Rigel Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
Rigel Pharmaceuticals (RIGL) reported its financial results for Q4 2022, with total revenues of $51.3 million, including $21.9 million from TAVALISSE and $0.9 million from REZLIDHIA. The launch of REZLIDHIA, approved in December 2022, is progressing well, aided by its inclusion in NCCN Guidelines for AML. Rigel also received $20 million from Kissei due to TAVALISSE's approval in Japan. Despite a net income of $1.4 million in Q4 2022, Rigel faced increased total expenses of $49.2 million. For the full year, total revenues reached $120.2 million but resulted in a net loss of $58.6 million.
- Total revenue increased by 6% compared to Q4 2021.
- TAVALISSE net product sales grew by 25% from Q4 2021.
- Successful launch of REZLIDHIA with initial sales of $0.9 million.
- $20 million milestone payment received from Kissei.
- REZLIDHIA added to NCCN Guidelines for AML.
- Total expenses rose to $49.2 million in Q4 2022, up from $41.8 million in Q4 2021.
- Net loss of $58.6 million for the full year 2022, significantly higher than $17.9 million loss in 2021.
- Cash reserves decreased to $58.2 million from $125 million year-over-year.
- Fourth quarter 2022 Total Revenue of
which includes TAVALISSE® net product sales of$51.3 million and REZLIDHIA™ net product sales of$21.9 million $0.9 million - REZLIDHIA
U.S. commercial launch continues to progress and is supported by recent addition to NCCN Guidelines® for AML - Conference call and webcast scheduled today at
4:30 p.m. Eastern Time
"2022 was a year of significant accomplishments for Rigel, as we expanded our commercial hematology-oncology portfolio with the approval and launch of REZLIDHIA, an important new treatment option for AML patients. We also continued to strengthen our commercial execution, with TAVALISSE net product sales reaching a record high in the fourth quarter," said
Business Update
- In the fourth quarter of 2022, a total of 2,417 bottles of TAVALISSE were sold in the
U.S. , 2,196 of which were shipped directly to patients and clinics, representing the highest number of daily bottles shipped to patients and clinics in a quarter since launch. For the full year endedDecember 31, 2022 , 8,112 bottles of TAVALISSE were shipped directly to patients and clinics, representing an increase of20% compared to 2021. - On
December 1, 2022 , REZLIDHIA was approved by theU.S. Food and Drug Administration (FDA) for the treatment of adult patients with R/R AML with a susceptible IDH1 mutation as detected by an FDA-approved test. FromDecember 22, 2022 , when REZLIDHIA became commercially available in theU.S. , toDecember 31, 2022 , a total of 64 bottles of REZLIDHIA were sold in theU.S. to fill initial orders from our distributors, 2 of which were shipped to patients and clinics. - REZLIDHIA was added by the National Comprehensive Cancer Network® (NCCN®) to the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for AML in
January 2023 . REZLIDHIA is included as a recommended targeted therapy for adult patients with R/R AML with IDH1 mutation. - Rigel announced a peer-reviewed publication of data in Blood Advances in
February 2023 , which summarizes clinical results from the Phase 2 registrational trial of REZLIDHIA in patients with mIDH1 R/R AML. The published data demonstrate that REZLIDHIA induced durable remissions and transfusion independence with a well-characterized safety profile. - In
December 2022 , Rigel's partner Kissei announcedJapan's Pharmaceuticals and Medical Devices Agency (PMDA) approval of TAVALISSE for the treatment of chronic ITP. During the fourth quarter, Rigel recognized a regulatory milestone earned from Kissei in connection with the approval. The payment was received during the first quarter of 2023.$20.0 million - Rigel continues to advance the 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. The first patients have been dosed and enrollment is underway.
- R552, an investigational, potent, and selective RIPK1 inhibitor, is being advanced by Rigel's partner Eli Lilly (Lilly). The initial Phase 2a trial in approximately 100 patients with moderately to severely active rheumatoid arthritis (RA) is anticipated to begin in the first half of 2023 and will involve global recruitment. The Phase 2a trial analysis is expected by the end of 2024.
- Data was published in Transplantation and Cellular Therapy, which summarizes the results of an investigational Phase 1 clinical trial of fostamatinib, Rigel's oral spleen tyrosine kinase, for the treatment of chronic graft-versus-host disease (cGvHD). Highlights included a promising overall response rate of
77% for fostamatinib in steroid-refractory cGvHD patients with70% of responses lasting >1 year and a manageable safety profile in the post-transplant setting.
Financial Update
For the fourth quarter of 2022, Rigel reported a net income of
For the fourth quarter of 2022, total revenues were
For the fourth quarter of 2022, total costs and expenses were
For the full year 2022, Rigel reported a net loss of
For the full year 2022, total revenues were
For the full year 2022, total costs and expenses were
As of
Conference Call and Webcast with Slides Today at
Rigel will hold a live conference call and webcast today at
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
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 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 in1% 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 in1% 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 (both2% ), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all1% ). - 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
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 |
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
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
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 (≥
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 trademark of
About Rigel
- R289 is an investigational compound not approved by the FDA
- The
American Cancer Society . Key Statistics for Acute Myeloid Leukemia (AML). RevisedJanuary 12, 2023 . AccessedFeb. 15, 2023 : 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 . AccessedFeb 15, 2023 : 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 Jul 16;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 in the
Contact for Investors & Media:
Investors:
650.624.1232
ir@rigel.com
Media:
212.600.1902
david.rosen@argotpartners.com
STATEMENTS OF OPERATIONS | ||||||||
(in thousands, except per share amounts) | ||||||||
Three Months Ended | Year Ended | |||||||
2022 | 2021 | 2022 | 2021 | |||||
(unaudited) | ||||||||
Revenues: | ||||||||
Product sales, net | $ 22,783 | $ 17,569 | $ 76,718 | $ 63,010 | ||||
Contract revenues from collaborations | 26,495 | 1,840 | 39,024 | 75,726 | ||||
Government contract | 2,000 | 1,000 | 4,500 | 10,500 | ||||
Total revenues | 51,278 | 20,409 | 120,242 | 149,236 | ||||
Costs and expenses: | ||||||||
Cost of product sales | 342 | 487 | 1,749 | 1,083 | ||||
Research and development (see Note A) | 15,365 | 13,304 | 60,272 | 65,237 | ||||
Selling, general and administrative (see Note A) | 32,172 | 24,515 | 112,451 | 91,891 | ||||
Restructuring charges (see Note A) | 1,320 | 3,521 | 1,320 | 3,521 | ||||
Total costs and expenses | 49,199 | 41,827 | 175,792 | 161,732 | ||||
Income (loss) from operations | 2,079 | (21,418) | (55,550) | (12,496) | ||||
Interest income | 429 | 16 | 684 | 47 | ||||
Interest expense | (1,107) | (1,299) | (3,707) | (4,860) | ||||
Income (loss) before income taxes | 1,401 | (22,701) | (58,573) | (17,309) | ||||
Provision for (benefit from) income taxes | - | (60) | - | 605 | ||||
Net income (loss) | $ 1,401 | $ (22,641) | $ (58,573) | $ (17,914) | ||||
Net income (loss) per share, basic and diluted | ||||||||
Basic | $ 0.01 | $ (0.13) | $ (0.34) | $ (0.11) | ||||
Diluted | $ 0.01 | $ (0.13) | $ (0.34) | $ (0.11) | ||||
Weighted average shares used in computing net income (loss) per share, basic and diluted | ||||||||
Basic | 172,851 | 171,071 | 172,406 | 170,492 | ||||
Diluted | 172,856 | 170,071 | 172,406 | 170,492 | ||||
Note A | ||||||||
Stock-based compensation expense included in: | ||||||||
Selling, general and administrative | $ 3,426 | $ 1,712 | $ 10,217 | $ 7,337 | ||||
Research and development | 654 | 178 | 2,168 | 1,700 | ||||
Restructuring charges | - | 449 | - | 449 | ||||
$ 4,080 | $ 2,339 | $ 12,385 | $ 9,486 | |||||
SUMMARY BALANCE SHEET DATA | ||||||||
(in thousands) | ||||||||
As of | ||||||||
2022 | 2021 | |||||||
Cash, cash equivalents and short-term investments | $ 58,206 | $ 124,967 | ||||||
Total assets | 134,279 | 167,328 | ||||||
Stockholders' equity (deficit) | (13,616) | 30,374 |
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