SOUTH SAN FRANCISCO, Calif.,
Aug. 6, 2019 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL), today reported
financial results for the second quarter ended June 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.
"Execution is the key to Rigel's success, and has enabled us to
increase awareness of the benefits of TAVALISSE for chronic ITP as
seen by the 26% growth in net product sales quarter over quarter,"
stated Raul Rodriguez, president and
CEO. "Our commercial team continues to drive uptake of our product
and the interest level among the patient and physician communities
is very encouraging. In parallel, our pivotal trial of TAVALISSE in
warm autoimmune hemolytic anemia is underway and enrolling
patients. With the only warm AIHA treatment in a Phase 3 trial and
no FDA-approved therapy for the indication, this is a substantial
opportunity for Rigel."
Financial Update
For the second quarter of 2019, Rigel reported a net loss of
$20.6 million, or $0.12 per share, compared to a net loss of
$25.6 million, or $0.16 per share, in the same period of
2018.
For the second quarter of 2019, Rigel reported net product sales
from TAVALISSE of $10.2 million,
compared to $1.8 million in the same
period of 2018. The increase in net product sales reflects the
expansion of TAVALISSE use since its commercial launch in
May 2018.
Contract revenues from collaborations were $234,000 for the three months ended June 30, 2019, which were related to Rigel's
collaboration agreements with Kissei Pharmaceutical Co., Ltd. and
Grifols, S.A. There were no contract revenues from collaborations
during the three months ended June 30,
2018.
Rigel reported total costs and expenses of $31.7 million in the second quarter of 2019,
compared to $27.9 million for the
same period in 2018. The increase in costs and expenses was
primarily due to increased personnel costs for Rigel's
customer-facing team and third-party costs related to Rigel's
commercial launch of TAVALISSE in chronic ITP, as well as research
and development costs related to its Phase 3 pivotal trial of
TAVALISSE in patients with warm AIHA.
For the six months ended June 30,
2019, Rigel reported a net loss of $38.2 million, or $0.23 per share, compared to a net loss of
$49.9 million, or $0.32 per share, for the same period of 2018.
Rigel reported total revenues of $23.0
million for the six months ended June
30, 2019, compared to $1.8
million for the same period in 2018. Total revenues for the
six months ended June 30, 2019
consisted of $18.2 million in net
product sales and $4.8 million in
revenue related to Rigel's collaboration agreements with Grifols
and Kissei. Total revenues for the six months ended June 30, 2018 consisted of $1.8 million in net product sales. There were no
contract revenues from collaborations for the six months ended
June 30, 2018.
Total costs and expenses for the six months ended June 30, 2019 were $62.7
million, compared to $52.6
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 chronic ITP.
As of June 30, 2019, Rigel had
cash, cash equivalents and short-term investments of $112.4 million, compared to $128.5 million as of December 31, 2018.
Business Update
- Sales of TAVALISSE have achieved consecutive double-digit
quarterly growth since product launch in May of 2018. This reflects
an increase in prescribers, a broadening awareness among patients
and physicians, growing early line use, and continued strong refill
rates.
- Rigel has received the EMA's 180-day questions related to the
European marketing authorization application (MAA) for fostamatinib
in chronic ITP. The approval process remains on track for a
potential EMA decision by the end of this year.
- The first patients have been enrolled in FORWARD (Fostamatinib
Research in Warm Antibody AIHA Disease), Rigel's pivotal Phase 3
clinical trial in warm AIHA. The addition of clinical trial sites
is ramping. Topline results are expected in mid 2021, positioning
TAVALISSE to potentially become the first FDA-approved treatment
for warm AIHA.
- At the 2019 Congress of the European Hematology Association
(EHA), Rigel presented TAVALISSE data supporting its ability to
improve the lives of patients with chronic ITP and highlighting its
clinical trial progress in warm AIHA. These data were presented in
two posters which highlighted long-term safety and efficacy results
of TAVALISSE in a Phase 3 extension study for the treatment of
chronic ITP, as well as a Phase 2 open-label extension study in
patients with warm AIHA.
- Rigel plans to provide data from its Phase 1 trial of
R8351, an IRAK 1/4 inhibitor, in the second half of
2019.
- The company continues to explore additional opportunities to
expand its pipeline, which includes pursuing other indications for
TAVALISSE to take advantage of the anticipated product exclusivity
until 2031.
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, platelet
production amplifiers (TPO-RAs - thrombopoietin receptor agonists),
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 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.
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) 407-8309 (domestic) or (201) 689-8057 (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 (e.g., rosuvastatin) and P-Glycoprotein (P-gp)
substrate drugs (e.g., 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), 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) and an ongoing Phase 1 study of R835, a proprietary
molecule from its interleukin receptor associated kinase (IRAK)
program. In addition, Rigel has product candidates in clinical
development with partners BerGenBio ASA, Daiichi Sankyo, Aclaris
Therapeutics, and AstraZeneca.
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
ability to drive interest in and sales of TAVALISSE; the potential
for fostamatinib in ITP to obtain approval in the EU by the end of
2019; expectations related to the market opportunity for ITP;
Rigel's ability to broaden its pipeline; 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," "anticipate," 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 March 31, 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.
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
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2019
|
2018
|
|
2019
|
2018
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
Product sales,
net
|
$
10,173
|
$
1,787
|
|
$
18,227
|
$
1,787
|
|
Contract revenues
from collaborations
|
234
|
—
|
|
4,804
|
—
|
|
Total
revenues
|
10,407
|
1,787
|
|
23,031
|
1,787
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
Cost of product
sales
|
311
|
30
|
|
418
|
30
|
|
Research and
development (see Note A)
|
13,226
|
10,797
|
|
24,175
|
22,039
|
|
Selling, general and
administrative (see Note A)
|
18,209
|
17,071
|
|
38,155
|
30,563
|
|
Total costs and
expenses
|
31,746
|
27,898
|
|
62,748
|
52,632
|
Loss from
operations
|
(21,339)
|
(26,111)
|
|
(39,717)
|
(50,845)
|
Interest
income
|
733
|
554
|
|
1,513
|
903
|
Net loss
|
$
(20,606)
|
$
(25,557)
|
|
$
(38,204)
|
$
(49,942)
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.12)
|
$
(0.16)
|
|
$
(0.23)
|
$
(0.32)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net loss per share, basic and
diluted
|
167,191
|
161,577
|
|
167,182
|
154,385
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
|
|
|
Selling, general and
administrative
|
$
1,742
|
$
779
|
|
$
3,908
|
$
1,719
|
|
Research and
development
|
911
|
333
|
|
1,698
|
933
|
|
|
$
2,653
|
$
1,112
|
|
$
5,606
|
$
2,652
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30,
|
December
31,
|
|
|
|
|
|
2019
|
2018
(1)
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
$
112,377
|
$
128,537
|
|
|
|
|
Total
assets
|
156,158
|
139,109
|
|
|
|
|
Stockholders'
equity
|
78,291
|
109,877
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Derived from audited
financial statements
|
|
|
|
|
|
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SOURCE Rigel Pharmaceuticals, Inc.