SOUTH SAN FRANCISCO, Calif.,
Nov. 6, 2018 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL), today reported
financial results for the third quarter ended September 30, 2018, and also provided an update
on the commercial launch of TAVALISSE™ for treatment of
thrombocytopenia in adults with chronic immune thrombocytopenia
(ITP) who have had an insufficient response to a previous treatment
and its clinical development pipeline.
Recent Highlights
- Net product sales of $4.9 million
for TAVALISSE during the third quarter
- On October 29, entered into an
exclusive license and supply agreement with Kissei Pharmaceutical
Co., Ltd. (Kissei) for development and marketing rights to
fostamatinib in Asia; Rigel to
receive upfront cash payment of $33
million, with the potential for up to an additional
$147 million in milestone payments
and product transfer price payments based on tiered net sales
- On October 4, the European
Medicines Agency (EMA) validated the company's Marketing
Authorization Application (MAA) for fostamatinib1 in
adult chronic ITP, initiating the review process
- Phase 3 trial design for fostamatinib1
investigational candidate in autoimmune hemolytic anemia (AIHA) to
be submitted to U.S. Food and Drug Administration (FDA) in early
November
"We continue to advance our corporate strategy with solid
execution across all business areas. The success of our TAVALISSE
commercial launch in the United
States, our collaboration with Kissei in Asia, and our MAA validation highlight the
expanding capabilities of our organization," said Raul Rodriguez, president and CEO of Rigel. "In
parallel, our clinical development plans continue to increase the
potential of our pipeline. For our investigational agents, we plan
to initiate our Phase 3 study for fostamatinib in autoimmune
hemolytic anemia in the first half of 2019 and we continue to
explore potential drug development opportunities including for our
IRAK1/4 inhibitor, R835."
Financial Update
For the third quarter of 2018, Rigel reported a net loss
of $23.8 million, or $0.14 per share, compared to a
net loss of $17.7 million, or $0.14 per share, in
the same period of 2017.
For the third quarter of 2018, Rigel reported net product sales
from TAVALISSE of $4.9 million. Rigel recognizes revenue using
the sell-in methodology when products are delivered to its
distributors. There were no product sales in the third
quarter of 2017.
There were no contract revenues from collaborations in the third
quarter of 2018. Contract revenues from collaborations of
$900,000 in the third quarter of 2017
were related to a payment received from a license agreement with a
third party.
Rigel reported total costs and expenses of $29.2
million in the third quarter of 2018, compared
to $18.8 million for the same period in 2017. The
increase in costs and expenses was primarily due to the increases
in personnel costs as Rigel expanded its customer-facing team,
third party costs to support Rigel's ongoing commercial efforts for
TAVALISSE in chronic ITP, as well as stock-based compensation
expense related to certain performance-based stock options.
For the nine months ended September 30, 2018, Rigel
reported net product sales from TAVALISSE of $6.7 million.
There were no product sales for the nine months ended September 30, 2017. For the nine months
ended September 30, 2018, Rigel reported a net loss
of $73.7 million, or $0.47 per share, compared to a
net loss of $52.1 million, or $0.43 per share, for
the same period of 2017.
As of September 30, 2018, Rigel had cash, cash equivalents
and short-term investments of $115.6 million, compared
to $115.8 million as of December 31, 2017. With the
$33.0 million upfront payment Rigel
will receive under its collaboration agreement with Kissei, as
discussed below, Rigel expects that its cash, cash equivalents and
short-term investments will be sufficient to support its current
and projected funding requirements, including the on-going
commercial launch of TAVALISSE for chronic ITP in the U.S., into
the first quarter of 2020.
Business Update
Since commercial launch in May
2018, demand for TAVALISSE in adult patients with previous
treatment failure in cITP continues to grow, with broad usage seen
in steroid refractory patients. TAVALISSE has been utilized by a
broad base of prescribers and community physicians, and the payor
response has been positive with an approval rate of 85-90%.
Outside of the U.S., the company continues to further its global
commercialization strategy. Rigel has entered an exclusive license
and supply agreement with Kissei for the development and
commercialization of fostamatinib in all indications in
Japan. The agreement also provides
Kissei with rights to fostamatinib in China, Taiwan, and the Republic of Korea. In
exchange, Rigel will receive an upfront cash payment of
$33 million with the potential for up
to an additional $147 million in
development and commercial milestone payments. The company will
also receive product transfer price payments in the mid to upper
twenty percent range based on tiered net sales for exclusive supply
of fostamatinib.
In the EU, which is the second largest market for adult chronic
ITP, the EMA validated the MAA for fostamatinib1 in the
indication. The review process was initiated in October and the
company anticipates an opinion from the Committee on Human
Medicinal Products (CHMP) of the EMA by the fourth quarter of
2019.
Rigel continues to progress with its expansion plans for
fostamatinib in other indications1 and will submit its
Phase 3 trial design for the treatment of warm AIHA (wAIHA) to the
FDA in early November. The trial, designed in consultation with the
FDA, is a placebo-controlled study of approximately 80 patients
with primary or secondary wAIHA who have failed at least one prior
treatment. The primary endpoint will be a durable hemoglobin
response by week 24, defined as Hgb > 10 g/dL and > 2 g/dL
greater than baseline and durability of response, with the response
not being attributed to rescue therapy. Enrollment is expected to
begin in the first half of 2019.
About ITP
In patients with ITP, 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 (TPOs) and splenectomy. However, not
all patients are adequately treated with 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 (IL-1R) family receptor 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.
Conference Call and Webcast with Slides Today at 5:00PM
Eastern Time
Rigel will hold a live conference call and
webcast today at 5:00pm Eastern Time (2:00pm Pacific Time).
Participants can access the live conference call by dialing
855-892-1489 (domestic) or 720-634-2939 (international) and using
the Conference ID number 1398326. The webcast, with slide
presentation, 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 and RIGEL ONECARE are trademarks 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), an 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 an upcoming Phase 3 study of
fostamatinib1 in autoimmune hemolytic anemia and an
ongoing Phase 1 study of R8351, a proprietary molecule
from its interleukin receptor associated kinase (IRAK) program. In
addition, Rigel has product candidates in development with partners
BerGenBio AS, Daiichi Sankyo, and Aclaris
Therapeutics.
1 The 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, Rigel's partnership with Kissei; Rigel's
ability to achieve development and commercial milestone payments;
the sufficiency of Rigel's cash, cash equivalents and short-term
investments and the timing of its current cash runway; Rigel's
interactions with the FDA and EMA; the timing of the EMA's MAA
review process and when Rigel expects a decision; 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," "expect," 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, 2018. 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.
Contact: David Burke
Phone: 650.624.1232
Email: dburke@rigel.com
Media Contact: Jessica Daitch
Phone: 917.816.6712
Email: jessica.daitch@syneoshealth.com
RIGEL
PHARMACEUTICALS, INC.
|
STATEMENTS OF
OPERATIONS
|
(in thousands,
except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2018
|
2017
|
|
2018
|
2017
|
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
Product sales,
net
|
$
4,865
|
$
-
|
|
$
6,652
|
$
-
|
|
Contract revenues
from collaborations
|
—
|
900
|
|
—
|
4,484
|
|
Total
revenues
|
4,865
|
900
|
|
6,652
|
4,484
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
Cost of product
sales
|
69
|
—
|
|
99
|
—
|
|
Research and
development (see Note A)
|
11,097
|
10,808
|
|
33,136
|
34,708
|
|
Selling, general and
administrative (see Note A)
|
18,069
|
7,947
|
|
48,632
|
23,177
|
|
Total costs and
expenses
|
29,235
|
18,755
|
|
81,867
|
57,885
|
|
|
|
|
|
|
|
Loss from
operations
|
(24,370)
|
(17,855)
|
|
(75,215)
|
(53,401)
|
Interest
income
|
604
|
195
|
|
1,507
|
548
|
Gain on disposal of
assets
|
—
|
—
|
|
—
|
732
|
|
|
|
|
|
|
|
Net loss
|
$
(23,766)
|
$
(17,660)
|
|
$ (73,708)
|
$ (52,121)
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.14)
|
$
(0.14)
|
|
$
(0.47)
|
$
(0.43)
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net loss per share, basic and
diluted
|
166,464
|
124,628
|
|
158,456
|
120,282
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
|
|
|
Selling, general and
administrative
|
$
2,194
|
$
591
|
|
$
3,913
|
$
1,950
|
|
Research and
development
|
801
|
282
|
|
1,734
|
978
|
|
|
$
2,995
|
$
873
|
|
$
5,647
|
$
2,928
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
December
31,
|
|
|
|
|
|
2018
|
2017
(1)
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
$
115,637
|
$
115,751
|
|
|
|
|
Total
assets
|
123,169
|
119,111
|
|
|
|
|
Stockholders'
equity
|
103,473
|
100,646
|
|
|
|
|
|
(1)
|
Derived from audited
financial statements
|
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SOURCE Rigel Pharmaceuticals, Inc.