Inari Medical(US:NARI)2024-07-31 01:53Financial Data and Key Metrics - Revenue for Q2 2024 was $145.8 million, up 22.5% YoY and $2.6 million sequentially [19] - Global VTE revenue in Q2 2024 was $137.7 million, up 20.7% YoY [19] - Global Emerging Therapies revenue in Q2 2024 was $8.1 million, up 65.6% YoY [19] - International revenue in Q2 2024 was $10 million, up 92.9% YoY [19] - R&D expense in Q2 2024 was $24.9 million, up 18.1% YoY [8] - SG&A expense in Q2 2024 was $114.2 million, up 33.4% YoY [43] - GAAP operating loss in Q2 2024 was $22.4 million, compared to $1.5 million in the same period of the prior year [44] - Non-GAAP operating loss in Q2 2024 was $13.2 million [44] - Net loss in Q2 2024 was $31.3 million, compared to a net income of $2.1 million in the same period of the prior year [30] - Cash and investments totaled $109.7 million at the end of Q2 2024 [4] Business Line Data and Key Metrics - Global VTE revenue growth was driven by strong adoption of FlowTriever and ClotTriever, with a 21% YoY increase in Q2 2024 [6][19] - Emerging Therapies revenue reached $8.1 million in Q2 2024, up 66% YoY, driven by the introduction of VenaCore and other new tools [2][19] - The international business grew 93% YoY in Q2 2024, with strong adoption in Europe and Latin America, and plans to enter China and Japan in Q4 [39] Market Data and Key Metrics - The US VTE market is expected to grow at around 20% annually, driven by mechanical thrombectomy adoption [6] - The Emerging Therapies segment addresses a $4 billion TAM in the US alone, with significant unmet needs in chronic venous disease and acute limb ischemia [2][7] - The LimFlow business targets a $1.5 billion TAM for no-option CLTI patients, with early US launch progress and upcoming catalysts in Q4 2024 [36][37] Company Strategy and Industry Competition - The company is focused on driving growth in VTE, Emerging Therapies, and international markets, with a goal of achieving sustained operating profitability by H1 2025 [20][33] - The introduction of VenaCore and the second-generation Arctic system are key strategic initiatives to address unmet needs in chronic venous disease and acute limb ischemia [3][7] - The company is advancing three major RCTs (PEERLESS, PEERLESS II, and DEFIANCE) to establish FlowTriever and ClotTriever as the standard of care for VTE treatment [26][34] Management Commentary on Operating Environment and Future Outlook - Management remains confident in the company's ability to self-fund its business and strategic objectives, with a cash balance expected to remain above $100 million for the rest of the year [4] - The company raised its full-year 2024 revenue guidance to $594.5 million to $604.5 million, reflecting growth of 20.5% to 22.5% over 2023 [84] - Management expects sequential operating loss decreases in Q3 and Q4 2024, with a path to profitability in H1 2025 [20] Other Important Information - The company announced the retirement of CFO Mitch Hill and the appointment of Kevin Strange as his successor, effective October 1, 2024 [14][24] - The company issued a voluntary field notice for the ClotTriever XL catheter, providing additional procedural guidance without any device malfunction or defect [25][124] Q&A Session Summary Question: U.S. VTE performance and growth outlook [122] - The company saw balanced growth across DVT and PE in the U.S., with 21% YoY growth in VTE revenue, despite seasonal headwinds [114] - The company remains confident in its market leadership and expects robust growth to continue, driven by strong technology performance and commercial execution [50] Question: Drivers of sequential growth in Q3 and Q4 [86] - Key drivers include the full market release of VenaCore, the re-entry into acute limb ischemia with the Arctic system, and the launch of LimFlow in China and Japan [52] - The company expects stronger growth in Q4 compared to Q3, with catalysts such as NTAP approval and new product updates [52] Question: Update on PEERLESS II and DEFIANCE trials [95] - Enrollment for PEERLESS II and DEFIANCE is on schedule, with a focus on completing PEERLESS I data readout in Q4 2024 [95] - PEERLESS I is expected to have a significant market impact by comparing FlowTriever to catheter-directed thrombolysis, potentially changing treatment guidelines [64] Question: CFO transition and retirement plans [67] - Mitch Hill expressed confidence in Kevin Strange as his successor and plans to support the transition through early 2025 [68] - Hill does not plan to take another executive role in the medtech industry post-retirement [83] Question: Voluntary field notice for ClotTriever XL [123] - The notice provides additional procedural guidance for a small subset of complex DVT patients, with no device defect or revenue impact expected [124] Question: Growth outlook for 2025 [126] - The company is confident in sustaining mid-to-high teens growth in the U.S. VTE market, driven by technology iteration, clinical evidence, and market development programs [127] Question: PEERLESS trial timeline and commercialization strategy [128] - The company remains on track to present PEERLESS data at a major medical meeting in Q4 2024, with a focus on leveraging the win ratio to establish FlowTriever as the standard of care [129]