Q2 2023 Incyte Corp Earnings Call

Speaker 2: Hello and welcome to the InSite second quarter earnings conference call and webcast. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer will follow the formal presentation. You may press star one at any time to be placed into question queue.

Speaker 2: As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Greg Schurzer, Investor Relations for Insight. Please go ahead, Greg.

Speaker 3: Thank you, Kevin. Good morning and welcome to Insight's second quarter 2023 Earnings Conference Call and Webcast. The slides presented today are available for download on the investors section of our website. Joining me on the call today are Arvay, Pablo, Barry, and

Speaker 3: Stephen, and Christiana who will deliver our prepared remarks and participate in the Q&A.

Speaker 3: Before we begin, I'd like to remind you that some of the statements made during the call today are forward-looking statements and are subject to a number of risks and uncertainties that may cause our actual results to differ materially, including those described in our reports filed with the FCC.

Speaker 3: We will now begin the call with survey.

Speaker 4: Thank you Greg and good morning everyone.

Speaker 4: So we had another quarter of strong performance.

Speaker 4: with product revenues growing 25% year-over-year driven by Jackify, Obsiloa and launches in Europe .

Speaker 4: The Jackify network revenue grew 14% compared to the second quarter of 2022.

Speaker 4: For Opsellois, the growth trajectory continues with net product revenues in the second quarter angle.

Speaker 4: Driven by new patient flow and growth in refills.

Speaker 4: Additionally, the launch in Europe is underway and Opcellora is now available to patients in Germany and Austria. Our other hematology and oncology net product revenues were 64 million for the quarter, up 30% year over year, driven by the growth of Pemazir and Minjuvi in ex-US markets.

Speaker 4: Now turning to slide 5, we continue to execute on our development report.

Speaker 4: Recently, we announced positive top line results from two of our high potential programs. The true AD3 study evaluating ruxolitinib cream in pediatric atopic dermatitis and the Agave 201 study evaluating axotlumab in chronic GVHD met their respective primary endpoints.

Speaker 4: Steven will discuss this result in more detail during his prepared remarks, as well as provide updates on the important progress we made across many of our high potential programs, as shown at the bottom of the slide.

Speaker 4: We also strengthened our research and development organization by appointing Pablo Cagnoni as President and Head of R&D. And in this position, and as members of the executive team, Pablo will lead in size R&D activities. This new role aligns chemistry, biology, and early and late stage clinical development with the goal of maximizing speed and productivity.

Speaker 5: I'm thrilled to join the team at InSite, a company with such an impressive history of success and who has refined, redefined the standard of care in myeloproliferative neoplasms, graft-versus-host disease, and vitiligo.

Speaker 5: Since joining just a few weeks ago, I have spent time with our teams, and I'm even more enthusiastic about the capabilities of our organization and about the quality of our science.

Speaker 5: We're prosecuting a broad range of biology with a diversity of modalities, and I look forward to working with them to continue to deliver major advances across our portfolio in order to make a meaningful difference for patients. Pervez? Thank you, Pablo. With that, I would like to pass the call to Barry for a commercial update.

Speaker 6: Thank you, everybody. Good morning, everyone. Starting with Jackify on slide 7, net product revenues for the quarter were $682 million, up 14% year over year, driven by the continued growth in patient demand across all indications.

Speaker 6: Total patient demand grew 5% year over year. By new patient starts, a good indicator for future growth was up 9% year over year.

Speaker 6: Given the strong underlying demand for Jackify, we are raising the bottom end of our full year, 2023, revenue guidance to a new range of $2.58 to $2.63 billion.

Speaker 6: Turning to Opsalora on slide 8, the launch continues to be strong and is gaining positive momentum with both physicians and patients.

Speaker 6: The rapid adoption of Opsilora is driven by its compelling product profile and its ability to address significant unmet need in both atopic dermatitis and vitiligo.

Speaker 6: Opsilor net product revenues in the quarter were $80 million, up 42% compared to the prior quarter. US patient demand increased during the quarter with total prescription.

Speaker 6: growing 16% compared to the last quarter and refills growing by 23%.

Speaker 6: The monthly prescription trend, as shown on the right, demonstrates the continued growth of Opsilora, which is coming from both atopic dermatitis and vitiligo. In AD, growth was primarily due to new patient flow driven by Opsilora's efficacy and impact on inflammation and itch.

In Vitiligo, where Opsilora is the only approved treatment for repigmentation, growth was driven largely by refills and our educational and awareness initiatives. We are very optimistic about the long-term potential of Opsilora as we continue to see the strong uptake and positive momentum.

On slide 9, Monjovi net product revenue in the US for the quarter were $24 million, up 2% year over year, and were driven by continued growth in community accounts. Monjovi net product revenues outside of the US were $13 million, up 198%

year over year and includes $6 million of previously deferred revenue related to the Early Access Program in France, which ended in June .

Pemazir net product revenue grew to $22 million, a 14% increase year over year, with $5 million coming from outside the US, where the launch is ongoing in 10 key markets in Europe . With that, I'll turn the call over to Stephen.

Thank you Barry. Starting on slide 11.

As Urve mentioned we have two exciting program updates we want to highlight from this quarter.

First for Ruxtalid Nip Cream.

The primary endpoint was met in the Phase III True83 trial in pediatric atopic dermatitis patients aged 2 to 12.

The top line results show that significantly more patients achieved investigators global assessment treatment score or IGATS with ruxilinib cream 0.75% and 1.5% than with the vehicle control.

No new safety signals were observed and the overall safety profile is consistent with previously reported data.

The long-term safety portion of the trial is ongoing and data will be submitted for presentation at an upcoming scientific meeting.

We also plan to discuss these data with regulatory agencies.

and we anticipate a submission in the first quarter of 2024.

We are excited about the potential relief ruxilate and pecrin can bring to the roughly 2 million pediatric Atopic dermatitis patients in the United States.

the potential relief ruxilizumcrin can bring to the roughly 2 million pediatric atopic dermatitis patients in the United States. Moving to slide 12.

In partnership with CINDAX, the Agave 201 study, a global pivotal trial evaluating axotilumab in patients with chronic graft-versus-host disease.

after two or more prior therapies met its primary endpoint of overall response rate across all three treatment cohorts.

with the 0.3 milligram per kilogram every two week dose achieving a 74% overall response rate. In the 0.3 milligram per kilogram cohort 60% of responders maintain their response in one year.

and 55% of patients achieved at least a seven point decrease in their modified Lee's symptom scale indicating that responses were both durable and with symptom improvements.

Axotilumab was well tolerated and the most common adverse events were consistent with on-target effects. The full dataset is planned for presentation at a scientific meeting later this year with a potential BLA submission by year-end 2023.

We are excited about the potential of Exotilumab in chronic graft-versus-host disease.

and in this heavily pretreated and severe patient population.

A phase 1-2 trial of Exotilumab in combination with ruxolitinib is also being planned.

Moving to slide 13, an update on our broader dermatology pipeline.

For Obsolura, in addition to the positive top-line pediatric AD data, three phase II studies for lichen planus, lichen sclerosis, and hereroderinitis supertiva have completed enrollment.

For Povisitnib, the Phase 2 study in Prurago nodularis has completed enrollment and we expect to have data in this indication later this year.

Additionally, we previously announced the expansion of pulpositinib development into inflammatory and autoimmune diseases beyond dermatology.

And now I've initiated two phase two trials in asthma and chronic spontaneous urticaria, CSU. On slide 14, I want to provide a little more detail on our studies in asthma and chronic spontaneous urticaria.

Asthma is a chronic inflammatory disease.

chronic inflammatory disease with two endotypes.

Type II eosinophilic asthma, the most common type, is primarily driven by Th2 cytokines, whereas non-type II asthma is characterized by a neutrophilic response.

Many asthma patients have disease progression despite therapy with inhalers.

In preclinical data, oversitinib results in a reduction of eosinophil activation and may potentially reduce neutrophil activation as well.

The phase two study has been evaluated in moderate to severe uncontrolled type 2 and non type 2 asthmatic patients.

Unlike monoclonal antibodies that target a single cytokine, ovisitinib inhibits the actions of multiple cytokines.

potentially providing superior efficacy in both endotypes.

TSU is a mast cell driven disease presenting with hives and severe chronic itch. Over activation of dermal mast cells and basophils.

results in increased serum levels of Th1, Th2 and Th17 related cytokines.

We know JAK inhibition can modulate mast cell activation, including degranulation and cytokine production.

both of which are drivers of chronic spontaneous urticaria.

The phase two study has been evaluated in patients who are inadequately controlled or progress on second generation antihistamines.

Moving to hematology and oncology.

We achieve multiple clinical milestones across our high potential portfolio during the second quarter.

We continue to make progress in myeloproliferative neoplasms or MPNs where we presented updated clinical data at ASCO for our ELK 2 and BETT program. We also initiated the phase 1 study of INCA 33989 a mutant calorantibody.

and as previously discussed, axotilumab met the primary endpoint in chronic graft versus host disease.

For oncology, both of the phase III studies evaluating tafecidimab in first line diffuse large B cell lymphoma and in relapsed or refractory follicular and marginal zone lymphoma.

are fully enrolled and the Small Molecular RLPDL1 program continues to advance with multiple new studies initiated.

Turning to slide 16 and an update on our small molecule RLPDR1 program. Immune checkpoint inhibitors have transformed cancer treatments for patients.

Despite the remarkable clinical benefits, intravenous formulations have disadvantages.

and there is ample opportunity for innovation and improved outcomes in this space. As the first company to demonstrate clinical activity with an orally available PD-L1 targeted agent, we have a unique opportunity for differentiation.

As an oral small molecule, INCB 99280 has a short half-light, which can reduce the burden of managing immune-related toxicity.

and provides a switch off option if needed.

especially when combined with other agents. Additionally, the convenience of an at-home oral administration is often preferred by patients and may offer the potential for an improved quality of life. On the right you can see the current studies of INCB 99280.

We've initiated monotherapy phase 2 studies in both checkpoint inhibitor naive patients and in cutaneous squamous cell carcinoma.

We also initiated two phase 1-2 combination studies with exitinib and epilimumab.

A third phase 1-2 study in combination with Adagrassab is in preparation.

We also announced last night that in partnership with Replimune, we are starting a neoadjuvant study to evaluate 2-EDO in combination with RP-1, a tumor-derived oncolytic immunotherapy in patients with cutaneous squamous cell carcinoma. RP-1 is Replimune's lead oncolytic immunotherapy product and is based on a proprietary new strain of herpes simplex virus.

engineered for a bus tumor selective replication and is genetically armed with a fusogenic protein and GM-CSF.

RP1 has already demonstrated substantial activity in cutaneous squamous cell carcinoma.

At ASCO we presented data for Zolurgicertib, our ALK2 inhibitor, in patients with myelofibrosis.

Initial data from 36 patients demonstrated early signs of clinical activity through hepcidin reduction and anemia response in monotherapy and in combination with raxelitinib. Zilurgicertib was well tolerated with a favorable safety profile allowing for continued dose escalation.

Initial data from 36 patients demonstrated early signs of clinical activity through hepcidin reduction and anemia response in monotherapy and in combination with ruxolitinib. Zilurgicertib was well tolerated with a favorable safety profile allowing for continued dose escalation. We have added an additional treatment group.

and first line JAK-naive, modify fibrosis patients with anemia and we plan to have updated data later this year. Additional data presented at ASCO for our BET inhibitor, INCB 57643, demonstrate improvements in spleen volume and symptoms in both the monotherapy arm and in combination with ruxilizum.

It was generally well tolerated with two dose limiting toxicities observed in the higher 12 milligram once daily monotherapy arm.

We believe we have an active compound with encouraging early data. Dose finding work is ongoing with 10 mg once daily as monotherapy as well as continued dose escalation in the combination arm.

Turning to slide 19, we continued to make progress in other development programs. During the quarter, INCA33890, a TGF-?R2 by PD-1 bispecific antibody entered the clinic and a phase 1 study was initiated.

Additionally, Oromolumab are anti IL-15 receptor beta antibody.

received IND clearance and we plan for it to enter the clinic later this year.

Redefanderman, which was recently approved in Merkel cell carcinoma, has completed enrollment in the Phase III non-small cell lung cancer study and in the squamous cell anal carcinoma study.

Finally on slide 20, we have a number of upcoming data readouts. Another exciting milestone is expected and we look forward to sharing additional details throughout the remainder of this year.

With that I'd like to turn the call over to Christiana for the financial update Thank you Stephen and good morning everyone

Q2 was a very strong quarter with total product revenues increasing 25% year-over-year to $827 million driven by the strong performance of Jackify and Obselura.

Jackify net product revenues for the second quarter were $682 million, representing a 14% year-over-year increase driven primarily by continued growth in patient demand across all indications and an increase in channel inventory.

At the end of Q2, channel inventory had recovered from the depressed Q1 levels and was towards the high end of the normal range.

The increase in inventory represented around $35 million in net product revenues. Obserular net product revenues for the second quarter were $80 million, representing a 384% increase year over year, driven by increased patient demand and expanded coverage. Finally, other rheumatology oncology net product revenues were 64 million dollars.

two

Jacobian Olumi and Royald is for the quarter who are negatively impacted by FX headwind. Turning now to slide 24 and the performance of Obselura. The launch of Obselura has been very strongly with 2023 year to date net sales of $137 million. Since the launch of Vitylago, Obselura net product revenues have grown at an average quarterly rate of 28%.

Net product revenues grew 42% compared to last quarter, primarily driven by demand and the normalization of the typical Q1 dynamics. Moving on to slide 25 and our operating expenses on a gap basis. Totality in the expenses were $401 million for the second quarter, representing a 15% year over year growth driven primarily by the progression of our pipeline, including the expansion of the clinical development program evaluating, accelerating cream in additional indications.

and be able to declare where we want to go. It's incredibly safe in terms of tolerability, so we're able to continue to dose escalate at the moment. In terms of the BET program, it's a little bit of a different thing in terms of tolerability. There's no one on target toxicity in terms of thrombocytopenia, in terms of going in entire doses. So in monotherapy at the 12 milligram, we saw dose limiting toxicity there, and we back at the 10 milligram dose in terms of monotherapy. We've seen again, extremely encouraging spleen response, symptom response, and also occasionally hemoglobin improvement. But to your point, we have to think carefully about where to go.

in terms of first line or suboptimal study and obviously also there's a competitor reporting out that data later this year, which we're going to watch carefully and again to be repetitive, you know powering in terms of symptoms. You have to be very careful in the first line setting because rocks are looking to be so good.

So that program as well, we'd like to declare by the end of your time frame next year, earlier part of the year, where we go in in terms of registration direct to the efforts. And then also just to remind you, completely different efforts, the calor antibodies in the clinic now, potentially disease-modifying, dashed, even curative in the 30% of calor patients that are in the MF population and in the ET population. And that could be a completely different way of thinking if you can eliminate the clone.

in having excellent activity across all the dose levels, in patients who had actually a medium of four-private therapies and including prior rock inhibition, you get in that, you know, with the 0.3, a 74% best overall response. The 1 milligram per kilogram is not really different just to be clear. Now, when you're up at 67% on best overall response, and then...

There's clearly more Transaminitis and that is likely not the regulatory dose. It'll be the discussion with the regulators on the point three versus the one, both showing excellent activity in terms of overall response rate and tolerability. And we're still in the early days of working that out with regulators, but we'd like to get that submission in, the BLA in by the end of this calendar year 2023. I'll turn it over to Barry for your second question. I will take it on Minjouvin Europe . So there are two ways to look at it. I mean, the overall profile of patients that we are seeing using Minjouvin.

and obviously the very good efficacy that you can get there. Now the extent to which CART is used in different European countries is different from the US so I would say it's a little bit maybe earlier on the curve and what we see that the volume there's a group of patients that end up being

eligible for Minju-V is in fact larger in Europe and we see that from the uptake that we are seeing. Now we have reimbursements in Germany, Italy, Spain and a few other countries and we continue to work as you heard.

in France and the rest of Europe to have full access. But the adoption curve for Mingeuvi in Europe is in fact faster than what we saw in the US in terms of volume.

That's very helpful.

Thank you.

Thank you. Thank you.

Thank you. Next question today is coming from Allison Bratzel from Piper Sandler. Your line is now live.

Hi, good morning. Thank you for taking the questions. First just on Opsallura, could you help us understand gross net trends during the quarter, and also just the mix you are seeing between AtopicDerm and Vitiligo. I think it was 30% of scripts.

were thought to be for vitiligo last quarter. Is that consistent now that we're into the second half of the year? And I guess what are you seeing in terms of persistence and refill rates in vitiligo?

And then secondly, just a question on the pipeline. Just on the replimune agreement announced yesterday, could you talk about the rationale for entering that agreement now? You know, what aspects of RP1's clinical data and CSCC or other derm oncology indications give you confidence in...

evaluating the 99280 combo in neoadjuvant CSCC. And to help us understand that the scope of that trial expected to start early next year, is that going to have registration intent? Thank you.

Hi, Alison. It's Cristiana. Let me take the first part of your OBSCELURA question and then I will turn it to Barry to discuss the mix. So in terms of the gross-to-net, in IQ2 the average gross-to-net discount was 55%.

So that was down from 60% in Q1. As we were expecting, Q1 has the highest gross-to-net given the higher co-pays and deductibles at the beginning of the year that we have to pay down and that then comes down through the year. So we are at 55% average gross-to-net.

In terms of dynamics, one thing that we saw in Q1 and we continue to see in Q2 was an increase in Medicaid utilization. That has continued in Q2 with Medicaid increasing as a percent of the total payer mix.

So, Alison, it's Barry. So as far as your other questions, vitiligo now represents about 35% of total prescriptions.

In terms of refills, so for atopic dermatitis, I think we've said before that we expect two to three refills.

two to three tubes per patient, and that's where we are now with AD. We're over two tubes per patient. For vitiligo, we don't have enough time yet. Most of the vitiligo patients coming on, as you can imagine, are new patients, and we need more time.

to reach the average number of refills. As we've said in the past, we expect the average to be around 10 tubes per year. And we think we're progressing towards that. I'll turn it over to Stephen for a Reppelmanian question.

Thanks Barry. So, Allison, in terms of cutaneous scramous cell carcinoma, it's an entity that's not very well captured by the groups that capture cancer statistics just because of the way it's treated, variability, often with surgery alone, et cetera. But it could be common enough that there may be upwards of 1 million cases across the board.

that's doing some dose ranging work with 2-8-0 and then will expand, you know, with a declared dose going forward and could potentially serve on its own as a registration effort, but that's down the pike and to be determined. You know, why Replimune? Why RP1? It's a tumor oncolytic virus with actually...

Outstanding efficacy already demonstrated incutaneous squamous cell cost phenomena that's advanced with checkpoint inhibitors. Activity in terms of response rates in the 70% range complete responses in a 47% range. So really, outstanding activity with checkpoints already demonstrated but with intravenous.

Given on how this is administered with intratumoral injections, it really lends itself to combining with an oral agent like 2-Ado. And we view this as an exciting potential going forward. This is a proof of concept study, though, in the neoadjuvant setting. And then we'll determine if there's a registration path afterwards. So thank you for the question. Thank you. Thank you. Our next question today is coming from the audience.

from Morgan Stanley , your line is now live. Hi, good morning. Thanks for taking our questions. So we had two, both on Jackify. So first, could you comment on whether there were any outsized or large inventory purchases that contributed to Jackify's 2Q sales base? And then secondly, could you remind us where your dialogue stands with the FDA on QDRux and just what the next steps are for moving this program forward?

As you may recall, inventory at the end of Q1 was below the low end of the normal range. And that was because of the timing of an order. What we saw in Q2 was an increase in inventory to that broad inventory.

the higher end of the range, but that variability you see from quarter to quarter within that normal range. So we are back at the normal range. And as I commented during my remarks, the inventory…

increase during Q2 represented 35 million INET sales.

Let me turn it to body for the second part of you, the question. Actually, I'll take it. Thanks, Cristiana. So Vikram, in terms of raxxR, just to remind you, the CRL from the FDA was a concern around C-Men at steady state, not area under the curve and not C-Max.

then resulting in a potential theoretic concern in terms of efficacy and that there was a you know 24% lower semen when you compared it to the IR so in terms of the go-forwards There's a potential approach that's quicker and involves modeling work That we we're doing at the moment and we need to discuss with regulatory agency

We can't give you timing yet on that and then a potentially longer effort that that may take a little longer and But clearly for both We'll have them in ready and and be able to submit way before the loss of exploration for rocks itself So it's too early to give you regulatory time in but both efforts are underway Thanks

yet on that and then a potentially longer effort that that may take a little longer and but clearly for both we'll have them in ready and and be able to submit way before the loss of exploration for rocks itself so it's too early to give you regulatory time in but both efforts are underway thanks got it thank you

Thank you. Next question is coming from Salveen Richter from Goldman Sachs for Linus Now Live. Good morning. Thanks for taking my question. You will share more combo data on the Jackify out to embed combo in the second half, but in the context of where QD stands and the overall combination strategy here.

Can you just help us understand what you're thinking is and how this could play out from a life cycle management standpoint? Yes, so thanks, Sylvie and Steven. You know, both as I alluded to in my prepared remarks, both BET and ELK 2 are progressing well.

best clearly activity with monetary therapy and in combination. And that's just about declaring the dose and then the registration intent for that and then also watching the competitive space. Health too, very well tolerated, we can keep escalating and hopefully continue to see improved efficacy. And then that may be...

in ruck dose intensity and then I just outlined you know the QDF on its own in terms of formulation development. We also working on fixed dose combinations for both BET and L2 and those aren't impacted by the CRL in any way.

But it is likely that when we go to pivotal studies with Betanel 2, that those will be done with the IR in combination with Betanel 2, and then should we want to use FDCs, we pivot to that with bioavailability bioquivolence work at that time. All of those efforts...

are underway aggressively. And again, we very much want to complete and should complete them before the loss of exploration of rocks itself. Thanks.

Is that just a follow-up here? So then how does CalR and CK0804 kind of fall into this strategy as well?

Yeah, thank you. So mutant Calor is on its own an entity that as I said earlier about 30% of mitofibrosis and in fact 25 to 30% of essential thrombocythemia and is the oncogenic driver on its own it's mutually exclusive doesn't overlap with MIPL or V617F or anything else.

And so should this work the way it looks pre-clinically and be well tolerated, it's an entity on its own and would be a different treatment paradigm in terms of thinking. Because the idea would be to eliminate the malignant clone and potentially cure you of the condition. So you'd no longer have...

and should that pan out all the way to the end, then about a third of each of those entities would be taken care of on their own with the antibody and would be no need for jack inhibition, bet inhibition, elk to inhibition, etc. The Selenco 0804 effort is a different effort entirely.

It's a billy cord T-reg cells that are enriched to hone to the bone marrow and have already shown in small, in a single case studies, to change the natural history of malafarbrosis.

and potentially also improve fibrosis there as well, and to be safe. So it's early days with that, and we wanna again show data on that later this year, and it's too hard to comment on where that'll go from a strategic point of view, but the idea there again is to be disease-modifying, given the therapeutic modality.

Thanks. Thank you. Next question today is coming from Evan Segerman from BMO Capital Markets. Airline is now live.

Hi there, this is Connor McKay on for Evan. Thanks for taking our question. Congrats on the quarter. So you noted in your press release this morning increased demand for Opsalora, and I'm just wondering, you know, now that we're a bit further into the launch in Biddle Igoe.

Could you just comment on if you're seeing any previously inactive patients or patients who had stopped seeking treatment previously starting to come on to Upsilon? Thank you.

Hi Connor, it's Barry. So we obviously have patients that have been seeking treatment all along for their vitiligo and then new patients that learned about Opsilor and go in to see their dermatologist. I can't give you any numbers at all.

about the number of patients who were in fact inactive. Part of our entire effort for any direct-to-consumer activity is really just to let those patients...

who want to have their vitiligo treated to know that there's a treatment available for the very first time that can actually help them to repigment their skin. So that's what we'll continue to do to drive the patients back to the office. Thanks.

their vitiligo treated to know that there's a treatment available for the very first time that can actually help them to repigment their skin. So that's what we'll continue to do to drive the patients back to the office. Thanks. Yeah, thank you.

Thank you. Next question is coming from Jay Olson from Bob and I'm here. Line is now live. Oh, hey, congrats on the quarter and thank you for taking the question. Can you talk about the pace of U.S. and any comments you could share on the momentum of

today. So

The approval of the launch in Germany and Austria took place at the end of the end of the quarter. In the last days of June , we are in the process of launching the launch of the launch in Germany.

Now we have a month and a half, we see a good uptake, in fact, we see adoption in Germany, where you see the most important market, and it will continue to be the most important for a year because we anticipate the next reimbursement to take almost that long.

to become effective in other countries in Europe . So what you can anticipate there is another 10 months where Germany and Austria would be the only main countries.

where OPCIroir is being used and what we see, I mean there was a in Europe when the approval was done first, the label in Europe is excellent. It's different from the label in the US in terms of the entire safety profile. In fact, it has no equivalent of the black box in Europe . So all of this

issue of systemic exposure to Jack has been looked at by the European authorities very differently from what the FDA has done in the US and the media impact of the approval has been very visible on on TVs and the everywhere across Europe we had

number of patients and physicians speaking about the importance of treating and re-pigmenting vitiligo. So the awareness of optilor is already very high. We have a lot of demand. We have programs we are trying to put in place to help patients where we can and and we are fairly optimistic that it would be a good product for insight and it will have a...

it will have a reasonable potential. And the second part of your question is about guidance for OpCelois. I think you can.

So in terms of the guidance, we still want to see a few more quarters of uptake. It's still early. We want to be able to see back to the earlier discussion how vitiligo patients, especially that have been inactive, come into therapy.

and also more information on refills before we are in a position to provide guidance.

more information on refills before we are in a position to provide guidance. Great, thank you for taking the questions.

Are you seeing a difference between AD and vitiligo? Can you comment on the moving forward rates for the rest of 2023? And then looking towards axotilumab, could you share how Inflite and SynDax are applying to share responsibilities for the upcoming BLA filing and maybe potential commercialization as well? Thank you. So, Jerry, for Opsilor for a free drug, we don't really see any difference whatsoever between, with a free drug for atopic dermatitis and vitiligo. Obviously, said before that there's more AD patients that are on Opsilor and a growing number of patients.

with the LIGOs that are on Opson, Laura, but the free drug difference we don't know. Jerry, it's Stephen. In terms of the the BLA, obviously both companies have worked really well together, the study was executed well, brought in well, high quality etc, but inside will be

It's a co-commercialization led by Insight where we would be booking the revenue and where there is an option for SynDax to fill up to 30% of FTEs in the field force if they choose to. So that would be for them to decide if they want to do that and at the end we will do a 50-50 profit split of the commercial activities in the US. Outside of the US it's a license where we will be paying a royalty to SynDax and we will be prosecuting all activities related to regulatory and commercial for access to its PAYS.

The next question is coming from Eva Pravatera from TD Cal and your line is now live.

Thank you. Congrats on the quarter. A few questions from us. Can you help set expectations for povarsitinib in parietal nodularis? What would be considered a good profile in that disease? And what's the efficacy bar for moving into phase 3?

The povacitinib, piragin, nodularis phase 2 enrolled really well. It's complete. We'll have data later this year. The central problem for those patients is a very intense and severe itch. And then obviously, you know, the actual skin lesions. So what the patients really want is the itch relief.

And that's why we feel an oral JAK inhibitor is appropriate in these patients with more severe pyragonodularis. There is an already approved drug in terms of Depixant in PN in general, so the regulatory path is pretty well established.

This study though is a phase two proof of concept study. If we get the profile we want in terms of itch relief and then lesion resolution, then we'll advance to phase three development. But we'll talk about that later this year. Thanks.

Thanks, and another question on povarsitnib. Can you give a quick enrollment update for the Phase 3 and HS? We know that AbbVie has recently opened a Phase 3 for RINVOC.

Yeah, thank you. So we don't give it in numbers as we progress. We have two phase threes up and going. They enroll in really well. You know, we obviously started before them. I think across dermatology in general, when you go back to RaxCREAM, AD, Vitilaga, etc. Our operational execution has been excellent.

So we've got really good at knowing the derm space and how to conduct these studies, but we don't provide patient by patient enrollment updates. Thanks.

Thank you for taking your question.

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

Oh hey, good morning. This is Kelsey Onfer, Michael. Thanks for taking our questions. I just had two on axotilumab. Maybe could you just remind us how it might be positioned competitively versus Sanofi's Reserock in the third line setting based on the previously announced top line data?

And then I guess, could you just tell us how you're tracking with the planned Jackify combo study in the frontline setting, and maybe what you might need to see in order to advance that into a Phase III trial, any specific efficacy outcomes. Thanks so much.

With a large molecule and no theoretic concern in terms of drug-drug interactions non overlapping MOA a jack inhibitor with With a macrophage monocyte targeted drug so we don't expect to run into talks and then you know We want to very now very active drugs in graft versus host disease. It's really appealing Can you move up the treatment paradigm? So we're going to start that combination as soon as possible with with raxanaxa, you know tested likely in the first second line set in And then we'll either work out see that activity and see where we want to go. There is appeal to go first line

Because steroids are dominantly used they are active but have a lot of you know long-term toxicity But there's also appeal in second line as well, so we'll see where the data leads that leads us, but an exciting time for that combination

Okay, great. Thank you so much and congrats on the quarter. Thank you. Your next question is coming from David Lebowitz from Citi. Your line is now

Thank you very much for taking my question. Could you provide more detail on the number of tubes per patient on Opsilora? Just curious as to where the extent that overall growth in the quarter was driven by new patients coming to therapy or increase in the tubes per patient.

Sure. So David Sperry. So basically, I mean, where they're driven from is we said that the total RXs grew by 16%. So that's across AD and vitiligo and refills grew by 23%. So we expect refills to continue to grow.

and be more than 50%, in fact, going up much higher than that over time. As far as the growth from AD and vitiligo, both are growing. New patient starts in both vitiligo and AD continue in the right direction.

terms of the refills for each. I discussed it before that we expect in fact that you know two to three tubes for the AD patients and we hope to get to an average of ten tubes per patient for vitiligo. We think we're headed in that direction now and will continue to reinforce.

how to use the drug both with dermatologists and with patients, and we think we'll achieve at least that number.

Thanks for taking my question. Thank you. Next question is coming from Derek Archilla from Wells Fargo. Your line is now live. Thanks for taking my question.

Hi, good morning. This is Evelyn for Derek. Thanks for taking our questions. We'll be back with more questions once for a moment.

First, how are you thinking about M&A and what would be your priority between I&I and oncology assets? And second, what are your thoughts on the HS opportunity for publicity in light of resident competitor data?

Do you want to take care of the HS? So I'll do the second question first. So the profile in HS for porvus sitna, which we presented earlier this year at a medical meeting, is outstanding in terms of efficacy. In fact, we think...

As far as we can tell, it's the first time ever that a Hiscol 100 has been reported by a compound in the entity, and that by that I mean a complete response. So, abscess nodules, fistillers completely disappearing, and that's really encouraging for the profile going forward.

for porevo. You're right, it's now an active space of research. There's many biologics, including IL-17 targeted drugs.

you know, there's lots of unmet need and so it's good that other people are trying to address that. I would just say when you compare studies, you know, look carefully at patient populations, look carefully at concomitant antibiotic administration. We didn't allow that on our studies and then obviously the placebo arm activity as well when comparing.

But the profile we saw in our phase two is outstanding. And if we replicate that in phase three, we'll have a potentially best in class compound there. Thanks. Maybe I can say a word about M&A. I mean, we are in a position where, as you can see, the growth of our

Existing business is very strong. The pipeline is very promising. We have a number of very good products that we are now developing at late stage. We didn't speak very much about some of the early stage projects, but they are also very interesting. So we are looking at what could be the best use of the cash that we have. We have north of 3 billion now.

and how we could add to this diversification and growth that we are doing with our organic portfolio. It could be M&A or it could be licensing business development. You see, you know, AccessTVMAB was a license from...

It's clearly helping us strategically with the portfolio and the Limber program and also adding mechanisms that we can combine with Jackify. So this type of agreement could continue when we see them, when we find them or acquisition that could be...

in dermatology or oncology, assuming that these products that we would be acquiring have the potential to contribute to the growth in the year 25, 26 and beyond because that's where really we need to add to the portfolio at that point. So that's really the criteria we are using.

We are sort of agnostic of Onco versus Derm. I think the question is the quality of the science, the quality of the product, and the timing and the potential of the products we would be adding to our portfolio.

Okay, thanks. Thank you. Next question today is coming from Ben Benjamin from J&P Securities. The storyline is now live.

Great, thank you. Congratulations on a great quarter and thanks for taking the questions.

Can you talk a little bit about the opportunity in Parygo, Naju-Laris? How big or small is this opportunity? And how should we be thinking if these current studies are positive? How should we be thinking about pivotal studies and how big they might be going forward? And maybe a bigger picture question is,

you know, when we think about Durham as a business, is this something that, you know, ultimately will be part of insight, you know, kind of going forward and taking up a significant part of the revenues as something that might get spun off at some point, just given the size of the studies that you might need to conduct for these other indications? Any thoughts there would be helpful.

Yeah, Ren it's Stephen. So paragonodularis is often not diagnosed or under diagnosed. It's hard to be precise on the epidemiology, but they're probably around 200,000 or north of that patients in the United States with PN. And as I said earlier, their biggest morbidity is itch. It's hard to be precise on the epidemiology, but they're probably around 200,000 or north

and it's massive impact on quality of life. So that's what we're looking for in terms of herb porvacitinib. The regulatory parts have already been defined by the depictions of approval and how to get there. And it's premature to talk about sizing and powering till we see our phase two proof of concept data there. Just by the way, you know.

I mean the question is really is dermatology a business that we believe has the potential to continue to grow to be of a meaningful size and the answer is yes and yes and you can see it. You can see the program we are developing for RockScreen.

For five new indications we are prosecuting on top of the T-LIGO and atopic Derm where we believe there is a clear medical need and where in fact the power of topical jack is with a safety profile it has and with the efficacy it has is really competitively well positioned.

We choose to develop poverty in a number of indications where there is interest. And you can see that interest in fact now coming from the biologics and some other ways of approaching this biology. But we believe again that the jacket inhibitor is a very good way with the fact that we are ahead of the pack in that development process.

is a very good way to help these patients and being first or best in class in that case is very feasible. And then we have Remolimab which is a new mechanism that needs to be proven but could be also very promising. So we have this view of developing an IAI dermatology portfolio over time that will be contributing to the patient's health.

equally to the revenue or at least to the growth of the corporation in the next few years. And we see a lot of complementarity in the research that we are doing in inflammation, in immunology, and how it could apply for cancer on one hand.

And in some cases, how it can apply for autoimmune disease or inflammation, inflammatory disease on the other hand. So all of that now is something that is well established. We have the team on the commercial side in the US now fully, fully fielded. And we are building it in Europe . So I think it's a picture of insight for the next.

You know, five years will be both done and an uncle in parallel. Thank you. We reach out to our question and suggestion. I'd like to turn the floor back over to management for any further closing comments.

Thank you all for participating in the call today and for your questions. The IR team will be available for the rest of the day for follow-up. Thank you and goodbye. Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time. Have a wonderful day. We thank you for your participation today.