Q2 2025 Incyte Corp Earnings Call

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Greg Shertzer: It's now my pleasure to turn the call over to Greg Shertzer, Senior Director of Investor Relations. Please go ahead. Thank you, Kevin.

A question and answer session will follow the formal presentation. You may be placed into the question queue at any time by pressing *1 on your telephone keypad. We ask you to please ask one question, one follow-up, then return to the queue. As a reminder, this conference is being recorded. It’s my pleasure to turn the call over to Greg Shertzer, Senior Director of Investor Relations. Please go ahead.

Bill: Good morning, and welcome to Incyte's second quarter 2025 earnings conference call. Before we begin, I'd encourage everyone to go to the investor section of our website to find the press release, related financial tables, and slides that follow today's discussion.

Thank you. Kevin, good morning, and welcome to Insight's second quarter 2025 earnings conference call. Before we begin, I'd encourage everyone to go to the investor section of our website to find the press release related to the financial tables and slides that follow today's discussion.

Bill: On today's call, I am joined by Bill, Christiana, and Pablo, who will deliver our prepared remarks.

Bill: Matteo, Mohamed, and Steven will also be available for the Q&A I would like to point out that we will 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 from those of the U.S. Department of State.

On today's call, I am joined by Bill Christiana and Pablo Cagnoni, who will deliver our prepared remarks. Mateo Muhammad and Steven will also be available for the Q&A.

Bill: I encourage you to consult the risk factors discussed in our SEC filings for additional detail.

Bill: I will now hand the call over to Bill. Thanks, Greg, and good morning, everyone.

I would like to point out that we will 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 Bill.

Bill: Before I get started, and on behalf of the Incyte management team and the employees, I'd like to thank and recognize Herve Hoppenot for his leadership and commitment to Incyte over 10 years.

Bill: His contributions to this company were invaluable and greatly appreciated, and we wish him the best in his retirement.

Bill: As you know, I started at Incyte very recently, roughly 30 days ago, and so before jumping into the quarterly results, I'd like to touch on two fundamental questions I've been asked since joining Incyte. The first one is, what specifically attracted me to the company? And second, what are my initial thoughts on strategic priority? I believe there's a foundation in place and a path to value creation, but time is of the essence. The non-trivial challenge Incyte faces is navigating the company through 2029 and transitioning to a new set of durable product growth drivers. On the potential for meaningful new product flow, Incyte has several important product launches between now and 2030.

Thanks, Greg, and good morning, everyone. Before I get started, and on behalf of the Incyte management team and the employees, I'd like to thank and recognize Irvy Openo for his leadership and commitment to Incyte over 10 years. His contributions to this company were invaluable and greatly appreciated, and we wish him the best in his retirement.

As you know, I started at Incyte very recently, roughly 30 days ago. Before jumping into the quarterly results, I'd like to touch on two fundamental questions I've been asked since joining Incyte. The first is what specifically attracted me to the company. The second is what are my initial thoughts on strategic priorities?

In response to the first question, I naturally studied the company and the business in great detail and spoke to many different stakeholders, including physicians, patients, and investors, before joining. My initial impression is that Incyte has all the intrinsic characteristics of a high-quality growth business. That is, the potential for new meaningful product flow, attractive markets, R&D and commercial capabilities, and a strong balance sheet.

I believe there's a foundation in place and a path to Value creation. But time is of the essence, the non-trivial challenge Insight faces is navigating the company through 2029 and transitioning to a new set of durable product growth drivers.

Bill: These products, of course, will vary in size. Some will contribute substantially and others incrementally to growth. But either way, there is substrate here. Marketed products, Opsalora, Nictimbo, Monjuvi, and pipeline compounds like 989, our mutant Cal-R monoclonal antibody, and Porvacitinib, our JAK1 specific inhibitor, have the potential to drive future sales growth and form the company's core. More work remains, of course, but we've made progress with these compounds scientifically and commercially. Opsalur is showing strong, broad-based growth today across AD and vitiligo, has close to 20,000 prescribers, and has the potential for new indications in the coming months.

On the potential for meaningful new product flow, Incyte has several important product launches between now and 2030. These products, of course, will vary in size; some will contribute substantially and others incrementally to growth. But either way, there are substrate-here marketed products, Opsa, Nick Timbo, Manuvie, and pipeline compounds, like 9891 specific inhibitor, that have the potential to drive future sales growth and form the company's core.

More work remains of course but we've made progress with these compounds scientifically and commercially.

Bill: Nick Timbo is off to a very strong start. Phase 1 results with 989 and ET are promising, and we will share data on MF at the end of the year. And finally, Pobresitnib could support at least three different indications.

Opsol is showing strong, broad-based growth today across ad, and Vitiligo has close to 20,000 prescribers and has the potential for new indications in the coming years. Nick Timbo is off to a very strong start; Phase 1 results with 989 and ET are promising, and we will share data on MF at the end of the year. Finally, Parekh could support at least three different indications.

Bill: Next, Incyte operates in two of the most structurally attractive markets in the industry, hematology-oncology and immunology. They're built on solid foundations of science, need, and opportunity, and we have differentiated knowledge and capabilities in these areas, and we'll focus on them. And finally, Incyte has well-developed high-quality R&D and commercial capabilities. Yes, there have been R&D setbacks, and we need to convert science into regulatory approvals and business results, but I believe our discovery and development capabilities in our core areas are a competitive advantage.

Next Insight operates in 2 of the most structurally attractive markets in the industry, Hematology Oncology and Immunology. They're built on solid foundations of science, need and opportunity. And we have differentiated knowledge and capabilities in these areas and we'll focus on them.

And finally inside has well-developed high-quality R&D and Commercial capabilities. Yes, there have been R&D setbacks and we need to convert science into regulatory approvals and business results, but I believe our Discovery and development capabilities. In our core areas are a competitive advantage.

Bill: Now regarding our strategic priorities, here's my initial thinking, and I will come back to you in the coming months with more specifics on the direction we plan to take the company strategically, operationally, and financially. We intend to build a comprehensive plan for acceleration that goes beyond just filling a revenue gap. We'll take a fresh look at this business, including our R&D productivity, operating expenses, and capital allocation, and dedicate resources to accelerating product flow and growth. My framework for the business will likely have the following set of priorities. First, take care of the core. That's straightforward.

Now, regarding our strategic priorities. Here's my initial thinking, and I will come back to you in the coming months with more specifics on the direction we plan to take the company, strategically, operationally, and financially.

We intend to build a comprehensive plan for acceleration that goes beyond, just filling a revenue Gap. We'll take a fresh look at this business, including our R&D productivity, operating expenses and capital, allocation, and dedicate resources to accelerating product flow and growth.

Bill: Driving utilization of our major product in the short term is necessary for long-term success. Second, accelerate product development. Pablo and I have spent many hours on this topic. It's almost all we talk about. Our mid-to-late stage pipeline has the potential to unlock the next phase of growth for Incyte, but there are still unanswered questions, which is not uncommon. 989 is arguably the most scientifically promising asset in the NPN space as a targeted, mutation-specific approach. Our success will depend on translating early Phase I data into a regulatory approval and a marketed product. The medical need and the market potential for 989 is significant.

First, take care of the core. That's straightforward. Driving utilization of our major products in the short term is necessary for long-term success.

To further accelerate product development, Pablo and I have spent many hours on this topic; it's almost all we talk about.

Our mid to late-stage pipeline has the potential to unlock the next phase of growth for Insight. However, there are still unanswered questions, which is not uncommon.

989 is arguably the most scientifically promising asset in the MPN space as a targeted mutation-specific approach. Our success will depend on translating early Phase 1 data into regulatory approval and a marketed product.

Bill: If we're successful, 989 should trigger a fundamental shift in the treatment of MPNs like we've seen in other cancers. For Povacitinib, we have a clear and credible path to turning this into a major product for Incyte. Its success will be predicated on execution in areas where Povacitinib can have differentiation such as HS, PN, and vitiligo. In H.S., povositinib could be the first oral option, which is perhaps the most challenging disease in dermatology. It's not like IL-3-mediated psoriasis or IL-4-13-mediated AD. It's more complex, involves more pathways, treatment success is variable, and so a new treatment option like povositinib should be very marketable.

The medical need and the market potential for 989 is significant. If for successful, 989 should trigger a fundamental shift in the treatment of mpns, like we've seen in other cancers.

For Pogba, sib. We have a clear and credible path to turning this. Into a major product for insight, its success will be predicated on execution in areas where poverty nib can have differentiation such as hspn and vitiligo.

NHS Publishers could be the first oral option, which is perhaps the most challenging disease in dermatology. It's not like io3 mediated psoriasis or L4 13. Mediated ad. It's more complex involves more Pathways. Treatment success is variable and so a new treatment option, like Pogo snib should be very marketable.

Bill: As it relates to our early-stage pipeline, the scientific rationale behind CDK2, G12D, TGF-β, BiPD-1, for Select Solid Tumors, among others, is strong. But as you know, early-stage projects inherently involve uncertainty. We will be continuously assessing these and other programs. They'll be put through a framework to be scored and compared to other programs based on strategic importance, PTRS, commercial potential, and return on investment. and I recognize that every use of capital, R&D capital, is an opportunity cost for other users.

As it relates to our early stage pipeline, the scientific rationale behind cdk2, g12d tgfb at a bip pd1.

For select solid tumors, among others, the opportunity is strong. But as you know, early-stage projects inherently involve uncertainties.

We will be continuously assessing these and other programs. They'll be put through a framework to be scored and compared to other programs. Based on strategic importance ptrs commercial potential and return on investment.

And I recognize that every use of capital R&D, capital is an opportunity cost for other users.

Bill: Third, capital allocation. We're generating significant cash flow and have a growing balance sheet. The first call on capital will be the core business, our marketed product. The second is the late stage pipeline, and the third is business development. Sometimes our best investments will be inside the company, and other times the reverse will be true. We'll have a governance mechanism for allocating capital internally and externally to ensure long-term growth and maximize shareholder value.

Third Capital allocation we're generating significant cash flow, and have a growing balance sheet. The first call on Capital will be the Core Business. Our marketed products

Bill: Regarding business development, we'll look hard at finding de-risked pre-revenue or revenue stage opportunities. As you know, there are very few positive asymmetrical opportunities out there, and it's easy to mistakenly turn a dollar into 50 cents. will be careful about where and how much capital we put to work. But when strategically sourced, appropriately priced, and well-executed, BD can create a lot of value. We will have a well-defined framework for BD, and we will look for opportunities that fit that framework.

The second is the late-stage pipeline, and the third is business development. Sometimes our best investments will be inside the company, and other times, the reverse will be true. We'll have a governance mechanism for allocating capital internally and externally to ensure long-term growth and maximize shareholder value.

Regarding Business Development.

We'll look hard at finding de-risked pre-revenue or Revenue stage opportunities.

As you know, there are very few positive asymmetrical opportunities out there, and it's easy to mistakenly turn a dollar into fifty cents.

We will be careful about where and how much capital we put to work.

Bill: Finally, it's important to keep a close eye on execution. Converting science and strategic plans to results is the job. We'll run the business at a detailed level, enhance the quality and speed of decision making inside the company and manage our expenses in a disciplined way, which means focusing on doing more with less versus more with more.

But when strategically sourced appropriately priced and well-executed BD can create a lot of value, we will have a well-defined framework for BD and we will look for opportunities that fit that framework.

Finally, it's important to keep a close eye on execution converting science and strategic plans to results is the job.

Bill: I look forward to sharing more details on our strategic framework later this year.

We'll run the business at a detailed level and enhance the quality and speed of decision-making inside the company and manage our expenses in a disciplined way, which means focusing on doing more with less versus more with more.

I look forward to sharing more details on our strategic framework later this year.

Christiana Stamoulis: Now, moving to our second quarter results, which Christiana will review next, Jackified demand remains very strong across three indications.

Christiana Stamoulis: Obsolera growth was exceptional across two indications. and the Nick Timbo launch is exceeding expectations with rapid adoption among BMT centers reinforcing its commercial potential. The growth prospects for these products are excellent if we continue to export them.

Now, moving to our second quarter results, which Cristiano will review next. If demand remains very strong across three indications, Laura's growth was exceptional across two indications, and the NikTimbo launch is exceeding expectations with rapid adoption among BMT centers, reinforcing its commercial potential.

Christiana Stamoulis: On the R&D front, we made excellent progress. We will release phase one data on 989 and MF at the end of the year to supplement the data we presented at EHA in ET. We expect an FDA approval for Opsalora in pediatric patients two to 11 years of age with mild to moderate AD in September. And importantly, the pivotal trials for povositinib and vitiligo in PN and combination trials with axotilumab and GVHD are rolling on track.

The growth prospects for these products are excellent if we continue to execute.

On the R&D front, we made excellent progress. We released Phase 1 data on 989 and MF at the end of the year to supplement the data we presented at EHA. We expect an FDA approval for opiates in pediatric patients aged 2 to 11 years, with mild to moderate ADD in September. Importantly, the pivotal trials for poverty have been Vitiligo and PN, and combination trials with ailab and GVHD are enrolling on track.

Christiana Stamoulis: With that, I'd like to turn the call over to Christiana who will provide the second quarter commercial and financial update. Thank you, Bill, and good morning, everyone. In Q2, we delivered strong financial results with total product revenues of $1.06 billion, representing an increase of 17% year-over-year, driven by continued demand growth for Jaka Phi and Opselura, as well as the contribution from the ongoing commercial launch of Total revenues were $1.22 billion, up 16% versus the same period last year.

With that, I'd like to turn the call over to Christiana, who will provide the second-quarter commercial and financial update.

Thank you, Bill, and good morning, everyone.

Nick Timber.

Total revenues were 1.22 billion dollars up, 16% versus the same period last year.

Christiana Stamoulis: Turning to Jessica Fye on slide 9. Jakafi Net Product Revenue was $764 million for the second quarter representing an 8% growth year-over-year driven by paid demand which also increased 8% versus the prior year. Demand for Jagat Thai continues to grow across all indications.

Turning to jakafi on slide 9.

Jakafi, net product Revenue was 764 million for the second quarter representing an 8% growth year-over-year driven by pay demand which also increased 8% versus the prior year period.

Christiana Stamoulis: Channel Inventory Levels and is a quarter within normal. As a result of the strong demand seen in the first half of the year, we are raising our full year revenue guidance for Jackathi to a new range of $3 to $3.05 billion.

The month for job. I continue to grow across all indications.

Channel inventory levels are within a normal range for the quarter.

As a result of the strong demand seen in the first half of the year, we are raising our full-year revenue guidance for Jack of High to a new range of $3.0 billion to $3.05 billion.

Christiana Stamoulis: Turning now to Auxilio on slide 10, total net product revenue for the second quarter was $164 million, representing a 35% increase year-over-year. U.S. net product revenue of $132 million was up 19% year-over-year, driven by increased patient demand and refills in both atopic dermatitis and VT Lyme Channel Inventory Levels ended the quarter with a normal run. Ex-U.S. net product revenues of $32 million were driven by continued uptake in France and Germany, as well as the recent launches in Italy, Spain, and Canada. In France and Italy, Opsalura has seen very rapid adoption.

Turning now to obscure and slide 10 total net product revenue. For the second, quarter was 164, million representing a 35% increase year-over-year.

as net product, revenue of 132 million was up 19% year-over-year driven by increased patient demand and refills in both a topic dermatitis and vitiligo

Trying to inventory levels and it is a quarter within normal range.

In Q2 2025, net product revenues of $32 million were driven by continued uptake in France and Germany, as well as the recent launches in Italy, Spain, and Canada.

In France and Italy of Surah has seen very rapid adoption.

Christiana Stamoulis: Turning to slide 11 in InkTinvo launch. Ninctivo Net Product Revenues in the second quarter were $36 million, driven by high patient need and strong commercial agreement. We continue to see positive launch metrics with widespread product awareness.

Turning to slide 11 and invo launch.

Nivo net product revenues in the second quarter were $336 million, driven by high patient need and strong commercial execution.

Christiana Stamoulis: We have achieved roughly 82% account penetration with rapid and broad uptake in BMT centers across the U.S. Since the beginning of the launch, over 4,000 infusions have been administered to an estimated 700 patients, representing approximately 10% of the third-line plus GVHD market. of all the patients that went on Ictimvo, approximately 80 to 90% remain on therapy.

We continue to see positive launch metrics with widespread product awareness and interest.

We have achieved roughly 82% account penetration with rapid and Broad uptake in BMT centers across the US.

Since the beginning of the launch over 4,000 infusions have been administered to an estimated 700 patients representing approximately 10% of the third line Plus gvhd Market.

Of all the patients that went on in Timbo approximately 80 to 90% remain on therapy today.

Christiana Stamoulis: Turning now to other hematology-oncology products on slide 12, net product revenues for the second quarter were $131 million, representing a 66% year-over-year increase.

Christiana Stamoulis: This is primarily driven by the commercial launch of Nictimbo as well as increased contribution from Zionists following the approval in. As a result of the strength of the Nictimvo launch, higher demand for Sinise, and the earlier than anticipated approval for Monjuvi in FL, we are raising our full year revenue guidance for other oncology products to a new range of $500 to $520 million.

Turning now to other Amgen oncology products on slide 12, net product revenues for the second quarter were $131 million, representing a 66% year-over-year increase.

this is primarily the driven by the commercial launch of Nick Timbo as well as increased contribution from zenes following the approval in ACAC

As a result of the strength of the nuclear launch and higher demand for Sinus, along with the earlier than anticipated approval for Monjuvi in FL, we are raising our full year revenue guidance for other oncology products to a new range of $400 million to $520 million.

Christiana Stamoulis: Moving on to slide 13 and our operating expenses, during the second quarter we recorded a benefit of $242 million from the contract dispute settlement with Novartis. Relating to Jacka Fye royalty payments through the first quarter of 2025. The settlement also resulted in a reduction in COGS driven by an ongoing 50% reduction in the royalty rate payable to Novartis. As a result, we are reducing the lower end of our COGS guidance. The revised guidance range is now 8 to 9% of net product revenue.

Moving on to slide 13 and our operating expenses. During the second quarter, we recorded the benefits of $242 million from the contract dispute settlement with Novartis.

Relating to Jakafi, royalty payments through the first quarter of 2025.

the settlement also resulted in a reduction in cogs driven by an ongoing 50% reduction in the royalty rate payable to Novartis

as a result, we are reducing the lower end of our cogs guidance.

The revised guidance range is now 8% to 9% of net product revenues.

Christiana Stamoulis: Shifting now to R&D, total R&D expenses on a gap basis were $495 million for the second quarter. Excluding the one-time Asian cost in 2024 and other one-time expenses in both years, R&D expenses increased 8% year-over-year, driven by continued investment in our late-stage development. In the first half of the year, we entered into two new development collaborations with Genesys and BioTherapy. As a result of the up-front and ongoing expenses related to these new collaborations, we are increasing our full-year guidance for R&D by 35%. $1.965 to $1.995 billion.

Shifting now to R&D, total R&D expenses on a gap basis were 495 million for the second quarter.

Excluding the one-time Asian cost in 2024, another one-time expense in both years is included in the expenses, increased 8% year-over-year, driven by continued investment in our late-stage development assets.

In the first half of the year, we entered into two new development collaborations with Genesis and BioEr.

As a result of the upfront and ongoing expenses related to this new collaborations, we are creating a full year guidance for R&D by 35 million dollars, to a new range of 1.965 to 1.99 5 billion dollars.

Christiana Stamoulis: Moving to SG&A, total GAAP SG&A expenses were $331 million for this. Excluding the one-time costs for the prior year, GAAP SG&A expenses increased 16% year-over-year, primarily driven by increased legal costs related to the Novartis contracts, dispute settlement, and other matters, and timing of certain consumer market Finally, we continue to execute on our commitment to grow operating expenses at a slower pace than revenue. Ongoing operating expenses in the second quarter of 2025 increased 13% year-over-year compared to a 16% increase in revenues during the same period, leading to continued increase in operating leverage in March.

Moving to sgna. Total Gap. Sgna expenses were 331 million for the second quarter.

Pablo Cagnoni: Given the very strong performance of our commercial portfolio in the first half of the year, and based on our updated guidance for the year, we expect net product revenues for the full year to grow at a rate of 14-17% year-over-year, and ongoing operating expenses to grow at a rate of 5-7%, leading to further expansion in operating I'll now turn the call over to Pablo for an R&D update. Thank you, Christiana, and good morning, everyone. As we highlighted a year ago when we summarized on this slide, our portfolio remains on track to deliver more than 10 launches by 2030.

Finally, we continue to execute on our commitment to grow operating expenses at a slower pace and revenues ongoing operating expenses. In the second quarter of 2025 increased, 13% year-over-year compared to a 16% increase in revenues during the same period. Leading to continued, increase in operating leverage in margins.

Given the very strong performance of our commercial portfolio in the first half of the year. And based on our updated guidance, for the year, we expect, net product revenues for the full year to grow to at a rate of 14 to 17% year-over-year and ongoing operating expenses to grow at a rate of 5 to 7% leading to further expansion in operating margins.

I'll now turn the call over to Pablo for an R&D update.

Thank you, Christian, and good morning, everyone.

As we highlighted a year ago, when we summarized on this slide, our portfolio remains on track to deliver more than 10 launches by 2030.

Pablo Cagnoni: Moving to slide 16, the phase 1 data in essential thrombocytemia for INCA-033989, our mutant-colored monoclonal antibody, was presented at EHA 2025. 989 is the first truly targeted therapy for a subset of patients with MPNs that includes 25% of patients with essential thrombocytemia and 35% of patients with myelofibrosis Importantly, this dataset demonstrated the normalization of platelet counts in patients with ET, which is consistent with the mechanism of action of 9A9, and a key point of differentiation from seroductive therapy. 99 was very well tolerated, but only 1 out of 49 patients discontinued therapy. It is very reassuring that at this point in the development of 989, it appears to have an excellent safety profile.

For me, slide 16, the Phase 1 data is essential.

989 is the first truly targeted therapy for a subset of patients with MPNs. This includes 25% of patients with essential thrombocythemia (ET) and 35% of patients with myelofibrosis. Importantly, this data set demonstrated that normalization of platelet counts in patients with ET is consistent with the mechanism of action of 989 and a key point of differentiation from cytoreductive therapies.

99 was very well tolerated, but only 1 out of 49 patients discontinued therapy.

Pablo Cagnoni: We also observed rapid and sustained reductions in VAF in most patients, despite the short follow up for patients in the highest dose cohort. We believe this data will continue to improve as it matures, delivering an important outcome for patients. Treatment with 9A9 also resulted in a reduction in mutant color positive megakaryocytes in the bone marrow, as well as a reduction in mutant color positive CD34 positive stem and progenitor cells in peripheral blood, confirming the potential of 9A9 to be a disease-modifying therapy that offers a potential path to extension.

It is very reassuring that at this point in the development of 9899, it appears to have an excellent safety profile.

We also observed rapid and sustained reductions in VIF in most patients, despite the short follow-up for patients in the highest dose cohorts. We believe this data will continue to improve as it matures, delivering an important outcome for patients.

Treatment with 989 also resulted in a reduction in mutant color-positive mega carrier sites in the bone marrow, as well as a reduction in mutant color-positive CD34-positive stem and progenitor cells in peripheral blood, confirming the potential of 989 to be a disease-modifying therapy that offers a potential path to a cure.

Pablo Cagnoni: On slide 17, let me summarize the key steps for the 999 development plan. We will advance this program with great urgency, with the goal of starting pivotal trials in ET by early 2020. We continue to gather data and have expanded certain dose cohorts to better understand what the optimal dose is for further development. We are committed to presenting data in MF as monotherapy and in combination with Rux litinib by the end of the year. Additionally, we have established a collaboration with QIAGEN to develop a co-diagnostic across NPNs with an initial focus in collar mutations. Importantly, we continue to develop a subcutaneous formulation, and that work is ongoing.

On 517. Let me summarize the key steps for the 989 development plan.

We'll advance this program with great urgency, with the goal of starting pivotal trials in ET by early 2026.

We continue to gather data and have expanded, certain dose cohorts to better understand what the optimal doses for further development.

We are committed to presenting data in MF as monotherapy and in combination with RX lnib by the end of the year.

Additionally, we have established a collaboration with Qiagen to develop a code diagnostic across MPNs, with an initial focus on color mutations.

Pablo Cagnoni: We believe that initially the IV formulation every two weeks is acceptable, but we'll work to advance the sub-Q in parallel.

Importantly, we continue to develop a subcutaneous formulation and that work is ongoing.

We believe that initially the IV formulation every 2 weeks is acceptable, but we'll work to advance the subq in parallel.

Pablo Cagnoni: Turn to our dermatology portfolio starting on slide 8.

Pablo Cagnoni: I'm pleased to share an important update on Ruxlydne Cream. As you know, Opsalura is currently approved in the U.S. for the treatment of adult and adolescent patients with mild to moderate atopic dermatitis and vitiligo, and in Europe for the treatment of vitiligo.

Turn to our dermatology portfolio, starting on slide 18.

I'm pleased to share an important update on RX. Linen cream.

Pablo Cagnoni: Today, we announce the top line results from the Pivotal Phase III through AD4 study, which evaluated Raxolitinib cream in adult patients with moderate atopic dermatitis with extensive bite of surface area involvement of 10 to 20% and significantly impaired quality of life with a DLQI greater than 10. I'm happy to report that the True84 study met its co-primary endpoints at Week 8, with statistically significantly larger proportion of patients receiving 1.5% RUC screen compared to vehicle, achieving both IgA-TS and EC75. At Week 8, Rockscreen demonstrated a vehicle-adjusted difference in IGA-TS of 47.6% and a vehicle-adjusted difference in EC75 of 51.4%, both highly statistically significant.

As you know, Opel is currently approved in the US for the treatment of adult and Adolescent, patients with mild to moderate atopic dermatitis and Vitiligo. And in Europe for the treatment of vitiligo.

Today's, we announced the Topline results from the pivotal phase 3, through 84 study, which evaluated RX lennick cream in adult patients with moderate atopic dermatitis with extensive body surface area, involvement of 10 to 20% and significantly impaired. Quality of life with a dlqi greater than

10.

I'm happy to report that the true 84 study made its co-primary endpoints this week. 8 with a statistically significantly larger proportion of patients receiving 1.5% Rock screen compared to vehicle achieving both IGA TS and EC75.

A week, 8 rock screen demonstrated a vehicle. Adjusted difference in IG ATS is 47.6%, and the vehicle adjusted difference in EC75 is 51.4%. Both are highly statistically significant.

Pablo Cagnoni: In addition, the study met all key secondary endpoints, further reinforcing the efficacy profile of Ruxelena cream in this patient population. Importantly, the safety profile observed in 284 was consistent with previously reported data in atopic dermatitis. Roxaline cream was well tolerated. No new safety signals were observed. This result confirms that Ruxolitinic cream is a highly effective treatment option for patients with moderate AD who are eligible for systemic therapies.

In addition, the study met all key secondary endpoints for the reinforcing, the efficacy profile of Rexall in the cream in this patient population.

Observed in 284 was consistent with previously, reported data in a topic dermatitis.

Roxy named cream was well tolerated. No new safety signals were observed.

Pablo Cagnoni: Based on the results of the study, plans are underway to submit a type 2 variation for apsalurin in Europe where there's a strong demand for innovative topical therapies in patients that have failed topical corticosteroids or topical calcineurin inhibitors. Looking ahead, we plan to present the full Phase 3 top line results at an upcoming medical meeting, and we look forward to engaging with regulators to discuss next steps for potential label expansion.

This result confirmed that rockson cream is a highly effective treatment option for patients with moderate add, who are eligible for systemic Therapies.

Based on the result of the study plans are underway to submit a type 2 variation for absolutely in Europe where there's a strong demand for Innovative. Topical Therapies in patients that have failed, topical cortical, steroids or topical calcineurin inhibitors.

Looking ahead. We plan to present the full phase 3, Topline results at an upcoming medical meeting, and we look forward to engaging with Regulators to discuss next steps for potential label expansion.

Pablo Cagnoni: Moving to slide 19, and the near-term opportunities for Poverty We're advancing poverty in three indications and believe these represent significant opportunities for near-term revenue and long-term value creation.

For me to slide 19, and the near-term opportunities for Provaris in it.

Pablo Cagnoni: The positive phase 3 data in patients with moderate to severe HS, which affects over 300,000 patients in the U.S., will be our first submission for povositnib and will support worldwide regulatory filings in 2026. The Phase III studies in patients with vitiligo and prurigo nodularis are progressing well and we anticipate presenting data in 2026 with potential approvals in 2027.

We're advancing power significant in 3 indicators and believe this represent significant opportunities for near-term, revenue and long-term value creation.

The positive phase 3 data in patients, with moderate to severe HS which affects over 300,000 patients in the US will be our first submission for power Sydney and will support worldwide regulatory filings in 2026.

The Phase 3 studies in patients with Vitiligo and Prurigo Nodularis are progressing well, and we anticipate presenting data in 2026. We expect potential approvals in 2027.

Pablo Cagnoni: 2025 is a pivotal year for Incyte, with over 18 key milestones including 4 new product launches, 4 pivotal trial readouts, at least 3 phase 3 study initiations, and 7 proof-of-concept study results. As shown on slide 20, we have already achieved several of these milestones with multiple important catalysts still to come. I would like to note that the initiation of our Bed Phase 3 studies now planned for the second half of the year, pending regulatory feedback, and the release of V617F Phase 1 data has shifted from the second half of 2025 to the first half of 2026.

2025 is a pivotal year for insight with over 18 key milestones, including 4 new product launches, 4 pivotal trial readouts, at least 3 Phase 3 study initiations, and 7 proof of concept study results, as shown on slide 20. We have already achieved several of these milestones, with multiple important catalysts still to come.

Pablo Cagnoni: We look forward to sharing additional updates on these milestones in the second half of 2025.

Bill: I will now turn it back over to Bill for his closing. Thanks, Pablo. To summarize the key takeaways before we open the line for Q&A, our second quarter sales and growth for our key products were strong, resulting in revenue guidance being increased for the full Next, we are making excellent progress with our R&D pipeline, both for hematology-oncology as well as for INI.

I would like to note that the initiation of our BED Phase 3 studies, now planned for the second half of the year pending regulatory feedback and the release of V617F PACE 1 data, has shifted from the second half of 2025 to the first half of 2026. We look forward to sharing additional updates on these milestones in the second half of 2025. I will now turn it back over to Bill for his closing remarks.

Thanks. Pablo to summarize, the key takeaways, before we open the line for Q&A our second quarter of sales and growth for our key products were strong. Resulting in Revenue. Guidance being increased for the full year,

Bill: Lastly, our focus is converting science and strategic plans into product flow and generating durable revenue and cash flow.

Next, we are making excellent progress with our R&D pipeline, both for Hematology Oncology, as well as for ini.

Lastly, our focus is converting science and strategic plans into product flow and generating durable revenue and cash flow.

Bill: That concludes our prepared remarks.

Operator: Kevin, please open up the line and give your instructions for Q&A. Certainly. We will now be conducting a question and answer session. If you'd like to be placed into question queue, please press star 1 on your telephone keypad. As a reminder, we ask that you please ask one question and one follow-up to return to the queue. That star 1 be placed into queue and star 2 if you'd like to remove yourself from the queue.

That concludes our prepared remarks Kevin, please open up the line and give your instructions for Q&A.

Jay Olson: Our first question today is coming from Jay Olson from Oppenheimer. Your line is now live.

Certainly, we will now be conducting a question and answer session. If you'd like to be placed into the question queue, please press star 1 on your telephone keypad. As a reminder, we ask that you please ask one question and one follow-up to return to the queue. That star 1 will be placed into the queue, and star 2 will remove you from the queue.

Our first question today is coming from Jay Olson from Alpenheim. Your line is now live.

Bill: Oh hey, congrats on the quarter and welcome to Bill. It's a pleasure to reconnect with you, especially after having had the pleasure of working with you in the past. Thank you so much for outlining your strategic vision and the rigorous prioritization process that you're planning. Can you just share with us your thoughts on the relative importance of the three therapeutic areas at Incyte, oncology, hematology, immunology? Do any of those get prioritized in your strategic plan or are you agnostic to therapeutic area?

Bill: Thank you. Yeah, look, it's a good question, Jay. It should be pretty clear to everybody that NPNs is our most important therapeutic area right now. I think we have We have, as a company, an asymmetrical advantage in that space. I believe there's a window of opportunity here to completely transform the treatment of that group of blood cancer. As you know, Targeting driver mutations in NPNs is the holy grail. And if you talk to a hematologist and ask, would you rather use a targeted monoclonal antibody versus a pathway approach, they'll select the target approach every time.

Oh, hey. Congrats on the quarter and welcome to Bill. It's a pleasure to reconnect with you, especially after having had the pleasure of working with you in the past. Thank you so much for outlining your uh, strategic uh, vision and the rigorous, um, prioritization process that you you that you're planning. Can you just share with us your thoughts on the relative importance of the 3 therapy areas at Insight oncology hematology Immunology? Do any of those get, um, prioritized in your strategic plan, or are you agnostic to therapeutic area? Thank you.

Yeah. Look, it's a good question, Jay. It should be pretty clear to everybody that MPNs is our most important therapeutic area right now. I think we have.

We have, as a company, an asymmetrical advantage in that space.

Um, I believe there's a window of opportunity here to completely transform the treatment of that group of blood cancers. Um, as you know,

Bill: We have potentially the ability to create a series of innovations. Obviously, starting with 989, we have 617, we have a bispecific, we also have compounds in discovery. and when you have an opportunity to sort of dominate and control and never see the market, you got to take advantage of it.

Targeting driver mutations in MPNs is the Holy Grail. If you talk to a hematologist and ask, would you rather use a targeted monoclonal antibody versus a pathway approach, they will still select the target approach. Every time we have potentially.

The ability to create a series of Innovations, obviously starting with 989. We have 617 we have it by specific. We also have a compounds uh in in Discovery.

um,

Bill: And so strategically speaking, that is our our number one priority. And I think, you know, we can set a new standard of care in MPN . set what I would describe as a new high-water mark.

Opportunity to sort of dominate and control and never see the market. You got to take advantage of it, and so strategically speaking, that is our number one priority. I think, you know, we can set a new standard of care in MPNs.

Bill: Now look, no one should take my word for it. We have to convert, as I said, science into results. And of course, the progress that we're making with 989 has been incredibly important. I think in I&I, I do believe that there's a credible path to building a large product. We're not, for example, with Pover-Sitnib, copying all the indications for Renvoke. And I do believe we have differentiated knowledge and capabilities in the three immune-mediated skin conditions that we're targeting. And we do have a franchise strategy with Opsalor and Pover-Sitnib, which other companies don't have. The product has the potential to be first in HS, first in vitiligo.

set. What I would describe as a, a new high water Mark. Um, now Look, No, 1 should take my word for it. We have to convert, as I said, science into into results. And of course, the progress that we're making with 989 has been has been incredibly important. I think in ini, I do believe that there's a credible path.

Bill: And I think Paragonodularis was a disease made for JAX. And so I like the potential there.

Bill: And as it relates to our oncology business, Jay, You know, there are certain principles that you have to apply, find the right product first, pick a winning market, and make sure that you can defend that position. And we will apply those principles and make sure we make good decisions as it relates to the other programs that we're developing for solid tumors. Beyond those three areas, Look, the pressure to The pressure to fill a pipeline in biopharma, this is true, not just at Incyte, but it's true at every company, is pretty unforgiving. We're focused on these areas right now.

To building a large product. Uh, we're not for example, with oversight nib copying all the indications for invoke and I do believe we have differentiated knowledge and capabilities in the 3 immigration that we're we're targeting and we do have a franchise strategy with opsol and poob which are the companies don't have. The product has the potential to be first in HS first in Vitiligo. And I think you know, Les was a disease made for Jax and so I like the potential there and as it relates to our our oncology business J.

You know, there are certain principles that you have to apply to find the right product. First, pick a winning market.

and make sure that you can defend that position and we will apply those those principles and make sure we make good decisions as it relates to the other programs that we're developing uh for solid tumors, Beyond those 3 areas,

look, the pressure to

Bill: If we were to look at other areas, it would have to make sense strategically and operationally, and I would never stretch the capabilities of the company. But at the end of the day, what we're solving for is new product flow, and the knowledge and skills we have in those three areas can be transferable. Thanks Jack. Thank you Bill. Thank you.

The pressure to fill a pipeline in biofarma is true, not just that insight, but it's true at every company. It's pretty unforgiving. Um, we're focused on these areas right now. If we were to look at other areas, it would have to make sense strategically and operationally, and I would never stretch the capabilities of the company. But at the end of the day, what we're solving for is new product flow, and the knowledge and skills we have in those three areas can be transferable.

Thanks Jack.

Thank you, Bill.

Tazeen Ahmad: Next question is coming from Tazeen Ahmad from Bank of America. Your line is now live. Hi guys, good morning. Thanks for taking my question.

Thank you. Next question is coming from Tina mark from Bank of America. Your line is now live.

Hi guys. Good morning.

Pablo Cagnoni: I just wanted to get a sense, maybe this is for Pablo, on the read-through from the CalAr data that you saw from ET, and what to maybe expect to see for MF, and then related to that, you're going to show monotherapy as well as combo, but is there a minimal threshold that you're looking for for activity on monotherapy, if you could just help set expectations for that, we'd appreciate it. Thanks.

You're taking my question.

Operator: For more information, visit www.FEMA.gov Good morning, Tazeen. Thank you for the question. Look, let me make a couple of comments here. The important thing to remember is mechanistically, the mutant color antibody 989 would work the same way in MF that it does in ED. So whatever one's preconception on the probability of success was before the ET data, it certainly has to increase with the ET data in hand, A, because of the safety that was so clean, and B, because the efficacy, not only the clear normalization of playlist, reduction in VAF and reduction in mutant cholera positive omegas was so clear in the ET data, but because those were our fundamental based on the mechanism of action of the mutant cholera antibody.

I just wanted to get a sense. Um, maybe this is for Pablo on the read through from from the kalhar data that you saw from ET and what to maybe expect to see for MFS. And then related to that, you're going to show monotherapy as well as combo. But is there a minimal threshold that you're looking for for activity on monotherapy? If you could just help set expectations for that, we'd appreciate it. Thanks.

Uh, good morning, thank you for the question. Uh, look, let me make a couple comments here. The important thing to remember is mechanistically, um, the mutant color, anybody 989 would work the same way in a math that it does in ET.

Pablo Cagnoni: So when you have that mechanistic clarity in a set of patients, the probability that it will work on a different disease with the same molecular basis is certainly high.

Pablo Cagnoni: The reason why we decided to shift the release of the data in MF2 later this year is, as you pointed out, because we want to have combination data with Ruxolitinib. As we all know, Ruxolitinib increases survival in first-line patient and patients with MF. And so we believe that the development of 989 in MF will be at least in part in combination with Rux, which is why we wanted to have a more comprehensive data set when we present the data later this year. In terms of specific numbers, what I would say is we would expect to see improvement in MF in all the basic endpoints that we've discussed over the years in MF patients, obviously, spleen volume reductions, improvement in symptoms, improvement in hemoglobin, perhaps.

So, whatever once preconception on the probability of success was before the ET data, it certainly has to increase with at dating in hand, a because of the safety that I was so clean and B. Because the efficacy not only the clear normalization of playlist reduction, in vif and reduction in in mutant color. Positive megas was so clear in the ET data but because those were, our fundamental based on the mechanism of action of the mutant color antibody. So when you have that mechanistic Clarity in a set of patients, the probability that it will work on a different disease. With the same molecular basis is certainly High. Um, the reason why we decided to shift the release of the data on a map to later this year, is that you pointed out, because we want to have combination data with RX L, as we all know, RXV increases survival and first-line patient in patients with MF.

Pablo Cagnoni: And we expect to see a component of that in the data released later this year. Thank you.

And so, we believe that the development of 99 in MF will be at least in part in combination with rugs, which is why we wanted to have a more comprehensive data set. Um, when we present the data later this year, in terms of specific numbers, what I would say is we would expect to see Improvement in MF in all the basic endpoints that we've discussed over the years in MF patients, obviously spleen size reduction, volume reductions Improvement in symptoms Improvement uh in hemoglobin perhaps. And we expect to see a component of that um in their data released later this year.

Salveen Richter: Next question is coming from Salveen Richter from Goldman Sachs. Your line is now live. Good morning. Thank you for taking my question. Just a follow-up to two comments that were mentioned earlier.

Thank you. Next question is coming from saline Richter from Goldman. Sachs your line is now live.

Pablo Cagnoni: One is, initial data for 617F is now expected in the first half of 2026, and should we read anything into this delay? And then secondly, you talked about the enthusiasm for POVO in the HS market and its competitive differentiation. Maybe just walk us through that, particularly when you look at the context of superior efficacy that we've seen for some of the currently approved therapies, such as Benz-Lex. Thank you. Great, Salveen.

Into this delay. Um, and then, secondly, um, you talked about the enthusiasm for povo in the HS market and it's and it's competitive. Um, differentiation maybe just walk us through that. Um, particularly when you look in in at the context of um Superior efficacy that we've seen for some of the currently approved therapy such as bins Flex. Thank you.

Bill: I'll answer the second question, and Pablo, why don't you take the first question? Certainly. So this is simply related to the fact that this is a phase one dose escalation study. And, you know, you make projections when you start the studies about what dose will give you a certain exposure that would be sufficient in this case to reach the IC35, which we've been talking about over the years about inhibiting the mutated cells. It turns out we need higher doses than we expected. You always need a certain amount of follow up in these patients. As you know, in MF, you know, you know, data needs to mature a little bit because of those two reasons.

Great, Saline. I'll, uh, I'll answer the second question, and Pablo, why don't you take the first question?

uh, certainly so

This is simply related to the fact that this is a phase 1 dose escalation studies.

Pablo Cagnoni: The data has moved to the first half of 2026. Importantly, we have opened the study also now to patients with ET and PV. So the study is progressing well. We simply need higher dose levels with a longer follow up to get the kind of data that we're willing to release. Our conviction, the mechanism on this program continues to be strong. And this is simply a matter of escalating a little bit further.

And you know, you make projections when you start this study is about what dose will give you a certain exposure, that would be sufficient. In this case to uh reach the IC 35, which we've been talking about over the years about inhibiting, the mutated cells. It turns out we need higher doses than we expected. You always need a certain amount of follow-up in this patience, as, you know, uh, in MF, you know, you know, data needs to mature a little bit because of those 2 Reasons, the data has moved to the first half of 2026. Importantly, we have opened the study also now to patients with ET and PV. So the studies progressing. Well, we simply need higher dose levels with the longer follow-up to get the kind of data that we're willing to to release our conviction on the mechanism. On this program continues to be strong. And this is simply a matter of escalating a

A little bit further.

Bill: And then Salveen, on AHS and poversity, and if Muhammad has, excuse me, Muhammad, Matteo has any comments he can add? First of all, as you know, it's one of the most challenging conditions in dermatology. Ask any dermatologist that. Aisle 17 don't work almost half the time. One dermatologist described high score 50 or even 75 as a beauty contest. It's very hard to compare high score rates from one study to the next. The condition, as you know, is fundamentally different than IL-23 mediated psoriasis or IL-413 mediated AD. That is to say, it's inflammation soup. There are multiple pathways involved.

And then saline on on HS and Pulver sitting have been and if uh, uh, Muhammad has excuse me. Muhammad mate has any, uh comments? He can add first of all, as you know, it's 1 of the most challenging conditions in in dermatology ask any any dermatologists that

Is 17.

Bill: If you ask a dermatologist what's most important, they'll first say make the patient feel better and then make them look better, meaning clearance. And this is a quality of life condition. If you look at the data from Pobositt and you look at the effect that the drug has on pain and flare control. It's pretty remarkable and it's a very competitive data set. It also does, you get out past week 12, at week 16 or 18, those clearance rates are in the 50% range. And if you look at the effect of the drug across all those endpoints, clearance, pain, flare control, half the effect is in the first three weeks.

Don't work almost half the time. Um, 1 dermatologist described high score 50 or even 75 as as a beauty contest. It's very hard to compare High School rates from 1 Study uh, to the next the condition as you know, is fundamentally different than Isle 23 mediated psoriasis or 413 uh mediated um, add that is to say it's inflammation. Soup. There are multiple Pathways, uh involved.

If you ask a dermatologist what's most important, they'll first say make the patient feel better and then make them look better, meaning clearance. This is a quality of life condition. If you look at the data from POV,

And you look at the effect that the drug has on pain and flare control.

It's pretty remarkable, and it's a very competitive data set. Also, you get out past week 12, at week 16 or 18, those clearance rates are in the 50% range.

Bill: So I believe that. A systemic option like povositinib is going to have a place in the treatment paradigm for HS, whether they're starting with povositinib and then going to a biologic, or they go to a biologic and then to povositinib. I don't think anyone has a clear view on the future, but this is a condition that there's a lack of treatment options. We have good data, and when you look at the totality of the evidence, there's going to be a place for povositinib as well as the IL-7. Thank you.

And if you look at the effect of the drug across, all those endpoints clearance pain flare control half the effect is in the first 3 weeks.

so, I believe that

A a systemic option. Like poverty is going to have a place in the treatment paradigm.

for HS, whether starting with POV and then going to a biologic or they go to a b biologic and then the poor vitamin, I don't think anyone

Has a clear view on the future, but this is a condition that there's a lack of treatment options. We have good data, and when you look at the totality of the evidence, there's going to be a place for SIT, as well as the aisle 17s.

Salim Syed: Our next question today is coming from Salim Syed from Zero Security. Your line is now live. Great.

Thank you. Our next question. Today is coming from SIM said from zero security if your line is not left,

Bill: First of all, my welcome to Bill, and thanks for the question. I guess maybe one for us on Nick Timbo. So you had a good beat again on the quarter, and obviously the J code went into effect here around April, April 1st, I believe. Can you maybe comment on some of the inter-quarter dynamics there that you saw from the J code going into effect, or do you ascribe the strength of the quarter to any other particular part of the launch? And I don't think you guys mentioned the inventory impact there for the quarter. Maybe just remind us what the inventory impact was for the quarter.

Great. Um, first of all, my welcome to, uh, Bill, um, and, uh, thanks for the question. Um, I guess maybe one for us on, uh, Nick Timbo. So you had a good beat again on the quarter, and obviously the J Code went into effect here. Um,

Around April. April 1st, I believe. Um, can you maybe comment on some of the inter quarter Dynamics there that you saw?

Bill: Yeah, thanks for the question. I'll give you my overall assessment and either Muhammad or Christiana can can fill in some of the some of the details. As Christiana said, you know, we're five months in, and we're at a 10% penetration of that third, fourth line market. And what we watch on a weekly basis, and which is important for any new product launch is what do your new patient starts Every pharmaceutical product is like a leaky bucket and you have to maintain, the same is true with Opsalura, you have to maintain new patient starts, so when I look at the dynamics underneath Nictembo, that's what I'm focused on.

From the JK going into effect or do you describe the strengths of the quarter to any other particular part of the launch? And um I don't think you guys mentioned the inventory impact there for the quarter, for me. We just, uh, remind us what the inventory impact was for the quarter. Thank you.

Yeah, thanks for the question. I'll give you my overall assessment, and either Muhammad or Christiana can fill in some of the details.

As Christiana said, you know, we're five months in and we're at a 10% penetration of that third, fourth line market. What we watch on a weekly basis, which is important for any new product launch, is what do your new patient starts look like? Look, like all pharmaceutical products, it’s like a leaky bucket, and you have to maintain. The same is true with Obscure.

Bill: This product over the next, you know, five, six, seven months, say the balance of the of the year has the potential to reach over 1000 patients. That would be a very, very good first year. If you take a look at the adoption curve, for example, of Sanofi's Resiroc, and you look at the adoption curve right now, for Nictimbo, they're both in the same zip code. Now, new product launches are very unpredictable. They can be fickle, and there can be a lot of choppiness from from quarter to quarter. But I like the momentum, the underlying momentum of the business right now.

You have to maintain new patient starts, so when I look at the Dynamics underneath, Nick tmbo, that's what I'm focused on.

And patience that would be a very, very good. First year, if you take a look at the adoption curve, for example, of Santa fees, nick, uh, resurrect and you look at the adoption curve right now for Nick Timbo, they're both in the same zip code.

Now.

Bill: As you heard, over 80% of BMT centers in the United States are using the Nictimbo. That's also important because you need a large group of users, prescribers, or in this case, accounts. The other thing that is reassuring to me is we have 4,500 infusion. and roughly 700 patients. which means the large majority of patients, my estimate could be 90% of patients are still on. and so with a When you have a chronic disease like this, duration of therapy isn't necessarily measured in months. It can be measured much longer than that.

New product launches are very unpredictable, they can be fickle and there can be a lot of choppiness from from quarter to quarter, but I like the momentum the underlying momentum of the business right now. As you heard over 80% of BMT centers in the United States,

Thank you for using Timbo. That's also important because you need a large group of users, prescribers, or in this case, accounts. The other thing that is really...

reassuring to me, is we have 45,500 infusions

And roughly 700 patients.

Which means the large majority of patients, my estimate could be. 90% of patients are still on product.

and so, with a

Mohamed: And so, I don't think we could have gotten off to a better start, but I'm very paranoid we're in the middle of the first year of launch. You have to really manage the details very carefully, and of course, the Ops designation makes this economically feasible for institutions. Mohamed, do you wanna cover anything that I missed? Yeah, you didn't miss much, but I think, you know, here, Salim, it's just really important to just underscore that we're pleased with the performance so far. You heard earlier about 10% penetration in that third line plus setting. Also important to note that there's about 3,500 patients that are in play at any given time in the third line plus setting.

When you have a chronic disease like this duration of therapy isn't necessarily measured in months, it can be measured much longer than than that. And so I think I don't think we could have gotten off to a better start.

But I'm very paranoid. We're in the middle of the first year of launch. You have to really manage the details, uh, very carefully and of course, the the Ops, uh, designation.

Mohamed: That means these are the patients that are up for grabs, that are changing therapy in some capacity. So we're either at 10% of the third line plus setting in total, or we're at 20% of that in-play opportunity, which, again, is a testament of commercial execution. You heard some of the metrics around infusions and penetration from Bill. I think the last thing maybe I'd say is that we know prescribers are seeing real-world results, very similar to what they saw in our clinical trials, which is not always the case in this disease, and this is going to naturally encourage providers not only to use Nictimvo more often, but perhaps also consider Nictimvo earlier in their treatment paradigm for more.

Makes this economically feasible, for instance, in institutions Muhammad. Do you want to cover anything that I missed? Yeah. Yeah. You didn't miss much. But I think, you know here, uh, seems, it's just really important to just underscore that we're pleased with the performance so far. You heard earlier, uh, about 10% uh, penetration that third line plus setting. Also important to note that there's about 3,500 patients that are in play at any given time in the third line plus setting. That means these are the patients that are up for grabs that are changing therapy in some capacity. So we're either at 10% of the third line plus setting in total over a 20% of that Inplay opportunity, which again is a testament of commercial execution. You heard some of the metrics around infusions and um uh and uh penetration uh from from Bill. I think the last thing, maybe I'd say is that we know prescribers are seeing real world results, very similar to what they saw in our clinical trials which is not always the case in this disease and this is going to naturally encourage providers. Not only to use Nick Timbo more often but perhaps also considering a Timbo earlier in their treatment

Christiana Stamoulis: Thanks for the questions. Inventory Accounted for less than 5% of Q2 sales so far, and that's stabilizing in that expected range, so the performance that you're seeing and the volume is driven primarily by Thank you.

Treatment Paradigm for more patients.

Great. Thanks for the question.

Just an inventory. Can you comment on that? Yeah, yeah, the inventory just to put that in perspective, inventory, accounted for less than 5% of Q2, uh, sales so far and that stabilizing, and that expected range. So, the the performance that you're seeing and, and the, and the volume is driven primarily by by demand.

Claire Harrison: Next question is coming from Kelly Shee from Jeffries. Your line is now live. Hi, good morning.

Thank you. Next question, is coming from Kelly shei from Jeffrey. Your line is now live.

Claire Harrison: This is Claire. I'm for Kelly. Thanks for taking our question and congrats on the quarter. So you have the initial G12D and bi-specific data representing an asthma.

Pablo Cagnoni: So I wonder whether you can provide more granularity on the scope of proof of concept data and maybe help us understand what would be the key metrics you're looking for to define the success and move the program forward. Thank you. Great.

Pablo Cagnoni: Pablo, you want to take that? Certainly. What we should expect, what you should expect for these two presentations at ASIMO, in a way, is consistent with what we did last year with CDK2. As we've made, we try to be disciplined about presenting data. We want to present substantial data sets that give you clarity on how well these compounds work in terms of both efficacy and safety, and to be able to have with you a discussion about next steps for the programs. And that's exactly what you should expect here. We're going to have a substantial number of patients for both our KRST-12D program and our TGF-beta receptor by PD-1 by Specific.

Clara on for Kelly dashboard. Taking our question and congrats on the quarter. So you have the initial G2 the, and by specific data representing that as well. So wondering, whether you can provide more granularity on the scoop of proof of concept data. Um, and maybe help us on that, understand what would be the key metrics? You're looking for to define the success and move the program forward. Thank you.

Great. Pablo, you want to take that. Uh certainly so

What we should expect, what you should expect for this 2 presentations that I asked tomorrow in a way it's consistent with what we did last year with cdk2 as we've made, uh we try to be disciplined about presenting data. We want to present substantial data sets that give you Clarity on how well this this compounds work in terms of both efficacy and safety and to be able to have with you a discussion about next steps for the programs. And that's exactly what you should expect here. Um, we're going to

Pablo Cagnoni: And we believe that both demonstrate proof of concept in a range of tumor types, and the amount of data, we'll be able to use that to have a discussion with you on the next steps for these two programs, which we expect to do at ASIMO in the next couple of months. Thank you.

Have a substantial number of patients for both our KS g12d program and our TGF beta receptor by pd1 by specific. And I, we believe that both demonstrate proof of concept in a range of tumor types and the amount of data will be able to will be able to use that to have a discussion with you on the next steps for these 2 Programs, which we expect to do at esmo, um in in the next couple of months.

Thank you.

Brian Abrahams: Next question today is coming from Brian Abrahams from RBC Capital Markets. Your line is now live. Hey, good morning. Congrats on all the progress. And welcome to Bill. Look forward to working with you again. Hey, so a question on Opsalora. I know your guidance was unchanged, but I wanted to unpack the dynamics underlying that. And I'm curious, the degree to which pediatric indication is embedded there, and then maybe how we should be thinking about the XUS cadence going forward. I know you saw a big uptick, but international can be a bit lumpy. And then maybe longer term, the degree to which the moderate AD data from 284 might expand the market opportunity down the road.

Thank you. Next question, today, is coming from Brian Abrams from RBC Capital Market. Trail Line is now live.

Bill: Thanks. Yeah, Brian, good question. You know, I'll give you my my initial observations after the after the first 30 days. Obviously, 60% of the business is AD and 40% is vitiligo, right? That AD business is growing at plus 20%. And the vitiligo business is growing at at plus plus 10%. Our penetration of this market, if you just think about the AD market as systemic and topicals, is still relatively modest, 7% of the overall AD market systemic, and about 17% of the topical market, right? Markets growing at 20% year over year because of migration from topical corticosteroids to a non-steroidal option, topical or systemic.

The xus Cadence going forward, and I just saw a big uptick but International uh, can be a bit lumpy and then maybe longer term the degree to which the moderate add data from True ad4. Uh might expand the market opportunity, um, down the road. Thanks

Yeah, Brian good question. You know I'll give you my my initial observations after the um

After the first 30 days um obviously 60% of the business is AD and 40% is vitiligo. All right? That ad business is growing at plus 20% and the Vitiligo business is growing at eighteen plus plus 10% um,

Bill: And that TCS market in the United States at branded pricing is about $15 billion. Now, it's moving at a modest rate, but that's what's fueling the growth of the market that they're in. And as I said, I see it as a – I see this as a double-digit kegger business, both U.S. and, of course, internationally over the next several years, just with AD and with vitiligo.

Bill: As it relates to pediatrics… I would think about it as an incremental growth driver, all right? Here's what we know. There's about $2 billion in Triumph Cinelon use at branded pricing in the United States. But I think we have to be realistic about the extent to which we're going to drive utilization in pediatrics. I think the core business right now is what's going to drive growth over the next several years. The product's got 20,000 users in the United States, prescribers, which is second only to PIXENT and AD, and so there's a large prescriber base here, and when you're thinking about the long-term growth potential of any product, that's important, and then, as you know, the coverage both commercial Medicaid and Medicare is solid.

Our penetration of this Market. If you just think about the ad Market as systemic and topicals is still relatively modest 7% of the overall ad Market systemic and about 17% of the topical Market, all right? Market's growing at 20% year-over-year because of migration from topical, corticosteroids to a non-steroidal option, topical, or, or systemic. And, you know, that TCS Market in the United States at branded pricing is about 15 billion dollars, all right? Now it it's moving at a modest rate but that's what's fueling, the growth of the market that that they're in. And as I said, I see it as a, I see this as a double digit kegger business, both us and of course, internationally over the next several years, just with ad and with vitiligo.

It relates to Pediatric.

I would think about it as an incremental growth driver, all right. Here's what we know. There's about 2 billion dollars in triumphs in on use at branded pricing in the United States. But I think we have to be realistic about the extent to which we're going to drive utilization in Pediatrics. I think the core business right now is what's going to drive growth over the next several years.

The products got 20,000 users in the United States prescribers, which is second to only depicts an ad. And so there's a large prescriber base here and where you when you're thinking about the long-term growth potential of any product that's important. And then as you know, the coverage

Bill: It's not cheap, but it's it's solid coverage.

Bill: And so I like the way it looks as it relates to the international business. I just spoke with the the person who runs our international business the other day about this. France, Italy, Germany, and Canada, right? We had a good first or second year. It's gone from 60 million to roughly $120 million in sales. We'll get the AD, that was just in vitiligo. And the indication for AD, you know, has the potential to keep that business growing and maybe you two exit over several years. Do you have anything you want to add? No, you covered it all, and on the pitch side, we see the same way.

Both commercial Medicaid and Medicare are solid. It's not cheap, but it's solid coverage, and I like the way it looks as it relates to the international business. I just spoke with the...

the person who runs their international business, the other day about this,

France.

Italy, Germany, and Canada. All right, we had a good first or second year, it's gone from 60 million to roughly 120 million dollars in sales. Uh, we'll get the add indicator that was just in Vitiligo and, and the indication for for add, you know, has the potential to keep that business growing and maybe you 2 exit over several years.

Do you have anything you want to add?

Bill: It's a great tailwind to sustain the growth of our already strong budget proposition in that. Great. Thanks, Brian. Thank you.

No, you called it all. And uh and on the pizza side, we see the same way. It's a great Tailwind to sustain the growth of our already strong value proposition. In that disease. Great, thanks, Brian.

Thank you.

Jessica Fye: Next question today is coming from Jessica Fye from J.P. Morgan. Your line is now live. Great, good morning, thanks for taking my questions. A couple more for Bill.

Thank you. Next question is coming from Jessica Fire from JP Morgan. Your line is now live.

Bill: Curious how you plan to balance investment in pipeline advancement relative to external opportunities, relative to the need for investment to support kind of near-term commercial performance. And I guess if we think about kind of looking out five years from now, how do you see Incyte? Is this going to be mainly organically grown, transformed through M&A, some kind of combination? Thank you. Yeah, it's a really good, really good question. I think there's a there's a lot of there's a lot in that. Look, the job here and such as mine, it's, you know, Pablo and Steven and Christiana and the people who run the commercial business.

Great. Good morning. Thanks for taking my questions. Um, a couple more for Bill curious, how you plan to balance investment in pipeline advancement relative to external opportunities, relative to the need for in investment to support kind of near-term, commercial performance

And I guess if we think about kind of looking at 5 years from now, how do you see Insight? Is this going to be me in the organically grown transformed through m&a? Some kind of combination. Thank you.

Bill: It's about forgive the baseball metaphor, it's about calling balls and strikes. And you have to look at Internal investments and external investments, the exact same way. You know, there are no sacred cows inside the company. It's also not true that everything outside the company is a shiny penny. And, you know, I've been here 30 days, but I will tell you, all we think about is capital allocation, both internally and externally. In terms of a balance between the two, I don't like to force any ratio. I think we have to just look at facts, details and analysis and make our calls.

Yeah, it's it's a really good, a really good question. I think there's a there's a lot of, there's a lot in that. Look the job here and it's not just mine. It's, you know, Pablo and and Steve and and Christian and the, and the people who run the the commercial business, it's about forgive the, the baseball metaphor. It's about calling balls and Strikes. And you have to look at

um,

internal Investments and and external Investments the exact same way. You know, there are no sacred cows inside the company.

Um, it's also not true that everything outside. The company is a, is a shiny penny. And um, you know, I've been here 30 days, uh, but I will tell you all we think about is capital allocation.

Bill: You know, as it relates to where I want to see the company in five years, it'd be nice to two exit. But I think what we want to do is to, and I mentioned this earlier, you know, set a new high watermark for this company. I mean, we have to get through 2029, but set new highs for the company. And that means getting our growth portfolio right. and I include that Opsalur and Actembo and then 989 and Pope. and I know there's no guarantee there. We have to manage those programs. Next, get R&D priorities right, which is what every company has to do.

Exit. Um but I think what we want to do is to and I mentioned this earlier, you know, set

A new high water mark for this company. I mean, we have to get through 2029.

But set new highs for the company and that means getting our growth portfolio, right?

And I include that upsell or a new Timbo and then 989 and pobo.

Um, and I know there's no guarantee there. We we have to we have to manage those programs.

Bill: then get the cost base right. That's just good corporate hygiene. Get BD right. and build a business for the long term so that we really never see the end of the road.

Next, we need to get R&D priorities right, which is what every company has to do.

Then get the cost base, right? That's just good corporate hygiene.

Um, get Beady right?

Bill: And as I mentioned earlier, I do believe we have a win of opportunity in MPNs where we have differentiated knowledge and capabilities to build a really great business. Thanks for the question. Thank you.

And build a business for the long term so that we really never see the end of the road. Um, and as I mentioned earlier, I do believe we have a win of opportunity in mpns, where we have differentiated knowledge and capabilities to build a really great business there.

Thanks for the question.

Marc Frahm: Next question today is coming in from Marc Frahm from TD Cowen. Your line is now live. Thanks for taking my questions. Maybe one quick one, clarifying an earlier answer, just on the thresholds in MF for me and Cal-R. Even if maybe the best path forward is combinations, do you need to see kind of convincing monotherapy activity that, you know, if that was all you had, would have justified moving forward as well, in order to kind of move the program forward either as a monotherapy or as a combo, or is just convincing combo data enough? And then similar to that, maybe, Bill, when you're talking through the kind of the way to think about prioritizing financial resources, you can't put solid tumor oncology or oncology outside PMONC.

Thank you. Next question. Today is coming from Mark? From TD cow when your line is now live.

I think for taking my questions, maybe 1 quick, 1 clarifying in a earlier answer just on the kind of thresholds in MF for for me and kalhar. Um, even if maybe the the best pass forward is, is combinations. Do you need to see kind of convincing monotherapy activity that, you know?

Pablo Cagnoni: as maybe the third priority. When you think about the G12D data coming, you know, you guys are not first in class there necessarily. And the next steps are likely some combinations in addition to monotherapy work where this program really starts to blossom. Does it need to be a convincing best-in-class agent in order to justify that investment or, you know, is it kind of over time competing in various combinations but with a more similar asset enough to justify an Good, Marc. Thanks for the question.

It. If that was all you had would have Justified moving forward as well. Um, in order to kind of move the program forward either as a monitor, or as the combo or is just convincing combo data enough and then similar to that maybe bill when you were talking through the um, kind of the way to think about prioritizing Financial Resources. Um, you can't put solid tumor oncology or oncology outside of whom, um,

as maybe the third priority, when you think about the g12d data coming, you know, you guys are not first in class there necessarily. Um, and the next steps are likely some combinations in addition to monotherapy work where, where this program really starts to Blossom.

Does it need to be convincing best-in-class agent in order to justify the investment, or, you know, is kind of over time, competing in various combinations. But with a more uh, similar asset enough to justify investment

Pablo Cagnoni: I'll turn over the first question to Pablo and then probably Pablo and I will take the second question together. Go ahead, Pablo. So let me address the 999. And the short answer, Marc, is... We absolutely have to have single-agent activity in MS. I think it's an expectation based on the mechanism of action of 9A9 that it will have single-agent activity in patients with myelofibrosis. The question here is, as we build a comprehensive plan to basically cover the needs of every single patient with a myeloperipheral neoplasm, we wanna make sure we can address early MF, first-line MF, and patients with MF that failed on Jackify, either for intolerance or progression on Jackify.

Good Mark. Thanks for the question. I'll turn over the the first question, uh, to Pablo and then probably Pablo and I will take the second question together. Go ahead, Pablo

So let me address the 9999 and the short answer, Mark, is.

Pablo Cagnoni: And to do that, we need a comprehensive data set to show you single agent and combination data with Jackify. But it's an expectation, based on the mechanism of Action 989, that it will have single agent activity in myelofibrosis.

Bill: Great, thanks, Paul. And as it relates to G12D, and Pablo will also comment. First thing I said is we're very clear eyed about this. There are dozens in development, and in the hands of big companies, the hurdle here is high. and we'll be clear eyed about making a decision. If you're not first, you better be early. And most importantly, the position has to be defensible. All right. And when we get that data, we're going to have to make that decision. We do believe that the properties of G12D could be differentiating, and we believe that it will have a pace and a place in the treatment paradigm.

We absolutely have to have single agent activity in Ms. I think it's an expectation based on the mechanism of action of 989 that it will have single agent activity in patients with male fibrosis. The question here is, as we build a comprehensive plan to basically cover the needs of every single patient with a myop peripheral neoplasm. We want to make sure we can address early MF first line MF and patients with MF that failed, uh, on Jack. Ofi either for intolerance or progression on Jack ofi. And to do that, we need a comprehensive data set to show you a single agent in combination data, uh, which I can find. But it's an expectation based on the mechanism of action 989 that it will have single agent activity in Milo fibrosis.

Great. Thanks. Paul. And as it relates to g12d and and and Pablo will also comment uh, the first thing I said is we're very clear about this. There are dozens in development and in the hands of of big companies, the hurdle here is is High. Um,

And will be cleared out about making a decision. Uh, if you're not first, you better be early and most importantly, the position has to be defensible. All right? And when we get that data, we're going to have to make uh, that decision. We do believe that the properties of g12d

Pablo Cagnoni: And I'll let Pablo talk a little bit about. So, to complement what Bill said, this is, as you know, Marc, a very competitive space, G12D, and there's some excellent programs advancing in this setting. What we think we have with our G12D program, and we look forward to sharing the data so we can discuss this in more detail with data in hand, is a compound that not only might be competitive in terms of single agent activity, but the combinability might be better than some of our competitors. And when you think about the really, really big opportunity here, which is first-line pancreatic cancer, that's going to require, more likely than not, a combination therapy with intensive chemotherapy.

Could be differentiating, and we believe that it will have a patient place in the treatment paradigm. I'll let Pablo talk a little bit about that.

So uh, to to complement what Bill said this is, as, you know, Mark a very competitive space, uh, g12d and there's some, some excellent uh, uh, programs advancing, um, in this, in this setting.

Pablo Cagnoni: In that context, we think we have a path to compete with some of the other programs. So as Bill said, we may not be first in class, but we're certainly in the front of the pack when it comes to positioning. And if the combinability of our G12D inhibitor is better than some of our competitors, perhaps there is a way to accelerate the development in early lines of therapy in pancreatic cancer. That's the way we're seeing the program.

What we think we have our D12 D program and and we look forward to sharing the data so we can discuss this in more detail with data. We did in hand is a company that not only might be competitive in terms of single engine activity, but they combine ability might be better that some of our competitors. And when you think about the really, really big opportunity here, which is first line, um, pancreatic cancer, that's going to require more likely than not a combination therapy with intensive chemotherapy.

Bill: As Bill said in his introductory remarks, we will have a very high bar to continue to advance this program forward once we share all the data and we'll make those decisions later this year. Thank you.

We think we have a path to compete with some of the other programs. So as Bill said, we may not be first in class, but we're certainly in the front of the pack, when it comes to positioning. And if the combined ability of our g12d inhibitor is better than some of our competitors. Perhaps there is a way to accelerate the development in early lines of therapy in pancreatic cancer. That's the way we're seeing the program. As Bill said, in his introductory remarks we will have a very high bar to continue to advance this program forward. Once we share all the data and we'll make those decisions later this year.

Connor McKay: Next question today is coming from Evan Seigerman from BMO Capital Markets. Your line is now live. Hi there, this is Connor McKay on for Evan. Thanks for taking our question and congrats on the quarter. This is the second quarter in a row that Nick Timpo has come in ahead of consensus expectations, and you shared a little bit today about, you know, kind of the dynamics in the early days of the launch. But I'm curious, maybe, can you remind us how you're thinking about sort of the peak opportunity for this product? And kind of has the launch trajectory in the early days changed that at all?

Thank you. Next question for today is coming from Evan, seeking insight from Be More Capital Markets. Your line is now live.

Bill: And then I guess maybe just one quick follow up for Bill as well. You know, we discussed a little bit about business development and how you're prioritizing that versus the internal pipeline. I guess, are there any therapeutic areas that you'd be most focused on sort of as it relates to business development? Thank you. Great, and I'll take, I'll take a.

Hi, there. This is. Connor McKay on, for Evan, thanks for taking our question and congrats on the quarter. Uh, this is the second quarter in a row that Nick Timbo has come in ahead of consensus expectations and you shared a little bit today about, you know, kind of the Dynamics in the early days of the launch, uh, but I'm curious, maybe can you, uh, remind us how you're thinking about sort of the peak opportunity for this product and kind of has the launch trajectory in the early days uh changed that at all. And then I guess maybe just 1 quick follow-up for Bill as well. Um you know we discussed a little bit about business business development and higher prioritizing that versus the internal pipeline I guess. Are there any therapeutic areas that you'd be most focused on sort of as it relates to Business Development? Thank you.

Bill: a shot at first at the first question and then let Mohamed fill in. and then I'll come back to the second question. You know, as it relates to the peak potential of Nictimbo. It's really hard to figure out what's going to happen in five years. I'm pretty modest about the accuracy of my future predictions, but I will tell you that It's only two quarters, and I've been on both sides of this, positive and negative. I'm reassured by what I see. I think the potential of this product, in part, is going to trade on, can we get it into combination with Jackify and with steroids?

Great. And I'll take a, I'll take a

a a shot at first at the first question and then let Muhammad uh, fill in

and then I'll come back to the second question.

You know, as it relates to the peak potential of Nick Timbo.

It's really hard to.

Figure out what's going to happen. In five years, I'm pretty modest about the accuracy of my future predictions. But I will tell you that.

It's only 2 quarters and I've been on both sides of this positive and negative. I'm reassured by what what I see. I think the potential of this product in part is going to trade on. Can we get it?

Into combination with Jack ify.

Bill: And those studies are ongoing. That's number one. We also have a team working on a sub-Q formulation, which I think is very important. And that's gonna get you into frontline, whether you're a monotherapy or whether you're a combination therapy. Now, we have to take care of the short term and build a real solid business in the indication that we have today. And all estimates are that we're doing that. things can sort of Wobble around quarter to quarter, but since your question was about the long term, my expectations are, you know, when you look at a product like Resiroc at Sanofi, you know, that could be the low watermark for us.

And with uh steroids and those studies are, are ongoing. Um,

That's number 1.

We also have a team working on a subq formulation which I think is is very important and that's going to get you into front line whether you're a monotherapy or whether you're a combination therapy. Now, we have to take care of the short term and build a real solid business in the indication that we have today. And all estimates are that we're doing that. Um,

Things can sort of.

wobble around quarter to quarter, but since your question was about the long term, my expectations are, you know, when you look at a product, like, resur rock at Santa Fe

Mohamed: And I think if you get these additional indications, then you're going to travel north of that. Yeah, maybe just to quickly compliment there, I think, look, in the first five months we mentioned, we've been able to capture 20% of that in-play segment. If by the end of the year we can capture, to Bill's point earlier, 1,000 patients, so let's call it 30% of that in-play market, we'd be ahead of GVHD analogs and overcome any order of entry discounts. So if you consider those same analogs, then I think it'll be conceivable for just our indication that we have today to deliver several hundred million dollars of annual sales by, you know, 2028.

Um, you know, that could be the low water mark for us and I think if you get these additional indications, then you're going to travel north of that.

Mohamed: So we're currently working ahead and performing ahead of analogs in the space, and I think we're, you know, performing to an extent where we're going to mute, I think, order of entry analogs to a certain extent, and I think you can put projections based on that.

Bill: And as it relates to this, this second question, you know, if you study companies that have great business There are a couple criteria that are common in terms of new therapeutic areas. And I'll just say up front, we'd never go into a new therapeutic area that would stretch our capabilities or we would go beyond our competencies. Because I do believe right now, we're in two excellent areas with excellent prospects for growth. But you look, first of all... Chronic Disease Management is, has a lot of sort of attributes to it. You look for a fairly sizable population, unmet need.

Muhammad. Yeah, maybe just to quickly complement their, I think look in in the first 5 months, we mentioned, we've been able to capture 20% of that in place segment. If by the end of the year, we can capture to Bill's Point earlier a thousand patients. So let's call it 30% of that in play market. We'd be ahead of gvhd, analogs and overcome any entry, uh, of order of Entry discounts. So, if you consider those same analogs then, I think it'll be conceivable for just our indication that we have today to deliver several hundred million dollars of annual sales by you know 2028. So uh we're currently working ahead and Performing ahead of uh analogs in the space. Uh and I think we're we're you know, performing to an extent where we're going to mute. I think order of Entry analogs to a certain extent and I think you can put projections uh based on some of those develops. Yeah. And as it relates to this this second question, you know if you study companies that have great businesses

there are a couple um, criteria that

Are common in terms of new therapeutic areas. And and I, I'll, I'll just say up front. We'd never go into a new therapeutic area that would stretch our capabilities, or we would go beyond our our competencies because I do believe right now, we're into excellent areas with excellent. Prospects for growth.

um,

but you look first of all.

Chronic disease management.

It has a lot of sort of attributes to it. Um, you look for.

a fairly sizable population.

Srikripa Devarakonda: The potential to have a standard of care approach and where duration of therapy is measured in years, not. and there are some logical extensions of our current business in hemong and immune mediated skin conditions or INI and we'll continue to continue to look at it but you know my focus right now is on what we have and if there's an opportunity to enter another therapeutic area that makes sense strategically operation financially we'll explain it and do it but the focus right now is is what's inside the Thank you.

Um, unmet need

the potential to have a standard of care approach and where duration of therapy is is measured in years, not months.

Um, and there are some logical extensions of our current business.

immune mediated skin conditions or ini uh and we'll continue to continue to look at it but you know my focus right now is on what we have and if there's an opportunity

To enter another therapeutic area that makes sense. Strategically, operationally, financially, we'll explain it, uh, and do it. But the focus right now is what's inside the company.

Mohamed: Our next question today is coming from Srikripa Devarakonda from Jewish Security. Your line is now live. Hey, thank you so much for taking my question. And Bill, let me extend my welcome. Looking forward to working with you. I have a question on Jackify in PV. You know, you've showed continued growth in PV. It continues to be, Jackify continues to be a key growth driver here. Can you talk about the patient population where you're seeing increased uptake?

Thank you. Our next question. Today is coming from sweet crypto. Dear condo from Jewish security. Your line is now live,

Mohamed: And also, given the footprint you have established here, any thoughts on life cycle management beyond XR and V617F, which we're going to see data hopefully next year, would be helpful? And also, one follow-up question. Monjuvi was approved for relapsed refractory FL in June. Just any thoughts on expectations there for the remainder of the year? Yeah, thanks for the question.

Hey, uh, thank you so much for taking my question and let me extend my welcome. Uh, looking forward to working with you. Um, I have a question on Jack IFI in, uh, PV, you know, you've sort of continued growth in PV. It continues to be, that's why I continues to be a key growth driver. Um, here, can you talk about the patient population where you're seeing increased uptake? Um, and also, you know, given the footprint, you have established here. Any thoughts on life cycle management, beyond the XR and you know, these 617 F which we're going to see data hopefully next year would be um helpful and also 1. Follow-up question 1. Juvie was approved for a relapse refractory FL in June just any thoughts on um expectations there for the remainder of the Year? Thank you.

Mohamed: I'll just go ahead and turn it over to Muhammad to address the question on Jackify. Yeah, maybe let me take a stab on Jackify. I'm on Juven and Bill, I'll give it back to you for any added remarks. Look, PV is the least penetrated indication for Jackify when compared to the other two indications, thus being our biggest growth driver. Our team is doing a very effective job in educating the market on the importance of treating PV earlier with Jackify and its benefits of thrombosis-free survival. As a result, you continue to see strong double-digit growth in Q2 and we're confident in that momentum going forward.

Mohamed: So, there the patient population is simply patients on an earlier line therapy that are experiencing symptoms and or need an intervention. And when using Jackify for those patients, they benefit from thrombosis-free survival.

Mohamed: If I can just quickly touch on Monjuvi and then Bill, I'll give it back to you. Look, I think it's important to note Monjuvi showed a 59% risk reduction in disease progression or death versus what is currently the standard of care. So, we believe naturally Monjuvi has the potential to be the new standard of care for patients living with FL. And we expect the growth ramp, though, here to be reflective of the indolent nature of the disease. And our expectations for the balance of the year are captured in the guidance that Christiana provided for the other He-Monk portfolio.

Yeah, thanks for the question. I'll just go ahead and turn it over to, um, Muhammad to address. Uh, the question on, on, uh, on Jacki. Yeah, maybe let me take a stab on Jack. If I am on juvenile bill, I'll give it back to you for any added remarks. Look, um, uh, PV is the least penetrated indication for Jack ofi when compared to the other 2 indications, thus being our biggest growth driver, our team is doing a very effective job in educating the market on the importance of treating PV earlier with Jack ofi, and its benefits of thrombosis free survival. As a result, you can continue to see strong double-digit growth in Q2 and we're confident in that momentum going forward. So there, the patient population is simply patients on, uh, an earlier line, uh, uh, uh, therapy that are experiencing symptoms. Andor need, uh, an intervention and when using Jack apply for those patients, they benefit from thrombosis free survival. If I can just quickly touch on M juvie, uh, and then and then bill, I'll give it back to you. Look, I think it's important to note muv

Bill: With really good execution, Monjuvi and FL alone, excluding any other indication, can be one of those incremental growth drivers and deliver $200 million or so in annual revenue by 2020. Yeah, I think I think Mohammed said it well, very focused on the growth of Jackify over the next several years. Obviously, our penetration in MF is high. And as Mohammed said, in GVHD, I would describe it as medium. And then in PV, it's low, which is why you're seeing double digit growth. With that product right now, or with that indication right now, I think we'll continue to see that in the magic PV study is only a couple of years Thanks for the questions.

Showed a 59% risk reduction disease, progression or death. Versus what is currently the standard of care. So we believe naturally muvi has the potential to be the new standard of care for patients, living with FL. And we expect the growth ramp though here to be reflective of the indolent nature of the disease, and our expectations, for the balance of the year, or our captured in the guidance that Cristiano provided for the other. Heck portfolio, with really good execution, mju and FL alone. Excluding any other indication can be 1 of those those

Incremental growth drivers and deliver, you know, 200, you know, million dollars or so in annual revenue by by 2028. Yeah, I think, I think, um, Muhammad said it, well, very focused on the growth of of Jack of I over the next uh, several years. Um, obviously our penetration in uh, MF is high and as Muhammad said, in, in gvhd it, I would describe it as medium and

And then in PV it's low, which is why you're seeing double digit growth, uh, with that product right now or with that indication right now, I think we'll continue to see that in the magic. PV study is only a couple years old, so

Thanks for the question.

Thank you.

Stephen Willey: Thank you.

Pablo Cagnoni: Next question today is coming from Stephen Willey from Steeple. Your line is now live. Yeah, good morning. Thanks for taking the questions. Just a couple on 989. Can you say anything about the characteristics of the the MF patients enrolled into the phase. Were there any restrictions placed on eligibility criteria? I suspect that this is going to look like a typical check. And then just wondering how we should also be thinking about the duration of follow-up we'll have relative to what we're doing. Thanks for the question.

Thank you. Next question, today, is coming from Stephen. Willie from staple. Your line is now live.

Yeah, good morning. Thanks for taking the questions. Just a couple on 989. Can you say anything about the characteristics of those?

Um, the MS patients enrolled in the Phase 1 with respect to just baseline. Cytopenia is hemoglobin. Were there any restrictions placed on eligibility criteria? Or should we expect that this is going to look like a typical Jack experience patient population? And then just wondering how we should also be thinking about the duration of follow-up relative to what was just presented in ET. Thanks.

Pablo Cagnoni: Pablo, take it. So the population is, as you call it, typical of patients that have been exposed to Jackify. There are patients that are intolerant or progressed to Jackify. So it's a pretty representative population in MF. We were not very restrictive in terms of enrollment criteria. So I think it would be very, very informative in order to discuss next steps for 989 in patients with MF. Follow-up is going to be variable. This has been a dose escalation study, as you know. So the early dose cohorts will have longer follow-up than the later dose, higher dose cohorts.

Thanks for the question, Pablo. Take it.

Pablo Cagnoni: But all in all, we'll have patients with pre-substantial follow-up because the studies are enrolling patients at low doses more than a year ago. So we'll have we'll have a fair amount of follow-up. Thanks for the question. Thank you.

More than a year ago. So we'll have we'll have a fair amount of follow-up.

Thanks for the question.

David Lebowitz: Next question today is coming from David Lebowitz from City Your Line Is Now Live. Hello, thanks for taking my question.

Thank you. Next question, today is coming from David leitz. From City of your line is now live.

Bill: And Bill, welcome to the team. I guess on Jack, if he in the current quarter, what were the particular drivers? Which side of the, you know, which indication drove the therapy the most and curious as to what IRA and the out-of-pocket changes might have had an impact in the quarter, and how we should see that impacting going forward? Yeah, good question.

Hello. Thanks for taking my question and Bill, welcome to the team. Um, I guess on Jack at the current quarter, uh, what was the particular drivers? Um, uh, which side of the um, you know, which indication, uh, drove the drove, the therapy, the most and and curious as to what IRA and the out of pocket changes, might have had an impact in the quarter and how we should see that impacting going forward.

Mohamed: I'll give you some initial comments and then and then Muhammad can take over. I think the most important point about the quarter is that there was growth in all three indications. I would view MF and GVHD as mid-single-digit growing indications, and I think this is true over the longer term, and PV as a double-digit growing indication. We saw that last quarter. We saw it again this quarter. And I think given where the product sits in each one of those markets or those indications, that's what the growth profile or the mix is going to look like for the next three-plus years.

Yeah, good question. I'll give you some initial, uh, comments and then and then Muhammad could take over. I think the most important point about the quarter is that there was growth in all 3 indications.

And I think you can; I would view MF and GVH and GVHD as, you know, mid-single-digit grower indications. And I think this is true over the longer term, and PV as a...

Mohamed: And then as it relates to the IRA, Mohamed? Yeah, nothing to add on the growth drivers. On the IRA, the simple answer is that it had no impact on our performance in Q2. As you remember, the IRA dynamics had a favorable GTN impact in Q1, but that was a one-time effect as we communicated there. And in Q2, the demand really drove the growth, and that's where you see the performance for Jack Final. Thank you.

Double digit uh growing indication. We saw that last quarter. We saw it again this quarter and I think given where the product sits in each 1 of those markets or those indications that that's what the growth profile or the mix is going to look like for the next you know 3 plus years and then as relates to the IRA Muhammad. Yeah. Nothing to add on the growth drivers on Ira. The the simple answer is that it had no impact on our performance in Q2, as you remember, the IRA,

Dynamics had a favorable gtn uh impact in q1 but that was a 1-time effect as we communicated there and in Q2 uh the demand, uh really drove the growth, and that's where you see the performance for Jack. Find the quarter.

Michael Schmidt: Our next question is coming from Michael Schmidt from Guggenheim.

Pablo Cagnoni: Your line is now live.

Pablo Cagnoni: Oh, hey guys, good morning. I just had another bigger picture question for Bill. So in terms of capital allocation, and sort of reading between the lines, Prior comments, it sounds like there may be opportunity to perhaps optimize the earlier stage R&D portfolio. So longer term, as you think about potentially increasing R&D productivity for the company, are there specific areas where you think Incyte is underinvested, you know, be it in terms of targets, modalities or disease areas within the broader framework of oncology and INI?

Thank you. Our next question is coming from Michael Schmidt, from Google home. Your line is now live,

Pablo Cagnoni: And then just a quick one for Pablo on Provo-Sidney. Could you just help us understand the importance of the upcoming phase two data in asthma in the second half of the year? I know you've noticed in the past that the bar is high to advancing this, but I'm just curious what we should expect there.

Pablo Cagnoni: Thank you. Yeah, Michael, good question. Listen, Pablo and I speak a lot about the first question that you just asked regarding specific specific areas, putting External opportunities aside, as soon as I make a comment about an area, the prices of all those companies would go up. But why don't you just talk about how we're thinking about internal R&D and oncology. So, if I understand your question, Michael, it's more specifically related to the early preclinical pipeline. And what we've been doing there, a lot of which is honestly not visible because we don't disclose pre-IND programs, but we have, over the past couple of years, increasingly tightened our focus around novel biology and applying novel platforms to novel biology.

Oh, hey guys. Good morning. Um, I just had another bigger picture question for bill. So in terms of capital, allocation and sort of reading between the lines and of your prior comments, it sounds like there may be opportunity to perhaps um, optimize the earlier stage or the portfolio. So um, longer term, as you think about potentially increasing R&D productivity uh for the company, Are there specific areas where you think um, Insight is under invested, you know, be it in terms of targets modalities or disease areas within the broader framework of oncology and ini. Um, and then just a quick 1 for Pablo on puberty snip just um, could you just help us understand the importance of the upcoming? Uh, Phase 2 data in a and asked minus second half of the year? I know you've noticed in the past that the bar is high to advancing this but yeah, I'm just curious. What we should expect there. Thanks so much.

Yeah, Mike. A good question. Listen, Pablo and I speak a lot about the first question that you just asked regarding specific specific areas putting

External opportunities aside, as soon as I make a comment about an area, the prices of all those companies would go up. But why don't you just talk about how we're thinking about internal R&D and oncology?

Pablo Cagnoni: So, our goal over time is to truly focus on trying to be first-in-class applying novel platforms. And that was the impetus behind the collaboration we established with Genesys to take advantage of their capabilities in AI and machine learning drug discovery. The collaboration that we put in, we expanded with Biotherics to give access to a molecular glucose library. And we will continue to do those because we believe, fundamentally, in order to win in the next 10 years, we need to focus on novel areas, novel targets by applying novel platforms. So, that's a lot of the emphasis when it comes to the preclinical pipeline.

So if I understand your question, Michael, it it's more specifically related to the early, uh, preclinical, uh, Pipeline and and what we've been doing there uh a lot of which is honestly not visible because we don't disclose pre-ind programs, but we have over the past couple of years increasingly tighten, our Focus around novel biology and applying novel platforms to novel biology. Um, so our goal over time is to truly focus on. Try to be first in class applying Noble platforms and that what that was the impetus behind the collaboration. We established with Genesis to take advantage of the capabilities and AI machine learning drug Discovery. The collaboration that we put in we expanded uh with bioex to get access to a molecular Google's library, and we will continue to do those because we believe fundamentally in order to win the next 10 years. We need to focus on novel areas, novel targets by applying novel platforms. So that's a lot of the emphasis, uh, when it comes

To the preclinical pipeline.

Pablo Cagnoni: Thanks for the question.

Pablo Cagnoni: There was a question on Asthma. So. This remains a really important potential indication for POVO. We think there's a type of patients, particularly those with non-type 2 asthma, where there remains a need to reduce exacerbations and deliver substantial improvements in FEV1. And I'm talking about over 100 to 150 mLs. So we are, you know, we are really excited about having this data later this year. It's been a program that does not, has not received a lot of attention. So we look forward to deliver results before the end of the year. And depending on those results, obviously discussed next.

Thanks for the question. Uh, there was a question on asthma. So

This remains a really important potential indication for POA. We think there's a type of patients, particularly those with non-type 2 asthma where there remains a need to reduce exacerbations and deliver, substantial improvements in fev1 and I'm talking about over 100 to 150 MLS. So we are you know we are really excited about having this data later this year. It's been a program that does not has not received a lot of attention so we look forward to deliver results before the end of the year and depending on those results. Obviously discuss next steps.

Pablo Cagnoni: Thank you all.

Thank you.

Pablo Cagnoni: Our final question today is coming from Gavin Clark, partner from Evercore ISI. Your line is now live. Hey guys, very quick one. For 989, should we expect updated ET data alongside the MS data later this year? Thanks. Yes, Kevin, there will be an update on ET data as well later this year, absolutely. We are, as I mentioned in my remarks, we're moving as quickly as we can in ET. We will obtain later this year regulatory feedback with the goal of starting pivotal trials early 2026.

From Gavin, Clark Carter from isi. Your line is now live.

Hey guys, very quick 1. Um, for 989. Should we expect updated ET data? Alongside the MF data later this year? Thanks.

Pablo Cagnoni: So we will provide an update on the ET data that we present at EHA later this year. Thank you.

Uh, yes, Kevin, it will be an update on ET data as well later. This year. Absolutely. Um, we are as, as I mentioned, in my remarks, we're moving as quickly as we can, in ET. We will obtain later this year regulatory feedback with the goal of starting a pivotal trials, early 2026. So we will provide an update on the ET data that we present our eha later this year.

Operator: We've reached the end of our question and answer session. I'd like to turn the call back over for any further closing comments. Thank you all for participating in the call today and for your questions. The IR team will be available for the rest of the day for follow-up. Thank you and goodbye. Thank you.

Thank you. We have reached 10 of our question-and-answer sessions. I'd like to turn the call back over for any further closing comments.

Look for the rest of the day for follow-up. Thank you and goodbye.

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

Thank you. I just conclude today's teleconference webcast. You may disconnect your line at this time and have a wonderful day. You. Thank you Peter because patience today.