Incyte Corporation (INCY) Earnings Call Transcript & Summary

Greetings. And welcome to the Pemazyre FDA approval conference call. [Operator Instructions] As a reminder, this conference is being recorded. It's now my pleasure to introduce your host, Mike Booth, Head of Investor Relations for Incyte. Please go ahead, Mike.

Thank you, Kevin. Good morning. And welcome to our conference call and webcast to discuss the FDA approval of Pemazyre, which was announced late Friday. I'm joined on the call today by Hervé, Steven and Barry, who will deliver our prepared remarks; and by Christiana, who will participate in the Q&A session. [Operator Instructions] I also ask that we seek to split the Q&A session, first, asking questions related to Pemazyre and cholangiocarcinoma; and towards the end of the hour, transitioning to any COVID-19 topics that you might wish to raise. Before we begin, I must remind you that safe harbor rules govern our remarks today and any forward-looking statements that we may make, and I, therefore, encourage you to review the risk factors detailed in Incyte's SEC filings including in our Form 10-K for the year ended December 31, 2019. 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 business. Accordingly, it's 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. Thank you all for joining today's call to discuss the approval of Pemazyre. Before we begin, I would like to recap the business update in relation to the global COVID-19 outbreak that we shared with investors on a conference call a couple of weeks ago, and I will start with a quick summary of our proactive efforts to evaluate JAK inhibition as a treatment for the cytokine storm associated with COVID-19. So cytokine storm is a severe immune overreaction that can be triggered by a viral infection and leads to serious complication, including acute respiratory distress syndrome, a form of respiratory failure that is one of the leading cause of mortality in COVID-19 patients. We believe that treating cytokine storm may help prevent this severe complication and that regulation of overactive signaling through the JAK-STAT pathway may be a promising treatment approach. On Friday last week, we announced that we have initiated the Phase III RUXCOVID clinical trial to evaluate the efficacy and safety of ruxolitinib plus standard of care compared to standard of care alone in patients with COVID-19 associated cytokine storm. The collaborative study is sponsored by Incyte in the U.S. and by Novartis outside of the United States. We have also launched an emergency expanded access program in the U.S. In addition, Lilly recently announced agreements for baricitinib to be part of the NIH adaptive COVID-19 treatment trial. The study will investigate the efficacy and safety of baricitinib as a potential treatment for hospitalized patients diagnosed with COVID-19 in the U.S., and Lilly also announced it is planning an expansion to include Europe and Asia. Turning now to the impact that the pandemic has had on our business. To date, we have not seen any impact on patients on Jakafi and Iclusig or on our supply chain and manufacturing processes. On the regulatory front, the approval of Pemazyre marks the first of 3 potential approvals that we expect this year. The 2 other applications currently under FDA review are the NDA for capmatinib in non-small cell lung cancer, which was submitted by Novartis; and the BLA for tafasitamab in DLBCL under our collaboration with MorphoSys. Both of these are proceeding as expected. In addition, we recently shared detailed data from our successful Phase III program for ruxolitinib cream in atopic dermatitis, and we remain on track to submit our first NDA for FDA approval in dermatology by the end of the year. In terms of clinical development, we continue to anticipate that short-term effects may begin to emerge across different aspects of our clinical trial program. For example, while we expect ongoing monitoring of already enrolled patients to continue, new patient recruitment in certain clinical studies may be impacted. We also expect the conduct of clinical trials may vary by disease state and by severity of disease as well as by geography as some regions are more adversely impacted. Despite these uncertain times, I continue to be optimistic about our future prospects, and the approval of Pemazyre provides an excellent example of how Incyte continues to move forward in developing important medicines. Pemazyre is the third Incyte-discovered molecule to receive FDA approval, and it is the first targeted FGFR inhibitor to be approved for use in cholangiocarcinoma. Pemazyre also has potential utility in other cancer types, especially in the tumor-agnostic setting, as there are numerous malignancies that appear to be driven by FGFR alteration. I will end my short introduction here and pass the call to Steven to discuss today's approval in more details.

Thank you, Hervé. The approval of Pemazyre is an important milestone for Incyte and for patients with cholangiocarcinoma. Until now, there was no approved therapy for patients with cholangiocarcinoma driven by an FGFR2 fusion or rearrangement, and we are proud to have successfully developed a targeted therapy for these patients. Cholangiocarcinomas are bile duct cancers that arise in the intrahepatic region within the liver, also in the perihilar region where the bile ducts join; or distally in the extrahepatic biliary tree outside the liver. Cholangiocarcinoma is a rare disease, where there is a significant need for new and effective therapies. The only potentially curative treatment is surgery, but approximately 70% of patients are diagnosed with unresectable disease, and for these patients, surgery is not a curative option. First-line chemotherapy, typically a combination of gemcitabine plus cisplatin, results in modest responses and poor survival rates. 5-year survival in cholangiocarcinoma patients is in the range of 5% to 15%. And for patients with unresectable or metastatic cholangiocarcinoma, median survival is less than 1 year. There is, therefore, a significant need for new therapies that can improve outcomes for patients with cholangiocarcinoma. Approximately 15% of intrahepatic cholangiocarcinoma patients have FGFR2 fusions or rearrangements, which means that there are, therefore, approximately 2,000 to 3,000 such patients across the United States, Europe and Japan. Pemazyre is a selective and potent oral inhibitor of FGFR isoforms 1, 2 and 3 and was granted accelerated approval under Priority Review and with a breakthrough therapy designation based on the FIGHT-202 trial, a multicenter open-label study. The FDA prescribing information shows that in the FIGHT-202 trial, Pemazyre generated an overall response rate of 36%, with a median duration of response of over 9 months in patients harboring FGFR2 fusions or rearrangements. The most common adverse events of all grades was hyperphosphatemia, which is an on-target effect of FGFR inhibition. Most cases were low grade and in general, were managed with a low phosphate diet, phosphate binders and diuretics. If needed, dose reductions or interruptions were possible. Other warnings and precautions described in the product information for Pemazyre are the risk of eye disorders and the risk to pregnancy, both of which are known and on-target effects of FGFR inhibition. I believe that the safety and efficacy profile of Pemazyre will represent an important advance in the treatment of eligible cholangiocarcinoma patients. Before turning the call over to Barry, I would like to offer sincere thank you to all of my colleagues who have worked tirelessly to successfully develop Pemazyre, and of course, to the patients, their families and caregivers without whom clinical development is impossible. Barry?

Thank you, Steven. It is an exciting opportunity for us to be able to bring this much-needed therapy to patients living with cholangiocarcinoma. We believe we have everything in place for a successful launch and to ensure that all patients that are eligible for Pemazyre are able to access it. We are dedicating the necessary resources to Pemazyre without compromising any of our focus on the ongoing commercial efforts behind Jakafi. Over the past several months, we have gained a strong understanding of patient and health care provider needs based on our detailed profiling work, and this will enable us to appropriately direct our resources. Unbranded educational resources focused on -- focusing on the needs for testing in cholangiocarcinoma have been live with health care professionals since November of last year and with patients since February of this year. And a targeted media campaign is ongoing to drive awareness and engagement. In adapting to the current restrictions related to COVID-19, our sales, market access and medical affairs teams are actively scheduling virtual appointments with our customers. We have the technology in place to share resources and materials in virtual meetings, an approach we are already successfully using for customer engagements related to Jakafi. We will also seek to drive awareness of Pemazyre through targeted investments in digital, paid search and print media. As more patients are treated with precision medicines like Pemazyre, it is increasingly important to ensure that appropriate diagnostics and testing are available. Foundation Medicine's companion diagnostic, FoundationOne CDx, for Pemazyre was also approved on Friday, which we expect will further increase existing levels of testing for FGFR status. We also have programs in place that will help us to identify health care providers with new cholangiocarcinoma patients, thereby enabling us to direct resources efficiently. Incyte has also partnered with Biologics by McKesson as the exclusive specialty pharmacy for Pemazyre in the United States. They are a great asset for us to have as part of our effort to provide Pemazyre education and resources to both patients and health care professionals. With regard to product availability, we have ample supply available and are ready to ship immediately. Currently, we do not anticipate any impact from COVID-19. We have priced Pemazyre at approximately $17,000 per cycle, which we believe is appropriate given the potential benefit it brings to this underserved patient population. It is also important, of course, that patients are able to access our medication. Incyte is committed to supporting patients, and as needed, Pemazyre will be available under the IncyteCARES program, which offers a comprehensive suite of patient support services, including financial assistance and ongoing education and other resources to eligible patients. In closing, we are excited by the opportunity to provide patients with an innovative new therapy. This is why Incyte was founded, and this is what we work hard for every day. Operator, that concludes our prepared remarks. Please give your instructions and open the call for Q&A.

[Operator Instructions] Our first question today is coming from Michael Schmidt from Guggenheim.

This is Kelsey Goodwin on for Michael Schmidt. I guess we were just wondering, first, kind of what percentage of diagnosed patients are currently being tested to determine mutation best given there aren't any targeted options available until now. And how do you expect that to ramp up following the launch?

So Kelsey, it's Steven Stein. I'll go first. Barry may want to add something to what I say. Obviously, it's not an entity like breast cancer or lung cancer in that there aren't established markers, for example, in breast, hormone receptors or HER2; in lung, EGFR, et cetera, et cetera. Once you get a critical mass of those, it becomes a standard of care to do baseline diagnostic testing. For cholangiocarcinoma, you now have, obviously, with this approval, a targeted therapy for an FGFR2 fusion or rearrangement, and then hopefully soon down the pike, other companies in terms of IDH inhibitors may be there as well. I think with that occurring, there will certainly be a ramp-up in testing. In terms of an exact percentage going on across the United States, for example, at the moment, I don't know if Barry has the number, but it's certainly -- it's something we're going to have to work hard to get done. And I'll just leave it at that. I don't know, Barry, if you want to add anything.

Yes. No, just exactly what Steven said is that once we have an effective therapy, then testing will start. Just like in lung cancer and colorectal cancer, once there was a drug that physicians could use, then testing ramps up. Fortunately, we have -- Foundation Medicine will be out there talking about the importance of testing in cholangiocarcinoma. We have increased our efforts. And as Steven said, other therapies coming along in cholangiocarcinoma with other mutations or alterations will actually encourage more physicians to make sure they're testing their patients.

Congratulations.

Our next question is coming from Marc Frahm from Cowen and Company.

Congratulations on the approval. Maybe one question, just a follow-up on that testing there. Barry, I mean, you mentioned a couple of examples there in lung cancer and colorectal, where certainly testing did ramp up. So I mean, looking at cholangio, maybe can you put some metrics on how quickly you think it could ramp up? Should it double in 3 years or 5 years or some sort of pace there? And then I have a follow-up.

Not sure I can give you an exact number, but we believe that with our efforts, with our educational efforts that are ongoing now, with our ability to reach virtually every treater of cholangiocarcinoma in the country, that we can have this ramp-up very soon. And I think physicians really want to be able to test so that they know what the most effective therapy is that they can choose from.

Okay. Great. And then maybe for Steven, the label has the retinal attachment -- detachment at about 7%, which includes several hundred patients beyond FIGHT-202. Can you discuss kind of the differences in dosing within that safety database and how those may be driving any differences in the rate of retinal detachment?

Yes, Marc. Obviously, you can't make cross compound comparisons when you haven't done a head-to-head study. But there are other FGFR drugs out there and one's approved, obviously, in bladder cancer with different dosing regimens. Our dose is 13.5 milligrams daily for 14 days and then 7 days off. With that, in a 466 patient experience, so across our whole clinical trial program, our rate is 6% or, but in terms of grade 3 and grade 4, it's much, much lower. It's of the order of 0.6%. Obviously, we have a monitoring program in place, which includes all the regular clinical stuff plus ocular coherence tomography, an OCT test, it's called, which you do to begin with. And we think with that management that we've been able to keep to this low rate, plus our drug itself. If you look at just for that toxicity, the dose interruption rate is 1.7%. The dose reduction rate is 0.4%, and the dose discontinuation rate for that toxicity is also only 0.4%. So we're very, very encouraged in this data set, which I said is more than the study alone, as you alluded to, to have this low rate and be manageable in terms of interruptions, reductions or discontinuations. Obviously, it's a lot lower rate than was seen with another drug in another histology with another dosing regimen. So I'll just leave it at that.

Our next question is coming from Salveen Richter from Goldman Sachs.

Congratulations on the approval. Could you maybe just talk about the length of the cycle here and whether it is the 3 weeks pursued in the trial and what the assumption is of duration as you look to pricing and how that compares to what's been seen so far?

So Salveen, it's Steven. I'll start on your clinical question, and then maybe Barry can speak to your second part. Just -- if I understood you correctly, it's 13.5 milligram daily, 14 days on and 7 days off repeated. The median -- the overall response rate by independent review is 36%. The median duration of response is 9.1 months. And as pointed out in the label, 63% of patients were still in response for 6 months or greater and 18% for 12 months or greater. The permanent discontinuation rate across the whole program for any toxicity was about 9%, dose interruptions about 40% and reductions about 14%. So it just speaks to how patients are managed with it. Barry can talk to the second part of your question around how I spoke to the assumptions made.

Sure. So if I remember the study right, the median treatment -- the median number of months that patients were on therapy was 6, 181 days. So that's about 8 or 9 cycles. So what we said was $17,000 per cycle, 8 or 9 cycles for the average patients.

Our next question today is coming from Brian Abrahams from RBC Capital Markets.

Congrats on the approval. I guess a question for Barry. I was wondering if you could maybe speak to any commercial synergies this launch might have with your existing sales force and then with any potential future launches. And I'm also curious what you guys foresee as the biggest hurdles to launching a drug virtually and how you plan to overcome those.

Sure. Well, first of all, about 2/3 of our -- the targets that we estimate that are treating cholangiocarcinoma are already covered by our Jakafi sales force. And we've really identified the top 1,000 docs that are treating cholangiocarcinoma, so we know exactly where they are. And we know that there's about 8,000 health care professionals that are prescribing in -- for patients with cholangiocarcinoma, so we can reach out to all of those. So we think we overlap actually very well with that. Sure, there's a hurdle. We'd like to have our salespeople and all of our field force in the offices today. But we've gotten very good at multichannel engagement, using all the digital resources that are available to us and our ability to actually target those health care professionals I talked about, the 1,000 docs and the 8,000 health care professionals, through rep-driven e-mails, through geo-targeting efforts and to obviously advertise on all of the sites, websites that physicians, particularly physicians treating cholangiocarcinoma. So we think we really have it covered. We are actually doing virtual meetings, virtual speaker programs, virtual promotional visits to the offices, and we've gotten good at that using Skype and webcast and Zoom for visiting the offices. And we think they're actually going to be very open to us because they want to hear about this new therapy.

Our next question today is coming from Evan Seigerman from Crédit Suisse.

Congrats on the approval. Just how should we think about the potential cadence of the launch near term? And is there a bolus of patients that you think will want to get on therapy? Or is this really building the market?

Well, I'll take that. I think it really is building the market. There could be a bolus of patients, obviously, patients who are failing first-line therapy. Currently, they would just go on to yet another chemotherapy. We do know that somewhere between 60% and 90% of patients who progress after first-line therapy go on to second-line therapy, and we think they'll want to get the best therapy available to them. But as we emphasized over and over again, we have to make sure that cholangiocarcinoma patients are being tested for these mutations in operations and specifically for FGFR2 fusions and rearrangements. So we think it'll build over time as we continue to educate. We know that health care professionals in hospitals, for example, academic medical centers, are already doing this. We just have to make sure that community oncologists realize that there is a good diagnostics available and that now we have an effective therapy for patients with this particular alteration.

And without any of the major oncology medical meetings happening near term, how is that impacting your promotional efforts? And I guess how are you overcoming the fact that you won't have a big booth, say, at ASCO?

Well, ASCO is going to be a virtual meeting, so we'll do the best we can. We actually -- again, we think that we've created an excellent group of people who are really skilled at digital promotion and doing this multichannel engagement that we involve our field force around the country and giving them resources to be able to reach out to all of their health care professionals, who we need to continue to educate not just on Pemazyre but also on Jakafi. So we're doing the best. Every medical meeting seems to be going virtual, if it's not just moved to a different date in the future. But we think we'll be able to launch this product effectively and then move forward from there once we're able to get back into the offices and the hospitals.

Our next question is coming from Tyler Van Buren from Piper Sandler.

Congrats on the early approval. Just a couple of quick ones on comparing the labels. Balversa seems to have more drug-drug interactions, so are there any potential significant competitive differences there? And then just secondarily, related to the eye exams, can you speak a little bit more towards that requirement, especially given the ongoing situation of having to conduct a lot of the commercialization virtually?

Yes. Tyler, it's Steven. So our main issue would be potentially sub 3A inhibitor type interactions. Obviously, you heard from the overall data in terms of the safety profile, we think we have an acceptable one that's manageable. I'll just re-mention the numbers. The overall permanent discontinuation rate for any toxicity was 9%, which is, again, about half of what a competitor has seen again in another histology with another dosing regimen. So there are many caveats. Dose interruptions about 40%, but then they can restart, and dose reductions about 14%. So it just speaks to how people are -- understand how to manage it. The principal adverse events seen is hyperphosphatemia of all grades, about 60%. It's managed mostly with diet, sometimes phosphate binders, and if necessary, diuretics. In terms of your specific question related to the eye, it's a recognized on-target toxicity. There's a baseline done in terms of a regular exam, plus a test called an OCT, an ocular coherence tomography test. It's sort of like an ocular CAT scan if you will. It can be done in an office -- in an ophthalmology office. Initially, on the study, we did them every 2 months for the first 6 months and then spread that out to every 3 months thereafter. And then as I'll just be repetitive, the rate of retinal pigment epithelial detachment overall was 6% all grade. But the grade 3, 4 rate was 0.6%. So we're very encouraged by that profile. We don't see -- and it's actually -- if you look even under COVID-19, oncology patients globally are -- because they're oncology patients, so getting, for the most part, treated, getting seen in offices, getting their therapies, we don't see this being an impediment per se. Obviously, there are all sorts of precautions that would have to be done as they are being done in medical offices anyway. But in terms of getting the cholangiocarcinoma metastatic patient treated, I personally don't see an obstruction to doing this.

Our next question is coming from Cory Kasimov from JPMorgan.

Just wondering if you had any additional details from the FDA on what you need to demonstrate for the confirmatory trials for Pemazyre. And could the frontline FIGHT-302 trial suffice on this front? And maybe if you can just remind us on the status of that study as well.

Yes. Cory, it's Steven again. No, absolutely, that's sort of prenegotiated as you go down the path of priority review breakthrough designation and getting your approval. Your confirmatory study has to be up and going and enrolling. So very much so, that study would serve as the confirmatory study. It's first-line cholangio versus chemotherapy GemCis. What's encouraging is they've opened -- the FDA, particularly, has allowed us to enroll patients initially with local results and then come on the study and then be confirmed centrally, and we think that will be helpful. So that study is enrolling, and we're encouraged by -- again, even given the COVID-19 situation, they've been able to conduct our trials. On the actual FIGHT study for approval, 96% of patients had prior platinum therapy, and of those, 76% was GemCis. So you can see the care standard is pretty entrenched as GemCis upfront, so we don't see a problem with that being the control arm. And obviously, we're encouraged by this data set.

Our next question is coming from Mara Goldstein from Mizuho.

Can you hear me?

We can now.

Congratulations on the approval. Just a question on the availability of the commercial diagnostic and wondering if there's any synergy between that and enrollment for the other indications of urothelial and the tumor-agnostic program.

Yes, I'll start and then Barry may add. It's Steven. FoundationOne has been available for a long time already, so it is widely available. They're a very established company. I think they may be close to do the most sequencing in the country, if not, the most. So -- and they got an approval the same night as us for the diagnostics. So in terms of availability, there's no issue in the United States. The issue that we spoke about upfront is getting physicians to start profiling patients with cholangiocarcinoma for eligibility for treatment. Does it help enrollment in the bladder or agnostic trials? Just in general, awareness of doing proper profiling of patients with metastatic disease will help. The -- neither of those studies have been problematic at all. FGFR3 is already widely accepted as an oncogenic driver for that type of bladder cancer. And the agnostic program is actually enrolled much -- even better than expectations across the board. So I think when physicians are motivated to look for targeted therapies that may work for their patients, they are doing profiling. So the studies aren't having problems.

I didn't really have anything to add. I think Steven answered the question.

Our next question is coming from Tazeen Ahmad from Bank of America.

All of my Pemazyre questions have been asked. So being that we're in the second part of the call, I'm hoping to ask a couple of questions on COVID. Specifically, can you talk to whether or not there are specific challenges as it relates to Jakafi by indication? Or are you seeing more impact on one indication versus others? And then as a follow-up, the opportunity that you're pursuing for cytokine storm for RUX for COVID patients, can you give us an idea of how big that commercial opportunity could be?

Well, I'll try to answer the first part of the question. And we don't see any real impact yet on Jakafi for polycythemia vera, myelofibrosis or GVHD. But obviously, we sort of shut down around March 13, where we began asking our field force, in particular, to stay home for their safety and for the safety of our patients. And when we follow the data up to this point, we don't see any impact at all. And I think oral oncology products, I think we'll see the same. We have many patients who are coming back for refills. Now what the future will bring, I'm really not sure. But so far, we haven't seen any impact in any of our 3 indications for Jakafi. I don't know if Steven wants to take the other question or Hervé, yes.

Yes. On the -- so let me speak a minute on the COVID-19 studies and how we are there. I mean we have been working on JAK inhibition for CRS, which was related to CAT-19 use in some patients with leukemia. And so we had a lot of work preclinically, and we have a clinical trial ongoing in that setting of CRS with one of our JAK inhibitors. So when this COVID-19 situation started to emerge when the understanding of the lung injury was starting also to be better known. We worked with Novartis, who is our partner for ex U.S. And in fact, it was an extraordinarily fast and collaborative interaction where we decided it would make all the sense in the world to test the hypothesis that you could block the cytokine storm with a JAK inhibitor, Jakafi being on the market available with a very strong manufacturing capabilities behind it was the obvious choice to do that. So that's really the genesis of how we embarked into doing these studies. The past days and -- have been with the FDA to finalize the protocol, and we have announced on Friday that the study is now open. It's open internationally. I think it's mostly in Europe and U.S. with Novartis. The goal here is literally to provide physicians with an improved way to treat patients infected with COVID, and we don't -- we didn't see it as something that would be a commercial opportunity for Jakafi. So to be clear, I mean, our attempt here is really to improve treatment for these patients with COVID-19. We have established an early access program with 3 drug in the U.S. that is available as we speak. And the goal here is really very different from what is our established franchise with Jakafi in MF, PV and GVHD.

Our next question today is coming from Ren Benjamin from JMP Securities.

Congratulations as well. Just going back to pemi. Maybe one for Steven. Can you just update us on the ongoing pemi programs? And are there any that you're expecting to start that will likely get delayed to either later this year or next year? And then one for Barry. Is there any read-through or learnings that we could get or you guys have gotten from the erdafitinib launch to date?

Ren, it's Steven. I'll start. So for pemi, in terms of the clinical development programs, obviously, as we've already spoken about, there's the ongoing confirmatory study in first-line cholangio against gemcitabine and cisplatin chemotherapy. Then there's the entirety of the bladder program, the monotherapy data coming in and will be complete in terms of enrollment. We think there will be an impact there on getting the data in fully cleaned and presented. We were hoping to try to do that this year at an appropriate meeting, but that's likely to sneak into the first half of next year in terms of presenting the bladder data just in terms of getting to sites, getting it cleaned and ready. As we also spoke about, there's a first-line bladder study that's ongoing, and it's a space we're watching carefully because of evolving care standards. And we may end up making some tweaks to that study as well, but nothing definitive yet. The tumor-agnostic program is very important to us. We think we're first in sort of class in terms of doing it. We're very proud of it. And that study is actually enrolling well, and we want to keep the pedal down there to keep going because it's such an important data set for us to get. So overall, in summary, good, in good shape, other than the bladder data being cleaned and ready for presentation will be in the first half of next year.

Yes. Ren, so to answer your second question, I'm not really sure that we learned a lot from the early launch. J&J hasn't revealed a whole lot of information, including details on their sales. I suppose the only thing we could learn is that diagnostic testing is very important there as well, so educating physicians around the appropriate tests they should be using in order to identify patients who would most benefit from these therapies, but that's about it.

[Operator Instructions] Our next question is coming from Andrew Berens from SVB Leerink.

Congrats on the approval. My question is on the Jakafi trial in COVID-19. There have been some recent reports that COVID patients have hypercoagulable states that lead to acute MI, strokes and peripheral extremity injuries. I was wondering if you think there could be concerns using JAK in the setting and if there are any -- you're taking any precautions in the trial. And then my follow-up is also on this program. And what would be the potential impact on Jakafi pricing if the drug is approved for COVID? I sincerely hope it works in the setting, but are there risks to your pricing power if you have to offer Jakafi for COVID?

Yes. I can take the second part, and Steven will speak about the protocol and the hypercoagulation events. But our -- as I said, our view here, it's a treatment that is most around -- there is a 2-week and a 4-week endpoint. It's a relatively short treatment. We have a package. We have organized the distribution of free Jakafi in a package of 28 tablets of 5 milligrams that can be used through the compassionate use program. And frankly, our goal and our expectation is that will be used, assuming that the data we have from the Phase III study is positive, that the way it should be used. So we don't think it should have an impact on our non-COVID use of Jakafi in the U.S. And we also expect that most of the use will come from the compassionate use program in COVID.

Yes. Andy, and it's Steven, just in terms of your question. So remember, we're using ruxolitinib here to ameliorate the cytokine storm when it occurs. So it's not for everybody. It's in that phase of infection, usually in the second week when the viral load has disappeared or gone down, and the patients develop this devastating consequence in terms of this hyperimmune activation and cytokine storm. So that's the goal. And it's for patients who have raised IL-6 levels. Evidence of acute phase reactions like D-dimers being positive in C-reactive protein. The dose we're using is 5 milligrams twice daily for 14 days on purpose because that's the -- we have evidence that it would decrease cytokines there but don't interfere with interferon signaling in terms of the viral response. And the goal, as we were saying, is to hopefully improve survival and keep people off ventilators or get them not even to go on them. That's the goals of the study. You're absolutely right, there's emerging evidence around hypercoagulant states and clots seen in lung and other organs like the kidney is intriguing in terms of pathophysiology and obviously also devastating in terms of morbidity. Just to be clear, we allow patients to have any best available therapy at the time. So whatever viral therapy they need or other therapies are allowed and that will be controlled for. And it looks like from what I've seen in terms of guidance given at various centers across the U.S. that a lot of them are now adding anticoagulant therapy to their protocols. That will not be a problem in terms of our drug at all in terms of what we're trying to do here.

Congrats again.

Our next question is a follow-up from Marc Frahm from Cowen and Company.

Steven, just it seems one of the more important and potentially exposed to COVID impact trials is the vitiligo Phase III. So could you maybe provide an update on kind of where you are in enrollment? And then to the extent you -- it would seem that the primary endpoint, since it's mostly done by pictures and things like that, would be amenable to virtual visits, but have you been able to implement that into the protocol?

Yes, Marc, thanks for your question. Obviously, one of our concerns going into this, as I said, the oncology studies, for the most part, seem to be on track. And obviously, oncology patients need to be treated. There are some issues, as I said, on the bladder study in terms of data collection. But we were concerned about the derm program for all the obvious reasons. However, the vitiligo studies were enrolling really well, continue to enroll well and are on track, which is very encouraging. So obviously, there are ways that people are finding to get the study complete, and we'll see if that continues to occur over time. As Mike said upfront, it's a rapidly evolving situation, but we're encouraged where enrollment is. We have not adapted those Phase IIIs yet to purely virtual visits, but it's something we're exploring across the board in terms of using vendors that can do all sorts of things at virtual visits, including vital sign monitoring, et cetera, et cetera, et cetera, but not in this Phase III at the moment for this particular endpoint. And then just to reiterate, enrollment remains on track at this -- at the present time.

Just to -- in general, to comment on this question about the impact on clinical trials, enrollment, et cetera, we spoke about monitoring for some studies. And here, we speak about the speed of enrollment in the vitiligo study. It's very important to realize that the impact of COVID-19 pandemic is very different from one region of the world to another. North Europe, South Europe, Asia and in the U.S. even some parts of the country are far less impacted than some others. So it's difficult for us to give you like the quick response saying it's all good or it's all bad because, in fact, what we are observing is that there are very different types of impact by geographic regions.

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

Okay. Thank you for joining us today and for all of your questions. And we look forward to talking to many of you on our Q1 call on May 5. During the rest of the day, of course, the IR team are available to answer any additional questions. But for now, thank you all again, and goodbye.

Thank you. That does conclude today's teleconference. You may disconnect your lines at this time, and have a wonderful day. We thank you for your participation today.