Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In Inspire (INSP) To Contact Him Directly To Discuss Their Options If you purchased or acquired Inspire stock and would like to discuss your legal rights, call Bragar Eagel & Squire partner Brandon Walker or Marion Passmore directly at (212) 355-4648. Click here to participate in the action. NEW YORK, Oct. 03, 2025 (GLOBE NEWSWIRE) -- What’s Happening: Bragar Eagel & Squire, P.C., a nationally recognized ...

Core Insights - Inspire Medical Systems, Inc. is facing challenges in the commercial rollout of its new Inspire V system, impacting revenue growth in 2025 due to delays in onboarding treatment centers and reimbursement processes [2][3] - The company is experiencing increased competition from GLP-1 drugs, which are FDA-approved for weight management and obstructive sleep apnea treatment, leading to reduced demand for its implantable devices [3] - Inspire has revised its 2025 sales forecast to a range of $900–$910 million, with CEO Tim Herbert indicating that the slower U.S. commercial launch and transition to Inspire V will affect annual financial performance [3] Company Developments - Despite current challenges, Inspire Medical Systems' Board has authorized a $200 million share buyback plan, indicating confidence in the company's long-term prospects [4] - The company plans a marketing push and expansion of treatment centers in the second half of 2025, which could enhance procedure volumes and revenue growth into 2026 [4] - CFO Rick Buchholz announced plans to transition to an advisory role at year-end to ensure a smooth leadership transition [4]

Core Viewpoint - Nyxoah has filed a patent infringement lawsuit against Inspire Medical Systems, claiming that Inspire's devices infringe on three of its patents related to Obstructive Sleep Apnea treatment [1] Group 1: Company Overview - Nyxoah is a medical technology company focused on innovative solutions for treating Obstructive Sleep Apnea (OSA) [3] - The company's lead product is the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy for OSA [3] - Nyxoah aims to provide patients with restful nights and improve their quality of life [3] Group 2: Product and Market Position - The Genio system received its European CE Mark in 2019 and has recently gained FDA approval as a prescription-only device in August 2025 [4][5] - The company has completed two successful IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [4] - Positive outcomes from clinical studies, including the BETTER SLEEP study and the DREAM IDE pivotal study, have supported the expansion of therapeutic indications for the Genio system [4] Group 3: Legal Action - The lawsuit against Inspire Medical Systems was filed in the United States District Court for the District of Delaware, seeking injunctive relief and damages for patent infringement [1] - The patents in question are U.S. Patent Nos. 8,700,183, 9,415,215, and 9,415,216 [1] Group 4: Leadership and Commitment - Olivier Taelman, CEO of Nyxoah, emphasized the company's commitment to defending its intellectual property and providing a differentiated solution for OSA treatment [2] - The company has received positive feedback from physicians and patients following the U.S. commercial launch of the Genio system [2]

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Inspire Medical Systems, Inc. for possible violations of federal securities laws and unlawful business practices following a significant reduction in the company's earnings guidance for fiscal 2025 [1][3]. Financial Performance - On August 5, 2025, Inspire reported better-than-expected second quarter results but drastically cut its full-year earnings guidance from $2.20 - $2.30 to $0.40 - $0.50, and revenue expectations from $940 million - $955 million to $900 million - $910 million [3]. - The company attributed the guidance reduction to challenges in the rollout of Inspire V, including training and onboarding issues, customer delays, and technical Medicare adoption delays [3]. Stock Market Reaction - Following the announcement of the revised guidance, Inspire's stock price dropped by $46.44, opening at $83.51 per share [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, 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]