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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of
earliest event reported): January 13, 2025
RIGEL PHARMACEUTICALS, INC.
(Exact name of registrant as specified in
its charter)
Delaware
(State or other jurisdiction of incorporation)
| 0-29889 |
|
94-3248524 |
| (Commission File No.) |
|
(IRS Employer Identification No.) |
| |
|
|
611
Gateway Boulevard
Suite 900 |
|
|
| South San Francisco, CA |
|
94080 |
| (Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone number, including
area code: (650) 624-1100
Not Applicable
(Former name or former address, if changed
since last report)
Check the appropriate box below if the Form 8-K filing
is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
¨ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
| Title of Each Class |
|
Trading
Symbol(s) |
|
Name of
Each Exchange on Which
Registered |
| Common Stock, par value $0.001 per share |
|
RIGL |
|
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging
growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of
the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with
any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| Item 2.02. | Results of Operations and Financial Conditions. |
In connection with the press
release described in Item 8.01 below, on January 13, 2025, Rigel Pharmaceuticals, Inc. (“Rigel”) provided, on
a preliminary and unaudited basis, certain estimated financial results for its fourth quarter and fiscal year ended December 31,
2024. The preliminary estimates are based on currently available information and do not present all necessary information for a complete
understanding of Rigel’s financial condition as of December 31, 2024 or Rigel’s results of operations for the fourth
quarter or fiscal year ended December 31, 2024.
On January 13, 2025,
Rigel issued a press release titled “Rigel Provides Business Update and 2025 Outlook.” A copy of the press release is attached
hereto as Exhibit 99.1 and incorporated herein by reference.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
| Dated: January 13,
2025 |
RIGEL PHARMACEUTICALS, INC. |
| |
|
| |
|
By: |
/s/ Raymond J. Furey |
| |
|
|
Raymond J. Furey |
| |
|
|
Executive Vice President, General Counsel, Chief Compliance Officer, and Corporate Secretary |
Exhibit 99.1
Rigel Provides Business Update and 2025 Outlook
| · | Preliminary fourth quarter 2024 total revenue of approximately $57.6 million
which includes TAVALISSE® net product sales of $31.0 million, REZLIDHIA® net product sales of
$7.4 million and GAVRETO® net product sales of $8.1 million |
| · | R289 granted Orphan Drug designation by the FDA for the treatment of MDS |
| · | Rigel anticipates 2025 total revenue of approximately $200 to $210 million |
SOUTH SAN FRANCISCO,
Calif., January 13, 2025 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology
company focused on hematologic disorders and cancer, today provided a business update including preliminary total revenue and net
product sales for the fourth quarter of 2024, ongoing
activity from the commercial business and development pipeline, and its financial outlook for 2025.
“2024 was
a transformational year for Rigel as we successfully executed on our corporate strategy
to grow our hematology and oncology focused organization. We generated record sales of both TAVALISSE
and REZLIDHIA and welcomed a third product to our commercial portfolio, GAVRETO, which
made a substantial contribution to our sales in the latter half of the year. This commercial success, combined with our commitment to
financial discipline, enabled Rigel to reach financial breakeven, a key milestone
for the company,” said Raul Rodriguez, Rigel’s president and CEO. “In
addition, we advanced our development pipeline, with the Phase 1b study of R289 in lower-risk MDS continuing to enroll patients and publishing
promising initial safety and efficacy data. Building on this progress,
we will continue to implement effective strategies that further grow and advance our portfolio in 2025, thereby generating significant
value for Rigel and our shareholders.”
Preliminary
2024 Financial Results and Business Update
Preliminary
Financial Results
| · | While Rigel is still determining final results for the fourth quarter of
2024, the company expects to report fourth quarter total revenue of $57.6 million, compared
to $35.8 million for the same period of 2023. |
| · | Rigel expects to report fourth quarter net product sales of $46.5 million,
compared to $29.5 million for the same period of 2023, including: |
| o | TAVALISSE® (fostamatinib disodium hexahydrate)
net product sales of $31.0 million compared to $25.7 million for the same period of 2023. |
| o | REZLIDHIA® (olutasidenib) net product sales of
$7.4 million compared to $3.9 million for the same period of 2023. |
| o | GAVRETO® (pralsetinib) net product sales of $8.1 million.
GAVRETO became commercially available from Rigel in June 2024. |
| o | The following table summarizes total bottles shipped for the fourth quarter: |
| | |
TAVALISSE | | |
REZLIDHIA | | |
GAVRETO* | |
| Bottles shipped to patients and clinics | |
| 2,855 | | |
| 503 | | |
| 874 | |
| Change in bottles remaining in distribution channel | |
| 317 | | |
| 62 | | |
| 64 | |
| Total bottles shipped | |
| 3,172 | | |
| 565 | | |
| 938 | |
*GAVRETO
bottle count represents 60-count bottle equivalent
| · | Contract revenues from collaborations for the fourth
quarter of 2024 is expected to be approximately $11.1 million,
including a $4.0 million upfront cash payment from Dr. Reddy’s Laboratories
Ltd. (Dr. Reddy’s); $3.6 million of revenue from Grifols S.A. related to delivery
of drug supplies and earned royalties; $2.9 million
of revenue from Kissei Pharmaceutical Co., Ltd. (Kissei) related to delivery of drug supplies; and $0.3 million
of revenue from Medison Pharma Trading AG related to delivery of drug supplies and earned royalties. |
| · | For the full year, Rigel expects to report total
revenue of $179.3 million, including
net product sales of $144.9 million and contract revenues from collaborations
of $34.4 million, compared to total revenue of $116.9 million in 2023, which included net
product sales of $104.3 million, contract revenues from collaborations of $11.5 million and government contract revenue of $1.1 million. |
| · | Rigel expects to report cash, cash equivalents,
and short-term investments of approximately $77.3 million as of December 31, 2024, compared to $56.9 million as of December 31,
2023. |
The above information
is preliminary, has not been audited, and is subject to change upon the audit of Rigel’s financial statements for the year ended
December 31, 2024. Rigel expects to provide complete fourth quarter and full year 2024 financial results in March 2025.
Commercial
Update
| · | TAVALISSE surpassed $100 million in net product sales in 2024, reporting
$104.8 million in net product sales. |
| · | Rigel entered into an exclusive license agreement with Dr. Reddy’s
in November to develop and commercialize REZLIDHIA in all potential indications throughout Dr. Reddy’s territory, which
includes Latin America, South Africa, certain countries in the Commonwealth of Independent States (CIS), India, certain countries
in Southeast Asia and North Africa, Australia and New Zealand. Rigel is entitled to receive an upfront cash payment of $4.0 million with
the potential for up to $36.0 million in future regulatory and commercial milestone payments. |
| · | In December, Rigel’s partner Knight Therapeutics
announced Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios approved TAVALISSE for the treatment
of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. |
Clinical
and Development Update
| · | R2891,
a novel and selective dual IRAK1/4 inhibitor, has been granted Fast
Track designation for the treatment of previously-treated
transfusion dependent lower-risk MDS and Orphan Drug designation
for the treatment of MDS by the U.S. Food and Drug Administration (FDA). |
| · | Rigel continues to advance its
Phase 1b clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of R289 in patients with relapsed
or refractory (R/R) lower-risk myelodysplastic syndrome (MDS). Enrollment in the fifth dose level (500mg / 250mg split dose) is ongoing. |
| · | Rigel
presented
initial data from the ongoing Phase 1b clinical
study of R289 at the 66th American Society of Hematology
(ASH) Annual Meeting and Exposition in December, demonstrating that R289 was generally well
tolerated in this heavily pretreated R/R lower-risk MDS patient population, the majority
of whom were high transfusion burden (HTB) at baseline. |
| · | In an ad-hoc analysis of the R289
Phase 1b initial data, responding patients (those achieving transfusion independence) appeared to have a greater increase in hemoglobin
level over time compared to non-responding patients. |
| · | Also
at the ASH Annual Meeting, four posters were presented
on olutasidenib, which included data that adds to the growing
body of evidence supporting the benefits of its use in patients with mIDH1 AML. |
| · | As part of a multi-year strategic
development alliance, Rigel and The University of Texas MD Anderson Cancer Center (MD Anderson), opened enrollment for two trials in December.
The trials are a Phase 2 study in patients with IDH1-mutated clonal cytopenia of undetermined significance (CCUS), lower-risk MDS
and chronic myelomonocytic leukemia (CMML), and a Phase 1/2 study of olutasidenib maintenance therapy following an allogeneic stem cell
transplant for patients with IDH1-mutated myeloid malignancies. The Phase 1b/2 triplet therapy trial of decitabine and venetoclax
in combination with olutasidenib in patients with mIDH1 AML is ongoing. |
| · | In
December, in a paper titled “Olutasidenib demonstrates significant clinical activity
in mutated IDH1 acute myeloid leukaemia arising from a prior myeloproliferative neoplasm”,
was published by Stéphane de Botton, M.D., Ph.D., head of translational research in
hematology, Institut Gustave Roussy, France, in the British
Journal of Haematology. |
| · | In November, the National Comprehensive
Cancer Network® (NCCN®) added olutasidenib to the latest NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines®) for Myelodysplastic Syndromes. Olutasidenib was added as a recommended option to the following treatment algorithms:
Management of Lower-Risk Disease, Management of Lower-Risk Disease - Evaluation of Related Anemia and Management of Higher-Risk Disease,
and was recommended as NCCN Category 2B in all circumstances. If mIDH1 positive, olutasidenib was either recommended as a single
agent, in combination with azacitidine, or both.* |
*NCCN makes no
warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or
use in any way.
2025 Outlook
Rigel anticipates
2025 total revenue of approximately $200 to $210 million, including:
| · | Net product sales of approximately $185 to $192
million |
| · | Contract revenues from collaborations of approximately
$15 to $18 million. |
The company anticipates it will report positive net
income for the full year 2025, while funding existing and new clinical development programs.
In addition, Rigel plans to initiate a Phase 2 clinical
study in recurrent glioma in 2025.
Additional information
is included in Rigel’s corporate presentation, which can be found in the Investor Relations section of the company’s website
at www.rigel.com.
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, 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.
| 1. | R289 is an investigational compound not approved by the FDA. |
| 2. | The
American Cancer Society. Key Statistics for Acute Myeloid Leukemia (AML). Revised June 5,
2024. Accessed January 3, 2025: https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html |
| 3. | Leukaemia
Care. Relapse in Acute Myeloid Leukaemia (AML). Version 3. Reviewed October 2021. Accessed
January 3, 2025: https://media.leukaemiacare.org.uk/wp-content/uploads/Relapse-in-Acute-Myeloid-Leukaemia-AML-Web-Version.pdf |
| 4. | 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 January 3, 2025. doi: https://doi.org/10.1182/blood-2014-10-551911 |
| 5. | The
American Cancer Society. Key Statistics for Lung Cancer. Revised January 29, 2024. Accessed
January 3, 2025: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html |
| 6. | 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 for the fourth quarter and year ended December 31, 2024, projected financial performance and
outlook for 2025, expectations to grow and advance our commercial portfolio
and hematology and oncology pipeline, results of our study of R289 in lower-risk MDS including safety and efficacy data, continued ability
for developing and commercializing TAVALISSE, REZLIDHIA, and GAVRETO domestically and in certain international markets, 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 “anticipates”,
“plan”, “outlook”, “potential”, “may”, “look to”, “expects”,
“will”, “initial”, “promising”, 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 September 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
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-Publisher SEC
-Name Securities Act
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-Section 425
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Rigel Pharmaceuticals (NASDAQ:RIGL)
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