MINNEAPOLIS, Oct. 10, 2025 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (NYSE: INSP) (Inspire), a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea (OSA), today published Inspire V clinical outcomes data from its Singapore clinical study as well as the Company’s limited market release in the United States including single site experience at two leading centers. These data will be presented at ...

Core Viewpoint - The Schall Law Firm is investigating Inspire Medical Systems, Inc. for potential violations of securities laws following a significant drop in share price due to disappointing earnings and operational delays [1][2]. Group 1: Company Performance - Inspire Medical Systems reported Q2 earnings on August 4, 2025, which included a lowered full-year revenue guidance [2]. - The company disclosed delays in the rollout of its "Inspire V" system, as treatment centers postponed adoption due to billing issues with Medicare [2]. - Following the announcement, shares of Inspire fell by almost 40.6% in intraday trading on August 5, 2025 [2]. Group 2: Legal Investigation - The investigation by the Schall Law Firm focuses on whether Inspire issued false or misleading statements or failed to disclose important information to investors [2]. - The firm is representing investors who may have suffered losses and is encouraging them to participate in the investigation [3].

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]

Financial Data and Key Metrics Changes - The company reported revenue of $201.3 million for Q1 2025, a 23% increase compared to $164 million in Q1 2024 [19] - Net income for the quarter was $3 million, translating to diluted net income of $0.10 per share, compared to a net loss of $10 million or $0.34 per share in the prior year [12][21] - Adjusted EBITDA totaled $33.2 million, representing a 16% adjusted EBITDA margin, compared to $11.9 million and 7% in Q1 2024 [21] - The company reiterated its full-year 2025 revenue guidance of $940 million to $955 million, indicating a growth of 17% to 19% year-over-year [12][22] Business Line Data and Key Metrics Changes - The U.S. revenue for the quarter was $193.6 million, a 24% increase from $155.8 million in the prior year [19] - Revenue outside the U.S. was $7.7 million, reflecting a 6% decrease year-over-year [19] Market Data and Key Metrics Changes - The company noted that European revenue in Q1 2024 benefited from pent-up demand due to supply shortages, which impacted year-over-year comparisons [19] Company Strategy and Development Direction - The company is focused on expanding the limited market release of the Inspire V system and is preparing for a full launch in the U.S. [10][11] - The Inspire V system incorporates advanced sensing capabilities, which are expected to enhance therapy and patient outcomes [11][90] - The company plans to increase investments in medical education and marketing to drive awareness and adoption of Inspire therapy [17][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand for Inspire therapy, noting that patient flow remains strong despite a transition period for the new system [42][41] - The second quarter is expected to be a transition quarter, with revenue growth anticipated in the mid to high single digits sequentially [14][22] - Management is optimistic about a strong second half of 2025 as the full launch of Inspire V progresses [14][22] Other Important Information - The company has appointed two new Vice Presidents and Senior Medical Directors to enhance its medical education and training efforts [8] - The transition to CPT code 64568 has been incorporated into policies covering approximately 80% of the covered lives, which is expected to facilitate reimbursement [15] Q&A Session Summary Question: What happened with the Q2 revenue guidance and the destock? - Management indicated that increased patient awareness and the transition to Inspire V led to some patient warehousing, affecting Q2 revenue guidance [28] Question: How confident is the company about Inspire IV inventories in the marketplace? - Management stated they have close knowledge of existing inventories and expect high-volume centers to work through their Inspire IV inventory quickly [36] Question: How should investors think about the balance of restocking and pent-up demand? - Management emphasized strong patient outcomes and continued growth in the number of implants, which supports confidence in the second half of the year [41] Question: What is the company's confidence in the manufacturing and reimbursement for Inspire V? - Management expressed confidence in the device's performance and the manufacturing processes, noting that the transition to the new system is well-prepared [50] Question: What is the expected timeline for the transition to Inspire V? - Management reiterated that they expect to complete the transition by the end of the year, with a focus on high-volume centers first [115] Question: How is the marketing strategy for Inspire V evolving? - The company plans to step up direct-to-consumer marketing efforts to increase awareness and educate potential patients about Inspire V [121]

Financial Data and Key Metrics Changes - The company reported revenue of $201.3 million for Q1 2025, a 23% increase compared to $164 million in Q1 2024 [10][17] - Net income for the quarter was $3 million, translating to diluted net income of $0.10 per share, compared to a net loss of $10 million or a loss of $0.34 per share in the same period last year [10][19] - Adjusted EBITDA was $33.2 million, representing a 16% margin, up from $11.9 million and a 7% margin in Q1 2024 [19] - The company ended the quarter with $414 million in cash and investments, despite a reduction due to $75 million in share repurchases [20] Business Line Data and Key Metrics Changes - The U.S. revenue for the quarter was $193.6 million, a 24% increase from $155.8 million in the prior year [17] - Revenue outside the U.S. was $7.7 million, reflecting a 6% decrease year-over-year, attributed to prior pent-up demand from supply shortages [17] Market Data and Key Metrics Changes - The company is expanding the limited market release of the Inspire V system in the U.S. and is preparing for a full launch [9][10] - The transition to CPT code 64568 has been incorporated into policies covering approximately 80% of the 300 million covered lives, including commercial payers and Medicare [13] Company Strategy and Development Direction - The company aims to drive high-quality patient flow and increase provider capacity through the addition of advanced practice providers and certified surgeons [16] - A focused patient marketing and education program will be initiated to promote the Inspire V system, with an emphasis on digital scheduling tools [14][15] - The company plans to submit for regulatory approval of the Inspire V system in Europe and Asia this year while continuing to provide the Inspire IV system during the review process [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the full-year revenue guidance of $940 million to $955 million, representing a 17% to 19% growth year-over-year [10][20] - The second quarter is expected to be a transition quarter with mid to high single-digit sequential revenue growth, followed by a strong second half of 2025 [12][20] - Management noted that the demand for Inspire therapy remains strong, with many patients waiting for the new device [12][39] Other Important Information - The company hosted over 300 physicians in Inspire programs during Q1, including training for new ENT residents and sleep fellows [15] - The Inspire V system incorporates new technical capabilities that will allow for future therapy enhancements, including sleep detection [9] Q&A Session Summary Question: What happened with the Q2 revenue guidance and the destock? - Management indicated that increased awareness of the Inspire V technology led to patient warehousing, affecting Q2 revenue expectations, but they expect to make up for this in Q3 and Q4 [26][27] Question: How confident is the company about Inspire IV inventories in the marketplace? - Management stated they have close knowledge of existing inventories and expect high-volume centers to work through their Inspire IV inventory quickly [32][33] Question: What is the company's confidence in the Inspire V launch regarding manufacturing and reimbursement? - Management expressed confidence in the device's performance and the manufacturing processes, noting that the transition to the new CPT code has been well received [45][48] Question: How does the company plan to onboard generalist ENTs during the full market launch? - The company plans to involve both academic and general practice ENTs in the training programs to ensure a smooth transition to Inspire V [60][61] Question: What is the expected impact of operating expenses on profitability? - Management indicated that they will continue to invest in operating expenses to drive revenue growth, with expectations for revenue to outpace operating expense growth [68] Question: How is the company addressing the lower professional fee associated with the new CPT code? - Management believes that the simplicity of the new procedure will outweigh the lower fee, and they are monitoring physician acceptance closely [72][74]

Core Insights - Inspire Medical Systems reported a year-over-year revenue growth of 23% in Q1 2025, reaching $201.3 million, compared to $164.0 million in Q1 2024 [4][11] - The company achieved a net income of $3.0 million in Q1 2025, a significant improvement from a net loss of $10.0 million in the same period last year [7][11] - Inspire surpassed 100,000 patients receiving its therapy and is set to launch the Inspire V system in the U.S. [3][4] Financial Performance - Revenue for Q1 2025 was $201.3 million, a 23% increase from $164.0 million in Q1 2024 [4][11] - U.S. revenue was $193.6 million, reflecting a 24% increase year-over-year, while international revenue decreased by 6% to $7.7 million [4] - Gross margin for Q1 2025 was 84.7%, slightly down from 84.9% in Q1 2024 [4] Operating Expenses and Profitability - Operating expenses increased by 11% to $172.1 million in Q1 2025, up from $154.5 million in the prior year, primarily due to investments in the U.S. sales organization [5] - The operating loss improved to $1.5 million in Q1 2025, compared to a loss of $15.2 million in Q1 2024, indicating better revenue growth and operating leverage [6] - Adjusted EBITDA for Q1 2025 was $33.2 million, compared to $11.9 million in the same quarter last year [7][26] Guidance and Future Outlook - Inspire maintains its full-year 2025 revenue guidance of $940 million to $955 million, representing a growth of 17% to 19% over 2024 [9] - The company has increased its diluted net income per share guidance for 2025 to between $2.20 and $2.30, up from the previous range of $2.10 to $2.20 [9]