Rigel Reports Third Quarter 2024 Financial Results and Provides Business Update
Rigel Pharmaceuticals reported strong Q3 2024 financial results with total revenue of $55.3 million, including TAVALISSE net sales of $26.3 million (8% growth), REZLIDHIA net sales of $5.5 million (107% growth), and GAVRETO net sales of $7.1 million. The company secured a $10 million upfront payment from Kissei for REZLIDHIA development rights in Japan, Korea, and Taiwan. Rigel achieved Q3 net income of $12.4 million ($0.71 per share) compared to a net loss of $5.7 million in Q3 2023. Cash position strengthened to $61.1 million as of September 30, 2024.
Rigel Pharmaceuticals ha riportato risultati finanziari solidi per il terzo trimestre del 2024, con un fatturato totale di 55,3 milioni di dollari, comprendente vendite nette di TAVALISSE pari a 26,3 milioni di dollari (crescita dell'8%), vendite nette di REZLIDHIA di 5,5 milioni di dollari (crescita del 107%) e vendite nette di GAVRETO di 7,1 milioni di dollari. L'azienda ha ricevuto un pagamento anticipato di 10 milioni di dollari da Kissei per i diritti di sviluppo di REZLIDHIA in Giappone, Corea e Taiwan. Rigel ha registrato un utile netto per il terzo trimestre di 12,4 milioni di dollari (0,71 dollari per azione) rispetto a una perdita netta di 5,7 milioni di dollari nel terzo trimestre del 2023. La posizione di cassa è migliorata fino a 61,1 milioni di dollari al 30 settembre 2024.
Rigel Pharmaceuticals informó resultados financieros sólidos para el tercer trimestre de 2024, con ingresos totales de 55,3 millones de dólares, que incluyen ventas netas de TAVALISSE por 26,3 millones de dólares (un crecimiento del 8%), ventas netas de REZLIDHIA de 5,5 millones de dólares (un crecimiento del 107%) y ventas netas de GAVRETO de 7,1 millones de dólares. La compañía obtuvo un pago inicial de 10 millones de dólares de Kissei por los derechos de desarrollo de REZLIDHIA en Japón, Corea y Taiwán. Rigel logró un ingreso neto del tercer trimestre de 12,4 millones de dólares (0,71 dólares por acción) en comparación con una pérdida neta de 5,7 millones de dólares en el tercer trimestre de 2023. La posición de efectivo se fortaleció hasta 61,1 millones de dólares al 30 de septiembre de 2024.
리겔 제약(Rigel Pharmaceuticals)은 2024년 3분기 강력한 재무 결과를 발표했으며, 총 수익은 5530만 달러로, 여기에는 타발리스(TAVALISSE)의 순매출 2630만 달러(8% 성장), 레질디아(REZLIDHIA)의 순매출 550만 달러(107% 성장), 가브레토(GAVRETO)의 순매출 710만 달러가 포함됩니다. 회사는 일본, 한국 및 대만에서 REZLIDHIA 개발 권한에 대해 키세이로부터 1000만 달러의 선급금을 확보했습니다. 리겔은 3분기 순이익 1240만 달러(주당 0.71 달러)를 기록했으며, 이는 2023년 3분기 순손실 570만 달러에 비해 성장한 수치입니다. 현금 보유 위치는 2024년 9월 30일 기준으로 6110만 달러로 강화되었습니다.
Rigel Pharmaceuticals a annoncé des résultats financiers solides pour le troisième trimestre 2024, avec un chiffre d'affaires total de 55,3 millions de dollars, comprenant des ventes nettes de TAVALISSE de 26,3 millions de dollars (croissance de 8 %), des ventes nettes de REZLIDHIA de 5,5 millions de dollars (croissance de 107 %) et des ventes nettes de GAVRETO de 7,1 millions de dollars. L'entreprise a obtenu un paiement initial de 10 millions de dollars de Kissei pour les droits de développement de REZLIDHIA au Japon, en Corée et à Taïwan. Rigel a enregistré un bénéfice net de 12,4 millions de dollars (0,71 dollar par action) au troisième trimestre, contre une perte nette de 5,7 millions de dollars au troisième trimestre 2023. La position de trésorerie s'est renforcée pour atteindre 61,1 millions de dollars au 30 septembre 2024.
Rigel Pharmaceuticals hat starke Finanzzahlen für das dritte Quartal 2024 gemeldet, mit einem Gesamterlös von 55,3 Millionen Dollar, einschließlich Nettoumsatz von TAVALISSE in Höhe von 26,3 Millionen Dollar (8 % Wachstum), Nettoumsatz von REZLIDHIA in Höhe von 5,5 Millionen Dollar (107 % Wachstum) und Nettoumsatz von GAVRETO in Höhe von 7,1 Millionen Dollar. Das Unternehmen erhielt eine Vorauszahlung von 10 Millionen Dollar von Kissei für die Entwicklungsrechte von REZLIDHIA in Japan, Korea und Taiwan. Rigel erzielte im dritten Quartal ein Nettoergebnis von 12,4 Millionen Dollar (0,71 Dollar pro Aktie) im Vergleich zu einem Nettoverlust von 5,7 Millionen Dollar im dritten Quartal 2023. Die Liquiditätsposition wurde zum 30. September 2024 auf 61,1 Millionen Dollar gestärkt.
- Record Q3 revenue of $55.3 million with strong growth across product portfolio
- TAVALISSE sales grew 8% to $26.3 million
- REZLIDHIA sales increased 107% to $5.5 million
- Secured $10 million upfront payment from Kissei partnership
- Achieved Q3 net income of $12.4 million versus prior year loss
- Cash position improved to $61.1 million from $49.1 million in Q2 2024
- Total costs and expenses increased 27% to $41.3 million year-over-year
- New safety signal identified for GAVRETO requiring Dear Health Care Provider letter
Insights
The Q3 results demonstrate strong commercial execution with
- TAVALISSE sales grew
8% YoY to$26.3M - REZLIDHIA sales surged
107% YoY to$5.5M - New GAVRETO contributed
$7.1M in first full quarter
Most notably, Rigel achieved profitability with
The clinical pipeline shows encouraging progress, particularly with R289 in lower-risk MDS. Initial data reveals
- Third quarter total revenue of
, which includes TAVALISSE® net product sales of$55.3 million , REZLIDHIA® net product sales of$26.3 million and GAVRETO® net product sales of$5.5 million $7.1 million - Entered into an agreement with Kissei to develop and commercialize REZLIDHIA in all potential indications in
Japan , theRepublic of Korea andTaiwan , recording an upfront cash payment of during the third quarter$10.0 million - Initial data from the ongoing Phase 1b study evaluating R289, a dual IRAK1/4 inhibitor, in LR-MDS to be presented at the 66th ASH Annual Meeting
- Conference call and webcast scheduled today at 4:30 p.m. Eastern Time
"2024 has been a significant year for Rigel, marked by the acquisition of GAVRETO, our third commercial product, strong revenue growth across our commercial portfolio, and the advancement of our development pipeline," said Raul Rodriguez, Rigel's president and CEO. "This great progress is underpinned by our focus on financial discipline, resulting in positive third-quarter and year-to-date net income. As we close out the year, we will continue driving momentum in our commercial portfolio and hematology and oncology development pipeline."
Third Quarter 2024 Business Update
Commercial Update
- Commercial strength continues for all products with record bottles shipped to patients and clinics and total bottles sold.
- GAVRETO became commercially available from Rigel in June 2024. Third-quarter results reflect the successful transition of existing patients on therapy to Rigel's product. For the fourth quarter, the focus will be on continuing to transition patients.
- The following table summarizes total bottles shipped for the third quarter:
TAVALISSE | REZLIDHIA | GAVRETO* | |
Bottles shipped to patients and clinics | 2,797 | 444 | 717 |
Change in bottles remaining in distribution channel | (4) | (15) | 35 |
Total bottles shipped | 2,793 | 429 | 752 |
*GAVRETO bottle count represents 60-count bottle equivalent |
- In September, Rigel entered into an exclusive license and supply agreement with Kissei Pharmaceutical Co., Ltd. ("Kissei") to develop and commercialize REZLIDHIA in all potential indications in
Japan , theRepublic of Korea andTaiwan . Under the terms of the agreement, Rigel received an upfront cash payment of from Kissei, with the potential for up to an additional$10.0 million in development, regulatory and commercial milestone payments.$152.5 million - In late October, Rigel issued a Dear Health Care Provider (DHCP) letter related to a new safety signal for GAVRETO after consultation with the
U.S. Food and Drug Administration (FDA). The DHCP letter has been posted to the GAVRETO Healthcare Provider website at www.gavreto-hcp.com.
Clinical and Development Update
- Rigel continues to advance its Phase 1b clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of R2891, a novel and selective dual IRAK1/4 inhibitor, in patients with R/R lower-risk myelodysplastic syndrome (LR-MDS). Enrollment in the fifth dose level (500mg / 250mg split dose) is underway.
- In early November, Rigel announced six poster presentations highlighting data from the company's commercial and clinical-stage hematology and oncology portfolio at the upcoming 66th American Society of Hematology (ASH) Annual Meeting and Exposition. Initial data from the ongoing Phase 1b study evaluating R289 in patients with R/R LR-MDS indicate that R289 was generally well tolerated in a heavily pretreated LR-MDS patient population, the majority of whom were high transfusion burden at study entry. As of the data cutoff, 14 of 19 patients were evaluable for efficacy and per International Working Group (IWG) 2018, RBC-transfusion independence (RBC-TI)/hematologic improvement (HI-E) occurred in
36% of patients receiving R289 doses ≥500 mg QD, with a median duration of RBC-TI of 29 weeks. RBC-TI >24 weeks was achieved in 2 high transfusion burden patients following 3 and 5 prior therapies, including a hypomethylating agent. The company will also present additional data for olutasidenib in patients with R/R mIDH1 AML and MDS. - In September, Rigel announced the first patient was enrolled in a Phase 1b/2 triplet therapy trial of decitabine and venetoclax in combination with REZLIDHIA in patients with mIDH1 AML, which is being sponsored and conducted by The University of Texas MD Anderson Cancer Center (MD Anderson). This is the first trial in Rigel's multi-year strategic development alliance with MD Anderson.
- A paper detailing the differences in molecular structure, binding characteristics and clinical outcomes between olutasidenib and ivosidenib, including response rates in patients previously treated with ivosidenib or venetoclax, was published by Dr. Justin M. Watts, Associate Professor of Medicine, Division of Hematology, Chief, Leukemia Section at the University of Miami Health System, in Current Treatment Options in Oncology in October 2024.
Third Quarter 2024 and Year-To-Date Financial Update
For the third quarter ended September 30, 2024, total revenues were
Total costs and expenses were
Rigel reported net income of
For the nine months ended September 30, 2024, total revenues were
Total costs and expenses were
Rigel reported net income of
Cash, cash equivalents and short-term investments as of September 30, 2024 was
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 ITP (immune thrombocytopenia), 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. People 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 20,800 new cases in
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 230,000 adults in the
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, visit 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
- R289 is an investigational compound not approved by the FDA.
- The American Cancer Society. Key Statistics for Acute Myeloid Leukemia (AML). Revised June 5, 2024. Accessed June 30, 2024: https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html
- Leukaemia Care. Relapse in Acute Myeloid Leukaemia (AML). Version 3. Reviewed October 2021. Accessed June 30, 2024: https://media.leukaemiacare.org.uk/wp-content/uploads/Relapse-in-Acute-Myeloid-Leukaemia-AML-Web-Version.pdf
- 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 June 30, 2024. doi: https://doi.org/10.1182/blood-2014-10-551911
- The American Cancer Society. Key Statistics for Lung Cancer. Revised January 29, 2024. Accessed June 30, 2024: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html
- 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, expectations for developing and commercializing REZLIDHIA in certain international markets, study results relating to safety and tolerability of R289 for the treatment of lower-risk myeloid dysplastic syndrome, expectations for development of Rigel's commercial portfolio and hematology and oncology pipeline, 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 "plan", "potential", "may", "look to", "expects", "will", "initial", 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 June 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, INC. | |||||||
STATEMENTS OF OPERATIONS | |||||||
(in thousands, except per share amounts) | |||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
(unaudited) | |||||||
Revenues: | |||||||
Product sales, net | $ 38,927 | $ 27,129 | $ 98,380 | $ 74,755 | |||
Contract revenues from collaborations | 16,380 | 1,005 | 23,302 | 5,335 | |||
Government contract | — | — | — | 1,000 | |||
Total revenues | 55,307 | 28,134 | 121,682 | 81,090 | |||
Costs and expenses: | |||||||
Cost of product sales | 8,026 | 1,268 | 12,858 | 3,320 | |||
Research and development (see Note A) | 6,182 | 6,475 | 17,748 | 21,336 | |||
Selling, general and administrative (see Note A) | 27,043 | 24,856 | 83,539 | 78,891 | |||
Total costs and expenses | 41,251 | 32,599 | 114,145 | 103,547 | |||
Income (loss) from operations | 14,056 | (4,465) | 7,537 | (22,457) | |||
Interest income | 425 | 672 | 1,570 | 1,594 | |||
Interest expense | (2,060) | (1,899) | (5,963) | (4,965) | |||
Net income (loss) | $ 12,421 | $ (5,692) | $ 3,144 | $ (25,828) | |||
Net income (loss) per share (1) | |||||||
Basic | $ 0.71 | $ (0.33) | $ 0.18 | $ (1.49) | |||
Diluted | $ 0.70 | $ (0.33) | $ 0.18 | $ (1.49) | |||
Weighted average shares used in computing net income (loss) per share(1) | |||||||
Basic | 17,600 | 17,436 | 17,556 | 17,389 | |||
Diluted | 17,648 | 17,436 | 17,599 | 17,389 | |||
Note A | |||||||
Stock-based compensation expense included in: | |||||||
Selling, general and administrative | $ 2,360 | $ 1,596 | $ 9,067 | $ 5,127 | |||
Research and development | 284 | 347 | 1,239 | 1,746 | |||
$ 2,644 | $ 1,943 | $ 10,306 | $ 6,873 | ||||
(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 all periods presented. |
SUMMARY BALANCE SHEET DATA | ||||
(in thousands) | ||||
As of September, | As of December 31, | |||
2024 | 2023(1) | |||
(unaudited) | ||||
Cash, cash equivalents and short-term investments | $ 61,114 | $ 56,933 | ||
Total assets | 139,419 | 117,225 | ||
Stockholders' deficit | (14,636) | (28,644) | ||
(1) Derived from audited financial statements |
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SOURCE Rigel Pharmaceuticals, Inc.
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