Incyte Q4 2023 Earnings Call Transcript

Quartr
Provided by Quartr
February 13, 2024

There are 18 speakers on the call.

Operator

Hello, and welcome to the Incyte 4th Quarter Earnings Call and Webcast. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Ben Strain, Associate Vice President, Investor Relations. Please go ahead, Ben.

Speaker 1

Thank you, Kevin. Good morning, and welcome to Incyte's Q4 2023 earnings conference call. Before we begin, I encourage everyone to go to the Investors section of our website to find the press release, related financial tables and slides that follow today's discussion. On today's call, I'm joined by Herve, Barry, Pablo, Steven and Cristiano, who will deliver our prepared remarks will participate in the Q and A. I would like to point out that we will be making forward looking statements, which are based on our current expectations and beliefs.

Speaker 1

These statements are subject to certain risks and uncertainties and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail. I will now hand the call over to Herve.

Speaker 2

Thank you, Ben, and good morning, everyone. So on Slide 5, we achieved another strong year with 2023 product and royalty revenues growing 14% versus 2022 to reach €3,700,000,000 continuing the strong performance we have delivered since 2018. We also achieved the symbolic milestone in the Q4. Total product and royalty revenue reached €1,000,000,000 quarterly for the first time, driven by the continued growth of Jakafi and successful launch of Occellua. So moving to Slide 6.

Speaker 2

2023 Jakafi net sales were $2,600,000,000 growing 8% versus the prior year with growth across all indications year over year. And OccelloRaz saw strong momentum in 2023, growing 162 percent to 338000000, driven by new patient and refills in both A. D. And Vitiligo. We expect Occeira to continue to be a key contributor to growth in the next years.

Speaker 2

On Slide 7, our clinical pipeline has the ability to deliver transformative therapies to patients across multiple programs and provides the opportunity for 10 high impact launches by 2,030 as presented recently in San Francisco. Importantly, some of the programs highlighted on this slide are de risked as they are post proof of concept, including axatilimab, which has been submitted to the FDA for approval, Rockstream in pediatric atopic dermatitis to be submitted to the FDA by MEDIA, Workscream in HS where we have randomized Phase 2 data and paricitinib where we are in Phase 3 in HS Vitiligo and in PN where we are on track to initiate a Phase 3 study this year. Each of these programs have the potential to address a significant market and provide an opportunity to contribute to the top line before the end of the decade. I would also like now to highlight the recent transaction with MorphoSys on Slide 8. As described in the press release we issued last week, We entered into an asset purchase agreement with MorphoSys, which gave us exclusive global rights for tafacitamab, also known as Monjuvy or Minjuvy.

Speaker 2

This acquisition provides a number of benefits to Incyte in the short term. 1st, going forward, we will now record all revenues from Monjuvie in while eliminating MorphoSys' share of the royalties ex U. S. And all future milestone to MorphoSys. 2nd, we will realize significant operating efficiencies and cost synergies in U.

Speaker 2

S. Commercialization and in global development by removing redundant position and redundant external expenses and by simplifying the org chart. Therefore in 2024, this deal will add to Incyte's revenue and will have a limited impact on operating income. For the future, while the currently approved indication of relapsed refractory DLBCL represents a smaller opportunity for tafacitamab, We see upside potential in 2nd line follicular lymphoma and marginal zone lymphoma with Phase III data expected later this year and in first line DLBCL for which Phase III data are expected in 2025. These programs have been co founded by MorphoSys until now and if positive, Incyte will fully benefit from the upside from this indication.

Speaker 2

And this acquisition will be value accredit for Incyte in all scenario. I will now turn the call over to Barry, who will discuss our commercial performance in more details.

Speaker 3

Thank you, Ervane, and good morning, everyone. Starting with Jakafi on Slide 10. In the 4th quarter, Jakafi net product grew 7% year over year to $695,000,000 and grew 8% for the full year to $2,600,000,000 Total patients increased 6% in 2023 with growth being seen across all indications. We experienced some variation in Jakavi dynamics during the Q4, including an increase in patients on free drug as well as an inventory fluctuations. Recall inventory drew down modestly in Q3 and rebounded in the Q4.

Speaker 3

Additionally, we anticipate the increase in patients on free drugs seen at the end of 2023 to reverse and return to more normalized levels through 2024, supported by the lower out of pocket expenses under the Part D redesign. Christiana will provide more details on these dynamics in her prepared remarks. We continue and we expect continued growth of Jakafi and have updated the full year net product revenue guidance for 2024 to a range of $2,690,000,000 to $2,750,000,000 As highlighted on Slide 11, Jackify continues to maintain its leadership and market share in MF driven by its unmatched product profile. Based on market research, Other competitors have not had an impact on Jakafi in regards to total patient market share or new patients and is consistent with our expectations. Jakafi demand remains strong and we expect continued future growth driven by maintaining its leadership as standard of care in myelofibrosis, Growth opportunities in polycythemia vera and chronic graft versus host disease as well as earlier use in chronic GVHD.

Speaker 3

Additionally, we anticipate the positive changes in out of pocket expenses for Medicare Part D patients to contribute to the growth in the coming years with the biggest impact starting in 2025. Turning to Slide 12 and Opseloraforthquarterperformance. Opseloraf net product revenues in the 4th quarter were $109,000,000 up 78% when compared to the same quarter last year. Total 2023 full year net sales grew 162% versus 2022 to reach $338,000,000 U. S.

Speaker 3

Patient demand increased during the quarter with total prescriptions growing 77% year over year and refills growing by 22% versus the prior quarter. The weekly prescription trend as shown on the right demonstrates typical end of Q4 dynamics as well as the continued growth of OXOLORA, which is coming from both atopic dermatitis and vitiligo. In AD, growth was primarily driven by Opseloras efficacy and impact on inflammation and itch. In Vitiligo, where Opselorra is the only approved treatment for repigmentation, growth was driven largely by refills, improved access and our educational initiatives. We remain very optimistic about the long term potential of OXOLLORA as we continue to see strong uptake.

Speaker 3

The launch continues to be strong and is gaining positive momentum with both physicians and patients as Opselor becomes Established as one of the best recent dermatology launches. Looking at the 1st 27 months post FDA approval, OXELURA continues to outperform other dermatology products on a launch aligned basis when measured by monthly dermatologists Prescribed TRxs on the left and when comparing quarterly net revenues on the right. The successful launch of OXOLLORA is driven by its compelling product profile, its ability to address significant unmet need in both atopic dermatitis and vitiligo and our strong market access relative to competition where we continue to improve access and growing net sales. Turning to Slide 14, we have a number of initiatives in place for Opselor to drive demand in 2024 in both AD and vitiligo. We know that based on Opselor's compelling efficacy and safety, Healthcare professionals want to use Upsilora sooner in the treatment algorithm.

Speaker 3

In addition to securing improved access for 2020 We are also continuing to look for ways to improve utilization management and we have an exceptional value proposition that supports these advancements. For Vitiligo, we continue to drive patient awareness through consistent marketing campaigns with the goal of educating and inspiring these patients with positive real world patient experiences, we believe this will drive further demand and activate patients to discuss treatment options with their dermatologists. With that, I'll turn the call over to Pablo.

Speaker 4

Thank you, Barry, and good morning, everyone. I want to highlight some of the key R and D milestones that we accomplished in 2023 and to provide a framework for how we are evolving our R and D focus with the near term goals to increase the rigor of our decision making, accelerate the progression of our pipeline and to optimize our resource allocation. As you can see on Slide 16, we have three areas of focus where we're building a robust and diverse portfolio of medicines for the treatment of MPNs and graft versus host disease, oncology and inflammatory diseases. We're advancing a pipeline to delivering impactful innovation with a focus on best in class and or 1st in class differentiated medicines in areas with large unmet medical needs. Our discovery process is target and pathway centric and leverages cross program knowledge and deep biology expertise in our established disease areas of interest to identify and prosecute novel targets as well as disease and genotype specific dependencies with a modality agnostic approach.

Speaker 4

In addition to our established small molecules expertise, We have expanded our drug discovery capabilities to include monoclonal antibody discovery in house and have access to bispecific antibody discovery capabilities through our partnership with Merus. Turning now to Slide 17. We made significant advancements across all three priority areas of focus the R and D portfolio in 2023. In MPNs and graft versus host disease, we submitted the BLA for axotilumab for the treatment in 3rd line chronic graft versus host disease. We presented updates for our bet and our 2 inhibitors in MF and highlighted our new potentially transformative therapies for MF, PV and ET, our mutant collar monoclonal antibody, which is enrolling well in a Phase 1 study and our JAK2V617F inhibitor for which we plan to initiate a Phase 1 study in the next month.

Speaker 4

In oncology, we initiated several monotherapy and combination studies with our small molecule oral PD L1 inhibitor and highlighted early signs of clinical activity with our small molecule CDK2 inhibitor. Additionally, We unveiled a new program in development, our KRAS G12D inhibitor, which entered the clinic earlier this year. Stephen will provide more detail on the KRAS G12D program in his prepared remarks. In dermatology, we continue to maximize the potential ruxolitinib train. In 2023, OXOLURA was approved in Europe for vitiligo as the first and only approved treatment for repigmentation.

Speaker 4

We also presented positive Phase 3 data in pediatric atopic dermatitis and announced that the primary endpoint was met in a randomized Phase 2 study in patients with hidradenitis suppurativa. For poversitinib, we presented positive randomized Phase 2 data in vitiligo and initiated 2 Phase 3 studies for patients with extensive vitiligo. We also announced that polvorositanib had met the primary endpoint in a randomized Phase 2 study in patients with prurigo nodularis and we initiated 2 randomized Phase 2 studies many patients with asthma and another in patients with chronic spontaneous urticaria. We believe that with ruxolitinib Cream and povarsitinib, will be the only company with the ability to address a broad spectrum of patients from mild to severe, potentially providing both a topical and oral option for a number of indications, including for rigor nodularis, adenitis suppurativa and vitiligo. Apart from an exhaustive list of all the R and D achievements in the past year, this demonstrates that 2023 was a very successful impactful year for Incyte and it serves as a foundation for a number of pivotal trials that will deliver results in the next few years.

Speaker 4

As you can see from Slide 18, we anticipate that 2024 will be another very exciting year with multiple clinical and regulatory milestones. Stephen will provide more details on these, but I would like to highlight certain events. Within our oncology pipeline, we believe that our potentially best in class CDK2 inhibitors is an active agent and we look forward to sharing data as well development plan later this year. In addition, the pivotal trial of tafasitamab in patients with follicular and marginal zone lymphoma, also known as InMIND will read out later this year and we look forward to sharing those results. We submitted a BLA for axotilumab late last year And we look forward to working with the FDA to make axitilomab available to patients with chronic graft versus host disease later this year and to initiate additional combination studies in patients with less pretreated chronic graft versus host disease.

Speaker 4

Within our dermatology portfolio, we expect submit the sNDA for OXELURA for pediatric atopic dermatitis and expect multiple data readouts throughout the year. With that, I would like to pass the call to Steven, who will provide further details on our clinical development pipeline.

Speaker 5

Thank you, Pablo. Starting on Slide 20. In December, we presented more than 40 hematology and oncology abstracts, including a plenary presentation at the ASH Annual Meeting. Key highlights included a plenary scientific session, which featured the full data from AGAVI-two zero one evaluating axotilumab, an anti CSF-1R monoclonal antibody in patients with chronic graft versus host disease And additional data from the Phase onetwo study of zilergisertib, Phase 1 data from our BET inhibitor and preclinical data of the JAK2V617F inhibitor. For our BET inhibitor, dose escalation is ongoing.

Speaker 5

In monotherapy and in combination therapy, we are seeing reductions in spleen length and volume as well as improvements in both symptoms and hemoglobin, suggesting that this is an active compound. We plan on advancing this program to Phase 3 later this calendar year. As we get closer, we will provide additional data details on study design and timing. Based on the efficacy and favorable safety profile seen in the Phase 2 AGGARV-two zero one pivotal study, the BLA for axotilumab was submitted to the FDA for approval for the treatment of patients with chronic graft versus host disease. We anticipate a decision by the FDA in the second half of twenty twenty four and are excited by the possibility of bringing a new treatment option to these patients.

Speaker 5

We continue to expand and advance our IAI and dermatology portfolio as seen on Slide 22. For ruxolitinib Cream, we recently presented positive Phase 3 data in pediatric patients, where ruxolitinib met its efficacy endpoints for both investigator global assessment treatment success and EASI-seventy five. We expect to submit the sNDA by the middle of 2024 with potential approval in 2025. We also disclosed that RUX C met the primary endpoint in the Phase 2 study in mild to moderate heredinitis and we expect to present those results at a medical conference later this year, while a Phase 3 study is being evaluated. Ruxolitinib Cream is also currently being evaluated in 2 Phase 3 studies in paragorenodularis and 2 Phase 2 studies in LICA planus in lichen sclerosis with data expected for both later this year.

Speaker 5

Orvacitinib, our oral JAK1 inhibitor is currently being evaluated in Phase III studies in here adenitis, suprativa and vitiligo, and we have recently announced that porvacitinib met the primary endpoint greater than or equal to a 4 point improvement in the itch NRS across all three treatment groups in a Phase 2 study in paragogonodularis. We expect the full data set at a medical conference later this year and Phase 3 planning is underway. Our earliest stage dermatology program, our IL-fifteen The 15 receptor beta antibody has begun evaluation in healthy volunteers. Moving to Slide 23. Last week at the European Heuridinitis Supertiva Foundation Conference, we presented additional data from the open label extension of the Phase 2 study of povacitinib in HS.

Speaker 5

As a reminder, povacitinib demonstrated dose dependent efficacy in patients with HS during the initial placebo control period at week 16. The data presented demonstrate that treatment with porvacitinib through week 52 resulted in a decrease in disease severity as classified by the International HS Severity Scoring System or IHS IV. At week 52, the Significant decrease in disease severity was observed with approximately 25% of patients achieving an IHS IV score of 0, which represents the complete resolution of abscess, nodule and drain in tunnels. On Slide 24, an additional analysis was maintenance of response, which demonstrates that porvacitinib treated patients achieved a response at week 16 were likely to maintain the Hiscar response through week 52. Both of these data sets build upon porvacitinib's potential as a best in disease medicine for patients suffering from HS.

Speaker 5

As a reminder, 2 Phase 3 studies evaluating porvacitinib in HS, STOP HS1 and STOP HS2 are ongoing and enrolling very well. Our high potential oncology pipeline is currently focused on 3 advanced programs. The first is tafasizumab, which has currently been evaluated in 2 Phase 3 studies in patients with follicular and marginal zone lymphoma and in patients with previously untreated diffuse large B cell lymphoma. We're expecting Phase 3 results for follicular and marginal zone lymphoma or the IN MIND study in the second half of this year with the first line diffuse large B cell lymphoma front month study readout in 2025. The second is our small molecule oral PD L1 program.

Speaker 5

We have multiple ongoing studies as monotherapy or in combination with other agents such as axitinib, adagracib and ipilimumab. And we expect to have combination data later this calendar year. And the 3rd program is our small molecule CDK2 inhibitor, where we recently announced early signs of clinical activity With multiple patients demonstrating partial responses, we expect to share data as well as the development plan later this calendar year. On Slide 26, we recently announced that INCB-sixteen seventeen 34, a potent, selective An orally available KRAS G12D inhibitor recently entered the clinic in a Phase 1 study. This program has shown encouraging preclinical anti tumor xenograft models with no currently approved G12D targeting agents could address a high unmet need.

Speaker 5

As a reminder, the KRAS G12D mutation is found in approximately 40% of pancreatic ductal adenocarcinoma, 15% of colorectal cancer and 5% of non small cell lung cancer and could thus represent a significant opportunity for Incyte if successful. In summary, we anticipate a number of upcoming pipeline updates in 2024, including sharing top line results from both the Phase 2 studies in RUX cream in HS and porvacitinib in PN at a medical conference in the first half of this year. 2nd half of the year is looking to be catalyst rich period As highlighted on Slide 20 that we anticipate includes but is not limited to an approval with axitilomab, Phase 3 results from tafasitamab and the initiation of a number of Phase 3 studies including with our BAT inhibitor. With that, I would like to turn the call over to Christiana for the financial update.

Speaker 6

Thank you, Stephen, and good morning, everyone. 2023 was another year of strong financial performance with total product revenues of $862,000,000 for the Q4 of the year and $3,200,000,000 for the full year, representing a 13% 15% year over year increase, respectively. Total royalty revenues, which are primarily comprised of royalties from Novartis for Jakavi and Tabreca and royalties from Lilly for Olumiant were $150,000,000 in the 4th quarter $523,000,000 for the full year, up 13% 8% respectively compared to 2022. Total revenues grew 9% in the 4th quarter compared to the prior year period, reaching the $1,000,000,000 mark, an important milestone for Incyte. For the full year, total revenues were $3,700,000,000 Turning to Jakafi on Slide 30.

Speaker 6

Jakafi net product revenues were $695,000,000 for the 4th quarter and $2,600,000,000 for the full year 2023. In 2023, Jakafi net sales grew 8% compared to the prior year. Jakafi sales were negatively by a significant increase in free drug in the Q4 of the year, driven by an increase in the number of patients seeking support from Incyte's patient assistance program. The impact of the increase in free drug was more than offset by an increase in channel inventory levels. This increase was in anticipation of patients moving into paid demand starting in Q1 of 2024.

Speaker 6

The increase in Q4 channel inventory levels represented $46,000,000 in sales. Turning now to Oxelura. Net product revenues for the 4th quarter were $109,000,000 representing a 78% increase year over year driven primarily by increased patient demand. For the full year, total OXELURA net Product revenues were $338,000,000 representing a 162% increase compared to the prior year. Moving on to Slide 32 and our operating expenses on a GAAP basis.

Speaker 6

Total R and expenses were $444,000,000 for the quarter, representing an 11% year over year decrease, which was primarily as a result of the $70,000,000 upfront payment made as part of the Villaris acquisition in Q4 2022 and partially offset by the $20,000,000 development milestone payment to former Villaris shareholders in the 4th quarter of 2023. For the full year 2023, total R and D expenses were $1,600,000,000 representing a 3% year over year increase. This increase was primarily due to the progression of our pipeline and was mainly offset by lower upfront and milestone expenses in 2023. Total SG and A expenses were $294,000,000 for the 4th quarter $1,160,000,000 for the year. The year over year increase of 8% for the Q4 and 16% for the full year were mainly due to increased sales and marketing activities for Opsilura in both the U.

Speaker 6

S. And Europe, unfavorable effects and timing of certain G and A related expenses. Moving on to 2024, I will now discuss the key components of our guidance on a GAAP basis, which includes revenues and expenses related to the recent acquisition of the exclusive global rights to tafasitamab, but excludes any potential impact related to the accounting treatment of the $25,000,000 purchase price paid. For Jakafi, we expect net product revenues to be in the range of $2,690,000,000 to $2,750,000,000 on track to achieve our long term guidance of over $3,000,000,000 in net product revenues by 2028. We expect net products revenue growth to be driven exclusively by continued demand growth and be partially offset by lower net pricing as a result of IRA imposed price increase caps and continued growth in 340B volumes.

Speaker 6

As in previous years, We expect the gross to net adjustment to be higher in the Q1 of the year relative to the previous quarter and subsequent quarters due to the higher deductibles and our share of the donut hole for Medicare Part D patients, which are primarily impacting the Q1 of the year. While for Opselura, we will not be providing full year guidance at this point, in the Q1, we expect to see again the effect Of typical Q1 dynamics on net sales, including higher patient out of pocket costs due to the planned deductibles resetting at the beginning of the year and the impact of holidays, medical conferences and other events on dermatology product sales. As of a result, Q1 OXELURA net product revenues are expected to be below the previous quarter and the subsequent quarters and represent a smaller share of the full year net product revenues consistent with what we saw in 2023. For other hematology oncology products, which now include Iclusig, Pemazyr, Monjuvie and mid juvie, we expect total net product revenues to be in the range of $325,000,000 to $360,000,000 which at the midpoint represents approximately 47% growth over 23. Turning to operating expenses on a GAAP basis, we expect COGS to range from 7% to 8% of net product revenues, which is in line with 2023.

Speaker 6

R and D expense is expected to be in the range of $1,720,000,000 to $1,760,000,000 representing 7% growth at the midpoint versus 2023, primarily driven by the progression of our pipeline. We expect SG and A expense for the year to be in the range of $1,201,000,000 to $1,240,000,000 representing 6% year over year growth at the midpoint, primarily driven by the inclusion of sales and marketing expenses associated with MONJUVY in the U. S. Under SG and A, whereas prior to the acquisition of full product rights, they were included under the collaboration profit or loss share. Operator, that concludes our prepared remarks.

Speaker 6

Please give your instructions and open the call for Q and A.

Operator

Certainly, we'll now be conducting a question and answer session. Our first question is coming from Kripa Divarikanda from Truist Securities. Your line is now live.

Speaker 7

Thank you so much for taking my question. On Jakafi in myelofibrosis, thank you so much for providing the market details on our patients and the share of new patients. So just wondering if you anticipate stabilization of Jakafi share at these levels? And If pelabrasib were to be approved in combination with RUX, assuming it happens sometime next year, should we expect to see an inflection point? Thank you.

Speaker 3

So stabilization of market share in myelofibrosis. So Jakafi, as you know, is the leader in myelofibrosis because of its safety, efficacy, overall survival And really tolerability, which is really a big advantage. We think that myelofibrosis will continue

Speaker 4

the

Speaker 3

largest portion of our patient share until polycythemia vera patients ultimately take over because as you know those patients Stay on for a long period of time. Your question around pelagressa, if and when it gets approved in combination with Jakafi, of course, That's a good thing for us. If in fact, the profile of the drug is as it appears or the combination is as it peers then many physicians may choose to use that combination and Jakafi will only benefit, but we have to wait and see What happens with the approval process?

Speaker 7

Great. Thank you so much.

Operator

Your next question is coming from Andrew Berens from Leerink. Your line is now live.

Speaker 8

Hi. Wondering if you guys could expand upon the development of Jakafi XR in light of the recently announced bid by Novartis from Restasis. Does Novartis' control of Jakavi outside the U. S. Impact how you're thinking about developing your BET inhibitor?

Speaker 8

Do they have Any direction or say any other directions of the XR version of Jakafi? And then also, just wondering if you think that I'm going to add on drug to Jakafi and MF still requires symptomatic improvement as an endpoint for regulatory endorsement or do you think that there's been a material change And thinking at the agency.

Speaker 2

So let me take the piece about Our agreement with Novartis on Jakatai and Steven can speak about the development of Exar. So the agreement is such that both parties can be co developing New formulations of ruxolitinib in oncology, including the once a day. It has not been the case yet, but there is still an optionality for Novartis to Co develop XR if they wish and that would mean that they would be able to commercialize the XR formulation outside of the U. S, but Not in the U. S, where obviously it will be commercialized by Incyte.

Speaker 5

And then Andy, I'll take the other part of your question. So for RUX XR as Pablo communicated at the ASH investor event, we have now clear feedback from the FDA That we need to do new formulation strength, which are already developed, which are slightly higher And then demonstrate BEBA with those primarily around semen and AUC. That's the clear guidance from the FDA we estimate this should be completed in a 2 year process, so well before the LOE. It doesn't affect our development of FTC's fixed dose combinations with any of our products. So that continues.

Speaker 5

For our BET inhibitor, again, we showed data at ASH and alluded in my prepared remarks, We have a clearly an active compound showing very good rates of spleen reduction, both volume and length, Very good symptom improvement and occasional hemoglobin increases just like seen with the other BAT inhibitor. We have been operating like other companies under the assumption that at least in first line, you need SER-thirty five and symptoms to date to get approvals. I can't comment on where they are in their regulatory progresses or how the FDA may change in that regard, But that has been the standard to date. Thank you.

Speaker 8

Okay. Thank you very much.

Operator

Thank you. Our next question today is coming from Michael Schmidt from Guggenheim. Your line is now live.

Speaker 9

Hey, guys. Thanks for taking my questions. I had one on porvacitinib. So as we think about the opportunity for this drug In multiple indications, I believe the HS Phase 3 trial is most advanced. Could you talk a bit about your expectation on how the drug may be positioned relative to some of the biologics in HS, Humira or some of the IL-seventeen antibodies?

Speaker 9

And then also in PN where you had the positive top line data last year, Dupinex is obviously approved here. Again, could you talk a bit about how the drug might be fitting into that treatment paradigm relative to Dupinex? Thanks so much.

Speaker 5

Michael, hi, it's Steven. I'll start with your question. Thank you for the question. So Porvoo in HS, We think we have outstanding efficacy data, which we've now updated with 52 week data That shows prolonged effect that's maintained. And so remember, this is a JAK1 specific agent about 50 fold selective for JAK1 has a long half life and a very high volume of distribution, Which may translate to more penetration in the skin, which is why we've seen this degree of efficacy shown to date.

Speaker 5

Both Phase 3 stop HS1 and HS2 are enrolling very, very well. So that probably speaks to Some of the belief out there in the agent and that is clearly our lead indication as you alluded to. It's hard to always cross compare With many caveats to other studies where these drugs aren't directly compared and you spoke about the IL-17s here and the biologics. And clearly, there's some variable activity there. You have to look at placebo corrected rates.

Speaker 5

But I think ours tackles Multiple aspects of the disease pathophysiology, not just one interleukin. And as I said, the drug profile With a long half life and high volume of distribution may lend itself to increased efficacy here. Obviously, time will tell with the Phase 3 data. It'll be once daily oral tablet, which offers that sort of convenience. In What patients suffer from primarily is intense itching.

Speaker 5

And again, our Phase 2 proof of concept data is very strong in of the itch relief here and the ability to eliminate that symptom pretty quickly as well as over time disease resolution in the actual skin manifestations. There is, as you allude to, an approved agent there in Dupixent, but that has provided us The regulatory pathway on the way to go in terms of itch resolution and skin change resolution. And again, we'll offer the once daily oral convenience. We think we'll have really good agents in terms of high efficacy there. So we're excited about this program as well.

Speaker 5

Thanks.

Operator

Thank you. Our next question today is coming from Vikram Parikh from Morgan Stanley. Your line is now live.

Speaker 10

Hi, good morning. Thanks for taking our questions. We had 2 on the pipeline. So first for the ALK2 program, You've guided to POC data by mid-twenty 4. We were just wondering what we can expect to learn with this update and what you will be reviewing specifically to decide What the next step of development could be for this program?

Speaker 10

And then secondly, for the mutant CALAR antibody, when can you expect to see initial Phase 1 data there? And What are you hoping to establish to get conviction that the program is headed in the right direction? Thank you.

Speaker 4

Yes. Thank you for the question. This is Pablo. So For the ALK2 inhibitor program, what we're in the process of doing and we need to establish is efficacy in a larger number of patients with newly diagnosed Hemaf in combination with ruxolitinib and that's what the team is focused on right now and as we mentioned at ASH last December. So We continue to push the dose.

Speaker 4

We need to get to doses of around 400 to 600 milligrams a day in order to get a maximum effect on hepcidin. 2, we need longer duration of therapy in a larger group of patients in combination with RUX. So That will happen over the course of the year. We haven't provided specific timeline for when we're going to disclose the data. But as mentioned at ASH last year, it would happen this year.

Speaker 4

And we'll provide clarity on what the next steps for that program are. On the second question for the mutant color antibody program. We started dose escalation very recently as you know, that study is accruing very well. The initial goals like for any first in human study are obviously to establish that this molecule antibody is safe, get a Good view of the pharmacokinetics in this first in human study and establish initial evidence of efficacy, which in this case will be by traditional endpoints in and also potentially a view on the effect of the mutant CAL R monoclonal antibody on a real burden in some of these patients. That will happen over the course of the year.

Speaker 4

We haven't decided yet when we're going to present data, whether it's this year or whether at some point in 2025.

Speaker 10

Got it. Thank you.

Operator

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

Speaker 11

Good morning. This is Anumit on for Salveen. Thank you for taking our question. We had one question on OXOLLORA. Outside of the 1Q dynamics that you spoke to, can you help us understand the forward launch trajectory in AD and Vitiligo in the context of reimbursements and and also gross to net, in order to be fully able to capture the opportunity as you have additional indications coming in, in the coming years?

Speaker 11

Thank you.

Speaker 3

Yes. Thanks for the question. So, of course, as far as launch trajectory, we're continuing to launch very well in both AD and Vitiligo. We continue to expect growth in vitiligo just based upon our educational efforts directed both at patients and healthcare professionals, we know that the profile in AD, in terms of its itch relief and clearance of the skin is unmatched for any therapy, topical therapy. We even believe that in AD, for example, the profile is so good that As far as payers are concerned, they're interested in the fact that more than 80% of the patients will be clear and have their itch relieved and can delay or not even go on to biologics.

Speaker 3

So We think those dynamics are good for both AD and Vitiligo going forward and Yes, we're looking forward to future growth. I'll turn the call over to Christiana to talk about gross to net.

Speaker 6

So in terms of gross to net, first of all, when you look in 2023, the average gross to net was around 55%. Our goal is to maximize the value of Opsilura and maximize net sales. If going forward, we make the decision to provide any additional discounts, it would be because we expect that these will improve access and will have a disproportionate impact on volume and thus lead to higher net sales. So as such, Our comments are going to be focused on net sales versus gross to net in isolation.

Operator

Thank you. Our next question is coming from Derek Archila from Wells Fargo. Your line is now live.

Speaker 12

Hey, good morning and thanks for taking the questions. So one just piggybacking on the last. Just in terms of Opsilura, is there one any chance we get an in terms of potential guidance this year? And then will you ever look to kind of break out, both kind of the vitiligo and And AD kind of scripts or sales, if you could figure that out. And then secondly, just on tavacitinib, I guess, can you quantify maybe the incremental growth for this asset and the follicular and marginal zone lymphoma indications?

Speaker 12

Thanks.

Speaker 3

So as far as breaking out AD versus Vitiligo, I think

Speaker 2

we've said

Speaker 3

before, it's about 60% currently For AD 40% currently for vitiligo, it could be changing a little bit. Ultimately, we expect vitiligo total tubes perhaps surpass AD. AD patients are many new patients always come on for atopic dermatitis And in Vitiligo, it's about continued use and refills. As far as MANJUV tafasitamides goes, obviously, we're looking forward to hopefully positive data in Flicker lymphoma, indolent lymphoma and in first line diffuse large B cell lymphoma. So we think there's great opportunities ahead for these two indications.

Speaker 3

We think it's a great drug for lymphoma. Obviously, it's a crowded marketplace, but we think The profile of the drug and the trials we put together for those two new indications are going to serve us well

Speaker 2

in the future. But in terms of calibration of follicular lymphoma, we need to see the Phase III data. It's a fairly competitive place, there are a lot of new products. So we need to see the Phase III data before we can give you a good calibration of that. I The number of patients we are speaking about in the U.

Speaker 2

S. Is around

Speaker 3

So, Alex, 29,000 patients in 1st line diffuse large B cell lymphoma, there's about 13,000 patients in second line plus Inflammatory lymphoma in the United States.

Speaker 12

Got it. Understood. Thank you.

Operator

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

Speaker 13

Thank you very much for taking my question. You said that the 4th quarter revenues were negatively impacted by the number of Medicare Part D patients receiving product, could you perhaps elaborate on this? And also looking ahead to 2024 2025, You had spoken about how IRA dynamics could shift, which will drive PV share. Could you possibly give us some way to quantify the potential impacts of this shift over time? Thank you.

Speaker 3

So to answer the first question, in Q4 we saw a significant increase in patients seeking assistance from Incyte in the form of free drug of course. We know that these were paid patients who had Medicare Part D and our assumption is these patients were receiving financial assistance from independent charitable foundations to cover their out of pocket expenses. This assistance was no longer available to them apparently at the towards the end of the year. And of course they came to us and they met our eligibility criteria for a free drug. With the changes in Medicare in 2024, as you know, the out of pocket in 2024 for Medicare Part D is greatly reduced.

Speaker 3

Therefore, we expect these patients to return to being paid patients. And in fact, we know already that many of these patients already have. In terms of 2024, 2025 and the changes to Medicare Part D, we think it's been very positive. We've been saying it for a long time that These co pays out of pocket costs for patients, cancer patients who are in Medicare Part D was very much too high and should be reduced. And in fact, they probably are still too high.

Speaker 3

But Because of the way it happens in 2025, dollars 2,000 maximum out of pockets, they can spread that out over throughout the year. So they pay about $157 per month for a 12 month period. We think that there's lots of patients perhaps over the years who have walked away, who have abandoned drug because they could not afford these out of pocket costs. We think that there's an opportunity at least for those patients who abandoned drug or just thought they could not afford the drug Now that the Medicare Part D is greatly reduced, they could come back. So, come back or option into the drug therapy now.

Speaker 13

Thanks for taking my question.

Operator

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

Speaker 11

Hey, guys. Good morning. Thanks for taking my questions. A couple of follow ups on some of the previous questions. What's your expectation for the proportion of Jakafi patients receiving free drug in 2024?

Speaker 11

And then on OXOLURA for Europe, how are you expecting the average price to shake out, for Vitiligo? And can you recap your latest thinking on doing AD there. And then in the U. S, I think you mentioned that recent script trends reflect kind of normal year end seasonality. Is that to say you expect a volume reacceleration near term?

Speaker 11

I wasn't sure how to reconcile that with some of the other 1Q comments you made about OXOLURA. Thank you.

Speaker 3

Okay. I'll try to answer the first and third question, maybe ask Herve to talk about Europe. So the expectation for Free Drug is easy Jakafi, it's been 3% to 4% of our volume for years years years. We expect it to go back. We think this is a one time exceptional thing that happened because of Changes coming for Medicare Part D.

Speaker 3

So again, no more than it has been historically, which is around 3% or 4% of our volume. As far as what we talked about seasonality, we do expect that the Q1 to be down mostly because of change because of out of pocket expenses because of deductibles, because of resetting of the co pays, but then we should go back to our acceleration in volume in Q2, Q3 and so on. And Herve, Europe?

Speaker 2

So in Europe today, Opdivo is launched In Germany and Austria, in fact, where it's commercially available, the price there is €750 per 100 gram tube. And then we recently received reimbursement in France under a process called Acccel Direct, which is a way to make it's one of the first product, in fact, it's the second product to get access to be part of that program and that gives access to patients through a special distribution system And why is the price is being discussed? So the price discussion will probably take 10 months and we will start Booking sales or recognizing revenue in France when the price is finally approved. So that should be late this year in the best case. And then we are also in the process of getting reimbursement in other countries in Europe.

Speaker 2

So Hopefully, we will get multiple countries launching in 2024 and 2025. Regarding atopic dermatitis, We decided obviously to start with Vitiligo for reimbursement reason because it's a better case leading to a better price in most of these countries. And we have ongoing studies that have been in fact started relatively recently that could be used If we want to have a limited label in atopic dermatitis, which would be required to be able to maintain the price. So That process is ongoing and it's not going to lead to a new indication in the next 2 years. It will be coming after that.

Speaker 7

Thank you.

Operator

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

Speaker 14

Hi, good morning. Thank you for taking my questions. I was just curious as to the payer mix differences, if there are any for OXOLURA between the AD indication versus vitiligo? And then secondly, as both of these launches start to mature a bit, do you have a better sense of how you're going to land The number of tubes on average used per patient for a full year. Thank you.

Speaker 3

As far as the payer mix goes, there's no real difference Between peri mix for AD, more patients perhaps have step therapies in Vitiligo, more patients I don't have any steps or have one step. In terms of the number of tubes, we've said in the past that for AD, it's around The 2 tubes are a little bit more. We think that will continue to grow as people use the drug over larger portions of the body. Obviously, they can go up 20% of body surface area, which is a very large body surface area. Some people started out in sensitive areas and now they'll continue to use it over a larger period of their skin.

Speaker 3

For Vitiligo, it's just too early. We'll figure out, but we're anticipating, obviously, as we've said, that the refills will be much greater In Vitiligo compared to AD.

Operator

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

Speaker 15

Hi, thanks for taking my questions. Maybe following up on a couple of the pair dynamic questions. On Jakafi, can you quantify the level of kind of script abandonment and things like that you are seeing and kind of what this opportunity is for volume gains with this redesign recognizing, yes, some of it's not going to play out over just in 1 year. And then similarly For Absolura, you had some formulary wins late last year that came into effect at the beginning of the year. Christiana, to your comment of Only wanting to give price concessions to see enough volume benefit to end up in a net sales method.

Speaker 15

Are you seeing early returns from that that are consistent with that view? Or you kind of need to recalibrate, how you do those negotiations for next year to make sure that that trend is kept?

Speaker 3

Sure, Mark. Barry first. So quantified level of script abandonment for Jakafi, we don't actually know. We know that It's at least 10% just because we know when we go to specialty pharmacies, the patients who go through specialty pharmacies, it's a little we have a little bit more data there or clarity there and it's at least 10%. But we don't know people who scripts never get sent To a pharmacy, we don't know about that.

Speaker 3

So we're not exactly sure, but we think there's a significant portion of patients that could benefit from Jakafi specifically, that aren't because of the out of pocket And that's getting better and better all the time we hope in 2024 2025. As far as Upsolara goes and formulary wins, for example, CVS, Aetna That got changed this year to preferred status with 1 step therapy for AD, no step therapies for vitiligo. It's a little bit too soon to see anything because, obviously when CVS makes a decision with us, it takes a while to funnel down to the various plans at the local level. Okay?

Speaker 15

Okay. Thank you.

Operator

Thank you. Next question today is coming from Ren Benjamin from Citizens JMP. Your line is now live.

Speaker 16

Guys, thanks for taking the questions. Given the rumors of your bid from MorphoSys, are you considering any other acquisitions in the MF space? Or Was the rumor incorrect the whole time and you were just going after TAFSA? That's question number 1. Question number 2, back to Steven on the jackup I'm still I'd love to get a little bit more color on the 2 years that it takes to get to the end of this To solve this issue, what really is kind of involved and is the probability of success, I would think it would be just quite high.

Speaker 16

It's Just for lack of a better word, an engineering problem, but maybe I'm thinking about this wrong.

Speaker 2

Yes. Maybe on the first question, as I said, I think the TAFSA acquisition for us is an It's in fact very, very asymmetric because it's, as I said, with all of the synergies we can realize in the short term, It can compensate for what is left in term of development costs in these two indications, where in fact most of the development Has already been paid for in the past year. So it is a case where the actual impact on the bottom line will be very minimal in the short term and very positive in the long term, whatever the scenario of the new indications. Now, if any of this new indication is hitting and It's positive, then it becomes obviously a super deal because we get all the benefit in terms of top line. So that's the aspect.

Speaker 2

Now in the field of myelofibrosis, as you can See from our pipeline, we have a number of projects that we are pursuing ourselves. We have our own bet. There is still the ALK2 program where, As Pablo was saying, there is some additional data that we need to get certainty, but it's very promising. And obviously, we have the 17F and Kala program on top of the XR formulation. So all of that is giving us a very full pipeline in the field of myelofibrosis.

Speaker 2

So that would not be the first priority for acquisitions.

Speaker 5

Then, Ren, your question on XR. So just to go back to the CRL, remember, when we did that submission, we missed on cmin to a small degree that Per the FDA resulted in a theoretic concern on efficacy. And then we tried to do some more population PK analyses in that to reassure them, but that pathway didn't work. And as we gave more granular detailed end of last year, the route forward is new formulation, slightly larger tablet size And then repeat the EBA work. And you're right, it's not doesn't take a great length of time, but to get that data in, Analyze it, put it into a package and send it to the FDA and then have the discussions and approximation or best guess is an approximately 2 year journey from the beginning of this year to get it done.

Speaker 5

And that we feel has enough conservatism in it that we should make it. In terms of probably of success, we can model from the formulations What we will likely achieve in terms of area under the curve, C min and even actually C MAX as well, And we think that is relatively high. Obviously, that's why we're doing it. And we'll share that data as it becomes available and then take it to regulatory agencies. Thanks.

Speaker 16

Thank you.

Operator

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

Speaker 17

Hi, everyone. This is Nevan on for Brian. Thank you for putting us in.

Operator

We just had a couple

Speaker 17

of questions on our part. So on OXOLURA, what is the latest that you're kind of seeing on patient retention so far? How many patients Persistent through the 6 to 12 months so far to kind of see the benefit versus how many are kind of dropping off for perhaps seeing early efficacy. And then if you could speak to a little bit of the education around the retention strategies as well. And then a second question on the MF space.

Speaker 17

So as you kind of see the entry of additional competitors into the space, do you potentially foresee an expansion of the market as these Competitors entered.

Operator

Thank you.

Speaker 3

Sure, Nevan. So this is Barry. So as far as patient retention, I guess what mean is that how many patients. So obviously the vitiligo patients stay on for a much longer period of time. Of course, atopic dermatitis patients, patients with eczema, They have flares, they use Optilora, it goes away, and it's very effective.

Speaker 3

So sometimes some patients get immediate relief. Obviously, we talk about the itch relief all the time. They get good itch relief and the skin begins to clear over time. So these patients will come back, we think year after year as long as they have their eczema and use the drug when they see the flares until it goes away and then start using it again. Vitiligo patients we've seen from our long term data, patients can use the drug for 2 years and continue to get benefit.

Speaker 3

So that's what we keep on reinforcing around education so that patients understand how to use the drug, What they're going to see at 3 months, 6 months, 9 months, 12 months and beyond, and that's how we'll continue to retain them. Yes, it's very important, the strategies around, patients adherence, particularly for vitiligo And particularly we know we can make improvements around what healthcare professionals, dermatologists in our offices are telling the patients how to use the drug And then the patients themselves understanding how to use the drug. As far as competitors in the M and A space, I mean, there are 3 other JAK Inhibitors approved for myelofibrosis, where we continue to be the market leader And myelofibrosis will continue to be as far as the combinations that have been studied recently, We'll see. But it certainly does expand the market because you have the opportunity of going early, Earlier patients starting, we know if they start early with Jakafi, their survival advantages could be better. And then in fact, They'll go to 2nd line drugs and 3rd line drugs.

Speaker 3

So yes, we created the market and it could expand if there are good drugs approved after Jakafi.

Operator

Thank you. Our final question today is coming from Matt Phipps from William Blair. Your line is now live.

Speaker 12

Thanks for squeezing me in. I'll just add one on the CDK2 inhibitor. Curious if you can comment on the safety profile you've seen so far, if you're seeing any ocular Thank you.

Speaker 4

Yes, thank you for the question. We have not. We are happy with the safety profile so far, which consistent with the mechanism of CDK2 inhibition. And we have not seen ocular toxicity, which as you know led to a clinical hold in one of our competitors. So We're very excited about the early data of our CDK2 inhibitor, as we mentioned.

Speaker 4

And we look forward to sharing data over the course of the year as well as our future development plans for the CDK2 inhibitor program.

Operator

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

Speaker 1

Thank you for participating in today's call and for your questions. The IR team will be available for the rest of the day. Thank you.

Operator

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

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Earnings Conference Call
Incyte Q4 2023
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