Talphera(US:TLPH)2020-08-11 01:11Financial Data and Key Metrics Changes - The company ended Q2 2020 with $43.7 million in cash and short-term investments, a decrease of $9 million from Q1 2020 [21] - Revenues for Q2 2020 were $2.9 million, compared to $0.9 million in Q2 2019, with approximately $2.6 million attributed to previously deferred revenues [23] - Cash operating expenses for the quarter were $7.3 million, down from $11.2 million in Q2 2019, primarily due to a reduction in DSUVIA-related commercialization expenses and personnel costs [22] Business Line Data and Key Metrics Changes - The company received Milestone C approval for DSUVIA placement in U.S. Army sets, kits, and outfits, with initial stocking orders expected to approximate $30 million over the next three years [8][9] - An exclusive promotion and distribution partnership with Zimmer Biomet for DSUVIA in dental and oral surgery markets is anticipated to accelerate sales, with initial benefits expected in Q4 2020 [11][13] Market Data and Key Metrics Changes - The Department of Defense represents a significant market opportunity, with expectations for initial orders to be placed in Q3 2020 [9][25] - The dental and oral surgery market is estimated to involve 7.5 million annual procedures suitable for DSUVIA, with various procedures identified as potential applications [32][33] Company Strategy and Development Direction - The company aims to advance the use of DSUVIA through partnerships and internal sales teams focused on hospitals and ambulatory surgery centers [6] - Future growth is expected to be supported by successful partnerships in specialty markets, such as plastic surgery and fertility services, with minimal investment required from the company [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of DSUVIA, particularly in light of recent approvals and partnerships, despite challenges posed by the COVID-19 pandemic [7][19] - The company is optimistic about the upcoming publications that will provide real-world data supporting the benefits of DSUVIA, which is expected to enhance its market position [18] Other Important Information - The company is in discussions for potential out-licensing of DSUVIA in Europe and exploring additional partnerships for marketing and distribution in specialty markets [26] - The timeline for the resubmission of the Zalviso NDA is still under evaluation, pending further guidance from the FDA [26] Q&A Session Summary Question: Can you elaborate on the market opportunity for the Zimmer deal? - The company estimates that all 7.5 million procedures are addressable for DSUVIA, including third molar extractions and dental implants [32][33] Question: Where is DSUVIA currently being used? - DSUVIA is being utilized in ambulatory surgery settings, emergency rooms, and fertility clinics, among others [35] Question: How is the onset of action and duration of effect being reported in practice? - The onset of action is consistent with clinical trials, and the duration of analgesia is reported to be longer in real-world settings [42][45] Question: What feedback have you received from dentists regarding using the product in-office? - Dentists are comfortable with the product as they already have the necessary infrastructure for opioid storage and administration [52]