Incyte Q2 2025 Earnings Call Transcript

Quartr
Provided by Quartr
July 29, 2025

Key Takeaways

  • Positive Sentiment: Revenue growth in Q2 with total product revenues up 17% year-over-year to $1.06 billion and full-year revenue guidance raised.
  • Positive Sentiment: Strong R&D progress, including promising Phase I data for mutant CALR antibody INCA 338989 in ET, MF data and pivotal trials for povorcitinib in HS, vitiligo and PN on track.
  • Positive Sentiment: Settlement with Novartis delivered a $242 million benefit and cut Jakafi royalties by 50%, prompting a reduced COGS guidance.
  • Negative Sentiment: Operating expenses are rising, with R&D guidance increased by $35 million to $1.965–1.995 billion and SG&A up 16% year-over-year, which could pressure near-term margins.
AI Generated. May Contain Errors.
Earnings Conference Call
Incyte Q2 2025
00:00 / 00:00

Transcript Sections

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Operator

Greetings, and welcome to the Incyte Second Quarter twenty twenty five Earnings Conference Call and Webcast. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Greg Kirtser, Senior Director of Investor Relations. Please go ahead.

Greg Shertzer
Greg Shertzer
Senior Director - IR at Incyte

Thank you, Kevin. Good morning, and welcome to Incyte's second quarter twenty twenty five earnings conference call. Before we begin, I'd encourage everyone to go to the Investors section of our website to find the press release, related financial tables and slides that follow today's discussion. On today's call, I am joined by Bill, Cristiano and Pablo, who will deliver our prepared remarks. Matteo, Mohamed and Steven will also be available for the Q and A.

Greg Shertzer
Greg Shertzer
Senior Director - IR at Incyte

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
Bill Meury
CEO, President & Director at Incyte

Thanks, Greg, and good morning, everyone. Before I get started, and on behalf of the Insight management team and the employees, I'd like to thank and recognize Herve Opineau for his leadership and commitment to Insight over ten 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 Insight very recently, roughly thirty 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 Insight.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

The first one is what specifically attracted me to the company, and 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. And my initial impression is that NSAID has all the intrinsic characteristics of a high quality growth business. That is the potential for new meaningful product flow, attractive markets, R and 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.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

The nontrivial challenge Insight 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, Insight has several important product launches between now and 02/1930. These products, of course, will vary in size. Some will contribute substantially and others incrementally to growth. But either way, there is substrate here.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

Marketed products, Opsilora, Nictimbo, Monjuvy, and pipeline compounds like nine 89, our mutant CalR monoclonal antibody, and Porvastatinib, 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. Opsilor 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. Nictimbo is off to a very strong start. Phase I results with nine eighty nine and ET are promising, and we will share data on MF at the end of the year.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

And finally, povastatinib 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'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 and d and commercial capabilities. Yes, there have been R and D setbacks, and we need to convert science into regulatory approvals and business results.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

But I believe our discovery and development capabilities in our core areas are a competitive advantage. 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 and 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.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

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. Second, accelerate product development. Pablo and I have spent many hours on this topic.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

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. Nine eighty nine 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 I data into a regulatory approval and a marketed product. The medical need and the market potential for nine eighty nine is significant.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

If we're successful, nine eighty nine should trigger a fundamental shift in the treatment of MPNs like we've seen in other cancers. For povocitinib, 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 povastatin can have differentiation such as HS, PN, and vitiligo. In HS, povastatin could be the first oral option, which is perhaps the most challenging disease in dermatology. It's not like IL-three mediated psoriasis or IL-four thirteen mediated AD.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

It's more complex, involves more pathways, treatment success is variable, and so a new treatment option like povocitinib should be very marketable. As it relates to our early stage pipeline, the scientific rationale behind CDK2, G12D, TGF beta by PD-one for select solid tumors, among others, 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.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

And I recognize that every use of capital, R and 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.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

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 derisked 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¢.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

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

Bill Meury
Bill Meury
CEO, President & Director at Incyte

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. Opsilora growth was exceptional across two indications and the Nictimvo launch is exceeding expectations with rapid adoption among BMT centers reinforcing its commercial potential.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

The growth prospects for these products are excellent if we continue to execute. On the R and D front, we made excellent progress. We will release Phase I data on September and MF the end of the year to supplement the data we presented at EHA and ET. We expect an FDA approval for Opsilora in pediatric patients two to eleven years of age with mild to moderate AD in September. Importantly, the pivotal trials for povacitinib and vitiligo in PN and combination trials with axatilamab and GVHD are enrolling on track.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

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

Christiana Stamoulis
Christiana Stamoulis
EVP & CFO at Incyte

Thank you, Bill, and good morning, everyone. In Q2, we delivered strong financial results with total product revenues of $1,060,000,000 representing an increase of 17% year over year, driven by continued demand growth for Jakafi and Opsilura as well as the contribution from the ongoing commercial launch of Nictimvo. Total revenues were $1,220,000,000 up 16% versus the same period last year. Turning to Jakafi on Slide nine. Jakafi net product revenue was $764,000,000 for the second quarter, representing an 8% growth year over year driven by paid demand, which also increased 8% versus the prior year period.

Christiana Stamoulis
Christiana Stamoulis
EVP & CFO at Incyte

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 $3,000,000,000 to $3,050,000,000 Turning now to Opsalura on Slide 10. Total net product revenue for the second quarter was $164,000,000 representing a 35% increase year over year. U.

Christiana Stamoulis
Christiana Stamoulis
EVP & CFO at Incyte

S. Net product revenue of $132,000,000 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 U. S.

Christiana Stamoulis
Christiana Stamoulis
EVP & CFO at Incyte

Net product revenues of $32,000,000 large were driven by continued uptake in France and Germany as well as the recent launches in Italy, Spain and Canada. In France and Italy, ObsEleura has seen very rapid adoption. Turning to Slide 11 and Nyctivo launch. Nyctivo net product revenues in the second quarter were $36,000,000 driven by high patient need and strong commercial execution. We continue to see positive launch metrics with widespread product awareness and interest.

Christiana Stamoulis
Christiana Stamoulis
EVP & CFO at Incyte

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 ten percent of the third line plus GVHD market. Of all the patients that went on IKTIMBO, approximately eighty percent to ninety percent remain on therapy today. Turning now to other hematologyoncology products on Slide 12.

Christiana Stamoulis
Christiana Stamoulis
EVP & CFO at Incyte

Net product revenues for the second quarter were $131,000,000 representing a 66% year over year increase. This is primarily driven by the commercial launch of Nectinvo as well as increased contribution from ZYNES following the approval in ACAC. As a result of the strength of the Nectinvo launch, higher demand for ZYNES and the earlier than anticipated approval for MONJUVY in FL, we are raising our full year revenue guidance for other oncology products to a new range of 500,000,000 to $520,000,000 Moving on to Slide 13 and our operating expenses. During the second quarter, we recorded a benefit of $242,000,000 from the contract dispute settlement with Novartis relating to Jakafi royalty payments through the 2025. The settlement also resulted in a reduction in COGS driven by an ongoing 50% reduction in the royalty rate payable to Novartis.

Christiana Stamoulis
Christiana Stamoulis
EVP & CFO at Incyte

As a result, we are reducing the lower end of our COGS guidance. The revised guidance range is now eight to 9% of net product revenues. Shifting now to R and D. Total R and D expenses on a GAAP basis were $495,000,000 for the second quarter. Excluding the onetime Asian costs in 2024 and other onetime expenses in both years, R and D expenses increased 8% year over year, driven by continued investment in our late stage development assets.

Christiana Stamoulis
Christiana Stamoulis
EVP & CFO at Incyte

In the first half of the year, we entered into two new development collaborations with Genesis and BioTherix. As a result of the upfront and ongoing expenses related to these new collaborations, we are increasing our full year guidance for R and D by $35,000,000 to a new range of $1,965,000,000 to $1,995,000,000 Moving to SG and A. Total GAAP SG and A expenses were $331,000,000 for the second quarter. Excluding the onetime costs for the prior year, GAAP SG and 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 marketing activities. Finally, we continue to execute on our commitment to grow operating expenses at a slower pace than revenues.

Christiana Stamoulis
Christiana Stamoulis
EVP & CFO at Incyte

Ongoing operating expenses in the 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 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 and D update.

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

Thank you, Cristiano, 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 02/1930. Moving to slide 16. The Phase I data in essential thrombocythemia for INCA thirty three thousand nine hundred eighty nine, our mutant cholera monoclonal antibody, was presented at 2025. September is the first truly targeted therapy for a subset of patients with MPNs that includes twenty five percent of patients with essential thrombocythemia and thirty five percent of patients with myelofibrosis.

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

Importantly, this data set demonstrated a normalization of platelet count in patients with ET, which is consistent with the mechanism of action of 9A9 and a key point of differentiation from cytoreductive therapies. 9A9 was very well tolerated, but only one out of forty nine patients discontinued therapy. It is very reassuring that at this point in the development of 9A9, it appears to have an excellent safety profile. We also observed 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.

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

Treatment with 9A9 also resulted in a reduction in mutant positive megakaryocytes in the bone marrow, as well as a reduction in mutant COLR positive CD34 positive stem and progenitor cells in peripheral blood, confirming the potential of nine eighty nine 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 nine eighty nine development plan. We will advance this program with great urgency, with the goal of starting pivotal trials in ET by early twenty twenty six. 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.

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

Additionally, we have established a collaboration with QIAGEN to develop a co diagnostic across MPNs with an initial focus in CAR 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 subcu in parallel. Turning to our dermatology portfolio starting on slide 18. I'm pleased to share an important update on ruxolitinib cream.

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

As you know, Opsilura 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 III TRuE AD4 study, which evaluated ruxolitinib cream in adult patients with moderate atopic dermatitis with extensive body surface area involvement of ten to twenty percent, and significantly impaired quality of life with a DLQI greater than 10. I'm happy to report that the TRuE 84 study met its co primary endpoints at week eight, with statistically significantly larger proportion of patients receiving one point five percent rux screen compared to vehicle, achieving both IGA TS and EC 75. At week eight, Roxgren demonstrated a vehicle adjusted difference in IGATS of 47.6% and a vehicle adjusted difference in EC 75 of fifty one point four percent, 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.

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

Importantly, the safety profile observed in TRuE eighty four was consistent with previously reported data in atopic dermatitis. Ruxolitinib cream was well tolerated. 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 two variation for Opsilver in Europe where there's a strong demand for innovative topical therapies in patients that have failed topical corticosteroids or topical calcineurin inhibitors.

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

Looking ahead, we plan to present the full phase three 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 povircitinib. We're advancing povircitinib in three indications and believe this represent significant opportunities for near term revenue and long term value creation. The positive phase three data in patients with moderate to severe HS, which affects over three hundred thousand patients in The US, will be our first submission for povircitinib and will support worldwide regulatory filings in 2026. The phase three studies in patients with vitiligo and prurigo nodularis are progressing well, and we anticipate presenting date in 2026 with potential approvals in 2027.

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

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 three 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 III study is now planned for the second half of the year, pending regulatory feedback, and the release of V617F Phase I data has shifted from the 2025 to the 2026. We look forward to sharing additional updates on these milestones in the 2025. I will now turn it back over to Bill for his closing remarks.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

Thanks, Pablo. To summarize the key takeaways before we open the line for Q and 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 and D pipeline both for hematology oncology as well as for I and I. Lastly, our focus is converting science and strategic plans into product flow and generating durable revenue and cash flow.

Greg Shertzer
Greg Shertzer
Senior Director - IR at Incyte

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

Operator

Certainly. We'll now be conducting a question and answer Our first question today is coming from Jay Holzman from Oppenheimer. Your line is now live.

Jay Olson
Managing Director & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.

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? Thank you.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

Yeah. Look. It's a 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.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

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 nine eighty nine, we have six one seven.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

We have a bispecific. We also have compounds in in discovery. And when you have an opportunity to sort of dominate and control and never see the market, you gotta take advantage of it. 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 MPNs, set what I would describe as a a new high watermark.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

Now look. No one 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 nine eighty nine has been has been incredibly important. I think in I and I, I do believe that there's a credible path to building a large product.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

We're not, for example, with povircitinib, copying all the indications for RINVOQ. And I do believe we have differentiated knowledge and capabilities in the three immune mediated skin conditions that we're we're targeting. And we do have a franchise strategy with Opsilor and povocitinib, which other companies don't have. The product has the potential to be first in HS, first in vitiligo. And I think, you know, prurigo nodularis was a disease made for JAKs.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

And so I like the potential there. And as it relates to our 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 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.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

The pressure to the pressure to fill a pipeline in biopharma, this is true not just at Insight, 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, and I would never stretch the capabilities of 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.

Jay Olson
Managing Director & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.

Thank you, Bill.

Operator

Thank you. Next question is coming from Tazeenah Ma from Bank of America. Your line is now live.

Tazeen Ahmad
Tazeen Ahmad
Analyst at Bank of America

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 from the Kallar data that you saw from ET and what to maybe expect to see for MF. And then related to that, you're gonna show monotherapy as well as combo.

Tazeen Ahmad
Tazeen Ahmad
Analyst at Bank of America

But is there a minimum 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
Pablo Cagnoni
President and Head of Research & Development at Incyte

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 nine a nine would work the same way in MF that it does in ET.

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

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 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. The reason why we decided to shift the release of the data on 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 patient in patients with MF. And so we believe that the development of nine eighty nine in MF will be at least in part in combination with rux, which is why we wanted to have a more comprehensive dataset when we present the data later this year.

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

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. And we expect to see a component of that in their data release later this year.

Operator

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

Salveen Richter
Salveen Richter
Biotechnology Equity Research at Goldman Sachs

Just a follow-up to two comments that were mentioned earlier. One is initial data for six seventeen F is now expected in the '26. And should we read anything into this delay? And then secondly, you talked about the enthusiasm for povo in the HS market and its and its competitive differentiation. Maybe just walk us through that, particularly when you look in in at the context of superior efficacy that we've seen for some of the currently approved therapies such as BENSLEX? Thank you.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

Great, Salveen. I'll, I'll answer the second question. And Pablo, why don't you take the first question?

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

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 I c thirty five, 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.

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

As you know, in MF, you know you know, data needs to mature a little bit. Because of those two reasons, the data has moved to the 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 to release.

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

Our conviction, the mechanism on this program continues to be strong, and this is simply a matter of escalating a little bit further.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

And then, Salveen, on on HS and povastatin, and and if Mohammed has excuse me, Mohammed. Matea has any comments he can add. First of all, as you know, it's one of the most challenging conditions in in dermatology. Ask any any dermatologist that. IL seventeens don't work almost half the time.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

One dermatologist described high score 50 or even 75 as 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 twenty three mediated psoriasis or IL four thirteen, mediated, AD. That is to say it's inflammation soup. There are multiple pathways, involved.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

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 povastatin and you look at the effect that the drug has on pain and FLAIR control, it's pretty remarkable, and it's a very competitive dataset. It also does you get out past week twelve at week sixteen or 18, those clearance rates are in the fifty percent fifty percent 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.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

So I believe that a a systemic option like povircitinib is gonna have a place in the treatment paradigm for HS, where they're starting with povastatin and then going to a biologic or they go to a biologic and then to povastatin. 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 gonna be a place for porvastatin as well as the IL-seventeen.

Operator

Thank you. Our next question today is coming from Salim Syed from Mizuho Securities. Your line is now live.

Salim Syed
MD & Senior Biotechnology Analyst - Equity Research Americas at Mizuho Securities

Great. First, my welcome to, Bill, and thanks for the question. I guess maybe one for us on Niktinvo. So you had a good beat again on the quarter. And obviously, the J code went into effect here around April, April 1, I believe.

Salim Syed
MD & Senior Biotechnology Analyst - Equity Research Americas at Mizuho Securities

Can you maybe just comment some of the intra quarter dynamics there that you saw from the JCAD going into effect? Or do you describe 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. You maybe just remind us what the inventory impact was for the quarter? Thank you.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

Yeah. Thanks for the question. I'll give you my overall assessment, and either Mohammad or Christiana can can fill in some of the some of the details. As 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 what is important for any new product launch is what do your new patient starts look like.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

Every pharmaceutical product is like a leaky bucket, and you have to maintain. The same is true with Opsilora. You have to maintain new patient starts. So when I look at the dynamics underneath Niktembo, that's what I'm focused on. This product over the next, you know, five six, seven months, say, the the balance of the of the year, has the potential to reach over a thousand patients.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

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 Nick Timbo, 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.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

As you heard, over 80% of BMT centers in The United States are using the Timbo. That's also important because you need a a a large group of users, prescribers, or or, in this case, accounts. The other thing that is reassuring to me is we have 4,500 infusions and roughly seven hundred patients, which means the large majority of patients, my estimate, could be ninety percent of patients are still on product. 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 than that.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

And so I think I don't think we could have gotten off to a 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 the ops, designation makes this economically feasible for in in institutions. Mohamed, do you wanna cover anything that I missed?

Mohamed Issa
Mohamed Issa
EVP & Head - U.S. Oncology at Incyte

Yeah. 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.

Mohamed Issa
Mohamed Issa
EVP & Head - U.S. Oncology at Incyte

That means these are the patients that are up for grabs, that are changing therapy in some capacity. We're either at ten percent 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 and penetration 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 Niktymbo more often, but perhaps also consider Nyktymbo earlier in their treatment paradigm for more patients.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

Great. For the question.

Salim Syed
MD & Senior Biotechnology Analyst - Equity Research Americas at Mizuho Securities

Just an inventory.

Mohamed Issa
Mohamed Issa
EVP & Head - U.S. Oncology at Incyte

Can you just

Salim Syed
MD & Senior Biotechnology Analyst - Equity Research Americas at Mizuho Securities

Sorry. Comment on that?

Mohamed Issa
Mohamed Issa
EVP & Head - U.S. Oncology at Incyte

Yeah. Yeah. The inventory, just to put that in perspective, inventory accounted for less than 5% of q two 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 demand.

Operator

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

Analyst

Hi. Good morning. This is Clara on for Kelly. Thanks for taking our question, and congrats on the quarter. So you have the initial G12D and bispecific data presenting at ASML.

Analyst

So wondering 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 a success and move the program forward? Thank you.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

Great. Pablo, you wanna take that?

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

Certainly. So what we should expect what you should expect for these two presentations at ESMO, in a way, is consistent with what we did last year with CDK two. 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 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.

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

We're gonna have a substantial number of patients for both our KRAS t twelve t program and our TGF beta receptor PD-one bispecific. 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 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 ESMO, in in the next couple of months.

Analyst

Thank you.

Operator

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

Brian Abrahams
Brian Abrahams
MD & Co-Head of Biotechnology Research at RBC Capital Markets

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

Bill Meury
Bill Meury
CEO, President & Director at Incyte

Hey, Brian.

Brian Abrahams
Brian Abrahams
MD & Co-Head of Biotechnology Research at RBC Capital Markets

Hey. So a question on Opsilora. I 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 ex U. S.

Brian Abrahams
Brian Abrahams
MD & Co-Head of Biotechnology Research at RBC Capital Markets

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 February might expand the market opportunity down the road? Thanks.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

Yeah, Brian. Good question. I'll, you know, I'll give you my my initial observations after the after the first thirty days. Obviously, 60% of the business is AD and 40% is vitiligo. Right?

Bill Meury
Bill Meury
CEO, President & Director at Incyte

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. Seven percent of the overall AD market 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 nonsteroidal option, topical or or systemic.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

And, you know, that TCS market in The United States at branded pricing is about $15,000,000,000. Alright? Now it's 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 CAGR business, both US and, 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.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

Alright? Here's what we know. There's about $2,000,000,000 in triamcinolone use at branded pricing in The United States, but I think we have to be realistic about the extent to which we're gonna drive utilization in pediatrics. I think the core business right now is what's gonna drive growth over the next several years. The product's got 20,000 users in The United States, prescribers, which is second to only DUPIXENT and AD.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

And so there's a large prescriber base here. And when you're 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. It's it's not cheap, but it's it's solid coverage. And so I like the way it looks.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

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 60,000,000 to roughly a $120,000,000 in sales. We'll get the AD that was just in vitiligo.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

And and the indication for for AD, you know, has the potential to keep that business growing and maybe you too exit over several years. Tayo, anything you wanna add?

Matteo Trotta
Matteo Trotta
EVP & GM - U.S. Dermatology at Incyte

No. You covered it all. And and on the PED 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
Bill Meury
CEO, President & Director at Incyte

Great. Thanks, Brian.

Brian Abrahams
Brian Abrahams
MD & Co-Head of Biotechnology Research at RBC Capital Markets

Thank you.

Operator

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

Jessica Fye
Jessica Fye
MD & Equity Research Analyst - Biotechnology at JP Morgan

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.

Jessica Fye
Jessica Fye
MD & Equity Research Analyst - Biotechnology at JP Morgan

And I guess if we think about kind of looking out five years from now, how do you see insight? Is this gonna be mainly organically grown, transformed through M and A, some kind of combination? Thank you.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

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, it's not just mine.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

It's it's, you know, Pablo and and Steven 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 internal investments and and external investments the exact same way. You know?

Bill Meury
Bill Meury
CEO, President & Director at Incyte

There are no sacred cows inside the company. It's also not true that everything outside the company is a is a shiny penny. And, you know, I've been here thirty days, but I will tell you all we think about is capital allocation both internally, and and externally. In terms of a balance between the two, I don't like to force any any ratio. I think we have to just look at facts details and analysis and and make our calls.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

You know, as it relates to where I wanna see the company in in in five years, it'd be nice to two exit. But I think what we wanna 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 Opsilor and Nictimbo and then September MPOVO.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

And I know there's no guarantee there. We we have to we have to manage those programs. Next, get r and d priorities right, which is what every company has to do. Then get the cost base right. That's just good corporate hygiene.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

Get BD right and build the business for the long term so that we really never see the end of the road. 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.

Operator

Thank you. Next question today is coming from Mark Frome from TD Cowen. Your line is now live.

Marc Frahm
Marc Frahm
Biotechnology Equity Research Analyst at Cowen

Hi. Thanks for taking my questions. Maybe one quick one clarifying an earlier answer just on the kind of thresholds in MF for mutant KALR. 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 pro program forward either as a monotherapy or as a combo, or is just convincing combo data enough? And then kinda similar to that, maybe, Bill, when you're talking through the kind of the way to think about prioritizing financial resources, you you can't put solid tumor oncology or oncology outside of hem onc as maybe the third priority. When you think about the g twelve d 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 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 kind of over time competing in various combinations but with a more, similar asset enough to justify investment?

Bill Meury
Bill Meury
CEO, President & Director at Incyte

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

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

So let me address the nine ninety nine. And the 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 nine eighty nine 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 every single patient with a myeloproliferative neoplasm, we wanna 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. And to do that, we need a comprehensive data set to show you single agent and combination data, with Jakafi.

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

But it's an expectation based on the mechanism of action nine eighty nine that it will have single agent activity in myelofibrosis.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

Great. Thanks, Paul. And as it relates to g twelve d, and and 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 of big companies.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

The hurdle here is 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. Alright? And when we get that data, we're gonna have to make that decision. We do believe that the properties of g 12 d could be differentiating, and we believe that it will have a pace in a place in the treatment paradigm.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

And I'll let Pablo talk a little bit about that.

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

So, to to complement what Bill said, this is, as you know, Mark, a very competitive space, g 12 d, and there's some some excellent, programs advancing, in this in this setting. What we think we have with our D12D program, and and we look forward to sharing the data so we can discuss this in more detail with data 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. And when you think about the really, really big opportunity here, which is first line pancreatic cancer, that's gonna 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. 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.

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

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. 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.

Operator

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

Conor MacKay
Conor MacKay
Equity Research Senior Associate at BMO Capital Markets

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 Niktinvo has come in ahead of consensus expectations. And you shared a little bit today about kind of the dynamics in the early days of the launch.

Conor MacKay
Conor MacKay
Equity Research Senior Associate at BMO Capital Markets

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

Bill Meury
Bill Meury
CEO, President & Director at Incyte

Great. I'll take a I'll take a shot at first at the first question and then let Mohamed, fill in, and and then I'll come back to the the second question. You know, as it relates to the peak potential of Nick Timbo, it's really hard to figure out what's gonna happen in in five years. I'm pretty modest about the accuracy of my 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.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

I'm reassured by what what I see. I think the potential of this product in part is gonna trade on, can we get it into combination with Jakafi and with, steroids? And those studies are are ongoing. That's number one. We also have a team working on a sub q formulation, which I think is is very important.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

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 a product like Resuroc at Sanofi, you know, that could be the low watermark for us. And I think if you get these additional indications, then you're gonna travel north of that. Mohamed?

Mohamed Issa
Mohamed Issa
EVP & Head - U.S. Oncology at Incyte

Yeah. Maybe just to quickly complement there. I think, look, in in the first five months, we mentioned we've been able to capture twenty percent 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 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 $100,000,000 of annual sales by, you know, 2028.

Mohamed Issa
Mohamed Issa
EVP & Head - U.S. Oncology at Incyte

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

Bill Meury
Bill Meury
CEO, President & Director at Incyte

Yeah. And as it relates to this this second question, you know, if you study companies that have great businesses, there are a couple, criteria that are common in terms of new therapeutic areas. And and I'll I'll 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 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.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

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. And there are some logical extensions of our current business in hem onc 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, operationally, financially, we'll explain it and do it. But the focus right now is is what's inside the company.

Operator

Thank you. Our next question today is coming from Sri Krupa Devarakonda from Truist Securities. Your line is now live.

Kripa Devarakonda
Kripa Devarakonda
VP - Biotechnology Equity Research at Truist Securities

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 Jakafi in PV.

Kripa Devarakonda
Kripa Devarakonda
VP - Biotechnology Equity Research at Truist Securities

You've showed continued growth in PV. Continues to be Zaxxay continues to be a key growth driver here. Can you talk about the patient population where you're seeing increased uptake? And also, you know, given the footprint you have established here, any thoughts on life cycle management beyond the XR and, you know, v six one seven f, which we're gonna see data hopefully next year, would be helpful. And also one follow-up question.

Kripa Devarakonda
Kripa Devarakonda
VP - Biotechnology Equity Research at Truist Securities

MONJUVY was approved for relapsedrefractory FL in June. Just any thoughts on expectations there for the remainder of the year? Thank you.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

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

Mohamed Issa
Mohamed Issa
EVP & Head - U.S. Oncology at Incyte

Yeah. Maybe let me take a stab on Jakafi.

Mohamed Issa
Mohamed Issa
EVP & Head - U.S. Oncology at Incyte

I'm on Juven, and then, Bill, I'll give it back to you for any added remarks. Look. P, 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 q two, and we're confident in that momentum going forward.

Mohamed Issa
Mohamed Issa
EVP & Head - U.S. Oncology at Incyte

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 Jakafi for those patients, they benefit from thrombosis free survival. If I can just quickly touch on MONJUVY, and then and then, Bill, I'll give it back to you. Look. I think it's important to note MONJUVY showed a fifty nine percent risk reduction disease progression or death versus what is currently the standard of care.

Mohamed Issa
Mohamed Issa
EVP & Head - U.S. Oncology at Incyte

So we believe, naturally, Montjuvy 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 hem onc portfolio. With really good execution, Mondjuvian FL alone, excluding any other indication, can be one of those those incremental growth drivers and deliver, you know, 200, you know, million dollars or so in annual revenue by by 2028.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

Yeah. I think I think, Mohammed said it well. Very focused on the growth of of Jakafi over the next, several years. Obviously, our penetration in MF is high. And as Mohammed said, in in GVHD, I would describe it as medium.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

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, and the MAGIC PV study is only a couple years old. So thanks for the question. Thank you.

Operator

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

Stephen Willey
Managing Director at Stifel Institutional

Yeah. Good morning. Thanks for taking the questions. Just a couple on 989. Can you say anything about the characteristics of those, the MF patients enrolled into the phase one with respect to just baseline cytopenias, hemoglobin?

Stephen Willey
Managing Director at Stifel Institutional

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? And then 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
Bill Meury
CEO, President & Director at Incyte

Thanks for the question. Pablo will take it.

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

So the population is, as you call it, typical of patients that have been exposed to to Jakafi. There are patients that are intolerant or progressed progressed in in Jakafi. 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 nine ninety nine in patients, in patients with MF.

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

Follow-up is gonna 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. But all in all, we'll have patients with pretty 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.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

Thanks for the question.

Operator

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

David Lebowitz
David Lebowitz
Senior Research Analyst - Biotechnology at Citi

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

David Lebowitz
David Lebowitz
Senior Research Analyst - Biotechnology at Citi

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.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

Yeah. Good question. I'll give you some initial, comments, and then and then Mohammad can take over. I think the most important point about the quarter is that there was growth in all three indications. And I think you can I would view MF and and GVHD as, you know, mid single digit grower growing indications?

Bill Meury
Bill Meury
CEO, President & Director at Incyte

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 that's what the growth profile or the mix is gonna look like for the next, you know, three plus years. And then as it relates to the IRA, Mohamed?

Mohamed Issa
Mohamed Issa
EVP & Head - U.S. Oncology at Incyte

Yeah. Nothing to add on the growth drivers. On IRA, the the simple answer is that it had no impact on our performance in q two. As you remember, the IRA dynamics had a favorable GTN impact in q one, but that was a onetime effect as we communicated there. And in q two, the demand, really drove the growth, and that's where you see the performance for Jakafi in the quarter.

Operator

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

Michael Schmidt
Senior MD & Equity Research Analyst - Biotechnology at Guggenheim Securities, LLC

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 and sort of your prior comments, it sounds like there may be opportunity to perhaps optimize the earlier stage R and D portfolio. So longer term, as you think about potentially increasing R and

Michael Schmidt
Senior MD & Equity Research Analyst - Biotechnology at Guggenheim Securities, LLC

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 I and I? And then just a quick one for Pablo on povastatin. Just could you just help us understand the importance of the of quarter twenty very

Bill Meury
Bill Meury
CEO, President & Director at Incyte

nineteen. And we had 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 and d and, oncology?

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

So if I understand your question, Michael, the it's more specifically related to the early, preclinical pipeline. And 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. So our goal over time is to truly focus on try to be first in class applying novel platforms. And that's what that was the impetus behind the collaboration we established with Genesys to take advantage of the capabilities on AI machine learning drug discovery, the collaboration that we put in we expanded with BioTherics to get access to a molecular glucose library. And we will continue to do those because we believe, fundamentally, in order to win the next ten years, we need to focus on novel areas, novel targets by applying novel platforms.

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

So that's a lot of the emphasis, when it comes to the preclinical pipeline.

Bill Meury
Bill Meury
CEO, President & Director at Incyte

Thanks for the question.

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

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 two asthma, where there remains a need to reduce exacerbations and deliver substantial improvements in f e v one, and I'm talking about over a 100 to a 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.

Operator

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

Gavin Clark-Gartner
Director - Biotechnology Equity Research at Evercore ISI

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

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

Yes, Gavin. There will be an update on ET data as well later this year. Absolutely. 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 pivotal trials early twenty twenty six.

Pablo Cagnoni
Pablo Cagnoni
President and Head of Research & Development at Incyte

So we will provide an update on the ET data that we'll present at later this year.

Operator

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

Greg Shertzer
Greg Shertzer
Senior Director - IR at Incyte

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

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

Executives
    • Greg Shertzer
      Greg Shertzer
      Senior Director - IR
    • Bill Meury
      Bill Meury
      CEO, President & Director
    • Christiana Stamoulis
      Christiana Stamoulis
      EVP & CFO
    • Pablo Cagnoni
      Pablo Cagnoni
      President and Head of Research & Development
    • Mohamed Issa
      Mohamed Issa
      EVP & Head - U.S. Oncology
    • Matteo Trotta
      Matteo Trotta
      EVP & GM - U.S. Dermatology
Analysts
    • Jay Olson
      Managing Director & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.
    • Tazeen Ahmad
      Analyst at Bank of America
    • Salveen Richter
      Biotechnology Equity Research at Goldman Sachs
    • Salim Syed
      MD & Senior Biotechnology Analyst - Equity Research Americas at Mizuho Securities
    • Analyst
    • Brian Abrahams
      MD & Co-Head of Biotechnology Research at RBC Capital Markets
    • Jessica Fye
      MD & Equity Research Analyst - Biotechnology at JP Morgan
    • Marc Frahm
      Biotechnology Equity Research Analyst at Cowen
    • Conor MacKay
      Equity Research Senior Associate at BMO Capital Markets
    • Kripa Devarakonda
      VP - Biotechnology Equity Research at Truist Securities
    • Stephen Willey
      Managing Director at Stifel Institutional
    • David Lebowitz
      Senior Research Analyst - Biotechnology at Citi
    • Michael Schmidt
      Senior MD & Equity Research Analyst - Biotechnology at Guggenheim Securities, LLC
    • Gavin Clark-Gartner
      Director - Biotechnology Equity Research at Evercore ISI
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