Incyte Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
April 30, 2024

There are 19 speakers on the call.

Operator

As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Ben Strain, Associate Vice President, Investor Relations. Please go ahead, Ben.

Speaker 1

Thank you, Kevin. Good morning, and welcome to Incyte's Q1 20 24 earnings conference call. Before I begin, I encourage everyone to go to the Investors section of our website to find the press release, related financial tables and slides follow today's call. On today's call, I'm joined by Herve, Pablo, Christiana, who will deliver our prepared remarks. Barry, Steven and Matteo will also be available for Q and A.

Speaker 1

I would like to point out that we'll 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.

Speaker 2

Thank you, Ben, and good morning, everyone. Before I get into the quarterly results, I'm pleased to share that Matteo Trotta has recently joined Incyte as General Manager of our U. S. Dermatology Business Unit reporting to me. Matteo comes to us from Novartis where he was responsible for the immunology business in the U.

Speaker 2

S. And he will be leading the U. S. Dermatology team at Incyte to continue to grow OXELOIR, prepare for the launches of povacitinib and other promising IAI pipeline product in the coming years. Now turning to our Q1 results.

Speaker 2

Total revenue grew 9% in Q1 versus last year, and I will discuss in the next slide the details of the underlying demand growth for Jakafi and Opterra to clarify the performance of both brands in Q1. Starting with Jakafi on Slide 6. In the Q1, Jakafi net product revenue of $572,000,000 does not fully reflect the demand growth as total patients increased 5% in the Q1 versus the same quarter last year with growth driven by PV and GvHD. Sequential growth versus Q4 was also strong in all indications as you see on the graph on the right. Jakafi channel inventory reduction in the Q1 had a negative impact on net revenues of approximately $55,000,000 Based on the strong patient demand seen this quarter and anticipated growth for the balance of the year, we are reiterating our full year 2024 Jakafi net revenue guidance of $2,690,000,000 to 2,750,000,000 dollars Turning to Slide 7 and looking at Jakafi, total paid demand by indication during the quarter of 2022, 2023 2024.

Speaker 2

As you can see, total paid demand growth in the top left corner continues to be strong. MF in the top right is consistent year after year and the largest growth is coming from PV and GVHD. Additionally, Jakafi continues to maintain its leadership and market share in myelofibrosis. Based on market research, total patient market share and discontinuation rate have remained stable in the first line selling over the past several months with virtually no impact from competitors, which has been consistent with our expectations. Moving to Opcella.

Speaker 2

Total Opcella network revenues in the Q1 were 86 $1,000,000 up 52 percent when compared to the same quarter last year. The weekly prescription trend as shown on the right of slide 8 reflects continued growth of Opsela in both atopic dermatitis and vitiligo with typical Q1 seasonality. U. S. Total prescriptions for Opselor grew 41% year over year, outpacing the total ED market, which grew 23%.

Speaker 2

The AD market, including Occello was impacted by the change healthcare cyber attack, particularly in March. Importantly, we are beginning to see in April a rebound in field prescription to levels seen before the cyber attack. From an access perspective, we have seen early encouraging results since Opellera moved in January to preferred position in the CVS network as TRx growth within the CVS network outpaced growth seen in other plants. Moving to Slide 9. As discussed in the past, we are on track to provide 10 high impact launches by 2,030.

Speaker 2

Importantly, many of the programs highlighted on this slide are derisked as they are post proof of concept including axotilumab, which has been submitted to the FDA for approval, ruxolitinib cream in pediatric AD to be submitted to the FDA in Q3 and povarcytinib where we are in Phase 3 in HS and vitiligo and initiating a Phase 3 study in prurigo nodularis later this year. Moving to Slide 10. In addition to our internal efforts to deliver multiple launches by 2,030, we recently announced an agreement to acquire Essient Pharmaceutical for $750,000,000 with cash on hand. This acquisition further strengthens our pipeline with 2 novel 1st in class medicines, EP-two sixty two and EP-five forty seven, which has the potential to treat a broad range of inflammatory disorder. I will now turn the call over to Pablo.

Speaker 3

Thank you, Herve, and good morning, everyone. In the Q1, we continued to make solid progress across our pipeline, which is focused on 3 areas: MPNs and graft versus host disease, oncology and inflammatory diseases. In MPNs and graft versus host disease, we initiated a Phase 1 study earlier this quarter with our JAK2V617F inhibitor. As a reminder, the JAK2V617F mutation is the most common somatic mutation in myeloproliferative neoplasms and is present in 55%, 60% 95% of patients with MF, ET and PV respectively. Unlike ruxolitinib, which inhibits both wild type and V617F mutation positive cells, 58 selectively binds to the JAK2 JH2 site, disrupting the V617F induced confirmation and thus allowing selective inhibition of mutant activity in the JAK2 receptor while sparing wild type.

Speaker 3

Together with our anti mutant collar program, these 2 potentially disease modifying programs represent a fundamentally new approach to addressing MF, ET and PV and could help to solidify our leadership in MPNs. As previously disclosed, we submitted the BLA for axotilumab for the treatment in third line chronic graft versus host disease late last year. In February, the filing was accepted for prior review and we anticipate a decision by the FDA in the second half of twenty twenty four. We are excited by the possibility of bringing a new treatment options to patients with this devastating complication of hematopoietic stem cell transplant. In oncology, we continue to build out a robust pipeline with the potential to deliver meaningful innovation for patients.

Speaker 3

This quarter, we initiated a Phase 1 study with our KRAS G12D inhibitor, INCB-one hundred and sixty one thousand seven hundred and thirty four. 734 is a potent, selective and orally bioavailable KRAS D12T inhibitor and as highlighted at ACR earlier this month, has shown excellent efficacy in several preclinical models. With no currently approved G12D targeting agents, 734 could address an important patient need as a KRAS G12D mutation is found in 40% of pancreatic ductile adenocarcinoma, dermatology, we In dermatology, we continue to maximize the potential of ruxolitinib cream and povarsitinib and believe the acquisition of Essien Pharmaceuticals will substantially expand our II pipeline by adding 2 1st in class medicines with the potential to address a number of medical needs. The key driver of our interest in Essient is our MRGPRX2 program. MRGPRX2 is a specific novel mechanism for blocking mast cell activation independent from IgE and has been a high priority target to add to our IAI pipeline.

Speaker 3

EP-two sixty two is a 1st in class medicine, which entered the clinic in January 2023 and has been evaluated in Phase 2 studies. In the Phase 1 healthy volunteer study, AP262 was well tolerated, had low inter patient PK variability and achieved exposures well above predicted efficacious levels. AP262 is currently in a Phase 1b open label study in Sindhu and in 2 randomized Phase 2 studies in CSU and atopic dermatitis with data for all three studies expected by early 2025. EP-five forty seven is a potent and highly selective antagonist of MRG PRX004. MRGPRX004 is expressed on neurons in the dorsal root ganglia and specifically activated by bile acids that are increased in cholestatic patients.

Speaker 3

Initial evaluation is being conducted in cholestatic pruritus with clinical proof of concept for cholestatic pruritus associated with PBC and PSC anticipated by early 2025. A number of exciting readouts are expected by early 2025 with the potential first launch in CSU by 2029. At AAD, earlier this quarter, we presented additional data from the randomized Phase 2 study of ruxolitinib Cream in patients with mild to moderate haderinitis suppurativa, reinforcing the potential of ruxolitinib Cream in this indication. The study at this primary endpoint demonstrated a significantly greater reduction in abscess and inflammatory nodule count compared to CONTROL at week 16 and further reinforces the efficacy and safety profile of ruxolitinib Cream. We are currently engaging with the FDA to obtain agreement on a potential Phase III design.

Speaker 3

We also presented positive data at AAD from the randomized Phase II study evaluating polvoricitinib in patients with prurigo nodularis and are on track to initiate a Phase 3 study in the coming months. Sidelighted on Slide 21, the study met its primary endpoint of a 4 greater point improvement in the itch numerical rating scale score, which was achieved by significantly more patients who received povarsitinib across all dosing groups at week 16 versus placebo. We believe that with ruxolitinib cream and povarsitinib, we will be the only company with the ability to potentially provide both a topical and oral option for a number of indications, including prurigo nodularis, adenitis suppurativa and vitiligo. We continue to make important progress in the Q1 by achieving several clinical and regulatory milestones. Within our oncology pipeline, we believe that our potentially best in class CDK2 inhibitor is an active agent and we look forward to sharing data as well as our development plan later this year.

Speaker 3

In addition, the pivotal trial of tafasitamab in patients with follicular and marginal zone lymphoma, also known as in mind, will read out later this year and we look forward to sharing those results. With the BLA for axotilumab submitted late last year, we look forward to working with the FDA to make axitilumab available to patients with chronic graft versus host disease later this year and to initiate additional combination studies in patients with less pretreated chronic graft versus host disease. Within our dermatology portfolio, we expect to submit the sNDA for Opselura for pediatric atopic dermatitis and expect multiple data readouts throughout the year. With that, I would like to turn the call over to Christiana for the financial update.

Speaker 4

Thank you, Pablo, and good morning, everyone. Our first quarter results reflect continued strong growth with total revenues of 881 $1,000,000 up 9% versus the same period last year. Total product revenues of $730,000,000 in Q1 were driven by demand growth for Jakafi and OXELURA and increased revenue contribution from MONJUVY following the acquisition in February of the global exclusive rights to tafasitamab. The product demand growth was partially offset by an anticipated reduction in channel inventory for Jakafi and the typical Q1 dynamics for Jakafi and Opselura. Total royalty revenues, which are primarily comprised of royalties from Novartis and for Jakavi and Tabreca and royalties from Lilly for Olumiant were $126,000,000 up 9% compared to the Q1 of 2020 3, driven by strong demand for Jakavi.

Speaker 4

Total revenues include a $25,000,000 upfront payment received under our collaboration and license agreement with CMS for the development and commercialization of poicitinib in China and select other Asian countries. Turning to Jakafi on Slide 26. Jakafi net product revenues were $572,000,000 for the Q1. Net product revenues reflect continued demand growth with total patients up 5% year over year, driven by growth in PV and GvHD and continued stable demand in MS. As a result, we experienced the highest quarter pay demand for Jakafi since launch.

Speaker 4

As expected in Q1, we saw patients that were on free drug in the Q4 of 2023 return to paid demand and the related decrease in channel inventory levels. As you may recall, channel inventory levels increased by $46,000,000 in the 4th quarter of 2023. In the Q1 of this year, we saw a drawdown in channel inventory, which had $55,000,000 negative impact on net sales versus the Q4 of 2023. While we expect channel inventory to remain around the levels we ended in Q1, buying decisions of our customers cannot always be net deductions as a result of both contributions to close the Medicare gap and commercial co pay assistance. Turning now to Opselur on Slide 27.

Speaker 4

Net product revenues for the Q1 were $86,000,000 representing a 52% increase year over year, driven by growth in net new patient starts and refills across both AD and Vitiligo, as well as early contribution from the commercialization of OXELURA for Vitiligo in Germany, Austria and France. As expected, Opselura net product revenues in the Q1 reflected the typical Q1 seasonality and the reset of deductibles and co pays at the beginning of the year. Beyond the typical Q1 dynamics, Opellura product revenues were impacted by the Sabera attack on UnitedHealth change healthcare unit. Moving on to Slide 28 and our operating expenses on a GAAP basis. Total R and D expenses were $429,000,000 for the Q1, representing a 6% year over year increase, which was primarily as a result of the progression of our pipeline.

Speaker 4

Total SG and A expenses were $300,000,000 for the Q1, representing a 5% year over year decrease, driven by the timing of direct to consumer marketing activities and certain other expenses. Now turning to the acquisition of Ascient Pharmaceuticals. Under the terms of the agreement, we will acquire Ascient for $750,000,000 in an all cash transaction. We believe ACN's 2 lead programs offer a multibillion dollar potential commercial opportunity across multiple indications and have the potential to contribute to our revenue by 2029. In addition, we expect to be able to realize synergies by leveraging our current development in commercial capabilities and add approximately $5,000,000 per month in incremental R and D expense.

Speaker 4

Depending on the timing of the close, we expect the acquisition to add $20,000,000 to 30 to $30,000,000 to the full year 2024 R and D expenses. Finally, following this acquisition, we'll continue to have a strong balance sheet, which will allow us to consider additional opportunities. As of the end of the Q1, we have $3,900,000,000 in cash and no debt. Moving to our guidance for 2024, excluding the impact of the acquisition of Ascent, we are reiterating our full year 2024 guidance for Jakafi, our other hematology oncology products, COGS, R and D and SG and A. Operator, that concludes our prepared remarks.

Speaker 4

Please give your instructions and open the call for Q

Operator

and A. Certainly. We'll now be conducting a question and answer session. Our first question is coming from Kelly Hsieh from Jefferies. Your line is now live.

Speaker 5

Thank you for taking my questions. So for OXOLURA, could you give us some more color on the go to net for the rest of the year? And what is the latest refill guidance you see in both AD and the vitiligo? Thank you. And I also have a follow-up.

Speaker 4

Hi, Kelly, it's Cristiana. Let me take the part of the question, and then I will turn it to Matteo to comment on the second part. So in terms of the gross to net, in the first quarter, it was at the same level as last year Q1, so at around 60%. Going forward, as we have previously discussed, we will not be making forward looking comments of gross to net. Our focus is on maximizing the potential of Occellura.

Speaker 4

And by this, I mean the maximizing net sales versus looking at gross to net in isolation.

Speaker 6

And on the split of business between the two indication, when we look at the IQVIA data, triangulated with external internal sources, we see a forty-sixty split consistent over time with 40% is non segment of vitiligo and 60% is atopic dermatitis. And we're very happy to see that both indications are growing at quite a healthy pace.

Speaker 5

Thank you. And also at AAD Dermatology Conference, we saw the data of topical Oraxol cream in both Hurley Stage 1 and the 2 HS patients. Could you share what kind of physician feedbacks do you hear? And also, how do they fit on my needs in both early stage 1 and 2 patients for a novel topical drug like OXOLURA needed to manage disease in this specific population? Thank you.

Speaker 7

Yes. Thank you for the question. It's Steven. So the milder type of HS still represents about 100,000, 150,000 patients in the United States. It still has morbidity and unmet need and these patients have abscesses and nodules that cause them discomfort and morbidity and lends itself to a topical treatment because it's not as extensive as the moderate and severe, which has fistulas, etcetera.

Speaker 7

So we conducted this POC study and saw this data, which is extremely encouraging in this mild stage of HS in terms of abscess and nodule decreases. And as Pablo said in his prepared remarks, we're now working with regulators to get an appropriate endpoint in this entity for which no drug is approved and has this physician and KOL feedback is excellent. I mean, they were surprised by the efficacy seen with the topical agent in this entity. So we're excited about it as well.

Speaker 8

Thank you very much.

Operator

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

Speaker 9

Thank you very much for taking my question. Could you comment on Jakafi growth dynamics going forward given IRA and shifts in the out of pocket expenses for patients?

Speaker 10

Sure. As you saw from our guidance, 2.69, 2.75, We're very optimistic about the continued growth of Jakafi. Obviously, we benefit in the IRA because as we talked about before, we have the small biotech exemption. So beginning in 2025, for example, with the reduced out of pockets for patients, it really just helps the patients of course, but we don't have to contribute that 20% to catastrophic that other oral drugs will. So we think there's a benefit in 2024 for the reduced out of pocket Medicare Part D being around 3,250 for patients for the entire year and then next year being 2,000 all patients who are taking oral oncology drugs, I believe will benefit.

Speaker 10

But we continue to see our growth, as Herve pointed out, coming from PV, GVHD and in mild fibrosis, we're very stable and remain the market leader in that setting.

Speaker 9

Would you be able to comment further on whether how growth in 2025 might look visavis 2024 given these dynamics?

Speaker 10

No. We obviously said we're still confident about $3,000,000,000 plus by the time we hit 2028. So that's what we're still confident in. And so we think that 2024 and 2025 should be just fine.

Operator

Thank you. Next question is coming from Kripita Veraconda from Truist. Your line is now live.

Speaker 8

Hey, guys. Thank you so much for taking my question. On Jakafi, Herve, you mentioned that you see very little impact on Jakafi share from competitors. Can you talk a little bit about whether the competition has changed the average duration on Jakafi? They do go on to Jakafi as the front line, but is there any are you observing people getting off of Jakafi sooner?

Speaker 8

And also for the BET inhibitor combination, there was a recent report of increased AML incidents in patients on the Jakafi bet combo for a competitor. I just wanted to get your insights into how this may or may not impact your internal bet program? Thank you.

Speaker 10

So, Krip, I'll take the first call and then I hand it over to Pablo. The second part of your question, so for Jakafi, share from competitors, there really hasn't been any impact on our duration of therapy or discontinuation rates at all, certainly in myelofibrosis. So we're very confident. We remain the market leader. Other JAK inhibitors may be used in the second line, third line setting.

Speaker 10

If anything, the market size itself is growing because now patients will go on 1, 2, 3 therapies. And I'll hand it over to Pablo for the second part of your question.

Speaker 3

Yes. Thank you for the question. So I mean, obviously, I'm not going to comment on data from other companies. Our BED inhibitor program, as we've discussed, is going very well and we'll discuss additional data over the course of the year and we're planning a potential pivotal trial going forward, which we'll unveil later this year. Reviewing the data from our internal program, we have at this point no concerns over the safety when it comes to AML transformation.

Speaker 3

Now you I'm sure you know that, if you follow a number of patients with MF for long enough, some of them will have transformation to AML as part of the natural history of the disease. But at this point, we have no concerns with our program.

Operator

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

Speaker 11

Hey, guys. Good morning. I had a question on porcitanib and again commenting about another data set, but I just wanted to get your insights on the recent RINVOC head to head study against Dupixent in AD and whether or how that impacts perhaps your view on the potential of porcitanib across various dermatology indications?

Speaker 3

Yes, Michael, thank you for the question. We've seen the data. Obviously, it's an impressive data set. At this point, as you know, we have a number of studies ongoing with povarsitinib. We've had internal discussions about the potential to extending the trials of povo to atopic dermatitis.

Speaker 3

What I can say right now is we're encouraged by the data from Rimboc. I think that it's an indication that povo could work very well in this disease. We have not made an internal decision that yet as to whether to develop povarsitinib in atopic dermatitis yet, but it's certainly something we're contemplating.

Operator

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

Speaker 12

Hi. Thanks for taking my questions. Maybe just start one just following up on the prior bet question. Were your comments just based on the clinical data you're seeing in those concern of AML? Or maybe can you speak to preclinical?

Speaker 12

So I believe that BET inhibitor from a competitor has shown genotoxicity in some preclinical assays. Has yours shown genotoxicity?

Speaker 7

Yes. It's Steven answering your question. So just to reiterate Pablo's remarks and remind you that our BED program was in the clinic a while ago in solid tumors. And then we've obviously pivoted to study myeloproliferative neoplasms. We've treated close to 200 patients to date.

Speaker 7

And in the clinical data set, which is the most powerful, as Pablo said, we have no concern as regards AML transformation or any concerns that we've seen in that regard. From a prior competitor drug. We also have no issue and we are aware of the issue with the competitor drug that was seen in preclinical work.

Operator

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

Speaker 12

Hey guys, good morning. Thanks so much for taking my questions.

Speaker 13

I wanted to drill down a

Speaker 12

little bit more on the Jakafi dynamics. What's your explanation or I guess what do you think is the best explanation for the sequential downtick in total Jakafi demand? Was that something that's just seasonally related that you typically see in Q1? And then I guess on the competitive front, I'm curious why you think you're not seeing any impact at this point to market share patient persistence. Is this something you might expect to change going forward?

Speaker 12

Or would you expect market share and persistence to remain stable based on sort of what you're hearing in terms of market research and on the ground KOL discussions? Thanks.

Speaker 2

Maybe I can start on the uptick. I mean, what we said and you can see on the slide is that in fact there is an increase in the number of patients treated across all three indication in Q1 versus Q4. And there is a growth that you can see on the so called paid demand graph also that shows that versus last year, there is a lot of growth in PV and GVHD. So the unit growth of Jakafi sequential to Q4 and versus Q1 of last year is there and fairly visible. So reason for the sequential growth versus Q4

Operator

is what we discussed

Speaker 2

when we discussed free drug ratio in Q4 that has been free drug ratio in Q4 that has been completely fixed in Q1. So we are back to normal rates of free drug in Q1. Now on the competitive side, maybe, Kari, if you want to speak of why we don't see the impact of the new competitors? Sure.

Speaker 10

I think in fact the new competitors, let's take VANJIO and momelotinib as examples, as far as we can tell from all of our market research, from all of our experience working with hematologists, they're all being used in the second line setting or maybe in patients that have very, very low platelets, for example. So we anticipate because of really the overall survival benefit of Jakafi, because of the tolerability of Jakafi, because of the symptom release of Jakafi, it's a great drug and it will continue to be very useful to patients who have myelofibrosis going forward.

Operator

Thank you. Next question today is coming from Vikram Parohit from Morgan Stanley. Your line is now live.

Speaker 14

Hi, good morning. Thanks for taking our questions. So we had 2, 1 on Limber and then 1 on OXOLURA. So on Limber, for the ALK2 POC data set we're expecting to see by the middle of the year. Could you just frame for us kind of what the scope and size of that data set is going to be?

Speaker 14

And what you would define as sufficient for continued development for that program based on what we see for that POC data set? And then secondly on Oxtellara, I just wanted to revisit the topic of potential guidance and see when you think might be a good potential time to provide revenue guidance for Oxtellar since you mentioned that it seems like the script shares seems stable between AD and Vitiligo? Thanks.

Speaker 7

Yes. Hi, Vikram, it's Steven. So on your first question, just reminding, ELK2's mechanism is felt to work through hepcidin inhibition and then ameliorate anemia by releasing iron and make it available for hemoglobin production. As we've already shown in multiple presentations, we can decrease hepcidin levels. The question you get into, does this translate to some sort of clinical benefit?

Speaker 7

Just to remind you of the study, it has 3 groups, treatment group A, B and C. A was monotherapy, B with RUX, but those were in later line patients. And the real focus right now as you can see on plintrial.gov is treatment group C, which is the treatment naive group of patients to see in combination with RUX will help make an effect that will be of clinical benefit to patients either by raising hemoglobin or preventing the decrease that sometimes occurs with JAK2 inhibition. And then if we're able to demonstrate that as we dose increase in the second half of this year, then we'll have a clinical proof of concept that we can then potentially take forward to a regulatory environment. But we'll have to be clear that we are benefiting patients from a clinical benefit point of view in that treatment naive group, and we'll have that data set second half of this year.

Speaker 7

I'll turn it over for the second question.

Speaker 4

Vikram, it's Christian. I'll take the second part. As we discussed on our last call, before we provide guidance for OXELURA, we are looking to have more real world data on utilization, especially for Vitiligo. And data that goes beyond that first initial phase on therapy, which may represent a phase of experimentation by patients. So we are still early into the launch.

Speaker 4

We are still going through that initial phase of patients on therapy. So we're waiting for more real world data before we are in a position to give you guidance.

Operator

Thank you. Next question today is coming from Derek Archila from Wells Fargo. Your line is now live.

Speaker 12

Hey, good morning. Thanks for taking the questions. Just two quick ones from us. I guess, first, just on Jakafi. As you noted, the Jakafi growth coming from GVHD and PV.

Speaker 12

So I guess, what does this mean for future assumptions around myelofibrosis? I know you said stable, but how should we be thinking about that for the rest of this year? And then in terms of CDK2, I guess, where do you think the bar is right now, I guess, from a PPP? And I guess, what do you intend to show this year for proof of concept? Thanks.

Speaker 10

I'll take the first part of your question. It's Barry. So for Jakafi, we continue to see myelofibrosis being the way I look at the myelofibrosis patient population, there's about 18,000 patients, prevalent patients with myelofibrosis. And because we're the market leader, because of the overall survival and symptom benefit that JAK5 provides, we will continue to think of patients as either being on Jakafi, which is most of the myelofibrosis patients or they have been on Jakafi or they will be on Jakafi. When they progress on Jakafi, then there's other options fortunately that are available to them.

Speaker 10

But going forward for 20 24 and beyond, we continue to expect to be the market leader in first line myelofibrosis. And I'll turn the call over to Pablo.

Speaker 3

Yes. Thank you for the question. So in our CDK2 inhibitor program, we continue to be encouraged by the data that we've seen. And regarding a part of your question about what data we're going to reveal later this year, we're in the final stages of optimizing the dose for the CDK2 inhibitor program. Our idea will be later this year to provide a substantial clinical data set, including the dose selection for patients initial, the focus would be ovarian cancer, but not necessarily only over the longer term, as well as we are starting combination trials in ovarian cancer and we're continuing to enroll patients with breast cancer.

Speaker 3

So later this year, you will see the dose selection as well as the data for ovarian cancer as well as the development plan in ovarian cancer. When it comes to the bar for efficacy, if you look at the CDK2 inhibitor landscape today, most of our competitors have decided to focus on breast cancer or other areas. We continue to believe that ovarian cancer is an important opportunity. Other competitors in this space like ADCs that are coming into play, we're tracking those closely to figure it out what is the overlap between the different patient populations in different with different molecular markers. But basically, in 2nd part of the year, later this year, we'll provide clarity on dose schedule and the development plan in ovarian cancer patients.

Operator

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

Speaker 15

Hey, guys. Good morning. Thanks for taking my questions. First on OXOLLURA, is it possible to quantify the impact of the change health care issue for that product? And what about for Jakafi?

Speaker 15

Was that impacted at all by the change health care issue in the quarter? And then on povercitanib, the Phase III studies in vitiligo, I noticed on clinicaltrials dot gov, it looks like there is a single primary endpoint of FVAS E75 for the Phase III trials, whereas RINVOC, I think has 2 primary endpoints of FVAS FVAS75 and T VAS E50. So what's the rationale for only having a single primary endpoint here relative to the competition? And how do you expect that to kind of play out based on the endpoints you're studying? Thank you.

Speaker 6

Hi, Jessica. I'll take the change in health care on OXELURA. What we see at the end of February that there was this cyber attack reported pretty much caused a network interruption for a few weeks. So as a result, the Change Healthcare was unable to process the claim for a few weeks. When we looked at when we deep dive in the data, we saw a softer March when you look at the entire atopic dermatitis market basket that we monitor.

Speaker 6

And that caused an estimate of $4,000,000 $5,000,000 negative impact from Opselura in Q1. The good news for us is that we're monitoring April and we see demand weekly demand back on track to the levels we saw pre cyber attack and a little more recently.

Speaker 10

And Jessica, just on Jakafi, we may have actually had an impact from chain shops, but we don't know. We did have when it first happened, some requests from specialty pharmacies wanted extended terms for payment. But we really can't see a big impact because these most of these specialty pharmacies were able to switch over to the other the other system that provides this service for the specialty pharmacies.

Speaker 7

And then just to address your question on pobacitinib in Vitiligo, we have 2 identical Phase 3 studies ongoing, STOP V1 and STOP V2 in patients 18 years or older with 5% or greater body surface area involvement of non segmental vitiligo. It's a little tricky on the endpoints. But just to tell you, our primary endpoint for the FDA in the United States is actually identical. It's facial VASI 75 and total VASI 50. For other parts of the world, there may be a different primary endpoint.

Speaker 7

For example, in Europe, they're interested mostly in the total VASI 50. So that leads to some of the confusion. But for our study, for the FDA, it's both, facial VASI 75 and total VASI 50, together measured at week 52. Thanks.

Operator

Thank you. Next question today is coming from Tazeen Ahmad from Bank of America. Your line is now live.

Speaker 15

Hi, good morning guys. Thanks for taking my question. On OXOLLURA, can you and I'm sorry if I missed this in your prepared remarks, but can you talk about refill rates for patients maybe now that have been on therapy for a few quarters? Can you talk about how you're seeing their use of tubes? What the average use of tubes is?

Speaker 15

I'm just curious that if patients are having good results with the cream, whether they're taking many drug holidays in between when they don't have as much itch, for example. Thanks.

Speaker 2

Yes. Matteo can add to the comment. I mean, the picture in term of refill rate has been the following, is that in atopic dermatitis, we have observed a refill that is slightly north of 2 tubes per patient. And that's relatively stable. Now it's still increasing a little bit, but it is relatively stable.

Speaker 2

In Vitiligo, it's moving very quickly, complying with the treatment as it was prescribed and we are obviously working with physicians and patients directly to improve it. And as you know, I mean, from the experience we had in the clinical trial, we are estimating that if we are successful, it will be around 10 tube per patient, but we are still at the number that is lower than that today when you try to look at patients who have enough history. So do you want to speak about what we are doing on the

Speaker 6

Yes. Yes. The only comment that I can add is on just in this quarter, we're launching very promising adherence program that are confident will impact the will continue to impact the refill rate growth that we see across both indications, AD and vitiligo.

Operator

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

Speaker 16

Good morning. Thanks for taking my questions. Could you just give us an update on how the ex U. S. Launch of OXOLLURA is business development.

Speaker 16

Post the if I could also just ask one on business development. Post the recent acquisition, you still have significant balance sheet capacity. Could we see you do meaningful M and A in the near term on top of Essent? Thank you.

Speaker 2

Okay. So maybe starting, I'll take the first part about the European launch because in fact there is a lot of activities going on there. As you know, we launched in Germany and Austria. So that's the base that we have. We recently were part of AXA Direct, which is a French process where you can commercialize your product while you are negotiating the price.

Speaker 2

So what you see in the numbers today is that there are around 2,000,000 that are recognized sales from France. And it's a sort of an estimate of with a conservative price per tube that we are using to do that. But the process there is moving very well and we anticipate by the second half of the year to be fully reimbursed and paid for at a good price in France. And we have now in Italy and Spain agreement on the price where we will be launching between mid year and the second half of the year in both countries. So Germany, Italy, Spain and France will be fully operational by Q3 and will be contributing to the top line.

Speaker 2

There is also some smaller countries in Europe where the process is ongoing and there is always a big question mark of the United Kingdom, England, whereas you know the pricing discussion can take more time and we are in the process there. So it's a very positive outcome for Opcellular in Europe because we got reimbursement now in many countries and most of the large countries. And we see a very good uptake of the demand in term of volume in the countries where it's available, specifically in France. The second part of your question was about the pediatric uptake in the U. S.

Speaker 2

When we get approval. So maybe Matteo, if you want to speak about that.

Speaker 6

Yes, sure. Thanks for the question. And we are very excited by the potential opportunity to help 2,000,000, 3,000,000 children in U. S. And we see data consistent with what we would expect.

Speaker 6

So pending FDA approval, we are excited by another contribution and tailwind to our top line. This is a patient population that maybe the parents will be a little more sensitive to our box warning, but at the same time, it's 2,000,000, 3000000 patients and children that we potentially have the opportunity to help going forward.

Speaker 2

On the business side, maybe Christiane, you can

Speaker 4

Yes. Sure. So Salvin, as you commented on, we have a strong balance sheet. We'll continue to have a strong balance sheet following the Ascent acquisition. So as of the end of this quarter, we have EUR 3,900,000,000 of cash.

Speaker 4

We don't have any debt, which obviously that could give us additional firepower. So that puts us in a position to be able to look at additional opportunities, and that's something that we are continuing to explore.

Operator

Thank you. Our next question today is coming from Eric Schmidt from Cantor Fitzgerald. Your line is now live.

Speaker 17

Thanks for taking my question. Maybe just following on Salveen's question on capital redeployment. Can you talk about your broader strategy there about also whether you consider returning cash to shareholders in the form of a dividend or share buyback to potentially using cash to expand your business?

Speaker 2

I can take that. I mean, we have been speaking about acquisition and external opportunities, which is obviously one very clear goal for the corporation is to diversify our revenue in the future and to increase to the growth coming from the current portfolio that we have. So that's one option. And obviously, as we are doing with our Board, there are discussions about alternatives to that. But today, as you have seen with Essient, I mean, there are opportunities that are very much in the range of what we are looking for in term of timing and in term of therapeutic areas and that would be an interest.

Speaker 2

So we are basically looking at both.

Operator

Thank you. Next question is coming from Jay Olson from Oppenheimer. Your line is now live.

Speaker 18

Hey, congrats on the progress of your KRAS G12D. It seems like Incyte is increasingly focused on targeted oncology versus immuno oncology. Can you describe your strategy in oncology? And also how are you planning to leverage your oral PD L1 for your targeted oncology programs in combination with your KRAS G12D or do you plan to develop additional KRAS inhibitors? Thank you.

Speaker 3

Yes. So thank you for the question. So your observation is correct. We are moving more aggressively into targeted oncology and trying to shift away from immuno oncology. And that's a journey that has started a little bit over a year ago and we intend to accelerate in the future.

Speaker 3

The idea here is well defined patient populations, large treatment effect, ideally single agent activity with early proof of concept and that will allow us to have much more efficient drug development process to accelerate some of these programs. We're very excited about the G12T program. We think it has the potential to be best in class. And as you point out, one of the things that we can leverage is we have access to what we believe is the most advanced for sure oral PD L1 inhibitor. And that will allow us to do oral combinations in patients with a range of indications.

Speaker 3

And that applies also to the rest of the pipeline. And as I mentioned, that journey will continue to accelerate in the future.

Operator

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

Speaker 17

Hi. Thanks for taking my questions. I guess I'll ask about the CALAR mutant antibody and data in early 2025. Will that be monotherapy or mono and Jakafi combo and also myelofibrosis only or also including essential thrombocytopenia? And I guess just from a high level, the combination with Jakafi, is that primarily to provide faster symptom relief or do you think it is just kind of necessary to achieve efficacy for the antibody?

Speaker 3

So we haven't decided exactly the scope of the data KLAR antibody later this year. What I can tell you is the plan is to combine the mutant KLAR antibody with Jakafi. And the idea there is, as you know, and we pointed out many times, Jakafi has a profound effect on symptom relief in these patients, which we believe early in the management of the disease could be very important even in the presence of a mutant color antibody. The idea of a mutant color antibody here, as you know, is to transform is to change the treatment objective to really eradicate the malignant clone, but still a potential early treatment or induction with Jakafi could be very, very helpful for patients. And regarding the other part of your question, yes, we will have data in MF and ET as well.

Operator

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

Speaker 13

Hi, guys. Thank you so much for taking the question. 2 from me. 1, just taking a step back looking at P and L Management, how do you think about being most efficient with your OpEx? And then kind of a follow-up there, would you ever consider using some of your balance sheet to say do buybacks, especially with the stock in the 50s?

Speaker 13

And then just as you think about your positioning in the derm space, a lot of focus on OXOLLURA. Where do you want to win over the next 5 years when it comes to derm? Where do you think Incyte is best suited to really take share? Maybe you could walk me through some of the most exciting parts of your pipeline in your view. Thank you.

Speaker 2

Okay. So I think the first question was about the efficiency of the spending. So as you see, I mean, we have in our P and L, we had a relatively quarter, we had a very flat SG and A and relatively slower growing R and D. And that's what we have been speaking about for years now is basically growing the top line at a faster rate than we are growing both components of the expenses and increasing leverage. So that's sort of happening.

Speaker 2

That's depending on the event on the quarterly, it's not always at the same rate, but it's clearly the direction that we are taking. Concerning the buyback, I spoke about it. What I'm basically saying is that nothing is excluded from discussions and that's something that is certainly part of the current dialogue. And now in the dermatology, maybe Pablo, if you want to speak about Stephen on the

Speaker 3

I'm happy to comment. Look, I think what we're building is an important portfolio of 1st in class or best in class, in some cases, best in disease medicines in the I would expand the question saying in the inflammation space. And I think that was a key driver of the acquisition of SCN to complement that with 2 first in class medicines, 2 62 and 547 that can really address a range of indications. We believe that that added to the portfolio that we have with pulvercitanib, which is arguably a pipeline within a drug. We can win across a range of indications by providing patients and payers with a portfolio approach to some of these diseases, including prurigo nodularis, atopic dermatitis, and other neuro inflammatory diseases.

Operator

Thank you. Our next question is coming from Ren Benjamin from Cision JMP. Your line is now live.

Speaker 13

Hey, great. Thanks for taking the questions. Just a couple of quick ones. One on Jakavi XR, can you provide any sort of an update as to how that's progressing? And as you think about the strategy going forward, is this something that you're already starting to evaluate in combinations?

Speaker 13

Or do you only start doing that after an approval? And then just as a follow-up, tafasitamab, just wanted to get your thoughts on the FLNCL data that's coming out. Is this really going to be meaningful from a commercial perspective? Or is the real opportunity in first line DLBCL, which is expected in 2025? Thanks.

Speaker 7

So Ren, it's Steven answering your question. So as Pablo said in remarks earlier this year, the XR process is underway with the regulators in terms of doing bioavailability and then followed by BE work. That will include stability. So it's about a 2 year process, which we expect to complete in a way in time for the LOE. And the idea there is obviously to have the once daily available in time.

Speaker 7

It doesn't change any of our FDC work. We can still do fixed dose combination work with BET and Elk as we need to do and we continue to progress those. In terms of tafasitamab, the studies are complete both in mind and front mind. So the low grade follicular and marginal zone lymphoma study will be in the second half of this year and in the first line diffutile large B cell lymphoma probably in Q1 2025. And we await that data.

Speaker 7

We know we have an active very active and well tolerated regimen in lymphomas and we look forward to that data. As someone also brought up earlier there and Pablo said, there's also interest now potentially in autoimmune work with CD19 antibodies. And that's something we're just looking at the moment. To the meat of your question, yes, we very much expect the data to be meaningful with a well tolerated active regimen and we look forward to those data sets.

Operator

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

Speaker 13

Hey, thanks for fitting me in. Just wanted to ask one quick clarification on the CALOR data. Did you note that you're planning to show some of that data later this year or could that still be a 2025 event?

Speaker 3

We haven't provided specific guidance. I think we said 2025. So if I imply 2024, I apologize for misunderstanding, but for misunderstanding, but 2025 is the goal.

Operator

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

Speaker 1

Thank you all for participating in the call today and for your questions. The IR team will be available for questions throughout the day. Thank you and goodbye.

Operator

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

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Key Takeaways

  • Total revenue grew 9% to $881 million in Q1 with Jakafi net product revenue of $572 million (patients +5%) despite ~$55 million in channel inventory reductions, and full-year guidance of $2.69–2.75 billion reiterated.
  • Opselura delivered $86 million in Q1 net revenue (+52% YoY), U.S. prescriptions up 41% (vs. 23% market growth), partially offset by a ~$4–5 million impact from the Change Healthcare cyberattack, and benefited from preferred placement in the CVS network.
  • Incyte remains on track for 10 high-impact launches by 2030, with key milestones including the BLA acceptance for axatilimab (FDA decision H2 2024), ruxolitinib cream pediatric AD sNDA in Q3, and Phase 3 studies of povacitinib in HS, vitiligo and prurigo nodularis.
  • The pipeline advanced with a Phase 1 start for a selective JAK2V617F inhibitor, Phase 1 KRAS G12D inhibitor (INCB-734) initiation, ongoing CDK2 inhibitor dose selection ahead of ovarian cancer proof-of-concept data later in 2024, and pivotal tafasitamab data in follicular/marginal zone lymphoma due H2 2024.
  • R&D expenses rose 6% to $429 million while SG&A fell 5% to $300 million; Incyte closed the $750 million Essent acquisition to expand its IAI pipeline and ended Q1 with $3.9 billion in cash and zero debt to fund further growth and M&A.
AI Generated. May Contain Errors.
Earnings Conference Call
Incyte Q1 2024
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