On January 9, 2023 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported an business update including preliminary total revenue for the fourth quarter, ongoing activity from the commercial portfolio, including TAVALISSE (fostamatinib disodium hexahydrate) tablets and REZLIDHIA (olutasidenib) capsules, and upcoming catalysts for 2023 (Press release, Rigel, JAN 9, 2023, View Source [SID1234626101]).
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"2022 was a transformative year for Rigel. We expanded our commercial hematology-oncology portfolio with the FDA approval and commercial launch of REZLIDHIA during December, and fourth quarter TAVALISSE net product sales reached a new high," said Raul Rodriguez, Rigel’s president and CEO. "As we look ahead to 2023, we are executing on the commercial launch of REZLIDHIA to bring this important new therapy to patients in need. We continue to drive growth for TAVALISSE ITP sales in the U.S., while working with our partners to expand its global reach. We remain committed to building our hematology-oncology franchise and advancing our pipeline programs."
Commercial and Preliminary Financial 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 daily bottles shipped to patients and clinics in a quarter since launch. While Rigel is still determining final results for the fourth quarter of 2022, it expects to report net product sales of TAVALISSE of $21.9 million for the fourth quarter compared to $17.6 million for the same period of 2021.
REZLIDHIA became commercially available in the U.S. on December 22, 2022. In the fourth quarter of 2022, a total of 64 bottles of REZLIDHIA were sold in the U.S. to fill initial orders from our distributors, 2 of which were shipped to patients and clinics. While Rigel is still determining final results for the fourth quarter of 2022, it expects to report net product sales of REZLIDHIA of $0.9 million for the fourth quarter.
Contract revenues for the fourth quarter of 2022 are expected to be approximately $28.5 million, consisting of $26.5 million in contract revenue from collaborations and $2.0 million in government contract revenue. Contract revenue from collaborations includes a $20.0 million milestone earned from Kissei Pharmaceutical Co., Ltd. (Kissei) upon Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) approval of TAVALISSE for the treatment of chronic ITP, $5.7 million in non-cash revenue from its collaboration agreement with Medison Pharma Trading AG, $0.6 million in royalty revenue from Grifols, and $0.2 million in revenue related to its license agreements with Eli Lilly and Grifols.
For the fourth quarter of 2022, Rigel expects to report total revenue of approximately $51.3 million.
For the fourth quarter of 2022, Rigel expects its cost of product sales to include a 15% royalty on its REZLIDHIA net product sales.
The company expects to report cash, cash equivalents, and short-term investments as of December 31, 2022, of approximately $58.2 million compared to $125.0 million as of December 31, 2021. Additionally, Rigel expects to receive the $20.0 million milestone payment from Kissei during the first quarter of 2023.
The above information is preliminary, has not been audited, and is subject to change upon the audit of the company’s financial statements for the year ended December 31, 2022. Rigel expects to provide complete fourth quarter and full year 2022 financial results in March 2023.
Q4 Business Update
REZLIDHIA was approved by the U.S. Food and Drug Administration (FDA) 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. REZLIDHIA is now available in the U.S. by prescription and the commercial launch is underway.
Rigel’s partner Kissei announced Japan’s PMDA approval of TAVALISSE for the treatment of chronic ITP. During the fourth quarter, Rigel expects to recognize a $20.0 million regulatory milestone earned from Kissei in connection with the approval. The payment is expected during the first quarter of 2023.
The first patients have been dosed in Rigel’s 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 primary endpoint for this trial is safety with key secondary endpoints including preliminary efficacy and evaluation of pharmacokinetic properties. Rigel will also collect key biomarker data to further characterize R289’s mechanism of action in LR-MDS.
R552, an investigational, potent, and selective RIPK1 inhibitor, is advancing with Rigel’s partner Eli Lilly. The initial Phase 2a study 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. RIPK1 is implicated in a broad range of inflammatory cellular processes and plays a key role in tumor necrosis factor (TNF) signaling, especially in the induction of pro-inflammatory necroptosis. The Phase 2a study 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 an impressive overall response rate of 77% for fostamatinib in steroid-refractory cGvHD patients with 70% of responses lasting >1 year and a manageable safety profile in the post-transplant setting.
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 20,050 new cases, most in adults, in 2022.2
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.