Financial Data and Key Metrics Changes - Worldwide sales for the first quarter of 2025 reached $22.5 million, representing a 20% increase year-over-year and a 21% increase on a constant currency basis [6][30] - U.S. revenue for the first quarter was $14.2 million, an 11% increase from $12.9 million in the prior year [31] - International revenue was $8.3 million, a 39% increase from $6 million during the same period last year, and a 43% increase on a constant currency basis [31][32] - Gross margin for the first quarter was 73%, down from 75% in the prior year [32] - Total operating expenses were $30.9 million, an 8% increase from $28.6 million in the first quarter of 2024 [33] - Net loss for the first quarter was $14.4 million, or a loss of $0.36 per share, compared to a net loss of $13.7 million for the same period last year [34] Business Line Data and Key Metrics Changes - The company is executing its "acquire, test, and treat" strategy, focusing on increasing clinician and patient awareness to drive growth in the COPD market [7][11] - The company hosted over 40 peer-to-peer events to educate providers about the selection criteria and benefits of Zephyr Valves [9] - The company added 10 new U.S. accounts, ending the quarter with 285 active accounts [16] Market Data and Key Metrics Changes - The company identified a $12 billion market opportunity for COPD treatment [7] - International revenue growth was particularly strong in China, driven by underlying demand and increased distributor stocking [31][32] - The company is exploring targeted approaches to increase severe emphysema screening in existing accounts [19] Company Strategy and Development Direction - The company aims to build a strong foundation for sustained growth by increasing patient engagement and clinician education [7][11] - The strategy includes expanding the global footprint and seeking to expand indications for Zephyr valves [17][20] - The company is focused on establishing comprehensive lung health programs in hospitals to improve patient care [13][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the previously communicated revenue guidance of $96 million to $98 million for the full year 2025 [6][30] - The company anticipates that the second half of 2025 will see accelerated growth in the U.S. as patient engagement initiatives take effect [38][41] - Management noted that while U.S. growth has moderated, targeted initiatives are expected to set the foundation for future growth [22][27] Other Important Information - The company received notice from the U.S. Department of Justice that it formally declined to intervene in a civil investigative demand related to the False Claims Act [28] - The company ended the first quarter with $88.7 million in cash, cash equivalents, and marketable securities [36] Q&A Session Summary Question: Additional color on guidance outlook - Management reiterated the 2025 revenue guidance of $96 million to $98 million, citing the need to monitor the global macroeconomic environment [45][46] Question: Upside potential for full year guidance - Management indicated that upside could come from the adoption of initiatives in the U.S. and strong performance in international markets [48][50] Question: Impact of Acquire Test Treat strategy - Management highlighted the success of marketing and peer-to-peer education programs as impactful early initiatives [55][57] Question: International partners' response to tariffs - Management noted that there has been little change in ordering patterns from international partners, with most in a wait-and-see mode [61][64] Question: China sales metrics and future orders - Management indicated strong demand in China, with expectations for continued purchasing in Q2 [68][69] Question: Balancing SG&A leverage with expansion - Management emphasized a focus on operating leverage while investing in revenue-driving initiatives [74] Question: U.S. revenue performance and future expectations - Management attributed lower U.S. revenue growth to tough comparisons and expressed optimism about future initiatives [80][81]

Financial Data and Key Metrics Changes - Worldwide sales for Q4 2024 reached $23.8 million, reflecting a 23% growth year-over-year [9][42] - U.S. sales in Q4 were $15.9 million, representing a 16% increase compared to the same period last year [9][43] - International sales in Q4 were $7.9 million, showing a 42% year-over-year growth [9][43] - Full year 2024 worldwide revenue was $83.8 million, a 22% increase over 2023 [9][43] - Gross margin for Q4 2024 was 74%, slightly down from 75% in the prior year [44] - Net loss for Q4 2024 was $13.2 million, improving from a loss of $13.9 million in Q4 2023 [48] Business Line Data and Key Metrics Changes - The company added 52 new centers in 2024, ending the year with 283 active accounts [10] - The LungTrax platform was piloted to streamline workflows and identify eligible patients [11] - The AeriSeal CONVERT II trial was launched, expected to expand the addressable market [12][37] Market Data and Key Metrics Changes - International revenue for fiscal year 2024 was $27.3 million, a 20% increase over 2023 [44] - Strong growth was noted in major European markets and recurring orders from a new distributor in China [34][75] Company Strategy and Development Direction - The company aims to drive sustainable growth of at least 20% over the long term through initiatives focused on patient acquisition, testing, and treatment [12][15] - The strategy includes enhancing physician education and expanding geographic reach [14][21] - The company is exploring new patient acquisition channels through hospital systems [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow breakeven with current cash reserves [49] - The company anticipates strong international growth in the first half of 2025, with a re-acceleration of U.S. growth in the second half [52] - Management expects gross margins to trend higher in the second half of 2025 due to increased production volumes [53][106] Other Important Information - The company ended Q4 2024 with $101.5 million in cash, a decrease from the previous quarter [49] - Adjusted EBITDA loss for Q4 2024 was $7.5 million, an improvement from $8.4 million in Q4 2023 [48] Q&A Session Summary Question: Guidance for 2025 growth rates - Management expects strong international growth in the first half and acceleration in the second half, but does not provide specific growth rates for each half [58][60] Question: Insights on LungTraX pilot program - Feedback from pilot sites indicates positive results in identifying new patients, with integration and interface functioning well [62][64] Question: International business growth and ASP changes - No significant stocking orders were noted; growth was driven by recurring business and strong performance in Europe and China [71][75] Question: Operating expenses versus revenue growth - Management expects to continue driving leverage, with revenue growth outpacing expense growth [92][94] Question: Measuring investments in new centers and campaigns - The company tracks patient acquisition through direct-to-patient advertising and measures the effectiveness of new hires in the COPD community [96][100] Question: Gross margin outlook - Gross margins are expected to fluctuate based on geographic mix and production costs, with a long-term expectation of improvement [102][106] Question: Impact of hospitalizations on procedures - No significant impact on procedures has been observed, but there may be opportunities to identify additional patients through hospital systems [108]