Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) Q3 2023 Earnings Call Transcript

Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) Q3 2023 Earnings Call Transcript November 7, 2023

Rigel Pharmaceuticals, Inc. beats earnings expectations. Reported EPS is $-0.03, expectations were $-0.07.

Operator: Greetings, and welcome to Rigel Pharmaceuticals Financial Conference Call for the Third Quarter of 2023. At this time, all participants are in 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, Ray Furey, Rigel’s Executive Vice President, General Counsel and Corporate Secretary. Thank you, Mr. Furey, you may begin.

Ray Furey: Welcome to our third quarter 2023 financial results and business update conference call. The financial press release for the third quarter 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 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, 2022, and subsequent filings with the SEC, including our third quarter quarterly report on Form 10-Q 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 Chief Executive Officer, Raul Rodriguez. Raul?

Raul Rodriguez: Thank you, Ray, and thank you, everyone, for joining today. Also with me today are Dave Santos, our Chief Commercial Officer; and Dean Schorno, our Chief Financial Officer. Let me begin on slide 4. The third quarter 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. We review the components of this during today’s presentation. Regarding product sales. In the third quarter, we delivered a robust performance for our first approved product, TAVALISSE, for adult chronic ITP. Demand bottles shipped to patients and 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 TAVALISSE. For our second approved product, REZLIDHIA for adult relapsed or refractory mutant IDH1 positive AML, we saw continued growth in bottles shipped to patients in clinics in the third quarter as we increased awareness of the product through our new institutional sales team. Just last week, we announced several poster presentations at the ASH meeting, which include new supportive data on REZLIDHIA in various mutant IDH1 relapsed or 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 IRAK1/4 inhibitor in Phase 1b for lower-risk MDS, we are currently enrolling in the third cohort, and we expect initial results from all dose groups in mid-2024. We continue to evaluate clinical development options to expand our pipeline, particularly with olutasidenib. We believe olutasidenib 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 heme/onc 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.

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 a financial expense discipline. Now let us review this in more detail, starting with Dave on our commercial business. Dave?

Dave Santos: 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 REZLIDHIA launch in the first nine 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 CIDP, who’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 and clinics, resulting in an impressive 19% growth over Q3 of 2022. We achieved our fourth consecutive record high for the number of bottles shipped to patients and clinics in a quarter since launch, and our demand is continuing to grow with more new patients starting TAVALISSE For Q3, we produced TAVALISSE net sales of $24.5 million, $5.3 million 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. And Slide 8 provides a little more detail on how our new patient starts have been trending over the last three 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 second quarter 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 and beyond. 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 REZLIDHIA through the first nine months of 2023.

On Slide 10, you will see our FDA-approved indication for REZLIDHIA, 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 REZLIDHIA addresses exactly those needs and that has been our focus during the ongoing launch. Moving to Slide 12 and our view of the currently eligible patient population for REZLIDHIA. 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 two 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 mutant IDH1 patients in the relapsed or refractory setting each year. Slide 13 shows our continued launch today progress in bringing REZLIDHIA to those 1,000 patients. We shipped a total of 221 bottles of REZLIDHIA to patients and clinics in the third quarter, representing 18% growth over Q2. We sold 210 bottles resulting in $2.7 million in net sales. We sold 11 fewer bottles that 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 $7.6 million. We continue to remain focused on growing awareness of REZLIDHIA through our field teams and other launch activities.

Moving to Slide 14. I want to share our progress on improving new patient starts on REZLIDHIA, particularly within key institutional accounts, because mutant IDH1 relapsed or refractory AML is a rare disease, and we are still building awareness of REZLIDHIA in this launch period. New patient starts can vary from month to month. 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 REZLIDHIA. 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. First, as we have discussed, our evidence in mutant IDH1 relapsed/refractory 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 REZLIDHIA’s efficacy of that population. And our medical affairs team continues to receive feedback that the olutasidenib 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 REZLIDHIA awareness at their key institutions.

In a very short time, we have significantly improved our ability to raise REZLIDHIA awareness to a broader audience of key leukemia treaters. And as a result, our new patient starts in key institutional counts 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 REZLIDHIA in the community. Overall, we are very encouraged by the new patient increase in September and believe we are on the right track to grow our REZLIDHIA business in both the institutional and community segments as we move through this important first year of launch.

Moving to Slide 15, based on our first nine months of 2023 and especially, the success we saw in September new patient starts, we believe that REZLIDHIA 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 REZLIDHIA, and I look forward to providing you with additional launch updates as we move into the future.

Finally, on Slide 16, just a brief word on ASH. ASH is critically important to both TAVALISSE and REZLIDHIA. And this will be the second 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 olutasidenib Phase 1/2 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. We’re looking forward to showcasing Rigel’s growing hem/onc portfolio, raising awareness of Rigel, our pipeline and of course, TAVALISSE and REZLIDHIA.

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?

Raul Rodriguez: Thank you, Dave. I will now summarize our expansion plans for olutasidenib 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 two ways of accomplishing these. First, there is the potential to grow our current products with new supportive data and particularly, with new indications. In addition, there is the potential for in-licensing of new products. Based on an in-depth review, we believe that olutasidenib has potential in numerous cancers where mutant IDH1 plays a role. We see additional segments in AML, Glioma and MDS is promising indications for olutasidenib. Fostamatinib also has potential in other heme/onc 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 REZLIDHIA was a success and provided Rigel with an approved product that is highly synergistic with our heme/onc capabilities. 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 heme/onc and related assets that are in late-stage clinical development and 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. Included in Abstract 2888, reporting post-hoc analysis in a subset of patients with mutant IDH1 relapsed or refractory AML or MDS. There were relapsed or refractory to hematopoietic stem cells transplant, olutasidenib or venetoclax. The analysis suggests that olutasidenib along or in combination with azacitidine may induce complete remissions in these patients. This answers a frequent question we receive from treating clinicians, and we are delighted to present this encouraging data in patients with these prior treatments.

Abstract 1872 reports the results from our Phase 1/2 trial of olutasidenib, alone or in combination with azacitidine in a subset of 22 patients with mutant IDH1 MDS. These encouraging results show that olutasidenib has clinically meaningful activity in patients with mutant IDH1 MDS. Our partner Kissei will present abstract 2578, highlighting their Phase 3 study, including long-term efficacy and safety of fostamatinib in Japanese patients with primary ITP. These results support the use of fostamatinib as a second-line treatment in patients with primary ITP. And lastly, in abstract 3247 is a trial in progress post providing an overview of the Phase 1b study of R289 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 IRAK1/4 inhibitor R289 could address the unmet need in the treatment landscape for lower-risk MDS. As you may know, MDS is a disorder of hematopoietic stem cells, resulting 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. 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 effects. 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 R289 has 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. The study continues to progress well. Enrollment in the third cohort is currently underway, and we expect to have preliminary data in mid-2024. Moving on to Slide 22. Our RIPK1 inhibitor, R552 is with our partner, Eli Lilly. They are investing this program in their Phase 2a study in rheumatoid arthritis. With that, I will turn the call over to Dean.

Dean Schorno: Thank you, Raul. I’m on Slide 24. For the third quarter of 2023, we shipped 2,551 bottles with TAVALISSE to our specialty distributors, resulting in $35.2 million of gross product sales. 2,412 bottles of TAVALISSE were shipped to patients and clinics, while 139 bottles increased the levels remaining in our distribution channels at the end of the quarter. For the third quarter of 2023, we shipped 210 bottles of REZLIDHIA to our specialty distributors, resulting in $3.4 million of gross product sales. 221 bottles of REZLIDHIA were shipped to patients and clinics, while 11 bottles decreased the levels remaining in our distribution channels at the end of the quarter. We reported net product sales from TAVALISSE of $24.5 million in the third quarter of 2023, a 27% increase compared to the same period in 2022.

We reported net product sales from REZLIDHIA of $2.7 million in the third quarter of 2023. Our net product sales from TAVALISSE and REZLIDHIA were recorded net of estimated discounts, charge backs, rebates, returns, co-pay assistance and other allowances of $11.5 million. So the third quarter of 2023, our gross to net adjustment for TAVALISSE and REZLIDHIA 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 fourth quarter of 2023. We continue to be pleased with the strength of our business in the third quarter and expect to see continued strength in our bottle ship to patients and clinics for the remainder of the year. 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 fourth quarter of 2023 to be approximately 31% for TAVALISSE and approximately 21% for REZLIDHIA. On to the next slide. In addition to net product sales for the three months ended September 30, 2023, Rigel’s contract revenues from collaborations were approximately $1 million primarily to Grifols. Moving on to costs and expenses. Our cost of product sales was approximately $1.3 million for the third quarter of 2023. Total costs and expenses were $32.6 million in the third quarter of 2023 compared with $40.8 million in the same period of 2022. The decrease is primarily due to decreased research and development costs related to our Phase 3 clinical trials of fostamatinib and warm autoimmune, hemolytic anemia and COVID-19.

Lower facility-related costs and upfront payment to form a therapeutics recorded in the third quarter of 2022. These decreases were partially offset by increased research and development costs due to the timing of activities related to our IRAK1/4 inhibitor program. As you’ll note, this is a second quarter where we’ve seen operating expense in the $32 million 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 REZLIDHIA in both the community and academic settings within this cost structure. We do expect to see an increase in operating expense in the fourth quarter due to certain programs and events, we look to maintain this focused and disciplined approach into the future.

We ended the quarter with cash, cash equivalents and short-term investments of $62.4 million. With that, I’d like to turn the call back over to Raul. Raul?

Raul Rodriguez: Thank you, Dean. 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 REZLIDHIA 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 right apart how 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.

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Q&A Session

Operator: Thank you. [Operator Instructions] One moment please for the first question. The first question comes from the line of Eun Yang with Jefferies. Please proceed with your question.

Q – Unidentified Analyst: Hi, this is Alan [ph] 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 TAVALISSE in the US, Europe and Japan. And then for REZLIDHIA, with the quarterly sales run rate of about $3 million 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? Thank you very much.

Raul Rodriguez: I’ll ask Ray to answer the first question on TAVALISSE exclusivity in the US and elsewhere.

Ray Furey: Yes. We have a composition of matter patent for TAVALISSE that is with PTA and PTE is expected to run until September of 2031. I’d have to check and get back to you on exclusivity in Japan and elsewhere

Raul Rodriguez: I think it’s comparable or similar

Ray Furey: It is comparable. I don’t have the exact dates.

Ray Furey: On REZLIDHIA, Dave, do you want to comment on our view?

Dave Santos: Yes. From a standpoint of REZLIDHIA, we are still earlier in the launch. You have to remember that clinicians have been using on IDH1 inhibitor for five 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 REZLIDHIA. 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 will help grow our business by themselves. But every time we have a new patient start and they do well on REZLIDHIA remember that the composite complete remission is upward more than 40%, they’re going to stay on the product.

We try to keep people on the product for at least six 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 early in the third full quarter of launch. And so we haven’t really seen the benefit of that carryover with the patients that we started already I hope that helps put some color around why we expect REZLIDHIA sales to grow.

Q –Unidentified Analyst: Got it. Thank you very much. If I may ask one follow-up on TAVALISSE. Currently, what percent of the uses in second-line ITP? And what would you need in order to further capture the second-line market? Thank you very much.

Raul Rodriguez: So the data we have by line of therapy comes from our RIGEL ONECARE database and as I showed you — we 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 third line. So we’ll continue to, of course, try to move patients up 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.

Q –Unidentified Analyst: Thank you so much.

Raul Rodriguez: Thank you.

Operator: Thank you. The next question comes from the line of Kristen Kluska with Cantor Fitzgerald. Please proceed with your question.

Unidentified Analyst: Hi. This is Rick Miller [ph] on for Kristen. Thanks for taking our questions. Given the commercial strategy, sort of dovetailing TAVALISSE with REZLIDHIA, 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 or how you’re thinking about approaching the sort of educational aspects of the conference, given the new institutional sales force approach?

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

Dave Santos: Yes, I will say – we are bringing our entire institutional team to ASH because we do think it’s an important opportunity for them to interact with their customers. The fact is most important hematology treaters attend ASH. And so it’s a very specific audience, especially AML treaters. And so we will be deploying our team there.

Raul Rodriguez: 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 in there on the booth on REZLIDHIA. 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. And earlier this year at EHA and in other places, we published data supporting the use of REZLIDHIA. 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.

Unidentified Analyst: 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.

Raul Rodriguez: Yes, I’ll comment. Dave, do 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. Just to remind you, in the Phase 2 study done by our colleagues in pharma, it included patients with MDS. So we have some idea on that opportunity already with, I think, 22 patients

Dave Santos: In the abstract presented at [indiscernible]. And just, Rick, could you just repeat the first part of your question? I just want to make sure I got that right.

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

Raul Rodriguez: I don’t have those specifics right here with me, but it is a smaller population than the AML population.