Full Press Release Details
Rigel Reports Third Quarter 2022 Financial Results
and Provides Business Update
SOUTH SAN FRANCISCO,
Calif., Nov. 3, 2022 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today reported financial results for the third quarter
ended September 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.
to have several poster presentations at ASH that showcase our hematology-oncology portfolio. In particular, updated data from the Phase
2 registrational study of olutasidenib in patients with mIDH1 relapsed or refractory acute myeloid leukemia demonstrate durable remissions,
which we believe truly differentiates olutasidenib as a potential market leading therapy," said Raul Rodriguez, Rigel's president
and CEO. "In addition, during the third quarter of 2022, we made meaningful progress to position the company for the potential launch
of olutasidenib and to drive growth in TAVALISSE ITP sales."
*CR+CRh: Complete remission (CR) plus a complete remission with partial
hematological recovery (CRh)
For the third quarter
of 2022, Rigel reported a net loss of $19.0 million, or $0.11 per basic and diluted share, compared to a net loss of $21.0 million, or
$0.12 per basic and diluted share, for the same period of 2021.
For the third quarter
of 2022, total revenues were $22.4 million, consisting of $19.2 million in TAVALISSE net product sales, $0.7 million in contract revenues
from collaborations and $2.5 million in government contract revenue. TAVALISSE net product sales of $19.2 million increased by 20%, compared
to $16.0 million in the third quarter of 2021. Contract revenues from collaborations during the third quarter of 2022 consisted primarily
of 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. Government contract revenue for the third 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.
For the third quarter
of 2022, total costs and expenses were $40.8 million, compared to $41.3 million for the same period of 2021. The decrease in costs and
expenses was primarily due to a decrease in research and development costs related to the Phase 3 clinical trial for wAIHA, the Phase
3 clinical trial in high-risk hospitalized patients with COVID-19 and the IRAK 1/4 inhibitor program. These decreases were partially
offset by increased personnel related costs and commercial activities.
ended September 30, 2022, Rigel reported a net loss of $60.0 million, or $0.35 per basic and diluted share, compared to a net income
of $4.7 million, or $0.03 per basic and diluted share, for the same period of 2021.
ended September 30, 2022, total revenues were $69.0 million, consisting of $53.9 million in TAVALISSE net product sales, $12.5 million
in contract revenues from collaborations and $2.5 million in government contract revenue. TAVALISSE net product sales of $53.9 million
increased by 19% compared to $45.4 million in the same period of 2021. Contract revenues from collaborations for the nine months ended
September 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, $2.4 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, and $0.5 million in revenue related to the license agreement with Eli Lilly. Government contract revenue for the nine months
ended September 30, 2022, was related to the income recognized pursuant to the agreement with the DOD as mentioned above.
ended September 30, 2022, total costs and expenses were $126.6 million, compared to $119.9 million for the same period of 2021.
The increase in costs and expenses was primarily due to increased personnel costs from the sales force expansion, increased commercial-related
activities, and increased research and development costs for the IRAK1/4 inhibitor program. These increases were partially offset by
decreased research and development costs related to the Phase 3 clinical trial for wAIHA and the ongoing Phase 3 clinical trial in high-risk
hospitalized patients with COVID-19.
2022, Rigel had cash, cash equivalents and short-term investments of $81.6 million, compared to $125.0 million as of December 31,
Conference Call and Webcast with Slides
Today at 4:30pm Eastern Time
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
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 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 treatment.3
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.
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.
(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
| Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required. | ||
| Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to 3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation. |
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. (Nasdaq: RIGL) 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. Founded in 1996, Rigel is based in South
San Francisco, California. For more information on Rigel, the Company's marketed product and pipeline of potential products, visit www.rigel.com.