Earnings Labs

Rigel Pharmaceuticals, Inc. (RIGL)

Q4 2021 Earnings Call· Wed, Mar 2, 2022

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Transcript

Operator

Operator

Greetings, and welcome to the Rigel Pharmaceuticals Financial Conference Call for the Fourth Quarter and Year-End 2021. 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, please go ahead.

Dolly Vance

Analyst

Welcome to our fourth quarter and year-end 2021 financial results and business update conference call. The financial press release for the fourth quarter and year end 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 site on 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 most recent Annual Report on Form 10-K for the year ended December 31, 2021 on file with the SEC. 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 President and CEO, Raul Rodriguez.

Raul Rodriguez

Analyst

Thank you, Dolly, and thank you everyone for joining today. Also with me today are Dr. Wolfgang Dummer, our Chief Medical Officer; Dave Santos, our Chief Commercial Officer; and Dean Schorno, our Chief Financial Officer. Beginning on Slide 5. I'd like to discuss the strategic steps we took in 2021 to grow our hematology/oncology commercial capabilities and to advance our late stage clinical programs. Importantly, we undertook a sales force expansion with the goal of broadening our reach, improving efficiency and increasing in-person interactions in the field. We also announced plans to focus our resources on our mid to late-stage programs and our overall clinical efforts. We believe this will strengthen our ability to build value for shareholders in 2022 by executing on the near-term value drivers, as shown on this slide. First, I want to reiterate the progress we made with our first value driver, growing sales in ITP. In the fourth quarter, we shipped the highest number of bottles of TAVALISSE to patients and clinics in any quarter since launch, and our new patient starts continue to grow. Dave will provide further details later on in the call. In just a moment, Wolfgang will walk us through a review and timelines of our near-term pivotal Phase 3 readouts for TAVALISSE in warm autoimmune hemolytic anemia and COVID-19, as well as advancements of our IRAK1/4 and RIP1 programs. I would like to provide a few highlights. From our second value driver, warm autoimmune hemolytic anemia, the pivotal Phase 3 FORWARD trial completed enrollment in the fourth quarter of 2021. We expect to report top line data from this study in mid 2022. And if the data is positive, we expect to move forward to regulatory filings. An approved indication for warm autoimmune hemolytic anemia would be the first approved…

Wolfgang Dummer

Analyst

Thank you, Raul. Slide 8, warm autoimmune hemolytic anemia is a rare disorder caused by the destruction of red blood cells, leading to low hemoglobin levels and showing measures of hemolysis. Due to decreased ability to transport oxygen in the blood, clinical manifestations develop like fatigue, dyspnea, palpitations, or severe weakness. Moreover, splenomegaly, hepatomegaly or even heart failure can occur. There's also a risk of dangerous thromboembolic events. And finally, the overall mortality risk is approximately 8% to 11%. Taken together, warm AIHA remains a clinically significant disease with a high unmet medical need for new, safe and effective therapies. Slide 9, there are currently no approved therapies for warm AIHA. The current first treatment for almost all patients is to initiate systemic oral corticosteroids at relatively high doses. Although steroids can be tapered off a while, many patients still require dose levels for long periods of time that lead to side effects such as diabetes, osteoporosis, hypertension, and many others. Another treatment currently being used is rituximab. Rituximab works by depleting all B cells in a patient for many months, and thereby decreasing all the antibody production against red blood cells. But prolonged B cell depletion is also immunosuppressive and carries increased risks, particularly infections and a decreased response to vaccines. Splenectomy is still offered by some clinicians, but it means getting a major surgery and an irreversible removal of an organ from the body. For all these reasons, we believe that a safe and effective oral treatment such as TAVALISSE for AIHA could represent a very compelling treatment option for physicians and patients. Slide 10 explains how and why TAVALISSE should work in warm AIHA. Very similar to ITP, in AIHA the human body begins to produce autoantibodies that bind to components of the red blood cells. The…

Dave Santos

Analyst

Thank you, Wolfgang. I'd like to just briefly build on Raul's and Wolfgang's comments on warm autoimmune hemolytic anemia, or wAIHA, and give you a sense of why we are very excited about the commercial opportunity ahead of us. Moving to Slide 14, we believe that wAIHA is a very attractive market opportunity for TAVALISSE, especially when you look at the patients who move beyond first-line therapy. In 2021, we conducted both qualitative and quantitative research to get the most updated look at the market. And I wanted to review that information for you today. The prevalence of autoimmune hemolytic anemia is approximately 17 per 100,000 or 45,000 adults with AIHA. Of those patients, the majority or about 80% of them are warm. And that's how we get to the 36,000 patients Raul mentioned earlier. The remainder have cold agglutinin disease. In our quantitative research last year, we found that about 35% or 13,000 patients are not actively treated for their disease, leaving approximately 65% or about 23,000 patients who are treated. And of those 23,000 patients being treated each year, about 9,000 patients are treated with first-line therapy, and they overwhelmingly received steroids. That leaves a significant patient population of up to 14,000 patients each year who are looking for additional options. This is a large treatable population and that represents an exciting opportunity for TAVALISSE. On Slide 15, the results of our latest quantitative research from last year show how wAIHA patients in each line of therapy are currently treated. In conducting this research, we asked 150 clinicians to think about their wAIHA patients in each line of therapy and then assign percentages for the treatments they utilized in those patients. The results show multiple entry points for TAVALISSE in wAIHA, especially because of the heterogeneity of treatments.…

Wolfgang Dummer

Analyst

Thanks, Dave. I would now like to give you a quick update on our COVID-19 program. Slide 23. We have taken you a few times through the very compelling scientific rationale for TAVALISSE in COVID-19, supported by several pieces of external research at independent institutions. That scientific rationale was confirmed by very positive clinical data from NIH, which was published in September in the journal Clinical Infectious Diseases. There are additional studies ongoing, most importantly our own Phase 3 trial, which neared enrollment completion and will generate a robust data package. If positive, the data should be sufficient for approval of TAVALISSE in this indication. Given persistent resistance to vaccination in some places and the possibility of new virus variants, we believe a need for effective treatment options for severely ill patients remains. If approved, TAVALISSE would be available immediately for commercial use. Slide 24 shows you our Rigel Phase 3 study design. The study started out with hospitalized patients with mild disease. However, it turns out that mostly patients were enrolled who were on the brink of severe disease already. Therefore, we have adjusted inclusion criteria to shift the focus on more severe patients and along with that, changed the primary endpoint to days on oxygen for more sensitive measure and better comparison to other trials, such as the NIH ACTIV trials. As mentioned in prior discussions with FDA, this trial could be the basis for potential label extension for fostamatinib to treat patients with COVID-19 if the data is positive. Enrollment is at over 85% at this point, and we continue to expect the data readout around mid-year. On Slide 25, you can see an overview of the NIH ACTIV-4 trial. The trial is evaluating fostamatinib and other compounds in a patient population similar to the NIH Phase…

Dean Schorno

Analyst

Thank you, Wolfgang. I'm on Slide 33. For the fourth quarter of 2021, we shipped 1,814 bottles to our specialty distributors, resulting in $22.5 million of gross product sales. 1,785 of those bottles were shipped to patients and clinics, while 29 bottles were made in our distribution channels at the end of the quarter. As of December 31, a total of 937 bottles remained in our distribution channels. We reported net product sales from TAVALISSE of $17.6 million, a 1% decrease compared to the fourth quarter of 2020. Our net product sales from TAVALISSE were recorded net of estimated discounts, charge-backs, rebates, returns, co-pay assistance and other allowances of $4.9 million. Our gross to net adjustment is approximately 21.9% of gross product sales. For the full year, our gross to net adjustment was approximately 22.4% of gross product sales. Before we move on from net product sales, let me review our expectations for the first quarter of 2022. As we've experienced in the past, during the first two months in the quarter, we've seen a reduction in our daily shipments to patients and clinics as compared to the daily shipments to patients and clinics in the fourth quarter of 2021, resulting from the typical first quarter reimbursement issues confronting our industry, such as the resetting of co-pays and the Medicare doughnut hole. We're also experiencing the continued impact of COVID-19 with the Omicron variant. Also, as we have seen in the past, we expect to see increases in our bottles shipped to patients and clinics in March. Given these factors and despite prior year's sequential decreases in bottles shipped to patients at clinics in the first quarter, we expect to see a small increase in bottles shipped to patients and clinics in the first quarter of this year. Given these…

Raul Rodriguez

Analyst

Thank you, Dean. And moving on to the next slide, Slide 35, as we have reviewed on this call, in 2021, the Rigel team advanced all our commercial and clinical priorities. This sets us up for what we believe will be a transformational year in 2022. Our priorities for this year are rooted in our key value drivers; growing sales in ITP with our expanded sales force, increasing the market opportunity for TAVALISSE with pivotal Phase 3 trial readouts in both warm autoimmune hemolytic anemia and COVID-19. And lastly, advancing our IRAK1/4 and RIP1 programs in the clinic. We are very excited about the significant commercial initiatives and clinical milestones coming in 2022, and the potential to really transform our business. Thank you again for your interest on our progress this quarter and throughout 2021. With that, we'll turn the call over to your questions. Operator?

Operator

Operator

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions]. Our first question today is coming from Do Kim from Piper Sandler. Your line is now live.

Do Kim

Analyst

Good afternoon, everyone. Thanks for taking my question. First, on the wAIHA Phase 3 data, could you remind us what level of details we could expect when you put the data out? Are we going to get the durable response rate numbers and any of the secondary endpoints?

Raul Rodriguez

Analyst

Do, how are you? Thank you so much. I'll ask Wolfgang to comment on that.

Wolfgang Dummer

Analyst

Yes, sure. Thanks, Do, for your question. Yes, once we present top line results, which is expected to happen in the June timeframe, we will have the primary endpoint as well as the pre-specified secondary endpoint available along with crucial and key safety information that will be required to understand the data. So you should get a pretty comprehensive picture upon data unblinding.

Do Kim

Analyst

Thanks, Wolfgang. And a follow-up question. Just based on your discussions with physicians, how important is it to them on this primary endpoint that a patient has a durable response? Would they put more weight on it over just 2 grams per deciliter increase or achieving a hemoglobin level greater than 10? How much emphasis do you think we should put on that durable endpoint?

Raul Rodriguez

Analyst

Let me --

Wolfgang Dummer

Analyst

Well, we -- sorry.

Raul Rodriguez

Analyst

No, go ahead, Wolfgang.

Wolfgang Dummer

Analyst

I wouldn’t put too much weight on the three prime points in the primary endpoint. It is first and foremost a regulatory requirement that we have discussed with FDA. Of course, physicians will wonder, well, does the drug work? And if the drug works, is the response sustained? So that is an important question. But there are so many other ways to describe clinical benefit. For example, just the mere fact if somebody gets his hemoglobin up by 2 units, say from 6 to 8, that is a very, very positive clinical benefit. But primary endpoint definition, it doesn't make the cut. So that person wouldn't be responding according to our primary endpoint. The other things that are important are quality of life improvements, such as fatigue improvements or just an overall improvement in hemoglobin over time, and we will slice and dice the data when it becomes available. And the totality of the data is what's going to be most important for the clinicians.

Do Kim

Analyst

Thanks. That's helpful. And last question for Dean. In the first quarter, gross to net in 2022, what's driving this higher number versus prior quarter first quarters?

Dean Schorno

Analyst

Let me ask Dave just to start with the answer there, and then I'll follow up.

Dave Santos

Analyst

Thanks, Dean. I think the really important thing that I mentioned during my comments and Dean mentioned during his is that we want patients to get TAVALISSE if their clinicians prescribe it. And we don't want coverage decisions to get in the way of that. And that's why we have patient assistance programs in place to help patients when their coverage falls short. And when we looked at where our challenges were in commercial coverage, it was actually in those plans where there were either formulary exclusions or blocks. And while providers could still get TAVALISSE for their patients, it represented some hassle factors for them as they had to supply additional backup and support their decision to use TAVALISSE. So that's what happened. Our market access team worked with key PBMs to improve that situation, and that's how we got preferred status. And to achieve that, we had to demonstrate that TAVALISSE was safe and effective, and we had to differentiate our mechanism of action. And frankly, we think it's a huge benefit for us being preferred, because it gives the providers an important proof source of efficacy and safety. And we needed to be competitive, of course, in terms of costs, because even a rare disease like ITP is reviewed by the payers. So in the end, this is the driver of our gross to net. But we fully believe by improving commercial coverage for patients with preferred status, we'll be able to now fully realize our opportunity in ITP, accelerate our new prescribers and accelerate new patient growth. So I think overall, all of us were aligned that it wasn't just the right thing to do for patients, but it was the right investment at the right time. Hope that helps kind of set the stage on the gross to net, Do.

Dean Schorno

Analyst

So, Do, with the 30%, that estimate is always dependent on the mix of patient type as well as pricing changes and a variety of factors, but the majority of that shift is a result of the programs that Dave just described.

Do Kim

Analyst

Great, very helpful. Congrats on the progress and thanks for taking my questions.

Raul Rodriguez

Analyst

Thank you, Do.

Operator

Operator

Thank you. The next question is coming from Eun Yang from Jefferies. Your line is now live.

Eun Yang

Analyst

Thank you. For the Phase 3 FORWARD study, so the primary endpoint is hemoglobin response on fully consecutive or variable visits during the 24-week period. So how often is the visit? Is that every two weeks?

Raul Rodriguez

Analyst

It is, Eun. Over that 24-week period, they come to the clinic every other week.

Eun Yang

Analyst

Okay, thanks. And then a second question is on TAVALISSE sales. So you did mention that the first quarter is going to be down from the fourth quarter last year for the seasonality issues. But I know you don't give guidance, but last year you have expanded your sales force. So when I look at the consensus number, it's around 92 million. But from 4Q, run rate is about 70 million. So how do you feel about the consensus of 92 million for this year? Thank you.

Raul Rodriguez

Analyst

Sure. Thank you for that. I'll ask Dean to comment as well. We don't give guidance. We give some discussion or description of what we see. But don't expect guidance from us. The business is just too early, and with COVID little too difficult to predict as yet. But Dean, do you want to comment?

Dean Schorno

Analyst

No. I think that's right, Raul. And as we've historically done, we've given a view of what Q1 looks like. And I think Dave described some favorable trends, and we think we've got a good setup and a foundation for the business with the programs that Dave described. And hopefully we'll be moving into greater post COVID access as the year progresses. I would note that we've seen historically as we come off of the impact on bottle shipped to patients and clinics causing the first quarter due to resets and in the Medicare doughnut hole that the second quarter we typically see as a strong quarter relative to the first quarter.

Eun Yang

Analyst

Thank you.

Raul Rodriguez

Analyst

And I think we see good growth for the balance of the year. I think we're excited about what the year will look like with the larger sales force, improved access, more and more in-person interactions, which are just so much more effective. Combine those three things together and they're synergistic one to the other. And we're very positive on the balance of the year, especially as this Omicron variant fades rather quickly even now.

Eun Yang

Analyst

Great. Thank you.

Raul Rodriguez

Analyst

Thank you.

Operator

Operator

Thank you. Next question today is coming from Joe Pantginis from H.C. Wainwright. Your line is now live.

Joe Pantginis

Analyst

Hi, everybody. Good afternoon. Thanks for taking the question. So my first question regarding wAIHA. I don't think this is a stretch too much. So when you look at Slide 15, the prescribing landscape that you put out there, if you were to essentially remove all of the labels from this chart, it would look very characteristic with the ITP landscape being very heterogeneous. So I guess the question is, how do you expect your sales force to be able to leverage their experience in marketing TAVALISSE for ITP in a very similar heterogeneous market when they get wAIHA in their bag hopefully?

Raul Rodriguez

Analyst

Sure. Let me ask Dave to comment, and I'll add a comment afterwards.

Dave Santos

Analyst

Yes, that's a great question, Joe. And I think that's our biggest strength here, because we're learning every day in ITP in terms of awareness. And by the way, we've actually made good progress in our awareness in ITP where we're nearly at the same level of [indiscernible] I think where we have some work to do and that's both aided and unaided awareness. I think where we have some work to do is to increase our unaided awareness, and we're doing that. And I think it's just a matter of time opening up and we've got more people on the team now. We'd get great messages, as I said, with that -- especially with preferred formulary status on some key formularies. All of these messages, everything's coming to place. But this is why we're the experts here now in warm autoimmune hemolytic anemia. We'll be the first one to launch. We'll be able to really tell that story of steroids, Rituxan, some of those issues, and then all the other options out there that are unproven and not labeled in the disease. And so I think we're doing a lot of research in this space. And we want to -- we know we can definitely own this space in the third-line setting, but really what we're really talking about is how do we really focus on this opportunity with Rituxan, what's the reason clinicians are using it, because even in ITP, Rituxan retains the highest awareness of any product in ITP. And so that's the same in warm autoimmune hemolytic anemia. I think the beauty is going to be that we don't have a whole bunch of promoted products trying to get into the -- kind of confuse the message. We'll be the first and we'll be able to shape that. So I think we got a lot of opportunity, a lot of synergies. There may be different docs treating the different diseases at different times, but it's highly synergistic. And I think our team is going to do a great job leveraging what we learned in ITP to really launching strong in warm autoimmune hemolytic anemia.

Joe Pantginis

Analyst

Got it. No, that's very helpful color. And if I just stick with ITP for a second, especially as you talk about going to earlier lines. I guess in prior calls, and I'll preface this by saying obviously COVID has had a real impact on my question. On prior calls, you talked about your desire to provide a good sense of visibility as to the kind of traction you're getting into earlier lines of ITP. I guess how is that looking right now with regard to what you're seeing and when you think you might be able to share more data on that?

Raul Rodriguez

Analyst

Yes, I'll have to say that our ability to determine use by line of therapy is a bit limited. But from what clinicians tell us, and we just had a speakers training program this past weekend with over 40 clinicians on the line. And this included physicians, advanced practice providers as well as [indiscernible]. They told us that in their experience when they're talking to clinicians, they do. They start late because if they need more comfort, they move it up. And I think that's what we're looking for as we move forward. You have to recognize that we still feel like we are in launch because of COVID. And some providers are getting their first run, especially now that we've improved our coverage, commercial coverage. They're just getting their first patients on the brand. And it takes some experience and they move up in line once they get more comfortable with that. And so I don't have that data for you today. But I do think that as we move forward and we get more patients on the brand, more and more of them will move upfront -- not upfront, I'm sorry, in second line, especially because we have equal footing to the [indiscernible] now with that preferred status.

Joe Pantginis

Analyst

Great. Thanks, guys. I appreciate the details.

Raul Rodriguez

Analyst

Sure.

Operator

Operator

Thank you. [Operator Instructions]. Our next question today is coming from Yigal Nochomovitz from Citigroup. Your line is now live.

Yigal Nochomovitz

Analyst

Hi, everyone. Thank you very much for taking the questions. Regarding the potential label in COVID, do you think you can get a label as either of the Phase 3 works or do you at least need the Rigel sponsored study to work? And if the NIH study works, that would be a bonus. Or do you think you could get a label if just the NIH trial works? And then would the label look any different if both worked versus only one of the trials, because obviously these trials are enrolling highly overlapping patient populations.

Raul Rodriguez

Analyst

Hello, Yigal. Good question. Thank you. I'll ask Wolfgang to comment and then I'll add a comment.

Wolfgang Dummer

Analyst

Yes, thanks for the question. So number one, if the Rigel-sponsored focus Phase 3 study is positive, that together with the already existing NIH Phase 2 study should give us a label. That's something we have discussed. And we have been in interactions with FDA and that agreement about that. Now if the Rigel focus study for whatever reason does not fit, but the ACTIV-4 study is very positive, then despite the fact that it's not Rigel sponsored, it's a large Phase 3 like study run by the NIH in the severe patient population, I would have a hard time to believe that that is not critical information, supporting the use of fostamatinib in this more severe patient population. And your last part was if both studies are positive? Well, they have differences in the patients that they included in general, they are all done and hospitalized patients who need some sort of oxygen. And I would say that should be what I would envision the label should be hospitalized patients with COVID-19, maybe requiring some oxygen, maybe just hospitalized. I hope that helps answer the question.

Yigal Nochomovitz

Analyst

Yes, that’s helpful.

Raul Rodriguez

Analyst

We expect our readout to be in mid-year and I think the ACTIV-4 probably is afterwards. So obviously, we'll have the first answer -- our own answer first. And we'll proceed from there.

Yigal Nochomovitz

Analyst

Okay. And then, Raul, just thinking about your partner in Japan, Kissei. So assuming your Phase 3 AIHA works, which we hope it does obviously, do you think that Kissei could leverage your data or do you think they need to run their own Japanese Phase 3 wAIHA in the same way that they did their own ITP trial?

Raul Rodriguez

Analyst

We believe they will need to do their own trial there. It's typically what the regulatory authorities asked for. So it'd be a bit of a surprise if that was not the case. So they probably will. But obviously, it's -- our own data would be very, very useful. Recall for ITP they conducted their own smaller Phase 3 trial with positive results in Q4 to support our data and our larger Phase 3 trial I imagine be exactly the same. They're excited about the opportunity in AIHA just as they are with moving forward to an NDA filing in Japan with ITP.

Yigal Nochomovitz

Analyst

Okay. And then just one question on IRAK4, I know in the past you've talked about partnering. Can you discuss what indications you'd like to explore with a partner? You just don't have the resources to do independently.

Raul Rodriguez

Analyst

The good thing about an IRAK, and particularly an IRAK1 and 4 inhibitor is that it's so broadly suppressive of so many key signaling pathways, and therefore tremendous opportunity here with an IRAK1/4 for a wide range of diseases, those being severe diseases like low-risk MDS and less severe diseases as well. So it's a real opportunity to do a good deal with this molecule. Our first objective is to launch this -- we're launching this low-risk MDS trial, and then come back with more specificity in terms of the next indication for an immune side, probably a more rare disease to move forward with. At some point, we might partner this. It's not the priority right now, but we might find a partner for it. It might be different than the RIP partnership, because it's a very different opportunity here, one where there are indications that fit nicely with our own strategy in the heme-onc space, it may be in rare immune diseases. So that's a bit later to come, but it might be useful to see some data.

Yigal Nochomovitz

Analyst

Thank you.

Operator

Operator

Thank you. Our next question is coming from Gary Nachman from BMO Capital Markets. Your line is now live.

Unidentified Analyst

Analyst

Good afternoon. This is Denis [ph] on for Gary. Thank you for taking our questions. The first is on the COVID trial. Assuming a positive readout and increased demand, can you confirm that you're going to be able to fully handle all exponential increases in supply? Secondly, could you comment more about how the sales force interactions have been in January and February of this year? And then finally, any comment on how your partner Grifols is doing in the EU? Thanks so much.

Raul Rodriguez

Analyst

Sure. Let me address the COVID supply. We have ample supply. We can make more. We have a very good position in terms of supply for TAVALISSE. You said, can you meet all demands? The answer is I don't know what the demands are. And it depends where the pandemic is in the future. And obviously, we have the ability to make more. So we're comfortable with the addition we have in terms of supply and our ability to meet demand should the COVID trials read out positively. And in the future, we'll make more as needed. The good thing about having a molecule that they have a good deal of experience that is commercialized is that it could very readily be made into something that's commercially available for COVID patients. And that's something that I think sets us apart from many agents in clinical trials. On the sales force issue, what is the interaction receptivity in January, February? I'll ask Dave to comment.

Dave Santos

Analyst

Yes. Sure, absolutely. There's actually some good news here. As everybody knows, the current search is subsiding. Anecdotally, we are seeing more opening. And actually our call activity, at least that through February, shows that it is in fact slowly building back to where we were in November. And I think that bodes well for the end of this quarter and certainly as we move into the spring. So I can say that we have improved our interactions of late, particularly in February, and we're almost at the level that we were at in November.

Raul Rodriguez

Analyst

Denis, I apologize. Your third question was what?

Unidentified Analyst

Analyst

Just any commentary about how your partner Grifols is doing in the EU?

Raul Rodriguez

Analyst

Sure, absolutely. So our partner Grifols is working hard in EU. The product is approved and they've been working on getting pricing approvals throughout the countries in Europe. Last year, they were very successful and have approvals in all the large countries and a few of the smaller ones. And now they're working on the remaining of the smaller ones. And like the U.S., this pandemic has weighed in terms of ability to communicate with their customers, but it's lifting there as it is here. And that bodes very well in terms of the uptake in Europe. So we like them are very enthusiastic about it. They're also very enthusiastic about autoimmune hemolytic anemia and having that data coming as well, because obviously it's completely additive there as well. So we share their enthusiasm and look forward to continuing progress there and increasing the sales level.

Unidentified Analyst

Analyst

Great. Thank you so much.

Raul Rodriguez

Analyst

Absolutely, Denis. Thank you.

Operator

Operator

Thank you. The next question today is coming from Kristen Kluska from Cantor Fitzgerald. Your line is now live.

Kristen Kluska

Analyst

Hi, everyone. Thanks for taking the question. So on wAIHA, it looks like over a third of the prevalent patients are currently not actively treated. So what do you believe are some of the main drivers behind that and how an approved therapy such as TAVALISSE could help penetrate this specific opportunity alone? And then in the survey you conducted, it took place in May 2021. So wondering how much of these responses and the different lines you think are also influenced by the COVID-19 pandemic environment, given some physicians are trying to avoid use of immunosuppressants?

Raul Rodriguez

Analyst

That's very good questions, Kristen. Thank you. I'll ask Dave to comment.

Dave Santos

Analyst

Yes. So the patients who aren't actively being traded, those are clinicians who either the clinician or the patient has determined that they didn't want to be treated at this time. And so it does call into question, a, if they do have low hemoglobin and they are potentially interested in being treated, but don't want steroids, but don't want Rituxan or any of these other products, maybe a chronic treatment like TAVALISSE could make it more appealing. But our focus hasn't been on that patient population, because those are patients who are cycling in and out and for various reasons. So I'm not sure that that's our focus right now. But we'll certainly as we continue to look at the patient journey, we'll definitely understand those reasons a little bit more about why patients aren't being treated. But I do want to talk a little bit about your second question. And I think it's an important one, because actually even this weekend during the speakers training, as we were talking, it came up that clinicians can be very uncomfortable about using Rituxan and immunosuppressants during this time. And we don't think that's necessarily just for this period in time. We think it's going to be potentially longer term. And so I do think there's an opportunity there. Now whether that swayed their kind of shares that they attributed to each of these products, I can't really say. It could have, because we did ask them and a snapshot in time, which patients are on which products, what percentage of patients are on which products. So certainly that could have if they had elected to stay away from or Rituxan during that period, that could be the case. But again, we don't think that that's necessarily something that isn't going to stick around as we move forward. And frankly, I think it could be a real differentiator for TAVALISSE.

Kristen Kluska

Analyst

Okay, thank you. I appreciate that. And then lastly, I just wanted to ask about your IP strategy. I saw on your 10-K filing, you reiterated that you have the potential for certain patents that are filed I believe through 2034. So just wanted to see if you had any color about ways you're looking to expand beyond where it's at today? Thanks, again.

Raul Rodriguez

Analyst

Absolutely. Thank you, Kristen. We always evaluate our IP strategy and feel that we have a very strong composition of matter and in addition various formulations, manufacturing patents, et cetera, in addition to that might explain that further. So we continue to work at that to provide ample. Obviously, 2032, 2034 is a decade. So we have tremendous opportunity and runway in order to make this product a success. And we will continue to see if the further patents that we file allow us to continue to further that.

Kristen Kluska

Analyst

Thank you.

Raul Rodriguez

Analyst

Thank you, Kristen.

Operator

Operator

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

Raul Rodriguez

Analyst

Absolutely. Thank you. And in closing, I'd like to thank you for joining us on this call today and for your interest in Rigel. We expect 2022 to be a year of continued progress and momentum for the company. In closing, I'd also like to thank our employees for their constant commitment to improving the lives of patients, our first value. And we look forward to keeping you updated on our progress on all of these programs in future calls. Have a great day.

Operator

Operator

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