Full Press Release Details
Rigel Reports Third Quarter 2021 Financial Results
and Provides Business Update
SOUTH SAN FRANCISCO, Calif., November
2, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:
RIGL) today reported financial results for the third quarter ended September 30, 2021, 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.
"Rigel has expanded the commercial organization and our pipeline
candidates are advancing in the clinic, setting us up for a transformative year in 2022," said Raul Rodriguez, Rigel's president
and CEO. "We recently achieved an important development milestone, completing enrollment of our pivotal FORWARD study in wAIHA,
with an anticipated data readout in mid-2022. In addition, our sales force expansion is now complete, allowing us to have a greater impact
in driving awareness and uptake for TAVALISSE as a novel, targeted therapy for ITP in the U.S."
For the third quarter of 2021, Rigel reported
a net loss of $21.0 million, or $0.12 per basic and diluted share, compared to a net loss of $14.2 million, or $0.08 per basic and diluted
share, for the same period of 2020.
In the third quarter of 2021, total revenues
were $21.5 million, consisting of $16.0 million in TAVALISSE net product sales, $4.5 million in contract revenues from collaborations,
and $1.0 million in government contract revenue. TAVALISSE net product sales of $16.0 million in the third quarter of 2021 decreased by
2% from $16.3 million for the same period in 2020.
Contract revenues of $4.5 million from collaborations
for the third quarter of 2021 consisted of $2.4 million in revenue related to the achievement of the remaining performance obligations
in Rigel's license agreement with Eli Lilly (Lilly), $1.8 million in revenue related to the achievement of a certain milestone from
Daiichi Sankyo (Daiichi), $0.2 million in revenue related to the performance of certain research and development services pursuant to
its collaboration agreement with Grifols, and a $0.1 million milestone payment from Medison. Government contract revenue of $1.0 million
for the third quarter of 2021 was related to the income recognized pursuant to the agreement Rigel entered in January 2021 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.
Rigel reported total costs and expenses of
$41.3 million in the third quarter of 2021, compared to $32.2 million for the same period in 2020. The increase in costs and expenses
was primarily due to the research and development costs related to Rigel's ongoing Phase 3 clinical trial of fostamatinib for the
treatment of hospitalized patients with COVID-19, as well as increased commercial activities, including the recent sales force expansion.
For the nine months ended September 30, 2021,
Rigel reported net income of $4.7 million, or $0.03 per basic and diluted share, compared to a net loss of $10.5 million, or $0.06 per
basic and diluted share, for the same period of 2020.
Rigel reported total revenues of $128.8 million
for the nine months ended September 30, 2021, consisting of $45.4 million in TAVALISSE net product sales, $73.9 million in contract revenues
from collaborations, and $9.5 million in government contract revenues. TAVALISSE net product sales of $45.4 million increased by 3% from
$43.9 million for the same period of 2020.
Total costs and expenses for the nine months
ended September 30, 2021, were $119.9 million, compared to $100.3 million for the same period in 2020. The increase in costs and expenses
was primarily due to increases in research and development costs related to Rigel's various ongoing clinical studies, including
its Phase 3 clinical trial of fostamatinib for the treatment of hospitalized patients with COVID-19, increased commercial activities that
include the recent sales force expansion, personnel-related costs, and stock-based compensation expense.
As of September 30, 2021, Rigel had cash,
cash equivalents, and short-term investments of $143.1 million, compared to $57.3 million as of December 31, 2020.
Conference Call 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 and accompanying slides 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.
Autoimmune hemolytic anemia (AIHA) is a rare,
serious blood disorder in which the immune system produces antibodies that destroy the body's own red blood cells. AIHA affects approximately
45,000 adult patients in the U.S. and can be a severe, debilitating disease. To date, there are no disease-targeted therapies approved
for AIHA, despite the unmet medical need that exists for these patients. Warm antibody AIHA (wAIHA), the most common form of AIHA, is
characterized by the presence of antibodies that react with the red blood cell surface at body temperature.
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.1 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.2
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.3,4,5,6 Furthermore, SYK inhibition
in neutrophils and platelets may lead to decreased thrombo-inflammation, alleviating organ dysfunction in critically ill patients with
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
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.
Rigel Pharmaceuticals,
Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly
improve the lives of patients with hematologic disorders, cancer and rare immune diseases. Rigel's pioneering research focuses on signaling
pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE (fostamatinib
disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor for the treatment of adult patients with chronic immune
thrombocytopenia who have had an insufficient response to a previous treatment. The product is also commercially available in Europe,
the United Kingdom (TAVLESSE) and Canada (TAVALISSE) for the treatment of chronic immune thrombocytopenia in adult patients.
is currently being studied in a Phase 3 clinical trial (NCT03764618) for the treatment
of warm autoimmune hemolytic anemia (wAIHA)7; a Phase 3 clinical trial (NCT04629703) for
the treatment of hospitalized high-risk patients with COVID-197; an NIH/NHLBI-sponsored Phase 3 clinical trial
(ACTIV-4 Host Tissue Trial, NCT04924660) for the treatment
of COVID-19 in hospitalized patients, and a Phase 2 clinical trial (NCT04581954)
for the treatment of COVID-19 being conducted by Imperial College London.