Full Press Release Details
Rigel Reports Fourth Quarter and Full Year 2021
Financial Results and Provides Business
| Fourth quarter total revenues of $20.4 million; full year total revenues of $149.2 million | ||
| On track to report topline data from Phase 3 pivotal trials of fostamatinib in warm autoimmune hemolytic anemia (wAIHA) and COVID-19 in mid-2022 | ||
| Rigel Phase 3 trial in high-risk patients with COVID-19 has enrolled 265 patients | ||
| Phase 1b trial of R289, a potent and selective IRAK1/4 inhibitor, in lower-risk myeloid dysplastic syndrome (LR-MDS) is being initiated | ||
| Conference call and webcast today at 4:30 p.m. Eastern Time |
SOUTH SAN FRANCISCO, Calif., March 1,
2022 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:
RIGL) today reported financial results for the fourth quarter and full year ended December 31, 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.
"In 2021 we implemented several key activities to drive success
in 2022, including expanding our hematology/oncology commercial capabilities, completing enrollment of our pivotal Phase 3 wAIHA trial,
and our continued pipeline advancement," said Raul Rodriguez, Rigel's president and CEO. "In 2022 we look forward to
reporting Phase 3 fostamatinib results from both our wAIHA and COVID-19 trials in mid-2022. With respect to wAIHA, this new indication
fits well within our existing commercial infrastructure and would be the first approved treatment for these patients. For COVID-19, we
believe that if the data is positive, fostamatinib could be an important new treatment for physicians treating high-risk patients hospitalized
For the fourth quarter of 2021, Rigel reported
a net loss of $22.6 million, or $0.13 per basic and diluted share, compared to a net loss of $19.2 million, or $0.11 per basic and diluted
share, in the same period of 2020.
In the fourth quarter of 2021, total revenues
were $20.4 million, consisting of $17.6 million in TAVALISSE net product sales and $2.8 million in contract revenues from collaborations
and a government contract. TAVALISSE net product sales of $17.6 million decreased by 1% from $17.8 million in the fourth quarter of 2020.
Contract revenues of $2.8 million for the fourth quarter of 2021 consisted of $1.8 million in revenue from collaborative partners and
$1.0 million in revenue from a government contract with the U.S. Department of Defense (DOD).
total costs and expenses of $41.8 million in the fourth quarter of 2021, compared to $37.3 million for the same period in 2020. The
increase in costs and expenses was primarily due to the research and development costs for various ongoing clinical studies, including
Rigel's Phase 3 clinical trial of fostamatinib for the treatment of hospitalized patients with COVID-19, increased commercial activities,
including the recent sales force expansion, and the restructuring charges due to the exit from early-stage research and development.
For the full year 2021, Rigel reported a net
loss of $17.9 million, or $0.11 per basic and diluted share, compared to a net loss of $29.7 million, or $0.18 per basic and diluted share,
for the same period of 2020.
Rigel reported total revenues of $149.2 million
for the full year 2021, consisting of $63.0 million in TAVALISSE net product sales and $86.2 million in contract revenues from collaborations
and the government contract. TAVALISSE net product sales of $63.0 million for the full year 2021 increased by 2% from $61.7 million for
the same period of 2020. Contract revenues of $86.2 million for the full year 2021, consisted of $66.6 million in revenue related to Rigel's
license agreement with Lilly, $9.1 million revenue from other collaborative partners, and $10.5 million revenue from the government contract
Total costs and expenses for the full year
2021 were $161.7 million, compared to $137.6 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, including the recent
sales force expansion, personnel-related costs, stock-based compensation expense, and the restructuring charges due to the exit from early-stage
research and development.
As of December 31, 2021, Rigel had cash,
cash equivalents, and short-term investments of $125.0 million, compared to $57.3 million as of December 31, 2020. In February 2022,
Rigel accessed an additional $10.0 million term loan through its credit facility with MidCap Financial Trust and amended the terms of
the agreement to extend our option to access the remaining $30 million of principal available on this credit facility through March 31,
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 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.1 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
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.2 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.3
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. 4,5,6,7 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
| 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. | ||
| Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe ( Grade 3), interrupt, reduce dose or discontinue TAVALISSE. |
| Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation. | ||
| TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose. |
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)8; a Phase 3 clinical trial (NCT04629703) for the treatment of hospitalized high-risk patients
with COVID-198; 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.