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获批FDA!捷迈邦美新型膝关节植入物
思宇MedTech· 2025-03-13 03:59
报名:首届全球心血管大会 | 奖项报名倒计时 报名:首届全球骨科大会 | 奖项报名倒计时 2025年3月7日, 捷迈邦美Zimmer Biomet (纽约证券交易所代码:ZBH)宣布,其 Persona Revision SoluTion Femur(股骨)膝关节植入物组件 已获得美国食品药品监督管理局(FDA)的510(k)许可。 该组件是 Persona膝关节翻修系统(Persona Revision Knee System) 的一部分,为某些金属敏感的患者提 供了一种替代方案。它采用了一种专有的表面硬化处理技术,旨在提高耐磨性能。该产品为外科医生提供了一 系列解剖组件,包括胫骨和股骨锥,以及多种茎选择,以解决区域固定问题。 合作伙伴征集:2025全球手术机器人大会 报名:首届全球眼科大会 | 暂定议程 # 产品介绍 皮肤金属过敏影响着10%-15%的普通人群,而带有金属植入物的患者中这一比例可能高达25%。当患者接 触到某些常用于金属膝关节植入物的金属时,可能会出现炎症反应、疼痛和植入物松动等问题。 而 Persona Revision SoluTion Femur膝关节植入物 是一款专为膝关节翻修手术 ...
ZBH Stock to Gain From Global Expansion Amid Difficult FX Scenario
ZACKS· 2025-03-12 17:20
Core Viewpoint - Zimmer Biomet (ZBH) is experiencing growth driven by strong procedural performance, effective execution, and innovation momentum, although the stock is facing challenges from a tough macroeconomic environment that has increased expenses [1] Group 1: Growth Factors - The company is focusing on strengthening its presence in both developed and emerging international markets, which are expected to provide long-term growth opportunities [2] - Strong revenue growth in the Asia Pacific market has been noted, supported by product launches and customer adoption [3] - The global musculoskeletal market has shown gradual stability, with improved sales growth in certain regions due to favorable demographics and increased healthcare utilization [4] Group 2: Financial Performance - In Q4 2024, Zimmer Biomet reported growth in large joints, with global sales for Knees, Hips, and S.E.T. increasing by 5.6%, 4%, and 8.4% respectively at constant exchange rates [5] - Over the past three months, ZBH shares have increased by 0.7%, while the industry has grown by 4.6% [6] Group 3: Challenges - Industry-wide staffing shortages and supply chain issues are negatively impacting growth [7] - High policy rates and geopolitical complications are affecting raw material and labor costs, as well as freight charges [8] - The company is facing reimbursement challenges in the Restorative Therapies business and acute supply challenges in Sports and Trauma, which are pressuring revenues and operating profits [8] Group 4: Cost and Margin Analysis - In Q4, the cost of products sold increased by 5.1%, and selling, general, and administrative expenses rose by 3.4%, leading to a contraction in adjusted gross margin by 123 basis points and adjusted operating margin by 43 basis points [9] - Projections indicate a 5.7% increase in the cost of products sold and a 4.2% rise in selling, general, and administrative expenses for 2025 [9] Group 5: Foreign Exchange Impact - A significant portion of Zimmer Biomet's revenues comes from Europe and Japan, where the strengthening U.S. dollar has adversely affected operations [10] - In 2024, net sales were impacted by a 1% decline due to foreign exchange rate changes, with expectations of a 1.5%-2% adverse impact on 2025 revenues [11]
Zimmer Biomet Highlights Diverse Portfolio of Orthopedic & Musculoskeletal Innovations at AAOS 2025 Annual Meeting
Prnewswire· 2025-03-10 11:30
Core Insights - Zimmer Biomet Holdings, Inc. is showcasing its diverse orthopedic and musculoskeletal innovations at the AAOS 2025 Annual Meeting, emphasizing its comprehensive hip portfolio and newly launched knee and upper extremities reconstructive technologies [1][2] Hip Reconstruction Technologies - The Z1™ Triple-Taper Femoral Hip System features a triple-taper design with extensive innovations aimed at providing more solutions for a wider range of patients [7] - The HAMMR® Automated Hip Impaction System is designed to reduce surgeon strain and fatigue during procedures [7] - The OrthoGrid Hip AI® technology offers AI-powered tools for intra-operative assistance in achieving optimal surgical outcomes [7] - The HipInsight™ System is the first FDA-cleared mixed reality system for hip navigation, utilizing Microsoft HoloLens 2 for real-time guidance [7] Knee Reconstruction Technologies - The Persona® Revision SoluTion™ Femur is a newly cleared revision knee implant component, providing an alternative for patients with sensitivities to certain metals [7] - The Oxford® Cementless Partial Knee is the only FDA-approved cementless partial knee implant in the U.S., known for its efficiency and longevity [7] - The Persona® OsseoTi® Keel Tibia is a cementless anatomic tibia designed for stable fixation and intra-operative versatility [7] - The Persona IQ® 30 mm Stem is the world's only smart knee implant that collects data for post-operative recovery insights [7] Upper Extremities Technology - The OsseoFit™ Stemless Shoulder System is designed for stable fixation by optimizing anatomic fit for stemless shoulder arthroplasty [5] ASC Solutions - The ZBX™ program offers a comprehensive ASC solution tailored to the needs of surgeons, enhancing efficiency in the operating room [6]
Zimmer Biomet Receives FDA Clearance for Persona® Revision SoluTion™ Femur
Prnewswire· 2025-03-07 12:30
Core Viewpoint - Zimmer Biomet Holdings, Inc. has received FDA 510(k) clearance for the Persona® Revision SoluTion™ Femur, a knee implant designed for patients with metal sensitivities, marking a significant advancement in the revision knee implant market [1][2]. Product Details - The Persona Revision SoluTion Femur is part of the Persona Revision Knee System and utilizes a proprietary surface-hardening treatment to enhance wear performance [1][2]. - This new implant is made from a proprietary Tivanium® (Ti-6Al-4V) alloy, which has over 17 years of clinical use, and is treated with the Ti-Nidium Surface Hardening Process to improve material strength and wear resistance [2][3]. - The implant will be available in standard and plus sizes to accommodate various patient needs, particularly addressing flexion instability and soft tissue balancing [2][3]. Market Context - Metal hypersensitivity affects 10-15% of the general population, with prevalence in patients with metallic implants reaching up to 25%, indicating a significant market need for alternatives to traditional metal implants [2][3]. - The Persona Revision SoluTion Femur is positioned as the first metal alternative option for patients with sensitivities to common metal allergens such as nickel, cobalt, and chromium [2][3]. Company Overview - Zimmer Biomet is recognized as a global leader in medical technology, focusing on maximizing mobility and improving health through innovative products and integrated digital technologies [3][4]. - The company has a legacy of over 90 years in the industry, emphasizing a culture of evolution and innovation to deliver high-quality solutions [4].
Zimmer Biomet Names Kristen Cardillo as Senior Vice President, Chief Communications Officer
Prnewswire· 2025-03-06 12:30
Core Insights - Zimmer Biomet Holdings, Inc. has appointed Kristen Cardillo as Senior Vice President and Chief Communications Officer, effective March 10, 2025, to enhance its global communications strategy and stakeholder engagement [1][2] Group 1: Appointment Details - Kristen Cardillo will report to President and CEO Ivan Tornos and is expected to amplify Zimmer Biomet's innovation narrative and strengthen brand engagement in the MedTech industry [2] - Cardillo previously served as Vice President of Corporate Communications at 10x Genomics and held significant roles at Becton, Dickinson and Company, CareFusion, and Cardinal Health, showcasing her extensive experience in corporate communications [2][3] Group 2: Company Overview - Zimmer Biomet is recognized as a global leader in medical technology, focusing on maximizing mobility and improving health through innovative products and integrated digital and robotic technologies [4][5] - The company has over 90 years of experience and is committed to delivering high-quality solutions to patients and healthcare providers [5]
Zimmer Biomet to Present at the 27th Annual Barclays Healthcare Conference
Prnewswire· 2025-02-28 12:30
Company Overview - Zimmer Biomet is a global leader in medical technology with a focus on maximizing mobility and improving health through innovative products and integrated digital and robotic technologies [2][3] - The company has over 90 years of experience and is committed to delivering high-quality solutions to patients and providers [3] Upcoming Event - Zimmer Biomet management will present at the 27th Annual Barclays Healthcare Conference on March 13, 2025, at 9:30 a.m. ET [1] - A live webcast of the presentation will be available on Zimmer Biomet's Investor Relations website, with an archived replay following the conference [1]
Zimmer Biomet Appoints Jehanzeb Noor as Senior Vice President, Chief Strategy, Innovation and Business Development Officer
Prnewswire· 2025-02-27 12:30
Core Insights - Zimmer Biomet Holdings, Inc. has appointed Jehanzeb Noor as Senior Vice President, Chief Strategy, Innovation and Business Development Officer, reporting to President and CEO Ivan Tornos [1][2] Group 1: Leadership and Responsibilities - Jehanzeb Noor will lead strategy development and execution, oversee M&A activities including the integration of the pending acquisition of Paragon 28, and manage research and product development organizations [2] - Noor will also serve as Chief of Staff to the CEO, indicating a significant role in the company's strategic direction [2] Group 2: Background and Experience - Prior to joining Zimmer Biomet, Noor was President and Managing Director for Europe, Africa, and Asia at Trivium, where he focused on operational excellence and margin expansion [3] - Noor has held various leadership roles, including CEO of Smiths Medical and positions at Amcor, McKinsey, Ford Motor Company, and Constellation Energy Commodities Group [3] Group 3: Educational Qualifications - Jehanzeb Noor holds a Master of Science in Product Development, a Bachelor of Science in Finance, and a Bachelor of Science in Mechanical Engineering, all from the Massachusetts Institute of Technology (MIT) [4] Group 4: Company Overview - Zimmer Biomet is a global leader in medical technology, focusing on maximizing mobility and improving health through innovative products and integrated digital and robotic technologies [5][6] - The company has over 90 years of experience and is committed to delivering high-quality solutions to patients and providers [6]
Zimmer Biomet Launches You'll Be Back Campaign with Chief Movement Officer Arnold Schwarzenegger
Prnewswire· 2025-02-26 12:30
Core Insights - Zimmer Biomet Holdings, Inc. has launched the "You'll Be Back" campaign aimed at creating an online community for individuals suffering from joint pain, encouraging them to share their experiences and connect with healthcare professionals [1][2] - The campaign is led by Arnold Schwarzenegger, who emphasizes the importance of community support in overcoming mobility challenges and aims to inspire individuals to take action against their pain [2][3] - Osteoarthritis is highlighted as a prevalent condition affecting nearly 27 million Americans over the age of 65, with projections indicating that by 2030, approximately 4 million people in the U.S. will require joint replacement surgery [3] Company Overview - Zimmer Biomet is recognized as a global leader in medical technology, focusing on enhancing mobility and health through innovative products and integrated digital solutions [5][6] - The company has over 90 years of experience in the industry, positioning itself to deliver high-quality solutions to both patients and healthcare providers [6] Campaign Details - The "You'll Be Back" campaign invites individuals with joint pain to submit their stories on a dedicated website, with selected participants featured in a motivational docuseries [2][3] - The campaign aims to empower patients by providing them with resources and a platform to voice their health journeys, thereby fostering a sense of community [2][3]
Zimmer Biomet(ZBH) - 2024 Q4 - Annual Report
2025-02-25 21:01
Financial Performance - In 2024, the company's net sales increased by 3.8% to $7,678.6 million compared to 2023, driven by market growth, new product introductions, and positive price realization [171]. - Net earnings for 2024 were $903.8 million, a decline from $1,024.0 million in 2023, primarily due to higher restructuring charges and intangible asset amortization [172]. - The company expects 2025 revenue growth of 1.0% to 3.5%, with foreign currency exchange rates negatively impacting net sales by approximately 1.5% to 2.0% [173]. - U.S. net sales grew by 3.5% in 2024, while international net sales increased by 4.3%, both driven by market growth in key product categories [176][182]. - The company's Knees and Hips product categories saw net sales increases of 4.4% and 1.6%, respectively, in 2024 compared to 2023 [177][183]. Cost and Expenses - Cost of products sold, excluding intangible asset amortization, was 28.5% of net sales in 2024, an increase from 28.2% in 2023, primarily due to higher manufacturing costs [184][185]. - Intangible asset amortization expense increased to 7.7% of net sales in 2024, reflecting acquisitions and buyouts of licensing agreements [186]. - Gross margin for 2024 was 63.8%, a decrease from 64.2% in 2023, primarily impacted by manufacturing costs and changes in foreign currency exchange rates [187]. - Research & development expenses decreased in both amount and as a percentage of net sales in 2024 compared to 2023, driven by lower compliance spending and savings from the 2023 Restructuring Plan [188]. - Selling, general & administrative expenses increased in amount but decreased as a percentage of net sales in 2024, attributed to variable selling costs and higher bad debt-related charges [189]. - Total expenses related to restructuring programs were $219.0 million in 2024, up from $151.9 million in 2023, mainly due to the initiation of the 2023 Restructuring Plan [190]. Cash Flow and Investments - Cash flows from operating activities were $1,499.4 million in 2024, a decrease from $1,581.6 million in 2023, primarily due to higher payments for accounts payable and restructuring-related costs [203]. - Cash flows used in investing activities increased to $888.1 million in 2024 from $778.9 million in 2023, including $276.3 million for acquisitions and $153.0 million for technology access [204]. - As of December 31, 2024, the company had $525.5 million in cash and cash equivalents and $1.0 billion available to borrow under a revolving credit agreement [201]. - The company plans to acquire Paragon 28, Inc. for approximately $1.2 billion, expected to be funded through cash on hand and debt financing [211]. Tax and Shareholder Returns - The effective tax rate for 2024 was 12.7%, significantly higher than 4.0% in 2023, influenced by foreign rate differentials and changes in unrecognized tax benefits [194]. - A $2.0 billion share repurchase program was authorized in May 2024, with $868.0 million executed in 2024 to return cash to investors [214]. Restructuring Plans - The 2023 Restructuring Plan is expected to incur total pre-tax charges of approximately $120 million by the end of 2025, with $114 million already incurred through December 31, 2024 [215]. - The 2021 Restructuring Plan resulted in $169 million of total pre-tax charges and is estimated to have reduced gross annual pre-tax operating expenses by approximately $190 million relative to the 2021 baseline expenses by the end of 2024 [215]. - The 2019 Restructuring Plan is expected to incur total pre-tax restructuring charges of approximately $400 million by the end of 2025, with $368 million incurred through December 31, 2024 [215]. Liabilities and Risks - The company has a remaining liability of $154.6 million from the transition tax related to the deemed repatriation of foreign earnings, with $68.7 million recorded in current income tax liabilities and $85.9 million in non-current income tax liabilities as of December 31, 2024 [217]. - Total liabilities for litigation matters were estimated at $156.4 million as of December 31, 2024, with potential for additional charges upon resolution of uncertainties [218]. - The company has entered into contractual arrangements that may result in future payments ranging from $0 to $325 million, dependent on product R&D milestones and sales [221]. - The company had net assets in legal entities with non-U.S. Dollar functional currencies amounting to $1,950.5 million as of December 31, 2024 [238]. - The majority of the company's debt is fixed-rate, and a 10 percent change in interest rates would not have a material effect on interest expense, net [244]. - The company is exposed to credit risk primarily through cash and cash equivalents, derivative instruments, and accounts receivable, but believes reserves for losses are adequate [246]. - The company performs sensitivity analyses related to potential commodity price changes as part of its risk management program [241].
ZBH Stock Hurt by Margin Concerns and Difficult Solvency
ZACKS· 2025-02-17 16:56
Core Viewpoint - Zimmer Biomet (ZBH) is currently facing significant challenges due to macroeconomic factors, staffing shortages, and supply chain issues, leading to a negative outlook reflected in its Zacks Rank of 5 (Strong Sell) [1][2]. Group 1: Growth Challenges - The company is experiencing growth impediments due to industry-wide staffing shortages and supply chain hazards, exacerbated by geopolitical complications and high policy rates aimed at combating inflation [2][3]. - Specific challenges include reimbursement headwinds in the Restorative Therapies business and acute supply challenges in Sports and Trauma, which are pressuring revenues and operating profits [3]. - The adverse impact of foreign exchange rates has been notable, with a 1% decline in net sales in 2024 and an expected 1.5%-2% impact on 2025 revenues [5]. Group 2: Financial Performance - In Q4 2024, Zimmer Biomet reported a 5.1% increase in the cost of products sold and a 3.4% rise in selling, general, and administrative expenses, leading to a contraction in adjusted gross and operating margins [4]. - The company ended Q4 2024 with cash and cash equivalents of $525.5 million and total debt of $6.20 billion, indicating a concerning solvency position as near-term payable debt exceeds cash on hand [6]. - The debt-to-capital ratio improved slightly to 33.2% from 34.3% in the previous quarter, but the overall debt levels remain high relative to cash reserves [7]. Group 3: Positive Factors - Despite the challenges, there has been gradual stability in the global musculoskeletal market, with certain geographies showing better-than-expected sales growth driven by improved procedural volume [8]. - In Q4 2024, the company experienced strong growth in large joints, with global sales in Knees, Hips, and S.E.T. categories increasing by 5.6%, 4%, and 8.4% respectively at constant exchange rates [9]. - Zimmer Biomet is focusing on expanding its presence in international developed and emerging markets, which are expected to provide long-term growth opportunities [10][11]. Group 4: Market Performance - Over the past three months, Zimmer Biomet's shares have declined by 10.8%, contrasting with a 6% growth in the industry, although strategic market expansion and new product launches are anticipated to help regain momentum [12].