Avinger(US:AVGR)2024-08-09 16:42Financial Data and Key Metrics Changes - Total revenue for Q2 2024 was $1.8 million, down from $1.9 million in Q1 2024 and $2 million in Q2 2023, attributed to reduced field sales headcount [18] - Gross margin for Q2 2024 was 20%, compared to 18% in Q1 2024 and 30% in Q2 2023, reflecting lower production activity [18][44] - Operating expenses decreased to $4.5 million in Q2 2024 from $5.4 million in Q1 2024 and $4.3 million in Q2 2023, following a 24% reduction in headcount [19] - Net loss for Q2 2024 was $4.4 million, an improvement from $5.5 million in Q1 2024 and comparable to $4.2 million in Q2 2023 [45] Business Line Data and Key Metrics Changes - The company has streamlined operations in its peripheral business while maintaining a field presence to support existing users [13] - The Pantheris LV atherectomy system is set for full commercial launch, having completed its limited launch phase [39][40] Market Data and Key Metrics Changes - The partnership with Zylox-Tonbridge is expected to open the Greater China market for Avinger's products, with regulatory approval anticipated in 2025 [16][41] - Avinger will sell finished goods to Zylox, which will be royalty-bearing, enhancing revenue potential from the Chinese market [17] Company Strategy and Development Direction - The company is focusing on advancing its coronary CTO program towards IDE filing, with plans to file by the end of Q3 2024 [4][37] - Avinger aims to improve gross margins and reduce operating costs in the second half of 2024 following recent headcount reductions [19][33] - The strategic partnership with Zylox is expected to enhance manufacturing capabilities and reduce costs [25][42] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the coronary device to redefine treatment for chronic total occlusions, emphasizing its advantages over existing solutions [9][34] - The company anticipates that the cost reductions will positively impact financial performance in the latter half of 2024 [19][33] - Management highlighted the enthusiasm from physicians regarding the new coronary device, indicating strong interest in participation in clinical studies [60] Other Important Information - Avinger has improved its balance sheet, with cash and cash equivalents totaling $8.8 million as of June 30, 2024 [20] - The company converted $11 million of debt into equity, significantly enhancing stockholders' equity [20][32] Q&A Session Summary Question: Impact of personnel reduction on revenue - Management clarified that the recent headcount reduction was not related to the Zylox collaboration and was a strategic decision to focus on the coronary program [49][50] Question: Timeline for Zylox's regulatory filings - Management indicated that Zylox is well along in the regulatory process and expects a robust filing package for the NMPA, aiming for a 2025 launch [27][52] Question: Full commercial launch of Pantheris LV - Management confirmed that the full commercial launch of Pantheris LV is imminent following successful limited launch experiences [58] Question: IDE filing and study initiation timeline - Management expects to file the IDE in the near term, with a typical clearance timeframe of four to six months, aiming for early 2025 to begin clinical studies [59][62]