Financial Data and Key Metrics Changes - Inari reported record revenue of $132.1 million for Q4 2023, representing a 23% increase year-over-year [104] - For the full year 2023, revenue reached $493.6 million, up 29% compared to the previous year [12] - Gross margin for Q4 2023 was 87.1%, down from 87.8% in the prior year [10] - Operating expenses for the full year 2023 were $448.6 million, a 22% increase from $367.1 million in 2022 [12][32] - The net loss for Q4 2023 was $4.7 million, compared to a net loss of $5.8 million in the same period of the prior year [106] Business Line Data and Key Metrics Changes - The VTE segment accounted for over 85% of revenue growth, while emerging therapies contributed nearly 15% year-over-year [12][104] - InThrill, a thrombectomy system for small vessels, is targeting a total addressable market of 250,000 procedures per year in the U.S., representing a $1 billion opportunity [6] - The LimFlow acquisition is expected to provide new treatment options for 55,000 no-option CLTI patients, with a total addressable market of $1.5 billion in the U.S. [7] Market Data and Key Metrics Changes - International revenue was nearly $8 million in Q4 2023, up more than 130% compared to the prior year [27] - The U.S. VTE market is estimated to be a $6 billion opportunity, with significant growth potential as the market transitions to frontline therapy [38][76] Company Strategy and Development Direction - The company aims to achieve sustained operating profitability in the first half of 2025, despite the operating deficit associated with the LimFlow acquisition [22][108] - Inari is focused on expanding its market presence through the VTE Excellence program, which aims to increase penetration within existing accounts [4][77] - The company plans to continue innovating its product offerings, with multiple new products launched in the past year to enhance its VTE franchise [78] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the underlying strength of the VTE market, anticipating continued robust growth in 2024 [41] - The company is cooperating with a civil investigative demand from the Department of Justice, but does not expect it to impact commercial execution [11][16] - Management highlighted the importance of high-quality clinical evidence to drive market growth and change the standard of care for VTE patients [24][49] Other Important Information - R&D expenses for the full year 2023 were $87.5 million, an 18% increase from $74.2 million in 2022 [85] - SG&A expenses for Q4 2023 were $101.5 million, up 27% compared to the same period in the prior year, primarily due to increased personnel and professional fees related to the LimFlow acquisition [105] Q&A Session Summary Question: What is the status of the DOJ investigation? - Management stated that they are cooperating with the DOJ and do not expect it to impact commercial execution [11][16] Question: What are the expectations for the core U.S. VTE market in 2024? - Management reiterated that the core U.S. VTE market is expected to continue growing, with no change in the view of its underlying strength [41] Question: How is the company addressing competition in the market? - Management acknowledged the presence of new entrants but expressed confidence in maintaining market leadership due to strong product performance and clinical data [56][115] Question: Can you provide insights on the emerging therapies revenue? - Management indicated that emerging therapies are primarily generating U.S. revenue, with plans for international expansion as regulatory approvals are pursued [45][127] Question: What is the expected contribution from LimFlow in 2024? - Management expects a modest revenue contribution from LimFlow in 2024, viewing it as a foundational year for the integration and launch [86][128]
Inari Medical(NARI) - 2023 Q4 - Earnings Call Transcript