Financial Data and Key Metrics Changes - Revenues for the year ended December 31, 2025, were $1.2 million, a decrease of $1.2 million or 50% compared to $2.4 million in 2024, primarily due to lower participant demand for clinical trials and reduced contract manufacturing services [11][12] - General and administrative expenses increased to approximately $12 million in 2025 from $10.3 million in 2024, reflecting a 17% rise due to increased personnel costs [12] - Research and development expenses rose to approximately $12 million in 2025 from $8.1 million in 2024, marking a 48% increase driven by personnel costs and technology transfer expenses [13][14] - The net loss increased to approximately $22.7 million in 2025 from $16 million in 2024, a rise of 41% [14] Business Line Data and Key Metrics Changes - Clinical trial revenue for 2025 was $1 million, down from $1.4 million in 2024, while contract manufacturing revenue decreased from $0.5 million to $0.2 million [11][12] Market Data and Key Metrics Changes - The company has secured $15 million in new capital from institutional investors, with a potential second tranche of $15 million contingent on meeting certain milestones [3][4] - The HLHS program has been granted rare pediatric disease designation by the FDA, making it eligible for priority review vouchers (PRVs) upon approval of a BLA [7] Company Strategy and Development Direction - The company aims to pursue a robust partnering strategy across all development programs to accelerate time to market and leverage resources from larger organizations [4][5] - The focus is on the HLHS program with a near-term pathway to potential approval, and the company plans to initiate a pivotal phase 2 registrational study for pediatric dilated cardiomyopathy (PDCM) [8][10] - The company is also exploring opportunities in Alzheimer's disease and age-related frailty, with plans to seek licensing partners for these initiatives [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming pivotal data for HLHS and the strengthening of the balance sheet, indicating a potentially exciting time for the company [18] - The CEO highlighted the importance of strategic partnerships and the potential for significant financial outcomes from PRVs [7][18] Other Important Information - The company anticipates that existing cash and cash equivalents will fund operations into Q4 of 2026 following a recent private placement [15] - The company is actively engaged in clinical trials and has made significant progress in stem cell research, with multiple patents issued globally [16][17] Q&A Session Summary Question: Commercial perspectives for laromestrocel manufacturing - Management confirmed the potential for a separate PRV for PDCM and emphasized the priority of manufacturing and CMC for future growth [22][23] Question: Non-dilutive capital sources for Alzheimer's disease - Management indicated that seeking licensing partners for Alzheimer's disease and age-related frailty is a priority, with preliminary conversations already set up [24] Question: Timeline for BLA filing for HLHS - Management stated that if data is positive in Q3 2026, they would aim for a rolling submission for the BLA, targeting submission in 2027 [28][31] Question: Pediatric dilated cardiomyopathy program details - Management outlined plans for a hierarchical composite endpoint in the PDCM trial, aiming to reduce heart transplant needs and hospitalization [40][42] Question: Strategy for laromestrocel in female sexual dysfunction - Management sees this indication as a ripe opportunity for partnerships, addressing a significant unmet need in women's health [46][50]

Financial Performance - In Q3 of fiscal 2026, total revenue reached $24.6 million, reflecting a 63% increase year-over-year [9][20] - Gross margin improved to 52.6%, up 9 percentage points year-over-year and 200 basis points sequentially, marking the ninth consecutive quarter of gross margin expansion [9][10] - The company aims to achieve gross margins of over 70% in the coming years [10][21] Business Line Performance - The company accepted over 5,400 prescriptions for the ASSURE System, contributing to a 58% year-over-year increase in prescriptions [9][20] - The revenue growth was driven by market share gains, activation of new accounts, and higher revenue per fit [20] Market Dynamics - The wearable cardioverter defibrillator (WCD) market is estimated to have grown in the low to mid-teens percentage range in 2025, with expectations for continued expansion into a multi-billion-dollar market [10][11] - The company has noted that six out of seven patients indicated for a WCD are currently unprotected, indicating significant market potential [10] Company Strategy and Competitive Landscape - The company is focused on expanding its sales organization to penetrate existing accounts and attract new prescribers, targeting approximately 130 sales territories by the end of the fiscal year [15][19] - A strategic collaboration with Biobeat Technologies aims to enhance diagnostic insights for patients, further differentiating the company's offerings in the market [13][14] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, citing strong revenue growth and margin expansion as indicators of operational leverage [10][18] - The management team highlighted the importance of clinical data, such as the ACE-PAS study, in driving market awareness and physician engagement [12][48] Other Important Information - The company recently became an approved provider for Florida's managed Medicaid, which is expected to enhance market access and growth in that state [16][60] - The monthly Medicare reimbursement rate for WCDs increased by 2% to $3,589, positively impacting revenue cycle management metrics [17] Q&A Session Summary Question: Thoughts on early 2027 and consensus modeling - Management is confident in delivering top-tier med tech growth in 2027 but will provide more details at the next earnings call [29] Question: Acceleration in WCD market growth - The acceleration is attributed to an expanded commercial team and clinical studies highlighting patient risks, which are driving market discussions [31][34] Question: Prescription growth sources - Approximately 70%-75% of prescription growth is from market share shift, with 25% from new prescribers [38] Question: Competitive environment and pricing - Management noted no significant headwinds in pricing and emphasized ongoing competition without major obstacles from competitors [42][46] Question: Florida Medicaid provider status impact - The approval is expected to enhance market share and gross margins in Florida, although the benefits will materialize gradually [60][61] Question: CapEx spending and cash burn outlook - The company plans to maintain a CapEx investment of about $30 million annually, with current cash burn expected to remain in the mid-$20 million range [84][85]

Financial Data and Key Metrics Changes - The company ended 2025 with approximately $188 million in cash equivalents and marketable securities, providing a runway into 2028 to fund key clinical trials [18][17] - The financial position allows the company to provide top-line data in pivotal clinical trials, including the phase 2B trial in refractory chronic cough and the phase 3 trial in IPF-related chronic cough [18] Business Line Data and Key Metrics Changes - Trevi Therapeutics is preparing to initiate two pivotal phase 3 clinical trials for its lead indication, Haduvio, targeting IPF-related chronic cough, with plans to enroll approximately 300 patients in one trial and 130 in another [8][9] - The company is also planning a phase 2B trial for non-IPF interstitial lung disease (ILD) chronic cough, estimating a patient population of approximately 228,000, with 50%-60% having uncontrolled cough [11][12] Market Data and Key Metrics Changes - In the US, there are approximately 150,000 IPF patients, with two-thirds experiencing uncontrolled chronic cough, indicating a significant unmet medical need [10] - The market opportunity for non-IPF ILD chronic cough more than doubles that of IPF chronic cough, as these patients are primarily seen by the same pulmonologists [12] Company Strategy and Development Direction - The company aims to become a leader in chronic cough therapies, focusing on providing solutions for patients with high unmet needs [16] - Trevi is actively preparing for an investor and analyst day to discuss clinical and commercial strategies, as well as recent commercial learnings [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clarity of the path forward for the registration trials following a positive end-of-phase 2 meeting with the FDA [6][7] - The company is optimistic about the enrollment demand for the IPF chronic cough pivotal study, noting increased awareness among physicians and patient advocacy groups [79][80] Other Important Information - The company plans to file for orphan drug designation this year, although there is skepticism about approval due to the broader applicability of the treatment [73] - Trevi is preparing for significant presentations at the American Thoracic Society meeting, where new data from various trials will be shared [15][16] Q&A Session Summary Question: Can you elaborate on the remaining phase 1 studies? - The studies are label-informative, focusing on drug-drug interactions and metabolism, and will not be rate-limiting [20][22][23] Question: Any design features for the non-IPF ILD trial? - The design will leverage learnings from the IPF trial, focusing on dose-ranging and adaptive design [24][25] Question: Will there be any discussions about orphan drug designation? - The company plans to file for orphan drug designation after aligning with the FDA on the program [73] Question: What are the expectations for recruitment in the phase 3 IPF cough trial? - Enrollment is expected to take about a year, with 80 to 100 sites primarily in the US [102] Question: Will additional phase 1 drug-drug interaction studies be needed? - It depends on the timing of other drug approvals, but it is not seen as a barrier [104] Question: What is the anticipated placebo effect in the longer trial? - The company expects to be well-powered to handle the placebo response based on previous studies [97] Question: How will the company broaden the patient population for the phase 3 trial? - The trial will include patients on background anti-fibrotic medications and will not have a cough count requirement [120]

Financial Data and Key Metrics Changes - Q4 revenue reached $153.3 million, a significant increase from $33.5 million in the prior year quarter, reflecting strong project execution and initial contributions from the Asset Vault portfolio [39] - Full year revenue was $203.7 million, representing over 340% growth year-over-year, driven by energy storage solutions in Australia and the US [39] - Q4 GAAP gross profit was $31.6 million, compared to $2.6 million in the prior year quarter, resulting in a gross margin of 20.6% versus 7.8% [40] - Full year GAAP gross profit reached $48 million, improving nearly eight-fold versus the prior year, with a gross margin of 23.6%, up 10 percentage points from 13.4% [40] - Adjusted EBITDA turned positive at $9.8 million in Q4, compared to a loss of $13.4 million in the prior year quarter [40] - Total cash as of December 31, 2025, was $103.4 million, up more than three-fold versus the prior year [41] Business Line Data and Key Metrics Changes - The contract backlog increased to $1.3 billion, representing 3x growth versus the prior year and 42% sequential growth [43] - The company reported contracted megawatts increased to 540 MW, which includes contributions from AI digital infrastructure projects [9][18] - The Asset Vault platform is expected to generate $10 million in annualized adjusted EBITDA from operational assets [47] Market Data and Key Metrics Changes - The company is actively progressing opportunities valued at more than $3 billion associated with 1.8 gigawatts of capacity [46] - The Australian development partner was awarded a 14-year long-term energy service agreement for the Ebor battery project, expected to commence operations in 2028 [45] Company Strategy and Development Direction - The company is transitioning to an Asset Vault model, focusing on owning and operating energy storage projects rather than just delivering technology [16][25] - The strategic own and operate platform is designed to create a vertically integrated ecosystem that captures value across the entire energy storage life cycle [46] - The company aims to scale to over 3 gigawatts by 2030, with a projected EBITDA of over $1.5 billion [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in liquidity and the ability to execute the growth strategy, highlighting the importance of cash for funding large projects [12][15] - The company faced challenges in the market due to tariffs and uncertainty but managed to maintain revenue guidance [11][23] - The outlook for 2026 estimates revenue in the range of $225-$300 million, reflecting growth from third-party projects and contributions from the Asset Vault [48] Other Important Information - The company completed a $300 million preferred equity agreement to support the Asset Vault platform [42] - The company is focusing on sustainability, finishing in the top 2% in corporate sustainability assessments [28] Q&A Session Summary Question: Can you discuss the evolution of the EMS platform? - Management highlighted significant investments in software to optimize operations and asset management, including predictive analytics for safety and efficiency [55][56] Question: What are the market demands for fuel cells in microgrids? - The company is developing technologies to optimize data center operations, including hybrid systems that combine renewable and storage assets [60][62] Question: Can you provide details on the margin improvement? - Management attributed margin improvement to effective project delivery, cost management, and supply chain efficiency [63][66] Question: What are the project financing plans for Sosa and Stoney Creek? - The Sosa project is expected to cost $125 million-$150 million, while Stoney Creek is projected at AUD 350 million, with significant leverage anticipated [75][76] Question: How much of the revenue comes from third-party deployments versus Asset Vault? - The majority of revenue in 2026 is expected to come from third-party projects, with Asset Vault contributions ramping up in subsequent years [82]

Financial Data and Key Metrics Changes - For the full year 2025, total net sales increased by 16.8%, driven by new store expansion and comparable sales growth of 7.7% [4][18] - Adjusted EBITDA grew by 24.1%, resulting in an adjusted EBITDA margin of 10.2% [18] - In Q4 2025, net revenue increased by 8.2% to $648.8 million, with adjusted comparable sales increasing by 2.8% [19][20] - Net income grew over 6% to $41 million compared to $38.6 million last year [21] - Gross margins increased by 20 basis points to 45.7% in Q4 2025 [20] Business Line Data and Key Metrics Changes - The company opened 20 new stores in 2025, ending the year with a total of 209 locations, representing an 11% growth [10][19] - The average store manager tenure is over seven years, indicating strong internal promotion and employee retention [3] Market Data and Key Metrics Changes - The company entered two new markets in 2025: North Carolina and Vermont, with strong performance in these locations [19] - Aided brand awareness increased to 45%, with top 10 DMAs averaging approximately 70% [8] Company Strategy and Development Direction - The company focuses on three primary strategies for long-term growth: expanding the store base, driving comparable sales, and leveraging scale for efficiency and margin expansion [9][10] - The company aims to open approximately 20 new stores in 2026, with a long-term goal of over 500 stores by 2035 [11][30] - The merchandising strategy emphasizes a narrow and deep curated assortment, maintaining pricing approximately 10% below competitors [5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating macroeconomic uncertainties and highlighted a strong history of market share gains [16][29] - The company anticipates comparable sales growth of approximately 1.0%-1.5% in Q1 2026, despite weather-related impacts in early 2025 [23][24] - Management remains optimistic about the long-term financial model, expecting approximately 9% revenue growth and 10%-12% EBITDA growth [28] Other Important Information - The company completed its IPO in February 2025, raising $302 million in net primary proceeds, which were used to prepay a $350 million term loan, resulting in a debt-free balance sheet [22] - The company plans to invest approximately $110 million-$115 million in capital expenditures focused on store growth and infrastructure [26] Q&A Session Summary Question: Impact of weather on fiscal year outlook - Management indicated that the wider range in EBITDA guidance is primarily due to weather-related impacts in Q1, affecting store traffic and sales [32][34] Question: Recovery of demand post-weather events - Management noted that while there is typically a partial recovery of demand after weather events, they expect to see a significant portion of lost sales recaptured [34][35] Question: Cushion in outlook for the second half of the year - Management expressed confidence in their plans for the second half of the year, despite potential macroeconomic uncertainties [40][42] Question: Changes in profitability outlook - Management stated that the profitability outlook has been adjusted to account for increased marketing spend and current tariff impacts, but they remain confident in their ability to manage costs [48][51] Question: Trends in e-commerce and omnichannel sales - Management highlighted the importance of e-commerce as a growing channel, with over 70% of customers engaging across multiple channels [92]

Financial Data and Key Metrics Changes - Q4 revenue reached $153.3 million, a significant increase from $33.5 million in the prior year quarter, reflecting strong project execution in Australia and the US [35] - Full year revenue was $203.7 million, representing over 340% growth year-over-year, driven by energy storage solutions ramp-up [35] - GAAP gross profit for Q4 was $31.6 million, compared to $2.6 million in the prior year quarter, resulting in a gross margin of 20.6% versus 7.8% [36] - Full year GAAP gross profit reached $48 million, improving nearly eight-fold versus the prior year, with a gross margin of 23.6%, up 10 percentage points from 13.4% [36] - Adjusted EBITDA turned positive at $9.8 million in Q4, compared to a loss of $13.4 million in the prior year quarter [36] - Total cash as of December 31, 2025, was $103.4 million, up more than three-fold versus the prior year [37] Business Line Data and Key Metrics Changes - The company reported a contract backlog of $1.3 billion, representing 3x growth versus the prior year and 42% sequential growth [39] - Contracted megawatts increased to 540 MW, which includes projects in operation and construction [8][16] - The Asset Vault platform is expected to generate $10 million in annualized adjusted EBITDA from the first two operational assets [43] Market Data and Key Metrics Changes - The company is actively progressing opportunities valued at more than $3 billion associated with 1.8 gigawatts of capacity [42] - The Australian development partner was awarded a 14-year long-term energy service agreement for the Ebor battery project [39] Company Strategy and Development Direction - The company is transitioning to an Asset Vault model, focusing on owning and operating energy storage projects rather than just delivering technology [15][19] - The strategy aims to create predictable, recurring, and high-margin infrastructure cash flows while unlocking synergies with the EPC integration business [43] - The company is targeting to scale to over 3 gigawatts by 2030, with a projected EBITDA of $1.5 billion+ [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in liquidity and the ability to execute the growth strategy, highlighting the importance of cash for project financing [11][14] - The company faced challenges in the first half of 2025 due to tariffs and market uncertainty but managed to achieve its original revenue guidance [10][21] - The outlook for 2026 estimates revenue in the range of $225-$300 million, reflecting growth from third-party projects and contributions from the Asset Vault [44] Other Important Information - The company completed a $300 million preferred equity agreement to support the Asset Vault platform [38] - The company is focusing on sustainability, finishing in the top 2% in S&P Global's corporate sustainability assessments [25] Q&A Session Summary Question: Can you discuss the evolution of the EMS platform? - Management highlighted significant investments in software to optimize operations and asset management, including predictive analytics for safety and efficiency [50][51] Question: What are the market trends for fuel cells in data centers? - The company is exploring various technologies to optimize data center operations, including hybrid systems that combine renewable and storage assets [56][57] Question: Can you provide details on project financing for Sosa and Stony Creek? - The Sosa project is expected to cost $125 million-$150 million, while Stony Creek is quoted at AUD 350 million, with expected project leverage exceeding 50% [70][71] Question: How much of the 2025 revenue comes from third-party deployments versus Asset Vault? - The majority of revenue in 2026 is expected to come from third-party projects, with Asset Vault contributing upwards of $10 million in recurring EBITDA [72][76] Question: Does the contract backlog include the latest project signed after December? - Yes, the backlog includes the fifth project, with additional upside associated with the fourth project [78]

Financial Data and Key Metrics Changes - ClearPoint Neuro reported total revenues of $37 million for the year ended December 31, 2025, compared to $31.4 million in 2024, marking an increase of approximately 18% [10] - The gross margin for the full year 2025 was 61%, consistent with 2024 [12] - Net cash flows used in operating activities for 2025 were $23.9 million, an increase of $15 million from 2024, primarily due to a higher net loss and pay down of accounts payable [19] Business Line Data and Key Metrics Changes - Biologics and Drug Delivery revenue increased by 10% to $19 million in 2025, up from $17.3 million in 2024, driven by increased product sales [11] - Neurosurgery navigation revenue grew to $14.8 million in 2025, including $1.2 million from the IRRAS product line, attributed to an increased installed base and the full market release of new systems [11] - Capital equipment and software revenue was $3.1 million for 2025, showing a slight decrease compared to the previous year [12] Market Data and Key Metrics Changes - The company expects revenues for 2026 to be in the range of $52 million to $56 million, reflecting factors such as FDA communications regarding rare diseases and integration efforts from the IRRAS acquisition [8] - ClearPoint is participating in more than 25 active clinical trials and has over 60 active biopharma partners, with more than 10 partner programs accepted for FDA expedited review [5][24] Company Strategy and Development Direction - ClearPoint Neuro is focused on developing a complete neuro ecosystem for minimally invasive treatments, including cell and gene therapies [4] - The company has entered two phases of growth strategy: "Fast Forward" to penetrate a $1 billion market and "Essential Everywhere" to build a new market for commercial cell and gene therapy delivery [6][7] - The company aims to achieve 20% market share in various segments, including pre-commercial biologics and drug delivery, neurosurgery navigation, laser therapy, and neurocritical management [34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's strong position and momentum going into 2026, highlighting the successful integration of the IRRAS acquisition and the potential for significant revenue growth [21] - The management noted that the FDA's recent communications regarding rare diseases have influenced revenue guidance, leading to a more cautious approach in forecasting [41] Other Important Information - The company has invested over $100 million in the past five years to build a strong foundation, including a robust pipeline of development programs and an expanded manufacturing footprint [5] - ClearPoint's unique biologics and drug delivery ecosystem is expected to play a crucial role in the future of neurological treatments, with a focus on supporting biopharma partners [4][26] Q&A Session Summary Question: Clarification on 2026 guidance and organic growth - Management explained that the guidance was tightened due to FDA communications on rare diseases and the integration of IRRAS, with expectations for balanced organic and inorganic growth [38][46] Question: Pathway to $200 million revenue - Management indicated that they expect to grow at a rate of 15%-20% as they capture market share across their segments, with potential for significant revenue bumps from large GLP studies [48][50] Question: Updates on expedited review partners - Management confirmed that there are over 10 partners in expedited review pathways, with indications including Parkinson's disease and drug-resistant epilepsy, providing higher confidence in potential revenue [60][61] Question: Timeline for expansion in neuro-oncology - Management discussed the strength of their commercial team and the importance of upcoming clinical data to support expansion into neuro-oncology, indicating a serious commitment to this market [62]

Financial Data and Key Metrics Changes - As of December 31, 2025, cash and cash equivalents were $9.9 million, with a subsequent capital raise of $22.3 million in January 2026, extending the company's runway [22][23] - Operating expenses were reduced by approximately $10 million across R&D and SG&A for the full year of 2025, with R&D expenses at $9.4 million and SG&A at $5.1 million for Q4 2025, down from $12.4 million and $6.8 million respectively in the prior year [23][24] - The net loss for Q4 2025 was $31.9 million, compared to $25.8 million in the same period last year [24] Business Line Data and Key Metrics Changes - The rice program is projected to generate $200 million in potential annual royalty opportunities through herbicide-tolerant traits, with initial market entry in Latin America expected in 2027 [9][10] - The sustainable ingredients program has completed pre-commercial pilot runs for two biofragrance products, leading to the first payment in Q4 2025, with potential annual royalties estimated between $20 million and $40 million [14][15] Market Data and Key Metrics Changes - The EU's political agreement on New Genomic Techniques legislation opens up approximately 100 million acres of greenfield opportunity, significantly impacting the gene editing market [16] - The company is targeting 5-7 million acres in the Americas for its rice traits, with potential expansion into the Indian market, which encompasses around 120 million acres [44] Company Strategy and Development Direction - The company is transitioning to a commercially driven model, focusing on gene editing as a core technology for agricultural innovation [5][6] - Cibus aims to serve as a gene editing engine for plant breeding capabilities, moving beyond traditional trait licensing to establish ongoing genomic editing relationships with seed companies [6][8] Management's Comments on Operating Environment and Future Outlook - Management views 2026 as a year focused on execution and momentum, with plans to expand customer relationships and advance commercialization agreements [27] - The regulatory landscape is evolving positively, with significant developments in Europe and the Americas that are expected to accelerate commercial conversations globally [16][27] Other Important Information - The company has consolidated operations from its Oberlin facility into its San Diego headquarters, which is part of a broader effort to streamline operations and reduce cash usage [24][25] - The advancements in gene editing technology have led to improved efficiency and scalability, enabling the company to respond to market demands more effectively [18][46] Q&A Session Summary Question: Impact of EU NGT framework on CapEx and canola program - Management highlighted the EU regulatory progress as a watershed moment, opening up significant opportunities for crops like winter oilseed rape, which is a major crop in Europe [32][33] Question: Next steps for rice commercialization in Latin America - The company outlined the process of editing elite genetics and the partnership with Interoc for commercialization in Ecuador and Colombia, with a focus on chemical registration and trait work [36][38] Question: Trend line for acres touched by technology - Management indicated a target of 5-7 million acres in the Americas, with potential for additional revenue from the Indian market in the future [44] Question: Scale of gene editing services - The company emphasized its efficient production system and automation, which allows for rapid scaling of gene editing services without significant increases in R&D expenses [46][49] Question: Royalty rates for gene edits as a service - Management noted that the speed and scalability of their gene editing process allow for favorable negotiations on trait royalties, as customers can see value added quickly [51][52] Question: Scale of fragrance projects - The company is currently focused on a few fragrances but sees potential to scale quickly, targeting around 17 fragrances for future development [53]

Financial Performance - In Q3 2026, revenue reached $24.6 million, reflecting a 63% increase year-over-year [8][19] - Gross margin improved to 52.6%, up 9 percentage points year-over-year and 200 basis points sequentially, marking the ninth consecutive quarter of gross margin expansion [8][19] - The company aims for gross margins of 70% or higher in the coming years [9][20] Business Line Performance - The company accepted over 5,400 prescriptions for the ASSURE System, contributing to a 58% year-over-year increase in prescriptions [8][19] - The conversion rate improved to approximately 46%, up from an adjusted 43% in the prior year [20] Market Dynamics - The wearable cardioverter defibrillator (WCD) market is estimated to have grown in the low to mid-teens percentage range in 2025, with expectations for continued expansion into a multi-billion-dollar market [10][11] - The company has seen increased market share and is actively expanding its sales organization to penetrate existing accounts and attract new prescribers [14][17] Strategic Direction - The company is focused on enhancing its product offerings, including a new ASSURE algorithm update approved by the FDA, aimed at reducing false alarms and inappropriate shocks [12][68] - A strategic collaboration with Biobeat Technologies was announced to integrate advanced blood pressure monitoring into the ASSURE WCD product line [12][13] Management Commentary - Management expressed confidence in the company's growth trajectory, citing strong revenue growth and operational leverage as key drivers for long-term value [9][17] - The management team highlighted the importance of clinical data from the ACE-PAS study in driving clinician engagement and market expansion [11][49] Other Important Information - The company has recently become an approved provider for Florida's managed Medicaid, which is expected to enhance market access and growth in that state [16][60] - The monthly Medicare reimbursement rate for WCDs increased by 2% to $3,589, positively impacting revenue cycle management [16] Q&A Session Summary Question: Thoughts on early 2027 model and consensus - Management is confident in delivering top-tier med tech growth in 2027 but will provide detailed guidance at the next earnings call [29] Question: Acceleration in WCD market growth - The acceleration is attributed to an expanded commercial team and clinical studies highlighting patient risks, which are driving market growth [30][32] Question: Prescription growth sources - Approximately 70%-75% of prescription growth is from market share shift, with 25% from new prescribers [37] Question: Competitive environment and pricing - There are no significant pricing headwinds, and the competitive landscape remains stable with entrenched competitors focusing on service levels [41][46] Question: Florida market access impact - Gaining Medicaid provider status is expected to enhance market share and gross margins in Florida, although growth will be gradual [60][61] Question: Future territory expansion plans - The company is evaluating the pace of territory expansion and is open to accelerating growth based on market conditions [52] Question: Cash burn and CapEx outlook - Cash burn is expected to remain in the mid-$20 million range, with ongoing investments in CapEx to support growth [86]

Financial Data and Key Metrics Changes - The company ended 2025 with approximately $188 million in cash equivalents and marketable securities, providing a runway into 2028 to fund key clinical trials [15][14] - The cash runway is expected to support top-line data in pivotal phase 3 clinical trials for IPF-related chronic cough and phase 2B trials for RCC and non-IPF ILD [15] Business Line Data and Key Metrics Changes - The company is preparing to initiate two pivotal phase 3 clinical trials for Haduvio in IPF-related chronic cough, with the first trial expected to start in Q2 2026 [6][4] - The second phase 3 trial is anticipated to begin in the second half of 2026, focusing on a 12-week primary efficacy endpoint [6][7] Market Data and Key Metrics Changes - In the US, there are approximately 150,000 IPF patients, with two-thirds experiencing uncontrolled chronic cough, indicating a significant unmet medical need [8] - The market opportunity for non-IPF ILD patients is estimated to be around 228,000, with 50%-60% suffering from uncontrolled cough, effectively doubling the market potential [10] Company Strategy and Development Direction - The company aims to become a leader in chronic cough treatment, focusing on developing therapies for patients with high unmet needs [12] - The strategy includes conducting adaptive phase 2B trials for non-IPF ILD and refractory chronic cough, with plans to file supplemental NDAs for these indications [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clarity of the path forward for registration trials following positive FDA interactions [5][4] - The company is optimistic about the enrollment demand for the IPF chronic cough pivotal study, citing increased awareness among physicians and patient advocacy groups [78][77] Other Important Information - The company plans to hold an investor and analyst day on May 7, 2026, to discuss clinical and commercial strategies in detail [12] - The company will also participate in the American Thoracic Society meeting, sharing new data from various trials [12] Q&A Session Summary Question: Can you elaborate on the remaining phase 1 studies discussed with the FDA? - The studies are label-informative, focusing on drug-drug interactions and metabolism, which are not rate-limiting and can be conducted in parallel with phase 3 trials [17][19] Question: What design features are being aligned with the FDA for the non-IPF ILD trial? - The company plans to propose an adaptive phase 2B trial design, leveraging insights from the IPF end-of-phase 2 meeting [20][22] Question: Will the label dose in RCC be the same as in IPF? - The company is exploring the dosing strategy and may require additional IP if the dosing differs significantly [58] Question: What are the expectations for recruitment pace in the phase 3 IPF cough trial? - The company anticipates a one-year enrollment period for the phase 3 trial, focusing on 80 to 100 sites primarily in the US [102] Question: Will there be any pre-specified analyses for dyspnea and exacerbations in the phase 3 trial? - The company will track various metrics related to cough, breathlessness, and other patient concerns, but the primary focus remains on cough [116][115]