Incyte Corporation Q1 2026 Earnings Call Transcript

Note: This is a preliminary transcript and may contain inaccuracies. It will be updated with a final, fully-reviewed version soon.

Incyte Corporation (NASDAQ: INCY) Q1 2026 Earnings Call dated Apr. 28, 2026

Presentation

Operator

Greetings and welcome to the insight first quarter 2026 earnings conference call and webcast. At this time, all participants turn your listen only mode. A question and answer session will follow the formal presentation. You may be placed into question queue at any time by pressing one on your telephone keypad and we ask that you please limit yourselves to one question then return to the queue. As a reminder, this conference is being recorded. If anyone should require operator assistance, please press 0.

It’s now my pleasure to turn the call over to Alexis Smith, Vice President Head of Investor Relations. Please go ahead Alexis.

Alexis Smith — Vice President & Head of Investor Relations

Thank you. Good morning and welcome to Insight’s first quarter 2026 earnings conference call. Before we begin, I encourage everyone to go to the Investors section of our website to find the press release, related financial tables and slides that follow today’s discussion. On today’s call, I am joined by Bill, Pablo and Tom who will deliver our prepared remarks. Stephen, Dave and Mohamed will also be available for the Q and A portion of today’s call. 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.

William Meury — CEO, President & Director

Thank you Alexis and good morning everyone. We’re off to a strong start in 2026 with net sales up 20% year over year driven by strong demand across our entire portfolio. In parallel, we advanced the pipeline with key regulatory and clinical milestones. We view 26 as a year of strategic progress as we transition Insight beyond a single cornerstone product toward a high quality, growth oriented portfolio across hematology, oncology and immunology. This progress will come from multiple sources the continued organic growth from our commercial portfolio, the execution of life cycle launches of key brands, the advancement of a broad, increasingly late stage pipeline and a focused approach to business development.

The sequencing and pace of execution here matters as these efforts are intended to lay the foundation for a future beyond Jakify. During the quarter the FDA accepted our regulatory application for Povacitinib in patients with moderate to severe hs. The application was submitted ahead of schedule and is supported by a robust, high quality data set across both pre and post biologic patient populations. If approved, we believe POVO should be a significant growth driver for Insight as the first FDA approved oral anti inflammatory treatment for HS disease which affects more than 300,000 people in the United States.

We also remain on track for several regulatory decisions this year, including jackify xr, which has the potential to generate meaningful sales and serve as an important sales bridge and opzelure for moderate atopic dermatitis in Europe, a key future growth opportunity for the brand and our international business. Finally, we expect global submissions from Anjuvi in the first line DLBCL in the first half of the year, with approval and launch anticipated in early 2027. Across the pipeline, we continue to advance novel compounds that support our broader transition to a hemonc INI company.

The pipeline reflects a deliberate balance of risk and reward, combining programs with the potential for outsized returns alongside opportunities that can deliver incremental but highly reliable growth. This work is backed by an experienced clinical development and clinical operations team and consistent execution across trials. In hematology, we had a positive end of phase meeting with the FDA in the first quarter and are on track to initiate our Phase 3 studying evaluating our mutant CALR antibody 989 in previously treated CALR positive patients with ET by midyear.

This represents an important step as we continue to build a portfolio of molecularly targeted therapies that which Pablo will discuss in more detail shortly. In oncology, we now have four pivotal trials underway across colorectal, ovarian and pancreatic cancers, including the recent initiation of our G12D program in first line pancreatic cancer earlier this month. These programs target areas of significant unmet need and represent meaningful long term growth opportunities for the company. In immunology, we are advancing registration programs in mild to moderate HS for Opzelura and moderate to severe HS Vitiligo and PN for Povacitinib.

In addition to the regulatory acceptance for POVO and HS mentioned earlier. Today we announced positive results from both Phase 3 registration studies in adults with non segmental vitiligo. These results will support a regulatory application in non segmental vitiligo expected in the first half of 2027. Over time, we believe the INI portfolio at Insight has the potential to become a significant contributor to the business and representing approximately one third of total revenue by 2030. Finally, I want to take a moment to talk about management at this stage of the company.

Our results depend largely on the strength of our management team, experience, judgment, decision making and the ability to execute strategic plans. With that context, we have made several executive appointments. This morning we announced the appointment of Suki Opidia as Chief Financial Officer. Suki brings deep experience leading large finance organizations, most recently Zimmer Biomet and Bristol Myers Squibb. We also announced the appointment of Pablo Cagnoni as President, Insight and Global Head of Research and Development and Steven Stein as Executive Vice President, Chief Medical Officer and Head of Late Stage Development.

Additionally, Mohamed Issa was appointed as Executive Vice President Head of US Commercial Coinciding with the integration of our US Commercial operations into a single organization, Mohamed is an experienced executive with a track record in new product launch planning and operations. The new structure is intended to establish consistent standards and enterprise level capabilities across analytics, market access, sales, operations and patient services, creating a launch Ready organization in 2026.

These capabilities can be leveraged across the portfolio to maximize the return on our commercial investments. Taken together, these appointments give us the management experience and operational oversight for the next phase of the company. Now turning to the quarter Total revenue in 1Q26 was 1.27 billion, up 21% over prior year. Net sales in the first quarter totaled 1.1 billion, representing 20% growth year over year. Sales increased for every marketed product both in the United States and internationally and was driven by strong prescription and volume demand across the portfolio.

Jackify sales in the first quarter were 758 million, up 7% year over year. Prescription demand increased 6% with broad based growth across all indications. MF, PV and GVHD New patient starts remain strong, the prescriber base is stable and a formulary coverage is broad, providing an important foundation for the Jakify XR launch. We anticipate the approval and launch of XR in the middle of the year. Our immediate focus will be on securing adequate formulary coverage for XR over the next 12 months post launch.

We estimate that XR can achieve 10 to 30% of Jakify’s business by 2029 will provide more insights on the launch in future quarters. Sales for our core business excluding jakify were up 63% year over year with contributions across hematology, oncology and immunology. This business will be supported by four new product launches over the next 12 months including Jakify XR Opzeler for moderate ad dermatitis in Europe, Manjuvi in first Line, DLBCL and Povacitinib in hs. As we’ve discussed, our core business Exjackify has the potential to approach 3 billion to $4 billion by 2030, reflecting the strength of the portfolio and continued execution.

It is becoming an increasingly important part of how we transition the company for long term growth. Opsolor continues to be the largest single contributor to the core business Exjackify with sales of 143 million up 20% versus prior year in the U.S. Sales were 106 million, an increase of 12% versus 1Q25. The underlying prescription demand for this business is strong, up 17% year over year, which is supported by the continued adoption of non steroidal topical therapies. Internationally growth remains robust in Vitiligo where we see strong uptake across markets.

In the first quarter sales totaled $37 million, up 56% year over year. Internationally growth remains robust in Vitiligo where we see strong uptake across markets. Excuse me. As a reminder, Opsolor is under review by European regulators for moderate ad and we expect approval and launch in the second half of the year. The moderate ad indication has the potential to contribute meaningfully to top line revenue beginning later this year. For full year 26, we anticipate that roughly 80% of revenue will come from the US and 20% from international markets.

In hematology and oncology, net sales grew 116% to 204 million. Niktimbo, Monjuvy and Zinas were the largest contributors to growth in the quarter. Niktimvo has now entered its second year following its launch in 1Q25. Net sales were 55 million in 1Q26, reflecting a strong consistent new patient start profile and solid persistency. We built a broad growing prescriber base with virtually every BMT center in the United States using Nick Timbo, with all becoming repeat customers within 12 months. Naktimbo has captured 32% of the third line plus market.

Finally, formulary and payer coverage remains strong for the brand man Juby. Sales were 49 million in the first quarter, up 67% year over year. Growth was primarily driven by uptake in follicular lymphoma following approvals in the US and international markets. Looking ahead, a potential US approval in first line DLBCL represents an incremental growth opportunity starting in 2027. Finally, Zyna’s sales were $41 million in the first quarter with rapid and robust adoption in SCAC. Now I’ll turn the call over to Pablo.

Pablo J. Cagnoni — President, Head of Research and Development

Thank you Bill and good morning everyone. We have made strong progress year to date across our hematology, oncology and immunology franchises, delivering key regulatory and clinical accomplishments. Starting with hematology, we achieved several important milestones for 999, our mutant choler monoclonal antibody, where pivotal development efforts continue to advance. Most notably, this includes the positive endophase meeting with the FDA in the first quarter. As a result, we’re on track to initiate the phase 3 study evaluating 9a9 in patients with previously treated essential thrombocytemia mid year, a key inflection point for this program, our JAK2V617F inhibitor program O5.8 continues to progress.

During the first quarter we initiated our phase one dose escalation study evaluating the ASD formulation of O5.8 in MPN patients with a JAK2 mutation. Preliminary data in a modest number of patients anticipated by year end, which we expect will provide early evidence of clinical efficacy as well as an increased understanding of the viability of the ASD formulation for future development efforts. In parallel, we’re progressing our next generation compounds through preclinical studies. We remain confident in the underlying thesis that the inhibition of V617F will lead to positive clinical outcomes in patients with MPNs that harbor this mutation.

Lastly, in addition to the previously announced positive top line data for tafacitamab in first line dlbcl, we plan to present the full data set during a featured oral presentation at the upcoming ASCO Annual Meeting in June. This data support global regulatory submissions for Tacitimab in first line DLBCL with approval and launch anticipated early next year. Turning to oncology during the quarter, Zynase was approved by the European Commission for patients with previously untreated squamous cell anal carcinoma, adding a second indication for Xynase in Europe in our pipeline.

This month we initiated a phase 3 study evaluating our KRASG12D inhibitor 734 in combination with chemotherapy in first line pancreatic ductal adenocarcinoma or PDAC patients. This marks a significant step for the program as it enters late stage development in a setting with substantial medical need. Finally, in immunology we have made meaningful regulatory and clinical progress advancing our late stage portfolio. Notably, this includes the new drug application acceptance by the FDA for povercitinib and moderate to severe heteronitis suprativa as well as the positive results of our Phase 3 registrational program evaluating povacitinib in patients with non segmental vitiligo.

I will now turn to 9A9. During the first quarter we had a positive end of phase meeting with the FDA on the development program in ET. The phase 3 trial will evaluate 9a9 compared to best available therapy in both type 1 and non type 1 mutant cholera positive patients with ET who are resistant or intolerant to at least one prior cytoreductive therapy. The trial will utilize a flexible dosing schedule starting with 750mg IV every two weeks with a single dose escalation option built in to allow for appropriate optimization based on early platelet response.

The primary endpoint is durable complete hematologic response or DCHR at week 24. The reduction of mutant choler vav from baseline will be evaluated as a key secondary input in the trial, further underscoring the unique mutation specific and potentially disease modifying profile of 9A9. We are encouraged by a dialogue with the FDA and have a clear and executable path towards forward in second line et with a phase three study on track to initiate midyear. In parallel to et, we’re progressing our development efforts in myelofibrosis or MF where We are evaluating 9A9 as a first and second line treatment option.

Data from our ongoing phase one program will be shared throughout the year. We remain on track to initiate a phase 3 trial evaluating 9a9 as a second line treatment in mutant choler palsy patients with MF in the second half of 2026, pending alignment with the FDA in the middle of the year, the phase one cohort evaluating 989 as a single agent and in combination with ruxolitinib in patients with previously untreated MF is enrolling well. Finally, we initiated and completed a phase one study evaluating a subcutaneous formulation of 999 in healthy volunteers, supporting our strategy to expand utility and improve convenience for patients.

This results enabled the initiation of a phase one study in mutant collar palsy patients in the second quarter. I will now turn to our oncology portfolio starting with 734iKeras C12D inhibitor, which is emerging as a very important pipeline opportunity for Insight. The phase 3 trial evaluating 734 in combination with standard of care chemotherapy, gemcitabine plus NAP paclitaxer or modified fulfirinox in first line PDAC is underway. More than 200,000 patients are diagnosed with PDAC with G12D being the most common driver mutation impacting 40% of patients.

Today there are no molecular targeted therapies for patients with pancreatic cancer and chemotherapy has been the foundation of care for decades. What we believe is particularly important is the combination profile of 734 with standard of care chemotherapy. To date, 734 has demonstrated a manageable tolerability profile. We combine with either gemcitabine plus napoxitaxel or modified fulfirnox without compromising chemotherapy dose intensity. Given how PDAC is treated in practice, especially in the first line setting, that ability to combine effectively with both full dose chemotherapy regimens is critical.

This is reflected in our phase three development program. Our maturing phase one data reinforces our conviction in this opportunity, which we view as increasingly de risked. We plan to share efficacy and safety Data from the Phase 1 study in combination with modified Fulfirinox and Gemnab in first line PDAC patients in the second half of the year. A distinguishing feature of our development approach is the scale and depth of our phase 1 clinical program where roughly 400 patients have been treated with 734 across PDAC, colorectal, non small cell lung and other 12D mutated cancers.

This has allowed us to build a robust and comprehensive understanding of both clinical activity, safety and tolerability across tumor types and treatment settings which is informing our development efforts. With a strong early clinical foundation and phase three development now underway, our focus remains on execution as we advance this program that has the potential to become the first KRASG12D specific inhibitor approved in first line PDAC. In parallel, we continue to evaluate expansion opportunities in additional G12D driven tumors and we plan to share more about our efforts later this year.

Our oncology portfolio has reached an important inflection point with each of our core programs now in registrational development and actively enrolling patients. Pivotal efforts for a 9.0@TGF beta receptor 2 by PD1PI specific are underway. The phase 3 trial evaluating a 9 serum combination with Falfox bevacizumab in first line MSS colorectal cancer patients is ongoing in the second half of the year. We anticipate sharing additional Data from the Phase 1 study in combination with Falspox BEV in first line colorectal patients as well as a combination with Bevacizumab in previously treated patients with colorectal cancer.

667 are CDK2 inhibitors in pivotal development in patients with platinum resistant ovarian cancer with cyclin E1 overexpression, a biomarker defined population with significant medical need. The Maestro clinical program consists of three studies, two ongoing trials, a phase two single arm study and a phase three versus investigators chose chemotherapy and a planned phase three study in the first line maintenance setting which we expect to initiate in the second half of 2026. Finally, in immunology we have made significant progress advancing our late stage development efforts for povorcitinib, our oral JAK1 small molecule inhibitor.

This includes the NDA acceptance in HS and as announced today, the positive result from our Phase 23 registrational program in non segmental vitiligo in HS. Last month at the American Academy of Dermatology Annual meeting we presented late breaking 54 week data from our Phase 3 stop HS program which reinforced both the durability and the breadth of response associated with long term povorcitinib treatment. Continuous improvements in clinical outcomes were observed at week 54 with up to 71 and 57% of patients achieving high score 50 and high score 75 respectively.

Further, up to 29% of patients achieved highscore 100, the most stringent endpoint in HS which represents 100% reduction in abscesses and inflammatory nodules count with no increase in draining tunnels. Up to 20% of patients achieve complete clearance of draining tunnels and nodules at week 54. Clinically meaningful improvements in skin pain, fatigue and quality of life measures outcomes are highly relevant to patients and clinicians managing this chronic disease were also observed. Finally, from a safety perspective, both 45 and 75 milligram doses were generally well tolerated throughout the study supporting the profile for chronic use in hs.

This data support the potential for povercitinib to deliver symptom control and durable disease improvement in patients with moderate to severe or HS both before and after biologic therapy. With the regulatory application accepted, we look forward to working with the FDA towards potential approval on launch in early 2027. Today we also announced positive results from our Phase 3 program evaluating povorcitinib in adults with non segmental vitiligo. Our phase three program is evaluating the efficacy, safety and tolerability of povacitinib compared to placebo in patients with non segmental vitiligo across two identical phase three studies, STOP V1 and STOP V2.

For 52 weeks. The program enrolled over 900 patients including 456 patients who received a 30 milligram dose of povorcitinib. In both trials, povorcitinib achieved a primary endpoint of greater than or equal to 75% reduction in facial vitiligo area scoring index FVASI 75 from baseline to week 52 demonstrating statistically significant and clinically meaningful reductions in facial vitiligo compared to placebo. Statistically significant improvements were also observed in key secondary endpoint measures including total vitiligo Area Score Index 50 or TVASI 50.

At week 52, the 30mg dose of porocitinib was well tolerated. The overall safety profile through 52 weeks is consistent with prior studies with no new safety signals observed across both studies. Rates of treatment emergent adverse events of special interest were low between 2 and 3% and similar between the porosity and placebo treatment groups. There were no major adverse cardiovascular events. Only one tea of VTE was observed in the porvostinib treatment group in a patient with multiple confounding risk factors including smoking history, IBMI and intercurrent pneumonia.

These results provide a clear and compelling path towards registration planned for the first half of 2027 and underscored the opportunity to add an oral alternative treatment for patients with vitiligo to our portfolio. We plan to share additional data from the trials in the second half of 2026. Pulvar Sydney continues to produce compelling data in immune mediated dermatological conditions. We have seen success in translating early phase 2 findings into larger registrational programs with now four positive phase 3 trials across HS and vitiligo.

As we look ahead, we expect data from our third indication for rigonodularis by end of year. In addition to Bovacitinib, we are evaluating Opzelura in a phase three registrational program for the treatment of mild to moderate HS with top line results expected end of year. If positive, this result would support a supplemental new drug application in 2027 and if approved, Opzelura would provide the first topical treatment option for patients with hs. Our JAK anchor franchise is well positioned to provide topical to oral solutions across mild to severe immune mediated dermatological conditions and we look forward to providing more updates this year.

To close, we have a catalyst rich year ahead with multiple late stage data readouts, regulatory milestones and pivotal trial initiations across our three core franchises, underscoring the breadth, depth and maturity of our pipeline. With that, I’ll turn it over to Tom for a financial update on the quarter.

Thomas Tray — Principal Financial Officer, VP of Finance & Chief Accounting Officer

Thanks Pablo. As Bill mentioned earlier, our total revenues and net sales for the first quarter were $1.27 billion and $1.10 billion, respectfully increasing 21% and 20% from the prior year. Our GAAP warranty expenses were $516 million for the quarter, increasing 18% from the prior year driven by continued investment in our late stage development assets including our mutant CAL, R, G12D and CDK2 programs. Moving to SGA, GAAP SGA expenses were 328 million quarter increasing 1% year over year. Ongoing operating expenses for the first quarter of 2026 increased 14% year over year compared to a 19% increase in ongoing revenues during the same period, leading to a continued increase in operating leverage and margins.

We reaffirm Our full year 2026Total net sales, R and D and SGA operating expense guidance. Total net sales guidance for the full year 2026 is 4.77 to $4.94 billion, representing a 10 to 13% increase from the prior year. This includes net sales expectations for Jackify of 3.22 to 3.27 billion, Opletelora of 750 to 790 million and hematology and oncology products of 800 to 880 million. Total GAAP, R&D and SGA operating expenses are expected to be 3.495 to 3.675 billion for the full year. Finally, we anticipate cost of sales to remain relatively stable, representing approximately 9% of net sales.

I’ll now turn the call back over to Bill.

William Meury — CEO, President & Director

Thanks Tom. In closing, we’re off to a strong start to the year. Our core business continues to deliver durable growth, our pipeline is advancing with multiple catalysts ahead, and we’ve strengthened our leadership team to support the next phase of execution. As we look ahead, we see 2026 as a year of execution with multiple inflection points across the business that we believe will further strengthen both our near term performance and long term growth trajectory. And with that, I’ll turn the call over to the operator for Q and A.

Question & Answers

Operator

Thank you. We’ll now be conducting a question and answer session. If you’d like to be placed into question queue, please press star1 on your telephone keypad. As a reminder, we ask you please limit yourselves to one question then return to the queue. If you’d like to remove yourself from the queue, please press Star two once again. That’s Star one and a confirmation tone will indicate your line is in the question queue. And please limit yourselves to one question, then return to the Our first question today is coming from Tazit Ahmad from Bank of America.

Your line is now live.

Tazeen Ahmad

Okay, Good morning. Thanks for taking my question. Congrats on the positive data for Povor for non segmental Vitiligo. I wanted to ask what your thoughts are as you prepared the next steps. How do you see this coexisting with Opzelura in the commercial space? You know what’s been your experience with marketing in this indication so far? And do you think that each of these drugs could be appealing for a different segment of Vitiligo? Thanks.

William Meury — CEO, President & Director

Yeah, thanks for the question. Dezeen. I’ll make a few comments and then ask Mohammad, our US Commercial head, to also expand on how we’re thinking about Vitiligo. I think there’s a Real opportunity here with the FDA approvals of oral treatments to essentially unlock the Vitiligo market in the same way that advanced systemic therapies unlocked AD and psoriasis. I think that these approvals will create awareness that Vitiligo is a chronic inflammatory disorder. And I think that is important for everybody that’s going to be in the Vitiligo market.

This is definitely about medicalizing the condition. Frankly, I think Insight does have an advantage in that we have a topical to oral solution. There is a natural sequencing that sets up in the Vitiligo market and we’re able to cover sort of the waterfront with both Opzelura as well as with Povacitinib. And that’s ultimately going to be, I think, the key to success here. We have the advantage of incumbency. We have direct ties to the providers. We know how they think about this condition. We understand the education that’s required to increase the treatment rate.

And we of course have interactions with payers on this front too. And so I think it’s going to be an important contributor to POVO being one of the three indications that we’re pursuing right now. Mohamed, do you have anything to add?

Mohamed Issa — Executive Vice President & Head of US Oncology

Really well said, Bill. Maybe just some context to the indications. We have obviously reason to believe there’s 1.5 million people living with vitiligo in the US and only 20 to 30% seek treatment. Like Bill mentioned, a good portion of Those patients, about 35% of them have a BSA less than 5. Those are going to be really good patient segments for Opzelura. You even have a patient segment between 5 and 10 BSA that’s also a target patient population for Opzelura. And then for patients with BSA greater than 10, where systemic therapy is most likely, we estimate that total addressable market to be about 1.5 to $2 billion, which gives Povo a great opportunity to address that need as well.

And like Bill mentioned, having a topical to oral continuum for Vitiligo and even HS if both products get approved puts us in a really unique position as insight to satisfy that patient journey from the beginning all the way to advanced treatment. Thanks for the question, Tazeen. Thank you.

Operator

Next question today is coming from James Shin from Deutsche Bank. Your line is now live.

James Shin

Hey, good morning, guys. Appreciate all the color on 989, but I just wanted to check in. Will 989’s EHA update be mostly a checkbook, the box kind of update? Will there be some new wrinkles to glean and Just if I could sneak one in. I don’t know if Suki is on the call, but Bill, I know you guys mentioned previously having expense discipline, but what changes, if any, will Suki bring? Thank you.

William Meury — CEO, President & Director

Great. James, you snuck in a second question, so there may be a penalty after the call. I’ll let Pablo answer the first question.

Pablo J. Cagnoni — President, Head of Research and Development

Thank you for the question. So the update at eha, it’s going to be pretty substantial. We have continued to enroll in the studies, we have longer follow up and we have continued to deepen our translational understanding of the effects of 989 in patients with both ET and MF. So you should expect continued growth in number of patients in ET. We’ll have approximately 100 patients enrolled and we’ll report data in those for MF. In terms of the second line, we’ll have about 45 patients, 45 patients single agent and about 15 to 16 patients in combination with ruxolitinib.

And I think first of all the data has continued to evolve. Well, we think the durability is an important point. We think the continued tolerability of 999 in this patient population is very important and we do think that continue to see how the translational part of the story continues to evolve with clear evidence of disease eradication. Disease modification by989 in patients with MPN is very important. You should expect to see a lot more of that at eha.

William Meury — CEO, President & Director

Yeah, and as it relates to Suki, look, he has extensive experience at both large and small companies. We have a very strong finance department at the company. He’s going to focus on the things that a CFO needs to focus on both strategically and operationally. You want to make sure that your budget planning process is efficient and sharp. You want to make sure that capital allocation decisions are made intelligently. There’s of course a role in terms of setting up the right systems so that we can scale the company and you know, we’re really glad to have them.

So thanks James.

Operator

Thank you. Next question is coming from Steven William from Steeple. Your line is now live.

Stephen Willey

Yeah, good morning. Thanks for taking the question. So I guess congrats on securing the 24 week DCHR endpoint and the pivotal ET trial. But just wondering if you can provide some more detail around the mechanics of dose escalation just in terms of the platelet response criteria that will be used to trigger that and then just how that works from a timing perspective and then just as a follow up, just given some of the flexibility here that you were given from the agency around the et, around the ET endpoint.

Just curious how you think this now kind of reads into your ability to secure additional flexibility from the agency in the pivotal second line MF trial. Thank you.

William Meury — CEO, President & Director

Go ahead, Pablo.

Pablo J. Cagnoni — President, Head of Research and Development

Certainly. So let me start with your last point there, because I think it’s very important. We had a very constructive set of interactions with fda. So we’re very, very happy how these conversations are going. And I think they recognize how 999 is a fundamentally different way to treat patients with MPN. It’s truly not only molecular targeted therapy, but as the potential for disease modification. And that needs to be contemplated as we implement phase three trials and as we select endpoint for these phase three trials.

So in terms of the conversations on mf, we believe, as you alluded to, that this will allow us to have a conversation with FDA about defining endpoints in MF that truly reflect the effects of989 in terms of normalizing hematopoiesis, which we think it’s a critical difference compared with existing therapies for patients with Ms. So we’ll provide more updates on this later in the year. But we think that dialogue is going to be very constructive as it was in et. In terms of your specific question about et, if you remember, the data we presented last year with 99 dozen patients with ET is a very rapid normalization in platelet count that happens very soon after the first dose and by the end of the first cycle, in about a month, most of the patients that will normalize platelets have done so.

So we believe that an early dosage collision at that point for patients that are not early responders is the right approach here to take into account the heterogeneity that we see sometimes in the responses. So we believe that by this we’ll be able to COVID patients with all kinds of mutations and have a treatment effect across the board in patients with et.

Operator

Thank you. Next question today is coming from Edson Durout from Barclays. Your line is now live.

Peter Lawson

Great. Thanks for taking the question and for today’s earnings update. So we noticed the updated guidance for Rux Nick Denville now in the second half versus early 2027 for first line GVHD. Just maybe if you could talk about your expectation for that study and given sort of the move up in timelines potential to maybe accelerate the pivotal program in combo with RUCs. Thanks.

William Meury — CEO, President & Director

I just want to. I want to make sure your question is related to Nick Timbo and the phase three study with Jackify.

Peter Lawson

Yeah, the move in the second half now versus early 2027 that you had previously guided to.

William Meury — CEO, President & Director

Oh, go ahead, Pablo.

Pablo J. Cagnoni — President, Head of Research and Development

So let me take that. So this study, the randomized phase two study combining Nictimbo with Rox and comparing that with Rox and steroids, accrued very quickly, well ahead of schedule. As a result of that, we’ll have data before the end of this year and that will help us define the rest of the regulatory strategy to bring NickTimbo to first line chronographic CESOs disease patients. Thanks for the question, Edson.

Operator

Thank you. Next question today is coming from Ash Verma from ubs. Your line is now live.

Ashwani Verma

Hey guys, good morning. Thanks for taking our question. So just on 989, trying to understand the implications of this flexible dose escalation in ET pivotal trial design for the MF indication. So I mean, how do you think that plays out? Like, could this be a challenge if you have to titrate patients and some don’t get the benefit of the efficacy unless you get the 2500mg dose? And especially like, how would that be relevant if you’re pursuing the first line MF indication? Thanks.

Pablo J. Cagnoni — President, Head of Research and Development

So when you look at the data that we presented twice last year, a substantial percentage of patients with ET responding by normalizing platelet count at doses well below the dose escalation of 2,500. Based on that, we think that a starting dose of 750mg IV every other week is the right way to start because a lot of the patients would normalize platelet count with that and that alone will support achieving the primary endpoint of the study, which is durable complete hematologic response at 24 weeks.

Now, there’s a percentage of patients like it tends to happen molecular targeted therapies that are less sensitive to 9A9. And for those patients, we thought one step up to 2,500 should cover the efficacy in that patient population. So we basically designed a study to try to cover the heterogeneity in this population. We believe that the early dose escalation step is the right way to do it. We believe that the rapid effect of 999 normalizing platelets in patients that will do so will allow us to very quickly make that determination.

And obviously, as I mentioned at the beginning, we had a very constructive discussion with FDA and we reached an agreement on this.

William Meury — CEO, President & Director

Thanks for the question, Ash.

Operator

Thank you. Next question is coming from Michael Schmidt from Kruggenheimerlein is now live.

Michael Schmidt

Hey, good morning. Thanks for taking my question. I had one on 734, the KRAS T12D program. So nice to see the chemo combo study now up and running in pdac. Pablo, just curious how you think about, you know, either potentially pursuing other registration opportunities in pdoc, perhaps with investigational therapies such as pan Ras inhibitors, and then how do you think about addressing other tumor types such as lung and colorectal cancers? Thanks so much.

Pablo J. Cagnoni — President, Head of Research and Development

Thank you for the question, Michael. So first of all, let me just say we are very pleased how this data, the data evolving. We’ll have an update for all of you later in the year. But the combination with chemotherapy, which we showed the tolerability earlier this year at the ASCOGI meeting. But now the response rate data is coming in and we’ll have that as well as more durability data later in the year. And we’re very pleased on the progress of this program and implementation of the phase three, a pivotal trial in the first line.

In parallel with that, we’ve done a lot of work in other contexts. First of all, in pancreatic cancer, we have a strong interest in adjuvant and we’re trying to decide the right design there. You’ll hear more about that in the second half of the year. We’re also then combination with Erbitux, which I think one of the really important advantages of 734 in this competitive landscape is the absence of rash. And so the combination with EGFR inhibitors is key and it will be key, we believe, to develop these therapies in colorectal cancer.

So you’ll hear more about that later in the year, which could be both in combination with Irbitux alone or Irbitux plus chemotherapy in different lines of therapy in colorectal cancer. And finally, we have enrolled a cohort of patients in non small cell lung cancer. We’ll have data on that in the second half of the year. All this gives you an idea how we’re going to potentially expand this program later in the year and we’ll give you a comprehensive update when we present the updated data.

William Meury — CEO, President & Director

Thanks, Michael.

Operator

Thank you. Next question is coming from Matt Phipps, from William Blair. Your line is now live.

Madeleine Stone

Good morning. Thanks for taking my question. I’ll follow up on 734. Just wanted to confirm that all studies have resumed enrollment following that temporary pause a month or so ago to review those pneumonitis events. And I guess is a history of pneumonitis going to be an exclusion criteria for Don 303 phase? 230. Thank you.

Pablo J. Cagnoni — President, Head of Research and Development

So let me recap what happened here because it’s important to have clarity. We had the event of pneumonitis. We reported, we did a full program review that encountered four cases of pneumonitis in more than 350 patients treated. Importantly, three of those patients were receiving 734 in combination with chemotherapy. Two of the patients had concurrent infections. And an in depth review of the data concluded there was no signal about the incidence of 734 producing pneumonitis in these patients. That’s very important to remember.

Now, the phase three study was never put in pause. What we did is in order to amend consent forms and investigator brochure Europe. It’s an administrative reason. They put enrollment on hold in the phase one study. So those are being amended now. It will reopen. Nothing ever stopped in the U.S. We have continued to enroll patients. The implementation of the phase 3 study continues apace without any interruptions.

William Meury — CEO, President & Director

Thanks, Matt.

Operator

Thank you. Next question is coming from Judah Fromer from Morgan Stanley. Your line is now live.

Unidentified Participant

Yeah, hi guys. Thanks for taking the question. Just curious on Opzelura, if you could comment on competition within the non steroidal topical market, is that still a growing pie? Are you fighting for share just within the market kind of X steroids? And then just curious, in terms of the long term guide for Opzelura doubling, how important is it to have POVO approved in those indications for those multiple tools within the tool bag for those indications. Thanks.

William Meury — CEO, President & Director

Yeah, Judah, thanks for the question. I’ll start with the second question that you asked and then double back on the first. When you think about this business over the next five years, there’s essentially three components to growth. And I do believe Opsolor has the potential to grow at, let’s call it a 10 to 15% CAGRADE over this period of time. First component is organic growth, which is what you’re talking about, continued penetration of the AD and vitiligo markets. The second component of growth is the launch of the HS indication for Opzelure and mild to moderate HS.

And then there’s the launch of Opzelor in Europe for atopic dermatitis, which could throw off 2 or $300 million in incremental sales. And it doesn’t require any heroic math to forecast that Opsolor can approach a billion, you know, let’s call it a billion three roughly by 20, 20, 30. Now, as it relates to competition in the United States, I’m not so much focused on these modest market share shifts that you can see between products on a, on a, on a monthly basis. A few points here. In the first quarter our share of new patient starts in the United States was 46%.

And new patient starts as you know, or NBRX is sort of the Future. It’s growth TRXs tell you a lot about the base in the past, but when you’re really monitoring and managing a business, you’re focused on that MBRX number NBRX volume or new patient start volume in the first quarter was up over 30% year over year and was at a higher rate than the market. And we had two to four times more new patient starts in the first quarter than any of the other branded topicals. I think the real key here, and this is true for us as well as anybody else that has a topical, is that the use of TCIs is starting to moderate and there is a shift from TCIs and steroids to these non steroidal granted topicals.

And you see that month to month and quarter to quarter. I think the benefit we have is opzelure is superior in terms of skin clearance and itch relief relative to a TCI and it is a better long term option than asteroid. I think the product is set up perfectly over the next five years and we’re in a very, very strong position. And you have the benefit of operating in a market where there’s a real tailwind and that is the move away from steroids and TCIs. I think that probably covers it. I think as it relates to povo, I think that’s upside.

The fact that we are able in both vitiligo and in potentially HS to offer a complete treatment solution topical to oral. That’s how I think about it. Thanks for the question.

Operator

Thank you. Next question today is coming from Ren Benjamin from Citizens. Your line is now live.

Reni Benjamin

Hey, good morning guys. Thanks for taking the questions and congrats on the quarter. My question is on 058 and the phase one with the new ASD formulation. Can you talk to us a little bit more about how we should be evaluating those results and you know, when we see it in the second half, what you’re looking for and how we view this in lieu of the deal you made with Prelude and that molecule for which you have an option. When do you guys ultimately make a decision between the two and how. Thank you.

Pablo J. Cagnoni — President, Head of Research and Development

Thank you for the question. So as I mentioned during my prepared remarks, we are now in the clinic with the new formulation and we’re going to have an update for you before the end of the year. What we would love to see here is that with the new formulation, if we achieve the right exposures that our preclinical data predicted were necessary to see an effect that then we will be able to confirm our conviction that inhibiting V617F in this way with a pseudokinase inhibitor will deliver positive clinical outcomes to patients with MPNs.

So that’s basically the goal of the program for this year to deliver enough exposures with the new formulation to achieve concentrations that will hit the target hard enough to show clinical outcomes that matter. Now when it comes to Prelude, we see that as a next generation program. Potentially for us we have internal next generation programs and we have an external next generation program which is the prelude one that’s a time based option. We’ll have to make a decision at some point in time and that data will be compared with the data from our internal programs as well as the data from the lead 058 and then we’ll make a decision which ones we move forward.

William Meury — CEO, President & Director

Thanks for the question.

Operator

Thank you. Our next question is coming from Mitch Kapoor from 18 Wainwright. Your line is now live.

Unidentified Participant

Hi, this is Yanzi sitting in for Mitchell Corporation for Congratulations again on the data for taking my question. I was curious about povorcidinib in hf. So where do you expect the earliest uptake to take place? Would you say in biologic knife patients post biologic failures or patients with specific disease features, you know such as like brain internal pain or a high inflammatory burden?

William Meury — CEO, President & Director

Yeah. Mitchell, thanks for the or young. Excuse me. Thanks for the question. I’ll make a few comments and Muhammad will add. First of all I would just step back and say that I think the HS market is tailor made for an oral. This market is set up for sequencing oral to injectables and that’s something that’s been missing. Think about all the value that’s been ascribed to orals in the obesity market. Povo has the potential to be the first oral anti inflammatory. We expect to have a broad label both in the pre and post biologic setting which I think is a real advantage.

70% of our clinical data is in pre biologic patients as it relates to early uptake. You certainly could envision that patients who are on a biologic right now, one of the 17s or TNF who have active disease or aren’t achieving pain relief or have some injection fatigue could be an early source of utilization. And if you think about the size of the biologic market, there’s a range out there in terms of the estimates it’s 50 to 75,000 patients. If povacitinib was to get 10% of 50,000 on an annualized basis, she’d have a couple hundred million dollars in revenue.

But I think the most important point here is we expect that we will capture patients at two distinct inflection points. After an antibiotic before a biologic and then after a abiologic, whether it’s a 17 or a TNF Alpha. And, you know, Muhammad right now is working on preparing that launch, so it is completely wired for success. Muhammad, do you want to add anything?

Mohamed Issa — Executive Vice President & Head of US Oncology

Yeah, look, I mean, hs, as we know, is a large and growing market and has a significant unmet need. The disease is debilitating. It’s characterized by chronic pain, drainage and flares. And obviously highly heterogeneous. Right. With multiple cytokines. So when you think about the market as Bill just described, in terms of its size, 300,000 patients in the US 200,000 actively seeking treatment, and yet only 50,000 of them are an advanced therapy. So POVO is positioned to address this market as the first and only oral treatment with biologic like efficacy across all of the treatment parameters that are quite debilitating.

And by competing, like Bill mentioned, in both the pre and post biologic setting, POVO has the potential to be somewhere between $500 million to a billion dollars in peak sales. And I think at launch, you can expect an opportunity to capture patients on both sides of that inflection point.

William Meury — CEO, President & Director

Thanks, Mohammad.

Operator

Thank you. Our next question today is coming from Kripa Deverakonda from Truist. Your line is now live.

Srikripa Devarakonda

Hey, guys, thank you so much for taking my question. And congrats on the most recent clinical data as well with povo. I have a question on the Brux mutant CALR combo with the first line data that is expected year end. Can you remind us of data that suggests any synergistic benefit? And given how well jakfi is entrenched in the myelofibrosis market, if CALR mutant patients are doing well on Jakify, where do you envision mutant CALR fitting? Like, is it a combo? Could it be a switch? Add on. Thank you.

Pablo J. Cagnoni — President, Head of Research and Development

Thank you for the question. So let me offer a couple of points. So let’s start with the first part of your question about synergy. Preclinically we saw additive to synergistic effects combining 999 with Jakify in color mutated models. Now, I think what’s important to remember is, you know, first of all, Jakify as well as it works and as important as in step two forward has been in patients with MPNs, has particularly in cholera, mutated patients, very little if any disease modification potential.

It controls the symptoms, some of the symptoms of the disease. Obviously it leads to spleen responses. All those effects are much less in patients with calar mutations. In fact, if you look at the control arms from the comfort studies or the Manifest study, the SVR35 on Jakify in Calar mutated patients is approximately 20%. That’s in previously untreated patients. So obviously there’s a need for something better for color mutated patients even in first line mf. The second part of the question is Jakify does have a baggage which is obviously produces a fair amount of anemia and thrombocytopenia.

So what we’re looking to do with 989 is fundamentally different. We’re looking to restore normal hematopoiesis, we’re looking to eliminate malignant megakaryocytes from the bone marrow. We’re looking to eliminate CD34 positive mutant color positive cells from peripheral blood and as a result of that shift back to normal hematopoiesis, which as we’ve seen already translates into improvements in anemia as well as spleen responses and symptom improvement. So when we put this whole package together, we’ll show you the data by the end of the year in a larger group of first line patients.

We will have for you a regulatory strategy for 989 in first line Ms. But we think that the effect of 989 and Jakob are fundamentally different in this patient population.

William Meury — CEO, President & Director

Thank you for the question, Crippin.

Operator

Thank you. Next question is coming from Brian Abrams from RBC Capital Markets. Shirley is now live.

Brian Abrahams

Hey guys, good morning. Thanks so much for taking my question. Sounds like you’ve made a lot of Progress with the989sub Q form, having completed the Healthy Volunteer study. So I guess I was wondering if you could maybe tell us about the observations there and then the scope and dose range that you’re going to be testing in this ongoing phase 1 study in patients and whether that in and of itself could potentially be bridging or whether you’ll need integration of the sub Q form into the phase three.

Thanks.

William Meury — CEO, President & Director

Thanks for the question, Brian Pablo.

Pablo J. Cagnoni — President, Head of Research and Development

So the data from the Healthy Volunteer study, as I mentioned in my remarks, has allowed us now to move very quickly into patients. We’re going to test a very broad range of doses. Let me just reassure you that they will cover all the potential doses that we’re using in Phase 3 and ET and that we could conceivably use in Phase 3 patients with MF. So we will have that covered in terms of implementing this in phase three studies. This is a question of timing, Brian. You know, speed is really important here.

We need to bring this medicine to market for patients with ET and MF as quickly as possible. We will not slow down the ET study. We’re probably not going to slow down the second line MF study to incorporate the sub Q and we’ll have a bridging strategy at the back end. Our goal is to incorporate the sub Q formulation, the first line MF study and right now the plan allows us to do that. We’ll provide an update on both before the end of the year.

Operator

Thank you. Our next question today is coming from Jessica 5 from Morgan Stanley, from JP Morgan. Your live is now live.

Jessica Fye

Hey great. Thanks for taking my question. I had another one on989. I was hoping you could touch on the potential translatability of the ET design to Ms. As it relates to starting dose and I guess really more specifically the potential for an up titration approach, particularly in the context of a potential six month primary endpoint where we’re presumably going to be looking at SVR35 and TSS50 versus looking for an early platelet response like in et cetera.

Pablo J. Cagnoni — President, Head of Research and Development

Thank you for the question, Jeff. So the journey in MF is just a little bit earlier. We need to spend a little bit more time with FDA discussing the design of the second line MF study. So I’m going to be a little bit less open about answering the question in detail now. I think that the fact that we have an agreement on the potential for the potential on the step up escalation, ET certainly can build, we can build a framework around that. I think the more important thing in MF, to be honest, is to have a constructive dialogue with the agency on the primary endpoint for the study, which we intend to do and for which we have a lot of supporting data.

As I mentioned in an answer to a previous question,989 is a fundamentally different type of medicine for patients with mf. This is about normalizing hematopoiesis, not just in non specific inhibition of JAK that leads to some symptom improvement and spleen response. It’s about normalizing hematopoiesis. We think that needs to be contemplated into the primary endpoint for a study in MF and we intend to have that conversation with fda Conceivably, we could have the same to address the heterogeneity across the population.

We could have a dose escalation step as well. In this case, it could take a little bit longer, but we’ll have that conversation with FDA at the right time.

William Meury — CEO, President & Director

Thanks, Jess. And congratulations on the move to Morgan Stanley.

Operator

Sorry about that, gentlemen. All right, next question today. Actually, our final question today will be coming from Derek Archilla from Wells Fargo. Your line is now live.

Derek Archila

Hey, good morning. Thanks for taking the questions. Congrats on the progress. This one’s for Pablo. You framed the setup for EHA and the update there earlier, but I guess it’s the expectation we should see deepening responses in these Ms. Cohorts at the update. I just wanted to reconcile the eradication comment that you made. Thanks.

Pablo J. Cagnoni — President, Head of Research and Development

So it’s always. Look, we will have data that continues to show the effect of 9A9 as a disease modifying therapy and that consistently will show that we continue to eliminate, dramatically reduce and some patients close to eliminate the malignant population of megakaryocytes in the bone marrow and in peripheral blood. And you should see more of that translational data at eha.

William Meury — CEO, President & Director

Thanks, Derek, for your question.

Operator

Thank you. We reached out of our question and answer session. Ladies and gentlemen, that does conclude today’s teleconference and webcast. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation today.