Rigel(US:RIGL)2024-05-07 20:16Financial Performance - Total revenue for Q1 2024 was $29.5 million, including $21.1 million from TAVALISSE and $4.9 million from REZLIDHIA[5]. - Total revenues for Q1 2024 increased to $29,534,000, up 13.5% from $26,070,000 in Q1 2023[51]. - Product sales, net rose to $26,003,000, compared to $23,745,000 in the same period last year, reflecting an increase of 9.5%[51]. - Contract revenues from collaborations grew significantly to $3,531,000, up 51.8% from $2,325,000 in Q1 2023[51]. - Total costs and expenses for Q1 2024 were $36.5 million, a decrease from $38.8 million in the same period of 2023[10]. - Total costs and expenses decreased to $36,500,000, down 5.7% from $38,795,000 in Q1 2023[51]. - Rigel's net loss for Q1 2024 was $8.2 million, or $0.05 per share, an improvement from a net loss of $13.5 million, or $0.08 per share, in Q1 2023[11]. - Net loss for Q1 2024 was $8,247,000, an improvement of 39.5% compared to a net loss of $13,536,000 in Q1 2023[51]. - Net loss per share improved to $0.05, compared to $0.08 in the prior year[51]. - Rigel's cash, cash equivalents, and short-term investments totaled $49.6 million as of March 31, 2024, down from $56.9 million at the end of 2023[12]. - Cash, cash equivalents, and short-term investments decreased to $49,550,000 from $56,933,000 as of December 31, 2023[53]. - Total assets increased to $126,519,000, up from $117,225,000 at the end of 2023[53]. - Stockholders' deficit widened to $31,671,000 from $28,644,000 as of December 31, 2023[53]. - Stock-based compensation expense included in selling, general and administrative expenses was $4,484,000, significantly higher than $1,735,000 in Q1 2023[51]. Product Sales and Market Performance - TAVALISSE sales volume reached 2,193 bottles, the highest quarterly sales since launch, while REZLIDHIA sales grew significantly with 390 bottles sold[6]. - The company expanded its portfolio with the acquisition of GAVRETO, expected to start recognizing product sales in July 2024[5]. - Contract revenue from collaborations amounted to $3.5 million, with contributions from Kissei Pharmaceutical, Grifols, and Medison Pharma[9]. Clinical Development and Trials - Rigel is advancing its Phase 1b clinical trial for R289, a novel IRAK1/4 inhibitor, with preliminary data expected by the end of 2024[8]. - The company announced a strategic collaboration with CONNECT to evaluate REZLIDHIA in combination with temozolomide for high-grade glioma patients[7]. - Rigel Pharmaceuticals is focused on the commercialization of olutasidenib and pralsetinib for various cancers, with ongoing clinical trials[48]. Adverse Reactions and Safety - TAVALISSE patients experienced serious adverse reactions at a rate of 1%, with severe reactions including dyspnea and hypertension at 2%[31]. - Hepatotoxicity occurred in 23% of patients treated with REZLIDHIA, with 13% experiencing grade 3 or 4 hepatotoxicity[32]. - GAVRETO showed a 12% incidence of pneumonitis, with 3.3% classified as Grade 3-4 and 0.2% resulting in fatal reactions[43]. - 35% of GAVRETO patients experienced hypertension, with 18% having Grade 3 hypertension[43]. - Increased AST levels were observed in 49% of GAVRETO patients, with 7% experiencing Grade 3 or 4 increases[43]. - The median time to onset for increased AST in GAVRETO patients was 15 days, with a range from 5 days to 2.5 years[43]. - Common adverse reactions for GAVRETO included musculoskeletal pain, constipation, and fatigue, occurring in ≥25% of patients[46]. - The company advises against the use of REZLIDHIA with strong or moderate CYP3A inducers due to potential drug interactions[40]. - Rigel Pharmaceuticals emphasizes the importance of monitoring liver function tests for patients on REZLIDHIA, especially during the first two months of treatment[33]. Leadership and Management - Rigel appointed Lisa Rojkjaer, M.D. as Chief Medical Officer, bringing over 20 years of experience in clinical development and oncology[6].