Q2 2021 Incyte Corp Earnings Call

Hello, and welcome to the insight second quarter 2021 earnings call and webcast.

Operator: Hello, and welcome to the Insight second quarter 2021 earnings call and web tax. At this time, all participants are in the list-only mode. If anyone should require operator assistance, please press Star Zero on your telephone keypad.

At this time all participants are in a listen only mode.

And he wants to require operator assistance. Please press star zero on your telephone keypad, a question and answer session will follow the formal presentation.

Operator: A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It's not my pleasure to turn the callover to Christine Cho and Vestal Relations. Please go ahead.

As a reminder, this conference is being recorded its now my pleasure to turn the call over to Christine Cho Investor Relations. Please go ahead.

Kevin Good morning, and welcome to insight second quarter 2021 earnings conference call and webcast.

Christine Chiou: Thank you, Kevin. Good morning, and welcome to Insight's second quarter 2021 earnings conference call and webcast. The slides used today are available for download on our website. Joining me on the call today are Irvey, Barry, Steven, and Christiana, who will deliver their prepared remarks, and 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 actual results to differ materially, including those described in our 10-Q for the year-ended March 31, 2021, and from time to time in our other SEC documents. We will now begin the call with Irve.

<unk> is used today are available for download on our website.

Joining me on the call today are Barry Steven and Christiana, who will deliver our 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 actual results to differ materially including those described in our 10-Q for the year ended March 31, 2021, and from time to time and our other SEC documents, we will now begin the.

And with every day.

Thank you Christine and good morning, everyone.

Irvey: Thank you, Christine, good morning, everyone, on site. So at the beginning of the year, we laid out several key business objectives for 2021, and we executed on a number of our commercial and clinical goals in the first half, representing a continuation of the momentum we saw throughout 2020. We believe these achievements, including the success of the true V and true ADD programs in VTil and Atopic Dermatitis, will significantly contribute to our long-term strategy for growth and diversification.

And so at the beginning of the year, we laid out.

Business objective for 2020, 1 and we executed on a number of our commercial and clinical goals and the FERC tariff.

Presenting on a continuation of the momentum we saw throughout 2020.

We believe these achievements, including the success of the truth on fluids, you program and vitiligo and atopic dermatitis will significantly contribute to our long term strategy from growth and diversification.

And the second quarter, our product and royalty revenues grew 17% to reach nearly 700 million and <unk>.

Irvey: In the second quarter, our product and royalty revenues grew 17% to reach nearly 700 million. Jagafine net product sales were up 12%, with growth driven by the return of new patients to pre-COVID liver. Both Pemazir and Monjuvi revenues increased quarter over quarter, up 33% and 16%, as both new product launches continue to gain traction, and royalties grew 30% to 121 million for the quarter, with Jacavi up 24% and aluminum up 40%.

And I can find net product sales were up 12% with growth driven by the return on those new patient starts to pre COVID-19 levels.

<unk> revenues increased quarter over quarter up solid, 3% and 16%.

Both new product launches continued to gain traction.

And the royalties grew 30% to 121 million for the quarter with <unk> of 24% another 40%.

Our performance and the second quarter shows the strength of our business and that will new product launches are progressing well.

Irvey: Our performance in the second quarter shows the strength of our business, and our new product launches are progressing. We are looking forward to the second half as we await two important FDA decisions in September and the potential approval of Tafitamab in Europe following the positive CHMP opinion received in June. While we are disappointed by the pedophore extension for Roxolitinib prim in atopic dermatitis and for Roxolitinib in steroid refractory chronic GVG, we remain confident in the benefits these medicines can bring to patients based on the robust data from pivotal programs through ADD and witch tree, respectively.

We are looking forward to the civil and health as we await 2 important decisions in September and the <unk>.

On sort of provider of services that might be and Europe. Following the positive <unk> opinion and received in June.

And while we are disappointed by the <unk> extension for rux cream in atopic dermatitis and product they need and steroid refractory chronic gvhd.

We remain confidence and the value of these medicines can bring to patients based on the robust data from pivotal programs.

And which 3 respectively.

We will continue to work with the FDA on Ritchie from the map, which recently received a complete response letter for the BLA submission for <unk>.

Irvey: We will continue to work with the FDA on Ratif and Limab, which recently received a complete response letter for its BLA submission for SCST. Retifanlame remains under review by the European Medicines Agency. Moving on to our clinical development progress, in addition to the positive top-line results in VTiligo and long-term data in atopic dermatitis for Roxolitinib cream, we also announced positive phase 2 data for Paraclyb in patients with autoimmune emolytic anemia and the achievement of bioequivalence with QD Roxolitinib, which is on track for an ND NDA submission in Looking outside of the U.

Or is it on the map remains under review with the European Medicines Agency.

Moving on to our clinical development progress. In addition to the positive top line results and this is I go on long term data in atopic dermatitis for Worksite and a claim and we also announced positive phase 2 data from <unk> in patients with auto immune hemolytic anemia and.

On the achievement of Baidu equivalents with QD, Rux, and <unk>, which is on track for an NDA submission in early 'twenty 'twenty 2.

Looking outside of the U S. We have multiple growth opportunities across several market in the first half of the year. They measure was approved in Europe and Japan.

Irvey: We have multiple growth opportunities across several markets. In the first half of the year, Pemadier was approved in Europe and Japan, and we have seen encouraging uptake with XUS sales reaching 3 million. Further supporting the importance of Pemazir as a treatment for patients with colangis, NICE provided a positive recommendation for Pemad in the UK.

And we have seen on crushing uptake with ex U S. Ex U S sales, reaching 3 million.

So that's supporting the importance of <unk> as a treatment for patients with Cholangiocarcinoma nice provided a positive recommendation from famous here and the U K.

Turning to <unk> and the EU, if approved insights will be commercializing diversity and sales.

Irvey: Turning to Tafatatatimab in the EU, if approved, insights will be commercializing tapathatamab under the brand name Minjuvi, bringing the therapy to many patients in Europe. In Europe, 16 patients are diagnosed with relapse or refractory DSBCL each year, of which approximately 14,000 would be eligible for tapacetam. Our ematology team in Europe, which was already deployed for Ikllug, is launch ready, and we will be leveraging resources to support the launch of Tafitamab on a country-by-country basis.

And our brand name in Juvie, bringing the therapy to many patients in need.

In Europe 16000 patients are diagnosed with relapsed or refractory b cell each of which.

Approximately 14000 would be eligible for <unk>.

I will and metallurgy team in Europe, which was already deployed for Iclusig launch ready and we will be leveraging our resources to ship on the launch of diversity and either on a country by country busy.

So sites and slide 6 shows the key business objectives that we set for the year. So first to continue driving growth and our strong product portfolio.

Irvey: Slide six shows the key business objectives that we set for the year. First, to continue driving growth in our current product portfolio. Second, to continue to expand and diversify our revenue base through new products and new indication launches, and third, to continue to progress our late-stage pipeline as well as our earlier stage program. So with that, I will hand it over to Barry to cover individual product performance. Thank you, everybody.

And we're going to continue to expand and diversify our revenue base with new product and the new indication launches and.

And third to continue to progress our late stage pipeline as well as well.

H program.

So with that though we don't and you don't go to Barry to cover the individual product performance.

Thank you everybody good morning, everyone.

Barry: Thank you, everybody. Good morning, everyone.

And where we talk about our individual product performance I wanted to mention how encouraged we are as we see the gradual return of patients and physicians office offices, following a year of decreases and patient diagnosis and treatment due to COVID-19.

Barry: Before we talk about our individual product performance, I wanted to mention how encouraged we are, as we see the gradual return of patients to physicians' offices following a year of decreases in patient diagnosis and treatment due to COVID. While pharmaceutical representatives' access to oncology offices is still lagging behind other therapeutic areas across the industry, we are seeing that there is now meaningful improvement in rep access to in-person meetings with oncologists. We expect these positive trends to continue and are optimistic about a stronger recovery in the second half of the year.

While pharmaceutical representatives access to oncology offices is still lagging other therapeutic areas across the industry. We are seeing that there is now a meaningful improvement and rep rep access to in person meetings with oncologists and we expect these positive trends to continue and are optimistic about a stronger recovery and the second half.

Of the year.

On slide 8 we show that Jakafi sales grew 12% year over year to $525 million and $529 million per quarter with total patient demand increase and crossed all 3 of our improved indications.

Barry: On slide 8, we show that Jack V sales grew 12% year over year to $525 million dollars, $529 million for the quarter, with total patient demand increasing across all three of our improved indications. New patient starts, shown by the Magenta line on the chart, are now at pre-pendemic levels, signaling more patients are returning to their doctors and receiving the treatments they need. Regarding Jackify's guidance, we are reaffirming our growth prospects for the year.

New patient starts shown by the Magenta line on the chart are now at the pre pandemic levels signaling more patients are returning to their doctors and receiving and treatments they need.

Regarding jakafi guidance, we are reaffirming our growth prospects for the year, a slight reduction and the upper end of guidance has been made to account for the increase and gross to net due to greater percentage of Jakafi volume ordered from 340, <unk> accounts and the 3 month extension and if it <unk> for retrofit nib and steroid refractory chronic gvhd.

Barry: A slight reduction in the upper end of guidance has been made to account for the increase in gross to net due to a greater percentage of jackify volume ordered from 340B accounts and the three-month extension of Bedoufa for ruxilitinib and steroid refractory chronic GVD. We now expect jackfied net product sales between $2.125 billion and $2.17 billion for the year.

We now expect Jakafi net product sales between 2.125 billion and $2.1.7 billion for the year.

We expect the growth of Jakafi to continue in the second half of the year with a stronger recovery of new patient starts and a potential approval of Brookfield and for the treatment of steroid refractory chronic gvhd, representing an additional growth opportunity for Jakafi and we look forward to the Fda's decision next month.

Barry: We expect the growth of Jackify to continue in the second half of the year with a stronger recovery of new patient starts and a potential approval of ruxilinib for the treatment of steroid-refractory chronic GVD, representing an additional growth opportunity for Jackify. And we look forward to the FDA's decisions next month.

Turning to slide 9 <unk>.

<unk> continues to outpace our expectations product sales grew 33% quarter over quarter to $18 million, including $15 million and U S sales.

Barry: Pemizier continues to outpace our expectations. Product sales grew 33% quarter over quarter to $18 million, including $15 million in U.S. sales, as use in the second line continues to grow and the duration of therapy continues to drive performance. Since our initial launch, 60% of patients on Pemizier have been second-line patients, as reported by their physicians. However, in a recent survey of physicians who have prescribed Pemizier, that percentage is near 80%, indicating a shift in earlier adoption of this therapy.

As used in the second line continues to grow and a duration of therapy continues to drive performance.

Since our initial launch 60% of patients on <unk> had been second line patients as reported by their physicians, However, and a recent survey of physicians, who have prescribed <unk> that percentage is near 80%, indicating a shift and earlier adoption of this therapy.

Testing rates for Egfr to F GFR to fusions or rearrangements continues to grow and a recent survey showed that unaided awareness of <unk> fusions relative to intra hepatic cholangiocarcinoma increased to 61% up from 34% noted and in our survey prior to the <unk> launch.

Barry: Testing rates for FGFR2 fusions or rearrangements continue to grow, and a recent survey showed that unaided awareness of FGFR2 fusions relative to intra-hepatic Langarsinoma increased to 61%, up from 34% noted in a survey prior to the Pemezer launch. We are optimistic for the second half as our reps continue to drive awareness for FGF2 testing and usage in the second line. Turning to Manjubi on slide 10, Manjubi sales grew to $18 million in the second quarter, representing a 16% growth over Q1.

We are optimistic for the second half as our reps continue to drive awareness for FGF are 2 testing and usage and the second line.

Turning to non Julian on Slide 10, <unk> sales grew to $18 million and the second quarter, representing a 16% growth over Q1.

We continue to see and increasing uptake of line JV in the second line diffuse large b cell lymphoma, and are seeing positive trends and new patient starts with momentum continuing as we exited June.

Barry: We continue to see an increasing uptake of Monjuvi in second-difused large B-cell lymphoma and are seeing positive trends in new patient starts with momentum continuing as we exited June. As I said before, it has been a challenge to launch an injectable therapy in the midst of COVID. However, we are seeing positive trends, including the expanded number of accounts purchasing Manjubi, the increase in new patient share, and a higher percentage of Monjubi patients in the second line settings. Updated three years of results from Elmine were recently published, and we believe these data will help bring greater awareness to the potential benefit of Montjuvi in the second line setting.

As I said before it has been a challenge for lunch on injectable therapy and in midst of Covid wherever we are seeing positive trends, including the expanded number of accounts purchasing and Judy the increase and new patient share and higher percentage of went juvie patients and the second line setting.

Updated 3 year results from L. Mind were recently published and we believe these data will help bring greater awareness to the potential benefit of <unk> in the second line setting.

I'd like to turn now to our attention to Rex lithium cream in atopic dermatitis.

Barry: I'd like to turn now to our attention to ruxalitone in atopic dermatitis. As we wait for an FDA decision, we want to remind you of the high unmet need that exists for patients living with atopic dermatitis. There are currently 5.5 million patients with atopic dermatitis over the age of 12 on prescription medications. And yet, a significant number of patients continue to experience symptoms. Based on a recent survey of AD patients, over 40% of patients on prescription therapy experience flares at least once a week.

As we wait for an FDA decision, we want to remind you of the high unmet need that exists for patients living with atopic dermatitis.

There are currently 5.5 million patients with atopic dermatitis over the age of 12 on prescription medications and yet a significant number of patients continues to experience symptoms based on recent survey of 80 patients over 40% of patients on prescription therapy experienced players at least once a week clearly the need for and.

Barry: Clearly, the need for novel effective treatments is high. Shifting to another survey of dermatologists, over 70% of these dermatologists are aware of ruxlitnib cream's development in atopic dermatitis. 85% of dermatologists separately indicated that they would be highly likely to prescribe ruxlitin of cream to patients who were presented with a blinded safety and efficacy profile, and itch reduction was cited as the number one treatment driver. We are confident in the data supporting rux lytin of cream in AD, and we look forward to the FDA's decision next month. Now I'll turn the call over to Steven for clinical practice.

<unk> effective treatments is high.

Shifting to another survey a dermatologist over 70% of these dermatologists are aware of rectal cream and creams development in atopic dermatitis, 85% of dermatologists separately indicated that they would be highly likely to prescribe <unk> and a cream to patients who are presented.

And with a blinded safety and efficacy profile and itch reduction was cited as the number 1 treatment driver, we're confident and the data supporting <unk> and of cream and a day.

And we look forward to the Fda's decision next month.

Now I'll turn the call over to Steven for clinical update.

Thanks, Barry and good morning, everyone.

Steven: Thanks, Barry. Good morning, everyone. Starting with ruxillitinop cream, the FDA review of the NDA for ruxilinine cream in atopic dermatitis is ongoing with a new perdufa date of September 21st. At the revolutionizing at Topic dermatitis conference in June, 52-week data from the True AD program were presented, showing long-term disease control with as-needed use of ruxilitinop cream. The majority of subjects had clear or almost clear skin by week of age, and we saw no new safety signals during the long-term safety period, including no adverse events suggestive of a relationship to systemic exposure. We have also recently initiated our Phase 3 pediatric program in an effort to expand the patient populations who might benefit from ruxidinib cream. Turn onto slide 14.

Starting with <unk> cream, the FDA review of the NDA for ex Lytton cream in atopic dermatitis is ongoing with a <unk> date of September 21.

At the revolutionizing Atopic dermatitis conference in June 52 week data from the 280 program were presented showing long term disease control with as needed use of <unk> cream.

The majority of subject to teeth clear almost clear skin by week 8 and we saw no new safety signals during the long term safety period, including no adverse events suggestive of a relationship to systemic exposure.

We also recently initiated a phase III pediatric program and an effort to expand the patient populations, who might benefit from <unk> and of cream.

Turning to slide 14.

We previously announced at the beginning of Q2 that the phase III Vitiligo program had achieved its primary and key secondary endpoints at week 24.

Steven: We previously announced at the beginning of Q2 that the Phase 3 Vidaligo program had achieved its primary and key secondary endpoints at week 24. Patients were randomized to receive 1.5% ruxlitnip cream twice daily or vehicle for 24 weeks, at which point a crossover occurred from vehicle to 1.5% raxillin cream twice daily for an additional 28 weeks. The overall efficacy and safety profile of Raxilop cream were consistent with previously reported phase two data.

Patients were randomized to receive 1.5% rux lithium cream twice daily or vehicle for 24 weeks at which point to crossover occurred from vehicle to 1.5% <unk> cream twice daily for an additional 28 weeks.

The overall efficacy and safety profile of <unk> cream were consistent with previously reported phase II data.

As a reminder, 30% of patients and the phase 2 study achieved a facial <unk> 75.

Steven: As a reminder, 30% of patients in the Fave 2 study achieved a facial Vasi 75, and continued improvement was seen through 52 weeks. With these positive outcomes, we are on track for S&A and MAA submissions in the second half of 2021, and are optimistic that ruxlidinine cream may be a meaningful treatment option for patients living with Vittaliga. On slide 15, tapacitnav three-year data from the Elmine study were presented in June at the 2021 American Society of Clinical Oncology annual meeting and subsequently published in Hematologica in July.

And continued improvement was seen through 52 weeks.

With these positive outcomes, we are on track for and S. NDA and MAA submissions and the second half of 2021 and all.

Optimistic and racks lithium cream, maybe a meaningful treatment option for patients living with <unk>.

On slide 15 emphasis Nab 3 year data from the L. Mind study were presented in June 2021 American Society of clinical oncology annual meeting and subsequently published and hematologic and July.

These data demonstrated significant durable responses and reaffirmed the consistent safety profile with <unk> treatment in patients with relapsed or refractory diffuse large b cell lymphoma, who on eligible for transplant.

Steven: These data demonstrated significant durable responses and reaffirmed a consistent safety profile with tapacitinine treatment in patients with relapsed or refractory diffused diffuse large B-cell lymphoma who are eligible for transfer. We are particularly encouraged by the tolerability and high overall response, seen especially in the second line, which highlights the importance of starting therapy sooner. In addition, the study demonstrated that subsequent treatment, including an otoligous stem cell transplant and CART therapy, is not precluded in patients with disease progression during the taffacidamab plus linoidamide treatment. We are looking forward to the decision from the European Commission following the positive CHMP opinion received in June.

We are particularly encouraged by the Tolerability and high overall response rates seen especially in the second line setting, which exhibits the importance of starting therapy sooner.

In addition, the study demonstrated that subsequent treatment, including an autologous stem cell transplant and car T therapy is not precluded and patients with disease progression during the <unk> plus line a lot lenalidomide treatment.

We are looking forward to the decision from the European Commission following the positive <unk> opinion received in June.

Steven: Turning to the next slide, Taffacinav's clinical program continues to develop with multiple pivotal and proof of concept studies to start later this year. As of today, there are three updates, the first being front-line, which is now ongoing and enrolling patients in first-line diffuse large B-Lymphoma. Second, the initiation of core mind, a pivotal trial evaluating tapacitamab plus posthuclisib in relapse or refractory chronic lymphocytic leukemia based on the positive results of the Cosmos study.

Turning to the next slide Tempus and <unk> clinical program continues to develop with multiple pivotal and proof of concept studies to start later this year.

As of today, there are 3 updates to the program. The first being front of mind, which is now ongoing and enrolling patients and first line diffuse large b cell lymphoma.

And the initiation of coal mined a pivotal trial evaluating <unk> plus Pos successive in relapsed and refractory chronic lymphocytic leukemia based on the positive results of the Cosmos study.

Lastly, we expect to initiate mined way, which is our dose optimization study in relapsed or refractory diffuse large b cell lymphoma.

Steven: Lastly, we expect to initiate Mindway, which is our dose optimization study in relapse or refractory diffuse large B-cell lymphoma. On slide 17, the limba program continues to evolve in a positive way, represented by positive once-daily ruxalitinib bioavailability and bioequivalence data at E.R. in 2021, which demonstrated bioequivalence for area under the curve, once daily. Ruxalitab Stability testing is ongoing, and we expect to file an NDA in early 2022. Multiple trials are ongoing, including the potential for fixed dose combinations with Parthoclis plus ruxlittalit, and we anticipate the initiation of the bet and L2 combination components of their respective trials with ruxilitin in the second half of this Turn onto slide 18.

On slide 17, the Limber program continues to evolve and a positive way, we presented positive once daily <unk> bioavailability and bioequivalence data at <unk>, and 2021, which demonstrated bioequivalence for area under the curve.

Once daily Rux Elysium stability testing is ongoing and we expect to file an NDA in early 2022.

Multiple trials are ongoing including the potential for fixed dose combinations with <unk>, plus <unk> and we anticipate the initiation of the bet and <unk> 2 combination components of their respective trials with <unk> and the second half of this year.

Turning to slide 18, the results have reached 3 investigating <unk> in steroid refractory chronic graft versus host disease were recently published and the New England Journal of Medicine.

Steven: The results of Reach 3, investigating ruxalitnob and steroid refractory chronic graph versus, were recently published in the New England Journal of Medicine. This data shows that treatment with ruxilip significantly improved overall response rate at week 24, as well as a much higher best overall response rate versus best available therapy. Reach 3 also achieved statistically and clinically meaningful improvements in key secondary outcomes, including failure-survival and symptom- With the September 22, we are excited at the potential to help bring this therapy to patients living with steroid refractory chronic graft versus host disease who currently have very limited treatment options.

This data showed that treatment with <unk> significantly improved overall response rate at week 24, as well as a much higher best overall response rate versus best available therapy.

<unk> also achieved statistically and clinically meaningful improvements and key secondary endpoints, including failure free survival and symptom response.

With the September 22 per <unk> were excited at the potential to help bring this therapy to patients living with steroid refractory chronic graft versus host disease, who currently have very limited treatment options.

Turning to post the close of on Slide 19, we presented phase III data and autoimmune hemolytic anemia, and <unk> and 2021, which showed high response rates and a normalization of hemoglobin levels. During the initial 12 week treatment period.

Steven: Turn to Pars Eclis on slide 19. We presented phase 2 data in autoimmune hemalytic anemia at Eha in 2021, which showed high response rates and a normalization of hemoglobin levels during the initial 12-week treatment period. Clinically meaningful improvements in fatigue-related quality of life were observed, and Posiclissip was generally well tolerated. In a disease with no currently approved treatments, we continue our commitment to patients through the development of Parser Clissib and the initiation of the phase three trial to start later this year.

Clinically meaningful improvements and fatigue related quality of life, we observed and <unk> was generally well tolerated.

And a disease with no currently approved treatments, we continue our commitment to patients through the development of <unk> and the initiation of the phase III trial to start later this year.

In closing, we had a number of clinical development successes announcing positive data across multiple programs and making significant process progress within certain key development programs. During the first half of 'twenty 1 and.

Steven: In closing, we had a number of clinical development successes, announcing positive data across multiple programs and making significant progress within certain key development programs during the first half of 21, and we expect an event for the second half with multiple potential approvals and additional regulatory submissions. With that, I would like to turn the call over to Christiana for the financial application.

And we expect and eventful second half with multiple potential approvals and additional regulatory submissions with that I would like to turn the call over to Christina on and for the financial update.

Thank you Stephen and good morning, everyone.

Our total product and royalty revenues for the second quarter.

$696 million, representing a 17% increase over the second quarter of 2020.

Christiana: Thank you, Stephen, and good morning, everyone. Our total product and royalty revenues for the second quarter were $696 million, representing a 17% increase over the second quarter of 2020. Total product and royalty revenues for the quarter are comprised of net product revenues of 529 million dollars for Jakafai, 28 million dollars for Iclusig, and 18 million dollars for families. Royalty revenues are from Novartis of $82 million for Jakavi and $2 million for Tabarecta, and royalty from Lily of $36 million for Olu.

Total product and royalty revenues for the quarter are comprised of net product revenues of $529 million per jakafi $28 million per iclusig and $18 million per atmosphere.

Royalties from Novartis feel free to $2 million from Jack Avi and $2 million per ton per hectare and royalties from Lilly of $36 million for ILUVIEN.

The 2.1% year over year growth and Jakafi net product sales reflect higher patient demand across all indications and a continued recovery of new patient starts as the impacts of the COVID-19 pandemic subtype.

Moving on to our operating expenses on a GAAP basis ongoing R&D expenses of $339 million for the second quarter increased 20% from the prior year period, primarily due to the product supply costs are accelerating and cream.

Christiana: The 12% year-over-year growth in Jakafinet product sales reflects higher patient demand across all indications and a continued recovery of new patient starts as the impact of the COVID-19 pandemic subsides. Moving on to our operating expenses on a gap basis, ongoing R&D expenses of $339 million for the second quarter increased 20% from the prior year period, primarily due to the product supply costs for Axolitinip cream, the progression of our late stage pipeline, and our 55% share of the global and U.S. specific development costs for Tafasitama, excluding the $11 million impact of incremental products supply costs for raxolitanic cream, ongoing R&D expense for the quarter increased 16% from the prior year.

Progression of our late stage pipeline, and our 55% share of the global and U S specific development costs per deficit.

Excluding the $11 million impact of incremental product supply cost per absolutely cream ongoing R&D expense for the quarter increased 16% from the prior year.

Our SG&A expense for the quarter on $169 million increased 43% from the prior year quarter, primarily due to our investments related to the establishment of the new dermatology commercial organization and the U S and the related activities to support the potential launch of <unk>.

Christiana: RSGNA expense for the quarter of $169 million increased 43% 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 their related activities to support the potential launch of Raxolitine cream for atopic dermatitis. Our collaboration loss for the quarter was $10 million, which represents our 50% share of the U.S. Net Commercialization loss for Mung Jans. This is comprised of total net product revenues of $18 million and total operating expenses, including COGS and NSG&A expenses of $38 million.

Cream for atopic dermatitis.

Our collaborations loss for the quarter was $10 million, which represents our 50% share of the U S net commercialization and loss from 1 Julien this.

And this is comprised of total and net product revenues of $18 million and total operating expenses, including Cogs and SG&A expenses of $38 million.

Finally, our financial position continues to be strong as we ended the quarter with approximately $2.1 billion and cash and marketable securities.

As we on the midpoint of 2021, we're taking and the opportunity to update our revenue and expense guidance.

Christiana: Finally, our financial position continues to be strong as we ended the quarter with approximately $2.1 billion in cash and marketable securities. As we are at the midpoint of 2021, we are taking the opportunity to update our revenue and expense guide. As Barry detailed earlier, for Jakafi, we are tightening the range to $2.125 to $2.17 billion. Based on the strong performance of Pemazir in the first half of 2021, we are increasing the guidance range for other hematology oncology to $155 to $170 million.

As Barry and detailed earlier from Jakafi, we are tightening the range to 2.1 hundred 25 to 2.1 hundred $7 million.

Based on the strong performance of <unk> and the first half of 2021, we are increasing the guidance range for other hematology oncology to $155 million to $170 million.

Finally, we are lowering SG&A guidance.

$2.725 million to $755 million to reflect lower expenses for excellent and if claim as a treatment for atopic dermatitis and the U S based on that <unk> had day extension.

Christiana: Finally, we are lowering SGNA guidance to $7255 million to reflect lower sales for exulitinip cream as a treatment for atopic dermatitis in the US based on the PDUFA date extension. There are no changes in our guidance for COX and our R&G.

There are no changes in our guidance for Cogs and R&D.

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

Operator: Operator, that concludes our prepared remarks, please give your instructions and open the call for Q&A. Thank you. And now we will be conducting a question and answer session. If you'd like to be placed into question Q, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in question Q. You may press

And I will now be conducting a question and answer session, if you'd like to be placed and the question queue. Please press star 1 on your telephone keypad, a confirmation tone will indicate your line is and the question queue. You May press star 2 if you'd like to have your question from the queue from participants using speaker equipment and may be necessary to pick up your handset.

We will take your phone off mute before pressing star 1.

Operator: Thank you. We'll now be conducting a question and answer session. If you'd like to be placed in the question queue, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to move your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset or take your phone off mute before pressing star 1.

1 moment, please while we poll for questions.

First question today is coming from <unk> Richter from Goldman Sachs. Your line is now live.

Good morning. Thank you for taking my questions on queue from me..1 is could you just speak to what's happening on the regulatory side with regard to jacks and and how that impacts your process here on the interim franchise and then secondly, with the $30 million reduction and your guidance on how much of that is due to contribution.

Operator: One moment, please. I'll be pulled for questions. Our first question today is coming from Salvin Richter from Goldman Sachs. Your line is now live.

From steroid refractory gvhd versus impact from the $3.40 day rebates.

Steven: Hi Steven, I'll answer your first question. So in terms of, you know, the regulatory aspects of ruxilitin cream, obviously, we cannot and do not speculate on what the FDA will or will not do. But we can tell you, you know, we have tremendous confidence in the profile of the cream, given now that we have four completed phase three studies, two in atopic dermatitis and two in vitiligo, including the long-term follow-up now for both safety and efficacy in these studies that demonstrate no new safety concerns related to what one would expect from any untoward systemic exposure.

Hi, Sylvia and it's Stephen I'll answer your first question.

In terms of the regulatory aspects of the <unk> cream, obviously, we cannot and do not speculate on what the FDA will or will not do but we can tell you we have tremendous confidence in the profile of the cream given now that we have 4 completed phase III studies, 2 in atopic dermatitis 2 and.

And <unk>, including the long term follow up now for both safety and efficacy and these studies that demonstrate no new safety concerns related to what 1 would expect from any untoward systemic exposure.

The efficacy profile and atopic dermatitis that we presented before in mild to moderate <unk> outstanding and the safety profile is in keeping with what I, just said with the low systemic absorption of approximately 4% to 7% bioavailability compared to an oral tablet in other words, no untoward effects seen.

Steven: The efficacy profile in a topical dermatitis that we presented before in mild to moderate AD is outstanding, and the safety profile isn't keeping with what I just said with the low systemic exorption of approximately 4 to 7% bioavailability compared to an oral tablet. In other words, no untoward adverse reactions. So, given all of that, we remain, obviously, extremely confident in the profile, and we look forward to that Purdue date in September 2012. I'll hand over the second Pife. So Salveen, we don't really think of it as

So given all of that we remain obviously extremely confident and the profile and we look forward to the <unk> date on September 21, I'll handover and the second part.

And we don't really think of it as being just a tightening where as we get further and the year, we see that the the range that we had was appropriate at the low end of our range was appropriate and higher and of our range.

Unknown Executive: So Salveen, we don't, we really think of it as being just a tightening where, as we get further in the year, we see that the range that we had was appropriate, the low end of our range was appropriate, and the higher end of our range is tightened to what we're likely to hit. as far as what affects the gross net versus GVHD, you know, we actually anticipated that our gross to net would be 1% for the year lower than it is now, or that it seems to be now, so we're, that's taking up a good chunk of the amount that we reduced the top line from the high end of the

Is tightened to what were likely to hit as far as the what affects the gross to net versus gvhd.

We actually anticipated that our gross to net would be a 1% for the year.

Lower than it is now that it seems to be now so we are.

And that's taking up.

A good chunk of the amount that we've reduced the top line from day to high end of the.

Guidance from.

Operator: Thank you for the next question. Today's question is coming from Brian Abrams from RBC Capital Market. The line is now live.

Thank you.

Thanks, and that's a question today is coming from Brian <unk> from RBC capital markets from the line is now live.

Hey, guys. Thanks, so much for taking my questions.

Unknown Executive: Hey guys, thanks so much for taking my question.

2 questions from me on on Jakafi, obviously, very encouraging to hear that new patient starts have now returned to pre pandemic levels Im curious if youre seeing any recent changes with the delta waves currently and the pandemic.

Unknown Executive: Two questions for me on Jackify. It is obviously very encouraging to hear that new patient starts have now returned to pre-pandemic levels. I'm curious if you're seeing any recent changes with the Delta wave currently in the pandemic in terms of new patient diagnosis, visits to physicians, and new starts, as well as your ability for sales reps to engage with physicians to the extent maybe to which that shapes your full guidance. And then secondarily, on the one stage,

In terms of patient new patient diagnosis visits to physicians.

And new starts as well as your ability.

And the ability for sales reps to engage with physicians and the extent maybe to which that shapes. Your from your guidance and then secondarily on the on the once daily for them I know physicians.

And have this perception of Milo suppression with Jack at being intrinsically linked to spleen response and activity. So I'm just wondering how you hope to educate physicians around the potential to have comparable efficacy with a once daily form that may have had less toxicity and is there any clinical data.

Unknown Executive: I know physicians have this perception of myelopression with

Unknown Executive: suppression with Jacks being intrinsically linked to spleen response and activity. So I'm just wondering how you hope to educate physicians around the potential to have comparable efficacy with a once-daily form that may have less toxicity, and is there any clinical data beyond the bioequivalence that you're hoping to deploy to help support that education and awareness? Thanks. Brian, I'll take the first part and hand the other part over to

Beyond the bio bio equivalents that youre, hoping to deploy to help.

And support that education and awareness.

So Brian this is Barry I'll take the first part and hand to the other part over to Steven.

So obviously the delta of wave Delta variant is concerning but as of now we actually see new patient starts increasing for jakafi back to pre pandemic levels. We know that sites are opening up for a rep access and and actually all of our field based and players acts.

Unknown Executive: So obviously, the Delta wave and delta variant is concerning, but as of now, we actually see new patient starts increasing for Jackify back to pre-pendemic levels. We know that sites are opening up for our reps' access and actually all of our field-based employees' access to clinics, offices, and hospitals. Obviously, we don't know what the future is going to bring, but for right now, we're getting back to where we were at the beginning of 2020.

Yes.

2 clinics offices hospitals.

Obviously, we don't know what the future is going to bring but for right now we're getting back to where we were.

Back in the beginning of 2020 Steven.

Steven: Brian, Steven, thanks for the question on once-daily ruxilitnib. As you sort of allude to, albeit indirectly, the once-daily PK profile, while we demonstrated the comparability needed for area under the curve, the C-Max, as you would expect from a once-daily versus, you know, a quicker release formulation, is lower. We do think, although this still needs to be proven, that that is one of the aspects that drives, as you were alluding to, malo suppression, particularly through potentially Jack 2 inhibition, and that there may be less anemia with once daily.

And Brian It's Steven Thanks for the question on once daily <unk>.

And as you sort of alluded to LDL and directly the once daily PK profile, while we demonstrated.

And the comparability needed for area under the curve the C. Max as you would expect from a once daily versus.

A quicker release formulation is lower and we do think this is still need to be proven that that is.

1 of the aspects that drives as you're alluding to the myeloid suppression, particularly through potentially JAK <unk> inhibition and they may be less anemia with once daily.

I don't think that it's fully true and what you said and it's more perception than reality that modern precision suppression is linked to spleen volume reduction in fact, as you know we see SVR 35 of EBITDA improvements and many patients who don't have any modest suppression at all so I think that is definitely more perception than reality, but it's something.

Steven: I don't think, you know, that it's fully true in what you said, and it's more perception than reality, that myelopop compression is linked to spleen volume reduction. In fact, as you know, we see SVR 35 or better improvements in many patients who don't have any milder suppression at all. So I think that is definitely more perception.

We will have to counter.

Steven: and reality, but it's something, you know, we will have to counter. The route we're taking for once daily is, in terms of approval, a bioavailability bioequivalence route. The forms are now in stability testing, and, you know, if stability goes well, we'll be filing that early next year. However, there is no clinical data yet on outcomes in terms of efficacy or safety. That's something we would do after the fact if we wanted to. It's a very, quote-unquote, sort of simple BAB route. to prove the needed area under the curve equivalence and instability to get the approval thing.

And the route we've taken for once daily in terms of approval is bioavailability bioequivalence route.

Forms on now and stability testing and stability.

Stability goes well, we'll be filing that early next year. There is no clinical data yet on on <unk>.

Outcomes in terms of efficacy or safety and something we would do after the fact, if we wanted to it's a very quote unquote so on a simple.

Route to prove the needed.

And the curve equivalents and instability to get the approval.

Operator: Thanks, Stephen, Barry. Thank you. The next question is coming from Mark Fromm from Calvin & Company. Your line is now live.

Thanks, Steven and thanks Mac.

Thank you next question is coming from Mark from from Cowen and Company. Your line is now live.

Hi, Thanks for taking my questions.

1 for Stephen just on the.

Limber program on the combinations I mean, the monotherapy seem to been running for a while.

Unknown Executive: Hi, thanks for taking my questions. One for Stephen, just on the limber program, and the combinations. I mean, the monotheapies seem to have been running for a while. I mean, is the dose escalation just being much more expensive than maybe you thought, or is it really just enrollment, maybe from COVID, that's kind of keeping that from being able to advance into the combinations? And then for Barry, the increase in 340B use, I think we've been seeing that increase over time, you know, historically, but I guess that it's accelerated in the first half. Do you think that's, you know, maybe a mixed issue from COVID, or is that something that we should expect kind of going forward, that that's a more permanent change as well?

The dose escalation just being much more extensive and maybe solid or is it really just enrollment and maybe from COVID-19, that's kind of keeping that from being able to advance into the combination and then for Barry the increase and $3.40 be used I think we've been seeing that increase over time, and historically, but I guess it has accelerated and the first half do you think thats.

Maybe a mix issue from Covid or.

Is that something that we should expect kind of going forward.

That's a more permanent change as well.

And market Steven So in terms of lumber and it's an incredibly important program to us for all the obvious reasons.

Both for the company and a shareholder value commercial value, but also patient value and unmet need here and just to give you the different aspects. Firstly the formulation work on once daily has gone really well with the outcome. We desire as we just spoke about in terms of bioequivalence and stability now and that fall should go ahead and early 'twenty.

Steven: In terms of the combination, which is your direct question, just a reminder that we have three we have internally. There's the Paraclissib Combination Program.

2 if I, if stability fund, which we expect it to be in terms of the combination which is what your direct question. Just a reminder, there are 3 we have internally.

Steven: You know, that went very well. We presented the data multiple times. Both of the studies are open. The suboptimal study in patients who've had at least three months of ruxillitnib with either an inadequate spleen response or an adequate symptom response or both, and then are randomized to continue rucks or rux plus parser is ongoing and enrolling now.

<unk> combination program there.

And that went very well we presented the data multiple times both of the studies are open the sub optimal study and patients who've had at least 3 months of <unk> with EDA and inadequate spleen response on inadequate symptom response of both and then are randomized to continue rocks Rx plus Pos.

Is ongoing and enrolling now and then the first line study of the combination is also open and enrolling now so that program is growing as well as we expected and on track in terms of the earlier programs.

Steven: And then the first line study of the combination is also open and enrolling now. So that program is going as well as we expected and is on track. In terms of the earlier programs, the bet work with our bet inhibitor, we've always said we would do single agent safety in the first half of 21 and then the combination work in the second half. And then we'll have to make decisions on how aggressive to be in terms of the program thereof.

The best work without without bet inhibitor.

<unk> always said.

And we will do single agent safety and the first half of 'twenty, 1 and then the combination work and the second half and then we will have to make decisions on how aggressive to be in terms of our program thereafter, and we could vary.

Steven: and we could, you know, go very aggressively, for example, into first line if the data warranted that. There has been some COVID impact on enrollment in all early studies across the board in oncology and hematology. But, you know, we're comfortable with where that program is. And then the third program, Elk2, it's a different proposition, if you will. We think, through hepcid inhibition, there'll be amelioration of anemia. That is one of the main reasons patients, I'll remind you, discontinue RUX, so it'll be of enormous benefit if it works there.

Very aggressively for example into first line if the data warranted that there has been some COVID-19 impact on enrollment and all early studies across.

Across the board and oncology and hematology, but.

We are comfortable with where that program is and then the third program <unk> 2 it's a different proposition if you will.

Through we think through <unk> and inhibition that there'll be ameliorated and of anemia.

That is 1 of the main reasons patients I'll remind you discontinue rux. So it will be of enormous benefit if it works there and then not only that there'll be able to maintain rux adequate dose and so they'll probably be and efficacy upside as well and net program as we've always said as well first half of this year single arm safety and then combination work second on.

Steven: And then not only that, they'll be able to maintain RUX's adequate dosing, so there'll probably be an efficacy upside as well. And that program, as we've always said as well, first half of this year, single-arm safety, and then combination work second arm, and then the same process, you know, how aggressive do we want to be in terms of programs. There has been some COVID impact on enrollment in early studies, but we're comfortable with where the programs are. So Mark, as far as the three of them are concerned

And then the same <unk>.

And how aggressive do we want to be in terms of programs.

There again has been some COVID-19 impact on enrollment and early studies, but we're comfortable with where the programs on things.

So mark as far as a 3 party being used goes well we have a.

Barry: So, Mark, as far as the 340B use goes, well, you know, we have a limited controlled distribution process for Jacify and for PEMS there. For that matter, our volume of 340B orders is about 11% now, and the industry is about 15%. So we think we do a pretty good job of making sure that 340B orders don't get out of control. But, you know, we saw for a number of years 340B orders rising and the discounts, obviously, going back to those institutions. And then it slowed down, and this year it picked up again for a number of reasons.

Limited controlled distribution process for Jakafi and for <unk> or for that matter.

So our volume of 3.

340 B orders.

11% now and the industry is about 15%. So we think we do a pretty good job of making sure that 340, <unk> orders don't get out and control but.

We saw for a number of years 340, B orders rising and the discounts obviously going back to those institutions.

And then it slowed down and this year I picked up again for a number of reasons.

And some of those are that there is more on this.

Barry: And some of those are that there are more disproportionate share hospitals coming on to the 340B program, so dish hospitals, and then their, what's called their child sites, which is their satellite sites, more of those coming on as health systems buy up oncology practices, and they do it specifically to take advantage of the 340B program. And then, in fact, we see that some hospitals or health systems are establishing their own specialty pharmacies so they don't contract with other specialty pharmacies outside of their institution or their health systems, so more orders are going through there.

Disproportionate share hospitals coming on to 340 B program.

So the hospitals and then there what's called their child sites.

Which is their satellite sites more of those coming on as health systems by up oncology practices and they do and specifically for to take advantage of the 340 B program.

And then.

In fact, we see that some of the hospital or health systems are establishing their own specialty pharmacies.

So they don't contract with other specialty pharmacies outside of their institution or their health systems. So more orders are going through through there, we think we forecast and going forward.

Barry: We think we have forecasted going forward, and it's built into our forecast, the correct gross net, or the amount of gross to net that's attributed to 340Bs. And so anyway, we think that we have a good system to control inappropriate orders that might come through the 340 vehicle.

And it's built into our forecast the correct gross to net or the amount of gross to net that's attributed to $3.40 bps.

And.

So anyway, we think that we have a good system to control inappropriate orders that may come through the 340 <unk> accounts.

Yeah.

Yes.

Okay. Thank you.

Operator: Okay, thank you. Thank you. Our next question is coming from Aletia Young from Cancer Pit Shell. Your line is now live.

Thank you. Our 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 maybe.

The tender and scaling down and the opportunity for atopic dermatitis, I know, there's like 5 and half million people, but when you think about the initial opportunity and the uptake and switching from Cris R.

Operator: Thank you. Our next question is coming from Aletia Young from Cancer Pit Shell. Your line is now live.

Unknown Executive: Well, I'll try to answer that, Alicia. We think the opportunity is quite large to help patients who have eczema and atopic dermatitis. 5.5 million is obviously those patients who are actually drug treated. As you know, throughout the United States, it's estimated that 30 million people have atopic dermatitis from kids to adults. So we really believe that going from steroids up to biologics, there's a huge unmet need there for patients with mild to moderate atopic dermatitis, and Rucks Litem cream is just the thing for those patients.

And more specific population just if you can help us kind of think about what that and missile pool might look like from modeling. Thank you.

And we will try to answer and Alicia I think we think the opportunity is quite large to help patients who have ex amount of atopic dermatitis.

$5.5 million as obviously those patients who are actually drug treated as you know throughout the United States is estimated at 30 million people have atopic dermatitis from kids to adults.

So we really believe that going from steroids up 2 biologics theres, a huge unmet need there for patients with mild to moderate atopic dermatitis and.

And <unk> is just a thing for those patients.

Unknown Executive: Great, thank you.

Great. Thank you.

Operator: Thank you. Our next question is coming from Dippon Perit from Morgan Stanley. Your line is now live.

Thank you. Our next question is coming from different per <unk> from Morgan Stanley. Your line is now live.

Unknown Executive: Good morning. Thanks for taking my question. So, two from my side.

Good morning, Thanks for taking my question.

And 2 from my side.

First on line Jube understanding it's still relatively early days, but I was wondering if you could comment on the duration of use you've been observing and patients that have been prescribed months' UV and secondly, going back to the QD Rux program and limber.

Unknown Executive: First, on Monjubi, understanding is still relatively early days, but I was wondering if you could comment on the duration of use you've been observing in patients that have been prescribed Monjuvi. And secondly, going back to the QD. Rux program and Limber, so assuming that you do receive approval following your NDA submission plan for next year, how would you anticipate the commercial rollout here? Would you expect this to be an option for new patient starters, or would you expect to conduct a more aggressive switching campaign for all patients, including those that are currently on a BID regimen? Any color there would be helpful.

So assuming that you do receive approval following your NDA submission plan for next year.

How would you envision and the commercial rollout here.

Would you expect this to be an option for new patient starts or would you expect to conduct more aggressive switching campaign for all patients, including those that are currently on a PID regimen and any color there would be would be helpful.

So victor them on on <unk>.

Barry: So Victor Mungovia itself, so as expected when you launch a new drug in oncology, in particular, you end up getting patients who perhaps have had multiple prior lines of therapy. So as we started off, the duration of therapy was shorter but expected because patients might have been older, sicker, and had multiple lines of therapy. Now we're moving into true second-line patients more and more every day; more and more new patient starts are coming from true second-line patients, and we know that the duration of therapy will be much longer, and I think that's why the demand is really starting to pick up now. As far as the second part of the question, maybe Steven will take some of it, and I'll try to answer it.

<unk> itself, so as expected when you launch a new drug and oncology in particular, you end up getting patients who are perhaps had multiple prior lines of therapy. So as we started off the duration of therapy.

It was shorter but expected because patients might've been older and sicker had multiple lines of therapy now we're moving into true second line patients more and more every day more and more new patient starts are coming from true second line patients and we know that the duration of therapy will be much longer and I think that's why the demand is really.

Strength pick up now.

And as far as the second part of the question, maybe Steven will take some of it and I'll try to answer the other part.

Yes, Vikram, it's Stephen and I think as I said earlier.

Steven: Yeah, Vikram and Steven, I think, as I said earlier, it's a bioavailability and bioequivalence route initially to approval, so we won't have a whole ton of clinical data. But as we expect, you know, with the lower CMAX profile, there may be less anemia.

<unk> by available <unk> bio equivalents route initially to approval.

So we won't have a whole ton of clinical data, but as we expect with the lowest <unk> profile that they may be.

Yes, and EMEA. So if you step back you have a once daily which may have convenience aspect to patients who want to use once daily versus twice daily use and then you'll have potential use for which we may have to generate more data on patients who are more likely to experience cytopenia, particularly in EMEA.

Steven: So if you step back, you have a once-daily which may have, you know, a convenience aspect for patients who want to use it once-daily versus twice-daily use. And then you'll have, you know, potential use for which we may have to generate more data on patients who are more likely to experience cytopinias, particularly anemia, being more applicable to once daily use. And then just to mention, because I didn't earlier, you know, that the optionality on this for fixed dose combinations is also really important.

Being more applicable to once daily and then just to mention because I didn't earlier.

And that the Optionality on this for fixed dose combinations is also really important so for any of the combination as I mentioned earlier post the close up there to help to the ability to do a fixed dose combination with once daily will also be there should we elect to do so and there'll be a path forward day. So it has multiple aspects of value to both patients and.

Steven: So for any of the combinations I mentioned earlier, parsaclyssib, BET, or L2, the ability to do a fixed dose combination with once daily will also be there, should we elect to do so, and there'll be a path forward there. So it has multiple aspects of value to both patients and potentially commercially as well.

And potentially commercially as well and.

And maybe I think something on the on this.

Judy I mean, you can you see as the treatment of myelofibrosis evolving.

Unknown Executive: Maybe I think something on this QD, I mean, you see the treatment of mylofibrosis evolving with a number of combinations being developed, so three of them are from us, and other companies are also combining Jackafi with their own product, and all of them are once a day. So it's very important to realize that when you are on a combination regime of oral products for cancer, having both once a day is, in fact, a way to ensure that there is no mistake, and it is also a safety aspect of it.

With a number of combination being developed so 3 of them by by Us and others.

Companies are also and.

Binding.

Jakafi with zone.

Product and all of them are once a day.

So it's very important to realize that when you are and the combination regime on the well.

And while product for Canfor, having both once a day is in fact, a way to ensure that those on mistake and it is also a <unk> <unk>.

And so the way we see it is that assuming we are at the end of 2022 with an approved once a day there will be a transition of both existing patients moving to combination on the when it's appropriate on new patients being studied and the once a day. So there is and sort of and our plans there is a transition period.

Unknown Executive: So the way we see is that assuming we are at the end of 2022 with an approved once daily, there will be a transition of both existing patients moving to combination when it's appropriate and new patients being studied on the way. So there is a sort of a transition period where the once a day will basically replace the twice-day for most indications in my office.

The once a day will be.

Basically replacing that twice so therefore, most of the indication and myelofibrosis.

Operator: Thank you. The next question is coming from Corey Kazimov, from J.P. Morgan, whose line is now live.

Yeah.

Understood. Thank you.

Thank you next question is coming from Cory CASM, all from J P Morgan, who lives and Ella.

Great. Thanks, Good morning, guys. I. Appreciate you taking the question 2 from me around Rux cream first are you having to conduct <unk> share any new safety analysis for the product for the FDA ahead of the new producer and September and then secondly can you just speak to the anticipated timing of true 83.

Unknown Executive: Great, thanks. Good morning, guys. I appreciate you taking the question.

Unknown Executive: Two questions for me around Rux Cream. First, are you having to conduct and or share any new safety analyses for the product with the FDA ahead of the new Padufa in September? And then, secondly, can you just speak to the anticipated timing of true AD3 evaluating Rux Cream and children and maybe how you see this market opportunity for a topical relative to adults? Thank you.

And <unk> cream and children and maybe how you see this market opportunity for a topical relative to adults. Thank you.

Steven: Hi, hi, it's Steven. As I said up front earlier, you know, we don't comment per se on the to and fro with the FDA, and nor will I be doing so now. You know, we did say with our initial delay earlier that there was an information request that we had given them data on that may have contributed to the delay. I think, you know, stepping back from us alone and what the other three companies have communicated in the space with their oral programs, you know, Pfizer-Av and Eli Lilly, that it looks like there's quite an impact from the ongoing Zell Jan safety review from RR. in the room division, and that may be affecting actions across the class, so to speak, definitely with the other programs.

Alright, Hi, Hi, it's Steven so.

As I said upfront earlier, you know, we don't comment per se on.

And the to and fro with the FDA and and nor will it be doing so now we did say with our initial delay.

And that there was an information request that we had given them data on that that may have contributed to the delay I think stepping back from us alone and what the other 3 companies have communicated and this space where they are on programs.

Pfizer Abbvie and Eli Lilly that it looks like there's quite an impact from the ongoing Xeljanz safety review from Ara and the room division and that may be affecting actions across the class so to speak with definitely with the other programs.

Steven: And, you know, that's as much as I can say related to the cream. From the PED aspect, you know, Barry spoke about, within our current mild to moderate 12 and above, we serve the majority of the population there that has the need. However, as you point out, many patients start with topical dermatitis at much younger ages, and that's the importance of the PEDs program and getting those phase threes up and running already.

And that's as much as I can say related to the cream from from the peds aspect Barry spoke about and.

And within our current model 2 module 12 and above.

And we serve and the majority of the population that has a need however, as you pointed out you know many patients stocked with their atopic dermatitis at much younger ages and that's the importance of the pizza program and getting the phase III.

And up and started already.

And I can give you the time and yet it's a bit early but.

Steven: I won't give you the timing yet. It's a bit early, but, you know, our adult programs, as you know, have gone incredibly well and incredibly quickly, and we have the same expectation for the PES programs, given that there's even more knowledge now, as Barry said, of the compound. So we'll update you further, you know, once they sort of have a little bit more momentum on them. We expect them to enroll very quickly. Well and quickly.

And on programs as you know our crude incredibly well and incredibly quickly and we have the same expectation for the peds programs given that is even more knowledge now as Barry said of the compound. So we'll update you further once they sort of have a little bit more momentum on them and we expect them to enroll very well and quicker.

<unk>.

Okay. Thank you.

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

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

Unknown Executive: Hey, thanks for taking my questions. Two from me as well. On Pamazir, which has been launching ahead of expectations in Colangio, but we noticed that two additional studies

Hey, guys. Thanks for taking my questions on 2 from me as well on on time.

That's possible and launching.

Expectations and Cholangiole, but we noticed that 2 additional studies here, starting up and lung cancer and GBM.

Unknown Executive: Additional studies here are starting up in La Cancer and GBM.

And you just comment on the opportunity in addition to call on Geo for 10 months and up past.

Steven: comment on the opportunity in addition to Colangio for Pamazir and the path to market, perhaps in other

Path to market, perhaps and other indications.

And the second question on <unk>, I guess based on the experience so far.

Unknown Executive: And the second question on Monjubi: based on Earth's experience so far, how should we think about the potential launch trajectory in Europe, especially

How should we think about the potential launch trajectory and Europe, especially since you would presumably be launching into an environment, that's less impacted by Tom it at that time.

Unknown Executive: in Europe, especially since you would presumably be launching into an environment that is less impacted by COVID at that time.

Steven: Michael Hyatt, Steven, thanks for the question on Pemezia. So what we saw, we had an ongoing tumor agnostic program, as you know, looking at different potential biological drivers, whether they're fusions, rearrangements, or amplifications, or any other FGFR thing. And we started to see signals within that program in glioblastoma multiforma that had a particular molecular driver, and then in non-small cell lung cancer, that also had a particular molecular driver. And we elected to pull those two together to pursue them as standalone entities separately based on the biomarker.

Michael Hi, it's Steven Thanks for the question on <unk>. So what we saw we had and ongoing tumor agnostic program as you know looking at <unk>.

Different potential biologic drivers, whether they're fusions rearrangements or amplifications or any other FGF our thing and we started to see signals within that that program in glioblastoma multi form a that had a particular molecular driver and then in non small cell lung cancer that also have.

And a particular molecular driver and we elected to pull those 2.

And pursue them and standalone entity separately based on the biomarker.

So we will work that out regulatory path now over the next few months with the regulatory agency define the program and the eligibility criteria and then the study will go up on clinic trials Dot Gov and give you a little.

Steven: So we will work out the regulatory path now over the next few months with the regulatory agency to find the program and the eligibility criteria, and then the study will go up on clintrails.gov and give you, you know, a little more information and granular details you want.

More information and granular details you want but I will tell you. If you look at the prevalence of whether it be <unk> fusions or rearrangements or in some cases, FGF or <unk> as well, which may be particularly important in glioblastoma. The prevalence rates are.

Unknown Executive: But I will tell you, if you look at the prevalence of whether it be FGFR2, fusions or rearrangements, or in some cases, FGFR3 as well, which may be particularly important in glioblastoma, the prevalence rates are, you know, sometimes in the single digits, 5 to 10 percent; sometimes it'll be higher. But obviously, in lung cancer, that's a potentially enormous opportunity, given the number of patients, even if you have a 5 to 10 percent prevalence of a particular driver.

And sometimes in the single digits, 5% to 10%, sometimes a little higher but obviously in lung cancer that potentially enormous opportunity given the number of patients. Even if you have a 5% to 10% prevalence of a particular driver. So I can't give you a more detailed yet because we don't have regulatory agreement on the path, but you can sort of see Howard Weil.

Unknown Executive: So I can't give you more detail yet because we don't have regulatory agreement on the path, but you can sort of see how it would pan out. It would be a molecularly defined entity within that histology rather than a Tumagnostic program. I'll turn the question over to you on the launch trajectory in Europe. In Europe, as you know,

Pan out would be a molecular defined entity within that histology, rather than a tumor agnostic program I will turn the question over on the launch trajectory and Europe.

And Europe I mean, as you know launching on your product is.

Unknown Executive: In Europe, as you know, launching a new product is happening in a sequence. It's not like the U.S., where the entire country one day will have the product available. So you can anticipate that we'll be selling in Germany, and then from there, we will have other countries being added as we go. Interestingly, a nice recommendation has already been obtained, so that should accelerate the availability in the UK, which is very important.

Happening and the sequence, it's not like the U S where the entire country when the product becomes available and so you can anticipate that will be starting with Germany.

And then from there we will have other countries being added.

As we go interestingly.

A nice recommendation.

And now has been.

Obtained already so that should accelerate the availability in the UK, which is very important.

And.

Unknown Executive: And also, it's important to realize that the treatment for LBCL in Europe is not exactly following the same path as the U.S. And I think there is a very good chance that we can see, you know, based on the data that you know. I mean, the three-year data was recently published. It's reaffirming the duration of response, the high complete response rate.

Also it's important to realize that the treatment.

For <unk> sales in Europe is not exactly following the same paths on the U S and I think there is a very good.

Channel that we can see based on the data.

I mean does free up data was recently published its reaffirming the duration on the response of high complete response rate and the and I think it will have a very good.

Unknown Executive: And I think it will have a very good chance to be used in second line very quickly in many of these countries. A reminder that we are really ready to launch it because we have an emetology team in place already in many of these countries from the I-Clucic franchise. And the relationship with physicians, the prescribers, is already very well established. So the team is really optimistic about our ability to drive Monjuvi and Minjuvi in Europe quickly.

Channel to be used and so on line very quickly and many of these many of these countries are reminds us that we are really ready to launch it because we haven't and mythology team in place already and many of these countries from Iclusig.

Franchise and duration ship with physicians and prescribers is already very well established so the team is really optimistic about.

Our ability to drive.

On jewelry in the Missouri and the in Europe quickly.

Unknown Executive: and I think it will be successful. I mean, the COVID situation is very different from country to country. And frankly, it's difficult to predict how it's going to evolve over the next few months. But I think it would be better than what we have seen in the U.S., where we were really at the lowest point when the approval of Manjoui in Tafasitamab in the U.S. took place. So everybody is fairly optimistic. Everyone is prepared. And I think it would be,

And I think it would be successful and the Covid situation is very different from country to country and frankly, it's difficult to predict how it's going to evolve over the next few months, but I think it would be better than what we have seen in the in the U S where we were really at the lowest.

Lewis point, when the Wednesday, provoke non Julien in the diversity and the in the U S took place so.

Everybody is very optimistic everybody is prepared and I think it would be it would be a successful launch.

Operator: Thank you. The next question is coming from Maro Goldstein from Missoula. Your line is now live.

Great. Thank you.

Thank you next question is coming from Mara Goldstein from Mizuho. Your line is not alone.

Thank you for taking the question.

Unknown Executive: Oh, thank you for taking the question. So, just, I apologize if I missed this because I missed the beginning part of the call, but are you able to share with us the distribution of new patient starts for Jackify according to indication? And similarly, for Manjuvie, can you update us on the status of just that distribution of those patients who are being treated in the second line versus later lines of therapy? And I was also hoping that you could provide an update on itisitinib in the second. line, the mylofibrosis trial, the anticipated timing of data, and what the strategy is for that drug at this point.

Just.

I apologize if I missed this because I missed the beginning part of the call, but are you able to share with us the distribution on new patient starts for jakafi, According to new indications and similarly for months UV.

Can you update us on the status of just also that distribution of those patients.

On being treated in the second line versus later line of therapy and I was also hoping that you could provide an update on net and the.

And second line Myelofibrosis trial.

And anticipated timing of data and what's the strategy for that drug at this point.

Tomorrow I can tell you is that new patient starts for Jakafi for Gvhd, MF and PV.

Unknown Executive: So tomorrow, new patient starts for Jackify for GVD, MF, and PV are all back to pre-pandemic levels for a while there. You know, bone marrow transplants were down, and GBHD was down, but now it's come back strong over the last several months or even since the end of last year. MF and PV patients that really dropped off in early spring, in spring and early summer of 2020, all came back, and just even in the last month of June, they came back to about the highest new patient start level that we've had for a long time.

Are all back to pre pandemic levels for a while there.

Bone marrow transplants were down and Gvhd was down but now it's come back strong over the last several months or heat and since the end of last year.

MF and PV patients that really dropped off in.

Early spring and spring and early summer of 2020, all came back and just even in the last month of June.

Came back to about the highest and new patient start level that we've had for a long time, so it's really.

Unknown Executive: So it's really GVHD growth is the highest in new patient starts, and then PV, new patients after that, and then MF patients after that. As far as MNJUB goes, again, at least from our market research in the second line setting, we're now the number one drug used for diffuse large B-cell lymphoma patients in the second line setting in terms of new patient starts.

Gvhd growth as well.

<unk> and new patient starts and then PV, new patient starts after that and and MF patients after that as far as my Judy goes.

And then at least from our market research and the second line setting we're now number 1 drug or used for the.

Fuse large b cell lymphoma patients and the second line setting in terms of new patient starts so that's where all of the new growth comes from and.

Unknown Executive: So that's where all of the new growth comes from, and the third, fourth, or fifth line is, you know, falling off after that. Steven, Steven.

And third fourth or fifth line as it's falling off after that.

Steven and the system.

Yes, hi, Thanks for your question on <unk> and in Myelofibrosis. So this is a different JAK inhibitor in terms of its JAK inhibition profile and is relatively <unk>.

Steven: Yeah, thanks for your question on Edisitinib in mylofibrosis. So this is a different Jack inhibitor in terms of its Jack inhibition profile and is relatively Jack 1 selective compared to ruxilitinib, if you use that as a reference. And then in MF, as everybody was saying, you know, they're different patient populations with different needs in terms of their underlying phenotypes and cytopenias and thrombinias and thrombocytopenia, etc. So the idea here is, potentially, with another jack inhibitor, with a different jack inhibitory profile, with a different PK, that we might be able to leverage some of that difference in terms of cytopinias and look for efficacy in populations, for example, that are more thrombic cytopinic than others.

Jack 1 selective compared to <unk>, if you use that as a reference.

And then and in MF as ever we're saying the different patient populations with different needs in terms of their underlying phenotype, and cytopenia ism and thrombocytopenia et cetera. So the idea here is potentially with another JAK inhibitor with a different JAK inhibitory profile with a different PK.

And we'd be able to leverage.

Some of that difference in terms of Cytopenia is and look for efficacy and populations. For example that are more thrombocytopenic and others. It's still early days in terms of this program.

Steven: It's still early days in terms of this program. So although, you know, we have quite a bit of data from earlier studies, this is now a standalone study, and we'll see how it goes in terms of enrollment and then update you further. But I wouldn't anticipate data in the next year or so. Okay.

Although we have quite a bit of data from from earlier studies. This is now Standalone study and we'll see how it goes in terms of enrollment and then update you further but I wouldn't anticipate data and the next year or so thanks, okay. Thank you.

Unknown Executive: Okay, thank you. If I could also sneak in one more question, and it's on the SG&A spending and the delay in Rux Cream, and how much of that increase in SG&A spending was associated with the anticipated launch of Rux Cream?

Also could just sneak in 1 more question and it's on the SG&A.

And then.

And the delay.

And rux cream and how much of that.

The increase in SG&A spending risks associated with anticipated launch of rux cream.

Unknown Executive: So the adjustment that we made to the SGNA guidance is 10 to 10 million on the low end to around 20 million or 20 million on the high end of the range. And this is primarily or really driven by the extension of the three-month extension in the pedoufa for a rucks cream. So there are certain activities that were related to direct-to-consumer that we were planning to do this year once we launched that, now, given the timing, we don't anticipate doing this year anymore and will be pushed out to 2020. Okay, thank you.

So the adjustment that we made to the SG&A guidance.

Uh huh.

And 2 million on on the low and 2 at around 20 million on 20 million on the high end of day range and this is primarily are really driven by the expansion on the 3 month expansion.

And we do fast for rux cream.

And they are served that activity.

And that the weather related for example to direct to consumer that line.

Yeah, and once we launch that now given the timing, we don't anticipate doing any.

And more and it will be pushed out to 2022.

Operator: Thank you. The next question is coming from Jay Olsa from Up and Home. Your line is now live. Thank you for taking the questions. Can you please comment on your current thinking around European strategy for topical rucks? And then on the timeline for the Vidalago submission, does the...

Okay. Thank you appreciate it.

Thank you next question is coming from Jay Olson from Oppenheimer. Your line is now live.

Okay.

Thank you for taking the questions.

Can you. Please comment on your current thinking around European strategy for topical Rux and then on the timelines for the vitiligo submission does the.

Submissions for topical rux in atopic dermatitis have any impact on the regulatory filing and vitiligo and thank you.

Unknown Executive: Have submissions for topical rucks in atopic dermatitis had any impact on the regulatory filing in Vitil, Thank you. Jay, Stephen, I'll take your second question first and then turn it over to you on the European strategy. So it shouldn't, at the bottom line, just be a question of whether it would be an SNDA versus an NDA, right? But the idea would be that we, you know, get the approval for Perdufa on September 21st, and we file Vidalago as soon as possible thereafter. And it shouldn't have any impact, particularly in the U.S. You can have multiple files in at once. There's no issue related to that.

Jay It's Steven I'll take your second question first and then turn it over on on the European strategy.

It shouldn't and the <unk>.

Bottom line and just a question of whether it would be and S. Anda and NDA right, but the idea would be that we get the approval on the <unk> on.

On September 21st and we follow the law.

And as soon as possible thereafter.

And it shouldn't have any impact, particularly in the U S. You can have multiple filed and that once there is no issue related to that on your European strategy alternative so in Europe. What we are planning to do is to submit first with vitiligo indication and that should be happening and so on behalf of zetia.

Steven: On your European strategy, I'll, So in Europe, what we are planning to do is to submit first with a Vitiligo indication, and that should happen in the second half of this year, and that will give us an approval, if it's approved, that will help on the pricing side, and that's why we are doing it in that order. It doesn't mean that we will never submit in atopic dermatitis, but it means that we'll be setting the price first in Vitilago, and then we'll have to see what kind of data will be rebuttal.

And that will give us on.

Ah Provote, if it's approved that will help on the pricing side and Thats why we are doing it and that although it doesn't mean that we will never submit in atopic dermatitis, but it means that we'll be setting the price first and vitiligo and then we'll have to see what kind of data would be required to obtain a reasonable price.

Steven: required to obtain a reasonable price in atopic dermatitis. As you know, it has to do with comparators and the way, you know, the benefit can be evaluated compared to other products that have a certain level of reimbursement. So the sequence will be vitiligo in the second half of this year, potentially one year later being approved, and then moving into the topic dormitaphic.

And the atopic dermatitis as you know it has to do with comparator from the way.

On the.

The benefit can be evaluated compared to other products that have a certain level of reimbursement. So the sequence would be we see that go in for going on.

And for this year, but I'm sure the 1 year later being.

And being approved and then moving into atopic dermatitis.

Unknown Executive: Thank you. As a reminder, that's one question and one follow-up and return to the queue. Our next question today is coming from Andrew Barron, from SBB Lyrn. Your line is now live.

Thank you as a reminder, that's 1 question and 1 follow up and return to the queue.

And today is coming from Andrew Berens Seb Leerink. Your line is now line.

Hi, Thanks.

Operator: Hi, thanks. A couple of questions from me on the commercial infrastructure you're building for the topical rough franchise. Can you remind us how many sales reps you're planning to hire for both indications? And can we get an update on where you are in that process currently? And just to clarify Mara's question, was any of the lowered SG&A guidance that you announced today related to a delay in headcount reduction or hiring?

Couple of questions from me on the commercial infrastructure and you're building from the topical rux franchise on can.

Can you just remind us how many sales reps you're planning to hire for both indications and and we get and update on where you are on that process currently and just to clarify <unk> question was any of the lowered SG&A guidance that you announced today related to a delay and head count reduction or hiring and then.

Barry: And then, as a follow-up, what percentage of... atopic derm patients are treated in the community versus a center of excellence, and then what percentage of Atopic Durham scripts are actually written by primary care physicians? Thanks, as far as who writes what. So, dermatologists overwhelmingly write, at least for the first script anyway, for drugs like Rux Cream or, most likely, Euchar and so forth, and obviously, for drugs like DuPixant, dermatologists are writing those. So, and most of them are being treated in the community. Most dermatology patients go to their local dermatologists in their community, not necessarily academic medical centers.

As a follow up what percentage of atopic derm patients are treated and the community versus a center of excellence and then what percentage of atopic derm scripts are actually written by primary care physicians.

So Andrew I can tell you our our field force is fully in place we have 120 sales representatives and the United States.

And they are up ready to go there and a process of training and getting to know their accounts.

So that's that.

As far as the node SG&A has nothing to do with head count because we havent fully on board ready to go and anticipating the launch in September.

And so we're looking forward to that and.

As far as who writes what so dermatologist for overwhelmingly right at least for the first script anyway for drugs like rux cream or most likely you crista and so forth.

But and obviously for drugs like <unk> picks and dermatologists are writing and those so and.

Most of them are being treated and the community most of dermatology.

Barry: We're very happy that most of the KOLs, or all of the KOLs, in dermatology are fully anticipating the approval of Rux cream and looking forward to it. And as far as primary care goes, yeah, sure, they'll write for mild steroids, maybe they'll write a refill script, but very little, as far as our research goes, will they be writing for Rux Cream, at least currently. Now, in the years to come, as everybody sees the efficacy and safety of Rux Litem cream, then that could change.

Patients go to their local dermatologists in their community.

Not necessarily academic medical centers were very happy that most of the cash.

<unk> or all of the Kols and.

And dermatology are fully anticipating the approval of rux cream.

And looking forward to it.

And and.

And as far as primary care goes.

Sure they feel right for mild steroids may.

Maybe the rate of refills script.

But very little as far as our research shows that there'll be writing.

For rux cream at least currently now and the years to come.

And so everybody sees the efficacy and safety of Brexit and cream.

And that could change.

Okay, and how often do the most physicians most.

Unknown Executive: Okay. And how often do most patients go?

Patient and see their dermatologist once they're diagnosed.

Unknown Executive: Patients see their dermatologist once they're diagnosed. Well, it varies. I'm not sure if I can give you an exact answer.

Well it varies and I'm not sure if I can give you an exact answer certainly patients who have troublesome.

Unknown Executive: Certainly, patients who have troublesome eczema go back to their primary care physician or their dermatologist every month, every quarter. It all depends on how many flares they have, and whether they're controlled by whatever medication they're currently on. Obviously, if patients are severe and they're on biologics, they'll see their dermatologists.

Eczema they'll go back to their primary care physician or their dermatologist.

Every month every quarter it all depends on how many flares. They have if they are controlled by whatever medication.

Currently on obviously, if patients are severe and they're on biologic sales either their dermatologists more often.

Operator: Thank you. The next question is coming from Crepe de Veraconda, from SunTrustrainer's now live.

Thank you. Our next question is coming from pre buys of Eric Honda.

From Suntrust. Your line is that a lot.

Hey, guys. Thank you so much for taking my question.

Operator: Hey, thank you so much for taking my question. Just following up on the pediatric trial in Atopic Derm that you recently initiated, RKOL checks have indicated that there could be a slightly greater hesitancy amongst parents, especially for the under-12 age group, to use something like a ruck cream, even if it doesn't get a black box label, especially if the orals get a black box warning. Is there anything in your market research that gives you confidence that this opportunity is worth pursuing in this population, also in the context of other opportunities?

And just following up on the pediatric trial.

And the topic John that you recently initiated a kilo and checks have indicated that they could be slightly greater hesitancy amongst head and especially for the under 12, each group to use something like rux cream.

Even if it doesn't get a black box label, and especially the or and just get a black box warning is there anything in your market research that gives you confidence that this opportunity is.

Pursuing and this population also and the context of on.

And the competition.

And in the pediatric population.

Unknown Executive: in the pediatric population.

Thank you.

Unknown Executive: Kriper Hi Stephen. I'll start, and Barry will talk about any market research.

Crippa, Hi, it's Steven I'll start and and Barry will talk about any market research.

We enabled a program we have to do a lot of work with the regulatory agency, particularly with the FDA to make them comfortable that there would be any harm so to speak right. Remember <unk> has now been on the market. Since 2011 is used and myelofibrosis <unk> and graft versus host.

Steven: You know, to enable the program, we had to do a lot of work with the regulatory agency, particularly with the FDA, to make them comfortable that there wouldn't be any harm, so to speak, right? Remember, oral rucks has now been on the market since 2011, is used in myel fibrosis, P. Vera and Grafersis host disease, and has ongoing pediatric work in the leukemia population with the children's on So we have a lot of experience with much higher exposures, if you will, of rocks.

Disease and has ongoing pediatric work.

And in leukemia population with the children's oncology group. So we have a lot of experience with with much higher exposures. If you will of rocks.

To enable the pediatric program before it got started we had to do work around any potential on bone on et cetera, and we made obviously, the FDA comfortable and regulatory agencies around the world to do it so.

Steven: To enable the pediatric program, before it got started, we had to do work around any potential for bone harm, et cetera, and we made, obviously, the FDA comfortable and regular agencies around the world to do it. So, you know, we, as always, with a clinical trial, we have to have equipoise and first do no harm. And so we're very comfortable with the profile, and it has the potential to obviously have enormous benefit and, hopefully, no safety safety safety safety. From a market research point of view, Barrio,

As always with the clinical trial, we have to have equity pose and first do no harm and so we're very comfortable and the profile and its.

And our potential to obviously have enormous benefits and.

And hopefully no safety signals from a mall.

And could research point of view Barry loans.

Well, we think that the rux cream could be a very good.

Barry: Well, we think that Rux Cream could be a very good treatment for kids, you know, let's say 2 to 12, that have eczema, or atopidermatitis that can't be controlled by other things. You know, obviously, there are problems in those patients who, because they can, their only other choice really is steroids. We find that kids don't really like to use Eucharas, quite frankly, because it burns, and topical steroids can only be used for a short period of time. So we think once we have the clinical data for kids between 2 and 12, this could be a very good option for them.

Treatment for 4 kids.

Let's say 2 to 12 that have.

Eczema atopic dermatitis that can't be controlled by other things and obviously there is.

Problem and those patients who.

And because they are only other choice really is steroids, we find that.

Kids don't like really to use you, Chris or quite frankly, because it burns.

And the topical steroids can only be used for a short period of time. So we think once we have the clinical data.

For the kids.

Between 2 and 12 that this could be a very good option for them.

Unknown Executive: Great, thank you. I have a follow-up question on

Alright, Thank you and.

Unknown Executive: and ratasandumab. You know, the CRL for SCAC was certainly a disappointment, but

I have a follow up question on that is on the mob.

And for Us and see if he was senior disappointment, but sort of in line with was in line with how the compound and volatile and you maybe talked about and strategy moving forward I know you don't comment on discussions with the FDA, but.

Steven: but was sort of in line with, was in line with how the Adcom panel voted. Can you maybe talk about the strategy moving forward? I know you don't comment on discussions with FDA, but in the pivotal phase three trial, the panel talked about the rate of enrollment, particularly. Can you comment on how things have changed in the past few months, especially with things around COVID-20? You know, changing a bit.

But the safety trial upon and talked about the rate and Goldman and particularly can you comment on how things have changed in the past few months, especially with things and on Covid.

Changing or bolt.

Steven: Yeah, Stephen, thank you. Yeah, we were disappointed in the ODAC outcome and the 13 to 4 vote, you know, especially given we had done, to our knowledge, the largest study ever in squamous cell anal coshenoma, plus had addressed the HIV population, plus what we thought, as you saw, we presented, that the activity was in keeping with other checkpoint inhibitors in virally driven tumors. However, you saw the outcome, and we got the complete response letter.

Yes, it's Steven Thank you, yes, we were disappointed and the <unk> outcome and the 13 to 4 vote, especially given we have done to our knowledge the largest study ever and and squamous cell anal carcinoma, plus had addressed the HIV population plus what we thought as you saw we presented that the activity was in keeping with other <unk>.

<unk> inhibitors, and virally driven tumors. However, you saw the outcome and we got the complete response letter the way. It works now as you work with the agency on addressing the aspects of the complete response letter, which which will do and.

Steven: The way it works now is you work with the agency on a drug, addressing the aspects of the complete response letter, which we'll do, and, you know, again, confident in the data and hopefully leading to a, you know, if we make the FDA comfortable, a resubmission around with data that will make them comfortable with the risk benefit of it. You know, in terms of the ongoing first-line study, it was again presented at the ODAC.

Again confident and the data and hopefully lead.

Lead to a.

If we make the FDA comfortable and resubmission around with data that will make them comfortable and the risk benefit.

All of it.

In terms of the the ongoing first line study again was presented at Kodak.

It's done with the with the biggest group and this space interact they are the ones. We've done studies in this arena and actually had documented the first line standard.

Steven: It's done with the biggest group in the space interacts. They are the ones who've done studies in this arena and actually documented the first line care standard in their own study, and that study's going well. There's no real COVID impact to that, you know, given it's the only study in the space and it's a randomized study. So we're comfortable where we are there.

And their own study and that study is going well there is no real COVID-19 impact to that given it's the only study and the space and it's a randomized study. So we're comfortable where we are there. Thanks.

Unknown Executive: Thank you so much.

Great. Thank you so much.

Unknown Executive: Okay, thank you so much.

Operator: Thank you. The next question today is coming from Stephen Willie, from Steeple. Your line is now live. Yeah, good morning.

Thank you. Our next question today is coming from Stephen Willey.

From Stifel. Your line is now live.

Hi, Good morning, Thanks for squeezing me in just a couple of really quick questions on QD rux. So.

Unknown Executive: Yeah, good morning, thanks for squeezing me in. Just a couple of really quick questions on QD Rocks. So can you maybe just speak to any significant or potential differences that might exist between the current version of QD Rocks and, I guess, the prior sustained release version that was published a few years ago? I know, you know, both were similarly on the pharmacologist on the pharmacology side in terms of obtaining bioequivalence. So just wondering if there are any additional differences that you would highlight between the two. And then, just lastly, curious how you're thinking about a QD-fix dose combination in the context of potentially sacrificing some titrateability.

Can you, maybe just speak to any significant or potential differences that might exist between the current version of QD Rux and I guess the prior sustained release version that was.

Published a few years back I know.

Both were similarly on the pharmacology.

And on the pharmacology side in terms of obtaining bio equivalents. So just wondering if theres any additional differences that you would highlight between the 2 and then just lastly.

Curious, how youre thinking about acuity fixed dose combination and the context of potentially sacrificing some titrate and Billy thanks.

Steven: Steven, Steven, it's Steven Arsson with your question. So it's good you both bring up that older publication, which was the single strength, a 25 milligram slow release. That is actually one of the formulations. It's just that now we have multiple formulations. We've done the more complete work around bi-availability and bi-equivalence and obviously have the area under the curve we need to go forward with the submission, should stability be okay. But just to be repetitive, that 20-year-old.

Stephen Hi, it's Steven answering your question. So it's good you bring up that older publication, which was of the single strength at 25 milligram slow release that is actually 1 of the formulations. It's just that now we have multiple formulations, we've done the more complete work around.

Bioavailability and bioequivalence and obviously approved.

And have the area under the curve, we need to go forward with a submission should stability be okay, but just to be repetitive that 25 milligram strength published a few years ago is exactly 1 of the strength we have now.

Steven: milligrams strength published a few years ago is exactly one of the strengths we have now. In terms of fixed dose combinations, I don't think we'll lose optionality because we can make multiple of them and they're different ways of providing that, you know, and given that they're, um, um, know, very set strengths, and then, you know, for pasta clissip, for example, there may only be two doses that would be needed, so you'd have the dose that's approved, and then So, you know, optionality wouldn't be a problem. I don't think we'd lose any ability for people to titrate doses in any way. We're comfortable with where it may head, thanks.

In terms of fixed dose combinations I don't think we'll lose optionality, because we can make multiple of them and they have different ways of providing that and given that it's.

And a very set strength and then flow path.

Example, they may only be 2 doses that would be needed.

So you'd have to dose that's approved and then a reduction dose so.

Optionality wouldn't be a problem I don't think we'd lose any ability for people to titrate dose and anyway, we comfortable with where it may head.

Unknown Executive: Thank you. We have 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.

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

Unknown Executive: Thank you all for your time today and for your questions. The IR team will be available throughout the day for any follow-up questions you may have, and we look forward to talking to you at investor conferences in the coming weeks. Have a good day.

Thank you all for the time today and for your questions. The IR team will be available throughout the day for any follow up questions. You may have and we look forward to talking to you at investor conferences in the coming weeks have a good day.

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.

Operator: That does include 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.