On November 7, 2023 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported financial results for the third quarter ended September 30, 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 (Press release, Rigel, NOV 7, 2023, View Source [SID1234637160]).
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"The third quarter of 2023 was marked by strong momentum from our commercial hematology-oncology portfolio driven by record TAVALISSE net product sales and growing REZLIDHIA awareness among leukemia treaters," said Raul Rodriguez, Rigel’s president and CEO. "These strong net sales combined with our expense discipline have allowed us to make substantial progress on our plan to reach financial breakeven."
Business Update
· In the third quarter of 2023, a total of 2,551 bottles of TAVALISSE were sold in the U.S. During the quarter, 2,412 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 third full quarter of launch, a total of 210 bottles of REZLIDHIA were sold in the U.S. During this quarter, 221 bottles were shipped directly to patients and clinics.
· Last week, Rigel announced four poster presentations highlighting data from the Company’s commercial and clinical-stage hematology-oncology portfolio at the upcoming 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. Included is a poster, Abstract #2888, reporting post hoc analyses in a subset of patients with mIDH1 R/R AML or MDS that were R/R to hematopoietic stem cell transplant (HSCT), ivosidenib (IVO), or venetoclax (VEN). The analyses suggest that olutasidenib alone or in combination with azacitidine may induce complete remissions in these patients. To learn more about Rigel’s clinical and commercial hematology-oncology portfolio visit Booth #2805 during ASH (Free ASH Whitepaper) 2023.
· Rigel continues to advance its open-label, Phase 1b clinical trial of R2891, 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 is currently enrolling patients in the third cohort. Preliminary data results are expected by mid-year 2024.
· In September, the Data and Safety Monitoring Board (DSMB) recommended that the fostamatinib study arm of the ACTIV-4 Host Tissue (NECTAR) platform cease enrollment. No safety concerns were identified. The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, concurs with the DSMB’s recommendations and has asked the trial investigators to cease enrollment, complete follow-up for participants already enrolled, and complete study closeout. The full study data will be analyzed and disseminated as previously planned.
Financial Update
For the third quarter of 2023, Rigel reported a net loss of $5.7 million, or $0.03 per basic and diluted share, compared to a net loss of $19.0 million, or $0.11 per basic and diluted share, for the same period of 2022.
For the third quarter of 2023, total revenues were $28.1 million, consisting of $24.5 million in TAVALISSE net product sales, $2.7 million in REZLIDHIA net product sales, and $1.0 million in contract revenues from collaborations. TAVALISSE net product sales of $24.5 million increased by $5.3 million, or 27%, compared to $19.2 million in the same period of 2022. Contract revenues from collaborations for the third quarter of 2023 consisted primarily of royalty revenue from Grifols S.A. (Grifols) of $0.8 million.
For the third quarter of 2023, total costs and expenses were $32.6 million, compared to $40.8 million for the same period of 2022. The decrease in costs and expenses was partly due to decreased research and development costs due to the completion of activities related to the Phase 3 clinical trial of fostamatinib in wAIHA and the Phase 3 clinical trial of fostamatinib in high-risk hospitalized patients with COVID-19. Also contributing to the decrease, were lower facility-related costs and an upfront payment to Forma Therapeutics Inc. (Forma, now Novo Nordisk) recorded as in-process research and development (IPR&D) and included within cost and expenses in the third quarter of 2022. These decreases were partially offset by increased research and development costs due to the timing of activities related to the IRAK 1/4 inhibitor program.
For the nine months ended September 30, 2023, Rigel reported a net loss of $25.8 million, or $0.15 per basic and diluted share, compared to a net loss of $60.0 million, or $0.35 per basic and diluted share, for the same period of 2022.
For the nine months ended September 30, 2023, total revenues were $81.1 million, consisting of $68.1 million in TAVALISSE net product sales, $6.7 million in REZLIDHIA net product sales, $5.3 million in contract revenues from collaborations, and $1.0 million in government contract revenue. TAVALISSE net product sales of $68.1 million increased by $14.1 million, or 26%, compared to $53.9 million in the same period of 2022. Contract revenues from collaborations for the nine months ended September 30, 2023, consisted primarily of revenue from Grifols related to the delivery of drug supplies of $2.8 million and a royalty of $2.3 million. Government contract revenue for the nine months ended September 30, 2023, was related to income recognized in the second quarter of 2023 pursuant to the agreement with the U.S. Department of Defense to support Rigel’s Phase 3 clinical trial of fostamatinib in high-risk hospitalized patients with COVID-19.
For the nine months ended September 30, 2023, total costs and expenses were $103.5 million, compared to $126.6 million for the same period of 2022. The decrease in costs and expenses was partly due to decreased research and development costs due to the completion of trial activities related to the Phase 3 clinical trial of fostamatinib in 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 the IRAK 1/4 inhibitor program. Also contributing to the decrease were lower facility-related costs, and an upfront payment to Forma (now Novo Nordisk) recorded as IPR&D and included within cost and expenses in the third quarter of 2022.
As of September 30, 2023, Rigel had cash, cash equivalents and short-term investments of $62.4 million, compared to $58.2 million as of December 31, 2022.
Conference Call and Webcast with Slides Today at 4:30pm Eastern Time
Rigel will hold a live conference call and webcast today at 4:30pm Eastern Time (1:30pm Pacific Time).
Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call will also be webcast live and can be accessed from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.