Hologic (HOLX) is currently trading at a forward price-to-earnings (P/E) multiple of 17.62X, well below the industry average of 32.42X. The company, specializing in medical devices for women’s health, also stands out with respect to industry peers Globus Medical (GMED) and Masimo (MASI) , which trade at a higher P/E of 24.25X and 39.01X, respectively. Hologic currently has a Value Score of B.Price-to-Earnings Forward Twelve Months (F12M)Image Source: Zacks Investment ResearchYesterday, HOLX stock ended the ...

On Sunday, Hologic (HOLX) presented new research evaluating the performance of its Genius AI Detection 2.0 software across diverse patient populations at the 110 Scientific Assembly and Annual Meeting of the Radiological Society of North America ("RSNA"). The research, titled "Performance of a Digital Breast Tomosynthesis AI Detection Algorithm in Common U.S. Racial/Ethnic Groups," revealed that the measured performance of the algorithm was similar across all evaluated cohorts. Hologic is also introducing i ...

Hologic, Inc. (HOLX) is set to unveil groundbreaking technologies at the 110th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) in Chicago, to be held from Dec. 1-5. With a focus on enhancing breast health care, the company will showcase AI-powered breast imaging advancements designed to assess breast density, enhance workflows and improve cancer detection.Additionally, in the same event, Hologic will present the results of a recently published study demonstrating t ...

Business Segments - The company operates in four segments: Diagnostics, Breast Health, GYN Surgical, and Skeletal Health[23]. - The Diagnostics segment includes molecular diagnostic assays for STDs, HPV, and viral load tests for Hepatitis B and C, among others[24]. - The Breast Health segment offers advanced breast imaging systems, including 3D digital mammography systems and AI-based image analysis software[24]. - The GYN Surgical products include the MyoSure and NovaSure systems for tissue removal and endometrial ablation, respectively[25]. - The Skeletal Health segment features the Horizon DXA system for bone density evaluation and the Fluoroscan Insight FD mini C-arm for orthopedic procedures[26]. Product Development and Innovation - The company launched the Aptima SARS-CoV-2 assay and related tests in response to the COVID-19 pandemic[24]. - In May 2022, the company obtained CE-marking for two new molecular assays for Epstein-Barr virus and BK virus quantitation[24]. - The Genius Digital Diagnostics System received FDA marketing clearance for diagnostic use in January 2024, enhancing early detection of cervical cancer with AI technology[47]. - The Breast Cancer Index test is now included in the National Comprehensive Cancer Network guidelines as the only gene expression assay predicting benefit from extended endocrine therapy for early-stage HR+ breast cancer patients[50]. - The 3DQuorum technology reduces the number of 3D images to review by two-thirds, saving an estimated average of one hour per eight hours of daily image interpretation time[52]. - The acquisition of Endomagnetics Ltd adds wire-free breast surgery localization and lymphatic tracing solutions to the company's breast surgery portfolio[57]. - The NovaSure system utilizes Smart-Depth technology for customized endometrial ablation, improving treatment for abnormal uterine bleeding[59]. - The Acessa ProVu system treats fibroids using controlled radiofrequency energy, allowing for less invasive treatment options[61]. Sales and Market Dynamics - The company's U.S. sales force targets specific customer segments in Diagnostics, Breast Health, GYN Surgical, and Skeletal Health markets[67]. - No single customer accounted for more than 10% of consolidated revenues in fiscal years 2024, 2023, and 2022, indicating a diversified customer base[66]. - The healthcare industry is highly competitive, with significant pressure on average selling prices and overall procedure rates due to economic conditions and healthcare reforms[71]. - Major competitors in the Diagnostics business include Roche Diagnostics and Becton Dickinson, with competition also coming from companies offering limited assays in specific market segments[73]. - In the Breast & Skeletal Health business, primary competitors are large imaging companies such as Siemens Healthineers and GE Healthcare[75]. - The GYN Surgical business faces competition from full suite surgical solutions companies like Johnson & Johnson and Medtronic, as well as alternative treatments to the NovaSure system[76]. Regulatory and Compliance Issues - The company is subject to extensive FDA regulations, which govern the design, testing, and marketing of medical products[93]. - The FDA granted Emergency Use Authorization for the Panther Fusion SARS-CoV-2 assay in March 2020, highlighting the company's responsiveness to emerging health threats[94]. - The company is subject to extensive regulation under the Clinical Laboratory Improvement Amendments (CLIA), which could adversely affect sales if compliance is not maintained[96]. - The company anticipates significant costs to comply with various federal, state, and foreign laws, which may materially affect its business and financial condition[100]. - The company must maintain ISO Quality System certification and comply with European directives to market products outside the U.S.[101]. - The EU Medical Device Regulation (EU MDR) requires compliance by May 2024, with significant expenditures expected to meet these requirements[103]. - The company’s ability to market products in China may improve due to recent changes in the National Medical Products Administration's review process[103]. Financial and Operational Risks - The company has a significant amount of indebtedness, which limits operational flexibility and could adversely affect financial results[199]. - As of September 28, 2024, the company had approximately $2.55 billion in aggregate principal of indebtedness outstanding[201]. - Approximately $1.2 billion of the company's indebtedness is subject to floating interest rates, increasing vulnerability to economic conditions[208]. - The company's ability to generate sufficient cash flow to service its indebtedness and obligations is uncertain, influenced by various external factors[205]. - Financial covenants in the company's credit facilities may restrict its ability to engage in certain transactions, impacting operational flexibility[202]. - The company may face challenges in refinancing its indebtedness on commercially reasonable terms, which could affect liquidity[205]. - Changes in macroeconomic conditions, including inflation and rising interest rates, may adversely impact the company's sales volume and pricing[161]. Supply Chain and Manufacturing - The company relies on sole source third-party manufacturers for key products, which increases risks related to production delays and quality control[81]. - Manufacturing operations are concentrated in a limited number of facilities, and interruptions could significantly impact production capabilities[82]. - Global supply constraints have adversely affected the ability to meet customer demand and increased manufacturing costs, particularly for Breast Health capital equipment products[178]. - The reliance on a limited number of suppliers for key components exposes the company to risks related to supply chain disruptions[179]. - The company may need to find new contract manufacturers or suppliers, which could involve significant costs and delays[181]. Employee and Community Engagement - The company emphasizes employee engagement and development, conducting annual surveys to enhance workforce performance[111]. - The company has a commitment to diversity, with 56% of its Board of Directors being women[115]. - The company supports community engagement through volunteerism and scholarships for employees' children, focusing on women's health and STEM education[122]. Cybersecurity and Data Privacy - Increased cybersecurity threats pose risks to the company's systems and data, potentially leading to significant costs and operational disruptions[172]. - The cybersecurity risk management program is based on the NIST Cybersecurity Framework 2.0, emphasizing the importance of robust measures[215]. - The Chief Information Security Officer (CISO) leads the cybersecurity program, supported by a dedicated team and an executive-level steering committee[220]. - The Audit and Finance Committee oversees the company's cybersecurity risks, receiving quarterly updates from the CIO and CISO[222]. Market Acceptance and Reimbursement - Market acceptance of the company's medical products is heavily influenced by reimbursement policies from government and private payors[107]. - Changes in reimbursement policies by third-party payors could significantly affect the market acceptance of the company's products[139]. - The successful commercialization of new products is uncertain and may depend on establishing favorable reimbursement codes, which can delay market entry[132].

Hologic, Inc.’s (HOLX) robust strength in the Molecular Diagnostics business is poised to drive growth in the upcoming quarters. Solid demand for breast imaging solutions aids the Breast Health division’s growth, with the company’s new buyout further diversifying the business. On top of that, broad-based performance in the international markets is highly promising for the stock. Meanwhile, the uncertain macroeconomic volatilities as well as adverse currency fluctuations can dent Hologic’s operations.In the ...

On Monday, Hologic (HOLX) released its fiscal 2024 fourth-quarter financial report after the closing bell, with revenues slightly surpassing the consensus mark. The bottom line fell short of estimates by just 1% after three consecutive quarters of positive surprises. However, both metrics improved on a year-over-year basis. Closing the year with a solid operating margin, Hologic emerged as a top-tier performer within its peer group, with room for improvement in fiscal 2025.Shares of the Marlborough, MA-base ...

Hologic, Inc. (HOLX) reported adjusted earnings per share (EPS) of $1.01 in the fourth quarter of fiscal 2024, up 13.5% year over year. However, the bottom line missed the Zacks Consensus Estimate by 0.9%.The adjustments include charges and benefits related to the amortization of acquired intangible assets, restructuring and integration/consolidation costs and many others.The company’s GAAP EPS was 76 cents in the quarter compared with 37 cents in the year-ago period.Fiscal 2024 adjusted EPS was $4.08, up 3 ...

Financial Data and Key Metrics Changes - Total revenue for Q4 2024 was $987.9 million, representing a 4.2% increase year-over-year, and 5% organic growth excluding COVID [32] - Non-GAAP earnings per share (EPS) for Q4 were $1.01, a 13.5% increase [32] - For the full fiscal year 2024, total revenue was $4.03 billion, a slight decline of 0.2%, but grew 5.3% organically excluding COVID [33] Business Line Data and Key Metrics Changes - Diagnostics revenue for Q4 was $443.3 million, growing 6.2%, and 9.2% organically excluding COVID [21] - Molecular Diagnostics grew 9.1% in Q4 and 9% for the full year, driven by BV/CV/TV assays [22] - Breast Health revenue for Q4 was $375.5 million, increasing 6.2% or 5.3% organically [25] - Surgical revenue for Q4 was $156.5 million, up 5.4% year-over-year [25] - Scalable business revenue decreased 54.9% to $12.7 million due to a temporary stop ship of Horizon DXA [26] Market Data and Key Metrics Changes - The international business has grown nearly 50% compared to 2019, with significant growth opportunities still available [27] - The company anticipates that international growth will outpace domestic growth in fiscal 2025 [74] Company Strategy and Development Direction - The company is focused on M&A strategies, having acquired Endomagnetics and planning to acquire Gynesonics, which align with its women's health focus [11][35] - Hologic aims to leverage its strong balance sheet for both organic growth initiatives and share repurchase programs [12][35] - The company is committed to advancing women's health globally and expects to deliver durable long-term results [49] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business's ability to navigate transitory headwinds and expects accelerated revenue growth in the latter half of fiscal 2025 [65][66] - The company anticipates challenges in the first half of fiscal 2025 due to supply chain issues and strong prior year comparisons [40][66] - Management highlighted the importance of innovation and market creation as key drivers for future growth [16][18] Other Important Information - The company announced a new $250 million accelerated share repurchase program [12][35] - Gross margin for Q4 increased to 61.5%, up 110 basis points year-over-year [36] - Operating margins for Q4 finished at 30%, with net margin at 24% [38] Q&A Session Summary Question: Can you discuss the margin outlook for fiscal 2025? - Management indicated that transitory headwinds in the first half of the year would impact margins, but they expect improvements as these issues are resolved [52] Question: What is the outlook for the Breast Health business? - Management expects a slower growth rate in the Breast Health segment prior to the launch of new gantry products, but remains optimistic about existing products [54] Question: Can you provide sales figures for key growth drivers like Biotheranostics? - Management indicated that BV/CV/TV is expected to generate several hundred million dollars in revenue, while Biotheranostics is projected to be around $100 million [56] Question: What are the expectations for the international business growth? - Management expects international growth to outpace domestic growth in fiscal 2025 [74] Question: How is the company addressing the IV fluid shortage? - Management acknowledged the impact of the IV fluid shortage on surgical procedures and indicated it is a transitory issue [66] Question: Can you elaborate on the Gynesonics acquisition? - Management stated that Gynesonics complements the existing surgical portfolio and aligns with current procedures [62] Question: What is the expected impact of the skeletal stop ship on revenue? - Management estimated a loss of approximately $5 million per month due to the skeletal stop ship, with expectations to resume shipments in the latter half of Q1 [70]

For the quarter ended September 2024, Hologic (HOLX) reported revenue of $987.9 million, up 4.5% over the same period last year. EPS came in at $1.01, compared to $0.89 in the year-ago quarter.The reported revenue compares to the Zacks Consensus Estimate of $979.28 million, representing a surprise of +0.88%. The company delivered an EPS surprise of -0.98%, with the consensus EPS estimate being $1.02.While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street ...

Hologic (HOLX) came out with quarterly earnings of $1.01 per share, missing the Zacks Consensus Estimate of $1.02 per share. This compares to earnings of $0.89 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -0.98%. A quarter ago, it was expected that this medical device maker would post earnings of $1.02 per share when it actually produced earnings of $1.06, delivering a surprise of 3.92%.Over the last four quarters, the comp ...