MINNEAPOLIS, Aug. 26, 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, announced today that its Chief Financial Officer, Rick Buchholz, will be stepping down from his current position with the Company, effective December 31, 2025, in order to pursue other professional opportunities. Buchholz will remain employed wit ...

Core Viewpoint - The healthcare sector is highlighted as a critical area in the stock market, driven by the need for innovative therapies and medical technologies to address an aging population and rising chronic diseases. There are ten under-the-radar healthcare stocks identified as potential investment opportunities. Group 1: Company Highlights - **Certara**: Positioned to benefit from AI-driven transformations in medicine, providing bio-simulation software that accelerates drug development, with over 90% of novel drugs approved by the FDA since 2014 utilizing its technology [3][4]. - **Beam Therapeutics**: A clinical-stage biotech focusing on precision gene editing therapies for genetic diseases, with its lead candidate in phase 1/2 trials for sickle cell disease, showing promise for long-term growth [5][6]. - **Inspire Medical Systems**: Develops implantable devices for obstructive sleep apnea, reporting a 23% year-over-year revenue increase to $201 million, indicating strong market demand [8]. - **Insulet**: Specializes in tubeless insulin pump technology, targeting a revenue growth of 19% to 22% by 2025, with significant expansion opportunities in international markets [9]. - **Krystal Biotech**: Focuses on rare skin diseases, with its gene therapy expected to generate approximately $400 million in revenue this year, reinforcing its market position [10]. - **LifeMD**: Operates a telehealth platform with a 49% year-over-year revenue increase, driven by a partnership with Novo Nordisk, indicating potential for further growth [11]. - **Option Care Health**: Leading provider of home infusion services, positioned to benefit from the shift towards personalized healthcare [12]. - **Tempus AI**: Utilizes AI for precision medicine, projecting over 80% revenue growth this year to about $1.3 billion, highlighting its expansive data ecosystem [13]. - **TransMedics Group**: Innovates in organ transplantation with its FDA-approved Organ Care System, projecting a 30% revenue growth this year [14][15]. - **Veeva Systems**: Offers cloud-based software for life sciences, serving over 1,000 customers and positioned to capitalize on the industry's digital transformation [16].

Core Insights - Inspire Medical Systems, Inc. is a medical technology company specializing in innovative, minimally invasive solutions for obstructive sleep apnea [1][3] - The company will present at the Truist Securities MedTech Conference on June 17, 2025, at 11:20 a.m. Eastern Time, with a live webcast available [1][2] Company Overview - Inspire's proprietary Inspire therapy is the first and only FDA, EU MDR, and PDMA-approved neurostimulation technology for treating moderate to severe obstructive sleep apnea [3] - The company focuses on the development and commercialization of its innovative solutions [3]

Core Insights - Inspire Medical Systems, Inc. is participating in the Wells Fargo 2025 MedTech Innovation Spotlight on June 13, 2025 [1][2] - The company specializes in minimally invasive solutions for obstructive sleep apnea, with its proprietary Inspire therapy being the first and only FDA, EU MDR, and PDMA-approved neurostimulation technology for this condition [3] Company Overview - Inspire Medical Systems focuses on the development and commercialization of innovative solutions for patients suffering from obstructive sleep apnea [3] - The Inspire therapy offers a safe and effective treatment option for moderate to severe obstructive sleep apnea [3] Presentation Details - The presentation by Inspire is scheduled for 12:00 p.m. Eastern Time and will be accessible via a live webcast [2] - A replay of the presentation will be available for two weeks in the Event Archive section of Inspire's Investor website [2]

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]

Core Insights - Inspire Medical Systems, Inc. is a medical technology company specializing in minimally invasive solutions for obstructive sleep apnea [3] - The company will present at the BofA Securities 2025 Health Care Conference on May 13, 2025, at 2:20 p.m. Eastern Time [2] - Inspire's proprietary therapy is the first and only FDA, EU MDR, and PDMA-approved neurostimulation technology for treating moderate to severe obstructive sleep apnea [3] Company Information - Inspire focuses on the development and commercialization of innovative solutions for obstructive sleep apnea [3] - The company’s Inspire therapy is recognized for its safety and effectiveness in treating the condition [3] - Additional information about Inspire can be found on their official website [3]

Company Overview - Inspire Medical Systems, Inc. is a medical technology company focused on developing and commercializing innovative, minimally invasive solutions for patients with obstructive sleep apnea [3]. - The company's proprietary Inspire therapy is the first and only FDA, EU MDR, and PDMA-approved neurostimulation technology that provides a safe and effective treatment for moderate to severe obstructive sleep apnea [3]. Upcoming Presentation - Inspire is scheduled to present at the KeyBanc Capital Markets Healthcare Forum on March 18, 2025, at 3:00 p.m. Eastern Time [2]. - The presentation will be accessible via a live webcast, with a replay available for two weeks following the event in the Event Archive section of Inspire's Investor website [2].