Avinger(AVGR)2022-03-22 22:30Financial Data and Key Metrics Changes - Total revenue for the full year 2021 was 2.4 million, reflecting the impact of hospital access limitations and staffing shortages due to COVID-19 [24] - Gross margin for the full year 2021 was 34%, the highest annual gross margin in five years, and 30% in the fourth quarter [25] Business Line Data and Key Metrics Changes - Catheter sales increased approximately 20% year-over-year, indicating user case growth [24] - The company launched 23 new accounts during the year, including eight new accounts in the fourth quarter [7] Market Data and Key Metrics Changes - The emergence of the Omicron variant negatively impacted procedural volume and revenue in the first quarter of 2022 [9] - The company noted that approximately 80% of its business is in the hospital market, which remains strong despite reimbursement changes in office-based labs [43] Company Strategy and Development Direction - The company plans to expand the availability of the Lightbox 3 next-generation imaging console to full commercial launch in the second quarter of 2022 [10] - Avinger is developing its first product for the treatment of coronary artery disease (CAD), which is seen as a transformational opportunity due to its large addressable market [10][16] - The company is focused on expanding its platform through the treatment of peripheral artery disease (PAD) and developing new catheter usage opportunities [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about improving market conditions and a return to normal procedural volume in the second quarter of 2022 [9] - The company remains committed to its mission of changing the way vascular disease is treated and supporting physicians [23] Other Important Information - The company raised $7.6 million in gross proceeds through a preferred stock offering in January 2022 [28] - A reverse stock split was executed in March to regain compliance with NASDAQ stock market minimum bid rules [28] Q&A Session Summary Question: Impact on clinician workflow with the Lightbox 3 - Management highlighted the improved efficiency and clarity of imaging with the Lightbox 3, which has received positive feedback from physicians [32][33] Question: Manufacturing and logistical impacts of Lightbox 3 - The company has added flexibility to its operations for assembling and fulfilling orders for the Lightbox 3, which is expected to positively impact future performance [38] Question: Sequential move from Q4 2021 to Q1 2022 - Management noted that the impact of COVID-19 was significant in Q1 2022, but they are optimistic about recovery in procedural volumes [41] Question: Reimbursement changes and their impact - Management indicated that the reduction in office-based lab reimbursement has led to price pressure, but the hospital market remains strong [43] Question: Coronary market opportunity - Management discussed the potential for Avinger in the coronary market, estimating about 50,000 CTO PCI procedures performed annually in the U.S. [49][50] Question: Financial health of hospitals and OBLs - Management acknowledged staffing shortages in hospitals but expressed optimism about pent-up demand for elective procedures [54] Question: Achieving profitability - Management emphasized the importance of revenue growth and the potential for improved gross margins as catheter usage increases [59]