- Third quarter total revenue of $55.3
million, which includes TAVALISSE® net product
sales of $26.3 million,
REZLIDHIA® net product sales of $5.5 million and GAVRETO® net product
sales of $7.1 million
- Entered into an agreement with Kissei to develop and
commercialize REZLIDHIA in all potential indications in
Japan, the Republic of Korea and
Taiwan, recording an upfront cash
payment of $10.0 million during the
third quarter
- Initial data from the ongoing Phase 1b study evaluating R289, a dual IRAK1/4
inhibitor, in LR-MDS to be presented at the 66th ASH
Annual Meeting
- Conference call and webcast scheduled today at 4:30 p.m. Eastern Time
SOUTH
SAN FRANCISCO, Calif., Nov. 7, 2024
/PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a
commercial stage biotechnology company focused on hematologic
disorders and cancer, today reported financial results for the
third quarter ended September 30,
2024, including sales
of TAVALISSE® (fostamatinib disodium
hexahydrate) for the treatment of chronic immune thrombocytopenia
(ITP); REZLIDHIA® (olutasidenib) for the treatment
of relapsed or refractory (R/R) mutated isocitrate dehydrogenase-1
(mIDH1) acute myeloid leukemia (AML); and
GAVRETO® (pralsetinib) for the treatment of
metastatic rearranged during transfection (RET) fusion-positive
non-small cell lung cancer (NSCLC) and advanced or metastatic
thyroid cancer, and recent business progress.
"2024 has been a significant year for Rigel, marked by the
acquisition of GAVRETO, our third commercial product, strong
revenue growth across our commercial portfolio, and the advancement
of our development pipeline," said Raul
Rodriguez, Rigel's president and CEO. "This great progress
is underpinned by our focus on financial discipline, resulting in
positive third-quarter and year-to-date net income. As we close out
the year, we will continue driving momentum in our commercial
portfolio and hematology and oncology development pipeline."
Third Quarter 2024 Business Update
Commercial Update
- Commercial strength continues for all products with record
bottles shipped to patients and clinics and total bottles
sold.
- GAVRETO became commercially available from Rigel in
June 2024. Third-quarter results
reflect the successful transition of existing patients on therapy
to Rigel's product. For the fourth quarter, the focus will be on
continuing to transition patients.
- The following table summarizes total bottles shipped for the
third quarter:
|
TAVALISSE
|
REZLIDHIA
|
GAVRETO*
|
Bottles shipped to
patients and clinics
|
2,797
|
444
|
717
|
Change in bottles
remaining in distribution channel
|
(4)
|
(15)
|
35
|
Total bottles
shipped
|
2,793
|
429
|
752
|
*GAVRETO
bottle count represents 60-count bottle equivalent
|
- In September, Rigel entered into an exclusive license and
supply agreement with Kissei Pharmaceutical Co., Ltd. ("Kissei") to
develop and commercialize REZLIDHIA in all
potential indications in Japan, the Republic of Korea and Taiwan. Under the terms of the agreement,
Rigel received an upfront cash payment of $10.0 million from Kissei, with the potential for
up to an additional $152.5 million in
development, regulatory and commercial milestone payments.
- In late October, Rigel issued a Dear Health Care Provider
(DHCP) letter related to a new safety signal for GAVRETO after
consultation with the U.S. Food and Drug Administration (FDA). The
DHCP letter has been posted to the GAVRETO Healthcare Provider
website at www.gavreto-hcp.com.
Clinical and Development Update
- Rigel continues to advance its Phase 1b clinical study evaluating the safety,
tolerability, pharmacokinetics, and preliminary efficacy of
R2891, a novel and selective dual IRAK1/4 inhibitor, in
patients with R/R lower-risk myelodysplastic syndrome (LR-MDS).
Enrollment in the fifth dose level (500mg / 250mg split dose) is
underway.
- In early November, Rigel announced six poster presentations
highlighting data from the company's commercial and clinical-stage
hematology and oncology portfolio at the upcoming 66th American
Society of Hematology (ASH) Annual Meeting and Exposition. Initial
data from the ongoing Phase 1b study
evaluating R289 in patients with R/R LR-MDS indicate that R289 was
generally well tolerated in a heavily pretreated LR-MDS patient
population, the majority of whom were high transfusion burden at
study entry. As of the data cutoff, 14 of 19 patients were
evaluable for efficacy and per International Working Group (IWG)
2018, RBC-transfusion independence (RBC-TI)/hematologic improvement
(HI-E) occurred in 36% of patients receiving R289 doses ≥500 mg QD,
with a median duration of RBC-TI of 29 weeks. RBC-TI >24 weeks
was achieved in 2 high transfusion burden patients following 3 and
5 prior therapies, including a hypomethylating agent. The company
will also present additional data for olutasidenib in patients with
R/R mIDH1 AML and MDS.
- In September, Rigel announced the first patient was enrolled in
a Phase 1b/2 triplet therapy trial of
decitabine and venetoclax in combination with REZLIDHIA in patients
with mIDH1 AML, which is being sponsored and conducted by
The University of Texas MD Anderson
Cancer Center (MD Anderson). This is the first trial in Rigel's
multi-year strategic development alliance with MD Anderson.
- A paper detailing the differences in molecular structure,
binding characteristics and clinical outcomes between olutasidenib
and ivosidenib, including response rates in patients previously
treated with ivosidenib or venetoclax, was published by Dr.
Justin M. Watts, Associate Professor
of Medicine, Division of Hematology, Chief, Leukemia Section at the
University of Miami Health System, in
Current Treatment Options in Oncology in October 2024.
Third Quarter 2024 and Year-To-Date Financial Update
For the third quarter ended September 30,
2024, total revenues were $55.3
million, consisting of $26.3
million in TAVALISSE net product sales, $5.5 million in REZLIDHIA net product sales,
$7.1 million in GAVRETO net product
sales, and $16.4 million in contract
revenue from collaborations. TAVALISSE net product sales grew 8%
compared to $24.5 million in the same
period of 2023. REZLIDHIA net product sales grew 107% compared to
$2.7 million in the same period of
2023. GAVRETO became commercially available from Rigel in
June 2024. Contract revenue from
collaborations consisted of $13.0
million from Kissei Pharmaceutical Co., Ltd. (Kissei)
related to an upfront fee from sublicensing olutasidenib and
delivery of drug supplies, as well as $3.3
million from Grifols S.A. (Grifols) and $0.1 million from Medison Pharma Trading AG
(Medison) related to delivery of drug supplies and earned
royalties.
Total costs and expenses were $41.3
million compared to $32.6
million for the same period of 2023. The increase in costs
and expenses was mainly due to higher cost of product sales, driven
primarily by increased products sales, a sublicensing revenue fee
to Forma, increased royalties and amortization of intangible
assets. In addition, there were increases in personnel-related
costs and commercial-related expenses.
Rigel reported net income of $12.4
million, or $0.71 basic and
$0.70 diluted per share, compared to
a net loss of $5.7 million, or
$0.33 basic and diluted per share,
for the same period of 2023. The basic and diluted share and per
share amounts for the prior period have been restated to reflect
the 1-for-10 reverse stock split effected on June 27, 2024 on a retroactive basis.
For the nine months ended September 30,
2024, total revenues were $121.7
million, consisting of $73.8
million in TAVALISSE net product sales, $15.6 million in REZLIDHIA net product sales,
$9.0 million in GAVRETO net product
sales, and $23.3 million in contract
revenue from collaborations. TAVALISSE net product sales grew 8%
compared to $68.1 million in the same
period of 2023. REZLIDHIA net product sales grew 133% compared to
$6.7 million in the same period of
2023. As mentioned above, GAVRETO became commercially available
from Rigel in June 2024. Contract
revenue from collaborations consisted of $17.5 million from Kissei related to an upfront
fee from sublicensing olutasidenib and delivery of drug supplies,
as well as $5.5 million from Grifols
and $0.2 million from Medison related
to delivery of drug supplies and earned royalties.
Total costs and expenses were $114.1
million compared to $103.5
million for the same period of 2023. The increase in costs
and expenses was mainly due to higher cost of product sales driven
primarily by increased products sales, a sublicensing revenue fee
to Forma, increased royalties and amortization of intangible
assets. In addition, there were increases in personnel-related
costs, stock-based compensation expense and commercial-related
expenses. These increases were partially offset by decreased
research and development costs due to the timing of clinical trial
activities related to R289, the company's dual IRAK 1/4 inhibitor
program, as well as reduced trial activities related to the
completed Phase 3 clinical trials of fostamatinib in patients with
COVID-19 and in patients with warm antibody hemolytic anemia
(wAIHA).
Rigel reported net income of $3.1
million, or $0.18 basic and
diluted per share, compared to a net loss of $25.8 million, or $1.49 basic and diluted per share, for the same
period of 2023. As discussed above, the share and per share amounts
for the prior period have been restated to reflect the 1-for-10
reverse stock split on a retroactive basis for the periods
presented.
Cash, cash equivalents and short-term investments as of
September 30, 2024 was $61.1 million, compared to $49.1 million as of June
30, 2024, and $56.9 million as
of December 31, 2023.
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
2024.2
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 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.5 RET fusions are implicated in
approximately 1-2% of patients with NSCLC.6
About TAVALISSE®
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.
Please click here for Important Safety
Information and Full Prescribing Information for TAVALISSE.
About REZLIDHIA®
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.
Please click here for Important Safety Information and
Full Prescribing Information, including Boxed WARNING, for
REZLIDHIA.
About GAVRETO®
GAVRETO 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 and 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).*
*Thyroid 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).
Please click here for Important
Safety Information and Full Prescribing Information for
GAVRETO.
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, REZLIDHIA and GAVRETO are registered trademarks 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 June 5, 2024.
Accessed June 30,
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 June 30,
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. Accessed June 30,
2024.
doi: https://doi.org/10.1182/blood-2014-10-551911
- The American Cancer Society. Key Statistics for Lung Cancer.
Revised January 29, 2024. Accessed
June 30,
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 for developing and commercializing
REZLIDHIA in certain international markets, study results relating
to safety and tolerability of R289 for the treatment of
lower-risk myeloid dysplastic syndrome, expectations
for development of Rigel's commercial portfolio and hematology and
oncology pipeline, and expectations for Rigel's
partnering and collaboration efforts. 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", "look to", "expects", "will",
"initial", 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, olutasidenib and pralsetinib; risks that the FDA,
European Medicines Agency, PMDA or other regulatory authorities may
make adverse decisions regarding fostamatinib, pralsetinib or
olutasidenib; risks that clinical trials may not be predictive of
real-world results or of results in subsequent clinical trials;
risks that fostamatinib, pralsetinib 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 June 30, 2024
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
646.461.6387
david.rosen@argotpartners.com
RIGEL
PHARMACEUTICALS, INC.
|
STATEMENTS OF
OPERATIONS
|
(in thousands,
except per share amounts)
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
2024
|
|
2023
|
|
2024
|
|
2023
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
Product
sales, net
|
$
38,927
|
|
$
27,129
|
|
$
98,380
|
|
$
74,755
|
Contract
revenues from collaborations
|
16,380
|
|
1,005
|
|
23,302
|
|
5,335
|
Government
contract
|
—
|
|
—
|
|
—
|
|
1,000
|
Total
revenues
|
55,307
|
|
28,134
|
|
121,682
|
|
81,090
|
Costs and
expenses:
|
|
|
|
|
|
|
|
Cost of
product sales
|
8,026
|
|
1,268
|
|
12,858
|
|
3,320
|
Research
and development (see Note A)
|
6,182
|
|
6,475
|
|
17,748
|
|
21,336
|
Selling,
general and administrative (see Note A)
|
27,043
|
|
24,856
|
|
83,539
|
|
78,891
|
Total costs and
expenses
|
41,251
|
|
32,599
|
|
114,145
|
|
103,547
|
Income (loss) from
operations
|
14,056
|
|
(4,465)
|
|
7,537
|
|
(22,457)
|
Interest
income
|
425
|
|
672
|
|
1,570
|
|
1,594
|
Interest
expense
|
(2,060)
|
|
(1,899)
|
|
(5,963)
|
|
(4,965)
|
Net income
(loss)
|
$
12,421
|
|
$
(5,692)
|
|
$
3,144
|
|
$
(25,828)
|
|
|
|
|
|
|
|
|
Net income (loss) per
share (1)
|
|
|
|
|
|
|
|
Basic
|
$
0.71
|
|
$
(0.33)
|
|
$
0.18
|
|
$
(1.49)
|
Diluted
|
$
0.70
|
|
$
(0.33)
|
|
$
0.18
|
|
$
(1.49)
|
Weighted average shares
used in computing net income (loss) per
share(1)
|
|
|
|
|
|
|
|
Basic
|
17,600
|
|
17,436
|
|
17,556
|
|
17,389
|
Diluted
|
17,648
|
|
17,436
|
|
17,599
|
|
17,389
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
|
|
|
|
Selling,
general and administrative
|
$
2,360
|
|
$
1,596
|
|
$
9,067
|
|
$
5,127
|
Research
and development
|
284
|
|
347
|
|
1,239
|
|
1,746
|
|
$
2,644
|
|
$
1,943
|
|
$
10,306
|
|
$
6,873
|
(1) Share and per share
amounts have been restated to reflect the 1-for-10 reverse stock
split effected on June 27, 2024 on a retroactive basis for all
periods presented.
|
|
|
SUMMARY BALANCE
SHEET DATA
|
(in
thousands)
|
|
|
|
|
|
|
|
As of
September,
|
|
As of December
31,
|
|
|
2024
|
|
2023(1)
|
|
|
(unaudited)
|
|
|
Cash, cash equivalents
and short-term investments
|
$
61,114
|
|
$
56,933
|
Total
assets
|
139,419
|
|
117,225
|
Stockholders'
deficit
|
(14,636)
|
|
(28,644)
|
(1) Derived from
audited financial statements
|
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SOURCE Rigel Pharmaceuticals, Inc.