Rigel Pharmaceuticals Q1 2025 Earnings Call Transcript

Quartr
Provided by Quartr
May 6, 2025

There are 9 speakers on the call.

Operator

Greetings, and welcome to Rigel Pharmaceuticals Financial Conference Call for the First Quarter twenty twenty 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.

Speaker 1

Welcome to our first quarter twenty twenty five financial results and business update conference call. The financial press release for the first quarter twenty twenty five 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 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 ks for the year ended 12/31/2024, and subsequent filings with the SEC, including our quarter one 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 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?

Speaker 2

Thank you, Ray, and thank you everyone for joining today. Also with us today are Dave Santos, our Chief Commercial Officer Lisa Roiker, our Chief Medical Officer and Dean Schorno, our Chief Financial Officer. Beginning on Slide four, we will provide an overview of Rigel's business and our results for the first quarter of twenty twenty five. I want to start the call today by highlighting our strong start to the year. Today, for the first quarter of twenty twenty five, we reported year over year net product sales growth of 68% from our expanding commercial portfolio.

Speaker 2

In addition, we increased collaboration revenue from our ex U. S. Marketing partners. With total revenue of $53,300,000 for the quarter and continued financial discipline, we were able to generate $11,400,000 in net income this quarter. Now this is a time when the general business environment is challenging, especially for the biotech market, but highlights the robustness of our corporate strategy and consequently our unique position.

Speaker 2

Rogeril is a growing, profitable company with important clinical opportunities at hand that we are able to fund ourselves. On this call, the team will provide you with greater details on our position and this quarter's results. Dave will provide an overview update on the strength of our growing commercial business that now includes three commercial products after the acquisition of our latest product, GAVRETO. Lisa will provide updates on the advancement of our development pipeline, including ARQ289, our novel and selective dual IRAK1 and four inhibitor. ARQ-two eighty nine is currently being evaluated in a Phase Ib clinical study in patients with relapsed or refractory lower risk MDS.

Speaker 2

She will also highlight our plans to expand oludasitinib in the planned with the planned initiation of a Phase II study in recurrent glioma. Beyond these Rigel led development programs, we also remain committed to evaluating new opportunities to expand our hematology and oncology portfolio through business development, as we did with Reslidia and GAVRETO. In 2025, we will continue to focus on commercial growth while maintaining that financial discipline that has contributed to the results today and updates today. We continue to anticipate total we continue to anticipate 2025 total revenue of 200,000,000 to $210,000,000 and to report net positive net income for the full year 2025, while advancing and expanding our development pipeline. This is a testament to the strength of our business and the execution of our corporate strategy to grow our hematology and oncology business.

Speaker 2

Now before I turn the call over to Dave, I want to take a moment to discuss our RIPKINS1 inhibitor program that is partnered with Lilly. Last week, we notified Lilly that we will not exercise our right to share in future development expenses for ogadusertib, known previously as Rigel's R552. This incremental development cost share, which we believe could be substantial and near term, could have resulted in slightly higher royalty rates for Rigel on future net sales. While we continue to be very excited about the potential of vocadrosertib, we have concluded that it is optimal for us to invest our own and our own internal pipeline assets, such as R289 and oludasidenib. Dean will tell you a bit more about the financial impact of this in his remarks.

Speaker 2

Now with that, I'll turn the call over to Dave to provide a commercial update. Dave?

Speaker 3

Thank you, Rahul. On Slide six, you'll see our three commercial TAVALISSE, GIVRETO and RESLINIA. Moving to Slide seven, we are pleased with the strong year over year growth in revenues in the first quarter of twenty twenty five. You can see how our quarterly and annual sales have increased since 2021 in the chart. We have grown each quarter's sales over the previous year, and that growth continues.

Speaker 3

In the first quarter of twenty twenty four, we reported $26,000,000 and now for the first quarter of twenty twenty five, we generated $43,600,000 representing a 68% increase. Our year over year growth was driven by the addition of Gavretto to our portfolio last year as well as growth in both TAVALISSE and Reslidia. Our commercial team has been dedicated to execution, driving continued momentum for TAVALISSE, raising awareness for GAVRETO after a successful transition into our portfolio and improving both institutional and community demand for ResLidia. My sincere thanks to the entire team for all their hard work. Slide eight shows a summary of our commercial performance by product.

Speaker 3

First on TAVALISSE. I'm pleased to report another strong quarter in which we generated $28,500,000 in net product sales, an increase of 35 compared to the first quarter of twenty twenty four. This growth was driven by continued strong patient demand with another consecutive quarterly record high. For GIVRETO, we delivered $9,000,000 in net product sales in Q1. As a reminder, GIVRETO became commercially available from Rigel in late June twenty twenty four.

Speaker 3

And lastly, for Reslidia, we reported $6,100,000 in net product sales, an increase of 25% compared to the prior year period. Moving to Slide nine, I'll provide more color on our commercial performance. TAVALISSE continues to grow steadily as the foundation of our portfolio, consistently hitting new record quarterly highs in patient demand. That steady growth has been driven by new patients starting on TAVALISSE each quarter and the subsequent increased carryover that's generated. We expect this trend to continue throughout 2025.

Speaker 3

In addition, in the first quarter, we completed a successful streamlining of our distribution network to improve efficiency and be consistent across the entire portfolio. Goveretto continued to grow nicely under our ownership. In the first quarter of twenty twenty five, the third full quarter of Gavretto being in the portfolio, we generated $9,000,000 in revenue, approximately 15% year over year growth compared to the first quarter of twenty twenty four as reported by the previous owner of the product. On a sequential basis, we saw 11% revenue growth versus Q4 of twenty twenty four, driven by additional carryover from existing patients as well as new patients. The seamless transition into our portfolio has provided a solid platform for growth that we will continue to build on.

Speaker 3

We are confident we can continue to grow GIVRETO as we begin more targeted efforts on expanding our base of prescribers, particularly since the use of RET inhibitors in non small cell lung cancer should continue to expand in the frontline setting, consistent with the updated guidelines I discussed last quarter. Overall, we believe that RET inhibitor use will continue to grow beyond 2025, and GIVRETA will grow in turn. For ResLidia, we continue to drive new patient starts as we raise awareness for the product, and especially as clinicians become more aware of Reslidia's efficacy in post venetoclax patients. They believe that activity is clinically meaningful as these patients are very difficult to treat with other therapies. We are also focused on educating healthcare professionals on the benefits of patients remaining on therapy, consistent with data that was presented at the ASH meeting in December.

Speaker 3

The analysis showed that while some patients with mutant IDH1 relapsed or refractory AML achieve responses very quickly, sometimes within one to two months of treatment,

Speaker 4

Other patients who continue treatment with Reslidia require up to six months to achieve CRCRH, and even up to ten months for an overall response. This data supports the prescribing information that suggests treating patients for at least six months to allow time for clinical response in patients without disease progression or unacceptable toxicities. We believe we still have a significant opportunity to grow Reslidia's use in mutant IDH1 relapsedrefractory acute myeloid leukemia,

Speaker 3

and we are focused on building on the scientific data currently available in this important population of AML patients. Finally, moving to slide 10, we continue to work on expanding access to our products in markets outside of The U. S. TAVALISSE is commercially available in Japan, in Europe under the brand name TAVLESSE, and in Canada and Israel via our partners Kissei, Grifols and Medison. In addition, our partners continue to pursue regulatory approvals for TAVALISSE in new markets.

Speaker 3

Late last year, Kite Therapeutics announced it had received regulatory approval for TAVALISSE in Mexico, and in January, Kisei announced regulatory approval for TAVALISSE in The Republic Of Korea. For Reslidia, in 2024, we expanded our relationship with Kisei to include Japan, The Republic Of Korea, and Taiwan for all potential indications, and we entered into an exclusive license agreement with Doctor. Reddy's for 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 U.

Speaker 3

S, and we continue to explore other opportunities for partnerships outside The U. S. To bring our products to other patients and markets around the globe. I will now pass the call over to Lisa to provide an update on our development pipeline. Lisa?

Speaker 5

Thanks, Dave. I will now provide an overview of our pipeline progress and plans for the remainder of the year. I'm on Slide 12. From our development pipeline, we're particularly excited by the progress in the clinical development of R289, our novel dual IRAK1 and IRAK4 inhibitor in lower risk myelodysplastic syndrome or MDS and elutacitinib in mutant IDH1 recurrent glioma. Beginning with R289, our Phase Ib study in patients with relapsed refractory lower risk MDS is progressing well and we're currently enrolling dose level six.

Speaker 5

We look forward to providing updated data from this study in the second half of this year. From a regulatory perspective, the granting of both Fast Track designation for the treatment of patients with previously treated transfusion dependent lower risk MDS and orphan drug designation for MDS is an acknowledgment by the FDA of both the unmet medical need of the lower risk MDS patient population and the potential of R289. Furthermore, as part of Rigel sponsored development programs and alongside our partners, MD Anderson and the Connect Cancer Consortium, elutacitinib is being evaluated in new indications. We believe elutacitinib 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 II study to evaluate elutacitinib in recurrent glioma later this year.

Speaker 5

In addition, all four clinical trials under our MD Anderson collaboration are now open for enrollment, as is the CONNECT Target D study evaluating the combination of elutacitinib with temozolomide as maintenance therapy in adolescents and young adults with IDH1 mutated high grade glioma. Consistent with our strategy and evidenced by our acquisitions of elutacitinib and pralsetinib, we remain focused on evaluating potential opportunities to expand our portfolio by in licensing or acquiring products that would be a strategic fit for our hematology and oncology focus. Now we'll spend a few moments on our R289 program. I'm now on Slide 14, which presents an overview of the value proposition of R289 and lower risk MDS. There are about twelve thousand previously treated lower risk MDS patients in The U.

Speaker 5

S. With recent development efforts in lower risk MDS focusing primarily on first line therapies, 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 IRAK1 and four mediate this process. Blocking both IRAK1 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 IL-one receptor signaling in vitro and was active in various preclinical models of inflammation.

Speaker 5

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 being currently evaluated in the clinic, is the oral prodrug that is rapidly converted to R835 in the gut. As I mentioned, 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 Ib study.

Speaker 5

The initial dose escalation data that were recently presented at the ASH Annual Meeting escalation demonstrated promising preliminary safety

Speaker 5

and clinical activity in elderly, heavily pretreated patients with relapsed or refractory lower risk MDS. On slide 15, we outline 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 5

Aside from transfusions, initial therapies include erythropoiesis stimulating agents or ESAs, if patients are eligible, and luspatercept. Ometelstat was also approved last year for ESA failure, high transfusion burden, lower risk MDS. With eight week transfusion independence rates approaching forty percent with luspatercept 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's a high unmet need for safe, effective treatment options following failure of approved therapies, particularly for previously treated transfusion dependent patients.

Speaker 5

On slide 16, 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. Primary endpoints are safety and selection of the recommended phase two dose. And secondary endpoints include transfusion independence, hematologic improvement, response rates, and PK. Enrollment is ongoing into dose level six in the dose escalation part of the study, evaluating a dose of five hundred milligrams twice daily. Once enrollment of this cohort is complete, the plan is to select two doses to be compared head to head in the dose expansion part of the study to optimize selection of the recommended phase two dose for further evaluation.

Speaker 5

In addition, once the recommended phase two dose has been determined, an exploratory cohort of first line lower risk MDS patients will be opened to evaluate R289 at that dose in an earlier line of therapy. Initial data from the study was presented at ASH in late twenty twenty four. On slide 17, you'll see the initial safety data that was presented. To put the safety data into context, this was an elderly, heavily pretreated patient population with a median age of 76, more than seventy percent of whom had received either luspatercept or an HMA. Almost three quarters had a high transfusion burden, meaning they frequently received red cell transfusions before they enrolled in the study.

Speaker 5

In this population, R289 was generally well tolerated with low grade nausea, diarrhea, fatigue, chills, and pruritus being most frequently reported overall. Nausea and diarrhea were also two of the most frequently reported related adverse events that are indicated in the table on the slide. Overall, the most frequently reported grade three or four adverse events were anemia, decreased platelet count, pneumonia, and increased ALT occurring in only two patients each. So thus far, what we're not seeing is a high incidence of cytopenias and infections, which is encouraging. On slide 18, we show the preliminary efficacy data.

Speaker 5

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 R289 administration to establish the baseline transfusion frequency for each patient, shown to the left of day zero, which is indicated by the red arrow. Eighteen patients were evaluable for efficacy, meaning that they had received one or more R289 doses and had at least one efficacy assessment. Red blood cell transfusion independence lasting eight weeks or longer was achieved by three patients, one receiving 500 and two receiving seven fifty milligrams milligrams daily. Red blood cell transfusion independence lasted for more than six months in two patients.

Speaker 5

And one patient also achieved a marrow complete response. The median duration of transfusion independence was twenty nine weeks. In addition, one high transfusion burden patient receiving five hundred milligrams daily achieved a minor HIE response with a 64% reduction in red cell transfusions compared to baseline. Looking at PK, we noticed that at R289 doses of five hundred milligrams once daily and higher, R835 plasma concentrations reached or exceeded those correlating with 50 or 90% LPS induced cytokine inhibition that was previously observed in healthy volunteers. And what's interesting is that at these doses, I.

Speaker 5

E. Five hundred and seven fifty milligrams once daily, forty percent or four out of ten evaluable transfusion dependent patients achieved transfusion independence. Moving to slide 19, you see the summary of the responding patients. A few things to highlight here. The majority of responding patients were high transfusion burden at baseline and had received a variety of prior therapies, including luspatercept, hypomethylating agents, and even some experimental therapies.

Speaker 5

Both patients achieving durable transfusion independence lasting more than six months, patients four and ten were high transfusion burden at baseline and had received HMAs. Beneath the table, we see the hemoglobin levels over time for the three patients that became transfusion free. Although patient 10 in the middle eventually lost their response following a drug interruption and dose reduction, on the background of 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 preliminary activity in heavily pretreated transfusion dependent patients. We look forward to sharing additional data from the study in the second half of this year.

Speaker 5

Now I'll shift focus to elutacitinib, our IDH1 inhibitor. Beginning on slide 21, glioma is an area that is incredibly challenging, where there's not been much advancement in therapeutic options. Diffuse gliomas are the most common primary brain tumor in adults, affecting approximately twenty thousand in The U. S. Each year.

Speaker 5

IDH1 mutations occur in about seventy percent of patients with grade two and three glioma, and are found in up to almost thirty five percent of adolescent and young adult patients. Unfortunately, most standard of care therapy for relapsed patients. The recent approval of vorasidenib, an IDH1 and two inhibitor in grade two low grade gliomas has highlighted the potential for IDH inhibitors in glioma. Elutacitinib was previously evaluated in a Phase IbII study in twenty six patients, which was previously published in the journal Neuro Oncology. Two patients with high grade glioma achieved partial responses and both with enhancing tumors.

Speaker 5

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. Moving to slide 22, we outline our development approach in glioma. Last year, we entered a collaboration with the global neuro oncology consortium CONNECT. In CONNECT's TARGET trial, a molecularly guided phase two umbrella clinical trial for high grade glioma, the Rigel sponsored arm of the study, TARGET D, will evaluate a post radiotherapy 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.

Speaker 5

This study is open for enrollment. In addition, we're on track to initiate a phase two clinical study in recurrent glioma later this year. We think this is an important opportunity as there is a significant unmet need in this patient population. We, along with CONNECT, are excited about elutacitinib'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.

Speaker 5

On slide 23, you'll see another important collaboration, our strategic alliance with the MD Anderson Cancer Center to advance elutacitinib more broadly into AML, MDS, and beyond. All four studies included in this collaboration are open for enrollment, and we look forward to sharing updates from this collaboration in the future. Turning to our partnered program. On slide 25, as Raul mentioned, we're very excited about the Lilly collaboration for okaducertib and the CNS penetrant program. The RIPK1 inhibitor programs are progressing well with our partner Lilly, and we're very pleased with the program's potential.

Speaker 5

RIPK1 is implicated in a broad range of inflammatory cellular processes and plays a key role in TNF signaling. Ocadusertib, the 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 IIa enrollment is advancing well. The preclinical CNS penetrant RIPK1 inhibitor program is also progressing toward lead candidate nomination. Moving to slide 26.

Speaker 5

We outlined several upcoming milestones for our development programs in 2025. For our ongoing R289 program in lower risk MDS, we expect to complete the dose escalation part of the Phase 1b study. 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 updated dose escalation data in the second half of the year.

Speaker 5

Then for lutacitinib, we plan to initiate a Phase II clinical study in recurrent glioma by year end. We'll provide you with more details about that study later this year. In addition, we'll continue to support the four MD Anderson studies and the CONNECT study. We're excited about the potential of our development programs and look forward to providing updates in the future. Now I'll pass the call to Dean to discuss our financial results for the quarter.

Speaker 5

Dean?

Speaker 6

Thank you, Lisa. I'm on Slide number 28. We reported net product sales of $43,600,000 for the first quarter, growth of 68% year over year, including TAVALISSE net product sales of $28,500,000 a growth of 35% year over year GAVRETO net product sales of $9,000,000 As a reminder, GAVRETO became available from Rigel in June of twenty twenty four. And we reported Reslidia net product sales of $6,100,000 a growth of 25% year over year. Our net product sales from TAVALISSE, GABRITO and Reslidia were recorded net of estimated discounts, chargebacks, rebates, returns, co pay assistance and other allowances of $16,600,000 As anticipated, we saw a sequential decrease in net product sales from the fourth quarter of twenty twenty four.

Speaker 6

Consistent with our remarks on our fourth quarter earnings call and what we've seen in past first quarters, our revenues were impacted by a drawdown in inventory levels across our distribution channels. We also reported $9,800,000 in contract revenues from our collaborators for the first quarter, primarily driven by contributions from Riffles, Kissei, which included the $3,000,000 milestone payment and Medison, bringing our total revenues for the first quarter to $53,300,000 Finally, I'd like to take a moment to discuss the reporting impact from our notification to Lilly that we will not exercise our opt in right related to the development and commercialization of ocaducerative for the treatment of non CNS diseases. As a result of this notification, in the second quarter, we expect to recognize approximately $40,000,000 in collaboration revenue. This is noncash and related to the release of the remaining cost share liability currently on our balance sheet. Under the terms of our collaboration agreement, Roger will continue to be entitled to receive milestone and tiered royalty payments of future net sales.

Speaker 6

Moving on to the next slide, endowment income statement to costs and expenses. Our cost of product sales were approximately $4,400,000 for the first quarter of twenty twenty five. Total costs and expenses were $40,600,000 compared to $36,500,000 for the same period of 2024. The increase in costs and expenses was mainly due to increased personnel related costs and higher R and D costs driven by the timing of clinical activities related to R289 and lutacitinib. In addition, cost of product sales increased driven by increased product sales, higher royalties and amortization of intangible assets.

Speaker 6

These increases were partially offset by decreased stock based compensation expense. We reported net income of $11,400,000 for the first quarter compared to a net loss of $8,200,000 in the same period in 2024. We ended the quarter with cash, cash equivalents and short term investments of $77,100,000 similar to the $77,300,000 as of the end of twenty twenty four. Before I discuss our financial outlook for 2025, I want to spend a moment discussing potential tariffs to Rigel as a result of global trade tensions. Rigel uses a group of typical third party contract manufacturers for API and finished goods manufacturing, some of which are located outside The U.

Speaker 6

S. Given the uncertainty, we're not prepared to provide an expected impact of potential tariffs today. We do expect any impact to be modest and note that our IP is domiciled in The U. S. Turning to our financial outlook for 2025.

Speaker 6

We continue to anticipate total revenue in the range of approximately $200,000,000 to $210,000,000 This includes our unchanged expectation 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. In addition, we continue to anticipate reporting positive net income for the full year of 2025, while funding existing and new clinical development programs. Please note that our 2025 revenue guidance excludes the approximately $40,000,000 in non cash collaboration revenue that's expected to be recognized in the second quarter related to our Lilly agreement. To wrap up my section, we look forward to continued financial discipline for the remainder of 2025 and beyond. With that, I'd like to turn the call back over to Raul.

Speaker 6

Raul?

Speaker 2

Thank you, Dean. Moving on to Slide 30. We made significant strides over the past three years to expand our commercial portfolio via in licensing or acquiring assets that fit our commercial capabilities and portfolio focus. We have a proven track record of delivering top line growth, as evidenced by the 32 compound annual growth rate, or CAGR, in revenue growth from 2021 to 2024. This revenue growth enables us to fund our business and our strategic priorities, including to continue expanding our hematology and oncology business.

Speaker 2

And we're confident in our expectation of approximately 185,000,000 to $192,000,000 in net product sales this year. Turning to Slide 31. For the remainder of 2025, our priorities are clear: grow our commercial business advance our development pipeline identify new pipeline opportunities and continue to maintain financial discipline. We anticipate growing our net product sales in 2025 by approximately 30% year over year. We remain focused on advancing our Phase 1b clinical study evaluating R289 for the treatment of patients with lower risk MDS.

Speaker 2

And we are on track to publish updated data at a medical meeting late this year and initiate the dose expansion phase of this study by year end. For elutacitinib, we plan to initiate a new Rigel sponsored Phase II study in recurrent glioma, while continuing to support our strategic collaborations with both MD Anderson and the CONNECT organization. With our anticipated strong revenue growth, financial discipline in 2025, we will continue to invest in our development programs, but also expect to report positive net income for the full year. Finally, on Slide 32, our successful execution of our corporate strategy has resulted in Rigel being uniquely positioned in building a leading hematology and oncology business in a profitable and sustainable manner. And with that, I'd like to thank you for your interest.

Speaker 2

And we will now open the call to your questions. Operator?

Operator

Thank And our first question comes from Kapital with B. Riley Securities. Please state your question.

Speaker 7

Yes. Hey, good afternoon and thanks for taking the question. I had one on the target D program that you have ongoing in high grade glioma. I guess you have two different plans here for glioma. You have that study running and then you also have the planned company sponsored Phase II trial in recurrent glioma.

Speaker 7

Can you help us clarify the objectives and perhaps the design differences between the two? And longer term, what signal do you want to see in the target B program to justify moving forward in one program or the other?

Speaker 2

I'll ask Lisa to take a shot at it. And also, I think, you know, the two this is the start that there's two different studies here, two different patient populations. The Target D program, which, you know, we're delighted, it's an umbrella study that was already underway, which allows us to add our product to that one. So logistically, facilitates the start and initiation of that study. It's a bit different a population than what we're contemplating in our own clinical study.

Speaker 2

Maybe you can give us a bit more color, Lisa.

Speaker 5

Yeah, sure. Thanks for the question, Kalpit. So, yes, Raul mentioned, we're supporting this, the CONNECT umbrella study. Our arm is looking at the combination of, as I mentioned, elutacitinib with temozolomide as maintenance. So in the maintenance setting, so these will be targeting patients that are post surgery and radiotherapy.

Speaker 5

So it's temozolomide, elutacitinib for one year, followed by one more year of elutacitinib monotherapy maintenance. And this is going to be focused on patients with grade three astrocytoma. So looking for an impact on progression free survival. We're happy to be working with Connect on this one. It's a unique population.

Speaker 5

These are adolescents and young adults. We're looking to kind of help expand the sites also, because they're a pediatric organization potentially into more adult sites. And we think it complements our strategy nicely with, our plans to go into recurrent glioma. Now we're not, discussing any of the details about our plans yet, but we will be sharing more about that later on in the year.

Speaker 7

Okay, wonderful. And then one quick question on the patent litigation that you resolved with an ORF or Cavalese. I guess are there any other ANDA filers that investors need to be aware of?

Speaker 1

No. There's no ANDA filers that we are aware of.

Speaker 7

Okay. Perfect. Thank you very much for taking the question.

Speaker 2

Thank you, Kelvin.

Operator

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

Speaker 8

Hey guys. Good afternoon. Thanks for taking the question. So first when you're looking at your product sales and it's nice to see your core revenue from TAVALISSE continuing to expand. GAVRETO increased, you saw some a little bit of increase from Reslidia, a little bit down from TAVALISSE.

Speaker 8

So I guess any commentary with regard to typical first quarter resets? Are you seeing what you expected? And what I'm getting at here is the turbulence in the environment right now and I'll put in quotes drama around people trying to understand what might be happening with regard to Medicare changes as well.

Speaker 2

Yes. Why don't Dave, maybe you can comment and I know Dean has a comment on that as well.

Speaker 3

Sure. Thanks for the question, Joe. Actually, for Q1, we're quite pleased with our progress on all three brands. We grew demand for all three brands. And so I think we're right where we want to be, which is why we're sticking with our guidance.

Speaker 3

And I think our signs for Q1, obviously, we did go into it kind of prepared for the changes, particularly with respect to the Inflation Reduction Act, and I think we did a really the team did a terrific job making sure that patients understood the changes and all of the factors that would enable them to have medications at the beginning of the year, And I think we pulled that through quite successfully, and our demand continued to grow.

Speaker 6

Yes. I think Dave has that right. So we're pleased with the demand side of the equation, and we did see the expected drawdown in inventory, resulting in still a 68% year over year growth. So a strong quarter for us.

Speaker 8

Great. Thanks for the info.

Speaker 2

Thank you,

Operator

And your next question comes from Farzin Haq with Jefferies. Please state your question.

Speaker 4

Hi, thank you for taking my question. I had a couple. I guess I'll start with R289. Are you saying more on how you're setting expectations for the split doses that you're exploring post ASH, like with the dose level five and six? And then just to clarify, for advancing to the recommended Phase II dose, would you need regulatory feedback on dose escalation dataset?

Speaker 2

Yeah, I'll ask Lisa to comment on that.

Speaker 5

Yeah, thank you for the question. So in terms of we don't really have any expectations. I'm not sure I understand, the question. We had switched, I'll provide an answer and you can tell me if I've answered it satisfactorily. We switched some time ago from once daily to twice daily dosing because we thought that, biologically it makes more sense to maintain a tonic suppression of inflammation as opposed to having this once daily like peak and trough and peak and trough in terms of from that aspect.

Speaker 5

And that's why we switched to explore the BID dosing. We're progressing up. We had some preliminary data on the two fifty BID. We've now completed enrollment of the five hundredtwo 50 and now, into the five hundred VID. So as I mentioned, we're, going to be updating data at ASH, share that with you later on this year.

Speaker 5

I think we'll share some PK data as well that I think will contribute to what I mentioned in terms of it may be better to kind of, have that more prolonged, exposure as opposed to the up and down. With respect to the you mentioned the alignment or how to select the doses. So as you're aware, the FDA has encouraged companies now to align with Project OPTIMAIST to ensure more, robust dose selection early, before advancing into phase two. So consistent with that, we will be seeking, input from the FDA aligning with them on the two doses for comparison in the dose escalation part of the study, and we'll be doing that midyear.

Speaker 4

Got it. That makes sense. And then for a follow-up on the earlier question on the ANDA filing. So ANNOURA is one example, and they cannot enter the market. I think it mentioned prior to 2Q32, but if there are additional ANDA filers in the future, could they have an earlier market entry or is that 2Q32 pretty much when you should see a new entry?

Speaker 1

Yes. You can get secondhand filers and they would need to defeat the patents, which in order to enter the market earlier than the current last list of patent, which would be July of twenty seven, twenty twenty two thousand and thirty two. But there's a possibility of an antifilter, but once there's one entrant already, what is a settlement, it's a disincentive to second filers and tertiary filers, but it is technically possible that there could be a second filer.

Operator

Got it. Thanks.

Speaker 2

But we haven't seen

Speaker 7

the last yet.

Speaker 1

No, we have not. We have not there's no we have no notice of a second file.

Operator

Got it. Thank you.

Speaker 2

Sure. Thank you, Farshan.

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. Thank you.

Speaker 2

Thank you. I'd like to thank everyone for joining us on the call today. It was the start of a very strong year. First quarter was an excellent quarter for us. We're very happy with what we were able to accomplish in this quarter.

Speaker 2

It sets us up very well for a very strong calendar year. And so for that, I'd like to thank you for your continued interest at Rigel. I'd like to also thank our employees and for their commitment to Rigel and our values, particularly our commitment to improving the lives of patients. We will keep you updated on future calls as the year progresses. And with that, have a good day.

Operator

Thank you. 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 Q1 2025
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