Rigel Pharmaceuticals, Inc.NASDAQ: RIGL

Rigel Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

· Issued by Rigel Pharmaceuticals, Inc. via PR Newswire
  • Fourth quarter 2023 Total Revenue of $35.8 million which includes TAVALISSE® net product sales of $25.7 million and REZLIDHIA® net product sales of $3.9 million
  • Expanded product portfolio with acquisition of U.S. rights to GAVRETO®, an FDA approved targeted therapy for the treatment of RET fusion-positive metastatic non-small cell lung cancer and advanced or metastatic thyroid cancer
  • Conference call and webcast scheduled today at 4:30 p.m. Eastern Time

SOUTH SAN FRANCISCO, Calif., March 5, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today reported financial results for the fourth quarter and full year ended December 31, 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.

"In 2023, fueled by increased physician awareness and adoption for both TAVALISSE and REZLIDHIA, we achieved net product sales of $104.3 million, an increase of 36% compared to 2022," said Raul Rodriguez, Rigel's president and CEO. "We recently expanded our hematology and oncology portfolio with the addition of GAVRETO, a U.S. marketed product for the treatment of RET fusion-positive NSCLC. This addition is highly synergistic with our current portfolio and existing infrastructure, which we believe will further support top line growth. In 2024, we are focused on commercial expansion and execution, while advancing our pipeline with more strategic collaborations like MD Anderson and CONNECT."

Business Update

  • In the fourth quarter of 2023, we achieved the highest number of TAVALISSE bottles shipped to patients and clinics in a quarter since launch. A total of 2,671 bottles were sold in the U.S., 2,463 of which were shipped directly to patients and clinics. For the full year ended December 31, 2023, 9,396 bottles of TAVALISSE were shipped directly to patients and clinics, representing an increase of 16% compared to 2022.
  • During the fourth quarter of 2023, we achieved 47% growth in total REZLIDHIA bottles sold compared to the third quarter of 2023. A total of 308 bottles were sold in the U.S., 278 of which were shipped directly to patients and clinics. For the full year ended December 31, 2023, 795 bottles of REZLIDHIA were shipped directly to patients and clinics.
  • In February 2024, Rigel announced the acquisition of the U.S. rights to GAVRETO® (pralsetinib). GAVRETO is a once daily, small molecule, oral, kinase inhibitor of wild-type RET (rearranged during transfection) and oncogenic RET fusions. GAVRETO is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) and advanced thyroid cancer. The acquisition of this product further expands Rigel's portfolio and leverages Rigel's existing infrastructure in both the institutional and community medical practice settings. Rigel expects to complete the transition of the asset and start recognizing product sales in the third quarter of 2024.
  • In January 2024, Rigel and CONNECT announced a strategic development collaboration to evaluate REZLIDHIA (olutasidenib) in combination with temozolomide as maintenance therapy in patients with high-grade glioma (HGG) harboring an isocitrate dehydrogenase-1 (IDH1) mutation. Under the collaboration, CONNECT will include olutasidenib in CONNECT's TarGeT-D, a molecularly guided Phase 2 umbrella clinical trial for HGG. The Rigel-sponsored arm will study post-radiotherapy administration of olutasidenib in combination with temozolomide followed by olutasidenib monotherapy as maintenance treatment in newly diagnosed pediatric and young adult patients (