Financial Data and Key Metrics - The company's cash reserves as of June 30, 2024, exceeded RMB 2.1 billion, ensuring healthy operations and development for the next five years [1][2] - The company reported a loss of RMB 130 million in the first half of 2024, primarily due to increased R&D investments [1][2] - R&D personnel now account for 69% of the company's total workforce, reflecting a significant increase in R&D focus and efficiency [1][2] Business Line Data and Key Metrics - The company has focused on global BIC (Best-in-Class) and FIC (First-in-Class) pipeline development, particularly in metabolic diseases and oncology [1][2] - Key pipeline highlights include AAC40, which has successfully initiated Phase III trials, and AAC41, which showed promising Phase II results with 93.3% of patients achieving a 30% reduction in liver fat content [1][2] - The company has accelerated the development of global FIC and BIC candidates for metabolic diseases, with plans to continue this focus in the second half of 2024 [1][2] Market Data and Key Metrics - The company has engaged in extensive business development activities, including participation in major industry conferences such as the JP Morgan Healthcare Conference and the BioInnovation Biotechnology Innovation Organization's global PG conference [1][2] - A top-ten global chemical company expressed interest in the company's pipeline, selecting only 70 out of 1,000 biotech companies for meetings, with the company being one of the selected [1][2] Company Strategy and Industry Competition - The company's strategy is centered on global BIC and FIC pipeline development, avoiding "Me Too" drugs and focusing on top-tier competitive targets [1][2] - The company has increased its patent filings, with four new drug invention patents granted and 51 new applications filed in the first half of 2024, strengthening its competitive position [1][2] - The company plans to continue accelerating the development of global FIC and BIC candidates, particularly in metabolic diseases, to maintain its competitive edge [1][2] Management Commentary on Operating Environment and Future Outlook - Management emphasized the importance of healthy survival in a challenging industry environment, focusing on global BIC and FIC pipeline development and business development activities [1][2] - The company expects to complete key clinical milestones in the second half of 2024, including Phase III enrollment for AAC40 and Phase II completion for AAC41, with top-line data expected in the first half of 2025 [1][2] - Management expressed confidence in the company's cash reserves and R&D capabilities, aiming to maximize the value of its core pipelines before engaging in further business development activities [1][2] Other Important Information - The company has initiated a stock repurchase program, having already repurchased RMB 133 million worth of shares, with plans to continue repurchasing if cash reserves allow [1][2] - The company is exploring the potential of its AAC61 small molecule PD-L1 oral inhibitor, seeking potential partners following promising Phase I results [1][2] Summary of Q&A Session Question: What were the main projects driving the increase in R&D expenses in the first half of 2024? - The increase in R&D expenses was primarily driven by Phase III trials for AAC40, Phase II trials for AAC41, and the acceleration of global FIC and BIC candidate development for metabolic diseases [1][2] Question: When will the efficacy data for AAC40's Phase III trials be available? - Efficacy data for AAC40's Phase III trials is expected to be available in the first half of 2025, with safety follow-up data not impacting the efficacy data readout [1][2] Question: Is the company still working on the AS110 monkeypox project? - The company is conducting further internal evaluations of the AS110 monkeypox project, given the recent rise in monkeypox cases [1][2] Question: How does the company view the competition between its two NASH drugs and weight-loss drugs? - The company's NASH drugs (AAC40 and AAC41) are oral medications targeting liver fat reduction, while weight-loss drugs like GLP-1 are injectable and focus on weight management, indicating different market segments [1][2] Question: Will the company continue its stock repurchase program? - The company will prioritize R&D investments but may continue stock repurchases if cash reserves allow, with a focus on maintaining healthy operations and development [1][2] Question: When will the company form a commercialization team? - The company will consider forming a commercialization team once its pipelines receive regulatory approval, with a focus on global markets rather than domestic sales [1][2] Question: What are the company's future early-stage R&D pipeline plans? - The company's early-stage R&D pipeline will continue to focus on metabolic diseases, building on its current pipeline of AAC40 and AAC41 [1][2]
歌礼制药-B(01672) - 2024 Q2 - 业绩电话会