Rigel Pharma (RIGL) Earnings Call Transcript
Rigel Pharma (RIGL) Earnings Call Transcript
Motley Fool Transcribing, The Motley FoolTue, March 3, 2026 at 11:07 PM UTC
0
Logo of jester cap with thought bubble.
Image source: The Motley Fool.
Date
Tuesday, March 3, 2026 at 4:30 p.m. ET
Call participants -
Chief Executive Officer — Raul R. Rodriguez
Chief Commercial Officer — David A. Santos
Chief Medical Officer — Lisa Rojkjaer
Chief Financial Officer — Dean L. Schorno
Need a quote from a Motley Fool analyst? Email pr@fool.com
Takeaways -
Net product sales -- $232 million for the year, an increase of $87 million, or 60%, primarily due to portfolio demand, a onetime patient affordability effect, favorable gross-to-net adjustments, and partially offset by lower inventory.
Key product performance (Q4) -- TAVALISSE generated $45.6 million (up 47%), GAVRETO $10.2 million (up 27%), and RESLIDIA $9.6 million (up 29%) in net product sales compared to the previous year, with increases attributed to growth in each respective brand.
Fourth quarter total revenue -- $69.8 million, including $65.4 million in net product sales and $4.4 million from collaborations and contract revenues across global markets.
Profitability -- Reported net income of $367 million for the year, significantly impacted by a $245.9 million noncash deferred income tax benefit from release of valuation allowance, with underlying profitability preceding the tax impact.
Cash position -- Year-end cash, cash equivalents, and short-term investments totaled $155 million, up from $77.3 million at the prior year-end.
Cost structure -- Full-year cost of product sales was $19.6 million; total costs and expenses were $168.8 million compared to $155.1 million prior year, reflecting increased R&D and personnel costs.
2026 revenue guidance -- Forecast total revenue of $275 million to $290 million, with net product sales expected between $255 million and $265 million, and contract revenue of $20 million to $25 million.
R289 clinical progress -- Phase 1b data in heavily pretreated lower-risk MDS patients: 33% (6 of 18 evaluable at ≥500 mg) achieved ≥8-week red blood cell transfusion independence, with median RBC-TI duration 23 weeks and onset around 2 months; safety profile showed low Grade 3/4 cytopenia and infection rates.
Regulatory status -- R289 holds FDA Fast Track and Orphan Drug Designation for MDS, granting expedited review, potential priority review, and seven years exclusivity upon approval.
Pipeline milestone -- Expected completion of R289 dose-expansion enrollment and selection of recommended Phase 2 dose in the second half of the year, with top-line dose-expansion data anticipated by year-end.
Commercial expansion -- TAVALISSE is available internationally via partnerships, such as Grifols (Europe), Kissei (Asia), and Medison (Canada, Israel), with additional regulatory submissions underway.
Business development -- Management reiterated focus on in-licensing/acquisition of late-stage hematology or oncology assets that are NDA-ready, under review, or recently approved, aiming for rapid portfolio expansion and accretive growth by 2028.
Strategic collaborations -- Partnerships with academic and industry entities support evaluation of elutacitinib and ocaducertib in additional hematology, oncology, and immunology indications.
Summary
The call demonstrated Rigel Pharmaceuticals (NASDAQ:RIGL)'s multi-year strategic transformation from a single-product, negative cash-flow biotechnology entity to a profitable, diversified commercial organization executing on sustained growth and pipeline advancement. Management emphasized a disciplined capital allocation approach, rapid integration of acquired assets, and leveraging existing infrastructure for operational efficiency and cash generation. Plans for continued pipeline growth include advancing R289 in lower-risk myelodysplastic syndrome toward dose-expansion data and eventual registration study discussions with the FDA. The financial outlook highlights anticipated double-digit percentage revenue increases despite normalization following substantial onetime gains in patient affordability and product integration. Global commercial expansion and strengthened partnerships position the company to pursue additional in-licensing and acquisition opportunities that complement its hematology and oncology focus.
Management clarified that the exceptional 2025 net sales growth included a "onetime favorable effect from increased affordability," primarily due to "the elimination of the coverage gap" for Medicare Part D patients, which is not expected to recur.
The company reported releasing its valuation allowance on deferred tax assets, citing "track record of profitability," resulting in a significant noncash GAAP tax benefit that does not affect actual cash flow.
Lisa Rojkjaer stated the ongoing R289 Phase 1b dose-expansion is "We aim to complete enrollment of the dose-expansion phase of this study and selection of the recommended Phase 2 dose for future studies in the second half of this year," with sufficient patient recruitment currently proceeding without specific delays noted.
Guidance for 2026 assumes "double-digit growth" off a higher revenue base, acknowledging a lack of further similar onetime benefits and a need to drive new patient starts for TAVALISSE and RESLIDIA.
David A. Santos indicated no immediate plans for a sales force expansion, noting that "we are right-sized," and current resources are being maximized with targeted data-driven initiatives.
Industry glossary -
IRAK1/IRAK4 inhibitor: A molecule that blocks interleukin-1 receptor-associated kinases 1 and 4, key mediators of inflammatory signaling in hematologic diseases.
Red blood cell transfusion independence (RBC-TI): A clinical outcome where patients maintain adequate hemoglobin levels without receiving red blood cell transfusions for a specified duration, typically used as a primary endpoint in myelodysplastic syndrome trials.
HMAs (Hypomethylating Agents): Drugs that inhibit DNA methylation, used in the treatment of certain hematologic malignancies such as myelodysplastic syndromes.
NDA-ready: An asset that has completed pivotal clinical trials and is prepared for submission of a New Drug Application (NDA) to the FDA for marketing approval.
Gross-to-net dynamics: The adjustments from gross sales to net revenues after accounting for discounts, rebates, chargebacks, returns, and other allowances.
Valuation allowance (deferred tax assets): An accounting reserve against deferred tax assets, released when future profitability is sufficiently probable to realize these assets.
Full Conference Call Transcript
Raul R. Rodriguez: Thank you, Ray. And thank you all for joining us today. Also with me are David A. Santos, our Chief Commercial Officer; Lisa Rojkjaer, our Chief Medical Officer; and Dean L. Schorno, our Chief Financial Officer. On today's call, I will provide an overview of Rigel Pharmaceuticals, Inc.'s business, our accomplishments for the fourth quarter and full year 2025, as well as our strategic initiatives to drive growth. Beginning on slide four, I will outline Rigel Pharmaceuticals, Inc.'s transformational growth strategy in hematology and oncology.
For those of you less familiar with Rigel Pharmaceuticals, Inc., our strategy is built around four core strategic objectives: grow our commercial business, expanding our portfolio through in-licensing or acquisition, advancing our clinical development pipeline, and maintaining financial discipline. These four pillars are interlocking and collectively drive Rigel Pharmaceuticals, Inc.'s long-term growth. Today, I will highlight how we have executed on this strategy since 2020, building into the profitable company we are today and how this framework positions us for continued growth in the years ahead. Moving on to slide five. Let me begin by outlining the transformation at Rigel Pharmaceuticals, Inc. over the last five years. In 2020, Rigel Pharmaceuticals, Inc. was a single-product company.
TAVALISSE was our only approved product indicated for the treatment of adult chronic ITP. Our development pipeline was limited, and the company was operating with negative cash flows. Now, at the end of 2025 and now entering into 2026, we are fundamentally a different company. We now have three commercial products, TAVALISSE and GAVRETO, approved for four different indications. Our development pipeline is led by R289, a dual IRAK1 and IRAK4 inhibitor discovered at Rigel Pharmaceuticals, Inc. R289 is currently being evaluated in patients with lower-risk MDS, a potentially large commercial opportunity with significant unmet need.
R289 offers a novel mechanism, attenuating the hyperinflammatory signal present in lower-risk MDS, and so may offer a new approach to lower-risk MDS and potentially other diseases. Later in this presentation, Lisa will speak to the encouraging results from our Phase 1b study that were presented at the ASH meeting in December. And our financial position is fundamentally different today. Rigel Pharmaceuticals, Inc. is profitable and has been since 2024. Since then, we have increased our cash position by more than $100,000,000,000. This progress reflects disciplined capital allocation, thoughtful portfolio expansion, and consistent execution across operations. Now looking ahead to 2030, we plan again to be a fundamentally different company.
We are building on the commercial momentum of our three commercial products, while selectively pursuing late-stage in-licensing and acquisition opportunities to further expand our commercial portfolio. At the same time, we will continue to advance R289 in lower-risk MDS and potentially additional indications. These indications will be areas of significant unmet need and so are large commercial opportunities that, again, would be transformational for Rigel Pharmaceuticals, Inc. As illustrated on slide six, Rigel Pharmaceuticals, Inc. has delivered strong net product sales growth since emerging from the COVID pandemic. Based on the midpoint of our 2026 net product sales guidance of $260,000,000, we are achieving a compound annual growth rate of 35% since 2022.
Performance reflects strong commercial execution and successful portfolio expansion. What is even more compelling is the opportunity ahead, driven by the growth of our current products, additional in-licensed or acquired products, and particularly R289 in lower-risk MDS and other indications. These programs represent potentially billion-dollar opportunities that will expand our commercial in the 2030s and beyond. This strategy creates a clear roadmap for sustained growth and long-term shareholder value creation. Before I turn the call over to the rest of the team to discuss our other strategic objectives, I want to briefly highlight our approach to in-licensing and business development. Moving to slide eight.
We have a proven track record in business development, demonstrated by our acquisitions of RESLIDIA and GAVRETO. Leveraging our existing commercial infrastructure, we efficiently incorporated both products into our portfolio with limited integration costs and operating expenses. As a result, a significant portion of those products' revenue have contributed to our profitability and cash generation. As we evaluate future opportunities, we are focused on differentiated assets in hematology, oncology, or closely related areas. We are seeking late-stage assets that have completed registration trials, are NDA-ready or under review, or are already commercially available.
These late-stage assets are targeted opportunities that would be launched within the next three years, ideally no later than 2028, after which we will begin to shift our focus to the potential launch of R289 in lower-risk MDS and other potential indications. Consistent with our prior transactions, we are prioritizing assets that leverage our existing commercial infrastructure, which will enable operational efficiency and thus be rapidly accretive and drive sustained cash generation for the company. I will now turn the call over to David A. Santos to discuss our strategic priority of growing our commercial business.
David A. Santos: Thank you, Raul. On slide 10, you will see our three commercial products, TAVALISSE, GAVRETO, and RESLIDIA. Moving to slide 11, we are thrilled to report full-year results for 2025 and how our net sales have consistently grown over the last five years. In 2021, TAVALISSE was the only product in our portfolio, and we generated $63,000,000 in net sales. In 2022, we continued to grow TAVALISSE and brought RESLIDIA into our portfolio, launching the product in December. In 2023, the addition of RESLIDIA and continued growth of TAVALISSE propelled us over the $100,000,000 annual sales threshold. Then in 2024, we continued to grow those sales and added our third brand, GAVRETO, to our portfolio.
And in 2025, we exceeded our expectations, delivering $232,000,000 in net product sales, an increase of $87,000,000, or 60%, compared to 2024. This outstanding year-over-year growth was primarily driven by increased demand across our portfolio, which included the onetime favorable effect from increased patient affordability during the year and favorable gross-to-net dynamics, partially offset by lower inventory levels. To summarize, our strategy of focusing on both product and portfolio growth over the last four years has nearly quadrupled our net sales. And over just the last two years, that growth has accelerated, as we have more than doubled sales.
Our strategy to grow our commercial business is working, and I want to thank the entire organization, collaborating as one Rigel Pharmaceuticals, Inc. team, to create such outstanding results. Slide 12 shows a summary of our fourth quarter commercial performance by product. For the fourth quarter, we generated a record $65,400,000, an increase of $18,900,000, or 41%, compared to 2024. First on TAVALISSE, I am pleased to report another record quarter in which we generated $45,600,000 in net product sales, an increase of 47% compared to 2024. TAVALISSE was approved in 2018 and is our cornerstone product, now reaching $45,000,000 in quarterly sales, a true achievement for the team.
For GAVRETO, we delivered $10,200,000 in net product sales, an increase of 27% compared to 2024. GAVRETO became commercially available from Rigel Pharmaceuticals, Inc. in mid-2024, and following the successful integration of this product, we were able to maintain the sales level that was generated in the prior company hands, and we have now grown it to be a stable contributing product in our portfolio. And for RESLIDIA, we reported $9,600,000 in net product sales, an increase of 29% compared to the prior-year period. Since in-licensing this product in 2022, it has grown to nearly $10,000,000 a quarter, substantial growth from a year ago, and we believe there is more growth coming.
We have confidence that there is significant opportunity for RESLIDIA because we believe it has important differentiators in the IDH1-mutated relapsed or refractory AML patient population, namely our compelling data demonstrating durable responses and our consistent efficacy results in the challenging-to-treat post-venetoclax setting. Finally, on slide 13, we generated $4,400,000 in revenues from collaborations in the fourth quarter, driven by the availability of TAVALISSE in global markets. TAVALISSE is commercially available in Europe under the brand name TEVALESSE, in Japan and South Korea in Asia, and in Canada and Israel via our partners Grifols, Kissei, and Medison.
Our partners continue to pursue regulatory approvals for TAVALISSE in new markets, and we continue to work on expanding access to our products in markets outside of the U.S. For RESLIDIA, in 2024, we expanded our relationship with Kissei to include several countries in Asia for all potential indications, and we entered into an exclusive license agreement with Dr. Reddy’s for all potential indications throughout Dr. Reddy’s territory. These partners are now in the process of advancing RESLIDIA in preparation for future potential regulatory submissions. We are pleased that access to our products is expanding outside the U.S. I will now pass the call over to Lisa to provide an update on the advancement of our development pipeline. Lisa?
Lisa Rojkjaer: Thanks, Dave. I will now provide an update on our progress over the last quarter and plans for the year ahead. I am on slide 15. Our current hematology and oncology focus areas are the clinical development of R289, our potent and selective dual IRAK1 and IRAK4 inhibitor, and our strategic collaborations with academic partners to evaluate elutacitinib in clinical settings beyond relapsed/refractory IDH1-mutated AML. Our Phase 1b study of R289 in patients with relapsed or refractory lower-risk myelodysplastic syndrome, or MDS, is progressing well, and data from the dose-escalation part of the study was recently presented in an oral session at ASH.
I will provide an update on that study, as well as our planned next steps for R289, shortly. For elutacitinib, we have a number of strategic collaborations to study elutacitinib in additional therapeutic areas. Through our collaboration with MD Anderson, elutacitinib is being evaluated in five clinical studies as monotherapy or combination therapy in patients with a variety of IDH1 mutation–positive hematologic malignancies, including AML, higher- and lower-risk MDS, chronic myelomonocytic leukemia, or CMML, and as post-transplant maintenance therapy. In addition, a study of elutacitinib in combination with co-targeted therapy in patients with relapsed or refractory AML with additional signaling pathway mutations is underway.
Our second collaboration with the CONNECT Cancer and the Phase 2 TARGET D study is evaluating elutacitinib in combination with temozolomide followed by elutacitinib monotherapy as maintenance treatment in newly diagnosed pediatric and young adult patients with IDH1 mutation–positive high-grade glioma. First patient was enrolled in the study in October. Lastly, we are also partnering with the National Institutes of Health and National Cancer Institute’s MyeloMATCH precision medicine trial initiative. The planned study will evaluate elutacitinib in first-line IDH1-mutated AML and MDS. We are excited about elutacitinib’s potential to provide a new treatment option in these underserved patient populations and look forward to seeing the data that these studies generate in the future.
Now I will discuss R289, our novel dual IRAK1 and IRAK4 inhibitor. Let us start with the treatment landscape for lower-risk MDS. I am now on slide 17. 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. Therapies used in the upfront setting include erythropoiesis-stimulating agents, or ESAs, if patients are eligible. Luspatercept and more recently imetelstat are also approved for ESA-failure transfusion-dependent patients.
Finally, while hypomethylating agents, or HMAs, are also approved, the percentage of patients achieving transfusion independence is low. With 8-week transfusion independence rates approaching 40% with luspatercept and imetelstat, there is still a need for safe therapies for transfusion-dependent lower-risk MDS patients that are relapsed/refractory to or ineligible for ESAs. On slide 18, you will see the value proposition of R289 in lower-risk MDS. There are about 12,000 previously treated lower-risk MDS patients in the U.S., and as mentioned on the previous slide, there is a high unmet need for therapies in this disease area, particularly for transfusion-dependent patients. Dysregulation of inflammatory signaling is key to the pathogenesis of lower-risk MDS, and IRAK1 and IRAK4 mediate this process.
Blocking both IRAK1 and IRAK4 may suppress marrow inflammation and leukemic stem/progenitor cell function and restore normal hematopoiesis. R835, the active moiety of R289, blocks Toll-like receptor and IL-1 receptor signaling in vitro and was active in various preclinical models of inflammation. Clinical proof of concept of this anti-inflammatory effect came from a healthy volunteer study in which R835 markedly reduced 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 Fast Track for the treatment of patients with previously treated transfusion-dependent lower-risk MDS, and Orphan Drug Designation for MDS from the FDA, 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, the unmet need of the patient population, and the FDA's willingness to collaborate with Rigel Pharmaceuticals, Inc. in the development of R289. R289 has thus far demonstrated a promising clinical profile in our Phase 1b study, with encouraging safety and preliminary efficacy data that were highlighted recently at ASH in December.
On slide 19, I would like to quickly review the design of our multicenter, open-label Phase 1b study in patients with relapsed lower-risk MDS, which aims to evaluate the safety, tolerability, PK, and preliminary efficacy of R289 in this patient population, as well as select a dose for future studies. The dose-escalation phase evaluated six different R289 dosing regimens, administered once or twice daily using a modified 3+3 design. The dose expansion part of the study—up to 40 transfusion-dependent relapsed or refractory lower-risk MDS patients—will be randomized to receive R289 doses of either 500 mg once or twice daily in order to select the recommended Phase 2 dose for future clinical studies. The first dose-expansion patient was dosed in October.
We anticipate that we will have sufficient data to make a decision on the recommended Phase 2 dose in the second half of this year. Once we have selected the dose, we will evaluate R289 in a cohort of less heavily pretreated patients who are relapsed/refractory to or ineligible for ESAs. Now I would like to walk you through safety and efficacy results from the Phase 1b study with the data cutoff date of October 28, that were presented at ASH. On slide 21, you will see the characteristics of the 33 patients enrolled in the dose-escalation part of the study.
Median age was 75, and the patients were heavily pretreated with a median of three prior therapies, with around 70% having received prior luspatercept and HMAs. In addition, the majority of the patients had a high baseline transfusion burden. These characteristics are really representative of the lower-risk MDS population with the highest unmet medical need. Moving to slide 22, we will review the safety findings. Overall, R289 was generally well tolerated with a low incidence of Grade 3 or 4 cytopenias and infections. There was one dose-limiting toxicity reported, a Grade 3/4 AST/ALT increase at the 750 mg daily dose level, and no evidence of dose-dependent toxicity across the other dose groups.
On slide 23, the swimmer plot shows an overview of transfusion events by dose group, starting with the lowest dose group, 150 mg daily, at the top. Red cell transfusions occurring over 8 and 16 weeks prior to start of R289 are shown to the left of the colored bars, establishing the baseline transfusion frequency for each patient. All patients were transfusion dependent except for two. The median time on therapy was 5.5 months, ranging from 0.9 months to nearly 28 months of treatment. To be evaluable for hematologic response assessment, patients must have been treated for at least 16 weeks. No responses occurred at 250 mg once or twice daily.
Of 18 evaluable patients receiving dose levels of 500 mg daily or higher, six patients, or 33%, achieved red blood cell transfusion independence, or RBC-TI, lasting for 8 weeks or longer. In four patients, RBC-TI lasted for more than 16 weeks, and for three patients for more than six months. The median duration of RBC-TI was around 23 weeks, ranging from 9 weeks up to more than 24 months. Also, the median time to onset of RBC-TI was about two months, which is also encouraging. While this is a small dataset, we are encouraged by these results given the highly refractory nature of these patients. Slide 24 presents a summary of the patients achieving RBC-TI.
All patients had received two or more prior therapies; some had received experimental therapies; and five of the six had received prior HMAs. For these patients, peak hemoglobin increases ranging from 2.9 to 6.1 g/dL were also observed, indicating the potential of R289 to improve anemia. In summary, R289 was generally well tolerated with an encouraging safety profile and promising preliminary efficacy in an elderly, heavily pretreated lower-risk MDS patient population. On slide 25, I will review the next steps for R289. We aim to complete enrollment of the dose-expansion phase of this study and selection of the recommended Phase 2 dose for future studies in the second half of this year.
We anticipate sharing top-line data from the dose-expansion phase by the end of the year. Once the recommended Phase 2 dose has been selected, we will evaluate R289 in a cohort of less heavily pretreated patients who are relapsed/refractory to or ineligible for ESAs in the same study. In addition, upon completion of the Phase 1b study, we plan to follow up with the FDA to discuss a potential registration study. With its mechanism of action, we believe that R289 has potential in other indications where the proinflammatory cascade plays a role; we will provide more details as our plans progress.
Now turning to our partnered program with Eli Lilly, on slide 27, I would like to provide a short update on ocaducertib, a non–CNS-penetrant RIPK1 inhibitor previously referred to as R552, that is being evaluated in an adaptive Phase 2a/2b clinical trial in up to 380 patients with active moderate to severe rheumatoid arthritis. During the fourth quarter, enrollment in the Phase 2a part of the study was completed, and the trial is ongoing. Now I will pass the call to Dean to discuss our financials. Dean?
Dean L. Schorno: Thank you, Lisa. I am on slide number 29. We reported net product sales of $65,400,000 for the fourth quarter, a growth of 41% year over year, including TAVALISSE net product sales of $45,600,000, growth of 47% year over year; GAVRETO net product sales of $10,200,000, growth of 27% year over year; lastly, we reported RESLIDIA net product sales of $9,600,000, a growth of 29% year over year. Our net product sales were recorded net of estimated discounts, chargebacks, rebates, returns, co-pay assistance, and other allowances of $19,000,000.
We also reported $4,400,000 in contract revenues for the fourth quarter, primarily consisting of $3,400,000 of revenue from Grifols related to delivery of drug supplies and earned royalties, $300,000 of revenue from Kissei related to delivery of drug supplies, $300,000 in government contract revenues, and $200,000 of revenue from Medison related to earned royalties. This brings our total revenue for the fourth quarter to $69,800,000. Moving to slide 30. For 2025, our cost of product sales was approximately $6,000,000. Total cost and expenses were $46,600,000, compared to $40,900,000 for the same period in 2024.
The increase in cost and expenses was mainly due to increased research and development costs, driven by the timing of clinical activities related to R289 and elutacitinib, and higher personnel-related costs. Fourth quarter results included nonrecurring income tax benefit driven by the release of the valuation allowance on our deferred tax asset. For reference, a valuation allowance is recorded against deferred tax assets when it is more likely than not that those assets will not be realized. Given our track record of profitability, projected operating income, and positive outlook, we concluded that a release of the valuation allowance was appropriate as of 12/31/2025.
While this release impacts reported GAAP net income and earnings per share, it does not affect our cash position or our day-to-day operating performance. In this context, for the fourth quarter, income before income taxes was $22,700,000, compared to $15,200,000 for the same period of 2024. Benefit from income taxes was $245,400,000 in the fourth quarter, which was primarily driven by $245,900,000 of noncash deferred income tax benefit, partially offset by state tax expenses. Reported net income of $268,100,000 for the fourth quarter compared to $14,300,000 for the same period in 2024. For the full year, cost of product sales was $19,600,000. Total cost and expenses were $168,800,000, compared to $155,100,000 for the full year of 2024.
The increase in cost and expenses was primarily due to increased research and development costs driven by the timing of clinical activities related to R289 and elutacitinib, higher personnel-related costs, and higher cost of product sales. Income before income taxes was $121,800,000 for the year, compared to $18,400,000 for the full year of 2024. Benefit from income taxes was $245,200,000 for the year, which was primarily driven by $245,900,000 of noncash deferred income tax benefit, partially offset by state tax expenses. Reported net income of $367,000,000 for the full year compared to $17,500,000 for the full year of 2024.
We ended the year with cash, cash equivalents, and short-term investments of $155,000,000, compared to $77,300,000 as of the end of 2024. Now for our financial outlook for 2026. We expect total revenue in the range of approximately $275,000,000 to $290,000,000, comprised of approximately $255,000,000 to $265,000,000 in net product sales and $20,000,000 to $25,000,000 of contract revenues. We also anticipate reporting positive net income for the full year while funding existing and new clinical development programs. In closing, 2025 was a year of significant revenue growth and continued financial discipline for Rigel Pharmaceuticals, Inc. We will continue to work towards the key components of our growth strategy as we look to deliver on our financial guidance for 2026.
With that, I would like to turn the call back over to Raul. Raul?
Raul R. Rodriguez: Thank you, Dean. Moving on to slide 31 as we wrap up. Our key strategic objectives for 2026 are clear: grow our commercial business, pursue in-license opportunities to further expand our portfolio and thus enhance cash generation, advance our development pipeline, particularly R289, and maintain financial discipline as we deliver another year of top-line growth and positive net income. We are especially excited about our opportunity for R289. This year includes several anticipated milestones in lower-risk MDS, including dose-expansion phase data expected at the end of the year. In addition, we are evaluating additional opportunities for R289, and we look forward to sharing further updates later in the year.
In closing, the focused execution against our four strategic objectives has driven transformational growth since 2020 and culminated in a record performance in 2025. We believe this momentum positions us well for a strong 2026, as reflected in our financial guidance, and for continued value creation the rest of this decade. We will now open for questions. Operator, we are now ready for questions.
Operator: Thank you. Star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. Thank you. Our first question comes from the line of Joe Pantginis with H.C. Wainwright. Please proceed.
Joe Pantginis: Hey guys, thanks for taking the questions and thanks for all the details. So first, on the approved product growth. When you are looking at TAVALISSE, what do you feel the incremental growth drivers can be here right now since this is a relatively mature product? And then for GAVRETO, the way you described it obviously was a stable contributing product. I guess I would ask my question this way: How are the reintroduction efforts going to be able to look towards potential growth for GAVRETO?
Raul R. Rodriguez: Thank you, Joe. I will ask Dave to comment on those two questions.
David A. Santos: Yes, thanks for the question, Joe. You know, obviously, last year was an incredible year of growth with TAVALISSE. It was our single largest year of growth ever, and, as I said in my prepared remarks, demand was a driver of our growth for all of our products last year. But I will say that was helped by a onetime favorable effect from increased affordability, which means that the elimination of the coverage gap happened last year, and with that came an ability for patients with Medicare Part D to have improved affordability to move on to TAVALISSE.
So that helped certainly last year, but that was a onetime effect, and obviously we will not see that kind of effect happening in future years. But we are going to do what we have always done with TAVALISSE, which is continue to grow new patient starts. Look, Joe, it is a market of more than 14,000 patients in the second-line and later setting. There are a number of treatment options out there, but a lot of doctors treat ITP. And so our goal is to make sure we get to them with the message that TAVALISSE is an outstanding alternative for patients.
They can take this drug, and it can keep their platelet levels where a clinician and the patient want to have them, and they can go on living their life. And so what we try to do is to get that message as far and wide as possible. We have done some things last year that were very good to spread that message, like we even piloted a virtual sales team because that is both efficient and effective in kind of generating messages further than your field team, and we saw some really good results with that.
So those are the kinds of things we are going to focus on in 2026 and beyond to grow new patient starts with TAVALISSE. We think that is really important. And then with GAVRETO, I think as I said, you know, in the prior company's hands, this was about a $28,000,000 to $30,000,000 product, and we generated over $40,000,000 last year. And we think that is just great. It shows—and a big part of our growth, right, was having GAVRETO for a full year versus just a half a year in 2024. Obviously, we are not going to have that advantage in 2026, but it shows how our strategy of in-licensing and acquisition is working.
Advertisement
And so we will do some very targeted efforts there. We think there are some great opportunities with GAVRETO that we are going to continue to do. And, you know, as we have always done, try as hard as we can to continue growing our portfolio sales year over year.
Raul R. Rodriguez: Great.
Joe Pantginis: Appreciate the feedback, thanks. Thank you.
Operator: Next question comes from Yigal Nochomovitz with Citi. Please proceed.
Yigal Nochomovitz: Hi, thank you. I just had a few. I am curious on your decision with regard to the dosing, the 500 QD versus 500 BID. Pros and cons as far as which you would be more comfortable taking forward? You know, do you have a sense as to which would be more likely, on everything you know today? And then anything you can say with respect to BD in terms of getting closer to another asset? I know you obviously are looking at things all the time, and there is a lot to digest in terms of what the right fit is for the business. So if you could just comment as far as how that is going, please?
Thank you.
Raul R. Rodriguez: Thank you, Yigal. I will ask Lisa to comment on the dose, and I will take the BD question.
Lisa Rojkjaer: Thanks, Raul. Thanks for the question, Yigal. So at the time we selected the doses for comparison in dose expansion, and we wanted to be compliant with the FDA's Project OPTIMAT, so do the most robust dose selection possible. We compared the lowest effective dose, which is 500 mg daily, with the highest safe dose at that time, which was 500 mg BID. So I think that we do not really have a preference; we will see what unfolds with the data. One could think that with BID dosing, you may have more tonic suppression of inflammation instead of kind of peaks and troughs.
So that is one factor in favor of the BID potentially, but since both doses were active, as you saw with the ASH data, we are going to wait this one out.
Raul R. Rodriguez: Yigal, on your second question, we are looking at a great number of opportunities out there in hematology/oncology, and we are in a fortunate place that many opportunities out there are in the order of magnitude in terms of the size that would be appropriate for us. And we are evaluating a multitude of opportunities on a constant basis. The difficulty is projecting exactly when one will fall into place and we get to a yes and we sign the deal. But when you have enough balls in the air, one eventually does fall into place. We succeeded in acquiring GAVRETO a couple years ago in 2024, and we succeeded acquiring RESLIDIA a couple years before that in 2022.
So 2026 is a year that we hope to accomplish this. If not, we certainly will make a big effort to try to get it done. Like I said, we are looking for late-stage opportunities that are about ready to launch, that are NDA-ready or NDA-filed, or already approved, where a company of our size and our scale of business could add value to the launch of the product. And there are a number of things out there that look attractive for us. And so we are continuously working towards that, and we will tell you exactly when it is when we have a press release related to this. Okay.
Yigal Nochomovitz: Thank you very much.
Raul R. Rodriguez: Thank you, Yigal.
Operator: Thank you. Our next question comes from the line of Ashley Aker with Piper Sandler. Please proceed.
Ashley Aker: Hi. This is Ashley. I am on for Ally at Piper Sandler. Thanks for the question. So I just had one on R289. So we know you are launching the exploratory study in post-ESA or treatment-naive MDS. We know that this represents a really significant earlier-line population. So can you just remind me what the strategic rationale is for exploring this population now rather than waiting for a registrational trial? And also, what kind of benefit are you aiming to show in this population? Anything that you are able to frame in terms of response rates or durability just to have us thinking about this would be really helpful. Thank you.
Lisa Rojkjaer: Thanks for the question, Ashley. So the reason that we are going to do that is because if you think about the treatment landscape slide that I talked through, we are now in patients that are more heavily pretreated, high transfusion burden. So this is a really unique population where we started compared to the other agents on the market that, for example, is luspatercept and imetelstat. So they generated their data in a patient population that were more or less post-ESA or ineligible for ESA, transfusion-dependent patients. So we started here. We are very encouraged by the data that we are seeing thus far, given the refractory nature of the patients.
And we are optimistic that as we move the drug into an earlier line of therapy, that activity may be even better. So this is in the plans. Once we get the recommended Phase 2 dose, that is why we want to open the cohort of the less heavily pretreated patients to evaluate R289 in that patient population and get some preliminary data.
Raul R. Rodriguez: So on your second question, as Lisa said, the currently approved products have real limitations—luspatercept and imetelstat 38%–40% response rates in fairly early patients; HMAs 18%–20%. That leaves a lot to be desired in terms of products that provide a benefit. And having an agent like R289 that has a very different mechanism than all of those, we think will be a real benefit to patients with low-risk MDS. Already, in very refractory patients, as you heard Lisa, we are at about 33% of the patients tested that are above 500 mg, transfusion-dependent, and evaluable. Now small numbers still, but that is a pretty nice early result in very refractory patients.
So we are optimistic that we could have a benefit that is broader than that, especially if we move earlier and especially given that there is not that attractive a metric out there that we cannot improve on.
Ashley Aker: Got it. Thank you for the color.
Raul R. Rodriguez: Thank you, Ashley.
Operator: Our next question comes from the line of Farzin Haque with Jefferies. Please proceed.
Farzin Haque: Thank you for taking my question. I have a couple. For R289, where are you at with enrollment in the dose-expansion phase? And have there been any challenges in finding patients? And then can you clarify how much follow-up you would need before you meet with the regulators for the path forward? And then quickly on the net product sales guidance, it seems a bit conservative given the growth we saw in 2025. Are there any specific inventory shifts or competitive headwinds or conservative market access assumptions that are factored into this outlook?
Raul R. Rodriguez: Okay, thanks for the question, Farzin. I will take that.
Lisa Rojkjaer: So the enrollment is progressing. As I mentioned, we are aiming to select the recommended Phase 2 dose in the second half of the year, and we are on track to do that. In terms of the follow-up that we would need, as before, to be eligible for evaluation of red cell transfusion independence, the patient should have been treated for at least 16 weeks before we can make that determination. So it is going to be a combined look at PK, safety, and data in terms of recommended Phase 2 dose selection.
David A. Santos: Yes, that is a good question. I will be happy to take that. Listen, as I said, we are just absolutely thrilled that we just grew $87,000,000, generating $232,000,000 last year. And as I said in my prepared remarks, that was driven by demand growth across all the brands, and it was helped by a onetime favorable effect from improved patient affordability during the year and favorable gross-to-net dynamics. And as I just said, you should recall that we had GAVRETO for the full year versus half a year in 2024. And so, you know, we had just a phenomenal year. And you put everything together, and that is what generated $87,000,000, or 60% growth.
So moving to 2026, I am telling you we are really quite pleased to announce that, on top of that really strong and very remarkable growth last year, we are still expecting double-digit growth. So we would not call that a low expectation, but rather a challenging one, given that we are working off of a much higher base now with all three brands, and we do not have that onetime favorable effect of improved affordability, and we will not—We improved gross-to-net so much last year that it is really going to be difficult to have that kind of impact again in 2026. We still work on it, but there are things that are out of your control as well.
So, look, here is what we have to do. We have to drive new patient starts with TAVALISSE, after it just generated its single largest year of growth ever in its history. And we have to, you know, realize this outstanding opportunity we still believe we have with RESLIDIA. And those are big challenges for us as an organization. But we think we have the ability to do that. So, again, I would say we are actually setting high expectations after a very remarkable year, and we will work every single day to try to achieve those expectations. But I certainly would not call them muted by any stretch of the imagination.
Raul R. Rodriguez: I would have to agree with you, Dave. The onetime effects of last year got us to a very different level than we had ever been historically. And this level we are maintaining and building on into this year. It is not going to be the outstanding growth over last year. It is going to be growth in the double digits, but it is not going to be like 60%. That is not the case. The patient affordability helped a lot last year. Though it is still affordable this year, that is beneficial to us. So we are going to maintain those levels of sales and plan to grow those.
One thing I should note is because we got to this level of sales last year, and again this year, it means we are profitable. That is a fantastic place to be, generating cash as a business, and we have a great place to invest that cash in terms of opportunities like R289 that I think are truly transformational.
Farzin Haque: Very helpful. Thank you so much.
Operator: Thank you. Our next question comes from the line of Unknown Analyst with Cantor Fitzgerald. Please proceed.
Unknown Analyst: Hi, thanks for taking the question. Most of them have been asked, but maybe I could just ask one on the sales force. Given the big jump that you have seen in revenue in the last year or so, curious if you have any plans to put the gas on the sales force and expand that even more? Or do you feel by now most of the physicians out there have a pretty good sense of what you are doing and enough touch points? Thank you.
David A. Santos: Yeah. So a great question, Kristen. Listen, we look at the impactability of all of our brands consistently. We look at where we have the most opportunity to grow. And certainly, our sales force has been pivotal to spreading the word about TAVALISSE and RESLIDIA, and making sure people understood that it is now available, that GAVRETO is now available from Rigel Pharmaceuticals, Inc. And so we focus them on where the opportunity is. And certainly, we are constantly looking at whether we are having the right promotional effect out there in the field. But we think we are right-sized. We are calling on the right clinicians. We have a lot of data.
That is one of the areas that we have really improved on over the last several years, but particularly last year. We have really had a strong emphasis on really looking at our data sources and really understanding where the best opportunities are to generate business. And we have even incorporated some very innovative tools to target where that business is. So I think we are well positioned on our sales team to realize the opportunities that are out there. But it is challenging to access clinicians, I will say that over and over again. I mean, our team is superb at it, but it is not easy, and it just gets harder to access clinicians.
So that is why we really focus on where the business opportunity is. If there is an IDH1 patient there, that is where we are going with the RESLIDIA message. And we are really, you know, trying to be very thoughtful about where we can provide impact with a message like that. So to answer your question, we are not looking at expanding the sales organization at this point in time. As a matter of fact, we are looking at ways to make sure we are even more impactful with the resources we have.
Unknown Analyst: Thank you.
David A. Santos: Thank you, Kristen.
Operator: There are no further questions at this time. I would like to pass the call back over to Mr. Raul R. Rodriguez.
Raul R. Rodriguez: Thank you very much, operator. Everyone, thank you for joining us on the call today and for your continued interest in Rigel Pharmaceuticals, Inc. I would also like to take the opportunity to thank our employees for their ongoing dedication. Their innovation, integrity, and steadfast commitment to patients has driven our evolution as a company and has expanded access to important therapies for those living with hematology and oncology conditions. 2025 was a tremendous year for Rigel Pharmaceuticals, Inc., marked by strong growth in our commercial portfolio, advancement of our development pipeline, and a solid financial position.
These traits put us in a favorable and very select position within the biotech industry, and we look forward to updating you on our continued progress. Thank you, and have a good evening.
Operator: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
Should you buy stock in Rigel Pharmaceuticals right now?
Before you buy stock in Rigel Pharmaceuticals, consider this:
The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Rigel Pharmaceuticals wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years.
Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $523,599!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,118,640!*
Now, it’s worth noting Stock Advisor’s total average return is 951% — a market-crushing outperformance compared to 194% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors.
See the 10 stocks »
*Stock Advisor returns as of March 3, 2026.
This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. Parts of this article were created using Large Language Models (LLMs) based on The Motley Fool's insights and investing approach. It has been reviewed by our AI quality control systems. Since LLMs cannot (currently) own stocks, it has no positions in any of the stocks mentioned. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability.
The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.
Source: “AOL Money”
