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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): August 1, 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 August 1,
2023, Rigel Pharmaceuticals, Inc. (“Rigel”) announced certain financial results for its second quarter ended June 30,
2023. A copy of Rigel’s press release, titled “Rigel Reports Second 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.
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: August 1, 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 Second Quarter 2023 Financial Results and
Provides Business Update
| · | Second
quarter 2023 Total Revenue of $26.9 million which includes TAVALISSE®
net product sales of $21.3 million and REZLIDHIA®
net product sales of $2.6 million |
| · | Development programs continue
to advance with completion of target enrollment in cohort 2 of Phase 1b trial of R289 in
lower-risk MDS and initiation of Phase 2a trial of R552 in rheumatoid arthritis by partner,
Eli Lilly |
| · | Conference call and webcast
scheduled today at 4:30 p.m. Eastern Time |
SOUTH SAN
FRANCISCO, Calif., August 1, 2023 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today reported financial results for
the second quarter ended June 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.
“We are encouraged by the progress we made
in the second quarter in building our hematology/oncology company,” said Raul Rodriguez, Rigel's president and CEO. “We delivered
strong year-over-year revenue growth for TAVALISSE in ITP and hired our dedicated institutional sales team to drive our commercial launch
of REZLIDHIA with a focus on awareness and education with healthcare professionals. We also continued to advance our current development
programs while evaluating opportunities to expand our hematology/oncology business through internal and external opportunities.”
Business Update
| · | In the second quarter of 2023,
a total of 2,191 bottles of TAVALISSE were sold in the U.S. During the quarter, 2,265 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 second full quarter
of launch, a total of 200 bottles of REZLIDHIA were sold in the U.S., representing a 77%
increase over Q1 2023. Of those bottles, 187 were shipped directly to patients and clinics. |
| · | In
June, Rigel presented promising data from an analysis of the Phase 2 clinical trial
evaluating REZLIDHIA in 17 patients with mIDH1 AML who were relapsed/refractory to
prior venetoclax-based regimens at the European Hematology Association (EHA) 2023 Hybrid
Congress. The data showed clinically meaningful activity with
REZLIDHIA, a potent, selective, oral, small-molecule inhibitor of mIDH11,
representing an encouraging therapeutic advance in the treatment of this molecularly defined,
poor-prognosis patient population. |
| · | Rigel also announced the publication in June of an expert review article in Blood
Advances examining the development path and positioning of REZLIDHIA in the mIDH1 R/R AML treatment landscape. The
authors concluded, "The approval of olutasidenib is a critical addition to the mIDH1 AML treatment landscape with
encouragingly durable responses." They recommended treatment with olutasidenib in venetoclax plus HMA failures, based on the
available data. |
| · | Rigel continues to advance its
open-label, Phase 1b clinical trial of R2892, 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 expects to begin enrollment in the third cohort in the near
future. |
| · | R552,
an investigational, potent, and selective RIPK1 inhibitor, is being advanced by Rigel's partner
Eli Lilly. The Phase 2a clinical trial (NCT05848258) studying R552 in adult patients
with moderately to severely active rheumatoid arthritis (RA) has been initiated. The trial
plans to enroll 100 patients globally. |
Financial Update
For the second quarter of 2023, Rigel reported a net loss
of $6.6 million, or $0.04 per basic and diluted share, compared to a net loss of $13.5 million, or $0.08 per basic and diluted share,
for the same period of 2022.
For the second quarter of 2023, total revenues were $26.9
million, consisting of $21.3 million in TAVALISSE net product sales, $2.6 million in REZLIDHIA net product sales, $2.0 million in contract
revenues from collaborations, and $1.0 million in government contract revenue. TAVALISSE net product sales of $21.3 million increased
by $2.8 million or 15% compared to $18.6 million in the same period of 2022. Contract revenues from collaborations for the second quarter
of 2023 consisted primarily of revenue from Grifols S.A., related to the delivery of drug supplies of $1.2 million and a royalty of $0.8
million. Government contract revenue for the second quarter of 2023 was related to income recognized pursuant to the agreement with the
U.S. Department of Defense (DOD) to support Rigel’s ongoing Phase 3 clinical trial of fostamatinib in high-risk hospitalized patients
with COVID-19.
For the second quarter of 2023, total costs and expenses were
$32.2 million, compared to $42.8 million for the same period of 2022. The decrease in costs and expenses was primarily due to decreased
research and development costs due to trial completion activities related to the Phase 3 clinical trial of fostamatinib for 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 Rigel’s IRAK 1/4 inhibitor program.
For the six months ended June 30, 2023,
Rigel reported a net loss of $20.1 million, or $0.12 per basic and diluted share, compared to a net loss of $40.9 million, or $0.24 per
basic and diluted share, for the same period of 2022.
For the six months ended June 30, 2023, total revenues were
$52.9 million, consisting of $43.6 million in TAVALISSE net product sales, $4.0 million in REZLIDHIA net product sales, $4.3 million
in contract revenues from collaborations, and $1.0 million in government contract revenue. TAVALISSE net product sales of $43.6 million
increased by $8.9 million or 26% compared to $34.7 million in the same period of 2022. Contract revenues from collaborations for the
six months ended June 30, 2023, consisted primarily of revenue from Grifols S.A., related to the delivery of drug supplies of $2.8 million
and a royalty of $1.5 million. Government contract revenue for the six months ended June 30, 2023, was related to the income recognized
pursuant to the previously mentioned agreement with the DOD.
For the six months ended June 30, 2023, total costs and expenses
were $70.9 million, compared to $85.8 million for the same period of 2022. The decrease in costs and expenses was primarily due to decreased
research and development costs due to trial completion activities related to the Phase 3 clinical trial of fostamatinib for 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 Rigel’s IRAK 1/4 inhibitor program.
As of June 30, 2023, Rigel had cash, cash equivalents and short-term
investments of $64.4 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 2023.3
Relapsed AML affects
about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.4
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.5 Quality
of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory
disease remain an unmet need.
About TAVALISSE®
Indication
TAVALISSE (fostamatinib disodium hexahydrate)
tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had
an insufficient response to a previous treatment.
Important Safety Information
Warnings and Precautions
| · | Hypertension can occur with TAVALISSE
treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive
effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate
antihypertensive therapy for blood pressure control maintenance during therapy. If increased
blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required. |
| · | Elevated liver function tests (LFTs),
mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT
or AST increase to ≥3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption,
reduction, or discontinuation. |
| · | Diarrhea occurred in 31% of patients
and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for
the development of diarrhea and manage using supportive care measures early after the onset
of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue
TAVALISSE. |
| · | Neutropenia occurred in 6% of patients
treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly
and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation. |
| · | TAVALISSE can cause fetal harm
when administered to pregnant women. Advise pregnant women the potential risk to a fetus.
Advise females of reproductive potential to use effective contraception during treatment and for at least 1
month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present
in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed
during TAVALISSE treatment and for at least 1 month after the last dose. |
Drug Interactions
| · | Concomitant use of TAVALISSE with
strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406),
which may increase the risk of adverse reactions. Monitor for toxicities that may require
a reduction in TAVALISSE dose. |
| · | It is not recommended to use TAVALISSE
with strong CYP3A4 inducers, as concomitant use reduces exposure to R406. |
| · | Concomitant use of TAVALISSE may
increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of
the CYP3A4 substrate drug. |
| · | Concomitant use of TAVALISSE may
increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp)
substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate
drug. |
Adverse Reactions
| · | Serious adverse drug reactions
in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive
crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions
occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain,
diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia
(all 1%). |
| · | Common adverse reactions (≥5%
and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea,
dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest
pain, and neutropenia. |
Please see www.TAVALISSEUSPI.com for full Prescribing Information.
To report side effects of prescription drugs
to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).
TAVALISSE and TAVLESSE are registered trademarks of Rigel Pharmaceuticals,
Inc.
About REZLIDHIA®
INDICATION
REZLIDHIA is indicated for the treatment of adult
patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected
by an FDA-approved test.
IMPORTANT SAFETY INFORMATION
WARNING: DIFFERENTIATION
SYNDROME
Differentiation syndrome, which can be fatal,
can occur with REZLIDHIA treatment. Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension,
fever, and weight gain. If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and
hemodynamic monitoring until symptom resolution.
WARNINGS AND PRECAUTIONS
Differentiation Syndrome
REZLIDHIA can cause differentiation syndrome.
In the clinical trial of REZLIDHIA in patients with relapsed or refractory AML, differentiation syndrome occurred in 16% of patients,
with grade 3 or 4 differentiation syndrome occurring in 8% of patients treated, and fatalities in 1% of patients. Differentiation syndrome
is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal. Symptoms of differentiation
syndrome in patients treated with REZLIDHIA included leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney
injury, fever, edema, pyrexia, and weight gain. Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after
treatment or after dose interruption of REZLIDHIA. Differentiation syndrome occurred as early as 1 day and up to 18 months after REZLIDHIA
initiation and has been observed with or without concomitant leukocytosis.
If differentiation syndrome is suspected, temporarily
withhold REZLIDHIA and initiate systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours) for a minimum of 3 days and until
resolution of signs and symptoms. If concomitant leukocytosis is observed, initiate treatment with hydroxyurea, as clinically indicated.
Taper corticosteroids and hydroxyurea after resolution of symptoms. Differentiation syndrome may recur with premature discontinuation
of corticosteroids and/or hydroxyurea treatment. Institute supportive measures and hemodynamic monitoring until improvement; withhold
dose of REZLIDHIA and consider dose reduction based on recurrence.
Hepatotoxicity
REZLIDHIA can cause hepatotoxicity, presenting
as increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased blood alkaline phosphatase, and/or
elevated bilirubin. Of 153 patients with relapsed or refractory AML who received REZLIDHIA, hepatotoxicity occurred in 23% of patients;
13% experienced grade 3 or 4 hepatotoxicity. One patient treated with REZLIDHIA in combination with azacitidine in the clinical trial,
a combination for which REZLIDHIA is not indicated, died from complications of drug-induced liver injury. The median time to onset of
hepatotoxicity in patients with relapsed or refractory AML treated with REZLIDHIA was 1.2 months (range: 1 day to 17.5 months) after
REZLIDHIA initiation, and the median time to resolution was 12 days (range: 1 day to 17 months). The most common hepatotoxicities were
elevations of ALT, AST, blood alkaline phosphatase, and blood bilirubin.
Monitor patients frequently for clinical symptoms
of hepatic dysfunction such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. Obtain baseline liver function
tests prior to initiation of REZLIDHIA, at least once weekly for the first two months, once every other week for the third month, once
in the fourth month, and once every other month for the duration of therapy. If hepatic dysfunction occurs, withhold, reduce, or permanently
discontinue REZLIDHIA based on recurrence/severity.
ADVERSE REACTIONS
The most common (≥20%) adverse reactions,
including laboratory abnormalities, were aspartate aminotransferase increased, alanine aminotransferase increased, potassium decreased,
sodium decreased, alkaline phosphatase increased, nausea, creatinine increased, fatigue/malaise, arthralgia, constipation, lymphocytes
increased, bilirubin increased, leukocytosis, uric acid increased, dyspnea, pyrexia, rash, lipase increased, mucositis, diarrhea and
transaminitis.
DRUG INTERACTIONS
| · | Avoid concomitant use of REZLIDHIA
with strong or moderate CYP3A inducers. |
| · | Avoid concomitant use of REZLIDHIA
with sensitive CYP3A substrates unless otherwise instructed in the substrates prescribing
information. If concomitant use is unavoidable, monitor patients for loss of therapeutic
effect of these drugs. |
LACTATION
Advise women not to breastfeed during treatment with REZLIDHIA and
for 2 weeks after the last dose.
GERIATRIC USE
No overall differences in effectiveness were
observed between patients 65 years and older and younger patients. Compared to patients younger than 65 years of age, an increase in
incidence of hepatotoxicity and hypertension was observed in patients ≥65 years of age.
HEPATIC IMPAIRMENT
In patients with mild or moderate hepatic impairment,
closely monitor for increased probability of differentiation syndrome.
Click here for Full Prescribing Information, including Boxed
WARNING.
To report side effects of prescription drugs
to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).
REZLIDHIA is a registered trademark of Rigel Pharmaceuticals,
Inc.
About Rigel
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is
a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients
with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San Francisco, California. For more information on Rigel,
the Company's marketed products and pipeline of potential products, visit www.rigel.com.
| 1. | de Botton S, et al. Olutasidenib (FT-2102) induces durable complete remissions in patients with relapsed or refractory IDH1-mutated AML. Blood Advances. February 1, 2023.
doi: https://doi.org/10.1182/bloodadvances.2022009411 |
| 2. | R289 is an investigational compound
not approved by the FDA. |
| 3. | 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 |
| 4. | 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 |
| 5. | Thol F, Schlenk RF, Heuser M, Ganser
A. How I treat refractory and early relapsed acute myeloid leukemia. Blood (2015) 126 (3):
319-27. doi: https://doi.org/10.1182/blood-2014-10-551911 |
Forward Looking Statements
This press release contains
forward-looking statements relating to, among other things, the potential and market opportunity of olutasidenib as therapeutics for
R/R AML and other conditions, the commercialization of fostamatinib 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, and the advancement of
Phase 2a clinical trial of R552 for the treatment of rheumatoid arthritis. Any statements contained in this press release that are
not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements can be identified by
words such as "plan", "potential", "may", "expects", "will" and similar
expressions in reference to future periods. Forward-looking statements are neither historical facts nor assurances of future
performance. Instead, they are based on Rigel's current beliefs, expectations, and assumptions and hence they inherently involve
significant risks, uncertainties and changes in circumstances that are difficult to predict and many of which are outside of our
control. Therefore, you should not rely on any of these forward-looking statements. Actual results and the timing of events
could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties,
which include, without limitation, risks and uncertainties associated with the commercialization and marketing of 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 March 31, 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 June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
(unaudited) | |
Revenues: | |
| | |
| | |
| | |
| |
Product sales, net | |
$ | 23,881 | | |
$ | 18,550 | | |
$ | 47,626 | | |
$ | 34,747 | |
Contract revenues from collaborations | |
| 2,005 | | |
| 11,269 | | |
| 4,330 | | |
| 11,807 | |
Government contract | |
| 1,000 | | |
| - | | |
| 1,000 | | |
| - | |
Total revenues | |
| 26,886 | | |
| 29,819 | | |
| 52,956 | | |
| 46,554 | |
Costs and expenses: | |
| | | |
| | | |
| | | |
| | |
Cost of product sales | |
| 1,075 | | |
| 1,036 | | |
| 2,052 | | |
| 1,157 | |
Research and development (see Note A) | |
| 4,772 | | |
| 14,767 | | |
| 14,861 | | |
| 30,241 | |
Selling, general and administrative (see Note A) | |
| 26,306 | | |
| 26,981 | | |
| 54,035 | | |
| 54,382 | |
Total costs and expenses | |
| 32,153 | | |
| 42,784 | | |
| 70,948 | | |
| 85,780 | |
Loss from operations | |
| (5,267 | ) | |
| (12,965 | ) | |
| (17,992 | ) | |
| (39,226 | ) |
Interest income | |
| 529 | | |
| 42 | | |
| 922 | | |
| 63 | |
Interest expense | |
| (1,862 | ) | |
| (569 | ) | |
| (3,066 | ) | |
| (1,774 | ) |
Net loss | |
$ | (6,600 | ) | |
$ | (13,492 | ) | |
$ | (20,136 | ) | |
$ | (40,937 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share, basic and diluted | |
$ | (0.04 | ) | |
$ | (0.08 | ) | |
$ | (0.12 | ) | |
$ | (0.24 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average shares used in computing net loss per share, basic and diluted | |
| 173,748 | | |
| 172,147 | | |
| 173,659 | | |
| 171,961 | |
| |
| | | |
| | | |
| | | |
| | |
Note A | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation expense included in: | |
| | | |
| | | |
| | | |
| | |
Selling, general and administrative | |
$ | 1,796 | | |
$ | 1,933 | | |
$ | 3,531 | | |
$ | 4,672 | |
Research and development | |
| 376 | | |
| 458 | | |
| 1,399 | | |
| 926 | |
| |
$ | 2,172 | | |
$ | 2,391 | | |
$ | 4,930 | | |
$ | 5,598 | |
SUMMARY BALANCE SHEET DATA
(in thousands)
| |
As of | |
| |
June 30, 2023 | | |
December 31, 2022 (1) | |
| |
(unaudited) | | |
| |
Cash, cash equivalents and short-term investments | |
$ | 64,357 | | |
$ | 58,206 | |
Total assets | |
| 117,091 | | |
| 134,279 | |
Stockholders' deficit | |
| (28,115 | ) | |
| (13,616 | ) |
(1) |
Derived from audited financial statements |
v3.23.2
Cover
|
Aug. 01, 2023 |
Cover [Abstract] |
|
Document Type |
8-K
|
Amendment Flag |
false
|
Document Period End Date |
Aug. 01, 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 |
false
|
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Rigel Pharmaceuticals (NASDAQ:RIGL)
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Rigel Pharmaceuticals (NASDAQ:RIGL)
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