SOUTH SAN FRANCISCO, Calif.,
Nov. 5, 2019 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL)
today reported financial results for the third quarter ended
September 30, 2019, 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 continue to demonstrate progress in all of the key value
drivers for Rigel," said Raul
Rodriguez, Rigel's president and CEO. "Our commercial
business continues to expand with U.S. sales increasing 15% quarter
over quarter. We are moving forward with regulatory and
collaborative efforts in Europe,
Japan, and Canada to potentially make fostamatinib
available to ITP patients globally; our Phase 3 trial for
fostamatinib in warm autoimmune hemolytic anemia is enrolling; and
we have strengthened our pipeline with progress in our IRAK1/4 and
RIP1 programs. All of these achievements create valuable
opportunities for Rigel both in the near and long term."
Financial Update
For the third quarter of 2019, Rigel reported a net loss of
$11.5 million, or $0.07 per share, compared to a net loss of
$23.8 million, or $0.14 per share, in the same period of 2018.
For the third quarter of 2019, Rigel reported net product sales
from TAVALISSE of $11.7 million,
compared to $4.9 million in the same
period of 2018. The increase in net product sales reflects the
continued expansion of TAVALISSE use since its commercial launch in
May 2018.
Contract revenues from collaborations were $9.1 million for the three months ended
September 30, 2019, of which
$4.0 million related to a development
milestone from Aclaris Therapeutics, Inc., $3.8 million related to a commercial launch
milestone from Impact Biomedicines, Inc., which was subsequently
acquired by Celgene Corp., and $1.3
million from its collaboration agreements with Grifols, S.A.
and Kissei Pharmaceutical Co., Ltd. related to performance of
certain research and development services. There were no contract
revenues from collaborations during the three months ended
September 30, 2018.
Rigel reported total costs and expenses of $32.9 million in the third quarter of 2019,
compared to $29.2 million for the
same period in 2018. The increase in costs and expenses was
primarily due to increased research and development costs related
to its ongoing Phase 3 study in warm autoimmune hemolytic anemia
(AIHA).
For the nine months ended September 30,
2019, Rigel reported a net loss of $49.7 million, or $0.30 per share, compared to a net loss of
$73.7 million, or $0.47 per share, for the same period of 2018.
Rigel reported total revenues of $43.9
million for the nine months ended September 30, 2019, compared to $6.7 million for the same period in 2018. Total
revenues for the nine months ended September
30, 2019, consisted of $29.9
million in net product sales and $14.0 million in revenues related to Rigel's
collaboration agreements with Grifols, S.A., Kissei Pharmaceutical
Co., Ltd., Aclaris Therapeutics, Inc., and Impact Biomedicines,
Inc. Total revenues for the nine months ended September 30, 2018 consisted of $6.7 million in net product sales.
Total costs and expenses for the nine months ended September 30, 2019, were $95.6 million, compared to $81.9 million, for the same period of 2018. The
increase in total costs and expenses was primarily related to the
increase in personnel costs for Rigel's customer-facing team, as
well as third party costs related to Rigel's ongoing
commercialization of TAVALISSE in adult chronic ITP, and research
and development costs related to its ongoing Phase 3 study in warm
AIHA.
As of September 30, 2019, Rigel
had cash, cash equivalents and short-term investments of
$107.5 million, compared to
$128.5 million as of December 31, 2018.
Business Update
- Increased net product sales by 15% to $11.7 million from $10.2
million in the second quarter of 2019.
- Received positive trend vote from the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) on the Marketing Authorization Application (MAA) for
fostamatinib indicated for the treatment of chronic immune
thrombocytopenia in adult patients who are refractory to other
treatments.
- Entered into exclusive license agreements with Medison Pharma
to commercialize fostamatinib in Canada and Israel. Rigel received an upfront payment of
$5 million, which included an
advanced royalty payment, with the potential for approximately
$35 million in regulatory and
commercial milestones. In addition, Rigel will receive royalty
payments beginning at 30% of net sales after credit for the
advanced royalty payment is fulfilled.
- Began enrollment of a Phase 3 clinical trial of TAVALISSE in
patients with warm antibody AIHA. Enrollment is expected to
complete in mid-2020 with topline results in mid-2021.
- Completed a Phase 1 clinical trial of its IRAK1/4 inhibitor,
R835, which showed inhibition of cytokine production in a
proof-of-mechanism study done in humans. R835 showed tolerability
and a positive PK profile, supporting continued development of the
molecule.
- Initiated a Phase 1 clinical trial of R552, a
receptor-interacting protein kinase (RIP1) inhibitor. RIP1 is a key
driver of necroptosis, a form of cell death that is implicated in a
broad range of inflammatory processes.
- Appointed Wolfgang Dummer, MD,
PhD to the role of Chief Medical Officer. Dr. Dummer has more than
20 years of clinical and drug development experience with companies
such as Genentech, Inc., Biomarin Pharmaceuticals, Inc., and Aridis
Pharmaceuticals, Inc., as well as an extensive academic
history.
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
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 40,000 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.
About R8351
The investigational
candidate, R835, is an orally available, potent and selective
inhibitor of IRAK1 and IRAK4 that has been shown preclinically to
block inflammatory cytokine production in response to toll-like
receptor (TLR) and the interleukin-1 receptor (IL-1R) family
signaling. TLRs and IL-1Rs play a critical role in the innate
immune response and dysregulation of these pathways can lead to a
variety of inflammatory conditions. R835 is active in multiple
rodent models of inflammatory disease including psoriasis,
arthritis, lupus, multiple sclerosis and gout. The safety and
efficacy of R835 has not been established by the FDA or any
healthcare authority.
About R5521
The investigational
candidate, R552, is an orally available, potent and selective
inhibitor of receptor-interacting protein kinase (RIP1). RIP1 is
believed to play a critical role in necroptosis. Necroptosis is a
form of regulated cell death where the rupturing of cells leads to
the dispersion of their inner contents, which induces immune
responses and enhances inflammation. In preclinical studies, R552
prevented joint and skin inflammation in a RIP1-mediated murine
model of inflammation and tissue damage. The safety and efficacy of
R552 has not been established by the FDA or any healthcare
authority.
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 Rigel's website at www.rigel.com. The
webcast will be archived and available for replay after the call
via the Rigel website.
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 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), 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. Rigel's current
clinical programs include a Phase 3 study of fostamatinib in
autoimmune hemolytic anemia (AIHA); a recently completed Phase 1
study of R835, a proprietary molecule from its interleukin receptor
associated kinase (IRAK) program; and an ongoing Phase 1 study
of R552, a proprietary molecule from its receptor-interacting
protein kinase (RIP1) 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.; Rigel's ability to
broaden its pipeline of assets targeting immune-mediated diseases;
Rigel's regulatory and collaborative efforts in Europe, Japan, and Canada to make fostamatinib available to ITP
patients globally; the utility of fostamatinib in other
indications, including warm autoimmune hemolytic anemia and other
indications; Rigel's ability to achieve development and commercial
milestones; the sufficiency of Rigel's cash, cash equivalents and
short-term investments and the timing of its current cash runway;
and the design, timing and results of Rigel's clinical trials. 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 "planned", "will", "may", "expects", "anticipates",
"estimates", "hopes", "believes" 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 Quarterly Report on Form 10-Q
for the period ended June 30, 2019. 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
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2019
|
2018
|
|
2019
|
2018
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
Product sales,
net
|
$
|
11,716
|
$
|
4,865
|
|
$
|
29,943
|
$
|
6,652
|
|
Contract revenues
from collaborations
|
9,141
|
—
|
|
13,945
|
—
|
|
Total
revenues
|
20,857
|
4,865
|
|
43,888
|
6,652
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
Cost of product
sales
|
310
|
69
|
|
728
|
99
|
|
Research and
development (see Note A)
|
14,463
|
11,097
|
|
38,638
|
33,136
|
|
Selling, general and
administrative (see Note A)
|
18,121
|
18,069
|
|
56,276
|
48,632
|
|
Total costs and
expenses
|
32,894
|
29,235
|
|
95,642
|
81,867
|
Loss from
operations
|
(12,037)
|
(24,370)
|
|
(51,754)
|
(75,215)
|
Interest
income
|
555
|
604
|
|
2,068
|
1,507
|
Interest
expense
|
(8)
|
-
|
|
(8)
|
-
|
Net loss
|
|
$
|
(11,490)
|
$
|
(23,766)
|
|
$
|
(49,694)
|
$
|
(73,708)
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
|
(0.07)
|
$
|
(0.14)
|
|
$
|
(0.30)
|
$
|
(0.47)
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net loss per share, basic and
diluted
|
167,609
|
166,464
|
|
167,326
|
158,456
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
|
|
|
Selling, general and
administrative
|
$
|
1,611
|
$
|
2,194
|
|
$
|
5,519
|
$
|
3,913
|
|
Research and
development
|
487
|
801
|
|
2,185
|
1,734
|
|
|
$
|
2,098
|
$
|
2,995
|
|
$
|
7,704
|
$
|
5,647
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
December
31,
|
|
|
|
|
|
2019
|
2018
(1)
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
$
|
107,480
|
$
|
128,537
|
|
|
|
|
Total
assets
|
156,061
|
139,109
|
|
|
|
|
Stockholders'
equity
|
68,911
|
109,877
|
|
|
|
|
|
(1)
|
Derived from audited
financial statements
|
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SOURCE Rigel Pharmaceuticals, Inc.