SOUTH SAN FRANCISCO, Calif.,
Feb. 27, 2020 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today
reported financial results for the fourth quarter and full year
ended December 31, 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 are entering 2020 with a clear plan to drive shareholder
value for Rigel," said Raul
Rodriguez, Rigel's president and CEO. "We see substantial
opportunities for TAVALISSE to meet patient needs in the growing
adult chronic ITP market, particularly as an early line therapy.
Utilization in these less refractory patients continues to grow
with the support of ongoing physician education and data
generation. To expand the range of TAVALISSE indications, we are
conducting a Phase 3 trial in warm AIHA and expect to complete
patient enrollment midyear. In addition, we are extremely excited
about the potential of our early stage candidates and are currently
exploring partnership opportunities that would enable Rigel to
realize near-term value while also participating meaningfully in
the upside of these programs."
Business Update
At the 61st American
Society of Hematology (ASH) Annual Meeting & Exposition in
December 2019, the company presented
post-hoc data analysis from its Phase 3 clinical program of
TAVALISSE in adult patients with chronic ITP. In this analysis, 32
patients received fostamatinib as a second-line therapy, of which,
78% (25/32) achieved ≥1 platelet count of ≥50,000/µL (without
rescue therapy). Adverse events were manageable and consistent with
those previously reported with fostamatinib. These data highlight
the potential benefit of using TAVALISSE in earlier lines of
therapy.
In February 2020, Rigel received a
$20.0 million payment from its
collaborative partner Grifols, S.A. (Grifols). The payment is
comprised of $17.5 million for the
European Commission's approval of the marketing authorization
application for fostamatinib for the treatment of chronic immune
thrombocytopenia in adult patients who are refractory to other
treatments and a $2.5 million
creditable advance royalty payment based on the terms of the
collaboration agreement. Fostamatinib will be marketed in
Europe under the brand name
TAVLESSE™ (fostamatinib). Grifols is planning to launch the product
in the second quarter of 2020.
Enrollment is ongoing in Rigel's Phase 3 pivotal trial in warm
AIHA, FORWARD (Fostamatinib Research in Warm Antibody AIHA
Disease). A total of 34 patients have been randomized to date. The
trial remains on track to complete enrollment in mid-2020.
In February 2020, Rigel's partner
Kissei Pharmaceuticals Co., Ltd. (Kissei) was granted orphan drug
designation from the Japanese Ministry of Health, Labour and
Welfare for R788 (fostamatinib) in chronic idiopathic
thrombocytopenic purpura.
Financial Update
For the fourth quarter of 2019, Rigel reported a net loss of
$17.2 million, or $0.10 per share, compared to net income of
$3.2 million, or $0.02 per
share, in the same period of 2018.
In the fourth quarter of 2019, total revenues were $15.4 million, consisting of $13.8 million in net product sales and
$1.6 million in contract revenues
from collaborations. Net product sales of $13.8 million increased by 90% compared to
$7.3 million in the fourth quarter of
2018. This increase reflects the expanding patient and prescriber
base for TAVALISSE and the growing persistency rate for refills at
month 4, which is approximately 54%.
Contract revenues from collaborations of $1.6 million for the fourth quarter ended
December 31, 2019 consists of a
$1.5 million fee earned pursuant to
an amendment of the license and collaboration agreement with
Aclaris Therapeutics, Inc. (Aclaris) in October 2019, as well as deferred revenue from
Rigel's collaboration with Grifols related to the performance of
certain research and development services.
Rigel reported total costs and expenses of $32.7 million in the fourth quarter of 2019,
compared to $35.3 million for the
same period in 2018. The decrease in costs and expenses was
primarily due to decreases in personnel-related expenses and
various third-party costs.
For the full year ended December 31,
2019, Rigel reported a net loss of $66.9 million, or $0.40 per share, compared to a net loss of
$70.5 million, or $0.44 per share, for the same period of 2018.
Rigel reported total revenues of $59.3
million for the year ended December
31, 2019, consisting of $43.8
million in net product sales and $15.5 million in revenues related to Rigel's
collaboration agreements with Grifols, Kissei, Aclaris, and Impact
Biomedicines, Inc.
Total costs and expenses for the year ended December 31, 2019, were $128.4 million, compared to $117.2 million, for the same period of 2018. The
increase in total costs and expenses was primarily due to the
increases in third party costs related to Rigel's ongoing pivotal
Phase 3 study in warm AIHA, personnel-related costs, on-going
commercialization of TAVALISSE in adult chronic ITP, and research
and development costs related to its Phase 1 study in RIP.
As of December 31, 2019, Rigel had
cash, cash equivalents and short-term investments of $98.1 million, compared to $128.5 million as of December 31, 2018. Rigel previously announced
that in September 2019, we entered
into a $60.0 million term loan credit
facility with MidCap Financial. At closing, $10.0 million was funded to Rigel in an initial
tranche. The facility also gives Rigel the ability to access an
additional $50.0 million, of which
$40.0 million is subject to the
achievement of certain customary conditions.
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 antibody
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 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 pathological conditions. R835 treatment demonstrates
amelioration of clinical symptoms 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.
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. 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 recently
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 commercialization
of TAVLESSE in Europe and the
timing thereof; Rigel's ability to grow utilization of TAVALISSE in
early line therapy; the utility of fostamatinib in warm autoimmune
hemolytic anemia (AIHA); 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 product candidates;
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
Quarterly Report on Form 10-Q for the period ended September 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
December 31,
|
|
Year Ended
December 31,
|
|
|
|
2019
|
2018
|
|
2019
|
2018
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
Product sales,
net
|
$
13,829
|
$
7,295
|
|
$
43,772
|
$
13,947
|
|
|
Contract revenues
from collaborations
|
1,571
|
30,562
|
|
15,516
|
30,562
|
|
|
Total
revenues
|
15,400
|
37,857
|
|
59,288
|
44,509
|
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
Cost of product
sales
|
178
|
188
|
|
906
|
287
|
|
|
Research and
development (see Note A)
|
14,247
|
13,767
|
|
52,885
|
46,903
|
|
|
Selling, general and
administrative (see Note A)
|
18,312
|
21,370
|
|
74,588
|
70,002
|
|
|
Total costs and
expenses
|
32,737
|
35,325
|
|
128,379
|
117,192
|
|
|
|
|
|
|
|
|
|
Income (loss) from
operations
|
(17,337)
|
2,532
|
|
(69,091)
|
(72,683)
|
|
Interest
income
|
464
|
696
|
|
2,532
|
2,203
|
|
Interest
expense
|
(327)
|
-
|
|
(335)
|
-
|
|
|
|
|
|
|
|
|
|
Net income
(loss)
|
$ (17,200)
|
$
3,228
|
|
$ (66,894)
|
$ (70,480)
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share, basic and diluted
|
$
(0.10)
|
$
0.02
|
|
$
(0.40)
|
$
(0.44)
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net income (loss) per share
|
|
|
|
|
|
|
|
Basic
|
167,619
|
166,680
|
|
167,400
|
160,529
|
|
|
Diluted
|
167,619
|
167,617
|
|
167,400
|
160,529
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
$
934
|
$
1,470
|
|
$
6,453
|
$
5,383
|
|
|
Research and
development
|
477
|
587
|
|
2,662
|
2,321
|
|
|
|
$
1,411
|
$
2,057
|
|
$
9,115
|
$
7,704
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
|
|
|
|
|
2019
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
$
98,078
|
$ 128,537
|
|
|
|
|
|
Total
assets
|
147,569
|
139,109
|
|
|
|
|
|
Stockholders'
equity
|
53,815
|
109,877
|
|
|
|
|
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SOURCE Rigel Pharmaceuticals, Inc.