Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) is a biotechnology company dedicated to developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. The company's focus on products that address critical signaling pathways has led to the successful commercialization of two products and the recent acquisition of a third, positioning Rigel for continued growth in the years ahead.

Business Overview

Rigel's first FDA-approved product is TAVALISSE (fostamatinib disodium hexahydrate), the only approved oral spleen tyrosine kinase (SYK) inhibitor for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to other treatments. TAVALISSE is also commercially available in Europe, the UK, Canada, Israel, and Japan for the treatment of chronic ITP in adult patients.

Rigel's second FDA-approved product is 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. Rigel began commercializing REZLIDHIA in the US in December 2022.

In February 2024, Rigel entered into an Asset Purchase Agreement with Blueprint Medicines Corporation (Blueprint) to purchase certain assets comprising the right to research, develop, manufacture and commercialize GAVRETO (pralsetinib) in the US. GAVRETO is a once daily, small molecule, oral, kinase inhibitor of wild-type rearranged during transfection (RET) and oncogenic RET fusions. GAVRETO is approved by the FDA for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as well as adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer.

Financials

Rigel's annual revenue was $116.9 million in 2023. The company's annual net income was -$25.1 million, annual operating cash flow was -$5.7 million, and annual free cash flow was -$20.7 million.

In the first quarter of 2024, Rigel reported net product sales of $26.0 million, up from $23.7 million in the same period of 2023. This increase was driven by strong demand for both TAVALISSE and REZLIDHIA. TAVALISSE net sales were $21.1 million, down 5% from the prior year quarter, primarily due to a decrease in the number of bottles remaining in the distribution channel. REZLIDHIA net sales were $4.9 million, up significantly from $1.5 million in the first quarter of 2023, as the product continues to gain traction in the market.

Rigel's contract revenues from collaborations were $3.5 million in the first quarter of 2024, compared to $2.3 million in the same period of 2023. These revenues were primarily from Rigel's partnerships with Kissei Pharmaceutical Co., Ltd., Grifols S.A., and Medison Pharma.

The company's total costs and expenses decreased to $36.5 million in the first quarter of 2024, down from $38.8 million in the prior year period, primarily due to lower research and development expenses and reduced consulting and third-party services. Rigel ended the first quarter of 2024 with $49.6 million in cash, cash equivalents, and short-term investments.

Outlook

Looking ahead, Rigel is focused on continuing to grow sales of TAVALISSE and REZLIDHIA, while also integrating GAVRETO into its commercial operations. The company expects to begin shipping GAVRETO to patients and clinics in July 2024 and anticipates that the product will be highly synergistic with its existing hematology-oncology focused commercial and medical affairs infrastructure.

In addition to its commercial efforts, Rigel is advancing the development of its pipeline, including the evaluation of REZLIDHIA in a broad range of IDH1 mutant cancers through strategic collaborations with MD Anderson Cancer Center and the CONNECT Consortium. The company is also progressing its IRAK1/4 inhibitor program, R289, in a Phase 1b trial for patients with lower-risk myelodysplastic syndrome (MDS).

Conclusion

Rigel's strategy of expanding its hematology and oncology portfolio through both internal development and strategic acquisitions or in-licensing agreements has positioned the company for continued growth. With a focus on commercializing differentiated products that leverage its existing infrastructure, Rigel is well-positioned to achieve financial breakeven and become a self-sustaining company in the years ahead.