Full Press Release Details
Rigel Reports First Quarter 2021 Financial Results
and Provides Business Update
SOUTH SAN FRANCISCO, Calif., May
5, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:
RIGL) today reported financial results for the first quarter ended March 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.
"We continued to make significant
progress in achieving important corporate and clinical milestones in the first quarter, which is
a true testament to the dedication of our team to bring meaningful treatment options to those patients who need them the most,"
said Raul Rodriguez, Rigel's president and CEO. "Following our recent announcement
of positive topline data from the Phase 2 trial of fostamatinib in hospitalized patients with COVID-19 and our partnership with Eli Lilly
for our RIP1 inhibitor program, we are excited by the prospects that the rest of 2021 holds for Rigel."
In April 2021, Rigel reported positive topline data from the multi-center,
Phase 2 clinical trial evaluating the safety of fostamatinib, Rigel's oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of
hospitalized patients with COVID-19. The trial met its primary endpoint of safety, and showed
broad and consistent improvement in numerous efficacy endpoints including mortality, ordinal scale assessment, and number of days in the
ICU. The trial was conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes
of Health (NIH), and Inova Health System. The NHLBI is expected to publish a full analysis of the trial data in a peer-reviewed journal.
Rigel is discussing these results with health authorities, including the U.S. Food and Drug Administration (FDA), and intends to apply
for Emergency Use Authorization (EUA) for fostamatinib for the treatment of hospitalized COVID-19 patients.
Rigel's Phase 3 clinical trial to
further evaluate fostamatinib in hospitalized patients with COVID-19 is currently enrolling. 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 this Phase 3 clinical trial. The study is designed to evaluate fostamatinib for prevention of progression to
severe disease in hospitalized patients with COVID-19 without respiratory failure that have certain high-risk prognostic factors.
This multi-center, double-blind, placebo-controlled study will randomly assign patients 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. In addition, Rigel's COVID-19 program includes an investigator-sponsored trial currently being conducted by
Imperial College London.
Rigel's FORWARD study, a Phase 3 pivotal trial of TAVALISSE in patients
with warm autoimmune hemolytic anemia (wAIHA), has enrolled 72 of 90 patients as of May 5, 2021. If approved, TAVALISSE has the potential
to be the first to market therapy for patients with wAIHA. The FDA has granted Fast Track designation as well as Orphan Drug designation
to TAVALISSE for the treatment of wAIHA.
In the first quarter of 2021, 1,599 bottles of TAVALISSE were shipped
to patients and clinics, an increase of 14% year over year. Net product sales for the first quarter decreased 2% year over year to $12.4
million. During the quarter, the company experienced typical first quarter reimbursement issues such as the resetting of co-pays and the
Medicare donut hole, along with physician and patient access issues created by the COVID-19 pandemic. Incrementally, the company's
net product sales were negatively impacted by a significant 235 bottle decrease in bottles remaining in its distribution channels compared
In April 2021, Rigel received a $125 million
upfront cash payment from its collaboration with Eli Lilly and Company (Lilly), following the expiration of the waiting period under the
Hart-Scott Rodino Antitrust Improvements Act of 1976. In February 2021, Rigel and Lilly entered into a global exclusive license agreement
and strategic collaboration to develop and commercialize Rigel's R552, a receptor-interacting serine/threonine-protein kinase 1 (RIP1)
inhibitor, for all indications including autoimmune and inflammatory diseases. Rigel and Lilly are currently focused on the planning for
the initiation of a Phase 2 clinical trial. Pursuant to the collaboration, Lilly will also lead all clinical development of central nervous
system (CNS) penetrating RIP1 inhibitors. Rigel is eligible to receive up to an additional $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 is also advancing the development of its IRAK1/4 program, where
it intends to pursue both hematology/oncology and rare immune disease opportunities. Rigel has begun discussions with the FDA regarding
initiating a Phase 2 clinical trial in low-risk myelodysplastic syndrome (MDS) and is also in discussions regarding academic medical collaborations
in this indication. In rare immune diseases, the company is exploring opportunities including palmoplantar pustulosis (PPP), hidradenitis
suppurativa (HS), and others.
Rigel's partner Kissei Pharmaceutical Co., Ltd. (Kissei) has
completed enrollment of its Phase 3 clinical trial of fostamatinib in adult Japanese patients with chronic ITP. In October 2018, Rigel
and Kissei entered into an exclusive agreement to develop and commercialize fostamatinib in all current and potential indications in Japan,
China, Taiwan, and the Republic of Korea.
For the first quarter of 2021, Rigel reported
net income of $39.5 million, or $0.23 per basic share and $0.22 per diluted share, compared to net income of $21.2 million, or $0.13 per
basic and diluted share, for the same period of 2020.
In the first quarter of 2021, total revenues
were $81.0 million, consisting of $12.4 million in TAVALISSE net product sales, $65.6 million in contract revenues from collaborations
and $3.0 million in government contract revenue.
Contract revenues from collaborations of $65.6
million for the first quarter of 2021 consisted of $60.6 million in revenue related to Rigel's license agreement with Lilly, $4.0
million in revenue related to the grant of non-exclusive license of a certain patent to an unrelated third-party company, and $1.0 million
in revenue for the delivery of drug supply under its collaboration agreement with Grifols. Government contract revenue was related to
the income that Rigel recognized pursuant to the agreement it entered into in January 2021 with the 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
$39.3 million in the first quarter of 2021, compared to $34.7 million for the same period in 2020. The increase in costs and expenses
was primarily due to increases in personnel-related costs, stock-based compensation expense, and research and development costs related
to its ongoing Phase 3 clinical trial in hospitalized patients with COVID-19 and development of its IRAK 1/4 inhibitor program, partially
offset by the decrease in research and development costs due to the completion of a Phase 1 clinical trial for its RIP1 inhibitor program.
As of March 31, 2021, Rigel had cash, cash equivalents and short-term
investments of $39.3 million, compared to $57.3 million as of December 31, 2020. Cash, cash equivalents and short-term investments as
of March 31, 2021, does not include the $125.0 million upfront payment received from Lilly in April 2021.
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 result in the destruction of 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.
COVID-19 & SYK Inhibition
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