Vivos Therapeutics (NasdaqCM:VVOS) Fireside Chat December 16, 2025 11:00 AM ET Company ParticipantsR. Kirk Huntsman - CEOBrad Amman - CFOModeratorLet me start. As the year draws to a close, 2025 stands out as one of the most pivotal in the company's history. It marked the launch of a potentially transformative shift in Vivos' business model, highlighted by the June acquisition of the Sleep Center of Nevada, or SCN. Before we get into the operational progress of the transition, Kirk, could you start by shari ...

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]

Core Insights - A drug named "Suxamethonium," a carbonic anhydrase inhibitor, significantly reduces apnea episodes in patients with obstructive sleep apnea, improving sleep quality [1] - The clinical study involved 298 moderate to severe obstructive sleep apnea patients across four European countries, with a double-blind design [1][2] - High-dose Suxamethonium reduced apnea events by up to 47% compared to placebo, with notable improvements in blood oxygen levels [1] Group 1 - Obstructive sleep apnea is a common sleep disorder that can lead to serious health risks if untreated, including hypertension, cardiovascular diseases, stroke, and type 2 diabetes [1] - Continuous positive airway pressure (CPAP) is the primary treatment, but many patients struggle to adhere to it, with up to 50% abandoning treatment within a year due to discomfort [2] - Suxamethonium is already approved for treating pediatric epilepsy, and researchers have explored its potential for treating sleep apnea [2]

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]