Stereotaxis(STXS)2024-11-12 00:03Financial Data and Key Metrics - Revenue for Q3 2024 totaled $9.2 million, an 18% YoY increase compared to $7.8 million in Q3 2023 [22] - System revenue was $4.4 million, driven by partial revenue recognition from the delivery of three Genesis systems, compared to $3.5 million in Q3 2023 [22] - Recurring revenue was $4.8 million, up from $4.3 million in Q3 2023, reflecting the two-month contribution from the APT acquisition [23] - Gross margin for Q3 2024 was 45%, with recurring revenue gross margin at 70% and system gross margin at 16% [24] - Operating loss and net loss for Q3 2024 were $6.3 million and $6.2 million, respectively, compared to $5.6 million and $5.4 million in Q3 2023 [26] - Adjusted operating loss and adjusted net loss, excluding non-cash charges, were $3.1 million and $3 million, respectively [27] - Negative free cash flow for Q3 2024 was $4.2 million [27] - Cash and cash equivalents, including restricted cash, stood at $11 million at the end of September 2024, increasing to $13.3 million by the end of October 2024 [28] Business Line Data and Key Metrics - Revenue growth in Q3 2024 was driven by the partial revenue recognition of three Genesis systems delivered to European hospitals [6] - The company received orders for two additional Genesis systems in Q3, leaving a capital backlog of $15.5 million at the end of the quarter [7] - The APT acquisition contributed approximately $0.5 million in catheter revenue in Q3, with expectations for larger contributions in Q4 [10] - The company is advancing regulatory approvals for the MAGiC catheter, high-density mapping catheter, and vascular guidance catheter, with submissions expected in early 2025 [15][55] Market Data and Key Metrics - Europe remains the strongest market for the company, with the most advanced product ecosystem and regulatory approvals [9] - The U.S. and China are slightly behind Europe in terms of regulatory approvals, but the company expects these regions to increasingly contribute to capital orders and revenue [9] - The company is working with MicroPort in China to gain regulatory approval for the Genesis robot, mapping integration, and a novel ablation catheter [20] Company Strategy and Industry Competition - The company is focused on building a comprehensive product ecosystem, including the Genesis X system, MAGiC catheter, and vascular guidance devices, to drive growth and adoption [8][15] - The acquisition of APT is seen as a strategic move to enhance the company's product portfolio and recurring revenue streams [10][11] - The company is investing in innovation and regulatory efforts to expand its presence in the electrophysiology and broader endovascular markets [4][18] Management Commentary on Operating Environment and Future Outlook - Management is optimistic about the near-term approval of the MAGiC catheter in Europe and expects significant commercial adoption [12][13] - The company is maintaining its revenue guidance for 2024, expecting year-over-year growth in both system and recurring revenue in upcoming quarters [29] - Management is focused on protecting the balance sheet and managing expenses prudently while investing in growth opportunities [30][31] Other Important Information - The company is preparing for the regulatory submission of the high-density mapping catheter and vascular guidance catheter in early 2025 [15][55] - The company is also advancing preclinical studies for robotic PFA programs, with potential first-in-human studies expected in 2025 [63][64] Q&A Session Summary Question: Timeline for MAGiC catheter approval in Europe and the U.S. [33] - Management expects CE Mark approval for MAGiC in Europe in the very short term, with U.S. approval likely in the next couple of quarters [34][35] Question: Market dynamics in the U.S. and Europe [36] - Europe's advanced product ecosystem is driving strong commercial results, while the U.S. and China are catching up [39][41] Question: APT catheter portfolio and revenue growth expectations [47] - The APT catheter portfolio is seeing positive reception, with expectations for meaningful sequential revenue growth in Q4 and beyond [51][52] Question: Robotic HD mapping catheter and recurring revenue per case [54] - Regulatory submissions for the high-density mapping catheter and vascular guidance catheter are expected in early 2025, with potential to significantly increase recurring revenue per procedure [55][56] Question: MAGiC catheter supply and sales force [59] - The company is confident in its ability to supply the market with MAGiC and is preparing to expand its sales force in Europe [60][61] Question: PFA program updates [62] - The company is advancing two robotic PFA programs, with potential first-in-human studies in 2025 [63][64] Question: Guidewire and guide catheter development [66] - The guide catheter is expected to be submitted for regulatory approval in Q1 2025, while the guidewire development is progressing more slowly [67][68]