Outset Medical Conference Call Summary Company Overview - **Company**: Outset Medical (NasdaqGS:OM) - **Industry**: Medical Devices, specifically focused on dialysis technology Key Points and Arguments Company Transformation and Performance - Outset Medical has undergone significant transformation over the past 12 months, improving various aspects of its organization and commercial operations [1][2] - The company has resolved FDA issues, leading to a more mature regulatory organization [2] - A shift to an enterprise-based sales model has been implemented, focusing on large hospital systems, resulting in a 20% increase in average order size over the last three months [2] Product and Technology - The Tablo technology has received positive feedback from customers, demonstrating its effectiveness in reducing adverse patient events and improving the quality of dialysis care [3] - Over one million Tablo treatments have been conducted, showcasing its robust capabilities [3] Financial Performance and Guidance - Despite positive developments, the company reported disappointing quarterly results and lowered guidance for 2025, leading to a reduction in 2026 projections [4][5] - The company missed consensus estimates by approximately $1.3 million due to delays in closing a large deal and mismatches in order timing for consumables [7][8] Sales and Order Dynamics - The company is working on improving the predictability and timing of deal closures, which has been a challenge since 2023 [20][22] - There is a need for better communication and alignment with customers regarding inventory management and purchasing patterns [12][14] - The fourth quarter has shown normalization in the relationship between utilization and purchase data, indicating a return to expected trends [17][19] Revenue Strategy - Outset Medical aims to increase recurring revenue from consumables and services, with a focus on EMR integration as a future revenue driver [21][32] - The company has seen strong customer satisfaction scores and is focused on enhancing service margins, targeting a gross margin of 50% [39][40] Market Position and Competition - The market for acute care dialysis is substantial, with Outset Medical positioned ahead of competitors, facing minimal competition [49][50] - The company is confident in its ability to improve capital sales predictability and achieve profitability [50][51] Future Outlook - The company plans to enhance its marketing efforts to promote the clinical value of Tablo, focusing on improving patient care outcomes [36][37] - Guidance for 2026 will be provided at the beginning of the year, with a focus on addressing current challenges and leveraging strong recurring revenue streams [44][45] Additional Important Insights - The transition in sales leadership is being managed carefully to minimize disruption, with a strong existing sales team in place [28][30] - The integration of EMR systems is expected to become a significant revenue source in the future, although it is currently a small part of the revenue picture [32][33] - The company is actively working on generating case studies and white papers to highlight the clinical benefits of its technology [36][37]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $29.4 million, representing a 3% growth compared to Q3 2024 [14][18] - Non-GAAP gross margin reached 39.9%, an increase of 350 basis points year-over-year [20] - Non-GAAP operating loss was $10.4 million, a 35% improvement from the prior year [22] - Cash used during the quarter was approximately $6 million, reflecting improved gross margin and lower operating expenses [22][23] Business Line Data and Key Metrics Changes - Tablo console sales increased by 8% in Q3 2025 [12] - Product revenue was $20.6 million, slightly ahead of $20.3 million in the prior year [18] - Recurring revenue from Tablo consumables and service was $21.1 million, slightly above Q3 2024 [18] Market Data and Key Metrics Changes - The average size of sales opportunities increased by over 20% [12] - Hospital demand for insourcing dialysis with Outset's technology continues to grow, indicating a strong market opportunity [11][26] Company Strategy and Development Direction - The company is focusing on enterprise-wide insourcing, managing large opportunities across multiple hospitals [10][11] - Aiming to reach a gross margin milestone of 50% through disciplined expense management and revenue growth [12][20] - The company is committed to improving sales execution and forecasting to better anticipate deal dynamics [34][45] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that Q3 results fell short of expectations due to timing shifts in large deals [10][30] - There is confidence in the long-term growth potential, with a focus on improving execution under new sales leadership [45][49] - The company expects to see treatment revenue normalize in 2026 as ordering patterns align with actual utilization [19][50] Other Important Information - The resignation of the Head of Sales may cause internal disruption, but the company has a strong sales leadership team in place [12][14] - The company ended the quarter with $182 million in cash and equivalents, indicating sufficient capital for future operations [22][23] Q&A Session Summary Question: What factors contributed to the guidance trim? - Management indicated that a large console opportunity shifted from Q3 to Q4, impacting guidance [28][30] Question: How is the company addressing the sales leadership transition? - The search for a new sales leader is underway, with a focus on candidates with capital equipment and enterprise sales experience [36][39] Question: What is the outlook for 2026? - Management believes that 2025 serves as a good proxy for 2026, with expectations for improved execution and growth [45][82] Question: Are there any concerns about order cancellations? - Management confirmed that no deals have fallen out of the pipeline, and the sales team is actively working on closing remaining opportunities [70][71] Question: What is the status of the home channel and SNF opportunities? - The home channel has shown stable retention rates and growth, with positive feedback from patients using Tablo [75][76]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $29.4 million, representing a 3% growth compared to Q3 2024 [13][21] - Non-GAAP gross margin reached nearly 40% in Q3 2025, with a 350 basis point increase year-over-year [19][21] - Non-GAAP operating loss was $10.4 million, over 35% lower than the operating loss of $16.1 million in the prior year [20][21] Business Line Data and Key Metrics Changes - Tablo console sales increased by 8% in Q3 2025, with a significant growth in the average size of sales opportunities, which increased by more than 20% [12][17] - Product revenue was $20.6 million, slightly ahead of $20.3 million in the prior year, with consumable sales at $12.2 million [17][21] - Recurring revenue from Tablo consumables and service was $21.1 million, slightly ahead of Q3 2024 [17] Market Data and Key Metrics Changes - The demand for insourcing dialysis with Outset's technology continues to grow, supported by clinical, operational, and financial benefits [11][12] - The company is approaching 1,000 acute sites using Tablo, with a run rate of a million treatments per year [23] Company Strategy and Development Direction - The company is focusing on enterprise-wide insourcing and managing large opportunities that span multiple hospitals within health systems [11][23] - The strategy includes optimizing inventory levels and gradually increasing production to mitigate gross margin impacts [19][20] - The company aims to reach a gross margin milestone of 50% in the future [12][19] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that while progress has been made, there is still work to be done in transforming the sales process and improving execution [10][12] - The resignation of the Head of Sales may cause internal disruption, but the team remains committed to customer service [13][21] - Management remains optimistic about future growth, citing strong customer demand and a growing pipeline of larger deals [41][42] Other Important Information - The company revised its 2025 revenue guidance to a range of $115 million to $120 million, down from $122 million to $126 million [21][22] - Cash balances at the end of the quarter were $182 million, with a projected cash use of less than $50 million in 2025 [20][21] Q&A Session Summary Question: What factors contributed to the guidance trim? - Management indicated that a large console opportunity shifted from Q3 to Q4, and the departure of the Head of Sales was also a consideration in the revised guidance [26][27] Question: Can you elaborate on console revenues and order timing? - Console revenues showed positive growth, but management expressed frustration with execution and the ability to predict deal timing [29][30] Question: What qualities are being sought in a new sales leader? - The company is looking for someone with a background in capital equipment and enterprise sales, who can strategically lead and coach the sales team [32][34] Question: What is the growth outlook for 2026? - Management has not provided specific guidance for 2026 but remains optimistic about growth potential, emphasizing that demand continues to grow [40][42] Question: Are there any order cancellations or drops in the pipeline? - Management confirmed that no deals have fallen out of the pipeline, and the sales team is actively working to close pending opportunities [63][64]

Company Overview - The company operates in one of the largest markets in healthcare, maintaining a highly differentiated technology that has not seen new advancements in several decades [2] - There is a lack of competitors in the market, providing a wide open runway for continued growth [2] Growth and Development - Since the 2020 IPO, the company's product, Tablo, is now utilized in over 900 locations, indicating significant growth [3]

Company Overview - The company operates in one of the largest markets in healthcare, maintaining a highly differentiated technology that has not seen new advancements in several decades [2] - The competitive landscape remains sparse, providing a wide open runway for continued growth [2] Growth and Development - Since the 2020 IPO, the usage of the company's product, Tablo, has expanded significantly, now being utilized in over 900 locations [3]

Core Insights - The health care sector is experiencing a trend of oversold stocks, presenting potential buying opportunities for undervalued companies [1] - The Relative Strength Index (RSI) is a key indicator used to identify oversold conditions, with a value below 30 indicating potential buying opportunities [1] Company Summaries - **Exact Sciences Corp (EXAS)**: Reported strong quarterly results with a focus on earlier detection. Despite positive performance, the stock fell approximately 21% over the past month, with an RSI of 22.9 and a closing price of $40.99 [8] - **Tandem Diabetes Care Inc (TNDM)**: Announced mixed second-quarter results and narrowed FY25 sales guidance below estimates. The stock declined around 27% in the last five days, with an RSI of 22.7 and a closing price of $11.23 [8] - **Outset Medical Inc (OM)**: Reported better-than-expected second-quarter results and raised FY25 sales guidance. The stock fell about 34% over the past month, with an RSI of 29.6 and a closing price of $12.80 [8]

Market Overview - The annual spending on U S ESRD (End-Stage Renal Disease) patients is $73 billion, with $41 billion paid by Medicare[13] - Dialysis for ESRD patients accounts for 7% of the entire Medicare budget, while comprising only 1% of the Medicare population[13] - There are 600,000 dialysis patients in the U S receiving 90 million annual dialysis treatments[15] - Outset estimates the U S TAM (Total Addressable Market) for Tablo at $11 4 billion, including $2 5 billion for the acute and post-acute market and $8 9 billion for the home market[35, 65] Tablo System Advantages - Tablo offers potential cost savings of 50% – 80% in dialysis treatment, with a potential payback period of less than 1 year[49] - Tablo reduces the cost of acute dialysis to approximately $300 per treatment[49] - Tablo requires less than 25 hours of training per patient, significantly less than historical devices that require 100 hours[72, 74] - Tablo eliminates dialysate prep time, unlike historical devices that require 16–24 hours of prep time per week[72, 74] Commercial Progress - Outset has trained >10,000 nurses and 1,000 physicians[59] - Outset has secured contracts with 10 of the 10 largest subacute providers and 8 of the 8 top national health systems[56, 58] - Outset has recurring revenue of >60%[85] Financial Position - Outset estimates a cash position of $210 million entering 2025[90] - Outset received $169 million in gross proceeds from a January 2025 equity financing[90]