Product Portfolio and Market Presence - CooperVision's MiSight 1 day lens is the first and only FDA-approved product to slow myopia progression in children aged 8-12, also approved by China's NMPA in August 2021[24] - CooperVision operates in three primary regions: Americas, EMEA, and Asia Pacific, with major manufacturing facilities in Belgium, Costa Rica, Hungary, Puerto Rico, the UK, and the US[24][26] - CooperSurgical offers over 600 products and services in fertility and women's health, with major facilities in Costa Rica, the Netherlands, the UK, and the US[25] - CooperSurgical acquired Cook Medical assets, a fertility company specializing in sperm separation devices, and obp Surgical in fiscal 2024[40] - CooperVision's Biofinity brand is its highest-grossing product, offering monthly silicone hydrogel lenses in spherical, toric, and multifocal categories[30] - CooperSurgical's Paragard is the only FDA-approved non-hormonal IUD, preventing pregnancy for up to ten years[43] - CooperVision's MyDay and clariti 1 day brands offer single-use silicone hydrogel lenses, with MyDay being the softest line and clariti 1 day being the most affordable[31] - CooperSurgical's cryostorage services for cord blood and cord tissue are available in the US, Canada, and Australia[42] Research and Development - CooperVision's R&D focuses on new contact lens designs, myopia management, and manufacturing technologies, supported by 400 employees[63] - CooperSurgical's R&D activities focus on innovating and advancing products in fertility and women's health, including instruments, devices, and digital services[64] Regulatory Compliance and Approvals - The majority of CooperSurgical's products are classified as Class II medical devices, requiring premarket notification under Section 510(k) of the FDCA[68] - Class III medical devices, such as extended wear contact lenses, require extensive premarket testing and FDA approval[68] - A majority of the company's medical devices currently on the market have received FDA clearance through the 510(k) process or approval through the PMA process[71] - The FDA's Quality System Regulation (QSR) requires manufacturers to follow strict quality assurance procedures during the manufacturing process[72] - The FDA issued a final rule in May 2024 to phase out its general enforcement discretion approach for Laboratory Developed Tests (LDTs) over four years[75] - The company's genetic testing laboratory in New Jersey holds current certification under CLIA to perform testing[75] - The EU's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require recertification of medical devices, with extended transition periods for devices certified under previous directives[84] - Medical devices in the EU must meet general safety and performance requirements and undergo conformity assessment procedures to obtain a CE mark[85][86] - The UK's regulatory regime for medical devices and IVDs is undergoing reforms to align with EU MDR requirements, with unique requirements such as post-market surveillance and AI expected by mid-2025[93] - In Asia Pacific, regulatory approval timelines are lengthy and unpredictable, with some countries requiring proof of home country approval (e.g., US or EU) for product registration[94] - The NMPA in China requires in-country clinical trials for new medical device registrations, rather than relying on foreign clinical data[95] - In Japan, the PMDA requires local clinical trial data for novel medical devices, extending the approval timeline[96] - Japan and Australia participate in the Medical Device Single Audit Program, allowing acceptance of QMS audit reports from other regulatory authorities, including the FDA[97] Economic and Market Risks - The Inflation Reduction Act of 2022 mandates Medicare price negotiations for certain drugs starting in 2026, with price caps and rebates for inflation-exceeding price increases[103] - The company has a global workforce of over 16,000 employees, with 54% in the Americas, 41% in EMEA, and 5% in Asia Pacific as of October 31, 2024[116] - CooperVision and CooperSurgical experience lower net sales in the fiscal first quarter due to reduced patient traffic during the holiday season[115] - The company relies on sole suppliers for certain raw materials, including silicone hydrogel contact lenses and IVF products, which could lead to supply disruptions if alternative suppliers are needed[109] - CooperVision has expanded its sales capabilities with the addition of MiSight, including direct-to-consumer marketing campaigns[110] - CooperSurgical has enhanced its marketing efforts with direct-to-consumer campaigns for donor gametes, Paragard, and cord blood storage services[111] - The company faces risks from economic pressures, including inflation, labor cost increases, and currency fluctuations, which could impact manufacturing costs and revenues[133] - Inflation could materially impact the company's cost structure and revenue, potentially leading to increased costs and inability to raise prices sufficiently to keep up with inflation[135] - More than half of the company's net sales for fiscal years 2024 and 2023 were derived from outside the United States, with international sales expected to remain a significant portion of total net sales[136] - The company faces challenges in growing sales in emerging markets such as China, India, Russia, and Brazil due to regulatory restrictions, customer acceptance, and undeveloped distribution channels[139] - Economic and trade sanctions could restrict or prohibit the sale of certain products to specific governments, persons, entities, countries, and territories, potentially leading to fines and denial of export privileges[141] - Acquisitions and strategic transactions involve risks such as failure to achieve anticipated revenues, difficulties in integration, and potential loss of employees[142] - The company's manufacturing and distribution operations are vulnerable to disruptions, which could adversely affect its business, particularly in facilities located in Costa Rica, Hungary, Puerto Rico, the United Kingdom, and the United States[147][148] - Cybersecurity threats could disrupt the company's information technology systems, leading to potential loss of confidential data, financial harm, and reputational damage[152] - The company is implementing new enterprise resource planning (ERP) systems, which is a costly and complex process that could negatively affect financial accounting and reporting processes[155] - A material weakness in internal control over financial reporting related to IT general controls for CooperSurgical operations in the U.S. was identified, which could affect the accuracy of financial reporting and investor confidence[157][160] - Pricing pressure from competitors, customers, and changes in third-party coverage and reimbursement may adversely affect demand for the company's products and negatively impact operating results[161] - Increased competition and pricing pressure due to new market entrants, technologies, and competitive pricing strategies from established companies[162] - Potential inventory shortages due to reliance on independent suppliers for raw materials, packaging, and components[163] - Risk of supply chain disruption for silicone hydrogel contact lenses (e.g., MyDay, Biofinity, Avaira, clariti) due to dependency on few or sole suppliers[164] - Negative impact on supply chain and cost of goods from unanticipated price increases due to inflation or supply restrictions[165] - Risk of business impact if intellectual property rights are not adequately protected, including patents, trademarks, and trade secrets[166] - Potential for significant litigation costs and damages related to intellectual property disputes, including challenges to patents and trademarks[170][175] - Risk of product liability claims or recalls, particularly for direct-to-consumer products like stem cell storage and Paragard IUDs[180] - Market acceptance risk for new or existing products, particularly those reliant on future medical or therapeutic advancements[181] - Intense competition in the contact lens market from major players like Johnson & Johnson Vision Care, Alcon, and Bausch Health, with declining sales for older product lines[183] - Risk of product obsolescence due to rapid technological advancements in vision correction, fertility, and women's health markets[191] Environmental, Social, and Governance (ESG) Matters - The company faces risks related to environmental, social, and governance (ESG) matters, including compliance with evolving regulations and potential costs associated with environmental claims[197][199][200] - New ESG disclosure standards, such as the EU Corporate Sustainability Reporting Directive (CSRD) and California's carbon reporting requirements, may increase compliance costs and expose the company to potential litigation[199] - The company may incur additional manufacturing and product development costs due to changing customer preferences and regulatory requirements related to plastics, packaging, and sustainability[202] - Failure to meet ESG expectations could lead to reputational damage, loss of investor confidence, and reduced customer demand[201][205] Workforce and Operational Challenges - The company is experiencing challenges in workforce retention, particularly in markets with high inflation and competition, which could disrupt business operations[206] - Regulatory changes in the U.S. and EU, such as FDA reforms and the EU Medical Device Regulation (MDR), could delay product approvals and increase compliance costs[209][212][216] - Post-Brexit regulatory changes in the UK, including the need for medical device registration with the MHRA, may impact the company's ability to market products in the UK[217] - Product recalls and regulatory enforcement actions could harm the company's reputation and financial performance[218][219] - Compliance with FDA cGMP and QSR regulations is critical, and failure to meet these standards could result in manufacturing delays, fines, or product seizures[220]

Financial Data and Key Metrics Changes - For Q4, consolidated revenues were $1.018 billion, up 10% year-over-year or up 7% organically [12][32] - Non-GAAP earnings per share grew 19% to $1.04 [13] - Consolidated gross margin was 66.9%, up from 66.7% [33] - Operating income grew 16.2%, improving the margin to 25.9% [33] - Full year revenues reached $3.9 billion, up 8% and up 8% organically [36] Business Line Data and Key Metrics Changes - CooperVision reported quarterly revenues of $676 million, up 9% or 8% organically, driven by silicone hydrogel dailies and torics [12][36] - CooperSurgical posted quarterly revenues of $342 million, up 12% or 5% organically, with fertility growing 15% or 13% organically [12][36] - Daily silicone hydrogel lenses, MyDay and clariti, grew 14% and 8% respectively [14] Market Data and Key Metrics Changes - The contact lens market is expected to grow 5% to 7% in constant currency, with the company taking share growing 6.5% to 8.5% [11] - In the Americas, CooperVision grew 6%, EMEA grew 11%, and Asia Pac grew 7% [13] Company Strategy and Development Direction - The company aims to take market share, drive profitability, and execute strategic priorities including product availability and manufacturing capacity expansion [9] - Focus on myopia management and fertility as key growth areas [41] Management's Comments on Operating Environment and Future Outlook - Management noted unexpected softness in the U.S. market towards the end of Q4, attributed to various factors including potential weather impacts [46][47] - The company remains optimistic about growth in fiscal 2025, expecting continued demand for MyDay and MiSight products [51][130] Other Important Information - The company is committed to driving efficiency gains and EPS growth, with expectations for gross margin expansion and operating income growth of 10% to 12% in constant currency for fiscal 2025 [41][39] - The company has no manufacturing in China, Mexico, or Canada, mitigating potential tariff impacts [88] Q&A Session Summary Question: Can you provide more color on the unexpected softness at the end of the quarter? - Management noted softness in the U.S. market and some other regions like China, which was unexpected but has since returned to normal [46][47] Question: What is the outlook for PARAGARD given the 10% decline in Q4? - Management expects continued pressure on PARAGARD from competitive products, with fiscal 2025 growth anticipated to be flat to slightly up [56][57] Question: How do you see the pricing environment for contact lenses in FY '25? - Management is confident that the contact lens industry will offset inflation impacts, with expectations for stable pricing [92] Question: What is the expected contribution from acquired revenue? - Management confirmed approximately $25 million in annualized revenue from recent acquisitions, with a quiet M&A environment currently [96] Question: What are the upcoming product launches? - Management highlighted ongoing efforts to launch MyDay products in additional markets, with a focus on increasing availability [104][105]

The Cooper Companies (COO) came out with quarterly earnings of $1.04 per share, beating the Zacks Consensus Estimate of $1 per share. This compares to earnings of $0.87 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 4%. A quarter ago, it was expected that this surgical and contact lens products maker would post earnings of $0.91 per share when it actually produced earnings of $0.96, delivering a surprise of 5.49%.Over the las ...

Revenue and Growth - Q4 2024 revenue of $1,018.4 million, up 10% YoY, with organic growth of 7%[1] - Fiscal year 2024 revenue of $3.9 billion, up 8% YoY, with organic growth of 8%[1] - Q4 2024 CooperVision (CVI) revenue of $676.4 million, up 9% YoY, with organic growth of 8%[7] - Q4 2024 CooperSurgical (CSI) revenue of $342.0 million, up 12% YoY, with organic growth of 5%[10] - Fiscal 2025 revenue guidance of $4,080 - $4,158 million, with organic growth of 6% to 8%[15] - Net sales for Q4 2024 increased by 10% year-over-year to $1,018.4 million, with organic growth of 7%[57] - CooperVision's net sales grew by 9% year-over-year to $676.4 million, with organic growth of 8%[57] - CooperSurgical's net sales increased by 12% year-over-year to $342.0 million, with organic growth of 5%[57] Earnings and Profitability - Q4 2024 GAAP diluted EPS of $0.58, up 38% YoY, and fiscal 2024 GAAP diluted EPS of $1.96, up 33% YoY[2] - Q4 2024 non-GAAP diluted EPS of $1.04, up 19% YoY, and fiscal 2024 non-GAAP diluted EPS of $3.69, up 15% YoY[2] - Q4 2024 gross margin of 67%, up from 65% in the prior year, driven by price and efficiency gains[4] - Q4 2024 operating margin of 19%, up from 15% in the prior year, driven by SG&A expense leverage and stronger gross margins[4] - Fiscal 2025 non-GAAP diluted EPS guidance of $3.92 - $4.02[15] - GAAP Net Income for the three months ended October 31, 2024, was $117.5 million, compared to $84.5 million in the same period in 2023[27] - Non-GAAP Net Income for the three months ended October 31, 2024, was $208.5 million, compared to $173.2 million in the same period in 2023[27] - Net income for Q4 2024 rose to $117.5 million, up from $84.5 million in Q4 2023[54] - Earnings per share (diluted) for Q4 2024 were $0.58, compared to $0.42 in Q4 2023[54] - Gross profit for Q4 2024 was $677.7 million, up from $606.5 million in Q4 2023[54] Expenses and Charges - Acquisition and integration-related charges for the three months ended October 31, 2024, were $7.2 million, primarily related to the Cook Medical acquisition[28] - Business optimization charges for the three months ended October 31, 2024, included $1.5 million in employee severance costs and $1.0 million related to IT infrastructure changes[34] - The twelve months ended October 31, 2024, included $20.6 million in acquisition and integration-related charges, primarily related to the Cook Medical acquisition[28] - The twelve months ended October 31, 2024, also included $18.3 million in business optimization charges, with $10.6 million related to employee severance costs[34] - The company incurred $4.0 million in charges related to compliance with new EU medical device regulations for the three months ended October 31, 2024[32] - The twelve months ended October 31, 2024, included $12.9 million in other charges, with $5.9 million related to gains and losses on minority interest investments[37] - Research and development expenses increased to $37.7 million in Q4 2024 from $36.7 million in Q4 2023[54] Financial Position - Total assets increased to $12,315.2 million in 2024 from $11,658.9 million in 2023[51] - Long-term debt stood at $2,550.4 million in 2024, slightly up from $2,523.8 million in 2023[51] - Total current assets grew to $1,951.5 million in 2024 from $1,704.9 million in 2023[51] Corporate Developments - The company recorded a deferred tax asset of approximately $2.0 billion in fiscal 2021 due to the transfer of CooperVision intellectual property and goodwill to its UK subsidiary[39] - The company will host an audio webcast to discuss its fourth-quarter results and corporate developments, available on CooperCompanies' website[39]

SAN RAMON, Calif., Dec. 05, 2024 (GLOBE NEWSWIRE) -- CooperCompanies (Nasdaq: COO), a leading global medical device company, today announced financial results for its fiscal fourth quarter and full year ended October 31, 2024. Fourth quarter 2024 revenue of $1,018.4 million, up 10%, or up 7% organically. Fiscal year 2024 revenue of $3.9 billion, up 8%, or up 8% organically.Fourth quarter 2024 GAAP diluted earnings per share (EPS) of $0.58, up 38%. Fiscal 2024 GAAP diluted EPS of $1.96, up 33%.Fourth quarter ...

Breaking News: Brenmiller Energy COO Will Present At The Emerging Growth Conference Today At 11:25 AM ESTDecember 04, 2024 8:45 AM EST | Source: Hawk Point Media Group.Miami, Florida--(Newsfile Corp. - December 4, 2024) - Brenmiller Energy Ltd. (NASDAQ: BNRG) COO Nir Brenmiller will present at the Emerging Growth Conference on Wednesday, December 4, 2024, at 11:25 AM EST. The fireside-chat-styled interview provides a forum for Mr. Brenmiller to explain how recent announcements position his com ...

The Cooper Companies, Inc.’s (COO) fourth-quarter fiscal 2024 results are scheduled to be released on Dec. 5, after the closing bell.In the last reported quarter, the company’s earnings beat the Zacks Consensus Estimate by 5.49%. Its earnings beat estimates in three of the trailing four quarters and met once, delivering an average surprise of 3.87%.Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.Q4 EstimatesThe Zacks Consensus Estimate for revenues is pegged at $1.03 billion, indica ...

Wall Street analysts expect The Cooper Companies (COO) to post quarterly earnings of $1 per share in its upcoming report, which indicates a year-over-year increase of 14.9%. Revenues are expected to be $1.03 billion, up 10.8% from the year-ago quarter.Over the last 30 days, there has been a downward revision of 1% in the consensus EPS estimate for the quarter, leading to its current level. This signifies the covering analysts' collective reconsideration of their initial forecasts over the course of this tim ...

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CALGARY, AB, Nov. 27, 2024 /PRNewswire/ - Canadian Pacific Kansas City (TSX: CP) (NYSE: CP) (CPKC) President and Chief Executive Officer Keith Creel and Executive Vice-President and Chief Operating Officer Mark Redd will now address the 2024 UBS Global Industrials and Transportation Conference on Dec. 4, 2024, at 9:40 a.m. ET.CPKC will provide access to the live audio webcast at investor.cpkcr.com. A replay will also be available following the conclusion of the event.About Canadian Pacific Kansas CityWith i ...