Core Insights - Orchestra BioMed is focused on executing the BACKBEAT global pivotal study, which aims to establish AVIM therapy as a new standard of care for uncontrolled hypertension in pacemaker patients [2][5] - The company is also preparing to initiate a U.S. coronary pivotal study for the Virtue SAB program, with an updated trial design currently under FDA review [2][5] - The company is entering a formal mediation process with Terumo to resolve partnership negotiations, aiming for a resolution in the second quarter of 2025 [2][5] Financial Results for 2024 - Cash and cash equivalents and marketable securities totaled $66.8 million as of December 31, 2024 [10] - Revenue for 2024 was $2.6 million, a decrease from $2.8 million in 2023, primarily due to reduced partnership revenues from Terumo [10] - Research and development expenses increased to $42.8 million in 2024 from $33.8 million in 2023, driven by costs associated with the BACKBEAT study [10] - The net loss for 2024 was $61.0 million, or ($1.66) per share, compared to a net loss of $49.1 million, or ($1.48) per share, in 2023 [10][17] Product Development and Partnerships - AVIM therapy has shown promising results in pilot studies, with net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure at six months [8] - Virtue SAB is designed to deliver an extended-release formulation of sirolimus during balloon angioplasty without the need for a coating on the balloon surface [9] - The FDA has granted Breakthrough Device designation to Virtue SAB for specific indications, enhancing its development prospects [11] Leadership and Governance - The board of directors has been enhanced with the appointment of three experienced independent directors, including former executives from Medtronic and Siemens [5] - Mark Pomeranz has been appointed as Executive Vice President & General Manager, bringing over two decades of experience in medical devices [5]

Core Viewpoint - Avanos Medical, Inc. has appointed David Pacitti as the new CEO, effective April 14, 2025, to lead the company in its next phase of growth and success [1][3]. Company Overview - Avanos Medical is a medical technology company headquartered in Alpharetta, Georgia, focused on delivering clinically superior medical device solutions to improve patient quality of life [6]. - The company addresses critical healthcare needs, including providing nutrition support and reducing opioid use during patient recovery [6]. Leadership Background - David Pacitti has a distinguished career in the healthcare sector, previously serving as president of Siemens Medical Solutions USA and Head of the Americas for Siemens Healthineers, where he drove strategic growth and operational excellence [2][3]. - Prior to Siemens, Pacitti held leadership roles at Abbott Vascular, overseeing significant product launches and commercial operations [3]. Strategic Vision - Pacitti expressed his commitment to building on Avanos' success and driving long-term value for stakeholders, emphasizing the company's strong portfolio of market-leading products [5].

Market Overview - The global ultrasound image analysis software market is estimated to be USD 0.913 billion in 2024 and is expected to reach USD 2.20 billion by 2035, with a CAGR of 8.34% during the forecast period 2025-2035 [1][17]. Technological Advancements - The market growth is driven by advancements in ultrasound technology, particularly in image processing and AI-powered analysis, including developments such as 3D and 4D imaging, elastography, and Doppler imaging [4]. - These technological improvements enhance image quality, automate measurements, and enable real-time visualization, leading to increased demand for sophisticated ultrasound image analysis software [4][5]. Regional Insights - North America is anticipated to have the highest revenue share during the forecast period due to its well-established healthcare infrastructure and high adoption of advanced imaging technologies [6]. - The Asia Pacific region is predicted to grow at the fastest CAGR, driven by an expanding healthcare sector, increasing government investments, and rising prevalence of chronic diseases in emerging markets like China and India [7]. Market Segmentation by Type - The integrated software segment accounted for the highest revenue in 2024, driven by the adoption of comprehensive diagnostic solutions that enhance workflow efficiency [8]. - The standalone software segment is expected to grow at the fastest CAGR, catering to specific clinical needs in smaller clinics and diagnostic centers [9]. Market Segmentation by Product - The Doppler imaging segment accounted for the highest revenue in 2024, widely used in vascular imaging, obstetrics, and cardiology [10]. - The 3D & 4D ultrasound systems segment is predicted to grow at the fastest CAGR due to its advanced imaging capabilities [11]. Market Segmentation by Application - The cardiology segment accounted for the highest revenue in 2024, driven by the increasing prevalence of cardiovascular diseases [12]. - The oncology segment is expected to grow at the fastest CAGR, leveraging advanced image analysis tools for cancer detection and monitoring [13]. Market Segmentation by End-User - The hospitals segment accounted for the highest revenue in 2024, attributed to high patient volume and advanced infrastructure [14]. - The diagnostic centers segment is predicted to grow at the fastest CAGR, driven by the demand for quick and accurate diagnostic solutions [16].

Financial Data and Key Metrics Changes - In Q4 2024, consolidated revenue was $150.4 million, down 3.8% year-over-year. For the full year, consolidated revenue declined 8.8% to $572.5 million compared to $627.6 million in 2023 [31][33]. - Adjusted gross margin for Q4 was 49.6%, up from 48.8% in the same period last year. For the full year, non-GAAP gross margin improved by 100 basis points to 49.2% [35][36]. - GAAP net loss for Q4 was $41.9 million, or $0.59 per diluted share, compared to a net loss of $15 million, or $0.22 per diluted share, in the same period last year [39]. Business Line Data and Key Metrics Changes - Product revenue in Q4 fell by 4.8% to $105.1 million, with systems revenue down 1.5% to $46.7 million. Consumable revenue decreased by 7.3% to $58.4 million [31][32]. - For the full year, product revenue was $392 million, down from $433.7 million in 2023. Consumables revenue increased by 2.3% to $251.7 million [33][34]. Market Data and Key Metrics Changes - The company generated 36% of its revenues from manufacturing in 2024, up from 34% in 2023, indicating a shift towards end-part manufacturing [10]. - The dental market opportunity is projected to reach nearly $2.5 billion by 2028, with significant interest in the TrueDent resin [23][79]. Company Strategy and Development Direction - The company is focused on enhancing its leadership in additive manufacturing and is committed to right-sizing the business while maintaining R&D resources [9][51]. - The strategy includes a focus on high-value applications, particularly in manufacturing and the dental sector, with plans to expand its product offerings and customer base [10][80]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about future growth despite current macroeconomic challenges, emphasizing the long-term value proposition of additive manufacturing [56][108]. - The outlook for 2025 anticipates revenue in the range of $570 million to $585 million, with expectations for sequential growth throughout the year [45]. Other Important Information - The company ended Q4 with $150.7 million in cash and equivalents, with no debt, providing a stable financial position to support growth initiatives [12][44]. - A $120 million investment from Fortissimo Capital is expected to close in Q2 2025, which will further strengthen the company's financial position [13][44]. Q&A Session Summary Question: Market conditions and revenue cadence for 2025 - Management acknowledged current downturns but highlighted strong customer engagement and a focus on reliability and effectiveness of equipment as key areas of customer interest [56][58]. Question: Gross margin guidance for 2025 - Management indicated that gross margins are expected to remain stable, with improvements anticipated as cost-saving measures take effect [62][64]. Question: Organic revenue growth and FX impacts - Management noted minimal impact from divestitures and hedging strategies in place to mitigate FX risks [75][76]. Question: Consumables revenue decline - Management described Q4 as an outlier and expressed confidence in a rebound in consumables revenue for 2025 [88]. Question: Acquisition targets and strategy - Management emphasized a clear strategy focused on shareholder value and indicated interest in opportunities that align with their long-term goals [97][102]. Question: Market verticals with confidence - Management identified dental, aerospace, and tooling as key verticals with growth potential, while remaining cautious about overall market conditions [112][113].

Stratasys Ltd. (NASDAQ:SSYS) Q4 2024 Earnings Conference Call March 5, 2025 8:30 AM ET Company Participants Yonah Lloyd - Chief Communications Officer and Vice President, Investor Relations Yoav Zeif - Chief Executive Officer Eitan Zamir - Chief Financial Officer Conference Call Participants Greg Palm - Craig-Hallum Troy Jensen - Cantor Fitzgerald Jim Ricchiuti - Needham & Company Ananda Baruah - Loop Capital Markets Operator Greetings, and welcome to the Stratasys Q4 2024 Earnings Conference Call and Webca ...