Core Insights - Pomerantz LLP is investigating claims on behalf of investors of Inspire Medical Systems, Inc. regarding potential securities fraud or unlawful business practices by the company and its officers [1] - Inspire Medical Systems announced a reduction in its full-year revenue outlook and diluted net income per share for 2025, attributing this to slower-than-expected progress in the commercial launch of its next generation Inspire V neurostimulation system [3] - Following the announcement, Inspire's stock price experienced a significant decline of $42.04 per share, or 32.35%, closing at $87.91 per share on August 5, 2025 [4] Financial Performance - Inspire's revised full-year revenue outlook is now projected to be between $900 million and $910 million, down from the previous guidance of $940 million to $955 million [3] - The diluted net income per share has been adjusted to a range of $0.40 to $0.50, compared to the earlier forecast of $2.20 to $2.30 [3] Legal Context - The investigation by Pomerantz LLP highlights concerns regarding the company's compliance with securities regulations and the potential impact on investors [1][5] - Pomerantz LLP has a history of handling corporate, securities, and antitrust class litigation, indicating the seriousness of the claims being investigated [5]

Core Viewpoint - Inspire Medical Systems, Inc. is under investigation for possible securities fraud following a significant downward revision of its financial guidance, which has led to a substantial decline in its stock price [1][3][4] Financial Performance - On August 4, 2025, Inspire Medical revised its full-year revenue guidance to a range of $900 million to $910 million, down from a previous estimate of $940 million to $955 million [3] - The expected diluted net income per share was also reduced to $0.40 to $0.50, compared to the prior guidance of $2.20 to $2.30 [3] - The company attributed this revision to slower-than-expected progress in the commercial launch of its next-generation Inspire V neurostimulation system [3] Stock Market Reaction - Following the announcement of the revised financial outlook, Inspire's stock price fell by $42.04 per share, approximately 32.35%, closing at $87.91 on August 5, 2025 [4]

Core Viewpoint - Inspire Medical Systems has lowered its full-year revenue forecast for 2025, expecting sales to be between $900 million and $910 million, down from a previous estimate of $940 million to $955 million, with adjusted EPS projected between $0.40 and $0.50, significantly lower than the earlier forecast of $2.20 to $2.30 [2][3] Financial Performance - In Q2 2025, Inspire reported revenue of $217.1 million, a year-on-year increase of 10.8%, exceeding analyst expectations of $214.3 million. However, the company recorded a net loss of $3.6 million, a decline from a net profit of $9.8 million in the same period of 2024, primarily due to increased operating expenses and one-time costs [4] - Operating expenses for the quarter reached $185.7 million, a 15% increase year-on-year, while the gross margin was 84.0%, slightly down by 0.8 percentage points compared to the previous year [4] Inventory and Product Transition - As of June 30, the company's inventory stood at $121.6 million, up from $80.1 million at the end of the previous year, indicating transitional inventory pressure between Inspire IV and Inspire V [5] Product Development - Inspire Medical's core product, the Inspire neurostimulation system, is designed for treating moderate to severe obstructive sleep apnea (OSA) patients who cannot tolerate CPAP therapy. The system includes components that stimulate the hypoglossal nerve to prevent airway collapse during sleep [6][8] - Inspire V, the latest iteration of the product, received FDA approval in 2024 and has been launched in the U.S. However, market conversion has been slower than expected, impacting the company's financial performance [12] Legal and Competitive Challenges - The company incurred $1.7 million in legal expenses during the quarter, partly related to a civil investigation by the U.S. Department of Justice and a patent infringement lawsuit against competitor Nyxoah [13] - Inspire Medical emphasizes that these legal costs are temporary and do not reflect core operational performance. The company plans to enhance clinical data accumulation and improve market education to boost commercialization [15] Company Overview - Inspire Medical Systems, based in Minneapolis, Minnesota, focuses on OSA treatment and is the first company to achieve non-CPAP treatment through neurostimulation. Since product approval, over 100,000 patients have been treated globally [16] - The company has established over 1,435 implantation centers and 335 sales territories in the U.S. and has received regulatory approvals in Europe, Japan, and other regions. In 2024, the company reported annual revenue of $803 million, with a compound annual growth rate exceeding 60% [16] - Despite a slowdown in growth for 2025, the company remains focused on product conversion efficiency, international market expansion, and physician education to drive the penetration of Inspire V [16][17]

Core Insights - Inspire Medical Systems reported second-quarter earnings of 45 cents per share, exceeding analyst consensus estimates of 21 cents per share, with quarterly sales of $217.086 million, also surpassing the consensus estimate of $214.480 million [1][2] Financial Guidance - The company lowered its FY2025 GAAP EPS guidance from a range of $2.20-$2.30 to $0.40-$0.50 and reduced sales guidance from $940 million-$955 million to $900 million-$910 million [2] Product Launch and Market Reaction - The full launch of the FDA-cleared Inspire V system in the U.S. is highlighted as a significant milestone, with positive feedback from surgeons and patients regarding the simplified procedure and patient outcomes [3] - Following the earnings announcement, Inspire Medical Systems shares fell by 40.6%, trading at $77.14 [3] Analyst Ratings and Price Targets - Multiple analysts adjusted their price targets for Inspire Medical Systems post-earnings, with JP Morgan downgrading from Overweight to Neutral and lowering the target from $195 to $110, while Stifel maintained a Hold rating with a target reduction from $175 to $140 [4][6] - Piper Sandler maintained an Overweight rating but reduced the price target from $233 to $150, and RBC Capital kept an Outperform rating with a target cut from $215 to $180 [6] - UBS maintained a Buy rating with a target decrease from $270 to $230, while Wells Fargo lowered its Equal-Weight rating target from $174 to $101 [6] - Lake Street maintained a Buy rating with a target reduction from $270 to $150, and Truist Securities downgraded from Buy to Hold with a target cut from $190 to $125 [6]

ATLANTA, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Inspire Medical Systems, Inc. (“Inspire Medical” or the “Company”) (NYSE: INSP) complied with federal securities laws. On August 4, 2025, Inspire Medical announced second quarter 2025 results and updated its 2025 outlook, stating that “the U.S. commercial launch is progressing slower than expected, and the timeline to complete the full transition to Inspire V has been pushed forward, which will impact financial results ...

Core Insights - Inspire Medical Systems, Inc. (INSP) reported an earnings per share (EPS) of 45 cents for Q2 2025, reflecting a year-over-year increase of 40.6% and exceeding the Zacks Consensus Estimate by 104.6% [1][10] - The company's revenues reached $217.1 million in Q2 2025, marking a 10.8% increase year-over-year and surpassing the Zacks Consensus Estimate by 0.9% [2][10] Revenue Analysis - U.S. revenues amounted to $207.2 million, up 10.3% from the same quarter last year, while revenues from all other countries totaled $9.9 million, representing a 23% year-over-year increase [4][5] - The overall revenue growth was attributed to increased market penetration and heightened awareness among physicians and patients regarding the Inspire system, although this was partially offset by capacity constraints among ENT surgeons and delays in therapy adoption by some U.S. patients and physicians [3][10] Margin and Expense Overview - Gross profit for Q2 2025 increased by 9.9% year-over-year to $182.4 million, but the gross margin contracted by 74 basis points to 84% [6][10] - Selling, general, and administrative expenses rose by 20.8% year-over-year to $159.5 million, while research and development expenses decreased by 9.2% to $26.2 million [6] Financial Position - As of the end of Q2 2025, Inspire Medical had cash and cash equivalents and short-term investments totaling $300.9 million, down from $369.2 million at the end of Q1 2025 [8] - The cumulative net cash used in operating activities was $4 million, compared to net cash provided of $8.8 million in the previous year [8] Outlook and Guidance - The company has revised its revenue outlook for 2025 to a range of $900 million to $910 million, down from a previous estimate of $940 million to $955 million [11] - EPS guidance for 2025 has also been lowered to between 40 cents and 50 cents, significantly down from the prior forecast of $2.20 to $2.30 [12] Market Reaction - Following the earnings report, shares of Inspire Medical experienced a decline of nearly 24.9% in pre-market trading [3]

Inspire Medical Systems (INSP) came out with quarterly earnings of $0.45 per share, beating the Zacks Consensus Estimate of $0.22 per share. This compares to earnings of $0.32 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +104.55%. A quarter ago, it was expected that this maker of devices for treating obstructive sleep apnea would post a loss of $0.23 per share when it actually produced earnings of $0.1, delivering a surpris ...

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 [24] - U.S. revenue was $207.2 million, a 10% increase from $187.8 million in the prior year [24] - Gross margin decreased to 84% from 84.8% year over year, primarily due to a $2.1 million charge for excess INSPIRE IV subcomponents [24] - Operating loss for the quarter was $3.3 million compared to an operating income of $5.1 million in the prior year [26] - Net loss for the quarter was $3.6 million, compared to a net income of $9.8 million in the prior year [26] - Adjusted EBITDA for the quarter was $44.1 million, a 14% increase compared to $38.7 million in the prior year [27] - Adjusted net income per share increased by 40% year over year to $0.45 [27] Business Line Data and Key Metrics Changes - The majority of units sold in Q2 were INSPIRE IVs, leading to minimal inventory destocking [10] - Over 50% of U.S. centers have completed the implementation of SleepSync, which is crucial for the transition to INSPIRE V [9] - The company is experiencing a 20% increase in patient implants at U.S. centers that have transitioned to INSPIRE V compared to the same period in 2024 [15] Market Data and Key Metrics Changes - Revenue outside the U.S. was $9.9 million, a 23% increase year over year [24] - The approval of CPT code 64568 for INSPIRE V for Medicare patients was announced in April, with billing starting on July 1 [11] - The national average Medicare hospital reimbursement for CPT code 64568 is proposed to increase to $32,000, a 4% increase from 2024 [17] Company Strategy and Development Direction - The company is focused on transitioning customers to INSPIRE V and has ramped up marketing and footprint expansion efforts in the second half of the year [12][13] - The company aims to drive high-quality patient flow and increase provider capacity through training and certification of additional surgeons [21] - The company has become a corporate champion of the American Academy of Otolaryngology, enhancing its brand and trust within the ENT community [18] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in the commercial rollout of INSPIRE V, including delays in training and implementation at centers [7] - The company adjusted its full-year revenue guidance to a range of $900 million to $910 million, reflecting a 4% reduction at the midpoint [14] - Management expressed confidence in overcoming current headwinds and achieving long-term growth [21] Other Important Information - The company ended the quarter with $411 million in cash and investments, allowing it to focus on executing growth strategies [28] - A personnel announcement was made regarding the retirement of Randy Bann, Executive Vice President, Patient Access and Therapy Awareness, in January 2026 [19][20] 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 affecting guidance [34][35] Question: What is the expectation for revenue growth in 2026? - Management expects revenue growth to exceed the 12% to 13% guidance for FY 2025 [37] Question: Can you clarify the EPS guide change? - The reduction in EPS guidance is primarily due to lower revenue expectations and increased marketing costs [41][42] Question: What is the status of the Q3 guidance? - Management anticipates a 1% to 3% sequential increase in Q3 revenue based on patient flow trends [46] Question: What are the underlying volume trends and pressures? - Management noted that the transition to INSPIRE V and the ability to bill Medicare are key factors affecting volume trends [54][55] Question: How is the company addressing the increase in accounts receivable? - The increase is attributed to a transition to a new billing service, which caused temporary delays in invoicing [77] Question: What is the outlook for the fourth quarter? - Management expects a seasonal increase in revenue from Q3 to Q4, consistent with historical trends [96]

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]

Company Overview - Inspire Medical Systems has an underpenetrated U S market exceeding $10 billion[7,9,26] - The company achieved over $800 million in revenue in 2024, demonstrating a 28% year-over-year growth[7,10] - Inspire therapy has established reimbursement in all 50 U S states, covering over 300 million lives[7,9] - Over 100,000 patients have received Inspire therapy, highlighting a significant first-mover advantage[7,8,9,33] Financial Performance & Growth Strategy - The company projects FY2025 revenue between $900 million and $910 million, representing a 12%-13% growth over FY2024[65] - The gross margin for FY2025 is expected to be between 84% and 86%[65] - Inspire initiated the full launch of the Inspire V system in the U S in May 2025[70,71] - Second quarter revenue reached $217 1 million, an 11% increase year-over-year, with a gross margin of 84%[70] Therapy & Market - Inspire therapy demonstrates a median Apnea-Hypopnea Index (AHI) reduction from 33 0 events/hr at baseline to 10 2 events/hr at 12 months[43] - Inspire patients reported a median Epworth Sleepiness Scale (ESS) score reduction from 11 0 at baseline to 6 0 at the 12-month visit[44] - 91% of patients say Inspire is better than CPAP, and 93% would recommend Inspire to a friend or family member[46]