- Fourth quarter 2023 Total Revenue of $35.8 million which includes
TAVALISSE® net product sales of $25.7 million and REZLIDHIA®
net product sales of $3.9
million
- Expanded product portfolio with acquisition of U.S. rights
to GAVRETO®, an FDA approved targeted therapy for the
treatment of RET fusion-positive metastatic non-small cell lung
cancer and advanced or metastatic thyroid cancer
- Conference call and webcast scheduled today at 4:30 p.m. Eastern Time
SOUTH
SAN FRANCISCO, Calif., March 5,
2024 /PRNewswire/ -- Rigel Pharmaceuticals,
Inc. (Nasdaq: RIGL) today reported financial results for the
fourth quarter and full year ended December
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.
"In 2023, fueled by increased physician awareness and adoption
for both TAVALISSE and REZLIDHIA, we achieved net product sales of
$104.3 million, an increase of 36%
compared to 2022," said Raul
Rodriguez, Rigel's president and CEO. "We recently expanded
our hematology and oncology portfolio with the addition of GAVRETO,
a U.S. marketed product for the treatment of RET fusion-positive
NSCLC. This addition is highly synergistic with our current
portfolio and existing infrastructure, which we believe will
further support top line growth. In 2024, we are focused on
commercial expansion and execution, while advancing our pipeline
with more strategic collaborations like MD Anderson and
CONNECT."
Business Update
- In the fourth quarter of 2023, we achieved the highest number
of TAVALISSE bottles shipped to patients and clinics in a quarter
since launch. A total of 2,671 bottles were sold in the U.S., 2,463
of which were shipped directly to patients and clinics. For the
full year ended December 31, 2023,
9,396 bottles of TAVALISSE were shipped directly to patients and
clinics, representing an increase of 16% compared to 2022.
- During the fourth quarter of 2023, we achieved 47% growth in
total REZLIDHIA bottles sold compared to the third quarter of 2023.
A total of 308 bottles were sold in the U.S., 278 of which were
shipped directly to patients and clinics. For the full year ended
December 31, 2023, 795 bottles of
REZLIDHIA were shipped directly to patients and clinics.
- In February 2024, Rigel announced
the acquisition of the U.S. rights to GAVRETO®
(pralsetinib). GAVRETO is a once daily, small molecule, oral,
kinase inhibitor of wild-type RET (rearranged during transfection)
and oncogenic RET fusions. GAVRETO is approved by the U.S. Food and
Drug Administration (FDA) for the treatment of adult patients with
metastatic RET fusion-positive non-small cell lung cancer (NSCLC)
and advanced thyroid cancer. The acquisition of this product
further expands Rigel's portfolio and leverages Rigel's existing
infrastructure in both the institutional and community medical
practice settings. Rigel expects to complete the transition of the
asset and start recognizing product sales in the third quarter of
2024.
- In January 2024, Rigel and
CONNECT announced a strategic development collaboration to evaluate
REZLIDHIA (olutasidenib) in combination with temozolomide as
maintenance therapy in patients with high-grade glioma (HGG)
harboring an isocitrate dehydrogenase-1 (IDH1) mutation. Under the
collaboration, CONNECT will include olutasidenib in CONNECT's
TarGeT-D, a molecularly guided Phase 2 umbrella clinical trial for
HGG. The Rigel-sponsored arm will study post-radiotherapy
administration of olutasidenib in combination with temozolomide
followed by olutasidenib monotherapy as maintenance treatment in
newly diagnosed pediatric and young adult patients (<39 years
old) with IDH1 mutation positive HGG, including diffuse intrinsic
pontine glioma (DIPG), an aggressive brain tumor with limited
treatment options. Rigel will provide CONNECT funding up to
$3 million and study material over
the four-year collaboration.
- In December 2023, Rigel and The
University of Texas MD Anderson Cancer
Center (MD Anderson) announced a multi-year strategic development
collaboration to expand the evaluation of REZLIDHIA (olutasidenib)
in acute myeloid leukemia (AML) and other hematologic cancers.
Under the strategic collaboration, Rigel and MD Anderson will
evaluate the potential of olutasidenib to treat newly diagnosed and
relapsed or refractory (R/R) patients with AML, higher-risk
myelodysplastic syndromes (MDS), and advanced myeloproliferative
neoplasms (MPN), in combination with other agents. The
collaboration will also support the evaluation of olutasidenib as
monotherapy in lower-risk MDS and maintenance therapy in
post-hematopoietic stem cell transplant (HSCT) patients. Rigel will
provide MD Anderson $15 million in
time-based milestone payments and study material over the five-year
collaboration.
- In December 2023, Rigel also
presented four posters highlighting data from the Company's
commercial and clinical-stage hematology-oncology portfolio at the
65th American Society of Hematology Annual Meeting and Exposition.
Included was a poster, Abstract #2888, reporting post hoc analyses
in a subset of patients with mIDH1 R/R AML or MDS that were
R/R to HSCT, ivosidenib, or venetoclax. The analyses suggest that
olutasidenib alone or in combination with azacitidine may induce
complete remissions in these patients.
Financial Update
For the fourth quarter of 2023, Rigel
reported a net income of $0.7
million, or $0.00 per basic
and diluted share, compared to a net income of $1.4 million, or $0.01 per basic and diluted share, for the same
period of 2022.
For the fourth quarter of 2023, total revenues were $35.8 million, consisting of $25.7 million in TAVALISSE net product sales,
$3.9 million in REZLIDHIA net product
sales, $6.2 million in contract
revenue from collaborations, and $0.1
million in government contract revenue. TAVALISSE net
product sales of $25.7 million
represents a 17% increase compared to $21.9
million in the same period of 2022. REZLIDHIA net product
sales were $3.9 million compared to
$0.9 million in the same period of
2022. Contract revenue from collaborations for the fourth quarter
of 2023 consisted of $3.7 million of
revenue from Grifols S.A. (Grifols) and $0.3
million of revenue from Medison Pharma Trading AG (Medison)
related to delivery of drug supplies and earned royalties, as well
as $2.2 million of revenue from
Kissei Pharmaceutical Co., Ltd. (Kissei) related to delivery of
drug supplies.
For the fourth quarter of 2023, total costs and expenses were
$33.8 million, compared to
$49.2 million for the same period of
2022. The decrease in costs and expenses was partly due to
decreased research and development costs due to the timing of trial
completion activities related to the Phase 3 clinical trials of
fostamatinib in patients with COVID-19 and wAIHA, as well as the
timing of clinical trial activities related to the IRAK 1/4
inhibitor program. In addition, the decrease was also due to lower
facility-related costs, and a milestone payment to Forma
Therapeutics Inc. (Forma), now Novo Nordisk, recorded as in-process
research and development (IPR&D) included within cost and
expenses in the fourth quarter of 2022.
For the full year 2023, Rigel reported a net loss of
$25.1 million, or $0.14 per basic and diluted share, compared to a
net loss of $58.6 million, or
$0.34 per basic and diluted share,
for the full year 2022.
For the full year 2023, total revenues were $116.9 million, consisting of $93.7 million in TAVALISSE net product sales,
$10.6 million in REZLIDHIA net
product sales, $11.5 million in
contract revenue from collaborations, and $1.1 million in government contract revenue.
TAVALISSE net product sales of $93.7
million represents a 24% increase compared to $75.8 million in full year 2022. REZLIDHIA net
product sales of $10.6 million
increased by $9.7 million compared to
$0.9 million in the full year 2022.
Contract revenue from collaborations for the full year 2023,
consisted of $8.8 million of revenue
from Grifols related to the delivery of drug supplies and earned
royalties, $2.2 million of revenue
from Kissei related to the delivery of drug supplies, and
$0.5 million of revenue from Medison
related to delivery of drug supplies, earned royalties, and a
milestone payment. Government contract revenue for the full year
2023 was primarily related to income recognized in the second
quarter of 2023 pursuant to the agreement with the U.S. Department
of Defense to support Rigel's Phase 3 clinical trial of
fostamatinib in high-risk hospitalized patients with COVID-19.
For the full year 2023, total costs and expenses were
$137.4 million, compared to
$175.8 million for the full year
2022. The decrease in costs and expenses was partly due to
decreased research and development costs due to the completion of
trial activities related to the Phase 3 clinical trials of
fostamatinib in patients with COVID-19 and wAIHA, as well as timing
of clinical trial activities related to the IRAK 1/4 inhibitor
program. In addition, the decrease was also due to lower
facility-related costs, and an upfront and a milestone payment to
Forma recorded as IPR&D included within cost and expenses in
the full year 2022.
As of December 31, 2023, Rigel had
cash, cash equivalents and short-term investments of $56.9 million, compared to $58.2 million as of December 31, 2022.
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 there will be about 20,800 new cases in the United States, most in adults, in
2024.1
Relapsed AML affects about half of all patients who, following
treatment and remission, experience a return of leukemia cells in
the bone marrow.2 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.3 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 NSCLC
It is estimated that over 230,000 adults
in the U.S. will be diagnosed with lung cancer in 2024. Lung
cancer is the leading cause of cancer death in the U.S, with NSCLC
being the most common type accounting for 80-85% of all lung cancer
diagnoses.4 RET fusions are implicated in
approximately 1-2% of patients with NSCLC.5
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 is a registered trademark 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 GAVRETO®
(pralsetinib)
INDICATIONS
GAVRETO (pralsetinib)
is indicated for the treatment of:
- Adult patients with metastatic rearranged during transfection
(RET) fusion-positive non-small cell lung cancer (NSCLC) as
detected by an FDA-approved test
- Adult and pediatric patients 12 years of age and older with
advanced or metastatic RET fusion-positive thyroid cancer who
require systemic therapy and who are radioactive iodine-refractory
(if radioactive iodine is appropriate)*
*This indication is approved under accelerated approval based on
overall response rate and duration of response. Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in confirmatory trial(s).
IMPORTANT SAFETY INFORMATION
- Interstitial Lung Disease (ILD)/Pneumonitis: Severe,
life-threatening, and fatal ILD/pneumonitis can occur in patients
treated with GAVRETO. Pneumonitis occurred in 12% of patients who
received GAVRETO, including 3.3% with Grade 3-4, and 0.2% with
fatal reactions. Monitor for pulmonary symptoms indicative of
ILD/pneumonitis. Withhold GAVRETO and promptly investigate for ILD
in any patient who presents with acute or worsening of respiratory
symptoms (e.g., dyspnea, cough, and fever). Withhold, reduce dose
or permanently discontinue GAVRETO based on severity of confirmed
ILD.
- Hypertension: Occurred in 35% of patients, including
Grade 3 hypertension in 18% of patients. Overall, 8% had their dose
interrupted and 4.8% had their dose reduced for hypertension.
Treatment-emergent hypertension was most commonly managed with
anti-hypertension medications. Do not initiate GAVRETO in patients
with uncontrolled hypertension. Optimize blood pressure prior to
initiating GAVRETO. Monitor blood pressure after 1 week, at least
monthly thereafter and as clinically indicated. Initiate or adjust
anti-hypertensive therapy as appropriate. Withhold, reduce dose, or
permanently discontinue GAVRETO based on the severity.
- Hepatotoxicity: Serious hepatic adverse reactions
occurred in 1.5% of patients treated with GAVRETO. Increased
aspartate aminotransferase (AST) occurred in 49% of patients,
including Grade 3 or 4 in 7% and increased alanine aminotransferase
(ALT) occurred in 37% of patients, including Grade 3 or 4 in 4.8%.
The median time to first onset for increased AST was 15 days
(range: 5 days to 2.5 years) and increased ALT was 24 days (range:
7 days to 3.7 years). Monitor AST and ALT prior to initiating
GAVRETO, every 2 weeks during the first 3 months, then monthly
thereafter and as clinically indicated. Withhold, reduce dose or
permanently discontinue GAVRETO based on severity.
- Hemorrhagic Events: Serious, including fatal,
hemorrhagic events can occur with GAVRETO. Grade ≥3 events occurred
in 4.1% of patients treated with GAVRETO including one patient with
a fatal hemorrhagic event. Permanently discontinue GAVRETO in
patients with severe or life-threatening hemorrhage.
- Tumor Lysis Syndrome (TLS): Cases of TLS have been
reported in patients with medullary thyroid carcinoma receiving
GAVRETO. Patients may be at risk of TLS if they have rapidly
growing tumors, a high tumor burden, renal dysfunction, or
dehydration. Closely monitor patients at risk, consider appropriate
prophylaxis including hydration, and treat as clinically
indicated.
- Risk of Impaired Wound Healing: Impaired wound healing
can occur in patients who receive drugs that inhibit the vascular
endothelial growth factor (VEGF) signaling pathway. Therefore,
GAVRETO has the potential to adversely affect wound healing.
Withhold GAVRETO for at least 5 days prior to elective surgery. Do
not administer for at least 2 weeks following major surgery and
until adequate wound healing. The safety of resumption of GAVRETO
after resolution of wound healing complications has not been
established.
- Embryo-Fetal Toxicity: Based on findings from animal
studies and its mechanism of action, GAVRETO can cause fetal harm
when administered to a pregnant woman. Advise pregnant women of the
potential risk to a fetus. Advise females of reproductive potential
to use effective non-hormonal contraception during treatment with
GAVRETO and for 2 weeks after the last dose. Advise males with
female partners of reproductive potential to use effective
contraception during treatment with GAVRETO and for 1 week after
the last dose.
- Common adverse reactions (≥25%) were musculoskeletal
pain, constipation, hypertension, diarrhea, fatigue, edema,
pyrexia, and cough. Common Grade 3/4 laboratory abnormalities
(≥2%) were decreased lymphocytes, decreased neutrophils,
decreased hemoglobin, decreased phosphate, decreased leukocytes,
decreased sodium, increased aspartate aminotransferase (AST),
increased alanine aminotransferase (ALT), decreased calcium
(corrected), decreased platelets, increased alkaline phosphatase,
increased potassium, decreased potassium, and increased
bilirubin.
- Avoid coadministration of GAVRETO with strong or moderate
CYP3A inhibitors, P-gp inhibitors, or combined P-gp and strong or
moderate CYP3A inhibitors. If coadministration cannot be
avoided, reduce the GAVRETO dose. Avoid coadministration of GAVRETO
with strong or moderate CYP3A inducers. If coadministration
cannot be avoided, increase the GAVRETO dose.
- Lactation: Advise women not to breastfeed during
treatment with GAVRETO and for 1 week after the last dose.
- Pediatric Use: Monitor open growth plates in adolescent
patients. Consider interrupting or discontinuing GAVRETO if
abnormalities occur.
You may report side effects to the FDA
at 1-800-FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech
at 1-888-835-2555.
Please click here to see the full
Prescribing Information and Patient Information for
GAVRETO.
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.
- The American Cancer Society. Key Statistics for Acute Myeloid
Leukemia (AML). Revised January 17,
2024. Accessed Feb. 19, 2024:
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 19, 2024:
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
- The American Cancer Society. Key Statistics for Lung Cancer.
Revised November 20, 2023. Accessed
February 7, 2024:
https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html
- Kato, S. et al. RET aberrations in diverse cancers:
next-generation sequencing of 4,871 patients. Clin Cancer Res. 2017;23(8):1988-1997 doi:
10.1158/1078-0432.CCR-16-1679
Forward Looking Statements
This press release
contains forward-looking statements relating to, among other
things, expected commercial and financial results,
expectations related to the potential and market
opportunity of olutasidenib as therapeutics for R/R AML and other
conditions, the commercialization of fostamatinib or olutasidenib
in the U.S. and international markets, the transition and
commercialization of pralsetinib for the treatment of
non-small cell lung cancer and advanced thyroid
cancer and Rigel's ability to further develop its
clinical stage product candidates and Rigel's partnering and
collaboration efforts, including the progress of Phase 1b clinical trial of R289 for the treatment of
lower-risk myeloid dysplastic syndrome, olutasidenib's evaluation
in acute myeloid leukemia (AML) and other hematologic
cancers, and in newly diagnosed pediatric and young adult patients
with high-grade glioma (HGG) harboring an isocitrate
dehydrogenase-1 (IDH1) mutation. 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 fostamatinib
or olutasidenib; 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 Quarterly Report on Form 10-Q
for the quarter ended September 30,
2023 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
December 31,
|
|
Year Ended December
31,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
(unaudited)
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
Product sales,
net
|
$
29,539
|
|
$ 22,783
|
|
$ 104,294
|
|
$
76,718
|
|
Contract revenues from
collaborations
|
6,153
|
|
26,495
|
|
11,488
|
|
39,024
|
|
Government
contract
|
100
|
|
2,000
|
|
1,100
|
|
4,500
|
|
Total
revenues
|
35,792
|
|
51,278
|
|
116,882
|
|
120,242
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
3,790
|
|
342
|
|
7,110
|
|
1,749
|
|
Research and
development (see Note A)
|
3,186
|
|
15,365
|
|
24,522
|
|
60,272
|
|
Selling, general and
administrative (see Note A)
|
26,850
|
|
32,172
|
|
105,741
|
|
112,451
|
|
Restructuring
charges
|
-
|
|
1,320
|
|
-
|
|
1,320
|
|
Total costs and
expenses
|
33,826
|
|
49,199
|
|
137,373
|
|
175,792
|
Income (loss) from
operations
|
1,966
|
|
2,079
|
|
(20,491)
|
|
(55,550)
|
|
Interest
income
|
678
|
|
429
|
|
2,272
|
|
684
|
|
Interest
expense
|
(1,907)
|
|
(1,107)
|
|
(6,872)
|
|
(3,707)
|
Net income
(loss)
|
$
737
|
|
$
1,401
|
|
$ (25,091)
|
|
$ (58,573)
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share
|
|
|
|
|
|
|
|
|
Basic
|
$
0.00
|
|
$ 0.01
|
|
$ (0.14)
|
|
$ (0.34)
|
|
Diluted
|
$
0.00
|
|
$ 0.01
|
|
$ (0.14)
|
|
$ (0.34)
|
|
|
|
|
|
|
|
|
|
Weighted average shares
used in computing net income (loss) per share
|
|
|
|
|
|
|
|
|
Basic
|
174,376
|
|
172,851
|
|
173,897
|
|
172,406
|
|
Diluted
|
174,468
|
|
172,856
|
|
173,897
|
|
172,406
|
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
$
1,585
|
|
$
3,426
|
|
$ 6,712
|
|
$
10,217
|
|
Research and
development
|
348
|
|
654
|
|
2,094
|
|
2,168
|
|
|
$
1,933
|
|
$
4,080
|
|
$ 8,806
|
|
$
12,385
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
As of December
31,
|
|
|
|
|
|
|
2023
|
|
2022
|
|
|
|
|
Cash, cash equivalents
and short-term investments
|
$
56,933
|
|
$ 58,206
|
|
|
|
|
Total
assets
|
117,225
|
|
134,279
|
|
|
|
|
Stockholders'
deficit
|
(28,644)
|
|
(13,616)
|
|
|
|
|
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SOURCE Rigel Pharmaceuticals, Inc.