Hyperfine (NasdaqGM:HYPR) Q3 2025 Earnings Call November 13, 2025 04:30 PM ET Speaker2Good afternoon and welcome to Hyperfine's Third Quarter 2025 Earnings Conference Call. Currently, all participants are in a listen-only mode. We will be facilitating a question-and-answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Webb Campbell from Gill Martin Group for introductory disclosure.Speaker0Thank you for join ...

Core Insights - The eighth China International Import Expo (CIIE) has commenced in Shanghai, showcasing multinational medical device companies accelerating their localization efforts in China [2][3] - Boston Scientific has exhibited four unreleased products at the expo, all set to be produced at its Shanghai Lingang factory, marking a significant step in its localization journey [3][5] Localization Strategy - Boston Scientific's localization journey has progressed through three stages: from being an importer, to outsourcing production to local firms, and now establishing its own manufacturing facility in China [5][7] - The company has leveraged the Medical Device Registration Holder (MAH) system to facilitate local production, with the Polaris intravascular ultrasound system being a key milestone in this process [5][6] Recent Developments - In 2023, Boston Scientific made a strategic investment in Chinese medical device company Xianruida, enhancing its integration into the local supply chain and expanding its market reach [6][10] - The new factory in Lingang is designed to meet high standards and aims to become a leading smart factory for Boston Scientific globally, with plans for future expansion [6][7] Product Launches - By October 2024, the Lingang factory is expected to be operational, with four innovative products already in the pipeline for production, including the OptiCross/OptiCross HD catheter [9][12] - The AVVIGO+ intravascular ultrasound system, a complex machine developed with significant input from the Chinese team, is set to be one of the first products to be produced locally [12][14] Market Potential - The Chinese market is viewed as highly attractive due to its vast patient demand and the advantages of a local supply chain, which enhances efficiency and innovation [10][15] - Boston Scientific aims to better serve local markets and meet patient needs through its ongoing localization efforts, which are seen as a driving force for the company's growth in China [15]

Core Viewpoint - Recent announcements from global medical device giant Medtronic and pharmaceutical giant Samsung Biologics regarding their new spin-off plans aim to focus on high-growth areas and seek greater recognition from capital markets [1][2]. Group 1: Medtronic's Spin-off - Medtronic announced on May 21 that it will spin off its diabetes business into an independent company, with the stock price dropping over 4% following the announcement [1][2]. - The diabetes business has shown strong performance, maintaining double-digit growth for six consecutive quarters and holding a 70% global market share in insulin pumps as of 2022 [2]. - The diabetes segment accounted for 8% of Medtronic's total revenue and 4% of its operating profit in fiscal year 2025, with over 8,000 employees globally [2]. - The spin-off is expected to immediately enhance profitability and overall profit margins, allowing Medtronic to focus on high-growth areas such as surgical robotics [2][3]. Group 2: Samsung Biologics' Spin-off - Samsung Biologics announced on May 22 that it will spin off its biosimilar drug business to concentrate resources on its contract development and manufacturing organization (CDMO) sector, which has higher technical barriers and more stable profit margins [2][4]. - The CDMO division is projected to contribute approximately 75% of the company's total revenue by 2024, with a market capitalization nearing 80 trillion KRW (approximately $56.8 billion) [4]. - The spin-off aims to mitigate potential conflicts of interest as the CDMO business expands, addressing client concerns about the use of proprietary information in producing biosimilars [4]. Group 3: Industry Trends and Investor Influence - The trend of spin-offs in the medical sector is increasingly driven by activist investors, as seen in the case of Becton Dickinson's recent decision to split its life sciences division, following pressure from hedge fund Starboard Value [5][6]. - Analysts estimate that Becton Dickinson's valuation could increase by up to 30% post-split, highlighting the impact of activist investors on corporate restructuring [5]. - Activist investors are seen as catalysts for change, pushing companies to invest in promising R&D projects or divest unprofitable segments, although they can also introduce chaos into corporate management [5][6].

Group 1 - The Hong Kong pharmaceutical sector is experiencing a strong performance, with the CSI Hong Kong Stock Connect Medical Theme Index rising by 1.93% on May 20, 2023 [1] - Notable stock performances include CSPC Pharmaceutical Group increasing over 8%, and other companies like Sinopharm, Hansoh Pharmaceutical, and others rising over 6% [1] - The Hong Kong Medical ETF (159366) also saw a rise of 2.33%, with a trading volume of 10.5768 million yuan, reflecting the overall performance of listed companies in the medical field [1] Group 2 - Haitong International predicts a significant turning point for the Hong Kong medical industry by 2025, driven by stricter regulatory policies and accelerated review and approval processes for innovative drugs and medical devices [2] - The implementation of the "filing system" for medical representatives and the "licensing system" for doctors is expected to shift marketing behaviors towards compliance and academic focus, increasing the demand for digital marketing, with the digital medical marketing market projected to reach 20-40 billion yuan by 2025 [2] - The approval of 48 innovative drugs and 65 innovative medical devices by the National Medical Products Administration in 2024 is anticipated to boost the number of new products and drive industry innovation [2] Group 3 - Guosen Securities also anticipates a significant turning point for the Hong Kong medical industry by 2025, driven by policy incentives and breakthroughs in innovative technologies [3] - The acceleration of the review and approval process for innovative drugs and medical devices is expected to further enhance industry innovation, with 48 innovative drugs and 65 innovative medical devices approved in 2024 [3] - The deepening application of AI technology in the medical field, supported by policies for the construction of innovative platforms, is expected to significantly improve industry efficiency, particularly in cost reduction and precision medicine [3]