Atea Pharmaceuticals(AVIR) - 2024 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - In 2024, R&D expenses declined quarter over quarter but increased year over year, primarily due to higher external spending related to the COVID-19 phase three Sunrise-3 trial and the phase two HCV trial [34] - Interest income decreased quarter over quarter and year over year due to lower investment balances [35] - As of December 31, 2024, the company reported cash, cash equivalents, and marketable securities of $454.7 million, projecting a cash runway into 2028 [11][36] Business Line Data and Key Metrics Changes - The company made significant progress in its HCV program, reporting a 98% cure rate in the primary efficacy analysis from a global phase two trial with an eight-week treatment regimen [7][28] - The phase two trial included 275 treatment-naive patients, achieving a 98% SVR12 rate in adherent patients and a 95% rate regardless of adherence [27] Market Data and Key Metrics Changes - The global HCV market is approximately $3 billion in annual net sales, with a significant number of untreated HCV patients in the U.S. estimated between 2.4 to 4 million [8][13] - In the U.S., approximately 100,000 out of 160,000 new infections are treated annually, resulting in about $1.5 billion in net sales from treated patients [15] Company Strategy and Development Direction - The company is initiating a global phase three program for its HCV regimen, expecting enrollment to begin next month, with a focus on becoming a best-in-class hepatitis C treatment [10][39] - The company has retained Evercore to assist in exploring strategic partnerships related to its phase three HCV program and has taken cost-cutting actions to enhance efficiency [9] Management's Comments on Operating Environment and Future Outlook - Management emphasized the ongoing high rate of HCV infections and the need for new differentiated therapies, highlighting the potential for their regimen to address this healthcare issue [12][14] - The company believes its regimen, if approved, could disrupt the global HCV market and become the most prescribed treatment [40] Other Important Information - The company announced a workforce reduction of approximately 20-25% to enhance efficiency, expected to result in cost savings of about $15 million through 2027 [37] - Arthur Kirsch was appointed as a new independent director, bringing extensive financial and strategic advisory experience to the board [9][37] Q&A Session Summary Question: Any specific callouts from the FDA meeting regarding phase three trial design? - Management indicated that the FDA is fully aligned with their approach of conducting two open-label phase three trials and did not have substantive comments on the trial conduct [46][47] Question: What can be expected in terms of the scope of the phase two readout later this half? - Management expects to present additional data regarding efficacy and safety at the EASL conference in May [49] Question: Estimated number of cirrhotic patients across the two trials? - Management anticipates enrolling just over 10% cirrhotic patients in the trials, with flexibility in adjusting this number based on enrollment [55][58] Question: How does the modeling compare to Epclusa in the non-cirrhotic population? - Management referred to the model developed by Dr. Alan Perelson and suggested checking their publications for comparisons with other direct-acting antivirals [60]