Q1 2023 Rigel Pharmaceuticals Inc Earnings Call
Speaker 1: The TR.
Speaker 1: Restaurant PR.
Speaker 2: Greetings and welcome to the Roger Pharmaceuticals Financial Conference call for the first quarter of 2023.
Speaker 2: At this time, all participants are in a listen-only mode.
Speaker 2: A brief question and answer session will follow the formal presentation.
Speaker 2: If anyone should require operator assistance during a conference, please press star zero on your telephone keypad.
Speaker 2: As a reminder, this conference is being recorded.
Speaker 2: It is now my pleasure to introduce our first speaker, Ray Furey, Rigel's Executive Vice President, General Counsel, and Corporate Secretary. Thank you, Mr. Furey. You may begin.
Speaker 3: Hello, welcome to our first quarter of 2023 financial results business update conference call.
Speaker 3: Financial press release for the first quarter of 2023 was issued a short while ago and can be viewed along with the slides for this presentation in the news and events section of the investor relations.
Speaker 3: side and ride on that car.
Speaker 3: 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.
Speaker 3: These statements are subject to risks and uncertainties.
Speaker 3: that may cause actual results to differ from those forecasted.
Speaker 3: A description of these risks can be found in our most recent annual report on Form 10K for the year ended December 31, 2022, and subsequent filings with the SEC, including our Q1 quarterly report on Form 10Q on file with the SEC.
Speaker 3: 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.
Speaker 3: At this time I would like to turn the call over to our President, Chief Executive Officer Raul Rodriguez.
Speaker 3: Thank you Ray, and thank you everyone for joining today. Also with me today are Dave Santos, our Chief Commercial Officer, and Dean Shorno, our Chief Financial Officer.
Speaker 4: I'll be getting on slide five.
Speaker 3: We are pleased with our strong start to 2023 based on our first quarter, which was marked by significant progress on our commercial business.
Speaker 4: This positions as well for continued growth in the remainder of 2023 and beyond.
Speaker 4: Our first approved product, Savalisa NITP, had the highest number of bottle ships to patients and clinics in a quarter since launch and a meaningful corner-over-quarter sales growth.
Speaker 4: Despite the typical Q1s challenges, such as those associated with reimbursement, we were able to provide continued momentum for Tel Aviv.
Speaker 4: which we believe is a testament to our commercial team's commitment to patients with ITP.
Speaker 4: We are also pleased to see the continued expansion of TAVALES in patients worldwide, most recently with the launch of TAVALES in Japan by our partner Kisei. Congratulations to them.
Speaker 4: In addition to Tel Aviv, we are executing on our key launch initiatives for Reslydia in relapse or refractory AML. Our commercial team has been driving awareness with key physicians groups and will continue to do so with a particular focus on AML specialists at key academic institutions.
Speaker 4: Beyond our commercial focus, we are looking to expand our hematology oncology business further through our own internal development stage programs as well as in-licensing opportunities similar to our approach with Res Lydia.
Speaker 4: I will provide further updates and recent progress on our strategy in these efforts later on in this presentation.
Speaker 4: With that, I'll turn the call over to Dave for an overview of the quarter. Dave?
Speaker 5: Thank you, Raoul.
Speaker 5: Now, I'd like to take a few minutes to discuss our early progress with Res Lydia in the first three months of launch and then transition to our continued growth of Tovahlease during a record T1.
Speaker 5: On slide seven, you will see our FDA approved indication for Reslydia, which is for adult patients with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation is detected by an FDA approved test.
Speaker 5: Moving to slide eight, I would like to briefly review our view of the currently eligible patient population for Aslydia.
Speaker 5: The American Cancer Society estimates that more than 20,000 patients will be diagnosed with AML in 2023, and of those patients, our research showed that whether patients are treated with intensive therapy or not, must or refractory to treatment or relapse within two years.
Speaker 5: Specifically, with 6 to 9% of patients having the IDH1 mutation, we believe we have a near-term opportunity to impact the lives of around 1,000 new mutant IDH1 patients in the relapse to refractory setting each year. Slide 9 depicts our first three...
Speaker 5: December , with 109 of those bottles shipped in Q1.
Speaker 5: This represents new and refill bottles to an estimated 32 patients across 29 unique accounts or prescribers.
Speaker 5: Considering approximately a quarter of those 1000 mute 90h1 relapsed to refractory patients were available in Q1.
Speaker 5: We believe Res Lydia was used in more than 10% of our target patient population last quarter.
Speaker 5: During the first quarter, we sold an additional 113 bottles to our distribution network, resulting in Q1 2023 net sales of $1.5 million. Since our product became available on December 22nd,
Speaker 5: We have sold 177 bottles of Reslydia, resulting in $2.3 million in launch-to-date net product sales.
Speaker 5: Moving to slide 10, our team has continued to make excellent progress on our three priorities of driving awareness, maximizing access, and optimizing res-lity experience across both academic and community leukemia treaters.
Speaker 5: First, on the left, we continue to drive awareness among the more than 1,000 leukemia treaters by strengthening our medical evidence, broadening our KOL support, and refining our materials and messaging.
Speaker 5: The medical evidence with ResLidia is strongly supported by both the NCC and Guidelines recommendation in relapse to refractory disease with an IDH1 mutation, as well as the recent publication of our Phase 2 Pimino Data in Blood Advances.
Speaker 5: Our KOL support has also been broadening.
Speaker 5: through different scientific forums where leukemia treatments are discussed.
Speaker 5: and physician awareness and appreciation of Resolidious Clinical Data will further be supported with last month's launch of our speakers Bureau. We have already planned several promotional speaker programs for Q2 and beyond. And importantly, along with this medical evidence and KOL support,
Speaker 5: Our marketing materials and messaging continue to be refined. In fact, we have just launched our Transform Your Expectations campaign to HCPs, and our Salesforce has already been trained to appropriately differentiate our product through the delivery of our compelling efficacy and safety messages in every interaction with their customers.
Speaker 5: So we now have a full suite of materials and resources to deliver the message, identify appropriate patients, and support physicians and patients as they begin risk Lydia.
Speaker 5: In maximizing access for clinicians and patients, we made great progress in Q1. Our right to one care hub, process of patient enrollments is quickly as possible to ensure our limited pharmacy network can provide timely shipments for patients. Thank you.
Speaker 5: We have confirmed published coverage for over 90% of Medicare lives and coverage parity to other relapse refractory targeted agents in the majority of national commercial payer accounts.
Speaker 5: We continue to deliver our access messages to clinicians and particularly encourage them to enroll their patients in white Ryzen 1 care to maximize the response of this for both patients and clinicians who want to try Res Lydia.
Speaker 5: And lastly, on the right, we have made solid progress in optimizing RISLIDI experience across both academic and community leukemia treaters.
Speaker 5: Through Q1, three quarters of Resilient Bottles were ordered through our direct channel by 21 unique accounts that are mostly academic institutions.
Speaker 5: More than half of bottles were direct shipment to academic institutions and 22% were shipped to community accounts. Overall, about two-thirds of our Resolidia business so far is in the academic setting and community usage makes up the other third.
Speaker 5: This is a solid start on our journey of optimizing experience across the Kenya traders in both the academic and community settings.
Speaker 5: And we will continue to focus on driving awareness in both segments of our business to continue to expand the number of prescribers and award-a-ring accounts.
Speaker 5: Moving to slide 11.
Speaker 5: After our experience during the first full-corner launch, we believe now more than ever that Reslidia has the potential to address many key patient and HCP needs in relapsed refractory AML.
Speaker 5: It is a promising new treatment targeting mute 90H1 that has shown impressive durable responses in patients who have failed previous therapies.
Speaker 5: And as more clinicians review the demographics of our relapse refractory patient population in our pivotal cohort and put that together with the compelling efficacy of overall response in nearly half of patients, duration of CRCRH of 25.9 months, and an estimated 18 months survival rate for CRCRH of 78%.
Speaker 5: Overall, we continue to see exciting potential to become a market-leading treatment in Mutine IDH1 relapsor refractory AML and are looking forward to continuing to execute the launch plan. By thanks to the entire team for all their efforts in Q1 with Reslidia.
Speaker 5: Now, onto growing sales of Pavillice and ITP. I have a few brief comments on our continued momentum with Pavillice and Q1. On slide 13, you will see our Pavillice FDA approved indication, which is for adult patients with chronic immune thrombocytopenia or CITP.
Speaker 5: to patients in clinics, representing 23% growth over Q1 of 2022.
Speaker 5: This continued robust growth with again driven by strength in new patients starting to have a lease.
Speaker 5: Despite the typical headwinds during Q1 with coverage and reimbursement for all such specialty drugs, we are off to a solid start with Tauvelies.
Speaker 5: Growing bottle ship to patients and clinics, another 3% over the record quarter we had in Q4 2022.
Speaker 5: For Q1, we achieved net sales of $22.3 million. $6.1 million more than the same quarter last year, representing a 38% year-over-year increase. We are incredibly pleased with how we ended.
Speaker 5: 2022 and are starting 2023 with continued strong year over year growth in ITB sales.
Speaker 5: We will continue to focus on targeting clinicians to identify appropriate patients who can benefit from Tovolese to grow our new patient starts beyond the record levels we saw in 2022.
Speaker 5: I am grateful for the dedication and great collaborative work demonstrated every day across our entire team to continue our ITP growth with Tavalise while successfully launching Res Lydia.
Speaker 5: Finally, on Slide 15, an update of our global expansion of TavaLeaks.
Speaker 5: More recently, most recently, in April , our partner Kise announced the launch of Tauvalese for the treatment of chronic ITP in Japan. We remain committed to continuing to impact CITP patients around the globe with continued expansion of Tauvalese's commercial footprint through our partners.
Speaker 5: Thanks for your attention and I will now turn the call back over to Ralph to provide a free update on our development progress. Ralph, thank you Dave.
Speaker 4: I will briefly summarize our pipeline efforts.
Speaker 4: our pipeline efforts on to slide 17.
Speaker 4: You can see an overview of our ongoing programs. We are focused on growing our HEMON business, starting with our internal development programs.
Speaker 4: Our ongoing phase 1-B study of R289 in patients with lower risk MDS continues to progress well, and notably we have finished completed enrollment in the first dose group and are currently enrolling the second core. We also believe POSDA-MADNEM and OLSU have potential in other diseases beyond their approved indications, and we are currently evaluating several options.
Speaker 4: In addition, we are actively looking at new in-license opportunities to further bolster our He-Monk business. I will touch more on these initiatives on the next slide.
Speaker 4: More opportunistically, our primary lylyly is advancing R552, a ROOP K1 inhibitor, towards a phase 2A study in rheumatoid arthritis. And we look forward to that study starting this quarter.
Speaker 4: Moving on to slide 18.
Speaker 4: We are keenly focused on evaluating foster madness in all the students in additional indications beyond their approved indications. As part of this process, we have engaged in several discussions with KOLs and with regulators across multiple indications.
Speaker 4: as well as conducting market research to help inform our plans going forward.
Speaker 4: We look forward to providing you additional updates on these initiatives later on in 2023.
Regarding our business development efforts relating to in licensing of new assets, we are continually evaluating assets that are synergistic with our existing human business infrastructure and that are complementary or adjacent to our already improved products.
We are focused on programs that are in late stage clinical development, in review for potential approval, or in early stages of launch.
We believe that our development capabilities and commercial infrastructure, we can grow our business with internal programs as well as being the commercial partner of choice for in-license him on opportunities.
That concludes the development summary and I'll turn the call over to Dean.
Thank you, Ro. A month slide number 20, for the first quarter of 2023, we shipped 2,281 bottles of topoes to our specialty distributors, resulting in $31.4 million of gross product sales. 2,256 bottles of topoes were shipped to patients at clinics.
While 25 bottles increased the levels remaining in our distribution channels at the end of the quarter. For the first quarter of 2023, we shipped 113 bottles of Roslidia to our specialty distributors, resulting in $1.8 million in gross product sales. We shipped 109 bottles of Roslidia.
where shift to patients and clinics, while four bottles increase the levels remaining in our distribution channels at the end of the quarter.
We reported net product sales in Tobelice of $22.3 million in the first quarter of 2023, a 38% increase compared to the same period in 2022. We reported net products sales from Roslidia at $1.5 million in the first quarter of 2023. Our net product sales from Tobelice in Roslidia.
for recorded, net-investimated discounts, chargebacks, rebates, returns, copay assistance, and other allowances of $9.5 million.
For the first quarter of 2023, our gross tenet adjustment for Tovelies and Resglidia was approximately 29% and 20% of gross product sales respectively.
Before we move on from net product sales, let me review our expectations for the second quarter of 2023. We are pleased with the strength of our business and expect to see continued growth in total net product sales as bottom ship to patients and clinics continues to grow in ITP as we successfully continue our launch of our slidia. Thank you for your time.
We currently expect our votes to net adjustment in the second quarter of 2023 to be approximately 30% for Tovahleese and approximately 20 to 22% for Lydia.
As is typical with the newly launched product, a gross to net adjustment is dependent in part on our distribution channel mix. We'll continue to provide updates as our launch phase progresses.
Under the next slide. In addition, that product sales are contract revenues from collaborations where $2.3 million in the first quarter of 2023. Contract revenues and collaborations consisted of $1.6 million in revenue from Griffalls related to the delivery of drug supplies and $700,000 in royalty revenues.
Moving on to cost and expenses, our cost of product sales was approximately $977,000 for the first quarter of 2023. Our cost of product sales for the quarter, we're inclusive of a 15% royalty on our residilated, net product sales and amortization of intangible assets.
Total cost and expenses were $38.8 million compared to $43 million in the same period for 2022.
The decrease in cost and expenses was primarily due to decreased research and development costs related to the Phase III clinical trial of FOSTA-MATINED for warm-odermy and hemolidic anaesthesia, the Phase III clinical trial of FOSTA-MATINED and high-risk hospitalized patients COVID-19, and the Ira Q1 -4 Intimidate Program.
Lastly, we ended the quarter with cash equivalents and short-term investments of $58.7 million.
In commentally in March of this year, we accessed an additional $20 million term loan through our credit facility with NIDCAP financial trust. With that, I'd like to turn the call back over to Ronald. Thank you, Dee. As we reviewed on this call, we had an exceptional first quarter and a very strong start to the year. We look forward to continuing to drive momentum in top of these sales in ITP, both in the US and the U.S.
and all the students, as well as our partnered programs and our ongoing business development initiatives. So with that, thank you for your interest in our progress in the first quarter, and we will now open the call to your questions. Operators? Thank you. Ladies and gentlemen, at this time, we'll be conducting a question and answer session.
If you'd like to ask a question, you may press star one on your telephone keypad. A confirmation tunnel indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, you may be necessary to pick up your handset before pressing the star key.
Our first question comes from the line of Eun Yang with Jefferies. Please proceed with your question. Thank you. So question on the partner program with Lilly, RIPP inhibitor. So initially I think you mentioned that Lilly was interested in psoriasis, but now she's interested in psoriasis.
in as indications, such as ALS or multiple sclerosis. Thank you.
You and thank you for your question. I can answer that. You know, nobody has always been interested in the broad applications of the RIP 1 inhibitor program across immune indications, including RA, psoriasis, and others. So it's never been a single focus of one indication program.
and always with the idea of going after more than one, hopefully, multiple areas. And psoriasis and RA, we're always in that mix. I think there's a decision to go forward in RA, makes a lot of sense. The opportunity is very good. The need is great, especially as you know, some setbacks with other mechanisms that ever occurred.
And so I think it's a very exciting opportunity for them and they were clearly excited by it and are prioritizing RA. That's not to say that they won't pursue other indications in sequence, though. It just hasn't been revealed with that, might be, or a fact when they might start those.
But we're looking forward to the RAID trials starting. It's a good robust trial. An area like I said, a good medical need and in addition, because there's so many of these trials, it's you can compare cross-prials to a degree and get a judgment on how the product might perform.
in other areas. So we're looking forward to their starting that trial very shortly, this very quarter. And you're absolutely right on the second question, CNS. Lilly has rights to CNS program. We've delivered to them a basket of RIF kinase inhibitors. They're cross-breed blood barrier.
and they're deciding to move forward with one or multiple of those into various CNS indications. We were not able to disclose what their priori did. So these are in those areas, but we will in the future.
Thank you. And I have just a one more follow up. So in first quarter the tissue burn was like about, you know.
low double-digit million dollars. So how do you see your quarterly cash she burn going forward probably question to Dean. Thank you.
Yeah, hi you all right, so we ended the quarter with 58.7 million dollars in cash And we know that our last call that it Achieving cash flow break-even was was a priority for the business and that we were comfortable with it our cash position at year-end as we just
reported the results for Q1. Our beauty and change as a result have those, of these results. So we continue to be pleased with, pleased with our progress towards break even, and we'll continue to move in that direction. So when do you aim to become?
our beauty and change as a result of these results. So we continue to be pleased with our progress towards break even and we'll continue to move in that direction. So when do you aim to become break even?
We haven't provided top line guidance, which will enable us to crisply answer that question. On our last quarterly call, we kind of walk through some of the mechanics of our view of...
the growth in revenues as well as the $160 million of operating expense, the reduction in operating expense from 2022. So we see a path towards break even, we haven't been precise again because of the lack of guidance that we've provided on the top line. Thank you.
as well as the $160 million of operating expense, and the reduction in operating expense from 2022. So we see a path towards break even, we haven't been precise again because of the lack of guidance that we've provided on the top line. Thank you. Thank you. Thank you.
Our next question comes from the line of Yagul Nokumovich with Citi. Please proceed with your questions.
Hi, team. This is Carly on FurrierGall. Thanks so much for taking our questions. First, I'm Tavalee. I'm wondering if you can elaborate on any specific drivers behind the sequential growth you saw in the first quarter. And if you can just give an update on progress with...
penetrating the earlier lines of ITP therapy. That would be great. Thank you. Thank you, Carly. I was Dave to comment on that. Sure, great question, Carly. We were very pleased, of course, with our top-of-the-screws in Q1. We had the highest new patient starts in any Q1 that we've had.
launch. So that's really what's continuing to drive our growth and what's driving that. We're continuing to get that message out there to as many clinicians as possible. Our Salesforce is really doing a terrific job of targeting ITP prescribers out there.
And, you know, whether it's virtual, whether it's live, whether it's email follow-up, they're doing it all and activity is helping. And I think the additional kind of boost that we got in terms of access with a newly approved product like Reslydia, even though some of the many of the clinicians
They call on, because we're calling on over 6,000 targets for ITP, don't treat AML. It gives them the opportunity to tell them about Resletty, but also reinforce that Tommel East message. So I think that's exactly what happened, and we're just quite pleased with the performance in Q1.
Great, that's helpful. And then just one follow up. Wanted to ask about where you stand with respect to partnering with Lydia XUS. And if the strategy there will be to find one global partner for all XUS rights or if you would do. And then just one follow up.
maybe a series of deals with regional players like you did with TABELACE. Thank you for that. I could answer that. So as you may know, we received global rights with Reslinia when we in Licensed it. Obviously our commercial interest ourselves in the US is what's paramount.
and where we've launched the product, but outside of the U.S., there is a very good opportunity for the same reason, same application in Relapse Refractory AML. So we're in discussions with a variety of partners, some more PAN country, some more specific to some territories.
that have interest in ResVIDIA. The discussions are on terms of the financial terms, of course, but I think importantly here, there is so much opportunity with this product that we'd like to have the partner contribute clinically as well. And clinically in terms of maybe replicating what we've shown here already and providing additional data to help position the product even better.
or possible clinical trials in areas beyond our approved indication relapse for fractured AML. And so those discussions are part of the process because we'd like to have a partner that is truly a partner in that we can work with well in order to coordinate how we expand the understanding and does the value of this product globally in the US as well.
Very helpful. Thank you for taking your questions. Our next question comes from the line of Allison Bratzel with Piper Sandler. Please proceed with your question. Hi. Good afternoon, guys. Thanks for taking my questions. First, just on the Resolidia prescriber base, I think I heard you mention...
or could you just frame how you expect that to evolve over the course of the year?
Sure. David? Sure. Great question, Allison. I'll start with your last piece first in terms of what we expected. And I would say that we are very pleased. With just three months and about a week of having Reslydia available, we are very pleased with the fact that Reslydia is a very important component of our community. We are very pleased with the fact that Reslydia is a very important component of our community.
We estimate that the bottle shipped to patients in clinics, along with the incidence of newly diagnosed mutant IDH1 patients in the relapse setting, we're capturing, we believe, more than 10% of eligible patients.
So, we do expect that as awareness continues to grow, we'll continue to increase our patient numbers. And of course, then the carryover of refills should really begin to kick in and impact demand growth.
All that said, I am really proud of the team for the way they've constantly looked at our business and any opportunities to accelerate growth. And they did exactly that in Q1 and came up with a solution to accelerate our Reslydia growth in key leukemia treatment centers. I think this is critical.
to your question about academic centers. And we want to do that while maintaining our current growth trajectory with top lease. So we made the decision to create a specialized institutional team that'll focus on key leukemia treaters that primarily academic accounts.
And the great thing about this is we were able to redeploy the open territories we had to support it. And it resulted in us having about 49, we're not about, of having 49 representatives who will continue to have both top elites and reslidia in their territories and eight new institutional representatives who will focus on reslidia in key leukemia centers across the country. And so that's a total of 57 sales representatives. So with a net add of two positions and gives us a much more focused presence in these important leukemia centers critical for growth. And as you did here correctly, we're seeing about two.
nice momentum. A new patient starts longer term. I'm curious if you could talk to your sense that the biggest remaining growth levers, you have to pull an ITP just in the out years. Any color there will be helpful. Thanks.
I mean, we are starting a number of new patients on top of the lease, Allison, as you've heard. And I would just say there's plenty of opportunity to continue growing those new patients on top of the lease because every day patients...
fail other therapies or need a new therapy and I think that's really the importance of it. As I said before we've got 6,000 some targets for Tovolese and so we still have a lot of a long way to go in making sure all of those clinicians.
give Tavoli to try, especially in a second line or earlier line patient. So that's going to continue our growth. I mean, that's why we really, it's another reason that this institutionality really made a lot of sense to us. We don't want to disrupt that, getting that awareness message out to...
our targets for commonly. One of the things that we have seen post pandemic is just a more opening of various centers. And being receptive, I think patients for a couple of years there were Wisconsin, their houses. And now it's more open to considering, you know, there is a better therapy out there that I'd like to avail myself there. And we want to make sure that Tava Lease is part of that consideration. Because if doctors are aware of our data.
they tend to write substantially more. And obviously, if they're not aware of our data, they don't write very much at all. So our goal is simple, to tell a concise, coherent story to those doctors, so they consider our product. And generally, we do pretty well when we do that. So I think that's what we're looking forward to, continuing to raise awareness of this product and our data supporting it.
Got it. Thank you.
As we monitor to start one to ask a question, our next question comes from the line of Christine Kluska with Cantor Fitzgerald. Please continue with your question.
Hi everyone, this is Rick on for Kristen. Thank you for taking our questions. Maybe first you talk a little bit about the potential opportunity for allude of CID and ib in the maintenance setting as you mentioned on the pipeline expansion slide. Knowing that physicians often try to get AML patients to bone marrow transplant. Do you have a sense of what percentage of IDH1 B ???
maintaining a response in a patient who would have gone through, let's say, a Vanetta Clack, say, a society, a regiment or some other regiment. And we're not particularly talking about patients who have been to transplant. Because obviously that, you know, when you do intensive therapy with the game of getting patients to transplant,
It ends up being a relatively small number of patients going to transplant. So to us, that's not where the market is in terms of maintaining response after transplant. And, you know, we've looked at that. We think there's a greater opportunity in those patients who are receiving outpatient therapies like Venaza who might need to be maintained in their response. I hope that makes sense. Yes, I've got one more for you, if we may. You also talked about the pivotal phase 2 elutazidinib data published in Blood Advances.
to that. I mean, you're talking about median survival in many relapse refractory studies of less than four months. And so, you know, to hear that 78% of those CR CRA responders are alive at 18 months, that's a very important message for us.
So that, those two things really helped us to get that efficacy message out there and truly differentiate Riz Lydia.
But definitely that publication helped us a lot. And that just came out, as you know, this quarter, or in first quarter.
Great, okay, thank you for taking our questions. Our next question comes from the line of Caleb Patel with B Riley. Please proceed with your question. Yeah, hey, good afternoon. Thanks for taking the questions. I will be one, starting for
Is there any additional color on the prescribing behavior for selecting Brent Lydia versus Tipsobo in the real world? And maybe how is that choice being made for the 29 prescribers that started Brent Lydia?
That's a great question, CalPIT, and I wish I could be more precise. As you can see in our slides, a bunch of our businesses being directly shipped to accounts and so we don't have that prescriber insight that we would have if they're filled through the Specialty Pharmacy Network. And so our team goes back and follows up. But I can't really say what are the drivers specifically for those who prescribed it for using it. Other than they really have looked at the data, they believe it's compelling and they decide they're going to start a patient on Resolidia. We have had...
One institution already started more than actually three patients on Reslydia in the relapse setting, and they have made a made a conscientious decision based on reviewing the data that it will be their therapy of choice. So I think I think, you know, it's still early. We'd love to...
for a long period of time and so that's why they're choosing it. But more to come I think it's very early. It's hard to be specific at this point. We're just getting data in and evaluating it. Okay, and are you seeing, again this might be early, but are you seeing any combination based, maybe off-label uses with azacitidine in an earlier setting or do you not have data for that? We don't have data for what they're using it with. And we would only have that for those patients who go through our RYTO OneCare hub.
Okay, okay, got it. And then one last question on Fostomatinib for chronic graft-versus-host disease. We have been hearing on our end that there's additional interest from at least the KOL community for this program. So I'm curious if there's any progress on that and whether you've decided, you know, if this might be a 2023 event for that opportunity. Yeah, very good question. And thank you for your interest in a good call yesterday. And what was made a couple days ago, we are very interested in GVHD. We're looking at that area very closely. As I said earlier, we're looking at the area of the chronic graft-versus-host disease.
So, I'll look forward to later this year coming back to you with specifics. Here's what we want to do across these indications. And so we can share that with you at that point in much more detail. But we are doing a fair amount of work in this area. We think it's pretty exciting. Okay. Fantastic. Thank you very much. There are no further questions. I'd like to ask you, like Dan, to fall back to Mr. Rodriguez for closing remarks. So thank you, everyone. I'd like to thank you for joining the call and you're interested in the module. We'd like to also thank our employees for their continued commitment to improving the lives of patients.
And we look forward to updating you on future calls. This quarter was, I think, a fantastic quarter, a great start to the year. The rest of the year we have, I think, equally exciting things to update you on across a range of different products and indications. So, very much look forward to doing that as well in the not that distant future. So, thank you very much. Ladies and gentlemen, this does conclude today's teleconference.
Thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.