Rigel Pharmaceuticals Q4 Earnings Call Highlights

Key Points

• Commercial momentum: Rigel reported 2025 net product sales of $232 million, up 60% year-over-year, with a record Q4 of $65.4 million (TAVALISSE $45.6M, GAVRETO $10.2M, REZLIDHIA $9.6M) aided by a Medicare Part D affordability tailwind and favorable gross-to-net dynamics.
• R289 clinical progress: Lead candidate R289 showed early Phase 1b efficacy in lower‑risk MDS (33% transfusion independence among evaluable patients at ≥500 mg), has started a randomized 40‑patient dose‑expansion, and Rigel expects a Phase 2 dose decision in H2 with topline expansion data by year‑end.
• Financials and strategy: A large non‑cash deferred tax benefit drove GAAP net income to $268.1M in Q4 and $367.0M for 2025, Rigel finished the year with $155M in cash and guided 2026 revenue to $275–290M while pursuing late‑stage in‑licensing to expand the portfolio.

Rigel Pharmaceuticals NASDAQ: RIGL detailed record commercial performance for the fourth quarter and full year 2025, while outlining plans to pursue additional in-licensing opportunities and advance its lead pipeline candidate, R289, in lower-risk myelodysplastic syndromes (MDS).

2025 marked a shift to a broader commercial portfolio

Chief Executive Officer Raul Rodriguez said the company has transformed since 2020, when it was a single-product business centered on TAVALISSE for chronic immune thrombocytopenia (ITP). Entering 2026, Rigel now markets three commercial products—TAVALISSE, REZLIDHIA, and GAVRETO—across four approved indications, with a development pipeline led by R289, a dual IRAK1/IRAK4 inhibitor discovered at Rigel.

Rodriguez described the company’s strategy as built on four “interlocking” objectives:

• Grow the commercial business
• Expand the portfolio through in-licensing or acquisition
• Advance the clinical development pipeline
• Maintain financial discipline

Rodriguez also pointed to net product sales growth since 2022 and said Rigel plans to build on momentum from its three marketed products while “selectively pursuing late-stage in-licensing and acquisition opportunities” that could launch by 2028 and complement a potential future launch of R289.

Net product sales rose 60% in 2025; fourth quarter set a record

Chief Commercial Officer Dave Santos reported $232 million in net product sales for full-year 2025, up $87 million, or 60%, versus 2024. Santos said the increase was “primarily driven by increased demand across our portfolio,” including a “one-time favorable effect from increased patient affordability during the year and favorable gross to net dynamics,” partially offset by lower inventory levels.

Fourth-quarter net product sales were a record $65.4 million, up 41% year-over-year. By product in the fourth quarter:

• TAVALISSE: $45.6 million, up 47% year-over-year
• GAVRETO: $10.2 million, up 27% year-over-year
• REZLIDHIA: $9.6 million, up 29% year-over-year

On the call, Santos said TAVALISSE growth in 2025 was aided by a one-time Medicare Part D affordability tailwind related to the “elimination of the coverage gap,” which improved patient affordability and supported uptake. Looking ahead, he said the company’s focus would remain on driving new patient starts in a second-line-and-later ITP setting he described as “more than 14,000 patients,” and noted Rigel piloted a virtual sales team to extend reach efficiently.

For GAVRETO, Santos said Rigel generated over $40 million in 2025 and characterized the product as a stable contributor following the mid-2024 integration, while continuing “very targeted efforts” aimed at growth.

Santos also highlighted $4.4 million in fourth-quarter collaboration revenues tied to international availability of TAVALISSE (marketed as TAVLESSE in Europe) through partners including Grifols, Kissei, and Medison, and said partners continue pursuing approvals in new markets. He added that for REZLIDHIA, partners are advancing the product toward potential regulatory submissions in certain Asian markets and Dr. Reddy’s territory.

R289 Phase 1b data in lower-risk MDS highlighted at ASH; dose expansion underway

Chief Medical Officer Lisa Rojkjaer reviewed progress for R289 in transfusion-dependent lower-risk MDS, describing the disease’s burden and the need for additional therapies. She said R289 has FDA Fast Track designation for previously treated transfusion-dependent lower-risk MDS and Orphan Drug designation for MDS.

Rojkjaer discussed updated Phase 1b dose-escalation results presented at the American Society of Hematology (ASH) meeting, with a data cutoff of Oct. 28. The multicenter, open-label study is evaluating safety, tolerability, pharmacokinetics, and preliminary efficacy, and aims to select a recommended Phase 2 dose.

In the dose-escalation portion, 33 patients were enrolled, with a median age of 75 and a median of three prior therapies; around 70% had received prior luspatercept and hypomethylating agents, and most had high baseline transfusion burden. Rojkjaer said R289 was generally well tolerated, with a low incidence of Grade 3 or 4 cytopenias and infections. One dose-limiting toxicity was reported: a Grade 3/4 AST/ALT increase at the 750 mg daily dose level, with no evidence of dose-dependent toxicity across other dose groups.

Among 18 evaluable patients receiving 500 mg daily or higher, six patients (33%) achieved red cell transfusion independence lasting eight weeks or longer. Rojkjaer said four patients had transfusion independence lasting more than 16 weeks, and three lasted more than six months, with a median duration around 23 weeks (ranging from nine weeks to more than 24 months). Median time to onset was about two months.

For next steps, Rojkjaer said dose expansion will randomize up to 40 transfusion-dependent relapsed/refractory lower-risk MDS patients to 500 mg once daily or 500 mg twice daily, with the first dose-expansion patient dosed in October. Rigel expects to have sufficient data to decide on the recommended Phase 2 dose in the second half of the year and anticipates sharing top-line dose-expansion data by year-end. After dose selection, the company plans to evaluate R289 in a less heavily pretreated cohort relapsed/refractory to or ineligible for erythropoiesis-stimulating agents, and later plans to engage the FDA on a potential registration study.

In Q&A, Rojkjaer said the company chose 500 mg once daily as the “lowest effective dose” and 500 mg twice daily as the “highest safe dose” at the time, aligning with FDA Project Optimus and supporting robust dose selection. She said the company does not yet have a preference between once- and twice-daily dosing and will be guided by the data.

Financial results boosted by non-cash deferred tax benefit; 2026 guidance issued

Chief Financial Officer Dean Schorno reported fourth-quarter total revenue of $69.8 million, consisting of $65.4 million in net product sales and $4.4 million in contract revenues. Contract revenue was primarily driven by $3.4 million from Grifols related to drug supply delivery and earned royalties, plus smaller contributions from Kissei, government contract revenues, and Medison royalties.

Rigel recorded approximately $6 million in cost of product sales in the fourth quarter. Total costs and expenses were $46.6 million, compared with $49.0 million in the prior-year quarter, with Schorno citing increased R&D costs driven by the timing of clinical activities for R289 and olutasidenib, as well as higher personnel-related costs.

Schorno noted a non-recurring income tax benefit in the quarter related to releasing the valuation allowance on the company’s deferred tax asset, which he said was supported by Rigel’s “track record of profitability, projected operating income, and positive outlook.” He emphasized the deferred tax benefit was non-cash and did not affect cash position or day-to-day operating performance.

For the fourth quarter, Rigel reported income before taxes of $22.7 million and a benefit from income taxes of $245.4 million, primarily from a $245.9 million non-cash deferred income tax benefit. Net income for the quarter was $268.1 million, compared with $14.3 million in the prior-year quarter.

For full-year 2025, Rigel reported:

• Cost of product sales: $19.6 million
• Total costs and expenses: $168.8 million (vs. $155.1 million in 2024)
• Income before taxes: $121.8 million (vs. $18.4 million in 2024)
• Benefit from income taxes: $245.2 million
• Net income: $367.0 million (vs. $17.5 million in 2024)
• Cash, equivalents, and short-term investments: $155.0 million at year-end (vs. $77.3 million at the end of 2024)

For 2026, the company guided to total revenue of approximately $275 million to $290 million, including $255 million to $265 million in net product sales and $20 million to $25 million in contract revenues. Management said it expects positive net income for the full year while funding existing and new clinical development programs.

During Q&A, management also reiterated it is evaluating multiple late-stage business development opportunities in hematology and oncology, focusing on NDA-ready, under-review, or already-approved assets that could be launched within the next three years, though it said timing remains difficult to predict.

About Rigel Pharmaceuticals NASDAQ: RIGL

Rigel Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company headquartered in South San Francisco, California. Founded in 2003, Rigel focuses on the discovery, development and commercialization of novel small molecule therapeutics targeting immune, hematologic and oncologic diseases. Leveraging a proprietary chemistry platform and expertise in signal transduction pathways, the company aims to address significant unmet medical needs in both rare and common disorders.

Rigel's lead product, fostamatinib (commercially known as Tavalisse®), is an oral spleen tyrosine kinase (SYK) inhibitor approved in the United States for the treatment of adult patients with chronic immune thrombocytopenia (ITP).

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