Full Press Release Details
Rigel Reports Second Quarter 2022 Financial
Results and Provides Business Update
SOUTH SAN FRANCISCO, Calif., August 2,
2022 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:
RIGL) today reported financial results for the second quarter ended June 30, 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.
second quarter of 2022 was a significant one for Rigel, marked by the highest
quarterly net product sales for TAVALISSE in ITP
since launch. We are also excited about the strategic expansion of our hematology-oncology portfolio
to include olutasidenib, and the synergy it provides. We
believe the addition of olutasidenib will broaden the reach of the Rigel field force by providing a potential new therapy for
mIDH1 relapsed or refractory acute myeloid leukemia and
other malignancies," said Raul Rodriguez, Rigel's president and CEO. "I
am pleased with our progress, and believe Rigel is well-positioned to continue driving momentum for TAVALISSE in ITP and prepare for
the potential launch of olutasidenib in 2023."
For the second quarter of 2022, Rigel reported
a net loss of $13.5 million, or $0.08 per basic and diluted share, compared to a net loss of $13.8 million, or $0.08 per basic and diluted
share for the same period of 2021.
For the second quarter of 2022, total revenues
were $29.8 million, consisting of $18.6 million in TAVALISSE net product sales and $11.3 million in contract revenues from collaborations.
TAVALISSE net product sales of $18.6 million increased by 9%, compared to $17.1 million in the second quarter of 2021. Contract revenues
from collaborations during the second quarter of 2022 consisted of $7.5 million in revenue from Kissei related to a milestone payment
and delivery of fostamatinib supply, $2.0 million in revenue related to the license agreement with Knight, $1.4 million in revenue from
Grifols related to the delivery of fostamatinib supply and performance of certain research and development services pursuant to the collaboration
agreement, and $0.3 million in revenue related to the license agreement with Eli Lilly.
For the second quarter of 2022, total costs
and expenses were $42.8 million, compared to $39.3 million for the same period of 2021. The increase in costs and expenses was primarily
due to increased commercial activities related to the sales force expansion, and increased research and development costs for the IRAK1/4
inhibitor program, partially offset by decreased research and development costs related to the Phase 3 clinical trial for wAIHA and the
ongoing Phase 3 clinical trial in high-risk hospitalized patients with COVID-19.
For the six months ended June 30, 2022, Rigel reported a net
loss of $40.9 million, or $0.24 per basic and diluted share, compared to a net income of $25.7 million, or $0.15 per basic and diluted
share, for the same period of 2021.
For the six months ended June 30, 2022, total revenues were $46.6
million, consisting of $34.7 million in TAVALISSE net product sales and $11.8 million in contract revenues from collaborations. TAVALISSE
net product sales of $34.7 million increased by 18% compared to $29.4 million in the same period of 2021. Contract revenues from collaborations
for the six months ended June 30, 2022 consisted of $7.6 million in revenue from Kissei primarily related to a milestone payment
and delivery of fostamatinib supply, $2.0 million in revenue related to the license agreement with Knight, $1.7 million in revenue from
Grifols related to the delivery of fostamatinib supply and performance of certain research and development services pursuant to the collaboration
agreement, and $0.5 million in revenue related to the license agreement with Eli Lilly.
For the six months ended June 30, 2022, total costs and expenses
were $85.8 million, compared to $78.6 million for the same period of 2021. The increase in costs and expenses was primarily due to increased
commercial related activities related to the sales force expansion, and increased research and development costs for the IRAK1/4 inhibitor
program, partially offset by decreased research and development costs related to the Phase 3 clinical trial for wAIHA and the ongoing
Phase 3 clinical trial in high-risk hospitalized patients with COVID-19.
As of June 30, 2022, Rigel had cash,
cash equivalents and short-term investments of $89.2 million, compared to $125.0 million as of December 31, 2021. In July 2022,
Rigel accessed an additional $10.0 million term loan through its credit agreement with MidCap Financial Trust (MidCap) and amended the
terms of the credit agreement which, among other things, allows Rigel to defer the loan principal payment by one year and extends the
maturity date for the term loans.
Conference Call and Webcast Today at 4:30 p.m. Eastern
Time, with Key Opinion Leader and olutasidenib Phase 2 clinical trial investigator Jorge E. Cortes, M.D.
Rigel will host a live conference call and webcast today at 4:30 p.m. Eastern
Time (1:30 p.m. Pacific Time) to discuss financial results, and provide an update on the business, including the license agreement
with Forma. The conference call will also feature a presentation of the olutasidenib Phase 2 interim results by Jorge E. Cortes, M.D.,
Director, Georgia Cancer Center, Cecil F. Whitaker Jr., GRA Eminent Scholar Chair in Cancer, and Phase 2 trial investigator.
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
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 cancer that starts in a person's
bone marrow but often quickly moves into the blood. AML develops from immature blood cells, known as myeloid cells, that are supposed
to mature into white blood cells. However, the diseased myeloid cells do not function properly. They instead multiply rapidly, which
causes normal blood cell production to fail. 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 20,050 new cases, most in adults, in 2022.1
Relapsed 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
Autoimmune hemolytic anemia (AIHA) is a rare,
serious blood disorder in which the immune system produces antibodies that lead to the destruction of the body's own red blood cells.
Warm antibody AIHA (wAIHA), which is the most common form of AIHA, is characterized by the presence of antibodies that react with the
red blood cell surface at body temperature. wAIHA affects approximately 36,000 adult patients in the U.S.4 and can be
a severe, debilitating disease. To date, there are no disease-targeted therapies approved for wAIHA, despite the unmet medical need that
exists for these patients.
About COVID-19 & SYK Inhibition
COVID-19 is the infectious disease caused
by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). SARS-CoV-2 primarily infects the upper and lower respiratory tract and
can lead to acute respiratory distress syndrome (ARDS). Additionally, some patients develop other organ dysfunction including myocardial
injury, acute kidney injury, shock resulting in endothelial dysfunction and subsequently micro and macrovascular thrombosis.5 Much
of the underlying pathology of SARS-CoV-2 is thought to be secondary to a hyperinflammatory immune response associated with increased
risk of thrombosis.6
SYK is involved in the intracellular signaling
pathways of many different immune cells. Therefore, SYK inhibition may improve outcomes in patients with COVID-19 via inhibition of key
Fc gamma receptor (Fc R) and c-type lectin receptor (CLR) mediated drivers of pathology such as pro-inflammatory cytokine release
by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation. 7,8,9,10 Furthermore,
SYK inhibition in neutrophils and platelets may lead to decreased thrombo-inflammation, alleviating organ dysfunction in critically ill
patients with COVID-19.
For more information on Rigel's comprehensive
clinical program in COVID-19, go to: https://www.rigel.com/pipeline/proprietary-programs/covid-19
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.
Important Safety Information
Warnings and Precautions