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."
Business Update
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.
Financial Update
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 period of 2019.
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.
About ITP
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.
About AIHA
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.
About TAVALISSE
Indication
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.
Drug Interactions
- Concomitant use of TAVALISSE with strong CYP3A4 inhibitors
increases exposure to the major active metabolite of TAVALISSE
(R406), which may increase the risk of adverse reactions. Monitor
for toxicities that may require a reduction in TAVALISSE dose.
- It is not recommended to use TAVALISSE with strong CYP3A4
inducers, as concomitant use reduces exposure to R406.
- Concomitant use of TAVALISSE may increase concentrations of
some CYP3A4 substrate drugs and may require a dose reduction of the
CYP3A4 substrate drug.
- Concomitant use of TAVALISSE may increase concentrations of
BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp)
substrate drugs (eg, digoxin), which may require a dose reduction
of the BCRP and P-gp substrate drug.
Adverse Reactions
- Serious adverse drug reactions in the ITP double-blind studies
were febrile neutropenia, diarrhea, pneumonia, and hypertensive
crisis, which occurred in 1% of TAVALISSE patients. In addition,
severe adverse reactions occurred including dyspnea and
hypertension (both 2%), neutropenia, arthralgia, chest pain,
diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache,
syncope, and hypoxia (all 1%).
- Common adverse reactions (≥5% and more common than placebo)
from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea,
dizziness, ALT and AST increased, respiratory infection, rash,
abdominal pain, fatigue, chest pain, and neutropenia.
Please see www.TAVALISSE.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 is a registered trademark of Rigel Pharmaceuticals,
Inc.
About Rigel (www.rigel.com)
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 immune and
hematologic disorders, cancer and rare 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 has been approved by the European Commission for the
treatment of chronic immune thrombocytopenia in adult patients who
are refractory to other treatments, and will be marketed in
Europe under the name
TAVLESSE® (fostamatinib).
Rigel's clinical programs include a Phase 3 study of
fostamatinib in warm autoimmune hemolytic anemia (AIHA); a
completed Phase 1 study of R8351, a proprietary molecule
from its interleukin receptor associated kinase (IRAK) inhibitor
program; and an ongoing Phase 1 study of R5521, a
proprietary molecule from its receptor-interacting protein kinase
(RIP) inhibitor program. In addition, Rigel has product candidates
in clinical development with partners Aclaris Therapeutics,
AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.
1The product for this use or indication is
investigational and has not been proven safe or effective by any
regulatory authority.
Forward Looking Statements
This release contains
forward-looking statements relating to, among other things, the
commercial success of TAVALISSE in the U.S.; the sufficiency of
Rigel's supplies of TAVALISSE; the commercialization of TAVLESSE in
Europe and the timing thereof; the
utility of fostamatinib in warm autoimmune hemolytic anemia (AIHA);
the impact of the COVID-19 pandemic on Rigel's results and
operations; Rigel's ability to complete enrollment in its phase 3
clinical trial for AIHA and the timing thereof; Rigel's ability to
further develop its clinical stage products; the scientific
rationale for exploring use of fostamatinib to treat COVID-19 and
related conditions; and Rigel's partnering efforts. Any
statements contained in this press release that are not statements
of historical fact may be deemed to be forward-looking statements.
Words such as "potential," "may," "expects" and similar expressions
are intended to identify these forward-looking statements. These
forward-looking statements are based on Rigel's current
expectations and inherently involve significant risks and
uncertainties. Actual results and the timing of events could differ
materially from those anticipated in such forward looking
statements as a result of these risks and uncertainties, which
include, without limitation, risks and uncertainties associated
with the commercialization and marketing of TAVALISSE; risks that
the FDA, EMA or other regulatory authorities may make adverse
decisions regarding fostamatinib; risks that TAVALISSE clinical
trials may not be predictive of real-world results or of results in
subsequent clinical trials; risks that TAVALISSE may have
unintended side effects, adverse reactions or incidents of misuses;
the availability of resources to develop Rigel's product
candidates; market competition; as well as other risks detailed
from time to time in Rigel's reports filed with the Securities and
Exchange Commission, including its Annual Report on Form 10-K for
the year ended December 31, 2019 and
Quarterly Report on Form 10-Q for the quarter ended March 31, 2020. In addition, the COVID-19
pandemic may result in further delays in Rigel's studies, trials
and sales, or impact Rigel's ability to obtain supply of
TAVALISSE. Rigel does not undertake any obligation to update
forward-looking statements and expressly disclaims any obligation
or undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein.
IR Contact: David Burke
Phone: 650.624.1232
Email: dburke@rigel.com
RIGEL
PHARMACEUTICALS, INC.
|
STATEMENTS OF
OPERATIONS
|
(in thousands,
except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
2020
|
2019
|
|
|
(unaudited)
|
|
|
|
|
Revenues:
|
|
|
|
Product sales,
net
|
$
12,680
|
$
8,054
|
|
Contract revenues
from collaborations
|
43,081
|
4,570
|
|
Total
revenues
|
55,761
|
12,624
|
|
|
|
|
Costs and
expenses:
|
|
|
|
Cost of product
sales
|
155
|
107
|
|
Research and
development (see Note A)
|
16,149
|
10,949
|
|
Selling, general and
administrative (see Note A)
|
18,430
|
19,946
|
|
Total costs and
expenses
|
34,734
|
31,002
|
Loss from
operations
|
21,027
|
(18,378)
|
Interest
income
|
358
|
780
|
Interest
expense
|
(142)
|
—
|
Net income
(loss)
|
$
21,243
|
$
(17,598)
|
|
|
|
|
Net income (loss) per
share
|
|
|
|
Basic
|
$
0.13
|
$
(0.11)
|
|
Diluted
|
$
0.13
|
$
(0.11)
|
|
|
|
|
Weighted-average
shares used in computing net income (loss) per share
|
|
|
Basic
|
168,469
|
167,173
|
|
Diluted
|
168,568
|
167,173
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
Selling, general and
administrative
|
$
1,330
|
$
2,166
|
|
Research and
development
|
694
|
787
|
|
|
$
2,024
|
$
2,953
|
|
|
|
|
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
|
(in
thousands)
|
|
|
|
|
|
|
March
31,
|
December
31,
|
|
|
2020
|
2019
(1)
|
|
|
(unaudited)
|
|
|
Cash, cash
equivalents and short-term investments
|
$
95,926
|
$
98,078
|
|
Total
assets
|
143,363
|
147,569
|
|
Stockholders'
equity
|
78,499
|
53,815
|
|
|
|
|
(1)
|
Derived from audited
financial statements
|
|
|
|
|
|
|
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SOURCE Rigel Pharmaceuticals, Inc.