Full Press Release Details
Rigel Reports Fourth Quarter and Full
Year 2020 Financial Results and Provides Business Update
SOUTH SAN FRANCISCO, Calif., March
2, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:
RIGL) today reported financial results for the fourth quarter and full year ended December 31, 2020, 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.
its resilience as we continue to execute on our mission to serve patients who have diseases where few or no approved treatment
options exist," said Raul Rodriguez, Rigel's president and CEO. "Despite
the challenges brought on by 2020, we successfully expanded our global ITP reach and positioned ourselves for potential success
in wAIHA, announced a major collaboration with Lilly to develop RIP1 inhibitors, and launched a comprehensive COVID-19
clinical program which has gained the support from the NIH, DOD, and several universities.
Importantly, we also continued to explore opportunities in immunology, and more recently heme-onc, with our IRAK 1/4 inhibitor
In February 2021, Rigel and Eli Lilly
(Lilly) announced a global strategic collaboration to co-develop and commercialize R552, Rigel's receptor-interacting serine/threonine-protein
kinase 1 (RIP1) inhibitor, for all indications, including autoimmune and inflammatory diseases. In addition, Lilly will lead the
development and commercialization of all RIP1 inhibitors in central nervous system (CNS) indications. Under the terms of the agreement,
Lilly will pay an upfront cash payment to Rigel of $125 million and is eligible to receive up to $835 million in potential development,
regulatory and commercial milestone payments, as well as tiered royalties that will vary depending upon Rigel's clinical
development investment.
Rigel launched a Phase 3 clinical trial
to evaluate fostamatinib for the treatment of hospitalized COVID-19 patients. The Phase 3 trial is designed to evaluate the safety
and efficacy of fostamatinib in hospitalized COVID-19 patients without respiratory failure that have certain high-risk prognostic
This multi-center, double-blind, placebo-controlled,
adaptive design study is expected to enroll over 300 evaluable patients that will be randomly assigned to either fostamatinib plus
standard of care (SOC) or matched placebo plus SOC (1:1). Treatment will be administered orally twice daily for 14 days. There
will be a follow-up period to day 60. The primary endpoint of this study is the proportion of subjects who progress to severe/critical
disease within 29 days.
Rigel was awarded $16.5 million from
the U.S. Department of Defense's (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense
(JPEO-CBRND) to support Rigel's Phase 3 clinical trial of fostamatinib in hospitalized COVID-19 patients.
The Phase 2 clinical trial of fostamatinib in hospitalized COVID-19
patients sponsored by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), in
collaboration with Inova Health System has currently enrolled 57 patients. This is a double-blind, placebo-controlled Phase 2 clinical
trial that is randomly assigning fostamatinib plus standard of care (SOC) or matched placebo plus SOC (1:1) to approximately 60
evaluable patients who are a 5 to 7 on the 8-point ordinal scale (requiring supplemental oxygen via nasal canula or non-invasive
ventilation, requiring mechanical ventilation or extracorporeal membrane oxygenation). The primary endpoint of this study is cumulative
incidence of serious adverse events (SAE) through day 29. The NHLBI and Rigel expect to report topline data from this clinical
trial in April 2021.
Imperial College London's ongoing Phase 2 clinical trial
of fostamatinib in hospitalized COVID-19 patients is a two-stage open label, controlled trial with patients randomized (1:1:1)
to fostamatinib, ruxolitinib, or standard of care. The study has currently enrolled 106 patients. Treatment will be administered
twice daily for 14 days and patients will receive a follow-up assessment at day 14 and day 28 after the first dose. The primary
objective will be to determine the efficacy of fostamatinib and the efficacy of ruxolitinib compared to standard of care to reduce
the proportion of hospitalized patients progressing from mild or moderate to severe COVID-19 pneumonia.
Enrollment is progressing in Rigel's
FORWARD study, a Phase 3 pivotal trial of TAVALISSE in warm autoimmune hemolytic anemia (wAIHA). The study has enrolled 66 of 90
patients targeted for enrollment. Rigel has reached agreement with the U.S. Food and Drug Administration (FDA) on the durable response
measure for the primary efficacy endpoint of the study as well as the inclusion of additional secondary endpoints. The company
recently announced that the FDA had granted Fast Track designation to TAVALISSE for the treatment of wAIHA. The FDA previously
granted TAVALISSE Orphan Drug designation for this indication. If approved, TAVALISSE may be the first-to-market therapy for patients
Rigel continues to advance the development
of its IRAK1/4 program, which includes R835, an orally available, potent and selective inhibitor that inhibits both IRAK1 and IRAK4.
The company is currently identifying therapeutic opportunities in the areas of hematology/oncology and rare immunology diseases.
In November 2020, Rigel and its partner Medison Pharma
announced that Health Canada approved the new drug submission (NDS) for TAVALISSE for the treatment of
thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to other treatments. Medison is
also anticipating a decision on a New Drug Application (NDA) in Israel in Q2 2021. In July 2020, Rigel and its partner
Grifols S.A. announced the launch of TAVLESSE in Germany and the United Kingdom following approval by the European Commission
in January 2020. Currently, TAVALISSE is in a Phase 3b clinical trial in Japan with Rigel's partner Kissei. This trial
is required for approval by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.
For the fourth quarter of 2020, Rigel reported a net loss of
$19.2 million, or $0.11 per share, compared to net loss of $17.2 million, or $0.10 per share, in the same period of 2019.
In the fourth quarter of 2020, total revenues were $18.5 million,
consisting of $17.8 million in TAVALISSE net product sales and $697,000 in contract revenues from collaborations. TAVALISSE net
product sales of $17.8 million increased by 28% from $13.8 million in the fourth quarter of 2019. Contract revenues from collaborations
of $697,000 for the fourth quarter of 2020 consisted of $500,000 from Grifols related to an option for commercialization in additional
territories and $197,000 in revenues earned from the performance of certain research and development services from Rigel's
collaboration agreement with Grifols.
Rigel reported total costs and expenses of $37.3 million
in the fourth quarter of 2020, compared to $32.7 million for the same period in 2019. The increase in costs and expenses was
due to the increase in research and development costs primarily related to the continued work on Rigel's Phase 1
clinical trial in IRAK 1/4 inhibitor program, as well as its recently launched Phase 3 clinical trial for
hospitalized COVID-19 patients, partially offset by the decrease in costs on Rigel's ongoing Phase 3 clinical trial in
For the full year ended December 31, 2020, Rigel reported a
net loss of $29.7 million, or $0.18 per share, compared to a net loss of $66.9 million, or $0.40 per share, for the same period
Rigel reported total revenues of $108.6 million for the year
ended December 31, 2020, compared to $59.3 million in the same period of 2019. Total revenues for the year ended December 31, 2020
consisted of $61.7 million in TAVALISSE net product sales and $46.9 million in contract revenues from collaborations. TAVALISSE
net product sales of $61.7 million increased by 41% from $43.8 million in 2019. The increase in contract revenues from collaborations
related to revenue from the upfront fee previously received in 2019, as well as the milestone payment received from Grifols in
the first quarter of 2020 upon EC approval of the MAA for fostamatinib in Europe, and the $2.1 million in contract revenues
for the achievement of a milestone in accordance with the amended license and collaboration agreement with Daiichi-Sankyo, partially
offset by the developmental and commercial milestones from its-various collaborative partners in 2019.
Total costs and expenses for the year ended December 31, 2020,
were $137.6 million, compared to $128.4 million, for the same period of 2019. The increase in total costs and expenses was primarily
related to the increases in research and development costs due to the completion of Rigel's Phase 1 clinical trial in RIP1
inhibitor program, ongoing work on recently launched Phase 3 clinical trial for hospitalized COVID-19 patients, continued work
on Rigel's Phase 1 clinical trial in IRAK 1/4 inhibitor program and ongoing Phase 3 clinical trials in wAIHA, as well
as increases in personnel-related costs, partially offset by decreases in various third-party costs due to the COVID-19 pandemic.
As of December 31, 2020, Rigel had cash, cash equivalents and
short-term investments of $57.3 million, compared to $98.1 million as of December 31, 2019.
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.