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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): November 7,
2023
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 Condition. |
On November 7, 2023, Rigel
Pharmaceuticals, Inc. (“Rigel”) announced certain financial results for its third quarter ended September 30, 2023.
A copy of Rigel’s press release, titled “Rigel Reports Third Quarter 2023 Financial Results and Provides Business Update,”
is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto.
The information in this
report, including the exhibit hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange
Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of
1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing
with the U.S. Securities and Exchange Commission made by Rigel, whether made before or after the date hereof, regardless of any general
incorporation language in such filing.
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: November 7, 2023 |
RIGEL PHARMACEUTICALS, INC. |
|
|
|
By: |
/s/ Ray Furey, J.D. |
|
|
Ray Furey, J.D. |
|
|
Executive Vice President, General Counsel and Corporate Secretary |
Exhibit 99.1
Rigel Reports Third Quarter 2023 Financial
Results and Provides Business Update
| · | Third
quarter 2023 Total Revenue of $28.1 million which includes record TAVALISSE®
net product sales of $24.5 million and REZLIDHIA® net product sales of $2.7
million |
| · | New
data on olutasidenib in mIDH1 relapsed or refractory acute myeloid leukemia to be presented
at ASH Annual Meeting |
| · | Conference
call and webcast scheduled today at 4:30 p.m. Eastern Time |
SOUTH SAN FRANCISCO,
Calif., November 7, 2023 /PRNewswire/ --
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today reported financial results for
the third quarter ended September 30, 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.
“The
third quarter of 2023 was marked by strong momentum from our commercial hematology-oncology portfolio driven by record TAVALISSE net
product sales and growing REZLIDHIA awareness among leukemia treaters,” said Raul
Rodriguez, Rigel's president and CEO. “These strong net sales combined with our expense discipline have allowed us to make
substantial progress on our plan to reach financial breakeven.”
Business Update
| · | In
the third quarter of 2023, a total of 2,551 bottles of TAVALISSE were sold in the U.S. During
the quarter, 2,412 bottles 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 third full quarter of launch, a total of 210 bottles of REZLIDHIA were sold in the U.S.
During this quarter, 221 bottles were shipped directly to patients and clinics. |
| · | Last
week, Rigel announced four poster presentations highlighting data from the Company’s
commercial and clinical-stage hematology-oncology portfolio at the upcoming 65th American
Society of Hematology (ASH) Annual Meeting and Exposition. Included is 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 hematopoietic stem cell transplant (HSCT), ivosidenib (IVO), or venetoclax
(VEN). The analyses suggest that olutasidenib alone or in combination with azacitidine may
induce complete remissions in these patients. To learn more about Rigel’s clinical
and commercial hematology-oncology portfolio visit Booth #2805 during ASH 2023. |
| · | Rigel
continues to advance its 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. Target enrollment in
the second cohort of the trial has been completed and Rigel is currently enrolling
patients in the third cohort. Preliminary data results are expected by mid-year 2024. |
| · | In September, the
Data and Safety Monitoring Board (DSMB) recommended that the fostamatinib study arm of the
ACTIV-4 Host Tissue (NECTAR) platform cease enrollment. No safety concerns were identified.
The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of
Health, concurs with the DSMB's recommendations and has asked the trial investigators to
cease enrollment, complete follow-up for participants already enrolled, and complete study
closeout. The full study data will be analyzed and disseminated as previously planned. |
Financial
Update
For the third quarter of 2023, Rigel reported
a net loss of $5.7 million, or $0.03 per basic and diluted share, compared to a net loss of $19.0 million, or $0.11 per basic and diluted
share, for the same period of 2022.
For the third quarter of 2023, total revenues
were $28.1 million, consisting of $24.5 million in TAVALISSE net product sales, $2.7 million in REZLIDHIA net product sales, and $1.0
million in contract revenues from collaborations. TAVALISSE net product sales of $24.5 million increased by $5.3 million, or 27%, compared
to $19.2 million in the same period of 2022. Contract revenues from collaborations for the third quarter of 2023 consisted primarily
of royalty revenue from Grifols S.A. (Grifols) of $0.8 million.
For the third quarter of 2023, total costs and
expenses were $32.6 million, compared to $40.8 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 completion of activities related to the Phase 3 clinical trial of fostamatinib
in wAIHA and the Phase 3 clinical trial of fostamatinib in high-risk hospitalized patients with COVID-19. Also contributing to the decrease,
were lower facility-related costs and an upfront payment to Forma Therapeutics Inc. (Forma, now Novo Nordisk) recorded as in-process
research and development (IPR&D) and included within cost and expenses in the third quarter of 2022. These decreases were partially
offset by increased research and development costs due to the timing of activities related to the IRAK 1/4 inhibitor program.
For the nine months ended September 30,
2023, Rigel reported a net loss of $25.8 million, or $0.15 per basic and diluted share, compared to a net loss of $60.0 million, or $0.35
per basic and diluted share, for the same period of 2022.
For the nine months ended September 30,
2023, total revenues were $81.1 million, consisting of $68.1 million in TAVALISSE net product sales, $6.7 million in REZLIDHIA net product
sales, $5.3 million in contract revenues from collaborations, and $1.0 million in government contract revenue. TAVALISSE net product
sales of $68.1 million increased by $14.1 million, or 26%, compared to $53.9 million in the same period of 2022. Contract revenues from
collaborations for the nine months ended September 30, 2023, consisted primarily of revenue from Grifols related to the delivery
of drug supplies of $2.8 million and a royalty of $2.3 million. Government contract revenue for the nine months ended September 30,
2023, was 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 nine months ended September 30,
2023, total costs and expenses were $103.5 million, compared to $126.6 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 completion of trial activities related to the Phase 3
clinical trial of fostamatinib in wAIHA and the Phase 3 clinical trial of fostamatinib in high-risk hospitalized patients with COVID-19,
as well as timing of activities related to the IRAK 1/4 inhibitor program. Also contributing to the decrease were lower facility-related
costs, and an upfront payment to Forma (now Novo Nordisk) recorded as IPR&D and included within cost and expenses in the third quarter
of 2022.
As of September 30, 2023, Rigel had cash,
cash equivalents and short-term investments of $62.4 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 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
R289
R289
is a prodrug of R835, an IRAK1/4 dual inhibitor, which has been shown in preclinical studies to block inflammatory cytokine production
in response to toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) family signaling. TLRs and IL-1Rs play a critical role in
the innate immune response and dysregulation of these pathways can lead to various inflammatory conditions. Chronic stimulation of both
these receptor systems is thought to cause the pro-inflammatory environment in the bone marrow responsible for persistent cytopenias
in lower-risk MDS patients.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 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 January 12, 2023. Accessed Feb. 15, 2023:
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 Feb 15, 2023: 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.
doi: https://doi.org/10.1182/blood-2014-10-551911 |
| 5. | Sallman
DA et al. Unraveling the Pathogenesis of MDS: The NLRP3 Inflammasome and Pyroptosis
Drive the MDS Phenotype. Front Oncol. June 16, 2016. DOI: https://doi.org/10.3389/fonc.2016.0015 |
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 or olutasidenib in the U.S. and international markets, 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. 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 June 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 September 30, | | |
Nine Months
Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
| |
(unaudited) | |
Revenues: | |
| | |
| | |
| | |
| |
Product sales, net | |
$ | 27,129 | | |
$ | 19,188 | | |
$ | 74,755 | | |
$ | 53,935 | |
Contract revenues from collaborations | |
| 1,005 | | |
| 722 | | |
| 5,335 | | |
| 12,529 | |
Government contract | |
| - | | |
| 2,500 | | |
| 1,000 | | |
| 2,500 | |
Total revenues | |
| 28,134 | | |
| 22,410 | | |
| 81,090 | | |
| 68,964 | |
Costs and expenses: | |
| | | |
| | | |
| | | |
| | |
Cost of product sales | |
| 1,268 | | |
| 250 | | |
| 3,320 | | |
| 1,407 | |
Research and development (see Note
A) | |
| 6,475 | | |
| 14,666 | | |
| 21,336 | | |
| 44,907 | |
Selling, general
and administrative (see Note A) | |
| 24,856 | | |
| 25,897 | | |
| 78,891 | | |
| 80,279 | |
Total costs and
expenses | |
| 32,599 | | |
| 40,813 | | |
| 103,547 | | |
| 126,593 | |
Loss from operations | |
| (4,465 | ) | |
| (18,403 | ) | |
| (22,457 | ) | |
| (57,629 | ) |
Interest income | |
| 672 | | |
| 192 | | |
| 1,594 | | |
| 255 | |
Interest expense | |
| (1,899 | ) | |
| (826 | ) | |
| (4,965 | ) | |
| (2,600 | ) |
Net loss | |
$ | (5,692 | ) | |
$ | (19,037 | ) | |
$ | (25,828 | ) | |
$ | (59,974 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share,
basic and diluted | |
$ | (0.03 | ) | |
$ | (0.11 | ) | |
$ | (0.15 | ) | |
$ | (0.35 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average
shares used in computing net loss per share, basic and diluted | |
| 174,364 | | |
| 172,836 | | |
| 173,897 | | |
| 172,256 | |
| |
| | | |
| | | |
| | | |
| | |
Note A | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation expense included
in: | |
| | | |
| | | |
| | | |
| | |
Selling, general and administrative | |
$ | 1,596 | | |
$ | 2,119 | | |
$ | 5,127 | | |
$ | 6,791 | |
Research and development | |
| 347 | | |
| 588 | | |
| 1,746 | | |
| 1,514 | |
| |
$ | 1,943 | | |
$ | 2,707 | | |
$ | 6,873 | | |
$ | 8,305 | |
SUMMARY
BALANCE SHEET DATA
(in
thousands)
| |
As of | |
| |
September
30, 2023 | | |
December
31, 2022 (1) | |
| |
| (unaudited) | | |
| | |
Cash, cash equivalents and short-term investments | |
$ | 62,351 | | |
$ | 58,206 | |
Total assets | |
| 115,324 | | |
| 134,279 | |
Stockholders' deficit | |
| (31,834 | ) | |
| (13,616 | ) |
(1)
Derived from audited financial statements
v3.23.3
Cover
|
Nov. 07, 2023 |
Cover [Abstract] |
|
Document Type |
8-K
|
Amendment Flag |
false
|
Document Period End Date |
Nov. 07, 2023
|
Entity File Number |
0-29889
|
Entity Registrant Name |
RIGEL PHARMACEUTICALS, INC.
|
Entity Central Index Key |
0001034842
|
Entity Tax Identification Number |
94-3248524
|
Entity Incorporation, State or Country Code |
DE
|
Entity Address, Address Line One |
611 Gateway Boulevard
|
Entity Address, Address Line Two |
Suite 900
|
Entity Address, City or Town |
South San Francisco
|
Entity Address, State or Province |
CA
|
Entity Address, Postal Zip Code |
94080
|
City Area Code |
650
|
Local Phone Number |
624-1100
|
Written Communications |
false
|
Soliciting Material |
false
|
Pre-commencement Tender Offer |
false
|
Pre-commencement Issuer Tender Offer |
false
|
Title of 12(b) Security |
Common Stock, par value $0.001 per share
|
Trading Symbol |
RIGL
|
Security Exchange Name |
NASDAQ
|
Entity Emerging Growth Company |
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Rigel Pharmaceuticals (NASDAQ:RIGL)
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