Incyte - Earnings Call - Q2 2025

Executive Summary

• Q2 2025 delivered broad-based strength: total revenues $1.216B (+16% Y/Y) and total product revenues $1.059B (+17% Y/Y); GAAP diluted EPS $2.04 and Non-GAAP diluted EPS $1.57, with demand-led growth in Jakafi, Opzelura, and the Niktimvo launch.
• Management raised FY25 guidance for Jakafi to $3.00–$3.05B and “Other Oncology” to $500–$520M; COGS guidance lowered reflecting a 50% royalty rate reduction on U.S. Jakafi post Novartis settlement; R&D guidance increased due to new collaborations; Opzelura guidance unchanged.
• Results beat Wall Street consensus: Q2 revenue $1.216B vs $1.1516B* and EPS (non-GAAP) $1.57 vs $1.473*; Q1 also beat revenue/EPS, supporting estimate revisions higher across key franchises. Bolded beats below.
• Strategic narrative sharpened under new CEO Bill Meury: prioritizing MPNs (mutCALR “989” and JAK2V617F programs), dermatology (Opzelura franchise, povorcitinib), and disciplined capital allocation; multiple regulatory wins (Zynyz in SCAC, Monjuvi in FL) augment diversification.
• Near-term stock reaction catalysts: FY25 guidance raises, Niktimvo adoption momentum (82% account penetration), and pipeline catalysts (989 MF data by year-end; Opzelura pediatric AD PDUFA 9/19/25).

What Went Well and What Went Wrong

What Went Well

• Demand-led growth across core products: Jakafi net revenue $764M (+8% Y/Y) on +8% paid demand; Opzelura $164M (+35% Y/Y); Niktimvo $36M with rapid adoption; total royalty revenues +10% led by Jakavi.
• FY25 guidance raised and cost structure improved: Jakafi and Other Oncology guidance increased; COGS reduced (ongoing 50% royalty rate cut to Novartis); operating leverage improving per CFO.
• Strategic/regulatory progress: FDA approvals for Zynyz (SCAC) and Monjuvi (FL); strong early-phase mutCALR “989” data (ET) suggesting disease-modifying potential; clear path for povorcitinib across HS, PN, vitiligo.
• “As I begin my tenure as CEO… our second quarter results reflect strong growth for Jakafi, Opzelura and Niktimvo, positioning us well to deliver on our 2025 objectives.” — Bill Meury, CEO.

What Went Wrong

• R&D and SG&A increased (non-GAAP R&D +16% Y/Y; GAAP SG&A +8% Y/Y), with heightened legal costs and collaboration-related expenses; R&D guidance raised by $35M for FY25.
• Timeline slippage: initial proof-of-concept for JAK2V617F shifted to 1H26 (dose escalation needs higher doses and longer follow-up)*[0000879169_2230018_10]**.
• Ongoing pipeline and BD execution risks called out explicitly by management (competitive G12D space, need for defensible positioning); disciplined capital allocation emphasized.
• Management transition risk: CFO announced departure effective Sept 16, 2025 (company reaffirmed guidance).

Transcript

Operator (participant)

Greetings and welcome to the Incyte Second Quarter 2025 Earnings Conference Call and Webcast. At this time, all participants are in listen-only mode. If anyone should require operator assistance, please press star zero on your telephone keypad. A question-and-answer session will follow the formal presentation, and you may be placed into question queue at any time by pressing star one on your telephone keypad. We ask that you please ask one question and one follow-up, then return to the queue. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Greg Shertzer, Senior Director of Investor Relations. Please go ahead.

Greg Shertzer (Senior Director of Investor Relations)

Thank you, Kevin. Good morning and welcome to Incyte 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. On today's call, I am joined by Bill, Christiana, and Pablo, who will deliver our prepared remarks. 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 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 Meury (CEO and President)

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 Hervé Hoppenot 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 one is, what specifically attracted me to the company? Second, 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 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. These products, of course, will vary in size. Some will contribute substantially and others incrementally to growth. Either way, there is substrate here. Marketed products—Opzelura, Niktimvo, Monjuvi, and pipeline compounds like 989, our mutant CALR monoclonal antibody, and povorcitinib, 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. Opzelura 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. Niktimvo is off to a very strong start. Phase 1 results with 989 in essential thrombocythemia are promising, and we will share data on myelofibrosis at the end of the year. Finally, povorcitinib could support at least three different indications. Next, Incyte operates in two of the most structurally attractive markets in the industry: hematology-oncology and immunology. They are built on solid foundations of science, need, and opportunity, and we have differentiated knowledge and capabilities in these areas and will focus on them. 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. Now, regarding our strategic priorities, here is 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 will 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 is straightforward.

Driving utilization of our major products 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 is 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 MPN space as a targeted mutation-specific approach. Our success will depend on translating early phase 1 data into a regulatory approval and a marketed product. The medical need and the market potential for 989 is significant. If we are successful, 989 should trigger a fundamental shift in the treatment of MPNs like we have seen in other cancers. For povorcitinib, 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 povorcitinib can have differentiation, such as HS, PN, and vitiligo. In HS, povorcitinib could be the first oral option, which is perhaps the most challenging disease in dermatology. It is 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 povorcitinib should be very marketable. As it relates to our early-stage pipeline, the scientific rationale behind CDK2, G12D, TGF-β, and BiPD-1 for select solid tumors, among others, is strong. 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.

I recognize that every use of capital, R&D capital, is an opportunity cost for other uses. 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. 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 50 cents. We'll be careful about where and how much capital we put to work.

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. 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. I look forward to sharing more details on our strategic framework later this year. Now, moving to our second quarter results, which Christiana will review next, Jakafi demand remains very strong across three indications. Opzelura growth was exceptional across two indications, and the Niktimvo 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 execute. On the R&D front, we made excellent progress. We will release phase 1 data on 989 and MF at the end of the year to supplement the data we presented at EHA and ET. We expect an FDA approval for Opzelura in pediatric patients 2 to 11 years of age with mild to moderate AD in September. Importantly, the pivotal trials for povorcitinib in vitiligo and PN and combination trials with axatilimab in GVHD are enrolling on track. With that, I'd like to turn the call over to Christiana, who will provide the second quarter commercial and financial update.

Christiana Stamoulis (CFO)

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 Jakafi and Opzelura, as well as the contribution from the ongoing commercial launch of Niktimvo. Total revenues were $1.22 billion, up 16% versus the same period last year. Turning to Jakafi on slide nine, 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 period. Demand for Jakafi continued to grow across all indications. Channel inventory levels ended the quarter within normal range. As a result of the strong demand seen in the first half of the year, we are raising our full-year revenue guidance for Jakafi to a new range of $3-$3.05 billion.

Turning now to Opzelura on slide 10, total net product revenue for the second quarter was $164 million, representing a 35% increase year over year. US net product revenue of $132 million was up 19% year over year, driven by increased patient demand and refills in both atopic dermatitis and vitiligo. Channel inventory levels ended the quarter within normal range. Ex-US 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, Opzelura has seen very rapid adoption. Turning to slide 11 and Niktimvo launch, Niktimvo net product revenues in the second quarter were $36 million, driven by high patient need and strong commercial execution. 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 Niktimvo, approximately 80-90% remain on therapy today. 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. This is primarily driven by the commercial launch of Niktimvo, as well as increased contribution from Zynyz following the approval in ACAC. As a result of the strength of the Niktimvo launch, higher demand for Zynyz, 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-$520 million.

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 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 8-9% of net product revenues. Shifting now to R&D, total R&D expenses on a GAAP 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 assets. In the first half of the year, we entered into two new development collaborations with Genesis and BioTherx.

As a result of the upfront and ongoing expenses related to these new collaborations, we are increasing our full-year guidance for R&D by $35 million to a new range of $1.965-$1.995 billion. Moving to SG&A, total GAAP SG&A expenses were $331 million for the second quarter. Excluding the one-time cost for the prior year, GAAP SG&A expenses increased 16% year-over-year, primarily driven by increased legal costs related to the Novartis contract dispute settlement and other matters, and timing of certain consumer marketing activities. Finally, we continue to execute on our commitment to grow operating expenses at a slower pace than 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 and 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 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 margins. I'll now turn the call over to Pablo for an R&D update.

Pablo Cagnoni (President and Head of Research and Development)

Thank you, Christiana. 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. Moving to slide 16, the phase 1 data in essential thrombocythemia for INCA033989, our mutant CALR 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 thrombocythemia and 35% of patients with myelofibrosis. Importantly, this data set demonstrated the normalization of platelet counts in patients with ET, which is consistent with the mechanism of action of 989 and a key point of differentiation from cytoreductive therapies. 989 was very well tolerated, with only 1 out of 49 patients discontinuing therapy. It is very reassuring that at this point in the development of 989, it appears to have an excellent safety profile.

We also observe rapid and sustained reductions in VAF 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 CALR positive megakaryocytes in the bone marrow, as well as a reduction in mutant CALR 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. On slide 17, let me summarize the key steps for the 989 development plan. We will 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 dose is for further development.

We are committed to presenting data in MF as monotherapy and in combination with ruxolitinib by the end of the year. Additionally, we have established a collaboration with Caiogen to develop a codiagnostic across MPNs with an initial focus in CALR mutations. Importantly, we continue to develop a subcutaneous formulation, and that work is ongoing. We believe that initially, the IV formulation every two weeks is acceptable, but we'll work to advance the subQ in parallel. Turning to our dermatology portfolio starting on slide 18. I'm pleased to share an important update on ruxolitinib cream. As you know, Opzelura 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, we announced the top-line results from the pivotal phase 3 TRuE-AD4 study, which evaluated ruxolitinib cream in adult patients with moderate atopic dermatitis with extensive body surface area involvement of 10%-20% and significantly impaired quality of life with a DLQI greater than 10. I'm happy to report that the TRuE-AD4 study met its co-primary endpoints at week eight, with a statistically significantly larger proportion of patients receiving 1.5% ruxolitinib cream compared to vehicle, achieving both IGA-TS and EASI-75. At week eight, ruxolitinib cream demonstrated a vehicle-adjusted difference in IGA-TS of 47.6% and a vehicle-adjusted difference in EASI-75 of 51.4%, both highly statistically significant. In addition, the study met all key secondary endpoints, further reinforcing the efficacy profile of ruxolitinib cream in this patient population. Importantly, the safety profile observed in TRuE-AD4 was consistent with previously reported data in atopic dermatitis.

Ruxolitinib cream was well tolerated, and no new safety signals were observed. This result confirmed that ruxolitinib cream is a highly effective treatment option for patients with moderate AD who are eligible for systemic therapies. Based on the results of the study, plans are underway to submit a type II variation for Opzelura 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. Moving to slide 19 and the near-term opportunities for povorcitinib. We're advancing povorcitinib in three indications and believe these 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 povorcitinib 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 with potential approvals in 2027. 2025 is a pivotal year for Incyte, with over 18 key milestones, including four new product launches, four pivotal trial readouts, at least three phase 3 study initiations, and seven 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 BET phase 3 study is 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. 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.

Bill Meury (CEO and President)

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 year. 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.

Pablo Cagnoni (President and Head of Research and Development)

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

Operator (participant)

Certainly. We'll now be conducting a question-and-answer session. If you'd like to be placed into the question queue, please press star one 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 is star one to be placed into the queue and star two if you'd like to remove yourself from the queue. Our first question today is coming from Jay Olson from Oppenheimer. Your line is now live.

Jay Olson (Managing Director and Senior Analyst)

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 the therapeutic area? Thank you.

Bill Meury (CEO and President)

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, 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 cancers. As you know, targeting driver mutations in MPNs 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. 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. When you have an opportunity to sort of dominate and control and never cede the market, you got to take advantage of it.

Strategically speaking, that is our number one priority. I think we can set a new standard of care in MPNs, set what I would describe as a new high watermark. Now, look, no one should take my word for it. We have to convert, as I said, science into results. Of course, the progress that we're making with 989 has been incredibly important. I think in INI, I do believe that there's a credible path to building a large product. We're not, for example, with povorcitinib, copying all the indications for Rinvoq. I do believe we have differentiated knowledge and capabilities in the three immune-mediated skin conditions that we're targeting. We do have a franchise strategy with Opzelura and povorcitinib, which other companies don't have. The product has the potential to be first in HS, first in vitiligo. I think prurigo nodularis was a disease made for JAKs.

I like the potential there. As it relates to our oncology business, Jay, 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. 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 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. If we were to look at other areas, it would have to make sense strategically and operationally. I would never stretch the capabilities of the company.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, Jay.

Jay Olson (Managing Director and Senior Analyst)

Thank you, Bill.

Operator (participant)

Thank you. Next question is coming from Tazina Mott from Bank of America. Your line is now live.

Tazeen Ahmad (Managing Director)

Hi, guys. Good morning. Thanks for taking my question. I just wanted to get a sense, maybe this is for Pablo, on the read-through from the CALR 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.

Pablo Cagnoni (President and Head of Research and Development)

Good morning, Tazina. Thank you for the question. Look, let me make a couple of comments here. The important thing to remember is, mechanistically, the mutant CALR antibody 989 would work the same way in MF that it does in ET. 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 platelets, reduction in VAF, and reduction in mutant CALR-positive mega was so clear in the ET data, but because those were fundamental based on the mechanism of action of the mutant CALR antibody. 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.

The reason why we decided to shift the release of the data in MF to 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 patients in patients with MF. 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 improvements in MF in all the basic endpoints that we've discussed over the years in MF patients, obviously. Spleen size reduction, spleen volume reductions, improvement in symptoms, improvement in hemoglobin, perhaps. We expect to see a component of that in their data release later this year.

Operator (participant)

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

Salveen Richter (Managing Director for Global Investment Research)

Good morning. Thank you for taking my question. Just a follow-up to two comments that were mentioned earlier. One is initial data for 617F is now expected in the first half of 2026, and should we read anything into this delay? 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 Benflex. Thank you.

Bill Meury (CEO and President)

Great, Salvine. I'll answer the second question, and Pablo wants to take the first question.

Pablo Cagnoni (President and Head of Research and Development)

Certainly. This is simply related to the fact that this is a phase 1 dose escalation study. You make projections when you start the studies about what dose will give you a certain exposure that will 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, data needs to mature a little bit. Because of those two 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. 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 in the mechanism on this program continues to be strong, and this is simply a matter of escalating a little bit further.

Bill Meury (CEO and President)

Then Salvine, on HS and povorcitinib, and if Mohamed has—excuse me, Mohamed—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. IL-17s don't work almost half the time. One dermatologist described HiSCR 50 or even 75 as a beauty contest. It's very hard to compare HiSCR rates from one study to the next. The condition, as you know, is fundamentally different than IL-23 mediated psoriasis or IL-4/13 mediated AD. That is to say, it's inflammation soup. There are multiple pathways 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 povorcitinib 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. 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. I believe that a systemic option like povorcitinib is going to have a place in the treatment paradigm for HS, whether they're starting with povorcitinib and then going to a biologic, or they go to a biologic and then to povorcitinib. 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.When you look at the totality of the evidence, there's going to be a place for povorcitinib as well as the IL-17s.

Operator (participant)

Thank you. Our next question today is coming from Salim Said from Zero Security. Your line is now live.

Salim Syed (Managing Director, Senior Biotechnology Analyst, and Equity Research)

Great. First of all, my welcome to Bill, and thanks for the question. I guess maybe one for us on Niktimvo. You had a good beat again on the quarter, and obviously the J code went into effect here around April, April 1, I believe. Can you maybe comment to some of the interquarter 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? I don't think you guys mentioned the inventory impact there for the quarter. Can you just remind us what the inventory impact was for the quarter? Thank you.

Bill Meury (CEO and President)

Yeah, thanks for the question. I'll give you my overall assessment, and either Mohamed or Christiana can fill in some of the details. As Christiana said, 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 look like? Every pharmaceutical product is like a leaky bucket, and you have to maintain—the same is true with Opzelura. You have to maintain new patient starts. So when I look at the dynamics underneath Niktimvo, that's what I'm focused on. This product over the next six, seven months, say the balance of the year, has the potential to reach over 1,000 patients. That would be a very, very good first year.

If you take a look at the adoption curve, for example, of Sanofi's Rezuroc, and you look at the adoption curve right now for Niktimvo, 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 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 are using Niktimvo. 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 infusions and roughly 700 patients. Which means the large majority of patients, my estimate could be 90% of patients, are still on product.

And 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. I don't think we could have gotten off to a better start. I'm very paranoid we're in the middle of the first year of launch. You have to really manage the details very carefully. Of course, the ops designation makes this economically feasible for institutions. Mohamed, do you want to cover anything that I missed?

Mohamed Issa (EVP and Head of U.S. Oncology)

Yeah, you didn't miss much, but I think 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. That means these are the patients that are up for grabs, that are changing therapy in some capacity. We're either at 10% of the third-line plus setting in total, or we're 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. This is going to naturally encourage providers not only to use Niktimvo more often, but perhaps also consider Niktimvo earlier in their treatment paradigm for more patients.

Operator (participant)

Thanks for the question.

Salim Syed (Managing Director, Senior Biotechnology Analyst, and Equity Research)

Just on inventory, can you comment on that?

Pablo Cagnoni (President and Head of Research and Development)

Yeah. Yeah, the inventory, just to put that in perspective, inventory accounted for less than 5% of Q2 sales so far, and that's stabilizing in that expected range. The performance that you're seeing and the volume is driven primarily by demand.

Operator (participant)

Thank you. Next question is coming from Kelly Shea from Jefferies. Your line is now live.

Hi, good morning. This is Claire Alm for Kelly. Thanks for taking our question and congrats on the quarter. You have the initial G12D and bi-specific data you are presenting at last month. I wonder whether you can provide more granularity on the scope of proof of concept data. Maybe help us understand what would be the key metrics you are looking for to define the success and move the program forward. Thank you.

Bill Meury (CEO and President)

Great. Pablo, you want to take that?

Pablo Cagnoni (President and Head of Research and Development)

Certainly. What we should expect, what you should expect for the two presentations that I asked about, 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. That is exactly what you should expect here. We are going to have a substantial number of patients for both our KRAS G12D program and our TGF beta receptor by PD-1 bispecific.

We believe that both demonstrate proof of concept in a range of tumor types, and the amount of data we will be able to use to have a discussion with you on the next steps for these two programs, which we expect to do at ESMO in the next couple of months.

Bill Meury (CEO and President)

Thank you.

Operator (participant)

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

Brian Abrahams (Biotechnology Analyst)

Hey, good morning. Congrats on all the progress, and welcome to Bill. Look forward to working with you again.

Bill Meury (CEO and President)

Hey, Brian.

Brian Abrahams (Biotechnology Analyst)

Hey. A question on Opzelura. I know your guidance was unchanged, but I wanted to unpack the dynamics underlying that. I'm curious the degree to which pediatric indication is embedded there, and then maybe how we should be thinking about the ex-US cadence going forward. I know you saw a big uptick, but international can be a bit lumpy. Then maybe longer term, the degree to which the moderate AD data from 284 might expand the market opportunity down the road. Thanks.

Bill Meury (CEO and President)

Yeah, Brian, good question. I'll give you my initial observations 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 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 is systemic, and about 17% of the topical market, right? Market's growing at 20% year over year because of migration from topical corticosteroids to a non-steroidal option, topical or systemic. That TCS market in the United States at branded pricing is about $15 billion, right? Now, it's moving at a modest rate, but that's what's fueling the growth of the market that they're in.

I see this as a double-digit Kegger business, both US and then, of course, internationally over the next several years, just with AD and with vitiligo. As 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 in triamcinolone use at branded pricing in the United States. 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 to only Dapixent in AD. There's a large prescriber base here. When you're thinking about the long-term growth potential of any product, that's important. As you know, the coverage, both commercial, Medicaid, and Medicare, is solid.

It's not cheap, but it's solid coverage. I like the way it looks. As it relates to the international business, I just spoke with the person who runs our 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 in sales. We'll get the AD indication—that was just in vitiligo. The indication for AD has the potential to keep that business growing and maybe you two exit over several years. Taylor, anything you want to add?

Salveen Richter (Managing Director for Global Investment Research)

No, you covered it all. On the PEAT side, we see the same way. It's a great tailwind to sustain the growth of our already strong value proposition in that disease.

Bill Meury (CEO and President)

Great. Thanks, Brian.

Brian Abrahams (Biotechnology Analyst)

Thank you.

Operator (participant)

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

Jessica Fye (Managing Director and Equity Research Analyst)

Great. Good morning. Thanks for taking my questions. A couple more for 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. 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.

Bill Meury (CEO and President)

Yeah, it's a really good question. I think there's a lot in that. Look, the job here, and it's not just mine, it's Pablo and Steven and Christiana and the people who run the commercial business, it's about—forgive the baseball metaphor—it's about calling balls and strikes. You have to look at internal investments and external investments the exact same way. There are no sacred cows inside the company. It's also not true that everything outside the company is a shiny penny. 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.

Pablo Cagnoni (President and Head of Research and Development)

As it relates to where I want to see the company in five years, it'd be nice to two-exit. I think what we want to do is to—and I mentioned this earlier—set a new high watermark for this company. I mean, we have to get through 2029, but set new highs for the company. That means getting our growth portfolio right. I include in that Opzelura, Niktimvo, and then 989 and povorcitinib. 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. Get the cost base right. That's just good corporate hygiene. Get BD right. Build a business for the long term so that we really never see the end of the road.

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.

Operator (participant)

Thank you. Next question today is coming from Mark Fromme from TD Cal. Your line is now live.

Marc Frahm (Biotechnology Equity Research Analyst)

Thanks for taking my questions. Maybe one quick one clarifying an earlier answer. Just on the kind of thresholds in MF for mutant CALR are. Even if maybe the best path forward is combinations, do you need to see kind of convincing monotherapy activity that, 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 the combo? Is just convincing combo data enough? 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 as maybe the third priority. When you think about the G12D data coming, 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 the investment? Or is kind of over time competing in various combinations, but with a more similar asset enough to justify investment?

Bill Meury (CEO and President)

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

Pablo Cagnoni (President and Head of Research and Development)

Let me address the 989. The short answer, Mark, is we absolutely have to have single-agent activity in MF. I think it's an expectation based on the mechanism of action of 989 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 myeloproliferative neoplasm, we want to make sure we can address early MF, first-line MF, and patients with MF that failed on Jakafi, either for intolerance or progression on Jakafi. To do that, we need a comprehensive data set to show you single-agent and combination data with Jakafi. It's an expectation based on the mechanism of action of 989 that it will have single-agent activity in myelofibrosis.

Bill Meury (CEO and President)

Great. Thanks, Paul. As it relates to G12D, and Pablo will also comment, the 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. We'll be clear-eyed about making a decision. If you're not first, you better be early. Most importantly, the position has to be defensible, all right? 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 place in the treatment paradigm. I'll let Pablo talk a little bit about that.

Pablo Cagnoni (President and Head of Research and Development)

To complement what Bill said, this is, as you know, Mark, a very competitive space, G12D, and there are 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 company that not only might be competitive in terms of single-agent activity, but the combinability might be better than some of our competitors. When you think about the really, really big opportunity here, which is first-line pancreatic cancer, that is going to require, more likely than not, a combination therapy with intensive chemotherapy. In that context, we think we have a path to compete with some of the other programs.

As Bill said, we may not be first in class, but we are certainly in the front of the pack when it comes to positioning. 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 is the way we are 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 will make those decisions later this year.

Operator (participant)

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

Conor MacKay (Equity Research Analyst in Biopharma)

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 Niktimvo has come in ahead of consensus expectations. You shared a little bit today about kind of the dynamics in the early days of the launch. I'm curious, maybe can you remind us how you're thinking about sort of the peak opportunity for this product? Kind of has the launch trajectory in the early days changed that at all? I guess maybe just one quick follow-up for Bill as well. 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.

Bill Meury (CEO and President)

Great. I'll take a shot at the first question and then let Mohamed fill in. I'll come back to the second question. As it relates to the peak potential of Niktimvo, 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. 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 Jakafi and with steroids? 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. That's going to get you into front line, whether you're a monotherapy or whether you're a combination therapy.

We have to take care of the short term and build a real solid business in the indication that we have today. All estimates are that we're doing that. Things can sort of wobble around quarter to quarter. Since your question was about the long term, my expectations are when you look at a product like Rezuroc at Sanofi, that could be the low watermark for us. I think if you get these additional indications, then you're going to travel north of that. Mohamed?

Mohamed Issa (EVP and Head of U.S. Oncology)

Yeah, maybe just to quickly complement 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, or let's call it 30% of that in-play market, we'd be ahead of GVHD analogs and overcome any entry order of entry discounts. 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 2028. We're currently working ahead and performing ahead of analogs in the space. I think we're performing to an extent where we're going to mute, I think, order of entry analogs to a certain extent. I think you can put projections based on some of those analogs.

Bill Meury (CEO and President)

Yeah. As it relates to this second question, if you study companies that have great businesses, there are a couple criteria that are common in terms of new therapeutic areas. I'll just say upfront, we'd never go into a new therapeutic area that would stretch our capabilities or we would go beyond our competencies. I do believe right now we're in two excellent areas with excellent prospects for growth. You look, first of all, chronic disease management has a lot of sort of attributes to it. You look for a fairly sizable population, unmet need, the potential to have a standard of care approach, and where duration of therapy is measured in years, not months. There are some logical extensions of our current business in hem-onc and immune-mediated skin conditions or INI. We'll continue to look at it. My focus right now is on what we have.If there's an opportunity to enter another therapeutic area that makes sense strategically, operationally, financially, we'll explain it and do it. The focus right now is what's inside the company.

Operator (participant)

Thank you. Our next question today is coming from Sri Krupadhivera Kanda from Jefferies Securities. Your line is now live.

Kripa Devarakonda (Vice President and Biotech Equity Analyst)

Hey, thank you so much for taking my question. Bill, let me extend my welcome. Looking forward to working with you. I have a question on Jakafi in PV. You've showed continued growth in PV. Jakafi continues to be a key growth driver. Here, can you talk about the patient population where you're seeing increased uptake? Also, given the footprint you have established here, any thoughts on lifecycle management beyond XR and V617F, which we're going to see data hopefully next year would be helpful. 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? Thank you.

Bill Meury (CEO and President)

Yeah, thanks for the question. I'll just go ahead and turn it over to Mohamed to address the question on Jakafi.

Mohamed Issa (EVP and Head of U.S. Oncology)

Yeah. Maybe let me take a stab on Jakafi and Monjuvi, and then Bill, I'll give it back to you for any added remarks. Look. PV is the least penetrated indication for Jakafi 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 Jakafi 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. There, the patient population is simply patients on an earlier line therapy that are experiencing symptoms and/or need an intervention. When using Jakafi for those patients, they benefit from thrombosis-free survival. 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. We believe naturally Monjuvi has the potential to be the new standard of care for patients living with FL. We expect the growth ramp here to be reflective of the indolent nature of the disease. Our expectations for the balance of the year are captured in the guidance that Christiana provided for the other hem-onc portfolio. 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 2028.

Bill Meury (CEO and President)

Yeah, I think. Mohamed said it well. Very focused on the growth of Jakafi over the next several years. Obviously, our penetration in MF is high. As Mohamed said, in GVHD, I would describe it as medium. 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. The MAGIC PV study is only a couple of years old. Thanks for the question.

Thank you.

Operator (participant)

Thank you. Next question today is coming from Stephen Willey from Stifel. Your line is now live.

Stephen Willey (Managing Director)

Yeah, good morning. Thanks for taking the question. Just a couple on 989. Can you say anything about the characteristics of the MF patients enrolled into the phase 1 with respect to just baseline cytopenias, hemoglobin? Were there any restrictions placed on eligibility criteria, or should we expect that this is going to look like a typical JAK-experienced patient population? Just wondering how we should also be thinking about the duration of follow-up we'll have relative to what was just presented in ET. Thanks.

Bill Meury (CEO and President)

Thanks for the question. Pablo will take it.

Pablo Cagnoni (President and Head of Research and Development)

The population is, as you call, the typical of patients that have been exposed to Jakafi. There are patients that are intolerant or progressed in Jakafi. It is a pretty representative population in MF. We were not very restrictive in terms of enrollment criteria. I think it will be 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. The early dose cohorts will have longer follow-up than the later, higher dose cohorts. All in all, we will have patients with pretty substantial follow-up because the studies started enrolling patients at low doses more than a year ago. We will have a fair amount of follow-up.

Bill Meury (CEO and President)

Thanks for the question.

Operator (participant)

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

David Lebowitz (Senior Research Analyst for Biotechnology)

Hello. Thanks for taking my question. Bill, welcome to the team. I guess on Jakafi in the current quarter, what were the particular drivers? Which side of the, which indication drove the therapy the most? I am 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.

Bill Meury (CEO and President)

Yeah, good question. I'll give you some initial comments, and then Mohamed can take over. I think the most important point about the quarter is that there was growth in all three indications. I think you can—I would view MF and GVHD as mid-single-digit growing indications. I think this is true over the longer term. PV as a double-digit growing indication. We saw that last quarter. We saw it again this quarter. 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. As it relates to the IRA, Mohamed.

Mohamed Issa (EVP and Head of U.S. Oncology)

Yeah, nothing to add on the growth drivers. On 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. In Q2, the demand really drove the growth, and that's where you see the performance for Jakafi in the quarter.

Operator (participant)

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

Michael Schmidt (Senior Managing Director and Senior Biotech Analyst)

Oh, hey, guys. Good morning. I just had another bigger picture question for Bill. In terms of capital allocation and sort of reading between the lines and sort of your prior comments, it sounds like there may be opportunity to perhaps optimize the earlier-stage R&D portfolio. Longer-term, as you think about potentially increasing R&D productivity for the company, are there specific areas where you think Incyte is underinvested, be it in terms of targets, modalities, or disease areas within the broader framework of oncology and INI? Just a quick one for Pablo on povorcitinib. 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 noted 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.

Bill Meury (CEO and President)

Yeah, Michael, good question. Listen, Pablo and I speak a lot about the first question that you just asked regarding 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. Why don't you just talk about how we're thinking about internal R&D and oncology?

Pablo Cagnoni (President and Head of Research and Development)

If I understand your question, Michael, it's more specifically related to the early preclinical pipeline. 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. Our goal over time is to truly focus on trying to be first in class applying novel platforms. That was the impetus behind the collaboration we established with Genesis to take advantage of the capabilities on AI and machine learning drug discovery. The collaboration that we expanded with BioTherx to give access to a molecular glucose library. 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. That's a lot of the emphasis when it comes to the preclinical pipeline.

Bill Meury (CEO and President)

Thanks for the question.

Pablo Cagnoni (President and Head of Research and Development)

There was a question on asthma. This remains a really important potential indication for Pablo. 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. I'm talking about over 100-150 mL. We are really excited about having this data later this year. It's been a program that has not received a lot of attention. We look forward to deliver results before the end of the year. Depending on those results, obviously discuss next steps.

Michael Schmidt (Senior Managing Director and Senior Biotech Analyst)

Thank you.

Operator (participant)

Our final question today is coming from Gavin Clark Gardner from Evercore ISI. Your line is now live.

Gavin Clark-Gartner (Managing Director and Biotechnology Equity Research)

Hey, guys. Very quick one. For 989, should we expect updated ET data alongside the MF data later this year? Thanks.

Pablo Cagnoni (President and Head of Research and Development)

Yes, Gavin, 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. We will provide an update on the ET data that we present at EHA later this year.

Operator (participant)

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

Bill Meury (CEO and President)

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.

Operator (participant)

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