Incyte Corp (INCY) — Q2 2020 Earnings Call Transcript

Thank you, Kevin. Good morning, and welcome to Incyte's second quarter 2020 earnings call and webcast. The slides used today are available for download on the Investors section of incyte.com. I'm joined on the call today by Hervé, 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 ask questions as time allows. Before we begin, I'd like to remind you that some of the statements made during the call today are forward-looking statements, including statements regarding our expectations for 2020 guidance, the commercialization of our products, and 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. In addition, I would like to caution everyone that the COVID-19 pandemic is an evolving situation, and it is still relatively early to assess the full effect of governmental, business, and social actions and policies and overall economic conditions on our business. Accordingly, it is important to keep in mind that our statements on this webcast speak as of today. We'll now begin the call with Hervé.

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. Jakavi and Olumiant 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 Pemazyre and Tabrecta. Total product and royalty revenues were $593 million for the quarter, up 16% year-over-year. 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 Monjuvi in collaboration with MorphoSys. Monjuvi is the first FDA-approved therapy for the second-line treatment of adults with DLBCL, and we believe it has the potential to transform the treatment of patients who have relapsed or refractory disease. We also announced the positive results of REACH3, 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 ruxolitinib plus parsaclisib trial well as well as updated two-year data from the L-MIND trial, which confirms the durability of responses to tafasitamab. Our financial position is also very strong with $1.6 billion in cash and equivalents at the end of the quarter. Slide five shows our ongoing revenue momentum over the last several years, and we expect recent new approval to add further to our top line. During the remainder of this year, we expect to maintain the momentum of Jakafi in MPN and look to drive additional growth in GVHD. Furthermore, we are focusing on executing successful launches of both Monjuvi and Pemazyre, and we expect Tabrecta 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 submit the NDA for ruxolitinib cream, seeking approval in atopic dermatitis, and we also expect to initiate the pivotal program of ruxolitinib plus parsaclisib in patients with myelofibrosis. Before I hand off to Barry, I felt it's important to provide an overview of COVID-19 impact on our business. On the revenue and supply side, we have not seen any material impact to date and on the regulatory fronts, there has not been any impact on key timelines. With regards to clinical development, there has been no change to key late-stage programs since we reported Q1. While the original 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 has experienced a slowdown early in the quarter, recruitment has since rebounded to pre-pandemic levels. Therefore, we continue to expect results in 2021. In summary, since the beginning of 2020, we have announced three product approvals and announced positive results from two separate pivotal programs REACH3 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 to Barry.

Thank you, Hervé, and good morning. Jakafi sales increased 16% year-over-year. We continue to see robust demand across all three indications and the number of patients on therapy continues to grow. In April and May, new patient starts were negatively impacted due to regional shutdowns related to COVID-19. However, 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 multichannel engagements, and our field representatives are conducting multiple, virtual and digital programs with our customers. Turning to Slide 9. We have been successful in identifying the appropriate patients, 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 a much-needed therapy to help their patients. We are also excited about the approval of Monjuvi, the first FDA-approved second-line treatment for adults with diffuse large B-cell lymphoma. Monjuvi 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 diffuse large B-cell lymphoma. Our commercial and medical teams are fully staffed with a joint Incyte MorphoSys team of approximately 150 full-time equivalents. We have identified 11,000 potential prescribers, approximately 80% of whom are also Jakafi prescribers. We are executing successful launches for both Monjuvi and Pemazyre, and we expect Tabrecta royalties to increase following the approvals and subsequent launches by Novartis in both the U.S. and Japan. Before the end of 2020, we expect broad market access for Monjuvi 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 relapsed/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.

Thank you, Barry, and good morning, everyone. Recently, we announced the success of our REACH3 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 reinforce the importance of JAK inhibition in the treatment of graft-versus-host disease. Ruxolitinib met its primary endpoint of superior overall response rate at month six and achieved statistically significant and clinically meaningful improvements in both key secondary endpoints: the modified 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 REACH3 for presentation at an upcoming Medical Congress, and we are preparing the supplemental NDA submission to the FDA. 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 ruxolitinib, combinations with ruxolitinib and potentially new targets, and we are making progress on all fronts. The most advanced combination within LIMBER is our ruxolitinib plus parsaclisib program and we recently presented positive proof-of-concept data, which showed the additional benefit obtained from adding five milligrams of daily parsaclisib through ruxolitinib in myelofibrosis patients with an inadequate response to ruxolitinib monotherapy. Importantly, the addition of parsaclisib was well-tolerated and treatment-emergent adverse events common to PI3 kinase delta inhibitors were infrequent with the addition of parsaclisib. These results warrant further study of the combination and we are planning to initiate ruxolitinib plus parsaclisib trials in both first-line myelofibrosis patients and in MF patients with a suboptimal response to ruxolitinib monotherapy. Turning to slide 14. In June, at the European Hematology Association, we presented updated two-year data from the L-MIND study of tafasitamab 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 are only the beginning for tafasitamab. Working with MorphoSys, we believe that we have multiple near-term opportunities in diffuse large B-cell lymphomas and other non-Hodgkin's lymphomas, as shown in the summary slide. 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 tafasitamab plus R-CHOP or tafasitamab 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 tafasitamab plus parsaclisib in non-Hodgkin's lymphoma before the end of this year. Turning now to our development programs in inflammation and autoimmunity. As Hervé mentioned upfront, our development timeline for ruxolitinib cream remains 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 the dip at the beginning of the second quarter. We 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 ruxolitinib in 2021. We also have decided to discontinue development of our perm inhibitor and its combination trial with ruxolitinib. Lastly, a reminder of the various cover trials that are underway, including studies of both ruxolitinib and baracitinib. 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 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 Jakafi, $23 million for Iclusig and $4 million for Pemazyre. Royalties from Novartis of $66 million for Jakavi and $1 million for Tabrecta, and royalties from Lilly of $26 million for Olumiant. We recorded revenue growth across both the products commercialized by Incyte and those commercialized by our partners, with the exception of Iclusig, 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 COVID-19 pandemic. 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 Pemazyre. Total cost 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. Ongoing R&D expense for the quarter was $250 million on a non-GAAP basis, representing a 6% increase from the prior year quarter. This increase was primarily due to our 55% share of the global and U.S. Pacific development costs for tafasitamab, the clinical trials of ruxolitinib 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-GAAP basis, representing a 12% increase over the prior year quarter. This increase was primarily due to an increase in commercialization efforts related to Jakafi and Pemazyre in preparation for the potential commercialization of ruxolitinib cream. Collaboration loss for the quarter was $30 million, which represents our 50% share of the U.S. net commercialization loss for Monjuvi. 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 in 2019 year-end reflects the upfront payment and stock purchase related to the purposes 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 capturing the ranges provided. As a reminder, the R&D guidance excludes the $805 million around consideration related to our collaboration with Novartis. Finally, at this early stage of their launches, we are not providing guidance on Pemazyre sales or 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.

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 RUX data that led you to the decision to discontinue that facet of the LIMBER program? And then secondly, for the RUX plus PI3K combination studies, you're looking to start in 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? Thanks.

Vikram, hi, It's Steven. Thanks for your question. In terms of the PIM RUX program, as far as we know, we were the sort of last perm inhibitor left standing across R&D programs, and it's 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 tolerability profile in combination with some of the efficacy we've seen, although interest in and pre-clinically very interested in, it wasn't a program that we felt had high chance of success going forward. So for those two reasons, both tolerability, in terms of the liver and reaching adequate efficacy buyers. 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 and clearly, there's a delta effect. If you go back to the biology, PI3-kinase delta as a pathway is upregulated in myelofibrosis, this 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 RUX and a stable dose for a couple of months. Even with that, we saw increased spleen response, as well as symptom responses. So we're initiating two studies, a suboptimal responder RUX study, as we've spoken about for people who've been on at least three months and they're not having an adequate RUX response, as well as a first-line study. In terms of the endpoints, you're going to have to wait for the clinicaltrials.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 will go up on that particular listing. Thanks.

Good morning, everyone. I appreciate you taking my question. I wanted to inquire about GVHD. Could you explain the next steps and the timeline we should consider for the chronic GVHD opportunity and the label expansion for the syndication? Also, while I understand you won't be going to market just yet, do you anticipate more spontaneous use in this area even before approval, especially in light of the encouraging REACH3 data and the existing unmet need?

So Cory, I'll start off and then Barry will take the second part of your question. I assume you're referring to the REACH3 study for which we recently announced the outcomes. It’s a remarkable result for patients and for us, as we achieved both the strictly defined primary overall response rate endpoint at month six, along with failure-free survival and the patient reported outcome regarding the modified lease symptom score. This is an excellent outcome for us. We have also filed REACH2, and now we will proceed with filing REACH3 as a supplemental New Drug Application as quickly as possible to include it in the label. I’m not sure if you were also referring to steroid-naive chronic graft-versus-host disease; our work with itacitinib continues this year in terms of dose exploration. We are examining various doses and schedules, along with the steroid effect, before moving forward with further studies of itacitinib. We remain very active across the full range of graft-versus-host disease, including filing and in our work with itacitinib for steroid-naive conditions. Now, what was your question, Barry?

Hey, Cory, yeah, in terms of spontaneous use in chronic GVHD, obviously, we know that there's already some use in chronic GVHD with Jakafi and I think because we only released the top-line results from REACH3, not until there's a full presentation or 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 COVID on the GVHD front, fewer transplants that was presumably taking place?

Well, we certainly saw a decrease in new patients. So, as you know, Cory, new patient starts really represents a relatively small part of the total number of patients that are on Jakafi. 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 have to come back when they're feeling more safe and when their disease requires it. So as more bone marrow transplants go up, then GVHD will go up.

Hi, 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 Jakafi, 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 stockpiling 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 Jakafi use? Thanks.

Sure, Brian. Well, I don't think that the percentage of patients who are taking Jakafi 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 patients start to relatively small in each given quarter and each given month anyway. But we have seen week over 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 bottles sold.

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 on 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. So in terms of our oral PD-L1 program, we've been progressing well, and we're in this phase now where 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 directionally the right degree of PD-L1 inhibition, T cell changes that we want, et cetera, 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 presented in the second half of this year and a prepared median are supportive of continuing. Thanks.

Hi, all. Thank you so much for taking my question and congrats on a really great week with strong results today and the approval of Monjuvi late last Friday. So just on Pemazyre, the tumor-agnostic setting, can you just remind us of the status of this program, I can't remember if you mentioned it earlier, is it also delayed as with the bladder trial? And then any color on the penetration into the eligible patient population and cholangiocarcinoma following the launch earlier this year?

Evan, Steven, thanks. So in terms of your question, actually, the tumor-agnostic program has not been affected by COVID much at all. It enrolled in extremely well, probably speaking to an extreme unmet need there, so it's across in various fusions in terms of the molecular biology as well as rearrangements as well as testing if there's any activity in amplifications as well. So they're different buckets. We fill up that are histology agnostic, and that's progressing well. Now you spoke a little bit about the bladder 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 will be next year. So that's the status of the bladder program, and then I'll turn it over to Barry.

Sure, Evan. So you talk about penetration. I think I said in my prepared remarks that there was over 100 patients treated already. And actually, we know that most of those patients have come back for refills as well as 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 is ahead of what we predicted internally.

Good morning, guys. Thanks for taking my questions. I just wanted to get a sense perhaps on how you're thinking about the first-line study. Is there a particular combination of the two that you're looking at that you would prefer? 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 of how that might impact some patients' desire to be on therapy? Thanks.

Yes. It’s Steven. Thanks for your question. If you look at first-line diffuse B-cell lymphoma, the standard of care remains R-CHOP with approximately a 40%, 50% care rate. Many have tried to beat that and 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 – and a little bit maybe in terms of sacrificing tolerability because it's about care upfront. So we'll see. The safety data, as we said on the call yesterday, will be key, looking at either tafasitamab alone, plus the R-CHOP regimen or tafasitamab plus len plus the R-CHOP regimen. If the safety ends up and let's get the data by the end of this year, being a wash, and there's no increased toxicity that's worrying from the doublet with R-CHOP, that may be the way we end up going because it's about getting to the efficacy bar. As the MorphoSys 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 endpoint. So those are the caveats there. 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.

Yes. Thanks Barry to take my questions. Barry, just to follow-up on your comments about the Pemazyre launch and the success relative to your internal expectations. I guess, what learnings have you had on virtual launch about things that are working, maybe some things that aren't working and how are those going to get applied to the launch of tafasitamab?

Yeah, Mark, we've gained a lot of insights. Despite the pandemic, we discovered effective strategies that we intend to continue. Virtual programs, visits, speaker events, and advisory boards have proven successful. For Pemazyre, we focused on reaching specific gastroenterology doctors specializing in cholangiocarcinoma and liver cancer ahead of time, and we connected with them virtually through our representatives. Prior to that, our medical affairs team had established relationships with these doctors, and our oncology clinical nurse educators assisted them with managing dosing and side effects, ensuring effective communication. We also learned that during the Pemazyre launch, which is similar to the launch of Monjuvi, physicians are eager to learn about new launches and the usage of these drugs. Pemazyre is the first approved treatment for a patient population that previously lacked effective options, and Monjuvi is the initial drug approved for second-line diffuse large B-cell lymphoma. Doctors are looking for new treatment options for their patients who urgently need them.

Hey, guys. Thanks for taking my question, and congrats on all the progress. I just wanted to ask you a question on the Pemazyre program, and now that you have the combination data. It looks interesting, kind of, wanted to talk about your focus on monotherapy there? And then can you just talk a little bit about continued investment for AB heading into the upcoming launch for the program? Thanks.

So Alethia, I'll start off. It's 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. We have in the range of the high activity we wanted, as well as the durability of response that we wanted. So 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 authorizations. And we'll meet, as you allude to, confirmatory programs, and those are likely to be in combination. The designs of which still need further refinement and discussion with regulators, but they're likely to include combinations with CD20 or even CD19 antibodies, given that we are treating lymphomas. And then, I'll hand the question over about the investment related to the launch.

Yes. So, Alethia, 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 relatively soon after we get approval for atopic dermatitis. But I think Hervé said multiple times that we're building a separate business unit for dermatology or autoimmune diseases. So we already have on board are 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, just – so that's for the U.S., where the situation is very clear. Regarding the rest of the of the world, in the – in Europe, we are looking at the scenario where, in fact, vitiligo 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., like more than slightly, it can be a few months behind. And we are still looking at the best commercial deployment there. And frankly, we want to have – take our time. And I know some of you are asking with the model that we'll be following in Europe, and we are really going through a level of division that requires more time and we'll be able to communicate how we are going to commercialize in Europe probably early next year.

Great. Thanks so much for taking my question. I had a question just on retifanlimab and the status of 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 Jakafi COVID-19 program from CRS?

Yes. In terms of retifanlimab, our IV PD-1 inhibitor, the niche programs have, again, all enrolled incredibly well. Squamous cell anal carcinoma, MSI-high endometrial in the Merkel cell program, we intend to submit data from Merkel and anal cell carcinoma at a medical meeting second half of this year, and that's when that data will be public. In terms of RUX in COVID-19, just a reminder, there are two programs. There's one in conjunction with Novartis globally called RUX-COVID, those that's in patients that are pre-mechanical ventilation, but have evidence of cytokine storm and is looking at RUX 5 milligrams twice daily, plus standard 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 or require ICU care by day 29. And that's progressing well. And obviously, we hope to have data, a complete 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. So it's again, adults with COVID-19 associated respiratory failure who are on ventilation, it has two dosage arms in terms of RUX, a 5-milligram BID arm and a 15-milligram BID arm, both with standard of care versus standard of care and that is tracking a little bit behind in terms of enrollment, largely because there's less because there's less ventilation than there was those people are trying to avoid that. So again, we hope that data before the end of the year, but it's hard to tell you exactly when at the moment, the N on that study, just to remind you, was a little larger. So that was of 500 patients because there's three arms. And the primary endpoint was a very clean one, was overall survival due to any cause through day 29. So that's the status of those studies. Thanks.

Hi. Congrats 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 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, Jay, it's Steven. So it's an extremely important program to us for all the obvious reasons, plus we have a lot of scientific ownership of the myeloprotective neoplasm space, just even beyond ruxolitinib, the diseases we feel very passionately about. Just remind you, the LIMBER 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 that is important in itself and also potentially from a convenience point of view, and it may lend itself down the pike to us doing fixed-dose combinations with other once-daily mechanisms. 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 parsaclisib 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 BET inhibitor program, so we're doing in monotherapy work this year, just to prove safety at the dose we've chosen, and then we'll very quickly go to combination to work there. And we'll see where that leads us. Again, that could be potentially in a second-line setting as well as in the first-line setting. And then very importantly, although on the surface, it looks like a tolerability play in terms of the ALK2 inhibitor, and the hepcidin mechanism improving anemia, either due to the underlying disease, myelofibrosis or due to the effect of a JAK inhibitor, not only if that works, should it improve the anemia, but then it will also allow patients to stay on RUX 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 it's all around discovery efforts run out of Dash shop looking at 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 that's the entirety of the program. Thanks.

Hey good morning. Great to see the quarterly results, especially in the light of the ongoing pandemic. I had a question on the Jakafi product revenue guidance, which was reiterated and seems very conservative. You mentioned that new patient starts have 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 a deceleration in the second half. 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 consider?

Tyler, you are absolutely right. If you look at Jakafi in the first half of the year, we grew 19% when you compare to the first half of 2019, with the growth primarily coming over 70% of this growth coming from volume, from demand. 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, the risk for a broader resurgence, we felt that this year, it's 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 impact that we may see from a resurgence in COVID-19.

Thanks for taking the question. Was the positive REACH3 data reflected in your long-term guidance for $3 billion peak sales of Jakafi? And are you considering expanding your dermatology portfolio to further complement ruxolitinib cream? And if so, what might that look like? Thanks.

The REACH3 results are certainly very positive, and while they may not be more than expected, they are indicative of a strong study. You will have the chance to review the results once they are published. Your question about the implications for our long-term guidance is relevant. Previously, we projected $2.5 billion to $3 billion for Jakafi, and if you assess this year, you can see we are on the right track. We are mindful of political uncertainties in the U.S., particularly the ongoing questions regarding the health care system and product reimbursement. The best approach is to monitor how the situation develops and to examine the publicly available data from REACH3, which may prompt us to reassess our long-term guidance after this year. Regarding dermatology, we are very enthusiastic about recent advisory board discussions and feedback from dermatologists in the U.S. and Europe regarding RUX cream. This feedback has led us to adjust our expectations for this franchise, as we are hearing that no other products match the level of efficacy demonstrated in TRuE-AD, particularly with minimal systemic exposure and a favorable safety profile for a topical treatment. This positions RUX cream as a potentially transformative product. We are now considering its larger market potential. The vitiligo study is progressing rapidly, suggesting possibilities for submissions in 2020 for atopic dermatitis and approval in 2021, along with submissions for vitiligo later on. There is a cycle of new products emerging in the next couple of years, and we are also exploring additional products to strengthen this franchise. Internally, we are advancing programs focused on our own immunomodulating products that could address various indications, as well as seeking external scientific opportunities in dermatology that could enhance our portfolio. We are effectively creating a new division within Incyte centered around RUX cream, which holds significant potential to contribute to our growth in the oncology and hematology sectors over the next five years.

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.