Full Press Release Details
SOUTH SAN FRANCISCO, Calif.,Nov. 4, 2025/PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today reported financial results for the third quarter ended September 30, 2025, including sales of TAVALISSE®(fostamatinib disodium hexahydrate), GAVRETO®(pralsetinib) and REZLIDHIA®(olutasidenib), and recent business progress.
"Our strong third-quarter performance demonstrates our strategic focus on commercial execution, pipeline development, and financial discipline. We are raising our full-year 2025 guidance due to our outstanding commercial performance year-to-date," said Raul Rodriguez, Rigel's president and CEO. "Our development pipeline continues to advance, including our ongoing Phase 1b study evaluating R289 for the treatment of patients with lower-risk MDS. With enrollment complete in the dose escalation phase of the study, we look forward to presenting updated data in an oral presentation at ASH in December. We're also excited to have reached the next milestone of this program with the initiation of the dose expansion phase of the study."
Third Quarter 2025 Business Update
Commercial
Clinical Development
Corporate
Third Quarter 2025 and Year-to-Date Financial UpdateFor the third quarter ended September 30, 2025, total revenues were $69.5 million, consisting of $64.1 million in net product sales and $5.4 million in contract revenues from collaborations. Net product sales grew 65% compared to $38.9 million in the same period of 2024. TAVALISSE net product sales were $44.7 million, growth of 70% compared to $26.3 million in the same period of 2024. GAVRETO net product sales were $11.1 million, growth of 56% compared to $7.1 million in the same period of 2024. REZLIDHIA net product sales were $8.3 million, growth of 50% compared to $5.5 million in the same period of 2024. Contract revenues from collaborations primarily consisted of $3.1 million of revenue from Grifols S.A. (Grifols) related to delivery of drug supplies and earned royalties, $1.8 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 $41.0 million compared to $41.3 million for the same period of 2024. The decrease in costs and expenses was mainly due to lower cost of product sales, as the prior period included a sublicensing fee. This decrease was partially offset by increased research and development costs driven by the timing of clinical activities related to olutasidenib and R289 and higher personnel-related costs.
Rigel reported net income of $27.9 million, or $1.55 basic and $1.46 diluted per share, compared to $12.4 million, or $0.71 basic and $0.70 diluted per share, for the same period of 2024.
For the nine months ended September 30, 2025, total revenues were $224.5 million, consisting of $166.6 million in net product sales and $57.9 million in contract revenues from collaborations. Net product sales grew 69% compared to $98.4 million in the same period of 2024. TAVALISSE net product sales were $113.3 million, growth of 54% compared to $73.8 million in the same period of 2024. GAVRETO net product sales were $31.9 million, growth of 252% compared to $9.0 million in the same period of 2024. GAVRETO became commercially available from Rigel in late June 2024. REZLIDHIA net product sales were $21.4 million, growth of 38% compared to $15.6 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, $9.9 million of revenue from Grifols related to delivery of drug supplies and earned royalties, $6.9 million of revenue from Kissei related to a milestone payment and delivery of drug supplies and $0.8 million of revenue from Medison related to delivery of drug supplies and earned royalties.
Total costs and expenses were $122.2 million compared to $114.1 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.
Rigel reported net income of $99.0 million, or $5.52 basic and $5.38 diluted per share, compared to $3.1 million, or $0.18 basic and diluted per share, for the same period of 2024.
Cash, cash equivalents and short-term investments as of September 30, 2025 was $137.1 million, compared to $77.3 million as of December 31, 2024.
2025 OutlookRigel is updating its 2025 total revenue guidance to approximately $285 to $290 million, an increase from the previous range of approximately $270 to $280 million, which includes:
The company anticipates it will report positive net income for the full year 2025, while funding existing and new clinical development programs.
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 atwww.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.
About ITPIn patients with immune thrombocytopenia (ITP), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. Patients suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.
About NSCLCIt is estimated that over 226,000 adults in the U.S. will be diagnosed with lung cancer in 2025. Lung cancer is the leading cause of cancer death in the U.S, with non-small cell lung cancer (NSCLC) being the most common type accounting for 85-90% of all lung cancer diagnoses.2RET fusions are implicated in approximately 1-2% of patients with NSCLC.3
About AMLAcute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that there will be about 22,010 new cases in the United States, most in adults, in 2025.4
Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.5,6Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.7Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need.
About TAVALISSE®TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
Please clickherefor Important Safety Information and Full Prescribing Information for TAVALISSE.
About GAVRETO®GAVRETO is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).*
*Thyroid indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
Please clickherefor Important Safety Information and Full Prescribing Information for GAVRETO.
About REZLIDHIA®REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.
Please clickherefor Important Safety Information and Full Prescribing Information, including Boxed WARNING, for REZLIDHIA.
To report side effects of prescription drugs to the FDA, visitwww.fda.gov/medwatchor call 1-800-FDA-1088 (800-332-1088).
TAVALISSE, GAVRETO and REZLIDHIA are registered trademarks of Rigel Pharmaceuticals, Inc.
About RigelRigel Pharmaceuticals, Inc. (Nasdaq:RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San Francisco, California. For more information on Rigel, the Company's marketed products and pipeline of potential products, visitwww.rigel.com.
Forward Looking StatementsThis press release contains forward-looking statements relating to, among other things, expected commercial and financial results, increased projections of financial performance and outlook for 2025, expectations for growing ourcommercial business, continued enrollment of our R289 study, presentation of study data, development ofocadusertib,expectation of clinical outcomes,continued ability for developing and commercializing TAVALISSE, GAVRETO, and REZLIDHIA domestically and in certain international markets, and expectations for Rigel's partnering and collaboration efforts. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements can be identified by words such as "anticipates", "plan", "outlook", "potential", "may", "look to", "expects", "will", "initial", "promising", and similar expressions in reference to future periods. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Rigel's current beliefs, expectations, and assumptions and hence they inherently involve significant risks, uncertainties and changes in circumstances that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of fostamatinib, olutasidenib and pralsetinib; risks that the FDA, European Medicines Agency, PMDA or other regulatory authorities may make adverse decisions regarding fostamatinib, pralsetinib, ocadusertibor olutasidenib; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that fostamatinib, pralsetinib, ocadusertibor olutasidenib may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended June 30,2025 and subsequent filings. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. Rigel does not undertake any obligation to update forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law.
Contact for Investors & Media:
Investors:Rigel Pharmaceuticals, Inc.650.624.1232[email protected]
Media:David RosenArgot Partners646.461.6387[email protected]
| RIGEL PHARMACEUTICALS, INC. | ||||||||
| STATEMENTS OF OPERATIONS | ||||||||
| (in thousands, except per share amounts) | ||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||
| 2025 | 2024 | 2025 | 2024 | |||||
| (unaudited) | ||||||||
| Revenues: | ||||||||
| Product sales, net | $ 64,067 | $ 38,927 | $ 166,565 | $ 98,380 | ||||
| Contract revenues from collaborations | 5,395 | 16,380 | 57,915 | 23,302 | ||||
| Total revenues | 69,462 | 55,307 | 224,480 | 121,682 | ||||
| Costs and expenses: | ||||||||
| Cost of product sales | 4,753 | 8,026 | 13,666 | 12,858 | ||||
| Research and development (see Note A) | 7,353 | 6,182 | 22,610 | 17,748 | ||||
| Selling, general and administrative (see Note A) | 28,936 | 27,043 | 85,908 | 83,539 | ||||
| Total costs and expenses | 41,042 | 41,251 | 122,184 | 114,145 | ||||
| Income from operations | 28,420 | 14,056 | 102,296 | 7,537 | ||||
| Interest income | 1,094 | 425 | 2,438 | 1,570 | ||||
| Interest expense | (1,894) | (2,060) | (5,621) | (5,963) | ||||
| Income before income taxes | 27,620 | 12,421 | 99,113 | 3,144 | ||||
| (Benefit from) provision for income taxes | (280) | — | 154 | — | ||||
| Net income | $ 27,900 | $ 12,421 | $ 98,959 | $ 3,144 | ||||
| Net income per share | ||||||||
| Basic | $ 1.55 | $ 0.71 | $ 5.52 | $ 0.18 | ||||
| Diluted | $ 1.46 | $ 0.70 | $ 5.38 | $ 0.18 | ||||
| Weighted average shares used in computing net income per share | ||||||||
| Basic | 18,038 | 17,600 | 17,912 | 17,556 | ||||
| Diluted | 19,156 | 17,648 | 18,379 | 17,599 | ||||
| Note A | ||||||||
| Stock-based compensation expense included in: | ||||||||
| Selling, general and administrative | $ 2,961 | $ 2,360 | $ 8,172 | $ 9,067 | ||||
| Research and development | 402 | 284 | 1,791 | 1,239 | ||||
| $ 3,363 | $ 2,644 | $ 9,963 | $ 10,306 |
| SUMMARY BALANCE SHEET DATA | ||||||||
| (in thousands) | ||||||||
| As of September 30, | As of December 31, | |||||||
| 2025 | 2024(1) | |||||||
| (unaudited) | ||||||||
| Cash, cash equivalents and short-term investments | $ 137,143 | $ 77,321 | ||||||
| Total assets | 242,534 | 163,976 | ||||||
| Stockholders' equity | 117,609 | 3,288 | ||||||
| (1) | Derived from audited financial statements |