Full Press Release Details
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., August 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
| 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. |
Clinical Development
| 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 m IDH1 inhibitor plus hypomethylating agent (HMA) combination in patients with treatment-na ve and R/R MDS. The paper showed olutasidenib, alone or in combinati on 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 m IDH1 . |
Second Quarter 2025 and Year-to-Date Financial
For 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.
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
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.
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
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.
Rigel 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 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.
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
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.2 RET fusions are implicated in approximately 1-2% of patients with NSCLC.3
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 2025.4
Relapsed AML affects about half of all patients who,
following treatment and remission, experience a return of leukemia cells in the bone marrow.5,6 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.7 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.
(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.
here for Important Safety Information and Full Prescribing Information for TAVALISSE.
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.
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.
To report side effects of prescription drugs
to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).