Q3 2019 Earnings Call

Greetings and welcome to inside Corp's third quarter 2019 financial results Conference call.

Operator: Thanks, and welcome to Incyte Corp's third quarter 2019 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. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mike Booth, Head of Investor Relations. Please go ahead.

At this time, all participants are not listen only mode.

So the answer session will follow the formal presentation.

If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.

As a reminder, this conference is being recorded.

I'd now like to turn the conference over to your host Mike Booth head of Investor Relations. Please go ahead.

Mike Booth: Thank you, Brock. Good morning, and welcome to Incyte's third quarter 2019 earnings conference call and webcast. The slides used today are available for download in the investor section of Incyte.com. I am joined on the call today by Herve, Barry, Steven, and Christiana, who will deliver our 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 Before we begin, however, 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 2019 guidance, the commercialization of our products, and our development plans for the compounds in our pipeline, as well as the development plans of our collaboration partners. These forward-looking statements are subject to a number of risks and uncertainties that may cause our actual results to differ materially, including those described in our 10-Q We'll now begin the call with Herve.

Thank you broke good morning, and welcome to insights third quarter 2019 earnings conference call and West Coast.

Slides used today are available for download on the Investor section of insight Dot com.

I'm joined on the call today by a they battery Steven Christiana will deliver our prepared remarks and by Dashel join us for the Q any section.

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

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

Any statements, including statements regarding our expectations for 2019 guide.

The commercialization of our product.

I'm trying to the compounds in our pipeline as well as a dependent on plans about collaboration partners.

These forward looking statements are subject to a number of risks and uncertainties that may cause our actual results to differ materially including those described in our 10-Q for the quarter ended June Thirtyth 2019, and from time to time in our other she documents well now begin the call with others.

Mike Booth: Thank you, Mike, and good morning, everyone. Incyte continues to do well across all aspects of the business. We have delivered multiple positive updates from our late-stage portfolio in recent weeks, and our product and royalty revenues continue to grow at a remarkable rate for a company of our size. Product and royalty revenues in the third quarter grew by 24% over the same period last year, totaling over $530 million and including $433 million in JAKA 5 sales, which increased 25% in Q3. Sales of iClosing in Europe, as well as royalties from JAKA V and Allumiant, also increased year over year.

Thank you my jumped a good morning, everyone.

In fact continues to execute went across all aspects of the business. We have developed multipurpose give updates from my well it stage booked for you in recent weeks I know what product.

Revenues continued to grow.

Hi, good better rates for a company about west side.

Well, that's kind of what are your revenues, Kansas City water grew at 24% of of the simple you have left yeah. So starting over 540 million and including 443 million in check a fight sales, which increased 25% in Q3.

Sales of Iclusig in Europe , as whereas royalties from <unk> and the room young also increased year over year.

Herve: At the beginning of 2019, we set out an ambitious list of R&D goals for the year, and I am pleased to report today that we have already achieved the majority of them. The NDA for pemigatinib seeking approval as a treatment for patients with FGFR2-driven cholangiocarcinoma has been submitted to the FDA, and the positive updated data that supported the submission were presented in September at S&P. We recently reported that REACH-2, the Phase 3 trial evaluating roxolitinib in steroid-refractory acute GVHD, met its primary endpoint of superiority over best available therapies. This data further reinforces the efficacy of JAKAFI as a standard of care treatment option for this patient, following FDA approval in this indication in May. We were also pleased to provide 52-week follow-up data from our randomized phase 2 trial of roxfalutinib cream in vitiligo at EADV. This data shows that patients treated with a higher concentration of ROCKSCREAM experience continued improvement in their disease with additional time on therapy, and we have already launched a global phase 3 program for ROCKSCREAM in vitiligo with results due in 2021. We still have some key items we expect.

At the beginning of 2019, we set out an ambitious system R&D go to probably get on I'm pleased to report today that we have already achieved the majority of them.

And then you get the any seeking approval as a treatment for patients with MTF up to driven <unk> has been submitted to the FDA.

The positive updated data that's your body the submission and represented in September at ESMO.

We are we talking to everybody that reach to the phase three trial evaluating ruxolitinib in steroid refractory acute gvhd.

Met its primary endpoint the superiority over best available therapy.

These days, though further reinforced the if you could see objectify as the thought of gift treatment option for these patients following idea providing this indication in may.

We were pleased to provide 52 weeks, what I'd say, though [laughter] from my were randomized phase two probably I don't know Brooks <unk> cream in Richard I go at you TV.

These data showed that patients treated with higher concentration or Brooks screen expands continues improvement is that disease with additional time on therapy.

We have already launched a global phase three program for work screaming Richard I go with results due in 2021.

We did have some key items, we expect to that even before the end of the jail with pharma. So from now I don't have that sort of up to Barry for an update on.

Barry: For now, I'll turn the call over to Barry for an update on Jessica Fye.

Barry: Thank you, everybody, and good morning, everyone. Net product revenues for Jackify were very strong in the quarter, totaling $433 million. This was an increase of 25% when compared to the same period last year. Growth was primarily driven by patient demand, which grew 18% year over year, and there were no appreciable effects of inventory in the quarter. Because of the strong demand for Jackify today, we are very pleased to be increasing both the bottom and top end of full year 2019 guidance for net sales of Jackify to a new range of $1.65 to $1.68 billion.

Thank you everybody and good morning, everyone.

Net product revenues for Jack if I were very strong in the quarter totaling $433 million [noise].

This is an increase of 25% when compared to the same period last year.

Growth was primarily driven by patient demand, which grew 18% year over year and there were no appreciable effect that inventory in the quarter.

Because of the strong demand for Jacobite today, we're very pleased to be increasing both the bottom end top and a full year 2019 guidance for net sales objectify to a new range of $1.65 billion to $1.68 billion.

Barry: We are seeing good demand for Jessica Fye in all three approved indications. Additionally, more than 50% of eligible myelofibrosis patients in the U.S. are currently on Jackify. And total patients on therapy increased approximately 5% year-over-year. We continue to be encouraged by the growth we see in this indication, especially in its eighth year since approval. Patient growth in polycythemia vera continues to be higher than in myelofibrosis, and within the eligible population, Jackify has reached more than 20% penetration.

We're seeing good demand for jacobine, all three approved indications.

More than 50% the eligible myelofibrosis patients in the U.S. are currently on Jack a five.

In total patients on therapy increased approximately 5% year over year.

We continued to be we continue to be encouraged by the growth we see in this indication, especially in its eighth year since approval.

Patient growth in probably probably excited me there continues to be higher than myelofibrosis and within the eligible population Jacobite has reached more than 20% penetration.

Steven: We saw an opportunity to increase disease awareness in both the PV patient and physician community. And in an effort to augment the patient voice, we recently launched a pilot television and social media disease awareness campaign. This pilot was conducted in several key target markets where it was very well received, and we have now expanded the education campaign nationwide. This is the first full quarter of sales since approval for steroid refractory acute GVHD, and while early, the launch is currently outpacing our internal expectations. Importantly, we are seeing comprehensive access in both the inpatient and outpatient treatment settings, and we continue to see strong uptake and broad utilization across bone marrow transplant centers. I'll now turn the call over to Steven for the clinical update.

We saw an opportunity to increase disease awareness in both PD patient and physician community and an effort to augment the patient voice. We recently recently launched a pilot television and social media disease awareness campaign.

This pilot was conducted in several key target markets, where it has been very well received and we have now expanded the education campaign nationwide.

This is the first full quarter sales since approval in steroid refractory acute gvhd and while early launch is currently outpacing pacing our internal expectations. Importantly, we are seeing comprehensive access in both the inpatient and outpatient treatment settings.

We continue to see strong uptake take and broad utilization across bone marrow transplant centers.

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

Steven: Thanks, Barry, and good morning, everyone. Continuing with graft-versus-host disease, we were pleased to report the positive outcome for REACH-2, the randomized trial of ruxolitinib-versus-best-available-therapy in steroid-refractory acute graft-versus-host disease. We plan to share these data with the FDA for inclusion in the Jackify label, and we look forward to sharing the detailed data REACH-3, the randomized trial evaluating ruxolitinib in patients with steroid-refractory chronic graft-versus-host disease, is ongoing and has almost completed recruitment. A recent interim efficacy and safety analysis conducted by an independent data monitoring committee recommended that REACH-3 should continue without modification, with results expected in 2020. Moving on to Pammy Gatnip for Calangio Caustic.

Thanks, Barry and good morning, everyone.

Continuing with graft versus host disease. We were pleased to report the positive outcome for reach to the randomized trial of Ruxolitinib. This is best available therapy, and steroid refractory acute graft versus host disease.

We plan to share the data with the FDA for inclusion in the Jackup our label and we look forward to sharing the detailed data with you at an upcoming scientific meeting.

Reached three the randomized trial evaluating ruxolitinib in patients with steroid refractory chronic graft versus host disease is ongoing and there's almost completed recruitment.

A recent interim efficacy and safety analysis conducted by an independent data monitoring committee recommended that reached three should continue without modification with results expected in 2020 .

Moving onto Penny GAAP net for Cholangio carcinoma.

Steven: Slide 11 shows the data that were presented at ESMO and which formed the basis of our recent new drug application. As you can see, in cohort A, the overall response rate was 36%. Median progression-free survival was 6.9 months, and median overall survival was 21.1 months. Importantly, the vast majority of patients experienced some degree of tumor size reduction, as evidenced by the 82% disease control rate and as illustrated in the Waterfall plot on slide 11. We believe that Pemigatnib offers a meaningful improvement over the current standard of care in the second line, which typically results in single-digit response rates, median progression-free survival of three months, and an overall survival of approximately six months. The most common adverse event of all grades was hyperphosphatemia, which is an on-target effect of FGFR inhibition that can be managed with a low phosphate diet, phosphate binders, and di Hypophosphatemia occurred in 23% of patients, which was likely due to the treatment for hyperphosphatemia. Serous retinal detachment was seen in 4% of patients, which was mostly grade 1 or 2. If you recall, the only potential curative therapy for cholangiocarcinoma is surgery, but approximately 70% of patients are diagnosed with unresectable disease.

Slide 11 shows the data that were presented at ESMO, and which formed the basis of our recent new drug application.

As you can see in coordinate the overall response rate was 36%.

Median progression free survival was 6.9 months and median overall survival was 21.1 month.

Importantly, the vast majority of patients have some degree of tumor size reduction as evidenced by the 82% disease control rate and as illustrated in the waterfall plot on slide 11.

We believe that Penny Gartner offers a meaningful improvement over the current standard of care in the second line.

Which typically results in single digit response rates median progression free survival of three months have an overall survival of approximately six months.

The most common adverse event of all grades was high cost for team in which is an on target effect of FGF. Our inhibition that can be managed with the low phosphate duck phosphate binders and die ratings.

Hi code pasta team occurred in 23% of patients, which was likely due to the treatment for hyperphosphatemia.

Cerus retinal detachment proceeding focus into patients, which is mostly grade one or two.

If you recall, the only potential curative therapy for cut Andrew Carcinomas surgery.

Proximately, 70% of patients diagnosed with unresectable disease, so the need for new therapeutic options for these patients is clear.

Steven: So the need for new therapeutic options for these patients is clear. My third slide summarizes updated data from a randomized phase 2 trial of ruxolitinib cream in vitiligo, which were presented a few weeks ago at EADV. These data showed continued improvement in repigmentation with additional time on therapy as objectively measured by Vaseline. For example, in patients dosed with 1.5% BID and followed for 52 weeks, the facial VASI 75 was achieved in 52% of patients, up from 30% of patients at 24 weeks, and the facial VASI 90 was achieved in 33% of patients, up from 12% at 24 weeks. The global phase 3 program of Raxolid Lip Cream in patients with vitiligo is already enrolling, with the facial VASI 75 at 24 weeks being the primary endpoint, and we expect the results to be available in 2021. With that, I'd like to turn the call over to Christiana for a financial update.

My third slide summarizes updated data from the randomized phase two trial Ruxolitinib cream in July .

Presented a few weeks ago at EEI TV.

These data showed continued improvement in re pigmentation with additional time on therapy as objectively measured by vasey scores.

Don't pull in patients dosed with 1.5%.

Okay and funded for 52 weeks the facial that 75 was achieved in 52% of patients.

30% of patients at 20 weeks 24 weeks sorry.

In the face of assay 90 was achieved in 33% to patients up from 12% at 24 weeks.

The global Phase three program of Ruxolitinib cream in patients with Vitol Iga is already in rolling with the Facebook 75 at 24 weeks being the primary endpoint and we expect the result to be available in 2021.

With that I'll like to turn the call over to Christiane for financial update.

Christiana: Thanks Steven and good morning everyone. 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 19 and 20 in the backup section of the deck and to the press release we issued this morning. Our third quarter results reflect continued strong growth, with total product and royalty revenues of $534 million, representing an increase of 24% over the third quarter of 2018. This is comprised of $433 million in Jackafi and $21 million in Acluthiq Net Product Revenues, $58 million in Jacavi royalties from Novartis, and $22 million in Olumion royalties from Lily. We also recognize $18 million in contract revenues under our collaboration agreement with i. The lab, resulting in total revenues for the quarter of $562 million.

Thanks, Steven and good morning, everyone. 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 19 and 20 in the backup takes another deck and to the press release, we should this morning.

Our third quarter results reflect continued strong growth with total product and royalty revenues of $534 million, representing an increase of 24% over to third quarter of 2018.

This is comprised of $433 million in Jackup high and $21 million connecting sick net product revenues $58 million and jakavi royalties from Novartis and $22 million lumen royalties from lately.

We also recognize $18 million in contract revenues under our collaboration agreement with that lab, resulting in total revenues for the quarter of $552 million.

Our total costs and expenses for the quarter on a non-GAAP basis of $365 million decreased by 1% from the prior year quarter.

Christiana: Our total costs and expenses for the quarter, on a non-gap basis of $365 million, decreased by 1% from the prior year quarter. Ongoing R&D expenses for the quarter were $251 million on a non-cap basis, unchanged from the prior year period, reflecting our decision to reallocate capital from the co-funding of Paracitinib and the development of Epocatastat to our other late-stage development programs. SG&A expenses for the quarter were $90 million on a non-gap basis, representing a 6% increase over the prior year quarter Moving to our guidance for 2019, given the strong performance of Jackify in the first nine months of the year, we are increasing Jackify's full-year guidance to a range of $1.65 to $1.68 billion. Our guidance for both R&D and SG&A remains the same as we continue to invest in our commercial operations and our clinical development portfolio, and we expect certain of these expenses to be more backend loaded into Q4 2019. I will now turn the call back to Herve.

Ongoing R&D expenses for the quarter was $251 million on the non-GAAP basis.

Changed from the prior year period, reflecting our decision to reallocate capital from nickel funding capacity named as the development. Okay. Okay. At this back to our either late stage development program.

Aegean a expenses for the quarter was $19 million on the non-GAAP basis, representing a 6% decrease over the prior year quarter.

Moving to our guidance for 2019, given the strong performance of Jackup. The first nine months of the year, we are increasing jackup full year guidance to a range of one point 65 to one point $68 billion.

Our guidance for both R&D NSG may remains the same as we continue to invest in our commercial operations and our clinical development portfolio and we expect second of these expenses to be more backend loaded into Q4 2019, I will now turn to cardiovascular. Thanks.

Thank you Christina So I'll go next slide reminds you of I welcome.

With two debt in 2019 as well as all remaining gene use really events, we expect during the year.

These expectations includes the India submission by Novartis commitment to me, but in patients with met exon skipping mutations in non small cell lung cancer.

Yes, Matt today, because I know development company did discover insight laboratories.

And has the potential to be an important product in lung cancer.

It was recently positioned in the Novartis up quite on my tenure as a key a provider for them in 2020.

And for insight definite today also has the potential to be a meaningful contributor to our top line with over 500 million inputs on milestone on 12 to 14 Bucks on royalties on global net sales.

Herve: Thank you, Christiana. So our last slide reminds you of our progress to date in 2019 as well as the remaining key news flow events we expect during the year. These expectations include the NDEA submission by Novartis for CAP-Metfinib in patients with MET-Xon14-skipping mutations in non-small cell lung cancer. Capmatinib is another development candidate discovered in Incyte laboratories and has the potential to be an important product in lung cancer. It was recently positioned in Novartis' third quarter material as a key approval for them in 2020. For insight, Cap Matinib also has the potential to be a meaningful contributor to our top line with over $500 million in potential milestones and 12 to 14% royalties on global net sales. We are also looking forward to having the result of the Gravitas 301 trial of Itacitinib in first-line acute GVHD in-house at the end of the year.

We also looking forward to having the result of the gravity Thats real one trial of it does it.

In first line acute gvhd in house at the end of CEO .

It does it it has the potential to be another key contributor to near term revenue grows.

With this strong execution across our late stage development program, we are making significant progress toward our strategy goals of adding diversification to the topline and further accelerating revenue growth.

That concludes our prepared remarks on we are now happy to take your questions.

Operator, please give you instructions and open the call for Q any.

Thank you.

At this time will be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone indicate your line is in the question Q.

You May press star to be we'd like to remove your question from the Q.

For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Herve: Itacitinib has the potential to be another key contributor to near-term revenue growth. With this strong execution across our late-stage development programs, we are making significant progress toward our strategic goals of adding diversification to the top line and further accelerating revenue growth. And that concludes our prepared remarks, and we are now happy to take your questions. Operator, please give your instructions and open the call for Q&A.

One moment, please while we pull for questions.

The first question today comes from Salveen Richter of Goldman Sachs. Please go ahead.

Thanks for taking my questions. So with regard to the early uptake and feedback for Jack a bunch of HD, where does that suggest for the trajectory here and have there been any gating factors and then a follow up for today given the progress of your pipelines in both oncology and Hi, how are you thinking about business development.

Operator: Thank you. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the list. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button. One moment, please, while we poll for questions. The first question today comes from Salveen Richter of Goldman Sachs. Please go ahead. Thanks for taking my questions. So, with regard to

Opportunities.

Sure Salveen, so gvhd as I said the uptake has been.

Very good.

Since the beginning we think the opportunity for it if it is ultimately.

Where the opportunities lies.

Jack defies, giving patients benefit right now we believe we'll get benefit in.

Acute gvhd as we are now and then in the future for chronic gvhd and we await the results of Gravitas rail one.

It is sitting there have been a potential worldwide for that drug.

So if I didnt.

Good progress those early stage, but for the obviously it.

I mean, you know our strategic goal of diversification among growth I mean, thats really what we are.

Aiming at obviously a lot of it is now starting to take place. We spent me get in Asia.

Salveen Richter: Given the early uptake and feedback for JAKA-FYE and GVHD, what does that suggest for the trajectory?

Weve spoken attribute to both Capmatinib, which is not going away is the most.

Barry: Gating, Pat

Herve: And then, you know, a follow-up question for Herve: given the progress of your pipelines in both oncology and IAI, how are you thinking about business development opportunities?

No one of our pipeline products at Novartis has been license to Novartis. So we have we are a good track to.

To succeed on getting these products to market over the next few years at the same time.

Barry: Sure, Salveen. So GVHD, as I said, the uptake has been very good since the beginning. We think the opportunity for itifitnib is ultimately where the opportunity lies because Jackify is giving patients benefit right now. We believe it will give benefit in acute GVHD as we are now and then in the future for chronic GVHD. And we await the results of Gravitas 301 for itifitnib and the potential worldwide for that drug.

We obviously looking at BD opportunities that would fit with our portfolio. We are mostly looking at oncology methodology type of vice type of assets.

The.

Got it is process, where we are reviewing opportunities and.

We should we are expecting we hope to be able to get to gain some additional.

Alex to fuel the growth of the topline.

The next few years.

Thank you.

The next question is from Mark from of Cowen and company. Please go ahead.

Herve: So Salveen, on the progress of the Late Stage Portfolio, obviously, I mean, you know our strategic goal of diversification and growth, I mean that's really what we are aiming for, and obviously, a lot of it is now starting to take place with Pemigatinib. We spoke a little bit about Capmatinib, which is not always the most known of our pipeline products that Novartis has been licensed to Novartis At the same time, we are obviously looking at BD opportunities that would fit with our portfolio. We are mostly looking at oncology and hematology assets, and it's a continuous process where we are reviewing opportunities, and we expect, and we hope to be able to gain some additional products to fuel the growth of the top line in the next few years.

Thanks for taking my questions.

James for Berry in the prepared remarks, you mentioned that the awareness campaign PV is you are having some success.

Maybe to find that a little bit better.

Are you already seeing it uptake in sales within those regions or is it more qualitative measures.

And then what type of budget are we talking about now that you're expanding it nationally and trying to broaden that success.

Well.

The way we measure uptake it's very early as we said we did in five key markets across the country first and what we saw there was really the uptake and higher.

Social media sites.

For example, take action PV is what we direct patients to go to or healthcare professionals to go to to get more information Theres education materials, there materials. They can download to track their symptoms and we saw spikes in those first five key.

Operator: Thank you.

Marc Frahm: The next question is from Marc Frahm of Cohen & Company. Please go ahead.

Barry: Thanks for taking my questions. This is for Barry.

Barry: In your prepared remarks, you mentioned that the Awareness Campaign, PV, is having some success. Can you maybe define that a little bit better? Are you already seeing an uptick in sales within those regions, or are qualitative measures? And then what type of budget are we talking about now that you're expanding it nationally and trying to broaden that success?

Regions now as we expanded.

Destination, which only started October onest. So we don't really have all that much.

Data, yet, but it certainly has grown dramatically on those sites that were sending.

Patients to and the the budget.

Barry: Well, the way we measure uptake is very early. As we said, we did it in five key markets across the country first. And what we saw there was really the uptake on our social media sites. For example, Take Action PV is what we direct patients to go to or healthcare professionals to go to to get more information. There's education materials there, materials they can download to track their symptoms. And we saw spikes in those first five key regions.

Nationwide is relatively.

Small this is a 32nd commercial.

We're placing it.

Time curious that we think.

Patients will see it but at the same time don't cost of fortune. So it's not.

Going to the superbowl, but it is in fact, we think being very effective as an educational tool for patients and healthcare professionals.

Okay, Great and then maybe short follow up on kind of market dynamics for Jack say, maybe some comments on what the initial impacts of fed Radnets launch, which you may or may not have senior.

Barry: Now as we expand across the nation, which only started on October 1, we don't really have all that much data yet, but it certainly has grown dramatically on those sites that we're sending patients to. And the budget, you know, nationwide is relatively small. And we call this a 30 second commercial. You know, we're placing it at time periods that we think patients will see it, but at the same time, it doesn't cost a fortune. So it's not, it's not going to the Super Bowl, but it is, in fact, we think it is very effective as an educational tool for patients and healthcare professionals.

Yes, I think it's early we haven't really seen much of the impact yet we know that.

Celgene is really positioning it as a second line agent just by there.

Their pricing strategy that they came out with and then.

Barry, particularly their marketing materials that we have seen our positioning as the second line drug.

Maybe you also are aware that the only two.

Clinical trials that they have ongoing now.

As a single arm trial and a.

Phase three trial compared to best available therapy are both after Jack So clearly the ambition conditioning positioning it for a second line drug and we havent seen the impact yet on.

Barry: Okay, great. And then maybe a short follow-up on kind of the market dynamics for Jack Fye, maybe some comments on the initial impacts of FedRatnib's launch that you may or may not have seen yet.

Jack a fi and we're fully.

Confidence because we have long term follow up data eight years of data.

More than 50000 patients treated in the United States, where the drugs for the safety profile is there and of course in overall survival advantage that.

Barry: You know, I think it's early. We haven't really seen much of an impact yet.

Barry: We know that, um... Cellgene is really positioning it as a second-line agent just by their pricing strategy that they came out with, and then, very particularly, their marketing materials that we have seen position it as a second-line drug. Maybe you are also aware that the only two clinical trials that they have ongoing now, a single-arm trial and a Phase III trial compared to best-available therapy, are both after Jackify. So clearly, they're positioning it as a second-line drug, and we haven't seen the impact yet on Jackify, and we're fully... I'm confident because we have long-term follow-up data, 8 years of data, more than 50,000 patients treated in the United States with a drug, so the safety profile is there, and of course, an overall survival advantage that I don't think that Fidratinib will ever be able to achieve, particularly with the Ricardo study, because it was never followed up on.

That I don't think that congrats and it will ever be able to achieve particularly weather Jakarta study because it was never followed up on.

Okay, great. Thank you.

The next question is from Tyler Van Buren of Piper Jaffray. Please go ahead.

Hey, guys. Good morning groups to solid results on the quarter just had a couple of follow up questions to Mark line of questioning.

As you look at Jack apply in MF and PV can you give us an update on.

Duration of treatment for both of those indications also as we think about long term.

And in terms of PV could we see ultimate.

Attrition of the patient population to reach the kind of that 50% level that we're seeing with MF.

And perhaps just some updated thoughts on the long term guidance that you guys gave last year I believe it was two and a half to 3 billion by 2027, if we see the continued growth in PV and gvhd that seems.

Barry: Great, thank you.

Tyler Van Buren: The next question is from Tyler Van Buren of Piper Jaffray. Please go ahead.

Barry: Hey guys, good morning. Great to see the solid results for the quarter. I just had a couple follow-up questions to Marc's line of questioning. As you look at Jackify and MF and PV, can you give us an update on duration of treatment for both of those indications? Also, as we think about the long term in terms of PV, could we see ultimate penetration of the patient population and reach that 50% level that we're seeing with MF? And perhaps just some updated thoughts on the long-term guidance that you guys gave last year. I believe it will be $2.5 to $3 billion by 2027. If we see the continued growth in PV and GBHD, that seems exceedingly achievable. So, I'd be interested to hear your updated thoughts.

Seemingly.

Capable so it would be.

Be interested to hear your updated thoughts.

Sure Tyler as Barry we're still confident that 2.53 billion long term guidance.

That's clear.

As Terry in terms of persistence, it's what we've said all along to be honest with you I think we have to turn to the clinical trials for persistence. When you look at PV. When you look at this response.

Data you saw 80, plus 83% of the patients were still on therapy at two years and in in the country trial, you saw that 50% of patients were still on a three year, so thats still our touchstone for.

Persistence in PV, we continue to grow year over year. This year, we grew.

Total patients in PV, 15% year.

Year over year and that continues to exceed the continued growth in patients and Matt. So we see that NPV will catch up to the MF patients sooner or later and we certainly are confident that the clinical profile objectify and Polys I think Vera patients could hit the 50% market standpoint.

Barry: Sure, Tyler. This is Barry. We're still confident in the $2.5 to $3 billion long-term guidance. So it's clear in terms of persistence, you know, it's what we've said all along, to be honest with you, I think we have to turn to the clinical trials for persistence. When you look at PV, when you look at this response data, you see 80 plus 83% of the patients were still on therapy at two years, and in the comfort trial, you saw that 50% of the patients were still on at three years. So that's still our touchstone for persistence, year-over-year, and that continues to exceed the continued growth in patients with MF, so we see that in PV, we'll catch up to the MF patients sooner or later, and we certainly are confident that the clinical profile of Jackify and polycythemia vera patients could hit the 50% mark at some point.

Thanks for taking the questions.

The next question is from Brian Abrahams of RBC. Please go ahead.

Hi, there. Thanks, so much for taking my questions and congratulations on the strong quarter on Gvhd can you provide any perspectives on the reached three stopping rule of the interim and maybe frame expectations now that that read outs been pushed out to next year and related to that Im curious your latest views on the potential impact of Jack one versus Pan JAK.

So for efficacy and Gvhd and the bar for the sitting at breed out now that you guys have more clinical and commercial experience space. Thanks.

Yes, hi, Stephen So in terms of reached three we don't normally guide two interim results, but this time working with our partner Novartis. We obviously did expect to potentially have some results by the end of 2019 as you can see the this study at interim made it through.

Brian Corey Abrahams: Thanks for taking the questions.

The interim analysis by the Idmc and they recommended to continue the study to completion without modification. The recruitment itself is about to finish should be literally every only a few patients left there is always a higher by the nature of an interim there's always a higher bar to achieve it interim analysis to close this study.

Steven: The next question is from Brian Abrahams of RBC. Please go ahead.

Steven: Hi there. Thanks so much for taking my questions and congratulations on a strong quarter. On GVHD, can you provide any perspectives on the Reach 3 stopping rule at the interim and maybe frame expectations now that that readout's been pushed out to next year? And related to that, I'm curious about your latest views on the potential impact of JAK1 versus PanJack inhibition on the potential for efficacy in GVHD and the bar for it to sit in a readout now that you guys have more clinical and commercial experience in the Thanks.

Because you have to be very careful that you do it appropriately.

Not at all worried we remain extremely confident in the datasets the primary endpoint.

In the chronic graft versus host disease studies, and overall response rate at month six but they are numerous secondary endpoints that are important including failure free survival symptom improvement overall survival in others.

Sometime in 2020 will get those results we extremely we remain extremely confident in that and as I've just to reiterate it was little unusual for us to guide to an interim but again working with a partner Thats what we did.

Steven: Yeah, hi, it's Steven. So in terms of REACH3, you know, we don't normally guide to interim results, but this time, working with our partner Novartis, we obviously did expect to potentially have some results by the end of 2019. As you can see, the study at interim made it through, you know, the interim analysis by the IDMC, and they recommended continuing the study to completion without modification. The recruitment itself is about to finish.

In terms of.

Reading through to get to setting of anymore, Jack one agent or relatively more.

His Jack one more than the other jacks.

You saw proof of concept data for me to sit NIPA was strong across the spectrum of disease, but it was even stronger in steroid naive acute graft versus host disease, which is why which led to gravitate three or one in addition patients with steroid naive acute graft versus host disease or immediately post bone marrow transplant originate.

Transplant tend to be Sikka tend to have cytopenias, particularly low wide cell counts and low platelets. So to have a relative Jack to sparing agent that doesn't cause as much cytopenias as the others.

Steven: We literally have only a few patients left. There's always a higher bar to achieve an interim analysis to close a study because you have to be very careful that you do it appropriately. So, you know, we're not at all worried.

Potentially beneficial from a therapeutic ratio point of view, but in terms of the biology of the disease immediate rates to body biology appropriately and again and we remain confident in that.

That's really helpful. Thanks.

Okay.

The next question is from Michael Schmidt of Guggenheim. Please go ahead.

Steven: We remain extremely confident in the data sets. The primary endpoint in the Chronic Graft-Versus-Host Disease Study is an overall response rate at month six, but there are numerous secondary endpoints that are important here, including failure-free survival, symptom improvement, overall survival, and others. So, you know, sometime in 2020, we'll get those results. We are extremely, you know, we remain extremely confident in that. And as I, just to reiterate, you know, it was a little unusual for us to guide to an interim, but again, working with a partner, you know, that's what we did.

Hi, Thanks for taking my questions just had a follow up on Gvhd as well I think you set the launches outpacing your internal expectations. Just wondering if you could.

Hi bus with a little bit more information around what treatments share do you have at this point then maybe what what percentage of top line sales was contributed by Gvhd.

Sure Michael well treatments your I'm not exactly sure I think that where where the.

Most used agents maybe are already in the second line setting, but I can't be share that.

Trying to get information on Gvhd is little bit harder than MF and PV since its all hospital used.

Steven: In terms of, you know, reading through to itacitinib and a more JAK1 agent, a relatively more JAK1 hits JAK1 more than the other JAKs, you know, we saw our proof-of-concept data for itacitinib. It was strong across the spectrum of disease, but it was even stronger in steroid-naive acute graft-versus-host disease, which led to In addition, patients with steroid-naive acute graft-versus-host disease are immediately post bone marrow transplant or allogeneic transplant, tend to be sicker, tend to have cytopenias, particularly low white cell counts and low platelets. So to have a relative JAK2 sparing agent that doesn't cause as much cytopenia as the others is potentially beneficial from a therapeutic ratio point of view, but That's really...

So.

That said, so I think last year, I said, something like with spontaneous use and then with the approval.

We'd hit somewhere around $80 million for this year.

Think we're ahead of that but I can't give you an exact number for that but we're very pleased with the uptake in gvhd and we think with that now the reach two data it will even be stronger in the future.

Great. Thanks, then maybe a bigger picture questions question far away. So regarding the earliest stage pipeline.

I guess, you're pursuing both new immuno therapies as well as targeted oncology drugs and obviously that's been some very interesting data generated in the last couple of years, specifically with Teekay is going after driving mutations and killing Pammi gotten theyve, obviously, but but the other tied into the slow.

On the other AD I think many would agree that the success rates for new immune oncology drugs has been rather mixed I guess in that context I was just wondering how do you see your bigger picture pipe and strategy of off our longer term going after both areas.

Steven: That's really helpful. Thanks, Steven.

Yes, I think so thanks for the question because obviously it is very important on it.

Michael Schmidt: The next question is from Michael Schmidt of Guggenheim. Please go ahead.

It's a field where the effect of the decisions we made.

Barry: Hey, thanks for taking my questions. I just had a follow-up on GVHD as well. I think you said the launch is outpacing your internal expectations. Just wondering if you could help us with a little bit more information around, you know, what treatment share you have at this point and maybe what percentage of top-line sales was contributed by GVHD.

Over the past few years out was seen with with the delays so.

Well.

Obviously with a very heavy shale so research if growth in immuno oncology community engine, the odd which led to a number of goes up a drag beyond the beyond oncology and what has been happening over the past to Europe is a rebalance where we have no more targeted therapy.

Barry: Sure, Michael. Well, treatment share, I'm not exactly sure. I think that we're the most used agent, maybe, already in the second line setting, but I can't be sure that, you know, trying to get information on GVHD is a little bit harder than MF and PV, since it's all hospital use. So, that's it.

These targeted.

I mean targeting.

I'm good genetic mutation type of of project that.

But larger path of our portfolio.

At the same time, we are keeping it.

You May know project.

Today, So it's I would say, it's a balance that is properties 60, 40, or 40, 60 kind of kind of ratio where maybe in the past. It was more heavy onsite aspect on dash. If you want to speak about it yes. Thanks, a question Michael just sort of echo what to avoid was saying I think you're right at some level on the promising.

Barry: So, I think last year I said something like, with spontaneous use and then with approval, we'd hit somewhere around $80 million for this year. I think we're ahead of that, but I can't give you an exact number for that. But we're very pleased with the uptake in GVHD, and we think with the Reach 2 data now, it'll even be stronger in the future.

You mean oncology is being tempered by clinical data. However, we still think this particular plenty of opportunities out there in both the targeted and the immuno oncology space.

Herve: Great, thanks. And maybe a bigger picture question for Herve regarding the earlier stage pipeline. I guess you're pursuing both new immunotherapies as well as targeted oncology drugs, and obviously, there's been some very interesting data generated in the last couple of years, specifically with TKIs going after driving mutations, including pamigatinib, obviously, but there are other targets as well. On the other hand, I think many would agree that the success rate for new immuno-oncology drugs has been rather mixed. I guess in that context, I was just wondering how you see your bigger picture pipeline strategy evolving longer term going after both areas?

Remember all you know from our.

Access to modality said, we have both small molecule and biologics capability, so having both of those.

Options open to US does keep the entire area open and we have a number of programs that we think will enter the clinic in the coming months that target both.

Coming off trade Larry.

Traditional targeted therapeutic approach as well as say immuno approach and then combinations thereof.

Thank you.

The next question is from Macquarie CASM off of Jpmorgan. Please go ahead.

Hey, good morning, guys. Thanks for taking my questions first one for use on expenses so.

DNA in R&D, both came in pretty meaningfully below expectations for the quarter, but guidance was unchanged, which would imply a decent step up in Fourq you just to get to the low end of your range. So is that something we should be anticipating and maybe to the extent you're willing to qualitatively comment on trends into 2020 do you have any kind of preliminary.

Herve: Yeah, I think, so thanks for the question, because obviously, it's very important. And it's a field where the effect of the decisions we made over the past few years is always seen with a delay.

Dash: So we obviously had a very heavy share of the research effort in immuno-oncology and immunity in general, which led to a number of other projects beyond oncology. And what has been happening over the past two years is a rebalance where we now have more targeted therapies or targeted, I mean targeting oncogenic mutation type of projects that are a larger part of our portfolio. At the same time, we are keeping immunoprojects today, so I would say it's a balance that is probably in the 60-40 or 40-60 kind of ratio, where maybe in the past it was more heavy on the immuno aspect. And Dash, if you want to speak about it,

Big picture expense thoughts going forward and I have one follow.

Hi, guys Christiana. Thank you for your question first of all Big picture in terms of guarantee and as Janet.

We continue to invest aggressively invest in our clinical development portfolio as well as Ken or not.

Commercial operations, what you're seeing with NBC, yes, and as expenses coming.

On the lower side. This is that we're able to reallocate expenses that were adequately previously.

For Epacadostat and Baricitinib to our either late stage development program, so that allowed us to be able to push forward. The other development programs without seeing an increase in R&D going forward. However that we have discussed in the past we are looking to it.

Dash: Yes, thanks for the question, Michael. Just to sort of echo what Ove was saying, I think you're right.

Dash: At some level, the province of immuno-oncology is being tempered by clinical data. However, we still think there are plenty of opportunities out there in both the targeted and the immuno-oncology space. You'll remember, or you'll know from our sort of access to modalities that we have both small molecule and biologics capabilities. So having both of those options open to us does keep the entire area open. And we have a number of programs that we think will enter the clinic in the coming months that target both going after a very sort of traditional targeted therapeutic approach as well as the immuno approach and then combinations thereof.

Yes, and merit based on the quality and the progress of the program. So.

Based on data.

Merits of the programs if those programs progress.

Later stage of development yield expects.

I would expect that to drive R&D expenses.

In terms of Fat Q4, we reiterated guidance that we provided both R&D and SDMA because there is a timing factor for some of the expenses on both lines that we expect to be more.

Backend loaded into Q4 2019, and therefore, we will continue to be comfortable with initial guidance that we have provided.

Okay. That's helpful. Then my follow up is quick one for Steve and how much.

Reni John Benjamin: The next question is from Corey Kazimoff of JP Morgan. Please go ahead. Hey, good morning, guys.

How much patient follow up are you wait for and that site to a one penny bladder study before potentially topline in that data.

Christiana: Thanks for taking my questions. The first one for you is on expenses. So SG&A and R&D both came in pretty meaningfully below expectations for the quarter, but guidance was unchanged, which would imply a decent step up in 4Q just to get to the low end of your range. So is that something we should be anticipating? And maybe to the extent you're willing to qualitatively comment on trends into 2020, do you have any kind of preliminary big picture expense thoughts going forward? And I have one follow-up.

Hi course, Steven so typically across the board ballpark follow up in the sort of studies required by regulatory agencies is around 12 months, but thats for your last respond. So you what I'm, saying as you complete recruitment if that loss very last patients.

To respond to you typically require about 12 months. So if you think you know we've just recently.

And completed recruitment on the study we looking at data sometime mid 2020 or beyond to get a complete view of that picture.

Christiana: Thank you for your question. First of all, the big picture in terms of R&D and SG&A costs, we continue to invest aggressively in our clinical development portfolio as well as in our commercial operations. What you are seeing with R&D this year and the expenses coming on the lower side is that we were able to reallocate expenses that were previously for Epocatastat and Barasitinib to our other late-stage development programs. So that allowed us to be able to push forward the other development programs without seeing an increase in R&D. Going forward, however, as we have discussed in the past, we are looking to invest in R&D based on the quality and the progress of the program. So based on data and merits of the programs, if those programs progress through later stages of development, you would expect that to drive R&D expenses. In terms of Q4, we reiterated the guidance that we provided on both R&D and SG&A because there is a timing factor for some of the expenses on both lines that we expect to be more back-end loaded into Q4 of 2019. And therefore, we continue to be comfortable with the initial guidance that we have provided.

Yes, the board on that blended data.

Okay perfect. Thanks for taking the questions.

Your next question is from Evan Seigerman of Credit Suisse. Please go ahead.

Hi, Alex Thanks for taking my question Congrats on the progress so our Christiane out one for you how would you characterize your capacity to transact I know Herve mentioned some high level thoughts on BD and then I have a follow up on that just basically what are some characteristics of assets that you would consider bringing in house one for you for January .

For you or bad.

So in terms of the capacity as we have discussed in the past that we have a strong balance sheet. We currently have 2 billion of cash on our balance sheet, because that gives us the opportunity to concede that bringing that external asset swap that too.

Internal portfolio.

In terms of the nature of the assets assets that we're looking at programs that will contribute to revenue diversification and growth in the meter.

A timeframe so continuing to add to growth ashwin getting closer to the Jack a high potential patent expiration at period, so bringing additional growth driver said that obviously makes a lot of sex congrats.

So I.

The type of assets are fairly strategy I mean, the first is I've just the metallurgy oncology anything.

That would be good friends that would be innovate is that would provide a benefit.

Steven: Okay, that's helpful. Then my follow-up is a quick one for Steven. How much patient follow-up will you wait for in that FITE 201 PEMI bladder study before potentially lining that data?

That is unique in the field of cancer treatment group fit with our portfolio, where we have a very strong methodology franchise both in Europe .

The U.S. on where we have.

Joining solid tumor.

Steven: Hi Corey, Steven. Typically, across the board, ballpark follow-up in these sorts of studies required by regulatory agencies is around 12 months. But that's for your last responder. So what I'm saying is you complete recruitment. If that last, very last patient is a responder, you typically require about 12 months. So if you think you know, we've just recently completed recruitment for the study, we look at that data, you know, sometime, mid 2020, or beyond, and get a complete view of that picture across the board on our bladder data. Okay, perfect. Thanks for taking the time to answer the question.

Thanks, guys.

Also in the us on early to declaring the in Europe . So that makes sense in terms of timing, we're looking at the window between 25, and Saudi and its Saudi abuse, why because that's where we would need.

Model diversification.

So going to aspect is to complement our MF and PV franchisees, whereas they are new mechanisms that can be complementary to what we have in our portfolio on where you see our leadership in MF and PV could be Irene reinforced by.

External assets if any.

Ben if it could be shown from this and then we have a little bit of a longer.

View on the non oncology.

Aspect as we said we will be commercializing.

Our rugs cream in the us.

Evan Sigerman: Okay, perfect. Thanks for taking the questions. The next question is from Evan Sigerman of Credit Suisse. Please go ahead.

We may have partnership if needed, but we wouldn't be leading the commercialization into you as.

We will be partnering.

I will dermatology assets outside of Europe on U.S. on we're still looking at what's the best.

Christiana: Well, thanks for taking my question and congrats on the progress.

Herve: I have one for you. How would you characterize your capacity to

Strategy for Europe . So they have that you'd be also but on social media aspect to the dermatology franchise, we I'm really confident in the benefits we are showing boosting that dumping dermatitis.

Christiana: Transact. I know Herve mentioned some high-level thoughts on BD, and then I have a follow-up on that, just basically, what are some characteristics of assets that you would consider bringing in-house? So one for you, Christiana, and one for you, Herve.

As you saw in VTI go it's a fairly striking data with the long term follow up on we'd believes there is a true value in this franchise and complementing it with external assets could be on upshot, it's not it's not that shouldn't be one thats already because we believe in the U.S.. We can build the team to success when it goes.

Herve: So, in terms of capacity, as we have discussed in the past, we have a strong balance sheet. We currently have $2 billion of cash on our balance sheet, so that gives us the opportunity to consider bringing in external assets to add to our internal portfolio. In terms of the nature of the assets, we are looking at programs that could contribute to revenue diversification and growth in the mid-term time frame, so continuing to add to growth as we are getting closer to the Jack-of-five potential patent expiry period. So bringing additional growth drivers then obviously makes a lot of sense for us. So, do you want to... Yeah, I mean, the type of assets is fairly... it's fairly clear. I mean, the first is obviously a methodology, oncology, anything...

Right, but there could be some conclusions to it so it's really it's fairly clear methodology oncology for 25 to Saudi where that's where.

He knows the contribution to the topline we'd be the most valuable it's lifecycle management of him FMTV and potentially if we find the right that fit.

In the dermatology somewhere in the immuno.

Non cancer immunology could be or so and as I mentioned.

Okay, and then I'll just follow up there I mean are we talking $1 billion 2 billion or really Havent you give color on in terms of what you pay.

So the main focus c., so what I would characterize aspect type of.

Asset has that kind of bring gain either through licensing or M&A. So we agnostic in terms of this tax or whatever it makes sense.

Herve: That would be good science, that would be innovative, that would provide a benefit, that is unique in the field of cancer treatment, and it could fit with our portfolio, where we have a very strong hematology franchise both in Europe and the U.S. and where we have this emerging solid tumor franchise also in the U.S. and a little bit later in Europe. So that makes sense in terms of timing.

Okay.

Okay. Thank you.

Okay.

The next question is from Jay Olson of Oppenheimer <unk> co. Please go ahead.

Oh, you guys congrats on the quarter and all the progress.

I had a couple questions.

Could you comment on.

What were the best available therapies to Jack if I beat in reached two and is or overlap between those best available therapies.

Herve: We are looking at the window between 25 and 30, and it's fairly obvious why because that's where we will need more diversification. The second aspect is to complement our MF and PV franchises where there are new mechanisms that can be complementary to what we have in our portfolio and where, obviously, our leadership in MF and PV could be reinforced by external assets if any benefit could be shown from this. Our Rock Scream in the U.S. We may have a partnership if needed, but we will be leading the commercialization in the U.S. We will be partnering our dermatology assets outside of Europe and the U.S., and we are still looking at what's the best strategy for Europe. So there could also be potential biddy aspects to the dermatology franchise.

In reach two and reached three and then.

Just a follow up on kind of gotten it.

Could you provide some additional color on how the enrollment is going in fight to five and fight to seven and also the bladder cancer continuous dosing cohort.

Yes, Hi, Jay Stephen Thank you for your questions. So both reach two and reach three are randomized studies against best available therapies. Just to mention you know reached two that we just said reported out as positive and will be presented at an upcoming medical meeting too.

Our knowledge is the first randomized study and graft versus host diseases that as reported out as positive. So that's that's really good news, obviously for patients and for US. The therapies themselves are listed on Clin trials, but just to give you a sense. They are slight differences because a different disease entities for reached two.

Herve: We are very confident in the benefits we are showing both in atopic dermatitis and, as you saw in vitiligo, it's fairly striking data with long-term follow-up, and we believe there is a true value in this franchise, and complementing it with external assets could be an option. It's not, it's not absolutely mandatory because we believe in the U.S. that we can build a team to successfully commercialize it, but there could be some complement to it. So it's fairly, it's fairly clear. It's a methodology oncology for 25 to 30, where that's where, you know, the contribution to the top line will be the most valuable. It's life cycle management of MF and PV, and potentially, if we find the right assets in dermatology or somewhere in immunology, non-cancer immunology, it could be another dimension.

Include things like anytime aside club Dillon.

Extra couple Oreo Photophoresis. This means a common stromal cells low dose methotrexate.

Mark offended late and even Mtwo inhibitors like Everolimus can be used for reached three that there's some overlap but they also in addition, because chronic graft versus host disease include therapies like Rituximab.

And Matt NAV as well as a brief net which is approved in chronic graft versus host disease. The complete list is available on.

Unclaimed trials that.

Enrollment to the second part of your question.

Evan Sigerman: Okay, and then I just follow up there. I mean, are we talking a billion dollars, two billion, or really? How do you give color on that, in terms of what you'd pay?

On on the studies you mentioned for the entirety of the of depending Gartner program. Obviously includes completed first part in Cholangio carcinoma, and then the ongoing first line study there in the large.

Christiana: So the main focus is on what I would characterize as a stacking type of assets that we can bring in either through licensing or M&A. So we are agnostic in terms of the structure; whatever makes sense.

Bladder cancer program, and then the tomb agnostic as well as a small entity that we don't speak about match, but very important to patients is an IP 11, Motta proliferative neoplasm, we don't guide to the exact.

Jay Olson: Okay, thank you.

Steven: The next question is from Jay Olson of Oppenheimer & Co. Please go ahead. Oh, hey guys, congrats on the quarter and all the progress.

Dates in terms of enrollment other than when we start and sometimes when we entered into studies, but just to give you a sense that.

Jay Olson: I had a couple questions. Could you comment on what were the best available therapies? Did Jackify beat in REACH 2? And is there overlap between those best available therapies in REACH 2 and REACH 3? And then just to follow up on Pemigatinib, could you provide some additional color on how the enrollment is going in FITE-205 and FITE-207 and also the bladder cancer continuous dosing cohort?

Ignostic study to a seven which you mentioned has started enrollment.

And we'll be looking at different driving mutations.

There and then we expect to complete as I've just alluded to the second line lattice study before the end of this year and have data latter part of next year and then we about.

Steven: Yeah, hi Jay, it's Steven. Thank you for your question. So both REACH2 and REACH3 are randomized studies against best available therapies. Just to mention, you know, REACH2 that we've just said, reported out as positive, and will be presented at an upcoming medical meeting, to our knowledge, is the first randomized study in graft-versus-host disease that has been reported out as positive. So that's really good news, obviously, for patients and for us. The treatments themselves are listed on ClinTrials.gov, but just to give you a sense, there are slight differences because they're different disease entities. For REACH2, they include things like anti-thymocyte globulin, extracorporeal photophoresis, mesenchymal stromal cells, low-dose methotrexate, mycophenolate, and even mTOR inhibitors like everolimus can be used. For REACH3, there's some overlap, but they also, in addition, because chronic graft-versus-host disease, include therapies like The complete list is available on ClinTrials.gov.

Slide let US study so that gives you a sense of the the cadence of enrollment and the entirety of the program.

Great. Thanks for taking the questions.

Your next question is from Ren Benjamin of JMP Securities. Please go ahead.

Good morning, guys and thanks for taking the questions graduations on a great quarter.

I guess just as a follow up regarding the reach two data Steven is there anything here that kind of increases your confidence.

Just reached three are there or the two diseases really.

Separate and distinct acute versus crop.

Great. Thank you.

It was great to see.

A randomized study again, that's available therapy been positive and again as I. Just said, we look forward to sharing those results too. So it further does increase our confidence in what we already know per se that ruxolitinib is a really good drug for steroid refractory acute graft versus host disease chronic does have a slightly different path.

Physiology as if it's more a disease of fibrosis with more skin manifestations as opposed to more apoptotic disease in an acute where there's more sort of cell death.

Steven: Enrollment in the second part of your question on the studies you mentioned for the entirety of the PEMI-GATNA program obviously includes our completed first part in cholangiocarcinoma and then the ongoing first-line study there. Bladder Cancer Program, and then the tumor agnostic, as well as a smaller entity that we don't speak about much but is very important to patients, an 8p11 myeloprolifer We don't guide to exact dates in terms of enrollment other than when we start and sometimes when we end the studies. But just to give you a sense that the agnostic study, 207, which you mentioned has started enrollment, and we'll be looking at different driver mutations there. And then, you know, we expect to complete, as I just alluded to, the second line bladder study before the end of this year and have data in the latter part of next year. And then we're about to do the first line bladder study. So that gives you a sense of the pace of enrollment and the entirety of the program.

In 11, Gi tract, but there is enough overlap and our proof of concept data was strong enough that we remain confident in chronic graft versus host disease. We do think although the pathophysiology, there's there's a little bit of a different there's a good good read through and we're confident in getting that data next year.

Got it will just as a follow the utilize those studies of Star you can you give us any sort of the sense. If its enrollment is on track or.

Schedule and kind of all the sites open.

Yes, so you're correct.

Lago studies have started as you saw in my formal presentation, we just presented the.

52 week data at the with continuing improvement quite dramatic in patients through through one yet.

The studies have just recently started but but I will tell you. It's a it's a pleasant surprise to us working in dermatology. These studies accrue really really well.

So we sites open quickly if dedicated dermatology centers across the globe. Good it doing clinical research who put patients on quickly.

Ren Benjamin: Great, thanks for taking the question. The next question is from Ren Benjamin of JMP Securities. Please go ahead.

And we up and go in with Gusto and very positive about it.

Steven: Hey, good morning, guys. And thanks for taking the questions. And congratulations on a great quarter. I guess just as a follow-up regarding the REACH2 data, Steven, is there anything there that kind of increases your confidence in regards to REACH3?

Thanks for taking the questions.

As a reminder, if you would like to ask a question. Please press star one on your telephone keypad.

Our next question is from at least the a young of Cantor Fitzgerald. Please go ahead.

Steven: Or are the two diseases really, you know, separate and distinct, acute versus chronic?

Hey, guys. Thanks for taking my question congrats on the quarter to one.

Maybe Steve can you talk a little bit about.

Steven: Ren, thank you. You know, it was great to see a randomized study against the best available therapy being positive. And again, as I just said, we look forward to sharing those results with you. So it further increases our confidence in what we already know, per se, that ruxolitinib is a really good drug for steroid-refractory acute bowel versus host disease. Chronic does have a slightly different pathophysiology, as it's more a disease of fibrosis with more skin manifestations, as opposed to a more apoptotic disease in acute, where there's more sort of cell death in the liver and GI tract. But there's enough overlap, and our proof of concept data was strong enough that we remain confident in chronic graft-versus-host disease. We do think, although the pathophysiology there's a little bit of a difference, there's a good read-through, and we're confident in getting that data next year.

Best supportive care for restrain how it varies across the world.

Do you think there is any kind of variability there the Asia considering the trial that's ongoing in the second question probably is.

I have more fair and maybe herve.

I guess I'm just curious how you think about kind of.

Long term margins for the business.

Where we are exactly in kind of the peak cycle for Jack defined seems like there's still a lot of room to move and you're you're building NPV kind of an awareness and there's penetration that can be had but maybe view the frame that from a high level perspective that'd be helpful. Thanks.

Hi, Lisa it's Steven So you do allude to suddenly seeing graft versus host disease, not only across the world, but even within the United States and even within cities themselves. There are treatment differences in patents and bone marrow transplant centers in house and how people have treated this condition to date and continue.

Due to both in terms of preparative regimens and actual regimen, which is exactly why for best available therapy, we have to account for a number of therapies.

Steven: Got it. And then, just as a follow-up, the vitiligo studies have started. Can you give us any sort of a sense of if enrollment is on track or ahead of schedule and if we have all the sites open?

So there's no dramatic differences across the world compared to just as I said, even within the U.S. itself, we always as a matter of course do analyses that look at differences. If there are any between different parts of the world to explain response rates et cetera. So those analyses will be done typically you do the us.

Steven: Yes, so you're correct. The vitiligo studies have just started. As you saw in my formal presentation, we just presented the 52-week data at EADV with continuing improvement, quite dramatic in patients, you know, through one year. The studies have, you know, just recently started, but I will tell you it's a pleasant surprise to us working in dermatology. These studies accumulate really, really well. So we start to open quickly. We have dedicated dermatology centers across the globe who are good at doing clinical research, who put patients on quickly, and we go in with gusto and are very positive about it.

Western Europe , and rest of World analyses, and we'll look at those but nothing that we concerned about.

Regarding the site going on in the south of medium to long term cycle of the business obviously.

The growth of Jessica Fye into us is very key to to the entire PML lover of inside as you can see I mean this quarter in fact is growing even faster than the previous one investors, let Joe now Q3 last year was that it.

Ren Benjamin: Thank you for taking the questions.

Operator: As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad. Our next question is from Alethea Young of Cantor Fitzgerald. Please go ahead.

Look a little bit lower maybe is on the you should have been so the ratios of 25 built on gross project for us.

Maybe slightly higher sales on the truth trend over the year I think we I'm going to 20 bundle, which is still very very strong for a suppose seven so ace euro.

Reni John Benjamin: Hey guys, thanks for taking my question, congrats on the quarter. One, maybe Steve, can you talk a little bit about best supportive care for Reach 3 and how it varies across the world? Do you think there's any kind of variability there that you should consider in the trial that's ongoing? And the second question is more for maybe Herve.

Commercialization and we see a lot of potential for continued growth of objectify into us in MF. This deal volume grows patients.

Steven: I guess I'm just curious how you think about long-term margins for the business and where we are in kind of the peak cycle for Jackify. It seems like there's still a lot of room to move, and you're building in PV, kind of an awareness, and there's penetration that can be had. But maybe if you could frame that from a high-level perspective, that'd be a helpful thing.

Tumor is increasing in MF and PV as we said there is.

Larger potential for two reasons, one is because the treatment rates is still on the low end below 50 profound and the duration of treatment for every patient studies on checkout.

He is very much longer than what we have in them. If so what we see the south of cronies sizes Shannon.

Herve: Hi Alicia, it's Steven. So you allude to, you know, something we see in graft-versus-host disease, not only across the world but even within the United States and even within cities themselves, there are treatment differences in patterns at bone marrow transplant centers in how people have treated this condition to date and continue to, both in terms of preparative regimens and actual regimens, which is exactly why, for best available therapy, we have to account for a number of therapies. So, you know, there are no dramatic differences across the world compared to just, as I said, even within the U.S. itself. We always, as a matter of course, do analyses that look at differences if there are any between different parts of the world to explain response rates, etc. So those analyses will be done. Typically, you do the U.S., you know, Western Europe, and rest of the world analyses, and we'll look at those, but nothing that we're concerned about.

Of the disease in MF that is leading to this gross but I'm sure that is obviously, we're not changing the long term guidance very frequently but we have made a lot of progress two of the numbers that we we gave a few years ago of 2.23 and Thats something we are very confident in.

Regarding the PNNT cell phones, a margin as Chris Dennis said I mean, we are investing in R&D based on quality and those are required workforce sets that we have and so it may be fluctuating as you have seen and when it back at us that.

Does not work as planned to says that if you could see that it has a positive impact on the R&D budget, which is obviously the products of our industry is that if you step of project. It will it will improve margins, but obviously our goal is to manage the margin shot.

Herve: Regarding the cycle, I mean the sort of medium to long-term cycle of the business, obviously, the growth of Jessica Fye in the U.S. is very key to the entire P&L of Incyte. As you can see, this quarter, in fact... growing even faster than the previous one versus last year. Now, Q3 last year was a little bit lower, maybe, than it should have been.

Activity, but to maximize the value to the company on the shower gels by doing the right clinical development for each of the says that we have.

And at the same time, you may have seen from 2000 and flipped into today is that we are in the trend of improving ratios in the PNM, whereas the growth of the top line has been that not every single quarter, but on the should look at it on the cumulative for Sterling.

Herve: So the ratio of the 25% growth for JCAFA US is maybe slightly higher than the true trend over the year. I think we are more in the 20%, but which is still very, very strong for a sort of a seventh or eighth year of commercialization. And we see a lot of potential for continued growth of JCAFA in the US in MF. It is still volume growth; patients' volume is increasing in MF. And in PV, as we said, there is a larger potential for two reasons. It's because the treatment rate is still on the low end, below 50%. And the duration of treatment for every patient started on JCAFA is very much longer than what we have in MF.

All that margin has been improving over time, and Thats, where well why we are where we have today we have the.

Yes.

Has the ship that it has today so thats something we will continue to look for but it may include Quater elsewhere investment will increase because some of the says that we have our requiring an increase investment at some point. So overall the way we have been sort of looking at this is tough and the growth sums it up.

Line is driving our ability to invest in R&D and they are the two components to create value that would be sustainable long term trying site.

Herve: So what we see is a sort of chronicization of the disease in MF that is leading to this growth potential that is obviously higher. We are not changing the long-term guidance very frequently, but we have made a lot of progress toward the numbers that we gave a few years ago of 2.5 to 3. And that's something we are very confident in.

Our next question is from Vikram pure ahead of Morgan Stanley . Please go ahead.

Hi, good morning, Thanks for taking the question.

So I wanted to go back to long term, Jack Inphi and the tail on that franchise.

Herve: Regarding the P&L itself and the margin, as Christian has said, we are investing in R&D based on the quality and the required work for the assets that we have. And so it may be fluctuating, as you have seen, when a package starts, it does not work as planned, to say the least. You can see that it had a positive impact on the R&D budget, which is obviously the paradox of our industry, that if you stop a project, it will improve margins. But obviously, our goal is not to manage the margin short-term proactively but to maximize the value to the company and the shareholders by doing the right clinical development for each of the assets that we have in our hands.

And I had two questions on Jack Aside lifecycle extension program. So.

I believe it earlier you alluded to.

Possibly getting some extended release data in 2020, so I just wanted to see what the status of that program was it gets in the clinic, yet or not and then secondly, I believe the last time, we saw some Jack defy combination data was at Ash last year in combination with the Pithree K molecules I just wanted to see when further data from that combination.

Could be available as well as from other combinations like Tim Anderson.

In Dms setting thanks.

Herve: At the same time, you may have seen from 2014 to today that we are in a trend of improving ratios in the P&L, where the growth of the top line has not been every single quarter, but if you look at it on the cumulative four quarters in a row, that margin has been improving over time, and that's why we are where we are today; the PNL has the shape that it has today. So that's something we will continue to look for. But it may include quarters where investment will increase because some of the assets that we have are requiring an increased investment at some point. So overall, the way we have been sort of looking at this is this.

Hi, Stephen So thank you for your question related to Ruxolitinib lifecycle management, which we view as something for Ruxolitinib itself as well as for Modeler proliferative neoplasms in general.

There are three pillars to the program and you mentioned all of them. So firstly in terms of formulation work. What you brought up that's been ongoing this year it involves.

At an extended release approach in terms of formulations and bioavailability and bio equivalents work that is underway, it's been going well as you as you just said complete in 2020 at some point and then we'll we'll use it to have regulatory discussions probably through the middle of 21, we'll find an appropriate meet.

Into presented at but I'll remind you that we actually presented some Rex limited XR data in 2011 with a 25 milligram XR tablets. So we have already and that work is ongoing and progressing well in terms of the second pillar combinations. We are running as you said pithree kinase Delta.

Herve: Certainly, growth of the top line is driving our ability to invest in R&D, and these are the two components to create value that will be sustainable for the long term for Incyte.

Vikram Purohit: Our next question is from Vikram Purohit of Morgan Stanley. Please go ahead. Hi, good morning.

The combination that's the most mature of them. We also have a rux plus some combination and Rx plus it to setup combination ongoing we'll have ourselves in a data in house to look at ourselves with Rex plus Delta.

Steven: Thanks for taking the question. So I wanted to go back to long-term Jackify and the tail on that franchise. And I had two questions on the Jackify Lifecycle Extension Program. So I believe earlier you alluded to possibly getting some extended release data in 2020. So I just wanted to see what the status of that program is, if it's in the clinic yet or not. And then, secondly, I believe the last time we saw Jackify combination data was at ASH last year in combination with the PI3K molecule. So I just wanted to see when further data from that combination could be available, as well as from other combinations like PIM and idacitinib in the MF setting. Thanks.

Absolutely.

End of this year, and we'll find inappropriate meeting to present to that and 2020 and make decisions go forward decisions or not in either first or second line moderate fibrosis. When we look at the completeness of the data will also should have enough data with with and it is setting the also to present in 2020 it.

At an appropriate meeting and then the third pillar and very important is new targets to look look at in MF, and PV and collaborations with academia and different vendors, including epigenetic screens to look if there any new targets, there and we haven't announced anything publicly yet but thats it.

Very very active endeavor as well.

Okay I appreciate it thank you.

Steven: Vikram, hi, it's Steven. So thank you for your question related to ruxolitinib life cycle management, which we view as something for ruxolitinib itself as well as for myeloproliferative neoplasms in general. There are three pillars to the program, and you mentioned all of them. So, firstly, in terms of the formulation work that you brought up, that's been ongoing this year. It involves an extended release approach in terms of formulations and bioavailability and bioequivalence work that is underway. It's been going on and will, as you just said, be completed in 2020 at some point, and then we'll use it to have regulatory discussions probably through the middle of 21. We'll find an appropriate meeting to present it at, but I'll remind you that we actually presented some ruxolitinib XR data in 2011 with a 25 milligram XR tablet. So we have already, and that work is ongoing and progressing well. In terms of the second pillar, combinations, you know, we are running, as you said, a PR3 kinase delta combination. That's the most mature of them.

The next question is from George Farmer of BMO capital markets. Please go ahead.

Hi, good morning, Thanks for taking my questions.

I was wondering if you could comment a bit on pick at Nab and how do you believe this molecule differentiates from other FGF our inhibitors.

So it's Steven I'll go first dash may want to add something Tourette, where we are in FGF far 123 specific inhibitor.

We know the PK and PD effects of this compound really well we've done both.

Intermittent dosing as well as continuous dosing.

And we've we've got a very good PD marca pharmacodynamic marker in Hypophosphatemia. So we can dose to that and as I said earlier manage appropriately all compounds. Obviously chemically are different obviously the the only approved if our inhibitor currently is or the fitness the janssen compound and that does hit.

FGF, our four as well and May explain some of the difference in safety profile that we that we seen but we'll wait for the full datasets to bear that out as regards the other compounds that just.

I don't know enough to comment on unattached wants to add anything.

Yes, I mean, I think you covered the may major points there Steven we feel that Penny gardening is probably the most selective as Jeff our inhibitor out there.

Steven: We also have a rux plus PIM combination and a rux plus itacitinib combination ongoing. We'll have ourselves, you know, data in-house to look at ourselves with rux plus delta, you know, approximately the end of this year, and we'll find an appropriate meeting to present it at in 2020 and make decisions, go forward decisions, or not in either first or second line myelofibrosis when We should also have enough data with PIM and itacitinib also to present in 2020 at an appropriate meeting. And then, you know, the third pillar, which is very important, is new targets to look at in NMF and PV and collaborations with academia and different vendors, including epigenetic screens, to look if there are any new targets there. And we haven't announced anything publicly yet, but that's a very, very active endeavor as well.

Focused on next year for one two and three we don't really touched the other Isis volumes.

Version by Kevin Glass say, so selling process et cetera, we have.

What we think is a great PK profile clinically. So overall, we feel it's a balance of.

Optimal selectivity for our target proteins as Wallace.

Equal profile to sort of leverage that selectivity in an optimal way.

Okay, Great. That's helpful. And then I know I know, it's early days, but do you have any sense for.

Duration of therapy in steroid refractory acute setting with Jacko Fi.

Well, we can only go on again reach one trial and we believe in tracked in the duration of response of 173 days that said, it's in our label where therapy is unchanged or and patients don't come off for whatever reason so.

Vikram Purohit: Okay, appreciate it. Thank you. The next question is from George Farmer of BMO Capital Markets. Please go ahead. Hi, good morning. Thanks for taking my questions. I was wondering if you could comment a bit on Pemigatinib and how you believe this molecule differentiates from other FGFR inhibitors.

Thats what were going by but we don't really have from a commercial standpoint, a follow up yet on what the true.

Nature is but we do know that its successful that patient seem to be staying on it for long time.

As you know in.

Graft versus host disease in general, but it's particularly in acute graft versus host disease.

Steven: So Stephen, I'll go first. Dash may want to add something to it. You know, we're an FGFR 1, 2, 3 specific inhibitor. We know the PK and PD effects of this compound really well. We've done both intermittent dosing as well as continuous dosing, and we've got a very good PD marker, a pharmacodynamic marker, for hyperphosphatemia. So we can dose according to that and, as I said earlier, manage appropriately. You know, all compounds are obviously chemically different. Obviously, the only approved FGFR inhibitor currently is ertifitinib, the Janssen compound, and that does hit FGFR 4 as well and may explain some of the difference in safety profile that we've seen. But we'll wait for the full data sets to bear that out. As regards the other compounds, I don't know enough to comment on them. I don't know if Dash wants to add anything.

Physicians bone marrow transplant docs want to taper off drugs like.

Like steroids, and then even like Jack of high over a period of time.

But just so they can do it safely and make sure. They fully managed the effects of gvhd before they do so.

Okay, great. Thanks very much.

The next question is from Mara Goldstein of Mizuho. Please go ahead.

Great. Thank you very much for taking my question.

A couple of questions and warm.

The promotional sensitivity.

In the PD indication you mentioned that you thought that that category to get 50%.

Penetrated so I'm wondering where the resistance is among the prescribing community in is that something that is subject to also greater promotion and then just secondarily. If you could update us on the status of the commercial organization for GAAP net as you had that Andy filed for Cholangio sarcoma.

Dash: Yeah, I mean, I think you covered the major points there, Steven. We feel that pantygatinib is probably the most selective FGFR inhibitor out there. We're focused on FGFR 1, 2, and 3. We don't really touch the other isozymes, you know, virulence in biochemical assays, or cellular assays, etc. We have what we think is a great PK profile clinically. So overall, we feel it's a balance of optimal selectivity for our target proteins, as well as the clinical profile to sort of leverage that selectivity in an optimal way.

Sure so.

Jeff I is actually promotionally sensitive across all indications.

It's it's both MF and PV can sometimes most of our treating physicians and healthcare professionals don't see these patients.

That often.

You know there, sometimes they're often worried about some of their other patients that might have lung cancer pancreatic cancer. So they don't.

George Farmer: Okay, great, that's helpful. And then, I know it's early days, but do you have any sense for duration of therapy in the steroid-refractory acute setting with Jackify?

Pay enough attention to the symptoms in fact that these patients are experiencing and other indicators that their disease may be getting worse. So we have oncology clinical nurse educators, we have obviously RMS Allison we have our sales representatives are continuing to try to edges.

Barry: Well, we can only go on again to reach one trial, and we believe, in fact, in the duration of response of 173 days that's in our label, where therapy isn't changed or the patients don't come off for whatever reason. So that's what we're going by, but we don't really have, from a commercial standpoint, a follow-up yet on what the true nature is, but we do know that it's successful, and patients seem to be staying on it for a long time. As you know, in Greffer's and psoas disease in general, but particularly in acute Greffer's and psoas disease, physicians, bone marrow transplant docs, want to taper off drugs like steroids and then even Jackify over a period of time, but just so they can do it safely and make sure they fully manage the effects of DVHD before they do so.

Kate healthcare professionals that they need to look more closely at these patients, particularly PV patients who are suffering and that's one of the reasons. We do our educational campaign, obviously to encourage patients themselves to go out and in fact.

Advocate for themselves if they don't feel like they're getting the appropriate treatment.

Your second question was Oh, the commercial footprint for kind of getting them. So we do plan in fact to add a few more people in 2020 to get ready for the kind of getting their launch so.

We do our we're going to keep the full amount of current ft is against Jacka, Fivefour MF and PV.

We're going to increase slightly the number of ft ease that we have that are targeting graft versus host disease in but bone marrow transplant centers and then a few ft ease.

Barry: Okay, great. Thanks very much. The next question is from Mara Goldstein of Mizzou. Please go ahead.

That will be concentrated on pena Getnet. We also have a couple of oncology clinical nurse educators, and obviously our market access and people that are in fact fully ready for and fully trained on pending getnick and cholangio carcinoma.

Mara Goldstein: Great. Thank you very much for taking the question.

Barry: Just a couple of questions, and one is on the promotional sensitivity of Jack Fye in the PV indication. You mentioned that you thought that that category could get 50% penetrated, so I'm wondering where the resistance is among the prescribing community, and is that something that is also subject to greater promotion? And then, just secondarily, if you could update us on the status of the commercial organization for pimigantinib as you have the NDA filed for cholangiosarcoma.

For the launch in 2020.

Our final question is from Christopher Mariah of Nomura Instinet. Please go ahead.

Hey, good morning, Thanks for taking your question.

Yes, maybe touching upon some of rock so life cycle management.

Recall previously in pipeline.

In the Craig.

Barry: Sure, so Jack Fye is actually promotionally sensitive across all indications, you know it's both MF and PV can sometimes, you know most of our treating physicians and healthcare professionals don't see these patients That often, you know, sometimes they're often worried about some other patients that might have lung cancer or pancreatic cancer, so they don't pay enough attention to the symptoms, in fact, that these patients are experiencing and other indicators that their disease may be getting worse. So we have oncology clinical nurse educators, we have, obviously, our MSLs, and we have our sales representatives that are continuing to try to educate healthcare professionals that they need to look more closely at these patients, particularly the PV patients who are suffering, and that's one of the reasons we do our educational campaign, obviously, to encourage patients themselves to go out and, in fact, advocate for themselves if they don't feel like they're getting the appropriate care that they need.

Looking at that article.

Hi, there was some great data for the one.

Hi.

In myelofibrosis.

So to actually working in second line, but also be off net cost so in first line.

Well the fibrosis and I was wondering if perhaps you could comment on your profits.

Hey, Mike Latimore bar.

Pardon.

Thank you.

Yes, Chris Hi, Stephen So just remind you know we ourselves have a bit BRD programs. Obviously, you know we had preclinical data that showed that racks plus that target.

We had in haunt still potentially enhanced efficacy in myelofibrosis, and we ran into toxicity in terms of an on target toxicity in terms of thrombocytopenia and currently have put ourselves the program on clinical hold with with the regulators as a company you alluded to a competitor.

That DRD program, which showed you write some interesting data and have an abstract in for future medical meeting that they may show more on will follow that.

Closely we are interested in anything that enhances rex activity and we'll keep looking across that.

Programs.

Are there for us to use should we need to resurrect them.

Barry: Um, and your second question was, oh, the commercial footprint for Pemigetinib. So we do plan, in fact, to add a few more people in 2020 to get ready for the Pemigetinib launch. So we do, we're going to keep the full amount of current FTEs against JAKA5 for MF and PV. We're going to increase slightly the number of FTEs that we have that are targeting graft-versus-host disease in both bone marrow transplant centers. And in a few, FTEs that will be concentrated on Pemigetinib. We also have a couple of oncology clinical nurse educators, and obviously, our market access people that are, in fact, fully ready for and fully trained on Pemigetinib and cholangiocarcinoma for the launch in 2020.

Okay.

Yes.

Yes, I think it sounds like the competitor.

But as you noted that was something you're still investigating.

And we'll present on the therapeutic index there again.

Hi, Thank you might differ from.

The competitors. Thank you.

So I want to address this directly but its knowing that fit BRD inhibitor as have on target thrombocytopenia that can be profound.

So you have to lead the therapeutic ratio carefully in terms of potentially dosing to get there.

I can't speak to the competitor compound there.

There are no additional questions at this time I'd like to turn the call back over to earn opera not for closing remarks.

Reni John Benjamin: Our final question is from Christopher Moriah of Nomura Internet. Please go ahead.

Okay. Thank you. Thank your for your friend to Dan for your question on the we look forward to seeing you at upcoming Investor on mitigating circumstances that for now. Thank you again for your participation is a core today, thank you and goodbye.

Steven: Oh, hey, good morning. Thank you for taking the question. Just, you know, maybe touching upon some of the Roxo lifecycle management plans. You know, previously, if I had a mutation inhibitor in the pipeline, looking at that target, and at EHR, there was some great data for one.

This concludes todays conference you may disconnect your lines at this time. Thank you for your participation.

Reni John Benjamin: [inaudible]

Steven: Christopher, hi, it's Steven. So I'll just remind you, we ourselves had a BEST-BRD program, so obviously, we had preclinical data that showed that RUX plus that target had enhanced or potentially enhanced efficacy in myelofibrosis, and we ran into toxicity in terms of an on-target toxicity in terms of thrombocytopenia, and currently, we put ourselves on clinical hold with the regulator You allude to a competitor, the BEST-BRD program, which showed, you're right, some interesting data, and they have an abstract for a future medical meeting that they may show more, and we'll follow that closely. We are interested in anything that enhances RUX activity, and we'll keep looking at that. Our own programs are there for us to use should we need to resurrect.

Steven: [inaudible]

Reni John Benjamin: The toxicities, I think it sounds like the competitor has them, but as you noted, that's something you're still investigating. Any improvement on the therapeutic index there? Maybe any mechanistic reason why?

Steven: and the competitors. Thank you.

Steven: Yeah, so I won't address this directly, but it's known that BRD inhibitors have on target thrombocytopenia that can be profound, so you have to, you know, weave the therapeutic ratio carefully in terms of potentially dosing to get there. You know, I can't speak to the competitor compound there.

Yes.

Herve Hoppenot: There are no additional questions at this time. I'd like to turn the call back over to Herve Hoppenot for closing remarks.

Herve Hoppenot: Okay, thank you. Thank you all for your time today and for your questions, and we look forward to seeing you at upcoming investor and medical conferences. For now, we thank you again for your participation in the call today. Thank you, and goodbye.

Operator: This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

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