Affimed(AFMD) - 2021 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Affimed ended 2021 with cash and cash equivalents of €197.6 million, an increase from €146.9 million at the end of 2020 [40] - Total revenue for 2021 was €40.4 million, up from €28.4 million in 2020, primarily driven by collaborations with Genentech and Roivant [41] - Net loss for 2021 was €57.5 million, or €0.48 per common share, compared to a net loss of €41.4 million, or €0.50 per common share in 2020 [43] Business Line Data and Key Metrics Changes - R&D expenses increased by 63% from €50 million in 2020 to €81.5 million in 2021, mainly due to costs associated with AFM24 and AFM28 [41][42] - General and administrative expenses rose by 77% from €13.7 million in 2020 to €24.2 million in 2021, largely due to higher share-based compensation and consulting expenses [42] Market Data and Key Metrics Changes - The company is focusing on significant unmet medical needs in various cancers, including peripheral T-cell lymphoma and acute myeloid leukemia, with a potential market of approximately 1500 patients in Europe for AFM13 [9][28] - The annual incidence of Hodgkin and non-Hodgkin lymphoma in the U.S. is estimated at around 20,000 patients, indicating a substantial market opportunity for AFM13 [9] Company Strategy and Development Direction - Affimed aims to develop multiple Innate Cell Engagers, with a focus on fast-to-market development strategies for unmet medical needs [8] - The company is pursuing a three-pronged development strategy for AFM24, targeting various solid tumor indications, including non-small cell lung cancer and colorectal cancer [12][27] - The ambition for AFM28 is to address the needs of AML patients, with plans to initiate combination studies with NK cell therapies [28][38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver significant market opportunities through innovative therapies, particularly in the context of ongoing collaborations and clinical trials [16][44] - The management highlighted the importance of aligning with FDA guidelines to expedite the commercialization of AFM13, especially in light of potential accelerated approval [50][52] Other Important Information - The company has made significant progress in clinical trials, with AFM13 showing a 100% objective response rate in early studies [10][22] - Affimed is actively recruiting experienced oncology marketers to prepare for potential commercialization of its therapies [52] Q&A Session Summary Question: What are the expectations for accelerated approval for AFM13? - Management indicated that the FDA has not provided clear guidance, but response rates around 27%-28% and duration of response of 8-10 months may be considered for accelerated approval [50] Question: How many patients are expected in the AFM13 study? - The study allows for a total of 40 patients, with a focus on both Hodgkin and non-Hodgkin lymphoma [56] Question: What will be the criteria for the go/no-go decision for AFM24? - The decision will be based on initial data from approximately 10-12 patients, with specific response rates varying by cohort [60] Question: Will there be updates at ASCO? - Management is discussing potential updates with MD Anderson, but no specific announcements have been made yet [58]