SOUTH SAN FRANCISCO - Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today provided a business update including preliminary total revenue for the fourth quarter of 2023, ongoing activity from the commercial portfolio, including TAVALISSE (fostamatinib disodium hexahydrate) tablets and REZLIDHIA (olutasidenib) capsules, and upcoming catalysts for 2024.
'2023 was a year of significant growth across our commercial hematology-oncology portfolio. We grew TAVALISSE net product sales nearly 24% over 2022 and successfully achieved more than $10 million of REZLIDHIA revenue during its first full year of launch. This enabled us to generate more than $104 million of total net product sales this year,' said Raul Rodriguez, Rigel's president and CEO. 'Also, our recent collaborations with MD Anderson and CONNECT will allow us to evaluate the potential of REZLIDHIA as a possible therapy in a broad range of IDH1-mutant cancers. As we head into the future, we are focused on commercial execution, the advancement of our hematology-oncology pipeline, and our plan to reach financial breakeven.'
Commercial and Preliminary Financial Update
In the fourth quarter of 2023, a total of 2,671 bottles of TAVALISSE were sold in the U.S., of which, 2,463 bottles 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 2023, it expects to report net product sales of TAVALISSE of $25.7 million for the fourth quarter compared to $21.9 million for the same period of 2022.
In the fourth quarter of 2023, a total of 308 bottles of REZLIDHIA were sold in the U.S., of which, 278 bottles were shipped directly to patients and clinics. While Rigel is still determining final results for the fourth quarter of 2023, it expects to report net product sales of REZLIDHIA of $3.9 million for the fourth quarter compared to $0.9 million for the same period of 2022.
Overall, Rigel expects to report net product sales of $104.3 million in 2023, representing 36% growth over 2022.
Contract revenues for the fourth quarter of 2023 are expected to be approximately $6.1 million, consisting of $6.0 million in contract revenue from collaborations and $0.1 million in government contract revenue. Contract revenue from collaborations is expected to include $3.7 million of revenue from Grifols S.A., related to delivery of drug supplies and earned royalties, as well as $2.2 million of revenue from Kissei Pharmaceutical Co., Ltd. and $0.1 million of revenue from Medison Pharma Trading AG, related to delivery of drug supplies.
For the fourth quarter of 2023, Rigel expects to report total revenue of approximately $35.7 million.
Rigel expects to report cash, cash equivalents, and short-term investments of approximately $56.9 million as of December 31, 2023, compared to $58.2 million as of December 31, 2022.
The above information is preliminary, has not been audited, and is subject to change upon the audit of Rigel's financial statements for the year ended December 31, 2023. Rigel expects to provide complete fourth quarter and full year 2023 financial results in March 2024.
Q4 Business Update
Rigel and The University of Texas MD Anderson Cancer Center (MD Anderson) recently announced a multi-year strategic development collaboration to expand the evaluation of REZLIDHIA (olutasidenib) in acute myeloid leukemia (AML) and other hematologic cancers. Under the strategic collaboration, Rigel and MD Anderson will evaluate the potential of olutasidenib to treat newly diagnosed and relapsed or refractory (R/R) patients with AML, higher-risk myelodysplastic syndromes (MDS), and advanced myeloproliferative neoplasms (MPN), in combination with other agents. The collaboration will also support the evaluation of olutasidenib as monotherapy in lower-risk MDS and maintenance therapy in post-hematopoietic stem cell transplant (HSCT) patients. Rigel will provide $15 million in time-based milestone payments and study material over the five-year collaboration.
Rigel and CONNECT recently announced a 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 (
RIGEL PHARMACEUTICALS, INC. 
