SOUTH SAN FRANCISCO, Calif.,
Feb. 28, 2019 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), today reported
financial results for the fourth quarter and full year ended
December 31, 2018 and provided a
business update.
Recent Highlights
- Fourth quarter 2018 total revenues were $37.9 million; including $30.6 million in collaboration revenues and
$7.3 million in net product sales of
TAVALISSE® (fostamatinib disodium hexahydrate) for the treatment of
thrombocytopenia in adults with chronic immune thrombocytopenia
(ITP) who have had an insufficient response to a previous
treatment
- Full year 2018 total revenues were $44.5
million, including $13.9
million in net product sales of TAVALISSE®
- As of December 31, 2018, cash,
cash equivalents, and short-term investments were $128.5 million
- On January 23, 2019, Rigel
entered into an exclusive license and supply agreement with
Grifols, S.A. (Grifols) to commercialize fostamatinib in
Europe and Turkey
"Since the successful U.S. launch of TAVALISSE in May of 2018,
our momentum has continued to build with a growing number of
physicians utilizing our product as an early treatment option,"
stated Raul Rodriguez, president and
CEO. "Our recent commercial collaborations with European and
Japanese partners, Grifols and Kissei, lay the groundwork for us to
advance fostamatinib globally and to access the worldwide ITP
market which is estimated to be $1.8
billion annually. These recent collaborations, along with
growing TAVALISSE sales, have also provided additional funds to
strengthen our balance sheet. While we remain focused on building
our commercial business, we will continue the expansion of our
pipeline with the upcoming initiation of our Phase 3 trial in warm
autoimmune hemolytic anemia."
Financial Update
For the fourth quarter of 2018, Rigel reported net income
of $3.2 million, or $0.02 basic and diluted net income
per share, compared to a net loss of $25.9 million,
or $0.18 basic and diluted net loss per share, in the
same period of 2017.
For the fourth quarter of 2018, Rigel reported total revenues of
$37.9 million, consisting of
$30.6 million in collaboration
revenues and $7.3 million in net
product sales of TAVALISSE. There were no net product sales nor
contract revenues from collaborations in the fourth quarter of
2017.
Contract revenue from collaborations of $30.6 million in the fourth quarter of 2018 were
related to the portion of the $33.0
million upfront fee recognized as revenue upon delivery of
license rights to Kissei Pharmaceutical Co., Ltd. (Kissei) for the
development and commercialization of fostamatinib in all current
and potential indications in Japan, China,
Taiwan and the Republic of
Korea.
Rigel reported total costs and expenses of $35.3
million in the fourth quarter of 2018, compared
to $26.2 million for the same period in 2017. The
increase in costs and expenses was primarily due to the increase in
personnel costs as Rigel expanded its customer-facing and medical
affairs teams, third party costs to support Rigel's ongoing
commercial efforts for TAVALISSE, as well as research and
development cost for its warm autoimmune hemolytic anemia (AIHA)
and other preclinical studies.
For the year ended December 31, 2018, Rigel reported a net
loss of $70.5 million, or $0.44 per share, compared
to a net loss of $78.0 million, or $0.62 per share,
for the same period of 2017.
Rigel reported total revenues of $44.5
million for the year ended December
31, 2018, compared to $4.5
million in 2017. Total revenues in 2018 consisted of
$30.6 million in collaboration
revenue related to Rigel's collaboration agreement with Kissei and
$13.9 million in net product sales of
TAVALISSE. Contract revenues from collaborations in 2017 consisted
of a $3.3 million payment Rigel
received from BerGenBio ASA as a result of advancing BGB324, an
investigational and orally available small molecule AXL kinase
inhibitor, to a Phase 2 clinical study, and a $1.2 million payment Rigel earned pursuant to its
license agreement with a third party. There were no product sales
for the year ended December 31,
2017.
Total costs and expenses for the year ended December 31, 2018 were $117.2 million, versus $84.1 million for the full year 2017, primarily
related to an increase in personnel and third-party costs
associated with the launch of TAVALISSE.
As of December 31, 2018, Rigel had cash, cash equivalents
and short-term investments of $128.5
million, compared to $115.8 million as
of December 31, 2017.
Business Update
Revenue from sales of TAVALISSE grew approximately 50% in the
fourth quarter of 2018 compared to the third quarter of 2018,
driven in part by continued use of the product as an early
treatment option in steroid refractory patients and strong
continuation of therapy among patients.
In January 2019, Rigel announced
that it had entered into an exclusive license and supply agreement
with Grifols to commercialize fostamatinib disodium
hexahydrate in all potential indications
in Europe and Turkey.
With this agreement, Rigel is positioned to access the three
largest markets for ITP (U.S., EU, and Japan), an indication with a global market
that is estimated to be over $1.8
billion annually. This collaboration partners fostamatinib
with one of the largest intravenous immunoglobulin (IVIG)
manufacturers globally that has established relationships with
European hematologists and hematologist/oncologists, as well as a
distribution infrastructure across the EU. Fostamatinib is on track
for potential EMA approval by the end of 2019, which could enable a
product launch in initial European markets as early as 2020.
Under terms of the commercial license agreement, Rigel received
a $30.0 million upfront cash payment, with the potential
for $297.5 million in payments related to regulatory and
commercial milestones, which includes a $20.0
million payment upon EMA approval of fostamatinib for the
treatment of chronic ITP. Rigel will also receive stepped
double-digit royalty payments based on tiered net sales which may
reach 30% of net sales of fostamatinib. In return, Grifols receives
exclusive rights to fostamatinib in human diseases in Europe and Turkey, including chronic ITP, autoimmune
hemolytic anemia (AIHA), and IgA nephropathy (IgAN). In the event
that, in 2021, after the second anniversary of the agreement,
fostamatinib has not been approved by the EMA for the treatment of
ITP in Europe, Grifols will have
the option during a six-month time-frame to terminate the entire
agreement which would terminate all their rights to ITP, AIHA, and
all other indications. In this limited circumstance, Rigel will pay
Grifols $25.0 million and regain all
rights to fostamatinib in the Grifols territories. Rigel retains
the global rights to fostamatinib outside the Grifols and Kissei
territories.
In addition to growing its commercial business, Rigel has been
working to broaden its pipeline by expanding the potential use of
fostamatinib in other indications and developing new molecules.
Rigel is on track to initiate a pivotal Phase 3 trial of
fostamatinib in warm AIHA in the first half of 2019. Additionally,
the Phase 1 trial of R8351, Rigel's investigational IRAK
1/4 inhibitor, is expected to report initial data in the second
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. 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 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 2257425. 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 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), 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 fostamatinib in autoimmune hemolytic
anemia 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
partnership with Grifols, Kissei and other partnering
opportunities across its pipeline; Rigel's ability to
achieve regulatory and commercial milestone payments under its
agreement with Grifols; expectations related to the market
opportunity for ITP; Rigel's ability to broaden its pipeline; the
potential opportunity for fostamatinib to obtain approval in the EU
by the end of 2019 and obtain product launch in initial European
markets in 2020. 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 September 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
December 31,
|
|
Year Ended
December 31,
|
|
|
|
2018
|
2017
|
|
2018
|
2017
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
Product sales,
net
|
$
7,295
|
$
-
|
|
$
13,947
|
$
-
|
|
|
Contract revenues
from collaborations
|
30,562
|
-
|
|
30,562
|
4,484
|
|
|
Total
revenues
|
37,857
|
-
|
|
44,509
|
4,484
|
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
Cost of product
sales
|
188
|
-
|
|
287
|
-
|
|
|
Research and
development (see Note A)
|
13,767
|
11,561
|
|
46,903
|
46,269
|
|
|
Selling, general and
administrative (see Note A)
|
21,370
|
14,654
|
|
70,002
|
37,831
|
|
|
Total costs and
expenses
|
35,325
|
26,215
|
|
117,192
|
84,100
|
|
|
|
|
|
|
|
|
|
Income (loss) from
operations
|
2,532
|
(26,215)
|
|
(72,683)
|
(79,616)
|
|
Interest
income
|
696
|
344
|
|
2,203
|
892
|
|
Gain on disposal of
assets
|
-
|
-
|
|
-
|
732
|
|
|
|
|
|
|
|
|
|
Net income
(loss)
|
$
3,228
|
$ (25,871)
|
|
$ (70,480)
|
$ (77,992)
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share, basic and diluted
|
$
0.02
|
$
(0.18)
|
|
$
(0.44)
|
$
(0.62)
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net income (loss) per share
|
|
|
|
|
|
|
|
Basic
|
166,680
|
144,252
|
|
160,529
|
126,324
|
|
|
Diluted
|
167,617
|
144,252
|
|
160,529
|
126,324
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
$
1,470
|
$
2,540
|
|
$
5,383
|
$
4,490
|
|
|
Research and
development
|
587
|
519
|
|
2,321
|
1,497
|
|
|
|
$
2,057
|
$
3,059
|
|
$
7,704
|
$
5,987
|
|
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
|
(in
thousands)
|
|
|
|
|
|
|
December
31,
|
|
|
2018
|
2017
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
$ 128,537
|
$ 115,751
|
|
Total
assets
|
139,109
|
119,111
|
|
Stockholders'
equity
|
109,877
|
100,646
|
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SOURCE Rigel Pharmaceuticals, Inc.