Q1 2023 Incyte Corp Earnings Call
Speaker 2: Hello, and welcome to the InSite first quarter 2023 earnings calling webcast. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Christine Cho, head of investor relations. Please go ahead, Christine. Thank you, Kevin.
Speaker 3: Good morning and welcome to Insight's first quarter 2023 earnings conference call and webcast. The slides presented today are available for download on the investor section of our website.
Speaker 3: Joining me on the call today are Urve, Barry, Steven, and Christiana, who will deliver our prepared remarks, and Dash, who will join us for 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 followed with the SEC. We will now begin the call with Herve.
Speaker 4: Thank you, Christine, and good morning, everyone. So we'll be moving to slide 4.
Speaker 4: Thank you, Christine, and good morning, everyone. We'll be moving to slide four. And the
Speaker 4: So in the first quarter, product revenue grew 14% year over year.
Speaker 4: The growth for the Koala does not fully reflect the strength of the underlying patient demand for jacafai and opsy laura, which I will discuss in the next slide.
Speaker 4: In hematology and oncology, the ongoing launches of Pemazir and Minjuvi XUS drove the 17% year-over-year growth.
Speaker 4: We also received additional approval including our first indication for DINES in Merkel Cell Carcinoma in the US and more importantly the approval of OPCELORA for VT-LIGO in Europe with an excellent label.
Speaker 4: Zinniz is available commercially in the US and Opseloa will be launched in Europe in the next few months, starting with Germany.
Speaker 4: Moving to slide 5.
Speaker 4: Taking a closer look at the Q1 dynamics that affected net cells in the quarter for JAGA-5 and OPC-LOR.
Speaker 4: Jack-O-Thigh patient demand was strong across all indications, growing 7% on a year-on-year basis.
Speaker 4: On growth to net, we had the typical Q1 negative effect, with higher deductions due to an increase in Medicare coverage gap rebates and patient deductibles.
Speaker 4: We also had an increase in 340B purchases.
Speaker 4: Separately, channel inventories fell below normal level resulting in an 11 million impact.
Speaker 4: Given the strong underlying patient demand, we are confident in our full year outlook and are raising the low end of our guidance to a new range of $2.55 to $2.63 billion for the full year. Turning to Epsilon
Speaker 4: There are three components to fully understand the dynamics of the first color. First, we saw a continuation of strong trends in weekly prescription growth in the quarter. 60,000 new patients were treated with Obterua.
Speaker 4: Second, as you can see, in the TRX graph on the right, retills were being pulled forward in December , and this resulted in lower volume in the first two months of the year. And third, net price in the color was impacted by an increase in commercial copy and higher Medicaid utilization.
Speaker 4: So the outlook is strong for both track-a-fi and up-zero-a as we expect to drive further growth throughout the year.
Speaker 4: Moving to slide 6.
Speaker 4: With our R&D pipeline growing and advancing, we have recently decided to concentrate our resources behind the project with the highest potential to drive our revenue growth.
Speaker 4: deep pipeline growing and advancing. We have recently decided to concentrate our resources behind the project with the highest potential to drive our revenue growth in the next few years.
Speaker 4: This eighth program of first or best in class candidates
Speaker 4: have large potential with multiple indications such as obselura, povctenid and all pz1.
Speaker 4: or PDL1, or alternatively they address a significant unmet need in an existing franchise like the Limbo program with Alk2, Bet, Axotelimab and Kala.
Speaker 4: autoimmune and hemorrhetic anemia, accell members, two adenosine program and chemt them great request for support by 37th and 21st and sections in duez? quarterly term, 2018 beta Samaret callal pregnancy codes and st ?????? den ???? angeloid modlife biorexxy gen X
Speaker 4: This concentration of our internal and external resources will increase speed and efficiency for the eight hyper-contractor programs and allow us to further accelerate our promising early clinical programs like CDK-2, CGF Beta PD1 by specific and OMOlymap.
Speaker 4: With that I would like to pass the cord to Barry.
Speaker 5: Thank you, Arby, and good morning everyone.
Speaker 5: Starting with Jackify at slide 8, patient demand for jackify was strong across all indications.
Speaker 5: grew 8% year on year to reach an all-time high.
Speaker 5: first of the past two years.
Speaker 5: Turning to Opsilora. Net sales in a quarter were $57 million. On the right are total prescriptions as reported by Acudia.
Speaker 5: Launch trends continue to be strong, with robust growth seen in both March and April .
Speaker 5: As we continue to drive further awareness and adoption of the brand, the number of dermatologists gaining experience with Opsilora continues to increase.
Speaker 5: we have been able to accomplish with a launch of Opsilora. When reflecting on the first 18 months of launch, Opsilora outperformed other brands prescribed by dermatologist.
Speaker 5: on a launch-aligned basis. The rapid reduction of Opsilora highlights its compelling product profile and its ability to address significant unmet needs.
Speaker 5: In addition, we were able to secure pair access far quicker than any other recent launches in dermatology.
Speaker 5: we were able to secure pair access far quicker than any other recent launches in dermatology. Looking at slide 11.
Speaker 5: So momentum with Opsilura is strong, and we are continuing to see very positive trends in terms of uptake, awareness, and reception for the brand in Vidaligo. We launched our first TD Direct Consumer Campaign for Vidaligo on February 12th this year, and early data supports the success we've had in just a few weeks.
Speaker 5: Based on a survey conducted of approximately 100 dermatologists, MPs, and PAs, they indicated that nearly 20% of their Vidaligo patients requested Opsilore and at 85% of those patients request are filled.
Speaker 5: This level of brand awareness and patient activation is substantially higher than almost every other product in dermatology offices. And with our continued efforts, we believe we can reactivate a significant percentage of the diagnosed Bidoligo patient population.
Speaker 5: Brand awareness and patient activation is substantially higher than almost every other product in dermatology offices. And with our continued efforts, we believe we can reactivate a significant percentage of the diagnosed Bidoligo patient population. Turning to slide 12.
Speaker 5: Opsilora uptake in atopic dermatitis is driven by its efficacy and in particular by the impact on itch. This is the clear differentiator for the brand and Opsilora is the only topical therapy with itch reduction in its label.
Speaker 5: To understand how quickly obstaloric and work in some patients, this past weekend at the revolutionizing atopic dermatitis meeting, we presented data from our scratch AD study.
Speaker 5: Results showed that patients were able to attain substantial introduction as early as 15 minutes after the first application of Opsilora and peak reduction after four hours.
Speaker 5: We continue to focus our efforts on driving refills and have implemented several new initiatives to further grow the brand. Some of these programs include patient relationship and support programs, as well as partnering with pharmacies to help with the education and to drive patient adherence.
Speaker 5: And lastly, on Manjubi, Minjubi, and Pemizier on slide 13.
Speaker 5: On JuV sales in a quarter were $21 million, up 11% year-over-year, with community accounts making up the majority of the volume. Min JuV sales were $7 million, and the product is now reimbursed in 6T launch markets in Europe .
Speaker 5: Pemazir grew to 21 million in net sales in Q1 with 5 million coming from outside the US where the launch is now ongoing in 10 key markets in Europe .
Speaker 5: With that, I'll turn the call over to Stephen.
Speaker 6: Thank you very. On slide 15 is a snapshot of a few of our programs, including our high potential programs, as depicted in the red and blue boxes.
Speaker 6: segmented by estimated launch time in. Over the next six to 18 months, many of these programs will be expanding into new indications, new combination studies and into pivotal trials.
Speaker 6: By focusing resources on these assets, it could allow for an acceleration of certain timelines and increase efficiency as we bring these innovative therapies to patients.
Speaker 6: We are well positioned for growth and diversification with multiple launches expected in the near-to-med term.
Speaker 6: Moving to slide 16, we made significant progress across our high potential dermatology program.
Speaker 6: Opsilura was approved for Vidaligo in Europe , and we presented new data for both Opsilura and Porvositnav at two major dermatology conferences. We also progressed into new indications, including Paragonodularis with Opsilura and asthma and chronic spontaneous oticaria with Porvositnav.
Speaker 6: Now to highlight our dermatology portfolio in more detail, starting with Opsilura and the recent European approval on slide 17.
Speaker 6: The label was very favorable with regards to both efficacy and safety. The full indication is for the treatment of non-segmental middle-Igo with facial involvement in adults and adolescents from 12 years of age upwards. This encompasses the majority of middle-Igo patients in Europe where roughly 85% of all middle-Igo patients.
Speaker 6: of non-sigmental disease, where around 60 to 80% are facial involvement.
Speaker 6: Regarding safety, the most common adverse reaction was application fight acne.
Speaker 6: No black triangle was placed on the label, and the Regulatory Agency determined that the class effect identified for the oral class were not considered relevant for absurleta. And as such, the label does not include any special warnings or precautions as seen with the oral jack inhibitors.
Speaker 6: Turn into slide 18.
Speaker 6: We recently initiated two phase three studies evaluating obsular and paragon nodulaurus, a disease driven by inflammation and characterized by hard nodules and an intense itch.
Speaker 6: True PN1 and PN2 are 52-week studies where patients will receive Raxilicin of Cream or vehicle for 12 weeks followed by a 40-week open-label extension. The primary endpoint is WI-NRS.
Speaker 6: which is defined as a four point or greater improvement in worst-age numeric or rating scale score from baseline to week 12.
Speaker 6: with clearly defined endpoints.
Speaker 6: With no topical or oral therapies approved, we have a significant opportunity to help a large population of patients who are suffering from this disease.
Speaker 6: With no topical or oral therapies approved, we have a significant opportunity to help a large population of patients who are suffering from this disease. Turning to slide 19.
Speaker 6: We continue to expand the development of obsolary into new indications, which has the potential to provide significant value as either the first approved therapy or first topical therapy for patients living with these dermatologic conditions.
Speaker 6: Moving to Porva Sittenab on slide 20, we recently presented positive phase to results that the American Academy of Dermatology annual needed.
Speaker 6: highlighting the effect of porositinib on repigmentation in patients with extensive vital IGO. Substantial repigmentation was seen with porositinib treatment and continued to improve with longer duration of therapy with up to 36% of porositinib treated patients achieving a facial vase 75 by week 36.
Speaker 6: Based on these positive phase two results, we plan to move into phase three development.
Speaker 6: Being able to provide patience with an effective oral therapy to treat the vitaligo is part of our strategy to strengthen our leadership in vitaligo and to be able to provide multiple treatment options.
Speaker 6: for patients across the entire disease spectrum. On slide 21, at the European Higher Edinitis Super-Tea Foundation Conference.
Speaker 6: Represented Phase 2 data showing that 52 to 56% of patients treated with polvacid nerve achieved a Hiscar 50 at week 16. Perhaps even more impressive was that at up to 29% of patients on polvacid nerve reach Hiscar 100 at week 52.
Speaker 6: which is 100% reduction in abscess and nodule count with no increase in abscess or draining tunnels relative to the baseline. This is a very high clinical bar of efficacy and we were the first to ever present the achievement of Hisco-100 in HS. Based on the phase two results, we initiated two phase three trial. Stop HS1 and stop HS2.
Speaker 6: Similar to Raxelidium Cream, we are building a portfolio for poor recidium around the science, all while leveraging our extensive dermatology capabilities.
Speaker 6: As mentioned earlier, we are initiating two phase trials in moderate to severe asthma and chronic spontaneous erotic area.
Speaker 6: Likewise, we know Jack in Abyssin can modulate martial activation, including degranulation and cytokine production, both of which are drivers of chronic spontaneous search to carrier. Moving to our hematology and oncology portfolio on slide 23, looking at our high potential oncology programs, we continue to make progress in myeloprolift of neoplasms or MPNs with our O2 and Vet program, an exotellum app in chronic graft versus herst disease.
Speaker 6: Our small molecule RLPDL1 program is advancing into multiple phase 2 studies in combination of that aggressive epilumumap and exytenin. For our early stage assets, we recently presented data at the American Association for Cancer Research Annual Meeting for CDK2 and our newly disclosed by-specific CHIJAP beta R2PD1 antibody. And lastly, we recently announced the approval of ZINNES for Merkel-Celcosinoma, which is currently in phase 3 trials in the squamous cell analcosinoma and non-small cell lung cancer. Turning to slide 24, we have several programs for testing in MPNs and graft-versus-hosted disease.
Speaker 6: So Lurga's surtip is in dose escalation. We were currently at doses of 400 milligrams once daily in combination with Ruxilitinib, and we were adding a treatment arm for newly diagnosed patients. We continue to see signs of clinical activity, including decreased levels of Hepsardin, as well as hemoglobin responses with no dose limit in toxicities to date. For our bad inhibitor, dose escalation is ongoing.
Speaker 6: where we are currently at doses of 6 milligrams once daily in combination with Raxylidnub.
Speaker 6: In monotherapy and in combination therapy, we have seen reductions in spleen length and volume, as well as improvements in both symptoms and hemoglobin.
Speaker 6: Suggesting 57643 is an active compound. INC-A33989, our mutant calorentibody, is on track to enter the clinic later this year, and the study evaluating Celencosus CK-0804 in combination with ruxilin continues to progress.
Speaker 6: Lastly, we expect results from the Agarvi 201 study later this year. Before moving on to the next slide, I did want to speak briefly on the CRL for the rest of the hotel.
Speaker 6: The FDA determined that while biocovolence was achieved in the area under the curve of AUC, there had questions around semen and its correlation with efficacy.
Speaker 6: We will work with the FGAs to determine the appropriate next steps and we will provide an update at that time.
Speaker 6: Turning to slide 25. Preclinical data from our CDK-2 Integy F8R2 PD-1 by specific.
Speaker 6: INCB123667, a selective oral small molecule CDK2 inhibitor, is in the phase 1 dose range in study in advanced solid tumors. CDK2 in complex with cyclonee is a cell cycle regulator, which when inhibited has been shown to suppress tumor growth.
Speaker 6: mainly in satin e-high-tumor models in vivo. On the right is INCB33890, a CheJIF Beta R2 PD1 by specific, which has been engineered to invade the known toxicity of broad TJIF Beta pathway blockade.
Speaker 6: 33890 has a 10-fold higher affinity for PD-1 than TGF-8R2 and blocked TGF-8R's signal in, in cells co-expressed in PD-1, thus potentially protecting normal tissue.
Speaker 6: Preclinical in vivo data presented at ASER showed that 33890 has a greater anti-tumor effect than individual benchmark antibodies or a simple combination of these.
Speaker 6: clinical in vivo data presented at ASER showed that 33890 has a greater anti-tumor effect than individual benchmark antibodies or a simple combination of these. Turn into slide 26.
Speaker 7: With that, I would like to turn the call over to Cristiana for the financial update. Thank you, Steven, and good morning, everyone. Our first quarter results reflect continued strong revenue growth with total product revenues of $693 million, representing an increase of 14% over the first quarter of 2022. Total product revenues are comprised of JAKA-FI, other metology oncology products which include IClassic, Pemazere and Minjouvi and Obselora.
Speaker 7: JAKAFA Net Product Revenues for the first quarter were $580 million, which reflect continued growth in patient demand across all indications, partially offset by higher growth in net detactions as a result of both contributions to close the Medicare gap and commercial pay assistance in line with prior years first quarters.
Speaker 7: as well as an increase in 340B. The quarter was also negatively impacted by lower than normal channel limit at quarter end due to the timing of certain customer purchases.
Speaker 7: Other rheumatology oncology net product revenues worth $57 million, representing a 17% increase compared to the first quarter of 2022, driven by patient demand, partially offset by untaverable all changes in FX rate.
Speaker 7: On a constant currency basis, other immatology oncology.
Speaker 7: Net product revenues grew by 22% over the prior year period.
Speaker 7: This year, over year growth was partially upset by an acceleration of refills at the end of last year and by higher growth net deductions as a result of higher Medicaid utilization and higher commercial copay assistance, which is a typical Q&A dynamic. Turning to royalty revenues, total royalty revenues for the quarter were $115 million and a comprised of royalties from Novartis of $77 million for Jakaví and $4 million for Tabreqta and royalties from Lili of $34 million for Aluminium. Jakaví and Aluminium for royalties for the quarter were negatively impacted by effects headwinds.
Speaker 7: While alluminium royalties were also impacted by a decrease in net product sales of alluminium for use as a treatment for COVID-19. Excluding the impact of COVID-19 related sales and currency fluctuations, alluminium royalties increased 37% compared to the prior year period.
Speaker 7: Moving on to slide 30 and our operating expenses on the gap bases.
Speaker 7: On going R&D and total R&D expenses were $404 and $407 million respectively for the first quarter.
Speaker 7: Total R&D expenses increased 15% year over year, driven primarily by the progression of our pipeline, including the expansion of the clinical development program, evaluating actualitinip cream in additional indications, and the progression of the provositinip into pivotal studies.
Speaker 7: and were partially upset by lower upfront and milestone expenses in 2023.
Speaker 7: Total SGNA expenses were $316 million for the first quarter. SGNA year-over-year growth was treated primarily by promotional activities launched at the beginning of the year to support of Celura and Naidi and Invitilago and the timing of certain other expenses.
Speaker 7: Moving on to our guidance for 2023, as a result of Jacobi's strong demand growth, we are raising the bottom end of our full-year Jacobi guidance range of $2.53 to $2.63 billion to a new range of $2.55 to $2.63 billion.
Speaker 7: We are affirming our other hematology oncology revenues, COGS, R&D and SGNA guidance for the year.
Speaker 7: Operator data, conclusion, prepare remarks, please give your instructions and open the Foldcam its here's the same project as this and open the folder located here as well.
Speaker 2: Certainly, when I'll be conducting a question and answer session, if you'd like to be placed in the question Q, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question Q. You may press star Q if you'd like to move your question from the Q.
Speaker 2: One moment please, while we pose for questions. Our first question is coming from Sabine Richter from Goldman Sachs, Revined is now live. Good morning, thanks for taking my questions. Two questions here for me. One is, given the first quarter headwind for Opsilura, where you saw an increase in commercial copay and higher Medicaid utilization.
Speaker 8: the CRL for Judy Jackify, what is your view on the base case on the path forward here and how does this impact that the combo program with Bet and Alc 2 in terms of your registration path? Would you run a FA3 combo with BID Jackify and do bridging studies or does the path you have?
Speaker 7: ongoing kind of a job, you know, stand on the board. Thank you. Hi, Salvini, Cristiana. Let me take the first two questions on Cross-Denette and I give you and then I will turn it to Steven. First of all, regarding Obselura Cross-Denette, there were two main factors that impacted Cross-Denette in Q1.
Speaker 7: The first one is the higher copay and deductibles at the beginning of the plan year. And this is typical. We see it every for every product in the first quarter. Those deductibles and copays are higher and we are paying them down which are impacting growth to net.
Speaker 7: The second is an increase in Medicaid utilization. And that was driven by the very rapid update that we saw for Celura across all 50 states.
Speaker 7: That increase in Medicaid utilization had two components that impacted Q1. The first one was the actual utilization that we saw for Medicaid in Q1. And the second one is related to the actual claims.
for Q3 and Q4 received during Q1, which were higher than we were expecting. And therefore, there are certain two apps related to those claims for Q3 and Q4 that are reflected in Q1. So the average gross to net for the quarter was 60%.
But as we look at the average for the year, we continue to expect this to be at around 50%. The first factor, the higher copays and deductibles that we saw in Q1 are expected to come down through the course of the year. And in terms of the Medicaid, even though the utilization will be higher, the true ups that we saw in this quarter.
really reflective or accurate relative to our actual numbers. So it's good to look at it directionally, but there are a couple of things that are happening with the Accuracy data. One is it includes a free drug and as we have discussed in this past, expect that that is at around 20%.
in the level of words we mention to...
during the quarter and that can be as high as 20%. So it's better to look at the IQV data more in terms of the trend. But the trend, over here, the trend is sort of reflecting the demands that we are observing. I was certain, just that IQV data is, in fact, overestimating.
A little bit by, you tend to 20% depending on the week.
And then Selvene, in terms of your question on the CRL for RuxilitnebecsR, as I said in my prepared remarks and the FDA was clear that we had met the area under the curve criteria for RuxilxR versus IR, but had concerns on the lower C-men theoretical concerns that it may potentially impact efficacy. In terms of base cases, it's hard to see right now how long it will take, but we...
studies you're correct, we will proceed with the RUXIR, IOR, with the intent to do bridge and work on the back end to an FDC. Just to mention that the fixed dose combination work is not impacted by anything to date and that continues to move forward for both better and Elk II as well. Thanks. Thank you. Thank you. Next question is coming from IBA Pervotero from TD Cowan, your line is now live.
Hi, good morning and thanks for taking your questions. My sister is also on the brosinette and more specifically on the shift towards Medicaid. Do you expect this to continue into Q2 and for the rest of the year is this lightly permanent?
So, hi, I have a question. The medicated utilization or the uptake was faster than we were expecting. So now we have an up-to-lure available under medicated in all fields.
state. So the increase is not expected to be at that same level, but we would expect to continue to see those levels of Medicaid utilization. So it got to the levels that we were expecting eventually, but the at-take was faster than we were expecting.
is the assumption correct that the rest of the year, the average should be around in the high 40s.
You would expect the gross tonight to gradually come down through the course of the year. Okay. Great.
Thank you. Next question is coming from Dickram Barovit. From Morgan Stanley , your line is now live. Hi, good morning. Thanks for taking our question. So we also had a question on Obsolura. We just wanted to get your updated thoughts on when in the coming quarters, you might feel comfortable providing a break out of sales.
and or scripts between middle I go and ad and is guidance for the product either total guidance or indication specific guidance Something you would consider for this year, and then we had a follow up
So, hi, we can let me start and then I will turn it to Barry. In terms of the guidance for Obselura, we want to see more quarters of the uptake before we can provide guidance for annual guidance for Obselura. We are still early in the launch for VTLIGO. We still want to...
As we estimated, it seems to be about 30% of the total RXs are related to vitiligo. Vitiligo growth is continuing and we'll have to have more time to figure out exactly how many vitiligo refills we'll have per patient. But as we said in the past, we fully believe that on average over time vitiligo patients should be receiving about 10.2.
Yeah, Vikram, thank you for the question. So just to separate each program and deal with it separately, you know, as I said in my prepared remarks and I'll deal with that first, it's really encouraging to see that both with monotherapy...
We see in spin volume reduction symptom improvement and hemoglobin response and in combination with Raxylitinab as well. So we aim at an appropriate meeting in the second half of the year to show as much data as we can. It's hard to quantitate that for you right now because different meetings have different cutoffs.
and get a sense of where we are in terms of the combination dosing thus far. And then we'll proceed with registration intent decisions by the end of the year sort of time frame. For ELF 2, we see in both, again, in monotherapy, good, hepsadon suppression.
and some evidence of early hemoglobin responses and then in combination as well. But it looks like we're gonna have to go to higher doses than we initially projected there. And also we have no dose limiting toxicity, so that's good as well. And the same sort of thing, how to quantitate for exactly how many patients will be presenting at the appropriate meeting.
the second half of the year because of cutoffs, but it's appreciable numbers and we've able to enroll both studies well and the same intent to declare, you know, registrationally intent programs in that time frame as well because both are proceeding well.
Thank you. Thank you. Next question is coming from Kripa Debarakanda from Truist. Your line is now live.
The next question is coming from Krippleta Baratanda from Truist, your line is now live. Krippleta perhaps your phone is on mute.
I have a couple of big-picture questions. When I look at the pipeline mix right now, it seems like maybe it's this time of the timeframe, but there seems to be a gradual switch towards inflammatory diseases.
maybe shift away from oncology and even with an oncology, the earlier stage programs seem to be more focused on biologics with a piece of view of the small molecule programs being discontinued. Is this just a dynamic shift or is it intentional?
And then a question on the proposed EU legislation, I would just would love to get your thoughts on it and if you think that it could potentially impact insight or if you insight could be immune from it because the market you target.
Let me take some of that and maybe Stephen can speak and dash on the pipeline. Starting on the EU legislation, frankly, what we have seen is a proposed draft. It's not yet even close to be the final one. It has impact on exclusivity, which is obviously...
You know, the key for the entire biotech industry. So we live with patents and patents rights. And that will be the subject of our effort in Europe to make it work for us. I mean, inside is a company.
investing in R&D and the only way we can be viable in the long term is with enough you know patent and exclusivity after that. So that's the big picture. I frankly...
way we'll take time to be implemented. I mean it's not a very short term.
So on the portfolio, is this clear that we have been...
moving resources into inflammation and Dermatology, but not just Dermatology. I mean you have the scope of the program. We have for over city nib We have our emulimab coming also very soon. We have workstream, which is in Dermatology and there are all three very important Program we are not moving away from oncology, but we are certainly consolidating our portfolio in immunology and I think it's an important
indication. So regarding the biologics frankly we have bispecific, we have antibodies and we have small molecule, we treat them equally so there is no strategic goal of moving away from small molecule for example like you have heard from some other companies. In our case we are totally...
committed to each of them, it just happened that some of the targets we are pursuing and you saw that with color, for example, well-reduced for an antibody or biologic type of approach and that's what's describing the mix between biologic and small molecules for them.
to each of them, it just happened that some of the target we are pursuing and you saw that with color, for example, well-reduced for an antibody or biologic type of approach and that's what's thriving the mix between biologic and small molecules for them. Okay, thank you so much. It doesn't have to.
Thank you next question today. You're coming from Jessica Fyfe from JPMorgan. Your line is now live.
Great. Good morning. Thanks for taking my question. Couple on Jack by first. Where is duration of therapy with Jack by an MF stand historically?
Is there any change in duration of therapy baked into the 2023 guidance? And then I think you mentioned the change in inventory year over year. Was there a sequential change in inventory relative to the fourth quarter?
Sure, so Jessica is very. So in terms of duration of therapy for MF, it's about 21 months as far as we can tell, but many patients are on drug. They've been on drugs since the Phase II studies. So we haven't seen any change at all, particularly if there's a couple of drugs that might be used in the second line setting. We have.
that were slightly below the low end of the normal range. The normal range that we see is 2.5 to 3 weeks of hand of a channel inventory. And that had to do with the timing of certain customer orders. In terms of the impact, when you look at this...
of the range but within normal levels and again this quarter we fell slightly below the low end of the range.
And then with regards to jackify, I'm curious what you're seeing that prompted the raise in the lower end of the guidance range. Any differences in demand versus your expectations, changes in your expected expectations for competitive dynamics in the back half of the year or something else. Thanks. Sure, Barry. So, Opsilore and in jackify. So, Opsilore just in terms of, yes, in March and April , refills have normalized. So, we said in the past and it seems to be holding up, that refills account for at least 30% of the TRXs. So, that will continue in terms of the number of tubes for patient at differs obviously between AD and Vidaligo in AD when we can follow cohort of patients for at least 30%.
In terms of new patient growth, it's been the best that we've seen since the launch of the brand. So we're very encouraged by that and that generally carries through to the rest of the year. So we're growing total patients and total demand in MF, PV, and GVHD.
So that's what led to the tightening of the guides.
of the guidance. Thanks, Barry.
The Brian on the refill, I think it is the key question for OXI. What is in perspective, we had when we launched this calibration of saying it would be 2-3 tube for atopic dorm, it could be up to 10 for VT-regor. What we are observing is that we are now north of 2 for atopic dorm. So that...
giving the curve a very different shape. So a lot of the commercial effort we do today is obviously bringing new patients to their dermatologist asking for a cellar, but the other side is refills and getting the refills done for VT-LIGO because that's what's going to impact the revenue for the next year. Thank you. Next question is coming from...
started off with the one-key result, how are you thinking about that guidance for the rest of the year? And then secondly, as it relates to the LIMBER program, just with the retirement of your pursuit of part, how should we be thinking about LIMBER going forward and can you highlight some of the potential catalyst for that program in the near term? Thank you. Thank you.
I'll take the first part of the question on gross to net. As I indicated, we do expect the gross to net to improve through the course of the year to come down from the 60% level that we saw in Q1 and to average for the year around that 50%.
that we typically see in the first quarter of the year as well as the higher Medicaid utilization and especially the true apps related to actual claims for prior quarters received in this court.
registration intent programs for both very important programs with different intents just you know that
both in terms of spleen reduction and symptom response and then help to the additive hemoglobin response from that Calor will enter the clinic in the middle of the year and will declare itself in terms of safety and efficacy Relatively quickly given its mechanisms of action and we can follow Calor allele burden reduction
And then in Grafus's host disease, acetylomab, the agave 2-1 results will come in as well and will hopefully be a filing opportunity in third line Grafus's host disease. We'll continue the RxXR work and work with the FDA on the POT forward and continue the FTC work. So it's still a very active program underway with LIMBA. Thanks. Can you clarify what would be good data for the vet?
that is platelet count directed and different doses being used depending on patients platelet counts may be the right way forward for a best combination. Stay tuned on that. Thanks. Okay, thank you.
PlataCount directed and different doses being used depending on patients' platelet counts may be the right way forward for a bet combination. Stay tuned on that. Thanks.
Thank you. Next question is coming from Rembingement from JMP Securities. Your line is now live. Good morning guys. Thanks for taking the questions. Can you give us an idea to split between Medicare, commercial, and the 340B hospitals and ultimately, you know, call it by the end of the year what that split might be? And what's, frankly, the ideals.
that is Medicare. About 16% or so of our volume currently is going to 340B institutions and mostly the rest is commercial but it's a variety of things. And remember that included in the 340B is some commercial patients as well.
So it's really, the rest is just a little bit of VA and other government ordering. And it will continue the same as the rest of the year. The 340B is it grows and it's going to continue to grow for everybody. But to grow at a reasonable rate, we just had a little bit of a bump this quarter and that's why we pointed it out. That's OK.
And then just switching gears to both Manjuvi and Mazir, I'm trying to get a sense as to, sticking with Manjuvi, the upcoming inflection points, when these trials might ultimately read out and at what point you kind of look at, call it the new indications, and either kind of assess whether this will be a commercial success or it's something that you ultimately write off.
And we saw some great data I thought that Pemissier at the AECR kind of curious what your plans are in terms of either doubling down on Pemissier in some other tumor indications or you kind of feel the commercial opportunities next up.
I'll take the development side to those questions, Ren. Thank you. So for Monjuvi, both the follicular and the front line, the fuselage B-cell studies have enrolled incredibly well. We expect data on in mind, the follicular marginals on trial in the second half.
next year and front-mind the year after. Very important studies in in this arena to get data on and and I certainly feel will be important for patients there. And thanks for also pointing out the perma zir, perma gasps data at AACR. You know I think if you have tumors that are driven biologically by by either Fgfr1, 2 or 3
And that is the oncogenic driver. Then, you know, perturb in that with a good inhibitor, which Pemiser is, you know, you can see results. And so we have ongoing work in Glioble Astoma Multi-Formay, where we are seeing activity there, and we'll see whether that translates to, you know, a more fuller registration program down the line with massive unmet need there as well. Thanks. So just in terms of commercial potential for M&JB.
in Lentland, or follicular lymphoma. Again, there in combination with R squared, retoxin, and reblamid compared to aridrogh, monjuby, and R squared. I think we have a good chance of succeeding there as well. And we have the opportunity to really take over that market share. As Steven said, for Pemizier,
You know, it's a good product. There's, you know, a few cholangiocarcinoma patients. Now we have an MLN indication. We don't really know how many MLN patients there are. It's a very rare tumor type. But in fact, as we have more physicians, clinicians,
testing for FGFR-1 rearrangements, we'll find out exactly how many MLN patients there are. And as Steven says, we have ongoing work with Pemazir, and we have hoped that we can bring some relief to patients with GPM.
Thanks guys.
Thank you. Next question is, can we have an agreement from BMO? Your line is now live.
Hi, this is Connor McKay on FRP and thanks for taking our question. Maybe just one on the ops-allure launch in the EU. Any nuances there versus the launch in the US in terms of SG&A expenses or expectations for uptake? Thank you. Good Senior,feet-in-a-are project,
So yes, so I mean, so the EU, I mean one of the
news today is the quality of the label for Opsalora in Europe . It's a very good label. It's for vitiligo so the sequence is...
Very different from the US where we started with AD followed by VTiRGO there we are VTiRGO first and then Additional indication will come in the future We have a team in Germany for the next year or so Actual months most of the activity in Europe will be in Germany because that would be the place where we have real
to lie. So that's the timing in terms of
As G&R resources, we have them in place, so you should not anticipate and increase in the next of the colors that will be related to the launch of accelerometer.
The next question is coming from Jay Olson from Up and Hymnier. Your line is now live.
Oh, hey congrats on the progress and thank you for this update. We have a question about the LIMBER program. What are some of the lessons learned from the parts of click-subsodies? And it's L2 now the priority in your LIMBER program. And then what kind of patient numbers and duration of follow-up should we expect to ask go on the L2 program. Thank you.
Jay Hyde, Stephen, thanks. I think in terms of the past, the studies obviously it's unfortunate that they did not meet the criteria to continue past their inter-analysis in terms of futility. In lessons learned, we always learn from studies and from patients. We learned how to enroll efficiently around the world.
on doing the right things for patients and their families in terms of the shutdown of the studies which we're doing now and then pivot into the other programs. Just to manage you know in terms of what you said it will not be at ASCO in terms of updates better note to their meetings in the second half of the year and as I said earlier hard to be precise on patient numbers that we'll be
And that's what we'll continue to dose, escalate there and I can't give you precision on numbers right now in a meeting yet. Thanks.
Thank you.
Thank you. Next question today is coming from Michael Schmidt from Guggenheim Securities. Your line is now live. Thanks for taking my questions. Maybe just another follow-up on on Limber. Steve, as you think about the ALK 2 and the bad combinations, you know, how do you think those...
could be positioned perhaps relative to the emerging competitive landscape in the MF space, where we have the Navita Clarks combo going on as well and then potentially more a lot of them coming in late this summer. Thanks so much. So my class starts and my colleagues may add things off, but I think there is still an unmanned need there despite you know, Rucks being a fantastically successful.
progress, get to a recommended dose and address those needs. ELK 2 is a difference. Here it's about addressing the anemia component of the disease, both the underlying disease of myelofibrosis and potentially the drug-induced anemia from rucks as well. And again, as I said in my remarks, we've seen a lot of progress in the disease.
the directionally hemoglobin responses that we want, but we can keep going in terms of dose increases. I think it just because you mentioned it in terms of Murmolartner, their study, in momentum study is afterrucks against Danazole.
And it probably works through elk inhibition as well as far as we can tell, but it is not as good a jack inhibitor as rucks as we saw from the early simplify study where there were non non inferior to rucks. So, you know, we expect and we'll see what the FDA does.
that they'll have a label post-RUX there and it's a different need for patients there in terms of that. I don't have anybody else on set anything. Maybe I can say a third world, the picture is really jacked inhibitors are the backbone of all the combinations.
And there you see Roxalitinib is obviously the most important JAK to combine with because it has all these benefits and survival. So there, Halk2 and BED, the question is where do you start introducing a combination versus a single agent JAK inhibitor. That's what we looked at with our suboptimal responder studies we are doing with Parseclizib and you can imagine that with a bed...
So BET and ALK are not really exactly at the same stage of disease progression in MF, and ALK2 could be used earlier than BET in many of the patients. Now, we'll see, we'll do the experiments, we'll do the clinical trial, but at the end of the day, that's what we are looking at. And then, there is a question of can you treat patients with MF who are refractory to...
JACFI with a non-JAC based type of treatment and that's also something that for a BET inhibitor we could we could test in the late stage setting. Thank you. Next question is coming from Mara Goldstein from Mizzou. Your line is now live. Great, thanks so much for taking the question. I just had two questions. In the first...
there.
And I think that data is driving enrollment in the Phase 3 program in stop HS1 and 2 incredibly well. I mean, so a lot of interest there. I don't see any impact quite frankly from the approvals of biologics there and a lot of excitement for the agents and we expect to get those studies done very, very efficiently. Asma, the pathophysiology here is, again, relevant jacks that biology in terms of the cytokines that it affects beyond IL 4 and 5, IL 13 as well, T helper 2 biology. It's targeted in the modrids of the year plus Asma, so people who are moderate plus doses are of inhaled corticosteroids and long-acting bronchodilators and are still having...
exacerbations on a yearly basis plus still have you know a sub normal forced expiratory volume So it's for the more severe patients who still have in exacerbations and that's a population Will be targeting to get to proof of concept with for the certain of in asthma. Thanks You thank your final question today is coming from Gavin Clark Gardner from Evercore ISI your line is now live Hey, thanks for taking the question
So, for JACFI and myelofibrosis specifically, roughly what percent of patients are on the lower 5-milligram dose? And I'm just wondering if you think these patients could be at higher risk from other JAC competition? All I can say is that 5 milligrams, so I don't know exactly for how many myelofibrosis patients, around 5 milligrams.
What we do know is that maybe about 25% of the bottles that we dispense are 5 milligram tablets, but as you can imagine, most of those are actually PV and GVHD patients.
Now, what's at risk in myelofibrosis? Well, we continue to grow strong in myelofibrosis. We continue to go up in the treatment paradigm, meaning that newly diagnosed patients more often are coming on JAK-Fi, and therefore they're less anemic, and they're better able to gain a spleen response and a severe
we think that any competitors that are coming will mostly be moved to the second line setting. We've seen that with sadratinib and procritinib. And we think that will continue just because of the advantages that Jackify has for all patients, regardless of dose.