Financial Data and Key Metrics Changes - The net loss from discontinued operations for Q1 2025 was $9.2 million compared to a net income of $170.9 million in Q1 2024, primarily due to a $153.6 million gain on the sale of the Similee ophthalmology franchise in March 2024 [49][50] - Revenue for Q1 2025 was flat at $7.3 million, attributed to a seasonal inventory drawdown despite a 15% growth in patient demand [39][40] - Cost of Goods Sold (COGS) from continuing operations increased to $2.7 million from $1.4 million in Q1 2024 due to increased sales of Lactorsi [48] Business Line Data and Key Metrics Changes - Lactorsi is projected to grow to approximately $150 million to $200 million annually over the next three years, providing non-dilutive funding for the development pipeline [10] - The commercial team reported a 15% growth in patient demand for Lactorsi, with an increase in new patient starts and duration of treatment [39][40] Market Data and Key Metrics Changes - The market for nasopharyngeal carcinoma (NPC) is estimated to be valued at $150 million to $200 million, with expectations for Lactorsi to achieve a dominant share [43] - The restructuring of the sales force was completed, and the team is now focused on driving growth in the NPC patient population [38] Company Strategy and Development Direction - The company is focused on innovative oncology, with three core pillars: Torapalumab (Lactorsi), CHS-114 (a selective CCR8 cytolytic antibody), and casdosoketogue (an anti-IL-27 antibody) [7][14] - A key part of the strategy includes partnerships for indication expansion, where the company supplies drugs to partners who fund clinical trials [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to adapt to changes in the FDA and emphasized the importance of strong development expertise [54][57] - The company anticipates that Q2 and Q3 will be times for growth, following the restructuring of the sales force [69] Other Important Information - The company expects to achieve approximately $25 million in annualized savings from lower headcount following the divestiture of UDENYCA [47] - The company has received $483 million in upfront cash from the UDENYCA divestiture and plans to repurchase remaining convertible notes [45] Q&A Session Summary Question: What needs to happen for a significant inflection point for Lactorsi? - Management noted that awareness among providers is increasing, and they expect to see an acceleration in growth following the restructuring of the sales force [53][58] Question: Can you clarify what you meant by patient demand for Lactorsi? - Demand refers to actual patient growth as indicated by clinics purchasing the product from wholesalers, which is distinct from revenue [66][67] Question: Will there still be an impact from the sales force restructure in Q2? - Management believes the impact was primarily in Q1, and they expect Q2 and Q3 to be times for growth [69] Question: Are PD-1s like Keytruda still being used off-label in NPC? - Yes, off-label use of PD-1s is prevalent, especially in community settings, despite NCCN guidelines recommending Lactorsi [73][79] Question: Can you discuss the Type D meeting with the FDA for CHS-114? - The meeting focused on aligning on Project Optimus, and the FDA found the company's approach acceptable [84][86]

Financial Data and Key Metrics Changes - The company reported a revenue of $7.3 million for Q1 2025, which remained flat due to a seasonal inventory drawdown despite a 15% growth in patient demand [38][39] - Cost of Goods Sold (COGS) from continuing operations increased to $2.7 million from $1.4 million in Q1 last year, attributed to increased sales of Lactorsi [47] - Research and Development (R&D) expenses decreased by 14% to $24.4 million, reflecting savings from reduced co-development with Junshi [48] - Selling, General and Administrative (SG&A) expenses decreased by 35% to $26 million, primarily due to lower headcount and non-recurring charges from the previous year [48] Business Line Data and Key Metrics Changes - The company is now focused solely on its innovative oncology business, with Lactorsi being the only FDA-approved treatment for metastatic recurrent locally advanced nasopharyngeal carcinoma [6][8] - Lactorsi is projected to grow to approximately $150 million to $200 million annually over the next three years, providing non-dilutive funding for the development pipeline [8][9] - The commercial team has successfully remapped territories and updated customer assignments post-UDENYCA divestiture, with a focus on driving growth in appropriate NPC patients [37][38] Market Data and Key Metrics Changes - The company noted a significant number of patients still receiving non-preferred chemotherapy and off-label immuno-oncology treatments, indicating a market opportunity for Lactorsi [38] - The NCCN guidelines now place Lactorsi in a preferred position for recurrent and metastatic patients, which the company is actively promoting to healthcare providers [38][41] Company Strategy and Development Direction - The company’s strategy is anchored around three core pillars: Lactorsi, CHS-114 (a selective CCR8 cytolytic antibody), and casdosoketogue (an anti-IL-27 antibody) [6][12][13] - The company aims to expand Lactorsi's indications through partnerships and combination therapies, enhancing its market presence and revenue potential [10][11] - The focus on innovative oncology is expected to drive long-term value for shareholders while addressing significant unmet medical needs in cancer treatment [50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company’s ability to navigate recent FDA changes and emphasized the importance of strong development expertise in adapting to regulatory environments [52][56] - The company anticipates that the restructuring of the sales force will lead to accelerated growth in Q2 and beyond, despite transitional challenges faced in Q1 [60][68] - Management highlighted the promising clinical data for CHS-114 and its potential to address PD-1 resistance, which could significantly impact treatment paradigms in oncology [30][36] Other Important Information - The company completed the divestiture of UDENYCA, receiving $483 million in upfront cash and repurchasing $170 million of convertible notes [43][44] - The net cash from these transactions is expected to provide substantial liquidity for ongoing operations and development initiatives [44] Q&A Session Summary Question: What needs to happen for a significant inflection point for Lactorsi? - Management noted that increased awareness among providers and ongoing clinical trials will be crucial for driving adoption and market share [51][56] Question: Can you clarify patient demand for Lactorsi? - Demand is defined as actual patient growth, with a 15% increase in end-user demand reported, indicating strong physician engagement [65][66] Question: Will the Salesforce restructure impact future projections? - The impact of the restructure was primarily felt in Q1, but management expects Q2 and Q3 to be growth periods for the brand [68] Question: Are there any competitor molecules that have proven the efficacy of CCR8 targeting? - Management indicated that while selectivity is a challenge, there are emerging data points suggesting the relevance of CCR8 targeting in certain tumor types [72][75]