Rigel Pharmaceuticals Q4 2024 Earnings Call Transcript

Quartr
Provided by Quartr
March 4, 2025

There are 11 speakers on the call.

Operator

Greetings and welcome to Rigel Pharmaceuticals Financial Conference Call for the Fourth Quarter and Full Year twenty twenty four. 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 Fury, Rigel's Executive Vice President, General Counsel and Corporate Secretary.

Operator

Thank you, Mr. Fury. You may begin.

Speaker 1

Welcome to our fourth quarter and full year twenty twenty four financial results and business update conference call. The financial press release for the fourth quarter and full year 2024 was issued a short while ago and can be viewed along with the slides for this presentation in the News and Events section of our Investor Relations site on bridal.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 on our most recent annual report on Form 10 K for the year ended 12/31/2024, on file with the SEC.

Speaker 1

Any forward looking statements are made as of today's date only, and we undertake no obligation to update these forward looking statements reflect subsequent events or circumstances. At this time, I'd 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 Lisa Roicher, our Chief Medical Officer and Dean Shornow, our Chief Financial Officer. Beginning on Slide four, we will provide an overview of Rigel's business and our numerous accomplishments in 2024. For those that are new to the company, let me take a moment to review Rigel's overall corporate strategy to grow our hematology and oncology business. Our strategy is focused on three main goals.

Speaker 2

First, expand our commercial portfolio and increasing product sales. Second, advancing and growing our pipeline through internal development and strategic collaborations. And third, maintaining financial discipline. 2024 was a transformational year for Rigel. As we delivered on all three of these goals, I will take you through each of these accomplishments in more detail.

Speaker 2

In 2024, we set another record year of sales. As a result of our effective commercial execution, we reached our highest commercial portfolio sales ever at $145,000,000.39 percent growth over 2023. The significant revenue growth was driven by the strength of TAVALISSE and Resledia sales and the addition of Devreto, our third product and our second in licensed product, which contributed $17,100,000 in net product sales since we added it to our portfolio in June. We also generated revenues from our partners where Tavalis is commercially available and our partners continue to make progress towards expanding Tavalis access in other geographies. Recently, Knight and Kisse announced regulatory approvals for TAVALISSE in two new countries, Mexico and The Republic Of Korea, respectively.

Speaker 2

Once commercially launched, ITP patients in these countries can also benefit from TAVALISSE. For Resilidya, we actively pursued new collaborations and executed new license agreements with our partner Kissei in three countries in Asia and with Doctor. Reddy for numerous territories outside of The U. S. Also in 2024, on our second goal, we made significant progress in our development pipeline.

Speaker 2

We continue to evaluate R289, our dual IRAC1 and four inhibitor in an ongoing Phase 1b study in patients with lower risk MDS. We presented encouraging initial safety and efficacy data from that study at the ASH annual meeting in December. Enrollment in the dose escalation portion of the trial where we recently completed the fifth dose level and have now opened for enrollment on new sixth dose level at five hundred milligrams BID. For eludacitinib, our strategic collaborations with MD Anderson and CONNECT organization continue to progress. These trials provide us with the opportunity to explore ludacitinib in a range of IDH1 mutant cancers in a time and cost efficient manner.

Speaker 2

We're excited to report that all four studies from our multi year strategic development alliance with MD Anderson have now opened for enrollment. And the Phase two study of olosutinib in high grade glioma in collaboration with CONNECT has also recently opened for enrollment. Lisa will provide you an update on these development programs in a few minutes. And lastly, in 2024, on our third goal, maintaining financial discipline. By maintaining financial discipline, we were able to, for the first time, generate full year net income of $17,000,000 and our cash balance increased by more than $20,000,000 for the year.

Speaker 2

All of these accomplishments enabled Rigel to continue to successfully implement our strategy. Moving on to the next slide. We have continued to grow our net product sales over time with a compound annual growth rate of 32%, up from between 2021 and 2024. TAVALISSE grew nicely over that period and the addition of Resideo in late twenty twenty two and Gareto in 2024 has provided additional contributions to that growth. All three of these products achieved new highs in 2024.

Speaker 2

And in 2025, as you can see on Slide six, we're expecting approximately $145,000,000 to $192,000,000 in net product sales for the year, approximately a 28% to 32% growth compared to 2024. So just to summarize, 2024 was a transformational year where we continue to grow our hematology and oncology business, while at the same time becoming a profitable company. And With that, I'll turn the call over to Dave to provide a commercial update.

Speaker 3

Dave? Thank you, Raul. On Slide eight, you'll see our three commercial products, TAVALISSE, RESLydia and DEVREDO. We are very pleased with the strong growth in revenues in the fourth quarter and full year 2024. Moving to Slide nine, you see how our quarterly and annual sales have evolved since 2021.

Speaker 3

We've grown each quarter sales over the previous year and that growth continues, particularly from last year to this year. We started the first quarter of twenty twenty three with $23,800,000 and are now reporting $46,500,000 for the fourth quarter of twenty twenty four. That growth has been driven by our strong commercial execution in consistently building quarterly demand for TAVALISSE and driving broader awareness of Resilidya through the first two years of its launch. In addition, our ability to successfully and seamlessly transition Gevreto into our portfolio has significantly expanded our top line. Compared to the fourth quarter of twenty twenty three, we generated 58% growth in the fourth quarter of twenty twenty four.

Speaker 3

For full year 2024, we delivered record revenues of nearly 145,000,000, an increase of $41,000,000 or 39% compared to 2023 net sales of 104,000,000. Our commercial team has been dedicated to execution, driving continued momentum for Tavalis and improving both institutional and community demand for Resilidya and successfully transitioning Gaveredo patients and accounts to Rigelabel product. My sincere thanks to the entire team for all their hard work to grow our business in 2024. Slide 10 shows a summary of our commercial performance by product. First on TAVALISSE, I'm pleased to report another strong quarter in which we generated $31,000,000 in net product sales, an increase of 21% compared to the fourth quarter of twenty twenty three.

Speaker 3

This growth was driven by strong patient demand with another consecutive quarterly record high. We continue to grow TAVALISSE demand through both refills from patients who stay on the product and new prescriptions for patients who are starting TAVALISSE for the first time. Moving to Reslydea, we reported $7,400,000 in net product sales, almost doubling revenue from the prior year period as we focus on improving Reslydea adoption, both in institutions and the community by raising awareness of Reslydia's efficacy, particularly in patients who have failed upfront therapy with venetoclax. And lastly, for Gaveredo, in our second full quarter selling the product, we delivered $8,100,000 in net product sales in Q4. We are very happy with the success in transitioning over Gevreto patients, prescribers and accounts to Rigel's distribution network.

Speaker 3

Importantly, our $8,100,000 of net product sales in the fourth quarter represent a run rate above the $28,000,000 in annual sales of Givretto in 2023 under prior ownership. We are especially pleased with Givrtta's upward trajectory during last year's transition and are now focused on building on that momentum in 2025. Moving to Slide 11, we hit several meaningful milestones with our portfolio in 2024. Importantly for Tavalis, twenty twenty four was the first year to achieve more than $100,000,000 in net sales. It continues to grow steadily as the foundation of our portfolio, consistently hitting new record quarterly highs and bottle shipped to patients in clinics.

Speaker 3

That steady growth has been driven by more new patients starting on top of these each quarter and the subsequent increased carryover that's generated. In 2025, we expect that trend to continue. RESLydia more than doubled both bottles shipped to patients in clinics as well as net sales in 2024. And we believe we still have significant opportunity to grow Reslydia's use in mutant IDH one relapsed to refractory acute myeloid leukemia. We continue to find that as clinicians become more aware of Resideo's efficacy in post venetoclax patients, they believe it's clinically meaningful as these patients are very difficult to treat with other therapies.

Speaker 3

We believe we can build on the scientific data currently available in this important population of AML patients and continue to grow Resilidio's use in 2025. Lastly, in 2024, our successful transition of Gavreto demonstrates our nimble and highly adaptable organizational capabilities. We fully leveraged our commercial and medical affairs infrastructure and expertise to meaningfully expand our hematology and oncology portfolio and quickly generated $17,100,000 of incremental net sales in 2024. The Q4 Gaveretto net sales result of $8,100,000 reinforces how smoothly and effectively both new and existing patients were transitioned. And furthermore, the fact that we were also able to significantly grow TAVALISSE and RESLydia while that transition was ongoing is a testament to our organizational capabilities and operational efficiency.

Speaker 3

In 2025, we can continue to grow Gevreto, particularly since the use of RET inhibitors in non small cell lung cancer should continue to expand in the frontline setting. New non small cell lung cancer treatment guidelines released by the National Comprehensive Cancer Network or NCCN in January, now recommend that if a RET inhibitor was not used in the frontline setting, clinicians may switch frontline therapy to a RET inhibitor once the RET fusion is confirmed. We believe that RET inhibitor use will expand in non small cell lung cancer in 2025 and beyond and Gavereda will grow in turn. Finally, moving to slide 12, we're incredibly excited about our work to expand access to our patients in markets outside of The U. S.

Speaker 3

TAVALISSE is commercially available in Japan, in Europe under the brand name TAVALISSE and in Canada and Israel via our partners Kisei, Grifols and Medison and that's generating sustainable revenues each quarter. In addition, our partners continue to pursue regulatory approvals for TAVALISSE in new markets. As Raul mentioned, Knight Therapeutics announced it has received regulatory approval for TAVALISSE in Mexico and recently Kisei announced regulatory approval for TAVALISSE in Korea. In 2024, we also look to find partners to develop and commercialize Reslydia in ex US markets. We expanded our relationship with Kisei to include Japan, Korea, and Taiwan for Reslydia in all potential indications.

Speaker 3

And in late twenty twenty four, we entered into an exclusive license agreement with doctor Reddy's for Resilidio and all potential indications throughout doctor Reddy's territory, which includes Latin America and other territories. We are pleased that access to our products is expanding outside The US and we continue to explore other opportunities for partnerships outside The US to bring our products to other markets and patients around the globe. I will now pass the call over to Lisa to provide an update on our development pipeline. Lisa?

Speaker 4

Thanks, Dave. We made meaningful progress in 2024 and look forward to continued execution on our strategy to expand our hematology and oncology portfolio in 2025. I'm on slide 14. First, from our development pipeline, R289 is our novel dual IRAC1 and four inhibitor that is currently being evaluated in a Phase 1b study in patients with relapsedrefractory lower risk myelodysplastic syndrome or MDS. We're excited that R289 has been granted both fast track designation for the treatment of patients with previously treated transfusion dependent lower risk MDS and orphan drug designation for MDS by the FDA.

Speaker 4

Furthermore, as part of Rigel sponsored development programs and alongside our partners MD Anderson and the CONNECT Cancer Consortium, olutocitinib is being evaluated in new indications. We believe olutacitinib has potential in several cancers where mutated IDH1 plays a role, such as glioma, additional AML segments, and MDS, either as monotherapy or in combination. We expect to initiate a Rigel sponsored phase two study to evaluate a lutocinib in recurrent glioma in 2025. In addition, as Raul mentioned, all four clinical trials under our MD Anderson collaboration are now open for enrollment as is the CONNECT study focused on high grade glioma. We also remain focused on evaluating potential opportunities to in license or acquire products that would be a strategic fit for our portfolio.

Speaker 4

We're looking for differentiated products in hematology, oncology, or related areas, products that are late stage, possibly with registrational data, soon to have registrational data, or more advanced, and products that can leverage our hematology and oncology infrastructure. As demonstrated with our acquisitions of elutuxitinib and pralsatinib, our goal is to continue to find assets that align with our organization pipeline and ability to execute. Now we'll spend a few moments discussing the updates from our R289 program. To help frame the discussion, Slide 16 presents an overview of the value proposition of R289 and lower risk MDS. There are about 12,000 previously treated lower risk MDS patients in The US.

Speaker 4

Recent development efforts in lower risk MDS have focused primarily on first line therapies. However, there's a high unmet need for next line therapies, particularly for previously treated transfusion dependent patients. Dysregulation of inflammatory signaling is key to the pathogenesis of lower risk MDS and IRAC1 and four mediate this process. Blocking both IRAC1 and four may suppress marrow inflammation and leukemic stem and progenitor cell function and restore hematopoiesis. R835, the active moiety of R289, blocks toll like receptor and IL1 receptor signaling in vitro and was active in various preclinical models of inflammation.

Speaker 4

Clinical proof of concept of this anti inflammatory effect came from a healthy volunteer study in which R835 markedly suppressed LPS induced cytokine release compared to placebo. As a reminder, R289, which is currently being evaluated in the clinic, is the oral prodrug that is rapidly converted to R835 in the gut. R289 has both FDA fast track and orphan drug designations, giving the molecule an expedited regulatory pathway, potential priority review, and seven years of market exclusivity upon approval. Both of these designations underscore the agency's interest in this rare disease and their willingness to collaborate with Rigel in the development of R289. In addition, R289 has thus far demonstrated a promising preliminary clinical profile in a phase 1b study.

Speaker 4

The initial dose escalation data that were recently presented at the ASH annual meeting will be reviewed on today's call. On slide 17, you see the treatment landscape for lower risk MDS. MDS is a clonal disorder of hematopoietic stem cells leading to dysplasia and ineffective hematopoiesis. The main consequences for patients are anemia and transfusion dependence, which adversely impact their quality of life. In addition, infections, iron overload from transfusions, and subsequent organ dysfunction all negatively impact the patient.

Speaker 4

Aside from transfusions, initial therapies include erythropoiesis stimulating agents or ESAs if patients are eligible and luspatercept. Imetelstat was approved earlier this year for ESA failure, high transfusion burden, lower risk MDS. With eight week transfusion independence rates approaching forty percent with mluspatercept and Imetelstat, many patients require an alternative treatment option. Although hypomethylating agents or HMAs are approved, the percentage of patients achieving transfusion independence is low. Therefore, there is a high unmet need for safe effective treatment options following failure of approved therapies, particularly for previously treated transfusion dependent patients.

Speaker 4

On slide 18, you'll see the design of our ongoing open label dose escalation dose expansion Phase 1b study in relapsedrefractory lower risk MDS patients with either symptomatic anemia or transfusion dependence. The study was recently updated to include a sixth dose level, five hundred milligrams BID, and to facilitate the randomized comparison of two dose levels in expansion to optimize selection of the recommended Phase two dose. The primary endpoints are safety and selection of the recommended dose for expansion, and secondary endpoints include transfusion independence, hematologic improvement, response rates and PK. The study continues to progress well with the six dose level of five hundred milligrams BID now open for enrollment. Once the recommended Phase two dose has been determined, an exploratory cohort of of first line lower risk MDS patients will be open to evaluate R289 in an earlier line of therapy.

Speaker 4

Now I'd like to walk you through the initial dose escalation data that were recently presented at the ASH annual meeting. On slide 19, we start with patient characteristics. Data on 22 patients were reported using an 10/25/2024 data cutoff date. The median age was 76 and about sixty percent of the patients were age 75 or above. The median number of prior therapies was three ranging from one up to eight and more than seventy percent of patients had received an HMA or luspatercept.

Speaker 4

The majority of patients, seventy three percent, were high transfusion burden at baseline. The median time on therapy was four point six months. In summary, these were elderly, heavily pretreated patients with a high transfusion burden at baseline. Moving to slide 20, we'll review the safety findings. R289 was generally well tolerated.

Speaker 4

The most common treatment emergent adverse events in twenty percent or more patients, which are not shown on the slide, were diarrhea and fatigue followed by chills, nausea, and pruritus, all of which were grade one or two. The most frequent grade three or four adverse events was two events each where anemia, platelet count decreased, pneumonia, and alanine aminotransferase or ALT increased. The treatment related adverse events are shown on the slide. Importantly for this patient population, the incidence of grade threefour cytopenias and infections was low. There was one dose limiting toxicity reported, a grade threefour transaminase increase in one patient at the seven fifty milligram daily dose level.

Speaker 4

Serious adverse events occurring in two or more patients were pneumonia and upper GI bleed, both occurred in two patients each and were unrelated to therapy. On slide 21, we show the preliminary efficacy data. The swimmer plot shows each patient and the red cell transfusions by dose group, starting with the lowest dose group, two fifty milligrams daily on top. Per the IWG twenty eighteen criteria, the transfusion history for each patient was collected for sixteen weeks prior to our February administration to establish the baseline transfusion frequency shown to the left of day zero indicated by the red arrow. Two patients, numbers nine and nineteen, were not transfusion dependent at baseline.

Speaker 4

18 patients were valuable for efficacy, meaning that they had one or more r two eight nine doses and at least one efficacy assessment. Red blood cell transfusion independence lasting eight weeks or longer was achieved by three patients, one receiving five hundred milligrams daily and two receiving seven fifty milligrams daily. In two patients, RBC transfusion independence lasted for more than six months, and one patient also achieved a marrow complete response. The median duration of transfusion independence was twenty nine weeks. One high transfusion burden patient receiving five hundred milligrams daily achieved a minor HIE response with a 64% reduction in red blood cell transfusions compared to baseline.

Speaker 4

Regarding PK, at doses at or higher than five hundred milligrams once daily, r835 plasma concentrations reached or exceeded those associated with 50% or 90% LPS induced cytokine inhibition that was previously observed in healthy volunteers. We thought it was interesting that at these doses, hematologic responses occurred in four out of ten or forty percent of evaluable transfusion dependent patients. On Slide 22, we see a summary of the responding patients. The majority were high transfusion burden at baseline and had received a variety of prior therapies including luspatercept, hypomethylating agents and some experimental therapies. The two patients with durable transfusion independence lasting more than six months, patients four and ten were both high transfusion burden at baseline and had received HMAs.

Speaker 4

Beneath the table are the hemoglobin levels over time for the three patients that achieved transfusion independence. Peak hemoglobin increases ranging from 2.3 to 5.6 grams per deciliter compared to baseline were observed, indicating that R289 has the potential to correct anemia, providing support for its evaluation earlier in treatment. In summary, the initial data is encouraging, showing R289 is generally well tolerated with promising signs of efficacy in heavily pretreated transfusion dependent patients Now, I'll shift focus to elutosidinib, our IDH1 inhibitor Beginning on slide 24, glioma is an area that is incredibly challenging where there has not been much advancement in therapeutic options. Diffuse gliomas are the most common primary brain tumor in adults, affecting approximately twenty thousand in The US each year. IDH1 mutations occur in about seventy percent of patients with grade two and three glioma and are found in up to almost forty percent of younger patients.

Speaker 4

Unfortunately, most disease recurs, and there is no standard of care therapy for relapsed patients. The recent approval of vorasidenib, an IDH one and two inhibitor in grade two gliomas has highlighted the potential for IDH inhibitors in glioma. Olutosidenib was previously evaluated in a phase 1b2 study in twenty six patients, which was published in the journal Neuro Oncology. Two patients with high grade glioma achieved partial responses, both had enhancing tumors and ten patients achieved stable disease for a disease control rate of forty eight percent. This clinical proof of concept supports further evaluation of elutacitinib in glioma.

Speaker 4

Moving to slide 25, last year, we entered a collaboration with the global neuro oncology consortium, CONNECT. In CONNECT's TARGET trial, a molecularly guided phase II umbrella clinical trial for high grade glioma, the Rigel sponsored arm of the study, target d, will evaluate a postradiotherapy maintenance regimen of elutacitinib in combination with temozolomide followed by elutacitinib monotherapy in newly diagnosed patients between 12 and 39 years of age with IDH1 mutation positive high grade glioma. This study was recently opened for enrollment. In addition, we recently announced that this year, we plan to initiate a Phase II clinical study in recurrent glioma, and we look forward to providing more details about that study later this year. We think this is an important opportunity as there is a significant unmet medical need in this patient population.

Speaker 4

We, along with CONNECT, are excited about elutasitinib's potential to provide a much needed new treatment option to this underserved patient population, and we look forward to the data generation from the CONNECT study in addition to our planned study in recurrent glioma. On slide 26, you'll see another important collaboration, our strategic alliance with the MD Anderson Cancer Center to advance a lutocitinib more broadly into AML, MDS and beyond. We're pleased to report that the four studies indicated in this collaboration are now open for enrollment. Turning to our partnered program. On Slide 28, our RIKK1 inhibitor programs are progressing well with our partner Lilly.

Speaker 4

RipK1 is implicated in a broad range of inflammatory cellular processes and plays a key role in tumor necrosis factor signaling. OcaducerTib, our non CNS penetrant RipK1 inhibitor, previously referred to as R552, is currently being studied in an adaptive Phase IIa2b clinical trial in up to three eighty patients with active moderate to severe rheumatoid arthritis. Phase 2a enrollment of approximately 100 patients is advancing well with preliminary analysis of the results anticipated within the first half of twenty twenty five. Our preclinical CNS penetrant RYBK1 inhibitor program is also progressing toward lead candidate nomination. In closing, as you see on Slide 29, there are several upcoming milestones for our development programs in 2025.

Speaker 4

For our R289 program and lower risk MDS, we expect to complete the dose escalation portion of the Phase 1b study. The new six dose level, five hundred milligrams twice daily, is actively enrolling. We then plan to initiate the dose expansion phase later this year. Also during the year, we plan to seek health authority input on the registrational path for R289, and we're anticipating presenting the dose escalation data from the Phase 1b study in the second half of the year. Then for lutacitinib, we plan to initiate a Phase two clinical study in recurrent glioma by year end and also plan to provide you with more details about that study later this year.

Speaker 4

In addition, we'll continue to support the four MD Anderson studies and CONNECT study. We're excited about the progress we've made in 2024 to advance these programs and look forward to providing further updates on these planned milestones in 2025. Now, I'll pass the call to Dean to discuss our financial results for the quarter.

Speaker 5

Thank you, Lisa. I'm on Slide number 31. We reported net product sales of $46,500,000 for the fourth quarter, a growth of 58% year over year including TAVALISSE net product sales of $31,000,000 a growth of 21% year over year, Resilidian net product sales of $7,400,000 growth of 92% year over year and Gavereddo net product sales of $8,100,000 in the fourth quarter. As a reminder, Gavereddo became available for Rigel in June of twenty twenty four. Our net product sales from TAVALISSE, RESOLID and Gavereddo were recorded net of estimated discounts, chargebacks, rebates, returns, co pay assistance and other allowances of $19,700,000 For the fourth quarter of twenty twenty four, our gross to net adjustment for TAVOIS, Resiliy and Gabreto was approximately 33%, twenty one % and twenty three % of gross product sales respectively.

Speaker 5

Our fourth quarter revenues reflect strong patient demand and were aided by year end increase in inventory in our distribution channels that we've seen in the past. As we've also seen in the past, we expect to experience a drawdown in these inventory levels in our distribution channels in the first quarter of twenty twenty five. Incrementally, we highlighted in the fourth quarter, we made certain changes to our distribution channel arrangements for top of lease. It would result in continued high quality access while reducing our distribution costs and favorably impacting our gross to net adjustment into the future. While this change is not expected to impact our bottle shipped to patients and clinics, we expect to experience a reduction in bottles remaining in our distribution channel of approximately three fifty bottles during the first quarter of twenty twenty five.

Speaker 5

We expect the effect of these distribution channels will have normalized by the end of Q1. We also reported $11,100,000 in contract revenues from our collaborations for the fourth quarter, primarily driven by Grifols and Kisei along with $4,000,000 in revenue from Doctor. Reddy's related to the upfront fee from sub licensing of lucitanib. Onto the next slide and moving down the income statement to cost and expenses. Our cost of product sales was approximately $5,800,000 for the fourth quarter of twenty twenty four.

Speaker 5

Total costs and expenses were $40,900,000 compared to $33,800,000 for the same period of 2023. The increase in cost and expenses was mainly due to higher R and D costs driven by the timing of our clinical activities, increased personnel related costs and increased commercial related activities. In addition, cost of product sales increased driven primarily by increased product sales, higher royalties, higher amortization of intangible assets and sub licensing revenue fees. For the full year, cost of product sales were approximately $18,600,000 Total cost and expenses were $155,100,000 compared to $137,400,000 for the full year of 2023. The increase in cost and expenses was mainly due to higher cost of product sales, driven primarily by increased product sales, higher royalties, higher amortization of intangible assets and sub licensing revenue fees.

Speaker 5

In addition, there were increases in personnel related costs, stock based compensation expense and commercial related expenses. These increases were partially offset by reduced R and D costs due to the timing of clinical trial activities related to R289, our dual IRAP1four inhibitor program as well as reduced trial activities related to completed Phase three clinical trials during 2023. '20 '3. For the full year, we reported net income of $17,500,000 compared to a net loss of $25,100,000 for 2023. We ended the quarter with cash, cash equivalents and short term investments of $77,300,000 up from $56,900,000 as of the end of twenty twenty three.

Speaker 5

Turning to our financial outlook for 2025, we expect total revenue in the range of approximately $200,000,000 to $210,000,000 comprised of approximately $185,000,000 to $192,000,000 in net product sales and $15,000,000 to $18,000,000 of contract revenues from collaborations. We also anticipate reporting positive net income for the full year while funding existing and new clinical development programs. To wrap up my section, 2024 was a tremendous year of revenue growth and continued financial discipline for Rigel, and we look to continue into 2025 and beyond. With that, I'd like to turn the call back over to Raul. Raul?

Speaker 2

Thank you, Dean. Moving on to Slide 33. As I have stated on this call, 2024 was a year of significant achievements for Rigel. We reached profitability and cash flow breakeven, while delivering on our corporate strategy to grow our hematology and oncology business. Going forward into 2025, our priorities are clear, continue to grow our commercial business, advance our development programs, identify new pipeline opportunities and continue to maintain financial discipline.

Speaker 2

We anticipate growing our net product sales by approximately 30% year over year. We remain focused on advancing our Phase 1b study of R289 for the treatment of lower risk MDS and complete the dose escalation portion of this study. We plan to initiate the dose expansion phase of the study and provide the updated data at a medical meeting later this year. For lenicitinib, we plan to initiate a new Rigel sponsored Phase two study in recurring glioma and continue to support our strategic collaborations with both MD Anderson and the CONNECT organization. Even with all these investments to advance our current and new pipeline programs, we expect to report positive net income for the full year of 2025.

Speaker 2

Moving on to Slide 34, I am thrilled that Rigel has reached this pivotal point in the company's history. Our implementation of our corporate strategy has brought us to a place where our commercial sales levels now allow us to grow the business in a profitable and sustainable manner. It's a really exciting time for the company. And with that, I would like to turn the call over to your questions.

Operator

Thank you. And our first question comes from Yigal Luchomovitz with Citi. Please state your question.

Speaker 6

Hi guys. Thanks so much for taking the questions. I have a few. The first one on the product guidance, I think you said 01/1992 to 01/1995. So using the fourth quarter as a base, I'm just could you just give a little more color as far as the comments there in terms of the range?

Speaker 6

It seems a little conservative. It looks like it's about a 1% to 2% quarter on quarter CAGR going off the 4Q base. That was my first question. Thank you.

Speaker 5

Yes. So the net revenue guidance is for $185,000,000 to $192,000,000 and the Q4 was $46,500,000 of net product sales. That was aided by, as as I as we said in our prepared comments, it was aided by, you know, inventory build in Q4. And we've seen this typically, that accounted for about $4,500,000 of that $46,500,000 of of net revenues in in q four. So as you normalize that and you you start to build Q1 through Q4, that creates the revenue guidance that we described.

Speaker 5

And that's a represents at the midpoint about a 30% year over year growth in net product sales.

Speaker 6

Okay. Thanks, Dean. And then I'm curious on RESOLIDIA. Do you have any data from the field in terms of the duration of therapy there? I recall from couple of years ago, there was some very, very good data you had showing the strength of that durability.

Speaker 3

Yigal, great question. This is Dave. We won't share any of that today, but what I can tell you is we have a lot of room to grow. At the end of the day, whenever you launch a product and we're only two years into this, you're going to get a lot of later line patients. And those patients you know, are not gonna have the duration of therapy that you would have seen in the clinical trial where they were probably in the second line or third line setting.

Speaker 3

And so, you know, that's kind of where we are right now. So, obviously, we do believe our duration of therapy is a significant driver of, you know, adoption, but also a significant driver of carryover as we before. That's why I'm optimistic about our ability to grow as awareness grows, as we get more patients on therapy and we get earlier patients on therapy, particularly those who've had first line venetoclax, we think we can drive duration higher.

Speaker 6

Thanks. And just one last one, if I might. Do you have any data as to the percent of patients that are on GAVREDO by Rigel versus GAVREDO from the prior commercial sponsor?

Speaker 3

I don't have specific data, but I can tell you, our goal was to transition every single patient that was on Gavereddo over to Raja label product. I think the fact that we sold $8,100,000 and that our demand grew, from q three to q four and our run rate was higher than the previous run rate of $28,000,000 last year. I think we achieved that. So I really don't think, we lost any patients in the mix. And as a matter of fact, obviously, I think we're adding new patients.

Speaker 3

It's hard for us at this point in time to say new patients on brand versus new patients to Rigel. We know they're all new patients to Rigel, but we think we are getting new patients to brand because our demand continues to to move up.

Speaker 2

You know, Yale, that was pretty remarkable achievement, that transition because you typically see a a sell of a product from one company to another. And for probably six months, you see a lower sales base than originally before. And that wasn't the case here. So this is really pretty remarkable that we achieved that and we're really pleased with it. It also shows that we have the entirety of the team, medical affairs, market access, the sales organization, really focused on the right things and getting those patients across.

Speaker 2

And so it really worked remarkably well. I'm actually incredibly impressed.

Speaker 6

Got it. Thank you very much for taking the question.

Operator

Thank you. And our next question comes from Talpit Patel with B. Riley Securities. Please state your question.

Speaker 7

Yes. Hey, good afternoon and thanks for taking the question. Maybe I want to start first with the TAVALISSE sales, the increase in the fourth quarter relative to the third quarter. Maybe comment on how much of that was an organic volume increase versus maybe any price increases that may have occurred?

Speaker 3

I'm sorry, can you repeat the last part of your question, Calpet? You said volume versus

Speaker 2

price?

Speaker 7

Yes, exactly. This just was this accounted for by any price increases?

Speaker 3

Yes, we didn't have any price increase in Q4. So that was all volume. What I will say is we had our highest quarterly demand ever that's bottle shipped to patients and clinics. Matter of fact, it was the ninth consecutive quarterly high that we'd hit. We also had a higher percentage of new patients starts, or new patients versus existing patients kind of driving that volume in fourth quarter.

Speaker 3

And so again, as Dean said, we were also aided by some inventory build, which is typical in the last, in the last quarter of the year. But demand definitely increased, from q three to q four as the new patient starts.

Speaker 5

And we did we did our press release highlight the the unit volume, the demand volume as Dave suggested, the demand or the the bottle shipped to patients and clicks, that's really the key to the business. That's the, those are the bottles that are going to go to patients. Incrementally there's the, the bottles left in the distribution channels that we report, and those are inventory levels. For Tava Least, that inventory level benefit for q four was about $3,000,000 And that's in the 4,500,000.0 I described. Again, Tava Least was benefited by about $3,000,000 That said, again, the demand is consistently growing and that's the important measure of the business.

Speaker 7

Okay, okay, great. And then maybe switching over to your glioma program, the planned study. I know you're still working on the design there. But I'm curious on the strategy here. Are you going to do a head to head study against vorasidinib?

Speaker 7

Or are you trying to maybe position your drug for a different grade glioma, maybe a higher grade three or four? Iso?

Speaker 4

Yes. Thanks for the question. I think at this point, it's still too early to comment on the design of the study. We've just kind of started our KOL discussions and ad boards and are working on that plan, but we'd certainly be happy to give you more information on this later in the year.

Speaker 2

So for both two eighty nine and Oluda and Glioma, our plan is to later this year as we have some discussions with regulatory agencies is settled on what the plan is exactly. We'll come back to you and share that with you, but it probably will be in the second half of the year.

Speaker 7

Okay, great. Thank you very much.

Operator

Thank you. And our next question comes from Joe Pantginis with H. C. Wainwright. Please state your question.

Speaker 8

Hi, everybody. Good afternoon. Thanks for taking the questions. So my first question is a two parter for TAVALISSE, if you don't mind. So in The U.

Speaker 8

S, I guess, how would you describe well, first, can you describe the difference or the percentages of refills and the growing aspect of new prescriptions? And what are you doing to help grow new prescriptions, say, today versus where you were one to two years ago? That's part one.

Speaker 3

Yes. So I think great question, Joe. I think, as I said before, what we noticed in Q4, which was really nice, is that a larger percent of our patients, and that's total patients on therapy, those who are carrying over from previous quarters as well as new patients. A higher percentage was driven by new patients. As a matter of fact, the highest percentage we've ever seen.

Speaker 3

And so clearly, I think, you know, adoption's growing. I think some of the things that we're doing now that we've learned over the past is certainly, you know, targeting of of clinicians is something we've spent a lot of time and effort to make sure that we're doing. Expanding reach through different channels is another thing that we're doing. And then, I think, the last part is, you know, community practices play a lot a big role in the management of ITP. And I think, you know, we we we target the, the specific, TPOs out there among the community practices, to to ensure that they're aware of our, of ITPs unique value proposition

Speaker 5

or what

Speaker 3

Tom's unique value proposition in ITP. Sorry.

Speaker 8

No, of course. So and part two is, I guess, taking some of the components that you were just discussing, I want to discuss the ex U. S. Opportunities as you expand geographically. Are there any components that are unique to XUS, like you said, community centers, for example, how are they how is the drug delivered there?

Speaker 8

Are there differences in the initial lines of therapy? Any particular components you can point to ex U. S. That might differ from The U. S?

Speaker 3

I think the best thing for me to do is kind of talk about how The U. S. May be unique in that its use of T pose. And it particularly, end play, is, is probably more driven by, you know, that community practice kind of, buy and bill, sort of mentality. And I think, you know, particularly in Japan, some of the differences there that they've seen is, you know, a more a higher willingness to use combination therapy.

Speaker 3

And so I think there are some differences across the globe in how patients are treated and and, the way clinicians approach ITP management. But like I said, here in The US, it's a lot is treated. You know, it's not it's not a disease. It's a benign hematologic condition where if a hematologist, oncologist sees this, you know, they're not gonna refer it. They're gonna treat it.

Speaker 3

So I think, you know, we have a very kind of diffuse model here in The US, which I think might be a little more concentrated in in other countries outside The US.

Speaker 8

No, that's helpful. I appreciate that color. And then my last question, if you don't mind, is more of an infrastructure question. So as of right now, would you define your sales force as right sized And as you look to add assets and are in early launch stages, what would you envision as potential growth of the size of your sales force? Thanks.

Speaker 3

Yes. Great question, Joe. I would say that what we've done with Reslidia and Gaveredo is ensure that we have synergies. And it's not just sales, right? It's across the brand team.

Speaker 3

It's across market access, which is a

Speaker 5

a

Speaker 3

big component in in, commercializing products these days, as well as our operational and analytical capabilities and business operations. So we have tremendous synergies there. But, you know, I'll just say that our our we're constantly looking at our impactable market and who how many customers we need to call on to ensure that we create impact positive impact on our brands in the market. And depending on the product we bring aboard, the the subspecialists that might be involved, it it it could vary in terms of whether we would need to build sales, sales support or not. And if it's something that is used primarily in the community or, then I think we have the capacity to cover.

Speaker 3

But if it's something that's in a subspecialty that might, that we're maybe not calling on today, then obviously we need to address that.

Speaker 2

But it's part of the assessment of each of those individual opportunities as we decide to bring them in or not.

Speaker 8

Sure, sure. Thank you for all the comments.

Speaker 2

Thank you, Joe.

Operator

Your next question comes from Kristin Kluska with Cantor. Please state your question.

Speaker 9

Hi, this is Ayan on Kristin's line. Thank you for taking our questions. Could you talk a bit about your plan to initiate the expansion phase of the Phase one study of R289 this year? Any color you can provide here particularly when you plan to start and how you go about choosing the doses?

Speaker 4

Yeah. Thanks for the question. As you know, as I mentioned, we're currently enrolling in dose level six for dose escalation. So, first thing we're going to have to do is complete enrollment at that dose level and have a look at the safety and activity. Dose selection for expansion, will be based on, you know, the typical things like safety, PK, PD, you know, a little bit of activity.

Speaker 4

As you see on the you may have noticed on the slide, we we plan to enroll up to 20 patients per arm because we really want to conduct a a robust determination of, of a dose to carry forward and to for further clinical evaluation. So as we mentioned, we're looking forward to, opening that later this year. And the exact timing of that, as I mentioned, will really depend on, what's going on in dose escalation in this last cohort.

Speaker 9

That's helpful. Thank you so much.

Speaker 6

Thank you.

Operator

Our next question comes from Farsin Haak with Jefferies. Please state your question.

Speaker 10

Hi. Thank you for taking my question. Also on R289 low risk MDS program, So I wanted to ask on the further dose evaluations that are ongoing with split dosing, how are you setting expectations there? And then timing for the data updates, will it be more of an ASH update in second half?

Speaker 6

And then I have a follow-up.

Speaker 4

Yes. So, as you noticed in our and thanks for the question. Very interesting. As you noticed, during the course of the dose escalation phase, we changed TAC from once daily to twice daily dosing because we think, biologically, it makes more sense to have

Speaker 5

a

Speaker 4

more or less continuous, suppression of inflammation as opposed to kind of an on off, on off. So, we're really looking forward to to seeing the, the data from the the BID dose levels. And related to the, anticipated timing of the data presentation, Well, I think our best opportunity is ASH. So we're anticipating having an opportunity there to present the updated study data.

Speaker 2

First of all, keep in mind that we want to have four to six months of exposure in each of these patients in order to properly assess whether the product's working, its efficacy, importantly its safety. So that does take some time to do that. So by necessity has to be towards the end of this calendar year.

Speaker 10

Got it. That makes sense. And then we'll be waiting for the mature dose escalation data prior to meeting with the regulators for your registrational path?

Speaker 4

I think we'll give some more information on that later as the data mature more.

Speaker 2

But we won't wait till the end of the year to have some interaction with them. The nice thing about Fast Track designation is that it allows them and us to work more closely together. That's really helpful.

Speaker 10

Got it. Thank you so much.

Operator

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

Speaker 2

Well, thank you. I'd like to thank you for joining this call today and your good questions, and specifically for your continued interest in Rigel. It's been a really monumental year for us. We're really proud of what we achieved in 2024 and incredibly excited about 2025. We have some significant things ahead of us and I think we're really well positioned to execute successfully against them.

Speaker 2

Before we leave, I'd like to thank our employees for their continued interest in improving the lives of patients and for making 2024 such as a successful year for us. So with that, look forward to updating you on future calls and 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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Earnings Conference Call
Rigel Pharmaceuticals Q4 2024
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