Rigel Reports Second Quarter 2025 Financial Results and Provides Business Update
Second quarter 2025 total revenue of approximately $101.7 million, which includes net product sales of $58.9 million and contract revenues from collaborations of $42.7 million
Completed enrollment in the dose escalation part of the ongoing Phase 1b study evaluating R289, a dual IRAK1/4 inhibitor, in patients with R/R lower-risk MDS
Generated $59.6 million of net income in the second quarter of 2025
Updated 2025 Outlook: Total revenue of approximately $270 to $280 million, which includes net product sales of $210 to $220 million
Total revenue and net income are inclusive of $40 million in non-cash contract revenue related to Rigel's agreement with Lilly
Conference call and webcast scheduled today at 4:30 p.m. Eastern Time
SOUTH SAN FRANCISCO, Calif., Aug. 5, 2025 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today reported financial results for the second quarter ended June 30, 2025, including sales of TAVALISSE® (fostamatinib disodium hexahydrate), GAVRETO® (pralsetinib) and REZLIDHIA® (olutasidenib), and recent business progress.
"Our strategic and disciplined approach to building our business has generated another strong quarter for the company. In the second quarter, we grew net product sales by 76% year-over-year, generated $59.6 million in net income and increased our cash balance to $108.4 million. This strong performance has enabled us to raise our 2025 financial guidance," said Raul Rodriguez, Rigel's president and CEO. "We're also excited by the continued advancement of our hematology and oncology development pipeline. In July, we completed enrollment in the dose escalation part of our ongoing Phase 1b study evaluating R289 in patients with relapsed or refractory lower-risk MDS. Later this year, we plan to share updated data from that study and initiate the dose expansion part of the study."
Second Quarter 2025 Business Update
Commercial
Net product sales were $58.9 million, an increase of 76% from the same period of 2024.
Rigel's partner Kissei Pharmaceutical Co., Ltd. (Kissei) announced that its licensing partner, JW Pharmaceutical Corporation, commercially launched TAVALISSE in South Korea in early July.
Corporate
In April, Rigel notified Eli Lilly and Company (Lilly) that it would not exercise its opt-in right related to the development and commercialization of ocadusertib (previously R552) for the treatment of non-central nervous system (CNS) diseases. As a result of the notification, Rigel recognized $40.0 million in non-cash revenue resulting from the release of the remaining cost share liability in the second quarter. Per the agreement with Lilly, Rigel will continue to be entitled to receive milestone and tiered royalty payments on future net sales of ocadusertib and the companies' CNS penetrant program.
Clinical Development
Rigel continues to advance its Phase 1b clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of R2891, a novel and selective dual interleukin receptor-associated kinases 1 and 4 (IRAK1/4) inhibitor, in patients with relapsed or refractory (R/R) lower-risk myelodysplastic syndrome (MDS). Enrollment in the dose escalation part of the study was completed in July. The company expects to share updated data from the study later this year and plans to initiate the dose expansion part of the study in the second half of this year.
Rigel presented 4 posters at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and 3 posters at the European Hematology Association (EHA) 2025 Congress. Presentations included the final data from the GAVRETO (pralsetinib) Phase 1/2 ARROW study in RET fusion-positive non-small cell lung cancer (NSCLC) and other solid tumors, and supportive data for REZLIHDIA (olutasidenib) in patients with mutated isocitrate dehydrogenase-1 (mIDH1) relapsed or refractory (R/R) acute myeloid leukemia (AML).
Key Publications
A paper titled "Effectiveness of Olutasidenib versus Ivosidenib in Patients With Mutated Isocitrate Dehydrogenase 1 Acute Myeloid Leukemia Who Are Relapsed or Refractory to Venetoclax: The 2102-HEM-101 Trial Versus a US Electronic Health Record-Based External Control Arm," was published in June by Catherine Lai, M.D., MPH, lead author and associate professor of Clinical Medicine, Division of Hematology-Oncology, Department of Medicine at University of Pennsylvania, in Leukemia & Lymphoma.
A paper titled "Olutasidenib Alone or Combined with Azacitidine in Patients with Mutant IDH1 Myelodysplastic Syndrome," was published in July by Jorge E. Cortes, M.D., lead author and director, Georgia Cancer Center, Cecil F. Whitaker Jr., GRA Eminent Scholar Chair in Cancer, in Blood Advances. This is the first full report of the safety and clinical activity of an mIDH1 inhibitor plus hypomethylating agent (HMA) combination in patients with treatment-naïve and R/R MDS. The paper showed olutasidenib, alone or in combination with azacitidine, induced a high rate of clinically meaningful complete remission and hematologic improvement responses with durable remission duration, accompanied by low rates of serious treatment-emergent-adverse events in patients with intermediate-, high- or very high-risk MDS harboring mIDH1.
Second Quarter 2025 and Year-to-Date Financial UpdateFor the second quarter ended June 30, 2025, total revenues were $101.7 million, consisting of $58.9 million in net product sales and $42.7 million in contract revenues from collaborations. Net product sales grew 76% compared to $33.5 million in the same period of 2024. TAVALISSE net product sales were $40.1 million, growth of 52% compared to $26.4 million in the same period of 2024. GAVRETO net product sales were $11.8 million compared to $1.9 million in the same period of 2024. GAVRETO became commercially available from Rigel in late June 2024. REZLIDHIA net product sales were $7.0 million, growth of 36% compared to $5.2 million in the same period of 2024. Contract revenues from collaborations primarily consisted of $40.0 million in non-cash revenue resulting from the release of the remaining cost share liability related to the agreement with Lilly for the development and commercialization of ocadusertib, $2.0 million of revenue from Grifols S.A. (Grifols) related to delivery of drug supplies and earned royalties, $0.4 million of revenue from Kissei related to the delivery of drug supplies, and $0.2 million of revenue from Medison Pharma (Medison) related to delivery of drug supplies and earned royalties.
Total costs and expenses were $40.6 million compared to $36.4 million for the same period of 2024. The increase in costs and expenses was mainly due to higher cost of product sales, increased research and development costs driven by the timing of clinical activities related to olutasidenib and R289, and higher personnel-related costs and stock-based compensation expense.
Rigel reported net income of $59.6 million, or $3.33 basic and $3.28 diluted per share, compared to a net loss of $1.0 million, or $0.06 basic and diluted per share, for the same period of 2024.
For the six months ended June 30, 2025, total revenues were $155.0 million, consisting of $102.5 million in net product sales and $52.5 million in contract revenues from collaborations. Net product sales grew 72% compared to $59.5 million in the same period of 2024. TAVALISSE net product sales were $68.5 million, growth of 44% compared to $47.5 million in the same period of 2024. GAVRETO net product sales were $20.8 million compared to $1.9 million in the same period of 2024. GAVRETO became commercially available from Rigel in late June 2024. REZLIDHIA net product sales were $13.1 million, growth of 31% compared to $10.0 million in the same period of 2024. Contract revenues from collaborations primarily consisted of $40.0 million in non-cash revenue resulting from the release of the remaining cost share liability related to the agreement with Lilly for the development and commercialization of ocadusertib, $6.7 million of revenue from Grifols related to delivery of drug supplies and earned royalties, $5.1 million of revenue from Kissei related to a milestone payment and delivery of drug supplies and $0.6 million of revenue from Medison related to delivery of drug supplies and earned royalties.
Total costs and expenses were $81.1 million compared to $72.9 million for the same period of 2024. The increase in costs and expenses was mainly due to higher cost of product sales, increased research and development costs driven by the timing of clinical activities related to olutasidenib and R289, and higher personnel-related costs. These increases were partially offset by decreased stock-based compensation expense primarily from performance-based stock awards.
Rigel reported net income of $71.1 million, or $3.98 basic and $3.91 diluted per share, compared to a net loss of $9.3 million, or $0.53 basic and diluted per share, for the same period of 2024.
Cash, cash equivalents and short-term investments as of June 30, 2025 was $108.4 million, compared to $77.3 million as of December 31, 2024.
2025 OutlookRigel is updating its 2025 total revenue guidance to approximately $270 to $280 million, an increase from the previous range of approximately $200 to $210 million, which includes:
Net product sales of approximately $210 to $220 million, an increase from the previous range of approximately $185 to $192 million.
Contract revenues from collaborations of approximately $60 million, an increase from the previous range of approximately $15 to $18 million.
The company anticipates it will report positive net income for the full year 2025, while funding existing and new clinical development programs.
The above total revenues and contract revenues from collaborations are inclusive of $40 million in non-cash contract revenue related to Rigel's agreement with Lilly.
Conference Call and Webcast with Slides Today at 4:30pm Eastern TimeRigel will hold a live conference call and webcast today at 4:30pm Eastern Time (1:30pm Pacific Time).
Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.
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