Loading…
Loading…
On today's call, I am joined by Herve Hoppenot, Pablo Cagnoni, and Christiana Stamoulis, who will deliver our prepared remarks. Matteo Trotta, Mohammed, and Steven Stein will also be available for the Q&A. I would like to point out that we will be making forward-looking statements which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially.
I encourage you to consult the risk factors discussed in our SEC filings for additional detail. I will now hand the call over to Herve Hoppenot.
Thank you, Greg, and good morning, everyone. The first quarter of 2025 was very important for Incyte Corporation not only because of the good performance of the commercial portfolio, but mostly because Q1 2025 puts us on a great trajectory for long-term growth with the continuous expansion of Apteloa, successful launch of NixTimo, and the successes of the pivotal studies in HS and proof of concept study in CSU. The financial performance was very strong with growth above 20% in both product and total revenues. Our cash position at the end of the quarter reached $2.4 billion.
On the commercial side, Nikkynvo's successful launch is one of the four planned launches for Incyte Corporation in 2025 in the US. On the R&D front, we report significant progress so far this year with several key data positive readouts. Exa bioequivalents for oaxlatinib, proof of concept data in for Povo, and phase three results for oxylutinib in preregional nodularies. And pravositinib in HS.
In Q1, product revenue grew 26% with total revenues increasing 20% year over year to $1.05 billion. This growth was driven by the ongoing demand for Jakafi and Upseroa, the initial launch of Nick Dimbo in third line chronic GVHD. Moving to slide seven and the first quarter of commercial performance for Jakatay. Jakafi net product revenue in the first quarter grew 24% year over year to $709 million.
Total patients increased 10% when compared to the same quarter in 2024. Due to strong demand and the expected continued growth of Jakafi, we are raising the full year 2025 net product revenue guidance to a new range of $2.95 to $3 billion. Turning to slide eight. I am looking at Jakafi weekly dispenses by indication. During 2023, 2024, and the first quarter of 2025. As you can see, unit growth remains robust across all three indications.
Myelofibrosis showed growth again this quarter, while the most significant increase was seen in polycythemia vera. We expect PV to become the largest contributor for TAKATA over time, supported by the data from the Magic TV study, which underscores the benefit of early intervention with Checkatrade and its impact on thrombosis-free survival. Moving to slide nine, Total Upsilon net product revenue in the first quarter was $119 million, up 38% when compared to the same quarter last year, driven by continued growth in the U.S., increased contribution from Germany and France, and the more recent launches in Italy and Spain.
In the US, annual prescription trends for 2024 and the first quarter of 2025, as shown on the right of Slide nine, reflect continued growth of Obelura for both atopic dermatitis and DTLAGO. Effective March first, Optum Premium added Upsilon to their preferred formulary, which means Upsilon is now preferred on two out of the three big PBM national formularies. This change has enhanced our commercial coverage from 86% to 94%. On Slide ten, and our newest commercial product, NIKE TIMVOC, NIQTYVOU is the seventh product commercialized directly by Incyte Corporation that Jack Afre is Obserli, IQOSIC, Pemazier, Monjuvie, and Zenit.
A novel medicine launched at the end of January for patients with sub line chronic graft versus host disease addresses an important medical need and it has significant long-term growth potential. After two months of commercialization, Neximbo net product revenues in the first quarter were $14 million driven by high patient need and strong commercial execution, along with our partner, SimDAC. So we are seeing positive early launch metrics with widespread product awareness and interest. Ninety-five percent of top BMC centers have used nicotine bull and seventy percent of all BMC centers have ordered.
NIKTIMO is the first anti CSF1R antibody approved to target the inflammation and fibrosis associated with chronic GVHD and we are already seeing the impact it is having for patients giving us increased optimism for the long-term potential of this product as it is moving to earlier line of treatment. On slide eleven, a reminder that 2025 will be a pivotal year for Incyte Corporation with numerous defining catalysts set to create a significant inflection point. Launch of Nick Dimple has already shown strong initial success, and we are preparing for three additional launches this year. Collectively offering important near-term revenue potential.
We plan to initiate at least three phase three studies and anticipate that seven early-stage programs will generate informative data. This development has the potential to transform our company. Finally, before I turn the call to Christiana, I would like to address the topic of tariffs. Seven years ago, we started a strategy to establish dual sourcing for key Incyte Corporation products with the goal of having a backup FDA or EMA approved facility in case of technical issues.
This approach is giving us today flexibility for key products to manufacture in the US for the US market and for Europe. From Europe, for ex US. Therefore, we expect the impact to Incyte Corporation of any potential tariffs on pharmaceuticals to be minimal. Finally, our exposure to China is now limited to some starting material for some of our drugs, and we currently hold inventory of starting material to support our forecasted supply needs over a multiyear period.
And have alternative sources of supply of starting materials that we could consider moving to if needed. Now I will hand over the call to Christiana Stamoulis for the financial update.
Thank you, Herve, and good morning. In the first quarter of 2025, we delivered total revenues of $1.05 billion, up 20% versus the same period last year. Total products revenues of $922 million in the first quarter represent an increase of 26% year over year. Driven by strong demand growth for Jakafi and Opselura, as well as initial contribution from the commercial launch of Nixinibor during the quarter.
Turning to Jakafi on Slide sixteen. Jakafi net product revenue was $709 million for the first quarter representing 24% growth versus the first quarter of 2024. Pay demand increased 10% versus the prior year period reflecting continued growth in all indications. Net product revenue growth also reflects a positive gross to net impact from the removal of the party coverage gap liability under the inflation reduction act and inside phase in participation in the Part D initial and catastrophic phases partially offset by growth in 340B. As a result of Jakafi qualifying for the small biotech exception, Incyte Corporation's participation in the Part D cover is limited to 1% in both the initial and catastrophic phases.
We expect this gross to net favorability per party to be limited to Q1 and for the remaining quarters in 2025, we expect the party coverage liability to be in line with 2024. Lastly, the year over year comparison of net product revenue includes a 7% positive impact due to less destocking in the first quarter of 2025 versus the first quarter of 2024. At the end of Q1 2025, Jakafi inventory levels were within normal range. Turning now to OXXELUR on slide seventeen. Net product revenue for the first quarter was $119 million representing a 38% increase year over year. US net product revenue of $95 million was up 20% year over year driven by a 24% increase in pay demand, partially offset by a reduction in channel inventory.
Channel inventory levels ended the quarter within normal range. Ex US net of product revenues of $23 million were driven by uptake in Germany and France, as well as the recent launches in Italy and Spain. As in prior years, Obsilura first quarter results reflect the typical seasonality we see in the first quarter of each year driven by the reset of insurance plan annual deductibles in the US as well as holidays and other events that negatively impact scripts. Turning now to other hematology oncology products.
On slide nineteen. Net product revenues for the first quarter were $94 million representing a 30% increase year over year. This is primarily driven by the commercial launch of Niktimpo during the first quarter of 2025, which contributed $14 million in net product sales. Growth from ONJUVI in the first quarter of the year primarily reflects a full quarter of sight recording net product revenues in the US versus two months of net product revenues in 2024 as a result of the acquisition of the exclusive US rights to Monjuvie that closed in February 2024. Moving on to slide twenty and our operating expense.
Total GAAP R&D expenses were $437 million for the first quarter an increase of 2% year over year driven by continued investment in our late-stage development assets offset by the timing of certain expenses which favorably impacted Q1 2025. Moving to SG&A, total GAAP SG&A expenses were $326 million for the first quarter, representing an 8% year over year increase primarily driven by timing of consumer marketing expenses and certain other expenses. Finally, total going operating expenses in the first quarter of 2025 increased 6% year over year compared to a 20% increase in revenues during the same period leading to further increase in operating leverage and margins.
Moving on to our guidance for 2025. We are increasing our full year guidance for Jakafi from a range of $2.925 to $2.975 billion to a new range of $2.95 to $3 billion. We are reiterating our full year guidance for Obselura, our other hematology oncology products, COGS, R&D, and SG&A. For R&D, our guidance excludes the impact of the recent deal we signed with Genesis, which is expected to add $15 million to our full year R&D spend. I will now turn the call to Pablo Cagnoni for an R&D update.
Thank you, Christiana, and good morning, everyone. As we highlighted a year ago and we summarized on this slide, we remain on track to deliver more than ten high-impact launches by 2030 from programs across the portfolio. In the next few slides, I would like to provide an update on two of these programs. The phase two proof of concept study of pobarsidinib in patients with chronic spontaneous circulatory care and an update on the phase three results for poorsitinib in patients with heredionitis super.
We are delighted to announce the positive top line results for the phase two study evaluating poursitinib in patients with chronic spontaneous tikarria. The study met the primary endpoint at the seventy-five milligram dose, of change from baseline into urticaria activity scores summed over seven days or US seven, at week twelve. Treatment with over Sydney was well tolerated with known safety signals observed. These results open the door to a potentially new treatment option for over three hundred thousand patients with CSU are inadequately controlled, on antihistamines.
We are pleased with this proof of concept results which will be presented at an upcoming medical conference. And we will be engaging with regulatory agencies to determine next steps as we plan a pivotal study for poursitinib in patients with CSU. Just a few weeks ago, we presented the results of the phase three studies, STOPHS one and STOPHS two, evaluating povarsitinib in patients with moderate to severe HS. The studies showed statistically significant and clinically meaningful improvements in high score at both doses in both studies.
Slides twenty-five and twenty-six summarize updated results through eighteen weeks of follow-up in these two studies. As a reminder, patients on placebo were allowed to crossover at week twelve and were randomized to either forty-five or seventy-five milligrams of roversitinib. As illustrated in the chart, for those patients who started on pobacitinib and stop h s one, the number of patients achieving high score increased from one hundred and seventy-six at week twelve to two hundred and three by week eighteen. Among the patients who crossed over from placebo to receive either porvacitin forty-five or seventy-five milligrams, high score at week eighteen improved from twenty-eight point six percent and plus which placebo and fifty-seven point eight respectively.
Importantly, for the crossover patients, the number of responders increased from fifty-eight to one hundred in just six weeks. Demonstrating once again the rapid onset of benefit produced by poursindiv in patients with HS. Similar findings are observed in stop HS1 summarized on this slide. For those patients who started on pobricitinib, the number and proportion of patients achieving high score continues to increase from one hundred and sixty-four patients at week twelve to a hundred and seventy-seven patients at week eighteen.
Among the patients who crossed over from placebo, to receive either poursidinib forty-five or seventy-five milligrams, high score week eighteen improved from twenty-nine point seven percent on placebo to fifty-eight percent and fifty-five point two percent respectively while the number of those achieving high school increased from sixty to ninety-nine. This week eighteen results from both stop ages one and stop HS two clearly show that the response rates in the power sydney farms continue to increase over time. And perhaps more importantly, demonstrated doubling of the responses in patients initially randomized to placebo after they were switched to either poursidinib dose level.
We previously reported a greater differential efficacy in favor of poracitinib in patients previously treated with biologics with an average placebo adjusted difference in high score of nineteen point one percent for pravosidinib forty-five milligrams and eighteen point three percent for porbarsidinib seventy-five milligrams in the pooled analysis for stop h s one and stop h s two. In slides twenty-seven and twenty-eight, show that this is true regardless of the type of biologic being considered. Either anti TNF or anti l seventeen agents. Shown on this slide is a high score, but prior anti TNF therapy with a placebo subtracted high score of thirteen to twenty-three percent in the different arms of these two studies.
On slide twenty-eight, we see the high score by prior anti IL seventeen therapy with a placebo subtracted high score of five to twenty-five percent in favor of porvacitinib treated patients. In all, totality of the data presented clearly demonstrates that patients with HS have the potential to benefit from over Sidney therapy regardless or whether they have received treatment with a biologic and regardless of the type of biologic they received. We are pleased by the positive data that Power Cyndic continues to generate. With positive phase three data for HS, positive phase two proof of concept data previously presented for Vitiligo, Perrigo Nodularis, and now at CSU, where Sydney solidifies itself as a potential new medicine across several indications in development.
We are securing a broad development plan and anticipate additional proof of concept data for asthma to be available in the second half of 2025. We continue to evaluate additional opportunities for provercitinib and plan to share these updates in the second half of 2025. As mentioned by Herve, 2025 will be a pivotal year for Incyte Corporation. With over eighteen 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 you can see on slide thirty-two, we have achieved several of these milestones with the launch of NickTimbo, bioequivalency data for ruxolitinib extended release, phase three data for roxolitinib cream and paragon nodularis, and povarsitinib and hydronetis suppurativa as well as the phase two proof of concept data for CSU.
We look forward to sharing additional updates on these milestones over the course of 2025. I will now hand the call over to Herve Hoppenot for closing remarks.
Thank you. Before we close the presentation following Pablo's update on the Provo data in HS, I would like to comment on the HS market in 2027 in the US. When PoVault would be launched. It is a fast-growing market where there are more than one hundred thousand diagnosed patients with moderate and CBHS who do not yet receive advanced systemic therapies.
The illustration on slide thirty-two reflects the group of patients on systemic therapy. Are around three thousand patients who are not eligible for injectable treatment with biologics. As research shows that ten to fifteen percent of eligible diagnosed chest patients are not receiving injectable therapy for practical, financial, reasons or at the patient's request. COVA will be the only oral treatment approved in the prebiologic setting, and we anticipate this segment to grow significantly in the years following the approval of Povacitinib.
In 2027, PovartiTene will compete for the sixteen thousand new biologically eligible patients started on systemic therapy that year in dark blue on the graph with a product profile based on an oral treatment with high high score durable responses, and fast pain relief. The largest segment at launch in 2027 will be the group of patients in light blue on the right who have received biologic treatment including anti IL seventeen and require a new treatment option for lack of good disease control. We estimate that group at twenty-seven thousand patients or around one third of a pool of seventy-four thousand patients on biologics that year.
This is equivalent to an estimate of average biologics treatment duration of three years. In this patient population, as Pablo has presented earlier, progressive gene efficacy profile is unique and will drive the early adoption curve. Overall, this estimate shows that porcetine will be potentially targeting forty-six thousand HS patients in 2027. With the longer-term data shown today for new patient, with efficacy data maintained in the post biologics setting, we see HS as an important contributor to the total potential of povarsitinib with BT Ligo, ProEgo Naluaris, and now CSU as the subsequent indication.
To recap, we have delivered a very strong commercial execution in the first quarter in both oncology and in dermatology. The successful launch of Nixinvo that there is a clear need for new treatments in GVHD giving us optimism for the long-term potential of Nikkynbo. This quarter is when we confirm that Poro will be potentially launched in 2027 for HS with positive data on all primary endpoint in both phase three studies the competitive profile in treatment naive and post biologic HS, and now proof of concept in CSU. This result reinforces positive potential as a multibillion driver of future growth for our company.
Our pipeline continues to advance with short-term deliverable for three additional in 2025, Roxxa in 2026 and good progress of the earlier project. And importantly, we have multiple upcoming milestones and catalysts remaining in 2025 which will further shape our trajectory and create additional value. Operator, that concludes our prepared remarks. Please give your instruction and open the call for Q&A.
Certainly. We will now be conducting a question and answer session. In the interest of time, we ask you to please ask one question then return to the queue. Our first question today is coming from Michael Schmidt from Guggenheim. Your line is now live.
Hey, good morning. Thanks for taking my questions. I had a question on Jakafi where PV, as you mentioned, is now the most important growth driver for the product. You know, capturing about one third of sales and can you talk a bit more about your expectations for how much of that is driven going forward by new patients versus continued, you know, use of the drug by patients on therapy.
And secondly, there was some recent positive announcement of phase three data of a hepcid mimetic in PV as an add on to standard of care. How do you expect that potential approval to impact potential use of Jakafi going forward? Thanks so much.
Hi, Michael. Mohammed here. Thank you for the question. Let me just address the PV growth drivers first.
The team is doing a really nice job today executing on our PV strategy. Educating the marketplace on the importance of treating PV earlier with Jakafi, which results in reducing the risk of thrombosis. And because of that, we are seeing actually new patient growth as well as patients continuing on therapy. So the drivers for growth for us in the future will be a combination of both new patient starts as well as persistency within that.
And then from the phase three data that you are mentioning, look, I think, you know, first and foremost, it is always good to see new treatment options available for patients. That said, the agent that you are referring to is currently being studied in combination with other agents. We think that that is going to be used generally in combination with Jackify and others. And JackFi, on the other hand, remains you know, the only FDA approved JAK inhibitor for PV after HU failures or intolerance that addresses both hematocrit and disease progression.
That is a really unique profile for us that we think continues to put us in a really competitive leading position. Thanks again for the question, Michael.
Thank you. Next question today is coming from David Lebowitz from Citi. Your line is now live.
Thank you very much for taking my question. In terms of Coval for chronic spontaneous urticaria, ultimately, where do you see it fitting? Is this something that would be before moving to biologics such as Zolair and other therapies, but after things like the antihistamines in montelukast, or do you see it more competing directly with the post Zolair crowd?
So let me take that question. So look. I think that as you know, most of the patients, more than half the patients fail, not only conventional antihistamines by neck generation antihistamines and high dose antihistamines. And those patients we believe, will benefit from having an oral option to manage their chronic spontaneous reticare.
So I think it will be both populations. I think it will be a patient preference to some extent. Some patients will prefer to try another oral like boracitinib before trying a biologic. Other patients, particularly perhaps those with high IgE, which are about half the patients will prefer to try biologic first.
Those patients still have a very high failure rate, and they could be treated with over significant alternative after that. So I think we will potentially address both patient populations.
Thank you. Next question is coming from Andrew Barrons from Leerink Partners. Your line is now live.
Thanks, and congrats on the new PovO HS data. I know the placebo patients crossed over in this trial, but what would you have expected the control arm to do based on historical data? Are you guys gonna continue following these patients beyond eighteen weeks? And then you also suggested in the press release that there may be increased activity in naive patients crossing over some placebo.
Was this the data that you shared in the presentation in patients that have received a prior biologic over these true naive patients?
Morning, Andy. So a couple of points to address your questions. Yes. We will continue to follow the patients.
For efficacy and safety to fifty-two weeks. So as you know, we are not gonna provide an update every few weeks, but there will be future updates on the maturity of the data both for efficacy and safety from the two studies. I think we wanted to provide an update now because our study was analyzed at week twelve, which is a little bit earlier than other studies from our competitors. So we wanted to show longer follow-up from both treatment arms and particularly important in this case, the crossover arm, which shows how quickly the placebo patients improve when they are crossed over to povarsitinib.
I think that when it comes to naive versus biologic exposed, I think the important point is the overall of the two studies met the primary endpoint both studies in both dose levels. And that is, I think, important to remember. We wanted to give clarity on the post biologic use because we think that, Rube highlighted, is one of the areas where proversitinib could have a very important role for patients. And so the clarity that it worked very well regardless of cryobiology use and regardless of the type of biology.
We thought it was an important thing to remind everyone of.
Thank you. Next question is coming from Tazeen Ahmad from Bank of America. Your line is now live.
Hi. Good morning. Thanks for taking my question. I just wanted to get an update on one of your pipeline assets, namely the Kellogg compound. You had guided the data for this calendar year. Is that still the plan? And if so, can you just give us a little bit of guidance on what level of data to expect? Thanks.
This is Pablo. I think you are asking about the you can call our monoclonal antibody. We promised data in 2025 and we will present data this year. It will be a substantive amount of data.
We have doses collation. We are gonna have a range of doses. We are gonna have data need ET and data in myelofibrosis, and we will present clinical endpoints as well as early data on VAF variability infraction burden over time. So I think you should expect a reasonable number of patients with a range of doses that will be presented.
Thank you. Next question is coming from Salveen Richter from Goldman Sachs. Your line is now live.
Hey. Great. Thank you. This is Matt on for Salveen.
Maybe just to follow-up on that last question. Could you share any more details in terms of how we should assess the kind of curative efficacy potential for CalR. And then kinda just walk us through what is, like, the base case in terms of mono versus a Jacoby combo. And then if I could just on tariffs, it seems like you all are well positioned from a manufacturing perspective.
Is there anything you guys can share in terms of where IP is based and how much profit you book in the US? Thank you.
Let me take the first part of the question on KALAR. So I think that the data for a new intervention, in this case, a cholera antibody for patients with E and MF. Obviously, we would like to change the treatment paradigm in this patient. Patients.
And over time, we would like to see evidence of disease modification. That could take time, but we would like to see early on there is a decrease in the allele burden in these patients. And that is an important part of the studies. However, the immediate benefit for patients or in the near term will be the classic signs and symptoms of these diseases, blood counts, symptoms etcetera, both in ET and NMF.
What we intend to present is a comprehensive data package as addressing both sides of that question, the clinical endpoints as well as early burden reduction. And over time, we expect a sustained and more pronounced effect in this patient's continued treatment with the antibody.
And on the tariff question, so as I said, I mean, we have manufacturing available for each of the key products in Europe and in the US. So that gives us basically, an opportunity to supply the US market from the US. Therefore, there is no tariff eligibility there. Regarding IPs, the ownership of the patents for our key product is in the US.
Thank you. Next question is coming from Brian Abrahams from RBC Capital Markets. Your line is now live.
Hi, everyone. This is Nevin on for Brian. Just a quick question on Aflalura. Was been the contribution to of a top derm and Betelago to one q for Abiloyne? How do you how do you kinda see that moving forward? We have heard from some physicians that to AD continues to be a hurdle. So how how are you currently working to improve from the access to Absolutron AD?
Yeah. The two-part question is, Matthew, I will take the first part on the contribution of AD versus Vitiligo. Right now, we see that this split to be pretty constant as both indications are growing at pretty much a similar pace. In terms of access to AD in the future, there are two components of it that we are working on.
One is the formal reposition that we have, particularly on the commercial plan. And as Herve mentioned before, as of March first, we had Optum premium moving from Knockover for Obsilura to preferred position, and that brings us not just two out of three major PBMs in their preferred position, but also, as Sergei mentioned, more than ninety percent of patients on commercial plan covered. The other area of work that we are doing and we are receiving initial positive feedback on improvement that AC ACPs and their office staff see on the accessibility to Obserra, is on the patient service that we offer.
So we continue to work on both fronts. To make sure that the feedback and the easy to access Obsilura feedback continues to improve in the coming quarters.
Thank you. Our next question today is coming from Jessica Fye from JPMorgan Chase. Your line is now live.
Hey, guys. Good morning. Thanks for taking my question. Curious if you could update us on how the company is thinking about capital allocation and business development, Do you wanna see the rest of this year's pipeline readouts play out before making any moves there and with the stock back in the fifties, is another ASR on the table? Thank you.
Repeat that. I mean, the big picture on capital allocation is obviously our internal pipeline success and or lack of. So the evolution of the internal pipeline is driving a lot of the way capital is allocated. You can imagine with seven proof of concept events happening.
Each of them can lead to a phase three program, and therefore, it would be utilizing a large portion of our R&D budget. So that is the first capital allocation is in our R&D. In terms of external business development, we spoke about it. We would be like we have done recently with Genesis, looking at research partnership or very early products where we have an interest on the scientific side, like preclinical or very early clinical sort of a partnership, and we continue to look for that.
And regarding future strategies in term of share repurchase, I cannot comment on that.
Thank you. Next question is coming from Marc Frahm from TD Cowen. Your line is now live.
Hi. Thanks for taking my question. A couple of follow-ups just on some of the earlier topics. On the CalR update, would you expect to be able to talk about kinda next steps and whether you think there is a pivotal path forward yet, or is it the state likely to maybe not quite be that level of maturity?
And then on the updated the HS data, just the potentially better efficacy in the IL seventeen experience patients is obviously provocative. Any ideas as to how you can kind of perspectively identify these patients that may do very well on a JAK relative to an IL seventeen to maybe help them avoid months of what might be ineffective IL seventeen therapy.
Hi, Marc. This is Pablo. On Callar, we will certainly discuss next steps when we present the data. We always try to do that.
That is why we wait to have a reasonable number of patients and some follow-ups so we can tell you what we are planning to do next. So you should expect the conversation on that to happen when we disclose the caller data. On your the second part or your second question, you know, it is hard to tell at this point. I think that we will look more depth at the data that we have, which are two large positive phase three studies to see if we can identify any specific baseline characteristics that predict for better results.
But it is gonna be hard to figure it out ahead of time which patients are more likely to respond to an seventeen, that to a JAK inhibitor. I think Herve highlighted very clearly where do we think that patients are more likely to benefit or to use JAK inhibitor from the start of therapy. And in a proportion of patients that will happen after now, seventeen or after onto TNF. But it is gonna be hard to identify those patients ahead of time.
Thank you. Next question today is coming from Vikram Purohit from Morgan Stanley. Your line is now live.
Hi. Good morning. Thanks for taking our questions. Following up on the immune Kellar question.
We actually had a similar one for the JAC two b six one seven f I program. Just wanted to see what level of update we can expect this year for that program and also kind of what you might be able to communicate on next steps there once we have that dataset. And then secondly, guess revisiting RUX XR, just wanted to get an update on where that program stands what next steps are in. How you would do that moving forward.
You know, assuming you know, positive update from the FDA there. Thank you.
So on six one seven f, that program is if you remember, is behind the mutant color antibody program because we started in healthy volunteers. We had to do some work on the formulation. So it started to be tested in patients later than the mutant color antibody. So the update that we provide, which we intend to do this year, may be a smaller number of patients than the mutant caller antibody.
We are still gonna discuss for the next steps out of that time, but the extent of the update could be more limited. Let me hand it over to Steven to talk about where we are with the Rock six r program.
Yeah. Thanks. On the extended release, as we communicated earlier this year, the key component that we had to achieve was to meet bioequivalence, which we did and we have in writing from the regulators that that was achieved. What follows is to lay down stability and complete that towards the end of this year and then immediately file that response towards the end of this year.
It is a response to a CRL that timeline clock on that from a regulatory point of view is six months. So we expect approval for XR should that all go well by the middle of next year. Thanks.
Thank you. Next question is coming from Kripa Devarakonda from Truist Securities. Your line is now live.
Hi. This is Alex on for Kripa. In reference to the slide of the HS market, with the forty-six thousand eligible patients that can be treated by povo, is that a snapshot of the current market and when we think about penetration into the different segments there, is it equal penetration that you see Pogo going into for all those three different segments. Or does some stand out more than others?
And how do you see the landscape evolving? In the future?
Yeah. I mean, and Matteo can complete the report. The way the slide was was really to give you a picture of 2027. So it is when Pogo will be launching, and the idea is to show that, in fact, there are three different segments that are part of where Pogo could fit and would be competing. One of them, the first one, is for patients who do not want to get injection for many reasons, but and that is not a nothing.
It is around ten to fifteen percent of newly diagnosed patients who are moving to systemic therapy today. We have some research on that. So that is the top line that is the top segment. It will start at around this ten to fifteen percent, which is three thousand patients.
And, obviously, as the other piece, which is the dark blue in the graph, is evolving, is a place where newly started patients who are eligible to biologics, and that is where basically, the competition will be between starting with a biologics versus starting with Povo. And I think that will take time. So at the beginning, we will be dealing with patients who are not eligible for injectable therapy and a lot of patients who are basically coming out of the pool of existing biologic treated patients. And what I wanted to say with this slide is that that number is in fact the largest of the three.
And that is a place where, as you have seen the data from Pablo was speaking about on the prior biology exposed patients, we think the first pool of patients treated with Povo will be there. In addition to the three thousand early patients. So the light blue. And then over time, the dark blue, which is the newly studied patient on systemic therapy, will be evolving to oral treatment when people are comfortable with the profile of Pro.
So that is what we are trying to say, that there is a market with biologics post patient. There is a small segment who do not want to receive injectable and then over time, we will be gaining share in the third segment, which is the newly treated patient.
I can complement on a couple of comments on the evolution of the landscape. As Herve said, we are already seeing now 2024 and beginning of 2025 quite a dramatic increase in the journal patients that go from r seventeen to d and f and vice versa. And we see that continuing to grow all the way to 2027 when we expect to come with Volvo and beyond. And that is actually the segment in terms of penetration that we see the highest unmet need from the very beginning.
So we are very confident in the market growth that we see from the last four POBO.
Thank you. Next question today is coming from Matt Phipps from William Blair. Your line is now live.
Great. This is Madeline on for Matt. Thanks for taking the question. Related to Povo and CSU, how does the efficacy profile you are seeing compare to the profile with MRGPRX two inhibition? And does the positive data with Covo change your view on the potential to develop backup x two antagonist programs? Thanks.
So we will discuss how the data compares with the datasets once we show the data later this year. I think that related to the x two program, we have no intention on restarting this program. We are very happy with the results of both and CSU. Think this proof of concept is very important for proven for patients with CSU, and we intend to advance to pivotal studies.
We will talk about the details of the data later this year.
Thank you. Next question is coming from Ash Verma from UBS. Your line is now live.
Hi. Thanks for taking my question. So I had a question on Manju. We just found these phase three in the first line and relapsed refractory DLBCL. Would the be in the front, mind studies. Just if you can share what are your expectations, here in these studies in terms of, the efficacy that would be great. Thanks.
Yeah. Thank you. It is Steven. So, you know, TAP has now, obviously, as positive data in relapse refractory diffuse large b cell lymphoma and that indication is approved.
And then more recently at ASH last year, the in line study in follicular lymphoma with really outstanding efficacy in terms of, you know, hazard ratios. Etcetera, and now waiting for the first line study to report out. It is event driven. It is a large study.
And, you know, we have got it to having data potentially in the first half of this year as soon as we have sufficient events. Should that be positive, you know, we have been moved very rapidly to complete a submission package and get it across the finish line. But we really like the way the c d nineteen antibody is shaping now as it moves sort of forward in, as I said, in relapse refractory follicular now potentially in first line and with more and more evidence accumulating that CD nineteen expression is not affected by treatment with this antibody, it is maintained, and so people can, for example, use CAR T directed against CD nineteen off the therapy.
So it is a profile that we are becoming, you know, increasingly encouraged by. Thanks.
Thank you. Next question is coming from James Shin from Deutsche Bank. Your line is now live.
Good morning, guys. Thank you for the question. Maybe one for Steve and Pablo. For the week eighteen COBRA sit in the update, it looks like about half of the placebo patients crossed over.
Did these crossover patients experience rapid pain reduction from the week like, we saw in week twelve? And if I recall, around thirty-six to thirty-seven percent of the placebo patients were biologic exposed. Can you give us a breakout of pre and post biologic for these placebo crossovers? Thank you.
Yeah. No. Thank you. It is Steven.
I will take that question. Pablo, may I add comments to what he had in his prepared remarks. We thought this was a really important update to reiterate what Pablo said. To demonstrate drug effect.
Because, you know, once you have that twenty-eight, twenty-nine percent placebo rate at week twelve and then introduce those patients to either the forty-five or the seventy-five. You can see in six weeks, you know, this dramatic twenty to thirty plus percent absolute improvement in his car rates and that really demonstrates the drug effect of placebo versus active drug there. So that is really, really encouraging. What is more is because of the market breakdown that Herve illustrated, you know, in the different eligible potentially eligible populations, whether it is naive or biologic exposed, again, we thought it was important to illustrate the data in biologic exposed patients both to TNF alpha inhibitors, IL-seventeen, potentially to both, and, again, demonstrate their, you know, really encouraging and potentially even better activity in those populations as demonstrated by the data.
You are absolutely right about one third, thirty-five percent to forty percent of patients on the whole of biologic exposed to the majority of the population sixty percent plus is naive. That is an important population to study. It was really important for Europe in terms of getting reimbursement there as well. So we the breakdown in the naive versus experienced, we did not tease out directly, but you can indirectly work it out.
And, again, the activity is shown across the board. Thanks.
Thank you. Next question is coming from Salim Syed from Mizuho Securities. Your line is now live.
Hey, Great. Thanks for the question, guys. Just maybe one for me on Nick Timbo, actually. So pretty good beat this quarter.
Just curious if you can maybe comment on just some of the dynamics with the fourteen million dollars of sales. Was there anything there that we should just be aware of and then kinda related to that, with the j cut going effective for one twenty-five, how much of a tailwind has that been kind of through the through the month of April? Thank you.
Hi, Saleem. Mohammed here again. Thank you for the question. Yeah.
Look. So let me just start by saying we are very pleased with the launch performance so far. Our team has done a really effective job of driving broad and productive utilization of Nkimbo. As you heard earlier in the prepared remarks, ninety-five percent of our top accounts are using Nikkymbo.
Seventy percent of all target accounts are already using Neximbo. And from a one-time perspective, there is not really much there. We are seeing that penetration and productivity continue. As you would expect, Niximbo, this early on is used primarily in that fourth line plus patient.
And there is obviously a bolus of patients with an urgent need for these treatment options. I think that is where you are seeing the TYMLOS rapid uptake really take hold. The great news though is that these patients are seeing a rapid response that is very favorable, which is going to naturally encourage providers to use Neximbo earlier in treatment. And then the last thing maybe I touch on from a one-time perspective as you know, we have a generous EAP program.
In the first quarter, only fifty percent of those patients moved on to paid drug and the other fifty percent or so will come in Q2. And then, you know, as you would expect when new product is launched, there is certainly an inventory dynamic that you see in Q1. So about, you know, a third of our sales in Q1 is also coming from some inventory build, but we expect that to be stable for the rest of the year.
Thank you. Our next question today is coming from Gavin Clark-Gartner from Evercore ISI. Your line is now live.
Gavin Clark-Gartner: Hey, guys. I just wanted to quickly follow-up on the TAFSA first line phase three DLBCL trial. I believe on the slides, you noted the data got moved to the second half of this year. I think, Steven, you may have noted data was still in the first half potentially. I just wanted to confirm the latest guidance and also clarify if a zero point seven three hazard ratio from Pilebe's trial is a reasonable benchmark. Thank you.
Yeah, Gavin. It is Steven. And it is always tricky with event-driven studies to be precise as you know and when data will ultimately come, especially when it spans, you know, a quarter change. But you can read in the marks, you know, from my remarks that we expected.
Sometime soon, we are getting close to the required events. To trigger the analysis. What will then follow is database closure, cleaning, know, independent review of radiology, etcetera. So it may track a little later we see, and that could be a positive thing if those obviously delay of events is due to activity.
You know, I think the policy effect in first line diffuse large b cell lymphoma is probably in the ballpark of a reasonable benchmark because it is the similar population of the more severe people with this disease, so the IPI higher scores in terms of prognostic index. And it was just to remind everyone, you know, the first positive study increasing cure rates in first line diffuse large b cell lymphoma in a long time obviously, with the CD seventy-nine mechanism, we are really interested now in dual inhibition of nineteen and twenty, we have shown data just to be repetitive in relapse refractory follicular, and now we will see what the first line data shows.
You know, we will announce because of the materiality of this data, you know, as soon as we have it available and we are waiting those events. Thanks.
Thank you. Our next question today is coming from Jay Olson from Oppenheimer. Your line is now live.
Oh, hey. Thanks for taking the question, and congrats on all the progress. For your CDK2 inhibitor, what are the key data points we should be looking out for in your ASCO update and what are the gating factors to starting the phase three study in ovarian cancer? And especially if you could talk about the companion diagnostic and how that is progressing. Thank you.
So thank you for the question. So what you will see at ASCO is an incremental update. Into you remember we presented a very comprehensive dataset at this small ass year, and ASCO will provide a little bit more data, more follow-up in some of those patients. I think more importantly, to the second part of your question is, we are in process of implementing the pivotal trials in platinum and resistant ovarian cancer.
So that is moving forward. Are moving forward with the diagnostic as well. That is advancing very well. And we are conducting a combination phase one study combination with bevacizumab, which is necessary to launch the platinum sensor ovarian cancer stiso.
All those things are moving forward as we speak.
Thank you. Our next question today is coming from Kelly Shi from Jefferies. Your line is now live.
Good morning. Is Clara on Berkley. Congrats on the update in the initial launch performance of the PINGO. So for PINGO, I wanted to give you particular share some key solutions, feedback, whether you are seeing more rather off experienced patients or rather off naive patients at the septumab and how you would how you expect this kind of MS to evolve over time.
Yeah. So apologies if I missed it. But what is the timeline for follow-up shots calculator submission?
Yeah. So The question was about Resiroq and where it is used on the launch. Thank you, Claire, for the question. Let me take the next envelope piece, and then I will pass the timeline for Povo HS.
To Pablo and Steven. As I mentioned, know, Nick Timbo when introduced in such an unmet need of that currently exists, we are currently seeing it used in you are really primarily in the fourth line plus patients. As you would expect, there is a bolus of patients with GVHD late stage that have an urgent need for a new treatment option, and that is where I think McTymbo will make an impact as soon as it gets introduced. Like I also mentioned, the great news though is that we are seeing these later stage patients respond very favorably.
Customer feedback has been very positive. With some sharing that they are seeing Neximbo really demonstrate its rapid and broad efficacy profile. That was seen in clinical trials in practice. And that will naturally move Nick Tembo earlier line Nictembo, you know, if our perspective, has a key differentiator, which is the mechanism of action, which is completely different than other approved agents making Neximbo, I think, a great addition an option to be used right after Jackify in the third line.
So whether it is, you know, in the third line, now versus Resiroc or or or not, I think it is soon to be told, but we are really optimistic about the competitive profile and the customer feedback so far. And again, we are really optimistic about it being used earlier in line once providers and patients get more experience with it.
Yeah. And, Kelly, in terms of the timeline for the HS submission, obviously, you know, you have seen the efficacy data and the safety profile through week twelve and now through week eighteen very clean. The key component of this is negotiating with the regulators as to how much of the safety they will require the time of initial submission versus the ability to supplement that as at the four-month safety update. So our guidance has not changed.
We want to do it as quickly as possible. Towards the end of this year, tracking potentially into early 2026 at the moment. And we will provide more precision on that when we have more precision. Thanks.
Thank you. Next question is coming from Eric Schmidt from Cantor Fitzgerald. Your line is now live.
Hi. This is Imogen on for Eric. Good morning, everyone. Two questions from me.
A quick one on axotilumab. Could you comment on that fourteen million of what proportion of that is inventory? It looks like a really strong launch, so congrats. And then one question on Pogo and the HS and the longer-term data after week twelve.
Could you talk about how the dropouts were treated in that later section? And whether patients who took rescue medications like antibiotics in the week twelve control period were then kind of added back in because I think that was part of the nonresponder criteria. Thanks.
Hi. Mujim Mohammed here. Thanks for the question on Nitembo. In just the first couple of months, we are seeing about twenty percent to thirty percent of the sales so far is really made up of inventory, but as I mentioned, multiple accounts have already reordered, and that inventory level continues to be stable. So that is what I would expect for the rest of the year.
And then, Imogen, thank you. On the long-term data, it is really interesting. So we obviously had a very conservative approach in terms of the analysis and the nonresponding imputation. And that anybody who discontinued for whatever reason was considered a nonresponder.
Furthermore, modified approach, which some other competitors are using. We will analyze both and at some point in time provide both. We expect the modified NRI actually to have slightly better numbers. Than the conservative approach we use.
So thank you for that question. It is an important one.
Thank you. Next question today is coming from Evan Seigerman from BMO Capital Markets. Your line is now live.
Hi. Malcolm Hoffman on for Evan. Thanks for taking our question. For Opselura, you noted a slight reduction in inventory, which maybe dampened sales.
Could you quantify the impact any further? And then also, can you provide any additional commentary on how you have seen tube usage in the US progress? I know at the start of the launch, this is highlighted as an expansion opportunity. Do you guys still think we could see more tube usage per patient over time?
Thank you.
Hi, Malcolm, miss Cristiano. Let me take the first part of the question regarding Obselura and the inventory. As I mentioned in my prepared remarks, in the U.S., the net revenue growth was 20% with the paid demand growth 24%. The difference came from the reduction in inventory.
The reduction in inventory was mainly because in given where the end of the year holiday happened took place this year, which was in the middle of the week. Call sellers bought before that. So it impacted Q4. And we saw that that inventory level coming back down in Q1 of the year. As I mentioned, we look at the current inventory levels as within normal range and expect to continue to be pretty stable at those levels.
And I will comment on the tube usage over time and what we expect. We expect increased utilization overall in both indications. I think it is driven by two dynamics, our continued subscription growth, which includes, obviously, additional communications over time in both indications, as well as the usage of the tubes across the extensive patient population that we have built so far. And then to continue to close with that is the feedback that we continue to get from on the patient side, highest level of patient satisfaction of people that have Obserra.
And on the ACP side, we continue to see the willingness to utilize it more in the coming future. So when we put everything together, we expect higher utilization in the coming quarters.
Thank you. Our next question is a follow-up from Michael Schmidt from Guggenheim. Your line is now live.
Oh, hey. Thanks guys for taking the follow-up. Just another one on poracitinib. This there is continued increase in high score fifty, you know, out to week eighteen.
Obviously, it looks very, very interesting. Did you observe a similar trajectory also for the high score seventy-five outcomes? And the other question I had is just on your KRAS t twelve d inhibitor where I know you have guided to POC data later this year. Just wondering how you think about differentiation and the competitive landscape there.
Given we have seen some data recently at AACR. Thanks for taking the follow-ups.
So, Michael, I will start on the perva HS question through the updated data through week eighteen. Obvious we just showed for efficiency reasons the Hiscar fifty because that was the primary endpoint and it is you know, we wanted to demonstrate that over time. We absolutely will have the others as well. Hiscar seventy-five, etcetera.
And the trend, I can say is similar. To your question. I will hand it over to Pablo for your twelve d question.
So, Michael, thank you for the question. As you know, KRAS inhibition continues to get increasingly competitive. I mean, I think there were fifty-seven posters and presentations at AACR and new data continues to be presented. We are very happy with the profile of our g twelve d inhibitor.
That study is advanced very well, and we will have data to discuss with you later this year. I think at that point, we are optimistic that our profile is gonna be very competitive. We are advancing only single agent, but we are starting combinations as well. So we will have a broader conversation when we have the data, but so far, we are very with the progress of that program, and we think we are gonna have a very competitive profile.
Thank you. We have reached the end of our question and answer session. I would like to turn the floor back over for any further or closing comments.
Thank you all for participating in the call today and for your questions. We will be available for the rest of the day for follow-up. Thank you, and goodbye.
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.