Full Press Release Details
Rigel Reports Third Quarter 2023 Financial
Results and Provides Business Update
SOUTH SAN FRANCISCO,
Calif., November 7, 2023 /PRNewswire/ --
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today reported financial results for
the third quarter ended September 30, 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.
third quarter of 2023 was marked by strong momentum from our commercial hematology-oncology portfolio driven by record TAVALISSE net
product sales and growing REZLIDHIA awareness among leukemia treaters," said Raul
Rodriguez, Rigel's president and CEO. "These strong net sales combined with our expense discipline have allowed us to make
substantial progress on our plan to reach financial breakeven."
For the third quarter of 2023, Rigel reported
a net loss of $5.7 million, or $0.03 per basic and diluted share, compared to a net loss of $19.0 million, or $0.11 per basic and diluted
share, for the same period of 2022.
For the third quarter of 2023, total revenues
were $28.1 million, consisting of $24.5 million in TAVALISSE net product sales, $2.7 million in REZLIDHIA net product sales, and $1.0
million in contract revenues from collaborations. TAVALISSE net product sales of $24.5 million increased by $5.3 million, or 27%, compared
to $19.2 million in the same period of 2022. Contract revenues from collaborations for the third quarter of 2023 consisted primarily
of royalty revenue from Grifols S.A. (Grifols) of $0.8 million.
For the third quarter of 2023, total costs and
expenses were $32.6 million, compared to $40.8 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 completion of activities related to the Phase 3 clinical trial of fostamatinib
in wAIHA and the Phase 3 clinical trial of fostamatinib in high-risk hospitalized patients with COVID-19. Also contributing to the decrease,
were lower facility-related costs and an upfront payment to Forma Therapeutics Inc. (Forma, now Novo Nordisk) recorded as in-process
research and development (IPR&D) and included within cost and expenses in the third quarter of 2022. These decreases were partially
offset by increased research and development costs due to the timing of activities related to the IRAK 1/4 inhibitor program.
For the nine months ended September 30,
2023, Rigel reported a net loss of $25.8 million, or $0.15 per basic and diluted share, compared to a net loss of $60.0 million, or $0.35
per basic and diluted share, for the same period of 2022.
For the nine months ended September 30,
2023, total revenues were $81.1 million, consisting of $68.1 million in TAVALISSE net product sales, $6.7 million in REZLIDHIA net product
sales, $5.3 million in contract revenues from collaborations, and $1.0 million in government contract revenue. TAVALISSE net product
sales of $68.1 million increased by $14.1 million, or 26%, compared to $53.9 million in the same period of 2022. Contract revenues from
collaborations for the nine months ended September 30, 2023, consisted primarily of revenue from Grifols related to the delivery
of drug supplies of $2.8 million and a royalty of $2.3 million. Government contract revenue for the nine months ended September 30,
2023, was 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.
For the nine months ended September 30,
2023, total costs and expenses were $103.5 million, compared to $126.6 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 completion of trial activities related to the Phase 3
clinical trial of fostamatinib in wAIHA and the Phase 3 clinical trial of fostamatinib in high-risk hospitalized patients with COVID-19,
as well as timing of activities related to the IRAK 1/4 inhibitor program. Also contributing to the decrease were lower facility-related
costs, and an upfront payment to Forma (now Novo Nordisk) recorded as IPR&D and included within cost and expenses in the third quarter
As of September 30, 2023, Rigel had cash,
cash equivalents and short-term investments of $62.4 million, compared to $58.2 million as of December 31, 2022.
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.
is a prodrug of R835, an IRAK1/4 dual inhibitor, which has been shown in preclinical studies to block inflammatory cytokine production
in response to toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) family signaling. TLRs and IL-1Rs play a critical role in
the innate immune response and dysregulation of these pathways can lead to various inflammatory conditions. Chronic stimulation of both
these receptor systems is thought to cause the pro-inflammatory environment in the bone marrow responsible for persistent cytopenias
in lower-risk MDS patients.5
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 is a registered
trademark 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