Biora Therapeutics(US:BIOR)2021-05-14 03:28Financial Data and Key Metrics Changes - The company reported $25 million in revenues for Q1 2021, representing a 72% growth quarter-over-quarter and a 46% growth compared to Q1 2020 [55][48][56] - Average selling prices (ASPs) improved during the quarter, contributing to revenue growth [56][55] - The net loss for Q1 2021 was $32.3 million, which included $14.8 million of income from changes in fair value related to convertible notes [63][55] Business Line Data and Key Metrics Changes - The core molecular testing business achieved a revenue growth of 72% quarter-over-quarter, driven by improvements in ASPs and revenue cycle management [48][55] - The Preecludia test is expected to launch by Q4 2021, targeting a multi-billion dollar market opportunity [19][18] - The GI Precision Medicine pipeline is advancing, with significant progress in drug delivery systems and targeted therapeutics [21][20] Market Data and Key Metrics Changes - The company identified a $2 billion to $3 billion opportunity for the Preecludia test based on payer research indicating an understanding of the economic burden of preeclampsia [19][18] - The inflammatory bowel disease (IBD) market is estimated at $15 billion, with the company targeting this market with its drug delivery systems [23][21] Company Strategy and Development Direction - The company plans to focus on strategic biotech areas with high value generation potential, particularly in GI Precision Medicine and preeclampsia programs [7][8] - The strategy includes transforming established drugs with known efficacy and safety profiles to enhance treatment for GI localized diseases [34][33] - The company aims to achieve breakeven and profitability for its core business by the end of 2022 or early 2023 [61][66] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, citing catalysts such as the Preecludia validation study results and ongoing advancements in GI programs [66][66] - The company is focused on generating non-dilutive capital and reducing cash burn while maintaining appropriate funding for key R&D programs [61][66] Other Important Information - The company completed a private placement raising $25 million in gross proceeds, ending Q1 2021 with a cash balance of $65 million [65][63] - The company is on track to initiate a clinical pilot study for its PIL Dx program in the second half of the year [41][42] Q&A Session Summary Question: Can you provide details on core women's health volumes? - Management indicated that volumes were generally flat due to weather-related demand dynamics and ongoing sales channel transitions [70][69] Question: Can you elaborate on the Crohn's & Colitis funding? - The funding is a cost-sharing arrangement aimed at supporting studies for the drug delivery system (DDS) development [71][70] Question: What is the latest on Innatal 4 development? - The next catalyst for Innatal 4 is expected in Q3, with commercialization anticipated by the end of Q2 or beginning of Q3 next year [73][72] Question: What factors influenced gross margin and cost of goods? - The increase in Q1 COGS was attributed to stock-based compensation accruals, while COGS per test remained stable [76][75] Question: What is the status of the Preecludia sales force preparation? - The sales force is being trained and prepared for a targeted launch, with no significant ramp-up needed as existing capabilities are sufficient [83][82]