- First quarter 2023 Total Revenue of $26.1 million which includes
TAVALISSE® net product sales of $22.3 million and REZLIDHIA® net
product sales of $1.5
million
- Global expansion of TAVALISSE in ITP with Japanese launch by
partner Kissei
- Conference call and webcast scheduled today at 4:30 p.m. Eastern Time
SOUTH
SAN FRANCISCO, Calif., May 2, 2023
/PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today
reported financial results for the first quarter ended March 31, 2023, 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
and sales of REZLIDHIA® (olutasidenib) capsules for
the treatment of adult patients with relapsed or refractory (R/R)
acute myeloid leukemia (AML) with a susceptible isocitrate
dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved
test.
"We are thrilled with our strong first quarter net product sales
performance, a 47% increase from Q1 2022. This reflects our
ability to advance our launch of REZLIDHIA in mIDH1 R/R AML
while driving continued growth in TAVALISSE ITP sales," said
Raul Rodriguez, Rigel's president
and CEO. "For the remainder of 2023, we have established a strong
foundation for our hematology-oncology business to successfully
deliver growth in both TAVALISSE and REZLIDHIA, and to advance our
development programs."
Business Update
- In the first quarter of 2023, a total of 2,281 bottles of
TAVALISSE were sold in the U.S., 2,256 of which were shipped
directly to patients and clinics, representing the highest number
of bottles shipped to patients and clinics in a quarter since
launch.
- During the first full quarter of launch, a total of 113 bottles
of REZLIDHIA were sold in the U.S., 109 of which were shipped
directly to patients and clinics.
- REZLIDHIA was added by the National Comprehensive Cancer
Network® (NCCN®) to the latest NCCN Clinical
Practice Guidelines in Oncology (NCCN Guidelines®) for
AML in January 2023. REZLIDHIA is
included as a recommended targeted therapy for adult patients with
R/R AML with IDH1 mutation.
- Rigel announced a peer-reviewed publication of data in Blood
Advances in February 2023, which
summarized clinical results from the Phase 2 registration trial of
REZLIDHIA in patients with mIDH1 R/R AML. The published data
demonstrate that REZLIDHIA induced durable remissions and
transfusion independence with a well-characterized safety
profile.
- In April, Rigel's partner Kissei announced the launch of
TAVALISSE in Japan for the
treatment of chronic ITP.
- Rigel continues to advance the open-label, Phase 1b clinical trial of R2891, an
investigational, potent, and selective IRAK1/4 inhibitor, in
patients with lower-risk myeloid dysplastic syndrome (LR-MDS) who
are refractory/resistant to prior therapies. Rigel has completed
enrollment of the first cohort of the trial and enrollment of the
second cohort is underway.
- R552, an investigational, potent, and selective RIPK1
inhibitor, is being advanced by Rigel's partner Eli Lilly (Lilly).
The initial Phase 2a trial in approximately 100 patients with
moderately to severely active rheumatoid arthritis (RA) is
anticipated to begin in the second quarter of 2023 and will involve
global recruitment. The Phase 2a trial analysis is expected by the
end of 2024.
Financial Update
For the first quarter of 2023, Rigel reported a net loss of
$13.5 million, or $0.08 per basic and diluted share, compared to a
net loss of $27.4 million, or
$0.16 per basic and diluted share,
for the same period of 2022.
For the first quarter of 2023, total revenues were $26.1 million, consisting of $22.3 million in TAVALISSE net product sales,
$1.5 million in REZLIDHIA net product
sales, and $2.3 million in contract
revenues from collaborations. TAVALISSE net product sales of
$22.3 million increased by 38% from
$16.2 million for the same period of
2022. Contract revenues from collaborations for the first quarter
of 2023 consisted primarily of revenue from Grifols S.A., with
$1.6 million related to the delivery
of drug supplies and a royalty of $0.7
million.
For the first quarter of 2023, total costs and expenses were
$38.8 million, compared to
$43.0 million for the same period of
2022. The decrease in costs and expenses was primarily due to
decreased research and development costs related to the Phase 3
clinical trial of fostamatinib for wAIHA, the Phase 3 clinical
trial of fostamatinib in high-risk hospitalized patients with
COVID-19, and the IRAK 1/4 inhibitor program.
As of March 31, 2023, Rigel had
cash, cash equivalents and short-term investments of $58.7 million, compared to $58.2 million as of December 31, 2022. In March 2023, Rigel accessed an additional
$20.0 million term loan through its
credit facility with MidCap Financial Trust.
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 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 AML
Acute myeloid leukemia (AML) is a rapidly
progressing cancer of the blood and bone marrow that affects
myeloid cells, which normally develop into various types of mature
blood cells. AML occurs primarily in adults and accounts for about
1 percent of all adult cancers. The American Cancer Society
estimates that in the United
States alone, there will be about 20,380 new cases, most in
adults, in 2023.2
Relapsed AML affects about half of all patients who, following
treatment and remission, experience a return of leukemia cells in
the bone marrow.3 Refractory AML, which affects
between 10 and 40 percent of newly diagnosed patients, occurs when
a patient fails to achieve remission even after intensive
treatment.4 Quality of life declines for patients
with each successive line of treatment for AML, and well-tolerated
treatments in relapsed or refractory disease remain an unmet
need.
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.TAVALISSEUSPI.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 TAVLESSE are registered trademarks of Rigel
Pharmaceuticals, Inc.
About REZLIDHIA®
INDICATION
REZLIDHIA is indicated for the treatment of
adult patients with relapsed or refractory acute myeloid leukemia
(AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation
as detected by an FDA-approved test.
IMPORTANT SAFETY INFORMATION
WARNING:
DIFFERENTIATION SYNDROME
Differentiation syndrome, which can be fatal, can occur with
REZLIDHIA treatment. Symptoms may include dyspnea, pulmonary
infiltrates/pleuropericardial effusion, kidney injury, hypotension,
fever, and weight gain. If differentiation syndrome is suspected,
withhold REZLIDHIA and initiate treatment with corticosteroids and
hemodynamic monitoring until symptom resolution.
|
WARNINGS AND PRECAUTIONS
Differentiation Syndrome
REZLIDHIA can cause
differentiation syndrome. In the clinical trial of REZLIDHIA in
patients with relapsed or refractory AML, differentiation syndrome
occurred in 16% of patients, with grade 3 or 4 differentiation
syndrome occurring in 8% of patients treated, and fatalities in 1%
of patients. Differentiation syndrome is associated with rapid
proliferation and differentiation of myeloid cells and may be
life-threatening or fatal. Symptoms of differentiation syndrome in
patients treated with REZLIDHIA included leukocytosis, dyspnea,
pulmonary infiltrates/pleuropericardial effusion, kidney injury,
fever, edema, pyrexia, and weight gain. Of the 25 patients who
experienced differentiation syndrome, 19 (76%) recovered after
treatment or after dose interruption of REZLIDHIA. Differentiation
syndrome occurred as early as 1 day and up to 18 months after
REZLIDHIA initiation and has been observed with or without
concomitant leukocytosis.
If differentiation syndrome is suspected, temporarily withhold
REZLIDHIA and initiate systemic corticosteroids (e.g.,
dexamethasone 10 mg IV every 12 hours) for a minimum of 3 days and
until resolution of signs and symptoms. If concomitant
leukocytosis is observed, initiate treatment with hydroxyurea, as
clinically indicated. Taper corticosteroids and hydroxyurea after
resolution of symptoms. Differentiation syndrome may recur with
premature discontinuation of corticosteroids and/or hydroxyurea
treatment. Institute supportive measures and hemodynamic monitoring
until improvement; withhold dose of REZLIDHIA and consider dose
reduction based on recurrence.
Hepatotoxicity
REZLIDHIA can cause hepatotoxicity,
presenting as increased alanine aminotransferase (ALT), increased
aspartate aminotransferase (AST), increased blood alkaline
phosphatase, and/or elevated bilirubin. Of 153 patients with
relapsed or refractory AML who received REZLIDHIA, hepatotoxicity
occurred in 23% of patients; 13% experienced grade 3 or 4
hepatotoxicity. One patient treated with REZLIDHIA in combination
with azacitidine in the clinical trial, a combination for which
REZLIDHIA is not indicated, died from complications of drug-induced
liver injury. The median time to onset of hepatotoxicity in
patients with relapsed or refractory AML treated with REZLIDHIA was
1.2 months (range: 1 day to 17.5 months) after REZLIDHIA
initiation, and the median time to resolution was 12 days (range: 1
day to 17 months). The most common hepatotoxicities were elevations
of ALT, AST, blood alkaline phosphatase, and blood bilirubin.
Monitor patients frequently for clinical symptoms of hepatic
dysfunction such as fatigue, anorexia, right upper abdominal
discomfort, dark urine, or jaundice. Obtain baseline liver function
tests prior to initiation of REZLIDHIA, at least once weekly for
the first two months, once every other week for the third month,
once in the fourth month, and once every other month for the
duration of therapy. If hepatic dysfunction occurs, withhold,
reduce, or permanently discontinue REZLIDHIA based on
recurrence/severity.
ADVERSE REACTIONS
The most common (≥20%) adverse
reactions, including laboratory abnormalities, were aspartate
aminotransferase increased, alanine aminotransferase increased,
potassium decreased, sodium decreased, alkaline phosphatase
increased, nausea, creatinine increased, fatigue/malaise,
arthralgia, constipation, lymphocytes increased, bilirubin
increased, leukocytosis, uric acid increased, dyspnea, pyrexia,
rash, lipase increased, mucositis, diarrhea and transaminitis.
DRUG INTERACTIONS
- Avoid concomitant use of REZLIDHIA with strong or moderate
CYP3A inducers.
- Avoid concomitant use of REZLIDHIA with sensitive CYP3A
substrates unless otherwise instructed in the substrates
prescribing information. If concomitant use is unavoidable, monitor
patients for loss of therapeutic effect of these drugs.
LACTATION
Advise women not to breastfeed during
treatment with REZLIDHIA and for 2 weeks after the last dose.
GERIATRIC USE
No overall differences in effectiveness
were observed between patients 65 years and older and younger
patients. Compared to patients younger than 65 years of age, an
increase in incidence of hepatotoxicity and hypertension was
observed in patients ≥65 years of age.
HEPATIC IMPAIRMENT
In patients with mild or moderate
hepatic impairment, closely monitor for increased probability of
differentiation syndrome.
Click here for Full Prescribing Information, including
Boxed WARNING.
To report side effects of prescription drugs to the FDA, visit
www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).
REZLIDHIA is a registered trademark of Rigel Pharmaceuticals,
Inc.
About Rigel
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL)
is a biotechnology company dedicated to discovering, developing and
providing novel therapies that significantly improve the lives of
patients with hematologic disorders and cancer. Founded in 1996,
Rigel is based in South San Francisco,
California. For more information on Rigel, the Company's
marketed products and pipeline of potential products, visit
www.rigel.com.
- R289 is an investigational compound not approved by the
FDA
- The American Cancer Society. Key Statistics for Acute Myeloid
Leukemia (AML). Revised January 12,
2023. Accessed Feb. 15, 2023:
https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html
- Leukaemia Care. Relapse in Acute Myeloid Leukaemia (AML).
Version 3. Reviewed October 2021.
Accessed Feb 15, 2023:
https://media.leukaemiacare.org.uk/wp-content/uploads/Relapse-in-Acute-Myeloid-Leukaemia-AML-Web-Version.pdf
- Thol F, Schlenk RF, Heuser M, Ganser A.
How I treat refractory and early relapsed acute myeloid
leukemia. Blood (2015) 126 (3): 319-27. doi:
https://doi.org/10.1182/blood-2014-10-551911
Forward Looking Statements
This press release
contains forward-looking statements relating to, among other
things, the potential and market opportunity of olutasidenib as
therapeutics for R/R AML and other conditions, the
commercialization of fostamatinib in the U.S. and international
markets including Japan, and
Rigel's ability to further develop its clinical stage and
early-stage product candidates and Rigel's partnering effort,
including the progress of Phase 1b
clinical trial of R289 for the treatment of lower-risk myeloid
dysplastic syndrome, and the advancement of Phase 2a clinical trial
of R552 for the treatment of rheumatoid arthritis. Any statements
contained in this press release that are not statements of
historical fact may be deemed to be forward-looking statements.
Forward-looking statements can be identified by words such as
"plan", "potential", "may", "expects", "will" and similar
expressions in reference to future periods. Forward-looking
statements are neither historical facts nor assurances of future
performance. Instead, they are based on Rigel's current beliefs,
expectations, and assumptions and hence they inherently involve
significant risks, uncertainties and changes in
circumstances that are difficult to predict and many of which are
outside of our control. Therefore, you should not rely
on any of these forward-looking statements. 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 or REZLIDHIA; risks that the FDA, European Medicines
Agency, PMDA or other regulatory authorities may make adverse
decisions regarding fostamatinib or olutasidenib; risks that
clinical trials may not be predictive of real-world results or of
results in subsequent clinical trials; risks that fostamatinib or
olutasidenib 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 Annual Report on
Form 10-K for the year ended December 31,
2022 and subsequent filings. Any forward-looking statement
made by us in this press release is based only on
information currently available to us and speaks only as of the
date on which it is made. Rigel does not undertake any obligation
to update forward-looking statements, whether written or oral, that
may be made from time to time, whether as a result of new
information, future developments or otherwise, and expressly
disclaims any obligation or undertaking to release publicly any
updates or revisions to any forward-looking statements contained
herein, except as required by law.
Contact for Investors & Media:
Investors:
Rigel Pharmaceuticals, Inc.
650.624.1232
ir@rigel.com
Media:
David
Rosen
Argot Partners
212.600.1902
david.rosen@argotpartners.com
RIGEL
PHARMACEUTICALS, INC.
|
STATEMENTS OF
OPERATIONS
|
(in thousands,
except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
2023
|
|
2022
|
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
Product sales,
net
|
$
23,745
|
|
$
16,197
|
|
Contract revenues from
collaborations
|
2,325
|
|
538
|
|
Total
revenues
|
26,070
|
|
16,735
|
Costs and
expenses:
|
|
|
|
|
Cost of product
sales
|
977
|
|
121
|
|
Research and
development (see Note A)
|
10,089
|
|
15,474
|
|
Selling, general and
administrative (see Note A)
|
27,729
|
|
27,401
|
|
Total costs and
expenses
|
38,795
|
|
42,996
|
Loss from
operations
|
(12,725)
|
|
(26,261)
|
|
Interest
income
|
393
|
|
21
|
|
Interest
expense
|
(1,204)
|
|
(1,205)
|
Net
loss
|
$
(13,536)
|
|
$
(27,445)
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.08)
|
|
$
(0.16)
|
|
|
|
|
|
Weighted average shares
used in computing net loss per share, basic and diluted
|
173,568
|
|
171,774
|
|
|
|
|
|
Note
A
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
|
Selling, general and
administrative
|
$
1,735
|
|
$
2,739
|
|
Research and
development
|
1,023
|
|
468
|
|
|
$
2,758
|
|
$
3,207
|
|
|
|
|
|
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
(in
thousands)
|
|
|
|
|
|
|
|
As
of
|
|
|
March 31,
2023
|
|
December 31, 2022
(1)
|
|
|
(unaudited)
|
|
|
Cash, cash equivalents
and short-term investments
|
$
58,662
|
|
$
58,206
|
Total
assets
|
123,612
|
|
134,279
|
Stockholders'
deficit
|
(24,257)
|
|
(13,616)
|
|
|
|
|
(1) Derived from
audited financial statements
|
|
|
|
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SOURCE Rigel Pharmaceuticals, Inc.