Q2 2020 Incyte Corp Earnings Call

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Hello, and welcome to the insight second quarter 2020 financial results conference call and webcast. At this time all participants are really listen only mode. If anyone should require operator assistance. Please press star zero under telephone keypad. A question answer session will follow the formal presentation.

Operator: Hello, and welcome to the Incyte second quarter 2020 financial results conference call and webcast. At this time, all participants are in a listen-only mode.

Operator: If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Mike Booth, Head of Investor Relations at Incyte. Please go ahead.

This conference is being recorded it's now my pleasure to trickle over so Mike Booth head of Investor Relations at Incyte. Please go ahead.

Thank you Kevin.

Mike Booth: Thank you, Kevin. Good morning, and welcome to Incyte's second quarter 2020 earnings conference call and webcast. All slides used today are available for download in the investors 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, I'd like to remind you that some of the statements made during the call today are forward-looking statements, including statements regarding our expectations for 2020 guidance, the commercialization of our products, and the development plans and expectations 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 for the quarter ended March 31, 2020, and from time to time in our other SEC documents.

Good morning, and welcome to inside second quarter 2020 earnings call earnings Conference call on 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 of a battery, Stephen and Christiana, who will deliver our prepared remarks and by Dash will join us for the Q and a session.

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

Before we begin I'd like to remind you that some of the statements made during the call today are forward looking statements, including statements regarding our expectations for 2020 guidance the commercialization of our product development plans and expectations for the compounds in our pipeline as well as the development 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 March 31st 2020 and from time to time in our other FCC documents.

In addition, I would like to caution everyone that the cobot 19 pandemic isn't evolving situation and it is still relatively early to be able to assess the full effect.

Mike Booth: In addition, I would like to caution everyone that the COVID-19 pandemic is an evolving situation, and it is still relatively early to be able to assess the full effects of governmental, business, and social actions and policies and overall economic conditions on our businesses. Accordingly, it is important to keep in mind that our statements on this webcast speak as of today. I will now begin the call with, Thank you, Mike, and good morning, everyone. In the second quarter, we continued to execute well across the various facets of our business, driving strong revenue growth, achieving success in regulatory actions and in key clinical programs, while further improving our sound financial position. Jakafi grew 16% year-over-year to reach $474 million in the second quarter.

Kevin mental business in social elections in policies and overall economic conditions on our business.

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

We'll now begin the call with others.

Thank you Mike good morning, everyone.

Yes. This is going quite a we continue to execute window cross device facets of our business driving strong revenue growth achieving success in regulatory actions and clinical programs wide for also improving some financial position.

Jack I fight it grew 16% year over year, after which 474 million during the second quarter.

I can be an aluminum royalties also grew nicely up 16% and 35% respectively.

Herve Hoppenot: Jacavi and Olumion Royalties also grew nicely, up 16% and 35%, respectively. And I'm also pleased to be able to report six sources of product and royalty revenues for the first time, with the approvals of Pemazir and Tabrek. Total product and royalty revenues were $593 million for the quarter, up 16% year-over-year.

I'm also pleased to be able to refill six so fees of product on a royalty revenues for the first time.

With the providers of him as the fabric though.

Total product on a royalty revenues were 593 million for the quarter up 16% year over year.

We announced two product approvals since we reported Q1 of them, including felt breakdown, which is licensed to novartis.

Herve Hoppenot: We announced two product approvals since we reported Q1, including Tabrecta, which is licensed to Novartis. And just recently, we received our first approval for Montjuvi, in collaboration with Morphosis. Montjuvi is the first FDA-approved therapy for the second-line treatment of adults with DL-BCL, and we believe it has the potential to transform the treatment of patients with relapsed or refractory disease. We also announce the positive results of RITCH3, which is the largest randomized clinical trial ever conducted in steroid-refractory chronic GVHD patients. At EHA, we presented encouraging proof-of-concept data from Our financial position is also very strong, with $1.6 billion in cash and equivalents at the end of the quarter.

Just recently, we received our first approval for movie in collaboration with Macquarie.

Andrew Visa first approved therapy for the second line treatment of adults with Dnbi CN and we believe it has the potential to transforms the treatment of patients with relapsed or refractory disease.

We also announced positive results of which three which is the largest randomized clinical trial ever conducted in steroid refractory chronic gvhd patients.

At its shape, we presented encouraging proof of concept data from my well Ruxolitinib plus perfectly the trial as well as updated.

From the end mine trial, which confirms the durability of responses to deficits mm.

Our financial position is also very strong with 1.6 billion cash and equivalents at the end of quarter.

Slide five shows that were ongoing revenue momentum over the last several years and we expect recent new approval to add for them to our topline.

Herve Hoppenot: Slide 5 shows our ongoing revenue momentum over the last several years, and we expect recent new approvals to add further to our top line. During the remainder of this year, we expect to maintain the momentum of Jacka Fye in MPN and look to drive additional growth in GVS. Sozomo, We are focusing on executing successful launches of both Monjuvi and Pemazir, and we expect Abrekta royalties to increase following the approvals and subsequent launches by Novartis in both the US and Japan. Before the end of 2020, we plan to submit an NDA for rotulatinib cream seeking approval for atopic dermatitis.

During the remainder of this year, we expect to maintains a momentum of objectifying MTN and look to drive additional growth in gvhd.

Furthermore, we are focusing on executing successful launches of both movie on Tim as area and we expect that breakdown royalties to increase following the approval.

Subsequent launches by Novartis in both the U.S. and Japan.

Before the end of 2020, we plan to submit trends year for Ruxolitinib creamed seeking a property that's being done with Eightys.

And we also expect to initiate the pivotal program of Ruxolitinib less Pacific is even patient with myelofibrosis.

Herve Hoppenot: And we also expect to initiate the pivotal program of roxolitinib plus parfeclizib in patients with myelofibrosis. Before I hand off to Barry, I felt it important to provide an overview of COVID-19's impact on us. On the revenue and supply side, we have not seen any material impact to date, and on the regulatory front, there has not been any impact on key timeframes. With regard to clinical development, there has been no change to key late-stage programs since we reported Q1.

Before I hand off to Barry Hi, fix is important to provides an overview of govies 19 impact on our business.

On the revenue and supply side, we have not seen any material impact today and on the regulatory fronts. There has not been any impact on Q timeline.

With regard to clinical development, there has been no chance to late stage programs since we reported Q1.

Why is original shutdowns due to credit 19 affected certain studies.

Herve Hoppenot: While the regional shutdowns due to COVID-19 affected certain studies, the impact has been largely transient, and we remain on track with key timelines. For example, while new patient recruitment in our vitiligo study experienced a slowdown early in the quarter, recruitment has since rebounded to pre-pandemic levels. Therefore, we continue to expect results in 2020. In summary, since the beginning of 2020, we have announced three product approvals and announced positive results from two separate pivotal programs with free and true AD. These achievements, on top of strong commercial performance and excellent progress in clinical development, are important parts of this transformational year for Incyte. I will now pass the call over to Barry. Thank you, Herve, and good morning. Jackupi's sales increased 16% year over year.

Impact has been largely transition and we remain on track with key timeline.

For example.

While the new patient recruitment in our view today will study has experienced a slowdown early in the quarter recruitment has since rebounded to pre pandemic levels. Therefore, we continue to expect results in 22 anyway.

In summary, since the beginning of 2020, we have announced the street products approval and announced positive results from two separate pivotal programs with free on cruelty.

These achievements on top of strength commercial performance I think some progress in clinical development are important parts of this transformational year for insight.

I will know Pensacola over to Barry.

Thank you Irving and good morning.

Justify sales increased 16% year over year, we continue to see robust demand across all three indications and a number of patients on therapy continues to grow.

Barry P. Flannelly: We continue to see robust demand across all three indications, and the number of patients on therapy continues to grow. However, in April and May, new patient starts were negatively impacted due to regional shutdowns related to COVID-19. However, since June, since early June, we have seen a rebound in new patient starts. Despite the challenges of the pandemic, I am proud of our team for their efforts to continue providing the level of service and responsiveness that our customers have been accustomed to over the years. We have expanded our multi-channel engagements, and our field representatives are conducting multiple virtual and digital programs with our customers.

In April and May new patient starts were negatively impacted due to regional shutdowns related to Kobe 19. However, since June since early June we have seen a rebound in new patient starts.

Despite the challenges of the pandemic I am proud of our team for their efforts to continue providing the level of service and responsiveness that our customers have been a custom to over the years.

We have expanded our multichannel engagements and our field representatives are continuing our conducting multiple virtual and digital programs with our customers.

Turning to slide nine we have been successful in identifying the appropriate patients and there are already more than 100 patients on therapy.

Barry P. Flannelly: Turning to slide 9, we have been successful in identifying the appropriate patient, and there are already more than 100 patients on therapy. We have not had any unexpected reimbursement issues, and patient refill rates are encouraging. We have maintained a good depth of prescribers in both academic and community settings, and we are proud to be able to provide these physicians with the much-needed therapy to help their patients. We're also excited about the approval of Monjuvi, the first FDA-approved, second-line treatment for adults with diffuse large B-cell lymphoma. Manjubi is an important non-chemotherapeutic option that has a convincing clinical profile as reflected in the clinical data included in the U.S. prescribing information, with compelling response rates and a long duration of response while avoiding many of the toxicities associated with other forms of treatment. Monjuvi represents a significant opportunity to transform the standard of care for patients with relapsed refractory diffused large B-cell lymphoma

We have not had any unexpected reimbursement issues and patient refill rates are encouraging we have maintained a good depth prescribers in both academic and community settings, and we are proud to be able to provide these positions with the much needed therapy to help their patients.

We're also excited about the approval of mine Julie the first FDA approved second line treatment for adults with diffuse large b cell lymphoma.

In GB is an important non chemo therapeutic option that has a convincing clinical profile as reflected in the clinical data included in the U.S. prescribing information.

With compelling response rates and a long duration of response, while avoiding many of the toxicities associated with other forms of treatment when JV represents a significant opportunity to transform the standard of care for patients with relapsed refractory refractory diffuse large b cell lymphoma.

Our commercial and medical teams are fully staffed with joint insight Morphoses team of approximately 150 full time equivalents, we have identified 11000 potential prescribers, which.

Barry P. Flannelly: Our commercial and medical teams are fully staffed with a joint Incyte Morphosis team of approximately 150 full-time equivalents. We have identified 11,000 potential prescribers, of which approximately 80% are also JAKA5 prescribers. [inaudible] executing successful launches for both Monjuvi and Pemazir, and we expect Tribeca royalties to increase following the approvals and subsequent launches by Novartis in both the U.S. and Japan. Before the end of 2020, we plan to, Oh, sorry. We expect broad market access for Manjubi and already have patient assistance programs in place. While the challenges presented by the COVID-19 pandemic are not ideal for new patient launches, we believe Monjuvi's strong clinical profile, the significant unmet need in relapse refractory diffuse large B-cell lymphoma, and our company's combined expertise leave us very well positioned for a successful launch. With that, I'll now turn the call over to Steven.

Of which approximately 80% are also jacka five prescribers.

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Executing successful launches for both when JV and Pam is here and we expect trifecta royalties to increase following the approvals in subsequent launches by Novartis in both the us in Japan.

Before the end of 2020, we plan to.

Thanks.

Thanks.

Thank you.

Oh, sorry.

We expect broaden market access.

Our main Jamie and already have patient assistance programs in place.

While the challenges presented by covert 19 pandemic are not ideal for new patient launches. We believe line to be strong clinical profile the significant unmet need in relapsed refractory diffuse large b cell lymphoma, and our companies combined expertise leave us very well positioned for a successful launch with that I'll now call the term.

This call over to Steven.

Thank you Barry and good morning, everyone.

Steven H. Stein: Thank you, Barry, and good morning, everyone. Recently, we announced the success of our REACH-3 trial evaluating ruxolitinib versus best available therapy in patients with steroid-refractory chronic graft versus host disease. This was the largest randomized trial ever conducted in this patient population, and the positive data reinforced the importance of JAK inhibition in the treatment of graft-versus-host disease. Raxa-Litnup met its primary endpoint of superior overall The Modified Lee Chronic Graft-Versus-Host Disease Symptom Scale and Failure-Free Survival. The safety profile of roxalitinib was consistent with previously reported studies of roxalitinib in graft-versus-host disease. Following these results, we expect to submit the data from Reach 3 for presentation at an upcoming medical congress, and we are preparing the supplemental NDA submission to the FDA.

Recently, we announced the success of our reach three trial evaluating ruxolitinib versus best available therapy in patients with steroid refractory chronic graft versus host disease.

This was the largest randomized trial ever conducted in this patient population and the positive data reinforces the importance of JAK inhibition in the treatment of graft versus host disease.

Ruxolitinib met its primary endpoint of superior overall response rate at months, six and achieve statistically significant and clinically meaningful improvements in both key secondary endpoints the modified the chronic graft versus host disease symptom scale and failure free survival.

The safety profile of Ruxolitinib was consistent with previously reported studies of Ruxolitinib in graft versus host disease.

Following these results we expect to submit the data from reached three for presentation at an upcoming medical Congress and we are preparing the supplemental NDA submission to the FDA.

Turning to our limited development program on Slide 13.

Steven H. Stein: Turning to our Limber Development Program on slide 13. As part of our life-cycle management, we have multiple strategies ongoing, including the development of a once-daily formulation of Ruxolitin. Combinations with RaxaLytnab and potentially new targets, and we are making progress on all fronts. The most advanced combination within limba is our Ruxolitinib plus parseclusive program, and we recently presented positive proof of concept data that showed the additional benefit obtained from adding 5 mg of daily parseclusive to Ruxolitinib in myelofibrosis patients with an adequate response to Ruxolit Importantly, the addition of parciclis was well tolerated, and treatment-emergent adverse events common to PR3 kinase delta inhibitors were infrequent with the addition of parciclis. These results warrant further study of the combination, and we plan to initiate ruxolitinib plus parseclusive trials in both first-line myelofibrosis patients and in MF patients with a suboptimal response Turning to slide 14.

As part of our lifecycle management, we have multiple strategies ongoing including the development of a once daily formulation of Ruxolitinib.

Combinations with Ruxolitinib and potentially new targets, and we're making progress on all fronts.

The most advanced combination within lumber is our ruxolitinib past pasta closer program and we recently presented positive proof of concept data, which showed the additional benefit obtained from adding five milligrams of daily Paucek listen to Ruxolitinib in myelofibrosis patients within adequate response to Rex.

Monotherapy.

Importantly, the addition of pasta 'cause it was well tolerated and treatment emergent adverse events come into Pithree kinase Delta inhibitors infrequent with the addition of passive glisten.

These results warrant further study of the combination and we plan to initiate ruxolitinib pasta closer trials in both first line myelofibrosis patients and in MF patients with a sub optimal response to Ruxolitinib monotherapy.

Turning to slide 14 in June at the European Hematology Association, we presented updated two year data from the Ellman study of Taffeta tomorrow in combination with Lenalidomide.

Steven H. Stein: In June, at the European Hematology Association, we presented updated two-year data from the L-MIND study of taphocytomab in combination with lenalidomide. These data were consistent with prior presentations. The overall response rate in this data set was 59%, and 41% of patients achieved a complete response. The median duration of response for complete and partial responders, collectively, was 34.6 months, driven by the median duration of response for complete responders, which has not yet been reached. We hope and expect that the data from the L-MIND study are only the beginning for taphocytomab. Working with morphosis, we believe that we have multiple near-term opportunities in diffuse large B-cell lymphomas and other non-Hodgkin's lymphomas, as shown in this summary slide.

These data were consistent with prior presentations.

Overall response rate in this dataset was 59% and 41% of patients achieved a complete response.

The median duration of response for completion partial responders collectively was 34.6 months driven by the median duration of response will complete responders, which has not yet been reached.

We hope and expect that the data from the L. mind only the beginning for tap POSIDUR map working with morphosis, we believe that we have multiple near term opportunities in diffuse large b cell lymphomas and other non hodgkin's lymphoma as as shown in the summary slide.

Later this year, we expect have initial results from our first line diffuse large b cell lymphoma trial first mind.

Steven H. Stein: Later this year, we expect to have initial results from our first-line diffuse large B-cell lymphoma trial. Based on results from the study, we expect to select the appropriate combination, either tafacetamide plus R-CHOP or tafacetamide plus lenalidomide plus R-CHOP, and move forward into a pivotal first-line diffuse large B-cell lymphoma trial in 2021. We also expect to initiate a proof-of-concept study evaluating taprocytomab plus paraclysm in non-Hodgkin's lymphoma before the end of this year. Turning now to our Development Programs in Inflammation and Autoimmunity. As Herve mentioned up front, our development timelines for ruxolid macrime remain on track as we continue to collect long-term safety data from our two pivotal atopic dermatitis studies and plan to submit the NDA at the end of 2020. The Phase III vitiligo trials are now recruiting very well, and new patient enrollment has rebounded since a dip at the beginning of the second quarter.

Based on results from this study, we expect to select the appropriate combination.

The toughest at AMAG, plus R chop or 10% among plus Lenalidomide plus R chop and move forward into pivotal first line diffuse large b cell lymphoma trial in 2021.

We also expect to initiate a proof of concept study evaluating tepid demand plus paucek listen in non Hodgkin's lymphoma before the end of this year.

Turning now to our development programs in inflammation in order immunity.

As I mentioned upfront development timelines for Ruxolitinib cream remain on track as we continue to collect long term safety data from our two pivotal atopic dermatitis studies and plan to submit the NDA at the end of 2020.

The phase III pivotal Argo trials are now recruiting very well and new patient enrollment has rebounded since a dip at the beginning of the second quarter remain on track from results in 2021.

Steven H. Stein: We'll remain on track for results in 2021. We have made significant progress within our key development programs thus far in 2020. We have announced three product approvals this year and have presented positive data from multiple programs. We continue to expect to have data in-house from the ongoing pharmacology studies of once-a-day ruxolitinib in 2020. While a transient COVID-related delay means the external presentation of these data won't be until next year, these data are not on the critical path, and we are still on track for an SNDA submission seeking approval of once-a-day arixalitinib in 2021. We have also decided to discontinue development of our PIM inhibitor and its combination trial with Raxolitin.

We've made significant progress within our key development programs, thus far in Twentytwenty, we've announced three product approvals this year and it presented positive data from multiple programs.

We continue to expect to have data in house from the ongoing pharmacology studies of once a day ruxolitinib in 2020.

While the transient covert related delay means the external presentation of these data won't be until next year. These data are not on the critical path and we are still on track for an EPS in the submission seeking approval of once a day ruxolitinib in 2021.

We also have decided to discontinue development of outcome inhibitor and its combination trial with Ruxolitinib.

Lastly reminder, the various covert trials that are underway, including studies of both Ruxolitinib and Baricitinib.

Steven H. Stein: Lastly, a reminder of the various COVID trials that are underway, including studies of both ruxolitinib and varicitinib. With that, I'd like to turn the call over to Christiana for the financial update. Thank you, 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 25 and 27 in the backup section of the deck and to the press release we issued this morning. Moving to our results for the second quarter, revenue growth continued to be strong, with total product and royalty revenues of $593 million, representing an increase of 16% over the second quarter of 2019. This is comprised of net product revenues of $474 million for Jackify, $23 million for iClusiq, and $4 million for Pemage.

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

Thank you Stephen and good morning, everyone. The financial update to this morning will include GAAP and non-GAAP numbers for a full reconciliation of GAAP to non-GAAP. Please refer to slide 25 in 27 in the backup section of the deck enter the press release, we should this morning.

Moving to our results for the second quarter revenue growth continued to be strong with total product and royalty revenues of $593 million, representing an increase of 16% over the second quarter of 2019.

This is comprised of net product revenues of $474 million for Jack up by $23 million for Iclusig and $4 million for pay my team.

Yes, this from Novartis over $66 million for Jack RV, and $1 million for breakfast and royalties from Lilly of $26 million 4 million.

Christiana Stamoulis: Royalties from Novartis of $66 million for Jacobi and $1 million for Tabrecta and royalties from Lilly of $26 million for Olumi. We recorded revenue growth across both the products commercialized by Incyte and those commercialized by our partners, with the exception of iClusiq, where we recorded a 7% decline in revenues as a result of some stocking that we experienced in the first quarter of the year due to the Total revenues increased 30% over the prior year quarter, driven by both the increase in product and royalty revenues, as well as $95 million of milestone revenue related to the approvals of TABRECTA and PEMAS. Total costs and expenses for the quarter of $400 million on a non-GAAP basis represent an increase of 5% over the prior year quarter, well below the growth rate in product and royalty revenues.

We recorded revenue growth across both at products commercialized by anti then those commercialized by our partners with exceptional pipe Lucy where we recorded a 7% decline in revenues as a result of stop some stocking that we experienced in the first quarter of the year due to the causing 19 pandemic.

Total revenues increased 30% over the prior year quarter, driven by both increasing product and royalty revenues as well.

$95 million of milestone revenue related to that provides that BRCA and pet machine.

Total cost of and expenses for the quarter of $400 million from the non-GAAP basis represent an increase of 5% over the prior year quarter, well below the growth rate in product and royalty revenues.

Ongoing R&D expense for the quarter was $250 million on a non-GAAP basis, representing a 6% increase from the prior year quarter.

Christiana Stamoulis: Ongoing R&D expense for the quarter was $250 million, a 6% increase from the prior year quarter. This increase was primarily due to our 55% share of the global and US-specific development costs for tafacitamab, the clinical trials of raxolitinib as a potential therapy for COVID-19, and other pipeline programs progressing to later stages of development. SG&A expense for the quarter was $104 million on a non-gap basis, representing a 12% increase over the prior year quarter.

This increase was primarily due to our 55% share of the global and us specific development cost for purposes.

The clinical trial of Ruxolitinib passive potential therapy for covet 19, and other pipeline programs are progressing to later stages of development.

As Jay expense for the quarter was $104 million on the non-GAAP basis, representing a 12% increase over the prior year quarter.

This increase was primarily due to an increase in commercialization efforts related to jacobine payments here and preparation for the potential commercialization of Ruxolitinib Green.

Christiana Stamoulis: This increase was primarily due to an increase in commercialization efforts related to Jackify and Pemazir and preparation for the potential commercialization of Raxolitinib cream. Collaboration loss for the quarter was $13 million, which represents our 50% share of the U.S. net commercialization loss for Monju. Our financial position continues to be strong as we ended the quarter with $1.6 billion in cash and marketable securities. The decrease from $2.1 billion at 2019 year-end reflects the upfront payment and stock purchase related to the Morphosis collaboration partially offset by the cash flow generated during the first half of 2020. Moving on to our guidance for 2020, we are reiterating our revenue and expense guidance for the year. While there continue to be uncertainties associated with COVID-19, including the risk of a broader resurgence, we believe these are captured in the ranges provided. As a reminder, the R&D guidance excludes the $805 million upfront consideration related to our collaboration with Morphosis. Finally, at this early stage of their launches, we are not providing guidance on Temazir sales.

Collaboration loss for the quarter was $13 million, which we present our 50%.

Of the U.S. net commercialization loss from one Julie.

Our financial position continues to be strong as we ended the quarter with $1.6 billion in cash and marketable securities.

Decreased from $2.1 billion had 2019 year end reflects an upfront payment is stock purchases related to the portfolios. This collaboration partially offset by the cash flow generated during the first half of Twentytwenty.

Moving on to our guidance for two entities Wendy we are reiterating our revenue and expense guidance for the year.

While there continue to be uncertainties associated with covered 19, including risk of broader resurgence. We believe these are capturing that ranges provided.

As a reminder, that in the guidance excludes today $105 million upfront consideration related to our collaboration with Merck forces.

Finally at this early stage of the launches, we're not providing guidance on payments entails.

Or on our collaboration net profit or loss, resulting from the commercialization activities from one Julie in thank you.

Operator: All on our collaboration net profit or loss resulting from the commercialization activities for Monjuvi in the U.S. Operator, that concludes our prepared remarks. Please give your instructions and open the call for Q&A.

Operator that concludes our prepared remarks, please give your instructions and open the call from QNX.

Certainly when other congressional question answer session. If you got to be placed in the question can you. Please press star one under telephone Keypad. As reminder, please ask one question. It if needed one follow up that return to the Q once again that star one to be placed into question Q.

Operator: As a reminder, please ask one question and, if needed, one follow-up, then return. Once again, that's star one to be placed into question. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star one.

For participants using speaker equipment may be necessary to pick up your handset before pressing star one one moment. Please what we pull for questions. What's your Thats one question and one follow up if needed. Our first question today is coming from the improvement from Morgan Stanley. Your line is now lives.

Operator: One moment, please, while we pull for questions. And once again, that's one question and one follow-up. Our first question today is coming from Vikram Purohit from Morgan Stanley. Your line is now: Hi, thanks for taking my question. So I had two questions on the Limber program. First, I just wanted to see if you could talk a bit more about what you saw in the initial PIM plus RUCS data that led you to the decision to discontinue that facet of the Limber program. And then secondly, for the RUCs plus PI3K combination studies, you're looking to start in the first line and the refractory setting. I just wanted to see if you could talk a bit more about what those studies would look like from a design perspective and how you're thinking about what the initial bar for success there is going to be. Vikram, hi, it's Steven.

Hi, Thanks for taking my question.

Two questions on the Limber program first just wanted to see if you could talk a bit more about what you saw in the initial Tim plus rux data that.

Led you to the decision to discontinue that facet of the Limber program and then secondly.

For the.

Plus through a combination studies you are looking to start in the first line and the refractory setting I just wanted to see if you could talk a bit more about what those studies would look like from a design perspective, and how you're thinking about what the initial bar for success theres going to be thanks.

Become Hyatt Stephen Thanks for your question in terms of the Permian Rex program.

Steven H. Stein: Thanks for your question. In terms of the PIMRx program, as far as we know, we were the sort of last PIM inhibitor left standing across R&D programs, and this was largely due to on-target effects in terms of the liver and transaminitis, and we weren't able to get the PIM dose much above 80 milligrams. And then if you look at that Toriboli profile in combination with some of the efficacy we've seen, although interesting and preclinically very interesting, it wasn't a program that we felt had a high chance of success going forward. So for those two reasons, both Toriboli in terms of liver and reaching adequate efficacy bars.

As we know we with this sort of lost Perm inhibitor left standing across R&D programs and it's largely due to.

On target effects in terms of 11, and trunks ammonite us and we weren't able to get the optimum dose much above 80 milligrams and then if you look at that Tolerability profile in combination with some of the efficacy we seen although interest in Preclinically very interesting. It wasn't a program that we felt had high chance of success going forward.

For those two reasons, both tolerability in terms of liver and reach an adequate efficacy bars.

Turning to the Rex Delta program as we alluded to in our remarks and this is the this is our lead program. We show in our internal proof of concept data, we explored various dosing and schedule regimens and clearly there's a delta effect. If you. If you go back to the biology.

Steven H. Stein: You know, turning to the RUX Delta program, as we alluded to in our remarks, this is our lead program. We've shown our internal proof of concept data. We explored various dosing and schedule regimens.

Three kinase Delta as a pathways up regulated in myelofibrosis. These preclinical data that make sense and in terms of the clinical effect, we've seen although very strictly defined in our proof of concept that patients that have been on six months of rocks and a stable dose for a couple of months even.

Steven H. Stein: PR3 kinase delta is a pathway, it's upregulated in myelofibrosis, so this is preclinical data that makes sense, and in terms of the clinical effect we've seen, although very strictly defined in our proof of concept that patients had to have been on six months of RUCs and a stable dose for a couple of months, even with that, we saw, you know, increased spleen response So we're initiating two studies, a suboptimal responder RUC study, as we've spoken about, for people who've been on at least three months and are not having an adequate RUC response, as well as a first line study. In terms of the endpoints, you're going to have to wait for the clintrials.gov listings to go up when we start these studies before we make those public. They should be relatively obvious for the first-line study, and then the suboptimal responder study, that'll go up on that particular listing. Thanks. Alright, thank you.

Even with that we saw increased.

Clean response as well as symptom responses. So we are initiating two studies a sub optimal respond rock study as we spoken about.

People have been on at least three months and not having an adequate direct response as well as a first line study in terms of the endpoints you're going have to wait for the Clin trials.

Listings to go up when we when we start these studies before we make those public.

They should be relatively obvious for the first launch study and then the sub optimal respond to study that will go up on that that particular listen thanks.

Alright, thank you.

Thank you next question today is coming from Cory Kasimov from JP Morgan. Your line is now lives.

Hey, good morning, guys. Thanks for taking my question.

Barry P. Flannelly: Thank you. Our next question today is coming from Corey Kazimoff from J.P. Morgan. Your line is now live. Hey, good morning, guys.

Wanted to ask you around Gvhd in can you just kind of described next steps in timelines, we should be thinking about on so they're chronic gvhd opportunity and expanding the label. So the syndication and would you expect more I know you got from market to but would you expect more spontaneous use in this setting even ahead of approval given the promising.

Barry P. Flannelly: Thanks for taking the question. I wanted to ask you about GVHD and can you just kind of describe next steps and timelines we should be thinking about for the chronic GVHD opportunity and expanding the label for the syndication? And would you expect more?

Reached three data in the unmet need that's out there.

Steven H. Stein: I know you're not going to market it, but would you expect more spontaneous use in this setting even ahead of approval given the promising REACH3 data and the unmet need that's out there? So, Corey, I'll start off, and then the second part of your question, Barry, will take. You know, I assume you're alluding to the REACH3 study that we recently press-released the outcomes of. You know, it's an outstanding outcome for patients and for us in terms of hitting both the primary, very strictly defined overall response rate endpoint at month six, plus failure-free survival, and the PRO, the patient-reported outcome, in terms of the modified Lee symptom score. So, a great outcome for that.

So sorry, I'll start off and then the second part of your question very well take I assume you're alluding to to the reached three study that we recently press release the outcomes.

It's an outstanding outcome for patients and for US in terms of hits in both the primary very strictly defined.

Overall response rate endpoint at month, six plus failure free survival and the end the PRB the patient reported outcome in terms of the modified knee symptom score so great outcome.

For that obviously, we will.

We filed reached two as well now now will be going ahead.

Finally in reached three as a supplemental NDA as soon as we can in terms of getting it into the label.

Just I Wonder if you are talking also about steroid nine E chronic graft versus host disease that work with its assistant continues this year in terms of dose exploration, we're looking at at various doses and schedules plus the steering effect there before initiating further work with into certain of the so across the entire spectrum across Miss it.

Steven H. Stein: You know, obviously, we filed, you know, REACH2 as well now, and now we'll be going ahead with filing REACH3 as a supplemental NDA as soon as we can in terms of getting it into the label. Just, I don't know if you were talking also about steroid-naive chronic graft-versus-host disease. That work with itacitinib continues this year in terms of dose exploration. We're looking at various doses and schedules, plus the steroid effect there, before initiating further work with itacitinib there. So, you know, across the entire spectrum of graft-versus-host disease, we're still very active, both with filing and then with itacitinib and steroid-naive. In terms of your question for Barry. Hey, Corey.

This disease, which we still very active both with filing and then with its assistant of instead naive terms. Your question for Berry inquiry, yet in terms of spontaneous use and chronic gvhd, obviously, we know that theres already some use and chronic gvhd.

Jack if I and I think because we only really sort of in the top line results from reached three not until there's a full presentation publication will the awareness increase at that time, some additional spontaneous use may occur.

But we'll have to wait and see.

Okay, and Barry did you see any major impact from Kroger and the Gvhd French fewer transplants that will presumably taking place.

Barry P. Flannelly: Yeah, in terms of spontaneous use in chronic GPHD, obviously, we know that there's already some use in chronic GPHD with Jackify, and I think because we only released sort of the top-line results from REACH3, awareness will not increase until there's a full presentation or publication. At that time, some additional spontaneous use may occur, but we'll have to wait and see. Okay, and Barry, did you see any like a major impact from COVID on the GVHD front? Fewer transplants that were presumably taking place?

Well, we certainly saw a decrease in new patients so.

As you as you know Corey.

New patient starts really represents a relatively small part.

Total number of patients better on.

Jack or five so we do know that bone marrow transplants were delayed.

We saw a decrease perhaps in.

April and May and we know that patients that need a bone marrow transplant has to come back.

When they're feeling more safe and winter disease requires it so as more bone marrow transplants go up and Gvhd will go up.

Barry P. Flannelly: Well, we certainly saw a decrease in new patients. So, you know, as you know, Corey, new patient starts really represent a relatively small part of the total number of patients that are on Jackify. So we do know that bone marrow transplants were delayed. We saw a decrease perhaps in April and May.

Okay. Appreciate it thank you.

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

Hey, guys. Thanks, very much for taking my question, maybe a follow up question also for Barry.

Can you talk about any shifts in growth patterns that you saw with Jack by maybe across the other two indications due to Corona I guess Im curious if there's any inventory impact that you are seeing or any patient level stockpiling changes in compliance or persistence and then would you would you expect to see any changes now with the pandemic.

Barry P. Flannelly: And we know that patients that need a bone marrow transplant have to come back when they're feeling more safe and when their disease requires it. So as more bone marrow transplants go up, GBHD will go up. Okay, appreciate it.

Barry P. Flannelly: Our next question today is coming from Brian Abrahams from RBC Capital Markets. Your line is now live. Hey guys, thanks very much for taking my question. Maybe a follow-up question also for Barry.

Rebounding in July and August to the overall patterns.

Jack by use thanks.

Sure Brian.

Barry P. Flannelly: Can you talk about any shifts in growth patterns that you saw with Jackify, maybe across the other two indications due to Corona? I guess I'm curious if there's any inventory impact that you're seeing or any patient level stockpile, changes in compliance, or persistence, and then would you expect to see any changes now with the pandemic rebounding in July and August to the overall patterns of Jackify use? Thanks.

Well I don't think that the.

The percentage of patients who are taking Jack the five for TV.

The HD and myelofibrosis has really changed at all to Cove and now we do know as I said, particularly in certain regions you can imagine east coast, particularly in New York, and New Jersey, as our new patient starts for each of these indications go down in June and now in July we have seen week after week.

Barry P. Flannelly: Well, I don't think that the percentage of patients who are taking Jackify for PV, GVHD, and myelofibrosis has really changed at all due to COVID. Now, we do know, as I said, particularly in certain regions, you can imagine the East Coast, particularly New York and New Jersey, you saw new patient starts for each of these indications go down. In June, and now in July, we have seen week after week, small increases in new patient starts, but new patient starts are relatively small in each given quarter, in each given month anyway. But we have seen week after week, starting in June, new patient starts coming back. So, again, we haven't really seen any movement in one area versus another in terms of the total amount of bottles sold.

Okay.

Small increases in new patient starts, but new patient starts are relatively small.

In each given quarter in each given month anyway, but we have seen week after week starting in June new patient starts coming back so.

Again, we haven't really seen any movement in one area versus another in terms of total amount of bottle sold.

Thank you.

Thank you and his question is coming from Salveen Richter from Goldman Sachs. Your line is now live.

Good morning, Thanks for taking my question, so as we look towards.

Concept data from the or PD. One inhibitor. Later this year can you help frame expectations on that type of data, we'll see what level of activity here looking forward to move forward.

Moving that Stephen Thanks for the question. So in terms of our Aro PDL one program, we've been progressing well and.

We're in the phase now with the second half of this year from our clinical program will be able to present translational data from the actual clinical specimens to show Directionally.

Barry P. Flannelly: Thank you. Thank you. Our next question is coming from Salveen Richter from Goldman Sachs. Your line is now locked.

The rock degree of PDL, one inhibition T cell changes that we want to et cetera that are supportive of continuing the program.

Steven H. Stein: Good morning, thanks for taking my question. So as we look towards proof of concept data from the oral PD-L1 inhibitor later this year, can you help frame expectations for the type of data we'll see and what level of activity you're looking for to move forward? Salveen, it's Steven. Thanks for the question.

Substantial clinical data in its entirety will be more likely next year, but all the data we have in hand and that we presented in the second half of this year at an appropriate meeting are supportive of continuing.

Thanks.

Thank goodness question today is coming from Evan Seigerman from Credit Suisse. Your line is no line.

Steven H. Stein: So in terms of our oral PD-L1 program, we've been progressing well, and we're in this phase now where, in the second half of this year, from our clinical program, we'll be able to present translational data from the actual clinical specimens to show the directionally right degree of PD-L1 inhibition, T cell changes that we want, etc., that are supportive of continuing the program. Substantive clinical data in its entirety will be more likely next year, but all the data we have in hand and that we've presented in the second half of this year, in appropriate medians, are supportive of continuing. Thanks.

Hi, all thank you so much for taking my question Congrats on a really great week with strong results today and the approval of under these late last Friday.

So just on premise iron the tumor agnostic setting can you just remind us of the status of is for you I cant remember if you mentioned it earlier that also delayed as with the bladder trial and then any color on the penetration into the eligible patient population, including go carcinoma. Following the launch earlier this year.

Steven H. Stein: Thank you. Our next question today is coming from Evan Segerman from Credit Suisse. Your line is now live.

Evan Stephen Thanks, So in terms of your question actually the tumor agnostic program has it has not been affected five by cobot much at all and enroll in extremely well probably speaking to a in earnings extreme unmet need there so it's across various.

Steven H. Stein: Hi all, thank you so much for taking my question and congratulations on a really great week with strong results today and the approval of UNRUBY late last Friday. So just on Pemezire and the tumor agnostic setting, can you just remind us of the status of this program? I can't remember if you mentioned it earlier.

Fusions in terms of the molecular biology, as well as rearrangements as well as testing.

If there's any activity in applications as well so they are different buckets, we fill up that I celledge agnostic and Thats progressing well you spoke a little bit about the bladder program data, we will be getting in the second half year, we'll complete the continuous dosing experiment, but in terms of presenting the data it will be next year.

Steven H. Stein: Is it also delayed as with the bladder trial? And then any color on the penetration into the eligible patient population in cholangiocarcinoma following the launch earlier this year has not been affected much by COVID?

Steven H. Stein: It enrolled extremely well, probably speaking to an extreme unmet need there. So it's across various fusions in terms of molecular biology, as well as rearrangements, as well as testing if there's any activity in amplifications as well. So there are different buckets we fill up that are histology agnostic, and that's progressing well. Now, you spoke a little bit about the BLADR program. The data we will be getting in the second half of the year will complete the continuous dosing experiment, but in terms of presenting the data, it'll be next year. So that's the status of the BLADR program, and then I'll turn it over to Barry. Sure, Evan.

So thats the status of the bladder program and then I'll turn it over to Barry.

Sure Evan so you're talking about penetration I think I said in my prepared remarks that there is over a 100 patients.

Treated already and actually we know that.

There is more most of those patients have come back for refills as well. So they are continuing so the duration of therapy as something that will continue to follow but.

Even the 4 million that we reported in this quarter and more than 100 patients on therapy right. Now is ahead of what we predicted.

Internally.

Excellent. Thank you so much.

Thank you and his question is coming from because in the month from Bank of America. Your line is Ella.

Good morning, guys. Thanks for taking my question.

Barry P. Flannelly: So you talked about penetration. I think I said in my prepared remarks that there were over 100 patients treated already, and actually, we know that most of those patients have come back for refills as well, so they're continuing. So the duration of therapy is something that will continue to follow, but even the 4 million that we reported in this quarter and the more than 100 patients on therapy right now are ahead of what we predicted internally.

I just wanted to get us and perhaps on how you're thinking about the first line setting.

Is there.

Taking a combination is open to that you're looking at that you would prefer.

Consistently pomalidomide.

Is it somewhat of a priority potentially avoid having that.

Combo, given its side effect profile and its possibility or I'd like to hear your thoughts.

That might impact from patients desire to be on therapy, Inc.

Yes, Stephen Thanks for your question. If you look at first line diffuse B cell lymphoma stand of care remains our chop with approximately a 40, 50% care rate.

Barry P. Flannelly: Excellent. Thank you so much. Thank you. Our next question is coming from Tazeen Ahmad from Bank of America. Your line is now live. Good morning, guys.

Our rate many many have tried to beat that an hasn't been easy historically in the past to do that so it's really about.

Steven H. Stein: Thanks for taking my questions. I just wanted to get a sense, perhaps, on how you're thinking about the first mind study. Is there a particular combination of the two that you're looking at that you would prefer?

Upfront efficacy and improving the cure rate. That's what you have to achieve to beat that bar, so and a little bit maybe in terms of sacrifice intolerability because it's about care upfront. So we'll see you know the safety data as we sit on the call yesterday will be key looking at either tap assessment by low.

Steven H. Stein: As it relates specifically to lenalidomide, is it somewhat of a priority to potentially avoid having that in the combo, given its side effect profile and its possibility, or I'd like to hear your thoughts on how that might impact some patients' desire to be on therapy? Yeah, Steven, thanks for your question. You know, if you look at first-line diffuse B cell lymphoma, the standard of care remains our top with a, you know, approximately a 40-50% care rate and cure rate. Many, many have tried to beat that, and it hasn't been easy historically in the past to do that. So it's really about upfront efficacy and improving the cure rate, that's what you have to achieve to beat that bar. So, maybe a little bit in terms of doublet with RCHOP, that may be the way we end up going, because it's about getting to the efficacy bar. You know, as the Morphosis CMO said with us on the call yesterday, this is still subject to getting that data in house and then regulatory discussion on the appropriate endpoints. So those are the caveats there.

Soon plus the R chop regimen, or 10%, Matt plus lane plus the R. Chop regimen, if the safety ends up and we'll get the data by the end of this year.

Being is mostly a wash and there's no increase talks that warring from from the doublet with R. Chop that maybe the way we end up going because it's about getting to the efficacy bar as the morphosis CMO said with us on the call yesterday. This is still subject to getting that data in hand.

Our son and regulatory discussion on on the appropriate endpoint. So those are the caveat today, but I just want to reiterate you have to win on efficacy here you have to improve the cure rate in diffuse large b cell lymphoma upfront. Thanks.

Please see.

Maybe a follow up what percent of this population at the older patients given that they might be potentially more pro rata.

The in terms of the epidemiology on age will have to get back Im not sure what percent. If you asking is above 65 I'll have to find it out for you sorry.

Thank you.

Thank you next question today is coming from Mark from from Cowen and company. Your line is alive.

Steven H. Stein: But I just want to reiterate, you have to win on efficacy here; you have to improve the cure rate in diffuse large B cell lymphoma up front. Thanks. I appreciate that.

Yes, thanks for taking my questions.

Just follow up on your comments about the easier launch and the success relative to your internal expectations I guess.

Steven H. Stein: Just maybe a follow-up. What percent of this population would be older patients, given that they might be potentially more prone to side effects? In terms of the epidemiology of age, I will have to get back to you. I'm not sure what percent, if you're asking, is above 65. I'll have to find that out for you. Sorry.

Earnings are you had on kind of a virtual launch.

Things that are working maybe some things that aren't working and yet how are those going get applied to.

The launch of types.

Yes, Mark I think we learned a lot actually I think we.

Despite this pandemic, we learn things that.

That really work that will keep doing.

Barry P. Flannelly: No worries. Thank you. Thank you. The next question today is coming from Marc Frahm from Cowan & Company. Your line is now live.

Virtual programs virtual visits virtual speaker programs virtual advisory boards all of these things work preparing this year, we really targeted.

Barry P. Flannelly: Thanks for taking my questions. Barry, just to follow up on your comments about the Pemzier launch and kind of the success relative to your internal expectations, I guess, what learnings have you had on kind of a virtual launch about things that are working, maybe some things that aren't working? And how are those going to get applied?

The physicians that we wanted to target ahead of time that we know our G docs that specialize in cleanser carcinoma.

Liver cancer, and so forth and we were able to reach them.

Virtually.

Through our Representatives and then of course before that our medical affairs people had relationships with these stocks and our oncology clinical nurse educators help them.

Barry P. Flannelly: The launch of TAPS- Yeah, Marc, I think we learned a lot, actually. I think we, you know, despite this pandemic, we learned things that really work that we'll keep doing. Virtual Programs, Virtual Visits, Virtual Speaker Programs, Virtual Advisory Boards, all of these things work.

Management dosing and side effects and they were each able to to reach out and what we also learned about pendants here about a new launch during this time period and I think it relates to when Judy very much is that docs want to hear about new launches and how to use drugs, particularly benazir is being used for.

First approved drug for patient population, it's never had anything that was really effective before and in terms of mine JV.

Barry P. Flannelly: For Pemizer, we really targeted the positions that we wanted to target ahead of time that we know are GI docs that specialize in cholangiocarcinoma, liver cancer, and so forth. And we were able to reach them virtually through our representatives, and then, of course, before that, our medical affairs people had relationships with these doctors, and our oncology clinical nurse educators helped them manage the dosing and side effects, and they were each able to reach out to them. What we also learned about Pemizer, about a new launch during this time period, and I think it relates to Manjubi very much, is that doctors want to hear about new launches and how to use drugs. Particularly Pemizer is being used for, you know, the first approved drug for a patient population that's never had anything that was really effective before. And in terms of Manjubi, the first drug approved for second-line diffuse large B cell lymphoma, they want to hear about these new options for their patients who desperately need new therapy. Okay, and then.

The first drug approved for second line.

Diffuse large b cell lymphoma, they want to hear about these new options for their patients who desperately need new therapies.

Okay and then.

On the initial demand you're seeing is that all in Glendale carcinoma are you already seeing some off label use either in the.

Tumor agnostic indication or even maybe people who can't tolerate the available inhibitor once again.

Yes, so thats, our knowledge markets really all in plans you'll carcinoma for patients.

If our arrangements.

And fusions.

Okay. Thank you.

Thank you. Our next question today is coming from a we via young from Cantor Fitzgerald. Your line is our lives.

Hey, guys. Thanks for taking my question and congrats amount of progress.

Question on that they'll program and now that you had the combination data it looks interesting kind of wanted to talk about.

Let's focus on monotherapy there and then can you just kinda talk a little bit about.

Continued investment for 80.

Barry P. Flannelly: On the initial demand you're seeing, is that all in cholangiocarcinoma, or are you already seeing some off-label use, either in the tumor agnostic indication, or even maybe people who can't tolerate the available inhibitor? Yeah, so the best part of our knowledge, Marc, is really all in glandular carcinoma for patients that have FTFR rearrangements, infusion. Okay, thank you. Thank you. Our next question today is coming from Alethia Young from Canthropus Gerald. Your line is now live.

Heading into the upcoming launch.

Thanks.

Early I'll start off its Steven on on your first question related to the Citadel program. So all the studies have enrolled really well follicular.

Mantle cell and marginal zone, we presented data at various points along the route for for all three started jeez, we have in the range of the high activity, we wanted as well as the durability of response that we wanted.

In a we will get that in house and we will proceed with appropriate regulatory filings.

Steven H. Stein: Hey guys, thanks for taking my question and congrats on all the progress. I'm just going to ask you a question about the Citadel program. And now that you have the combination data that looks interesting, kind of wanted to talk about your kind of focus on monotherapy there, and then can you just kind of talk a little bit about kind of continued investment for AD heading into the upcoming launch for the RuckShrink. So, Alethea, I'll start off with Steven on your first question related to the Citadel program. So, all the studies have enrolled really well, follicular, mantle cell, and marginal zone. We presented data at various points along the route for all three histologies.

For monotherapy in the different parts of World, where it's where it's relevant they all likely to be under accelerated approval or conditional marketing authorizations, and we'll need as you alluded to a confirmatory programs and those are likely to be in combination to designs of which still need further refinement.

And discussion with regulators, but.

A lot to include combinations with CD 20, or even cdnineteen antibodies given that that we are treating lymphomas and then I'll hand, the question of about the investments related to the launch.

Yes, I guess you were asking about continuing investment in a Dave.

Related to launch obviously, it's 80 ended lygo, because we anticipate that Lego could be relatively soon after we get approval for a topic dermatitis, but I think herve said multiple times that we're building an.

Steven H. Stein: We have, you know, in the range of the high activity we wanted, as well as the durability of response that we wanted. So, you know, we will get that in-house, and we will proceed with appropriate regulatory filings for monotherapy in the different parts of the world where it's relevant. They are all likely to be under accelerated approval or conditional marketing authorization and will need, as you allude to, confirmatory programs, and those are likely to be in combination.

Separate business unit.

For dermatology or auto immune diseases.

So we already have onboard are a good part of our medical affairs team or market access team. We're building out the commercial organization. So thats, our continued investment and obviously really getting ready because we believe that rux cream.

Could really transformed the treatment of a topic dermatitis.

Steven H. Stein: The designs of which still need further refinement and discussion with regulators, but, you know, they're likely to include combinations with CD20 or even CD19 antibodies given that we are treating lymphoma, and then I'll hand the question over about the investment related to the launch. Yeah, so Althea, I guess you were asking about the continuing investment in AD related to the launch. Obviously, it's AD and vitiligo because we anticipate vitiligo could be approved relatively soon after we get approval for atopic dermatitis.

I'd say it.

Regarding the rest of so thats, where the us where the situation is very clear regarding the rest of world.

Ins.

In Europe, we are.

Looking at the scenario, where in fact Vinci. They go could be the first indications that we'd be submitting so the timing for Europe is slightly different from what we having the U.S. mogens slightly can be it can be a few months.

Behind and we're still looking at the best commercial.

Flowing month.

And frankly, we want to have.

Herve Hoppenot: But I think Herve said multiple times that we're building a separate business unit for dermatology or autoimmune diseases. So we already have on board a good part of our medical affairs team, our market access team. We're building out the commercial organization, so that's our continuing investment. And obviously, we're really getting ready because we believe that Rux cream could really transform the treatment of atopic dermatitis in the United States. Regarding the rest of the world, that is.

You can pick our time on the I know some of you our asking what is a model that will be following in Europe, and we are really going through a level of diligence that requires more time on the and we'll be able to communicate how we're going to commercialize in Europe probably.

Early next year.

Thank you and his question today is coming from Mara Goldstein from Mizuho. Your line is now lives.

Herve Hoppenot: In Europe, we are looking at the scenario where, in fact, VT LIGO could be the first indication that we will be submitting. So the timing for Europe is slightly different from what we have in the U.S. In fact, more than slightly.

Great. Thanks for taking my questions.

Good question just on.

Great.

And the status.

From a.

Perspective.

Which data from the podium program are we likely to see.

Herve Hoppenot: It can be a few months behind. And we are still looking for the best commercial deployment there. And frankly, we want to have, you know, take our time. I know some of you are asking, you know, what is the model that we'll be following in Europe?

And then secondarily, appearing on the Jack cycle Whitney.

Well the 19 program.

Yes in terms of ready fan out.

Herve Hoppenot: And we are really going through a level of diligence that requires more time. And we'll be able to communicate how we are going to commercialize in Europe early next year. Thank you. My next question today is coming from Mara Goldstein from Mizzou. Your line is now live.

PD one inhibitor that the initial programs again, all enrolled incredibly well squamous cell annual cost Sanomat am ESI high endometrial and the Merkel cell program.

We intend to submit.

Steven H. Stein: Great, thanks so much for taking my questions. I have a question just on Rita Phanlamab and where you are from a clinical trial perspective, and which data from the Podium program are we likely to see initially? And then secondarily, is there an update on the JAK-5 COVID-19 program from CRS? Yes, in terms of Retifanla, our IV PD-1 inhibitor, the NISH programs have, again, all enrolled incredibly well: squamous cell, anal carcinoma, MSI high, endometrial, and the Merkel cell program. We intend to submit data from Merkel and anal cell carcinoma at a medical meeting in the second half of this year, and that's when that data will be public. In terms of RUCS in COVID-19, just a reminder, there are two programs. There's one in conjunction with Novartis globally called RUCS COVID, which is in patients that are on pre-mechanical ventilation but have evidence of a cytokine storm and is looking at RUCS 5 milligrams twice daily plus standard of care versus standard of care.

Data from.

Cool and annual cell carcinoma at a medical meeting second half of this year and Thats when that data will be public in terms of rocks in.

Cobot 19, just a reminder, the two programs. This one in conjunction with Novartis globally called Rux covert.

That's in patients that are pre.

Mechanical ventilation.

I have evidence of cytokine storm and is looking at Rex five milligrams twice daily.

Plus stand of care versus standard of care. It's in 400 patients. The primary endpoint for that study was the proportion of patients who die develop respiratory failure show required to UK by day 29.

And that progressing progressing well have obviously, we hope to have data complete study with an endpoint and report out at before the end of the year. The second study, we running our sales largely in United States is the ventilator study. So it's again.

Adults with Covance 19 associated respiratory failure, who are on ventilation and has to dosage arms in terms of Roxa five milligram VIP arm and the 15 milligram be I'd on both with standard of care versus standard of care and that is tracking a little bit behind in terms of enrollment launch.

Steven H. Stein: That's in 400 patients. The primary endpoint for that study was the proportion of patients who die, develop respiratory failure, or require ICU care by day 29. That's progressing well, and obviously we hope to have data, complete the study with an endpoint, and report out before the end of the year. The second study we run in ourselves, largely in the United States, is the ventilator study. It's again adults with COVID-19 associated respiratory failure who are on ventilation. It has two dosage arms in terms of RUCS, a 5 milligram BID arm and a 15 milligram BID arm, both with standard of care versus standard of care.

Actually because there's less ventilation than the was because people are trying to avoid that so again, we hope to have data before the end of the year, but it's hard to tell you exactly when at the moment. The in on that study just remind us a little larger so that was 500 patients because as three arms and the primary endpoint was.

Very clean one was overall survival Judy any cause through day 29, so thats the status of those studies. Thanks.

Thank you very much.

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

Steven H. Stein: That is tracking a little bit behind in terms of enrollment, largely because there's less ventilation than there was because people are trying to avoid that. Again, we hope to have data before the end of the year, but it's hard to tell you exactly when. At the moment, the endpoint of that study, just to remind you, was a little larger, so that was 500 patients because there were three arms. The primary endpoint was a very clean one, i.e., overall survival due to any cause through day 29. That's the status of those studies. Thanks. Thank you very much.

Hi, guys congrats on the progress and thank you for taking the question.

Wanted to follow up on the Limber program, where you tightened up the focus a little by discontinuing Rux, plus Pam and you're moving rux plus parse it into pivotal trials, but you still have quite a few shots on goal. So I was wondering which of those are you. Most excited about with the highest probability of success and the greatest clinical differentiation. Thank you.

Yes Stephen.

Steven H. Stein: Thank you. Our next question is coming from Jay Olson from Oppenheimer. Your line is now live.

It's an extremely important program to us for all the obvious reasons plus we have a lot of.

Steven H. Stein: Oh hi, congratulations on the progress and thank you for taking the question. I wanted to follow up on the Limber program where you've tightened up the focus a little by discontinuing RUX plus PIM, and you're moving RUX plus PARSA into pivotal trials. But you still have quite a few shots at goal, so I was wondering which of those you are most excited about with the highest probability of success and the greatest clinical differentiation? Thank you. Yeah Jay, it's Steven.

Scientific.

Ownership of the model productive neoplasms space, just be even beyond ruxolitinib. They diseases, we feel very passionately about.

Just to remind you the lumber program has three pillars to it. The first one is a formulation work, which we spoke about in our prepared remarks and the once daily formulation work is going well and we intend to file that San Diego next year, and we believe that is important in itself and.

From a convenience point of view and the May lend itself down the pike to us to win.

Steven H. Stein: So it's an extremely important program to us for all the obvious reasons. Plus, you know, we have a lot of scientific ownership of the myeloproliferative neoplasm space, just be beyond ruxolitinib, the diseases we feel very passionately about. Just to remind you, the Limba program has three pillars to it. The first one is the formulation work, which we spoke about in our prepared remarks, and the once daily formulation work is going well, and we intend to file that SNDA next year. And we believe, you know, that is important in itself and also potentially from a convenience point of view.

So those combinations with other once daily mechanisms in terms of the second on which.

Ways to either in Han efficacy in a particular disease setting or safety or both.

Those programs the lead one is the rux plus plus plus a program again, we spoke about in the prepared remarks, we feel we have internal proof of concept data and we are initiating both the sub optimal responder to rock study as well as the first line Myelofibrosis study this year.

The other programs that are really important to us.

Our resurrected pet inhibitor program. So we doing in monotherapy work. This year just to prove safety at the dose we've chosen and then we'll very quickly go due to combination to work there and we'll see where that leads us again that could be potentially in the second line setting as well as in the first.

Steven H. Stein: And it may lend itself down the pike to us doing fixed dose combinations with other ones daily mechanism. In terms of the second arm, which are ways to either enhance efficacy in a particular disease setting, or safety, or both, those programs, the lead one is the RUX plus Parseclyssa program, again, we spoke about in the prepared remarks. We feel we have internal proof of concept data, and we're initiating both the suboptimal responder to RUX study, as well as the first-line myelofibrosis study this year. The other programs that are really important to us are our resurrected BAT inhibitor program, so we're doing monotherapy work this year, just to prove safety at the dose we've chosen, and then we'll very quickly go to Again, that could potentially happen in a second-line setting, as well as in a first-line setting.

Instead in and then and then very importantly, although on the surface looks like a tolerability play in terms of the two inhibitor and the hip side and mechanism and improving anemia, either due to the underlying disease modifying versus what Judy the effect of a JAK inhibitor not only sure if that works should improve.

The anemia, but then also allow patients to stay on the on Rex longer and should improve efficacy as well. So that is in again monotherapy safety now and should also go to combination hopefully by the end of this year and then the third pillar, which for obvious reasons, we speak less about but he is all around.

Discovery efforts ran out of Dasha shop looking at.

Steven H. Stein: And then, very importantly, although on the surface it looks like a tolerability play in terms of the L2 inhibitor and the hepcidin mechanism and improving anemia, either due to the underlying disease, myelofibrosis, or due to the effect of a JAK inhibitor, not only should that work, should it improve anemia, but then it will also allow patients to stay on RUX longer, and should improve efficacy So that is in, again, monotherapy safety now and should also go to combination, hopefully, by the end of this year. And then the third pillar, which for obvious reasons we speak less about, but is all about discovery efforts run out of DasherShop, looking at other ways, other new targets, epigenetic targets, or other ways that we may be interested in, even in PVRA itself. And those will obviously be announced if and when they get to the clinic. So that's the entirety of the program.

Other ways other new targets epigenetic targets or other ways that we may be interested in even in PVR itself and those will obviously be announced if and when they get to the clinic. So thats the entirety of the program. Thanks.

Great. Thanks for taking the question.

Thank you next question is coming from Tyler Van Buren from Piper Sandler Your line is now lives.

Hey, good morning grid pseudo quarterly results, especially in light of the ongoing pandemic related question on the justified product revenue guidance, which was reiterated and seems very conservative you mentioned that new patient starts rebounded in June you have a growing pool total patients and robust demand in all three indications.

The midpoint of the guidance assumes relatively flat quarter over quarter growth on an absolute basis and if you look at the top end to the guidance is still.

Lower year over year growth rates or deceleration in the second half. So this is Joe spak during in the ongoing uncertainty due to the pandemic or are there any potential year over year pressures.

Steven H. Stein: Alright, thanks for taking the question. Thank you. My next question is coming from Tyler Van Buren on behalf of Piper Sandler. Your line is now live. Hey, good morning.

The guidance is factoring that we should also consider.

Christiana Stamoulis: Great to see the quarterly results, especially in light of the ongoing pandemic. I had a question on the Jackify product revenue guidance, which was reiterated to be very conservative. You mentioned that new patient starts rebounded in June. You have a growing pool of total patients and robust demand in all three indications, yet the midpoint of the guidance assumes relatively flat quarter-over-quarter growth on an absolute basis. And if you look at the top end of the guidance, it's still lower year-over-year growth rates or deceleration in the second half.

Hi, Larry you are absolutely right if you look at.

Jackup high in the first half of the year, we grew 19% when you compare to the first half of 2019 with a growth primarily coming over 70% of this growth coming from volume from demand.

So if you work to to look at Lee you were saying that that at this point in the here we would be.

If anything bringing.

The low end of the guidance.

Low end of the guidance imply a flat.

Three in Q4 to get too so given the significant uncertainty that remains around covert 19 their risk for a broader resurgence we felt that this year, it's appropriate to keep the guidance to where we had said is to keep it broader guidance.

Christiana Stamoulis: So it's just factoring in the ongoing uncertainty due to the pandemic, or are there any potential year-over-year pressures that the guidance is factoring that we should also, Tyler, you are absolutely right. If you look at Jessica Fye, in the first half of the year, we grew 19% when compared to the first half of 2019, with the growth primarily coming over 70% of this growth coming from volume, from demand.

This point in the year to be able to.

Address any potential.

In fact that we may see from many surgeons in corporate 19.

Okay.

Christiana Stamoulis: So if you were to look at this, you would think that at this point in the year, we would be, if anything, bringing up the low end of the guidance. The low end of the guidance implies a flat Q3 and Q4 to Q2. So given the significant uncertainty that remains around COVID-19, and the risk for a broader resurgence, we felt that this year it was appropriate to keep the guidance to where we had set it, to keep a broader guidance at this point in the year, to be able to address any potential impact that we may see from a resurgence in COVID-19. Okay, thanks for the additional comments. Your next question today is coming from Josh Schimmer from Evercore ISI. Your line is now live.

Okay. Thanks for the additional comments.

Thank you and his question today is coming from Josh Schimmer from Evercore ISI. Your line is not alive.

Hey, Thanks for taking the questions was positive reached three data reflected in your long term guidance for.

3 billion peak sales of check and.

Considering expanding your dermatology portfolio further complement ruxolitinib cream and if so what might that look like.

Hey.

Thank you.

Obviously is already with free result.

Very positive on it I don't say more of an expected, but it's certainly a very very good 30, you will have the opportunity to seasonal results.

Herve Hoppenot: Thanks for taking the questions. Was the Positive Reach 3 data reflected in your long-term guidance? Are you considering expanding your dermatology portfolio? Your Herve here. I'll take it.

When they are published on the answer a question of what does it mean in term of long term guidance came up when we saw as a result, so I think your question is that the appropriate you know we have.

First in the past 2.5 to 3 billion for Jack a file you can see where this year is going so we.

Herve Hoppenot: So, obviously, the rich, rich results are... Very positive. I won't say more than expected, but it's certainly a very good study. You will have the opportunity to see the results when they are published, and the question of what they mean in terms of long-term guidance came up when we saw the results. So I think your question is totally appropriate. You know, we have said in the past $2.5 to $3 billion for Jakafa. You can see where this year is going.

Sort of ahead of the courage to look at it from that standpoint, what we also look that is.

Political uncertainty on the fact that.

So you with.

A number of questions.

Open related to.

So healthcare system in general on reimbursement.

Product so I think.

Herve Hoppenot: So we are sort of ahead of the curve if you look at it from that standpoint. What we also looked at was political uncertainty and the fact that, in the U.S., there are a number of questions still open related to the health care system in general and reimbursement of products. So I think the best way to think about it is probably to see how this is evolving and also see the data that we have in REACH3 publicly, and then it will give us, with both of them, an opportunity to look again at the long-term guidance if we need to, and that's, again, something that will be after the end of the year. Buzzer, the second question is dermatology. So, you know, we are very excited, I must say, about the past few months. We have had a number of...

So based with two to two to think about it is probably to see how is this is evolving.

Also sees with data that we have.

Free.

Okay, and then it will give us with both of them anup opportunity too.

To look again, that's a long term guidance, if we need them thats again, something that we'd be happy.

After the acquisition.

The second question is dermatology. So you know we are very.

Excited I must say over the past few months we have.

Had a number of.

Advisory boards.

Decisions of feedback with dermatologists in the U.S. and in Europe on.

Profile.

Herve Hoppenot: Advisory Board, and sessions of feedback with dermatologists in the US and in Europe on the profile of ROCKSCREAM, and that has made us evolve our expectation from that franchise because what we are hearing from them is that there are no other products that are providing that level of efficacy that you see in a true AD and, obviously, the lack of systemic exposure and the level of safety that you can expect from a topical. So it's not really, you know, in the category of other topical products; it is a product that has the potential to be transformative. So we are looking at it now with a new eye in terms of how big it could be. We still have the vitiligo study that is, as Stephen was describing, moving very quickly. So it gives us a potential submission in 2020 for AD, approval in 2021, submission in vitiligo, and then approval in vitiligo. So there is already a sort of cycle of new products that will come out for the next two years.

Of rock Scream and that has.

Many of those evolve our expectation from that franchise, because what we are hearing from them is that.

No as our product that is providing that level of if you get sees that you. So in a truly D.

The obviously is the lack of systemic exposure on delivered a 50 that you can expect from at the vehicle. So it's it's not really but.

In the category as you goes up topical product. It is a product that has the potential to be transformative. So we're looking at its now with the new high in term of how big it could be we see the hubs of Interlagos 30 that is as Stephen was describing moving very quickly. So it gives us a potential submission in 2024 80.

Providing 2021 submission in the today go up then approval in the tobacco. So there is already a sort of a cycle of new product that is coming for the next to euro and we are just looking at other product that could be complementing the franchise internally, we have programs ongoing with our own.

Herve Hoppenot: And we are obviously looking at other products that could be complementing the franchise. Internally, we have programs ongoing with our own, you know, group of products that potentially have an immuno-modulating potential. So that could apply to many indications. And we are also looking at external opportunities for. What would be good science applied to dermatology that could complement the portfolio?

Loan.

Yes.

Group of products that have potentially and immuno modulating baton charting so that could apply to many indication and we also looking at external opportunities for.

What would be.

Good science applies to dermatology that can be complementing the portfolio. So that is literally a new division of inside that is being built no.

Herve Hoppenot: So there is literally a new division of Incyte that is being built now that will start with Roxcreme and, I think, could have, you know, a very important potential over the next five years to add to the growth that we have in cancer and oncology and dermatology. Thank you. The next question today is coming from Ren Benjamin from J&P Securities. Your line is now live. Hi, good morning, guys.

That wouldnt be starting with through extreme unless include have.

During both on potential of over the next five years two to add to the growth that we haven't cancer on those oncology and immunology.

Thank you.

Thank you and his question today is coming from Ren Benjamin from JMP Securities. Your line is Alan.

Hi, Good morning, guys. Thanks for taking the questions and congrats on the quarter.

Herve Hoppenot: Thanks for taking the questions and congratulations on the quarter. Can we talk a little bit about patent extension strategies? You know, I see the ones that, you know, daily can, definitely seems to make sense and can extend, obviously, your patents there. But what do we think about these combinations that are being evaluated, particularly in the limber studies? Do they ultimately have to, you know, be developed as one's daily formulations as well to continue to extend the patent? I mean, the patent itself on rocks, I would not comment on that.

So we talk a little bit about the patent extension strategies.

I see the once daily can.

Definitely seems to make sense and and can extend.

Obviously your your patents there, but how do we think about these combinations that are being evaluated particularly in the lumber study.

Do they ultimately have to.

Be developed as once daily formulations as well to continue to extend extend to the patents.

Okay, perfect instead from Iraq, I Wouldnt comment on that so what is.

Obviously part of our plan is to improve over ruxolitinib from the clinical anticipation benefit standpoint and to do it in a way that will help both extends the life of our franchise in MF and PV on the but I'm truly in Gvhd. So security is very important for two reason is.

Herve Hoppenot: So what is it? Obviously, part of our plan is to improve Roxality NIP from the clinical and patient benefit standpoint and to do it in a way that will help us extend the life of our franchise in MF and PV and potentially in GVHD. So the QD is very important for two reasons. One is that, by itself, it has a longer pattern than we have with twice a day, and it is also a way to combine with other once a day products that we have in our portfolio.

By itself it has a longer patterns on we have with twice a day.

It is also.

With two drew combination with over one for that product that we have in our portfolio.

And when you think of two of our product being one for then you obviously.

Herve Hoppenot: And when you think of two oral products being once a day, then you are obviously looking at the possibility of doing a fixed-dose combination. And if the product you are combining with has a patent life that goes beyond the patent of Jack Fye-Roxolitinib itself, it's obviously increasing, you know, the exclusivity that you have on this fixed-dose combination. If possible, that would certainly help maintain the leadership that we have in the field of MFPV and TVHD. So that's really the way we are looking. Got it. And then, just as a quick follow-up with Manju, can you just remind us the gross to net assumptions that we should be factoring in? Well, this is Barry.

Looking at the possibility of doing fixed dose combination if the product you are combining with hasn't picked implies that goes beyond for patent the check a fight ruxolitinib itself, it's obviously increasing.

Those are exclusively that you have on this fixed dose combination. So you can think of.

The perfect received on Beth.

As potential partner for Ruxolitinib that we are testing in the clinic for us to establish superiority from the clinical standpoint, and then that could give us an opportunity to develop fixed dose combination.

Placebo.

It would be.

Andy helping maintains a leadership that we have in the field of MSP VM Gvhd, So thats, where it is a where we are looking at it.

Barry P. Flannelly: So we didn't really comment on the gross net assumptions. We talked about the price, the average monthly price. And, you know, obviously, we're working on that together with our partners. Some, obviously, discounts are required through government programs, through CMS, and so forth.

Got it and then just as a quick follow up with London can you just remind us the gross to net assumptions that we should be Patrick.

Well as as Barry So we didn't really comment on a gross to net assumptions, we talked about the price the average monthly price and obviously, we're working on that together with our partners some.

Barry P. Flannelly: But we really haven't said what the gross net will be. We'll have to see as we go forward. Thanks for taking the question. Thank you. Our next question today is coming from Aidan Husamoff from the Benchmark Company. Your line is now live. Thanks for taking my questions. I have one on Manjuli.

Obviously discounts are required.

Through government programs through CMS and so forth.

But we really haven't said what the gross to net will be will have to see as we go forward.

Great. Thanks for taking the questions.

Thank you and this question today is coming from either who is the most food benchmark company. Your line is Ella.

Thanks for taking my questions.

Oh I have one on one Julie.

So given this is a combination though agent and given that drip. Let me there's already expensive drop to think more than $20000 to expect any resistance or impediments, especially in budget conscious you environments such as item potential for this.

Herve Hoppenot: So given this is a combination agent and given that Revlimid is already an expensive drug, I think more than $20,000, do you expect any pay resistance or impediments, especially in budget-conscious EU pay environments, such as sides and French authorities? So, I'll take the first part of the question addressed to the United States, and Herve can address the outside of the United States. So, we think the combination of this injectable and oral drug together is priced appropriately for the benefit that the regimen provides. If you look at other analogs, for example, particularly in multiple myeloma, injectable drugs that are combined with Revlimid are approximately the same price per month, per year, and others are actually priced higher.

So I'll take the first part of the question dress, the United States nerve wracking addressed outside the United States. So we think the combination of this injectable and oral drug together is priced appropriately for the benefit that the regiment provides if you look to other analog for example is particularly in May.

Well myeloma.

Injectable drugs that are combined with.

Revlimid or approximately the same price per month per year.

Others are actually priced higher if you compare to two car T therapy is obviously there are many different complications there, but obviously that that's in the same sort of price range for per patient.

Herve Hoppenot: If you compare it to CAR T therapies, obviously, there are many different complications there, but obviously, that's in the same sort of price range for per patient. Just a comment on the EU; the cycle of patent expiration for lenalidomide is different in the EU; there are generics already available in a number of countries already today, and when we look at the approval timing for approval and reimbursement timing for Montjuvi of Tafessitamab in Europe. In fact, it is.

Just a comment on use the cycle of patent expiration. Following the demise is different in the U.S. They are generics already available in a number of countries already today.

On the when we look at the approval.

The timing for approval on the reimbursement timing.

Four.

On Dhruvi of service them up in Europe in fact it is.

Almost cool incidentals that it is when lenalidomide is going generic in many of the large.

Herve Hoppenot: It is almost coincidental that it is when linalidomide is going generic in many of the large countries. So what we anticipate is to be negotiating the price, as we have to do in all of these countries in Europe, at a time when the cost of linalidomide will be going down very drastically. So it should be, and it's a little bit by chance, but it should be a good time to, Thank you, appreciate that. And I have one follow-up regarding Jakafi. So how would you compare the performance of Jakafi versus Jakavi in Europe? Because both showed 16% growth, but Jakavi's actual sales only grew 9%.

Countries, so what we anticipated to be negotiating some price as we have to do in all of these countries in Europe at the time, where the cost of Lenalidomide will be going down very drastically so it should be.

It's a little bit by chance, but it shouldn't be a good.

A good timing to be able to.

Have a reasonable.

Price for deficits and maybe in Europe.

Thank you appreciate that and then I won't call up regarding justify so when you compare the performance of Jakafi versus Chicago in Europe, because both short 16% growth, but jakavi actual sales on the grew 9% and just was curious what's the.

Herve Hoppenot: And I just was curious, what's the MF growth in Jakafi, Jakafi indications, MF growth? Now the comment on JaccaVee in Europe versus JaccaFye in the US, I think what we have seen since the launch is a sort of a classical curve where obviously, the volumes are higher, and the price is lower outside of the US. That's a sort of a general statement on all of these products, and Novartis has done an excellent job to ensure that JaccaVee became standard of care in MF& The GVHD launch has not yet been done in Europe. GVHD, the decision was to submit together REACH-2 and REACH-3, so they are two large, largest ever pivotal studies that will be used for the submission in Europe and outside of the U.S., in fact, in general, that will be used together.

Growth in Jakarta, Jakafi indications and macro.

No the comment on the tech heavy in Europe second fine for US I think what we have seen since the launch is this sort of a classical curve, where obviously the volumes are higher over price are lower in outside of the U.S. as to sort of general statement on the on all of this product.

And.

And Novartis has done an excellent job too.

I'm sure that's like heavy.

Became thought of care in MF and PV is a gvhd launch has not been.

Yes.

In Europe.

D. is that this season, the west to submit together, which true unleveraged free. So there are two large largest ever pivotal studies that would be useful as a submission Europe and outside of the us in fact in general that wouldn't be used together also reason to do that is related to pricing because every new indicate.

Herve Hoppenot: The reason to do that is related to pricing because every new indication is leading to a price reduction. So the decision was made by Novartis to do it together, and now that we're, we know the results of REACH3 are fantastic, it is certainly a very good decision, so we will see the GVHD expansion happen later than what we have seen in the U.S., but overall, I must say the growth, ex-U.S. and in the U.S., has been meeting expectations for both sides and has been very parallel in So it's a story of good partnerships that, frankly, have been working very well for 10 years.

Sean is leading to price reduction. So those are the seasonal was mid by Novartis to do it together on now that we.

We know the results of rich free.

Fantastic.

It is certainly a very good very good. This season. So we will see the gvhd expansion happen later than what we have seen in the U.S., but overall I am us as a growth ex us on us has been.

First exceeding expectations for both sides and.

Has been very parallel in term of how MF and PV.

Have been have been evolving so it's a story of real good partnerships that frankly now for 10 years has been working very well.

Okay.

Herve Hoppenot: Thank you. Our next question is coming from George Farmer from BMO Capital Markets. Your line is now live. George, perhaps your phone is on mute; please pick up your handset.

Thank you and his question is coming from George Foreman from BMO capital markets. Your line is now live.

Mr. Paulo, perhaps your phone is on mute please pick up your handset.

Hi can you hear me.

Please proceed this weekend, okay, great Sams I'd like to talk more about your strategy will form for Sacco seven lots in maps and how do you see that combination setting.

Steven H. Stein: Hi, can you hear me? Yes, we can. Okay, great, thanks. I'd like to talk more about your strategy with Parsacla, Fibb, and Roxin in MS, and how do you see that combination fitting in with other JAK inhibitors. Steven, so again, just to reiterate the program as we set it up, so there will be two studies. The first line study would be RUCS plus PASA versus RUCS. So, you know, if it ends up being successful, then that particular combination would become the standard of care there. In terms of the suboptimal responder study, that is for patients who've been on at least three months of RUCS and have had a stable dose but are having, you know, a very carefully defined inadequate response in terms of spleen volume reduction and or symptoms.

Other JAK inhibitors.

Sure.

At Stephens again, just to reiterate the program as we said it up so there will be two studies. The first line study would be in racks plus pasta srecs.

If the ends up down the Pike being successful then that particular combination would become the standard of care there in terms of.

The sub optimal responded study.

That is for patients who've been on at least three months of Ruxolitinib at a stable dose, but having a.

Very carefully defined inadequate response in terms of spleen volume reduction and or symptoms and then you add on past success of to that particular patient profile and looking for added benefit the endpoint for that as I said earlier, we will announce when the study goes live animals are puntland trials OCA, but it's a very differ.

Steven H. Stein: And then you add PASA-CLISP to that particular patient profile and look for added benefits. The end point for that, as I said earlier, we will announce when the study goes live, and we'll go up on clintrials.gov, but it's a very different patient segment because these are people who have had an inadequate response to ruxolitinib. If you play this out in your head, if the first line study wins and is more efficacious, then there are fewer patients with inadequate responders down the pike. So that's how you work out the patient flow through the various lines of therapy in myelofibrosis.

And.

Patient segment.

Because these are people who have had an inadequate.

Response to Ruxolitinib. If you play this out in your head if the first line study wins and is more efficacious, then a less patients with inadequate responders down down the packs.

Thats, how you workout the patient flow through the various lines of therapy in myelofibrosis.

Okay, Great and then.

Hi, Greg could you comment a little bit more on how we should think about launching ramps for atopic dermatitis in Europe. In the meantime, you had said that maybe you filed with the Lygo.

Steven H. Stein: Okay, great. And then, Herve, could you comment a little bit more on how we should think about launching RUC for atopic dermatitis in Europe in the meantime? And you had said that maybe you'd file for vitiligo or maybe launch ahead of time with vitiligo ahead of AD. Can you just clarify that? Yeah, I said that because there was a discussion on how the price would be impacted by the sequence of launch, and what we believe today, and I'm not, you know, you never know what can happen, but at this point, it looks like that if we do a sequence of atopic derm followed by vitiligo, we will end up with a reimbursement that will be very much lower than if we do vitilig I was saying that because there were a lot of questions about the commercial model in Europe.

Maybe launch ahead of with Middle I go ahead of 80 can you just clarify that.

Yeah, I said that because there was.

A discussion on.

How is the price will be impacted by the sequence of launch.

What we believe today and I'm not.

You never know what can happen, but at this point what it looks like is that if we do a sequence of at the big followed by Vitiligo, We will end up with a reimbursement that will be very much lower than if we do vitiligo first.

So so thats, what we are now thinking about that were things up because.

There were a lot of questions on the commercial model in Europe, and I think what seems to be emerging is that the launch in Europe may be.

Herve Hoppenot: And I think what seems to be emerging is that the launch in Europe may be delayed compared to the launch in the U.S. if we start with VT-Line. Great, thanks very much. Thank you. Our next question today is coming from Steven Willey on behalf of Steve Poole. Your line is now live. Yeah, thanks for squeezing me in. Maybe for Steven.

Delays.

Compared to the launching the us if we start with VW.

Great. Thanks very much.

Thank you next question today is coming from Stephen Willey from Stifel. Your line is alone.

Yes, Thanks for squeezing me in maybe for Stephen.

I guess you your comments around endpoint selection in the inadequate responders trial, maybe implies like Theres still some regulatory dialogue that's ongoing there.

Steven H. Stein: I guess your comments around endpoint selection in the inadequate trial maybe implies that there's still some regulatory dialogue that's ongoing. I think AbbVie just posted details around the phase 3 transform study in the relapsed refractory setting, and it looks like they're using SVR 35 as a primary. Should we think about this as a surrogate of regulatory flexibility, or potential use of a lower SVR threshold?

I think abbvie just posted details around the phase three transforms study in relapsed refractory setting it looks like they're using SVR 35, as a as a primary I guess.

Should we think about this as as a surrogate a regulatory flexibility around the potential use of lower SVR thresholds.

Steven H. Stein: I'm not going to satisfy you with my response because you'll have to wait for the outcome when we publish it. But we did see they published their end point at an SVR 35% decrease on the second line. That is the established end point that we established in the first line, as you well know, and it's no secret that it's likely to be the end point in any further first line studies at the moment. So you'll just have to wait to see.

Yes, I'm not going to satisfy you with my response, because you'll have to wait for the outcome. When we publish it but we did see they publish their endpoint and SVR, 35% decrease in the second line that is the establish endpoint and we established in the first line as you will know and that it's no secret is likely to be the endpoint in any further first line.

Studies at the moment. So we'll just have to wait to see what we completed our negotiations with regulators and we're all set to go up as you'll have to wait till we put it up.

Steven H. Stein: We've completed our negotiations with regulators, and we're all set to go. Thank you. Our next question is coming from Matt Phipps of William Blair. Your line is now live. Good morning, thank you. An editorial associated with the recent Lancet publication on topical rux in vitiligo, it does bring up the acne side effect as a potential limitation given a lot of exposure to the face. So I'm just wondering if there's any temporal nature to acne, is it associated with chemo exposure, or was it more transient?

Thanks.

All right.

Thank you next question is coming from that flips from William Blair. Your line is allies.

Good morning, Thank you.

Editorial associated with the recent plans for publication.

Topical drops that awhile ago. It does bring up the ACMI side effect of the potential limitation, given a lot of exposure to the face. So just wondering if theres any temporal nature of acne as it associated with Sheila exposure or was it more transient and then business do you guys think this has any potential commercial impact mainly on duration.

Steven H. Stein: And then does this, you know, do you guys think this has any potential commercial impact, mainly on duration of therapy? Yeah, Steven, I'll comment a little bit. We haven't seen a temporal link per se, in terms of the onset of some acne, nor have we seen it be particularly problematic.

One of therapy.

Yes, Stephen I'll comment a little bit.

We haven't seen.

At 10 poor or link per se in terms of the onset to have some acne nor has it been particularly problematic.

So from the data we have thus far in the proof of concept study. That's the conclusion, obviously as we've been telling you in rolling now two large phase threes there'll be north of 600 patients total with longer follow up and we'll see how that plays out, but it's just not something that that.

Steven H. Stein: So, you know, from the data we have thus far in the proof of concept study, that's the conclusion. Obviously, you know, as we've been telling you, we're enrolling now in two large phase threes, they'll be north of 600 patients total, with longer follow-up, and we'll see how that plays out. But it's just not something that, you know, other than the adverse events being reported, which is important for patients, that's particularly problematic in terms of long-term use thus far.

Other than the adverse event being reported which is important for patients that's particularly problematic in terms of long term use thus far.

Well thanks.

Thank you. Our final question today is coming from Michael Schmidt from Guggenheim. Your line is allies.

Steven H. Stein: Thank you. Our final question today is coming from Michael Schmidt from Guggenheim. Your line is now live.

Hey, guys.

Steven H. Stein: Hey guys, I had a question about your bi-specific antibody program, MCLA-145. Maybe Steven, just wondering what your level of excitement is for this asset. And based on what we've heard from other similar product candidates, it seems like there's, you know, some interest there, so I'm curious where you are and when we might see initial data from the study. Thank you for mentioning our biospecific program. It's a very interesting doublet from a biology point of view.

Question on your by specific antibody program and C.L.A. 140 fives.

Maybe Steven just wondering what your level of excitement as for that asset and based on what we've heard from other similar product candidates.

Seems like there's.

Some some interest that's just curious where you are and when we might see initial data from the study.

Yes. Thank you for mentioned in up by specific program no. There, it's a very interesting.

Sublet from a biology point of view its four when BB or CD 137, as a target.

Steven H. Stein: It's 4-1BB or CD137 as the target, coupled with PD-L1. So 4-1BB has a long history in the past of other companies trying it on its own and running into toxicity, particularly liver tox. So the coupling with PD-L1 was done as a delivery mechanism to take that 4-1BB to PD-L1 expression areas, and the theory being that it would avoid the associated toxicity, plus then get the enhanced efficacy either additive or synergy-wise.

Coupled with PDL one.

For one BB has a long history in the past.

Other companies trying it on its own and ran into.

Excessively, particularly liver tox. So the coupling with PDL one was done as a delivery mechanism to take that for when BB to PDL, one expression areas and in the theory been would it would avoid.

The associated toxicity, plus then get the enhanced efficacy is added to our synergy wise and the program is going well.

Steven H. Stein: And the program is going well. We'll present data probably next year, but it continues to go well. There is a tremendous amount of interest from people who work in the field around it, and the ball's in our hands, so to speak, to get to a safe dose and then progress it.

Present data.

Probably next year, we won't see data this year from it but it continues to go well. This this is a tremendous amount of interest from people who work in the field around it and it.

Sort of bowls in our hands, so to speak to get to a safe dose and then progressive but we're encouraged by what we've seen thus far in the programs and rolling it pretty well thanks.

Steven H. Stein: But we're encouraged by what we've seen thus far, and the program's enrolling pretty well. All right, thank you. Thank you. We've reached the end of our question and answer session. I'd like to turn the floor back over to Mike for any further questions. So, thank you all for taking the time to join us on the call today and for your questions. Of course, Christine and I will be available for the rest of the day for any follow-ups. But for now, we thank you again, and we'll close the call. Thank you, and goodbye. Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation.

Right. Thank you.

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

So thank you all thanks for taking the time to join us on the call today and for your questions.

Of course, Christine and I will be available for the rest of the day for any follow ups, but for now we thank you again and we'll close the call. Thank you and goodbye.

Thank you. This concludes today's teleconference and webcast you may disconnect. Your lines at this time and have a wonderful day, we thank you for your participation today.