation for free drug it's easy for Jakafi, it's been 3% to 4% of our volume for years and years and years, we expect that to go back. We think this is a one time. Exceptional thing that happened because of the changes coming for Medicare part D. So again no more than it has been historically, which is around three or 4% of our volume as far as.
Speaker Change: So the expectation for free drug it's easy for Jakafi, it's been 3% to 4% of our volume for years and years and years, we expect that to go back. We think this is a one time. Exceptional thing that happened because of the changes coming for Medicare part D. So again no more than it has been historically, which is around three or 4% of our volume as far as.
Speaker Change: Exceptional thing that happened because of the changes coming for Medicare part D. So again no more than it has been historically, which is around three or 4% of our volume as far as.
Speaker Change: As far as when we talked about seasonality, we do expect the first quarter to be down mostly because of the changes, because of out-of-pocket expenses, because of deductibles, because of the resetting of the copays, but then we should go back to our acceleration in volume in the second quarter, third quarter and so on. And Herve, Europe. In Europe, OPZELURA launched in Germany and Austria in February. It's commercially available. The price there is 750 Euros for a 100 gram tube. And then we have recently received reimbursement in France in a process
As far as when we talked about seasonality, we do expect the first quarter to be down mostly because of the changes, because of out-of-pocket expenses, because of deductibles, because of the resetting of the copays, but then we should go back to our acceleration in volume in the second quarter, third quarter and so on. And Herve, Europe.
Speaker Change: We do expect that the first quarter to be down mostly because of the changes because of out of pocket expenses because of deductibles because the resetting of the Copays, but then we should go back to our to our acceleration in volume in the second quarter third quarter and so on. And urban Europe in Europe, the upside was launched in. Germany and Austria in February it's commercially available surprise there is seven. 750, Europe 100 Gram tube and then we have recently received. Reimbursement in France.
Speaker Change: And urban Europe in Europe, the upside was launched in. Germany and Austria in February it's commercially available surprise there is seven. 750, Europe 100 Gram tube and then we have recently received. Reimbursement in France.
Hervé Hoppenot: In Europe, OPZELURA launched in Germany and Austria in February. It's commercially available. The price there is 750 Euros for a 100 gram tube. And then we have recently received reimbursement in France in a process called [inaudible], which is a way to make--It's one of the first product [inaudible] to be part of the program and that gives access to patients through a special distribution system and while the price is being discussed. The price discussion will probably take ten months and we will start booking sales or recognizing revenue in France when the price is finally approved so that should be late this year in the best case. And then we are also in the process of getting a reimbursement in other countries in Europe so hopefully we will get the multiple countries launching in the '24 and '25. Regarding atopic dermatitis, we decided obviously to start with vitiligo for a reimbursement reason because it's a better case, leading to a better price in most of these countries and we have ongoing studies that have been in fact started relatively recently that could be used if we want to have a limited label in atopic dermatitis, which would be required to be able to maintain the price. So that process is ongoing and it's not going to lead to a new indication in the next two years, it would be coming October.
Speaker Change: Germany and Austria in February it's commercially available surprise there is seven. 750, Europe 100 Gram tube and then we have recently received. Reimbursement in France.
Speaker Change: 750, Europe 100 Gram tube and then we have recently received. Reimbursement in France.
Speaker Change: Reimbursement in France.
Speaker Change: called [inaudible], which is a way to make--It's one of the first product [inaudible] to be part of the program and that gives access to patients through a special distribution system and while the price is being discussed. The price discussion will probably take ten months and we will start booking sales or recognizing revenue in France when the price is finally approved so that should be late this year in the best case. And then we are also in the process of getting a reimbursement in other countries in Europe so hopefully we will get the multiple countries launching in the '24 and '25. Regarding atopic dermatitis, we decided obviously to start with vitiligo for a reimbursement reason because it's a better case, leading to a better price in most of these countries and we have ongoing studies that have been in fact started relatively recently that could be used if we want to have a limited label in atopic dermatitis, which would be required to be able to maintain the price. So that process is ongoing and it's not going to lead to a new indication in the next two years, it would be coming October.
Speaker Change: Access to patients through a special distribution system. Why is the price is being discussed. Price discussion, we'd probably take them months, and we will start booking sales or recognizing revenue in France. When the price is finally. So that should be less. Later this year. In the best case, and then we also in the process of getting a reimbursement in the other countries in Europe. So. Who do you will get the multiple countries launching in the 'twenty four 'twenty five regarding atopic dermatitis, we decided obviously to start with vitiligo for reimbursement reason, because it's a better case, leading to a better price in the most of these countries. We have ongoing studies that. Have been in fact started relatively recently that could be used. Want to have a limited label in atopic dermatitis, which would be required to be able to maintain the price. So that process is ongoing. Going to lead to a new indication in the next two years it would be coming October.
Speaker Change: Why is the price is being discussed. Price discussion, we'd probably take them months, and we will start booking sales or recognizing revenue in France. When the price is finally. So that should be less. Later this year. In the best case, and then we also in the process of getting a reimbursement in the other countries in Europe. So. Who do you will get the multiple countries launching in the 'twenty four 'twenty five regarding atopic dermatitis, we decided obviously to start with vitiligo for reimbursement reason, because it's a better case, leading to a better price in the most of these countries. We have ongoing studies that. Have been in fact started relatively recently that could be used. Want to have a limited label in atopic dermatitis, which would be required to be able to maintain the price. So that process is ongoing. Going to lead to a new indication in the next two years it would be coming October.
Speaker Change: Price discussion, we'd probably take them months, and we will start booking sales or recognizing revenue in France. When the price is finally. So that should be less. Later this year. In the best case, and then we also in the process of getting a reimbursement in the other countries in Europe. So. Who do you will get the multiple countries launching in the 'twenty four 'twenty five regarding atopic dermatitis, we decided obviously to start with vitiligo for reimbursement reason, because it's a better case, leading to a better price in the most of these countries. We have ongoing studies that. Have been in fact started relatively recently that could be used. Want to have a limited label in atopic dermatitis, which would be required to be able to maintain the price. So that process is ongoing. Going to lead to a new indication in the next two years it would be coming October.
Speaker Change: So that should be less. Later this year. In the best case, and then we also in the process of getting a reimbursement in the other countries in Europe. So. Who do you will get the multiple countries launching in the 'twenty four 'twenty five regarding atopic dermatitis, we decided obviously to start with vitiligo for reimbursement reason, because it's a better case, leading to a better price in the most of these countries. We have ongoing studies that. Have been in fact started relatively recently that could be used. Want to have a limited label in atopic dermatitis, which would be required to be able to maintain the price. So that process is ongoing. Going to lead to a new indication in the next two years it would be coming October.
Speaker Change: Later this year.
Speaker Change: In the best case, and then we also in the process of getting a reimbursement in the other countries in Europe. So. Who do you will get the multiple countries launching in the 'twenty four 'twenty five regarding atopic dermatitis, we decided obviously to start with vitiligo for reimbursement reason, because it's a better case, leading to a better price in the most of these countries. We have ongoing studies that. Have been in fact started relatively recently that could be used. Want to have a limited label in atopic dermatitis, which would be required to be able to maintain the price. So that process is ongoing. Going to lead to a new indication in the next two years it would be coming October.
Speaker Change: Who do you will get the multiple countries launching in the 'twenty four 'twenty five regarding atopic dermatitis, we decided obviously to start with vitiligo for reimbursement reason, because it's a better case, leading to a better price in the most of these countries. We have ongoing studies that. Have been in fact started relatively recently that could be used. Want to have a limited label in atopic dermatitis, which would be required to be able to maintain the price. So that process is ongoing. Going to lead to a new indication in the next two years it would be coming October.
Speaker Change: We have ongoing studies that. Have been in fact started relatively recently that could be used. Want to have a limited label in atopic dermatitis, which would be required to be able to maintain the price. So that process is ongoing. Going to lead to a new indication in the next two years it would be coming October.
Speaker Change: Have been in fact started relatively recently that could be used. Want to have a limited label in atopic dermatitis, which would be required to be able to maintain the price. So that process is ongoing. Going to lead to a new indication in the next two years it would be coming October.
Speaker Change: Want to have a limited label in atopic dermatitis, which would be required to be able to maintain the price. So that process is ongoing. Going to lead to a new indication in the next two years it would be coming October.
Speaker Change: Going to lead to a new indication in the next two years it would be coming October.
Jessica Fye: Thank you.
Operator: Thank you. Next question is coming from Tazeen Ahmad from Bank of America. Your line is now live.
Tazeen Ahmad: Hi, good morning. Thank you for taking my questions. I was just curious as to the payer mix differences if there are any for OPZELURA between the AD indication versus like vitiligo. And then secondly, as both of these launches start to mature a bit, do you have a better sense of how you're going to land a number of tubes on average use per patient for a full year? As far as the payer mix goes, there's no real difference between payer mix. For AD, more patients perhaps have step therapies in vitiligo and more patients
Tazeen Ahmad: Hi, good morning. Thank you for taking my questions. I was just curious as to the payer mix differences if there are any for OPZELURA between the AD indication versus like vitiligo. And then secondly, as both of these launches start to mature a bit, do you have a better sense of how you're going to land a number of tubes on average use per patient for a full year?
Celgene: Taking my question I was just curious as to the payer mix differences. If there are any perhaps the lora. D indication versus like Al and then secondly, as both of these launches start to mature at that time. That's how you're going to land a number of tubes on average use per patient for a full year. As far as the <unk>. Payer mix goes there's no real difference between pair mix for E D. More patients, perhaps have a step therapies in vitiligo more patients.
Celgene: D indication versus like Al and then secondly, as both of these launches start to mature at that time. That's how you're going to land a number of tubes on average use per patient for a full year. As far as the <unk>. Payer mix goes there's no real difference between pair mix for E D. More patients, perhaps have a step therapies in vitiligo more patients.
That's how you're going to land a number of tubes on average use per patient for a full year. As far as the <unk>. Payer mix goes there's no real difference between pair mix for E D. More patients, perhaps have a step therapies in vitiligo more patients.
Celgene: As far as the <unk>. Payer mix goes there's no real difference between pair mix for E D. More patients, perhaps have a step therapies in vitiligo more patients.
Steven H. Stein: As far as the payer mix goes, there's no real difference between payer mix. For AD, more patients perhaps have step therapies in vitiligo and more patients
Celgene: Payer mix goes there's no real difference between pair mix for E D. More patients, perhaps have a step therapies in vitiligo more patients.
Celgene: More patients, perhaps have a step therapies in vitiligo more patients.
Celgene: don't have any steps or have one step. In terms of the number of tubes, we have said in the past that for AD it's around two tubes to a little bit more. We think that will continue to grow as people use the drug over larger portions of the body, obviously they can go up to 10-20% body surface area, which is a very large body surface area. Some people started out in sensitive areas and now they'll continue to use it over a larger period of their skin. For vitiligo, it's just too early, we'll figure out, but we're anticipating obviously as we've said the refills will be much greater in vitiligo compared to AD.
Celgene: Started out in sensitive areas and now. They'll continue to use it over a larger period if their scans for vitiligo. It's just too early we'll figure out, but we're anticipating obviously as we've said the refills will be much greater in <unk> compared to <unk> 80.
Celgene: They'll continue to use it over a larger period if their scans for vitiligo. It's just too early we'll figure out, but we're anticipating obviously as we've said the refills will be much greater in <unk> compared to <unk> 80.
Operator: Thank you. Your next question is coming from Marc Frahm from TD Cowen. Your line is now live.
Marc Frahm: Hi, yes, thanks for taking my questions. Maybe following up on a couple of the the paradynamic questions. On JAKAFI, can you quantify the level of [inaudible] and things like that that you are seeing in terms of what this opportunity is for volume gains with this redesign, recognizing that some of it's not going to play out over just in one year? And then similarly for OPZELURA you had some formulary wins late last year that came into effect at the beginning of the year, Christiana to your comment of only wanting to give price concessions to see enough volume benefit to end up in a net sales method, are you seeing early returns from that that are consistent with that view or do you kind of need to recalibrate how you do those negotiations for next year to make sure that that trend is kept?
Mark: Maybe following up on a couple of the the paradigm of questions. On Jakafi and can you quantify the level of claims. Banned them and things like that that you are seeing in terms of what this opportunity is for volume gains. With this redesign Brett recognizing yeah. Some of it's not going to play out over just in one year.
Mark: On Jakafi and can you quantify the level of claims. Banned them and things like that that you are seeing in terms of what this opportunity is for volume gains. With this redesign Brett recognizing yeah. Some of it's not going to play out over just in one year.
Mark: Banned them and things like that that you are seeing in terms of what this opportunity is for volume gains. With this redesign Brett recognizing yeah. Some of it's not going to play out over just in one year.
Speaker Change: With this redesign Brett recognizing yeah. Some of it's not going to play out over just in one year.
Speaker Change: And then similarly for absolute where again you had some formulary wins late last year that came into effect at the beginning of the year.
Speaker Change: As you get into your comment of only wanting to give price concessions to see enough volume benefit to end up in a net sales method or are you seeing early returns from that that are consistent with that view or do you kind of need to recalibrate.
Speaker Change: how you do those negotiations for next year to make sure that that trend is kept?
Barry P. Flannelly: Sure Mark, Barry here. So quantified a level of a script abandonment for JAKAFI, we don't actually know. We know that it's at least 10% just because we know when we go to specialty pharmacies the patients who go through specialty pharmacies, we have a little bit more data there or clarity there and it's at least 10%, but we don't know. People who scripts never gets sent to a pharmacy, we don't know about that. So we're not exactly sure, but we think there's a significant portion of patients that could benefit from JAKAFI specifically that aren't because of the out of pocket [inaudible] that's getting better and better all the time, we hope in 2024 and 2025. As far as OPZELURA goes and formulary wins, for example, CVS that got changed this year to preferred status with a one step therapy for AD, no step therapies for vitiligo, it's a little bit too soon to see anything because obviously, when CVS makes a decision with us it takes a while to funnel down to the various plans at the local level.
Barry P. Flannelly: Sure Mark, Barry here. So quantified a level of a script abandonment for JAKAFI, we don't actually know. We know that it's at least 10% just because we know when we go to specialty pharmacies the patients who go through specialty pharmacies, we have a little bit more data there or clarity there and it's at least 10%, but we don't know. People who scripts never gets sent to a pharmacy, we don't know about that. So we're not exactly sure, but we think there's a significant portion of patients that could benefit from JAKAFI specifically that aren't because of the out of pocket [inaudible] that's getting better and better all the time, we hope in 2024 and 2025.
Mark Berry: So quantified a level of a script abandonment for Jakafi, we don't actually know we know that it's at least 10% just because we know when we go to specialty pharmacies the patients who go through specialty pharmacies, it's a little we have a little bit more data there or clarity there and it's at least 10%, but we don't know people who. ER scripts never gets sent to a to a pharmacy and we don't know about that so. We're not exactly sure, but we think theres a significant portion of patients that could benefit from these from from Jakafi specifically. Orange because of the out of pocket. Austin, that's getting better and better all the time, we hope in 2024 and 2025 as far as.
Mark Berry: ER scripts never gets sent to a to a pharmacy and we don't know about that so. We're not exactly sure, but we think theres a significant portion of patients that could benefit from these from from Jakafi specifically. Orange because of the out of pocket. Austin, that's getting better and better all the time, we hope in 2024 and 2025 as far as.
Mark Berry: We're not exactly sure, but we think theres a significant portion of patients that could benefit from these from from Jakafi specifically. Orange because of the out of pocket. Austin, that's getting better and better all the time, we hope in 2024 and 2025 as far as.
Mark Berry: Orange because of the out of pocket. Austin, that's getting better and better all the time, we hope in 2024 and 2025 as far as.
Mark Berry: Austin, that's getting better and better all the time, we hope in 2024 and 2025 as far as.
Mark Berry: As far as ups, Laura goes and formulary wins. For example, Cvs Aetna that got changed this year to preferred status with the one step therapy for a D. No step therapies for vitiligo, it's a little bit too soon to see anything because. Obviously, when Cvs makes a decision with us it takes a while to funnel down to the. To the various plans at the local level. Okay.
Barry P. Flannelly: As far as OPZELURA goes and formulary wins, for example, CVS that got changed this year to preferred status with a one step therapy for AD, no step therapies for vitiligo, it's a little bit too soon to see anything because obviously, when CVS makes a decision with us it takes a while to funnel down to the various plans at the local level.
Mark Berry: For example, Cvs Aetna that got changed this year to preferred status with the one step therapy for a D. No step therapies for vitiligo, it's a little bit too soon to see anything because. Obviously, when Cvs makes a decision with us it takes a while to funnel down to the. To the various plans at the local level. Okay.
Mark Berry: Obviously, when Cvs makes a decision with us it takes a while to funnel down to the. To the various plans at the local level. Okay.
Mark Berry: To the various plans at the local level. Okay.
Mark Berry: Okay.
Marc Frahm: Okay. Thank you.
Operator: Thank you. Your next question today is coming from Ren Benjamin from Citizens JMP. Your line is now live.
Ren Benjamin: Hey, guys. Thanks for taking the questions. Given the rumors of your bids from [inaudible], are you considering any other acquisitions in the MS space or was the rumor incorrect the whole time and you are just going after the Tapa? That's question number one. Question number two back even on the JAKAFI XR, I'd love to get a little bit more color on the two years that it takes to get to the end of this, to solve this issue. What really is kind of involved in this and the probability of success I would think it would be just quite high, just for a lack of a better word an engineering problem, but maybe I'm thinking about this wrong.
Ren Benjamin: Given the rumors of your bids from all sources are you considering any other acquisitions in the EMS space or was the rumor and correct. The whole time and you are just going after the Tampa.
Ren Benjamin: The number one question number two back even on the Jakafi XR.
Ren Benjamin: I'm still I'd love to get a little bit more color on the two years that it takes. To get to the end of this you know. To solve this issue what really is kind of involved in this. The ability of success I would think it would be just quite high it's just. A lack of a better word an engineering problem, but maybe I'm thinking about this fall.
Ren Benjamin: To get to the end of this you know. To solve this issue what really is kind of involved in this. The ability of success I would think it would be just quite high it's just. A lack of a better word an engineering problem, but maybe I'm thinking about this fall.
Ren Benjamin: To solve this issue what really is kind of involved in this. The ability of success I would think it would be just quite high it's just. A lack of a better word an engineering problem, but maybe I'm thinking about this fall.
Ren Benjamin: The ability of success I would think it would be just quite high it's just. A lack of a better word an engineering problem, but maybe I'm thinking about this fall.
Ren Benjamin: A lack of a better word an engineering problem, but maybe I'm thinking about this fall.
Ren Benjamin: Yes.
Hervé Hoppenot: Maybe on the first question, as I said, I think the Tapa acquisition for us is [inaudible] in fact, very, very asymmetric because as I said with all of the synergies we can realize in the short term it can compensate for what is left in terms of development growth in these two indications where in fact most of the development has already been paid for in the past year. So it is a case where the actual impact on the bottom line will be very minimal in the short term and very positive in the long term. Whatever the scenario of the new indication is.
Ren Benjamin: As I said I think the stuff.
Ren Benjamin: The acquisition for Us is unacceptable. In fact, very very asymmetric because it's as I said with all of the synergies we can realize in a shop for them. Can compensate for. What is left in term of development growth in these two indications where in fact most of the development has already been paid for in the past year or so it is a case, where the actual impact on the bottom line that will be very minimal in the short term I'm very positive in the long term whatever the scenario of the new indication.
Ren Benjamin: In fact, very very asymmetric because it's as I said with all of the synergies we can realize in a shop for them. Can compensate for. What is left in term of development growth in these two indications where in fact most of the development has already been paid for in the past year or so it is a case, where the actual impact on the bottom line that will be very minimal in the short term I'm very positive in the long term whatever the scenario of the new indication.
Ren Benjamin: Can compensate for. What is left in term of development growth in these two indications where in fact most of the development has already been paid for in the past year or so it is a case, where the actual impact on the bottom line that will be very minimal in the short term I'm very positive in the long term whatever the scenario of the new indication.
Ren Benjamin: What is left in term of development growth in these two indications where in fact most of the development has already been paid for in the past year or so it is a case, where the actual impact on the bottom line that will be very minimal in the short term I'm very positive in the long term whatever the scenario of the new indication.
Ren Benjamin: Now if any of this new indication is hitting and is positive then it becomes obviously [inaudible] because we get all the benefit in terms of top line so that's the aspect. Now in the field of myelofibrosis, as you can see from our pipeline we have a number of projects that we are pursuing our self. We have our own bet [inaudible] program, where as Pablo was saying there is some additional data that we need to get certainty, but it's very promising and obviously we have the [inaudible] program on top of the XR formulation. So all of that is giving us a very full pipeline in the field of myelofibrosis, so that would not be the first priority for acquisitions.
Ren Benjamin: It is then it becomes obviously. You build it because we get we get towards the benefit. In terms of top line. So that's a that's a that's the aspect no. In the field of Myelofibrosis as you can see from our pipeline we have a number of projects that we are pursuing our self we have our own bet.
Ren Benjamin: You build it because we get we get towards the benefit. In terms of top line. So that's a that's a that's the aspect no. In the field of Myelofibrosis as you can see from our pipeline we have a number of projects that we are pursuing our self we have our own bet.
Ren Benjamin: In terms of top line. So that's a that's a that's the aspect no. In the field of Myelofibrosis as you can see from our pipeline we have a number of projects that we are pursuing our self we have our own bet.
Ren Benjamin: In the field of Myelofibrosis as you can see from our pipeline we have a number of projects that we are pursuing our self we have our own bet.
Still Alex two program, where a stabler was saying there is some. Additional data that we need to get certainty, but it's very promising on abuse me. We have the <unk> 17 of them get out program on top of the XR formulation. So all of that is giving us a very full pipeline in the field of myelofibrosis, so that would not be the first priority for acquisitions.
Ren Benjamin: Additional data that we need to get certainty, but it's very promising on abuse me. We have the <unk> 17 of them get out program on top of the XR formulation. So all of that is giving us a very full pipeline in the field of myelofibrosis, so that would not be the first priority for acquisitions.
Ren Benjamin: Then Ren, your question on XR, so just to go back to the CRL, remember when we did that submission, we missed on C-Min to a small degree that per the FDA resulted in a theoretical concern on efficacy and then we tried to do some more population PK analyses in that to reassure them, but that pathway didn't work and as we gave more granular details end of last year, the route forward is a new formulation, slightly larger tablet size, and then repeat BEBA work. And you're right, it doesn't take a great length of time, but to get that data in, analyze it, put it into a package and send it to the FDA and then have the discussions, an approximation or best guess is an approximately two year journey from the beginning of this year to get it done. And that we feel has enough conservatism in it that we should make it. In terms of probability of success, we can model from the formulations what we will likely achieve in terms of area under the curve C-Min and even actually C-Max as well and we think that is relatively high obviously, that's why we're doing it. We will share that data as it becomes available and then take it to the regulatory agencies. Thanks.
Barry P. Flannelly: Then Ren, your question on XR, so just to go back to the CRL, remember when we did that submission, we missed on C-Min to a small degree that per the FDA resulted in a theoretical concern on efficacy and then we tried to do some more population PK analyses in that to reassure them, but that pathway didn't work and as we gave more granular details end of last year, the route forward is a new formulation, slightly larger tablet size, and then repeat BEBA work. And you're right, it doesn't take a great length of time, but to get that data in, analyze it, put it into a package and send it to the FDA and then have the discussions, an approximation or best guess is an approximately two year journey from the beginning of this year to get it done. And that we feel has enough conservatism in it that we should make it.
Ren Benjamin: Then we tried to do some more population PK analyses in that to reassure them, but that pathway I didn't work and as we gave more granular details end of last year. The route forward is a new formulation slightly larger tablet size, and then repeat B E. B, a work and you're right. It's not it doesn't take a great length of time, but to get that data and analyze it put it into a package and send it to the FDA and then have the discussions an approximation of best guess is an approximately.
Ren Benjamin: The route forward is a new formulation slightly larger tablet size, and then repeat B E. B, a work and you're right. It's not it doesn't take a great length of time, but to get that data and analyze it put it into a package and send it to the FDA and then have the discussions an approximation of best guess is an approximately.
Two year journey from the beginning of this year to get it done. And that we feel has enough conservatism in it that we should make it in terms of probably of success. We can model from the formulations, what we will likely achieve in terms of area under the curve cement and even actually see Max as well and we think that is.
Ren Benjamin: And that we feel has enough conservatism in it that we should make it in terms of probably of success. We can model from the formulations, what we will likely achieve in terms of area under the curve cement and even actually see Max as well and we think that is.
In terms of probability of success, we can model from the formulations what we will likely achieve in terms of area under the curve C-Min and even actually C-Max as well and we think that is relatively high obviously, that's why we're doing it. We will share that data as it becomes available and then take it to the regulatory agencies. Thanks.
Ren Benjamin: Relatively high obviously. That's why we're doing it well. We will share that data as it becomes available and then take it to regulatory agencies.
Ren Benjamin: That's why we're doing it well. We will share that data as it becomes available and then take it to regulatory agencies.
Ren Benjamin: We will share that data as it becomes available and then take it to regulatory agencies.
Ren Benjamin: Thank you.
Operator: Thank you. Next question is coming from Brian Abrahams from RBC Capital Markets. Your line is now live.
Unknown: Hi, everyone. This is Evan on for Brian. Thank you for taking our questions. We just have a couple of questions. So on OPZELURA, what is the latest that you're kind of seeing on patient retentions so far, how many patients persisted through the six to 12 months so far to kind of see the benefit versus how many are kind of dropping off for perhaps seeing early efficacy. And then if you could speak to a little bit of the education around the retention strategies as well.
Brian Abrahams: <unk> on for Brian Thank you for taking insulin. We just had a couple of questions on our part so on <unk> what is the latest that you're kind of seeing. On patient retention, so far how many patients persisted through the six to 12 months, so far to kind of see the benefit versus how many are kind of dropping off for perhaps seen early efficacy. And then if you could speak to a little bit of the education around the retention strategies as well.
Speaker Change: We just had a couple of questions on our part so on <unk> what is the latest that you're kind of seeing. On patient retention, so far how many patients persisted through the six to 12 months, so far to kind of see the benefit versus how many are kind of dropping off for perhaps seen early efficacy. And then if you could speak to a little bit of the education around the retention strategies as well.
Speaker Change: On patient retention, so far how many patients persisted through the six to 12 months, so far to kind of see the benefit versus how many are kind of dropping off for perhaps seen early efficacy. And then if you could speak to a little bit of the education around the retention strategies as well.
Speaker Change: And then if you could speak to a little bit of the education around the retention strategies as well.
Speaker Change: And then a second question on the MF space, so as you kind of see the entry of additional competitors into the space, do you potentially foresee an expansion of the market as these competitors enter? Thank you.
Speaker Change: And that's the base so as you kind of see the entry of additional. Competitors into the space do you potentially foresee an expansion of the market. As as these.
Speaker Change: And that's the base so as you kind of see the entry of additional. Competitors into the space do you potentially foresee an expansion of the market. As as these.
Competitors into the space do you potentially foresee an expansion of the market. As as these.
Speaker Change: As as these.
Speaker Change: Competitor's entry thank you.
Barry P. Flannelly: Sure Evin, this is Barry. So as far as patient retention I guess, what you mean is that how many patients. So obviously the vitiligo patients stay on it for a much longer period of time. Of course, atopic dermatitis patients, patients with eczema, they have flares, they use OPZELURA, it goes away, and it's very effective so some patients get immediate release. Obviously, we talk about the itch relief all the time, they get good itch relief and then the skin becomes clearer over time. So these patients will come back we think year after year as long as they have their eczema and use the drug when they see the flares until it goes away and then start using it again. Vitiligo patients we've seen from our long term data patients can use the drug for two years and continue to get benefit so that's what we keep on reinforcing around education, so that patients understand how to use the drug, what they're going to see at three months, six months, nine months, 12 months and beyond and that's how we'll continue to retain them. Yeah, it's very important the strategies around
Barry P. Flannelly: Sure Evin, this is Barry. So as far as patient retention I guess, what you mean is that how many patients. So obviously the vitiligo patients stay on it for a much longer period of time. Of course, atopic dermatitis patients, patients with eczema, they have flares, they use OPZELURA, it goes away, and it's very effective so some patients get immediate release. Obviously, we talk about the itch relief all the time, they get good itch relief and then the skin becomes clearer over time. So these patients will come back we think year after year as long as they have their eczema and use the drug when they see the flares until it goes away and then start using it again.
Barry: So as far as patient retention I guess, what do you mean is that how many patients. So obviously the vitiligo patients stay on it for a much longer period of time of course, atopic dermatitis patients patients with eczema. They have flares they use up to Laura It goes away. It's very effective so sometimes some patients get a immediate release, obviously, we talk about the itch relief all the time they get them. Good itch relief and then the skin become clearer over time. So these patients will come back we think year after year as long as they have their eczema and use the drug when they see the flares until it goes away and then start using it again. <unk> patients we've seen from my long term data patients can use the drug for two years and continue to get benefit. So that's what we keep on reinforcing around education, so that patients understand how to use the drug what theyre going to see a three months six months nine months 12 months and beyond. And that's how we'll continue to retain them yeah, it's very important the strategies around.
Barry: It's very effective so sometimes some patients get a immediate release, obviously, we talk about the itch relief all the time they get them. Good itch relief and then the skin become clearer over time. So these patients will come back we think year after year as long as they have their eczema and use the drug when they see the flares until it goes away and then start using it again. <unk> patients we've seen from my long term data patients can use the drug for two years and continue to get benefit. So that's what we keep on reinforcing around education, so that patients understand how to use the drug what theyre going to see a three months six months nine months 12 months and beyond. And that's how we'll continue to retain them yeah, it's very important the strategies around.
Good itch relief and then the skin become clearer over time. So these patients will come back we think year after year as long as they have their eczema and use the drug when they see the flares until it goes away and then start using it again. <unk> patients we've seen from my long term data patients can use the drug for two years and continue to get benefit. So that's what we keep on reinforcing around education, so that patients understand how to use the drug what theyre going to see a three months six months nine months 12 months and beyond. And that's how we'll continue to retain them yeah, it's very important the strategies around.
Barry P. Flannelly: Vitiligo patients we've seen from our long term data patients can use the drug for two years and continue to get benefit so that's what we keep on reinforcing around education, so that patients understand how to use the drug, what they're going to see at three months, six months, nine months, 12 months and beyond and that's how we'll continue to retain them. Yeah, it's very important the strategies around patients adherence, particularly for vitiligo, and particularly we know we can make improvements around what health care professionals, dermatologists in their offices are telling their patients how to use the drug and then the patients themselves understanding how to use the drug.
Barry: <unk> patients we've seen from my long term data patients can use the drug for two years and continue to get benefit. So that's what we keep on reinforcing around education, so that patients understand how to use the drug what theyre going to see a three months six months nine months 12 months and beyond. And that's how we'll continue to retain them yeah, it's very important the strategies around.
Barry: So that's what we keep on reinforcing around education, so that patients understand how to use the drug what theyre going to see a three months six months nine months 12 months and beyond. And that's how we'll continue to retain them yeah, it's very important the strategies around.
Barry: And that's how we'll continue to retain them yeah, it's very important the strategies around.
Barry: patients adherence, particularly for vitiligo, and particularly we know we can make improvements around what health care professionals, dermatologists in their offices are telling their patients how to use the drug and then the patients themselves understanding how to use the drug. As far as competitors in the MF space, there are three other JAK inhibitors approved for myelofibrosis where we continue to be the market leader in myelofibrosis, we'll continue to be. As far as the combinations that have been studied recently, we'll see. But it certainly does expand the market because you have the opportunity of going early, earlier patients starting, we know if they start early with JAKAFI their survival advantages could be better. And then in fact, they'll go to second line drugs and third line drugs. So, yes, we've created the market and it could expand if there are good drugs approved after JAKAFI.
patients adherence, particularly for vitiligo, and particularly we know we can make improvements around what health care professionals, dermatologists in their offices are telling their patients how to use the drug and then the patients themselves understanding how to use the drug.
As far as competitors in the MF space, there are three other JAK inhibitors approved for myelofibrosis where we continue to be the market leader in myelofibrosis, we'll continue to be. As far as the combinations that have been studied recently, we'll see. But it certainly does expand the market because you have the opportunity of going early, earlier patients starting, we know if they start early with JAKAFI their survival advantages could be better. And then in fact, they'll go to second line drugs and third line drugs. So, yes, we've created the market and it could expand if there are good drugs approved after JAKAFI.
Barry: <unk> inhibitors approved for myelofibrosis. Where we continue to be the market leader in myelofibrosis will continue to be as far as the. The combinations that have been studied recently. We'll see. But it certainly does expand the market because you have the opportunity of going early earlier patients starting we know if they start early with jakafi their survival advantages could be better. And then in fact, they'll go to a second line drugs in third line drugs. So, yes, we've created the market and it could expand. If there are good drugs approved after jakafi.
Barry: Where we continue to be the market leader in myelofibrosis will continue to be as far as the. The combinations that have been studied recently. We'll see. But it certainly does expand the market because you have the opportunity of going early earlier patients starting we know if they start early with jakafi their survival advantages could be better. And then in fact, they'll go to a second line drugs in third line drugs. So, yes, we've created the market and it could expand. If there are good drugs approved after jakafi.
Barry: The combinations that have been studied recently. We'll see. But it certainly does expand the market because you have the opportunity of going early earlier patients starting we know if they start early with jakafi their survival advantages could be better. And then in fact, they'll go to a second line drugs in third line drugs. So, yes, we've created the market and it could expand. If there are good drugs approved after jakafi.
Barry: We'll see. But it certainly does expand the market because you have the opportunity of going early earlier patients starting we know if they start early with jakafi their survival advantages could be better. And then in fact, they'll go to a second line drugs in third line drugs. So, yes, we've created the market and it could expand. If there are good drugs approved after jakafi.
Barry: But it certainly does expand the market because you have the opportunity of going early earlier patients starting we know if they start early with jakafi their survival advantages could be better. And then in fact, they'll go to a second line drugs in third line drugs. So, yes, we've created the market and it could expand. If there are good drugs approved after jakafi.
Barry: And then in fact, they'll go to a second line drugs in third line drugs. So, yes, we've created the market and it could expand. If there are good drugs approved after jakafi.
Barry: If there are good drugs approved after jakafi.
Operator: Thank you. Our final question today is coming from Matt Phipps from William Blair. Your line is now live.
Matt Phipps: Thanks for squeezing me in. I'll just ask one on the CDK-2 inhibitor. I'm curious if you can comment on the safety profile you've seen so far if you're seeing any [inaudible]?
Steven H. Stein: Thank you for the question. We have not. We are happy with the safety profile so far which is consistent with the mechanism of CDK-2 inhibition and we have not seen ocular toxicity, which as you know led to a clinical hold in one of our competitors. So we're very excited about the early data for our CDK-2 inhibitor as we mentioned and we look forward to sharing data over the course of the year as well as our future development plans for the CDK-2 inhibitor program.
Matt Phipps: Uh huh. And we look forward to sharing data over the course of the year as well as our future development plans for the CDK <unk> inhibitor program. Okay.
Matt Phipps: And we look forward to sharing data over the course of the year as well as our future development plans for the CDK <unk> inhibitor program. Okay.
Matt Phipps: Okay.
Operator: Thank you. We reached end of our question and answer session, I would like to turn the floor back over for any further or closing comments.
Ben Strain: Thank you for participating in today's call and for your questions. The IR team will be available for the rest of the day. Thank you.
Speaker Change: Thank you.
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.
Speaker Change: [noise].