Rigel Pharmaceuticals, Inc. (RIGL) Q3 2020 Earnings Report, Transcript and Summary

Greetings, and welcome to the Rigel Pharmaceuticals Financial Conference Call for the Third Quarter 2020. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce our first speaker, Dolly Vance, who is Rigel’s Executive Vice President, Corporate Affairs and General Counsel. Thank you, Ms. Vance. You may begin.

Thank you. Welcome to our third quarter 2020 financial results and business update conference call. The financial press release for the third quarter was issued a short while ago and can be viewed along with the accompanying slides for this presentation in the News & Events section of our Investor Relations page on our website, www.rigel.com. As a reminder, during today’s call, we may make forward-looking statements regarding our financial outlook and our plans and timing for regulatory and product development. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our Annual Report on Form 10-K for the year ended December 31, 2019, and subsequent filings with the SEC, including our Q3 quarterly report on Form 10-Q. Any forward-looking statements are made only as of today’s date, and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances. At this time, I would like to turn the call over to our CEO, Raul Rodriguez.

Thank you, Dolly, and thank you for joining us on our third quarter 2020 financial and business update call. Also joining me today are Wolfgang Dummer, our Chief Medical Officer; and Dean Schorno, our CFO. I also have the pleasure of introducing Dave Santos, our new Chief Commercial Officer who joined Rigel in August. Dave has significant commercial experience and has been involved in the successful launch in marketing of several pharmaceutical products, and we look forward to benefiting from his vast experience. Beginning on Slide 5, I would like to highlight the success we are having across all of our key value drivers as a result of the continued execution by the entire larger team. While we still face headwinds due to COVID-19, we are continuing to make very good progress. We continued to grow TAVALISSE sales, and have set a new high in this quarter. We are successfully positioning TAVALISSE as an attractive option for ITP patients and enhancing our supporting database with new studies. We’ve now launched a new observational study called FORTE focused on second line patients that Dave will touch on during his presentation. And our partner Grifols has commercialized the product in Germany and the UK with a phase rollout plan for the rest of Europe. I’m very pleased with our – the ability of our team to advance our Phase 3 trial in warm autoimmune hemolytic anemia, or AIHA. Our product is the furthest along in clinical development for AIHA. And our goal is to be the first approved product for this indication. Actually I think during this year, we have expanded on our lead only to the diverse geographic spread of our sites, as well as the – our oral administration, which facilitates patient trial participation. You may have seen, we announced our intention to lots of Phase 3 trials in hospitalized COVID-19 patients this quarter. This will be the third trial launch for fostamatinib in COVID-19, including one sponsored by the National Heart, Lung, and Blood Institute, NHLBI part of the NIH and one with Imperial College London, both of those trials are enrolling patients as we state. We are excited about the potential to play a role in aiding those affected by COVID-19 and based on our own preclinical data and research from well-regarded institutions. We believe that there is a significant rationale to explore fostamatinib in this disease. Wolfgang will provide more details around both the AIHA trial and our new COVID-19 program in a few minutes. In addition, I’d like to – we continue to develop our earlier stage assets. This includes our programs in the inhibition of both IRAK 1/4 and RIP1 pathways. These are two very important immune signaling pathways that impact a wide range of diseases and provide substantial opportunities. We continue to make progress in our discussions to secure a co-development/co-promotion agreement to one or both of these assets and we believe that we will have a partnership near year-end. I will now pass the call over to Dave who provide a commercial update. Dave?

Thank you, Raul. It’s been great to join Rigel. It’s such an exciting time as we work together to execute on our key value drivers. I’ve now been with Rigel for a full quarter and have been so impressed by the commitment of the commercial team and my colleagues across Rigel to continue making a meaningful difference for patients with chronic ITP, particularly as we deal with the impact of the global pandemic. I want to express my sincere thanks to our entire team for their hard work and persistence during the third quarter, as we continue to grow sales and build awareness of TAVALISSE for the treatment of ITP. On Slide 7, you will see our FDA approved indication, which is for adult patients with chronic immune thrombocytopenia or ITP who’ve had an insufficient response to a previous treatment. I would like to begin my discussion on Slide 8. We are continuing to grow TAVALISSE sales in the U.S. In fact, in the third quarter, we surpassed the $100 million milestone in total net sales since launch. And we are excited about the growth trajectory we have created during the second and third quarters of 2020, particularly as we have faced the unique challenges of this year. We are beginning to see patients and physicians truly realize the compelling value proposition that TAVALISSE brings to the $1.1 billion U.S. ITP market as a differentiated targeted therapy with a novel mechanism of action, addressing the underlying cause of the disease, which is platelet destruction and often overlooked aspect of our product. In the third quarter, we continue to gain momentum growing sales to $16.3 million, a 39% increase over the third quarter last year. That growth has been the result of new patients starting TAVALISSE therapy, as well as continued improvement in our persistency rate, which now shows that 55% of patients are receiving their four-month refill. We are also making progress, expanding our global access for ITP patients with collaboration agreements in the EU, Asia, Canada, and Israel. The third quarter saw the initial rollout of the product in Germany and the UK. And as I said before, even though we have already crossed the $100 million net sales mark, we are just at the beginning of our journey to provide patients with a differentiated treatment for ITP. We’re positioned to take advantage of the significant opportunity ahead. Having launched our new messaging, highlighting higher response rates in earlier line therapy and we have also – we are also beginning our efforts to compile a broader base of qualitative data with the recent initiation of our new observational study FORTE, which will provide real world evidence for the use of TAVALISSE in earlier lines. That is why we are so enthusiastic about the potential of TAVALISSE. Moving to Slide 9. As you may know, there are approximately 81,000 adult patients in the U.S. who have chronic ITP. In the light blue, this chart depicts more than 37,000 patients being actively treated on an annual basis with either steroids or later line therapy. And it is when they switch that they to become a candidate for TAVALISSE. In additionally, in the dark blue, the chart depicts nearly 44,000 patients in a group we refer to as watchful waiting, because their disease is being monitored and they’re not actively being treated. However, a portion of these patients during the year will also need to switch from watchful waiting to active treatment. And when that happens TAVALISSE can become their therapy. So we have many opportunities to impact patients who need a new therapy throughout the continuum of chronic ITP treatment. Since launch we’ve made good progress with patients who are switching in the later lines, just as we had anticipated and that’s because these patients are hard to treat, have limited options and so there is a much higher perceived need by both patients and clinicians. We have patient case studies that provide compelling evidence to use TAVALISSE in these late line patients, showing durable responses in some of the patients who failed multiple therapies. So for patients who yet to try TAVALISSE, this could be a great option. That said the greater opportunity to impact patients is in the earlier lines, either when they’re switching off steroids or moving to the third line setting. In fact, these early line patients represent approximately 75% of the post steroid market. It’s certainly is a more challenging sale as clinicians have developed habits with other options. And that’s why it’s so important for us to demonstrate to physicians that TAVALISSE can be as effective as the other post steroid treatments they’ve used historically, and importantly, that the responses they get can be durable. To do this, we’re leveraging the data from our post-hoc analysis that you see on Slide 10. These bar graphs are from a new promotional piece we launched in Q3 based on the British Journal of Haematology article that was published in July. The left bar graph on this slide depicts response rates at both the 50,000 and 30,000 platelet count levels in each line of therapy. And it shows the 78% overall response rate in second line compared to the responses seen in later lines. The higher response rates have been a key message for us to deliver to clinicians. Additionally, although the response rates varied by line of therapy, the right bar graph shows that once the response was achieved, it was maintained irrespective of line of therapy. This durability of response is meaningful to clinicians and patients when choosing therapy. To augment this existing data, we’ve also re-launched – recently launched an observational trial in up to 45 second line patients to collect additional evidence in the real world setting. So with our existing and future data in earlier line patients, we’re confident we can capture more of the significant opportunity ahead in ITP. On Slide 11, I’ll briefly highlight our expanding virtual commercial efforts. While we have great data to share out of the British Journal of Haematology publication, our challenge has been getting messages out to clinicians with limited access during COVID. Our sales team has made excellent progress in creating virtual opportunities to impact clinicians. This graph shows, how we have continued to increase our effectiveness in both scheduling and executing virtual interactions with our customers. While the pandemic has certainly challenged our ability to see customers strong execution with these virtual interactions has helped even the playing field of reach and frequency for smaller sales teams with larger geographies like ours. Although, it’s still early in using the data from the publication in our virtual efforts with clinicians, we are confident that it will add to our story of the unique MOA of TAVALISSE on platelet destruction and provide a strong reason to use TAVALISSE in earlier line patients who are switching from steroids or to a third line therapy. We are doing everything possible to ensure that physicians understand the benefits of TAVALISSE, and it stays top of mind for clinicians when they see patients in any line of therapy who are switching treatment. And I am confident we will continue to add more patients to the TAVALISSE journey. Finally, turning to Slide 12. We are now well on our way to expanding the impact of fostamatinib beyond the U.S. market. Our partner Grifols launched TAVLESSE in Germany and the UK. And we expect to hear from Health Canada on our new drug submission in early 2021, and from the Israel Ministry of Health in the second quarter, enabling medicine to begin commercial efforts in two markets. The Phase 3 study in Japan is also ongoing with Kissei. I look forward to providing quarterly business updates to you as we continue to broaden our impact with TAVALISSE in the future. Thanks for your attention. And now I will turn the call over to Wolfgang.

Thank you, Dave. I’ll begin on Slide 14 with a recap of our warm autoimmune hemolytic anemia Phase 3 pivotal trial and our progress over the past few months. This is a very exciting opportunity for us and maybe even greater than ITP, given the lack of an FDA approved therapy and our potential to be first to market. As you know, our trial sites had temporarily post-patient enrollment during the lockdown, just like most clinical trials worldwide. In recent months, we began to see sites reopen and screening activity has picked up. As of today, we have 57 patients randomized, which is approximately 63% of our target of 90 patients. And note that in October, we enrolled seven patients, which is close to the pre-pandemic pace of eight to nine patients a month. On another positive note, our trial sites have developed procedures and routines to deal with the pandemic and are better prepared to safely enroll and conduct clinical trials, when they were earlier this year. Also, we believe the oral administration of TAVALISSE provides an advantage over other trials, as it allows for outpatient visits and does not require in-hospital treatment, which makes things easier. We also leveraging FDA guidance on how to conduct clinical trials during the pandemic and take advantage of local labs or remote study visits to keep the patients as safe as possible, while participating in our trials. Of course, COVID-19 is not over yet. So we are unable to reliably predict enrollment completion at this point. With over 90 sites established in 22 countries, we believe we are well positioned to keep or even expand the lead for TAVALISSE to become the first drug approved for this indication. Switching gears on Slide 16 to our efforts in COVID-19. As we elaborated on previous calls, there is strong scientific rationale for SYK inhibition in COVID-19 patients to inhibit hyper inflammatory cytokines, hypercoagulation and thrombosis, as well as mitosis. There have been recent published reports, which we have shared with you before, from MIT and Harvard and the University of Amsterdam proposing TAVALISSE is a highly suitable drug to treat COVID-19. And we also have in-house preclinical data from a mouse model of acute respiratory distress syndrome in which TAVALISSE performed well. And as a commercial product, with a well established safety database of more than 4,500 patients treated in clinical trials, TAVALISSE is readily available and could be quickly adopted as a treatment for COVID-19. As a result of all of this, we have now taken TAVALISSE into the clinic for COVID-19. We have shared with you before two investigator initiated trial at the NIH and Imperial College of London. We are also pleased to announce our Rigel at the Phase 3 trial in COVID-19 to start later this quarter. On Slide 17, I’ll remind you where TAVALISSE fits in the course of COVID-19. TAVALISSE is an immune modulator that can treat over-reactive immune system. Typically, the immune system overreact in about 20% of patients after about one week, when they develop more serious symptoms and need to be hospitalized. TAVALISSE could prevent – that prevent the progression of mild disease to severe disease that puts patients on ventilators and ultimately can lead to death. If we were successful, then we would have a well tolerated, widely available treatment option that could ameliorate much of the fear of this disease, even before effective vaccines become available. And at this point, we do not know for sure when safe and effective vaccines will be approved and become available on a large scale. Slide 18, you may have seen this before, the only thing I want to reemphasize is that TAVALISSE mechanistically could interfere with a disease pathogenesis on multiple levels, not just one. It can inhibit excessive cytokine production. It can prevent hypercoagulation with macro and micro symbiosis, and it can inhibit a process called mitosis, which is accused of playing a major role in COVID-19. That makes TAVALISSE a really unique candidate for effective treatment of COVID-19 complications. On Slide 19, you can see a schematic of our Rigel sponsored Phase 3 clinical trial. We plan to select hospitalized patients with mild disease, who have certain risk factors to develop more severe disease. We expect to randomize approximately 308 patients one-to-one to either fostamatinib plus standard of care or placebo plus standard of care. The primary outcome measure is prevention of progression to severe disease is measured with an ordinary scale. If positive, this trial could be the basis for approval of fostamatinib to treat COVID-19. Slide 20 shows you the Phase 2 trial design conducted by the National Heart, Lung, and Blood Institute at NIH in collaboration with Inova Health System. This study focuses on more severe patients who may be on mechanical ventilation or even make more, which supplements very well the Rigel sponsored trial. Also NIH has very powerful translational research tools that can generate valuable new mechanistic data on fostamatinib in COVID-19. For example, they have established [indiscernible] that can directly study the effect of fostamatinib on their aspect of the disease. The trial randomized the first patient on October 9 and has already enrolled nine patients reflecting the great enthusiasm that the NIH and I know what teams have for their study. And just to remind you, there is a third fostamatinib trial ongoing in the UK, which has enrolled five patients. This is a Phase 2 sponsored by Imperial College of London studying fostamatinib and ruxolitinib on top of standard of care in patients with COVID-19 pneumonia. So in summary, we have a multi-pronged approach to COVID-19 and we’re excited by the positivity to come up with a safe and effective treatment that is desperately needed. With that, I’d like to turn the call back over to Raul. Raul?

Thank you, Wolfgang. Before Dean reviews our financials for the quarter, I wanted to take a quick look at our pipeline. As you know, we are focusing – we focused on the inhibition of immune signaling pathways. The graphics on Slide 22 provide a simplified view of that process for each of our three main targets. Starting on the left side of the screen, we have had and are having success with SYK inhibition in ITP. Our goal now is to create further attractive opportunities with SYK inhibition in other indications. These include warm autoimmune hemolytic anemia and COVID-19, which we’ve discussed with you today, but also acute respiratory distress syndrome and pneumonia, similar to COVID-19, but from other origins that COVID-19. Going forward, our plan is to replicate this success with our two earlier stage programs that target IRAK 1/4 and the RIP1 pathways. There’s been a great deal of interest in the industry in targeting the IRAK4 pathway. We have the only molecule in the clinic that inhibits both IRAK1 and IRAK4 kinases. Our research has demonstrated that inhibiting both of these can achieve a much more robust response, providing what we think is a key differentiator over IRAK4 alone. This allows us to block both innate and adaptive immune responses and so to have a broad, robust effect on chronic inflammation. We believe this could represent potentially many disease areas as shown on the slide. Our RIP1 program is also very exciting and there has been a great deal of interest in this area in our industry. RIP1 inhibition has the potential to treat multiple inflammatory diseases mediated by the Th2 and TNF pathways, including psoriasis, psoriatic arthritis, ankylosing spondylitis, IBD, and rheumatoid arthritis. To give you an idea of the potential of this space, there are numerous drugs that generate billions of dollars in revenue annually, that block TNF and/or Th2 pathways. If our molecules that are show benefit in these patients with these indications, the opportunity is tremendous. The convenience of our oral administration it’s we provide may also prove to be very attractive. In addition, there’s a broader opportunity with RIP inhibition, while our Phase 1 product is systemic. We are also exploring in CMS molecules that can cross the blood brain barrier to potentially treat a variety of neurodegenerative diseases, including Alzheimer’s and ALS. We have done significant amount of work on these molecules and plan to select a lead candidate to take into the clinic. We are very excited about these opportunities and exploring them further. So with that, I’ll turn the call over to Dean.

Thank you, Raul. Turning to Slide 24, for the third quarter of 2020, we shipped 1,727 bottles to our specialty distributors, 1,625 of those bottles were shipped to patients to clinics, while 102 bottles remained in our distribution channels at the end of the quarter. As of September 30, a total of 810 bottles remained their distribution channels. We reported net product sales in TAVALISSE of $16.3 million, 39% increase compared to the third quarter of 2019. Our net product sales from Our net product sales were recorded net of estimated discounts, chargebacks, rebates, returns, copay assistance and other allowances of $4.1 million, our gross to net adjustment, which is approximately 19.8% of gross product sales. Before we move on from net product sales, let me comment briefly on our expectations the fourth quarter. While we’re pleased with the continued growth of TAVALISSE, since we started the pandemic, the impact of COVID-19 on our business is expected to persist. Within this uncertain environment, we expect to see our sequential growth impacted in the fourth quarter of 2020. Once the significant impact and global restrictions are behind us and the future begins to normalize, we expect to see continued strength and growth in our business. On to the next slide. In addition to net product sales Rigel’s contract revenues from collaborations was $2.1 million for the three months ended September 30, 2020, which relates to a milestone payment under our collaboration agreement with Daiichi. Moving on to costs and expenses. On our cost of product sales was approximately $140,000 for the third quarter of 2020. Total costs and expenses were $32.2 million for the third quarter of 2020 versus $32.9 million in the third quarter of 2019. The small decrease in total cost and expenses was primarily due to reduced or delayed commercial activities, resulting from the COVID pandemic offset by increases in personnel related and consulting costs. As we look towards the fourth quarter of 2020, we expect our fourth quarter total costs and expenses to increase compared to the third quarter, as we continue to increase our commercial activities and further our research and development pipeline, inclusive of the COVID-19 efforts that our team has discussed. We ended the quarter with cash and short-term investments of approximately $72.8 million. With that, I’d like to turn the call back over to Raul.

Thank you, Dean. Looking at Slide 26, you will see that we are focusing on our four key value drivers. We’re well positioned to advance or capitalize on each of these opportunities. While our sales force is operating in a very unique environment, our creativity and flexibility has enabled us to implement a virtual approach. We are providing the team with the resources that they need to educate patients and physicians on the benefit of TAVALISSE, including it’s used in earlier lines of treatment. And as you’ve heard here, more support is coming. This work will also aid Grifols effort in Germany and the UK and other European markets, and they continue to roll out the product. We continue to make good progress on our warm autoimmune hemolytic anemia trial, as we enroll the third of our Phase 3, having the wide breadth and reach of our clinical sites, as well as an oral agent is an advantage during these times. The advance of our COVID-19 program is also very exciting. With our Phase 3 trial set to launch, we will be one step closer to potentially helping patients that are suffering from the hyperactive immune response and destruction caused by this virus. And finally, as we continue to meet – as we mentioned, we continue to make progress in our discussions to secure the co-development co-promotion agreement and believe that we will have a partnership near year end. With all of that, I’d like to turn the call over to your question.

[Operator Instructions] Our first question comes from the line of Yigal Nochomovitz of Citi. Please go ahead with your question.

Great. Hi, this is Carly on for Yigal. Can you hear me okay?

Yes.

Okay, great. The first question we had was on the Phase 3 trial in COVID-19 patients that you announced today. Can you clarify if the decision to start that study was made based on any emerging data from the ongoing investigator sponsored trials. And if not, can you just provide some color on why you decided to take the step to start the Phase 3 before seeing any of the data from the ISP? Thank you.

Thank you, Carly. I’ll ask Wolfgang to come in on that.

Yes. So as you heard in my presentation, there are pretty compelling data for fostamatinib in a mouse model of acute respiratory distress syndrome, which we have shared with you in a previous earnings call. And so we have pretty good preclinical confidence that the drug may work in COVID-19. In addition, there’s been some reports from other animal models that highly suggests a very strong rational for fostamatinib in COVID-19. That has led us to start this multi-pronged approach. So we were approached by the NIH and the Imperial College of London who were very enthusiastic about taking TAVALISSE into COVID-19 and those studies had started. And this is how you do it these days. We have started conversations with the agency and the FDA, and are working the plan to launch a Phase 3 study in later this quarter.

Okay, great. That’s helpful.

If I could just – go ahead, Carly.

No, sure, sure. Go ahead.

What I was going to add to that is, these calls are supportive, but if we want to, at some point, get a label to include this. We have to do a larger trial than the 60 patient trial we’re working on it in NIH. And so this allows us to potentially do that this larger trial and I think we’ll be in a solid position to do so sometime as early as next year.

Okay, great. That’s helpful. And then we had a follow-up. Can you just provide an any further details on how quickly you expect the study will be able to enroll, when we might expect to see some data and also how much you estimate it will cost to conduct the trial?

Wolfgang, I’ll let you…

Yes. I can take this. So it starts with the NIH. So we told you in the call NIH’s enrolled nine of 60 patients in their study. So it’s fair to assume the study should be enrolled in half data in the first half of 2021. That’s going to be the first robust placebo controlled data fit. And if that looks very compelling, then we would certainly seek initial conversations with FDA as to what it takes to get this commercially available and get the drug to patients quickly. Regarding our own studies or Phase 3, I told you, we targets to initiate that later this quarter. And we all working with an experienced CRO to execute this study and we plan to have a large number of sites into enroll in the United States, as well as in several places in Latin America. So I’m confident that we can complete the trial in an expeditious fashion. Raul, you want to add to that?

Yes. There are a lot of stuff we’ve talked, disclosed the dollar numbers associated with it. But keep in mind – keep this in mind, our exclusivity period for TAVALISSE fostamatinib and that goes to 2032. So quite a long time, if we feel it’s useful to invest in this area further, in the product further, given that it is commercially available already, and we can leverage that with more ease. Also everywhere, we were always planning and launching an additional study, we were working on several alternative indications before COVID. COVID came about and this is the perfect indication, not perfectly, the very good indication to pursue with this product. The fit mechanistically, as Wolfgang said is really a very excellent. There’s tremendous interest in novel mechanisms that are very well suited to the disease process in terms of a hyperactive immune system. And in addition, given that we have the product already available and we could make substantial provide substantial amounts of material. Should there be a positive? That is one of the key features of this product, which was made us so excited about it. And so we think that that’s a very useful investment for us. The fact that you can execute a pivotal trial such as, when we discussed today and get the results relatively quickly, I think is very helpful. Keep in mind also that COVID-19 pneumonia, hyperactive immune system is a key focus here. However, if we have good results here, this will allow us to launch up subsequent studies in other areas, other pneumonias treating acute respiratory distress syndrome from sources other than COVID-19, which happened very frequently. And those are a continuing issue in the healthcare system. So it really sets us up very nicely for doing that subsequent. So it’s a pretty exciting opportunity in terms of it. And like I said, we’re delighted to be able to launch this trials very shortly.

That’s super helpful. Thanks very much for taking our questions.

Thank you. Our next question comes from the line of Eun Yang of Jefferies. Please go ahead with your question.

Hi, this is Nalin [ph] on for Eun. So just have two questions. Number one is, for TAVALISSE opportunity in Europe. So Grifols commented this morning that in the first three months of launch over 90% of the target customers have been contacted by the [indiscernible] but only around 50 patients are currently on TAVALISSE. So could you please elaborate on the number of target customers, roughly, how many patients – how many percent of the more than 50 patients represents. And what are the key factors preventing patients from starting to TAVALISSE? That’s the first question. And the second question is on, wAIHA. So – and CRM manufacturer has commented that a CRN may be able to offer deeper response compared to TAVALISSE. Could you please comment on what criteria would define deep response in wAIHA and approximately what percent of the – 44% of patients who had a response in Phase 2 were deep responders. And would you quantify the depth of response in Phase 3? Thank you very much.

Sure. Thank you, Nalin [ph]. I will take those in sequence, maybe the first on TAVLESSE in Europe, we’re delighted with the performance of our partner Grifols in Europe and they are uptake and the execution of the launch in the UK and Germany. There’s still a lot of work to do in Europe. European market is a very attractive market, maybe second only to the U.S. market in ITP. So and we’re delighted that they’ve put so much effort and thought into the launch of the product and they’ve contacted quite a number of targets. They’re better positioned to comment on the penetration there since it’s really a mirror area. We’re a little – we hesitate to say, what we know what they shared with us, given that they haven’t shared more information than that. But the market is very attractive, very similar to the U.S. in terms of structure and what products are used. And we think that they’re off to a very good start. So it’s very, very early still, they’ve only been on the market in those two countries for a short period of time. So there’s still a lot of opportunity left. And maybe I’ll ask Dave to make any further comments on that.

I think you covered most of it, Raul, but I guess, I would just say that those numbers are quite impressive and it shows their commitment to really getting the word out about TAVLESSE to their clinicians in the EU. And I think the great success that are having in terms of receptivity to the messages around TAVLESSE for ITP patients in both Germany and the UK. But as Raul said, I think it’s important for them to share the specifics on their 90% hit of targets, as well as the 50 patients that they’ve already got on product.

And your second question, we are very pleased with TAVALISSE SYK inhibition has been able to show in AIHA. And we did a Phase 2 trial that showed a very good response is 44%, 48% response rates, which are very attractive. And based on that, we’ve launched our Phase 3 efforts and we’re approaching over 60% of role, which we’re very happy with. And as Wolfgang mentioned, seven patients enrolled, most recently in a month, that’s actually a very nice performance in terms of enrollment. So we’re very happy about that. It’s hard for me to make a comment on other people’s products, simply because I don’t have any data. They haven’t generated any data as yet. So when they do, we will be able to do so. And I’m sure others will as well. But I can’t say that we think that there’s a tremendously attractive opportunity there and that we are the first in the foremost product in development. We have a good Phase 2 trial already generated data that we think is very encouraging. And we’re eagerly waiting to finish this trial enrollment and get this product to these patients. They currently have nothing and that you makes a tremendous opportunity. And we think that we will be the first product approved for this indication. And that’ll give us a tremendous opportunity to really discuss the – and set the stage for this indication. Keep in mind that we are currently detailing our product to key marks that treat ITP based on our current indication. There was an almost perfect overlap between the patient – the doctors who treat ITP and those who treat AIHA. So all that work that we’re doing today, educating doctors, about our products our mechanism, how it works how you use it will be completely translatable to AIHA once that’s approved, because of the same product, same dose, same name, same doses, and that’s a tremendous advantage. A lot of the heavy lifting that’s required to get the knowledge based on SYK inhibition, we’re doing today well ahead of the launch in AIHA. So not only do we have a clinical lead over everybody else, it’s substantial. And I think we’ve expanded on it this year, but in addition to that, we’re building a tremendous installed base of knowledge of our product. That will be very helpful once we launched that. So I think we’re in pretty good shape for that competition.

Thank you very much.

Thank you.

Thank you. Our next question comes from the line of Joe Pantginis of H.C. Wainwright. Please go ahead with your question.

Hey guys. Good evening. Thanks for taking the question. So it’s nice to see the continually improving commercial profile of TAVALISSE, but obviously you continue to mention the COVID-19 headwinds. So that’s what I wanted to focus on. So when you talk about the mix or you talk about getting on new patients, as well as improvements in the persistency, which is great to see, I guess I wanted to ask about the mix that you’re seeing with regard to those two categories. And especially on the new patients, what is driving, obviously you have the increased virtual touch points with the sales force, but any anecdotes you can share of what’s helping to drive the new patients coming on.

Sure, Joe. Could you repeat your first part of your question? I didn’t understand the two different groups.

Sure, sure. So you talked about with regard to the commercial profile, you mentioned that you have the new patients as well as the improvements in persistency of the patients already on the drugs. So first, are you able to delineate the mix between those two? And then the second part of the question was, for the new patients, what’s driving them getting on TAVALISSE.

Great, good question. I’ll ask my colleague, Dave, to comment on that, and then I’ll add at some further comment.

Sure. I’d be happy to comment on that. I think first of all, what I’d like to do is make sure, how impressed I am with this team that I have been honored to be able to work with here at Rigel. I mean, the ability for us to look at our data, target our prescribers and execute against that has been absolutely incredible to me. Because I can tell you, I have a very, very committed team to get the word out. So both of those things you mentioned are really important to our growth, the new patients, as well as keeping the patients on that we had already started. And I would say, I’m not going to give specifics right now, but I would say that both have been contributing to our growth over the past year. But we have seen a little more difficulty in kind of getting the new patients on. And that’s simply because of our reach, which as I showed you, is continuing to improve even during COVID. So I think one of the big things that will happen is, when we finally open up and can get this message spread, we can get more new physicians prescribing the product. And because we’ll have expanded our reach and we think that’s going to really be an accelerator to getting new patients on product. But the persistency has helped us drive our growth as you pointed out, we are 55% on that four months refill and recognize that just represents one point in time. And the earlier we get patients on therapy, the better that can get, because those are better prognosis patients, they tend to respond and that’s what keeps them on therapy to the four month point. And then, well beyond that. So both of those things are driving our growth and we really do believe it’s been our ability to, despite COVID get in front of docs. But with that said, it could definitely accelerate things – if things would open up and we’d be able to see our clinicians in person through those things that normally we’re able to do drop in, go to any exhibit, see a doc as they come by our exhibit, those kind of live interactions, which really help reiterate the message just haven’t been happening as much during COVID.

That’s actually really helpful feedback. Thanks a lot, guys.

Thank you, Joe.

Thank you. Our next question comes from the line of Do Kim of BMO. Please go ahead with your question.

Good afternoon. Thanks for taking my questions. First, on the European ITP market, I was just wondering if you could share your thoughts on treatment landscape there. Any differences on how Europe would treat or use TAVALISSE versus how U.S. doctors would.

Sure. Thank you, Do. For your question, I’ll also ask my colleagues to comment as well, Dave and Wolfgang is helpful. As I mentioned that my response to an earlier question, I don’t think there’s much difference in the overall treatment landscape in Europe. It resembles the U.S. landscape very closely that is patients with ITP are initially put on steroids, as the most common form. IVIg is generally used as a rescue medication there, it is here in the U.S. Our partner Grifols, as you may know, is one of the foremost providers by IVIg and which is why this is a nice fit. That’s an acute care use. This is a rescue use. This is a chronic use. After steroids are deployed, then they move on to a second line, and they’re the choices similar to the U.S. TAVALISSE is available for that line, as well as TPO agents as well as Rituxan, Rituxan is not approved. Different doctors view those agents differently and select those in different orders. There are some differences country to country. I understand that in Germany, for example, there’s more TPO use, less Rituxan use. France, the opposite more Rituxan use, less TPO use, some variances country to country, but in total, they’re not that different in terms of the what’s been available to them and what they use and much like other areas of our industry. It really is a global market. And that’s an important thing to think about how we position the product here, facilitates the positioning of the product thereby our partner. So maybe Wolfgang, can you comment anything addition and maybe Dave can comment as well.

Raul, I think you summarized it pretty well. I mean I don’t see like major differences in treatment algorithms for ITP in Europe versus the U.S. and TAVALISSE or TAVLESSE in Europe should get to a good adoption. Dave, do you have any additional comments?

Yes. I think importantly and this – I’ve only had one meeting with our Grifols counterparts, but what I saw during that meeting is tremendous ability to partner interact with our commercial medical development team and them. And importantly, what they have that we didn’t have at launch is this new earlier line data. And so they’re out of the gate very quickly with this story that TAVLESSE is a option immediately after steroids with a 78% response rate. And I think that’s really important. And obviously they’re learning a lot from us through these interactions and we’re quite pleased with the things they’ve adopted and everything they’re doing to ensure that the message gets out globally on TAVALISSE and TAVLESSE.

I thought that was a time when splenectomy is where a lot more common in Europe than in the U.S. Is that that’s the case anymore, they move more towards therapeutic options ahead of splenectomy.

I think Do, that is a general in U.S. and Europe, I’m not sure – so sure about the Japan market, our Asian market, but I know they are increasingly not favored for patients prefer not to have to undergo a splenectomy, given the uncertainty of that outcome.

Right. Okay.

Yes, and I would just add very quickly there for about a treatment standpoint, remember, that the international consensus guidelines apply there as well as here, because that’s an international working group. And so I do think that’s important to note as well.

Great. Thanks. That’s very helpful. I just had a question on the Phase 3 study in COVID patients. Do you – could you share with us what your thoughts are on the expectation for the standard of care arm? How you are thinking about what the potential benefit of fostamatinib would be in terms of how you powered the study in the number of patients you are plan to enroll?

Wolfgang, would you like to comment?

Sure. Yes, so we are very much aware of the changing landscape, but also about the drugs that are being tested in are not successful. So but clearly in the U.S., we do expect patients to be on remdesivir, and probably more severe patients also be on dexamethasone, because it has worked in more severe patients. It has some effects in severe patients. But our patients are more on the milder side if it’s in the Phase 3. So that’s one thing. And we are stratifying patients by their use of remdesivir and dexamethasone. So they will not end up with an imbalance of patients all on this dexamethasone or remdesivir in one arm. So we have a insurance policy is in there. I also told you that, we are going to places outside of the United States where at least remdesivir will not be as widely available. So we also expect the number of patients who are not on remdesivir, but maybe on dexamethasone. Now, both drugs in my view have modest treatment effects. So assuming for example, a 30% progression rates, which we plan to achieve by enriching for some risk factors, some patients with some risk factors, we think we have adequate power to demonstrate statistical significance for fostamatinib over a standard of care regardless of the background therapies. I’ll pause Do and see, if you have a follow-up question.

No, that’s very helpful. Thank you for taking my questions.

Thank you, Do.

Thank you. Our next question comes from the line of Kristen Kluska of Cantor Fitzgerald. Please go ahead with your question.

Hi, good afternoon, everybody. Thanks so much for taking my question. So regarding the updates that you had to Canada, Japan, and Israel for chronic ITP, first, could you please remind us about how you view the market opportunities across these regions? And then second, do you know if your partners including Grifols intend to collect any data from the physicians and users related to the line of usage? I guess it’d be interesting to consider, especially in some of these countries outside of the U.S. and Europe, where there might be less approved treatment options available.

Great, thanks. Thank you, Kristen. I’ll comment in that, maybe Dave to comment if any further. The U.S. market is by far the largest market for ITP. I think it’s about $1.1 billion as we’ve said, and outside the U.S. made about $900 million. So that would be Europe is the lion’s share of that $900 million and a little bit of a guess $400 million, $500 million. Canada, Japan, and then Israel are smaller segments there, but attractive segments. And obviously in Japan, it’s an area where our partner Kissei is very interested in this indication and the subsequent AIHA opportunity as well. And they’re doing a study there, Phase 3 as required. I think they’ll do very well. The market is attractive in Japan. I would say probably aside from Europe and the U.S. probably the largest one of the remaining ones. So an attractive market, again, similar to the U.S., but I know it a bit less than the Europe so a little bit of positive. Canada is a very attractive market simply because it’s approximate to the U.S., again we’ve done clinical trials in Canada as part of our ITP and as well as AIHA studies. It’s an attractive market. Obviously cross border is useful. And this is a global business overall to cover all of this. It’s far smaller than the U.S. So old rule of thumb used to be 10%. I think it’s less than that in terms of relative to the U.S. market. And Israel is a very attractive market, highly technology, technologically advanced, and attractive market, but again much smaller given the population sizes of those. So I think there are attractive opportunities of those three. You mentioned Japan, the largest followed by Canada and Israel being the smallest. Other places outside the U.S., we – beyond Europe, Latin America is an opportunity as well as some areas in South or Eastern Asia that are not part of the Kissei collaboration. Any other comments on that Dave that you’d like to add.

Not on the market, Raul, but because I think you’ve covered that pretty well, but on the line of therapy question, all I could say Kristen is that we at least from what I’ve seen with a partner Grifols are very interested to learn information and share information. So we – and the goal is to continue to gain adoption of fostamatinib worldwide. And so obviously, we’ll continue to work closely with our partners as we’re doing now with medicine as they are preparing for Canada, the Canadian launch. And I think if we can get information that helps us with a line of usage certainly that of course is going to be useful to all of us across partnerships in continuing to move TAVALISSE to earlier lines of therapy.

And Kristen, the FORTE study that that Dave described in his presentation is very useful for that, because it’ll provide a very rich data source for use in second line patients that’ll help us really nail down further usage patterns that I think will help us in the discussion of our product with doctors and patients.

Great. Thank you so much for that. One quick follow-up, just during this COVID-19 pandemic over the last eight months or so, are you seeing or hearing of any shifts in terms of how physicians are now viewing their lines of therapy? So for example, the fact that TAVALISSE is an oral therapy. Are you noting any changes there? And then also, we’ve spoken to some docs where they’ve pointed out therapies like rituximab, that may have immunosuppressant related causes. So that’s kind of shifting their mindset. So curious overall through this last eight months whether you’re seeing a shift related to the therapy options in light of the pandemic.

Thank you. Dave, you want to comment on that?

Sure, absolutely. And it’s a great question, because obviously, patients are concerned and clinicians are concerned about patients having to spend time with infused products. And so I think you’re absolutely right. It has been good to be an oral medication during this time of COVID. And I think that’s something that is good for now, and I think is actually, it’s good for the future as well, because it’s more convenient for patients. And it really is something that they can use and becomes a part of their adaptation to their daily lifestyle, especially with a product like TAVALISSE. So yes, anecdotally, clearly physicians are doing more telehealth visits when possible. And they I think are very receptive to agents like TAVALISSE that allow patients to do things on their own at home.

Great. Thank you.

Thank you, Kristen.

Thank you. [Operator Instructions] Our next question comes from the line of Tessa Romero of JPMorgan. Please go ahead with your question.

Good afternoon, guys. Thank you for taking the question. Hope all is well. Just a few from me. So on the Phase 3 warm AIHA trial, are you able to provide any additional granularity on how you were thinking about timelines for full enrollment for the study? Is it a matter of finding the patients? Are there patients in queue that just needs to be dosed? And then my second question, if I could, we noticed a few ASH abstracts up yesterday for fostamatinib, and any new analyses or updates we should be monitoring for the conference – at the conference next month. Thanks so much, guys.

Thank you, Tessa. Wolfgang, would you like to address the first of those that the enrollment timelines for Phase 3?

I assume you mean autoimmune hemolytic anemia.

I’m sorry.

Yes.

Yes, okay. So as I alluded to in the presentation, I guess the message that I want to send to you things are going quite well, right. So we – before March, we had a very good momentum with about eight to nine patients a month. And then we had a shutdown over several months where nobody got enrolled and then the sites began to reopen. And we get like really, really good screening results in September. And that translated into seven randomizations in October. So seven is only one less than 8, what we have before the shutdown. So what I want to say is, well, it looks good and we are optimistic. But then we also know the second waves in there is – this COVID outbreaks in Europe and in other places. So it’s like really hard to commit and to promise something under the circumstances. That’s why we deliberately didn’t specify a date or something like that. But I would say we are optimistic, but we have to respect the pandemic that that could interfere with our plans. I hope that’s acceptable.

Yes. And we’ll obviously provide further updates as we progress, and it’s a good place to be at over 60% enrollment in this and as I said, having as many sites as we have open and available close to 90 sites about 90 sites, and we need 30 some patients, so really about a patient from maybe a third of the sites, that’s a pretty good place to be to finish this study. And we’re excited about that. Patients are there. And especially once they begin to be confident in terms of their pandemic passing a bit, and the fact that we’re in so many different countries 22 of them really helps us, because I think in some places, this is an issue and it’s come and gone and other places at different times is become an issue and come and gone. And – but many of them are screening patients. We are seeing that on a regular basis. And we look forward to continued enrollment with the caution that Wolfgang just said. And your second question on ASH, we have a few abstracts as you may have seen discussing some of the data and some different cuts of the data that I think people will find very useful. So let’s say a little bit more about that in the future. But I think it should be a very useful series of abstracts and in some numbers, I think we have one, two, three, four, I’m trying to come from, as we speak, there was quite a number at least four of them talking about AIHA disorders of platelets. I know we have some further trials in progress description of our Phase 3 program with a little more detail in AIHA, which is useful as well as a level one in the long-term use of TAVALISSE in long-term ITP patients, which I think to be pretty exciting, because that’s a key question we can frequently get and very proud of the durability of our ITP data that David said. So really a good series of posters that we have there four of them total, I think.

Great. Thank you so much for taking my question.

Thank you, Tessa.

There are no further questions at this time. I would like to turn the floor back over to Mr. Raul Rodriguez for – my apologies, for closing comments, please go ahead.

Thank you so much. I’d like to thank you for your interest in Rigel and your participation in the call. It’s a exciting time for Rigel as we wrap up this year, I think we’ve accomplished a great deal this year and made tremendous progress despite all the difficulties imposed upon us. But even with those difficulties saw some opportunities such as in this COVID area. That’s I think we’re really excited about. We look forward to sharing with you our plans for next year in a future call. And with that, I’d like to thank you. Have a good day.

This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.