Full Press Release Details
Rigel Reports Third Quarter 2020 Financial
Results and Provides Business Update
Third quarter total revenues of $18.4
Net product sales of $16.3 million, a
39% year-over-year increase
Launching Phase 3 clinical
trial of fostamatinib in COVID-19 patients
Conference call and webcast today at
SOUTH SAN FRANCISCO, Calif., November
5, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:
RIGL) today reported financial results for the third quarter ended September 30, 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.
"Our team has done an excellent
job advancing our key value drivers while adapting to the widespread changes in the current global environment," said Raul
Rodriguez, Rigel's president and CEO. "We have continued to grow our TAVALISSE franchise with third quarter sales increasing
39% year-over-year and our global Phase 3 clinical trial for warm AIHA having enrolled over 60% of our patient goal. Additionally,
exploration of fostamatinib's potential in COVID-19 is rapidly expanding with our Phase 3 clinical trial launching this quarter
and enrollment ongoing in the Phase 2 trials sponsored by the NIH/NHLBI and Imperial College London."
study, a Phase 3 pivotal trial of TAVALISSE in warm autoimmune hemolytic anemia (AIHA),
has enrolled 57 of the 90 patients targeted for enrollment. The trial currently
has over 90 clinical trial sites established across 22 countries.
plans to launch a Phase 3 clinical trial to evaluate
the safety and efficacy of fostamatinib in hospitalized COVID-19 patients without respiratory failure that have certain high-risk
prognostic factors. 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.
Phase 2 clinical trial sponsored by the NIH/NHLBI, in collaboration with Inova Health System, to evaluate the safety of fostamatinib
for the treatment of hospitalized COVID-19 patients has enrolled 9 patients. This multi-center, double-blind, placebo-controlled
study will randomly assign fostamatinib plus SOC or matched placebo plus SOC (1:1) to approximately 60 evaluable patients. 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 cumulative incidence of serious adverse events (SAE) through day 29. The trial also includes
multiple secondary endpoints designed to assess the early efficacy and clinically relevant endpoints of disease course.
Imperial College London-sponsored Phase 2 clinical trial to evaluate the efficacy of fostamatinib for the treatment of COVID-19
pneumonia has begun enrolling patients. The study is a two-stage, open label, controlled clinical trial with patients randomized
(1:1:1) to fostamatinib plus SOC, ruxolitinib plus SOC, or SOC. 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 endpoint of this study is progression
from mild to severe COVID-19 pneumonia within 14 days in hospitalized patients.
recently launched FORTE, an observational study to further evaluate TAVALISSE as a
second-line treatment for adult chronic ITP. The study goal is to generate additional
data on patient quality of life and financial expenditures relative to the healthcare
of ITP patients. Along with the post-hoc data analysis of its Phase 3 clinical program, Rigel
plans to use this study to further increase and enhance its database of TAVALISSE in early line treatment of adult chronic ITP
For the third quarter of 2020, Rigel
reported a net loss of $14.2 million, or $0.08 per share, compared to a net loss of $11.5 million, $0.07 per share, in the same
In the third quarter of 2020, total
revenues were $18.4 million, consisting of $16.3 million in net product sales and $2.1 million in contract revenues from collaborations
for the achievement of a milestone in accordance with the amended license and collaboration agreement with Daiichi-Sankyo. Net
product sales increased by 39% from $11.7 million in the third quarter of 2019. The decrease in contract revenues from collaborations
in the third quarter of 2020 from $9.1 million in the same period of 2019 was due to developmental and commercial milestones from
our various collaborative partners in 2019, partially offset by the milestone in the third quarter of 2020 from Daiichi-Sankyo
reported total costs and expenses of $32.2 million in the third quarter of 2020, compared to $32.9 million in the same period of
2019. The decrease in total costs and expenses was primarily due to decreases to the timing of certain commercial-related
activities due to the COVID-19 pandemic, partially offset by the increases in personnel-related costs and increased use of consultants.
For the nine months ended September
30, 2020, Rigel reported a net loss of $10.5 million, or $0.06 per share, compared to a net loss of $49.7 million, or $0.30 per
share, in the same period of 2019.
reported total revenues of $90.2 million for the nine months ended September 30, 2020, compared to $43.9 million in the same period
of 2019. Total revenues for the nine months ended September 30, 2020 consisted of $43.9 million in net product sales and $46.2
million in contract revenues from collaborations. 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 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 our various collaborative partners in 2019.
costs and expenses for the nine months ended September 30, 2020 were $100.3 million, compared to $95.6 million in the same period
of 2019. The increase in total costs and expenses was primarily related to increases in research and development cost for
the on-going Phase 3 trial in warm AIHA, Phase 1 trial in RIP 1 inhibitor program and Phase 1 trial in IRAK 1/4 inhibitor program,
partially offset by decreases in stock-based compensation expense and various third-party costs.
As of September 30, 2020, Rigel had
cash, cash equivalents and short-term investments of $72.8 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 1-800-954-0603 (domestic) or 1-415-226-5355 (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 include fatigue, 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. In addition to fostamatinib, 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
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. Warm 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. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists
Coronavirus Disease 2019 (COVID-19) & SYK-Signaling
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
Spleen tyrosine kinase (SYK) is involved