Q4 2022 Incyte Corp Earnings Call
Speaker 2: Slipping, slipping, slipping into the future
Speaker 3: Hello and welcome to the Insight 4th quarter and full year financial results conference 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.
Speaker 4: It is now my pleasure to turn the call over to Christine Cho, head of investor relations. Please go ahead, Christine. Thank you, Kevin. Good morning and welcome to Insight's fourth quarter and full year 2022 Earnings Conference Call and Webcast. The slides presented today are available for download on the investors section of our website.
Speaker 5: Joining me on the call today are Hervé, Barry, Steven, and Christiana, who will deliver our prepared remarks, and Dash, who will join us for the Q&A.
Speaker 6: Before we begin, I'd like to remind you that some of the statements made during the call today are for looking statements.
Speaker 7: 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 SEC.
Speaker 8: We will now begin the call with our VIC.
Speaker 9: Thank you, Christine, and good morning, everyone.
Speaker 10: 2022 was another successful year in which we delivered strong commercial performance.
Speaker 11: and made significant advancements across all stages of our oncology and dermatology pipeline.
Speaker 12: Robin Youse from our current portfolio of commercialized products
Speaker 13: Grew 18% year over year both in the fourth quarter and for the full year
Speaker 14: to $764 million and $2.7 billion respectively.
Speaker 15: Total revenues for the year, which include our RIRT grew 14% to 3.4 billion.
Speaker 16: As we look across our portfolio, the drivers of this double-digit growth are the continued commercial execution for Jackify,
Speaker 17: net sales of which increased 275 million in the year to reach 2.4 billion, and initial contributions from recently launched products and indications, including in JUVI and PEMAZI in Europe and Japan, and Opselura in the US.
Speaker 18: I want to touch briefly on Opselor which we believe will be a significant growth driver for InSight.
Speaker 19: Opcellura was approved in September 2021 for atopic dermatitis and this past July we received approval and launched Opcellura in DTL-iGO as the first FDA approved therapy for repigmentation.
Speaker 20: The approval was well received by dermatologists, patients, and patient advocacy groups, and the launch has been very successful.
Speaker 21: Strong patient demand and increasing formulary access drove net sales of 61 million in the fourth quarter and 129 million for the food year.
Speaker 22: In 2023, we expect an approval for OBSELOI in VT-LEGO in Europe , which adds another layer of growth for the franchise.
Speaker 23: Turning now to our regulatory and R&D achievement, our clinical development pipeline is focused on three therapeutic areas, MPNG, VHD, other hematology and oncology, and dermatology. And we made significant progress across each of these three areas.
Speaker 24: In Limber, we presented new data from ongoing combination studies
Speaker 25: and disclose an important new discovery asset targeting mutant calories, which has the potential to be a disease modifying therapy for approximately 30% of patients in MF and ET.
Speaker 26: In other methodology and oncology we presented updated data for our oral PDL1 inhibitor 28O.
Speaker 27: which shows PROMISE both as a monotherapy and combination agent.
Speaker 28: We also progress per cyclizib into phase 3 for warm autoimmune hemolytic anemia.
Speaker 29: So this is in which sound no approved therapies.
Speaker 30: In dermatology, we continue to expand our portfolio with Obserua and Poverctitinib, focusing in Digi's area where there is a significant and metany.
Speaker 31: Lastly, we had two important updates related to patterns.
Speaker 32: The first is that Insight earned pediatric exclusivity which entitles Insight to six months of exclusivity added to our patents for Jackify and Opsilor.
This expands our ability to enforce our JAK-5 patterns through December 2028.
This extension further applied to our existing Opzeroa patterns.
In addition, late last year we obtained an issued patent and the load claims for the treatment of atopic dermatitis and VT-LIGO respectively.
We are confident in the strengths of this claim, permitting us to protect Obserua out to 2040 in the US.
Before moving into the outlook for 2023, I wanted to take a moment to look back at the growth of our product revenues as shown on slide 6. Over the past five years, approvals for new products and indications, as well as strong commercial execution of our existing portfolio, has allowed us to grow our product revenues to a K heads-on of 18%.
On slide 7, looking at our historical operational performance.
On the left is our revenues, the R6R2 Total R&D and SGNA spend.
We have delivered strong operational performance over the past five years with total revenue growing at the 17% Kager and our operating expenses growing at the 13% Kager.
On the right, we are showing our operating leverage, excluding the impact of dermatology on revenues and sales and marketing expenses. We are showing our operating leverage, including the impact of dermatology on revenues and sales and marketing expenses.
Here you can see our operating performance is even more pronounced.
We can expect to drive further operating leverage over time with our high-growth dermatology franchise, which is in early stages of launch and where we could see two additional approvals in the near term.
Turning to slide 8, as we look ahead for insights, there are four main drivers of sustainable growth and we are already making significant progress in each of these areas and expect to continue to strong momentum throughout the year.
to continue the strong momentum throughout 2023.
The first driver is our Jacobi franchise and Limba program where we aim to expand our leadership in MPN and GVHD.
In 2023,
Beyond the approval of Roxolitinib-XR, we expect important data, including pivotal results for our parthaxis-zip combination in suboptimal responders to JAK-FI in MF.
Next is Opserua where we are launching in AD and DT LIGO and where in 2023 we will be launching in Europe .
In other areas of clinical development, we expect new data from our oral PD-L1 program.
and poverty in eb in poor legal nodularies and VT Lego.
Lastly, we will be monitoring early data from our CDK2 and mutant calor program.
With that, I would like to pass the call to Barry.
Thank you, Herve, and good morning, everyone.
In the fourth quarter of Jacketfinet sales grew 9% year-over-year to $647 million and grew 13% for the full year to $2.4 million.
Total patient demand rose 7% in 2022, driven by an increase in new patients' cross all indications.
The launch of JAKIFY in chronic GVHD continues to be strong, with the total number of patients in Q4 growing 11% versus prior year quarter. A key driver of growth in GVHD is the duration of therapy. And based on recent data, the average duration, which includes both acute and chronic, is approximately 15 months.
On slide 11, as you can see on the left, Jack Fai has grown consistently year over year, ranging from 200 to 250 million each year. We expect to continue strong growth in 2023 with full-year net product revenues to be between 2.53 to 2.63 billion dollars.
Turning to Opsilora on slide 12. We had a strong quarter for Opsilora with continued double digit sequential growth in patient demand in atopic dermatitis and a very successful launch in vitiligo.
As you can see on the chart on the right, total demand, which includes both free and paid drug, grew 34% in Q4 versus prior quarter to reach 84,700 units driven by both new patient growth and an increasing number of refills.
Pay demand as shown by the light blue bars grew 52% in Q4, driven by continued improvements in formulary access. As a result, net sales grew 61% versus prior quarter to $61 million.
Total full year net sales for Upsilon were $129 million.
Looking ahead, we expect both AD and vitiligo to be significant growth drivers for Opsilora.
In AD, Opsilor is the number one prescribed branded agent for new AD patients and its impact on itch, which remains unmatched by any other topical therapy, continues to be the primary driver of prescribing.
We expect the efficacy profile of the Opsilore to continue to drive uptake in AD.
In terms of additional near-term growth opportunities pending the results from the Phase III trial, we could see an approval in Pediatric A.D. next year for 2- to 11-year-olds.
In vitiligo, the size of the market and a potential opportunity is substantial. There are an estimated 1.5 million patients diagnosed with vitiligo in the U.S. And prior to Opsilora's approval, an estimated 150 to 200,000 patients were motivated to seek treatment.
As you know, Opsilor is the first and only product to be approved to help patients repigment their skin, and this provides us with an opportunity to activate many of the 1.3 million patients that are naive to treatment or who have stopped seeking treatment altogether.
And in the next few months, we expect the approval of Opsilora in Vitiligo in Europe , where there are an estimated 1.5 million diagnosed patients living with the disease. Slide 14 shows a few examples of patient advocacy and consumer activity within the Vitiligo community.
We are already seeing high awareness and excitement for Opsilora from patients and we will continue to build an avomentum throughout the year including the commencement of TV direct consumer this quarter.
And lastly on Monjuvi, Minjuvi, and Pemysir.
Monjuvi sales in Q4 were $24 million, up 13% year over year, and revenues were $89 million for the year. The launch of Minjuvi is ongoing in four markets and we continue to gain reimbursement in other European countries.
Net sales for the full year were $20 million, which includes a negative $2 million of foreign exchange impact.
Pemseer grew to $83 million in net sales in 2022, with $20 million coming from outside of the U.S. Again, negatively impacted by foreign exchange by $3 million.
In the U.S., Pemazir continues to grow in total patients on therapy and is established as the standard of care for patients living with cholangiocarcinoma with FGFR2 alterations. With that, I'll turn the call over to Steven.
Thank you, Barry, and good morning, everyone. We made significant progress across our clinical development portfolio in 2022.
We had multiple clinical and regulatory achievements throughout the year, and I would like to use the next few slides to highlight a few of the key programs.
Starting with our Limber Program on slide 18.
Key data were presented at the 2022 American Society of Hematology annual meeting, where we had 57 abstracts accepted for presentation.
Highlighting two of those presentations starting on the left, we presented initial results of the Phase I II study evaluating our L2 inhibitor, Zalurgi-Sertib, in monotherapy and in combination with Ruxilitnob.
which demonstrate improvement in anemia and hemoglobin responses in patients with myelofibrosis.
Additionally, we disclose our discovery of 989, a novel anti-mutant cattle reticulant monoclonal antibody.
which has been shown to selectively inhibit the proliferation and differentiation of cells harboring mutant calor while not affecting wild-type or normal healthy cells.
On the right is a list of key updates across Limba that are expected this calendar year.
Starting with Ruxolitinib XR, we have a PDUFA date of March 23rd this year and the expected approval is an important step towards fixed dose combinations with parsiclucib, sclergi sertib and ALBET inhibitor.
In terms of data, we expect pivotal Phase III data for raxelitinib plus parsiclosib in suboptimal responders as well as more mature datasets of raxelitinib with ELK2 and BETT in the second half of this year.
Depending on what we see with ALK2 and BET combinations, we could potentially see the start of pivotal trials with one or both of these compounds. Early in the pipeline is our anti-mutant-CalR monoclonal antibody, which will enter the clinic this year. We'll talk about that later.
Depending on what we see with ALK2 and BET combinations, we could potentially see the start of pivotal trials with one or both of these compounds. Early in the pipeline is our anti-mutant CalR monoclonal antibody, which will enter the clinic this year. With regards to graft versus host disease, while we wait till our academic Ha Judiciary Council
We're expecting pivotal data media from Agave 2021, the study evaluating acetylamab in third line chronic graft versus host disease.
Moving to the rest of our hematology and oncology portfolio.
Key data for the small molecule oral PD-L1 program were presented at the Society of Immunotherapy of Cancer Annual Meeting.
Both 280 and 318 demonstrated clinical activity with tumor shrinkage and were generally well tolerated.
and we expect to share more mature data set in the second half of this year.
In addition, we plan to initiate combination trials of 2-8-0 without a grasp
CTLA4 and an oral VJF inhibitor in the first half of the CO.
INCB123667, our novel potent and selective oral small molecule inhibitor of CDK2, entered phase 1 clinical development.
Here we could see utility in cyclin E amplified or over-expressing cancers as well as in cancers that are resistant to CDK46 inhibitors.
Now looking at our dermatology franchise on slide 20.
In July of last year, Opsilura gained its second indication in Vitiligo.
This was a huge achievement for the vitiligo community and people living with the disease.
As we continue to maximize the potential of the Ruxilidnev cream, we initiated multiple phase two studies in different conditions, including Lycan planus, Lycan sclerosis, and higher exonitis supertiva. In each of these diseases, there are no topical or oral therapies approved. We have many important milestones in dermatology upcoming in 2023.
For loraxalitinib cream, the CHMP opinion in vitiligo is currently on track for the first quarter of this year, while data from the phase 3 vitiligo maintenance and withdrawal study and the phase 3 pediatric AD study will be available in the first and second half respectively.
Turning to proboscipnB
We expect Phase 2 data in both vitiligo and paragonodularis later this year.
Additionally, I want to highlight that later this week at the European Higher and United Super Tiva Foundation, we have an oral presentation of the updated 52-week data from our Phase II study in H.S., which should provide some additional insights into the durability of response with this agent. Lastly, or a molar map.
newly acquired IL-15 receptor beta monoclonal antibody is expected to enter the clinic for vitiligo.
As you can see on slide 21, we're looking forward to another busy year with multiple regulatory and clinical updates.
With that I would like to turn the call over to Kristiana for the financial update.
Thank you, Stephen, and good morning, everyone. Our fourth quarter results reflect continued strong revenue growth with total product revenues of $764 million, representing an increase of 18% over the fourth quarter of 2021. Total product revenues are comprised of $647 million for Jack.
like Leucic, Pemazir, and Minjubi, who were infected by anti-verbal changes in FX rates.
On a constant currency basis, other hematology oncology net product revenues grew by 23% over the prior year period. Total royalty revenues for the quarter were $132 million and are comprised of royalties from the parties of $91 million for Jacobi.
and $4 million for Tabrector, and royalties from Lily of $36 million for Aluminum. Juckery and Aluminum royalties for the quarter were negatively impacted by FX headwinds, while Aluminum royalties were also impacted by a decrease in net product sales of Aluminum for users.
as a treatment for COVID-19. Excluding the impact of COVID-19-related sales and currency fluctuation, aluminum royalties increased 23% compared to the prior year period. For the full year 2022, total net product revenues were $2.7 billion and total revenues were $3.4 billion.
As payers continue to add up Solura to formularies and the share of covered claims increased, we continue to see improvement in the gross to net discount rate.
The gross to net discount rate decreased from an average of 71% in the third quarter of 2022 to an average of 57% in the fourth quarter of this year. And we exited 2022 at an agreed discount rate of abouthouse head.
to net discount rate of 50%.
While we will continue to work on reducing patient copay and in turn improving gross to net, an average gross to net of 50% is a good working assumption for 2023, with a gross net discount in the first quarter of the year expected to be higher than subsequent quarters as plans reset patient deductibles at the beginning of the year.
I would also like to take the opportunity to update you on the OBSCELURA prescriptions data provided by QVIA.
As you see on slide 26, in Q4, we saw the gap between the actual number of total prescriptions and the number of prescriptions reported by Icubia narrowing. While the Icubia data continues to overstate demand, this overstatement has been reduced to a level of 5-10%, which is within expectations for a newly launched vaccine.
In addition, it is important to note that IQVIA data reflects total demand, which includes both paid prescriptions and free drug. Going forward, free drug is expected to represent around 20% of total demand. When looking at IQVIA data, one would need to adjust for this overstatement.
as well as for free drug in order to get a better sense of paid demand. Moving on to slide 27 and our operating expenses on a GAAP basis, ongoing R&D expenses were $431 million for the fourth quarter and $1.5 billion for the second quarter.
drug in order to get a better sense of paid demand. Moving on to slide 27 and our operating expenses on a gap basis, ongoing R&D expenses were $431 million for the fourth quarter and one and a half billion for the full year 2022.
Total R&D expenses, which include the upfront consideration of $70 million for our acquisition of the Laris were $501 million for the fourth quarter.
For the full year 2022, total R&D expenses, which in addition to the Vilaris upfront payment also include $56 million in other milestone payments, were $1.6 billion, representing a 9% year-over-year increase. The increase was primarily due to the progression of our pipeline.
The year-over-year increase was driven by investments related to the new dermatology commercial organization in the US and the related activities to support the launch of OBSELURA and atopic dermatitis in Vitiligo.
Moving on to 2023, I will now discuss the key components of our guidance on a gap basis.
For Jackify, we expect net product revenues to be in the range of $2.53 to $2.63 billion, which at the midpoint represents an increase of approximately $170 million over 2022, driven by continued growth across all indications.
We expect our Gross to Net adjustments for 2023 to be approximately 23% reflecting expected continued growth in 340B volumes. As a reminder, the Gross to Net adjustment in the first quarter of the year is always higher relative to other quarter.
and it was a previous quarter and subsequent quarters due to our share of the doughnut hole for Medicare for the patients.
For other hematology oncology products, which include Temazir in the US, EU and Japan, and Iclusega and Minjubi in Europe , we are expecting total net product revenues to be in the range of $215 to $225 million.
Turning to operating expenses on a gap basis, we expect COGS in a range of 78% of net product revenues, which is in line with 2022. R&D expenses are expected to be in the range of 1.61 to 1.65 billion dollars, representing 3% year-over-year growth at the midpoint. R&D expenses are expected to be in the range of 1.75 billion dollars. R&D expenses are expected to be in the range of 1.75 billion dollars.
SG&A expenses are expected to be in the range of $1.05 to $1.15 billion, primarily reflecting continued investment in OPCELURA and the full year impact of the investment in the Vitilago indication.
Operator, that concludes our prepared remarks. Please give your instructions and open the call for Q&A.
Thank you. Now the conducting of question and answer session. If you'd like to be placed in the question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to move your question from the queue. For participants using speaker equipment, please press star 1 on your telephone keypad.
may be necessary to pick up your handset before pressing star 1. One moment please while we poll for questions. Our first question today is coming from Salveen Richter from Goldman Sachs Realign. Is that live?
Good morning, congratulations on the quarter. Two questions for me. One is, you know, I recognize you do not provide up to Laura Guidance for this year. But can you provide any details on duration of treatment or number of tubes per year and average for an 80 patients and how it might play out in Vidal Igo? And are there any inventory dynamics to highlight here?
The second question is on the bet in L2 inhibitor combinations. Can you speak to your confidence in these programs now given the early data? Do you think that represented proof of concept? And what do you want to see on the forward to move into later stage studies?
Sure. So I'll answer the first part of the question or the first question and get it to Stephen afterwards. So just in terms of duration of therapy for Opsila or in vitiligo, it's obviously very early in the launch. So as far as continued duration of therapy, you know what the studies had continued through 52 weeks and beyond.
And the tubes per year, we've said before that the average tubes per year we think will be about 10 for vitiligo patients. In terms of inventory at the end of the year, it's actually very low. The inventory was more like two to three weeks, just the standard inventory that we would have on hand. Stephen? Thanks, Sylvie. And I'll just separate out both programs.
monotherapy escalation and in combination with RUX, we saw a few patients with quite substantial hemoglobin increases which gave us you know a lot more confidence in that program going forward. For this year in the beginning of the year we'll continue to dose escalate. We still had relatively low doses particularly in combination with RUX to get you know towards a maximum effect. We don't expect to see much.
in terms of tolerability, in terms of negative side effects at all. The populations that would be in scope for pivotal studies, to begin with the obvious one would be anemic patients with transfusion dependence to convert them to independence, but then standard anemic patients with anemia from the underlying death and then potentially all comers.
And the reason is, you know, the duly effect. So both to treat the underlying anemia from malafibrosis itself, and then to ameliorate or even reverse the ruxilitin of induced anemia, which will allow you to maintain rux dose intensity.
And we know when we do that that we increase the efficacy of raxalitinib.
So, you know, we're extremely encouraged by what we've seen with L2, we'll continue to dose escalate, and then we'll make pivotal decisions on what population or populations to go after with their program towards the end of this year.
In terms of the bet program Again, we know that pathway epigenetically is important in myelofibrosis Fibrosis we see both
spleen response as well as as symptom responses we also continue to dose escalate this year particularly in combination with ruxolitinib will continue to push the the bed dose from six milligrams to eight milligrams to ten milligrams
We know that the on-target toxicity with BET will be thrombocytopenia. It's across the board with BET inhibitors. We've seen it with our own program and that'll be dose limiting. The likely population there to go after the pivotal study, at least to begin with, because of that profile, would be suboptimal responders. And just to note...
that the competition is doing a first-line study at the moment, so the suboptimal population we think is wide open to go after, and again we'll determine that towards the end of this year. Thanks. Thank you. Thank you. Next question today is coming from Brian Abrams from RBC. Your line is now live.
Hey, good morning. Thanks so much for taking my question. I was hoping you could unpack the Jackify guidance a little bit more. It sounds like at the midpoint of your range you may be expecting a little bit less contribution from both either demand growth or price growth. And it seems by our quick math that gross to net is going to be.
Hi Brian , it's Barry, so thanks for the question. Yeah, I mean as you know that JAK-Fi is really the number one treatment for myelofibrosis, the number one treatment for polycythemia vera in the second-line setting, and for GBHD in both the acute and chronic steroid refractory settings.
of the year for MF. There's two competitors for GVHD. Now, if you remember last year in terms of GVHD, we had a bolus of growth in the fourth quarter of 2021 as patients transitioned from our expanded access program, about more than 300 of them. Mhm.
transferred from our expanded access program to commercial drugs. So seeing that kind of growth again is not likely to happen this year, but we'll continue to see the drug grow quarter over quarter year over year in terms of new patients, total patients in MF, PV, and GVHD. But again, the guidance at this point.
is appropriate. That's really helpful. Thanks Barry. Thank you. Next question is coming from Jessica Fyfe from JP Morgan. Your line is now live. Great. Good morning. Thanks for taking my questions. Looks like you hit the 50% exit rate on ops Laura gross to nuts in the fourth quarter.
Can you talk a little bit about how we should think about gross to nets in 2023 for that product and any quarter to quarter variability we should look out for? Hi, this is Graciana. So in terms of the gross to net in 2023, I think the 50% average rate for the year is a good working assumption.
However, you will see variability between quarters and expect the rate in Q1 to be above that 50% average rate and above the rate that you will see in other quarters. And that's because, as I indicated, the rate in Q1 is below that 50% average rate.
At the beginning of the year, we set the plant's deductibles for patients and as a result, there is more for us to cover which increases further the growth of net rate.
Great. Thank you. The next question is coming from Tazina Maad from Bank of America. Your line is now live.
Hi, good morning. Thanks for taking my questions. On OBLURA, will the split between vitiligo and AD influence what your growth plan will be for this year? And then secondly, longer term, do you expect any difference in compliance rates between patients on vitiligo versus AD? Thanks. So I can take the first part of the question. No, we don't.
So obviously, these patients are staying on it for a long period of time, as long as 52 weeks and beyond. And in terms of AD, patients use it until their inflammation and itch is gone. Then they generally will stop for a while. If their flare comes back, their itching comes back, their inflammation comes back, then they'll start using it again. So...
I believe they're compliant. It's just different diseases, obviously. Some needing short-term use and some like the LIGO. They're going to use it probably for a long period of time. Thanks. And have you noticed any seasonality during holidays?
Well, seasonality during holidays, well, holidays generally, across the board for all of our products generally during holidays like Christmas and Thanksgiving, for example, you see prescription rates go down. But in terms of summer versus winter, we don't see any difference now and don't believe that there's really any evidence that there's a difference in seasonality for AD or vitiligo amongst individual patients.
they may perceive the difference being that there's differences in the summer versus winter and so forth. Okay, thank you. Thank you. Next question today is coming from Vikram Purohit from Morgan Stanley . Your line is now live.
Good morning. Thanks for taking the questions. The two on dermatology from our side. First, for the phase 3 data expected later this year for a record train in the pediatric AD population, what would you consider a strong outcome here, and how do you size the commercial opportunity with the pediatric population versus the adult population?
And then my second question is on Poverseutnant. For the data expected in the first half of this is a bit of LIGO. Again, what would you consider a good outcome? And how do you envision Poverseutnant being used if it eventually improves versus an observer? Thanks. The Chrome Hi, Steven. So the pediatric atopic dermatitis study
we expect so efficacy wise firstly we expect it to be you know the same as in adults there's no reason that the pathophysiology of the disease is the same and we expect the same outcomes and then safety wise we don't expect anything unusual either you know they separate the populations out for obvious reasons like you know this is a time when bone growth except was occurring
So there are other things that are monitored from a safety perspective. But from our preclinical data and then data with oral rucks, which is as much higher exposures in pediatric patients, we don't expect anything unusual there.
In porvositton of your second question in Vidaligo, it's a different population to the RUXC cream population. There is a slight overlap, but the porvositton of indication that we go in afterwards is for patients with body surface area involvement of 8% or above. The current Vidaligo label is 10% or below our body surface area involvement, which is to compromise the bad.
you know, 80% of vitiligo patients. Because of the slight overlap, it's not straight math, but the 8% or above is about 30% of vitiligo patients. And then we think because of the more extensive vitiligo there, there'll obviously be a different tolerability profile that would be accepted by patients and regulators in terms of therapeutic ratio.
every expectation of substantial efficacy given the mechanism of action. And also, you know, we know this will be a likely be treated as an oral JAK inhibitor in a quote unquote inflammatory condition from a safety perspective. And so we are wide open on that.
So again, substantial efficacy expected and the safety labeling will deal with at the end.
Yeah, so Stephen mentioned the commercial opportunity for children that are younger than 12, about 2 million. So when we think about pediatric patients overall, the percentage of pediatric patients that have eczema atopic dermatitis is greater than adults, but there's many, many more adults. So therefore, even a lower percentage, you end up with a higher number of patients that potentially have eczema.
So we think it's an exciting opportunity. We also think it's just great for patients because we believe that Opsulaura is going to improve the lives of some of these patients with eczema who are younger than 12.
Okay, got it. Thank you.
Thank you next question. Today is coming from Kripa De Veraconda from Truist. Your line is now live.
Hi guys, thank you so much for taking my question and congrats on the quarter. I had a question regarding the survey results that you have for, I think it's a doctor survey and they talked about patient candidacy. Is that growth in what the doctors are saying about patient candidacy being reflected in new patient starts or is there a lag?
And also if you compare new prescriptions for atopic derm versus vitiligo, are you seeing the patient's candidacies stats being reflected? It seems like there's more enthusiasm in the vitiligo. I mean, granted, it's the only drug approved. And just, I know you don't give up the lure of guidance, but I was just wondering if in the future...
who treat these diseases, we think it does rapidly turn into increased prescription volume. For Vidaligo, it just may take a little bit longer because remember where encouraging patients to come back because now there is a treatment for Vidaligo where there never was. So to go back and see their dermatologist so that might take a little longer period of time, then patients who are actively being treated for eczema but aren't getting results that they expect.
potentially about themselves in terms of the guidance I'll turn it over to Cristiana. So Crepa we would like to see a few more quarters of update before we provide any guidance on obselura which would also include VTLigo and especially around VTLigo asa.
very indicated. We are looking at the inactive patient population and how quickly they will get activated and will come to seek treatment. So we would like to see that before we are in a position to provide any guidance on Opsonura.
Thank you so much. Thank you. Next question today is coming from Eva Pivatera from Cowan and Company. Her line is now live. Okay. Thank you so much. Great. I'll turn it over to Eva and then we'll get to the next question. Eva, are you still there? Yes. Hi there. Hi, Eva. Hello. Hi, Eva. Hi, Eva. Hi, Eva. Hi, Eva. Hi, Eva. Hi, Eva. Hi, Eva. Hi, Eva. Hi, Eva. Hi, Eva. Hi, Eva.
Hi, good morning. Congrats on the quarter and thanks for taking your questions. So for OBSO-LORA, based on the press release numbers for total units and the Q4 net sales, we calculated a birth to net of 62 to 63%. Can you maybe help us understand what may account for the discrepancy between that and your Q4 57% first to net number? Yeah.
part of the gross to net. So you need to look at paid demand and apply the net price which would be around 2,000
the gross price times the 1 minus 57% gross net discount. Okay, thank you. And are you still comfortable with the 40 to 50% long-term guidance range? It sounds like in the near term it will be closer to 50. Can you possibly narrow that guidance now? Yes, so we will continue to work on…
Another question on ALK. So ALK2 has the potential applications in two other anemias outside of myofibrosis. Are you interested in some of these applications? And what do you need to see from the MS program in order to open up some of these other studies perhaps?
Thank you. It's a good question. You know mechanistically, as I was saying in my earlier remarks, it works through Hepsardin inhibition. That is the main mediator, if you will, of anemia of inflammation and chronic inflammation, which occurs in many chronic conditions. So there's potential across the board in some of those conditions.
including chronic renal failure. So you know we'll we start in some early work in some of these settings to see if there's potential there. We are encouraged by recent regulatory movement in the US from the FDA in improving products to treat anemia.
in areas like chronic renal failure, which has been difficult in the past. So that may make us look a little further. But for all those indications and the look there, it's still very early days. Thanks. Thank you, Steven.
Thank you. Next question is coming from Evan Segerman from BMO Capital Markets. Your line is now live. Hi guys. Thanks so much for taking my question and congrats on the progress. You know, it's clear that there are really no supply issues for Apsolera, but maybe talk to me about kind of what the sales team is focusing on this year to accelerate growth even further. I mean, you had a good 2022, you are getting growth to net more normalized.
What is your commercial organization focused on to get sales to the next level and ensure that you have the highest number of paid scripts over the year? Thank you. Sure, Evan. And so the sales team is actively engaged with their dermatologist on a regular basis. Fortunately, we have...
very good access as compared to some other therapeutic areas perhaps. They're focused both on AD and Vidaligo. It's exciting that Vidaligo launched just a short period of time ago.
very exciting because it's the only drug use that's available for re-peaping patient in these patients, but there's so many millions of patients that actually could be, could benefit from Opsilora or atopic dermatitis. So they're really focused on both. So their drive is to focus on itch and inflammation in AD and obviously.
on sticking with Opsilora to treat their Vidaligo. So they're concentrating on educating healthcare professionals, for example, in Vidaligo that, you know, what they should see over a period of time, over eight weeks, 12 weeks, 24 weeks, and so forth so that the...
They reinforce the compliance and the need to use the drug for a while before they see a real big impact on repeat pigmentation. And in the same way, they're concentrating on making sure that patients do, in fact, get their refills for atopic dermatitis so they get complete relief from their disease and know that if they have flares again, they should come back. So the sales team is very engaged and very excited about the opportunities that lay in front of them for both atopic dermatitis and vitiligo.
you be looking for in the Phase III readout of RUX plus parsaclisib later this year and how will that impact your overall strategy for the Limber Program. Thank you.
Okay, Stephen, thank you. So the LEMBA program obviously critically important to us and to patients and we're really happy with the movement particularly towards the end of last year in our combination work. So to start off with your Rucks plus Poster Cliffs of Question, just a reminder, there are two pivotal studies ongoing there.
The first one is the suboptimal study in about 212 patients, which we will get a read out on this year. That's on patients who've had at least three months or longer of ruxolid nerve and at least eight weeks of stable dosen and are having an adequate response in terms of spleen or symptoms. We showed the final phase to data at ash last year.
both in terms of spleen response and symptom response. And very encouragingly, the symptom response was even, you know, from a quantitative point of view and magnitude, was even better than the spleen response, which is really encouraging. Additionally, the safety profile in the MF looks very clean thus far with quite long-term follow-up. So it's not what's seen in lymphoma.
probably because the underlying disease is different, there is no, you know, B cell suppressor therapy is given long-term in MF and also additionally, using combination with RUX may emitterate some of the side effects. So we're very encouraged by the profile there, it's a randomized study that will report out this year and suboptimal.
responders. If we replicate the phase two data, we really think the phase three will be positive and is set up to be positive there. And then it will be exactly for those patients who are, you know, been on Rucks for a few months, stable doses and not having benefit. And then that would be the indication there. The first line study will take about a year longer to read out 440 patients and that's an all-comer first line.
standard in terms of endpoints, it's been volume response of 35% or greater and improvements in total symptom scores, you need both.
You mentioned the vet program, you know, that's that's earlier as I said in some comments earlier You know, we've continued to dose escalate this year and push the dose as high as we can We know we'll run into thrombocytopenia That'll be dose limiting and that's why we think it may be best suited more to a suboptimal population And you know again, it'll be similarly to both improve
efficacy and make sure it's horrible in that setting and then the populations will segment based on the data there. The rest of the health program as I said earlier will declare towards the end of this year what programs we're going after there.
Again, very encouraged by the hemoglobin responses we see, and we really have proof of mechanism and want to chase that very aggressively because we lead us in that field. Next question is coming from our goal scene from Azure Voterline of NLIs. Oh, great. Thanks for taking the question. So, um.
Firstly, on the covered prescription rate, you mentioned anticipate about 20% free drugs. So that would indicate you're at 70% covered at this point in time or 71%. How quickly do you expect to get to that incremental difference? And is it consistent among Vidaligo and atopic dermatitis? And secondarily, can you talk a little bit about the expectations for the...
rollout of RuxQD and how we should think about how that will affect Jackify. Sure. So, Mara, this is Barry. So, the covered rate, actually, the commercial patients that have access to commercial drug through their insurance is about 84% right now. In terms of Holly-
coverage beyond that, it's about 90%. But obviously, these numbers don't match up because there's a lag in getting utilization criteria written and so forth. But we're very happy with the coverage that has happened thus far. We're very happy with, for example, Medicaid coverage, which is covered in all 50 states. And like I said, the commercial insurance continues to get better and better. We still have some work to do and improving a variety of things.
including copay and utilization criteria, that might not be exactly where we want it to be. In terms of AD and vidiligo, the coverage is essentially the same. The commercial coverage is essentially the same. The Medicaid, VA, DoD coverage is essentially the same. The only thing about vidiligo is there's some less, but it's improving every day.
the number of utilization criteria that have been written related to Opsilor and Vitiligo. But I have to say, compared to when we launched Atopic Dermatitis, the number of issues, problems with getting Vitiligo scripts filled is very, very low. In fact, we don't hear that much about it at all.
In terms of RUXQD, I think we mentioned already that the PDUFA date comes in March. We plan on launching sometime after that, a few weeks after that in April . And when we announce the approval, we'll give you some more information about how we're going to roll this out, the positioning and so forth of RUXQD. But we're very excited about the upcoming launch.
We think it really gives an opportunity for better convenience for patients, which could lead to better compliance for patients. And at least for some patients, better compliance could lead to better outcomes. So we're really looking forward to that. All right. Thanks so much. Thank you. Next question is coming from Ren Benjamin from J&P Securities. Landmine family is also husband and wife of a couple. His wife Makpower handicap was offered a
where does AXA kind of fit into this program, especially after the pivotal data expected in mid-23? And if I can just squeeze one extra one, can you just give us some thoughts on TAFAA and how you're thinking about the reduced expectations for 2023, at least in the US? Sure, this is Barry.
So in terms of the split between acute and chronic, there's about 1,500 patients in steroid refractory acute GVHD. As I said before, we're the number one drug used there in steroid refractory acute GVHD. But there's much less patients, and they're treated for a shorter period of time.
So it might be, for example, six months for acute GVHD. For chronic GVHD, there's 14,000 patients, maybe 7,500 that are steroid refractory. So most of the growth is coming from chronic GVHD and the persistence in chronic GVHD. Now, most of the time, the claims that would come in don't really differentiate between acute and chronic. They don't look like any help is available, but most of the time they result in less then
But as far as we can tell, the vast majority of scripts that are coming in now are all for chronic GBHD. And as I said, in terms of persistent population, their position population is much, much bigger than any cute space. In terms of a Brutinib and...
Resirock, for example, these drugs are used perhaps in the third line setting. As far as we can tell, ibrutinib usage is declining and Resirock's use is third line after Jackify. But in terms of axotilumab's opportunity, ibrutinib usage is declining and Resirock's use is third line after Jackify.
we think it's a great opportunity. In fact, even the success of Resirac in the third line setting, I think, bodes well for the success of axotilumab in that setting. And I think it's a uniquely different drug. And when we talk to people who treat bone marrow transplant docs, who treat GVHD, they're looking forward to this product very much.
In terms of TAFAA, it's TAFAA-LEN combination. It's a great combination in the second line setting. You've seen the results in terms of overall response rate, complete response rate to 40%, a non-chemotherapy option in the second line setting.
I think the issue there is really that the second line and the whole diffuse large B-cell lymphoma marketplace has changed dramatically with increased competition, particularly with the CAR T therapies moving into the second line setting. It becomes a challenging place for us to break through, but it's absolutely...
a very good product that can have complete responses with long durations of response. And we're continuing to try to expand the use of this drug, because we think patients will really benefit from it. And it's really just the competition and the increasing competition in that particular setting, in the second line plus setting, that's somewhat of a challenge.
Great, thanks, Barry. Next question is coming from Allison Bratsole from Piper Sandler. Your life is in that life. Hi. Good morning. Thank you for taking my questions. One for me on OXILORA. I know a determinant of the ultimate size of the Vidal Eye Go opportunity is going to be activation of patients who are currently seeking treatment. I know it's clearly early days in the launch, but I just wonder if there's anything you can say about how. This channel is going really badly. It started in the morning or during various tests.
is checking against your expectations? Is this not really expected to be a driver until vitiligo specific ETC is underway? And then just a separate question on the other Hemon franchise. The 2023 guidance range seems to imply somewhat limited growth compared to 2022. So could you expand on the growth areas for that franchise for the year and any sort of pushes and pulls you considered in the 2023 guidance range? Thank you.
OK, so I'll start and then I'll hand off to Christiana, I guess. So in terms of patient activation for vitiligo, I think it's happening already. We haven't started linear and non-linear TB commercials, direct-to-consumer TB commercials, for vitiligo yet. That will start very soon. The patients are being activated. There's direct-to-consumer activities.
going on online, on social media, on internet searches. We work very closely with the Vitiligo patient advocacy community. We work with health care professionals and even do live programming between health care professionals and patients. That is occurring now and it will continue.
to a much greater degree in the future. I think you can see by our presentations, there's lots of excitement for patients who have gotten very good experience using the drug and are proud to share that. So that helps a great deal in informing patients who may actually benefit from this drug. And in terms of guidance, perhaps I'll hand it over to Christiana.
So in terms of the guidance for other HEMONC, the guidance range that we have provided is $120 to $225 million with primary driver being Minjubi.
terms of the guidance for other hemoan, the guidance range that we have provided is $215 to $225 million with primary driver being Minjouvi. Of the increase, yes.
Thank you. Our final question today is coming from Matt Pips from William Blair. Your line is now live. Hi, thanks for putting me in. Barry, you cited additional competition in MF this year as a reason for the appropriateness of your guidance today, but I guess don't really expect those labels to directly compete with JAG-ify. So I wonder if you're starting to see maybe patients who were kind of suboptimal responders switching a little earlier or now having another option to switch.
to determine that. In terms of future, obviously, we're looking to Moelatinib. Has a PDUFA date in June . And we don't know what GSK is necessarily going to do with that product. We don't know what the indication necessarily is. But we think that patients will continue to benefit from JAKA 5 because of the differentiation of clilla virus and its Sharks.
overall survival, un-un-un-un-surpast symptom improvement, and spleen volume reduction. We think that will continue, and these other drugs will be used in the second line setting, but we're not sure exactly, you know, how this is going to play out, and that's why I think we gave the guidance that we did. Thank you. We reached out to our question and answer session. I'd like to turn the floor back over 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 and have a wonderful day. We thank you for your participation today.