Avinger(US:AVGR)2024-11-08 02:43Financial Data and Key Metrics Changes - Total revenue for Q3 2024 was $1.7 million, down slightly from $1.8 million in both the previous quarter and the same period last year [22] - Gross margin for Q3 2024 was 26%, increased from 20% in Q2 2024 and 21% in Q3 2023, reflecting improved operating efficiency [23] - Operating expenses for Q3 2024 declined to $4.1 million compared to $4.5 million in Q2 2024 and $4.4 million in Q3 2023 [24] - Net loss for Q3 2024 was $3.7 million, reflecting a 15% improvement compared to $4.4 million in Q2 2024 and a 17% improvement compared to $4.5 million in Q3 2023 [25] - Adjusted EBITDA was a loss of $3.4 million, a 12% improvement compared to a loss of $3.8 million in Q2 2024 and a 10% improvement compared to a loss of $3.7 million in Q3 2023 [26] - Cash and cash equivalents totaled $5.9 million as of September 30 [26] Business Line Data and Key Metrics Changes - The field sales team now comprises 16 professionals, focusing on high-value accounts and demonstrating steady case activity [8] - Pantheris LV revenue increased over 20% compared to sales in Q2 2024, indicating early success in its full commercial launch [31][32] Market Data and Key Metrics Changes - The partnership with Zylox-Tonbridge aims to introduce Avinger's image-guided devices to the Greater China market, targeting an estimated 50 million people affected by peripheral artery disease [17][18] - Zylox received the innovative medical device review designation for the Pantheris device in China, which enables priority regulatory review [19] Company Strategy and Development Direction - The company implemented a cost savings program that reduced overall headcount by 24%, including a one-third reduction in the commercial team [8] - Avinger is focusing on the development of its coronary artery disease program, with significant progress made on an image-guided CTO crossing system [11][12] - The strategic partnership with Zylox includes investment alignment, market access, and cost-effective manufacturing [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing commercialization of the Pantheris LV and the potential of the coronary device to redefine treatment for coronary CTOs [13][14] - The company anticipates regulatory approval in China in the second half of 2025, with Zylox developing its manufacturing capabilities [34] Other Important Information - The company is actively engaging high-volume clinical sites for participation in the coronary trial, with plans to expand to 10 or more sites ahead of study initiation [12] - The design of the coronary CTO crossing system is expected to minimize X-ray radiation exposure and iodine-based contrast dye usage, enhancing safety for both physicians and patients [14][15] Q&A Session Summary Question: Feedback on Pantheris catheter and future adoption - Management noted positive feedback from physicians regarding the simplicity of operation and early success with a 20% revenue increase for Pantheris LV compared to Q2 2024 [30][31] Question: Confidence in Zylox's approval timeline and commercialization efforts - Management expressed confidence in Zylox's progress, stating that all products have successfully completed type testing and regulatory filings are expected to be completed by the end of the year, with approval projected in the second half of 2025 [33][34]