Rigel Pharmaceuticals Q3 2023 Earnings Call Transcript

Quartr
Provided by Quartr
November 7, 2023

There are 9 speakers on the call.

Operator

Greetings, and welcome to Rigel Pharmaceuticals Financial Conference Call for the Q3 of 2023. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce our first speaker, Ray Furey, Rigel's Executive Vice President, General Counsel Corporate Secretary.

Operator

Thank you. Mr. Furey, you may begin.

Speaker 1

Welcome to our Q3 2023 financial results and business update conference call. The financial press release for the Q3 2023 was issued a short while ago and can be viewed along with the slides of this presentation in the News and Events section of our Investor Relations site on righthand.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 ks for the year ended December 31, 2022 and subsequent filings with the SEC, including our 3rd quarter Quarterly report on Form 10 Q on file with the SEC.

Speaker 1

Any forward looking statements are made only as of today's date, 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 Chief Executive Officer, Raul Rodriguez. Raul?

Speaker 2

Thank you, Ray, and thank you, everyone, for joining today. Also with me today are Dave Santos, our Chief Commercial Officer and Dean Charnum, our Chief Financial Officer. Let me begin on Slide 4. The Q3 was an important one for Rigel, one in which we made meaningful progress on growing the sales of our commercial products. This growth coupled with tight financial discipline allowed us to make important progress on our plans to reach financial breakeven.

Speaker 2

We will review the components of this during today's presentation. Regarding product sales, in the Q3, we delivered a robust performance Our first approved product, TAVALISSE, for adult chronic ITP. Demand bottles shipped to patients in clinics reached a new quarterly record since launch. We grew net product sales by 15% quarter over quarter and 27% year over year. We are pleased with the continued momentum that our team is generating For our 2nd approved product, RESLIDIA, for adult relapsed or refractory mutant IDH1 positive AML, We saw continued growth in bottles shipped to patients and clinics in the Q3 as we increased awareness of the product through our new institutional sales team.

Speaker 2

Just last week, we announced several poster presentations at the ASH meeting, which include new supportive data on Reslydia in various mutant IDH1 relapse refractory AML patient populations. We look forward to engaging with the medical community at the ASH meeting to further raise awareness and highlight our products. Shifting to our development programs. Here, we're extremely focused and cost efficient in our efforts. With R289, our IRAK1 and 4 inhibitor in Phase 1b for lower risk MDS, we are currently enrolling the 3rd cohort And we expect initial results from all dose groups in mid-twenty 24.

Speaker 2

We continue to evaluate clinical development options to expand our pipeline, Particularly with olicitinib, we believe olicitinib has potential in a variety of settings in AML and in additional cancers where mutant IDH1 plays a role. We plan to be modest. We plan that modest focused investments in our HemOnc opportunities will be funded from our own internal business. I will touch on this more later in the presentation. In addition, we continue to assess in license opportunities for late stage Hematology oncology products to broaden our pipeline that are synergistic and further leverage our in house capabilities.

Speaker 2

In summary, this past quarter was important as we made good progress on our plan to reach financial breakeven. This is based on strong growth from our commercial business And financial expense discipline. Now let's review this in more detail starting with Dave on our commercial business. Dave?

Speaker 3

Thank you, Raul. Now I'd like to take a few minutes to discuss our continued growth of TAVALISSE during another sequential record quarter And our progress with the Reslyvia launch in the 1st 9 months of 2023. On Slide 6, You'll see the FDA approved indication for TAVALISSE, which is for adult patients with chronic immune thrombocytopenia or CITP, You've had an insufficient response to a previous treatment. Moving to Slide 7, I'm excited to report That we achieved yet another back to back new quarterly all time high with TAVALISSE in Q3, shipping 2,412 bottles to patients in clinics, resulting in an impressive 19% growth over Q3 of 2022. We achieved our 4th consecutive record high For the number of bottles shipped to patients in clinics in a quarter since launch and our demand is continuing to grow with more new patients starting TAVALISSE.

Speaker 3

For Q3, we produced TAVALISSE net sales of $24,500,000 $5,300,000 above the same quarter last year, representing more than 27% year over year growth. We were very excited to achieve this record high quarter in TAVALISSE net sales. Our achievement of sequential quarterly records demonstrates that our continued focus on bringing more new patients to TAVALISSE And consistently improving our Refill business is driving strong growth. We are pleased with how we have expanded Our TAVALISSE business during 2023 and look forward to maintaining this momentum as we close out the year. We will stay focused on targeting clinicians to identify appropriate patients who can benefit from TAVALISSE to continue growing our new patient starts.

Speaker 3

And Slide 8 provides a little more detail on how our new patient starts have been trending over the last 3 years. As you'll recall, in 2020 during the pandemic, we were challenged growing new patient starts. Then with our sales force expansion and the post COVID reopening in 2021, our new patient starts began to improve as we moved into the Q2 of that year. Ever since then, with our focus on reaching more clinicians And spreading awareness of TAVALISSE's durable efficacy in improving platelet levels over time, we have been growing new patient starts consistently. In fact, since 2020, we have achieved a double digit CAGR of 12% and that bodes well for continued brand growth as we move into the final quarter of 2023 beyond.

Speaker 3

Overall, I'm very proud of the strong TAVALISSE quarter and year to date growth trends our team produced. Moving to Slide 9, I'll take a few minutes to discuss our continued progress Launching Reslidia through the 1st 9 months of 2023. On Slide 10, you will see our FDA approved indication for Reslidia, which is for adult patients with relapsed or refractory acute myeloid leukemia with the susceptible IDH1 mutation as detected by an FDA approved test. To review on Slide 11, there continues to be an unmet need For efficacious targeted treatments in relapsed or refractory AML and in particular, agents that provide longer durations of response And an acceptable balance of efficacy and toxicity are needed. We continue to strongly believe that Reslyvia addresses those needs And that has been our focus during the ongoing launch.

Speaker 3

Moving to Slide 12 and our view of the currently eligible patient population The American Cancer Society estimates that more than 20,000 patients will be diagnosed with AML. And of those patients, Our research showed that whether patients are treated with intensive therapy or not, most are refractory or relapse within 2 years. 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 relapsedrefractory setting each year. Slide 13 shows our continued launch to date progress in bringing Reslydia to those 1,000 patients. We shipped a total of 2 21 bottles of Reslidia to patients in clinics in the 3rd quarter, Representing 18% growth over Q2.

Speaker 3

We sold 210 bottles, resulting in $2,700,000 in net sales. We sold 11 fewer bottles than we shipped to patients in clinics this quarter as our distributors reduced inventory on hand. Overall, since the product became available in late December of 2022, we have achieved total launch to date net sales of 7,600,000 We continue to remain focused on growing awareness of Reslidia through our field teams and other launch activities. Moving to Slide 14, I want to share our progress on improving new patient starts on RESOLIDIA, particularly within key institutional accounts. Because butane IDH1 relapsed or refractory AML is a rare disease and we are Still building awareness of Reslydea in this launch period, new patient starts can vary from month to month.

Speaker 3

With that context, I'm pleased to report that during Q3, new patient starts surged to our highest level within a single month in September. Importantly, this monthly high was driven by institutional starts. It was a combination of some key academic institutions starting more patients as well as new key institutions Starting their first patient on Resideo. We were very pleased to see both our depth and breadth grow across institutional accounts. We believe that this improvement in institutional adoption occurred because of two reasons.

Speaker 3

First, as we have discussed, Our evidence in mutant IDH1 relapsedrefractory AML continues to strengthen. Efficacy in the post venetoclax patient population is an important consideration for clinicians as this is a particularly difficult population to treat. Data that was presented at EHA supports Reslidia's efficacy in that population, and our medical affairs team continues to receive feedback That the oulucitinib data in that patient population is compelling to AML treaters. Secondly and importantly, we successfully deployed our institutional team during Q3. All team members were onboarded And have had a significant impact improving Rigel's presence and Reslidia awareness at their key institutions.

Speaker 3

In a very short time, we have significantly improved our ability to raise Resiliency awareness to a broader audience of key leukemia treaters. And as a result, our new patient starts in key institutional accounts have improved. In the graph on the right, You will see that nearly 90% of our new business in Q3 was driven by institutional accounts. We believe this bodes well for our new business as we move forward in the launch. As leukemia treaters in these key institutional accounts Influence and improve awareness of Reslydea in the community.

Speaker 3

Overall, we are very encouraged by the new patient increase in as we move through this important 1st year of launch. Moving to Slide 15, based on our 1st 9 months of 2023 And especially the success we saw in September new patient starts, we believe that Reslydia has the potential to address many key patient and HCP needs in refractory AML. It is a promising treatment targeting mutant IDH1 that has shown impressive durable responses in patients who have failed previous therapies, including venetoclax. Overall, we continue to see exciting potential to become a market leading treatment in mutant IDH1 relapsed or refractory AML and are looking forward to continuing to execute our launch plan. My thanks to the team for all their efforts during 2023 with Reslydea, And I look forward to providing you with additional launch updates as we move into the future.

Speaker 3

Finally, on Slide 16, Just a brief word on ASH. ASH is critically important to both TAVALISSE and RESLIDIA, and this will be the 2nd year We will be displaying both approved products at this major conference of hematology specialists. We will have a strong presence in San Diego, both from a promotional and scientific standpoint. On the scientific side, we will have additional data From the eludacitinib Phase III trial presented at ASH highlighting more key mutant IDH1 relapsed refractory patients along with the post venetoclax patient population. And we'll be providing more evidence from populations outside our pivotal cohorts.

Speaker 3

We're looking forward to showcasing Rigel's growing HemOnc portfolio, raising awareness of Rigel, our pipeline and of course, Tavalise and ResLydia. Thanks for your attention. And I will now turn the call back over to Raul to provide a brief update on our development progress. Raul?

Speaker 2

Thank you, Dave. I will now summarize our expansion plans for olicutinib and provide updates on our other development programs. Beginning on Slide 18, we like the growth of our commercial business and we want to expand our business even further. There are 2 ways of accomplishing this. First, there is the potential to grow our current products with new supportive data and particularly with new indications.

Speaker 2

In addition, there's the potential for in licensing of new products. Based on an in-depth review, we believe that olicitinib has potential in numerous cancers fostamatinib also has potential in other hemonc indications and we will provide additional data through investigator sponsored trials rather than through our own trials, as we think this is the best use of our resources. Any investments in new development Opportunities will be focused and cost efficient and can be funded by our own operations. As part of this, we expect to work with academic centers And government partners on these strategic efforts. Moving on to the right side of this slide, the in licensing of Resideo was a success And provided Rigel with an approved product that is highly synergistic with our HemOn capabilities.

Speaker 2

We look to replicate this as we continue to evaluate the in licensing of new assets That are also synergistic with our existing infrastructure. We are looking for HemOnc and related assets that are in late stage clinical development in review for potential approval or in the early stages of their commercial launch And that are complementary or adjacent to the areas where we already have approved products. Moving on to Slide 19. As Dave mentioned, generating and providing additional data benefits our product sales and helps us evaluate the expansion of our pipeline. I wanted to highlight a few abstracts that will be presented at the upcoming ASH meeting in December.

Speaker 2

Included in abstract 2,888, Reporting post hoc analysis in a subset of patients with mutant IDH1, relapsed or refractory AML or MDS, There were relapsedrefractory to hematopoietic stem cell transplant, ivocitanib or venetoclast. The analysis suggests that olitasutinib alone or in combination with dacicitidine may induce complete remissions in these patients. This answers a frequent question we received from treating clinicians and we are delighted to present this encouraging data in patients with these prior treatments. Abstract 1872 reports the results from a Phase onetwo trial of olicitinib alone or in combination with azacitidine In a subset of 22 patients with mutant IDH1 MDS, these encouraging results show that olicitinib has clinically meaningful activity In patients with mutant IDH1 MDS. Our partner, Kissei, will present Abstract 2,578, Highlighting their Phase 3 study, including long term efficacy and safety of fostamatinib in Japanese patients with primary ITP.

Speaker 2

These results support the use of fostamatinib as a second line treatment in patients with primary ITP. And lastly, in Abstract 3,247 is a trial in progress poster providing an overview of the Phase 1b study of R-two eighty nine In lower risk MDS, which is enrolling well, I will now spend a moment on that trial. Moving on to Slide 20, I wanted to spend a few moments discussing how we think our IRAP-onefour inhibitor, R289 could address the unmet need in the treatment landscape for lower risk MDS. As you may know, MDS is a disorder of the hematopoietic stem cells, resulted in dysplasia and ineffective hematopoiesis in the bone marrow. For patients with lower risk MDS, risk can include Autoimmune abnormalities, cytopenias, progression to AML and even death.

Speaker 2

Patients undergo different treatments in the first line and second line setting As shown in this slide, durable responses in the second line setting are not common. Subsets of patients show limited hematologic responses and these agents result in significant adverse events. Loss of response following second line therapy represents a poor prognosis for patients associated with significant morbidity and cytopenias. For lower risk MDS Patients who are refractory or resistant to current therapies, there remains a significant unmet need, and we believe R29 has the potential to address this need in this underserved patient population. Slide 21 shows our ongoing open label Phase 1b study of R289 in patients With lower risk MDS.

Speaker 2

The study continues to progress well. Enrollment in the 3rd cohort is currently underway and we expect to have preliminary data In mid-twenty 24. Moving on to Slide 22, our REP K1 inhibitor 552 is with our partner Eli Lilly. They are advancing this program in their Phase 2a study in rheumatoid arthritis. With that, I will turn the call over to Dean.

Speaker 4

Thank you, Raul. I'm on Slide 24. For the Q3 of 2023, We shipped 2,551 bottles of TAVALISSE to our specialty distributors, resulting in $35,200,000 of gross product sales. 2,412 bottles of TAVALISSE were shipped to patients at clinics, while 139 bottles increased the levels remaining in our distribution At the end of the quarter, for the Q3 of 2023, we shipped 210 bottles of Brasilia to our specialty distributors, resulting in $3,400,000 of gross product sales. 221 bottles of Versalidea were shipped to patients and clinics, while 11 bottles decreased the levels remaining in our distribution channels at the end of the quarter.

Speaker 4

We reported net product sales from TAVALISSE of $24,500,000 In the Q3 of 2023, a 27% increase compared to the same period in 2022. We reported net product sales from RESOLIDIA of $2,700,000 in the Q3 of 2023. Our net product sales from TAVALISSE and RESLIDIA were recorded net of estimate discounts, chargebacks, rebates, Returns, co pay assistance and other allowances of $11,500,000 For the Q3 of 2023, Our gross to net adjustment for TAVALISSE and RESLIDIA was approximately 30.5% and 21% of gross product sales respectively. Before we move on from net product sales, let me review our expectations for the Q4 of 2023. We continue to be pleased with the strength of our business in the Q3 And expect to see continued strength in our bottle shipped to patients and clinics for the remainder of the year.

Speaker 4

Incrementally, I would highlight that we saw a 139 bottle increase in the levels remaining in our distribution channels at the end of the quarter for TAVALISSE. These inventory levels are variable and outside of our control. Incrementally, we expect our gross to net adjustment in the Q4 of 2023 to approximately 31% for TAVALISSE and approximately 21% for ZILIDIA. Onto the next slide. In addition to net product sales, for the 3 months ended September 30, 2023, Rogers contract revenues from collaborations We're approximately $1,000,000 primarily from Grifols.

Speaker 4

Moving on to cost and expenses, our cost of product sales $1,300,000 for the Q3 of 2023. Total costs and expenses were $32,600,000 In the Q3 of 2023 compared with $40,800,000 in the same period of 2022. The decrease was primarily due to decreased research and development costs related to our Phase 3 clinical trials of fostamatinib In warm autoimmune hemolytic anemia and COVID-nineteen, lower facility related costs and an upfront payment to pharma therapeutics Recorded in the Q3 of 2022. These decreases were partially offset by increased research and development costs Due to the timing of activities related to our IRAK1four inhibitor program. As you'll note, this is the 2nd quarter where we've seen operating expense In the $32,000,000 range, this operating expense level is the result of our focused development efforts along with spending discipline Across our entire organization, we're pleased with the financial leverage that we're seeing and have been able to successfully launch Resilidya In both the community and academic settings within this cost structure, we do expect to see an increase in operating expense in the 4th quarter Due to certain programs and events, we look to maintain this focus and disciplined approach into the future.

Speaker 4

We ended the quarter with cash, Cash equivalents and short term investments of $62,400,000 With that, I'd like to turn the call back over to Rahul. Oh? Thank you, Dean.

Speaker 2

We are proud of the progress we have made so far in 2023 with TAVALISSE sales delivering another strong quarter marked by continued growth. We are executing on our launch of Resideo and driving awareness through our sales teams and engagements with the medical community at conferences, Including the upcoming ASH meeting in December, continued growth of our products, coupled with diligent financial discipline have resulted in a particularly good quarter, and we have made important progress towards our goal of reaching financial breakeven. This is an important objective, which I believe will set Rigel apart since it will allow us to grow and run our company With our own operation from our own operations and our own cash, we are creating a self sustaining company. With that, thank you for your interest in our progress in this quarter and we will now open the call to your questions.

Operator

Thank The first question comes from the line of Eun Yang with Jefferies. Please proceed with your questions.

Speaker 5

Hi, this is Malin on for Eun. Thank you so much for taking our questions. So for the first question on TAVALISSE, could you please remind us on the market exclusivity expiration for I believe it's in the U. S, Europe and Japan. And then for Reslydea, with the quarterly sales run rate of about 3,000,000 Dollars, do you expect gradual increases in sales or would there be an inflection point and how big do you expect the product To product sales to be.

Speaker 5

Thank you very much.

Speaker 2

I'll ask Ray to answer the first question on top of lease exclusivity in U. S. And elsewhere.

Speaker 1

Yes. We have a composition of matter patent for TAVALISSE that is with PTA and PTE It's expected to run until September of 2,031. I'd have to check and get back to you on Pat next to the facility in Japan and elsewhere.

Speaker 2

I think it's comparable or similar.

Speaker 1

Yes, it is comparable. I don't

Speaker 2

have the exact dates. On Resideo, Dave, do you want to comment on our view?

Speaker 3

Yes. From a standpoint of Resideo, we are still earlier In the launch, you have to remember that clinicians have been using 1 IDH1 inhibitor for 5 years now. And so that's something that I think will take some time. But the other piece that I want to make sure I bring up here is that one part of TAVALISSE has been new patients and the other part is the refills you get to carry over. That's going to be the same thing with Reslydea.

Speaker 3

Those new patients that we get, because it has a duration of response, which is Quite long for leukemia patients. We expect we'll have a good carryover business as we move into next year. So these patients starts We'll help grow our business by themselves. But every time we have a new patient start and they do well on Resideo and you'll remember that the composite Complete remission is upwards of 40 more than 40%. They're going to stay on the product.

Speaker 3

We try to keep people on the product for at least 6 months before they judge whether it's had a response or not. And then because there are late responses. And then obviously if patients are responding, they'll continue. So that's why we're still very early in this. We're only in the 3rd full quarter of launch.

Speaker 3

And so we haven't really seen the benefit of that carryover with the patients that we've started already. I hope that helps put some color around why we expect Resideo sales to grow.

Speaker 5

Got it. Thank you very much. If I may ask one follow-up on TAVALISSE. Currently, what percent of the users In second line ITP and what would you need in order to further capture the second line market? Thank you very much.

Speaker 3

So the data we have by line of therapy comes from our Rigel OneCare database. And as I showed you showed last quarter, about 70% of our patients are in second and third line, about 30% of that Is in second line. And that stayed pretty consistent this quarter. So that's why we didn't really provide any update on that. But We're really quite happy that in a market where rituxan and TPOs are used Very readily and have been for a long time that 70% of patients, at least in our database, are getting TAVALISSE either second or So we'll continue to, of course, try to move patients up.

Speaker 3

But really, I think the key is Continuing to grow new patient starts and that's what we've been doing. So hopefully that answers your question.

Speaker 5

Thank you so much.

Speaker 2

Thank you.

Operator

Thank you. The next question comes from the line of Kristin Kluska with Cantor Fitzgerald. Please proceed with your questions.

Speaker 6

Hi, this is Rick Miller on for Kristen. Thanks for taking our questions. Given the commercial strategy sort of dovetailing TAVALISSE with Reslidya and the institutional sales force focus there. Do you have any commentary on how the approach at ASH this year may differ from your approach in the past how you're thinking about approaching the sort of educational aspects of the conference given the new institutional sales force approach?

Speaker 2

Good question, Rick. Thank you. Dave, do you want to comment?

Speaker 3

Yes. I will say we are bringing our entire institution team to Ash because we do think it's an important opportunity for them to interact with their customers. The fact is, is most important hematology treaters attend DASH. And so it's a very specific audience, Especially AML Treaters. And so we will be deploying our team there.

Speaker 2

Rick, a year ago, we got the product approved just Days before the ASH meeting, and it's remarkable we were able to be ready and have information there at the booth on Resilidio. And since then, we create in the middle of this year, we created the institutional business team to help us penetrate the academic centers. So we're very, very much different in terms of preparedness this year than a year ago. And so it should be an exciting meeting for us Being able to interact with many of those academic centers, but also lots of community based clinicians for both of these products, Very, very different. We have data also being presented that I think is very compelling.

Speaker 2

And earlier this year at EHA and in other places, we Published data supporting the use of Reslydea. So we really have a very different, I guess, approach, data And individuals to share this information at this ASH meeting relative to a year ago.

Speaker 6

Great. And maybe just one follow-up with the ASH abstracts, specifically the MDS Analysis, can you talk a little bit about how you're thinking about the IDH1 positive prevalence in the MDS population and how This relates to what you're seeing in AML. Thank you and looking forward to seeing the team in San Diego.

Speaker 2

Yes, I'll comment. Dave, you want to comment as well? MDS is an attractive opportunity. We've seen IDH1 inhibitors work in this area. So it provides some exciting opportunities.

Speaker 2

Just to remind you, in the Phase 2 study done by our colleagues in Informa, it included patients with MDS. So we have some idea on that opportunity already with, I think, 22 patients.

Speaker 3

In the abstract presented at

Speaker 4

MS, yes.

Speaker 3

And just Rick, could you just repeat the first part of your question? I just want to make sure I got that right.

Speaker 6

Yes, more around prevalence and just sort of market size in the MDS population versus AML.

Speaker 3

Yes, I don't have those specifics right here with me, but it is a smaller population than the AML population.

Speaker 2

Yes, just smaller, I think, but I think the percentage of positive is a bit higher than an AML. So but it's still a smaller population on the whole.

Speaker 6

Great. Okay. Thank you very much.

Speaker 2

Thank you, Rick.

Operator

Next questions are from the line of Yigal Nochowicz with Citi.

Speaker 7

Hi, team. This is Carly on for Yigal. Thank you for taking our questions. We had a few follow ups on RESLIDIA. First, wondering if you can comment on the contribution from new versus existing patients During the Q3, and approximately what percent share of the market you believe you have within the Incident patient population.

Speaker 7

And then second, of the different label expansion opportunities that you outlined, just curious if there's One that you would maybe highlight as the highest priority and when we might get more details on your future plans there? Thank you.

Speaker 2

Dave, do you want to comment on Resideo contribution, new versus established patients and share of incident population?

Speaker 3

Yes. So if you're looking at our total bottles shipped in Q3, Obviously, the majority of those were carryover from previous. I'd have to let me see here. It's probably Generally, maybe 2 thirds to 3 quarters carryover and about a quarter To a third is new. And again, that always depends on when you get those new patients.

Speaker 3

We got our new patients, a lot of them, as I said, in September. So that's why I think That number is like the way or is the way it is. So I hope that makes sense. But the majority this quarter was carryover and again a lot of that is because our new patients really Because it is kind of lumpy, showed up in September. On your second question in terms of Share of those, if you do this, you're talking about maybe 250 patients a quarter.

Speaker 3

You heard from our Q1 on launch, We were around 30 patients. So, we think we're probably in that double digit share of incident new patients.

Speaker 2

And on the label expansion priority, all three of those I mentioned and there were others in fact, in other segments of AML, In glioma and MDS are attractive and different one to the other. AML, we know the product works and has shown a benefit in the relapsed refractory setting. Obviously, other opportunities within that patients maintenance in first line are things that we're thinking about. In addition, glioma is a sizable, sizable opportunity and just so poorly, poorly treated today. That is a very exciting opportunity, a larger opportunity, perhaps.

Speaker 2

And And MDS, while smaller, as we mentioned just a minute ago, an area with significant medical need as well, both in low risk and high risk So there really is a highly varied array of different opportunities for all the suit and clearly, We are going to focus on a subset of those and do so in a focused efficient cost wise manner, Perhaps with some cases with academic and government partners.

Speaker 7

Okay, great. That's helpful. Thank you very much.

Operator

Thank you. The next question is from the line of Joe Pantginis with H. C. Wainwright. Please proceed with your question.

Speaker 8

Hey, everybody. Good afternoon. Thanks for taking the question. So I was curious first wanted to go back to TAVALISSE patient And I guess I'll ask the question, but I don't know if you have this level of granularity in the data you collect. So in the Moving to 2nd line patients, do you have data that show, for example, patients that Are that you're replacing TPOs or say you're prescribing TAVALISSE in lieu of TPOs.

Speaker 8

Do you have that level of granularity that or

Speaker 3

Well, I just To be clear, where our data comes from is rock. We actually because we have those histories, we know what line of therapy that is. So we don't but we don't have is kind of what they would have intended to use. So we're mixing 2 kind of different things there. The Data that we are sharing in terms of 30% of those patients that are going through ROC are second line, but we don't know what they would have used Had they not chosen TAVALISSE.

Speaker 3

Does that make sense? They did not. So from our ATU, I think those clinicians who do use it second line, those are clinicians who've had experience with TAVALISSE, like how TAVALISSE works. And they just they tend to move it up because it's very predictable. So that's probably the best way I can say it.

Speaker 3

I don't want to Jump to any conclusions about where our second line business is coming from in terms of what product they would have chosen.

Speaker 8

No, that's completely fair. Appreciate that. And then with regard to Reslydea, obviously, the launch continues to be impressive. And I guess I wanted to touch upon any potential real world safety signals, for example, with regard to differentiation syndrome since it is one of the warnings on the label. Is there anything to discuss there and the fact that physicians are becoming much more Adept at handling that.

Speaker 3

No, I wouldn't say we have anything that indicates Look, this is a class effect. It's a black box wording across the class, both with FLT3 inhibitors As well as IDH1 inhibitors and IDH2. So it's a class effect and we have not heard anything Or have reason to believe that our differentiation syndrome would be a differentiator For Reslidia, that said, we do believe that it is a different toxicity profile. And we do believe that the lack of any reference to needing to do cardiac monitoring In our label is a differentiator for certain patients who might have cardiac comorbidities. So that continues to be something that we will look into and potentially, hopefully, in the future with real world evidence Help to show that.

Speaker 8

Great. Appreciate the color. Thank you very much.

Operator

Thank you. There are no further questions at this time and I would like to turn the floor back over to Mr. Raul Rodriguez for closing comments.

Speaker 2

Thank you. This quarter was a really good very good one. We grew our products very nicely and we're happy with that. We made progress on our financial goals as well. So we're very pleased where we are.

Speaker 2

So with that, I'd like to close by thanking everyone of you for your continued interest in And as always, I'd like to thank our employees for their commitment to improving the lives of patients. They work hard every single day. And with that, look forward to updating you on future calls. Have a great day.

Operator

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

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Key Takeaways

  • In Q3, TAVALISSE shipments hit a new record with 2,412 bottles, driving a 15% quarter-over-quarter and 27% year-over-year increase in net sales to $24.5 million.
  • The RESLIDIA launch gained traction with 221 bottles shipped, $2.7 million in net sales, and a surge in new patient starts—nearly 90% of which came from institutional accounts after deploying a dedicated team.
  • Rigel maintained tight financial discipline, cutting Q3 operating expenses to $32.6 million from $40.8 million a year ago and ending the quarter with $62.4 million in cash, advancing toward breakeven.
  • The R289 IRAK1/4 inhibitor program for lower-risk MDS is in Phase 1b cohort 3 enrollment, with initial data expected in mid-2024 as part of a cost-efficient development strategy.
  • Rigel is pursuing a focused pipeline expansion by investing modestly in olicitinib development for AML, in-licensing late-stage hematology-oncology assets, and partnering with academic and government groups.
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Earnings Conference Call
Rigel Pharmaceuticals Q3 2023
00:00 / 00:00