SOUTH SAN FRANCISCO - Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today reported financial results for the second quarter ended June 30, 2023, including sales of TAVALISSE 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.
'We are encouraged by the progress we made in the second quarter in building our hematology/oncology company,' said Raul Rodriguez, Rigel's president and CEO. 'We delivered strong year-over-year revenue growth for TAVALISSE in ITP and hired our dedicated institutional sales team to drive our commercial launch of REZLIDHIA with a focus on awareness and education with healthcare professionals. We also continued to advance our current development programs while evaluating opportunities to expand our hematology/oncology business through internal and external opportunities.'
Business Update
In the second quarter of 2023, a total of 2,191 bottles of TAVALISSE were sold in the U.S. During the quarter, 2,265 bottles were shipped directly to patients and clinics, representing the highest number of bottles shipped to patients and clinics in a quarter since launch.
During the second full quarter of launch, a total of 200 bottles of REZLIDHIA were sold in the U.S., representing a 77% increase over Q1 2023. Of those bottles, 187 were shipped directly to patients and clinics.
In June, Rigel presented promising data from an analysis of the Phase 2 clinical trial evaluating REZLIDHIA in 17 patients with mIDH1 AML who were relapsed/refractory to prior venetoclax-based regimens at the European Hematology Association (EHA) 2023 Hybrid Congress. The data showed clinically meaningful activity with REZLIDHIA, a potent, selective, oral, small-molecule inhibitor of mIDH11, representing an encouraging therapeutic advance in the treatment of this molecularly defined, poor-prognosis patient population.
Rigel also announced the publication in June of an expert review article in Blood Advances examining the development path and positioning of REZLIDHIA in the mIDH1 R/R AML treatment landscape. The authors concluded, 'The approval of olutasidenib is a critical addition to the mIDH1 AML treatment landscape with encouragingly durable responses.' They recommended treatment with olutasidenib in venetoclax plus HMA failures, based on the available data.
Rigel continues to advance its open-label, Phase 1b clinical trial of R2892, 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. Target enrollment in the second cohort of the trial has been completed and Rigel expects to begin enrollment in the third cohort in the near future.
R552, an investigational, potent, and selective RIPK1 inhibitor, is being advanced by Rigel's partner Eli Lilly. The Phase 2a clinical trial (NCT05848258) studying R552 in adult patients with moderately to severely active rheumatoid arthritis (RA) has been initiated. The trial plans to enroll 100 patients globally.
Financial Update
For the second quarter of 2023, Rigel reported a net loss of $6.6 million, or $0.04 per basic and diluted share, compared to a net loss of $13.5 million, or $0.08 per basic and diluted share, for the same period of 2022.
For the second quarter of 2023, total revenues were $26.9 million, consisting of $21.3 million in TAVALISSE net product sales, $2.6 million in REZLIDHIA net product sales, $2.0 million in contract revenues from collaborations, and $1.0 million in government contract revenue. TAVALISSE net product sales of $21.3 million increased by $2.8 million or 15% compared to $18.6 million in the same period of 2022. Contract revenues from collaborations for the second quarter of 2023 consisted primarily of revenue from Grifols S.A., related to the delivery of drug supplies of $1.2 million and a royalty of $0.8 million. Government contract revenue for the second quarter of 2023 was related to income recognized pursuant to the agreement with the U.S. Department of Defense (DOD) to support Rigel's ongoing Phase 3 clinical trial of fostamatinib in high-risk hospitalized patients with COVID-19.
For the second quarter of 2023, total costs and expenses were $32.2 million, compared to $42.8 million for the same period of 2022. The decrease in costs and expenses was primarily due to decreased research and development costs due to trial completion activities related to the Phase 3 clinical trial of fostamatinib for wAIHA and the Phase 3 clinical trial of fostamatinib in high-risk hospitalized patients with COVID-19, as well as timing of activities related to Rigel's IRAK 1/4 inhibitor program.
For the six months ended June 30, 2023, Rigel reported a net loss of $20.1 million, or $0.12 per basic and diluted share, compared to a net loss of $40.9 million, or $0.24 per basic and diluted share, for the same period of 2022.
For the six months ended June 30, 2023, total revenues were $52.9 million, consisting of $43.6 million in TAVALISSE net product sales, $4.0 million in REZLIDHIA net product sales, $4.3 million in contract revenues from collaborations, and $1.0 million in government contract revenue. TAVALISSE net product sales of $43.6 million increased by $8.9 million or 26% compared to $34.7 million in the same period of 2022. Contract revenues from collaborations for the six months ended June 30, 2023, consisted primarily of revenue from Grifols S.A., related to the delivery of drug supplies of $2.8 million and a royalty of $1.5 million. Government contract revenue for the six months ended June 30, 2023, was related to the income recognized pursuant to the previously mentioned agreement with the DOD.
For the six months ended June 30, 2023, total costs and expenses were $70.9 million, compared to $85.8 million for the same period of 2022. The decrease in costs and expenses was primarily due to decreased research and development costs due to trial completion activities related to the Phase 3 clinical trial of fostamatinib for wAIHA and the Phase 3 clinical trial of fostamatinib in high-risk hospitalized patients with COVID-19, as well as timing of activities related to Rigel's IRAK 1/4 inhibitor program.
As of June 30, 2023, Rigel had cash, cash equivalents and short-term investments of $64.4 million, compared to $58.2 million as of December 31, 2022.
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 20,380 new cases, most in adults, in 2023.3
Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.4 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.5 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.
About Rigel
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San Francisco, California.
Forward Looking Statements
This press release contains forward-looking statements relating to, among other things, the potential and market opportunity of olutasidenib as therapeutics for R/R AML and other conditions, the commercialization of fostamatinib or olutasidenib in the U.S. and international markets, and Rigel's ability to further develop its clinical stage and early-stage product candidates and Rigel's partnering effort, including the progress of Phase 1b clinical trial of R289 for the treatment of lower-risk myeloid dysplastic syndrome, and the advancement of Phase 2a clinical trial of R552 for the treatment of rheumatoid arthritis. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements can be identified by words such as 'plan', 'potential', 'may', 'expects', 'will' and similar expressions in reference to future periods. Instead, they are based on Rigel's current beliefs, expectations, and assumptions and hence they inherently involve significant risks, uncertainties and changes in circumstances that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of fostamatinib or olutasidenib; risks that the FDA, European Medicines Agency, PMDA or other regulatory authorities may make adverse decisions regarding fostamatinib or olutasidenib; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that fostamatinib or olutasidenib may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 and subsequent filings.
Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. Rigel does not undertake any obligation to update forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law.
Contact:
Tel: 650.624.1232
Email: ir@rigel.com
RIGEL PHARMACEUTICALS, INC. 
