Biora Therapeutics(BIOR) - 2021 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported a revenue of $18.7 million in Q2 2021, with $8.6 million coming from discontinued operations [28] - Total operating expenses were $46 million in Q2 2021, expected to decrease to less than $25 million by Q4 2021 [29][30] - A significant reduction of $97 million in annual operating expenses run rate has been achieved, with an additional $50 million expected by the end of Q4 2021 [22][27] Business Line Data and Key Metrics Changes - The company is transitioning away from molecular testing operations, which will alter its revenue profile [27] - The focus is now on managing cash burn and optimizing capital allocation towards the innovation pipeline [27] - The Oral Biotherapeutics Drug System (OBDS) and Drug Delivery System (DDS) platforms are prioritized for development, with promising initial data from preclinical studies [10][14] Market Data and Key Metrics Changes - The market for oral delivery solutions is estimated at $250 billion, with the company targeting the inflammatory bowel disease (IBD) market valued at $15 billion [10][14] - The Preecludia test addresses a significant unmet need in managing preeclampsia, with over 700,000 women presenting symptoms annually in the US [7][8] Company Strategy and Development Direction - The company is focused on transforming into an innovation-led biotech firm, emphasizing the development of its OBDS and DDS platforms [5][33] - Partnerships with major pharmaceutical companies are being pursued to enhance commercialization efforts for the Preecludia test and other products [8][19] - The company aims to reduce dependency on capital markets through strategic partnerships and asset divestitures [23][34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the successful completion of the Preecludia validation study and its potential to transform patient management [6][25] - The company is committed to reducing its cash burn rate and enhancing its innovation pipeline, with multiple key catalysts anticipated in the near future [25][34] - The management highlighted the importance of partnerships in achieving commercialization goals and expanding market access [8][19] Other Important Information - The company settled a lawsuit with Natera through a cashless agreement, avoiding further legal costs [24] - The Avero affiliate laboratory operations continue to perform well, with potential divestiture being explored to generate non-dilutive capital [23] Q&A Session Summary Question: What is the status of the journal for Preecludia data submission? - The principal investigator intends to submit to a top-tier clinical journal [35][36] Question: Does the OpEx guidance include scaling up for the Preecludia launch? - Yes, it includes support work for commercialization and clinical utility studies [37][38] Question: When is the expected launch for Preecludia? - The launch is likely dependent on securing a commercial partner [39] Question: What is the status of Avero's revenue? - Avero's revenue is classified under discontinued operations as the assets are held for sale [40] Question: When can we expect updates on strategic alternatives for Avero? - Updates should be available this year depending on the decision to transact or retain the business [42] Question: How does the company's platform differentiate from competitors like Rani Therapeutics? - The company can use a variety of formulations, which provides a distinct advantage over Rani's technology [43] Question: Why focus on inflammatory bowel disease first? - The focus is on established drugs with known efficacy to minimize variability during early development [45] Question: What are the key endpoints for feasibility studies? - The goal is to achieve around 15% average bioavailability with a high tolerance for variability [49][50] Question: What factors influence the decision to divest Avero? - The preference is to divest, but strategic opportunities related to Preecludia may influence the decision [57]