Rigel Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update.

SOUTH SAN FRANCISCO, Calif: Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today reported financial results for the fourth quarter and full year ended December 31, 2022, including sales of TAVALISSE(r) (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.

"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 Raul Rodriguez, Rigel's president and CEO. "We are focused on continuing the successful launch of REZLIDHIA in R/R AML, driving sales growth for TAVALISSE in ITP, and advancing our development programs. In 2023, we look forward to further expanding our hematology-oncology portfolio and clinical pipeline."

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 ended December 31, 2022, 8,112 bottles of TAVALISSE were shipped directly to patients and clinics, representing an increase of 20% compared to 2021.

On December 1, 2022, REZLIDHIA was approved by the U.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. From December 22, 2022, when REZLIDHIA became commercially available in the U.S., to December 31, 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.

REZLIDHIA was added by the National Comprehensive Cancer Network(r) (NCCN(r)) to the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines(r)) for AML in January 2023. REZLIDHIA is included as a recommended targeted therapy for adult patients with R/R AML with IDH1...