Full Press Release Details
Rigel Reports First Quarter 2020 Financial
Results and Provides Business Update
First quarter net product sales
of $12.7 million and collaboration revenues of $43.1 million
41 patients enrolled in pivotal
Phase 3 clinical trial in warm AIHA
Received $10.0 million in funding
from existing credit facility
Conference call and webcast today at
SOUTH SAN FRANCISCO, Calif., May
5, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:
RIGL) today reported financial results for the first quarter ended March 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.
"During these extraordinary times,
we continue to execute on our business strategy while maintaining our commitment to the well-being of our employees, patients,
customers, and community. As the COVID-19 pandemic evolves, we will continue to monitor the impact this will have on our business
and operations going forward," said Raul Rodriguez, Rigel's president and CEO. "While we began to experience
the impact of COVID-19 in the latter part of the first quarter, the performance of our commercial business and progress of enrollment
in our warm autoimmune hemolytic anemia clinical trial give us confidence in our ability to regain momentum as the future begins
to normalize. We are also exploring opportunities for our earlier stage programs and continue to believe that we can finalize a
collaboration by year end. Additionally, we added $30 million to our financial position through a combination of a milestone payment
from Grifols and non-dilutive funding from MidCap Financial."
In the first quarter of 2020, 1,398 bottles of TAVALISSE were
shipped to patients and clinics with net product sales increasing 57% year over year to $12.7 million. During the quarter, the
company experienced typical first quarter reimbursement issues such as the resetting of co-pays and the Medicare donut hole, and
was also impacted negatively by the COVID-19 pandemic in the latter part of the quarter. As of March 31, a total of 591 bottles
remained in its distribution channels, a decrease of 5 bottles from the previous quarter.
Resources have been deployed to enable
Rigel's field-based employees to engage remotely with health care providers and their offices. These virtual engagements have enabled
its field team to support existing prescribers, as well as partner with new prescribers to identify appropriate patients for TAVALISSE.
Rigel is exploring opportunities to
collaborate with research institutes to investigate the potential of TAVALISSE to treat COVID-19 pneumonia and related acute respiratory
distress syndrome (ARDS). The SYK signaling pathway plays a known role in mediating the release of cytokines in response to the
COVID-19 virus, providing scientific rationale for investigating the potential benefit of SYK-inhibition in these patients.
The company's FORWARD study,
a pivotal Phase 3 clinical trial in warm autoimmune hemolytic anemia (AIHA) has enrolled 41 patients to date. Currently, the FORWARD
study has over 80 active clinical trial sites established across 22 countries. A vast majority of these sites have temporarily
postponed new patient enrollment due to the ongoing COVID-19 pandemic. As such, Rigel is no longer able to provide guidance on
the timing of enrollment completion. Enrollment is expected to regain momentum as conditions permit across its over 80 globally
diverse clinical sites.
Rigel currently does not anticipate disruption in supply of
TAVALISSE tablets and drug substance to meet the needs of its U.S. ITP commercial business, as well as its collaborative partners
and clinical trials worldwide.
In February 2020, Rigel received a
$20.0 million milestone payment from its collaborative partner Grifols, S.A. (Grifols). The payment was received upon the European
Commission's (EC) approval of the marketing authorization application (MAA) for fostamatinib for the treatment of chronic immune
thrombocytopenia in adult patients who are refractory to other treatments. In addition, as a result of the EC approval, $25.0
million of the $30.0 million upfront fee that Rigel previously received from Grifols will no longer be repayable by Rigel to Grifols.
Fostamatinib will be marketed in Europe under the brand name TAVLESSE (fostamatinib).
In May 2020, Rigel accessed the second
$10.0 million tranche from its $60.0 million term loan credit facility with MidCap Financial. The facility provides the company
with access to an additional $40.0 million which is subject to the achievement of certain conditions.
For the first quarter of 2020, Rigel
reported net income of $21.2 million, or $0.13 per share, compared to a net loss of $17.6 million, $0.11 per share, in the same
In the first quarter of 2020, total
revenues were $55.8 million, consisting of $12.7 million in net product sales and $43.1 million in contract revenues from collaborations.
Net product sales increased by 57% compared to $8.1 million in the first quarter of 2019.
Contract revenues from collaborations of $43.1 million in the
first quarter of 2020 relate to revenue from the upfront fee Rigel previously received from Grifols in the first quarter of 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. The Company will recognize the remaining $2.2 million deferred portion of the above payments upon performance of certain
research and development services under the collaboration agreement with Grifols.
Rigel reported total costs and expenses
of $34.7 million in the first quarter of 2020, compared to $31.0 million for the same period in 2019. The increase in total costs
and expenses was primarily due to the increase in third-party costs related to Rigel's ongoing pivotal Phase 3 study in warm AIHA,
research and development costs related to other clinical programs, and personnel-related costs, partially offset by stock-based
compensation expense.
Rigel will continue to undertake efforts to prevent or minimize
disruptions to its business and operations while monitoring for new developments related to the evolving COVID-19 pandemic. Rigel
does not yet know the full impact of such disruptions on its business, operations or financial condition.
As of March 31, 2020, Rigel had cash,
cash equivalents and short-term investments of $95.9 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.
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
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.
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
Please see www.TAVALISSE.com for
full Prescribing Information.