Full Press Release Details
Rigel Reports Fourth Quarter and Full Year
2022 Financial Results and Provides Business Update
SOUTH SAN FRANCISCO,
Calif., March 7, 2023 /PRNewswire/ -- Rigel
Pharmaceuticals, Inc. (Nasdaq: RIGL) today reported financial results for the fourth
quarter and full year ended December 31, 2022, including sales of TAVALISSE (fostamatinib disodium hexahydrate)
tablets for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment
and sales of REZLIDHIA (olutasidenib) capsules for the treatment of adult
patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation
as detected by an FDA-approved test.
of significant accomplishments for Rigel, as we expanded our commercial hematology-oncology portfolio with the approval and launch of
REZLIDHIA, an important new treatment option for AML patients. We also continued to strengthen our commercial execution, with TAVALISSE
net product sales reaching a record high in the fourth quarter," said Raul Rodriguez, Rigel's president and CEO. "We are
focused on continuing the successful launch of REZLIDHIA in R/R AML, driving sales growth for TAVALISSE in ITP, and advancing our development
programs. In 2023, we look forward to further expanding our hematology-oncology portfolio and clinical pipeline."
the fourth quarter of 2022, Rigel reported a net income of $1.4 million, or $0.01 per basic and diluted share, compared to a net loss
of $22.6 million, or $0.13 per basic and diluted share, for the same period of 2021.
fourth quarter of 2022, total revenues were $51.3 million, consisting of $21.9 million in TAVALISSE net product sales, $0.9 million in
REZLIDHIA net product sales, $26.5 million in contract revenues from collaborations and $2.0 million in government contract revenue.
TAVALISSE net product sales of $21.9 million represents an increase of 25% from $17.6 million in the fourth quarter of 2021. Following
the approval of REZLIDHIA in December 2022, Rigel initiated the commercialization of REZLIDHIA in the U.S. and
recognized net product sales of $0.9 million in the fourth quarter of 2022. Contract revenues from collaborations for the fourth quarter
of 2022 consisted of $20.0 million in revenue from Kissei related to a milestone payment earned upon Japan's PMDA approval of TAVALISSE
for the treatment of chronic ITP, $5.7 million in non-cash revenue from the collaboration agreement with Medison Pharma Trading
AG (Medison), $0.6 million in royalty revenue from Grifols S.A. (Grifols),
and $0.2 million in revenue related to its license agreement with Lilly. Government contract
revenue for the fourth quarter of 2022 was related to the income recognized pursuant to the agreement with the U.S. Department of Defense
(DOD) to support Rigel's ongoing Phase 3 clinical trial of fostamatinib in hospitalized patients with COVID-19.
the fourth quarter of 2022, total costs and expenses were $49.2 million, compared to $41.8 million for the same period of 2021. The increase
in costs and expenses was primarily due to an increase in personnel-related costs and commercial
expenses, and higher research and development costs related to the IRAK 1/4 inhibitor program. These increases were partially offset
by decreased research and development costs related to the Phase 3 clinical trial for wAIHA and the Phase 3 clinical trial in high-risk
hospitalized patients with COVID-19.
the full year 2022, Rigel reported a net loss of $58.6 million, or $0.34 per basic and diluted share, compared to a net loss of $17.9
million, or $0.11 per basic and diluted share, for the same period of 2021.
the full year 2022, total revenues were $120.2 million, consisting of $75.8 million in TAVALISSE net product sales, $0.9 million in REZLIDHIA
net product sales, $39.0 million in contract revenues from collaborations and $4.5 million in government contract revenue. TAVALISSE
net product sales of $75.8 million increased by 20% compared to $63.0 million in the same period of 2021. REZLIDHIA net product sales
were related to shipments of products to customers following the FDA approval after commercial launch in December 2022. Contract
revenues from collaborations for the full year 2022 consisted of $27.6 million in revenue from Kissei primarily related to milestones
earned and delivery of fostamatinib supply, $5.7 million in non-cash revenue from the collaboration agreement with Medison, $3.0 million
in revenue from Grifols related to the delivery of fostamatinib supply, performance of certain research and development services pursuant
to the collaboration agreement and royalty revenue, $2.0 million in revenue related to the license agreement with Knight, and $0.7 million
in revenue related to the license agreement with Lilly. Government contract revenue for
the full year 2022 was related to the income recognized pursuant to the agreement with DOD.
the full year 2022, total costs and expenses were $175.8 million, compared to $161.7 million for the same period of 2021. The increase
in costs and expenses was primarily due to an increase in personnel-related costs and commercial
expenses, and higher research and development costs related to the IRAK 1/4 inhibitor program. These increases were partially offset
by decreased research and development costs related to the Phase 3 clinical trial for wAIHA and Phase 3 clinical trial in high-risk hospitalized
patients with COVID-19.
of December 31, 2022, Rigel had cash, cash equivalents and short-term investments of $58.2 million, compared to $125.0 million as
of December 31, 2021.
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 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.
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 in the United States alone, there will be about 20,380 new cases, most in adults, in 2023.2
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.
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.
Warnings and Precautions
Please see www.TAVALISSEUSPI.com
for full Prescribing Information.
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 and TAVLESSE
are registered trademarks of Rigel Pharmaceuticals, Inc.
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.
IMPORTANT SAFETY INFORMATION
WARNING: DIFFERENTIATION SYNDROME
Differentiation syndrome, which can be fatal,
can occur with REZLIDHIA treatment. Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension,
fever, and weight gain. If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and
hemodynamic monitoring until symptom resolution.
WARNINGS AND PRECAUTIONS
Differentiation Syndrome
REZLIDHIA can cause differentiation syndrome.
In the clinical trial of REZLIDHIA in patients with relapsed or refractory AML, differentiation syndrome occurred in 16% of patients,
with grade 3 or 4 differentiation syndrome occurring in 8% of patients treated, and fatalities in 1% of patients. Differentiation syndrome
is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal. Symptoms of differentiation
syndrome in patients treated with REZLIDHIA included leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney