Q1 2020 Earnings Call

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Greetings and welcome to the insight 2021st quarter Financial results Conference call. At this time, all participants are any listen only mode. A question and answer session will follow the formal presentation. If anyone's require obligor assistance during the conference. Please press star zero under telephone keypad.

Operator: Greetings, and welcome to the Incyte 2020 First Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Mike Booth, Head of Investor Relations. You may begin.

Please note. This conference is being recorded I'll now turn the conference over to your host Mike.

Booth head of Investor Relations you may begin.

Thank you Kevin Good morning, and welcome to insights first quarter 2020 earnings conference call on webcast slides used today are available for download on the investor section of insight Dot com.

Mike Booth: Thank you, Kevin. Good morning, and welcome to Incyte's first quarter 2020 earnings conference call and webcast. The slides used today are available for download in the investor section of Incyte.com. I'm joined on the call today by Herve, Barry, Steven, and Christiana, who will deliver their prepared remarks, and by Dash, who will join us for the Q&A session. During the question and answer session, I ask that you limit yourself to one question and, if needed, one follow-up, as this will enable as many of you to ask questions as time allows. Before we begin, I'd like to remind you that some of the statements made during the call today are forward-looking statements. Including statements regarding our expectations for 2020 guidance, the commercialization of our products, and our development plans and expectations for the compounds in our pipeline, as well as the development plans of our collaboration partners and uncertainties that may cause our actual results to differ materially, including those described in our 10k for the year ended December 31st, 2019 and from time to time in our other SEC documents.

I'm joined on the call today by of a Barry Stephen and Christiana will deliver our prepared remarks and by Dash, who will join us for the Q and a session.

During the question and answer session I ask that you limit yourself to one question and if needed one follow up as this will enable as many of you to ask questions as time allows.

Before we begin I'd like to remind you that some of the statements made during the call today.

Forward looking statements, including statements regarding our expectations for 2020 guidance.

Commercialization of our products.

Development plans and expectations for the compounds in our pipeline as well as the development plans of our collaboration pot uncertainties that may cause our actual results to differ materially including those described in our 10-K for the year ended December 31st 2019 and from time to time in our other FCC documents.

In addition, I would like to caution everyone. That's a coke at 19 pandemic is in involving situation and as you still relatively early to be able to assess the full impact with governmental business and social actions and policies and overall economic conditions on business.

Mike Booth: In addition, I would like to caution everyone that the COVID-19 pandemic is an ongoing situation, and it is still relatively early to be able to assess the full impacts of governmental, business, and social actions and policies, and overall economic conditions on our business. Accordingly, it is important to keep in mind that our statements on this webcast speak as of today. We will now begin the call with Herve.

Accordingly, it is important to keep in mind that our statements on this webcast speak as of today.

We'll now begin the call with other.

Herve Hoppenot: Thank you, Mike, and good morning, everyone. I hope that all of you and your families are safe. Stay Funder healthy! During this unprecedented... Uncertain time.

Thank you Mike good morning, everyone.

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They've found the Hep C.

During this unprecedented.

Uncertain time, it becomes a cobiz 19 foundry me has had the holiday impact on almost every aspect of peoples life has affected businesses or longer world.

Herve Hoppenot: It's evident that the COVID-19 pandemic has had a profound impact on almost every aspect of people's lives and has affected businesses all around the world. Before we begin, doctors, nurses, and all other essential workers who are continuing to provide their much-needed services with this pandemic at the forefront of everyone's mind. I want to start our earnings call by providing an update as it relates to the COVID-19 impact on four areas of our business, namely commercial, supply, regulatory, and clinical operations.

Before we begin I'd doctors nurses to although in some sort of walk girls, who are continuing to provides a much needed services.

With this pandemic at the forefront of everyone's mind I went to stop our own score by providing an update as it relates to the company's 19 impact on four areas of our business.

Namely on commercial supply regulatory and clinical operations.

When we NXT that were global business contingency plans over two months ago.

Herve Hoppenot: When we enacted our Global Business Continuity Plans over two months ago... Our key priorities were to ensure that patients continue to give customers the support they need and, importantly, to do this in a manner that minimizes the health risk to our employees and our customers. I am proud of the team here at Incyte for continuing to deliver throughout this period, and I am extremely grateful to those working onsite to maintain our critical operations. Today, there has been no impact on our commercial business, and with so, we continued our strong performance in the first quarter. We have an ample drug supply, and our manufacturing processes are proceeding without interruption. On the regulatory front, there has been no impact to date on key deadlines.

Our key priorities work to ensure that patients continue to receive customers is to Brooklyn, either and importantly to do this in a manner that minimizes the health risk to our employees and I work customers.

I'm proud of the team here at insights for continuing to deliver throughout this period I am extremely grateful to lose working on site to maintain our critical operation.

To date has been no impact on our commercial business.

And we saw continued strong performance into first quarter.

We have ample drug supply and I were manufacturing processes are proceeding without interruption.

On the regulatory from there has been going back to date on key timeline.

We recently announced one of our freedom to Cpcs are progressing 2020, and we continue to expect via the seasons on both government and event deficit that mab ins are coming months.

Herve Hoppenot: We recently announced one of our three anticipated approvals in 2020, and we continue to expect FDA decisions on both Capmetunib and Tafacitamab in the coming months. We do not expect disruption to other key regulatory timelines, including the NDA submission of Roxyretinib cream for atopic dermatitis at the end of the year. With regard to clinic... As of today, while our late-stage programs remain broadly on track, we anticipate that short-term effects may continue to emerge, including new patient recruitment. The degree of impact may vary by disease state and by severity of disease, as well as by geography, as some regions are more adversely impacted in terms of our effort to help address this pandemic.

We do not expect disruption to other generally good that's very time lines, including the India submission of Ruxolitinib Graeme fight to pick them at Eightys at the end of the year.

With regards to clinic.

Drug development as of today, while I will let Fitch programs remain broadly on track, we anticipate that shotgun effects may continue to him them, including new patient recruitment.

So the degree of impact may vary by disease States and bi severity of disease as well as by geography as some reasons are modestly impacted.

In terms of I worry for up to help address this brand image.

We were recently initiated the global phase three looks good we try out of the in partnership with Novartis.

Herve Hoppenot: We recently initiated the Global Phase 3 RxCovid trial, in partnership with Novartis, to assess roxalitinib in patients with COVID-19-associated cytokine storm. In the U.S., we are also starting another trial evaluating roxolitinib as a potential treatment for COVID-19 patients who are on mechanical ventilation. We have also opened an Emergency Expanded Access Program, which will allow eligible patients with severe COVID-19 to receive rock-solid... Studies are also ongoing with Baracitinib, where Lilly has recently entered into an agreement with the National Institute of Allergy and Infectious Diseases, which is part of the NIH, to study barcitinib as an arm in its COVID-19 clinical trial. Multiple investigator-initiated trials for both roxifilatinib and baracitinib are ongoing and planned as part of the global evaluation of whether JAK inhibition plays a role in improving outcomes in COVID-19. Turning to our first quarter performance,

To assess Ruxolitinib. In addition, with Govies 19 necessity cytokine storm.

In the U.S., we also starting and those of trial evaluating ruxolitinib as a potential treatment for Coveas 19 patients who own mechanical ventilation.

We have also opened an emergency expanded access program, which will allow eligible patients with severe govies 19 to receive ruxolitinib.

Studies also I'm going with Baricitinib, where levy has recently entered into an agreement with the National Institute of LG and infectious disease, which is part of their knowledge to study baricitinib as an omni scale with 19 clinical trial.

Multiple investigator initiated trial for both Ruxolitinib and balances you need the ongoing and planned as part of the global evaluation of without checking ambition plays a role in improving outcomes in Korea 90.

Turning to our first quarter performance.

Well results reflects a bit there's always have reflect the benefit of our long term strategy and our execution on the plans we have previously led out.

Herve Hoppenot: The results reflect the benefit of our long-term strategy and our execution on the plans we have previously laid out. In the first quarter of the year, we continued our strong commercial execution, with Jessica Fye achieving 22% growth over the first quarter of last year to reach $459 million, and total product and royalty revenues growing by 24% year-over-year to $569 million for the quarter. Our financial position is also strong, with $1.3 billion in cash at the end of Q1 2020.

In the first quarter. Obviously, you are we continued our strong commercial execution will rectify achieving 22% grows over the first quarter of Lester to reach 459 million.

Total product on a royalty revenues growing by 24% year over year to 569 million for the quarter.

Our financial position is also strong with 1.3 billion in cash at the end of Q1 2020.

In recent months, we also made significant progress on their regulatory and clinical development fronts. We recently received FDA approval of Chlamydia, which brings another inside discover molecule to market and provides further testament to the stronger R&D capabilities, we have here inside.

Herve Hoppenot: In recent months, we also made significant progress in regulatory and clinical development. We recently received FDA approval for Pemazir, which brings another Incyte Discover molecule to market and provides further testament to the strong R&D capabilities we have here at By the end of 2020, with our respective collaboration partners Novartis and Morphosis, we could see two additional new product approvals with capmetinib as a treatment for certain patients with metastatic non- In addition, we presented positive data from our TrueAD Phase III program at the Revolutionizing Atopic Dermatitis Conference, and we remain on track to submit an NDA for Roxyretinib cream at the end of the year.

By the end of 2020 with our respective collaboration partners Novartis on Mfas is we could see two additional new product approvals with capmatinib as a treatment for certain patients with metastatic non small cell lung cancer and deficits them up for relapsed refractory deal this year.

Both of which are under priority review with the FDA.

In addition, we presented positive there, though from my work through a de phase three program Adore Revolutionizing atopic dermatitis conference and we remain on track to submit that India for Ruxolitinib cream at the end of the year.

Herve Hoppenot: Despite the uncertainties brought on by COVID-19, I remain confident about our future prospects as we continue to execute on our goals. Slide 6 shows our ongoing revenue momentum over the last several years, with four sources of revenue driving top-line growth. We will be adding a fifth revenue stream following the recent approval of PEMADIF. Looking to the remainder of 2020, our key priorities are to maintain our revenue momentum and to drive continued growth of Jackafra in the U.S. We are also focused on executing a successful launch of Pemazir, which Barry will cover shortly, and preparing for the potential FD approval of Tafesit Ahmad. Our LIMBER development program remains a key priority, and we are working towards the planned initiation of our BET and ALC2 programs and the expected opening of the Pivotal Rocks plus Particle Zip Trial.

Despite uncertainties broke done by Coveas 19, I remain confident about our future prospects as we continue to execute on our goals.

Slide six shows our ongoing revenue momentum over the last several years with four sources of revenue driving topline growth.

We will be adding a fixed revenue stream following the recent approval of them as you.

Looking to the remainder of 2020, our key priorities are to maintain our revenue momentum and to drive continued growth of Jack I find the U.S.

We also focused on exists executing a successful launch of limousine, which Barry will cover softly and preparing for the potential FD approval of deficits or not.

I will limber development program remains a key priority and we are working to up the planned initiation of our best and help to programs.

And the expected opening.

Think of the pivotal rux, plus specifically the trial.

Herve Hoppenot: 2020 is shaping to be a transformational year for Incyte, and I look forward to Barry, who will provide more detail on both First Quarter Jakafi performance as well as our commercial activities for PMSD. Thank you, Herve, and good morning, everyone. Slide 8 shows strong growth of Jackify quarter over quarter, mostly driven by increases in patient volume. However, as expected, growth to net was much higher.

2020 is shipping to be a transformational year for insights and I look for of up to Barry will provide more detail on those first brought out like a high performance as well as our commercial activities.

Our family.

Thank you every day and good morning, everyone.

Slide eight shows strong growth objectify quarter over quarter, mostly driven by increases in patient volume.

As expected gross to net was much higher.

Fair in Q1 due to our portion of the Donut hole, we are responsible for under Medicare part D. Any increase in true out of pocket cost or does the total number of patients on therapy across all three indications. The total number of patients and new patients treated with Jack a five for MF.

Barry P. Flannelly: In Q1, due to our portion of the donut hole we are responsible for under Medicare Part D and the increase in true out-of-pocket cost or dose, the total number of patients on therapy across all three indications. The total number of patients and new patients treated with Jackify for MFPV and GBHD continues to grow. In GBHD, Jackify is rapidly becoming the standard of care in the steroid-refractory acute setting. We are very pleased to have REACH-2 published in the New England Journal of Medicine, underscoring the importance of Jackify as a treatment option for patients with steroid-refractory acute GVHD. In the 300 patient randomized REACH-2 trial, Ruxolitinib demonstrated a 62% overall response rate versus 39% seen with best available therapies. REACH-2 was the first randomized trial to show a benefit in this hard-to-treat patient population and showed convincingly that ruxolitinib was more effective than investigators' choice of therapy from a list of nine commonly used options in patients in whom steroid therapy We also applaud the FDA for granting full approval to ruxolitinib last year based on the single-arm REACH-1 trial. Results from REACH-3, our study evaluating ruxolitinib in steroid-refractory chronic GVHD, are expected in the second half of this year.

D and Gvhd continues to grow.

In Gvhd Jack of high as rapidly, becoming the standard of care in the steroid refractory acute setting.

We're very pleased to have reached two published in a new England Journal of Medicine, underscoring the importance of Jackup I as a treatment option for patients with steroid refractory acute gvhd.

In a 300 patient randomized reach two trial Ruxolitinib demonstrated a 62% overall response rate versus 39% seen with best available therapy.

Reach to first randomized trial to show a benefit in its hard to treat patient population and showed convincingly that ruxolitinib was more effective than investigators choice of therapy from less than nine commonly used options in patients in whom steroid therapy had failed.

Also applaud the FDA for granting full approval to Ruxolitinib last year based based on a single arm reach one trial.

Results from reached three our study evaluating ruxolitinib in steroid refractory chronic gvhd are expected in the second half of this year.

Our long term outlook for Jacobite remains positive patient demand remains strong and as a result, we are reiterating our guidance for the full year.

Barry P. Flannelly: Our long-term outlook for Jackify remains positive. Patient demand remains strong, and as a result, we are reiterating our guidance for the full year. It is during this time, however, that we must stay focused and work even harder to engage our customers to provide them with continued support and to drive disease awareness. We have had much success in implementing our digital and virtual strategies, and our top priority is to ensure that patients are able to receive their medicine. Our commercial focus in the U.S. remains on the success of Jackify, and we take these learnings and apply similar methods to our launch of Temazir. Temazir is the first treatment innovation for patients with cholangiocarcinoma in 25 years and represents an important addition to our portfolio of oral cancer medicines.

It is during this time, however that we must stay focused and work even harder to engage our customers provide them with continued support and to drive disease awareness. We have much success in implement that we've had much success in implementing our digital and virtual strategies and our top priority is to ensure that.

Patients are able to receive their medicine.

Our commercial focus in the U.S. remains on the success of Jackup by and we take these learnings and apply similar methods to our launch attempt here.

Benazir is the first treatment innovation for patients with Cholangio carcinoma in 25 years and represents an important addition to our portfolio oral cancer medicines.

We have launched Pembinas year and are focusing on a targeted group of approximately 1000 physicians two thirds of which are already prescribing Jack a flat. This our lap. This allows our commercial team to leverage existing relationships, helping to facilitate part of the promotional effort behind tenants here.

Barry P. Flannelly: We have launched Pemiseer and are focusing on a targeted group of approximately 1,000 physicians, two-thirds of whom are already prescribing Jackify. This allows our commercial team to leverage existing relationships, helping to facilitate part of the promotional effort behind Pemiseer. We will also drive healthcare professional interaction through our virtual programs and digital promotional assets, building on some of the existing strategies we are already successfully utilizing with Jackify. For example, our sales, market access, and medical affairs teams are actively scheduling virtual appointments with our customers and are using the technology in place to share resources and materials in virtual meetings.

We will also drive healthcare professional interaction through our virtual programs and digital promotional assets building on some of the existing strategies. We are already successfully is utilizing with Jack a fine.

Our sales market access and medical affairs teams are actively scheduling virtual appointments with our customers and are using the technology in place to share resources and materials in virtual meetings.

All of these efforts complement our ongoing unbranded educational campaign focused on Cholangio carcinoma.

Barry P. Flannelly: All of these efforts complement our ongoing, unbranded, educational campaign focused on cholangiocarcinoma. And, of course, as more patients are treated with targeted therapies like Pemizer, it is increasingly important to continue to educate and promote appropriate FGFR testing in order to enable the proper identification of those patients who stand to benefit. Post from Pemmes here. While we appreciate that the commercial potential for cholangiocarcinoma may be relatively modest, every company is developing pemigatinib in other tumor types that are driven by FGFR alterations. With that, I'll turn the call over to you.

And of course as more patients are treated with targeted therapies like 10 busier is increasingly important to continue to educate and promote appropriate FGF are testing in order to enable the proper identifications at those patients who stand to benefit.

Both from Pemex here.

While we appreciate that the commercial potential for Cholangio carcinoma may be relatively modest every helping penny getting them in other tumor types that are driven by FGF, our alterations with that I'll turn the call over to Steven.

Thanks, Barry and good morning, everyone.

Starting with Ruxolitinib cream, we were very pleased to share with you. The positive results from our phase three true 80 program at the revolutionizing Atopic dermatitis conference a few weeks ago.

Steven H. Stein: Thanks, Barry. And good morning, everyone, starting with ruxolitinib cream. We were very pleased to share with you the positive results from our Phase 3 TrueAD program at the Revolutionizing Atopic Dermatitis Conference a few weeks ago. As you can see in the graphs on the left, ruxolinib cream achieved clinical and statistical significance in the primary endpoint of Investigator Global Assessment Treatment Success, or IGA-TS, at Week 8. Similarly, clinical and statistical significance was demonstrated in a 75% reduction in the eczema area and severity index score, or EZ75, and in the analysis of the four-point reduction in the itch numerical rating scale, or NRS Substantial, and more importantly, a very rapid reduction of itch with Rux cream within 12 hours of initiation of therapy.

As you can see on the crops on the left Ruxolitinib cream achieve clinical and statistical significance in the primary endpoint of investigator global assessment treatments success or Ats at week eight.

Similarly, clinical and statistical significance was demonstrated in a 75% reduction in the eczema area and severity index score for easy 75.

And in the analysis of the four point reduction in the H numerical rating scale will in Rs, four which is what the FDA has defined to be a meaningful endpoint in terms of each reduction.

Substantial and more importantly, a very rapid reduction of edge with racks cream within 12 hours of initiation of therapy.

The strength of these data show that Ruxolitinib cream has been able to demonstrated jewel mode of action.

Anti inflammatory and anti Pruritic activities, which together could make for a very effective therapy.

As it relates to safety there were no notable safety findings either locally or systemically that were associated with treatment.

Steven H. Stein: The strength of these data shows that Ruxolytinib cream has been able to demonstrate a dual mode of action, anti-inflammatory and anti-pruritic activities, which together could make for a very effective therapy. As it relates to safety, there were no notable safety findings, either locally or systemically, that were associated with treatment. We are on track with the development timelines for ruxolidinib cream. Long-term safety data are being collected, and we continue to excel throughout the year. The vitiligo trials remain ongoing, and we continue to expect data in 2021.

We are on track with the development timelines for Ruxolitinib cream.

A lot.

On term safety data have been collected and we continue to expect next calendar year.

The Lago trials remain ongoing and we continue to expect data in 2021.

Turning now to Pemex here.

Hemisphere was approved based on data from the fight to two study.

We are treatment with Pemex catnip resulted in an objective response rate of 36% and.

And a median duration of response of over nine months in patients with FGF, our two fusions ori arrangements.

The most common adverse event was hyperphosphatemia, most of which was low grade and manageable.

The full dataset from five to two was recently published in the launches.

We're very proud to offer a therapy for patients living with Cholangio carcinoma, where prognosis is poor and where there's been limited treatment options to date.

Steven H. Stein: Pemisea was approved based on data from the FITE-202 study, where treatment with pemigatinib resulted in an objective response rate of 36% and a median duration of response of over nine months in patients with FGFR2 fusions or rearranged. The most common adverse event was hyperphosphatemia, most of which was low-grade and manageable. The full data set from FITE 202 was recently published in The Lawn. We are very proud to offer a therapy for patients living with cholangiocarcinoma where the prognosis is poor and where there have been limited treatment options to date. We continue to study pemigatinib in clinical trials for bladder cancer, an 8p11 myeloproliferative neoplasm, as well as for tumor agnostic indications.

We can continue to study pendergast NAV in clinical trials for bladder cancer.

And eight P. 11, marler proliferative neoplasm as well as the tumor agnostic indications.

Now turning to efforts in Cobot 19.

Cytokine storm is a severe immune over reaction that can be triggered by viral infection and needs to serious complications, including acute respiratory distress syndrome, which is a form of respiratory failure that is one of the leading causes of mortality uncovered 19 patients.

Patients with severe cobot 19 experience massive immune cell infiltration with associated pro influx.

Country cytokines ultimately lead into alveolar damage.

Many of the elevated cytokines that perpetuate the cytokine storm exemplified by interferon Gamma IL six GM CSF and G CSF signal either through Jack one or Jack too.

Steven H. Stein: Now turning to efforts in COVID-19. A cytokine storm is a severe immune overreaction that can be triggered by a viral infection. Leads to Serious Complications, including acute respiratory distress, which is a form of respiratory failure that is one of the leading causes of mortality in COVID-19 patients. Patients with severe COVID-19 experience massive immune cell infiltration with associated pro-inflammatory, ultimately leading to alveolar damage. Many of the elevated cytokines that perpetuate the cytokine, as exemplified by interferon gamma, IL-6, GM-CSF, and GC-SF, signal either through JAK-1 or JAK-2.

We believe that treating cytokine storm with Ruxolitinib as an inhibitor of both Jack one and Jack to May mitigate cobot 19 associated cytokine storm and thus reducing the overall disease burden.

We recently initiated our rux cobot program to evaluate ruxolitinib as a potential therapy for patients with cobot 19 associated cytokine storm.

Our team in collaboration with our partners at Novartis initiated a global phase three program.

We anticipate recruiting upon storm in rux, cobot, and we'll be evaluating ruxolitinib five milligrams, the I'd plus standard of care versus standard of care learn.

The compensated primary endpoint is the proportion of patients who die down.

Developer Spiritthree failure require mechanical ventilation or acquire I see you care by day 29.

We're also.

The opening a second phase three trial in United States. The 369 trial that will evaluate ruxolitinib in patients with the a rds is a tougher respiratory failure characterized by rapid onset of widespread inflammation in the lands and this trial will evaluate too.

Steven H. Stein: We believe that treating cytokine storm with ruxolitinib as an inhibitor of both JAK1 and JAK2 may mitigate COVID-19 associated cytokine storm and thus reduce the overall disease burden. We recently initiated our RUX COVID program to evaluate ruxolitinib as a potential therapy for patients with COVID-19 associated cytokine storm. Our team, in collaboration with our partners at Novartis, initiated a global Phase III program. We anticipate recruiting a prime storm for RUX COVID, and we'll be evaluating Roxaliznib 5mg BID plus standard of care versus standard of care alone. The composite primary endpoint is the proportion of patients who die, develop respiratory failure, require mechanical ventilation, or require ICU care by day 29. We are also...

Doses of Ruxolitinib, five milligrams, BRD and 15 milligrams be I'd and is expected to recruit around 500 patients.

The key difference between rux coated and the three six non trial is a patients in the former or not on ventilation, whereas those in the three six non trial are on mechanical ventilation.

My last slide is our news flow summary.

As you can see we have began the year well and have already announced several important milestones, including positive phase three data from Ruxolitinib cream and the recent FDA approval Pemex here.

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

Thanks, and good morning, everyone. This allows us to date. This morning will include the GAAP and non-GAAP numbers for the full you reconciliation of GAAP to non-GAAP. Please refer to slides and decided to wait to see good backup section of the bank and so the press release, we said the quality.

Steven H. Stein: Opening a second phase 3 trial in the United States. ARDS is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs, and this trial will evaluate two doses of ruxolite. 5mg BID and 15mg BID and is expected to recruit around 500 patients. The key difference between RUX COVID and the 3-6-9 trial is that patients in the former are not on ventilation, whereas those in the 3-6-9 trial are on mechanical ventilation. My last slide is our news flow summary. As you can see, we have begun the year well and have already announced several important milestones, including positive phase three data from Raxolitinib cream and the recent FDA approval of Pemezir. With that, I would like to turn the call over to Christiana for the financial update.

Before turning to our results for the quarter I'd like to review the accounting treatment for our collaboration with more closely.

Hey, mind, there I collaboration with more closely stressful component.

Nicole development nickel commercialization of stuff to see them up by side and more forces and they grow.

And then exclusive development commercialization of that you can buy side outside they grow.

It does will probably be accounting for the collaboration is definitely the parties have proved more forces will you recall all seem to the euro and tied you will recall all states outside the <unk>.

Okay.

Okay. We'll include only Cogs outside of the Euro as west side the wrong.

Christiana Stamoulis: Thanks, Steven. And good morning, everyone.

Christiana Stamoulis: The financial update this morning will include GAAP and non-GAAP numbers. For a full reconciliation of GAAP to non-GAAP, please refer to slides 25 and 26 in the backup section of the deck and to the press release we issued this morning. Before turning to our results for the quarter, I'd like to review the accounting treatment for our collaboration with Workforce. As a reminder, our collaboration with Morphosis has two components.

R&D expense will include that seems to 5% shale well, but and your specific development costs as well as a percent of any development costs specific to territory applied Broadway.

Additionally, it will include.

And yet fraud and milestones that are payable prior to October.

Alright, DNA expense will include only Alco, Mike why don't you will recall that sees the percent of the you all medical much standardization profit or loss as a single line item.

Christiana Stamoulis: The co-development and co-commercialization of Tafesitamab by Inside and Morphosis in the U.S., and the exclusive development and commercialization of Tafesitamab by Inside outside the U.S. In terms of how we will be accounting for the collaboration, if Tazeen Ahmad is approved, Morphosis will record all sales in the U.S., and Incyte will record all sales outside the U.S. Cogs will include only cogs outside of the U.S. as well as inside the U.S. Our R&D expense will include our 55% share of global and U.S.-specific development costs, as In addition, it will include any upfront and milestone payments that are payable prior to approval. Our SG&A expense will include only our commercial expenses, and finally, we will record our 50% of the U.S. net commercialization profit or loss as a single line item in our financial results, as a revenue item when it constitutes a net profit or as an operating expense item when it constitutes a net loss.

As a result.

I say revenue item would constitute a profit.

Good afternoon operating expense item would constitute a net loss.

Cogs and low cost associate.

Yes, it would the commercialization efforts related stuff that you talked about in big Wells will be included in this profit or loss setting.

We open the call.

And so it makes sense right.

Now moving Blair results for the first quarter revenue growth continued to be strong across all fall back with total product. The royalty revenues of 506 $9 million, we're presenting an increase of clinical percent, although the first quarter of 2019.

This is comprised of pull kind of $9 million and Jack API and Glenn This is Ed medium dollars Netflix.

Good net product revenues $56 million and Jakafi Ryan.

This from Novartis and blend to $5 million.

And while I agree non-GAAP basis of $1.2 billion includes the $805 million related to that well of course today suitable forces, which consisted of 700. Please.

Good million dollars upfront payments and it seems beside me.

Christiana Stamoulis: Cogs & All Costs Associated, and the commercialization efforts related to Kaffa Chittabad in the U.S. will be included in this profit or loss-sharing line. Note in the COGS and SG&A expense line. Now moving to our results for the first quarter, revenue growth continued to be strong across all products, with total product royalty revenues of $569 million, representing an increase of 24% over the first quarter of 2019. This is comprised of $469 million in Jack Fye and $27 million in Iclusive Funds. Net Product Revenues, $56 million from Jack Abbey Royal, from Novartis, and $25 million in Olympian Royal Glenon Gap Bases of $1.2 billion include the $805 million related to the upfront consideration to Borphosis, which consisted of a $760 million $50 million upfront payment, and a $55 million, excluding R&D upfront and milestone expenses. Total COGS, ongoing R&D, and SJ&A expenses for the quarter SG&A expense for the quarter was $98 million on a non-gap basis, representing a $12.5 million percent decrease over the tri-year quarter.

Excluding R&D upfront and milestone expenses total Cogs ongoing R&D and adjusted expenses for the quarter was $671 million on the non-GAAP basis.

Ongoing R&D expense for the quarter was $251 million and the non-GAAP basis, representing a 3% increase from the prior year quarter.

Thanks, Jay expense for the quarter was $98 million from the non-GAAP basis, representing a 12.

Per cent decrease over the prior year quarter.

This was primarily due to the tightening of certain expenses.

Collaborations is 2% center of the U.S. net commercialization lost purposes.

Our financial position continues to be stock as we ended the quarter with $1.3 billion cash and marketable securities.

<unk> decreased $2.1 billion up 2019 yen influx upfront payment stock purchase related to the Morphoses collaboration partially offset by the cash flow generated during the quarter.

Moving on to our guidance for Twentytwenty, we I reiterate our revenue all R&D I'm assuming expense guidance for the year.

Jeff I in my closing comments in the first quarter was strong goldmine good situation presents at 70.

This will be leave it this quarter to retain the cone range of the previously communicated revenue guidance of 1.8, the eight to $1.9 billion to $5 billion for Jack API, and 100 $205 million for Iclusig.

Well R&D, we are reiterating our previous guidance, one point $21 billion to $1.8 billion I.

Christiana Stamoulis: This was primarily due to the timing of certain expenses. Collaboration 50% share of the U.S. net commercialization loss for Tazeen Ahmad. Our financial position continues to be strong as we ended the quarter with $1.3 billion in cash and marketable securities.

As a result of reallocation of bonds between programs in our portfolio. Neil We now expect this to call, but also our 55% share of that we'll see some apco development costs.

Christiana Stamoulis: The decrease from $2.1 billion at 2019 year-end reflects the upfront payment and stock purchase related to the Morphosis collaboration partially offset by the cash flow generated during the quarter. Moving on to our guidance for 2020, we are reiterating our revenue, FOGS, R&D, and SG&A expense guidance for the year. While Jessica Fye and Iclusive's performance in the first quarter was strong, the COVID-19 situation presents a third challenge.

Hi, This is guidance range excludes say $205 million upfront consideration recorded in Q1 related to our collaborations with workforce.

Finally, I think early stage will not be provided guidance. So they might do you say oral now collaborations net profit or loss, resulting from nickel my transition activity contacted them up in anyway.

But I thought that concludes our prepared remarks, please give your instructions and open the call what's your name.

Certainly will not be conducting your question answer session. If you like to be placed in the question can you. Please press star one of your telephone Keypad Hotel information told will indicate your line is in the question Q you May press Star Q, if he'd like to remove your question from the Q for participants using speaker equipment, it may be necessary to pick.

Christiana Stamoulis: Therefore, we believe it is prudent to retain the full range of the previously communicated revenue guidance of $1.88 to $1.95 billion for Jackass Eye and $100 to $105 million for Eyeclusive. For R&D, we are reiterating our previous guidance of 1.21 to 1.28 billion dollars. As a result of reallocating funds between programs in our portfolio, ILIO, we now expect this to cover also our 55% share of Tafasita Map Co-Development Corp. For clarity, this guidance range excludes the $805 million upfront consideration recorded in Q1 related to our collaboration with Morphosis. Finally, at this early stage, we will not be providing guidance on Temaseer sales or on our collaboration net profit or loss resulting from the commercialization activities of Tafasitamab in the US.

Comprehensive b.

More pressing star one.

One moment, please what we pulled.

For questions.

The interest how we ask you. Please ask one question one follow up and return to the Q.

Our first.

Yes, thanks for taking my questions and congratulations on the on the quarter.

And maybe this question for Stevens seems like we're gonna be getting nice amount data out of the lumber program over the next six nine months.

Maybe if you can set the stage there when we see pithree kinase data in the first how should we think that is setting the bar although their combos.

To warn that does advancement or do you think that combinations are likely be effective in a different patient populations and therefore, they tend to be evaluated all on their own.

Operator: Operator, that concludes our prepared remarks. Please give your instructions and open the call for Q&A. Certainly. 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 two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star one. One moment, please, while we pull for questions. And in the interest of time, we ask you please ask one question, one follow-up question, and return to the queue. Hi, thanks for taking my questions and, Um, this question for Steven just seems like we're going to be getting a decent amount of data out of the LIMBER program. Maybe if you could set the stage there. When we see PI3 kinase data in the first half, should we think of that as setting kind of the bar for all other combos? Warren Advancement, or do you think the combinations are likely to be effective in different patient populations? do it all on their own.

Yes, Hi, Mark it's Steven Thanks for the question. So obviously as as I alluded upfront I mean, this remains a critical importance to us and of major focus to us and thankfully. Despite in at a pandemic remains on track as well in terms of this year's execution there.

Three aspects beyond everything else.

The safety components of Elk, too and the bed program done and moved to the combinations of racks, plus Elk, two and Rux plus bet and then as you alluded to is start the pivotal phase three of rock stress Pithree kinase Delta. The there are slightly different with.

Don't have a biomarker selection per se, but they are different intense behind the program. So if you look at at out to the combination Hans in efficacy, which we expect but also also safety in terms of anemia, there and hopefully ameliorate the anemia through the hip sudden inhibition, which then would translate to being.

Able to maintain ruxolitinib and.

Dosing and hopefully also enhanced efficacy so it's a jewel.

Saying that aspect in terms of pet BRD inhibition, obviously, we've watched the concentration data evolve.

But in the first line and later settings and it's a maturity.

Unknown Speaker: Yeah, hi Mark. It's Steven.

So as possible in terms of plate patients treated but the idea is to is to do the same thing there in terms of our enhance the efficacy of ruxolitinib in those settings.

Steven H. Stein: Thanks for the question. So obviously, as Herve alluded up front, I mean, this remains of critical importance to us and of major focus for us. And thankfully, despite, you know, the pandemic remains on track as well. In terms of this year's execution, you know, there are three aspects beyond everything else Unknown Executive, Vikram Purohit, Srdan Verstovsek, Reni Benjamin, Matt Phipps, and they don't have, you know, a biomarker selection per se, but they're different intents behind the program. So if you look at ELK2, the combinant-enhancing efficacy, which we expect, but also safety in terms of anemia there, and hopefully ameliorate the anemia through the hepcidin inhibition, which then would translate to being able to maintain ruxolitin. [inaudible] in that aspect

Particularly in second line and potentially in first line as well and obviously, we'll just see where the data leads us in terms of getting a combination done as efficiently as possible.

For Delta, we'd be very carefully built that date dataset, we've done different experiments with scheduling and dosing.

We've now come down to the constant dosing being the way to go in terms of Delta in terms of the magnitude of the dose. We think we've we've the therapeutic ratio correctly in terms of getting the efficacy we need from delta inhibition, but not the enhance toxicity from it and Thats why we initiating the phase three studies.

The bars.

In a may well end up being somewhat different in first line adverse later lines I think you know as as we speak today. The first line bar in terms of screen volume response, which we set with Ruxolitinib years ago remains a 35% measured reduction plus associated symptom reduction in later line settings, we will.

Steven H. Stein: In terms of BERT, BRD inhibition, obviously, you know, we've watched the consolidation data evolve, but in the first line and later settings, and there's some mature......as much as possible in terms of patients treated, but the idea is to do the same thing there in terms of enhancing the efficacy of ruxolitinib in those settings. Particularly in the second line and potentially in the first line as well, and obviously, we'll just see where the data leads us in terms of getting that combination done as efficiently as possible. For Delta, you know, we've very carefully built that data set. We've done different experiments with scheduling and dosing. We've now come down to constant dosing being the way to go in terms of Delta.

C.

You know as we work with regulators weather.

Lower bar may be acceptable for example, something like a 20% screen lack symptoms and that remains to be worked out with regulators. So the programs. Our full steam ahead as much as possible given cobot 19, and we're confident that they are in a good place and then have slightly different intends to all three programs.

Okay.

I can follow up.

Isn't that.

You mentioned here one.

Steven H. Stein: In terms of the magnitude of the dose, we think we've woven the therapeutic ratio correctly in terms of getting the efficacy we need from Delta inhibition but not the enhanced toxicity from it. And that's why we initiated the phase three study. The bars, you know, may well end up being somewhat different in the first line versus later lines. I think, you know, as we speak today, the first line bar in terms of screen volume response, which we set with Ruxelet years ago, remains a 35% measured reduction plus associated symptom reduction. In later line settings, we'll see... As we work with regulators, whether, you know, a lower bar may be acceptable, for example, something like a 20% split on symptoms, and that remains to be worked out with regulators. So the programs are full steam ahead as much as possible given COVID-19. And we're confident that they are in a good place and then have slightly different intentions for all three programs.

Hey, things is that that inhibitor and getting it eventually into combination in the press.

Surely says you're preparing a phase two does that mean into the beginning of combination does.

So mark you know just to remind you we had numerous bet inhibitors in the clinic over the last few years in a we put ourselves on on a hold from on target thrombocytopenia, a little over a year ago, and then sort of resurrected that second there to inhibitor to go into the clinic now serves so what I'm, saying is we know there compound for.

Well.

Obviously now we dosing that day at a much smaller absolute dose in terms of about a 20% to 30% dose range versus what we were in the clinic before.

For an expected on target toxicity should obviously be much less we just need to prove that to ourselves.

Okay, hopefully relatively official.

So there will be the.

The Cohen and into fuel.

We'll be can remove into the combination part, but I think the semantics on that important what you call. It here because it's about just getting sufficient safety and then going to combination as efficiently.

Unknown Speaker: Okay, and if I can do a follow-up based on that. You mentioned, you know, one of the big things is the BET inhibitor and getting it eventually into a combination. Truly says you're preparing phase two. Does that mean phase two is the beginning of combination dosing?

Hi, guys mall from JP Morgan Your line is now like.

Hey, good morning, guys. Thank you for taking my questions.

Steven H. Stein: So, Marc, just to remind you, we've had numerous BET inhibitors in the clinic over the last few years, and we put ourselves on hold from on-target thrombocytopenia a little over a year ago, and then we sort of resurrected that second BET inhibitor to go into the clinic now. So what I'm saying is we know that compound pretty well. Obviously, now we dose in at a much smaller absolute dose in terms of about a 20 to 30 percent dose range versus what we were in the clinic before, and the expected on-target toxicity should obviously be much less.

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Steven H. Stein: We just need to prove that to ourselves, hopefully relatively efficient. So that'll be the opponent, if you will, will be when we move into the combination part. But I think the semantics aren't that important, what you call it here, because it's about just getting sufficient safety and then going to combination as efficiently.

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Steven H. Stein: Kazimoff from JP Morgan, your line is now live.

Drug drug interaction.

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Unknown Speaker: Hey, good morning guys. Thank you for taking the time to answer my questions.

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Unknown Speaker: I wanted to ask you about your work that you do.

Roger.

Unknown Speaker: I wanted to ask you about your work on artists and patients who are sick and are in the hospital with evidence. [inaudible] Treatment arm, in this case, RuxLipnum, as well as the standard of care arm, to be as dictated on the day. So it's open to whatever would have evolved and very much prepared for Remdesivir being the potential standard of care, which it looks like it is now. So there's no issue related to that.

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Steven H. Stein: What we will have to watch from a statistical point of view, obviously, is that the arms are full, you know, with appropriate numbers of both patients. But given where we conduct the studies in Europe with Novartis and here in the United States with us, and the sites that are involved, we expect that to be the case. And Remdesivir would be rapidly adopted as a standard of care and wouldn't be a problem. There's no interaction to worry about in terms of drug-drug interaction with that particular antiviral in RuxLipnum.

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Unknown Speaker: So we're ready to do that. And then for the market opportunity part, I'll hand it over to Evanne. Yes, thank you.

Good morning.

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Okay Bernard Berman.

We promoted fruit.

Herve Hoppenot: So first, I mean, obviously, we hope that... It would be a relatively short-lived phenomenon, so frankly, we don't see COVID-19 as a commercial opportunity of any magnitude for Roxality Need. We moved very fast. I mean, it was, there is a very strong proclinical rationale.

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Herve Hoppenot: There is a lot of work that was done already with Jack Inhibition in CRS from CAR-T treatment. So there was, and there is very good science. We had scientists both at Novartis and Incyte work together to put the program in place. And frankly, it was very interesting to see the speed at which we were able to work on this with Novartis, where we made the decision to go into the protocol on the phone with VAS within a few minutes. We had teams work over the weekend to get the protocol prepared so that it could be submitted. And the speed at which everything moved was really driven by the emergency of trying to find a solution for this pandemic and the COVID-19 situation around the world.

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Potentially can you give for next year.

You bet.

The pipeline outlook as well.

Second question you had this year can you give your.

Good ground work around the launch pad your question.

Herve Hoppenot: We think in time, and then we put in place an early access program in the US that is open already and will be providing the opportunity for all patients to receive Roxelitinib as part of this protocol free of charge. So that's where we are; the success studies are starting, and we will have the results. I assume it will be in Q3, and then we will work with the FDA to see what we do from there. But from our side, we don't see it as a meaningful market opportunity over time. I think it's really trying to deal with the situation that we are all facing. Alright, great, thanks so much for taking the questions. Thank you, our next question is coming from Salveen Richter from Goldman Sachs. Your line is now live.

Okay. Thanks.

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Unknown Speaker: Good morning; thanks for taking my questions.

Hmm.

Unknown Speaker: In the context of your launch outlook, you've got three this year and potentially three to four next year. And then, given the pipeline outlook as well, and then

Well, we're reserving for women.

Hi, Rob Roley group to review.

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Unknown Speaker: A second question here was, can you discuss how the

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Herve Hoppenot: Groundwork around the launch in cholangiocarcinoma set you up for bladder cancer. I'll let Barry speak about the capital allocation and the BD strategy. I think we are very much in a mode that has been demonstrated by what we have done over the past few months. I mean, we are trying to continue to build the portfolios that will... Low Power Revenue Line, Continue to grow the revenue line at a fast pace over the next 5-6 years so that we have a diversified portfolio in 2025, in that window of 2025 to 2030. I think the agreement with Morphosis is a good example of that.

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Herve Hoppenot: It's synergistic from the commercial standpoint. It deals with a customer base that we know very well in hematology. It's adding a new product to our hematology portfolio, and it has the great potential to contribute to our revenue growth. So we will continue to look for that type of opportunity. There is a dermatology field that is also now the second division that we have, that we are building, so it could be another place where, if there are good opportunities in that field where we could also invest, we have a strong cash position now. We also have a very strong cash flow, so that's really the driver for our capital allocation and BD strategy is to continue to grow revenue and diversify the portfolio with the target in the year of 2025

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Herve Hoppenot: This is where we want to see the impact of these new products and these investments. So, for the second part of your question, Salveen, so the Pemazeer launch is going very well, we're very proud as a company that we got approved on a Friday night by the FDA, and we had drug in our distribution center by Sunday, and we shipped out drug on Monday, so prescriptions are coming in for Pemazeer, and to date we have no indication that there's been any problem with market access or payers not paying for it,

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Hi, Thanks, very much for taking my question.

Just a question on the commercial side of the bird.

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Barry P. Flannelly: Thank you.

Barry P. Flannelly: Thank you, our next question is coming from Brian Abrams from RBC. Your line is now live. Hi, thanks very much for taking my questions.

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Barry P. Flannelly: I guess a question on the commercial side for Barry, just wondering if you're seeing any changes in prescription patterns for Jackify exiting first quarter, maybe early in second quarter as a result of COVID-19, things like accelerations of refills or fills, longer duration scripts, any impact on compliance in either direction. And I'm wondering also if you're starting to see any impact on GBHD as transplant practices. Thanks. Sure, Brian. So, the first part of your question is, have we seen any changes in the amount of drug that patients are getting? And the answer is, no. So, places like New York City, for example, might see a slowdown in new patient starts.

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Barry P. Flannelly: But, in fact, because we are an oral therapy that's well-known, that's been on the market for GVHD and, of course, for MS and PV for a long period of time, those refills and those patients are coming back, and that's why we're so confident in the guidance that we provided today. That's really helpful, thanks. Thanks. Our next question is coming from Tyler Van Buren of Piper Jaffray. Your line is now live. Hi, thanks. Good morning. I had another question on RUX for COVID-19. So, I guess... Unknown Speaker, who's the head of the ICU COVID-19 Task Force and, She was discussing the history of immunomodulators and Respiratory Distress Syndrome.

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Unknown Speaker: Unknown Executive, David Lundquist, Ren Benjamin, Matt Phipps, Mara Goldstein, Daniel Lundquist, I wanted to ask you guys why... The history is not relevant here and why COVID-19 is different. Hey Tyler, Steven, thanks for your question. And it's always good, you know, to have these learnings from prior studies to refer to. You know, I think the central difference here is that I'm going to be careful of just attaching semantic labels to things that then, you know, apply to other things.

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Steven H. Stein: If you look biologically and pathophysiologically at what's going on, based on the information we have out of China and now other places, you know, in these patients, there is an elevation, moderate elevations of cytokines that have been documented, like IL-6. There's evidence of acute phase reactants going up, like D-dimer, C-reactive protein, and ferritin as well. And then, you know, we have evidence that with drugs like ruxolitinib, you can use them appropriately to suppress those. And then, you know, the question is, will they translate to a clinical improvement in that setting? So just to be clear, it's not across the board for every single patient with this entity. RuxCOVID is for sick patients in hospitals who are pre-ventilation but have biochemical evidence of cytokine storm or cytokine elevation and acute phase reactants being positive, and then they are randomized to ask the question very clearly. And in this setting, induced by COVID-19, does ameliorating those cytokines result in clinical improvement? And is it different from ARDS due to other entities that in the past may have caused it? And that's why I think it's a key question to ask.

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Steven H. Stein: And then you've seen the IL-6 data evolve. I mean, now the question is beyond, you know, direct IL-6 inhibition; does a more broad inhibitor like a JAK inhibitor like ruxolitinib or baricitinib able to modulate these cytokine elevations and then have a clinical benefit beyond that will be answered in these randomized studies. So I think, you know, your word of caution is good, but this is a different entity, and we have to be careful of some of the semantics. That's helpful. Maybe just a brief follow-up as we think about Jack. Is there any reason to believe that track inhibition will be better?

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Unknown Speaker: This is Ash. I'll take that question. So, in principle, as Steven mentioned, with something like an IL-6 antibody, you're only really blocking the one cytokine that's believed to be involved in the disease process. With something like JAK inhibition, you're now targeting multiple cytokines, which we know all signal downstream through the JAK-STAT pathway. So, in principle, we would argue, and I think there's data out there to support this, that by going further downstream of targeting multiple cytokines, you should have a bigger effect than targeting a single protein that we know is involved in the process. Great, thanks for taking the course. The next question is coming from Vikram Purohit from Morgan Stanley. Your line is now live. Hi, good morning. Thanks for taking my question. So I had a couple on tefacetamab.

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Hi, Good morning, Thanks for taking my question. So I had a couple on toughest it about first I wanted to see if the M.B.A. submission is still on Friday mid 2020, you and secondly, I wanted to see if I'm, hoping 19 rebutted disruption is having many impact your filled out a beep.

Unknown Speaker: So first, I wanted to see if the MAA submission is still on track for mid 2020 in the EU. And secondly, I wanted to see if COVID-19-related disruption is having any impact on your build out of the human infrastructure you'll eventually need to be able to commercialize tefacetamab in Europe. And lastly, for the initial phase one data, I believe we're expecting in first line DLBCL by the end of the year. What can we expect to see there? And how should we frame our expectations for what the benchmark should be?

Infrastructure, you'll eventually needs to be able to commercialize deficit about.

In Europe, and lastly, 40 initial phase one do though I.

I believe we're expecting him first line be up you see all by the end of the year, what can be either and how should be from our expectations for what the benchmark should be there.

Steven H. Stein: So Vikram and Steven, I'll do your first and third questions, and then the commercial question someone else will take. So, just to cut to the chase, in terms of the MAA filing, yes, it's completely on track, and we have had no problems getting it together and getting ready to submit it appropriately. In terms of first-line diffuse large B-cell lymphoma, the Phase 1 study looks at the regimen of TAFLA-LEN plus the care standard, RCHOP, and its safety profile there versus TAFLA plus RCHOP alone without the LEN addition. That is ongoing, and we should have data by the end of the year to then enable a decision on which of those two regimens should potentially be used against RCHOP in a So that remains on track to be done, the safety component. Maybe I can speak about Europe, and maybe Barry can speak about the U.S., which is coming sooner. So in Europe, we are at the stage of submission, so we are sort of targeting... Thank you all for joining us today.

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Herve Hoppenot: We will be expanding the team next year, and as you know, we already have a team in haematology today. We will be expanding the team, and we hope, we expect that the expansion will take place after the confinement has been lifted in that case. If it's not the case, obviously, it will lead us in different directions. We got things in the U.S. on the prep for the U.S., maybe Barry can say a little bit.

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Barry P. Flannelly: Sure. So, obviously, you know, we're co-promoting with Morphosis. So Morphosis has their team fully in place already, sales, medical, market access, and so forth. We actually have our medical affairs and market access team in place, and we are actively bringing on our sales people. Virtually, we're fully prepared to do that as well. Thank you. Our next question is coming from Matt Phipps from William Blair. Your line is now live.

And goes and our current situation. It's it's a very good time actually for them to training to become experts excuse or be selling poma.

Through them out, but they're not already there continue to go on interaction with healthcare professionals goes on as we continue to prepare for this long, but it we don't think you'll interfere with it and even if we have to do a lot of the are [noise] launch.

That's what about virtually were fully prepared to do that as well.

Matt Phipps: Thanks for taking my questions. Two quick ones on the I-O program. Just the decision to not start the Phase 3 non-cellulose cellulose cancer trial, I think that's probably prudent, but how do you think you get a return on investment with your PD-1 antibody and then as a follow-up for the oral compound? Um, you know, when you see data later this year, is there potential to kind of quickly advance this to later stage trials if you hit kind of a pharmacodynamic and safety profile, or are Transcribed by https://otter.ai, Maybe I can take the first question on the antibody, on the BG1 antibody O12, and Steven can speak about the, you know, perspective on the project for 550 and the rest of the portfolio of oral products. I think if you remember the rationale at the beginning, that is still totally true, is that it is very useful in the portfolio to have...

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Herve Hoppenot: The PID-1 antibody that you can combine with other products that would be potentially used in the same patient population. The typical example would be FGFR in bladder cancer, but there are many other combinations that are being done, and I think that rationale is absolutely valid. On top of it, we have...

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Herve Hoppenot: This is a so-called niche indication program where there could be, in the relatively short term, potential for approval of the product. So this is ongoing and is doing well. And then we had this program in lung cancer, and where we have one of the two phase three studies in lung cancer, in first line non-small cell lung cancer, is ongoing. Because the design of the study was such that it would be problematic to gain FDA approval without doing a study that was extraordinarily large or very risky. So we are in a situation where we believe there is a clear rationale for having an antibody against type BD1 in our portfolio, where we have a short-term opportunity with some of the niche indications, and we have to take a little bit more time, but the potential to have that product approved for the first time treatment of non-small cell lung cancer, and that would give us an overall ROI that would be very satisfying on top of a strategic opportunity Thanks, Herve.

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Herve Hoppenot: In terms of the oral PD-L1 inhibitor, the number we call 550, it's been in the clinic for a little over a year now, and obviously started off with a first in human dose escalation to get to a recommended phase 2 dose that we know is in the pharmacologically active range in terms of PD-L1 inhibition and what we want to see in the tumor microenvironment as well. And then move on to treating tumors, which broadly speaking we call benchmarking, but looking at areas that are potentially io-naive settings like lung and melanoma, where we can treat those patients in that part of the world, and that's going on now to get that data to see the efficacy bars, the efficacy signals that we get from the drug in those various entities.

In terms of the P.D.L. one inhabited the number equals 550.

For a little over a year now obviously started off with a first in human dose escalation to get a recommended phase two dose that we know it's a into PHARMAQ logically active range in terms of P.D.L., one ambition and all we want to see in a tree Mcrae environment as well and then move on to treating two minutes, which.

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And feed those patients.

Part of the World and that's going on now to get that data to see you know advocacy boss at the advocacy signals to be get from the dragon those various entities and once we able to look at that this year in Trinity would then decide you know do we have proof of concept weird existing way to go and the way. We then approach it which is the meeting your question is what are they.

Herve Hoppenot: Once we're able to look at that this year, internally, we would then decide whether we have proof of concept where it exists and where to go. And the way we then approach it, which is the meat of your question, is what are the rapid registration approaches once we have internal proof of concept and where we want to go and chase those various entities, and then look more broadly given that it's an oral therapy and given that it lends itself to maintenance and adjuvant settings. Again, if we've achieved proof of concept of the efficacy we've seen, look at those bigger phase 3s and those sort of settings and then include potentially large tumor types as well. But the program continues to progress well. We're enrolling patients as we speak in the benchmarking setting to work as quickly as we can to prove the concept. And I think we've demonstrated that once we hit that, and once we're comfortable internally, we can move to later trials very quickly. Thank you. This question is coming from Tazeen Ahmad from Bangalore, America. Your line is now active.

Rapid registration approaches then you know once we have internal proof of concept and where we want to go in and chased those various entities and then look at you know more broadly given that it's an oral therapy given that it lends itself to maintenance and <unk> again, if we've achieved <unk> proof of concept of advocacy we've seen look at those big if.

Based region those sort of sit in and then include potentially large tumor talks as well, but the program continues to to progress well, we enrolling patients as we speak in the benchmark and sit in to work as quickly as we can chew proof of concept I think we demonstrated once once we hit that once we comfortable infinity we could.

Move to later crawls very quickly.

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Tazeen Ahmad: Good morning. I have a couple of questions. Going back to Jack and Fye's estimates for the year, on reiterating your guidance, I just wanted to get a little bit of color on your thoughts maybe about MIPS. Can you give us an idea of what percent of sales right now are coming from Medicaid? And what part of maintaining guidance assumes that that proportion stays the same? And a pipeline question, if I might also ask, what have you been able to learn from the launch of Salversa? And the reason for this question is more to get a sense of how you're thinking about MEPIC and indications in your OCOEO and if there's any learnings you've gotten from that. Thank you.

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Barry P. Flannelly: Uh, sure, Tazeen. So, as far as, uh, you know, our mix of patients, so, um, I guess in this situation, we're fortunate that, uh, most of our patients are, in fact, covered by other government programs, Medicare Part D, VA, DoD, Tricare, and so forth. Our commercial patient population is about 30-35% of what it makes up, and yes, Medicaid is really only about 4% of our payer mix right now. Could it go up? Sure, but again, if it's like 30%, or is it going to go up 10%? We really don't think it's a big factor at all.

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I guess in this situation, we're fortunate that most of our patients are in fact covered by other government programs Medicare part D.

Dealer D. Tri care and so forth.

Par commercial patient population that 30, 35% to make something just Medicaid, there's really only about 4% of our our our pay or mix right now could grow up sure, but again, if it's like 30% or is it going to go up 10% really don't think it's a big factor at all.

Barry P. Flannelly: And as we go forward with our forecasting for the rest of the year and the guidance that we've provided today, we'll have to see. Obviously, there's uncertainty there, but nevertheless, we think we're okay with reinforcing our current guidance. As far as what we've learned from Valversa, you know, I don't know what we've learned. We haven't heard a lot from Janssen, or at least, I haven't heard a lot from Janssen. They don't seem to be releasing their sales on Valversa themselves.

As we go forward with our our forecasting for the rest of urine guidance that we provided today, we'll have to see obviously, there's uncertainty there, but nevertheless, you know we think we're okay with a reinforcing your current.

Barry P. Flannelly: And, you know, perhaps the most important thing, perhaps, is that they're continuing to educate us on testing for FDFR alterations that could help us. Okay, our next question is coming from Jay Olson from Oppenheimer. Your line is now live.

As far as far as what we learn from L. versa.

I don't know what we learned we haven't heard a lot from a chance or at least I haven't heard a lot from jensen or they don't seem to be read releasing their sales on biber elberson themselves and you know the most important thing for house is that there can continue to educate I'm testing for after you if our alteration second helpless in future.

Jay Olson: Hi, thanks for taking the question. I'm curious about your work in dermatology. What are the gating factors to filing your topical RUCS NDA for atopic dermatitis? And then what are your plans to build your dermatology commercial infrastructure? And for vitiligo, how is that study enrolling, and how has it been impacted by COVID-19? Thank you. Okay, Steven. Again, I'll do your first and third question, and someone will take the middle one.

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What are your plans to build your dermatology commercial infrastructure and forbid a while ago, how it's not studying rolling and how's it been impacted by coded 19. Thank you.

Steven H. Stein: So in terms of enrollment, remember, the atopic dermatitis studies have completed enrollment, obviously, we've presented the data now, and we alluded to it in the prepared remarks, and we are moving full steam ahead to get that file in place. You know, we were slightly worried about the impact of COVID-19 on the ability to go to sites, monitor, and gather data, but we haven't had any problems to date, and that's why we sit on the prepared remarks and remain on track to make that submission by the end of this year. That remains the plan, and it's full steam ahead on that. It's why the end of the year is to wait for safety follow-up, so we need that adequate range of safety follow-up from the lost patient to make the complete submission and get it in by the end of the year.

Case, even.

Some third question answering I'll take the middle one Saint James remember the a topic dermatitis studies have completed enrollment obviously, we've presented the data now we alluded to it in in the prepared remarks.

Moving full steam ahead to should get that fall in place.

You know we were slightly worried about you know the impact of of covert 19 on your ability to go to <unk> and gather data.

I haven't had any problems due date and that's why we we sit on the prepared remarks remain on track do that submission by the end of this year.

The plan and it's full steam ahead on that it's why why the end of the year, it's to wait for the safety products, we need that adequate range of safety fought up from the Los patients to make the complete submission and get anybody into the.

Steven H. Stein: In terms of the vitiligo studies, you know, they were enrolled really well. There was a minor impact from COVID-19, but as Herve said in his remarks, which I think are really important to remind you, you know, different parts of the world have been affected at different times, and again, our studies remain on track there, and we remain on track to deliver those studies in 2021 as planned.

Locker studies, you know they they were in running really well there see <unk> monitor impact from covert 19, but.

These remarks, which I think are really important to remind you know different parts of the world has acted at different times and again Ah studies remain on track then we remain on track to deliver those studies in 2021 S. plan.

Herve Hoppenot: [inaudible]

Yeah.

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Herve Hoppenot: On the commercial plan, so what we have said, and it's still very true today, is in the U.S. We are in the process of building a team, so we already have an excellent clinical development team that is in place. We are looking at all the other components of what will be a commercial group that is of high quality and has a lot of experience in the field of market access, medical affairs, and commercial groups. So all of that is ongoing. You have the timeline; the submission is planned for the end of this year, so you can expect the end of next year as being the potential launch date, so we are on track to doing that. Outside of the U.S., frankly, we are looking at many different options, which could be going alone in Europe or having a partner, and both options are still open, and we have discussions ongoing. Identify what would be the best way to do it.

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Herve Hoppenot: I can tell you following the excellent data we had in Atopic Dermatitis... It certainly stimulated a lot of interest, and I would say for the rest of the world, we are more certain that we will need a partnership instead of building, and we are also looking at the right timing for putting these partnerships in place for Asia and some other regions of the world. So the plan is really being executed now, and it's in good shape. And for the U.S., as we said, the buildup of the commercial team is already starting with the first components, market access, and some marketing. I think our next question is coming from Michael Schmidt from Jugendheimer: why is it not live?

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Michael Smith.

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I think we're thinking my question, maybe just going back to you to bladder accounts or you know could you just reminds us up Ah, yes, a profile.

Michael Schmidt: Hey, thanks for taking my question. Maybe just going back to bladder cancer, could you just remind us of Palsier's profile there and how you think it might compare, not only to Balsier but also to other recently launched drugs such as CL Genetics Palser? And then the second question was about the U.S. launch.

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And then be the second question was going back up and see them out on the west launch now people, but.

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Unknown Speaker: We've already seen some early FDA action recently. And I was just wondering, you know, more curious about potential overlap here in terms of marketing with your current Jaffa target market and the utilization of that, of course, for a launch. So Michael, it's Steven. I'll take your first question and thank you for it.

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So Michael it's even I'll take your first question and thank you for it. So you know again in terms of bad a cancer and if you fall three being the drive there obviously, we have the the morning therapy data, both with intermittent Goshen IND continuous dust in you know coming in and looking at it'd be really spoke on the court a couple of weeks ago.

Steven H. Stein: So, you know, again, in terms of bladder cancer and FGFR3 being the driver there, obviously, we have the monotherapy data, both with intermittent dosing and continuous dosing, coming in and looking at it. We already spoke on the call a couple of weeks ago that there had been some COVID-19 impact on our ability to gather this data in-house and present it. So it's more likely in early 2021 that we'll have that.

That there had been some code 19 impact inability together that eight or in house and presented so it's more likely in early 2021, they will have that that.

Monetary data for you.

Steven H. Stein: We have an ongoing first-line study in combination with a PD-1 inhibitor, with Pembro, and obviously, you allude to how it fits in terms of the Seattle drug, and we'll have to see, again, this is a targeted agent for FGFR3, and there may be an evolving care standard, and we'll have to watch carefully, and we may have to, you know, change the first-line study as that market evolves, What's very important to us, though, is the tumor agnostic program, given its potential ability to impact multiple different cancers with multiple different histologies, is enrolling incredibly well, and we've seen little to no COVID-19 impact there.

The first line studying combination with with a P.D. money inhibit that with Edinburgh, and obviously you know you'll do to how does it fit in in terms of these Seattle rock well. After see again. This is a targeted agent or if trip all three and they may be able being cast and and we'll have to watch carefully we may have to change the.

Con study at that that <unk>.

Profile treating patients are bold, but we are on track in terms of getting that that the data early next year, it's very important to us.

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Rolling incredibly well and day, we've seen the little little to no coded 19 impact.

Able to ponder stations and get them onto that study and and that's going to be important <unk> soccer management or the drug and then for the next crucial handed over to Barry.

Steven H. Stein: We're able to find those patients and get them into that study, and that's going to be important to our overall life cycle management of the drug. Now, for the next question, I'll hand it over to Barry. Yeah, Michael, so your comment about the FDA and approvals, you know, we're prepared any time between now and the BDUFA date to launch tafacitimab, and actually, the nice thing about tafacitimab and diffuse large B-cell lymphoma overlaps completely with our current target population for myelofibrosis, polycythemia, and GVA. Great, thank you, and Thank you, our next question is coming from Mara Goldstein from Zulu. Your line is now.

Yeah, Michael So already written your comment about the F.D.A. and approvals you know we're prepared anytime between now and with a duplicate to launched a set amount and yes actually the nice thing about that to put them out and if you'd like to be someone poma overlap completely with our current pretty population.

For my brother was probably setting it around gvhd.

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Mara Goldstein: Great. Thanks for taking the time to answer the question. I appreciate it.

Appreciated just on a P.H.D. and Jack if I do you have a sense that had a duration of treatment has evolved at this point and then I just thought question I don't remember program and when you look at the totality of that program.

Barry P. Flannelly: Just on GDHD and Jakafi, do you have a sense of how the duration of treatment has evolved at this point? And then I just had a question on the Limber Program. And when you look at the totality of that program, do you see it enhancing the overall number of patients that can be brought into the MS population?

He.

The overall number of P. since they can be brought into the population.

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Mara Goldstein: So I'll take the first part and hand it over to Steven for the second part.

Barry P. Flannelly: So, duration of therapy, we don't always really have to go by it; it's a little bit harder to get the duration of therapy for GVHD than it is for MS and PV, for example, but we just go by the clinical trials, and approximately six months is what we believe the duration of therapy for acute steroid infractory GVHD should be. Yeah, and for your second question in terms of the limbo program and the potential ability to reach more patients with MF, I think the clean on says yes. So, let me give you an example.

I have to go buy it it's a little bit harder to get the Gration therapy for T.D.T.D. Then it is for M.S.N.T.V. for example, but so we just go by the clinical trials and approximately six months is what I believe for the duration of therapy for acute store in factory.

G.P.H.D. so.

[laughter] and and we have second question in terms of the number program and and the potential ability to reach more patience with M.F. I think the the the keen on says yes. So they didn't give you. An example, so if you look at <unk> to you know one of the main reasons patients to the small number patients discontinued therapy is Judy.

Development of an email that becomes unmanageable, if the l. to effect on Epstein inhibition works and managers that I didn't patients walked experience that we'll be able to stay on drug and and and get extra benefit from it. In addition would open up potentially patients <unk> enable too it'd be treated dealing with the combinations.

Steven H. Stein: So if you look at L2, one of the main reasons patients, the small number of patients that discontinue therapy is due to the development of anemia that becomes unmanageable. If the L2 effect on hepsidin inhibition works and manages that, then patients won't experience that, and will be able to stay on the drug and get extra benefit from it. In addition, it would potentially open up patients who can't go on drugs and are able to be treated then with the combination. So that's one good example. If you look at, you know, our formulation work, the XOR formulation, the once daily formulation, I mean, there's potentially convenience there in terms of once daily being better for patients, although that hasn't been an issue to date, but that's a potential upside. In addition, if, ultimately, that drug has a PK effect and has a less strong effect, then that's a potential upside.

That's one. Good example, if you look at you know formulation work or the x. or formulation. The once daily formulation I mean, there's potentially convenience there in terms of once daily being a beta for patients. So that it hasn't been an issue to date, but <unk>. In addition, ultimately that drug has a because of its P.K. effect.

Let's see Max as ends up having a a flash approved fall in terms of the induction of anemia I you know that's another issue wherever you name. It stations. They may be increased huge there and then launched I'll just add you know beyond the everything bit or it's with bad with Delta you know if you have to just <unk>.

Because the then you know treating physicians will overall I'd be more likely to usual product in that setting so.

Keen on so on yes, if we if we get everywhere, we want to get to think is pretty clear.

Steven H. Stein: I will forget, I think. Thank you; I appreciate it.

Thank you appreciate it.

Operator: Thank you. Now, our next question...

[noise] thank goodness questions.

Operator: Thank you. Our next question is coming from George Farmer from BMO Capital Markets. Your line is now live.

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Hi morning sensitive questions wondered about.

George Farmer: Hi, good morning. Thanks for taking my questions. I'm wondering, Herve, if you can comment a bit more on the PD-1 strategy. What are your commercial expectations in the front line on cancer? And can you elaborate at all on any more on any of the niche indications that you have, So yeah, as we said, the niche indications are relatively small in terms of the number of patients for each of them. There are potential ways to have the product approved, which could be very important for many other aspects of the program and the combination with some of our pipeline products. In the first line of non-small cell lung cancer, as you know, the approach we have is a me-too approach in the first line treatment of patients receiving chemotherapy in non-small cell lung cancer, so it would be chemo plus O12 versus chemo, and if this is successful and allows us to get FDA approval in that indication, it will give us, You know, a position where it will become an alternative to existing treatment in that setting, and frankly, it's such a large.., number of patients that we believe it can be productive from the revenue standpoint it is also an opportunity to develop our oral pd1 In the right setting, because as you can imagine, if you give chemotherapy to a patient, it's not the right place to use an oral PD-1 versus an IV PD-1, while after the chemotherapy is over, there are 18 months of treatment with single-agent injectable antibody that could be obviously better managed with an oral product. So there is a scenario where it will help us, Organize the treatment of patients with non-small cell lung cancer where you receive chemo plus an injectable PD-1 and then you can have the consolidation or the next months of treatment being done with an oral product.

More on the T. one strategy what are your commercial that sort of patients.

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Herve Hoppenot: So there are a number of ways where this can fit very well with our portfolio and where, by itself, it is not a small number of patients. In first-line lung cancer, there are a number of ways where we could gain market share, just by having the approval of the FDA. Thank you very much. I think the next question is coming from Ren Benjamin from JMP Securities. Your line is now live. Hello, Ren. Perhaps your phone is on mute.

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Operator: Please pick up your handset. If you can hear me, we cannot hear you. Hey, good morning. Thanks for taking the questions. And congratulations on the quarter.

Mmm.

Nothing you.

And you could morning, thanks for taking the questions and resolution quarter, maybe even you talk a little bit more about the data collection and validation from from them fight to a long it's not something that's particular.

Ren Benjamin: Maybe for Steven, can you talk a little bit more about the data collection and validation disruptions on site 201? Is that something that's particular to that study and shouldn't impact other studies? Or if it could impact other studies like a true V, what kind of measures do you have in place to prevent that from happening?

Study and shouldn't impact on and so he's or it's included.

Like good food the what kind of measures you haven't played to prevent that from happening.

Steven H. Stein: And as a follow-up, maybe for Barry, you know, I keep getting amazed by the growth in MF. Every time I think we're hitting a plateau, you continue to find more patients. I see that looks like about 8,000 patients for MF, 4,500 for PV, and 1,500 for GVHD, roughly. Can you just talk a little bit more about how much growth you've seen, Transcribed by https://otter.ai, Ren and Stephen. I'll start. So, you know, across the board, there has obviously been a COVID impact on the program, and particularly, obviously, in places like New York City, in terms of the ability to get studies done there and access sites to get data. And I think, you know, for 5201, the particular issue was to try to get it ready to present it at a meeting in the second half of this year in time, just to meet those meeting timelines. And we realized from a site access point of view, in terms of getting it in, we're just not going to be able to do that in a timely manner.

As a follow up maybe for Barry.

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I think we're hitting the plot so you need apply more patients I see but.

8000 patients Renault 4500 for T.V. and 1500 for G.P.H.D. roughly can you just talk a little bit more about how much <unk>.

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Across the board there has obviously been <unk> impact on the program in particularly always seen pictures like New York City in terms of the ability to get studies done they had access thoughts to get data and I think you know for flock to wind up particularly issue was to try get ready to present it in a meeting in the second off of this year in time.

Just to meet there's meeting time lines and we ran out from a sock access point of view in terms of getting it then we would just not going to be able to do that in a timely manner. So that's the issue peculiar to that related to the particularly meeting and nothing more than that.

Barry P. Flannelly: So that's the issue peculiar to that related to the particular meeting and nothing more than that. So Ren, yeah, so MF continues to be the backbone even though PV continues to grow faster, quarter over quarter in terms of new patients or total patients, but MF certainly hangs in there. 8,000 patients might be right, you know, we think the prevalent population is still 15,000. Obviously, we have about 3,500 to 4,500 new MF patients a year, but I think mostly it's because we're starting new patients earlier. Physicians are recognizing that when they start earlier, that's when their survival benefit really comes through, and obviously, the duration of therapy. We have many patients that have been on therapy for eight years or more, in fact, so it's really starting patients earlier, getting all the new patients that are newly diagnosed, and the duration of therapy.

<unk>. So <unk> yeah. So M.F. continues to be a the backbone, even though P.B. continue to grow faster where over quarter in terms of a new patients were total patients but.

Certainly hangs in there.

8000 patients might be right. You know we think the Kremlin population is go 15000, obviously have about 3500 4500, new M.F. patients a year, but I think mostly it's because we're starting new patients earlier divisions, recognizing that when they start earlier.

There's the Bible benefit really come through and obviously the duration of therapy, we have many patients would've been on therapy for eight years or more in fact.

So it's really starting patients earlier.

New patients that are a newly diagnosed and the duration of therapy.

Ren Benjamin: Thanks for taking the question. Okay, our next question today is coming from Christopher Mariah from El Morya. Your line is now live. Hey, good morning.

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Reni John Benjamin: Just a follow-up on some of your GVHD cases for Jackify. I was wondering if you could collaborate on the number of patients treated, whether that's just the acute setting or the acute and the chronic setting. How do you look at growth?

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Barry P. Flannelly: So the number of patients in GBHD, so if it is approximately 1,000 patients maybe so far that are on it, obviously, there's spontaneous use of Jackify in chronic GBHD. So it's some of those patients that are included there. We think the chronic indication that's coming, if we get data at the end of this year, so far, there hasn't been necessarily pivotal data or compelling data that we would think would interfere with the current use of Jackify in steroid refractory or then chronic GBHD. Okay, and then just thinking about your PD-1 antibody and some of those combinations that you alluded to, when might we start to see some of the first combination data, and perhaps, you know what combination data you'd be looking at.

Oh Gee.

So so the number of patients contributes d. So you know if it is approximately a thousand patients maybe so far that are on it obvious leaders spontaneous use.

<unk> objectify in chronic D.P.H.D. So it's some of those patients included there are we think the chronicle indication, it's coming if we get at the end of this year.

Towards the end to this year for reached three it's very important for the continued growth I patient population, but <unk> as we said at the beginning in prepared statements that it's fast becoming the standard of care and it keeps directory G.P.H.D. some of the other studies or some of the other drugs are being developed.

And G.P.H.D. list or chronic gvhd, so far you know there hasn't been.

Steven H. Stein: Contrary to, I guess, combinations with your current internal pipeline, general, as well, one that would be of particular importance to us is the FGFR combination. Those are enrolling now, and I expect we'll present data in the next year, so more likely in 21, you'll be seeing that data in a meeting, but we'll be doing enabling safety work with all of them as we speak over this calendar year. All right, thank you. Thank you. We have reached the end of our question and answer session. I would like to turn the floor back over to Mike for any further closing comments. So, thank you all for your time today and for your questions. Of course, 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. But for now, though, we thank you again for your participation in the call. Stay safe and have a good day. Thank you. That does conclude today's teleconference webinar. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation today.

Fairly put a little bit are compelling data that would what do we think we would interfere with the the current used to justify.

Refractory word than chronic gvhd.

Okay.

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As well, but in addition, and thanks for bringing it up you know they're multiple studies on during looking at at combinations preparing for the future you will on how to use the P.D. ones are both with external compounds like but they Jeff inhibited, but internally as well one that would be particularly important to us.

If all combination those join Rolling now you know and I expect will present data in the <unk> you know the next year more locked in in 21, you'll be seen that data in a meeting, but we'll get any navy and safety work with with one of them as we speak over this calendar year.

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Thanks.

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I think you'll feel time today and fuel questions. So of course, the I'll team will get available throughout the day for any follow up questions. You may have when we look forward to talking to you I didn't Miss the conference is in coming weeks, but for now though.

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Speaking today.

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