Summary of Inspire Medical Systems Conference Call Company Overview - **Company**: Inspire Medical Systems (NYSE: INSP) - **Industry**: Medical Technology, specifically focused on sleep apnea treatment Key Points and Arguments Financial Performance - The company reported a strong quarter following a challenging second quarter due to the transition from Inspire 4 to Inspire 5 systems [4][3] - Patient outcomes from the Inspire 5 device were reported positively from clinical studies in Singapore and initial commercial experiences in the U.S. [4][4] - Over 98% of centers have been trained for Inspire 5, with 90% completing contracting and 75% ready for the Sleep Sync preparation [5][5] Product Transition - The transition from Inspire 4 to Inspire 5 is nearly complete, with most centers now using Inspire 5 [8][7] - The new Inspire 5 system has shown a 20% reduction in surgical time, making it easier for ENTs to perform more procedures [11][12] - The removal of the pressure-sensing lead in Inspire 5 has simplified the procedure, addressing previous discomfort for surgeons [11][12] Market Dynamics - The company is focusing on increasing awareness among ENTs and optimizing their practices to handle more cases [15][17] - Inspire Medical Systems is working to ensure consistent reimbursement policies across major payers, which is crucial for physician adoption [24][24] - The transition to a new reimbursement code (64568) has improved reimbursement rates, particularly for ASCs (Ambulatory Surgical Centers) [28][125] Growth Strategy - Inspire Medical Systems has trained over 1,600 ENT surgeons, with a target market of approximately 12,000 general ENTs and 8,000 head and neck specialists [45][46] - The company is optimistic about expanding its reach to general surgeons and enhancing its market penetration [47][47] - The focus is on community-based care, where the majority of procedures are performed, as these centers drive growth [30][32] Tailwinds and Challenges - The rise of GLP-1 medications has increased awareness of obstructive sleep apnea (OSA), leading to more patients seeking treatment [51][56] - The company anticipates low double-digit revenue growth (10-11%) for the upcoming year, balancing tailwinds from Inspire 5 and headwinds from existing Inspire 4 inventory [82][88] Operational Efficiency - Inspire Medical Systems has improved its operational efficiency, leading to a raised EPS guidance for the year [102][105] - The company is restructuring its commercial organization to enhance the effectiveness of territory managers and field clinical reps [108][111] Future Innovations - Inspire 6 is in development, aiming to automate the device's operation based on patient sleep patterns, which could significantly improve adherence to therapy [160][162] - Recent studies indicate improvements in cardiovascular health among patients using Inspire therapy, which could strengthen the case for payer coverage [164][167] Capital Allocation - The company has a $200 million share repurchase authorization, with $50 million already completed, indicating confidence in its stock valuation [152][152] Additional Important Insights - The company is focusing on direct-to-consumer advertising to increase patient awareness and drive demand for Inspire therapy [138][146] - The transition to Inspire 5 is expected to enhance patient outcomes and streamline procedures, which is critical for long-term growth [160][162]

据最新一期《柳叶刀》杂志报道，一种名为"舒噻胺"的碳酸酐酶抑制剂类药物，可显著减少阻塞性睡眠 呼吸暂停患者的呼吸暂停次数，从而提高他们的睡眠质量。这项由瑞典哥德堡大学参与的临床研究，为 无法耐受呼吸机面罩的患者带来了新的治疗希望。研究人员表示，若未来在更大规模临床试验中证实安 全有效，舒噻胺或将成为第一种治疗睡眠呼吸暂停的药物。 阻塞性睡眠呼吸暂停是一种常见的睡眠障碍。患者睡眠时上气道塌陷会导致呼吸暂停、缺氧和睡眠中 断。若长期未治疗，将增加高血压、心血管疾病、中风及2型糖尿病的风险。 目前持续气道正压通气是治疗该病的主要手段，虽然疗效显著，但许多患者难以长期坚持使用。研究显 示，多达一半的患者在使用一年内放弃持续气道正压通气治疗，原因包括面罩不适或干扰睡眠。 舒噻胺是一种已获批用于治疗儿童癫痫的药物。研究负责人、哥德堡大学萨尔格伦斯卡医学院肺病学教 授扬·赫德纳表示，团队多年来一直探索这一药物的治疗思路，结果表明，睡眠呼吸暂停可通过药物干 预来改善。 （文章来源：科技日报） 研究共纳入298名中度至重度睡眠呼吸暂停患者，其中四分之一患者服用安慰剂，其余患者分别服用不 同剂量的舒噻胺。试验在4个欧洲国家进行， ...

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was €1,300,000, an increase of 73.8% compared to €800,000 in Q2 2024 [16] - Gross margin for Q2 2025 was 63.4%, essentially flat compared to the previous year [16] - Total operating loss for Q2 2025 was $19,900,000, up from $13,300,000 in Q2 2024, driven by increased commercial investments in the U.S. [16][17] - Cash position as of June 30, 2025, was €43,000,000, down from €63,000,000 at March 31, 2025 [17] Business Line Data and Key Metrics Changes - The GENIOR system received FDA PMA approval, marking a significant advancement in treatment options for obstructive sleep apnea (OSA) patients in the U.S. [5][6] - The device demonstrated a compliance rate of 85.9% and a patient satisfaction score of 90% [10] Market Data and Key Metrics Changes - The U.S. market for OSA treatment is concentrated, with approximately 1,400 implanting accounts, of which 350 to 400 are high-volume accounts representing 75% to 80% of total revenue [34][35] - The company has identified demand from patients hesitant about receiving implanted batteries, which the GENIOR system addresses with its unique design [13] Company Strategy and Development Direction - The company has a two-pronged launch strategy targeting high-volume hypoglossal neurostimulation implanting centers and developing strong referral networks with physicians managing large populations of OSA patients [11][36] - The company aims to differentiate itself through its unique technology benefits and patient focus, particularly in the context of competition with GLP-1 treatments [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the success of the U.S. launch, citing enthusiastic responses from physicians and patients [19] - The remainder of 2025 is expected to be transformative as the company establishes GENIOR in the U.S. market [20] Other Important Information - The company has stopped enrollment in the ACCESS study, believing that the current number of patients enrolled is sufficient for meaningful conclusions [8] - A patent lawsuit initiated by Inspire Medical against the company will not impact the U.S. commercial launch [15] Q&A Session Summary Question: Year-end 2025 metrics and indicators to focus on - Management will track the number of trained physicians and value analysis committee applications as leading indicators [22][24] Question: Leveraging the differentiated label - The company plans to capitalize on the label differentiation by emphasizing the ability to treat positional OSA and the lack of contraindication for complete concentric collapse (CCC) patients [26][28] Question: Commercial strategy and targeted accounts - The sales team will focus on high-volume implanting accounts, which represent a significant portion of revenue [34][35] Question: Reimbursement strategy and payer onboarding - The company expects to see pre-authorization decisions coming in this year, while coverage decisions may be more of a 2026 story [41][42] Question: Access trial and CCC patient treatment - The company will not promote off-label indications but is optimistic about treating CCC patients once the ACCESS trial data is available [69][71] Question: Pricing strategy - The company intends to follow the same pricing strategy as competitors, pricing at approximately $25,000 [74] Question: Initial surgeon engagement and market share - Surgeons must present five defined patient cases before being trained, and the company does not set specific market share expectations at this stage [77][79]

Financial Data and Key Metrics Changes - LivaNova reported a 10% organic revenue growth compared to the previous year, driven by strong performance in the cardiopulmonary and neuromodulation segments [5][28] - Revenue for the quarter was $353 million, reflecting a 9% increase on a constant currency basis and a 10% increase on an organic basis [28] - Adjusted gross margin increased to 69% from 68% in the previous year, attributed to positive pricing and geographic mix [29] - Adjusted diluted earnings per share rose to $1.05 from $0.93 in the prior year [34] Segment Performance Changes - Cardiopulmonary segment revenue was $199 million, a 13% increase year-over-year, with heart-lung machine revenue growing in the low double digits [11][12] - Epilepsy segment revenue increased by 6% year-over-year, with U.S. revenue growing by 5% and Europe and rest of the world combined growing by 9% [13][14] - The company expects epilepsy revenue growth for the full year to be between 4.5% and 5.5%, up from previous guidance of 4% to 5% [16] Market Data and Key Metrics Changes - The cardiopulmonary segment anticipates a revenue growth of 12% to 13% for the full year, revised from 9% to 10% [12] - The company is preparing to launch the Essence product in China, which is expected to be a significant market for heart-lung machines [12][72] Company Strategy and Industry Competition - LivaNova is focused on expanding its portfolio into high-growth markets and addressing large patient populations with significant unmet needs, particularly in obstructive sleep apnea and difficult-to-treat depression [41] - The company is making progress towards CMS reimbursement reconsideration for VNS therapy in treatment-resistant depression, which could enhance market access [41][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining strong organic growth due to robust demand and disciplined execution across the portfolio [5] - The company is optimistic about the impact of the proposed CMS reimbursement changes for end-of-service procedures, which could significantly improve hospital economics [52][51] Other Important Information - The company has initiated a process with CMS to seek national Medicare coverage for VNS therapy in unipolar patients with treatment-resistant depression [21] - LivaNova's cash balance increased to $594 million, up from $429 million at the end of 2024, primarily due to the reclassification of restricted cash [34] Q&A Session Summary Question: Can you elaborate on the positive data from the epilepsy business and its implications for growth? - Management highlighted the large study demonstrating significant seizure reduction, which is expected to enhance patient access and drive growth [45][46] Question: What is the expected impact of the CMS proposal to boost end-of-service procedures to level five? - Management noted that this change could lead to a 48% increase in reimbursement, positively impacting procedure penetration and provider sustainability [51][52] Question: Can you break down the oxygenator business and underlying demand? - Management indicated healthy procedure growth and market share gains, with supply not yet catching up to demand [56][58] Question: How does the company view the commercialization of the obstructive sleep apnea program? - Management expressed confidence in internal commercialization capabilities while remaining open to potential partnerships [96][97]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $217.1 million, an 11% increase from $195.9 million in Q2 2024 [23] - U.S. revenue was $207.2 million, a 10% increase from $187.8 million in the prior year [23] - Gross margin decreased to 84% from 84.8% year over year, primarily due to a $2.1 million charge for excess INSPIRE IV subcomponents [23][24] - Operating loss for the quarter was $3.3 million compared to an operating income of $5.1 million in the prior year [25] - Net loss for the quarter was $3.6 million, representing a loss per share of $0.12 compared to net income of $0.32 per share in Q2 2024 [25][26] - Adjusted EBITDA for the quarter was $44.1 million, a 14% increase compared to $38.7 million in the prior year [26] Business Line Data and Key Metrics Changes - The majority of units sold in Q2 were INSPIRE IVs, leading to minimal inventory destocking [9] - The transition to INSPIRE V faced challenges, with many centers not completing necessary training and onboarding [6][7] - Over 50% of U.S. centers have completed the implementation of SleepSync, which is crucial for the transition to INSPIRE V [8] Market Data and Key Metrics Changes - Revenue outside the U.S. was $9.9 million, a 23% increase year over year [23] - The approval of CPT code 64568 for INSPIRE V for Medicare patients was announced in April, but billing could only begin on July 1, impacting the transition [10] Company Strategy and Development Direction - The company is focused on advancing the transition to INSPIRE V and has ramped up marketing and footprint expansion efforts in the second half of the year [11][12] - Investments in digital scheduling and community health talks are aimed at increasing patient awareness and building capacity [12] - The company aims to drive high-quality patient flow and increase provider capacity through training and certification of additional surgeons [21] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in the commercial rollout of INSPIRE V but remains confident in the platform's potential [6][21] - The company adjusted its full-year revenue guidance to $900 million to $910 million, reflecting a 4% reduction at the midpoint from previous guidance [13] - Management expressed optimism about future growth, expecting revenue growth to exceed 12% to 13% in 2026 [38] Other Important Information - The company announced the retirement of Randy Bann, Executive Vice President, Patient Access and Therapy Awareness, effective January 2026 [19][20] - The national average Medicare hospital reimbursement for CPT code 64568 is proposed to increase to $32,000, a 4% increase from 2024 [16] Q&A Session Summary Question: Can you provide more detail on the revised guidance and the headwinds faced? - Management identified the completion of training and the ability to bill Medicare as the primary factors impacting guidance [33][34] Question: Will revenue in 2026 accelerate beyond the 12% to 13% growth expected for 2025? - Management indicated that they expect revenue growth to exceed the current guidance for 2025 due to ongoing investments [38] Question: Can you clarify the EPS guidance change? - The reduction in EPS guidance is primarily due to lower revenue expectations and increased direct-to-consumer spending [42] Question: What is the current uptake of Medicare billing since the software update? - Uptake has been limited as many sites were not fully operational until they could bill Medicare [87] Question: What is driving the 20% increase in patient implants for INSPIRE V? - The increase is attributed to reduced surgical complexity and improved capacity at centers that have transitioned to INSPIRE V [75]

Summary of Inspire Medical Systems (INSP) Conference Call Company Overview - **Company**: Inspire Medical Systems (INSP) - **Event**: 2025 Conference on May 13, 2025 - **Key Speakers**: Tim Herbert (Chairman and CEO), Rick Buchholz (CFO), Ez Giajia (VP, Investor Relations) Key Points Industry and Product Launch - Inspire Medical has launched **Inspire five**, a new platform aimed at improving patient outcomes and surgeon efficiency [1][3][12] - The launch is significant as it marks a transition from the previous model, Inspire four, and is expected to enhance the company's growth trajectory [5][30] Financial Performance - In Q1 2025, Inspire reported a **23% growth** and achieved positive earnings for the first time in Q1, indicating strong operational leverage [7][8] - The company anticipates **mid to high single-digit sequential growth** for Q2, with a focus on transitioning to Inspire five [20][21] Market Dynamics - There was a noted **patient warehousing** effect, where patients opted to wait for Inspire five rather than proceed with Inspire four, impacting Q1 performance [10][24] - The company is optimistic about a strong second half of 2025 as the transition to Inspire five is completed [11][19] Marketing and Patient Engagement - Inspire plans to increase **direct-to-patient marketing** efforts to raise awareness and drive patient engagement [6][60] - The company is also focusing on educating healthcare providers, including family practice and sleep physicians, about the benefits of Inspire therapy [60] Surgical Efficiency and Training - The new Inspire five system simplifies the surgical procedure by eliminating the need for a pressure sensing lead, which is expected to reduce surgical time from **60-90 minutes to 45-60 minutes** [46] - Inspire has trained approximately **400 advanced practice providers (APPs)** to assist in patient management and post-operative care, enhancing surgical capacity [47] Future Developments - Inspire is looking ahead to **Inspire six**, which will include features like sleep detection and auto-activation, aimed at improving patient adherence to therapy [63][64] - The company is also exploring a subscription model for patient management through its upcoming **SleepSync** program, which will help sleep physicians manage patients more effectively [66] Financial Outlook - Inspire is committed to balancing growth with profitability, expecting improved margins as utilization increases and customer acquisition costs decrease [58][59] - The company is confident that the transition to Inspire five will lead to higher utilization rates and revenue per sales representative [68] Conclusion - Inspire Medical Systems is positioned for growth with the launch of Inspire five, a focus on patient engagement, and a commitment to improving surgical efficiency. The company is optimistic about its future developments and financial performance as it continues to innovate in the sleep apnea treatment market [73][74]