Full Press Release Details
Rigel Reports Fourth Quarter and Full Year 2024
Financial Results and Provides Business Update
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
"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."
| 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 |
bottle count represents 60-count bottle equivalent
warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or
Quarter and Full Year 2024 Financial Update
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.
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.
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.
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.
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).
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 total revenue of approximately $200 to $210 million, including:
The company anticipates it will report positive net
income for the full year 2025, while funding existing and new clinical development programs.
Call and Webcast with Slides Today at 4:30pm Eastern Time
a live conference call and webcast today at 4:30pm Eastern Time (1:30pm Pacific Time).
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.
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.
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
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.
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
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.
here for Important Safety Information and Full Prescribing Information for TAVALISSE.
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.
for Important Safety Information and Full Prescribing Information, including Boxed WARNING, for REZLIDHIA.
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.
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.
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.
This press release contains forward-looking statements relating to, among other things, expected