Q1 2021 Incyte Corp Earnings Call

Hello, and welcome to the insight first quarter earnings call. At this time all participants are in a listen only mode. If anyone should require operator assistance. Please press star zero under telephone keypad.

Operator: And welcome to the Incyte first quarter earnings call. At this time, all participants are in a listen-only mode. If anyone should require operator assistance, please press star zero on your telephone keypad.

And answer session will follow the formal presentation and.

Operator: A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Christine Chiou. Please go ahead.

As a reminder, this conference is being recorded and stuff.

And my pleasure to turn the call over to Christine Cho. Please go ahead.

Thank you Kevin Good morning, and welcome to insights first quarter, 2020, One earnings conference call and webcast. The slides used today are available for download on our website I'm joined on the call today by our day, Barry Steven and Christiana, who will deliver our prepared remarks and by dash or join us for the Q&A session.

Christine Chiou: Thank you, Kevin. Good morning, and welcome to Incyte's first quarter 2021 earnings conference call and webcast. The slides used today are available for download on our website. I'm joined on the call today by Herve, Barry, Steven, and Christiana, who will deliver their prepared remarks, and by Dash, who will join us for the Q&A session. Before we begin, I'd like to remind you that some of the statements made during the call today are forward-looking statements and are subject to a number of risks and uncertainties that may cause our results to differ materially, including those described in our 10-K for the year ended December 31, 2020, and from time to time in our other SEC documents. I will now begin the call with Herve.

Before we begin I'd like to remind you that some other statements made during the call. Today are forward looking statements and are subject to a number of risks and uncertainties that may cause our results to different materially including those described in our 10-K for the year ended December 31, 2020 and from time to time and our other SEC documents will now begin the <unk>.

All with her way.

Thank you Christine and good morning, everyone.

Herve Hoppenot: Thank you, Christine, and good morning, everyone. In the first quarter of this year, we continued to execute on our strategy to drive further growth and diversification. We entered the year following a strong 2020 where we were able to increase revenue by 24% and achieve multiple regulatory successes, including three product approaches. We continue to deliver across our portfolio in the first quarter. Our revenues grew 6% year-over-year to reach $605 million, with growth driven by new product launches and royalty revenues of $100 million. Which is typically a quarter impacted by higher growth to net and forward purchasing patterns in the US?

And the first quarter of this year, we don't see this to execute so and our strategies to drive sales growth and diversification.

We entered the year following the strong 'twenty 'twenty, where we were able to increase revenue by 24% and achieved multiple regulatory successes.

Including three product type program.

We continued to deliver all across our portfolio and the first quarter, our revenues grew 6% year over year to reach six.

600 on Friday.

With growth driven by new product launches and royalty revenues of $100 million.

Q1, which is typically a quarter are impacted by higher gross to net and forward purchasing patterns and so U S.

What is challenged by the ongoing tonnes image.

Herve Hoppenot: was further challenged by the ongoing pandemic. Total patients on JAKA-FYE grew year over year, and in March, new patients started to recover to pre-COVID levels. The launches of both Montjuvis and Pemazir continue to progress with good uptake from both academic and community fields. Barry will provide additional details in his remarks.

Total patients on Jakafi.

And in March and new patient starts we cover up to pre COVID-19 level.

The launches of both amongst movie and Timothy.

Continue to progress with good uptake from both academic and community physicians.

And he will provide additional details in his remarks.

We made significant progress across the clinical and the regulatory landscape with Vimizim and approved in both Europe, and Japan, becoming the first internally discovered product to be globally commercialized by insight.

Herve Hoppenot: We made significant progress across the clinical and regulatory landscape, with PEMASY approved in both Europe and Japan, becoming the first internally discovered product to be globally commercialized. We also have three regulatory applications under priority review at the FDA, as well as two applications under review in Europe, potentially increasing our sources of revenue in the near future. Last month, we presented updated data for ROCKSCREAM at the American Academy of Dermatology meeting, including two-year data from our Phase II vitiligo trial and updated pooled results from our Phase III TrueAID program in atopic dermatitis, with each highlighting the excellent potential of roxolitinib-prim as a treatment for these two indications.

We also have three a regulatory application and a priority review and the FDA as well as two applications under review in Europe, but also really increasing our sources of revenue in the near term.

Last month, we presented updated data for rux cream and the American Academy of Dermatology meeting, including the two year debt up from our phase two visit a good trial and updated results from our phase III two a day program in atopic dermatitis with each highlight things are exciting, but I'm sort of works.

Graeme.

Treatment for these two indications.

We also announced with our partner Lilly two positive pivotal trials from biopsies and Abe in alopecia or it though if.

Herve Hoppenot: We also announced, with our partner Lili, two positive pivotal trials for baracitinib in alopecia areata. If approved, paracetamol could be the first FDA-approved therapy for alopecia areata. Looking ahead, over the next one to two years, we have the potential to undergo a significant transformation here at Incyte, with several expansion opportunities as new products and new indications are launched across the US, Europe, and Japan. This includes Rox Scream in Atopic Dermatitis and BT LIGO, Rox Valentinib in Chronic GVHD, Papacetamab in Relapse Refractory DL-BCL in Europe, Parsaclizib in Multiple Types of Lymphomas, and QD, Rox Valentinib in MF, PV, and GVHD.

And if approved boxes and it could be the first day, yeah proof therapy and other fish area, though.

Looking ahead over the next one to two years, we have the potential to undergo significant transformation he has insight.

With several other expansion opportunities at new product and new indications all loans across the U S Europe and Japan.

These include the rux cream in atopic dermatitis, and vitiligo or actually do you need to be and chronic gvhd deficit I mab and relapsed refractory b cell and Europe not succeeded in multiple types of lymphomas and Judy Worksite, you need in MF PV and Gvhd.

As we look at and our key business objectives for the year.

Herve Hoppenot: As we look at our key business objectives for the year, we have three priorities. First, grow our existing revenue base by driving new patient starts for Jakafi and accelerating the uptake of Monjuvi and Pemaziz. Second, to expand upon our revenue base by successfully launching new products and new indications. We expect several regulatory decisions before the end of... And third, to continue to progress our late-stage pipeline as well as our earlier-stage program. Before I pass the call to Barry, I'd like to now take a minute to speak about our ESG initiative, which we call Global Responsibility, and which was launched in 2019.

We have three priorities first and to grow our existing revenue base by driving new patient starts from Jakafi and accelerating the uptake of months moving on Vimizim.

So we want to expand upon our revenue base by successfully launching new products and new indication.

We expect several other regulatory decision before the end of this year.

And so to continue to progress our late stage pipeline as well as all of our earlier stage programs.

Before I pass the call to Barry I'd like to now take a minute to speak about our ESG initiative, which we call global responsibility and which was launched in 2019.

Since then and we have increased our ESG disclosures and improved upon our objective.

Herve Hoppenot: Since then, we have increased our ESG disclosures and improved upon our objectives. In this slide, we list a few key accomplishments among our five priority areas, and I would like to specifically highlight our efforts on the environmental front, in an effort to reduce our environmental impact. We offset 100% of our 2019 measured carbon emissions in the US through verified reforestation carbon credits in partnership with the Arbor Day Foundation. Looking ahead, we have set a goal to achieve carbon neutrality through a combination of absolute reductions and offsets by 2025. With that, I'll hand it over to Barry to cover the individual product performance.

And this slide we list a few key accomplishment among our five priority areas and I'd like to specifically highlight a wife all on the environmental from.

And they talk to reduce our environmental impact, we offset 100% of our 2019 measure jamba and emissions in the U S through very fine reforestation Jamba and credits in partnership with all their foundation.

Looking ahead, we have a set of goals to achieve carbon neutral and we have set a goal to achieve carbon neutral and team through a combination of absolute reductions and upset by 2025.

With that I would hand, it over to Barry to cover all but didn't give us all product performance.

Thank you every day and good morning, everyone Jack.

Barry P. Flannelly: Thank you, Herve, and good morning, everyone. Zecify net sales in the first quarter grew year over year to $466 million. As you may recall, first quarter growth in 2020 was 22% year-over-year, due in large part to growth in patient demand but also to a one-time increase in purchasing due to concerns over COVID-19 restrictions. Our Q1 net sales growth this year was impacted by the pandemic, higher growth to net and forward purchasing patterns.

<unk> net sales and the first quarter grew year over year to $466 million.

As you May recall first quarter growth in 'twenty, and 'twenty was 22% year over year due in large part to growth and patient demand, but also to a onetime increase and purchasing due to concerns over COVID-19 restrictions.

Our Q1 net sales growth. This year was impacted by the pandemic are higher gross to net and forward purchasing patterns.

Patient demand growth of two 3% and Q1 was softer than normal due primarily to the decline and new patient starts since the beginning of the pandemic.

Barry P. Flannelly: Patient demand growth of 2.3% in Q1 was softer than normal, due primarily to the decline in new patient starts since the beginning of the pandemic. The graph on the right shows monthly new patient starts from 2019 to the end of 2021. In the first quarter of last year, new patient starts were higher versus the prior year, but then they significantly declined in Q2 and Q3 of 2020. This loss of new patients impacts total patient growth in subsequent quarters and explains part of the slow growth in Q1 of this year.

The graph on the right shows monthly new patient starts from 2019 to the end of 2021.

And the first quarter last year, new patient starts were higher versus prior year, but then significantly declined in Q2, and Q3 of 2020.

There's lots of new patients impacts total patient growth and subsequent quarters and explains part of the slow growth and Q1 of this year.

We are seeing a gradual return of cancer patients to oncologist offices and.

Barry P. Flannelly: We are seeing a gradual return of cancer patients to oncologist offices. And as you can see, by following the red line, new patient starts are now at pre-COVID levels due to patients returning for their treatment. Our representatives being able to have face-to-face meetings with oncologists. With our improved growth to net for the rest of the year and our anticipated launch in chronic GVHD, we expect strong growth in the second half of this year. Therefore, we are very confident in our full-year outlook for Jackify and are reaffirming our guidance of $2.125 billion to $2.2 billion.

And as you can see by following the Red line, New patient starts are now at pre COVID-19 levels.

So.

Due to patients returning for their treatments.

Our representatives being able to have face to face meetings with oncologists are improved gross to net for the rest of the year and our anticipated launch and chronic gvhd, we expect strong growth and our second half of this year. Therefore, we are very confident and our full year outlook for Jakafi and have reaffirmed.

Our guidance of 2.1, and two 5 billion to $2 $2 billion.

Barry P. Flannelly: Turning now to slide 10, the launch of Pemazir continues to perform well and has exceeded our initial expectations, and we continue to see increasing use in the second line setting. Since launch, the rapid adoption of FJFR2 testing by oncologists has facilitated the identification of appropriate patients for treatment with Pemizer, and as a result, we see a continuous flow of new patients. We launched Monjuvi with our partners Morphosis in the third quarter of last year, and our teams demonstrated their ability to launch an injectable drug in a difficult environment.

Turning now to slide 10, and the launch of Penn and <unk> continues to perform well and has exceeded our initial expectations and we continue to see and increasing use in the second line setting since launch the rapid adoption of FGF are two testing by oncologists has facilitated the identification of a <unk>.

<unk> patients for treatment with <unk> and as a result, we see a continuous flow of new patients.

We launched months UV with our partners more photos and the third quarter of last year.

And our teams demonstrated their ability to launch and injectable drug and a difficult environment. Our field teams continue to generate awareness amongst physicians of the strong efficacy and safety profile of mine, Judy and we have maintained leading share of voice near 50%.

Barry P. Flannelly: Our field teams continue to generate awareness amongst physicians of the strong Efficacy and Safety Profile of Manjubi, and we have maintained a leading share of voice near 50%. We are seeing encouraging growth in the number of purchasing accounts, which have risen by over 25% since Q4 of 2020 to over 500 at the end of March.

We are seeing encouraging growth and the number of purchasing accounts, which has risen by over 25% since Q4 of 2020 to over 500 at the end of March.

Looking ahead, we expect an acceleration and the adoption of them and Judy and the second half of this year as oncology offices reopen.

Barry P. Flannelly: Looking ahead, we expect an acceleration in the adoption of Monjuvi in the second half of this year as oncology offices reopen, patients' diagnosis and treatment rates normalize, and our field teams are able to fully educate oncologists on the benefits of Monjuvi through in-person, Our focus now and going forward is on continuing to grow our market share in the second line setting so more patients can benefit from Monjuvi earlier in their treatment plan. Additionally, at ASCO in June, we'll be presenting important three-year follow-up data from the L-MIND trial, which will provide additional insights into the use of Monjuvi and Len in patients with relapsed refractory diffuse large B-cell lymphoma.

<unk> diagnosis and treatment rates normalize and our field teams are able to fully educate oncologists and a benefits them and juvie with in person meetings.

Our focus now and going forward is on the contingent is on continuing to grow our market share and the second line setting so more patients can benefit from and Judy earlier and their treatment plan.

Additionally at <unk> in June we will be presenting important three year follow up data from the L mind trial, which will provide additional insights into the use of my Judy and land and patients with relapsed refractory diffuse large b cell lymphoma.

Turning our attention now to recreate and I'm cream in atopic dermatitis.

Barry P. Flannelly: Now, we turn our attention now to ruxolitinib cream in atopic dermatitis. We recently conducted a survey of key external experts and payers assessing their perspective on ruxolitinib cream. Physicians and payers perceive ruxolitinib cream to be differentiated from other topicals and systemic therapies from both a safety and efficacy standpoint and noted improvements in itch as the most impactful for both physicians and patients, in a separate survey of nearly 300 dermatologists. Results show that ruxolitinib cream has a significant opportunity to address a large unmet medical need in the treatment of atopic dermatitis and that physicians have a high willingness to prescribe it.

We recently conducted a survey of key external experts and payors assessing their perspective of Brookfield and cream.

Physicians and payers perceive wrestling and cream to be differentiated from other topical and systemic therapies from both the safety and efficacy standpoint.

And noted improvements in itch as the most impactful for both physicians and patients.

And a separate survey of nearly 300 dermatologists results show that <unk> cream has a significant opportunity to address a large unmet medical need and and treatment of atopic dermatitis and that physicians have a high and willingness to prescribe.

Our dermatology field force is fully assembled and we are ready for a rapid launch upon approval.

Barry P. Flannelly: Our Dermatology Field Force is fully assembled, and we are ready for a rapid launch upon turning to slide 13. Earlier this year, the FDA hosted a vitiligo panel in which patients living with the disease spoke on various subjects, including how vitiligo has impacted their quality of life and the lengths to which they go to seek treatment. Again, highlighting the need for a novel and effective therapy such as ruxolitinib cream. I'll now turn the call over to Steven for a...

Turning to slide 13.

Earlier this year the FDA hosted a it'll I go panel and which patients living with the disease spoke and various subjects, including how it'll all go has impacted their quality of life and the lengths to which they go to seek treatment.

<unk> highlighting the need for a novel and effective therapies, such as Russell and the cream I'll now turn the call over to Steven for a clinical update.

Steven H. Stein: Thank you, Barry, and good morning, everyone. I'm starting with ruxolitinib cream. Over the past year, we have presented data from the TRU-AD program highlighting the safety and efficacy of ruxolitinib cream in atopic dermatitis. At the American Academy of Dermatology conference in April, we presented additional pooled analysis from the two Phase III studies demonstrating ruxolitinib cream's impact on efficacy metrics such as itch, sleep, and other quality of life measures In patients living with atopic dermatitis, the cycle of itching and scratching can lead to infections or disruptions in sleep. These results further highlight the potential for ruxolitinib cream to become an important therapeutic option for these patients. Turning to slide 16.

Thank you Barry and good morning, everyone.

Starting with <unk> cream over the past year, we have presented data from the true 80 program, highlighting the safety and efficacy of <unk> cream in atopic dermatitis.

At the American Academy of Dermatology Conference in April we presented additional pooled analysis from the two phase III studies, demonstrating and racks, let nib creams impact on efficacy metrics, such as each sleep and other quality of life measures across multiple subgroups.

And patients living with atopic dermatitis, the cycle of itching, and scratching and can lead to infections or disruptions and sleep and.

And these results further highlight the potential for <unk> cream to become an important therapeutic option for these patients.

Turning to slide 16.

We previously showed and E V and 2019 phase II results for Rux cream in vitiligo and 52 weeks.

Steven H. Stein: We previously showed at EADV in 2019 phase 2 results for Ruxelidnib cream in vitiligo at 52 weeks. At AAD this year, we presented updated 104-week data from the Phase II vitiligo program showing treatment with ruxolidinib cream produced substantial repigmentation of vitiligo lesions through 104 weeks of treatment. Nearly three quarters of patients who received ruxolitinib cream 1.5% BID for 104 weeks achieved a facial VASI 75, and nearly 60% achieved 90% clearance of vitiligo lesions on their face by week 104. There were no treatment-related serious adverse events reported, and ruxolitinib cream was well tolerated throughout.

And AAD. This year, we presented updated 104 week data from the Phase III Vitiligo program show and treatment with <unk> lithium cream produced substantial re pigmentation of it'll all go lesions through 104 weeks of treatment.

Nearly three quarters of patients who received <unk> cream, one 5% B I D 404 weeks achieved a facial <unk> 75.

And nearly 60% achieved 90% clearance vitiligo lesions on their face by week 104.

There were no treatment related serious adverse events reported and rock solid and a cream was well tolerated throughout.

We are excited by the potential of <unk> cream in vitiligo and look forward to sharing with you. The results of the phase III <unk> program, which should read out in the second quarter.

Steven H. Stein: We are excited by the potential of ruxylinib cream in vitiligo and look forward to sharing with you the results of the Phase 3 True V program, which should read out in the second quarter. On slide 17, a reminder of the broad clinical development program for tafacilumab in combination with other therapies, including our PR3 kinase delta inhibitor, POSICLISP, across several non-Hodgkin's In mind, a pivotal trial evaluating taphocytomab plus R-squared in relapsed follicular lymphoma is ongoing, and we expect to initiate another pivotal trial, Front Mind, in first-line diffuse large B-cell lymphoma in the second quarter. TopMind, our proof-of-concept study of taphocytomab in combination with paraclysm, Turning to the next slide.

On Slide 17, a reminder of the broad clinical development program for <unk> in combination with other therapies, including our PR three kinase Delta inhibitor pasta closer.

<unk> several non Hodgkin's lymphomas, and both the first line and relapsed and refractory settings.

In mind, a pivotal trial evaluating <unk> plus R squared in relapsed Follicular lymphoma is ongoing and we expect to initiate another pivotal trial front of mind and first line diffuse large b cell lymphoma, and the second quarter.

Top of mind, a proof of concept study of <unk> in combination with Pos at close and is expected to initiate in 2020, one and a proof of concept study in collaboration with <unk> is expected to start later this year.

Turning to the next slide.

We continue to progress our limber development program.

Steven H. Stein: We continue to progress with our Limber Development Program. Once daily ruxolytum data is in-house, and we expect data to be released at an upcoming medical conference, followed by an NDA submission early next year. Apotheclista plus Raxolid in combination trials for Progressive, and our BET and ELK2 monotherapy dose escalation trials are ongoing with planned initiation of combinations in the second half of this year. On the right side of the slide are results from a turpentine-induced anemia mouse. Turpentine was used to elicit an inflammatory response, which acutely increased the levels of hepsidin production and thus anemia.

Once daily Rux, and lithium data is in house, and we expect data release and upcoming Medical conference followed by an NDA submission early next year.

I'll pass the cluster plus racks and letting them combination trials are progressing and.

And our pet and Elk, two monotherapy dose escalation trials ongoing with planned initiation of combinations and the second half of this year.

On the right side of the slide our results from a turpentine induced anemia mouse model.

Turpentine was used to listen and inflammatory response, which acutely increase the levels of hip Sade and production and thus anemia.

As can be seen in the chart anemia developed and marsh injected with turf and time and when given in conjunction with <unk> hemoglobin levels were further reduced.

Steven H. Stein: As can be seen in the chart, anemia developed in mice injected with turpentine, and when given in conjunction with ruxolitinib, hemoglobin levels were further reduced. The pink data on the right side show that ELK2-treated mice, when given with ruxolitinib, had less severe anemia, as demonstrated by the improved hemoglobin levels. In closing, we have made significant progress within our key development programs in the past year, and we expect another busy year for Incyte with multiple potential approvals and regulatory submissions throughout the year. With that, I'd like to turn the call over to Christiana for the financial update.

Pink data on the right side shows that L. Two treated mice when given with your excellent nib and less severe anemia as demonstrated by the improved hemoglobin levels.

In closing we have made significant progress within our key development programs and the posture and we expect another busy year for insight with multiple potential approvals and regulatory submissions throughout the year.

With that I'd like to turn the call over to Christiana for the financial update.

Thank you Stephen and good morning, everyone.

Christiana Stamoulis: Thank you, Steven, and good morning, everyone. Our total product and royalty revenues for the quarter were $605 million, representing a 6% increase over the first quarter of 2020. Total product and royalty revenues for the quarter are comprised of net product revenues of $466 million for Jaka Fye, $26 million for iQlusiq, and $30 million for Temazin, royalties from Novartis of $66 million for Jacavi and $2 million for Tabrekta, and royalties from Lilly of $32 million for Illumina.

Our total product and royalty revenues for the quarter were $605 million, representing a 6% increase over the first quarter of 2020 total product and royalty revenues for the quarter are comprised of net product revenues of $466 million from jakafi $26 million for it.

Lucy and $30 million for 10 months here.

Royalties from Novartis of $66 million from Jackoby and $2 million force breakdown and.

Royalties from Lilly of $32 million for aluminum.

Jakafi net product revenue was in the first quarter of 2021 were impacted by the decline in new patient starts since the beginning of the COVID-19 pandemic forward purchasing and the first quarter of 2020 in advance of the annual resetting of copay obligations and the typical higher gross to net adjustment in the first quarter.

Christiana Stamoulis: Jessica Fye Net Product revenues in the first quarter of 2021 were impacted by the decline in new patient starts since the beginning of the COVID-19 pandemic, forward purchasing in the first quarter of 2020 in advance of the annual resetting of copay obligations, and the typical higher gross-to-net adjustment in the first quarter compared to the other quarters during the year due to the impact of the Medicare Part D coverage gap or donut. The 1% year-over-year growth in Jaka Fynet product sales also reflects higher present demand and forward purchasing in the first quarter of 2020, driven by concerns that the COVID-19 pandemic could cause potential supply disruptions.

<unk>.

Compared to the other quarters during the year due to the impact of the Medicare part D coverage GAAP or doesn't at all.

The 1% year over year growth and Jakafi net product sales also reflects the higher pressure and demand and forward purchasing late in the first quarter of 2020, driven by concerns that the COVID-19 pandemic could cause potential supply disruption.

The decrease and Iclusig net sales and the first quarter of 2021 from the prior year quarter also reflects the impact of COVID-19 related forward purchasing and the prior year, partially offset by positive currency effects.

Christiana Stamoulis: The decrease in ICLOSIC net sales in the first quarter of 2021 from the prior year quarter also reflects the impact of COVID-related forward purchasing in the prior year, partially offset by positive current shifts. Despite the impact of the COVID-19 pandemic on patient demand, we remain confident in the outlook for the year and our ability to continue to grow revenues through our existing products and new product launches like Pemazir and Tabrekta

Despite the impact of the COVID-19 pandemic on patient demand, we remain confident in the outlook for the year and our ability to continue to grow revenues through our existing products and new product launches like payments here and that breakdown.

Moving onto our operating expenses from a GAAP basis ongoing R&D expenses of $295 million for the first quarter increased 6% from the prior year period, primarily due to cost.

Christiana Stamoulis: Moving on to our operating expenses on a gap basis, ongoing R&D expenses of $295 million for the first quarter increased 6% from the prior year period, primarily due to costs to support the continued progression of our pipeline program. Total R&D Express, for the first quarter of $307 million, decreased 72% from the prior year quarter, which included the upfront consideration of $805 million for our collaborative agreement with Morphosa. Our ongoing SG&A expense for the quarter of $141 million increased 27% from the prior year quarter, primarily due to our investments related to the establishment of the new dermatology commercial organization in the U.S. and the related activities to support the potential launch of Raxolitinib cream for atopic dermatitis, as well as the timing of certain expenses.

To support the continued progression of our pipeline programs.

Total R&D expenses.

For the first quarter of $307 million decreased 72% from the prior year quarter, which included the upfront consideration all Sean of $805 million for all collaborative agreement with Merck policy.

Our ongoing and SG&A expense for the quarter of $141 million increased 27% from the prior year quarter, primarily due to our investment related to all the establishment of the new dermatology commercial organization and the U S and the related activities to support the potential launch.

Proximate and a cream for atopic dermatitis as well as the timing of certain expenses.

Total SG&A expense for the first quarter of $154 million.

Christiana Stamoulis: Total SG&A expense for the first quarter of $154 million includes a $30 million reserve related to a settlement in principle in connection with the December 2018 Civil Investigative from the U.S. Department of Justice. Our collaboration loss for the quarter was $10 million, which represents our 50% share of the $20 million U.S. net commercialization loss for Monjuvi. This is comprised of total net product revenues of $15.5 million and total operating expenses, including COGS and SG&A expenses, of $35.5 million.

Includes a $13 million reserve related to a settlement in principle and connection with the December 2018, she really investigative development.

From the U S Department of Justice.

Our collaborations loss for the quarter was $10 million, which represents our 50% share of the $20 billion U S. Net commercialization loss from one Julien.

This is comprised of total net product revenues of 15, and a half million dollars and total operating expenses, including Cogs and SG&A expenses of 35, and a half million dollars.

Finally, our financial position continues to be strong as we ended the quarter with approximately $2 billion in cash and marketable securities.

Christiana Stamoulis: Finally, our financial position continues to be strong as we ended the quarter with approximately $2 billion in cash and marketable security. Moving on to our guidance for 2021, we are reiterating our revenue, COGS, R&D, and SG&A guidance for the year. We remain confident in our full-year guidance for JACAPI based on the recent recovery of new patient stats and the potential approval later this year for steroid refractory chronic GVHD. Operator, that concludes our prepared remarks. Please give your instructions and open the call for Q&A.

Moving onto our guidance for 2021, we are reiterating our revenue Cogs R&D and SG&A guidance for the year, we remain confident and our full year guidance from Jakafi based on the recent recovery of new patient starts and the potential approval later this year in steroid refractory chronic.

Gvhd.

Operator that concludes our prepared remarks, please give your instructions and open the call for Q&A.

Thank you and now conducting a question answer session, if you'd like to be placed and the question queue. Please press star one on your telephone keypad. We ask you. Please ask one question the return to the queue. Once again Thats star one to be placed and the Q and the interest of time. We ask you. Please ask one question and return to the queue. Our first question.

Operator: Thank you. And now, to conduct your question and answer session. If you'd like to be placed in the question queue, please press star 1 on your telephone keypad. We ask that you please ask one question, then return to the queue. Once again, that's Star 1 to be placed in the queue. In the interest of time, we ask that you please ask one question, then return to the queue. Our first question today is coming from Marc Frahm from Cameron & Company. Your line is now live.

Today is coming from Mark from Cowen and company. Your line is now live.

Hey, guys. Thanks for taking my questions and.

Marc Frahm: Yes, thanks for taking my questions. And thanks for the slides.

Thanks for the slides.

You gave a lot of detail on Jakafi, and new patient starts and the trends there and kind of.

Barry P. Flannelly: Barry, you gave a lot of detail on Jackify, new patient starts and the trends there, and kind of why you have confidence that things are going to improve through the rest of the year. Can you give a little bit more color on the Montjuvi side of things and why you're so confident? It would seem that that indicates DLBCL would be a little less susceptible to kind of pushing off appointments, diagnoses, and starting therapy than some of the indications, Jack. Thanks for the question, Marc. Yeah, so, you know, in diffuse large B-cell lymphoma, obviously, these patients are sick. They need to get treatments.

Why you have confidence that things are going to improve through the rest of the year can you talk a little bit more color on the <unk> side of things and why you're so confident it would seem that.

That indicate D. L D C all would be a little less susceptible.

And I am pushing off appointments diagnoses and starting therapy than some other indications jakafi has.

Thanks for the question Mark.

So.

And diffuse large b cell lymphoma, obviously these patients are sick they need to to get therapy. It's nevertheless, we know that from claims data that pacing.

Barry P. Flannelly: Nevertheless, we know from claims data that patient visits are down by about 10%. Nevertheless, our reason that we're optimistic about Monjuvi is because the Monjuvi-Len combination is a very good combination. Every time we talk to oncologists, hematologists, they're very excited when they see the profile. Our challenge is to continue to educate healthcare professionals, hematologists, and oncologists specifically about the benefits that the Monjuvi-Len combination gives. You can see the two-year update, and the duration of response just keeps getting better at 34 months.

Patient visits are down by about 10%. Nevertheless, a reason that we're optimistic about my Judy is because fine jewelry line combination is a very good combination.

Every time, we talk to oncologists Hematologists and.

Theyre very excited when they see the profile. Our challenge is to continue to educate health care professionals and Hematologist oncologist, specifically about the benefits debt Mount UV land combination gives you can see the two year update and a duration of response just keeps getting better at 34 months well have an update at <unk> free.

Barry P. Flannelly: We'll have an update at ASCO for a three-year follow-up of the L-mine data. Again, the safety and efficacy are there. I just don't think because of the pandemic, we hadn't been able to educate get in front of the doctors of diffuse large B-cell lymphoma as much as we wanted to. But now, we know that the offices are opening up again, not fully, but they are opening up again, and our field teams will be able to get in front of them and share with them, you know, what we think is exciting data for Monjuvi And how do you see, there's a new entrant coming into the market as well, but just how do you see that?

Three year follow up of the L mind data.

And the safety and efficacy are there I just don't think because of the because of the pandemic, we had and been able to educate to get in front of treaters and diffuse large b cell lymphoma as much as we want to and now we know that the offices are opening up again not fully but they are opening up again.

And our field teams will be able to get in front of them and share with them. What we think is exciting data for them and you the land.

And.

How do you see there's a new entrant coming into the market as well.

How do you see that playing out.

Well, it's going to prove that and third line setting you know we're the only.

Barry P. Flannelly: Well, it's been approved in the third line setting. You know, we're the only regimen that's been approved in the second line setting. You know, we'll see how Lonca does. But we know from feedback from our hematologist oncologist that, you know, the profile that they see from Anjuvi Len seems superior to other regimens, possible regimens that I have. We know that other antibody drug conjugates like Lonca have cumulative toxicities, so that could be a problem.

Regimen, and that's proved and the second line setting and we'll see how long it does.

We know from feedback from our Hematologist oncologist.

The profile that they see from and Juvie Len seem superior to other regiments possible regimens and I have we know that other.

And antibody drug conjugates.

And like Lanka have.

Accumulative toxicity, so that could be a problem. The other entrants that are potentially coming all have their own.

Barry P. Flannelly: The other entrants that are potentially coming all have their own toxicity problems, whether it's effusions or cytokine release syndrome. So we think really the safety and efficacy of Anjuvi Len will stand up and will be the first choice in the second line setting.

Toxicity problems, whether it's infusions or cytokine release syndrome. So we think really the safety and efficacy of mine JV land will stand up and will be the first choice and the second line setting.

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

Thank you. Our next question today is coming from Pasadena mud from Bank of America. Your line is now live.

Hi, Good morning. Thank you for taking my question and I wanted to focus line on Rux cream and you guys will have data coming up soon forget alike, all and I wanted to get a sense of what data we should expect at the top line press release and what is the expectation.

Steven H. Stein: Hi, good morning. Thank you for taking my question. I wanted to focus mine on Rux cream. You guys will have data coming up soon for vitiligo. And I wanted to get a sense of what data we should expect on the top line, in the press release, and what the expectation is for what should be considered clinically meaningful data. And then for the atopic dermatitis indication, I just wanted to get a sense of whether you have started any kind of label discussions with the agency. Thank you.

And for what should be considered clinically meaningful data and then for the atopic dermatitis indication and I just wanted to get a sense of whether you have started any kind of label discussions with the agency.

Tazeen Ahmad: Tazeen, it's Stephen. Thank you for your question. So on RUX Cream, as you allude to, we expect both Phase 3 to get its readout during this quarter, this half of the year, and we expect it to replicate the Phase 2 data we've seen. You just saw the 104-week update, including the continued repigmentation that's seen over time, especially you saw that facial data, you know, even the 90% rate is now greater than 60% of patients achieving that.

Susie and it's Steven Thank you for your question, so on and Rux cream as you allude to we expect the both phase III to get the readout during during this quarter. This half of the year, we expect it to replicate all the the phase II data. We've seen you just saw the <unk>.

104 week update including the continued re pigmentation that seen overtime, especially useful debt facial data and even the 90% right now getting greater than 60% of patients achieving that and.

Tazeen Ahmad: And, you know, there are very few spontaneous remissions of vitiligo, as you saw in our data we presented to date. You know, placebo rates are negligible. The studies are large because they require a safety database to hit the efficacy numbers.

You know, there's very little spontaneous remissions.

As you saw in out and all.

The data we presented to date plus.

Placebo rates all.

All negligible. The studies are large because to require a safety database and not to hit the efficacy numbers. So we have a profile that we've already seen now in phase two with a two year update that is.

Steven H. Stein: So we have a profile that we've already seen now in Phase 2, with, you know, a two-year update that is of enormous benefit to patients should they elect to be treated for it. And then you couple that with an extremely tolerable safety profile. From an atopic dermatitis point of view, we don't discuss the regulatory interactions.

Of enormous benefit to patient should they elect to be treated for it and then you couple that with an extremely tolerable safety profile.

And from an atopic dermatitis point of view, we don't discuss and regulatory interactions.

It's gone as expected and we're very comfortable where we sit and we remain on track for achieving everything we need hopefully by the <unk> date. So that's how we're comfortable in that regard. Thank you.

Steven H. Stein: It's gone as expected. We're very comfortable where we sit, and we, you know, remain on track for achieving everything we need, hopefully by the PDUFA date. So that's how, you know, we're comfortable in that regard.

Brian Corey Abrahams: Thank you. Our next question is coming from Brian Abrahams from RBC Capital Markets. Your line is now live.

Thank you. Our next question is coming from Brian Abrahams from RBC capital markets. Your line is now live.

Oh, Hey, guys. Thanks, so much for taking my question.

Brian Corey Abrahams: Hey guys, thanks so much for taking my question. So, another question on topical rocks.

So another question on the on topical rux.

The feedback from Kols has.

Steven H. Stein: The feedback from KOLs has..., which had some questions or unknowns around the durability of the effect.

And that's had some I guess some questions around our unknowns about and the durability of effect of a typical.

Steven H. Stein: Steven Goss, Michael Schmidt, Mark Hoppenot, Daniel Lundquist, Ren Benjamin, Peter Langmuir, Srdan Verstovsek, Ross Levine, Conor MacKay, John Mascarenhas, Daniel Lundquist, Srdan Verstovsek, Ron McCoy, Srdan Verstovsek, Ron MacKay, Steven Stein, John Mascarenhas, Srdan Verstovsek, Ron MacKay, Srdan Verstovsek, Srdan Verstovsek, Ron MacKay, Srdan Verstovsek, [inaudible]

Typical topical a day drugs and all.

And I'm sort of wondering if you could remind us what data you guys have producer plant to produce that might help improve perceptions around this durability question and what kind of education is going to be important to ensure that topical rux as utilized as a chronic rather than a free.

Bridge to biologics and then just maybe as a corollary to that.

And I know you don't give sort of a blow by blow of what they are the ongoing regulatory discussions are but just bigger picture just curious the degree to which the FDA is ongoing safety review of the JAK class and the oral Jackson atopic derm ties into the regulatory discussions there generally speaking thanks.

Steven H. Stein: Brian and Steven, thank you. In terms of atopic dermatitis, again, from the data we've already shown publicly on a few occasions, you see, obviously, the effect in terms of investigative global assessment, eczema areas, severity index, you know, being about the best presented to date in mild to moderate atopic dermatitis. But you couple that with the itch response, which is, you know, in our view and in the view of our opinion leaders, outstanding and also occurs rapidly.

Brian It's Steven Thank you in terms of atopic dermatitis again, you know from the data we've already shown publicly on a few occasions you see obviously.

And the effect in terms of.

Investigator Global assessment, eczema area, and severity index and it being about the best presented to date and in mild to moderate atopic dermatitis, but you couple that with the itch response, which is and.

And our view and opinion leaders view outstanding and also occurs rapidly.

So you get you know pay.

Steven H. Stein: So you get, you know, patients having their dominant symptom resolved pretty quickly. And then, you know, the resolution of the skin effect, in terms of the durability of effect, we expect and what we've seen is patients go into remission and then, you know, sort of go off the drug and then restart it again, in terms of when they get, you know, recurrence, because it's a chronic condition of the symptoms, including itch or the skin effect.

Patients, having well theyre dominant symptom resolved pretty quickly and then you know the resolution of the skin effect in terms of the durability of effect, we expect and with what we've seen is patients treat too to remission and then sort of go off the drug and then restarted again.

In terms of when they get.

From recurrence, because it's a chronic condition of the symptoms, including H or the skin effect, we estimate and Ah.

Steven H. Stein: We estimate, you know, from the clinical data that we've seen in the study, that somewhere around, you know, three to four 60 gram tubes a year would be used. But it's hard, you know, to see what will happen in the real setting because then patients won't be in a clinical trial. And obviously, you know, will be managed by physicians and their own effect. But that will give you a sense of the durability of response, and that's from the clinical trial setting.

From the clinical data that we've seen on the study that's somewhere around three to 460 Gram tubes, a year would be used but it's hard to see what will happen and the real setting because and patients won't be and the clinical trial, and obviously and it will be managed by physicians and their own.

Effect, but the the that will give you a sense of the durability of response and Thats from the clinical trial setting.

In terms of AR and AR to be repetitive on on the label and and discussions and the FDA review. We just you know as a rule don't speak about them and and are referred to the FDA in that regard but to be repetitive. We are very comfortable where we all with the review is progressing well and again our goal is to finish this by the Paducah date.

Steven H. Stein: In terms of, you know, being repetitive on the labeling and discussions in the FDA review, we just, you know, as a rule, don't speak about them and, you know, refer to the FDA in that regard. But to be repetitive, we're very comfortable where we are with the review; it's progressing well. And again, our goal is to finish this by the PDUFA date.

Thanks, Thanks, so much David.

Vikram Purohit: Thank you. The next question is coming from Vikram Purohit from Morgan Stanley. Your line is now live.

Thank you. The next question is coming from debt from Kuri from Morgan Stanley. Your line is that life.

Great. Thanks for taking my question.

Vikram Purohit: Great, thanks for taking my question. So I had two on the limber program. First, for once-a-day RUCs, you previously mentioned that you expect BAB data in the first half of this year, so I wanted to see if that data set is going to be presented publicly, and regardless of whether it's public or an internal readout, what constitutes a success for this data set? And then, secondly, on limber, it looks like there's a phase two study expected to start soon evaluating itacitinib as part of the limber program, so I was just wondering if you could speak a bit about the rationale for studying this drug in this setting.

Well I had two on the limber program.

Burst or once a day rux you previously mentioned that you expect.

The data and the first half of this year, so I wanted to see.

And if that data set is going to be presented publicly and and regardless of whether it's public or and internal readout.

Constitutes and success or this dataset and then secondly, all member.

It looks like Theres, a phase two study expected to start soon if all you wouldn't get a CIT and debit as part of a simple program. So I was just wondering if you could speak a bit about the rationale for studying this drug in this setting.

Steven H. Stein: Thanks.

Yeah.

Vikram Hi, it's Steven again, you are correct.

Steven H. Stein: Vikram, hi, it's Steven again. You are correct. So the RUX-XR Once Daily program has progressed well. It's a relatively pre-set route in terms of bioequivalence and bioavailability testing of the different tablet strengths. We've completed that. We have it in-house. And, you know, we follow FDA guidance on what needs to be achieved comparable to the RUX that's used in the clinic in terms of area under the curve. So there's very strict guidance on what you have to come within to meet that.

<unk> XR once daily program has progressed well, it's a it's a relatively preset route in terms of bio equivalents and bioavailability testing of the different tablet strength.

We've completed that we have and in house and we follow the FDA guidance and what needs to be achieved comparator real to the direct that's used in the clinic in terms of area under the curve the very strict guidance and what you have to come within our to meet that and we there and we have that day.

Steven H. Stein: And we then, we have that data in-house. Yes, we do expect to have a public presentation of the data this calendar year at an appropriate meeting and forum, and we'll give that to you. The other rate-limiting step there is just stability.

And the in house, Yes, we do expect to have a public presentation of the day to this calendar year at an appropriate.

Median and for them and we will give that to you. The other rate limiting step there is just stability. So once we completed the EPA and day all the strength of laid down for 12 months stability as soon as that completes then we expect to proceed with filing very early next year and what should be about a 10 month review.

Steven H. Stein: So once we've completed the BA and BE, all the strengths are laid down for 12-month stability. As soon as that completes, then we expect to proceed with filing very early next year. And what should be about a 10-month review period, we should have an approval, if everything goes well, right before the end of 22, early 23, sort of time period, if you work that out. But again, to be repetitive, we will present the data publicly to you this year.

Period, we should have and approval if everything goes well right before the end of 'twenty. Two early 'twenty three sort of time period. If you work that out but again to be repetitive we will present the data public too publicly to this year.

It's a sudden interest in it.

Relative.

And Jack one agent compared to <unk>, which is more JAK, one Jack too and.

And we're trying to leverage that effect in terms of its cytopenia is to see if we can have some benefit in myelofibrosis patients who require a modulation of the effect in terms of less Jack too and less cytopenia is so it'll be tested in a phase II setting there for the appropriate patients to see.

Steven H. Stein: So it'll be tested in a phase 2 setting there for the appropriate patients to see if we achieve proof of concept with this drug. But just let me remind you, it has ongoing work in multiple other settings, including cytokine release syndrome, including broncholitis obliterans, and including some other work as well in inflammation and autoimmunity. So that's not the only program it's been used for.

If we achieve proof of concept with this drug just let me remind you. It is ongoing work and multiple other settings, including cytokine release syndrome, including bronchitis, obliterans and including some other work as well and inflammation and autoimmunity.

So that's not the only program it's been useful thanks.

Steven H. Stein: Thanks. Oh, and sorry, also I should mention ongoing chronic GVHD work where we're doing some dose ranging work, which we'll get data on towards the end of this calendar year. Thanks. Got it. Thank you. Thank you. Next question is coming from Andrew Berens from SVB Larynx. Your line is now live.

Oh and sorry, you also mentioned ongoing chronic gvhd work, where we're doing some dose ranging work, which you will get data and towards the end of this calendar year.

Oh.

Got it thanks.

Thank you next question is coming from Andrew Burns from SVP Leerink. Your line is that lives.

Hi, Thanks, I'm also a question about the limber program.

Andrew Berens: Thank you. The next question is coming from Andrew Berens from SVB Learning. Your line is now

Some of them start to advance and I was wondering if you could give us any qualitative comments about which you're most excited about and then if I could sneak another one and on Jakafi or are you seeing any commercial and competitive impact and EM.

Steven H. Stein: So I'll start with the Limba program, Andy, and then hand it to Barry for your second question. So, firstly, it's importance to us, Limba.

Mouth.

Yeah.

So I'll start on the Limber program and your and then hand it to Barry for your second question. So remember firstly its importance to us lumber.

Steven H. Stein: I mean, you know, Barry has spoken about RUX, its enormous benefit to patients, the value it brings to patients, and then, you know, to the company and shareholders as well. So this is an internal effort that's cross-functional and appropriately large, directed at many different areas. So you have the Once Daily program we just spoke about, and its importance for Once Daily alone, plus optionality potentially on fixed-dose combinations with other Once Dailies down the line, should we decide to do that. Then the second pillar, you know, it's all the combination work.

Various spoken about racks, that's enormous benefit to patients and the value. It brings to patients and then to the company and and shareholders as well. So this is an internal effort that's cross functional and appropriately lodge directed at many different areas. So you have the once daily program, we just spoke about and its importance there for once daily.

Alone plus optionality potentially on fixed dose combinations with other once daily is down the line should we decide to do that then the second pillar and it.

It's all the combination work and you're asking more specifically, what what we may be more excited about versus others and I'll come back to that and the second but just to mention the third pillar of the program, which we more quiet about because its preclinical in terms of discovery research work in both MF and PV or were there other.

Steven H. Stein: And you ask, you know, more specifically what we may be more excited about versus others, and I'll come back to that in a second. But just to mention, you know, the third pillar of the program, which we're more quiet about because it's preclinical, in terms of discovery research work in both MF and PVera, where there are other potential targets which we may end up pursuing, and Dash, in his research endeavors, is looking at those, plus with various collaborators. Just to come back to that middle tier and the combos.

Central targets, which we may end up pursuing and dash and his research endeavors are looking at those plus with various collaborators just to come back to that middle middle tier and the combos. So the rux pasta program, both registration directed phase threes all open.

Steven H. Stein: So the RUX PASTA program, both registration-directed phase threes are open, and sites are already being initiated and are screening patients. Just to remind you, there's a suboptimal setting where patients have had at least three months of RUX elitinib, eight weeks of stable dose, but are not having sufficient benefit in terms of spleen reduction or symptoms and are then randomized to continue RUX versus RUX plus PASTA-Clisib in that setting. And that study is open.

<unk> already been initiated and are screening patients just to remind you. There's a sub optimal setting where patients have had at least three months of Brooks and letting them eight weeks of stable dose, but are not having sufficient benefit in terms of spleen reduction of symptoms and are then randomized to continue rux versus rux plus pasta.

A cluster of in that setting and that study is open and then the first line study of Rux, plus past service Rux alone and first line looking typically at a 24 week spleen volume response of 35% or greater and we also then internally have all our bet program, which this off to you.

Steven H. Stein: And then the first-line study of RUX plus PASTA versus RUX alone, in first line, looking typically at a 24-week spleen volume response of 35% or greater. We also then internally have our BET program, which this half of the year is looking at monotherapy safety, and then we want to initiate combinations with RUX in the second half of this year. Just also to remind you, this is not a new drug to us.

Looking at monotherapy safety, and and we want to initiate combinations with rux and the second half. This year. Just also to remind you there is not a new drug to us we're headed in the clinic a few years ago, we were dosing at multiples of where we were and now looking largely at solid tumors and make inhibition. So we really haven't experienced with this comp.

Steven H. Stein: We had it in the clinic a few years ago, where we were dosing at multiples of where we are now, looking largely at solid tumors and MYC inhibition. So we already have the experience with this compound in 100-plus patients or more in that setting, and we want to keep accelerating that. And then, as I had prepared remarks, the third program is the ELK2 program, a very little bit of a different mindset.

And over 100, plus patients or more and that setting and we want to keep accelerating that and then as I and my prepared remarks. The third program is the <unk> two program very little bit of a different mindset and are probably works as we illustrated a.

Steven H. Stein: You know, probably works, as we illustrated, through hepcidin inhibition and ameliorating the anemia, which has a two-fold effect. It'll potentially ameliorate the anemia of myelofibrosis itself, plus the ruxolitinib-induced anemia. And then not only that, should that be successful, that's one of the principal reasons patients discontinue ruxolitinib. So if we can ameliorate that, you'll get the added benefit of continued RUX use and the efficacy thereof. So that's also an exciting program. So I'm not giving you a priority list, because they all have slightly different nuances.

Through our hip Sade and inhibition.

And meliorate and the anemia and <unk>.

Which has a twofold effect.

All right potentially the anemia of myelofibrosis itself, plus the rocks and letting them induced anemia, and then not only that should that be successful and that's one of the principal reasons patients discontinue rux and letting them. So we can ameliorate that you'll get the added benefit of continued rux use and efficacy thereof. So that's all.

And exciting program, so I'm not giving you a priority list because they all have slightly different nuances. The one. Most ahead is obviously post the close of in terms of the registration studies underway. The other two we want to complete the monotherapy and combination safety this year and present data to your next year I'll hand, it to Barry for your second question, Yeah. So Andrew so for competition.

Steven H. Stein: The one most ahead is obviously the most advanced in terms of registration studies underway. The other two, we want to complete monotherapy and combination safety this year and present data to you next year. I'll hand it to Barry for your second question.

Barry P. Flannelly: Yeah, Andrew, so for competition in MF, the only drug that's approved besides Jakafi is Fidratinib from BMS. And it's only being used second line, if at all, and BMS just reported their... Their earnings, and really, the drug has been flat since launch, so no, and one of the reasons we're encouraged as we continue through 2021 is that MF patients grew very nicely from Q So patients are coming back to the office, and patients are getting treated.

And in MF and the only drug that's approved besides jakafi is the drought and there from BMS.

And it's only being used second line if at all and <unk>.

<unk> just reported there.

Our earnings and really the drug has been flat since launch so no and in fact, we are one of the reasons we're encouraged.

As we continue through 2020, one is MF patients grew very nicely from Q.

In Q1 compared to Q4, so patients are coming back to the office patients getting treated new patients are getting started on jakafi and MF.

Great. Thanks for all the color guys I appreciate it.

Barry P. Flannelly: Thank you. The next question today is coming from Corey Kazama from JP Morgan. Your line is now live.

Thank you next question today is coming from Cory CASM all from JP Morgan. Your line is now live.

Hey, good morning, guys. Thanks for taking my question and your press release mentions you're advancing and are you advance the seven O seven JAK one candidate and.

Reni John Benjamin: Hey, good morning guys. Thanks for taking my question. Your press release mentions you're advancing, or you advanced the 707 Jack 1 candidate into phase 2 in vitiligo. Can you just talk about the motivation here and what you see as the potential benefit of having this if Rux cream works in this indication and, you know, how you might be able to improve upon it or are there commercial considerations to think about to have a different compound? Thank you.

A phase II and vitiligo and could you just talk about the motivation here and what you see as the potential benefit of having this if rux cream works and this indication and how you might be able to improve upon it or their commercial considerations to think about to have a different compound and thank you.

Yeah Cory Thanks for the question that Stephen and thanks for bringing that up so our 707 is another in house JAK inhibitor currently being used in higher Ed we're not as Super TVA, Oh, sorry, a different profile to rocks, maybe in terms of more relative JAK one effect. This Jack too and it's good you bring this up because theres.

Steven H. Stein: Yeah, Corey, thanks for the question. It's Steven, and thanks for bringing that up.

Steven H. Stein: So 707 is another in-house JAK inhibitor currently being used in higher adrenitis supratevia, also a different profile to RUX, maybe, you know, in terms of more relative JAK1 effect versus JAK2. And it's good you bring this up because there's a spectrum of disease, if you will, in vitiligo that goes, you know, from mild to moderate to much more severe patients, where in the latter setting, in the more severe, you know, there may be more of a tolerance, both from the patient point of view and regulator point of view, for a different risk-benefit profile and need for a, quote-unquote, more potent effect, should this work.

A spectrum of Av.

Disease, if you will in with Lager that goes you know from mild to moderate to much more severe patients where in the latter setting and the most severe they may be more of a tolerance both from a patient point of view and regulated point of view from a different risk benefit profile and need for a quote unquote more potent effects should this work.

So the idea here would be to get we think JAK inhibition or we know from the cream is.

Steven H. Stein: So the idea here would be to get, we think, JAK inhibition, or we know from the cream that it is really effective therapy, and I just showed you in my prepared remarks 104-week data. But perhaps an oral having, you know, a different profile and potentially a more potent effect with a different risk-benefit profile would be worth testing. And in that way, we would look after vitiligo, you know, as an entity in completeness, in a more holistic manner, and be able to offer patients both a topical treatment for their illness and then also potentially an oral treatment for more severe cases. And that's the idea behind that.

Rarely effective therapy and I just showed you in my prepared remarks of 104 week data, but perhaps with and are all having a different.

Profile and potentially a more potent effect with albeit a different risk benefit profile is worth testing and that in that way, we would look after vitiligo.

And as an entity in completeness and the more and lets take manner and be able to offer patients both a topical treatment for their for their <unk>.

Illness, and then also potentially and oral treatment for more severe settings, and that's the idea behind that.

That's very helpful. Thank you.

Salveen Richter: Thank you. Our next question is coming from Salveen Richter from Goldman Sachs. Your line is now live.

Yeah.

Thank you. Our next question is coming from <unk> Richter from Goldman Sachs or why isn't that lives.

Good morning, Thanks for taking my questions on the screen could you just talk about the progress and on the sales force build out here and and you know potential pricing strategies and updates and payer discussions and then separately and just thoughts and.

Salveen Richter: Good morning. Thanks for taking my questions. On the RUC screen, could you just talk about the progress on the Salesforce build out here and potential pricing strategies and updates on payer discussions? And then separately, just thoughts on, given what we're seeing here with competitor JAX on the regulatory front and read through for your class. Thanks, Salveen.

Given what we're seeing competitor Jackson, and the regulatory front and and we do it for free.

Thanks, Kelvin and so on the sales force. So I think what we said upfront was that the derm.

Barry P. Flannelly: Thanks, Salveen. So on Salesforce, I think what we said up front was that the DERM team, whether it's medical affairs, sales, or market access, is complete. So they're all on board. They're being trained; some have already been trained. The medical affairs team has been working for a long time now, having discussions with external experts, learning more about, you know, their preferences. As far as price goes, well, we don't talk about price at this point, but we have had ongoing meaningful discussions with payers, including the top three PBMs that cover 80% of the lives in the United States.

<unk> team, whether its a medical affairs our sales.

Market access is complete so they're all on board.

And they are being trained some have already been trained and ready.

And the medical Affairs team has been working for a long time now.

And on having their discussions with external experts are learning more about their.

And their preferences.

As far as the price goes well, we don't talk about price at this point, but we have had ongoing meaningful discussions with payers, including the top three.

Pbms they cover 80% of lives and the United States and they've been very productive they've been very interested and impressed by the clinical data that's been presented to them from the two a day one and two studies.

Barry P. Flannelly: They've been very productive. They've been very interested in and impressed by the clinical data that's been presented to them from the TrueAID 1 and 2 studies. So, you know, we're very encouraged about that. The oral JAK inhibitors, obviously, they've been delayed, but, you know, we think the advantage of a topical JAK inhibitor like Ruxolitinib cream with the profile that it has in all atopic dermatitis patients is really an advantage for us because of that.

So we're very encouraged about that.

The oral JAK inhibitors, obviously, they've been delayed but we think the advantage the topical JAK inhibitor like rux lithium cream with a profile that it has.

And all atopic dermatitis patients is really an advantage for us because of the.

Our safety and of course, the excellent efficacy.

Barry P. Flannelly: Thank you. Our next question is coming from Michael Schmidt from Guggenheim Rewind.

Thank you.

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

Hey, guys. Good morning, Thanks for taking my question and perhaps one on a person.

Michael Schmidt: Hey guys, good morning. Thanks for taking my question. Perhaps one on parsecs, let's say...

Where you are potentially.

Potentially filing for approval later this year as well and this is my question is are.

Michael Schmidt: Where you are potentially filing for approval later this year as well. I guess my question is, are you planning to file in all three indications simultaneously? What are potential gating factors for filing? And lastly, I guess, how do you think the drug will be positioned in these pharma companies?

Are you planning to file in all three indications simultaneously.

What are potential gating factors to filing and and and lastly, I guess, how how do you think the drug will be possession that knees and I'm four months perhaps.

Michael Schmidt: Perhaps relative to other treatment options. What has the feedback been, perhaps?

Relative to other treatment options, what what has the feedback perhaps spend from from physicians and how they might incorporate the drug and that treatment paradigm.

Steven H. Stein: Transcripts provided by Transcription Outsourcing, LLC.

Steven H. Stein: Yeah, Michael. It's Steven. Thanks for the question. So again, you know, the data sets with parseclysib in non-Hodgkin's lymphomas are in three different entities, follicular lymphoma, relapsed refractory, marginal zone lymphoma, relapsed refractory, and mantle cell lymphoma, relapsed refractory. We've, you know, we've updated at So we really like the efficacy profile of the compound, and then the tolerability, you know, with the second-generation DELT inhibitors now largely dialing out the liver effect, and then an acceptable profile in terms of, you know, the other effects you see with DELT inhibitors.

And Michael it's Steve and thanks for the question. So again, the datasets with Pos are closer in and non Hodgkin's lymphoma zone, three different entities Follicular lymphoma, relapsed refractory marginal zone lymphoma, relapsed refractory and mantle cell lymphoma relapsed refractory <unk>.

David had a few meetings now the independently reviewed response rates, which are extremely robust and durable and L. P and and single arm studies with long progression free survivals. So we really like the efficacy profile of the compound and then the tolerability with the second generation.

And Delta inhibitors, now largely dial in and out to lever effect and then acceptable profile in terms of the other facts you see with with Delta inhibitors. So the intent in the U S is to file all three indications and Follicular marginal zone and mantle.

Steven H. Stein: So the intent in the U.S. is to file all three indications in follicular, marginal zone, and mantle cell lymphoma together. We still are working out the filing approaches in the other regions we operate in, in Europe and Japan, but we feel that it has a competitive profile there as well. There's no other gating effect.

Lymphoma together.

We still all working out the debt.

All in approaches and the other regions, we operate in and in Europe, and Japan, but.

We field and it has a competitive profile there as well and there's no. Other gating effect. It was merely the requirement to have a year's follow up on the last responders, which is typical in these settings and everything is progressing well on getting that filing and the second half of 2021.

Steven H. Stein: It was merely the requirement to have a year's follow-up on the last responders, which is typical in these settings, and everything's progressing well on getting that profile in the second half of 2021. In terms of how we'll be positioned in lymphomas versus other options, you know, as you indirectly alluded to, you know, it's an area where there is chemotherapy, there is other targeted therapy with BTK inhibitors, BCL-2 inhibitors, there are CAR-T therapies, and as we earlier in the call said, antibody drug conjugates as well. And, you know, again, these are not, these data sets are not first-line settings. They're relapsed refractory settings.

In terms of how it will be positioned and lymphomas versus other options.

And as you indirectly allude to.

And it's an area where theres a chemotherapy is other.

Targeted therapy with PTK inhibitors, Bcl two inhibitors the car T therapies.

And in the KOL said antibody drug conjugates as well and.

Again these are not.

And these datasets are not first line settings. The relapse refractory setting I think physicians will look at the efficacy and tolerability data on its face and use it appropriately. There you know, there's a little bit of a cloud over the area now.

Steven H. Stein: I think physicians will look at the efficacy and tolerability data on its face and use it appropriately there. You know, there's a little bit of a cloud over the area now early on in terms of idealistic data and some of the toxicity seen in combination that needs to be overcome. But now with a few Delta inhibitors out there showing really robust data in B-cell lymphomas, different tolerability profiles, physicians getting used to them again, you know, we feel, and we hear in that people will use them appropriately based on the data sets.

Early on in terms of other Elisa data and some other toxicity seen in combination that needs to be overcome but now with a few delta inhibitors out there showing really robust data and b cell lymphomas different tolerability profiles physicians getting used to it again, we feel and we hear in that people will use it appropriate to the data.

Thanks.

Reni John Benjamin: Great. Thank you, Steven. Thank you. Our next question is coming from Alethea Young from Cantor Fitzgerald. Your line is now live. Hey guys, thanks for taking my question.

Alright, Thank you Steven.

Thank you next question is coming from Alicia Young from Cantor Fitzgerald. Your line is now live.

Hey, guys. Thanks for taking my question I, just wanted to talk a little bit about how how like some other and this will pay a work you've done kind of how they think about kind of realizing value between debt.

And and topical I'm, sorry, atopic dermatitis I, just wonder if there's kind of a greater value proposition and put on kind of the efficacy that has been seen so far and there's a lag versus a day and any thoughts you have there would be appreciated. Thanks.

Reni John Benjamin: Thank you. The next question is coming from Alethea Young from Cantor Fitzgerald. Your line is now live. Hey guys.

Barry P. Flannelly: Thanks, Althea. So, for atopic dermatitis, you know, out of the pair, the discussions we've had so far, I think the efficacy and safety are compelling. They really think of it as, you know, a possibility of using a drug from newly diagnosed patients all the way up to biologics. They're always asking whether they can delay the use of biologics or systemic therapies. So they're very encouraged by that.

All right. Thanks Alethia so for.

Atopic dermatitis.

And the payers.

And as we've had so far I think it's the efficacy and safety.

And is compelling.

And they really think of it as a possibility of using a drug from <unk>.

From newly diagnosed patients and all the way up to biologics.

And they're always asking about can they delay the use of biologics or systemic therapies.

And so they're very encouraged by that and did a lego.

Barry P. Flannelly: In vitiligo, I think that, you know, it's an under-understanding that it's an autoimmune disease, vitiligo is, that needs to be treated. And treating with a topical therapy like ruxolitinib cream that will be safe and effective is the best way to go. Whether one is better than the other in terms of value is very difficult to say. I think that ruxolitinib cream is going to be an excellent drug for atopic dermatitis, and it could be life-changing for vitiligo.

I think debt.

It's a it's and they're beginning to understand that it's and autoimmune disease, the libraries that needs to be treated.

And treating with a topical therapy like rux cream.

Cream that'll be safe and effective.

<unk> is the best way to go.

Whether one is.

Better than the other in terms of value and it's very difficult to say I think that Rex letting them cream is going to be and excellent drug for atopic dermatitis and it could be life changing for vitiligo.

Srikripa Devarakonda: Thank you. Our next question today is coming from Srikripa Devarakonda from Truist Security. Your line is now live.

Great. Thank you.

Yeah.

Thank you and our next question today is coming from Sri Creeper Tabarrok Honda.

From two of Securities. Your line is all lives.

Well. Thank you so much for taking my question sale and dermatology given and we were so.

Srikripa Devarakonda: Thank you so much for joining us.

Srikripa Devarakonda: Thank you for taking my question.

Barry P. Flannelly: Staying on dermatology, given that we're so close to the PDUFA date, and you have talked a little bit about your launch preparedness, but I was wondering how soon after a potential approval can patients expect to have access to the drug? What steps does that entail? And finally, once the drug launches, what sort of metrics can we expect you to provide to us so we can understand and model the launch curve appropriately? Thank you so much.

So close to the pin yesterday, and you have talked a little bit about your launch preparedness and I was wondering how soon after potential approval and 10 patient growth.

All access to the drug and what's that.

Paul.

And finally, no one wants to do all the launch what sort of metric.

Can we expect you to provide two wise. So we can we can understand and model. The launch current appropriately. Thank you so much.

Yeah.

Barry P. Flannelly: Thanks, Kripa. So how soon will I have access to the drug? Right away, as soon as we possibly can get it out. It should be just a matter of a few days before we're able to ship it out to the wholesalers, and the wholesalers can ship it out to the pharmacies. So it'll be as rapidly as we possibly can in just a matter of days, if not a week. So what metrics can we provide for the curve?

Thanks, Chris.

So how soon will they have access to the drug right away as soon as we possibly can get it out and it.

It should be just a matter of a few days before it's and we're able to ship it out to the wholesalers and wholesales sellers can ship it out to the pharmacies. So it'll be as rapidly as we possibly can just a matter of days.

Days, if not a week.

So what metrics can we provide for the curve so.

You know what.

Barry P. Flannelly: So... You know, you'll be able to follow the new Rx data and the TRx data on a weekly basis, just like many people do for every prescription drug out there. And you'll see that we think there will be a rapid uptake for the drug. You know, our gross net may be impacted at the beginning, and it'll continue to improve over time. But we think that the total number of Rxs and new Rxs will grow week after week. And you'll be able to follow that along just like we will.

And you'll be able if all of the new Rx data and the T Rx data.

On a weekly basis, just like many people do for every prescription drug out there and so you'll see that we think there'll be a rapid uptake for the drug.

Our gross to net may be impacted at the beginning and it will continue to improve over time, but we think that the total Rx as a new Rx is we'll grow week after week.

And you'll be able to follow that and just like we will.

Great. Thanks that was helpful. And then if I can sneak in one more question following up on the Limber program.

Srikripa Devarakonda: Great. Thanks. That was helpful. And then I can sneak in one more question.

Srikripa Devarakonda: and Following up on the limber program, you're doing a phase one trial with your bed inhibitor. What is the bar?

It's all Youre doing a phase one trial with your bet inhibitor.

What is the bar you have internally for you to take it forward into phase two with a combo or are you comfortable enough that you do plan to initiate and propose to commvault and second homes.

Steven H. Stein: Transcription by Transcription Outsourcing, LLC.

Steven H. Stein: We plan to initiate the phase two combo in the second half.

Steven H. Stein: Hi Kripa, it's Steven. So the real bar is purely safety in the beginning, and again, just to be repetitive, we had this drug in the clinic a few years ago for quite a bit at multiples of the four milligram dose we are now treating above ten milligrams, and we withdrew it because of, you know, a lack of efficacy in solid tumors plus a safety profile around thrombocytopenia.

Hi, it's Steven so the real bar is purely safety and the beginning and again just to be repetitive. We mentioned we had this drug and the kind of a few years ago from quite a bit at multiples of the four milligram dose. We now and we are treating above 10 milligrams and we withdrew it because of.

And a lack of efficacy in solid tumors plus a safety profile around thrombocytopenia. We then watch this field evolve and have modeled did some modeling on the constellation and 610 compound and worked out you know that are at a much lower dose may be effective in myelofibrosis.

Steven H. Stein: We then, you know, watched this field evolve, you know, modeled, did some modeling on the Constellation 610 compound and worked out that a much lower dose may be effective in myelofibrosis. So we're now using the four milligram dose in phase one just to document that safety, but principally an acceptable profile in terms of thrombocytopenia, then quickly doing a smaller number of patients with raxolit At that juncture, round around the end of this year, early next year, we will have choices to make, which we're not there yet, which is what you alluded to, how aggressive to be.

So we now using the formula Gram dose and a phase one just to document that safety, principally and acceptable profile in terms of thrombocytopenia and then quickly do a smaller number of patients with rack. So let's now begin to document the safety aspect and that juncture.

And Ah round around the end of this year early next year, we will have choices to make which were not there yet which is what you alluded to how aggressive to be do we then have to repeat to want to repeat it.

Steven H. Stein: Do we then have to repeat or want to repeat phase two proof of concept work, or will we be comfortable enough, given the arena, to be more aggressive and go straight to phase three or registration-directed studies? And we will make that decision once we see the safety profile of the combination.

Phase II proof of concept work well will we be comfortable enough given the arena to be more aggressive and go straight to a phase III or registration directed studies and we will make that decision once we see the safety profile of the combination.

Thank you so much and also whoever made the decision. Thank you so much low paying to Star Wars music during the earnings call before the call started said thank you.

Srikripa Devarakonda: Great, thank you so much. And also, whoever made the decision, thank you so much for playing the Star Wars music during the earnings call before the earnings call started.

Srikripa Devarakonda: Before the earnings call started, so thank you.

Yeah.

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

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

And they start day my question and impressive 104 week Vitiligo data show and at the recent AAD meeting, but there wasn't a notable decrease in debt.

Matt Phipps: Hi, thanks for attending my question. Impressive 104-week vitiligo data shown at the recent AAD meeting, but there was a notable decrease in the valuable patients there, with some patients withdrawing from the study. I guess reasonable given it's a long follow-up, but if you just look at the patients that completed 104, you know, what percentage of those were responders at week 52? Just wondering if there's a bias in these response rates at week 104 by patients not responding being the ones that chose to withdraw from the study.

All evil patients there are some patients withdrawing from the study I guess reasonable given it's a long long follow up but if you just looked at the patients that completed one O. Four you know what percentage of those were responders at week 52, just wondering if there's a bias and these response rates at week, one and four by patients not responding to and the ones that chose to withdraw from study.

Steven H. Stein: Matt, it's Steven. I'll have to get back to you on the second part of your question. I don't have in front of me a match for the 52-week versus 104-week data, but I do want to make some points. Whenever you have a study and you decide to lock a database, you'll have what's in that database at that time, and there will, by its nature, potentially missing data or missing visits. And that's partly what you're seeing.

And Matt it's Steven.

I have to get back to you and the second part of your question and I don't have in front of me a match on a 52 week versus 104 week data, but I do want to make some points. So whenever you whenever you have a study and you decide to lock the database Youll just you'll have what's in that database at that time and it will be by its nature and I'm potentially missing data.

And visits and and that's partly what you're seeing in addition, and I think you indirectly alluding to this you know when people have that degree of improvement and they may elect for various reasons and the extension phase not to not to go onto the extension because they satisfied where they are or were they all.

Steven H. Stein: In addition, and I think you're indirectly alluding to this, when people have that degree of improvement, they may elect, for various reasons, not to go on to the extension phase because they're satisfied where they are at the time. These are things we have to work out, given the impressive efficacy we see with the drug over time. For me, the major message, though, is... And there's also, sorry, one more thing I want to say.

We're at at the time. These are things we have to work out given the impressive efficacy we see with the drug overtime for me the major message, though is and there's also sorry, one more thing I want to say there is there is a little bit of a COVID-19 impact on on the longer term study and people for example, wanting to come back to the clinic.

Steven H. Stein: There is a little bit of a COVID impact on the longer-term study in people, for example, wanting to come back to a clinic for a formal visit when it's not really needed for the primary endpoint. But what, for me, the major message of the study, which is really interesting in terms of the biology, is that you get continued improvement over time. And we think there's a two-fold effect happening there. The melanocytes are repopulating the area, they're present there, plus the T-cell suppression is probably largely gone and could be long-lived.

Formal visit.

And when it's not you know really needed for the primary endpoint, but what for me. The major message of the study, which is really the interest and in terms of the biology is you get continued improvement over time and.

And we think Theres, a two fold effect happened and the melanocytes all our repopulate in the area. They present, there plus the T cell suppression, and there's probably largely gone and could be long lived and you're seeing this continued improvement over time, which is which is just fascinating. It leaves the remaining questions too.

Steven H. Stein: And you're seeing this continued improvement over time, which is just fascinating. At least the remaining questions to ask are when you withdraw therapy, how long, how durable that is, will treatment be reneeded, et cetera. And all those experiments we'll conduct and will be ongoing here at Insight as we understand this further. But it really surprised us in a good way to see that even at two years later, you're still getting an increase in rates. But your comments noted on smaller patient numbers down the pike.

Ask is when you withdraw therapy, how long and how durable that is.

And well treatment be re needed et cetera, and all those experiments will conduct and will be ongoing.

Garrett inside as we understand this further but it rarely are somewhat surprised us and a good way to see debt even at two years later, you're still getting an increase and the rates, but your comments noted on smaller patient numbers down the pike.

Okay.

Ren Benjamin: Thank you. Our next question is coming from Ren Benjamin from J&P Securities. Your line is now live. Hi, good morning, guys. Thanks for taking the questions.

Yeah.

Thank you and next question is coming from Ren Benjamin from JMP Securities. Your line is now live.

Hi, Good morning, guys. Thanks for taking the questions.

Most of the focus on kind of garden and for a quick second.

Ren Benjamin: I'd love to focus on Pemigadmin for a quick second. Can you just talk us through maybe the longer-term strategy and the other indications that you're moving forward with and any feedback that you might have from sales on how this...

Can you just talk us through maybe the longer term strategy and the.

The other indications.

And that you're that you're moving forward with them and any feedback that you might have from sales on on how this.

Can you go up, especially given the competitive environment is going to continue and and maybe just as a follow up.

Ren Benjamin: Continued growth, especially given the competitive environment, is going to continue, and maybe just for Steven, as a follow-up to the two big data points.

The two day big data points, I guess I have written down our L mind data at <unk> and the B a day data for once daily Rux.

Ren Benjamin: The two big data points I guess I have written down are LMIND data at ASCO and the BADE data for Once Daily Rocks sometime later this year. Are those primarily the main ones, or are there other key updates that we should keep in mind? Thank you.

Sometime later this year is.

Is that is that primarily the main ones or are there other key updates that we should keep in mind. Thank you.

Steven H. Stein: So, I'll answer the clinical development part of your questions, Barry will talk about the sales performance question embedded there. So, just to talk about our first indication in second line, Chalangio carcinoma, which as Herve said, is now globally approved in Europe and Japan as well, and our first internally discovered global product, and then Barry showed you, you know, the excellent uptake on the launch so far in a rare entity. However, you know, again, in a good way, given now, you know, there's other targets beyond FGFR2, like IDH, more and more of these patients are getting molecularly profiled, more and more are discovering that they're FGFR2 driven, and additionally, there's an awareness now beyond Chalangio that one of the most common entities in carcinoma of unknown origin is potentially Chalangio carcinoma, so that, when that entity gets molecular profiled and is FGFR2 driven, there's a feeling that may be Chalangio carcinoma and lend itself to treatment with pemigatinib.

So I'll answer the clinical development part of your question Barry will talk about the sales performance question embedded there. So just to talk about our first indication in second line Cholangiocarcinoma, which is where they said he's now globally approved in Europe and Japan.

Well and our first internally discovered global product and and Barry showed you you know.

The excellent uptake on the launch so far and array entity, However, again and a good way given now you know theres other targets beyond the FGF are too like I D. H more and more of these patients are getting molecularly profiled more and more of discovering that day, if geoff or two driven and additionally, theres and.

Witness now beyond Cholangiole and one of the most common entities and carcinoma of unknown origin is potentially cholangiocarcinoma, so that that with net entity gets molecular profile and safety of our two driven there's a feeling that maybe cholangiocarcinoma and lend itself to treatment with payment Gatineau rims.

Members part of accelerated approval, we have and ongoing first line study. So that's critical in terms of lifecycle management, it's against first line chemotherapy and in terms of Jim Sidedly and platinum and if you're looking at other entities, where you have a molecular profile. It ends up being an oncogenic driver that drives it.

Steven H. Stein: Remember, as part of our accelerated approval, we have an ongoing first line study, so that's critical in terms of life cycle management, it's against first line chemotherapy in terms of gemcitopoietin and cisplatinib, and if you look in other entities where you have a molecular profile that ends up being an oncogenic driver that drives a particular tumor, so look at melanoma with BRAF MEK, etc., you see this, or even lung cancer with EGFR, you see this migration to earlier line settings in terms of a targeted therapy, and that's the idea behind first line Chalangio, plus, obviously, a very different tolerability profile versus chemotherapy. We have an ongoing large tumor agnostic study that is enrolled well, that looks at, not to belabor the molecular side of this, but fusions, rearrangements, amplifications, and then any other potential driver, and there are three different buckets there, and there's optionality around that as we gather the data now to either pursue, potentially, the tumor agnostic setting if there's a strong enough signal, or to look at a particular histology or two where there may be a driver there, and then to do standalone work in that setting.

And the killer tumors, so look at melanoma with BRAF Mec et cetera, you see this all even lung cancer with Egfr you see this migration to earlier line settings in terms of a targeted therapy and that's the idea behind first line Cholangiole, plus obviously, a very different tolerability profile versus chemotherapy, we have and ongoing.

All in a large tumor agnostic.

Diagnostic study that has enrolled well that looks at not to belabor. The molecular side of this but fusions rearrangements amplifications and then any other potential driver and the three different buckets, there and there's optionality around that as we gather the data and now to either pursue potentially.

The tumor agnostic setting and if theres a strong enough signal all to look at a particular histology or two where there may be a driver there and introduced standalone work in that setting. So that those are all very important and Davis to us that we'll be focusing on this year from a from a.

Steven H. Stein: Those are very important endeavors to us that we'll be focusing on this year from a clinical development point of view with pemigatinib. We don't think bladder cancer is the way to go, as we've said on prior calls, largely because of how the environment has changed there in terms of treatment paradigms and the use of EV earlier and earlier, plus checkpoint inhibitors, so that's the pemigatinib life cycle side, and Barry will speak about the performance side that we spoke about.

Clinical development point of view with payment GAAP net we don't think bladder cancer is the way to go as we've said on prior calls largely because of how the environment has changed there in terms of treatment paradigms and the use of EV earlier and earlier plus checkpoint inhibitors. So thats, a penny garden of life cycle side, and Barry will speak about the <unk>.

And sorry, just on on.

On the data releases.

And that we spoke about so as you said as Barry said, we'll have the very important three year follow up on the L. Mind study with a continued results, particularly on duration of response at ESCO.

Steven H. Stein: So, as Barry said, we'll have the very important three-year follow-up on the LMIND study with continued results, particularly on duration of response, at ASCO. I should have said the bioavailable and bioequivalent data with Ruxelin of XR; the intent is actually to present it in an appropriate forum or publish it in an appropriate forum this half of the year. And then, obviously, the idea is also, as soon as we have it, to also present the vitiligo phase three data, incredibly important for topical Rux. Barry, I'm going to speak about the performance side of PEMI. Sure. So, Ren,

And I Should've said, the bio available and bio equivalent data with <unk> saw the intent is actually to presented and an appropriate forum published and appropriate for them. This half of the year and then obviously the idea is also to watch.

And since we have it also present the vitiligo phase III data are incredibly important for topical rux myriad and speak about the performance out of Permian sure Saran. Yeah. So you know, we're very happy with our.

Barry P. Flannelly: So, Ren, yeah, we're very happy with Pemizer's performance so far. You know, I think when you launch into a tumor type, a disease area where there are no other therapies, sometimes you actually don't really know how many patients are out there. Steven alluded to carcinoma of an unknown primary. Some of those patients may, in fact, be cholangiocarcinoma patients. Some of them might have FGFR2 rearrangement or fusion.

With Penn and serious performance so far I think when you launch into a you know.

Tumor type of disease area, where there is no other therapies.

Sometimes you actually don't really know how many patients are out there Steven alluded to carcinoma of unknown primary and some of those patients may in fact be cholangiocarcinoma patients some of them might have the FTF are too.

Rearrangement or fusion.

So that's where I think we're experiencing is that are there might've been more patients and our initial assumption around 800 to 1000 patients and the United States.

Barry P. Flannelly: So that's what I think we're experiencing is that there might have been more patients than our initial assumption, around 800 to 1,000 patients in the United States. And then the duration of therapy turns out to be longer than perhaps we anticipated, both from the study and from our estimates in the regular patient population. So that's very encouraging that patients are getting therapy, they're getting tested, getting therapy, staying on therapy, and I think that helps us if, in fact, we do have competitors in this space for chlandriocarcinoma with FGFR2 alterations, because one, it's nice to launch first, and then it's nice to launch with an excellent drug like Pemazir. So we're all prepared for any competition, but we still think that patients will ultimately benefit from starting a drug like Pemazir because of its efficacy, safety, and duration of therapy that we can offer.

And then the duration of therapy, and it turns out to be longer than than perhaps we anticipated and both from the study and from our just estimates.

In the and.

The regular patient population.

So that's very encouraging that patients are getting therapy, they're getting tested getting therapy staying on therapy, and I think that helps us if in fact, if in fact, we do have competitors in this space and cholangiocarcinoma with FGF or <unk> alterations.

And because one its nice to launch first and then it's nice to launch with an excellent drug like pennies here. So we're all prepared for any competition, but we still think that patients will ultimately benefit from starting a drug like <unk> with its efficacy and safety and duration of therapy that we can offer.

Jay Olson: Thank you. Our final question today is coming from Jay Olson from Oppenheimer. Your line is now live.

Thank you. Our final question today is coming from Jay Olson from Oppenheimer. Your line is now live.

Oh, Hey, guys. Thanks for taking the question I'm curious about your priorities for business development. This year and specifically could you comment on any plans to seek a commercialization partner for topical rux and Europe. Thank you.

Jay Olson: Hey guys, thanks for taking the question. I'm curious about your priorities for business development this year and, specifically, could you comment on any plans to seek a commercialization partner for topical rocks in Europe? Thank you.

So in terms of the BD priorities first of all for our sales objectives have not changed from what we have discussed in the past. So we'll continue to look for assets that would.

Steven H. Stein: So in terms of the BD priorities, first of all, for us, the objectives have not changed from what we discussed in the past. So we continue to look for assets that would contribute to growth and diversification in the mid-20s plus timeframe, and where we could leverage our expertise and our existing infrastructure to develop and commercialize them.

Contribute to growth and diversification in the mid twenties last timeframe, and where we could leverage our expertise and our existing infrastructure to develop and commercialize them.

So this had remain day.

In terms of rux cream and Europe.

Steven H. Stein: In terms of RACSCREAM in Europe, as we have indicated in the past, we are in the process of determining what is the best way forward there. Also, from a timing point of view, we are going to wait for vitiligo data before we file for regulatory approval. And therefore, we have a little bit more time before we finalize our decision. So we should be finalizing it in the next few months. Who can follow up on that at a

We have indicated in the past we have a we are in the process. All saw determining what is the best way forward. There also from a timing point of view, we are going to be to wait for vitiligo data before we filed for regulatory approval and therefore, we have a little bit.

More time before we finalize our decisions so we should be finalizing it.

And in the next few months and we will.

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

And a follow up and that are at that line.

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

Unknown Executive: Thank you, Operator, and thank you, everyone, for joining us on the call today. We'll be available for questions following this call. Have a great day.

Thank you operator, and thank you everyone for joining us on the call today will be available for questions. Following this call have a great day.

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

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.