Q3 2023 Incyte Corp Earnings Call

October 31, 2023

Operator: Hello, and welcome to the Incyte third quarter earnings conference call. If anyone should require operator assistance, please press star zero on your telephone keypad. A question-and-answer session will follow the formal presentation. You may place into the question queue at any time by pressing star one on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Ben Strain, Associate Vice President, Investor Relations. Please go ahead.

If any what the prior operator assistance. Please press star zero on your telephone keypad.

A question and answer session will follow the formal presentation.

You may place a question into the question queue at any time by pressing star one on your telephone keypad.

As a reminder, this conference is being recorded.

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

Ben Strain: Thank you, Kevin. Good morning, and welcome to Incyte's Q3 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 that follow the discussion related to today's call. On today's call, I'm joined by Hervé, Pablo, Barry, Stephen, Christiana, who will deliver our prepared remarks and will participate in the Q&A. I would like to point out that we'll be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail. I will now hand the call over to Hervé.

Ben Strain: Thank you Kevin. Good morning and welcome to Incyte's third quarter 2023 earnings conference call. Before we begin, I encourage everyone to go to the investor's section of our website to find the press release, related financial tables and slides that follow the discussion related to today's call.

On today's call I'm joined by Herve, Pablo, Barry, Steven, Christiana, who will deliver our prepared remarks, and will will participate in the Q&A.

I would like to point out that we'll be making forward-looking statements, which are based on current expectations and beliefs. These statements are subject to certain risks and uncertainties and our actual results may differ materially.

I encourage you to consult the risk factors discussed in our SEC filings for additional detail. I will now hand the call over to Herve.

Hervé Hoppenot: Thank you, Ben, and good morning, everyone. In Q3, we continued to deliver double-digit revenue growth, important successes in pricing and reimbursement, and continued progress of the pipeline. Product and royalty revenues were $914 million in the quarter, with an 11% growth year over year, driven by Jakafi and Opzelura. Jakafi net sales in the quarter were impacted by inventory variation, which Christiana will detail in her prepared remark. As you see, in the first nine months, Jakafi growth continues at a rate of around 8% this year. The growth trajectory of Opzelura continued in Q3 with net product revenue of $92 million, driven by both new patients and refills in AD and vitiligo.

Hervé Hoppenot: Thank you Ben and good morning everyone.

Good morning, everyone.

In the third quarter, we continued to deliver double digit revenue growth important successes in pricing on the reimbursement and continued progress of the pipeline.

Product and royalty revenues were 914 million in the quarter, with an 11% growth year over year diven by JAKAFI.and OPZELURA. .

And up to a jackup.

JAKAFI net sales for the quarter were impacted by inventory valuation, which Christiana will detail in her prepared remarks.

As you see, in the first nine months, JAKAFI growth continues at a rate of around 8% this year. The gross trajectory of Opzelura continued into the third quarter with net product revenue of $92 million driven by both new patients and retailed [inaudible] and Vitiligo.

So gross trajectory of up to a continued into the third quarter with net product revenue of 92 million driven by both new patients on a refuse to rigel.

Hervé Hoppenot: In the first nine months of 2023, Opzelura revenues contributed $229 million, and we expect Opzelura to continue to be a key contributor to the growth of Incyte in the next years. On slide six, we made important progress this quarter on two fronts related to pricing and access. First, as the IRA is implemented, we secured small biotech exception status for ruxolitinib. This has two impacts on Jakafi pricing and gross-to-net in the coming years. One, we expect that Jakafi will be exempt from negotiation until 2029, making it de facto neutral to our initial business plan. And two, as you can see, we expect to benefit from the specified small manufacturer phase-in schedule for Part D catastrophic coverage versus the standard benefit, which will have a meaningful impact in the years 2025 to 2031.

In the first nine months of 2023, Opzelura revenues contributed $229 million, and we expect Opzelura to continue to be a key contributor to the growth of Incyte in the next years. On slide six, we made important progress this quarter on two fronts related to pricing and access. First, as the IRA is implemented, we secured small biotech exception status for ruxolitinib. This has two impacts on Jakafi pricing and gross-to-net in the coming years. One, we expect that Jakafi will be exempt from negotiation until 2029, making it de facto neutral to our initial business plan. And two, as you can see, we expect to benefit from the specified small manufacturer phase-in schedule for Part D catastrophic coverage versus the standard benefit, which will have a meaningful impact in the years 2025 to 2031.

In the first nine months of 2023, OPZELURA revenues contributed 229 million and we expect OPZELURA to continue to be a key contributor to the growth of Incyte into next year.

Our revenues contributed 229 million and we expect a zero ought to continue to be a key contributor to that. Growth of insight into next year.

Growth of insight into next year.

On slide six, we made important progress this quarter on two fronts related to pricing and access. First, as IR already implemented we secured small biotech exception status for [inaudible]. This has two impacts on JAKAFI pricing and gross to net in the coming years. One, we expect that JAKAFI will be exempt from negotiation until 2029, making it the facto neutral to our initial business plan. And two, as you can see, we expect to benefit from the specified small manufacturer phasing schedule profile [inaudible] catastrophic coverage [inaudible] start up benefits, which will have a meaningful impact in the years 2025 to 2031.

And I already implemented we secured small biotech exception status for a rock solid. This has two impacts on jakafi pricing and gross to net in the company in the coming years.

This has two impacts on jakafi pricing and gross to net in the company in the coming years.

One we expect that Jakafi will be exempt from negotiation until 2029, making it the facto neutral to our initial business plan. And two as you can see we expect to benefit from the specified small manufacturer phasing schedule profile D catastrophic coverage there.

And two as you can see we expect to benefit from the specified small manufacturer phasing schedule profile D catastrophic coverage there.

start up benefits, which will have a meaningful impact in the years 2025 to 2031.

Hervé Hoppenot: For Opzelura coverage in the US, starting in 2024, Opzelura will be listed as a preferred brand on the CVS Caremark and Aetna formularies, which will benefit roughly 30 million commercial lives. This achievement will move Opzelura to preferred brand from non-preferred brand tier, and will result in increased access by reducing both step edit requirements, patients' copay for many patients, while maintaining Opzelura's favorable utilization management criteria. Turning to Slide 7. We continue to make progress in our clinical development efforts across our portfolio. Just last week, we obtained new top-line results from the phase 2 randomized study assessing the efficacy and safety of povorcitinib, our oral JAK1 inhibitor in patients with prurigo nodularis. The study met its primary endpoint across all three treatment dose groups, and povorcitinib was generally well tolerated.

For Opzelura coverage in the US, starting in 2024, Opzelura will be listed as a preferred brand on the CVS Caremark and Aetna formularies, which will benefit roughly 30 million commercial lives. This achievement will move Opzelura to preferred brand from non-preferred brand tier, and will result in increased access by reducing both step edit requirements, patients' copay for many patients, while maintaining Opzelura's favorable utilization management criteria. Turning to Slide 7. We continue to make progress in our clinical development efforts across our portfolio. Just last week, we obtained new top-line results from the phase 2 randomized study assessing the efficacy and safety of povorcitinib, our oral JAK1 inhibitor in patients with prurigo nodularis. The study met its primary endpoint across all three treatment dose groups, and povorcitinib was generally well tolerated.

For OPZELURA, our coverage in the US starting in 2024, OPZELURA will be listed as a preferred brand on the CVS Caremark and [inaudible] formularies which would benefit roughly 30 million commercial lives. This achievement will move OPZELURA to preferred brand from non-preferred brand here and will result in increased access by reducing both the pellet requirements, patient co pay for many patients while maintaining OPZELURA's federal about utilization management criteria.

Which would benefit roughly 30 million commercial lives. Achievement will move up throughout two Preshrunk Brown from non preferred brand here and will result in increased access by reducing both the pellet requirements patient co pay for many patients while maintaining upset us federal about utilization management criteria.

Achievement will move up throughout two Preshrunk Brown from non preferred brand here and will result in increased access by reducing both the pellet requirements patient co pay for many patients while maintaining upset us federal about utilization management criteria.

Turning to slide seven. We continue to make progress in our clinical development across our portfolio. Just last week, we obtained new top line results from the phase two randomized study assessing the efficacy and safety of [inaudible] our JAK one inhibitor in patients with [inaudible]. The study met its primary endpoint across all three treatment dose groups and [inaudible] was generally well tolerated.

We continue to make progress in our clinical development progress across our portfolio. Just last week, we obtained new top line results from the phase two randomized study that says things. If he gets you in 50 of Bogo since your neighbor Oh.

Just last week, we obtained new top line results from the phase two randomized study that says things. If he gets you in 50 of Bogo since your neighbor Oh.

JAK one inhibitor in patients with pretty good into two areas.

<unk> met its primary endpoint across all three treatment those groups and porosity. It was generally well tolerated.

Hervé Hoppenot: There are approximately 100,000 treated patients in the US with prurigo nodularis, with limited treatment options, and we are excited to move this program forward based on the phase 2 data. Steven will provide additional details. During the quarter, we had a significant presence at EADV, where we presented the full Opzelura atopic dermatitis data in the pediatric population and positive long-term expansion data in vitiligo. We also shared new positive data from the phase 2b clinical trial of povorcitinib in adults with extensive vitiligo. By the end of the year, we anticipate providing additional data from other key programs, including an update on our oral PDL-1 program, additional combination data of ruxolitinib plus IL-2 and BET, and full disclosure of a novel preclinical program targeting the JAK2 V617F mutation, which has the potential to be a disease-modifying therapy for many patients with myeloproliferative neoplasms.

There are approximately 100,000 treated patients in the US with prurigo nodularis, with limited treatment options, and we are excited to move this program forward based on the phase 2 data. Steven will provide additional details. During the quarter, we had a significant presence at EADV, where we presented the full Opzelura atopic dermatitis data in the pediatric population and positive long-term expansion data in vitiligo. We also shared new positive data from the phase 2b clinical trial of povorcitinib in adults with extensive vitiligo. By the end of the year, we anticipate providing additional data from other key programs, including an update on our oral PDL-1 program, additional combination data of ruxolitinib plus IL-2 and BET, and full disclosure of a novel preclinical program targeting the JAK2 V617F mutation, which has the potential to be a disease-modifying therapy for many patients with myeloproliferative neoplasms.

There are approximately 100,000 treated patients in the US with [inaudible] with limited treatment options and we are excited to move this program for a while based on the phase two data. Steven will provide additional details.

So you've only will provide additional details.

During the quarter, we had a significant presence at [inaudible] where we presented the full OPZELURA atopic dermatitis in the pediatric population and positive long term extension data in Vitiligo. We also shared new positive data from the phase IIB clinical trial of [inaudible] in adults with extensive vitiligo.

By the end of the year, we anticipate providing additional data from Ozaki program, including an update on our oral PDL one program. Additional combination data of [inaudible] plus [inaudible] and full disclosure of our novel preclinical program targeting subject to B617F mutation, which has the potential to be a disease modifying therapy for many patients with [inaudible] neoplasms.

Solid unit plus two in bed and full disclosure of our novel preclinical program targeting subject to be 617, Fs mutation, which has the potential to be a disease modifying therapy for many patient with my look pretty sharp teeth neoplasms.

Hervé Hoppenot: I will now turn the call over to Barry, who will discuss our commercial performance in more details.

I will now turn the call over to Barry, who will discuss our commercial performance in more details.

I will now turn the call over to Barry who will discuss our commercial performance in more detail.

Barry Flannelly: Thank you, Hervé, and good morning, everyone. Starting with Jakafi on Slide nine. Jakafi continued to experience increasing patient demand during the quarter as we delivered 2023 year-to-date net sales of $1.9 billion, growing 8% year over year, while total patients for the first nine months has also grown 8% year over year across all indications. The quarter over quarter impact in net sales is primarily attributable to fluctuations in channel inventory. Recall that we reported exiting Q2 at the high end of our normal inventory range, and inventory drew down modestly in Q3. We continue to see strong growth in underlying demand and now are tightening our full year 2023 guidance to a new range of $2.59 to 2.62 billion.

Barry P. Flannelly: Thank you Herve and good morning everyone.

Starting with JAKAFI on slide nine. JAKAFI continued to experience increasing patient demand during the quarter as we delivered 2023 year-to-date net sales of $1.9 billion, growing 8% year over year, while total patients for the first nine months has also grown 8% year over year across all indications.

Jakafi continued to experience increasing patient demand during the quarter as we as we delivered 2023 year to date net sales of $1.9 billion growing 8% year over year, while total patients for the first nine months has also grown 8% year over year across. All indications.

All indications.

The quarter over quarter impact in net sales is primarily attributable to fluctuations in channel inventory. Recall that we reported exiting Q2 at the high end of our normal inventory range and inventory drew down modestly in Q3.

We continue to see strong growth in underlying demand and now are tightening our full year 2023 guidance to a new range of $2.59 billion the $2.62 billion.

Barry Flannelly: As we look to the future for Jakafi, PV will be a key growth driver, particularly considering that a significant portion of patients are not receiving adequate benefit with hydroxyurea. Now, for the first time, we have data that clearly demonstrates the thrombosis-free survival benefit that can be achieved with Jakafi. The data shows that patients who are not being adequately controlled and are switched to Jakafi experience a 44% reduction in the risk of major thrombosis. We are already hearing from thought leaders that this data is game-changing in PV and reinforces the importance of early intervention for these patients. We believe this important data will help drive earlier use, allowing us to further penetrate the PV market. Turning to Opzelura on Slide 11.

As we look to the future for Jakafi, PV will be a key growth driver, particularly considering that a significant portion of patients are not receiving adequate benefit with hydroxyurea. Now, for the first time, we have data that clearly demonstrates the thrombosis-free survival benefit that can be achieved with Jakafi. The data shows that patients who are not being adequately controlled and are switched to Jakafi experience a 44% reduction in the risk of major thrombosis. We are already hearing from thought leaders that this data is game-changing in PV and reinforces the importance of early intervention for these patients. We believe this important data will help drive earlier use, allowing us to further penetrate the PV market. Turning to Opzelura on Slide 11.

As we look to the future for JAKAFI, PV will be a key growth driver, particularly considering that a significant portion of patients are not receiving adequate benefit with hydroxyurea.

Now for the first time, we have data that clearly demonstrates the thrombosis free survival benefit that can be achieved with JAKAFI. The data shows that patients who are not being adequately controlled and are switched to JAKAFI experience a 44% reduction in the risk of major thrombosis.

The data shows. That patients who are not being adequately controlled in our switch to jakafi experience, a 44% reduction in the risk of major thrombosis.

That patients who are not being adequately controlled in our switch to jakafi experience, a 44% reduction in the risk of major thrombosis.

We're already hearing from thought leaders that this data is game changing in PV and reinforces the importance of early intervention for these patients. We believe this important data will help drive earlier use, allowing us to further penetrate the PV market.

Turning to OPZELURA on Slide 11, the launch continues to be strong and is gaining positive momentum with both physicians and patients as we established OPZELURA as one of the best recent dermatology launches.

Barry Flannelly: The launch continues to be strong and is gaining positive momentum with both physicians and patients, as we establish Opzelura as one of the best recent dermatology launches. Looking at the first two years post-FDA approval, Opzelura outperforms all other dermatology products on a launch align basis. The rapid adoption of Opzelura is driven by its compelling product profile and its ability to address significant unmet need in both atopic dermatitis and vitiligo. Opzelura net product revenues in the quarter were $92 million, up 141% when compared to the same quarter last year. US patient demand increased during the quarter, with total prescriptions growing 72% year over year, and refills growing by 19% versus the prior quarter, with over 9,100 dermatologists now having prescribed Opzelura.

The launch continues to be strong and is gaining positive momentum with both physicians and patients, as we establish Opzelura as one of the best recent dermatology launches. Looking at the first two years post-FDA approval, Opzelura outperforms all other dermatology products on a launch align basis. The rapid adoption of Opzelura is driven by its compelling product profile and its ability to address significant unmet need in both atopic dermatitis and vitiligo. Opzelura net product revenues in the quarter were $92 million, up 141% when compared to the same quarter last year. US patient demand increased during the quarter, with total prescriptions growing 72% year over year, and refills growing by 19% versus the prior quarter, with over 9,100 dermatologists now having prescribed Opzelura.

Looking at the first two years post FDA approval OPZELURA outperforms all other dermatology products on a launch aligned basis. The rapid adoption of OPZELURA is driven by its compelling product profile and its ability to address significant unmet need in both atopic dermatitis and vitiligo.

vitiligo.

OPZELURA net product revenues in the quarter were $92 million, up 141% when compared to the same quarter last year. US patient demand increased during the quarter with total prescriptions growing 72% year over year, and refills growing by 19% versus the prior quarter with over 9,100 dermatologists now having prescribed OPZELURA.

U S patient demand increased during the quarter with total prescriptions growing 72% year over year, and retrials growing by 19% versus the prior quarter with over 9100, dermatologists now having prescribed apso Laura.

Barry Flannelly: The weekly prescription trend, as shown on the right, demonstrates the continued growth of Opzelura, which is coming from both atopic dermatitis and vitiligo. In AD, growth was primarily due to new patient flow, driven by Opzelura's efficacy and impact on inflammation and itch. In vitiligo, where Opzelura is the only approved treatment for repigmentation, growth was driven largely by refills and our educational and awareness initiatives. We remain very optimistic about the long-term potential of Opzelura as we continue to see the strong uptake and positive momentum. We are also working to drive new patient growth and adherence through ongoing initiatives.

The weekly prescription trend, as shown on the right, demonstrates the continued growth of Opzelura, which is coming from both atopic dermatitis and vitiligo. In AD, growth was primarily due to new patient flow, driven by Opzelura's efficacy and impact on inflammation and itch. In vitiligo, where Opzelura is the only approved treatment for repigmentation, growth was driven largely by refills and our educational and awareness initiatives. We remain very optimistic about the long-term potential of Opzelura as we continue to see the strong uptake and positive momentum. We are also working to drive new patient growth and adherence through ongoing initiatives.

The weekly prescription trend, as shown on the right, demonstrates the continued growth of OPZELURA, which is coming from both atopic dermatitis and vitiligo. In AD, growth was primarily due to new patient flow 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 and our educational and awareness initiatives. We remain very optimistic about the long term potential of OPZELURA as we continue to see the strong uptake and positive momentum.

We are also working to drive new patient growth and adherence through ongoing initiatives. During the quarter, we kicked off a new marketing campaign called Moments of Clarity featuring Mandy Moore. The goal of this campaign is intended to bring to life the stories of real people struggling with eczema, who found relief by talking to their dermatologist and to build broad awareness of OPZELURA as a nonsteroidal topical option among mild to moderate AD patients.

Barry Flannelly: During the quarter, we kicked off a new marketing campaign called Moments of Clarity, featuring Mandy Moore. The goal of this campaign is intended to bring to life the stories of real people struggling with eczema, who found relief by talking to their dermatologist, and to build broad awareness of Opzelura as a non-steroidal topical option among mild to moderate AD patients. The campaign secured several high-profile media placements, including coverage with top-tier outlets like The Today Show and People Magazine. We are also continuing to roll out DTC initiatives in vitiligo, which is building awareness, driving demand, and activating patients to discuss treatment options with their dermatologist. Turning to Slide 14, we continue to make advancements with our payer coverage for Opzelura.

During the quarter, we kicked off a new marketing campaign called Moments of Clarity, featuring Mandy Moore. The goal of this campaign is intended to bring to life the stories of real people struggling with eczema, who found relief by talking to their dermatologist, and to build broad awareness of Opzelura as a non-steroidal topical option among mild to moderate AD patients. The campaign secured several high-profile media placements, including coverage with top-tier outlets like The Today Show and People Magazine. We are also continuing to roll out DTC initiatives in vitiligo, which is building awareness, driving demand, and activating patients to discuss treatment options with their dermatologist. Turning to Slide 14, we continue to make advancements with our payer coverage for Opzelura.

and to build broad awareness of OPZELURA as a nonsteroidal topical option among mild to moderate AD patients.

The campaign secured several high profile media placements, including coverage with top tier outlets like the Today Show and People Magazine. We are also continuing to rollout DTC initiatives in vitiligo, which is building awareness, driving demand, and activating patients to discuss treatment options with their dermatologist.

Options with their dermatologist.

Turning to Slide 14, we continued to make advancements with our payer coverage for OPZELURA. In AD, payer adoption continues to improve with regional plans and as of today, we have roughly 84% commercial coverage for OPZELURA in atopic dermatitis covering over 127 million lives.

Barry Flannelly: In AD, payer adoption continues to improve with regional plans, and as of today, we have roughly 84% commercial coverage for Opzelura in atopic dermatitis, covering over 127 million lives. In vitiligo, we have made significant progress since the launch and have improved our coverage by roughly 30% throughout 2023. The most recent progress was with Blue Cross Blue Shield Federal Employee Program, which accounts for over 5.5 million lives. Additionally, as Hervé mentioned, Opzelura will be moving from non-preferred to preferred brand tier, effective 1 January 2024, for CVS Caremark and Aetna formularies. With that, I'll turn the call over to Pablo.

In AD, payer adoption continues to improve with regional plans, and as of today, we have roughly 84% commercial coverage for Opzelura in atopic dermatitis, covering over 127 million lives. In vitiligo, we have made significant progress since the launch and have improved our coverage by roughly 30% throughout 2023. The most recent progress was with Blue Cross Blue Shield Federal Employee Program, which accounts for over 5.5 million lives. Additionally, as Hervé mentioned, Opzelura will be moving from non-preferred to preferred brand tier, effective 1 January 2024, for CVS Caremark and Aetna formularies. With that, I'll turn the call over to Pablo.

In vitiligo we have made significant progress since the launch and have improved our coverage by roughly 30% throughout 2023. The most recent progress was with Blue Cross Blue Shield Federal employee program, which accounts for over 5.5 million lives. Additionally, as Herve mentioned, OPZELURA

Additionally, as Herve mentioned, OPZELURA will be moving from non-preferred to preferred brand tier effective January 1st, 2024 for CVS, Caremark, and Aetna formularies. With that, I'll turn the call over to Pablo.

will be moving from non-preferred to preferred brand tier effective January 1st, 2024 for CVS, Caremark, and Aetna formularies. With that, I'll turn the call over to Pablo.

Pablo Cagnoni: Thank you, Barry, and good morning, everyone. As you may recall, earlier this year, we made the decision to increase our focus on eight high-potential programs. Consistently with this, our near-term goals for the R&D organization will be to increase the rigor of our decision-making, accelerate the progression of our pipeline, and increase our efficiency to optimize our resource allocation. Before I hand the call over to Steven for an update on some of our later-stage programs, I would like to spend a few minutes highlighting some of our key earlier-stage programs to give a more clear picture of the depth and quality of our pipeline. During Q3, our TGF-beta receptor 2/PD-1 bispecific antibody entered the clinic, and the phase 1 dose-escalation study is progressing well.

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

As you may recall, earlier this year, we made the decision to increase our focus on eight high potential programs. Consistently with this, our near term goals for the R&D organization, lead to increase in the rigor of our decision making, accelerate the progression of our pipeline and increase our efficiency to optimize our resource allocation.

Consistently with this our near term goals for the R&D organization would be to increase our rig or if our decision, making accelerated progression of our pipeline and increase our efficiency to optimize our resource allocation.

Before I hand the call over to Steven for an update on some of our later stage programs, I would like to spend a few minutes highlighting some of our key earlier stage programs to give you a more clear picture of the depth and quality of our pipeline.

During the third quarter, our TGF beta receptor two by PD-1 bispecific antibody entered the clinic and the phase one dose escalation study is progressing well. It has been designed with high selectivity from the PD-1 receptor, combined with TGF beta receptor 2 inhibition and it has the potential to enable a synergistic approach to target multiple immunosuppressive pathways across a number of cancers.

Pablo Cagnoni: It has been designed with high selectivity for the PD-1 receptor, combined with TGF-beta receptor two inhibition, and it has the potential to enable a synergistic approach to target multiple immunosuppressive pathways across a number of cancers. INCA34460 is a novel, humanized, anti-IL-15 receptor beta monoclonal antibody that's designed to target and deplete autoreactive tissue-resident memory T cells. It has demonstrated efficacy as a treatment for vitiligo in preclinical models and received IND clearance last quarter. We have since initiated the Phase 1 single-dose ascending study. We have also dosed the first patient for the Phase 1 study of our novel anti-mutant CALR-targeted monoclonal antibody, with the potential to eradicate the malignant clone in certain patients with myeloproliferative neoplasms and significantly modify disease outcomes. CALR mutations are responsible for disease development in approximately 25% to 35% of patients with MF and ET.

It has been designed with high selectivity for the PD-1 receptor, combined with TGF-beta receptor two inhibition, and it has the potential to enable a synergistic approach to target multiple immunosuppressive pathways across a number of cancers. INCA34460 is a novel, humanized, anti-IL-15 receptor beta monoclonal antibody that's designed to target and deplete autoreactive tissue-resident memory T cells. It has demonstrated efficacy as a treatment for vitiligo in preclinical models and received IND clearance last quarter. We have since initiated the Phase 1 single-dose ascending study. We have also dosed the first patient for the Phase 1 study of our novel anti-mutant CALR-targeted monoclonal antibody, with the potential to eradicate the malignant clone in certain patients with myeloproliferative neoplasms and significantly modify disease outcomes. CALR mutations are responsible for disease development in approximately 25% to 35% of patients with MF and ET.

And it's been designed we high selectivity for the PD one receptor combined with TGF beta receptor two inhibition and he has the potential to enable a synergistic approach to target multiple immunosuppressive pathways across a number of cancers.

INCA34460 is a novel humanized anti IL 15 receptor beta monoclonal antibody that is designed to target and deplete auto reactive tissue wrestling and memory T cells. It has demonstrated efficacy as a treatment for vitiligo in preclinical models and received IND clearance last quarter.

He has demonstrated efficacy as a treatment for vitiligo in preclinical models and received <unk> clearance last quarter.

We have since initiated the phase one single dose ascending study. We have also dosed our first patients for the phase one study of our novel anti-mutant [inaudible] targeted monoclonal antibody, with a potential to eradicate the malignant clone in certain patients with myeloproliferative neoplasms and significantly modify disease outcomes. [inaudible] mutations are responsible for disease development in approximately 25% to 35% of patients with MF and ET.

We are also dosed our first patients for the phase one study of our novel anti mutant call our targeted monoclonal antibody with a potential to eradicate the malignant clone and certain patients with myeloproliferative neoplasms and significantly modify disease outcomes, Colorado mutations are responsible for. Disease development, and approximately 25% to 35% of patients with MF and E T.

Disease development, and approximately 25% to 35% of patients with MF and E T.

Pablo Cagnoni: We're disclosing today, for the first time, a program targeting the JAK2 V617F mutation, the most common somatic mutation in myeloproliferative neoplasms. The JAK2 V617F mutation is located in the JH2 domain of the JAK2 receptor and is present in 55%, 60%, and 95% of patients with MF, ET, and PV, respectively. Unlike ruxolitinib, which inhibits both wild type and V617F mutation-positive cells, INCB160058 selectively binds to the JAK2 JH2 site, disrupting the V617F-induced conformation and thus allowing selective inhibition of mutant activity in the JAK2 receptor while sparing wild type. We expect to file the IND by year-end 2023 and enter into the clinic in 2024. Together with our anti-mutant CALR program, these two potentially disease-modifying programs represent a fundamentally new approach to addressing MF, ET, and PV and solidify our leadership in MPNs.

We're disclosing today, for the first time, a program targeting the JAK2 V617F mutation, the most common somatic mutation in myeloproliferative neoplasms. The JAK2 V617F mutation is located in the JH2 domain of the JAK2 receptor and is present in 55%, 60%, and 95% of patients with MF, ET, and PV, respectively. Unlike ruxolitinib, which inhibits both wild type and V617F mutation-positive cells, INCB160058 selectively binds to the JAK2 JH2 site, disrupting the V617F-induced conformation and thus allowing selective inhibition of mutant activity in the JAK2 receptor while sparing wild type. We expect to file the IND by year-end 2023 and enter into the clinic in 2024. Together with our anti-mutant CALR program, these two potentially disease-modifying programs represent a fundamentally new approach to addressing MF, ET, and PV and solidify our leadership in MPNs.

We're disclosing today for the first time, a program targeting the JAK2 V617 mutation, the most common somatic mutation in myeloproliferative neoplasms. The JAK2 V617 mutation is located in the JH2 domain of the JAK2 receptor and is present in 55, 60, and 95% of patients with MF, EP and PV respectively.

The <unk> 607 amputation is located in the <unk> domain of the JAK two receptor and is present in 50, 560, and 95% of patients with MF. And PV respectively.

And PV respectively.

Unlike [inaudible] which inhibits both wild type and V6178 mutation positive cells, INCB 160058 selectively binds to the JAK2 JH2 site disrupting the V618 induced confirmation and thus, allowing selective inhibition of mutant activity in the JAK2 receptor whilst sparing wild type. We expect to file the IND by year end 2023 and enter into the clinic in 2024.

CB 160058 selectively binds to the JAK two J H two site disrupting the V 607 F induced confirmation and thus, allowing <unk> selective inhibition of mutant activity in the JAK two receptor whilst bearing wild type.

We expect to file the IND by year end 2023 and enter into the clinic in 'twenty to 'twenty four.

Together, we're an on time mutant call out program, there's two potentially disease modifying programs representing a fundamentally new approach to addressing MS, EP, and PV and solidify our leadership in MPNs.

Pablo Cagnoni: With that, I would like to pass the call to Steven, who will further highlight some of our key achievements this quarter with our more advanced programs. Steven?

With that, I would like to pass the call to Steven, who will further highlight some of our key achievements this quarter with our more advanced programs. Steven?

With that, I would like to pass the call to Steven who will further highlight some of our key achievements this quarter with our more advanced programs. Steven?

Steven Stein: Thank you, Pablo. Starting on Slide 19, as Hervé mentioned, we obtained the top-line results from the phase 2 randomized, double-blind, placebo-controlled dose-ranging study, assessing the efficacy and safety of Povorcitinib in patients with prurigo nodularis. The study met the primary endpoint for all Povorcitinib doses studied of fifteen, forty-five, and seventy-five milligrams, and at week sixteen, 36.1%, 44.4%, and 54.1% of patients, respectively, achieved a primary endpoint versus an 8.1% rate for patients on placebo. The primary endpoint was designed to assess the proportion of patients achieving a greater than or equal to four-point improvement in itch at week sixteen. Povorcitinib was generally well-tolerated across all doses, and the safety analyses were consistent with previously presented data, with no new reported treatment-emergent adverse events.

Steven H. Stein: Thank you Pablo. Starting on Slide 19, as Herve mentioned, we obtained the topline results from the phase II randomized double blind placebo controlled dose ranging study assessing the efficacy and safety of [inaudible] in patients with Piragua and [inaudible].

The study met the primary endpoint for all [inaudible] doses studied for 15, 45, and 75 milligrams and at week 16, 36.1, 44.4, and 54.1% of patients respectively achieved the primary endpoint versus an 8.1% rate for patients on placebo. The primary endpoint was designed to assess the proportion of patients achieving a greater than or equal to four point improvement in itch at week 16.

The primary endpoint was designed to assess the proportion of patients achieving a greater than or equal to four point improvement in itch at week 16.

[inaudible] was generally well tolerated across all doses and the safety analyses were consistent with previously presented data with no new reported treatment emergent adverse events.

Steven Stein: We plan on presenting the full dataset at an upcoming medical conference in the first half of 2024. As a result of these very encouraging findings, plans are underway to initiate a phase 3 study in 2024. We had a significant presence at the European Academy of Dermatology and Venereology Congress earlier this month, which highlighted our commitment to the atopic dermatitis and vitiligo communities. In a late-breaking oral presentation, we presented positive 52-week data from a phase 2b clinical trial evaluating the safety and efficacy of povorcitinib in adult patients with extensive non-segmental vitiligo. These results showed that treatment with oral povorcitinib was associated with substantial total body and facial repigmentation across all treatment groups at week 52, and was well tolerated at all doses throughout the study.

We plan on presenting the full dataset at an upcoming medical conference in the first half of 2024. As a result of these very encouraging findings, plans are underway to initiate a phase 3 study in 2024. We had a significant presence at the European Academy of Dermatology and Venereology Congress earlier this month, which highlighted our commitment to the atopic dermatitis and vitiligo communities. In a late-breaking oral presentation, we presented positive 52-week data from a phase 2b clinical trial evaluating the safety and efficacy of povorcitinib in adult patients with extensive non-segmental vitiligo. These results showed that treatment with oral povorcitinib was associated with substantial total body and facial repigmentation across all treatment groups at week 52, and was well tolerated at all doses throughout the study.

As a result of these very encouraging findings plans are underway to initiate a phase III study in 2024.

We had a significant presence at the European Academy of Dermatology and Venereology Congress earlier this month, which highlighted our commitment to the atopic dermatitis and vitiligo communities.

In a late break in oral presentation, we presented positive 52-week data from a phase 2B clinical trial evaluating the safety and efficacy of [inaudible] in adult patients with extensive non-segmental vitiligo. These results showed that treatment with oral [inaudible] was associated with substantial total body and facial re-pigmentation across all treatment groups at week 52 and was well tolerated at all doses throughout the study.

These results showed that treatment with oral [inaudible] was associated with substantial total body and facial re-pigmentation across all treatment groups at week 52 and was well tolerated at all doses throughout the study.

Steven Stein: During the 24-week post-treatment period, total body and facial repigmentation was also maintained, which suggests durability of response following treatment discontinuation. These data further reinforce the efficacy and safety profile of Povorcitinib as an oral treatment for patients with extensive non-segmental vitiligo, and we plan to initiate the Phase 3 study by the end of this calendar year. Povorcitinib has already demonstrated outstanding efficacy in the Phase 2 program in hidradenitis suppurativa. As a reminder, 52 to 56% of patients treated with Povorcitinib achieved a HiSCR 50 at week 16, with HiSCR responses improving to 59 to 67% at week 52. Additionally, HiSCR 100 response, which is complete resolution of all manifestations of the disease, was reported at week 52 in up to 29% of patients.

During the 24-week post-treatment period, total body and facial repigmentation was also maintained, which suggests durability of response following treatment discontinuation. These data further reinforce the efficacy and safety profile of Povorcitinib as an oral treatment for patients with extensive non-segmental vitiligo, and we plan to initiate the Phase 3 study by the end of this calendar year. Povorcitinib has already demonstrated outstanding efficacy in the Phase 2 program in hidradenitis suppurativa. As a reminder, 52 to 56% of patients treated with Povorcitinib achieved a HiSCR 50 at week 16, with HiSCR responses improving to 59 to 67% at week 52. Additionally, HiSCR 100 response, which is complete resolution of all manifestations of the disease, was reported at week 52 in up to 29% of patients.

During the 24-week post treatment period, total body and facial re-pigmentation was also maintained, which suggest durability of response following treatment discontinuation. These data further reinforced the efficacy and safety profile of [inaudible] as an oral treatment for patients with extensive non-segmental vitiligo and we plan to initiate the phase III study by the end of this calendar year.

These data further reinforced the efficacy and safety profile of <unk> as an oral treatment for patients with extensive non sigma until the Lego and we plan to initiate the phase III study by the end of this calendar year.

[inaudible] has already demonstrated outstanding efficacy in the phase II program in [inaudible]. As a reminder, 52% to 56% of patients treated with [inaudible] achieved [inaudible] at week 16 with responses improving to 59% to 67% in week 52.

As a reminder, 52% to 56% of patients treated with <unk> achieved a his golf 50 at week 16 with responses improving to 59% to 67% and week 52.

Additionally, [inaudible] 100 response, which is complete resolution of all manifestations of the disease was reported at week 52 in up to 29% of patients.

Steven Stein: The two phase 3 studies, STOP HS1 and STOP HS2, are enrolling very well, and this reflects the strong phase 2 data presented earlier this year. We continue to expand the Povorcitinib program focused on the science, while leveraging our extensive dermatology capabilities. We look forward to advancing the development of Povorcitinib in areas of unmet need, where it is currently being evaluated in two phase 3 studies in HS, and moving into a phase 3 program for vitiligo and prurigo nodularis. Work continues in the phase 2 proof of concept studies in asthma and chronic spontaneous urticaria. Moving to ruxolitinib cream on slide 23. Also presented at EADV were the expanded results from the pivotal phase 3 TRU-AD 3 study, evaluating the safety and efficacy of ruxolitinib cream in children two to 12 years old with atopic dermatitis.

The two phase 3 studies, STOP HS1 and STOP HS2, are enrolling very well, and this reflects the strong phase 2 data presented earlier this year. We continue to expand the Povorcitinib program focused on the science, while leveraging our extensive dermatology capabilities. We look forward to advancing the development of Povorcitinib in areas of unmet need, where it is currently being evaluated in two phase 3 studies in HS, and moving into a phase 3 program for vitiligo and prurigo nodularis. Work continues in the phase 2 proof of concept studies in asthma and chronic spontaneous urticaria. Moving to ruxolitinib cream on slide 23. Also presented at EADV were the expanded results from the pivotal phase 3 TRU-AD 3 study, evaluating the safety and efficacy of ruxolitinib cream in children two to 12 years old with atopic dermatitis.

The two phase III studies Stop HS1 and Stop HS2 are enrolling very well and this reflects the strong phase II data presented earlier this year.

We continue to expand the [inaudible] program focused on the science, while leveraging our extensive dermatology capabilities. We look forward to advancing the development of [inaudible] in areas of unmet need where it is currently being evaluated in two phase III studies in HS and moving into a phase III program for vitiligo and [inaudible]. Work continues in the phase II proof of concept studies in asthma and chronic spontaneous urticaria.

We look forward to advancing the development of [inaudible] in areas of unmet need where it is currently being evaluated in two phase III studies in HS and moving into a phase III program for vitiligo and [inaudible]. Work continues in the phase II proof of concept studies in asthma and chronic spontaneous urticaria.

Work continues in the phase II proof of concept studies in asthma and chronic spontaneous urticaria.

Moving to [inaudible] cream on slide 23, also presented at the ADV with expanded results from the pivotal phase III true AD3 study evaluating the safety and efficacy of [inaudible] cream in children, two to 12 years old with atopic dermatitis.

Steven Stein: These data showed significantly more patients treated with ruxolitinib cream 0.75% and 1.5% achieved investigators' global assessment treatment success than patients treated with placebo. Treatment with ruxolitinib cream over eight weeks under maximum use conditions was also well tolerated in children. Expert feedback on the data has been consistently positive, namely that ruxolitinib cream could be advantageous to the currently available non-steroidal topical options, and an important option before resorting to currently available injectables. We are excited about the potential relief ruxolitinib cream can bring to the over two million pediatric atopic dermatitis patients in the United States. As a late-breaking oral presentation at EADV, new results from the pooled analysis of the long-term extension data from the pivotal phase 3 TRU-V program were presented.

These data showed significantly more patients treated with ruxolitinib cream 0.75% and 1.5% achieved investigators' global assessment treatment success than patients treated with placebo. Treatment with ruxolitinib cream over eight weeks under maximum use conditions was also well tolerated in children. Expert feedback on the data has been consistently positive, namely that ruxolitinib cream could be advantageous to the currently available non-steroidal topical options, and an important option before resorting to currently available injectables. We are excited about the potential relief ruxolitinib cream can bring to the over two million pediatric atopic dermatitis patients in the United States. As a late-breaking oral presentation at EADV, new results from the pooled analysis of the long-term extension data from the pivotal phase 3 TRU-V program were presented.

These data showed significantly more patients treated with [inaudible] 0.75% and 1.5% achieved investigator's global assessment treatment success in patients treated with placebo. Treatment with [inaudible] cream over eight weeks under maximum use conditions was also well tolerated in children.

Treatment with [inaudible] cream over eight weeks under maximum use conditions was also well tolerated in children.

Expert feedback on the data has been consistently positive, namely that [inaudible] cream could be advantageous to the currently available nonsteroidal topical options and an important option before resorting to currently available injectables. We are excited about the potential relief [inaudible] cream can bring to the over 2 million pediatric atopic dermatitis patients in the United States.

We are excited about the potential relief [inaudible] cream can bring to the over 2 million pediatric atopic dermatitis patients in the United States.

As a late break in oral presentation at the ADV, new results from the pooled analysis of the long term extension data from the pivotal phase III true V program we presented, the long term study extension evaluate OPZELURA in patients 12 years and older with non-segmental vitiligo, who previously experienced limited or no response to treatment at week 24.

Steven Stein: The long-term study extension evaluated Opzelura in patients 12 years and older with non-segmental vitiligo, who previously experienced limited or no response to treatment at week 24. The data demonstrated that prolonged treatment with ruxolitinib cream led to increased facial and total body repigmentation in those patients who were initial non-responders. Approximately 70% of patients saw improvements in facial VASI and total VASI at week 52, which increased to 85% by week 104. Throughout the long-term extension, Opzelura continued to be well tolerated, with no serious treatment-related adverse events. This data highlights the importance of prolonged treatment in patients with vitiligo, even when limited or no repigmentation is achieved in the first six months of treatment.

The long-term study extension evaluated Opzelura in patients 12 years and older with non-segmental vitiligo, who previously experienced limited or no response to treatment at week 24. The data demonstrated that prolonged treatment with ruxolitinib cream led to increased facial and total body repigmentation in those patients who were initial non-responders. Approximately 70% of patients saw improvements in facial VASI and total VASI at week 52, which increased to 85% by week 104. Throughout the long-term extension, Opzelura continued to be well tolerated, with no serious treatment-related adverse events. This data highlights the importance of prolonged treatment in patients with vitiligo, even when limited or no repigmentation is achieved in the first six months of treatment.

response to treatment at week 24.

The data demonstrated that prolonged treatment <unk> cream led to increased facial and total body re pigmentation in those patients who were initial non responders. Approximately 70% of patients saw improvements in facial [inaudible] and total [inaudible] at week, 52, which increased to 85% by week 104.

Approximately 70% of patients saw improvements in facial [inaudible] and total [inaudible] at week, 52, which increased to 85% by week 104.

Throughout the long term extension, OPZELURA continued to be well tolerated with no serious treatment related adverse events. This data highlights the importance of prolonged treatment in patients with vitiligo, even when limited or no repigmentation is achieved in the first six months of treatment.

This data highlights the importance of prolonged treatment in patients with vitiligo, even when limited or no re pigmentation has achieved in the first six months of treatment.

Steven Stein: On slide 25, we continue to advance Opzelura development beyond AD and vitiligo and into other indications where it has the potential to provide significant value as either the first approved therapy or first approved topical therapy for patients living with these dermatologic conditions. We currently have three Phase 2 studies, which have recently completed enrollment in lichen planus, lichen sclerosus, and mild to moderate HS, and two additional Phase 3 trials evaluating Opzelura in prurigo nodularis, which are all currently enrolling patients. Finally, on slide 26, we have a number of upcoming data readouts and other exciting milestones expected, and we look forward to sharing additional details throughout the remainder of this year. With that, I would like to turn the call over to Christiana for the financial update.

On slide 25, we continue to advance Opzelura development beyond AD and vitiligo and into other indications where it has the potential to provide significant value as either the first approved therapy or first approved topical therapy for patients living with these dermatologic conditions. We currently have three Phase 2 studies, which have recently completed enrollment in lichen planus, lichen sclerosus, and mild to moderate HS, and two additional Phase 3 trials evaluating Opzelura in prurigo nodularis, which are all currently enrolling patients. Finally, on slide 26, we have a number of upcoming data readouts and other exciting milestones expected, and we look forward to sharing additional details throughout the remainder of this year. With that, I would like to turn the call over to Christiana for the financial update.

On Slide 25, we continue to advance OPZELURA development beyond AD and vitiligo and into other indications where it has the potential to provide significant value as either the first approved therapy or first approved topical therapy for patients living with these dermatologic conditions.

We currently have three phase II studies, which have recently completed enrollment in like in [inaudible] sclerosis, and mild to moderate HS. And two additional phase III trials evaluating [inaudible] which are all currently enrolling patients.

And two additional phase III trials evaluating auxiliary garage R&R, Dolores, which are all currently enrolling patients.

Finally on Slide 26, we have a number of upcoming data readouts and other exciting milestones expected and we look forward to sharing additional details throughout the remainder of this year.

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. Q3 total product revenues were $783 million, representing a 10% year-over-year increase. In the first nine months of 2023, total product revenues were $2.3 billion, representing a 16% year-over-year increase. Total royalty revenues, which are primarily comprised of royalties from Novartis for Jakavi and Tabrecta, and royalties from Lilly for Olumiant, were $131 million in the third quarter and $374 million in the first nine months of the year. Turning to Jakafi. Jakafi net product revenues were $636 million for the third quarter, and $1.9 billion in the first nine months of 2023. In the first nine months of the year, Jakafi net sales grew 8% compared to the same period last year.

Christiana Stamoulis: Thank you Stephen and good morning everyone.

Q3 total product revenues were $783 million, representing a 10% year over year increase. In the first nine months of 2023, total product revenues were $2.3 billion, representing a 16% year over year increase. Total royalty revenues, which are primarily comprised of royalties from Novartis for JAKAFI [inaudible] and royalties from Lilly for ILUVIEN were $131 million in the third quarter and $374 million in the first nine months of the year.

In the first nine months of 2023 total product revenues were $2 $3 billion, representing a 16% year over year increase. Total royalty revenues, which are primarily comprised of royalties from novartis for jackup, the anti breakfast and royalties from Lilly for ILUVIEN $131 million in the third quarter and $374 million in the first nine months of the year.

Total royalty revenues, which are primarily comprised of royalties from novartis for jackup, the anti breakfast and royalties from Lilly for ILUVIEN $131 million in the third quarter and $374 million in the first nine months of the year.

Turning to JAKAFI, JAKAFI net product revenues were $636 million for the third quarter and $1.9 billion in the first nine months of 2023.

In the first nine months of the year, JAKAFI net sales grew 8% compared to the same period last year.

Christiana Stamoulis: While Jakafi demand net sales have continued to steadily increase quarter over quarter, in the first two quarters of 2023, we saw more notable fluctuations in channel inventory levels, which resulted in some variability in the quarterly reported net sales. As we had previously shared, at the end of Q1, channel inventory levels fell below the low end of the normal range, recovering in Q2 and ending the second quarter towards the high end of the normal range. At the end of Q3, channel inventory levels returned to the midpoint of the normal range. In the third quarter of 2023, the decrease in inventory had a $14 million negative impact on reported net sales. Turning now to Opzelura, net product revenues for the third quarter were $92 million, representing 141% increase year over year, driven by increased patient demand and expanded coverage.

While Jakafi demand net sales have continued to steadily increase quarter over quarter, in the first two quarters of 2023, we saw more notable fluctuations in channel inventory levels, which resulted in some variability in the quarterly reported net sales. As we had previously shared, at the end of Q1, channel inventory levels fell below the low end of the normal range, recovering in Q2 and ending the second quarter towards the high end of the normal range. At the end of Q3, channel inventory levels returned to the midpoint of the normal range. In the third quarter of 2023, the decrease in inventory had a $14 million negative impact on reported net sales. Turning now to Opzelura, net product revenues for the third quarter were $92 million, representing 141% increase year over year, driven by increased patient demand and expanded coverage.

While JAKAFI demand net sales have continued to steadily increase quarter over quarter, in the first two quarters of 2023, we saw more notable fluctuations in channel inventory levels, which resulted in some variability in the quarterly reported net sales.

reported net sales.

As we had previously said at the end of Q1, channel inventory levels fell below the low end of the normal range recovering in Q2, and ending the second quarter towards the high end of the normal range.

At the end of Q3, channel inventory levels returned to the midpoint of the normal range.

In the third quarter of 2023, the decrease in inventory had a $14 million negative impact on reported net sales.

Turning now to OPZELURA, net product revenues for the third quarter were $92 million, representing 141% increase year over year, driven by increased patient demand and expanded coverage.

Christiana Stamoulis: In the first nine months of the year, total Opzelura net product revenues were $229 million. Moving on to slide 32 and our operating expenses on a GAAP basis. Total R&D expenses were $376 million for the third quarter, representing a 2% year-over-year decrease, driven primarily by the decrease in one-time collaboration-related expenses, partially offset by continued investment in our late-stage development assets and timing of certain expenses. Total SG&A expenses were $268 million for the third quarter, representing a 1% year-over-year growth. Moving on to our guidance for 2023, we're tightening our guidance range for Jakafi to a new range of $2.59 to $2.62 billion. We are reaffirming our other Hematology Oncology revenue, COGS, R&D, and SG&A guidance for the year. Operator, that concludes our prepared remarks. Please give your instructions and open the call for Q&A.

In the first nine months of the year, total Opzelura net product revenues were $229 million. Moving on to slide 32 and our operating expenses on a GAAP basis. Total R&D expenses were $376 million for the third quarter, representing a 2% year-over-year decrease, driven primarily by the decrease in one-time collaboration-related expenses, partially offset by continued investment in our late-stage development assets and timing of certain expenses. Total SG&A expenses were $268 million for the third quarter, representing a 1% year-over-year growth. Moving on to our guidance for 2023, we're tightening our guidance range for Jakafi to a new range of $2.59 to $2.62 billion. We are reaffirming our other Hematology Oncology revenue, COGS, R&D, and SG&A guidance for the year. Operator, that concludes our prepared remarks. Please give your instructions and open the call for Q&A.

In the first nine months of the year, total OPZELURA net product revenues were $229 million.

Moving on to Slide 32, and our operating expenses on a GAAP basis, total R&D expenses were $376 million for the third quarter, representing a 2% year over year decrease driven primarily by the decrease in one-time collaboration related expenses, partially offset by continued investment in our late stage development assets and timing of certain expenses.

partially offset by continued investment in our late stage development assets and timing of certain expenses.

Total SG&A expenses were $268 million for the third quarter, representing a 1% year over year growth.

Moving onto our guidance for 2023, we're tightening our guidance range for JAKAFI to a new range of $2.59 to $2.62 billion. We are re-affirming our other dermatology oncology revenue, [inaudible] R&D and SG&A guidance for the year.

R&D and SG&A guidance for the year.

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

Operator: Certainly. We'll now be conducting a question-and-answer session. If you'd like to be placed in the question queue, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star one. One moment, please, while we poll for questions. Our first question today is coming from Salveen Richter from Goldman Sachs. Your line is now live.

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 remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star one.

One moment please while we poll for questions. Our first question today is coming from Salveen Richter from Goldman Sachs. Your line is now live.

[Analyst] (Goldman Sachs): Good morning. This is Anu Midan for Savine. Thank you for taking our question. First, could you help us understand Opzelura gross-to-net trends during the quarter and your expectations on the forward? And then just a quick question on the combo data with Jakafi, ALK2, and BET that's expected in Q4. I guess in the context of where the once a day dosing stands and the overall combination strategy and the positioning of each asset, can you just help us understand your thinking on how this could play out from a life cycle management standpoint? Thank you.

Anu Midan: Good morning. This is Anu Midan for Savine. Thank you for taking our question. First, could you help us understand Opzelura gross-to-net trends during the quarter and your expectations on the forward? And then just a quick question on the combo data with Jakafi, ALK2, and BET that's expected in Q4. I guess in the context of where the once a day dosing stands and the overall combination strategy and the positioning of each asset, can you just help us understand your thinking on how this could play out from a life cycle management standpoint? Thank you.

Unknown: Good morning. This is [inaudible] on for Salveen, thank you for taking our question. First, could you help us understand OPZELURA gross to net trends during the quarter and your expectations on the forward? And then just a quick question on the combo data with JAKAFI, [inaudible] that's expected in 4Q, I guess in the context of the once-a-day dosing stance and the overall combination strategy and the positioning of each asset, can you just help us understand your thinking on how this could play out from a lifecycle management standpoint? Thank you.

First could you help us understand ASO Lora gross to net trends during the quarter and your expectations on the far right and then just a quick question on the combo data with <unk> two. And that that's expected FY Q I guess in the context of weird. The once a day dosing stand in the overall combination strategy and the positioning of each asset can you just help us understand your thinking on how this could play out from a lifecycle management standpoint. Thank you.

And that that's expected FY Q I guess in the context of weird. The once a day dosing stand in the overall combination strategy and the positioning of each asset can you just help us understand your thinking on how this could play out from a lifecycle management standpoint. Thank you.

The once a day dosing stand in the overall combination strategy and the positioning of each asset can you just help us understand your thinking on how this could play out from a lifecycle management standpoint. Thank you.

Christiana Stamoulis: Hi, Anna, it's Christiana. I'll take the first part of your question and then turn it to Steven. Regarding the gross to net for Opzelura, in Q3, gross to net was 54%, down from 55% in Q2 and 60% in Q1. As we said in our prior call, in last quarter's call, we expect gross to net to continue around that 55% level, and any improvement would very much depend on the evolution of Medicaid.

Christiana Stamoulis: Hi, [inaudible], it's Christiana. I'll take the first part of your question and then turn it to Steven. Regarding the gross to net for OPZELURA in Q3 gross to net was 54%, down from 55% in Q2 and 60% in Q1. As we said in our prior call, in last quarter's call, we expect gross to net to continue around that 55% level and then improvement would very much depend on the evolution of Medicaid.

in Q3 gross to net was 54%, down from 55% in Q2 and 60% in Q1. As we said in our prior call, in last quarter's call, we expect gross to net to continue around that 55% level and then improvement would very much depend on the evolution of Medicaid.

As we said in our prior call in last quarters call. We expect our gross to net to continue around that 55% level. And then improvement with very much depend on evolution of Medicaid.

And then improvement with very much depend on evolution of Medicaid.

Steven Stein: And Anna, in terms of your second question in the life cycle management of ruxolitinib in myeloproliferative neoplasms and beyond, including graft-versus-host disease, just to take the components of your question separately. The once daily dosing, we continue to work with the FDA on a response, and one of the efforts involves modeling that may be a little short in terms of timeline, and one may require some further work. Regardless of the effort we undertake, both will be delivered way before the LOE for ruxolitinib, so that we'll pursue and continue. In terms of ALK2 and BET, both very important combinations, we're showing further monotherapy and combination data at the American Society of Hematology meeting in December, so you'll have to wait for those abstracts and the meeting itself to see the data.

Steven H. Stein: And then in terms of your second question in the lifecycle management of [inaudible] in myeloproliferative neoplasms and beyond including graft versus host disease, just to take the components of your question separately, the once daily dosing, we continue to work with the FDA on a response, and one of the efforts involves modeling that may be a little short in terms of timeline and one may require some further work. Regardless of the effort we undertake, both will be delivered way before the LOE for [inaudible] so that we will pursue and continue.

And one of the efforts.

Involves modeling that may be a little short in terms of timeline and one may require some further work regardless of the effort. We undertake both will be delivered way before the alloy for excellent. So that we will pursue and continue.

In terms of [inaudible] both very important combinations, we're showing further monotherapy and combination data at the American Society of Hematology Meeting in December so you'll have to wait for those abstracts and the meeting itself to see the data, but it's more data in terms of monotherapy and combination. Your question relates to how they may play out. [inaudible] is principally addressing [inaudible] inhibition and then resulting in hemoglobin improvement. And the idea there would be to treat both the anemia from out of fibrosis as well as potentially the dragging induced anemia from [inaudible] and we'll see how that data evolves.

Steven Stein: But it's more data in terms of monotherapy and combination. Your question relates to how they may play out. You know, ALK2 is principally addressing hepcidin inhibition and then resulting in hemoglobin improvement. And the idea there would be to treat both the anemia from myelofibrosis as well as potentially the drug-induced anemia from RUX, and we'll see how that data evolves. BET is already a mechanism that has demonstrated the ability to shrink spleen, spleen volume reduction, to improve symptoms, and also through epigenetic means, improve hemoglobins. And we've already shown, you know, quite substantial efficacy with our own program. We'll see how other competitive programs play out in the short term. We'll show you data at ASH.

But it's more data in terms of monotherapy and combination. Your question relates to how they may play out. You know, ALK2 is principally addressing hepcidin inhibition and then resulting in hemoglobin improvement. And the idea there would be to treat both the anemia from myelofibrosis as well as potentially the drug-induced anemia from RUX, and we'll see how that data evolves. BET is already a mechanism that has demonstrated the ability to shrink spleen, spleen volume reduction, to improve symptoms, and also through epigenetic means, improve hemoglobins. And we've already shown, you know, quite substantial efficacy with our own program. We'll see how other competitive programs play out in the short term. We'll show you data at ASH.

Play out you know L. Two is principally a dressing hep sodden inhibition, and then resulting in hemoglobin improvement and the idea there would be to treat both the anemia from out of fibrosis as well as potentially the dragging induced anemia from rocks.

That is already a mechanism that has demonstrated the ability to shrink spleen, spleen volume reduction to improve symptoms and also through epigenetic means improve hemoglobin. And we've already shown quite substantial efficacy with our own program. We will see how other competitors' programs play out in the short term. We will show you data at ASH and then we will direct you towards our registration directed efforts here. It could be plays in the first line setting in combination with rux in the sub optimal setting in combination with rux and even as monotherapy post JAK inhibitors, there's substantial efficacy with the bed program.

programs play out in the short term. We will show you data at ASH and then we will direct you towards our registration directed efforts here. It could be plays in the first line setting in combination with rux in the sub optimal setting in combination with rux and even as monotherapy post JAK inhibitors, there's substantial efficacy with the bed program.

Barry Flannelly: ... And then we'll, we'll direct you towards our registration-directed efforts here. It could be plays in the first-line setting in combination with RUX, in the suboptimal setting in combination with RUX, and even as monotherapy post-JAK inhibitors, there's substantial efficacy with the BET program. And then just to round out INCA, let me remind you, you know, Axetilimab had a positive phase 3 this year with really excellent data in third-line graft-versus-host disease, and that submission is going in, and we'll progress that through the regulatory cycle. Thanks.

And then just to round out, let me remind you [inaudible] a positive phase III this year with really excellent data in third line graph versus host disease and that submission is going in and we will progress that through the regulatory cycle. Thanks.

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

[Analyst] (Bank of America): Good morning, and thanks so much for taking my question. Just one for me. I just wanna get a sense of how you're thinking about the evolution of the competitive landscape as it relates to Jakafi. There's been a recent new approval for momelotinib for a subset of patients that might be on Jakafi. How are you thinking about marketing Jakafi in relation to this newly approved drug? And do you think that there's any risk of that drug taking market share? Thanks.

Tazeen Ahmad: Good morning, and thanks so much for taking my question. Just one for me. I just wanna get a sense of how you're thinking about the evolution of the competitive landscape as it relates to Jakafi. There's been a recent new approval for momelotinib for a subset of patients that might be on Jakafi. How are you thinking about marketing Jakafi in relation to this newly approved drug? And do you think that there's any risk of that drug taking market share? Thanks.

Tazeen Ahmad: Good morning, and thank you so much for taking my question. Just one for me, I'm trying to get a sense of how you're thinking about the evolution of the competitive landscape as it relates to JAKAFI. There has been a recent new approval [inaudible] for a subset of patients that might be on JAKAFI. How are you thinking about marketing JAKAFI in relation to this newly approved drug and do you think that there's any risk of that drug taking market share? Thanks.

Just one for me. A sense of how youre thinking about the evolution of the competitive landscape as it relates to Jakafi has been in recent Neil approval from Mama, Let me offer a subset of patients that might be on Jakafi. How are you thinking about marketing jakafi in relation to this newly approved. And do you think that there's any rest of. I tried taking market share thanks.

A sense of how youre thinking about the evolution of the competitive landscape as it relates to Jakafi has been in recent Neil approval from Mama, Let me offer a subset of patients that might be on Jakafi. How are you thinking about marketing jakafi in relation to this newly approved. And do you think that there's any rest of. I tried taking market share thanks.

And do you think that there's any rest of. I tried taking market share thanks.

I tried taking market share thanks.

Barry Flannelly: Sure, Tazeen, this is Barry. So as we think about competition in myelofibrosis, you know, there was already two other JAK inhibitors on the market. Neither of those JAK inhibitors have really penetrated, and their approvals have actually been in the first- and second-line setting, and haven't really moved at all over many quarters now in terms of their market share, or quite frankly, in terms of their net sales. For momelotinib itself, you know, Jakafi was compared directly in the SIMPLIFY-1 study to momelotinib, and momelotinib failed in that study. The approval that they received both in the first- and second-line setting for patients with anemia. Jakafi is in fact the only drug that really has superior overall survival in myelofibrosis patients, regardless of anemia.

Sure Tazeen, this is Barry. So as we think about competition in myelofibrosis, there was already two other JAK inhibitors on the market and neither of those JAK inhibitors have really penetrated and their approvals have actually been in the first and second line setting and haven't really moved at all over many quarters now in terms of their market share or quite frankly in terms of their net sales. [inaudible] itself,

Barry P. Flannelly: Sure Tazeen, this is Barry. So as we think about competition in myelofibrosis, there was already two other JAK inhibitors on the market and neither of those JAK inhibitors have really penetrated and their approvals have actually been in the first and second line setting and haven't really moved at all over many quarters now in terms of their market share or quite frankly in terms of their net sales.

So as we think about competition in myelofibrosis.

You know there is already two other JAK inhibitors on the market.

And neither of those JAK inhibitors have really penetrated and there are approvals I've actually been in the first and second line setting and Havent really moved at all over many quarters now in terms of their market share or quite frankly in terms of their net sales for a moment a lot in there but itself.

[inaudible] itself, JAKAFI was compared directly in simplify one study to [inaudible] and [inaudible] in that study. The approval that they received both in the first line and second line setting for patients with anemia, JAKAFI is in fact, the only drug that really has superior overall survival in myelofibrosis patients regardless of anemia. So in other words, patients who have anemia and got JAKAFI for myelofibrosis have a survival advantage. So that strong designation gives us confidence that we'll continue to be the leader in myelofibrosis.

JAKAFI was compared directly in simplify one study to [inaudible] and [inaudible] in that study. The approval that they received both in the first line and second line setting for patients with anemia, JAKAFI is in fact, the only drug that really has superior overall survival in myelofibrosis patients regardless of anemia. So in other words, patients who have anemia and got JAKAFI for myelofibrosis have a survival advantage. So that strong designation gives us confidence that we'll continue to be the leader in myelofibrosis.

To malott and there have been no malott and their child in that study. The approval of that are they received both into first line and second line setting for patients with anemia.

The approval of that are they received both into first line and second line setting for patients with anemia.

Jakafi is in fact, the only drug that really has superior overall survival in myelofibrosis patients regardless of anemia. So in other words patients who have anemia and got Jakafi for myelofibrosis have a survival advantage.

Barry Flannelly: So in other words, patients who have anemia and got Jakafi for myelofibrosis have a survival advantage. That strong designation gives us confidence that we'll continue to be the leader in myelofibrosis. Additionally, of course, myelofibrosis patients are mostly started on therapy when they have symptoms, and Jakafi clearly is the most effective therapy when it comes to managing symptoms and spleen. And then, momelotinib, just like the other drugs, are in fact much more costly than Jakafi, momelotinib being $26,900 per month, 60% or so higher than Jakafi. So seems like it was priced for a second line drug, and we think that's where it'll be mostly used.

So in other words, patients who have anemia and got Jakafi for myelofibrosis have a survival advantage. That strong designation gives us confidence that we'll continue to be the leader in myelofibrosis. Additionally, of course, myelofibrosis patients are mostly started on therapy when they have symptoms, and Jakafi clearly is the most effective therapy when it comes to managing symptoms and spleen. And then, momelotinib, just like the other drugs, are in fact much more costly than Jakafi, momelotinib being $26,900 per month, 60% or so higher than Jakafi. So seems like it was priced for a second line drug, and we think that's where it'll be mostly used.

So that strong designation gives us confidence that we'll continue to.

Additionally, of course, myelofibrosis patients are mostly started on therapy when they have symptoms and JAKAFI clearly is the most effective therapy when it comes to managing symptoms and spleen. And then [inaudible] just like the other drugs are in fact much more costly than JAKAFI, [inaudible] being a $26,900 per month, 60% or so higher than JAKAFI. So it seems like it was priced for a second line drug and we think that's where it'll be mostly used.

Just like the other drugs are in fact, a much more costly than jakafi. And there being a $26900. Per month, 60% or so higher than jakafi. So it seems like it was priced for a second line drug and we think that's where it'll be mostly used.

And there being a $26900. Per month, 60% or so higher than jakafi. So it seems like it was priced for a second line drug and we think that's where it'll be mostly used.

Per month, 60% or so higher than jakafi. So it seems like it was priced for a second line drug and we think that's where it'll be mostly used.

Operator: Thank you. As a reminder, that's star one to be placed in the question queue, and we ask you, please ask one question, then return to the queue. Our next question is coming from Brian Abrams from RBC Capital Markets. Your line is now live.

Operator: Thank you. As a reminder, that's star one to be placed in the question queue. And we ask you please ask one question the return to the queue. Our next question is coming from Brian Abrahams from RBC capital markets. Your line is now live.

[Analyst] (RBC Capital Markets): Hey, yeah, thanks. It's Leonid on for Brian, and thanks for taking our question. I just wanted to go back to maybe some of the reimbursement dynamics with Opzelura. You guys mentioned the preferred brand designation from Caremark and Aetna. I guess I'm curious, how do you anticipate that impacting access and ultimately pulling through to utilization? And did you guys have to make any net pricing concessions for that? And I guess related to that, I mean, is this contracting that you're working on with some of the other payers as well? Thanks.

Brian Abrams: Hey, yeah, thanks. It's Leonid on for Brian, and thanks for taking our question. I just wanted to go back to maybe some of the reimbursement dynamics with Opzelura. You guys mentioned the preferred brand designation from Caremark and Aetna. I guess I'm curious, how do you anticipate that impacting access and ultimately pulling through to utilization? And did you guys have to make any net pricing concessions for that? And I guess related to that, I mean, is this contracting that you're working on with some of the other payers as well? Thanks.

Unknown: Hey, thanks. It's [inaudible] on for Brian. Thanks for taking our question. I just wanted to go back to maybe some of the reimbursement dynamics with OPZELURA. You guys mentioned the preferred brand designation from Caremark and [inaudible], I guess I'm curious how do you anticipate that impacting access and ultimately pulling through the utilization and did you guys have to make any net pricing concessions for that? And I guess related to that, I mean is this contracting that you're working on with some of the other payers as well? Thanks.

Make any net pricing concessions for that and I guess related to that I mean is this.

Contracting that youre working on with some of the other payers as well thanks.

Barry Flannelly: Sure, Leonid, Barry again. So, you know, in terms of, CVS Caremark in particular, it's very important, in terms of access for the patients. We're trying to make it as easy as possible for dermatologists to prescribe the drug and then for patients to receive it. So, in this particular situation, we're going from, you know, a double step for atopic dermatitis, so patients would have had this to go through topical steroids and topical calcineurin inhibitors, before they get to, Opzelura, and in vitiligo, also had, to go through multiple steps. Now, in vitiligo, as it should be, because of the label and the only drug approved for, vitiligo, that repigments the skin for vitiligo, having no steps to go through. So first line therapy is excellent.

Barry P. Flannelly: Sure [inaudible], Barry again. So in terms of Caremark, CVS, Caremark in particular, it is very important in terms of access for the patients. We're trying to make it as easy as possible for dermatologists to prescribe the drug and then for patients to receive it. So in this particular situation, we're going from a double step for atopic dermatitis, so patients would have had to go through topical steroids and topical callison urine inhibitors are before they get to OPZELURA and in vitiligo it also had to go through multiple steps. Now in vitiligo as it should be because of the label and the only drug approved for vitiligo that pigments the skin for vitiligo, having no steps to go through so first line therapy is excellent and just having to go through one step because most patients will have in fact use topical steroids when they have AD, so that makes it much easier.

Barry again so. You know in terms of a. Caremark Cvs caremark in particular. It is very important in terms of access for the patients who were trying to make it as easy as possible for dermatologists to prescribe the drug and then for patients to receive it. So in this particular situation, we're going from a you know a double step for atopic dermatitis. So patients would have had to go through topical steroids and topical callison urine inhibitors are. Before they get to absolute era and in vitiligo that also had to go through multiple steps now in vitiligo as it should be because of the label and the only drug approved for vitiligo that pigments the skin for vitiligo.

You know in terms of a. Caremark Cvs caremark in particular. It is very important in terms of access for the patients who were trying to make it as easy as possible for dermatologists to prescribe the drug and then for patients to receive it. So in this particular situation, we're going from a you know a double step for atopic dermatitis. So patients would have had to go through topical steroids and topical callison urine inhibitors are. Before they get to absolute era and in vitiligo that also had to go through multiple steps now in vitiligo as it should be because of the label and the only drug approved for vitiligo that pigments the skin for vitiligo.

Caremark Cvs caremark in particular. It is very important in terms of access for the patients who were trying to make it as easy as possible for dermatologists to prescribe the drug and then for patients to receive it. So in this particular situation, we're going from a you know a double step for atopic dermatitis. So patients would have had to go through topical steroids and topical callison urine inhibitors are. Before they get to absolute era and in vitiligo that also had to go through multiple steps now in vitiligo as it should be because of the label and the only drug approved for vitiligo that pigments the skin for vitiligo.

It is very important in terms of access for the patients who were trying to make it as easy as possible for dermatologists to prescribe the drug and then for patients to receive it. So in this particular situation, we're going from a you know a double step for atopic dermatitis. So patients would have had to go through topical steroids and topical callison urine inhibitors are. Before they get to absolute era and in vitiligo that also had to go through multiple steps now in vitiligo as it should be because of the label and the only drug approved for vitiligo that pigments the skin for vitiligo.

So in this particular situation, we're going from a you know a double step for atopic dermatitis. So patients would have had to go through topical steroids and topical callison urine inhibitors are. Before they get to absolute era and in vitiligo that also had to go through multiple steps now in vitiligo as it should be because of the label and the only drug approved for vitiligo that pigments the skin for vitiligo.

Before they get to absolute era and in vitiligo that also had to go through multiple steps now in vitiligo as it should be because of the label and the only drug approved for vitiligo that pigments the skin for vitiligo.

having no steps to go through so first line therapy is excellent and just having to go through one step because most patients will have in fact use topical steroids when they have AD, so that makes it much easier. In terms of contracting of concessions, there's always a negotiation of course with the BEMs

Barry Flannelly: Just having to go through one step, because most patients will have, in fact, used topical steroids when they have AD, so that makes it much easier. In terms of contracting and concessions, you know, there's always a negotiation, of course, with the PBMs and the payers over rebates and fees and so forth. So, it might cost us a little bit more on the rebate end, but in fact, then the copays generally go down. And most importantly, what we're really trying to achieve is volume. And then I suppose your last question is, the negotiations with payers always continues. We don't really have to have any further negotiations, unless we choose to, until 2025 for Opzelura.

Just having to go through one step, because most patients will have, in fact, used topical steroids when they have AD, so that makes it much easier. In terms of contracting and concessions, you know, there's always a negotiation, of course, with the PBMs and the payers over rebates and fees and so forth. So, it might cost us a little bit more on the rebate end, but in fact, then the copays generally go down. And most importantly, what we're really trying to achieve is volume. And then I suppose your last question is, the negotiations with payers always continues. We don't really have to have any further negotiations, unless we choose to, until 2025 for Opzelura.

In terms of contracting of concessions, there's always a negotiation of course with the BEMs and the pairs over rebates and fees and so forth. So it might cost us a little bit more on the rebate but in fact then the co pays generally go down. And most importantly, what we're really trying to achieve is volume. And then I suppose your last question is the negotiations with the payers always continues. We don't really have to have any further negotiations unless we choose to until 2025 for OPZELURA, but there's always the chance that we'd come back and decide to do something slightly different in terms of making access easier for patients. Most of the contracts that we have in place currently in fact allow plans to step up and change their step therapy from two to one and so forth.

and the pairs over rebates and fees and so forth. So it might cost us a little bit more on the rebate but in fact then the co pays generally go down. And most importantly, what we're really trying to achieve is volume. And then I suppose your last question is the negotiations with the payers always continues. We don't really have to have any further negotiations unless we choose to until 2025 for OPZELURA, but there's always the chance that we'd come back and decide to do something slightly different in terms of making access easier for patients. Most of the contracts that we have in place currently in fact allow plans to step up and change their step therapy from two to one and so forth.

It might cost us a little bit more on the rebate and but in fact than the co pays generally go down and most importantly, what we're really trying to achieve is volume and then I. Suppose. Your last question is the negotiations with the payers always continues we don't really have to have any further negotiations. Unless we choose to until 2025 for absolute era, but there's always the Ah theres always the chance that we'd come back and decided to do something slightly different in terms of getting them. In terms of make. Making access easier for patients most of the contracts that we have in place currently in fact allow. Allow patients to allow plans to step up and change their step therapy from two to one and so forth.

Unless we choose to until 2025 for absolute era, but there's always the Ah theres always the chance that we'd come back and decided to do something slightly different in terms of getting them. In terms of make. Making access easier for patients most of the contracts that we have in place currently in fact allow. Allow patients to allow plans to step up and change their step therapy from two to one and so forth.

Barry Flannelly: But, there's always the chance that we come back and decide to do something slightly different in terms of making access easier for patients. Most of the contracts that we have in place currently, in fact, allow plans to step up and change their step therapy from two to one and so forth.

But, there's always the chance that we come back and decide to do something slightly different in terms of making access easier for patients. Most of the contracts that we have in place currently, in fact, allow plans to step up and change their step therapy from two to one and so forth.

In terms of make. Making access easier for patients most of the contracts that we have in place currently in fact allow. Allow patients to allow plans to step up and change their step therapy from two to one and so forth.

Making access easier for patients most of the contracts that we have in place currently in fact allow. Allow patients to allow plans to step up and change their step therapy from two to one and so forth.

Allow patients to allow plans to step up and change their step therapy from two to one and so forth.

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

[Analyst]: Thank you very much for taking my question. Would you be able to give us insight on the current, I guess, rate of the number of tubes per patient in AD and D, excuse me, AD and vitiligo, you're expecting. Have there been any changes in expectations and where do things stand right now?

David Lebowitz: Thank you very much for taking my question. Would you be able to give us insight on the current, I guess, rate of the number of tubes per patient in AD and D, excuse me, AD and vitiligo, you're expecting. Have there been any changes in expectations and where do things stand right now?

David Neil Lebowitz: Thank you very much for taking my question. Would you be able to give us insight on the current rate of the number of tubes per patient in AD [inaudible] and vitiligo you were expecting or have there been any changes in expectations and where things stand right now?

The current. Yes, right at the number of tubes per patient and a D and D C to a D and a bit of light go up you were expecting or have there been any changes in expectations and where things stand right now.

Yes, right at the number of tubes per patient and a D and D C to a D and a bit of light go up you were expecting or have there been any changes in expectations and where things stand right now.

Barry Flannelly: Sure. So in terms of AD, I think we had it on the slide, it's around two. We've been saying that for a while. We expect two tubes per patient for atopic dermatitis on average. Obviously, some patients will get a lot more than that. In vitiligo, we need some more time really to evaluate exactly in the real world, how patients will receive, who will receive Opzelura for vitiligo. So, patients who have, you know, might just apply the drug to the face, for example, or apply it all over their body, it varies. But, we'll continue to track the number of tubes for vitiligo, but obviously with our data so far, with long-term extension data, patients can use it safely for years and continue to get benefits.

Steven H. Stein: Sure. So in terms of AD, I think we had it on the slide, it's around two. We've been saying that for a while. We expect to two tubes for patients for our atopic dermatitis on average. Obviously some patients will get a lot more than that. And vitiligo we need some more time really to evaluate exactly in the real world how patients will receive OPZELURA for vitiligo. So patients who have might just apply the drug to the face for example or apply it all over their body, it varies but we'll continue to track the number of tubes for vitiligo, but obviously with our data so far, long term extension data patient can use it safely for years and continue to get benefits. So we will update you when we have more information as we gather more data as we have more use in vitiligo.

We will get a lot more than that and bid Lego we need some more time really to to evaluate are exactly in the real world how patients will. Receive who will see the opt to Laura for vitiligo. So Ah patients who have a you know might just apply the drug to the face for example, or apply it all over their body. It varies but we'll continue to track the number of tubes for vitiligo, but obviously with our <unk>. Later, so far. Long term extension data patient can use it safely for years. And continue to get benefits so well. We will update you when we have more information as we gather more data as we have more use in vitiligo.

Receive who will see the opt to Laura for vitiligo. So Ah patients who have a you know might just apply the drug to the face for example, or apply it all over their body. It varies but we'll continue to track the number of tubes for vitiligo, but obviously with our <unk>. Later, so far. Long term extension data patient can use it safely for years. And continue to get benefits so well. We will update you when we have more information as we gather more data as we have more use in vitiligo.

Later, so far. Long term extension data patient can use it safely for years. And continue to get benefits so well. We will update you when we have more information as we gather more data as we have more use in vitiligo.

Long term extension data patient can use it safely for years. And continue to get benefits so well. We will update you when we have more information as we gather more data as we have more use in vitiligo.

And continue to get benefits so well. We will update you when we have more information as we gather more data as we have more use in vitiligo.

Barry Flannelly: So, we'll update you when we have more information as we gather more data, as we have more use in vitiligo.

So, we'll update you when we have more information as we gather more data, as we have more use in vitiligo.

We will update you when we have more information as we gather more data as we have more use in vitiligo.

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

Operator: Thank you. Your next question is coming from Jessica Fye from JP Morgan. Your line is now live.

[Analyst] (JP Morgan): Hey, good morning, and thanks for taking my question. Curious, if you'll be in a position to provide Opzelura sales guidance for 2024, and with respect to your BET, what you'll be looking for in the upcoming Pelabresib results?

Jessica Fye [Managing Director and Equity Research Analyst: Hey, good morning, and thanks for taking my question. Curious, if you'll be in a position to provide Opzelura sales guidance for 2024, and with respect to your BET, what you'll be looking for in the upcoming Pelabresib results?

Jessica Macomber Fye: Hey, good morning. Thanks for taking my question. Curious if you'll be in a position to provide OPZELURA sales guidance for 2024? And with respect to your bet, what you'll be looking for in the upcoming [inaudible]?

Yes, if you'll be in a position to provide absolutely our sales guidance for 2024 and with respect to your bet, what you'll be looking for in the upcoming Poland, Russia, Brazil.

Christiana Stamoulis: So Jess, I'll take the first part of the question regarding the Opzelura guidance. As we've shared with you in the past, in order to provide guidance, we want to have a few quarters of real-world experience with Opzelura, especially for vitiligo, given that it is a new market. And be able to see how in the real world utilization is, how many tubes on average vitiligo patients use, and also how quickly and at what rate inactive patients can get in to see their physicians and get on therapy. So we are still very early in the launch of vitiligo, and we continue to monitor the progress and want to see a few more quarters before we are in a position to provide guidance.

Christiana Stamoulis: So Jessica, I'll take the first part of the question regarding the OPZELURA guidance. We chatted with you in the past that in order to provide guidance, we want to have a few quarters of real world experience with OPZELURA especially for vitiligo given that it is a new market and be able to see how in the real world utilization how many tubes on average vitiligo patients use and also how quickly and at what rate inactive patients and get in to see their physicians and get on therapy. So we're still very early in the launch of vitiligo and we'll continue to monitor the progress and want to say a few more quarters before we are in a position to provide guidance.

A few quarters of a real world experience with a. Especially for vitiligo given that it is a new market. And. We're able to see how in the real world utilization.

Especially for vitiligo given that it is a new market. And. We're able to see how in the real world utilization.

And. We're able to see how in the real world utilization.

We're able to see how in the real world utilization.

How many tubes or <unk>. Average vitiligo patient use and also how quickly and at what rate and active patients and getting them to see their physicians and get them on a therapy.

Average vitiligo patient use and also how quickly and at what rate and active patients and getting them to see their physicians and get them on a therapy.

So we're still very early in the launch of Vitiligo and we'll continue to monitor the progress and want to say a few more quarters before we are in a position to provide guidance.

Barry Flannelly: In terms of your question related to BET inhibition in myelofibrosis, you know, the competitor ongoing first-line study, which you allude to, is, you know, what we consider a pretty standard first-line study in about 440 patients. The primary endpoint is spleen volume reduction of 35% or greater, and, you know, already communicated it has to be an and in terms of the secondary endpoint of hitting total symptom score, 50% improvement or above, versus the competitor rux in that situation. For our own BET inhibitor, as I said earlier, you know, both monotherapy data, we've already shown spleen reduction, symptom response, and some hemoglobin responses, and then the ongoing combo work showing the same.

And then in terms of your question related to bet inhibition in myelofibrosis, the competitor ongoing first line study, which you alluded to is what we consider a pretty standard first line study in about 440 patients. The primary endpoint is spleen volume reduction of 35% or greater and already communicated it has to be an end in terms of the secondary endpoint of hitting total symptom score, 50% improvement or above versus the competitor [inaudible] in that situation. For our own bet inhibitor,

Barry P. Flannelly: And then in terms of your question related to bet inhibition in myelofibrosis, the competitor ongoing first line study, which you alluded to is what we consider a pretty standard first line study in about 440 patients. The primary endpoint is spleen volume reduction of 35% or greater and already communicated it has to be an end in terms of the secondary endpoint of hitting total symptom score, 50% improvement or above versus the competitor [inaudible] in that situation.

The competitor ongoing first line study, which you allude to is you know what we consider a pretty standard first line study in about 440 patients. The primary endpoint spleen volume reduction of 35% or greater and already communicated it has to be in and in terms of the secondary endpoint of hitting tote. It'll symptom score, a 50% improvement or above versus the competitor Rex in that situation for our own bet inhibitor.

It'll symptom score, a 50% improvement or above versus the competitor Rex in that situation for our own bet inhibitor.

For our own bet inhibitor, as I said earlier, both monotherapy data we've already shown in spleen reduction symptom responses, hemoglobin responses, and then the ongoing combo work showing the same. And we'll have to see how that data plays out versus what the competitor delivers in that first line study in terms of our registration efforts and we'll communicate further about that at the ASH meeting coming up in December. Thanks.

as I said earlier, both monotherapy data we've already shown in spleen reduction symptom responses, hemoglobin responses, and then the ongoing combo work showing the same. And we'll have to see how that data plays out versus what the competitor delivers in that first line study in terms of our registration efforts and we'll communicate further about that at the ASH meeting coming up in December.

Barry Flannelly: We'll have to see how, you know, that data plays out versus what the competitor delivers in that first line study in terms of our registration efforts, and we'll communicate further about that at the ASH meeting coming up in December. Thanks.

We'll have to see how, you know, that data plays out versus what the competitor delivers in that first line study in terms of our registration efforts, and we'll communicate further about that at the ASH meeting coming up in December. Thanks.

At the Ash meeting coming up in December.

Thanks.

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

Operator: Thank you. Next question is coming from Mark [inaudible] from TD Cowen. Your line is now live.

[Analyst]: Hey, thanks for taking my questions. Maybe first to start from the commercial side, to follow up on one of the prior questions. Just Barry, on a blended basis, you know, given, you know, this is a pretty large plan that you're moving up the formulary, yeah, but on a blended overall basis for the franchise, should we expect gross-to-net to kind of incrementally increase in 2024 versus the full year 2023, given that move?

Marc Frahm: Hey, thanks for taking my questions. Maybe first to start from the commercial side, to follow up on one of the prior questions. Just Barry, on a blended basis, you know, given, you know, this is a pretty large plan that you're moving up the formulary, yeah, but on a blended overall basis for the franchise, should we expect gross-to-net to kind of incrementally increase in 2024 versus the full year 2023, given that move?

Unknown: Hi, thanks for taking my questions. Maybe first to start on the commercial side to follow up on one of the prior questions, Barry on a blended basis given this is a pretty large plan that you're moving up the formulary but on a blended overall basis where [inaudible] we expect gross to net to be incrementally increased in '24 versus the full year '23 given that move?

First it starts on the commercial side to follow up on one of the prior questions just very on a blended basis. You know given you know this is a pretty large plan that you're moving up the formulary. Yeah, but on a blended overall basis, where the franchise should we expect gross to net to be pay incrementally increased in 24 versus the full year 'twenty three given that miss.

Yeah, but on a blended overall basis, where the franchise should we expect gross to net to be pay incrementally increased in 24 versus the full year 'twenty three given that miss.

Barry Flannelly: Mark, I'm not really sure, to be honest with you. We'll have to see what the volume is and what the improvement in co-pays is to see how it affects our gross-to-net. But anyway, we'll see, but there's always a, you know, a chance that we could actually benefit a great deal from net sales by making it much easier for patients to be able to access our drug.

Barry P. Flannelly: Mark, I'm not really sure to be honest with you. We'll have to see what the volume is and what the improvement in co pays is to see how it affects our gross to net. But yeah anyway, we'll see but there's always a chance that we could actually benefit a great deal from net sales by making it much easier for patients to be able to access our drug.

The improvement in co pays is to see how it affects our gross to net but yeah anyway, well, we'll see but theres always a chance that we could. Actually benefit a great deal from a net sales by making it much easier for patients to be able to access our drug.

Actually benefit a great deal from a net sales by making it much easier for patients to be able to access our drug.

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

Operator: Thank you. Next question is coming from [inaudible] from Morgan Stanley. Your line is now live.

[Analyst]: Good morning, this is Gus for our Vikram. We have two questions for Jakafi. I mean, due to the recent approval of GSK's Ojjaara. The first one is, what portion of MF patients using Jakafi do you estimate are using a suboptimal dose due to anemia? And in this patient population, have you seen an increased rate of discontinuations as prescribers and patients potentially move towards Ojjaara? And secondly, have you observed a decrease in Jakafi new patient start in MF since Ojjaara was approved? Thank you.

Vikram Purohit: Good morning, this is Gus for our Vikram. We have two questions for Jakafi. I mean, due to the recent approval of GSK's Ojjaara. The first one is, what portion of MF patients using Jakafi do you estimate are using a suboptimal dose due to anemia? And in this patient population, have you seen an increased rate of discontinuations as prescribers and patients potentially move towards Ojjaara? And secondly, have you observed a decrease in Jakafi new patient start in MF since Ojjaara was approved? Thank you.

Unknown: Good morning. This is [inaudible]. We have two questions for [inaudible]. Due to the recent approval for GSK [inaudible] the first one is what portion on patients using JAKAFI do you estimate are using at the optimal dose due to anaemia? And in this patient population have you seen an increased rate of discontinuation as prescribers and patients potentially move towards [inaudible]? And secondly, have you observed a decrease in JAKAFI in new patient [inaudible] was approved? Thank you.

We have two questions. Right. Due to the reason that people love GSK or Jarrod. The first one is Oh boy I. I met patient use of Jakafi estimates. Using the optimal dose. Yeah. And in this patient population have you seen an increased rate of discontinuation. As prescribers and patients potentially move towards all Jarrod on. And secondly have you observed a decrease in jakafi in new patient starts. Yeah, Yeah that was approved. Thank you.

Right. Due to the reason that people love GSK or Jarrod. The first one is Oh boy I. I met patient use of Jakafi estimates. Using the optimal dose. Yeah. And in this patient population have you seen an increased rate of discontinuation. As prescribers and patients potentially move towards all Jarrod on. And secondly have you observed a decrease in jakafi in new patient starts. Yeah, Yeah that was approved. Thank you.

Due to the reason that people love GSK or Jarrod. The first one is Oh boy I. I met patient use of Jakafi estimates. Using the optimal dose. Yeah. And in this patient population have you seen an increased rate of discontinuation. As prescribers and patients potentially move towards all Jarrod on. And secondly have you observed a decrease in jakafi in new patient starts. Yeah, Yeah that was approved. Thank you.

I met patient use of Jakafi estimates. Using the optimal dose. Yeah. And in this patient population have you seen an increased rate of discontinuation. As prescribers and patients potentially move towards all Jarrod on. And secondly have you observed a decrease in jakafi in new patient starts. Yeah, Yeah that was approved. Thank you.

Using the optimal dose. Yeah. And in this patient population have you seen an increased rate of discontinuation. As prescribers and patients potentially move towards all Jarrod on. And secondly have you observed a decrease in jakafi in new patient starts. Yeah, Yeah that was approved. Thank you.

Yeah. And in this patient population have you seen an increased rate of discontinuation. As prescribers and patients potentially move towards all Jarrod on. And secondly have you observed a decrease in jakafi in new patient starts. Yeah, Yeah that was approved. Thank you.

And in this patient population have you seen an increased rate of discontinuation. As prescribers and patients potentially move towards all Jarrod on. And secondly have you observed a decrease in jakafi in new patient starts. Yeah, Yeah that was approved. Thank you.

As prescribers and patients potentially move towards all Jarrod on. And secondly have you observed a decrease in jakafi in new patient starts. Yeah, Yeah that was approved. Thank you.

And secondly have you observed a decrease in jakafi in new patient starts. Yeah, Yeah that was approved. Thank you.

Yeah, Yeah that was approved. Thank you.

Thank you.

Barry Flannelly: Well, Gus, you know, the most important thing is that, so Ojjaara only got approved on 15 September 2023. It really only launched in the last week of the year. I'd be surprised if there was actually any sales except for stocking sales in the quarter. So I can't imagine that it affected any part of us yet. Patients might be receiving a suboptimal dose. You know, what we've only said before, I believe, is that the number of patients who are at steady state on, you know, 5mg twice a day dose or something like that, is only about 5% of our patients. I believe those patients are actually getting benefit, but that's the most.

Barry P. Flannelly: The most important thing is that [inaudible] got approved on September 15th. It really only launched in the last week of the year. I'd be surprised if there was actually any sales except for stocking sales in the quarter. So anyway, so I can't imagine that it affected any part of us yet. Now what percent of patients might be receiving a suboptimal dose, what we've only said before I believe is that the number of patients who are at a steady state on a five milligrams twice a day dose or something like that is only about 5% of our patients. I believe those patients are actually getting benefit but that's the most and just like in our clinical trials, cover one trial, I mean, only one patient discontinued for anemia. So we don't believe that that's a big part of it. And like I said before about the benefits that JAKAFI provides to MF patients whether they are anemic or non anemic, it's overall survival, it's symptom control, it's spleen control. So far we don't really anticipate an impact [inaudible] certainly in the third quarter.

So. So anyway, so I can't imagine that it affected in any part of us yet. Now what percent of patients. Might be. Receiving a suboptimal dose you know we've only said before I believe is that the.

So anyway, so I can't imagine that it affected in any part of us yet. Now what percent of patients. Might be. Receiving a suboptimal dose you know we've only said before I believe is that the.

Now what percent of patients. Might be. Receiving a suboptimal dose you know we've only said before I believe is that the.

Might be. Receiving a suboptimal dose you know we've only said before I believe is that the.

Receiving a suboptimal dose you know we've only said before I believe is that the.

number of patients who are at a steady state on a five milligrams twice a day dose or something like that is only about 5% of our patients. I believe those patients are actually getting benefit but that's the most and just like in our clinical trials, cover one trial, I mean, only one patient discontinued for anemia. So we don't believe that that's a big part of it. And like I said before about the benefits that JAKAFI provides to MF patients whether they are anemic or non anemic, it's overall survival, it's symptom control, it's spleen control. So far we don't really anticipate an impact [inaudible] certainly in the third quarter.

That's the most and just like in our clinical trials cover one trial I mean, only one patient discontinued for anemia. So we don't believe that that's a big part of it and like I said before about the benefits that jakafi provides to MF patients whether they are anemic right now I'm in non anemic. It's overall survival, it's symptom control its clean control. So so. So far we don't really see we don't really anticipate a impact by a lot and I'm certainly in the third quarter.

Barry Flannelly: You know, just like in our clinical trials in one trial, I mean, only one patient discontinued for anemia. So, we don't believe that that's a big part of it. And like I said before, about the benefits that Jakafi provides to MF patients, whether they're anemic or non-anemic, it's overall survival, it's symptom control, it's spleen control. So, so far, we don't really see; we don't really anticipate impact by momelotinib, certainly in Q3.

You know, just like in our clinical trials in one trial, I mean, only one patient discontinued for anemia. So, we don't believe that that's a big part of it. And like I said before, about the benefits that Jakafi provides to MF patients, whether they're anemic or non-anemic, it's overall survival, it's symptom control, it's spleen control. So, so far, we don't really see; we don't really anticipate impact by momelotinib, certainly in Q3.

So we don't believe that that's a big part of it and like I said before about the benefits that jakafi provides to MF patients whether they are anemic right now I'm in non anemic. It's overall survival, it's symptom control its clean control. So so. So far we don't really see we don't really anticipate a impact by a lot and I'm certainly in the third quarter.

So far we don't really see we don't really anticipate a impact by a lot and I'm certainly in the third quarter.

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

[Analyst]: Thanks for taking my questions. I wonder on the, Povorcitinib phase 3 plans in vitiligo, how you can structure that trial to complement the current Opzelura utilization opportunity? Is it really just around baseline VASI scores? And then, as you think further out about additional opportunities for Povorcitinib, what are you keeping in mind, considering it, it looks based on the profile so far as to work in a pretty wide range of more classical autoimmune indications, but clearly there you might have more competition?

Matt Phipps: Thanks for taking my questions. I wonder on the, Povorcitinib phase 3 plans in vitiligo, how you can structure that trial to complement the current Opzelura utilization opportunity? Is it really just around baseline VASI scores? And then, as you think further out about additional opportunities for Povorcitinib, what are you keeping in mind, considering it, it looks based on the profile so far as to work in a pretty wide range of more classical autoimmune indications, but clearly there you might have more competition?

Matthew Christopher Phipps: Thanks for taking my question. I'm wondering on the [inaudible] phase III plans on vitiligo how you can structure that trial to complement the current OPZELURA utilization opportunities, is it really just around baseline Bassi scores? And then as you think further out about additional opportunities for [inaudible] what are you keeping in mind considering it looks based on the profile so far to work in a pretty wide range of more classical autoimmune indications [inaudible]?

It looks based on the profile. So far is to work in a pretty wide range of more classical autoimmune indications. Let them work.

Let them work.

Steven Stein: Matt, hi, it's Steven. Thanks for the question. So in terms of vitiligo, as we showed you, you know, the data in more extensive non-segmental vitiligo, you know, we saw, you know, really good effect in terms of facial VASI, facial VASI 75 and above, and then total VASI as well, body repigmentation of 50% or above. We will disclose, you know, when we go onto clinicaltrials.gov, what the endpoints are and, and what doses we'll be using. So it's premature to, to point you towards that, other than just broadly tell you that the population we target in is people with more extensive body surface area involvement when you compare it to the cream, which is indicated for people with 10% or below.

Steven H. Stein: Matt, hi. It's Steven, thanks for the question. So in terms of vitiligo, as we showed you the data in more extensive non-segmental vitiligo we saw a really good effect in terms of facial [inaudible] E, facial [inaudible] 75 and above and then total [inaudible] as well body rate pigmentation of 50% or above. We will disclose when we go onto clintrials.gov what the endpoints are and what doses we'll be using so it's premature to point you towards that other than just broadly tell you that the population we are targeting is people with more extensive body surface area involvement

A 50% or above we will disclose you know when we go onto controls dot Gov, what the endpoints are and what doses will be using so it's premature to point you towards that other than just broadly tell you that the population. We are targeting is people with more extensive body surface area.

and then when you compare it to the cream, which is indicated for people with 10% or below this would open up the vitiligo community to people with much more extensive body surface area involvement where it becomes a little pragmatically hard to apply cream across the body and an oral JAK can be used in that setting with the right therapeutic ratio. And as we guided to, we want to get this study going by the end of this calendar year. [inaudible] is relatively JAK one specific. You saw the program in HS1, HS2 is enrolling really, really well based on what we think is excellent phase II data, including [inaudible] 100 response, but as you allude to, we have now data in [inaudible] that's excellent and we want to progress that into phase III, and then ongoing efforts beyond dermatology in asthma, and chronic spontaneous urticaria, where the biology points to this kind of JAK one agent potentially showing substantial benefit in patients with more severe asthma, who on inhaled corticosteroids long acting bronchodilator and still having yearly exacerbations. That's a phase II proof of concept study and then standard endpoints in chronic spontaneous urticaria. So this drug has demonstrated thus far remarkable activity in those areas where we're studying in phase III now and we'll see what happens in asthma in CSU, so thanks for the question.

Steven Stein: This would open up the vitiligo community with people with much more extensive body surface area involvement, where it becomes a little, pragmatically hard to apply, you know, cream across the body, and an oral JAK can be used in that setting with the right therapeutic ratio. As we guided to, you know, we want to get the study going by the end of this calendar year. Povorcitinib is, you know, relatively JAK1 specific. You saw, you know, the program in HS, both STOP HS1 and HS2 are enrolling really, really well based on the, you know, what we think is excellent phase 2 data, including that HiSCR 100 response. But as you allude to, you know, we have now data in prurigo nodularis, that's excellent, and we want to progress that into phase 3.

This would open up the vitiligo community with people with much more extensive body surface area involvement, where it becomes a little, pragmatically hard to apply, you know, cream across the body, and an oral JAK can be used in that setting with the right therapeutic ratio. As we guided to, you know, we want to get the study going by the end of this calendar year. Povorcitinib is, you know, relatively JAK1 specific. You saw, you know, the program in HS, both STOP HS1 and HS2 are enrolling really, really well based on the, you know, what we think is excellent phase 2 data, including that HiSCR 100 response. But as you allude to, you know, we have now data in prurigo nodularis, that's excellent, and we want to progress that into phase 3.

<unk> ratio and as we guided to you know we wanted to get this study going by the end of this calendar year. <unk>. Relatively JAK one specific you saw the programming H S. Both stop Hs ones Hs to enrolling really really well based on the you know what we think is excellent phase II data, including that his called 100 response, but as you allude to we have now you know data.

<unk>. Relatively JAK one specific you saw the programming H S. Both stop Hs ones Hs to enrolling really really well based on the you know what we think is excellent phase II data, including that his called 100 response, but as you allude to we have now you know data.

Relatively JAK one specific you saw the programming H S. Both stop Hs ones Hs to enrolling really really well based on the you know what we think is excellent phase II data, including that his called 100 response, but as you allude to we have now you know data.

in [inaudible] that's excellent and we want to progress that into phase III, and then ongoing efforts beyond dermatology in asthma, and chronic spontaneous urticaria, where the biology points to this kind of JAK one agent potentially showing substantial benefit in patients with more severe asthma, who on inhaled corticosteroids long acting bronchodilator and still having yearly exacerbations. That's a phase II proof of concept study and then standard endpoints in chronic spontaneous urticaria. So this drug has demonstrated thus far remarkable activity in those areas where we're studying in phase III now and we'll see what happens in asthma in CSU, so thanks for the question.

Steven Stein: And then ongoing efforts beyond dermatology in asthma and chronic spontaneous urticaria, where the biology points to this kind of JAK1 agent potentially showing substantial benefit in patients with more severe asthma who on inhaled corticosteroids, long-acting bronchodilators, and still having yearly exacerbations. That's a phase 2 proof of concept study and then standard endpoints in chronic spontaneous urticaria. So, you know, this drug has demonstrated thus far, you know, remarkable activity in those areas where we study in phase 3 now, and we'll see what happens in asthma and CSU. So thanks for the question.

And then ongoing efforts beyond dermatology in asthma and chronic spontaneous urticaria, where the biology points to this kind of JAK1 agent potentially showing substantial benefit in patients with more severe asthma who on inhaled corticosteroids, long-acting bronchodilators, and still having yearly exacerbations. That's a phase 2 proof of concept study and then standard endpoints in chronic spontaneous urticaria. So, you know, this drug has demonstrated thus far, you know, remarkable activity in those areas where we study in phase 3 now, and we'll see what happens in asthma and CSU. So thanks for the question.

This kind of JAK, one agent potentially showing substantial benefit in patients with more severe asthma, who on on inhaled corticosteroids long acting bronchodilator and still having yearly exacerbations. That's a phase II proof of concept study and then standard endpoints in chronic spontaneous urticaria. So you know we. This drug has demonstrated thus far you know remarkable activity in those areas, where we were where we sat in phase III now and we'll see what happens in asthma in CSU. So thanks for the question.

This drug has demonstrated thus far you know remarkable activity in those areas, where we were where we sat in phase III now and we'll see what happens in asthma in CSU. So thanks for the question.

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

[Analyst] (Guggenheim Securities): Hey, good morning. This is Paul on for Michael. Thanks for taking our question. I just wanted to build on the prior question. Can you talk about how you plan to position Povorcitinib in prurigo nodularis in the planned phase 3 relative to sort of how you design the ongoing phase 3 studies for Opzelura? Is there a meaningful difference in the target patient populations, and how should we think about the specific addressable opportunities within PN for the two programs? Thank you.

Michael Schmidt: Hey, good morning. This is Paul on for Michael. Thanks for taking our question. I just wanted to build on the prior question. Can you talk about how you plan to position Povorcitinib in prurigo nodularis in the planned phase 3 relative to sort of how you design the ongoing phase 3 studies for Opzelura? Is there a meaningful difference in the target patient populations, and how should we think about the specific addressable opportunities within PN for the two programs? Thank you.

Unknown: Hey, good morning. This is Paul on for Michael. Thanks for taking my question. I just wanted to build on the prior question, can you talk about how you plan to position [inaudible] in the planned phase III relative to sort of how you designed the ongoing phase III studies for OPZELURA. Is there a meaningful difference in the target patient populations and how should we think about the specific addressable opportunities within the year for the two programs?

Is there a meaningful difference in the target patient populations and how should we think about the specific addressable opportunities are within the yen for the for the two programs. Yeah. Okay.

Yeah. Okay.

Okay.

Steven Stein: Yeah, thank you for the question. You know, in terms, and Hervé said this upfront in his remarks, there's a prevalence, you know, upwards of 200,000 plus patients, but there are about 80 to 100,000, you know, that currently get treated in this setting. And their main manifestation of their disease is itch and very severe itch. And that's what the phase 2 showed, you know, that activity in that setting across the dose ranges. I think it's premature beyond that to talk about, you know, the endpoint and the dose we'll be using because we've just got the phase 2 data in. But it will be, again, because it's an oral agent, targeting the more severe spectrum of PN. That's what I can tell you now. Thanks.

Barry P. Flannelly: Yeah, thank you for the question. Just so you know, in terms what Herve said upfront in his remarks, there's a prevalence upwards of 200,000 plus patients, but they're about 80,000 to 100,000 that currently get treated in this setting and their main manifestation of their disease is itch and very severe itch, and that's what the phase II showed, that activity in that setting across the dose ranges. I think it's premature beyond that to talk about the endpoint and the dose we'll be using because we've just got the phase II data in, but it will be again, because it's an oral agent targeting the more severe spectrum of the end; that's what I can tell you now. Thanks.

Just so you know in terms of everybody said this upfront in his remarks, the there's a there's a prevalence upwards of 200000 plus patients, but they're about 80 to 100000, you know that currently get treated in this setting and the main manifestation of there there are diseases itch and very.

Severe itch, so and that's what the phase II showed you know that that activity in that setting across the dose ranges I think it's premature beyond that to talk about you know the endpoint and the dose will be using because we've just got the phase II data in <unk>, but it will be again, because it's an oral agent targeting the more severe spectrum of.

Yeah, and that's what I can tell you now thanks.

Operator: Thank you. Our next question is coming from Mara Goldstein, from Mizuho Securities. Your line is now live.

Operator: Thank you. The next question is coming from Mara Goldstein from Mizuho Securities. Your line is now live.

[Analyst]: Great. Thanks so much for taking the question. I just was hoping actually to get a little bit more color on the Medicaid penetration with respect to Opzelura, because, you know, last quarter it was identified as a jump in the payer mix that had an effect, right, on Opzelura and the gross-to-net. And then secondarily, I'm just hoping maybe you could talk a little bit about PV for Jakafi. I mean, it looks like the percentage, just eyeballing it, right, of Jakafi sales from PV has remained relatively stable. And I'm curious as to, with this new data and potentially earlier patient starts, where you think the growth could be?

Mara Goldstein: Great. Thanks so much for taking the question. I just was hoping actually to get a little bit more color on the Medicaid penetration with respect to Opzelura, because, you know, last quarter it was identified as a jump in the payer mix that had an effect, right, on Opzelura and the gross-to-net. And then secondarily, I'm just hoping maybe you could talk a little bit about PV for Jakafi. I mean, it looks like the percentage, just eyeballing it, right, of Jakafi sales from PV has remained relatively stable. And I'm curious as to, with this new data and potentially earlier patient starts, where you think the growth could be?

Mara Goldstein: Great. Thanks so much for taking the question. I just was hoping actually to get a little bit more color on the Medicaid penetration with respect to OPZELURA because last quarter it was identified as a jump in the payer mix that had an effect on OPZELURA and the gross net. And then secondarily, just hoping maybe you could talk a little bit about PV for JAKAFI, it looks like the percentage just eyeballing it right of JAKAFI sales from PV has remained relatively stable and I'm curious as to with this new data and potentially earlier patient starts where you think the growth could be?

And the question that and then secondarily I'm just hoping maybe you could talk a little bit about PV for Jakafi. But it looks like the percentage just eyeballing it right of Jakafi sales from PD has remained relatively stable and I'm curious as to with this new data and potentially earlier patient starts where are you thinking. Gross could be.

But it looks like the percentage just eyeballing it right of Jakafi sales from PD has remained relatively stable and I'm curious as to with this new data and potentially earlier patient starts where are you thinking. Gross could be.

Gross could be.

Barry P. Flannelly: Sure. So as far as Medicaid patients on OPZELURA goes, it's about 14% of paid patients as we said in the past we had such good coverage for Medicaid throughout all 50 states that it sort of grew faster than perhaps the commercial patients, so I think that answers part of your question. For JAKAFI and PV, I guess if you were looking at the slide that we had there, PV in terms of the patient share, it's about 35% or so at any given time for example, this year, year-to-date there's more than 8,000 patients on PV, but PV patients stay on the drug for a long time. So we're talking about what we think now the average is about 41 months that patients are staying on JAKAFI for PV. So that's important for every new PV patient that becomes more important and we think that there's lots of patients who are currently on other therapies, including hydroxyurea that would benefit from moving to JAKAFI earlier, and now that we have a study where there was no crossover so that you can actually evaluate the long term thrombosis free survival and in fact progression free survival for patients that that's really an indicator that you really should start earlier with an effective therapy like JAKAFI and we think that's really where the upside is here is that each and every PD patient is valuable and we can provide them with really effective therapy to manage their disease long term. So that's what our growth expectations are. Thanks.

Barry Flannelly: ... so in part, as Medicaid patients for, for, Opzelura goes, it's about 14% of paid patients. You know, as we said in the past, we had such good coverage for Medicaid throughout all 50 states, that it was sort of grew faster than perhaps the commercial patients. So, I think that answers part of your question. For Jakafi and PV, I guess if you're looking at the slide that we had there, you know, PV, it continued in terms of the patient share, it, you know, is about 35% or so at any given time. For example, this year, year to date, there's more than 8,000 patients on PV. But PV patients stay on the drug for a long time.

No as we said in the past we had such good coverage for Medicaid throughout all 50 states that it was sort of grew faster than perhaps the commercial patients. So I think that answers part of your question for Jakafi in PV I guess, if you were looking at the slide that we had there you know P V. It continue in terms of the patient. Sure. It's a you know it was about 35% or so at any given time for example, this year. Year to date Theres more than 8000 patients on P V, but PV patients. Stay on the drug for a long time, so we're talking about what we think NAV now the average is about 41 months that patients are staying on. Jack a five for P. V. So that's important for every new PV patient becomes more important and we think that there's lots of patients who are currently on other therapies, including hydroxyurea.

Sure. It's a you know it was about 35% or so at any given time for example, this year. Year to date Theres more than 8000 patients on P V, but PV patients. Stay on the drug for a long time, so we're talking about what we think NAV now the average is about 41 months that patients are staying on. Jack a five for P. V. So that's important for every new PV patient becomes more important and we think that there's lots of patients who are currently on other therapies, including hydroxyurea.

It's a you know it was about 35% or so at any given time for example, this year. Year to date Theres more than 8000 patients on P V, but PV patients. Stay on the drug for a long time, so we're talking about what we think NAV now the average is about 41 months that patients are staying on. Jack a five for P. V. So that's important for every new PV patient becomes more important and we think that there's lots of patients who are currently on other therapies, including hydroxyurea.

Year to date Theres more than 8000 patients on P V, but PV patients. Stay on the drug for a long time, so we're talking about what we think NAV now the average is about 41 months that patients are staying on. Jack a five for P. V. So that's important for every new PV patient becomes more important and we think that there's lots of patients who are currently on other therapies, including hydroxyurea.

Stay on the drug for a long time, so we're talking about what we think NAV now the average is about 41 months that patients are staying on. Jack a five for P. V. So that's important for every new PV patient becomes more important and we think that there's lots of patients who are currently on other therapies, including hydroxyurea.

Barry Flannelly: So we're talking about what we think now, now the average is about 41 months that patients are staying on Jakafi for PV. So that's important. So every new PV patient becomes, you know, that more important. And we think that there's lots of patients who are currently on other therapies, including hydroxyurea, that would benefit from moving to Jakafi earlier. And now that we have a study where there was no crossover, so that you can actually evaluate the long-term thrombosis-free survival, and in fact, progression-free survival for patients, that's really an indicator that you really should start earlier with an effective therapy like Jakafi.

So we're talking about what we think now, now the average is about 41 months that patients are staying on Jakafi for PV. So that's important. So every new PV patient becomes, you know, that more important. And we think that there's lots of patients who are currently on other therapies, including hydroxyurea, that would benefit from moving to Jakafi earlier. And now that we have a study where there was no crossover, so that you can actually evaluate the long-term thrombosis-free survival, and in fact, progression-free survival for patients, that's really an indicator that you really should start earlier with an effective therapy like Jakafi.

Jack a five for P. V. So that's important for every new PV patient becomes more important and we think that there's lots of patients who are currently on other therapies, including hydroxyurea.

that would benefit from moving to JAKAFI earlier, and now that we have a study where there was no crossover so that you can actually evaluate the long term thrombosis free survival and in fact progression free survival for patients that that's really an indicator that you really should start earlier with an effective therapy like JAKAFI and we think that's really where the upside is here is that each and every PD patient is valuable and we can provide them with really effective therapy to manage their disease long term. So that's what our growth expectations are. Thanks.

Barry Flannelly: We think that's really where the upside is here, is that each and every PV patient is valuable, and we can provide them with really effective therapy to manage their disease long term. That's what our growth expectations are. Thanks.

We think that's really where the upside is here, is that each and every PV patient is valuable, and we can provide them with really effective therapy to manage their disease long term. That's what our growth expectations are. Thanks.

That's really where the upside is here is that each and every vote PD patients valuable and we can provide them was really effective therapy to manage their disease long term. So that's what our growth expectations are.

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

Operator: Thank you. The next question today is coming from Andrew Berens from SPV Securities. Your line is in our live.

[Analyst] (SVB Securities): Hi. Thanks. Can you remind us how you see thirty-three ninety-nine fitting into the treatment paradigm for MF relative to the JAK agents? And then, do you see the regulatory pathway leveraging surrogate endpoints for approval, or would you want to show a decrease in malignant transformation in this subgroup?

Andrew Berens: Hi. Thanks. Can you remind us how you see thirty-three ninety-nine fitting into the treatment paradigm for MF relative to the JAK agents? And then, do you see the regulatory pathway leveraging surrogate endpoints for approval, or would you want to show a decrease in malignant transformation in this subgroup?

Andrew Berens: Hi, thanks. Can you remind us how you see 33 fitting into the treatment paradigm relative to the JAK agents? And do you see the regulatory pathway leveraging surrogate endpoints for approval or would you want to show a decrease in malignant transformation [inaudible]?

It's fitting into the treatment paradigm relative. Relative to the jacket agents. You see the regulatory pathway leveraging surrogate endpoints for approval. Would you want to show a decrease in malignant transformation.

Relative to the jacket agents. You see the regulatory pathway leveraging surrogate endpoints for approval. Would you want to show a decrease in malignant transformation.

You see the regulatory pathway leveraging surrogate endpoints for approval. Would you want to show a decrease in malignant transformation.

Would you want to show a decrease in malignant transformation.

Yes. Okay.

Okay.

Steven Stein: Andy, were you all asking about Steven, just to clarify your question about mutant CALR and V617F in the future? We couldn't hear clearly your first part of your question.

Steven H. Stein: Andy were you are asking about--Steven, just to clarify your question about mutant Cal RMB 607 F in the future? We couldn't hear clearly the first part of your question.

[Analyst] (SVB Securities): Yeah. Yeah, I'm just, I'm trying to understand how you see that fitting into the treatment paradigm relative to the JAK agents.

Andrew Berens: Yeah. Yeah, I'm just, I'm trying to understand how you see that fitting into the treatment paradigm relative to the JAK agents.

Andrew Berens: Yeah, I'm trying to understand how you see that fitting into the treatment paradigm relative to the JAK agents.

I understand how you see that sitting into the treatment paradigm. Notice of the JAK agents.

Notice of the JAK agents.

Steven Stein: Okay, great. Thank you. So, you know, as Pablo said in his remarks, you know, a remarkable effort from our research group to come up with compounds that now, you know, target new areas of biology. So in terms of mutant CALR, it's about 25% to 30% of myelofibrosis and ET. It's a neoantigen that's expressed, and the antibody targets that and could eradicate the clone. So you could be talking about a very new treatment paradigm that's disease-modifying or potentially, in inverted commas, curable, if you eliminate the clone in those settings. Obviously, we're early in the clinic. We need to prove it's safe and get there, but there's a lot of excitement, and obviously you've got a plenary at ASH last year because of that, with the mutant CALR antibody.

Steven H. Stein: Okay, great. Thank you. So as Pablo said in his remarks, a remarkable effort from our research group to come up with compounds that now target new areas of biology. So in terms of of mutant CAL R it's about 25-30% of myelofibrosis and ET. That's a neo antigen that's expressed and the antibody targets that and could eradicate the code. So you could be talking about a very new treatment paradigm that's disease modifying or potentially in inverted commas curable if you eliminate the clone in those settings. Obviously, we're early in the clinic, we need to prove its safe and get there, but there's a lot of excitement and obviously you got a plenary at ASH last year because of that with the mutant CAL R antibody.

That's our neo antigen, that's expressed and the antibody targets that and could eradicate the code. So you could be talking about a very new treatment paradigm, that's disease modifying or potentially in inverted commas curable. If you eliminate the clone in those settings. Obviously, we early in the clinic we need. To prove its safe and get there, but it's there's a lot of excitement and obviously you got a plenary at ash last year because of that with them you can cut our antibody.

To prove its safe and get there, but it's there's a lot of excitement and obviously you got a plenary at ash last year because of that with them you can cut our antibody.

Steven Stein: In terms of where it fits in, you know, it won't be an agent that's, you know, in the way we think about spleen volume reduction and symptom improvement. It could be, as I said, to be a little bit repetitive, eliminate the clone and sort of get rid of the disease, if you will. The same with V617F, you know, a target that many have pursued for a, a long time. And again, you know, credit to our research group for coming up with, as Pablo pointed out, a very novel way of targeting the mutation in the JH2 domain, and then again, the idea would be to eliminate the clone and disease modify it. And this is a bigger population. It's about 50% of MF, 60% of ET, and 95% plus of polycythemia vera.

In terms of where it fits in, you know, it won't be an agent that's, you know, in the way we think about spleen volume reduction and symptom improvement. It could be, as I said, to be a little bit repetitive, eliminate the clone and sort of get rid of the disease, if you will. The same with V617F, you know, a target that many have pursued for a, a long time. And again, you know, credit to our research group for coming up with, as Pablo pointed out, a very novel way of targeting the mutation in the JH2 domain, and then again, the idea would be to eliminate the clone and disease modify it. And this is a bigger population. It's about 50% of MF, 60% of ET, and 95% plus of polycythemia vera.

In terms of where it fits in, it won't be an agent that's in the way we think about spleen volume reduction and symptom improvement it could be as I said to be a little bit repetitive, eliminate the clone and sort of get rid of the disease if you will. The dame with V 617S target that many of pursuit for a long time and again credit to our research group for coming up with as Pablo pointed out a very novel way of targeting the mutation in the JH2 domain and then again the idea would be to eliminate the clone in disease modifier and this is a bigger population. It's about 50% of MS, 60% of ET, and 95% plus of Polycythemia Vera. So for the first time now we've been able to show you that you can come up with a targeting PV, where it's an area where we haven't been able yet to give you anything new beyond [inaudible] so we're very excited about that. Again, it's early, we have to get the R&D across the finish line and get into the clinic, but it's a superb science and would be a very different way of thinking about those entities. So thanks for the question.

Same with V 617, as you know a target that many of pursuit for a long time and again credit to our research group for coming up with as public pointed out a very novel way of targeting the mutation in the J H two domain and then again the idea would be to eliminate the clone in disease modified.

and this is a bigger population. It's about 50% of MS, 60% of ET, and 95% plus of Polycythemia Vera. So for the first time now we've been able to show you that you can come up with a targeting PV, where it's an area where we haven't been able yet to give you anything new beyond [inaudible] so we're very excited about that. Again, it's early, we have to get the R&D across the finish line and get into the clinic, but it's a superb science and would be a very different way of thinking about those entities. So thanks for the question.

Steven Stein: So for the first time now, we've been able to show you that we've come up with a target in PV, where it's an area where we, where we haven't been able yet to give you anything new beyond RUX. We're very excited about that. Again, it's early. We have to get the R&D across the finish line and get into the clinic, but it's superb science and would be a very different way of thinking about those entities. So thanks for the question.

So for the first time now, we've been able to show you that we've come up with a target in PV, where it's an area where we, where we haven't been able yet to give you anything new beyond RUX. We're very excited about that. Again, it's early. We have to get the R&D across the finish line and get into the clinic, but it's superb science and would be a very different way of thinking about those entities. So thanks for the question.

Again, it's early I forget the R&D across the finish line and get into the clinic, but it's a superb science and would be a very different way of thinking about those entities. So thanks for the question.

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

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

Barry Flannelly: Oh, hi, this is Chung, the line for Jay. Thanks for taking the question. So just follow on the prior question, just for the V617F mutations. I'm just wondering, your thinking about the monotherapy versus combination approach going forward. And just on the slide, it seems like those, CALR mutations and, V617F mutations are mutually exclusive. So just wanna confirm if that's correct. And just a quick question on Opzelura. Wondering if you can talk about the splits between AD and vitiligo in Q1. That'd be great. Thank you.

[Analyst] (Oppenheimer): Oh, hi, this is Chung, the line for Jay. Thanks for taking the question. So just follow on the prior question, just for the V617F mutations. I'm just wondering, your thinking about the monotherapy versus combination approach going forward. And just on the slide, it seems like those, CALR mutations and, V617F mutations are mutually exclusive. So just wanna confirm if that's correct. And just a quick question on Opzelura. Wondering if you can talk about the splits between AD and vitiligo in Q1. That'd be great. Thank you.

Unknown: Hi, this is Shawn online for Jay. Thanks for taking the question. So just to follow up on the [inaudible] question just [inaudible] I'm just wondering how you're thinking about the monotherapy versus combination approach going forward? On this slide it feels like the [inaudible] mutations are mutually exclusive so just want to confirm that that's correct. And just a quick question on OPZELURA, I'm wondering if you can talk about the split between AD and vitiligo, that'd be great. Thank you.

For them to put quite a question just sort of be 17 applications. I'm just wondering your thinking about the monotherapy versus combination approach going forward. On the slide it feels like the Carlyle mutations. Absolutely. Which leaves exclusive so just wanted to confirm that. That's correct, Yeah, and just a quick question on <unk>. Wondering if you can talk about the split between E D. That'd be great. Thank you.

I'm just wondering your thinking about the monotherapy versus combination approach going forward. On the slide it feels like the Carlyle mutations. Absolutely. Which leaves exclusive so just wanted to confirm that. That's correct, Yeah, and just a quick question on <unk>. Wondering if you can talk about the split between E D. That'd be great. Thank you.

On the slide it feels like the Carlyle mutations. Absolutely. Which leaves exclusive so just wanted to confirm that. That's correct, Yeah, and just a quick question on <unk>. Wondering if you can talk about the split between E D. That'd be great. Thank you.

Absolutely. Which leaves exclusive so just wanted to confirm that. That's correct, Yeah, and just a quick question on <unk>. Wondering if you can talk about the split between E D. That'd be great. Thank you.

Which leaves exclusive so just wanted to confirm that. That's correct, Yeah, and just a quick question on <unk>. Wondering if you can talk about the split between E D. That'd be great. Thank you.

That's correct, Yeah, and just a quick question on <unk>. Wondering if you can talk about the split between E D. That'd be great. Thank you.

Wondering if you can talk about the split between E D. That'd be great. Thank you.

That'd be great. Thank you.

Pablo Cagnoni: So, this is Pablo. Let me take the first part of the question. So, as Steven mentioned, and I explained in my remarks, it's early days for both programs. I think that when you start thinking about how to position them and the combination, potential combination with Jakafi, I think we need to get through a few cohorts in the phase 1 studies, understand the profile of these two new medicines, and then we'll start building a combination strategy. I think potentially that could be the case, particularly, as you start thinking about symptom resolution with Jakafi early in the treatment paradigm, and then using either V617F or the mutant CALR antibody, to then try to eliminate the clone and potentially transform the outcomes in these diseases.

Pablo J. Cagnoni: So this is Pablo, let me take the first part of the question. So as Steven mentioned and I explained in my remarks, it's early days for both programs. I think that when you start thinking about how to position them and the potential combination with JAKAFI, I think we need to get through a few cohorts in the phase one studies, understand the profile of these two new medicines and then we'll start building a combination strategy. I think potentially that could be the case, particularly just thinking about symptom resolution with JAKAFI early in the treatment paradigm and then using either V617S or the mutant CAL R antibody to then try to eliminate the clone and potentially transform the outcomes in these diseases.

When you start thinking about how to position them and they come in a potential combination with Jakafi I think we need to get through a few cohorts in the phase one studies understand the profile of these two new medicines and then we'll start building a combination strategy I think potentially that could be the case, particularly Oh I was just.

thinking about symptom resolution with JAKAFI early in the treatment paradigm and then using either V617S or the mutant CAL R antibody to then try to eliminate the clone and potentially transform the outcomes in these diseases. The second part of your question I think was related to whether these are mutually exclusive and they are and that's actually an important point in

The second part of your question I think was related to whether these are mutually exclusive and they are and that's actually an important point in understanding how to position them in the future. And then I think you had a question about AD, which I'll pass over to Barry.

Pablo Cagnoni: The second part of your question, I think, was related to whether these are mutually exclusive, and they are. That's actually an important point in understanding how to position them in the future. And then I think you had a question about AD, which I'll pass over to Barry.

The second part of your question, I think, was related to whether these are mutually exclusive, and they are. That's actually an important point in understanding how to position them in the future. And then I think you had a question about AD, which I'll pass over to Barry.

understanding how to position them in the future. And then I think you had a question about AD, which I'll pass over to Barry. Yeah, I didn't really hear you. So AD versus vitiligo what were you trying to say whether there's a split volume?

understanding how to position them in the future. And then I think you had a question about AD, which I'll pass over to Barry.

Barry Flannelly: Yeah, Chung, I didn't really hear you. So AD versus vitiligo, what were you trying to say? What is the, whether it's the script volume?

Barry P. Flannelly: Yeah, I didn't really hear you. So AD versus vitiligo what were you trying to say whether there's a split volume?

[Analyst] (Wells Fargo): ... Yeah, that's split between AD and vitiligo. Thank you.

[Analyst] (Oppenheimer): ... Yeah, that's split between AD and vitiligo. Thank you.

Unknown: Yeah, the split between AD and vitiligo. Thank you.

Scoop.

Barry P. Flannelly: Sure, currently it's about 60, 40, so 60 AD, 40% vitiligo.

Steven Stein: Sure. Currently, it's about 60/40. So 60% AD, 40% vitiligo. Thanks.

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

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

[Analyst]: Hey, good morning, guys. Thanks for taking the questions. Maybe for Steven, can you talk a little bit about how you view the competitive landscape in PN and HS, and could the landscape change prior to your phase 3 readouts, or, or are you the clear sort of, you know, market leader in, in, in both indications? And I guess just as a, as a second sort of follow-up question, maybe for Hervé, you guys are generating significant, you know, cash flow. You have a strong balance sheet. The pipeline's largely ignored by investors and is, is, you know, significantly down. Can you talk maybe a little bit about the process that you might be going through to, you know, maybe switch gears, maybe acquire an entire company platform, pipeline, and all, versus striking kind of one-off product collaboration agreements?

Reni Benjamin: Hey, good morning, guys. Thanks for taking the questions. Maybe for Steven, can you talk a little bit about how you view the competitive landscape in PN and HS, and could the landscape change prior to your phase 3 readouts, or, or are you the clear sort of, you know, market leader in, in, in both indications? And I guess just as a, as a second sort of follow-up question, maybe for Hervé, you guys are generating significant, you know, cash flow. You have a strong balance sheet. The pipeline's largely ignored by investors and is, is, you know, significantly down. Can you talk maybe a little bit about the process that you might be going through to, you know, maybe switch gears, maybe acquire an entire company platform, pipeline, and all, versus striking kind of one-off product collaboration agreements?

Ren Benjamin: Hey, good morning guys. Thanks for taking the question. Maybe for Steven, can you talk a little bit about how you view the competitive landscape in PN and HS and could the landscape change prior to your phase III readouts or are you the clear sort of market leader in both indications?

And I guess just as a follow up question, maybe for Herve, you guys are generating significant cash flow, you have a strong balance sheet, the pipelines largely ignored by investors and is significantly down. Can you talk maybe a little bit about the process that you might be going through to maybe switch gears, maybe acquire an entire company platform and pipeline in all versus striking kind of one off product collaboration agreements?

Follow up question, maybe for her day, you guys are generating significant.

Cash flow you have a strong balance sheet the pipelines largely ignored by investors. As you know significantly down can you talk maybe a little bit about the process.

As you know significantly down can you talk maybe a little bit about the process.

But you might be going through to. Switch gears, maybe acquire an entire company platform and pipeline in them and all versus striking kind of one off product collaboration agreements.

Switch gears, maybe acquire an entire company platform and pipeline in them and all versus striking kind of one off product collaboration agreements.

Steven Stein: I'll start and then hand it over to Steven. So, let me remind you, so Povorcitinib is an oral agent. In both entities you're talking about, you know, are becoming, you know, very interesting in terms of the science, a lot of targeting with different modalities, but they're mostly intravenous (IV), large molecules that target things like IL-17, so very specific biology. Whereas in, you know, these entities, there's more broad biology, and that's why we think JAK may be important here, both in PN and HS. An oral agent, now we've shown, you know, what we think is very strong proof of concept data in both entities. HS, we have ongoing two phase 3s, and PN will be proceeding there. Sure, you know, the landscape can always change.

Hervé Hoppenot: So I'll start and then hand it over to Steven. Let me remind you that [inaudible] is an oral agent. Both entities, you're talking about are becoming very interesting in terms of the science a lot of targeting with different modalities, but they're mostly intravenous IV large molecules that target things like IL 17, so very specific biology, whereas in these entities, there's more broad biology, and that's why we think JAK may be important here both in PN and HS as an oral agent. Now we've shown what we think is very strong proof of concept data in both entities, HS we have ongoing two phase threes and PN will be preceding it. Sure, the landscape can always change as part of any assessment we do, we look at the competitive landscape and what may occur. But in terms of an oral agent, we think that that's the big differentiator here and then I'll hand it over for the second part of your question.

Hervé Hoppenot: I'll start and then hand it over to Steven. So, let me remind you, so Povorcitinib is an oral agent. In both entities you're talking about, you know, are becoming, you know, very interesting in terms of the science, a lot of targeting with different modalities, but they're mostly intravenous (IV), large molecules that target things like IL-17, so very specific biology. Whereas in, you know, these entities, there's more broad biology, and that's why we think JAK may be important here, both in PN and HS. An oral agent, now we've shown, you know, what we think is very strong proof of concept data in both entities. HS, we have ongoing two phase 3s, and PN will be proceeding there. Sure, you know, the landscape can always change.

But let me remind you that promise to them as oral agent. Both entities, you're talking about and are. Becoming very interesting in terms of the science a lot of targeting with different modalities, but they mostly intravenous IV large molecules that target things like IL 17, so very specific biology, whereas in these entities, there's more broad biology, and that's why we think Jack may be important to you. Both in P. N N H S. An oral agent now we've shown what we think is very strong proof of concept data in both entities H S. We have ongoing two phase threes and pn will be preceding yeah. Sure. You know the landscape can always change as part of any assessment. We do we look at the competitive landscape and what what may occur. But in terms of you know. An oral agent, we think that that's the big differentiator here and then I'll hand, it over to the second part of your question.

Both entities, you're talking about and are. Becoming very interesting in terms of the science a lot of targeting with different modalities, but they mostly intravenous IV large molecules that target things like IL 17, so very specific biology, whereas in these entities, there's more broad biology, and that's why we think Jack may be important to you. Both in P. N N H S. An oral agent now we've shown what we think is very strong proof of concept data in both entities H S. We have ongoing two phase threes and pn will be preceding yeah. Sure. You know the landscape can always change as part of any assessment. We do we look at the competitive landscape and what what may occur. But in terms of you know. An oral agent, we think that that's the big differentiator here and then I'll hand, it over to the second part of your question.

Becoming very interesting in terms of the science a lot of targeting with different modalities, but they mostly intravenous IV large molecules that target things like IL 17, so very specific biology, whereas in these entities, there's more broad biology, and that's why we think Jack may be important to you. Both in P. N N H S. An oral agent now we've shown what we think is very strong proof of concept data in both entities H S. We have ongoing two phase threes and pn will be preceding yeah. Sure. You know the landscape can always change as part of any assessment. We do we look at the competitive landscape and what what may occur. But in terms of you know. An oral agent, we think that that's the big differentiator here and then I'll hand, it over to the second part of your question.

Both in P. N N H S. An oral agent now we've shown what we think is very strong proof of concept data in both entities H S. We have ongoing two phase threes and pn will be preceding yeah. Sure. You know the landscape can always change as part of any assessment. We do we look at the competitive landscape and what what may occur. But in terms of you know. An oral agent, we think that that's the big differentiator here and then I'll hand, it over to the second part of your question.

Steven Stein: As part of any assessment we do, we look at the competitive landscape and what may occur. But in terms of, you know, an oral agent, we think that's the big differentiator here, and then I'll hand it over for the second part of your question.

As part of any assessment we do, we look at the competitive landscape and what may occur. But in terms of, you know, an oral agent, we think that's the big differentiator here, and then I'll hand it over for the second part of your question.

But in terms of you know. An oral agent, we think that that's the big differentiator here and then I'll hand, it over to the second part of your question.

An oral agent, we think that that's the big differentiator here and then I'll hand, it over to the second part of your question.

Steven H. Stein: So your question about the way how we're sort of turning into a new direction regarding the use of cash, and the answer is we are still continuing to look at opportunities outside of the company, we are still investing in our pipeline, but as you have noticed our growth of the revenue continues to be faster, higher than the growth of our expenses, so we continue to generate leverage and we continue to have an increasing cash flow quarter after quarter and we are looking at opportunities to continue to add to the growth of the corporation in the year '25 to '30 so it's a relatively broad target. Obviously valuations have been frustrating a lot in the past months and it's creating opportunities that we are looking at so there is a clear willingness for the right price to add new products that would be fitting with our portfolio, if we can. We could do it through partnership or acquisition, in fact, we think both would be appropriate and it's a financial question, it's a question of willingness to go one route or the other but we could do it either way.

Hervé Hoppenot: So your question about, you know, the way, are we sort of turning into a new direction regarding the use of cash, and the answer is we are still continuing to look at opportunities outside of the company. We are still investing in our pipeline, but as you have noticed, you know, our growth of the revenue continues to be faster, higher than the growth of our expenses. So we continue to generate leverage, and we continue to have an increasing cash flow, you know, quarter after quarter. And we are looking at opportunities to continue to add to the growth of the corporation in the years 2025 to 2030. So it's a relatively broad target. Obviously, valuations have been fluctuating a lot in the past months, and it's creating opportunities that we are looking at.

So your question about the it goes away. Turning into a new direction regarding the use of cash. And the answer is we are still. Continuing to look at opportunities outside. Of the company, we are still investing in our pipeline, but as you'll have noticed you know I will gross up the revenue continues to be. Faster or higher than the growth of our expenses. So we continue to generate leverage and we continue to have an increasing cash flow. You know quarter after quarter and we are looking at opportunities to continue to add to the growth of the corporation into Europe 25 to Saudi. So it's a relatively broad target, obviously valuations have been a fluke. Trading a lot in the past in the past months and it's creating opportunities that we are looking up those areas. A clear willingness for the right price too. The new products that would be fitting with our portfolio. If we can we could do it through partnership or acquisition. In fact, we think both are would be appropriate and it's a financial question Oh. It's a question of willingness to go one route. But we could do it either way.

Steven Stein: So your question about, you know, the way, are we sort of turning into a new direction regarding the use of cash, and the answer is we are still continuing to look at opportunities outside of the company. We are still investing in our pipeline, but as you have noticed, you know, our growth of the revenue continues to be faster, higher than the growth of our expenses. So we continue to generate leverage, and we continue to have an increasing cash flow, you know, quarter after quarter. And we are looking at opportunities to continue to add to the growth of the corporation in the years 2025 to 2030. So it's a relatively broad target. Obviously, valuations have been fluctuating a lot in the past months, and it's creating opportunities that we are looking at.

Turning into a new direction regarding the use of cash. And the answer is we are still. Continuing to look at opportunities outside. Of the company, we are still investing in our pipeline, but as you'll have noticed you know I will gross up the revenue continues to be. Faster or higher than the growth of our expenses. So we continue to generate leverage and we continue to have an increasing cash flow. You know quarter after quarter and we are looking at opportunities to continue to add to the growth of the corporation into Europe 25 to Saudi. So it's a relatively broad target, obviously valuations have been a fluke. Trading a lot in the past in the past months and it's creating opportunities that we are looking up those areas. A clear willingness for the right price too. The new products that would be fitting with our portfolio. If we can we could do it through partnership or acquisition. In fact, we think both are would be appropriate and it's a financial question Oh. It's a question of willingness to go one route. But we could do it either way.

And the answer is we are still. Continuing to look at opportunities outside. Of the company, we are still investing in our pipeline, but as you'll have noticed you know I will gross up the revenue continues to be. Faster or higher than the growth of our expenses. So we continue to generate leverage and we continue to have an increasing cash flow. You know quarter after quarter and we are looking at opportunities to continue to add to the growth of the corporation into Europe 25 to Saudi. So it's a relatively broad target, obviously valuations have been a fluke. Trading a lot in the past in the past months and it's creating opportunities that we are looking up those areas. A clear willingness for the right price too. The new products that would be fitting with our portfolio. If we can we could do it through partnership or acquisition. In fact, we think both are would be appropriate and it's a financial question Oh. It's a question of willingness to go one route. But we could do it either way.

Continuing to look at opportunities outside. Of the company, we are still investing in our pipeline, but as you'll have noticed you know I will gross up the revenue continues to be. Faster or higher than the growth of our expenses. So we continue to generate leverage and we continue to have an increasing cash flow. You know quarter after quarter and we are looking at opportunities to continue to add to the growth of the corporation into Europe 25 to Saudi. So it's a relatively broad target, obviously valuations have been a fluke. Trading a lot in the past in the past months and it's creating opportunities that we are looking up those areas. A clear willingness for the right price too. The new products that would be fitting with our portfolio. If we can we could do it through partnership or acquisition. In fact, we think both are would be appropriate and it's a financial question Oh. It's a question of willingness to go one route. But we could do it either way.

Of the company, we are still investing in our pipeline, but as you'll have noticed you know I will gross up the revenue continues to be. Faster or higher than the growth of our expenses. So we continue to generate leverage and we continue to have an increasing cash flow. You know quarter after quarter and we are looking at opportunities to continue to add to the growth of the corporation into Europe 25 to Saudi. So it's a relatively broad target, obviously valuations have been a fluke. Trading a lot in the past in the past months and it's creating opportunities that we are looking up those areas. A clear willingness for the right price too. The new products that would be fitting with our portfolio. If we can we could do it through partnership or acquisition. In fact, we think both are would be appropriate and it's a financial question Oh. It's a question of willingness to go one route. But we could do it either way.

Faster or higher than the growth of our expenses. So we continue to generate leverage and we continue to have an increasing cash flow. You know quarter after quarter and we are looking at opportunities to continue to add to the growth of the corporation into Europe 25 to Saudi. So it's a relatively broad target, obviously valuations have been a fluke. Trading a lot in the past in the past months and it's creating opportunities that we are looking up those areas. A clear willingness for the right price too. The new products that would be fitting with our portfolio. If we can we could do it through partnership or acquisition. In fact, we think both are would be appropriate and it's a financial question Oh. It's a question of willingness to go one route. But we could do it either way.

You know quarter after quarter and we are looking at opportunities to continue to add to the growth of the corporation into Europe 25 to Saudi. So it's a relatively broad target, obviously valuations have been a fluke. Trading a lot in the past in the past months and it's creating opportunities that we are looking up those areas. A clear willingness for the right price too. The new products that would be fitting with our portfolio. If we can we could do it through partnership or acquisition. In fact, we think both are would be appropriate and it's a financial question Oh. It's a question of willingness to go one route. But we could do it either way.

So it's a relatively broad target, obviously valuations have been a fluke. Trading a lot in the past in the past months and it's creating opportunities that we are looking up those areas. A clear willingness for the right price too. The new products that would be fitting with our portfolio. If we can we could do it through partnership or acquisition. In fact, we think both are would be appropriate and it's a financial question Oh. It's a question of willingness to go one route. But we could do it either way.

Trading a lot in the past in the past months and it's creating opportunities that we are looking up those areas. A clear willingness for the right price too. The new products that would be fitting with our portfolio. If we can we could do it through partnership or acquisition. In fact, we think both are would be appropriate and it's a financial question Oh. It's a question of willingness to go one route. But we could do it either way.

Hervé Hoppenot: So there is a clear willingness for the right price to add new products that would be fitting with our portfolio, if we can. We could do it through partnership or acquisition. In fact, we think both would be appropriate, and it's a financial question, or it's a question of willingness to go one route or the other. But we could do it either way.

So there is a clear willingness for the right price to add new products that would be fitting with our portfolio, if we can. We could do it through partnership or acquisition. In fact, we think both would be appropriate, and it's a financial question, or it's a question of willingness to go one route or the other. But we could do it either way.

A clear willingness for the right price too. The new products that would be fitting with our portfolio. If we can we could do it through partnership or acquisition. In fact, we think both are would be appropriate and it's a financial question Oh. It's a question of willingness to go one route. But we could do it either way.

The new products that would be fitting with our portfolio. If we can we could do it through partnership or acquisition. In fact, we think both are would be appropriate and it's a financial question Oh. It's a question of willingness to go one route. But we could do it either way.

But we could do it either way.

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

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

[Analyst] (Wells Fargo): Good morning. This is Evelyn for Derek. Thanks for taking our question. A quick one from us. Can you provide some color on the pace of the pipeline development and whether it will be timely enough to offset Jakafi loss of exclusivity? Thanks.

Derek Archila: Good morning. This is Evelyn for Derek. Thanks for taking our question. A quick one from us. Can you provide some color on the pace of the pipeline development and whether it will be timely enough to offset Jakafi loss of exclusivity? Thanks.

Unknown: Good morning. This is [inaudible] on for Derek. Thanks for taking our question. A quick one from us, can you provide some color on the pace of the pipeline development and whether it will be timely enough to [inaudible] loss of exclusivity?

Thanks for taking our question a quick one for Matt can you provide some color on the peace pipeline development and whether it will be time being off small said shopify loss of exclusivity.

Steven Stein: So, thanks for the question. Absolutely, that's the case. So I'll be a little repetitive. You know, the XR program, we're busy in terms of response to the FDA now, and the idea is to get the XR approval prior to the loss of the LOE for RUX. Both BET and ALK programs, you know, we want to declare where we go, and if we go into registration studies, you know, end of this year, early part of next year, and it'll give us enough time to execute a Phase 3 program and get across the finish line there. So that's absolutely the intent. The mutant CALR and V617F, as Pablo said, are early, but great promise of disease-modifying agents. So it's a little unclear the regulatory path there, and it'll depend on demonstrating safety and efficacy.

Barry P. Flannelly: So thanks for the question. Absolutely that's the case, so I'll be a little repetitive. The XR program, we were busy in terms of response to the FDA now and the idea is to get the XR approval prior to the loss of the LOE for Rux. Both [inaudible] programs we want to declare where we go and if we go into registration studies end of this year early part of next year and that'll give us enough time to execute our phase III program and get across the finish line there, so that's absolutely the intent. The mutant CAL R and V617F, as Pablo said, are early but with great promise disease modifying agents and so it's a little unclear the regulatory path there, and it'll depend on demonstrating safety and efficacy, but we will see if that keeps going well, you could potentially execute a rapid phase III program, but it's really too early to say.

The XR program, we were busy in terms of response to the FDA now and the idea is to get the XR approval prior to the loss of the L. O E for Rex both Baton L programs, you know, we want to declare where we go and if we go into registration studies. End of this year early part of next year and that'll give us enough time to execute our phase III program and get across the finish line. There. So that's absolutely absolutely intent. The mutant cat are in V 617 F. As Pablo said, all early but with great promise as disease modifying agents and so it's a little unclear the regulatory path there. And it'll depend on demonstrating safety and efficacy. But we will. We'll see if if that keeps going well you could potentially execute a rapid phase III program, but it's really too early to say.

End of this year early part of next year and that'll give us enough time to execute our phase III program and get across the finish line. There. So that's absolutely absolutely intent. The mutant cat are in V 617 F. As Pablo said, all early but with great promise as disease modifying agents and so it's a little unclear the regulatory path there. And it'll depend on demonstrating safety and efficacy. But we will. We'll see if if that keeps going well you could potentially execute a rapid phase III program, but it's really too early to say.

And it'll depend on demonstrating safety and efficacy. But we will. We'll see if if that keeps going well you could potentially execute a rapid phase III program, but it's really too early to say.

Steven Stein: But we will, you know, we'll see if that keeps going well, you could potentially execute a, you know, rapid phase 3 program, but it's really too early to say.

But we will, you know, we'll see if that keeps going well, you could potentially execute a, you know, rapid phase 3 program, but it's really too early to say.

But we will. We'll see if if that keeps going well you could potentially execute a rapid phase III program, but it's really too early to say.

We'll see if if that keeps going well you could potentially execute a rapid phase III program, but it's really too early to say.

[Analyst] (Wells Fargo): Thanks.

Derek Archila: Thanks.

Hervé Hoppenot: Maybe I can add, I mean, on this view about the Jakafi patent expiration and the way we are sort of allocating resources, that's basically the eight program. You saw one of the slides is speaking about the eight program that we are prioritizing in R&D, and that's where you have the list of the programs that will be impacting our revenue in the years that are coming relatively soon, with CALR being maybe the one that is a little bit of a stretch, but for everything else, it could come before that time. The povorcitinib program, which is increasing, today we had the news of an additional indication in prurigo nodularis, is, you know, in phase 3 now for one indication, HS. Phase 3 is being planned for prurigo nodularis and vitiligo.

Hervé Hoppenot: Maybe I can add, I mean on this view about the JAKAFI on the configuration and the way we have thought of allocating resources, that's basically the eight program. You saw one of the slides speaking about the eight programs that we are prioritizing in R&D and that's where you have the list of the programs that will be impacting our revenue in the years that are coming relatively soon with CAL R being maybe the one that is a little bit of a stretch, but for everything else it could come before that time. And the [inaudible] program, which is increasing today, we had the news of an additional indication in [inaudible] is in phase three now for one indication. It says phase III is being planned for [inaudible] and vitiligo so all of that should be coming into [inaudible].

But on the exploration and the way we have thought of allocating resources. That's basically the eight program you saw one of the slides you speaking about the eight programs that we are prioritizing R&D and that's where you have the list of the programs that will be impacting our revenue into euros, but are coming relatively soon with cut out being maybe the ones that is a little bit of. Stretch, but for everything else it could it could come on before. Before that time and the publicity, but program, which is increasing today, we had the news of an additional indication in in Perrigo and <unk>. As you know in phase three now for one indication. It says phase III is being planned for perrigo. It goes through all of that should be coming into Europe. Proceeds from the exploration project.

That's basically the eight program you saw one of the slides you speaking about the eight programs that we are prioritizing R&D and that's where you have the list of the programs that will be impacting our revenue into euros, but are coming relatively soon with cut out being maybe the ones that is a little bit of. Stretch, but for everything else it could it could come on before. Before that time and the publicity, but program, which is increasing today, we had the news of an additional indication in in Perrigo and <unk>. As you know in phase three now for one indication. It says phase III is being planned for perrigo. It goes through all of that should be coming into Europe. Proceeds from the exploration project.

Stretch, but for everything else it could it could come on before. Before that time and the publicity, but program, which is increasing today, we had the news of an additional indication in in Perrigo and <unk>. As you know in phase three now for one indication. It says phase III is being planned for perrigo. It goes through all of that should be coming into Europe. Proceeds from the exploration project.

Before that time and the publicity, but program, which is increasing today, we had the news of an additional indication in in Perrigo and <unk>. As you know in phase three now for one indication. It says phase III is being planned for perrigo. It goes through all of that should be coming into Europe. Proceeds from the exploration project.

As you know in phase three now for one indication. It says phase III is being planned for perrigo. It goes through all of that should be coming into Europe. Proceeds from the exploration project.

It goes through all of that should be coming into Europe. Proceeds from the exploration project.

Hervé Hoppenot: So all of that should be coming in the years that, that precede the patent expiration for Jakafi.

Proceeds from the exploration project.

Operator: Thank you. Our final question today is coming from Evan Siegerman, from BMO Capital Markets. Your line is now live.

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

Unknown: Hi, [inaudible] on for Evan. Just wanted to ask with the pre-submission meeting the FDA planned for pediatric patients, are there any nuances with that submission in the pediatric population versus adults that you think will require special consideration for the FDA and Incyte? And has there been any indication on when that may take place? Thank you.

[Analyst]: Hi, Marc Frahm on for Evan. Just wanted to ask, with the pre-submission meeting with FDA planned for ruxolitinib cream in pediatric patients, are there any nuances with that submission in the pediatric population versus adults that you think will require special consideration for the FDA and Incyte? And has there been any indication on when that meeting may take place? Thank you.

Marc Frahm: Hi, Marc Frahm on for Evan. Just wanted to ask, with the pre-submission meeting with FDA planned for ruxolitinib cream in pediatric patients, are there any nuances with that submission in the pediatric population versus adults that you think will require special consideration for the FDA and Incyte? And has there been any indication on when that meeting may take place? Thank you.

Pediatric patients are there any nuances with that submission in the pediatric population versus adults.

School requires special consideration for the FDA and inside and has there been any indication on when that may take place.

Steven Stein: Steven, so we don't, you know, guide to when we have the actual meetings, but the only nuance in peds is, you know, some safety requirements to demonstrate under maximum use conditions, that there's no, you know, increased levels or untoward side effects. We've completed that work, we're satisfied with the results, and we're discussing it with the FDA. So that'll put our submission, you know, sometime, hopefully in the first half of next year, in terms of having that complete data set and submitting it then, and we're very comfortable with the data. Thanks.

Steven H. Stein: Steven, so we don't guide to when we have the actual meetings, but the only nuance in peds is some safety requirements to demonstrate under maximum use conditions that there's no increased levels or untoward side effects. We've completed that work, we're satisfied with the results and we're discussing with the FDA. So that will put our submission sometime hopefully in the first half of next year in terms of having a complete data set and submitting it then and we're very comfortable with the data. Thanks.

So that will put our submission you know sometime hopefully in the first half of next year in terms of having a complete data set and submitting it then and we're very comfortable with the data. Thanks.

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

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

Steven Stein: Thank you all for participating on today's call and for your questions. The IR team will be available for the rest of the day. Please don't hesitate to reach out. Thank you.

Ben Strain: Thank you all for participating on today's call and for your questions. The IR team will be available for the rest of the day. Please don't hesitate to reach out. Thank you.

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

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

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