Full Press Release Details
Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update
SAN FRANCISCO, Calif., March 5, 2024 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today reported financial results
for the fourth quarter and full year ended December 31, 2023, 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.
2023, fueled by increased physician awareness and adoption for both TAVALISSE and REZLIDHIA, we achieved net product sales of $104.3
million, an increase of 36% compared to 2022," said Raul Rodriguez, Rigel's president and CEO. "We recently expanded
our hematology and oncology portfolio with the addition of GAVRETO, a U.S. marketed product for the treatment of RET fusion-positive
NSCLC. This addition is highly synergistic with our current portfolio and existing infrastructure, which we believe will further support
top line growth. In 2024, we are focused on commercial expansion and
execution, while advancing our pipeline with more strategic collaborations like MD Anderson and CONNECT."
the fourth quarter of 2023, Rigel reported a net income of $0.7 million, or $0.00 per basic and diluted share, compared to a net income
of $1.4 million, or $0.01 per basic and diluted share, for the same period of 2022.
the fourth quarter of 2023, total revenues were $35.8 million, consisting of $25.7 million in TAVALISSE net product sales, $3.9 million
in REZLIDHIA net product sales, $6.2 million in contract revenue from collaborations, and $0.1 million in government contract revenue.
TAVALISSE net product sales of $25.7 million represents a 17% increase compared to $21.9 million in the same period of 2022. REZLIDHIA
net product sales were $3.9 million compared to $0.9 million in the same period of 2022. Contract revenue from collaborations for the
fourth quarter of 2023 consisted of $3.7 million of revenue from Grifols S.A. (Grifols) and $0.3 million of revenue from Medison Pharma
Trading AG (Medison) related to delivery of drug supplies and earned
royalties, as well as $2.2 million of revenue from Kissei Pharmaceutical Co., Ltd. (Kissei) related to delivery of drug supplies.
the fourth quarter of 2023, total costs and expenses were $33.8 million, compared to $49.2 million for the same period of 2022. The decrease
in costs and expenses was partly due to decreased research and development costs due to the timing of trial completion activities related
to the Phase 3 clinical trials of fostamatinib in patients with COVID-19 and wAIHA, as well as the timing of clinical trial activities
related to the IRAK 1/4 inhibitor program. In addition, the decrease was also due to lower facility-related costs, and a milestone payment
to Forma Therapeutics Inc. (Forma), now Novo Nordisk, recorded as in-process research and development (IPR&D) included within cost
and expenses in the fourth quarter of 2022.
the full year 2023, Rigel reported a net loss of $25.1 million, or $0.14 per basic and diluted share, compared to a net loss of $58.6
million, or $0.34 per basic and diluted share, for the full year 2022.
the full year 2023, total revenues were $116.9 million, consisting of $93.7 million in TAVALISSE net product sales, $10.6 million in
REZLIDHIA net product sales, $11.5 million in contract revenue from collaborations, and $1.1 million in government contract revenue.
TAVALISSE net product sales of $93.7 million represents a 24% increase compared to $75.8 million in full year 2022. REZLIDHIA net product
sales of $10.6 million increased by $9.7 million compared to $0.9 million in the full year 2022. Contract revenue from collaborations
for the full year 2023, consisted of $8.8 million of revenue from Grifols related to the delivery of drug supplies and earned royalties,
$2.2 million of revenue from Kissei related to the delivery of drug supplies, and $0.5 million of revenue from Medison related to delivery
of drug supplies, earned royalties, and a milestone payment. Government contract revenue for the full year 2023 was primarily related
to income recognized in the second quarter of 2023 pursuant to the agreement with the U.S. Department of Defense to support Rigel's
Phase 3 clinical trial of fostamatinib in high-risk hospitalized patients with COVID-19.
the full year 2023, total costs and expenses were $137.4 million, compared to $175.8 million for the full year 2022. The decrease in
costs and expenses was partly due to decreased research and development costs due to the completion of trial activities related to the
Phase 3 clinical trials of fostamatinib in patients with COVID-19 and wAIHA, as well as timing of clinical trial activities related to
the IRAK 1/4 inhibitor program. In addition, the decrease was also due to lower facility-related costs, and an upfront and a milestone
payment to Forma recorded as IPR&D included within cost and expenses in the full year 2022.
of December 31, 2023, Rigel had cash, cash equivalents and short-term investments of $56.9 million, compared to $58.2 million as
of December 31, 2022.
Call and Webcast with Slides Today at 4:30pm Eastern Time
will hold 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.
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.
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 the United States, most in adults, in 2024.1
AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.2 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.3 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.
is estimated that over 230,000 adults in the U.S. will be diagnosed with lung cancer in 2024. Lung cancer is the leading cause
of cancer death in the U.S, with NSCLC being the most common type accounting for 80-85% of all lung cancer diagnoses.4
RET fusions are implicated in approximately 1-2% of patients with NSCLC.5
(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.
see www.TAVALISSEUSPI.com for Full Prescribing Information.
report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch
or call 1-800-FDA-1088 (800-332-1088).
is a registered trademark of Rigel Pharmaceuticals, Inc.
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.
DIFFERENTIATION SYNDROME
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.
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 injury, fever, edema, pyrexia, and weight gain. Of the 25 patients who experienced differentiation syndrome, 19 (76%)
recovered after treatment or after dose interruption of REZLIDHIA. Differentiation syndrome occurred as early as 1 day and up to 18 months
after REZLIDHIA initiation and has been observed with or without concomitant leukocytosis.
differentiation syndrome is suspected, temporarily withhold REZLIDHIA and initiate systemic corticosteroids (e.g., dexamethasone 10 mg
IV every 12 hours) for a minimum of 3 days and until resolution of signs and symptoms. If concomitant leukocytosis is observed, initiate
treatment with hydroxyurea, as clinically indicated. Taper corticosteroids and hydroxyurea after resolution of symptoms. Differentiation
syndrome may recur with premature discontinuation of corticosteroids and/or hydroxyurea treatment. Institute supportive measures and
hemodynamic monitoring until improvement; withhold dose of REZLIDHIA and consider dose reduction based on recurrence.
can cause hepatotoxicity, presenting as increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased
blood alkaline phosphatase, and/or elevated bilirubin. Of 153 patients with relapsed or refractory AML who received REZLIDHIA, hepatotoxicity
occurred in 23% of patients; 13% experienced grade 3 or 4 hepatotoxicity. One patient treated with REZLIDHIA in combination with azacitidine
in the clinical trial, a combination for which REZLIDHIA is not indicated, died from complications of drug-induced liver injury. The
median time to onset of hepatotoxicity in patients with relapsed or refractory AML treated with REZLIDHIA was 1.2 months (range: 1 day
to 17.5 months) after REZLIDHIA initiation, and the median time to resolution was 12 days (range: 1 day to 17 months). The most common
hepatotoxicities were elevations of ALT, AST, blood alkaline phosphatase, and blood bilirubin.
patients frequently for clinical symptoms of hepatic dysfunction such as fatigue, anorexia, right upper abdominal discomfort, dark urine,
or jaundice. Obtain baseline liver function tests prior to initiation of REZLIDHIA, at least once weekly for the first two months, once