Talphera(US:TLPH)2019-11-07 02:19Financial Data and Key Metrics Changes - The company ended Q3 2019 with $80.4 million in cash and short-term investments, with a net cash outflow of $11.1 million driven mainly by $10.7 million in cash operating expenses [41] - Revenues for Q3 2019 were $0.6 million, reflecting $0.5 million in sales of Zalviso and $0.1 million from DSUVIA [43] - Combined R&D and SG&A expenses for Q3 2019 totaled $12 million, compared to $8.8 million for Q3 2018 [42] Business Line Data and Key Metrics Changes - The company achieved formulary approval for DSUVIA's use at 105 facilities and surpassed its REMS certifications objective with 130 facilities certified, compared to 43 formulary approvals and 51 REMS-certified facilities announced last quarter [10][11] - The adoption of DSUVIA is progressing, with a focus on hospitals and ambulatory surgical centers (ASCs), targeting a total of 800 hospitals and approximately 1,100 ASCs [15][16] Market Data and Key Metrics Changes - Approximately 25% to 30% of formulary approvals are in hospitals, with diverse applications including ER and PACU [49] - The outpatient surgical procedure market is evolving, with increasing interest in DSUVIA across various specialties [17] Company Strategy and Development Direction - The initial phase of the DSUVIA launch focuses on education and awareness to achieve positive formulary reviews and REMS certifications [9] - The company plans to increase focus on driving DSUVIA demand within approved facilities in the upcoming year [43] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term success of DSUVIA, highlighting its potential to change the standard of care for acute pain management [45] - The company is managing cash resources prudently while executing its launch plan [104] Other Important Information - The Department of Defense is a key partner in the development of DSUVIA, with military treatment facilities included in formulary approvals [37] - The company has set its DEA quota for 2020, ensuring supply stability amid opioid shortages affecting competitors [100] Q&A Session Summary Question: Can you provide color on the usage of DSUVIA in hospitals versus ASCs? - The mix of approvals shows about 25% to 30% in hospitals, with diverse applications in ER and PACU [49] Question: What feedback have you received from hospitals and P&T committees? - The drug is delivering on its promise in analgesia, with limited dosing needed and clarity of cognition maintained [55][58] Question: Will you expand the types of procedures using DSUVIA? - The range of procedures is broad, with potential expansion to include breast procedures [63] Question: How do the formulary approvals fit with different types of facilities? - There is a diverse mix of approvals, with hospitals moving slower than ASCs [70] Question: What gives you confidence that approvals will translate into revenues? - Facilities are seeking certification due to their interest in using the product, indicating a genuine need [80] Question: What is the expected trend for gross to net sales percentage? - The expectation remains at 35%, with variations driven by customer mix [88]