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Rigel Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

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Rigel Pharmaceuticals (RIGL) reported strong financial results for Q4 and full year 2024. Q4 total revenue reached $57.6 million, including TAVALISSE sales of $31.0M, REZLIDHIA sales of $7.4M, and GAVRETO sales of $8.1M.

Full year 2024 revenue totaled $179.3 million, with TAVALISSE sales at $104.8M (12% growth), REZLIDHIA at $23.0M (118% growth), and GAVRETO at $17.1M. The company achieved its first full-year net income of $17.5 million, with cash reserves increasing by over $20M.

Notable developments include R289 receiving FDA Fast Track designation for treating previously-treated transfusion dependent lower-risk MDS and Orphan Drug designation for MDS treatment. For 2025, Rigel projects total revenue of $200-210 million, including net product sales of $185-192M and contract revenues of $15-18M, expecting continued profitability.

Rigel Pharmaceuticals (RIGL) ha riportato risultati finanziari solidi per il quarto trimestre e per l'intero anno 2024. Nel quarto trimestre, il fatturato totale ha raggiunto 57,6 milioni di dollari, includendo le vendite di TAVALISSE per 31,0 milioni di dollari, le vendite di REZLIDHIA per 7,4 milioni di dollari e le vendite di GAVRETO per 8,1 milioni di dollari.

Il fatturato totale per l'intero anno 2024 è stato di 179,3 milioni di dollari, con le vendite di TAVALISSE a 104,8 milioni di dollari (crescita del 12%), REZLIDHIA a 23,0 milioni di dollari (crescita del 118%) e GAVRETO a 17,1 milioni di dollari. L'azienda ha raggiunto il suo primo utile netto annuale di 17,5 milioni di dollari, con riserve di liquidità in aumento di oltre 20 milioni di dollari.

Sviluppi notevoli includono il riconoscimento da parte della FDA della designazione Fast Track per R289 per il trattamento di MDS a basso rischio dipendente da trasfusioni precedentemente trattati e la designazione di Farmaco Orfano per il trattamento di MDS. Per il 2025, Rigel prevede un fatturato totale di 200-210 milioni di dollari, incluse vendite nette di prodotti per 185-192 milioni di dollari e ricavi da contratti di 15-18 milioni di dollari, con aspettative di continua redditività.

Rigel Pharmaceuticals (RIGL) informó resultados financieros sólidos para el cuarto trimestre y el año completo 2024. En el cuarto trimestre, los ingresos totales alcanzaron 57.6 millones de dólares, incluyendo ventas de TAVALISSE por 31.0 millones de dólares, ventas de REZLIDHIA por 7.4 millones de dólares y ventas de GAVRETO por 8.1 millones de dólares.

Los ingresos totales para el año completo 2024 fueron de 179.3 millones de dólares, con ventas de TAVALISSE de 104.8 millones de dólares (crecimiento del 12%), REZLIDHIA de 23.0 millones de dólares (crecimiento del 118%) y GAVRETO de 17.1 millones de dólares. La compañía logró su primer ingreso neto anual de 17.5 millones de dólares, con reservas de efectivo aumentando en más de 20 millones de dólares.

Desarrollos notables incluyen la designación de Fast Track por parte de la FDA para R289 en el tratamiento de MDS de bajo riesgo dependiente de transfusiones previamente tratados y la designación de Medicamento Huérfano para el tratamiento de MDS. Para 2025, Rigel proyecta ingresos totales de 200-210 millones de dólares, incluyendo ventas netas de productos de 185-192 millones de dólares y ingresos por contratos de 15-18 millones de dólares, esperando continuar siendo rentable.

리겔 제약 (RIGL)은 2024년 4분기 및 전체 연도에 대한 강력한 재무 결과를 보고했습니다. 4분기 총 수익은 5760만 달러에 달하며, 여기에는 TAVALISSE 판매가 3100만 달러, REZLIDHIA 판매가 740만 달러, GAVRETO 판매가 810만 달러 포함됩니다.

2024년 전체 연도 수익은 1억 7930만 달러에 달하며, TAVALISSE 판매는 1억 480만 달러(12% 성장), REZLIDHIA는 2300만 달러(118% 성장), GAVRETO는 1710만 달러입니다. 이 회사는 1750만 달러의 첫 연간 순이익을 달성하였고, 현금 보유고는 2000만 달러 이상 증가했습니다.

주목할 만한 발전으로는 R289가 FDA의 패스트트랙 지정을 받아 이전에 치료받은 수혈 의존 저위험 MDS 치료를 위해 승인되었고, MDS 치료를 위한 희귀의약품 지정을 받았습니다. 2025년을 위해 리겔은 총 수익을 2억~2억 1000만 달러로 예상하고 있으며, 여기에는 순 제품 판매 1억 8500만~1억 9200만 달러와 계약 수익 1500만~1800만 달러가 포함되며, 지속적인 수익성을 기대하고 있습니다.

Rigel Pharmaceuticals (RIGL) a annoncé des résultats financiers solides pour le quatrième trimestre et l'année entière 2024. Au quatrième trimestre, le chiffre d'affaires total a atteint 57,6 millions de dollars, y compris les ventes de TAVALISSE de 31,0 millions de dollars, les ventes de REZLIDHIA de 7,4 millions de dollars et les ventes de GAVRETO de 8,1 millions de dollars.

Le chiffre d'affaires total pour l'année 2024 s'est élevé à 179,3 millions de dollars, avec des ventes de TAVALISSE à 104,8 millions de dollars (croissance de 12 %), REZLIDHIA à 23,0 millions de dollars (croissance de 118 %) et GAVRETO à 17,1 millions de dollars. L'entreprise a réalisé son premier bénéfice net annuel de 17,5 millions de dollars, avec des réserves de liquidités augmentant de plus de 20 millions de dollars.

Parmi les développements notables, R289 a reçu la désignation Fast Track de la FDA pour le traitement de MDS à faible risque dépendant des transfusions précédemment traitées et la désignation de médicament orphelin pour le traitement de MDS. Pour 2025, Rigel prévoit un chiffre d'affaires total de 200-210 millions de dollars, y compris des ventes nettes de produits de 185-192 millions de dollars et des revenus de contrats de 15-18 millions de dollars, s'attendant à une rentabilité continue.

Rigel Pharmaceuticals (RIGL) hat starke Finanzergebnisse für das vierte Quartal und das gesamte Jahr 2024 berichtet. Im vierten Quartal erreichten die Gesamterlöse 57,6 Millionen Dollar, einschließlich TAVALISSE-Verkäufen von 31,0 Millionen Dollar, REZLIDHIA-Verkäufen von 7,4 Millionen Dollar und GAVRETO-Verkäufen von 8,1 Millionen Dollar.

Die Gesamterlöse für das Jahr 2024 beliefen sich auf 179,3 Millionen Dollar, wobei die TAVALISSE-Verkäufe bei 104,8 Millionen Dollar (12% Wachstum), REZLIDHIA bei 23,0 Millionen Dollar (118% Wachstum) und GAVRETO bei 17,1 Millionen Dollar lagen. Das Unternehmen erzielte sein erstes Nettojahresergebnis von 17,5 Millionen Dollar, wobei die Barreserven um über 20 Millionen Dollar zunahmen.

Bemerkenswerte Entwicklungen umfassen die FDA-Fast-Track-Designation für R289 zur Behandlung von zuvor behandelten transfusionsabhängigen niedrigrisikogenen MDS und die Orphan-Drug-Designation für die Behandlung von MDS. Für 2025 prognostiziert Rigel Gesamterlöse von 200-210 Millionen Dollar, einschließlich Nettoproduktverkäufen von 185-192 Millionen Dollar und Vertragsumsätzen von 15-18 Millionen Dollar, mit der Erwartung einer anhaltenden Rentabilität.

Positive
  • First-time full-year net income of $17.5M in 2024
  • Record net product sales of $144.9M, up 39% YoY
  • Cash balance increased by $20M
  • REZLIDHIA sales grew 118% to $23.0M
  • TAVALISSE sales grew 12% to $104.8M
Negative
  • Higher costs and expenses at $155.1M vs $137.4M in 2023
  • Increased research and development costs in Q4

Insights

Rigel Pharmaceuticals has delivered exceptional financial results for Q4 and full-year 2024, achieving multiple significant milestones. The company reported total revenue of $179.3 million for 2024, with its commercial portfolio demonstrating robust growth across all three products. Most notably, Rigel achieved profitability for the first time, reporting net income of $17.5 million for the year compared to a $25.1 million loss in 2023.

The commercial execution has been particularly impressive with TAVALISSE net sales growing 21% in Q4 and REZLIDHIA showing remarkable 92% growth compared to the same period last year. The addition of GAVRETO in June 2024 establishes a three-product commercial portfolio, providing revenue diversification that strengthens the company's financial foundation.

The most telling financial indicator is Rigel's ability to increase its cash position by over $20 million during 2024, ending with $77.3 million in cash and investments. This cash generation without equity dilution represents a fundamental inflection point in Rigel's business model, allowing simultaneous investment in pipeline advancement while maintaining profitability.

The 2025 revenue guidance of $200-210 million suggests continued strong growth of approximately 11-17%. Management's explicit projection of continued profitability while funding development programs indicates confidence in the commercial portfolio's momentum and operational efficiency.

Strategic business development, including the Dr. Reddy's licensing agreement for REZLIDHIA and international approvals in Korea and Mexico through partners, creates additional revenue streams through upfront payments, potential milestones, and royalties while expanding global market reach.

Rigel's clinical development strategy shows methodical progress across multiple blood cancer and disorder programs. The FDA's granting of both Fast Track and Orphan Drug designations for R289 in lower-risk MDS represents significant regulatory validation for this novel dual IRAK1/4 inhibitor program. The advancement to a sixth dose level (500mg twice daily) in the Phase 1b study indicates favorable safety that supports dose escalation.

The preliminary efficacy data presented at ASH demonstrated promising activity in heavily pretreated, high transfusion burden MDS patients, a population with treatment options. This positions R289 as a potentially valuable addition to the MDS treatment landscape if later-stage trials confirm these early signals.

Olutasidenib's inclusion in the NCCN guidelines for Myelodysplastic Syndromes represents important recognition by the leading authority in oncology treatment standards. The recommended use across multiple treatment algorithms for both lower-risk and higher-risk disease expands the potential patient population beyond the currently approved AML indication.

The strategic development alliance with MD Anderson Cancer Center creates a powerful combination of scientific expertise and clinical resources focused on understanding olutasidenib's potential across mIDH1-positive malignancies. The four now-enrolling studies examining various disease states could significantly expand therapeutic applications.

The initiation of the pediatric/young adult TarGet-D study for IDH1-mutated high-grade glioma addresses an important unmet need in a difficult-to-treat patient population. The publication of the 3-year Japanese data for fostamatinib in ITP confirming durable responses provides valuable long-term safety and efficacy evidence supporting chronic use.

  • Fourth quarter 2024 total revenue of approximately $57.6 million, which includes TAVALISSE® net product sales of $31.0 million, REZLIDHIA® net product sales of $7.4 million and GAVRETO® net product sales of $8.1 million
  • 2024 total revenue of approximately $179.3 million, which includes TAVALISSE® net product sales of $104.8 million, REZLIDHIA® net product sales of $23.0 million and GAVRETO® net product sales of $17.1 million
  • R289 granted Fast Track designation for the treatment of previously-treated transfusion dependent lower-risk MDS and Orphan Drug designation for the treatment of MDS by the FDA
  • 2025 Outlook: Total revenue of approximately $200 to $210 million
  • Conference call and webcast scheduled today at 4:30 p.m. Eastern Time

SOUTH SAN FRANCISCO, Calif., March 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 fourth quarter and full year ended December 31, 2024, including sales of TAVALISSE® (fostamatinib disodium hexahydrate) for the treatment of chronic immune thrombocytopenia (ITP); REZLIDHIA® (olutasidenib) for the treatment of relapsed or refractory (R/R) mutated isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML); and GAVRETO® (pralsetinib) for the treatment of metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) and advanced or metastatic thyroid cancer, and recent business progress.

"2024 was a year of significant accomplishments for Rigel. We continued to focus on commercial expansion and execution, achieving record net product sales of $144.9 million, an increase of 39% compared to 2023. Coupled with Rigel's commitment to financial discipline, for the first time we generated full-year net income of more than $17 million and increased our cash balances by more than $20 million," said Raul Rodriguez, Rigel's president and CEO. "These outstanding commercial and financial results provide us the resources to advance our promising internal development programs in 2025, including our ongoing Phase 1b clinical study of R289 for the treatment of lower-risk MDS and the initiation of a Phase 2 clinical study of olutasidenib for the treatment of recurrent glioma."

Business Update

Commercial

  • Commercial strength continued in the fourth quarter for all products with record bottles shipped to patients and clinics and total bottles sold.
  • The following table summarizes total bottles shipped for the fourth quarter:

TAVALISSE

REZLIDHIA

GAVRETO*

Bottles shipped to patients and clinics

2,855

503

874

Change in bottles remaining in distribution channel

317

62

64

Total bottles shipped

3,172

565

938


*GAVRETO bottle count represents 60-count bottle equivalent


  • Rigel's partner Kissei Pharmaceutical Co., Ltd. (Kissei) announced in January that The Korean Ministry of Food and Drug Safety approved TAVALISSE for the treatment of thrombocytopenia in adult patients with chronic idiopathic thrombocytopenic purpura who have had an insufficient response to a previous treatment. In the first quarter of 2025, Rigel will recognize a $3.0 million regulatory milestone earned from Kissei in connection with the approval.
  • In December, Rigel's partner Knight Therapeutics announced Mexico's Comisión Federal para la Protección contra Riesgos Sanitarios approved TAVALISSE for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.
  • Rigel entered into an exclusive license agreement with Dr. Reddy's Laboratories Ltd. (Dr. Reddy's) in November to develop and commercialize REZLIDHIA in all potential indications throughout Dr. Reddy's territory, which includes Latin America, South Africa, certain countries in the Commonwealth of Independent States (CIS), India, certain countries in Southeast Asia and North Africa, Australia and New Zealand. Rigel received an upfront cash payment of $4.0 million with the potential for up to $36.0 million in future regulatory and commercial milestone payments.

Clinical Development

  • R2891, a novel and selective dual IRAK1/4 inhibitor, has been granted Fast Track designation for the treatment of previously-treated transfusion dependent lower-risk MDS and Orphan Drug designation for the treatment of MDS by the U.S. Food and Drug Administration (FDA).
  • Rigel continues to advance its Phase 1b clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of R289 in patients with relapsed or refractory (R/R) lower-risk myelodysplastic syndrome (MDS). Enrollment in the fifth dose level (500mg / 250mg split dose) is complete and the new sixth dose level (500 mg twice daily) is now open for enrollment.
  • Rigel presented initial data from the ongoing Phase 1b clinical study of R289 at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition in December, demonstrating that R289 was generally well tolerated with preliminary signs of efficacy in this heavily pretreated R/R lower-risk MDS patient population, the majority of whom were high transfusion burden (HTB) at baseline. Also at the ASH Annual Meeting, four posters were presented on olutasidenib, which included data that adds to the growing body of evidence supporting the benefits of its use in patients with mIDH1 AML.
  • CONNECT, an international collaborative network of pediatric cancer centers, in collaboration with Rigel, opened for enrollment the "TarGet-D" study, a Phase 2 study (NCT06161974) evaluating olutasidenib in combination with temozolomide, followed by olutasidenib monotherapy, as maintenance therapy for newly diagnosed adolescent and young adult patients (ages 12 to 39 years) with a high-grade glioma (HGG) harboring an IDH1 mutation.
  • Rigel and The University of Texas MD Anderson Cancer Center (MD Anderson) have now opened for enrollment the four studies outlined in the multi-year strategic development alliance. Olutasidenib will be studied in disease areas where mIDH1 can play a role, including AML; higher-risk MDS, chronic myelomonocytic leukemia (CMML) and advanced myeloproliferative neoplasms (MPN); clonal cytopenia of undetermined significance (CCUS) and lower-risk MDS/CMML; and as post-transplant maintenance therapy.
  • In November, the National Comprehensive Cancer Network® (NCCN®) added olutasidenib to the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myelodysplastic Syndromes. Olutasidenib was added as a recommended option to the following treatment algorithms: Management of Lower-Risk Disease, Management of Lower-Risk Disease - Evaluation of Related Anemia and Management of Higher-Risk Disease, and was recommended as NCCN Category 2B in all circumstances. If mIDH1 positive, olutasidenib was either recommended as a single agent, in combination with azacitidine, or both.*

*NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Publication Highlights

  • A paper titled "Long‑term safety and efficacy of fostamatinib in Japanese patients with primary immune thrombocytopenia," was published in January by Masataka Kuwana, M.D., Ph.D., professor and chairman of the Department of Allergy and Rheumatology at Nippon Medical School Graduate School of Medicine in the International Journal of Hematology. The paper reported the 3-year safety and efficacy data from the Phase 3 trial of fostamatinib in Japanese patients with ITP, which included no new safety signals and a sustained platelet response during treatment.
  • A paper titled "Olutasidenib in combination with azacitidine induces durable complete remissions in patients with relapsed or refractory mIDH1 acute myeloid leukemia: a multicohort open-label phase 1/2 trial," was published in January by Jorge E. Cortes, M.D., Director, Georgia Cancer Center, Cecil F. Whitaker Jr., GRA Eminent Scholar Chair in Cancer, and Phase 2 trial investigator, in the Journal of Hematology and Oncology.
  • A paper titled "Olutasidenib demonstrates significant clinical activity in mutated IDH1 acute myeloid leukaemia arising from a prior myeloproliferative neoplasm," was published in December by Stéphane de Botton, M.D., Ph.D., head of translational research in hematology, Institut Gustave Roussy, France, in the British Journal of Haematology.

Fourth Quarter and Full Year 2024 Financial Update
For the fourth quarter ended December 31, 2024, total revenues were $57.6 million, consisting of $31.0 million in TAVALISSE net product sales, $7.4 million in REZLIDHIA net product sales, $8.1 million in GAVRETO net product sales, and $11.1 million in contract revenue from collaborations. TAVALISSE net product sales grew 21% compared to $25.7 million in the same period of 2023. REZLIDHIA net product sales grew 92% compared to $3.9 million in the same period of 2023. GAVRETO became commercially available from Rigel in June 2024. Contract revenue from collaborations primarily consisted of a $4.0 million upfront cash payment from Dr. Reddy's; $3.6 million of revenue from Grifols S.A. (Grifols) related to delivery of drug supplies and earned royalties; $2.9 million of revenue from Kissei Pharmaceutical Co., Ltd. (Kissei) related to delivery of drug supplies; and $0.3 million of revenue from Medison Pharma Trading AG (Medison) related to delivery of drug supplies and earned royalties.

Total costs and expenses were $40.9 million compared to $33.8 million for the same period of 2023. The increase in costs and expenses was mainly due to higher research and development costs driven by timing of clinical activities, increased personnel-related costs and increased commercial-related activities. In addition, cost of product sales increased, driven primarily by increased products sales, higher royalties and a sublicensing revenue fee, and higher amortization of intangible assets.

Rigel reported net income of $14.3 million, or $0.81 basic and $0.80 diluted per share, compared to a net income of $0.7 million, or $0.04 basic and diluted per share, for the same period of 2023. The basic and diluted share and per share amounts for the prior period have been restated to reflect the 1-for-10 reverse stock split effected on June 27, 2024 on a retroactive basis.

For the full year 2024, total revenues were $179.3 million, consisting of $104.8 million in TAVALISSE net product sales, $23.0 million in REZLIDHIA net product sales, $17.1 million in GAVRETO net product sales, and $34.4 million in contract revenue from collaborations. TAVALISSE net product sales grew 12% compared to $93.7 million in the same period of 2023. REZLIDHIA net product sales grew 118% compared to $10.6 million in the same period of 2023. As mentioned above, GAVRETO became commercially available from Rigel in June 2024. Contract revenue from collaborations primarily consisted of $20.4 million from Kissei related to an upfront fee from sublicensing olutasidenib and delivery of drug supplies; $9.1 million from Grifols and $0.5 million from Medison related to delivery of drug supplies and earned royalties; and $4.0 million from Dr. Reddy's related to an upfront fee from sublicensing olutasidenib.

Total costs and expenses were $155.1 million compared to $137.4 million for the same period of 2023. The increase in costs and expenses was mainly due to higher cost of product sales driven primarily by increased products sales, sublicensing revenue fees and increased royalties and amortization of intangible assets. In addition, there were increases in personnel-related costs, stock-based compensation expense and commercial-related expenses. These increases were partially offset by decreased research and development costs due to the timing of clinical trial activities related to R289, Rigel's dual IRAK 1/4 inhibitor program, as well as reduced trial activities related to the completed Phase 3 clinical trial of fostamatinib in patients with warm antibody hemolytic anemia (wAIHA).

Rigel reported net income of $17.5 million, or $0.99 basic and diluted per share, compared to a net loss of $25.1 million, or $1.44 basic and diluted per share, for the same period of 2023. As discussed above, the share and per share amounts have been restated to reflect the 1-for-10 reverse stock split on a retroactive basis for the respective periods presented.

Cash, cash equivalents and short-term investments as of December 31, 2024 was $77.3 million, compared to $61.1 million as of September 30, 2024 and $56.9 million as of December 31, 2023.

2025 Outlook

Rigel anticipates 2025 total revenue of approximately $200 to $210 million, including:

  • Net product sales of approximately $185 to $192 million.
  • Contract revenues from collaborations 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.

Conference Call and Webcast with Slides Today at 4:30pm Eastern Time
Rigel 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.

About ITP
In 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 AML
Acute 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 2025.2

Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.3 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.4 Quality 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 NSCLC
It 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.5 RET fusions are implicated in approximately 1-2% of patients with NSCLC.6

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 click here for Important Safety Information and Full Prescribing Information for TAVALISSE.

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 click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING, for REZLIDHIA.

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 click here for Important Safety Information and Full Prescribing Information for GAVRETO.

To report side effects of prescription drugs to the FDA, www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

TAVALISSE, REZLIDHIA and GAVRETO are registered trademarks of Rigel Pharmaceuticals, Inc.

About Rigel
Rigel 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, visit www.rigel.com.

  1. R289 is an investigational compound not approved by the FDA.
  2. The American Cancer Society. Key Statistics for Acute Myeloid Leukemia (AML). Revised January 16, 2025. Accessed January 31, 2025: https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html
  3. Leukaemia Care. Relapse in Acute Myeloid Leukaemia (AML). Version 3. Reviewed October 2021. Accessed January 31, 2025: https://media.leukaemiacare.org.uk/wp-content/uploads/Relapse-in-Acute-Myeloid-Leukaemia-AML-Web-Version.pdf
  4. Thol F, Schlenk RF, Heuser M, Ganser A. How I treat refractory and early relapsed acute myeloid leukemia. Blood (2015) 126 (3): 319-27. Accessed January 31, 2025. doi: https://doi.org/10.1182/blood-2014-10-551911
  5. The American Cancer Society. Key Statistics for Lung Cancer. Revised January 16, 2025. Accessed January 31, 2025: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html
  6. Kato, S. et al. RET Aberrations in Diverse Cancers: Next-Generation Sequencing of 4,871 Patients. Clin Cancer Res. 2017;23(8):1988-1997 doi: 10.1158/1078-0432.CCR-16-1679

Forward Looking Statements
This press release contains forward-looking statements relating to, among other things, expected commercial and financial results for the fourth quarter and year ended December 31, 2024, projected financial performance and outlook for 2025, expectations to grow and advance our commercial portfolio and hematology and oncology pipeline, results of our study of R289 in lower-risk MDS including safety and efficacy data, continued ability for developing and commercializing TAVALISSE, REZLIDHIA, and GAVRETO 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 or olutasidenib; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that fostamatinib, pralsetinib or 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 September 30, 2024 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
ir@rigel.com 

Media:
David Rosen
Argot Partners
646.461.6387
david.rosen@argotpartners.com

Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

 

RIGEL PHARMACEUTICALS, INC.

STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)





















Three Months Ended December 31,


Year Ended December 31, 



2024


2023


2024


2023



(unaudited)





Revenues:









Product sales, net

$        46,522


$ 29,539


$ 144,902


$ 104,294


Contract revenues from collaborations 

11,074


6,153


34,376


11,488


Government contract


100



1,100


Total revenues

57,596


35,792


179,278


116,882

Costs and expenses:









Cost of product sales

5,789


3,790


18,647


7,110


Research and development (see Note A)  

5,632


3,186


23,380


24,522


Selling, general and administrative (see Note A)

29,520


26,850


113,059


105,741


     Total costs and expenses

40,941


33,826


155,086


137,373

Income (loss) from operations 

16,655


1,966


24,192


(20,491)


Interest income 

522


678


2,092


2,272


Interest expense

(1,955)


(1,907)


(7,918)


(6,872)

Income (loss) before income taxes

15,222


737


18,366


(25,091)

Provision for income taxes

881


-


881


-

Net income (loss)

$        14,341


$      737


$   17,485


$ (25,091)










Net income (loss) per share (1)









Basic

$            0.81


$     0.04


$       0.99


$     (1.44)


Diluted

$            0.80


$     0.04


$       0.99


$     (1.44)

Weighted average shares used in computing net income (loss) per share(1)









Basic

17,647


17,437


17,579


17,401


Diluted

17,986


17,446


17,687


17,401










Note A








Stock-based compensation expense included in:









Selling, general and administrative

$          1,812


$   1,585


$   10,879


$     6,712


Research and development

275


348


1,514


2,094



$          2,087


$   1,933


$   12,393


$     8,806

(1)

Share and per share amounts have been restated to reflect the 1-for-10 reverse stock split effected on June 27, 2024 on a retroactive basis for the respective periods presented.

 










SUMMARY BALANCE SHEET DATA

(in thousands)












As of  December 31,







2024


2023





Cash, cash equivalents and short-term investments 

$        77,321


$ 56,933





Total assets 

163,976


117,225





Stockholders' equity (deficit)

3,288


(28,644)





 

 

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SOURCE Rigel Pharmaceuticals, Inc.

FAQ

What were Rigel Pharmaceuticals (RIGL) Q4 2024 revenue and product sales?

RIGL reported Q4 2024 total revenue of $57.6M, with TAVALISSE sales of $31.0M, REZLIDHIA sales of $7.4M, and GAVRETO sales of $8.1M.

How much revenue growth did RIGL's REZLIDHIA achieve in 2024?

REZLIDHIA net product sales grew 118% in 2024, reaching $23.0M compared to $10.6M in 2023.

What is RIGL's revenue guidance for 2025?

Rigel expects 2025 total revenue of $200-210M, including net product sales of $185-192M and contract revenues of $15-18M.

What regulatory designations did RIGL's R289 receive from the FDA?

R289 received Fast Track designation for treating previously-treated transfusion dependent lower-risk MDS and Orphan Drug designation for MDS treatment.
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