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What changed in Hologic's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Hologic's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+368 added−366 removedSource: 10-K (2025-11-18) vs 10-K (2024-11-27)

Top changes in Hologic's 2025 10-K

368 paragraphs added · 366 removed · 248 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

76 edited+19 added−30 removed120 unchanged
Biggest changeOur Biotheranostics laboratory in San Diego, California and the laboratories that purchase certain of our products, including the Aptima SARS-CoV-2 EUA, Aptima Flu Multiplex EUA, Fusion SARS-CoV-2 EUA, ThinPrep System, ThinPrep Imaging System, Rapid Fetal Fibronectin Test, Aptima Combo 2, Aptima HPV tests and Aptima HIV-1 Quant, HCV Quant Dx, HBV Quant, Aptima Trichomonas Vaginalis (Trich), Aptima Mycoplasma Genitalium (MGen), Aptima HSV 1 & 2, Aptima BV, Aptima CV/TV, and Panther Fusion Assays are subject to extensive regulation under the Clinical Laboratory Improvement Amendments of 1988, or CLIA, which requires laboratories to meet specified standards in the areas of personnel qualifications, administration, participation in proficiency testing, patient test management, quality control, quality assurance and inspections.
Biggest changeOur Biotheranostics laboratory in San Diego, California is subject to regulation under the Clinical Laboratory Improvement Amendments of 1988, or CLIA, which is administered primarily by the Centers for Medicare and Medicaid (CMS). CLIA requires laboratories to meet specified standards in the areas of personnel qualifications, administration, participation in proficiency testing, patient test management, quality control, quality assurance and inspections.
These solutions include 3D digital mammography systems, image analysis software utilizing artificial intelligence, reading workstations, minimally invasive breast biopsy guidance systems, breast biopsy site markers, localization, and specimen radiology systems. Our most advanced breast imaging platforms, Selenia 3D Dimensions and 3Dimensions systems, utilize tomosynthesis to produce 3D images that show multiple contiguous slice images of the breast.
These solutions include 3D digital mammography systems, image analysis software utilizing artificial intelligence, reading workstations, minimally invasive breast biopsy guidance systems, breast biopsy site markers, localization, and specimen radiology systems. Our most advanced breast imaging platforms, Selenia Dimensions and 3Dimensions systems, utilize tomosynthesis to produce 3D images that show multiple contiguous slice images of the breast.
In addition, in April 2022 the American Society of Clinical Oncology updated its clinical practice guidelines, which now include BCI as the only genomic test to help guide extended endocrine therapy decisions in early-stage, HR+ breast cancer patients.
In addition, in April 2022 the American Society of Clinical Oncology updated its clinical practice guidelines, which now include the BCI test as the only genomic test to help guide extended endocrine therapy decisions in early-stage, HR+ breast cancer patients.
Products sold by our direct sales force typically carry limited warranties covering parts and labor for twelve months. Products sold through dealers also carry limited warranties that are typically for twelve months and cover only parts and components. We also offer service contracts that generally cover equipment and maintenance after the original warranty period from one to three years.
Products sold by our direct sales force typically carry limited warranties covering parts and labor for twelve months. Products sold through dealers also carry limited warranties that are typically for one year and cover only parts and components. We also offer service contracts that generally cover equipment and maintenance after the original warranty period from one to three years.
In January 2021, the National Comprehensive Cancer Network revised its clinical practice guidelines to include BCI as the only gene expression assay to predict benefit from extended endocrine therapy for patients with early-stage HR+ breast cancer.
In January 2021, the National Comprehensive Cancer Network revised its clinical practice guidelines to include the BCI test as the only gene expression assay to predict benefit from extended endocrine therapy for patients with early-stage HR+ breast cancer.
Aptima-branded assays that are performed on the base Panther System Panther Fusion-branded assays that are performed on the Panther Fusion System Aptima HPV assay Panther Fusion Flu A/B/RSV assay Aptima HPV 16 18/45 Genotype assay Panther Fusion Paraflu assay Aptima HBV Quant assay Panther Fusion AdV/hMPV/RV assay Aptima CMV Quant assay Panther Fusion SARS-CoV-2/Flu A/B/RSV assay Aptima HIV-1 Quant Dx assay Panther Fusion GBS assay Aptima HCV Quant Dx assay Panther Fusion MRSA assay 2 Aptima Mycoplasma genitalium assay Panther Fusion Bordetella assay 2 Aptima Combo 2 assay (CT/NG) Panther Fusion EBV Quant assay 2 Aptima Chlamydia trachomatis assay (CT) Panther Fusion BKV Quant assay 2 Aptima Neisseria gonorrhoeae (NG) Panther Fusion SARS-CoV-2 assay 1,3 Aptima Trichomonas vaginalis assay Aptima HSV 1 and 2 assay Aptima CV/TV assay Aptima BV assay Aptima Zika assay 1 Aptima SARS-CoV-2 assay 1 Aptima SARS-CoV-2/Flu assay 1 1 This assay is subject to an Emergency Use Authorization (EUA) in the U.S. that may be revoked upon notice by the Food and Drug Administration (FDA). 2 This assay is available for sale in countries recognizing the CE-mark, and is not currently available for sale in the U.S. 3 This assay is not currently available for sale in countries recognizing the CE-mark.
Aptima-branded assays that are performed on the base Panther system Panther Fusion-branded assays that are performed on the Panther Fusion system Aptima HPV assay Panther Fusion Flu A/B/RSV assay Aptima HPV 16 18/45 Genotype assay Panther Fusion Paraflu assay Aptima HBV Quant assay Panther Fusion AdV/hMPV/RV assay Aptima CMV Quant assay Panther Fusion SARS-CoV-2/Flu A/B/RSV assay Aptima HIV-1 Quant Dx assay Panther Fusion GBS assay Aptima HCV Quant Dx assay Panther Fusion MRSA assay 2 Aptima Mycoplasma genitalium assay Panther Fusion Bordetella assay 2 Aptima Combo 2 assay (CT/NG) Panther Fusion EBV Quant assay 2 Aptima Chlamydia trachomatis assay (CT) Panther Fusion BKV Quant assay 2 Aptima Neisseria gonorrhoeae (NG) Panther Fusion SARS-CoV-2 assay 1,3 Aptima Trichomonas vaginalis assay Panther Fusion GI Bacterial assay Aptima HSV 1 and 2 assay Panther Fusion GI Extended Bacterial assay Aptima CV/TV assay Aptima BV assay Aptima Zika assay 1 Aptima SARS-CoV-2 assay Aptima SARS-CoV-2/Flu assay 1 1 This assay is subject to an Emergency Use Authorization (EUA) in the U.S. that may be revoked upon notice by the Food and Drug Administration (FDA). 2 This assay is available for sale in countries recognizing the CE-mark, and is not currently available for sale in the U.S. 3 This assay is not currently available for sale in countries recognizing the CE-mark.
Under the Federal Food, Drug and Cosmetic Act, known as the FD&C Act, manufacturers of medical products and devices must comply with certain regulations governing the design, testing, manufacturing, packaging, distribution, servicing and marketing of medical products.
Under the Federal Food, Drug and Cosmetic Act, known as the FD&C Act, manufacturers of medical devices must comply with certain regulations governing the design, testing, manufacturing, packaging, distribution, servicing and marketing.
Employee Engagement and Development Our goal is to develop and maintain a talented, engaged and diverse workforce that has a positive impact on our performance, and on our customers and their patients.
Employee Engagement and Development Our goal is to develop and maintain a talented and engaged workforce that has a positive impact on our performance, and on our customers and their patients.
Rapid Fetal Fibronectin Test The Rapid Fetal Fibronectin Test is a single-use disposable test used to determine a woman’s risk of pre-term birth by detecting the presence of a specific protein, fetal fibronectin, in vaginal secretions during pregnancy. The test utilizes a single-use, disposable cassette and is analyzed on our instrument, the TLi IQ System.
Rapid Fetal Fibronectin Test The Rapid Fetal Fibronectin Test, or Rapid fFN Test, is a single-use disposable test used to determine a woman’s risk of pre-term birth by detecting the presence of a specific protein, fetal fibronectin, in vaginal secretions during pregnancy. The test utilizes a single-use, disposable cassette and is analyzed on our instrument, the TLi IQ system.
These programs (which vary by country/region) include a variety of health plan options, annual performance incentive opportunities, employee stock purchase plan, and retirement savings programs, paid time off (including for charitable actions), leave programs, employee assistance programs and other wellness offerings. Equal pay for equal work is rooted in our values and foundational to fostering an inclusive environment.
These programs (which vary by country/region) include a variety of health plan options, annual performance incentive opportunities, employee stock purchase plan, and retirement savings programs, paid time off (including for charitable actions), leave programs, employee assistance programs and other wellness offerings. 16 Table of Contents Equal pay for equal work is rooted in our values and foundational to fostering an inclusive environment.
We also offer image analytic products such as the Genius AI Detection solution (Hologic’s first artificial intelligence cancer detection algorithm utilizing deep-learning technology for tomosynthesis), ImageChecker CAD-solution (provides markings of suspicious areas of the breast that may be cancerous in 2D exams), and Quantra software (automates breast density measurement for our mammography systems).
We also offer image analytic products such as the Genius AI Detection solution, including PRO, (Hologic’s artificial intelligence cancer detection algorithm utilizing deep-learning technology for tomosynthesis), ImageChecker CAD-solution (provides markings of suspicious areas of the breast that may be cancerous in 2D exams), and Quantra software (automates breast density measurement for our mammography systems).
Our respiratory infectious disease product line (including our assays for the detection of SARS-CoV-2) within our Diagnostics segment is also subject to significant seasonal and year-over-year fluctuations. In addition, the summer months, which occur during our fourth fiscal quarter, typically have had lower order rates internationally for most of our products.
Our respiratory infectious disease product line (including our assays for the detection of SARS-CoV-2) within our Diagnostics segment is also subject to significant seasonal and year-over-year fluctuations. In addition, the summer months, which occur during our fourth fiscal quarter, typically have had lower order rates internationally for most of our products. 17 Table of Contents
The MyoSure suite of devices offers four options to provide incision-less removal of fibroids, polyps, and other pathology within the uterus. The NovaSure portfolio is comprised of the NovaSure ADVANCED device and the NovaSure V5 device for the treatment of abnormal uterine bleeding. The Fluent and Fluent Pro fluid management system provides liquid distention during diagnostic and operative hysteroscopic procedures.
The MyoSure suite of devices offers four options to provide incision-less removal of fibroids, polyps, and other pathology within the uterus. The NovaSure portfolio is comprised of the NovaSure ADVANCED device and the NovaSure V5 device for the treatment of abnormal uterine bleeding. The Fluent and Fluent Pro fluid management systems provide liquid distention during diagnostic and operative hysteroscopic procedures.
ThinPrep System The ThinPrep System is the most widely used method for cervical cancer screening in the U.S.
ThinPrep System The ThinPrep System is the most widely used system for cervical cancer screening in the U.S.
Those manufacturing operations are also subject to additional challenges and risks associated with international operations described under the caption “Risk Factors” set forth in Part I, Item 1A of this Annual Report. 12 Table of Contents From time to time new regulations are enacted that can affect the content and manufacturing of our products.
Those manufacturing operations are also subject to additional challenges and risks associated with international operations described under the caption “Risk Factors” set forth in Part I, Item 1A of this Annual Report. From time to time new regulations are enacted that can affect the content and manufacturing of our products.
Each RNA amplicon serves as a new target for the reverse transcriptase and the process repeats automatically, resulting in an exponential amplification of the original target that can produce over a billion copies of the RNA amplicon in less than thirty minutes. 7 Table of Contents Hybridization Protection Assay (HPA) and Dual Kinetic Assay (DKA) Technologies.
Each RNA amplicon serves as a new target for the reverse transcriptase, and the process repeats automatically, resulting in an exponential amplification of the original target that can produce over a billion copies of the RNA amplicon in less than thirty minutes. Hybridization Protection Assay (HPA) and Dual Kinetic Assay (DKA) Technologies.
Our U.S. sales efforts also include the use of national account managers focused on obtaining purchasing contracts from large purchasing entities, such as managed care organizations, integrated delivery networks and government healthcare facilities. In addition, in certain regions of the U.S., we use a limited number of independent dealers or distributors to sell and service certain of our products.
Our U.S. sales efforts also include the use of national account managers focused on executing purchasing contracts with large purchasing entities, such as managed care organizations, integrated delivery networks and government healthcare facilities. In addition, in certain regions of the U.S., we use a limited number of independent dealers or distributors to sell and service certain of our products.
Our philanthropic and charitable efforts are an important part of our culture and linked to our efforts to work to improve the health of our 17 Table of Contents communities, customers, patients and employees, and seek to ensure that the decisions we make today have a positive effect on future generations.
Our philanthropic and charitable efforts are an important part of our culture and linked to our efforts to work to improve the health of our communities, customers, patients and employees, and seek to ensure that the decisions we make today have a positive effect on future generations.
In our GYN Surgical business, our primary competitors are large, full suite surgical solutions companies such as Johnson & Johnson and Medtronic, as well as a wide range of single technology or solutions companies that sell into a specific market segment or procedure (i.e., Hysterectomy).
In our GYN Surgical business, our primary competitors are large, full suite surgical solutions companies such as Johnson & Johnson and Medtronic, as well as a wide range of single technology or solutions companies that sell into a specific market segment or procedure.
Internationally, generally in locations where we sell directly, we also perform maintenance services for our products, and in other geographies we primarily use distributors, sales representatives and third parties to provide maintenance services for our products. Competition The healthcare industry is highly competitive and characterized by continual change and improvements in technology.
Internationally, generally in locations where we sell directly, we also perform maintenance services for our products, and in other geographies we primarily use distributors, sales representatives and third parties to provide maintenance services for our products. 11 Table of Contents Competition The healthcare industry is highly competitive and characterized by continual change and improvements in technology.
In connection with any such claims, we may seek to enter into settlement and/or licensing arrangements. There is a risk in these situations that no license 13 Table of Contents will be available or that a license will not be available on reasonable terms. Alternatively, we may decide or be required to litigate such claims.
In connection with any such claims, we may seek to enter into settlement and/or licensing arrangements. There is a risk in these situations that no license will be available or that a license will not be available on reasonable terms. Alternatively, we may decide or be required to litigate such claims.
We center our giving efforts in three specific areas to maximize our impact in ways that align with the values of our employees and customers: (i) women's health, and other healthcare fields in which Hologic operates; (ii) science, technology, engineering, and math education (STEM), especially for students from underserved communities; and (iii) social and racial equality, especially in healthcare.
We center our giving efforts in three specific areas to maximize our impact in ways that align with the values of our employees and customers: (i) women’s health, and other healthcare fields in which Hologic operates; (ii) science, technology, engineering, and math education (STEM), especially for students from underserved communities; and (iii) promoting equity, especially in education and healthcare.
Our primary Diagnostics products include our molecular diagnostic assays, which run on our advanced instrumentation systems (Panther and Panther Fusion), our ThinPrep cytology system, including our Genius Digital Diagnostics System, and the Rapid Fetal Fibronectin Test.
Our primary Diagnostics products include our molecular diagnostic assays, which run on our advanced instrumentation systems (Panther and Panther Fusion), our cytology systems, including the ThinPrep System, and the Genius Digital Diagnostics System, and the Rapid fFN Test.
Acessa ProVu System The Acessa ProVu system is used by laparoscopic surgeons to treat fibroids using controlled radiofrequency energy to cause coagulative necrosis. The treated tissue softens and shrinks over time, allowing fibroid symptoms to resolve without more invasive treatment.
Acessa ProVu System 10 Table of Contents The Acessa ProVu system is used by laparoscopic surgeons to treat fibroids using controlled radiofrequency energy to cause coagulative necrosis. The treated tissue softens and shrinks over time, allowing fibroid symptoms to resolve without more invasive treatment.
The Breast Cancer Index, or BCI, test is a PCR- 8 Table of Contents based gene expression test used for determining which patients with early-stage, hormone-receptor positive, or HR+, breast cancer are likely to benefit from extended endocrine therapy.
The Breast Cancer Index, or BCI, test is a PCR-based gene expression test used for determining which patients with early-stage, hormone-receptor positive, or HR+, breast cancer are likely to benefit from extended endocrine therapy.
Our professional development efforts are aimed at increasing organizational talent and capabilities and identifying and developing potential successors for key leadership positions. 16 Table of Contents Compensation and Benefits Our compensation philosophy aims to attract and retain top talent for today and the future.
Our professional development efforts are aimed at increasing organizational talent and capabilities and identifying and developing potential successors for key leadership positions. Compensation and Benefits Our compensation philosophy aims to attract and retain top talent for today and the future.
Our Panther Fusion system, including the related Fusion assays for flu, respiratory, Group B Strep (GBS), and transplant testing, extends the capabilities of our Panther system by adding the flexibility of polymerase chain reaction, or PCR, functionality to our existing Transcription Mediated Amplification, or TMA, based technology.
Our Panther Fusion system, including the related Fusion assays for respiratory infections, Group B Strep (GBS), and transplant testing, extends the capabilities of our Panther system by adding the flexibility of polymerase chain reaction, or PCR, functionality to our existing Transcription-Mediated Amplification, or TMA, 6 Table of Contents based technology.
Our acquisition of Endomagnetics Ltd (Endomag) complements and diversifies our expanding interventional breast health portfolio by adding wire-free breast surgery localization and lymphatic tracing solutions, including the Magseed marker, the Magtrace lymphatic tracer and the Sentimag platform, to Hologic’s breast surgery portfolio, providing breast surgeons and radiologists with an expanded range of options and enhanced user experience.
The addition of products from the Endomagnetics Ltd (Endomag) acquisition in fiscal 2024 complements and diversifies our expanding interventional breast health portfolio by adding wire-free breast surgery localization and lymphatic tracing solutions, including Magseed marker, Magtrace lymphatic tracer and the Sentimag platform, to Hologic’s breast surgery portfolio, providing breast surgeons and radiologists with an expanded range of options and enhanced user experience.
Patents and Proprietary Rights We rely primarily on a combination of trade secrets, patents, copyrights, trademarks and confidentiality procedures to protect our products and technology.
Patents and Proprietary Rights 13 Table of Contents We rely primarily on a combination of trade secrets, patents, copyrights, trademarks and confidentiality procedures to protect our products and technology.
An interruption in manufacturing capabilities at any of these facilities, as a result of equipment failure or other reasons, could reduce, delay or prevent the production of our products. Some of our manufacturing operations are located outside of the U.S., including in Costa Rica and the United Kingdom.
An interruption in manufacturing capabilities at any of these facilities, as a result of equipment failure or other reasons, could reduce, delay or prevent the production of our products. Some of our manufacturing operations are located outside of the U.S., primarily Costa Rica and England.
Our GYN Surgical products include our MyoSure hysteroscopic tissue removal system, our NovaSure endometrial ablation system, our Fluent fluid management system, our Acessa ProVu laparoscopic radiofrequency ablation system, as well as our CoolSeal vessel sealing portfolio and our JustRight surgical stapler.
Our GYN Surgical products include our MyoSure hysteroscopic tissue removal system, our NovaSure endometrial ablation system, our Fluent fluid management system, our Sonata transcervical radiofrequency ablation system, our Acessa ProVu laparoscopic radiofrequency ablation system, and our CoolSeal vessel sealing portfolio and our JustRight surgical stapler.
The Genius Digital Diagnostics System was CE-marked for diagnostic use in the EU in November 2020 and received marketing clearance from the FDA for diagnostic use in the U.S. in January 2024.
The Genius Digital Diagnostics System was CE-marked for diagnostic use in the EU in 8 Table of Contents November 2020 and received marketing clearance from the FDA for diagnostic use in the U.S. in January 2024.
If a laboratory is out of compliance with CLIA or with state laws or regulations governing licensed laboratories, penalties may include suspension, limitation or revocation of the license or CLIA certificate, assessment of financial penalties or fines, or imprisonment.
If a laboratory is non-compliant with CLIA requirements or with state laws or regulations governing licensed laboratories, penalties may include suspension, limitation or revocation of the license or CLIA certificate, assessment of financial penalties or fines, or imprisonment.
Approximately 4,113 of these employees are in the U.S. and approximately 2,950 were outside the U.S. In various countries outside the U.S., certain of our employees are unionized and, where local law requires, participate in works councils.
Approximately 4,055 of these employees are in the U.S. and approximately 3,015 were outside the U.S. In various countries outside the U.S., certain of our employees are unionized and, where local law requires, participate in works councils.
In addition, we also compete with alternative treatments to our NovaSure system, such as drug therapy, intrauterine devices, hysterectomy, dilation and curettage and rollerball ablation. Because drug therapy is an alternative to our NovaSure procedure, competitors to NovaSure also include many major pharmaceutical companies that manufacture hormonal drugs for women.
In addition, we also compete with alternative treatments to our GYN Surgical products, such as drug therapy, intrauterine devices, hysterectomy, dilation and curettage and rollerball ablation. Because drug therapy is an alternative to certain of our procedures, competitors also include many major pharmaceutical companies that manufacture hormonal drugs for women.
Our assay portfolio also includes diagnostic tests for a range of acute respiratory infections, including SARS-CoV-2, various strains of influenza and parainfluenza, and respiratory syncytial virus, as well as a test for the detection of Group B Streptococcus, or GBS, that are run on the Panther Fusion system, a field upgradeable instrument addition to the base Panther system.
Our assay portfolio also includes diagnostic tests for a range of acute respiratory infections, including SARS-CoV-2, various strains of influenza and parainfluenza, and respiratory syncytial virus, as well as a test for the detection of Group B Streptococcus, or GBS, as well as two assays that detect several bacterial gastrointestinal (GI) pathogens that commonly cause acute gastroenteritis; all of which are run on the Panther Fusion system, a field upgradeable instrument addition to the base Panther system.
The FDA will approve a PMA only if after evaluating the supporting technical data it finds that the PMA contains sufficient, valid scientific evidence to assure that the device is safe and effective for its intended use(s). This approval may be granted with post-approval requirements including inspection of manufacturing facilities and/or additional patient follow-up for an indefinite period of time.
The FDA will approve a PMA if the data provided is sufficient and contains valid scientific evidence to assure that the device is 14 Table of Contents safe and effective for its intended use(s). This approval may be granted with post-approval requirements including inspection of manufacturing facilities, additional clinical studies and/or additional patient follow-up for an indefinite period of time.
Regulatory The manufacture, sale, lease and service of medical diagnostic and surgical devices intended for commercial use are subject to extensive governmental regulation by the FDA in the U.S. and by a variety of regulatory agencies in other countries.
Regulatory The manufacture, sale, lease and service of medical devices and in vitro diagnostics (IVDs) intended for commercial use are subject to extensive governmental regulation by the FDA in the U.S. and by a variety of regulatory agencies globally.
We understand that we rely on our employees worldwide to propel our organization forward with great ideas, innovations and leadership. As of September 28, 2024, we had 7,063 full-time employees, including 2,208 in manufacturing operations, 1,774 in sales and marketing, 1,472 in support services, 784 in research and development, and 825 in general administration.
We understand that we rely on our employees worldwide to propel our organization forward with great ideas, innovations and leadership. As of September 27, 2025, we had 7,070 full-time employees, including 2,270 in manufacturing operations, 1,731 in sales and marketing, 1,472 in support services, 775 in research and development, and 822 in general administration.
Unless the context otherwise requires, references to “we”, “us”, “Hologic” or “the Company” refer to Hologic, Inc. and its consolidated subsidiaries. 5 Table of Contents Available Information Our internet website address is www.hologic.com .
Effective in fiscal 2026, we are discontinuing the sale of our Fluoroscan Insight FD systems. Unless the context otherwise requires, references to “we”, “us”, “Hologic” or “the Company” refer to Hologic, Inc. and its consolidated subsidiaries. 5 Table of Contents Available Information Our internet website address is www.hologic.com .
Our Aptima family of molecular diagnostic assays integrates a number of proprietary core technologies, including our target capture technology, our TMA technology, and our hybridization protection assay, or HPA, and dual kinetic assay, or DKA, technologies, to produce highly sensitive amplification assays.
Our Aptima family of molecular diagnostic assays integrates a number of proprietary core technologies, including our target capture technology, our TMA technology, and our hybridization protection assay, or HPA, and dual kinetic assay, or DKA, technologies, to produce highly sensitive amplification assays. Each of these technologies is described in greater detail below under the heading “ Proprietary Core Technologies ”.
Safety performance is assessed throughout the year by management and during annual performance reviews. In addition, we have developed several employee-focused initiatives to support the physical, mental, and financial well-being of our employees.
We have also developed safety rules and procedures to address behaviors and work practices that can lead to accidents and injuries. Safety performance is assessed throughout the year by management and during annual performance reviews. In addition, we have developed several employee-focused initiatives to support the physical, mental, and financial well-being of our employees.
In the event we are unable to obtain sufficient quantities of raw materials or components or subassemblies on commercially reasonable terms or in a timely manner, our ability to manufacture our products on a timely and cost-competitive basis may be compromised, which may have a material adverse effect on our business, financial condition and results of operations.
In the event we are unable to obtain sufficient quantities of raw materials or components or subassemblies on commercially reasonable terms or in a timely manner, our ability to manufacture our products on a timely and cost-competitive basis may be compromised, which may have a material adverse effect on our business, financial condition and results of operations. 12 Table of Contents Our current supplier of certain key raw materials for certain of our amplified NAT diagnostic assays is Roche, a direct competitor of our Diagnostics business.
In fiscal 2024, 2023, and 2022, no customer accounted for more than 10% of our consolidated revenues. Our U.S. sales force is structured to specifically target the customers in each of our business segments. We maintain distinct teams focused on the Diagnostics, Breast Health, GYN Surgical, and Skeletal Health markets.
Our U.S. sales force is structured to specifically target the customers in each of our business segments. We maintain distinct teams focused on the Diagnostics, Breast Health, GYN Surgical, and Skeletal Health markets.
Breast Biopsy and Surgery Products We offer a wide range of minimally invasive products for breast biopsy and breast surgery. Our breast biopsy portfolio includes three types of tethered vacuum-assisted breast biopsy products: the Brevera, ATEC, and Eviva devices. Each tethered device is powered by a console and utilizes our fluid management system.
The Affirm system is pre-programmed for use with our Brevera, Eviva and ATEC vacuum-assisted breast biopsy devices. Breast Biopsy and Surgery Products We offer a wide range of minimally invasive products for breast biopsy and breast surgery. Our breast biopsy portfolio includes three types of tethered vacuum-assisted breast biopsy products: Brevera, ATEC, and Eviva devices.
In May 2022, we obtained CE-marking for two new molecular assays, Panther Fusion EBV Quant assay for quantitation of Epstein-Barr virus, and the Panther Fusion BKV Quant assay for quantitation of the BK virus.
We also offer two CE-marked molecular assays, the Panther Fusion EBV Quant assay for quantitation of Epstein-Barr virus, and the Panther Fusion BKV Quant assay for quantitation of the BK virus.
We may be required to incur significant costs to comply with these laws and regulations in the future and complying with these laws may result in a material adverse effect upon our business, financial condition and results of operations. Sales of medical devices outside of the U.S. are subject to foreign requirements that vary widely from country to country.
We may be required to incur significant costs to comply with these laws and regulations in the future and complying with these laws may result in a material adverse effect upon our business, financial condition and results of operations.
These systems provide an alternative to open surgical biopsy and can be performed as an outpatient procedure under local anesthesia, allowing shorter recovery times. The Affirm tomosynthesis option provides faster lesion targeting and reduced patient procedure time compared to traditional stereotactic biopsy procedures. The Affirm system is pre-programmed for use with our Brevera, Eviva and ATEC vacuum-assisted breast biopsy devices.
These systems provide an alternative to open surgical biopsy and can be performed as an outpatient procedure under local anesthesia, allowing shorter recovery times. The Affirm tomosynthesis option provides faster lesion 9 Table of Contents targeting and reduced patient procedure time compared to traditional stereotactic biopsy procedures.
In our Diagnostics business, our primary competitors are Roche Diagnostics and Becton Dickinson, as well as a wide range of diagnostics companies that sell a single or limited number of assays or products in only a specific market segment (i.e., Cytology, Acute Care, or Oncology Services). 11 Table of Contents In our Breast & Skeletal Health business, our primary competitors are large imaging companies such as Siemens Healthineers and GE Healthcare, as well as a wide range of medical technology companies that sell a subset of technology solutions into a specific market segment (i.e., Breast Biopsy, Breast Surgery).
In our Breast & Skeletal Health business, our primary competitors are large imaging companies such as Siemens Healthineers and GE Healthcare, as well as a wide range of medical technology companies that sell a subset of technology solutions into a specific market segment (i.e., Breast Biopsy, Breast Surgery).
We also offer viral load tests for the quantitation of Hepatitis B virus, Hepatitis C virus, human immunodeficiency virus, or HIV-1, and human cytomegalo virus, or CMV, for use on our Panther instrument system. In addition, we offer bacterial vaginosis and candida vaginitis assays for the diagnosis of vaginitis, a common and complex ailment affecting millions of women a year.
We also offer viral load tests for the quantitation of Hepatitis B virus, Hepatitis C virus, human immunodeficiency virus, or HIV-1, and human cytomegalo virus, or CMV, for use on our Panther instrument system.
The JustRight 5 mm stapler features a smaller instrument profile and is used for laparoscopic general and pediatric surgery.
The CoolSeal portfolio includes the CoolSeal Trinity, CoolSeal Reveal, and CoolSeal Mini advanced bipolar vessel sealing devices. The JustRight 5 mm stapler features a smaller instrument profile and is used for laparoscopic general and pediatric surgery.
These measurements provide value in diverse settings, from clinical cancer care, obesity and diabetes medicine, and preventative healthcare, to athletic performance. 10 Table of Contents Fluoroscan Insight FD Our Fluoroscan Insight FD is a mini C-arm imaging system that provides low intensity, real-time x-ray imaging, with high-resolution images at radiation levels and at a cost below those of conventional x-ray and standard sized fluoroscopic equipment.
Fluoroscan Insight FD Our Fluoroscan Insight FD is a mini C-arm imaging system that provides low intensity, real-time x-ray imaging, with high-resolution images at radiation levels and at a cost below those of conventional x-ray and standard sized fluoroscopic equipment.
We anticipate that governmental authorities will continue to scrutinize the healthcare industry closely and that changes in laws, regulations or policies by governmental authorities may cause increases in uncertainties and compliance costs, exposure to litigation and other adverse effects to our business and operations.
The global regulatory environment continues to evolve, especially in the areas of cyber security and AI. We anticipate that regulators will continue to scrutinize the healthcare industry closely and that changes in laws, regulations or policies may cause increased uncertainty, compliance costs, exposure to litigation and other adverse effects to our business and operations.
Mini C-arm systems are used primarily by orthopedic surgeons to assist in performing minimally invasive surgical procedures on a patient’s extremities, such as the hand, wrist, knee, foot and ankle. Marketing, Sales and Service We sell and service our products through a combination of direct sales and service forces and a network of independent distributors and sales representatives.
Mini C-arm systems are used primarily by orthopedic surgeons to assist in performing minimally invasive surgical procedures on a patient’s extremities, such as the hand, wrist, knee, foot and ankle. Effective in fiscal 2026, we are discontinuing the sale of this system.
Stratec SE, or Stratec, is the only manufacturer of the Panther and Panther Fusion instruments; and Flextronics Medical Sales and Marketing, LTD, or Flextronics, is the only manufacturer of our Skeletal Health finished goods products.
We have sole source third-party contract manufacturers for each of our molecular diagnostics instrument product lines and for our Skeletal Health products. Stratec SE, or Stratec, is the only manufacturer of the Panther and Panther Fusion instruments; and Flextronics Medical Sales and Marketing, LTD, or Flextronics, is the only manufacturer of our Skeletal Health finished goods products.
Unless otherwise noted, the assays shown in the table below have been approved or cleared for sale in the U.S. and are available for sale in countries recognizing the CE-mark. Certain of the assays shown below are also available in certain other markets such as Australia, Canada, China, Japan, New Zealand, South Korea and the United Kingdom.
Certain of the assays shown below are also available in certain other markets such as Australia, Canada, China, Japan, New Zealand, South Korea and the United Kingdom.
The time required to obtain approval from a foreign country to market and sell our products may be longer or shorter than that required for FDA approval and the requirements may differ. In addition, we may be required to meet the FDA’s export requirements or receive FDA export approval for the export of our products to foreign countries.
The time required to obtain approval to market and sell our products varies by country and region and may be longer or shorter than that required for FDA clearance or approval and the requirements may differ.
Our Horizon line of x-ray bone densitometers incorporates advanced features designed for bone health screening and body composition assessment. Body composition assessment is the precise measurement of bone, lean mass, and fat mass within the body.
Our Horizon line of x-ray bone densitometers incorporates advanced features designed for bone health screening and body composition assessment. Body composition assessment is the precise measurement of bone, lean mass, and fat mass within the body. These measurements provide value in diverse settings, from clinical cancer care, obesity and diabetes medicine, and preventative healthcare, to athletic performance.
Transcription-Mediated Amplification (TMA) Technology . The goal of amplification technologies is to increase the copy number of a target nucleic acid sequences that may be present in samples in small numbers. These copies can then be detected using nucleic acid probes.
The goal of amplification technologies is to increase the copy number of a target nucleic acid sequence that may be present in samples in small numbers. These copies can then be detected using nucleic acid probes. Amplification technologies can yield results in only a few hours versus the several days or weeks required for traditional culture methods.
We may need to first obtain an investigational device exemption (for significant risk devices), known as an IDE, in order to conduct extensive clinical testing of the device to obtain the necessary clinical data for submission to the FDA.
In addition to bench and non-clinical testing, an investigational device exemption (for significant risk devices), known as an IDE, must be obtained in order to conduct clinical testing of the device to obtain the necessary clinical data for inclusion in the PMA.
Loss of a laboratory's CLIA certificate or state license may also result in the inability to receive payments from state and federal health care programs as well as private third-party payors. 14 Table of Contents Certain analyte specific reagents, referred to as ASR products, as with other Class I products, may be sold without 510(k) clearance or PMA approval.
Loss of a laboratory’s CLIA certificate or state license may also result in the inability to receive payments from state and federal health care programs as well as private third-party payors.
The PMA process involves a complex and lengthy testing process that is subject to review by the FDA and may require several years to obtain.
Class III or high-risk device development requiring a premarket approval (“PMA”) involves a complex and lengthy testing process that is subject to review by the FDA and may require several years to complete and gain approval.
We seek to reduce risk and protect our employees and communities by employing safe technologies and operating procedures, and by maintaining a business continuity program to stay prepared for emergencies. We have also developed safety rules and procedures to address behaviors and work practices that can lead to accidents and injuries.
We employ management systems and procedures designed to protect human safety, health, and the environment. We seek to reduce risk and protect our employees and communities by employing safe technologies and operating procedures, and by maintaining a business continuity program to stay prepared for emergencies.
Delays in receipt of, or failure to obtain, clearances or 15 Table of Contents approvals for future products could delay or preclude realization of product revenues from new products or result in substantial additional costs which could decrease our profitability.
Delays in receipt of, or failure to obtain, clearances or approvals for future products could delay or preclude realization of product revenues from new products or result in substantial additional costs which could decrease our profitability. 15 Table of Contents For additional information about the regulations to which our business is subject and the impact such regulations may have on our business, see the disclosures under the captions “Manufacturing” and “Reimbursement” in this Item 1, and “Risk Factors” in Item 1A below.
The Acessa ProVu system is a fully integrated system that uses laparoscopic ultrasound, guidance mapping and radiofrequency ablation to treat nearly all types of fibroids. The CoolSeal portfolio includes the CoolSeal Trinity, CoolSeal Reveal, and CoolSeal Mini advanced bipolar vessel sealing devices.
The Sonata system uses transcervical, intrauterine ultrasound guidance to treat a wide range of fibroid types without the need for incisions. The Acessa ProVu system is a fully integrated system that uses laparoscopic ultrasound, guidance mapping and radiofrequency ablation to treat nearly all types of fibroids.
We use magnetic separation to concentrate the target by drawing the magnetic beads to the sides of a sample tube, while the remainder of the sample is removed from the tube. When used in conjunction with our amplification procedures, target capture techniques concentrate the nucleic acid target(s) and also remove materials in the sample that might otherwise interfere with amplification.
When used in conjunction with our amplification procedures, target capture techniques concentrate the nucleic acid target(s) and also remove materials in the sample that might otherwise interfere with amplification. 7 Table of Contents Transcription-Mediated Amplification (TMA) Technology .
The ATEC device can be used under all standard imaging guidance modalities (stereotactic x-ray, ultrasound, MRI and molecular breast imaging) whereas our Brevera and Eviva devices are used exclusively under stereotactic x-ray guidance. We also offer non-tethered, spring-loaded, and vacuum-assisted core biopsy devices, such as the Celero and Sertera, which are exclusively used under ultrasound guidance.
Each tethered device is powered by a console and utilizes our fluid management system. The ATEC device can be used under all standard imaging guidance modalities (stereotactic x-ray, ultrasound, MRI and molecular breast imaging) whereas our Brevera and Eviva devices are used exclusively under stereotactic x-ray guidance.
The second enzyme, an RNA polymerase, makes thousands of copies of the complementary RNA sequence, known as the “RNA amplicon,” from the double-stranded DNA template.
TMA is a transcription-based amplification system that uses two different enzymes to drive the process. The first enzyme is a reverse transcriptase that creates a double-stranded DNA copy from an RNA or DNA template. The second enzyme, an RNA polymerase, makes thousands of copies of the complementary RNA sequence, known as the “RNA amplicon,” from the double-stranded DNA template.
These two assays are the first quantitative real-time PCR assays on the Panther Fusion system, and, together with the Aptima CMV Quant assay, expand our menu of transplant monitoring assays. The ThinPrep System is primarily used in cytology applications, such as cervical cancer screening, and the Rapid Fetal Fibronectin Test assists physicians in assessing the risk of pre-term birth.
These two assays are the first quantitative real-time PCR assays on the Panther Fusion system, and, together with the Aptima CMV Quant assay, comprise our menu of transplant monitoring assays.
Each of these technologies is described in greater detail below under the heading “ Proprietary Core 6 Table of Contents Technologies ”. Our Panther Fusion family of molecular diagnostic assays are performed on the Panther Fusion System and utilize PCR technology to amplify target nucleic acid sequences for easier detection.
Our Panther Fusion family of molecular diagnostic assays are performed on the Panther Fusion system and utilize PCR technology to amplify target nucleic acid sequences for easier detection. Unless otherwise noted, the assays shown in the table below have been approved or cleared for sale in the U.S. and are available for sale in countries recognizing the CE-mark.
We also 9 Table of Contents have products for surgical site marking, tissue localization, and sentinel lymph node biopsies, as well as specimen imaging products for radiology, surgery and pathology.
We also offer non-tethered, spring-loaded, and vacuum-assisted core biopsy devices, such as the Celero and Sertera devices, which are exclusively used under ultrasound guidance. We also have products for surgical site marking, tissue localization, and sentinel lymph node biopsies, as well as specimen imaging products for radiology, surgery and pathology.
As part of our continued commitment to transparency on diversity, our U.S. Federal Employment Information Report (EEO-1) is also publicly available on our website. Health, Safety and Wellness We seek to comply in letter and in spirit with applicable health and safety laws and regulations and implement programs, policies and procedures to achieve compliance throughout the Company.
Health, Safety and Wellness We seek to comply in letter and in spirit with applicable health and safety laws and regulations and implement programs, policies and procedures to achieve compliance throughout the Company. We also establish our own environmental health and safety standards in addition to those that are legally required.
Our Class I and Class II exempt medical devices must follow Hologic’s internal Quality System processes prior to commercialization and throughout their product lifecycle. We must meet requirements under FDA's quality system regulation (QSR), establishment registration, medical device listing, labeling and medical device reporting (MDR) regulations.
The FDA generally must clear or approve new medical devices in Classes II and III prior to commercial sales. Our Class I and Class II exempt medical devices must follow Hologic’s internal Quality System processes prior to commercialization and throughout their product lifecycle.
Adverse interpretations of current CLIA regulations or future changes in CLIA regulations could have an adverse effect on sales of any affected products or services. These laboratories are also licensed by the appropriate state agencies in the states in which they operate, where such licensure is required.
Adverse interpretations of current CLIA regulations or future changes in CLIA regulations could have an adverse effect on sales of services. The laboratory also holds a license from the state of California and licenses or permits as required from other state agencies where out-of-state clinical laboratories must be licensed to run samples obtained from their state.
The SEC maintains an internet website that contains reports, proxy and information statements, and other information regarding Hologic and other issuers that file electronically with the SEC. The SEC’s internet website address is www.sec.gov . Products We view our operations and manage our current business in four principal reporting segments: Diagnostics, Breast Health, GYN Surgical and Skeletal Health.
The SEC maintains an internet website that contains reports, proxy and information statements, and other information regarding Hologic and other issuers that file electronically with the SEC. The SEC’s internet website address is www.sec.gov . Proposed Merger On October 21, 2025, the Company entered into a definitive agreement to be acquired by funds managed by Blackstone Inc.
A 510(k) pre-market notification filing must contain information establishing that the device to be sold is substantially equivalent to a device commercially distributed prior to May 28, 1976 or to a device that has been determined by the FDA to be substantially equivalent.
We must meet requirements under FDA’s quality system regulation (QSR), establishment registration, medical device listing, labeling and medical device reporting (MDR) regulations. A 510(k) pre-market notification must contain information establishing that the device to be sold is substantially equivalent (SE) to a predicate device.
Removed
In response to the COVID-19 pandemic, we developed and launched the Aptima SARS-CoV-2 assay and the Aptima SARS-CoV-2/Flu assay (each of which runs on our standard Panther system) and the Panther Fusion SARS-CoV-2 assay and the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (which run on our Panther Fusion system).
Added
In addition, we offer bacterial vaginosis and candida vaginitis assays, or BV/CV, for the diagnosis of vaginitis, a common and complex ailment affecting millions of women a year.
Removed
We also generate service revenues from our CLIA-certified laboratory for testing related to breast cancer and all metastatic cancers. Our Breast Health segment offers a broad portfolio of solutions for breast imaging, biopsy, breast surgery and pathology.
Added
The ThinPrep System and the Genius Digital Diagnostics System are primarily used in cytology applications, such as cervical cancer screening, and the Rapid fFN Test assists physicians in assessing the risk of pre-term birth. We also generate service revenues from our CLIA-certified laboratory for testing related to breast cancer using our Breast Cancer Index or BCI test.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeAdditionally, the regulatory environment in China continues to evolve, and officials in the Chinese government exercise broad discretion in deciding how to interpret and apply regulations. It is possible that the Chinese government’s current or future interpretation and application of existing or new regulations will negatively impact our China operations, result in regulatory investigations or lead to fines or penalties.
Biggest changeIt is possible that the Chinese government’s current or future interpretation and application of existing or new regulations will negatively impact our China operations, result in regulatory investigations or lead to fines or penalties. BUSINESS DEVELOPMENT AND COMPETITION Our long-term success will depend upon our ability to execute on business development activities and integrate acquired businesses.
No customer represented more than 10% of Diagnostics revenue in fiscal 2023 or 2022. The loss of any of these key customers, or a significant reduction in sales volume or pricing to these customers, could significantly reduce our Diagnostics segment revenues or profitability.
No customer represented more than 10% of Diagnostics revenue in fiscal 2023. The loss of any of these key customers, or a significant reduction in sales volume or pricing to these customers, could significantly reduce our Diagnostics segment revenues or profitability.
The successful commercialization of our newly developed products and newly introduced enhancements to our existing products are subject to numerous risks, both known and unknown, including: • uncertainty of the development of a market for such product; • trends relating to, or the introduction or existence of, competing products or technologies that may be more effective, safer or easier to use than our products or technologies; • the perception of our products as compared to other products; • recommendation and support for the use of our products by influential customers, such as highly regarded hospitals, physicians and treatment centers; • the availability and extent of data demonstrating the clinical efficacy of our products or treatments; • competition, including the presence of competing products sold by companies with longer operating histories, more recognizable names and more established distribution networks; and • other technological developments.
The successful commercialization of our newly developed products and newly introduced enhancements to our existing products are subject to numerous risks, both known and unknown, including: • uncertainty of the development of a market for such product; 25 Table of Contents • trends relating to, or the introduction or existence of, competing products or technologies that may be more effective, safer or easier to use than our products or technologies; • the perception of our products as compared to other products; • recommendation and support for the use of our products by influential customers, such as highly regarded hospitals, physicians and treatment centers; • the availability and extent of data demonstrating the clinical efficacy of our products or treatments; • competition, including the presence of competing products sold by companies with longer operating histories, more recognizable names and more established distribution networks; and • other technological developments.
As a result, governmental actions may adversely affect our business, operations or financial condition, including : • new laws, regulations or judicial decisions, or new interpretations of existing laws, regulations or decisions, related to healthcare availability, method of delivery and payment for healthcare products and services; • changes in the FDA and foreign regulatory approval processes that may delay or prevent the approval of new products and result in lost market opportunity; • changes in FDA and foreign regulations that may require additional safety monitoring, labeling changes, restrictions on product distribution or use, or other measures after the introduction of our products to market, which could increase our costs of doing business, adversely affect the future permitted uses of approved products, or otherwise adversely affect the market for our products; and • new laws, regulations and judicial decisions affecting pricing or marketing practices.
As a result, governmental actions may adversely affect our business, operations or financial condition, including : • new laws, regulations or judicial decisions, or new interpretations of existing laws, regulations or decisions, related to healthcare availability, method of delivery and payment for healthcare products and services; • changes in the FDA and foreign regulatory approval processes that may delay or prevent the approval of new products and result in lost market opportunity; 19 Table of Contents • changes in FDA and foreign regulations that may require additional safety monitoring, labeling changes, restrictions on product distribution or use, or other measures after the introduction of our products to market, which could increase our costs of doing business, adversely affect the future permitted uses of approved products, or otherwise adversely affect the market for our products; and • new laws, regulations and judicial decisions affecting pricing or marketing practices.
BUSINESS CONTINUITY AND RELIANCE ON THIRD PARTIES Supply Chain and Manufacturing 25 Table of Contents Supply chain constraints and inflationary pressures have had, and in the future, may have, a material adverse effect on our ability to procure raw materials and components, including semiconductor chips, and to meet customer demand for, and increase our costs to manufacture, warehouse, and transport, certain of our products.
BUSINESS CONTINUITY AND RELIANCE ON THIRD PARTIES Supply Chain and Manufacturing Supply chain constraints and inflationary pressures have had, and in the future, may have, a material adverse effect on our ability to procure raw materials and components, including semiconductor chips, and to meet customer demand for, and increase our costs to manufacture, warehouse, and transport, certain of our products.
An interruption in manufacturing, testing capabilities or warehousing at any of these facilities, as a result of equipment failure, transportation interruptions, disruptions caused by strikes or other labor unrest, epidemics or pandemics, natural disaster, environmental factors or property damage could reduce, delay or prevent the production and distribution of our products.
An interruption in manufacturing, testing capabilities or warehousing at any of these facilities, as a result of equipment failure, transportation interruptions, disruptions caused by strikes or other labor unrest, epidemics or pandemics, natural disaster, 28 Table of Contents environmental factors or property damage could reduce, delay or prevent the production and distribution of our products.
Although we do not currently have any customers that represent more than 10% of our consolidated revenues, a material portion of product sales in our Diagnostics segment comes from (and we anticipate will continue to come from) a limited number of customers, two of which accounted for 12.8% and 10.1% of our Diagnostics segment revenue in fiscal 2024.
Although we do not currently have any customers that represent more than 10% of our consolidated revenues, a material portion of product sales in our Diagnostics segment comes from (and we anticipate will continue to come from) a limited number of customers, two of which accounted for 13.6% and 10.8% of our Diagnostics segment revenue in fiscal 2025 and 12.8% and 10.1% of our Diagnostics segment revenue in fiscal 2024.
We also have other contractual obligations and deferred tax liabilities, which as of September 28, 2024, are described under “Notes to Consolidated Financial Statements — Income Taxes, and Non-cancelable Purchase Commitments.” This significant level of indebtedness and our other obligations may: • make it more difficult for us to satisfy our obligations with respect to our outstanding indebtedness; • increase our vulnerability to general adverse economic and industry conditions, including increases in interest rates; • require us to dedicate a substantial portion of our cash flow from operations to interest and principal payments on our indebtedness, which would reduce the availability of our cash flow to fund working capital, capital expenditures, expansion efforts, strategic transactions and other general corporate purposes; • limit our flexibility in planning for, or reacting to, changes in our business and the markets in which we participate; • place us at a competitive disadvantage compared to our competitors that have less debt; and • limit our ability to borrow additional funds for working capital, capital expenditures, expansion efforts, strategic transactions or other general corporate purposes.
We also have other contractual obligations and deferred tax liabilities, which as of September 27, 2025, are described under “Notes to Consolidated Financial Statements — Income Taxes, and Non-cancelable Purchase Commitments.” This significant level of indebtedness and our other obligations may: • make it more difficult for us to satisfy our obligations with respect to our outstanding indebtedness; • increase our vulnerability to general adverse economic and industry conditions, including increases in interest rates; 30 Table of Contents • require us to dedicate a substantial portion of our cash flow from operations to interest and principal payments on our indebtedness, which would reduce the availability of our cash flow to fund working capital, capital expenditures, expansion efforts, strategic transactions and other general corporate purposes; • limit our flexibility in planning for, or reacting to, changes in our business and the markets in which we participate; • place us at a competitive disadvantage compared to our competitors that have less debt; and • limit our ability to borrow additional funds for working capital, capital expenditures, expansion efforts, strategic transactions or other general corporate purposes.
The integration of an acquired business, whether or not successful, requires significant efforts which may result in additional expenses and divert the attention of our management and technical personnel from other projects. Acquisitions, in particular, are inherently risky, and we cannot guarantee that any past or future transaction will be successful.
The integration of an acquired 24 Table of Contents business, whether or not successful, requires significant efforts which may result in additional expenses and divert the attention of our management and technical personnel from other projects. Acquisitions, in particular, are inherently risky, and we cannot guarantee that any past or future transaction will be successful.
In addition, on October 20, 2015, the American Cancer Society issued guidelines recommending that women start annual mammograms at age 45 instead of 40 and have a mammogram every two years instead of annually. We believe that this recommendation may have resulted in a decrease in the use of mammography systems.
In addition, on October 20, 2015, the American Cancer Society issued guidelines recommending that 26 Table of Contents women start annual mammograms at age 45 instead of 40 and have a mammogram every two years instead of annually. We believe that this recommendation may have resulted in a decrease in the use of mammography systems.
These and similar legislation that has been or is in the process of being enacted in Japan, China and various states 22 Table of Contents of the U.S. may require us to re-design our products to ensure compliance with the applicable standards, for example by requiring the use of different types of materials.
These and similar legislation that has been or is in the process of being enacted in Japan, China and various states of the U.S. may require us to re-design our products to ensure compliance with the applicable standards, for example by requiring the use of different types of materials.
We anticipate that we will enter into new licensing arrangements in the ordinary course of business to expand our product portfolio and access new technologies to enhance our products and develop new products. Many of these licenses will provide us with exclusive rights to the subject technology or disease marker.
We anticipate that we will enter into new licensing arrangements in the ordinary course of business to expand our product portfolio and access new technologies to enhance our products and develop new products. Many of these licenses will provide us with exclusive rights to the subject 29 Table of Contents technology or disease marker.
REGULATORY AND LEGAL We operate in a highly regulated industry and our business generally is subject to extensive and complex laws and governmental regulations, and changes in healthcare laws and regulations or our inability to obtain in a timely manner or at all U.S. or foreign regulatory clearances or approvals for our current and newly developed products and services or product or service enhancements or any adverse regulatory action could adversely affect our business and prospects. 20 Table of Contents We operate in a highly regulated industry.
REGULATORY AND LEGAL We operate in a highly regulated industry and our business generally is subject to extensive and complex laws and governmental regulations, and changes in healthcare laws and regulations or our inability to obtain in a timely manner or at all U.S. or foreign regulatory clearances or approvals for our current and newly developed products and services or product or service enhancements or any adverse regulatory action could adversely affect our business and prospects.
We also continue to face the challenges of maintaining employee well-being, recognizing that the continued additional financial, family and health burdens that many employees may be experiencing due to macroeconomic uncertainties, including inflation, and other factors, may adversely impact job performance and employee retention.
We also continue to face the challenges of maintaining employee well-being, recognizing that the continued additional financial, family and health burdens that many employees may be experiencing due to macroeconomic 22 Table of Contents uncertainties, including inflation, and other factors, may adversely impact job performance and employee retention.
In addition, changes in environmental laws and regulations, in particular relating to climate change and greenhouse gas (“GHG”) emissions, could require us, or our contract manufacturers or suppliers, to install additional equipment, or alter operations to incorporate new technologies or processes, which may result in additional expenses and adversely affect our operating results.
In addition, changes in environmental laws and regulations, in particular relating to climate change and 21 Table of Contents greenhouse gas (“GHG”) emissions, could require us, or our contract manufacturers or suppliers, to install additional equipment, or alter operations to incorporate new technologies or processes, which may result in additional expenses and adversely affect our operating results.
While the federal law applies only to products or services for which payment may be made by a federal healthcare program, state laws often apply regardless of whether federal funds may 21 Table of Contents be involved.
While the federal law applies only to products or services for which payment may be made by a federal healthcare program, state laws often apply regardless of whether federal funds may be involved.
Economic uncertainty, an increase in unemployment rates, as well as an 23 Table of Contents increase in health insurance premiums, co-payments and deductibles may result in cost-conscious consumers making fewer trips to their physicians and specialists, which in turn would adversely affect demand for our products and procedures.
Economic uncertainty, an increase in unemployment rates, as well as an increase in health insurance premiums, co-payments and deductibles may result in cost-conscious consumers making fewer trips to their physicians and specialists, which in turn would adversely affect demand for our products and procedures.
Changes in tax laws or regulations in the jurisdictions in which we operate, including the U.S. and as led by the Organization for Economic Cooperation and Development of a global minimum tax, could negatively impact the Company’s effective tax rate, results of operations and cash flows.
Changes in tax laws or regulations in the jurisdictions in which we operate, both in the U.S. and outside of the U.S., including the introduction of a global minimum tax as led by the Organization for Economic Cooperation and Development “OECD” , could negatively impact the Company’s effective tax rate, results of operations and cash flows.
Other federal and state laws generally prohibit individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent, or are for items or services that were not provided as claimed.
Other federal and state laws generally prohibit individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that 20 Table of Contents are false or fraudulent, or are for items or services that were not provided as claimed.
INTELLECTUAL PROPERTY 27 Table of Contents Our business is dependent on technologies we license, and if we fail to maintain these licenses or license new technologies and rights to particular nucleic acid sequences for targeted diseases in the future, we may be limited in our ability to develop new products.
INTELLECTUAL PROPERTY Our business is dependent on technologies we license, and if we fail to maintain these licenses or license new technologies and rights to particular nucleic acid sequences for targeted diseases in the future, we may be limited in our ability to develop new products.
Increased global cybersecurity vulnerabilities, threats, computer viruses, ransomware and phishing attacks and more sophisticated and targeted cyber-related attacks, as well as cybersecurity and other information technology failures resulting 24 Table of Contents from human error and technological errors, pose a risk to the security of Hologic and its customers, business partners' and suppliers' products, systems and networks and the confidentiality, availability and integrity of data on these products, systems and networks.
Increased global cybersecurity vulnerabilities, threats, computer viruses, ransomware and phishing attacks and more sophisticated and targeted cyber-related attacks, as well as cybersecurity and other information technology failures resulting from human error and technological errors, pose a risk to the security of Hologic and its customers, business partners and suppliers products, systems and networks and the confidentiality, availability and integrity of data on these products, systems and networks.
Our international operations and foreign acquisitions expose us to additional operational challenges that we might not otherwise face. International expansion is a key component of our growth strategy. In fiscal 2024, 25.0% of our revenue came from outside of the U.S.
Our international operations and foreign acquisitions expose us to additional operational challenges that we might not otherwise face. 23 Table of Contents International expansion is a key component of our growth strategy. In fiscal 2025, 25.7% of our revenue came from outside of the U.S.
As COVID-19 testing declines, and there is greater use of rapid tests and at-home collection tests, continued decline in demand for our COVID-19 assays without a corresponding increase in our other businesses or customers consolidating their molecular testing menu to high throughput, high automation platforms which may further increase the competition our Panther and Panther Fusion instruments face could have a material, adverse effect on our results of operations, cash flow and financial position. 18 Table of Contents Challenges in the development of our products could materially impact our long-term success.
As COVID-19 testing declines, and there is greater use of rapid tests and at-home collection tests, continued decline in demand for our COVID-19 assays without a corresponding increase in our other businesses or customers consolidating their molecular testing menu to high throughput, high automation platforms may further increase the competition our Panther and Panther Fusion instruments face and could have a material, adverse effect on our results of operations, cash flow and financial position.
Our growth depends in large part on our ability to identify and develop new products or new indications for or enhancements of existing products. The development of new products and enhancement of existing products requires significant investment in research and development, clinical trials and regulatory approvals.
Challenges in the development of our products could materially impact our long-term success. Our growth depends in large part on our ability to identify and develop new products or new indications for or enhancements of existing products. The development of new products and enhancement of existing products requires significant investment in research and development, clinical trials and regulatory approvals.
For example, collecting, measuring and reporting environmental data is subject to evolving reporting standards, including the SEC’s climate-related reporting requirements, if such reporting requirements survive pending judicial review, California’s disclosure requirements and similar regulations established by other international regulatory bodies, such as the Corporate Sustainability Reporting Directive in the European Union.
For example, collecting, measuring and reporting environmental data is subject to evolving reporting standards, including California’s disclosure requirements and similar regulations established by other international regulatory bodies, such as the Corporate Sustainability Reporting Directive in the European Union.
A significant portion of our indebtedness is subject to floating interest rates, which may expose us to higher interest payments. 29 Table of Contents A significant portion of our indebtedness is subject to floating interest rates, which makes us more vulnerable in the event of adverse economic conditions, increases in prevailing interest rates, or a downturn in our business.
A significant portion of our indebtedness is subject to floating interest rates, which makes us more vulnerable in the event of adverse economic conditions, increases in prevailing interest rates, or a downturn in our business.
As of September 28, 2024, approximately $1.2 billion aggregate principal of our indebtedness, which represented the outstanding principal under our credit facilities, was subject to floating interest rates. We currently have hedging arrangements (interest rate swaps) in place to partially mitigate the impact of higher interest rates.
As of September 27, 2025, approximately $1.2 billion aggregate principal of our indebtedness, which represented the outstanding principal under our credit facilities, was subject to floating interest rates. We currently have a hedging arrangement (interest rate swap) in place to partially mitigate the impact of higher interest rates.
Continued concerns about the systemic impact of potential long-term and wide-spread recession and geopolitical issues, including wars and terrorism, have contributed to increased market volatility and diminished expectations for economic growth in the world.
Continued concerns about the systemic impact of potential recession and geopolitical issues, including wars and terrorism, have contributed to increased market volatility and uncertainty for economic growth in the world.
Our long-term success will depend upon our ability to execute on business development activities and integrate acquired businesses. 19 Table of Contents As part of our long-term strategy, we are engaged in business development activities including evaluating future acquisitions, joint development opportunities, technology licensing arrangements and other opportunities to further expand our presence in or diversify into priority growth areas by accessing new products and technologies.
As part of our long-term strategy, we are engaged in business development activities including evaluating future acquisitions, joint development opportunities, technology licensing arrangements and other opportunities to further expand our presence in or diversify into priority growth areas by accessing new products and technologies.
The markets in which we sell our products are intensely competitive, subject to rapid technological change and may be significantly affected by new product introductions and other market activities of industry participants, and these competitive pressures may reduce the demand and prices for our products. Other companies may develop products that are superior to and/or less expensive than our products.
We face intense competition from other companies and may not be able to compete successfully. The markets in which we sell our products are intensely competitive, subject to rapid technological change and may be significantly affected by new product introductions and other market activities of industry participants, and these competitive pressures may reduce the demand and prices for our products.
If we do not generate sufficient cash flow from operations, and additional borrowings, refinancings or proceeds from asset sales are not available to us, we may not have sufficient cash to enable us to meet all of our obligations.
If we do not generate sufficient cash flow from operations, and additional borrowings, refinancings or proceeds from asset sales are not available to us, we may not have sufficient cash to enable us to meet all of our obligations. A significant portion of our indebtedness is subject to floating interest rates, which may expose us to higher interest payments.
Those manufacturing operations are also subject to additional challenges and risks associated with international operations described herein. 26 Table of Contents Pandemics or disease outbreaks, such as the COVID-19 pandemic, have created and may in the future create significant volatility, uncertainty and economic disruption in the markets we sell our products into and operate in, primarily the U.S., Europe, and Asia-Pacific and may negatively impact business and healthcare activity globally.
Pandemics or disease outbreaks, such as the COVID-19 pandemic, have created and may in the future create significant volatility, uncertainty and economic disruption in the markets we sell our products into and operate in, primarily the U.S., Europe, and Asia-Pacific and may negatively impact business and healthcare activity globally.
The EU General Data Protection Regulation (GDPR) applies uniformly across the EU and includes, among other things, a requirement for prompt notice of data breaches to data subjects and supervisory authorities in certain circumstances. The GDPR also requires companies processing personal data of individuals residing in the EU to comply with EU privacy and data protection rules.
The EU General Data Protection Regulation (GDPR) applies uniformly across the EU and includes, among other things, a requirement for prompt 27 Table of Contents notice of data breaches to data subjects and supervisory authorities in certain circumstances.
GENERAL RISK FACTORS Provisions in our charter, bylaws, and indebtedness may have the effect of discouraging advantageous offers for our business or common stock and limit the price that investors might be willing to pay in the future for shares of our common stock.
This interest rate swap contract hedges a notional amount of $500 million through September 25, 2026. 31 Table of Contents GENERAL RISK FACTORS Provisions in our charter, bylaws, and indebtedness may have the effect of discouraging advantageous offers for our business or common stock and limit the price that investors might be willing to pay in the future for shares of our common stock.
The implementation of more restrictive trade policies, such as more detailed inspections, higher tariffs or new barriers to entry, could negatively impact our business, results of operations and financial condition. For example, a government's adoption of “buy national” policies or retaliation by another government against such policies could have a negative impact on our results of operations.
The implementation of more restrictive trade policies, such as more detailed inspections, higher tariffs or new barriers to entry, could negatively impact our business, results of operations and financial condition.
A weakening of macroeconomic conditions may also adversely affect our suppliers, which could result in interruptions in supply. In addition, continuing social and political concerns and divisions in the U.S. and throughout the world, could have a material, adverse effect on the economic conditions in markets we serve, and our results of operations, cash flow and financial position.
In addition, continuing social and political concerns and divisions in the U.S. and throughout the world, including the impact of prolonged or recurring U.S. federal government shutdowns, could have a material, adverse effect on the economic conditions in markets we serve, and our results of operations, cash flow and financial position.
This report contains forward-looking statements; please refer to the cautionary statements made under the heading “Special Note Regarding Forward-Looking Statements” for more information on the qualifications and limitations on forward-looking statements. COMPETITION AND BUSINESS DEVELOPMENT We face intense competition from other companies and may not be able to compete successfully.
This report contains forward-looking statements; please refer to the cautionary statements made under the heading “Special Note Regarding Forward-Looking Statements” for more information on the qualifications and limitations on forward-looking statements.
TALENT AND EMPLOYEE RETENTION Our success depends on our ability to attract, motivate and retain key personnel and plan for future executive transitions. The loss of any of our key personnel, particularly executive management or key research and development personnel, could harm our business and prospects and could impede the achievement of our research and development, operational or strategic objectives.
The loss of any of our key personnel, particularly executive management or key research and development personnel, could harm our business and prospects and could impede the achievement of our research and development, operational or strategic objectives.
Some of our manufacturing operations are located outside the U.S., including in Costa Rica and the United Kingdom.
Some of our manufacturing operations are located outside the U.S., including in Costa Rica and the United Kingdom. Those manufacturing operations are also subject to additional challenges and risks associated with international operations described herein.
INDEBTEDNESS We have a significant amount of indebtedness outstanding, which limits our operating flexibility, and could adversely affect our operations and financial results and prevent us from fulfilling our obligations . 28 Table of Contents As of September 28, 2024, we had approximately $2.55 billion aggregate principal of indebtedness outstanding (exclusive of additional funds that would be available to draw under our revolver), and we may incur additional indebtedness in the future.
As of September 27, 2025, we had approximately $2.5 billion aggregate principal of indebtedness outstanding (exclusive of additional funds that would be available to draw under our revolver), and we may incur additional indebtedness in the future.
We are also subject to ongoing tax audits in various jurisdictions, and tax authorities may disagree with certain positions we have taken and assess additional taxes. GLOBAL CHALLENGES, INCLUDING MACROECONOMIC CONDITIONS AND RELATED FINANCIAL RISKS The continuing worldwide macroeconomic and geopolitical uncertainty may adversely affect our business and prospects, both domestically and internationally.
GLOBAL CHALLENGES, INCLUDING MACROECONOMIC CONDITIONS AND RELATED FINANCIAL RISKS The continuing worldwide macroeconomic and geopolitical uncertainty, as well as existing tariffs and trade wars, may adversely affect our business and prospects, both domestically and internationally.
Our products are also subject to approval and regulation by foreign regulatory and safety agencies.
In addition, the process of responding to and implementing changes as a result of such inspections can be costly and time consuming and negatively impact our business. Our products are also subject to approval and regulation by foreign regulatory and safety agencies.
Removed
Elections and political changes in various countries, including the U.S., may further exacerbate geopolitical and geoeconomic tensions and market instability.
Added
Some of the factors, events and contingencies discussed below may have occurred in the past, but the disclosures below are not representations as to whether or not the factors, events or contingencies have occurred in the past and instead reflect our beliefs and opinions as to the factors, events or contingencies that could materially and adversely affect our business in the future.
Removed
We have two consecutive interest rate swaps that will provide us with a continued hedge, in the notional amounts of $500 million, through September 25, 2026.
Added
PROPOSED ACQUISITION BY BLACKSTONE AND TPG There are uncertainties associated with the proposed Merger (as defined below), including the risk that the Merger may not close in the anticipated timeframe or at all due to one or more of the closing conditions to the Merger not being satisfied or waived, which may have an adverse effect on our business, financial condition, results of operations and stock price.
Added
On October 21, 2025, we entered into a definitive agreement (the “Merger Agreement”) to be acquired by funds managed by Blackstone and TPG.
Added
Under the terms of the agreement, Blackstone and TPG will acquire all outstanding Hologic shares for $76.00 per share in cash, without interest, plus a non-tradable contingent value right (“CVR”) to receive up to $3.00 per share, for total potential consideration of $79.00 per share in cash.
Added
The non-tradable CVR will be issued to Hologic stockholders at closing and paid, in whole or in part, following achievement of certain global revenue metrics for our Breast Health business in fiscal years 2026 and 2027.
Added
The transaction is expected to close in the first half of calendar year 2026, subject to the approval of Hologic’s stockholders, the receipt of required regulatory approvals and the satisfaction of certain other customary closing conditions (please see Note 2 to our consolidated financial statements for additional information related to the acquisition).
Added
If the Merger is completed, we will become a privately held company, meaning that the Company’s common stock will be delisted from the Nasdaq stock market and deregistered under the Securities Exchange Act of 1934, as amended.
Added
Completion of the Merger is subject to various closing conditions, including, among other things, approval of the adoption of the Merger Agreement by our stockholders and the receipt of applicable regulatory approvals.
Added
Further, if the Merger has not been consummated on or before July 21, 2026 (subject to (a) one three-month extension under certain circumstances for the purpose of obtaining certain regulatory approvals and (b) extension in certain circumstances if the marketing period for Blackstone’s and TPG’s debt financing has commenced but has not yet been completed), then the Merger Agreement may be terminated by either party.
Added
There is no assurance that receipt of all applicable regulatory approvals will occur, or that all of the other closing conditions will be satisfied (or waived, to the extent permitted by applicable law), or that the Merger will be completed on the terms reflected in the Merger Agreement, within the expected timeframe, or at all.
Added
The announcement and pendency of the Merger may create disruption in and uncertainties for our business, which could have an adverse effect on our ability to retain and hire key personnel and to maintain relationships with our business partners, suppliers, vendors and customers.
Added
These business partners, suppliers and customers could attempt to negotiate changes in existing business relationships, consider entering into business relationships with parties other than us, delay or defer decisions concerning their business with us, or terminate their existing business relationships with us during pendency of the Merger.
Added
Adverse changes in our relationships with employees, business partners, suppliers and customers may continue or intensify in the event the Merger is not consummated or is significantly delayed.
Added
As a result, there can be no assurance that our business, financial condition and results of operations will not be adversely affected, as compared to prior to the announcement of the Merger Agreement.
Added
Management’s attention may also be diverted towards activities focused on completing the Merger, which could further impact these relationships and also the execution of our business plan and the quality of our products. If the Merger is not completed, we and our stockholders may suffer other consequences.
Added
To the extent that the current market price of our stock reflects an assumption that the Merger will be completed, the price of our common stock could decrease if the Merger is not completed. Further, investor confidence in us could decline, and stockholder litigation could be brought against us.
Added
In addition, we will have incurred significant costs, expenses and fees for professional services and other transaction costs in connection with the Merger, including for activities that we would have not undertaken other than to complete the Merger.
Added
As a result, to the extent the Merger is not completed, we will receive little or no benefit from incurring these costs, and in the absence of the Merger, these costs may have been allocated elsewhere.
Added
In addition, if the Merger Agreement is terminated under certain circumstances, we may be required to pay Blackstone a termination fee equal to $540 million (or $225 million during the go shop period, as described in the Merger Agreement), which could have adverse effect on our financial condition and results of operations. 18 Table of Contents We are subject to certain restrictions on the conduct of our business under the terms of the Merger Agreement.
Added
Under the terms of the Merger Agreement, we have agreed to certain restrictions (unless approved by Blackstone and TPG) on the operations of our business that could harm our business relationships, financial condition, operating results, cash flows and business, including restrictions with respect to our ability to, among other things, subject to certain specified exceptions: amend our organizational documents, issue shares of capital stock, make loans or capital contributions, declare dividends, purchase shares of its capital stock, incur indebtedness for borrowed money, incur capital expenditures (other than pursuant to our capital expenditures budget), enter into or materially amend material contracts, change accounting policies, settle litigation, sell material assets, increase employee compensation above certain thresholds, enter into collective bargaining agreements, conduct mass layoffs, waive any noncompetition, nonsolicitation, nondisclosure or other restrictive covenants for certain employees, acquire other companies or businesses, change material tax elections or settle tax investigations or license, transfer, abandon or dispose of material Company intellectual property or source code.
Added
Because of these restrictions, we may be prevented from undertaking certain actions with respect to the conduct of our business that we might otherwise have taken if not for the Merger Agreement.
Added
Such restrictions could prevent us from pursuing certain business opportunities that arise prior to the effective time of the Merger and are outside the ordinary course of business and could otherwise adversely affect our business and operations prior to completion of the Merger.
Added
We have incurred, and will continue to incur, direct and indirect costs as a result of the Merger.
Added
We have incurred, and will continue to incur, significant costs and expenses, including regulatory costs, fees for professional services and other transaction costs in connection with the Merger, for which we will have received little or no benefit if the Merger is not completed.
Added
There are a number of factors beyond our control that could affect the total amount or the timing of these costs and expenses. Many of these fees and costs will be payable by us even if the Merger is not completed and may relate to activities that we would not have undertaken other than to complete the Merger.
Added
Lawsuits relating to the Merger could be filed against us, including by our stockholders. Although litigation is common in connection with acquisitions of public companies in the U.S., regardless of any merits related to the underlying acquisition, the outcome of any lawsuits filed against us is uncertain and could delay or prevent completion of the Merger.
Added
We may not be successful in defending against any such claims. Additionally, the costs of defense of such litigation, including costs associated with the indemnification of directors and officers, and other effects, such as negative publicity or damage to our relationships with business partners, suppliers and customers, could have an adverse effect on our business, financial condition and operating results.
Added
Because the value of the CVR payments is uncertain, our stockholders cannot be certain of the precise value of the consideration they may receive in the Merger.
Added
At the time the Merger is completed, each issued and outstanding share of our common stock (other than certain excluded shares), will be automatically cancelled and converted into the right to receive $76.00 per share in cash, without interest, plus a non-tradable CVR to receive up to $3.00 per share in cash, for total potential consideration of $79.00 per share in cash.
Added
The non-tradable CVR will be issued to Hologic stockholders at closing and paid, in whole or in part, following achievement of certain global revenue metrics for our Breast Health business in fiscal years 2026 and 2027. There can be no assurance that any payment will be made under the CVR, or regarding the amount or timing of any such payment.
Added
Any amounts to be received in connection with the CVR are contingent upon achievement of certain global revenue metrics for our Breast Health business in fiscal years 2026 and 2027, which may or may not occur.
Added
There are numerous risks and uncertainties associated with receiving payment under the CVR, including that our Breast Health business will not achieve the global revenue thresholds set forth in the CVR agreement.
Added
We also face increasing attention from investors, regulators, and other stakeholders, who may have conflicting views, related to our positions, performance, and disclosures relating to sustainability-related matters and are subject to legal and regulatory requirements relating to such positions, performance, and disclosures.
Added
These requirements continue to broaden and may be conflicting, both in terms of scope and geography, a trend we expect to continue.
Added
If we draw scrutiny for the positions we take or do not take on these matters (or for altering any such position) or receive unfavorable ratings from third-party organizations that provide information to investors on such matters, it could be used by investors, lenders, customers and employees to inform their investment, financing, purchasing or employment decisions, which could have a negative impact on our business.
Added
Additionally, a failure to adequately meet regulatory expectations may result in non-compliance, the loss of business and reputational impacts, and we may become the target of litigation or investigations initiated by government authorities or private actors alleging that our activities related to these matters are anti-competitive, discriminatory or otherwise unlawful.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeOur cybersecurity risk management program includes the following: • A dedicated staff of cybersecurity and risk management professionals; • Defined security policies and standards; • Annual mandatory employee cybersecurity and privacy compliance awareness training; • Cybersecurity tooling for detecting and responding to cyber incidents; • Cybersecurity incident response and major crisis plans that govern activities such as detection, coordination, remediation, recovery, and escalation to senior management and, where appropriate, our Audit and Finance Committee and our Board; • Disaster recovery plans; • Periodic tabletop exercises to promote awareness and improve internal processes; • Periodic penetration testing and vulnerability management processes; and • Third-party risk assessments for suppliers and vendors, which may require such third parties to sign data processing agreements, comply with particular security controls, or complete an additional security and privacy assessment.
Biggest changeOur cybersecurity risk management program includes the following: • A dedicated staff of cybersecurity and risk management professionals; • Defined security policies and standards; • Annual mandatory employee cybersecurity and privacy compliance awareness training; • Cybersecurity tooling for detecting and responding to cyber incidents; • Cybersecurity incident response and major crisis plans that govern activities such as detection, coordination, remediation, recovery, and escalation to senior management and, where appropriate, our Audit and Finance Committee and our Board; • Back-up & recovery plans; • Periodic tabletop exercises to promote awareness and improve internal processes; • Periodic penetration testing and vulnerability management processes; and • Third-party risk assessments for suppliers and vendors, which may require such third parties to sign data processing agreements, comply with particular security controls, or complete an additional security and privacy assessment.
On a quarterly basis, our CIO and CISO provide updates to the Audit and Finance Committee on 31 Table of Contents the cybersecurity and related risk management programs, including recent developments and current risk assessments.
On a quarterly basis, our CIO and CISO provide updates to the Audit and Finance Committee on 33 Table of Contents the cybersecurity and related risk management programs, including recent developments and current risk assessments.

Item 2. Properties

Properties — owned and leased real estate

1 edited+1 added−0 removed3 unchanged
Biggest changeMaterial Properties Owned: Primary Use Newark, DE Breast Health DirectRay digital detector research and development and plate manufacturing operations Manchester, UK Administrative and supply chain operations Londonderry, NH Diagnostics manufacturing operations San Diego, CA Diagnostics headquarters, including administrative and manufacturing operations San Diego, CA Diagnostics research and development, administrative and manufacturing operations Material Properties Leased: Primary Use Lease Expiration (fiscal year) Renewals Marlborough, MA Headquarters, including research and development, manufacturing and distribution operations 2034 1, five-year period Marlborough, MA Manufacturing operations 2029 None Alajuela, Costa Rica Administrative and Surgical and Breast Health manufacturing facility 2028 2, five-year periods Manchester, UK Diagnostics manufacturing operations 2035 None We also lease various administrative and customer support centers throughout the world including in Brussels, Belgium, Berlin, Germany, Madrid, Spain, United Kingdom and Shanghai and Beijing, China.
Biggest changeMaterial Properties Owned: Primary Use Newark, DE Breast Health capital equipment manufacturing operations and research and development Manchester, England Administrative and supply chain operations Londonderry, NH Diagnostics manufacturing operations San Diego, CA Diagnostics headquarters, including administrative and manufacturing operations San Diego, CA Diagnostics research and development, administrative and manufacturing operations Material Properties Leased: Primary Use Lease Expiration (fiscal year) Renewals Marlborough, MA Headquarters, including research and development, manufacturing and distribution operations 2034 1, five-year period Marlborough, MA Manufacturing operations 2029 None Alajuela, Costa Rica Administrative and Surgical and Breast Health manufacturing facility 2028 2, five-year periods Manchester, England** Diagnostics manufacturing operations 2030 1, 5-year period ** During the fourth quarter of fiscal 2025, the Company announced that it was shutting down its manufacturing operations at the Company’s Manchester, England location, which manufactures certain molecular diagnostics products that are also manufactured at our San Diego, California facility.
Added
Please refer to Note 8 to the consolidated financial statements for further details. We also lease various administrative and customer support centers throughout the world including in Brussels, Belgium, Berlin, Germany, Madrid, Spain, United Kingdom and Shanghai and Beijing, China.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

7 edited+0 added−2 removed2 unchanged
Biggest changeIssuer's Purchases of Equity Securities Period of Repurchase Total Number of Shares Purchased (#) (2) Average Price Paid Per Share ($) (2) Total Number of Shares Purchased As Part of Publicly Announced Plans or Programs (#) (2) Maximum Number (or Approximate Dollar Value) of Shares That May Yet Be Purchased Under Our Programs (in millions) ($) (1)(2) June 30, 2024 – July 27, 2024 4,010 $ 72.94 4,010 $ 248.3 July 28, 2024 – August 24, 2024 190,607 80.00 190,607 233.1 August 25, 2024 – September 28, 2024 534,228 79.96 534,228 1,690.3 Total 728,845 $ 79.93 728,845 $ 1,690.3 ___________________________________ (1) On September 12, 2024, the Board of Directors authorized a stock repurchase program, with a five-year term, to repurchase up to $1.5 billion of the Company’s outstanding stock.
Biggest changeIssuer’s Purchases of Equity Securities Period of Repurchase Total Number of Shares Purchased (#) (1) Average Price Paid Per Share ($) (1) Total Number of Shares Purchased As Part of Publicly Announced Plans or Programs (#) (1) Maximum Number (or Approximate Dollar Value) of Shares That May Yet Be Purchased Under Our Programs (in millions) ($) (1) June 29, 2025 – July 26, 2025 — $ — — $ 937.5 July 27, 2025 – August 23, 2025 — — — 937.5 August 24, 2025 – September 27, 2025 — — — 937.5 Total — $ — — $ 937.5 ___________________________________ (1) On September 12, 2024, the Board of Directors authorized a stock repurchase program, with a five-year term, to repurchase up to $1.5 billion of the Company’s outstanding stock.
For additional information regarding the Company’s repurchase programs, please see “ Management's Discussion and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources – Stock Repurchase Program.” 33 Table of Contents Stock Performance Graph The following information shall not be deemed to be “filed” with the SEC nor shall the information be incorporated by reference into any filings under the Securities Act, except to the extent that we specifically incorporate it by reference into a document filed under the Securities Act or the Exchange Act.
For additional information regarding the Company’s repurchase programs, please see “ Management’s Discussion and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources – Stock Repurchase Program.” 35 Table of Contents Stock Performance Graph The following information shall not be deemed to be “filed” with the SEC nor shall the information be incorporated by reference into any filings under the Securities Act, except to the extent that we specifically incorporate it by reference into a document filed under the Securities Act or the Exchange Act.
The existing covenants under certain of our credit facilities also place limits on our ability to issue dividends and repurchase stock. Recent Sales of Unregistered Securities. We did not sell unregistered securities during the fourth quarter of fiscal 2024.
The existing covenants under certain of our credit facilities also place limits on our ability to issue dividends and repurchase stock. Recent Sales of Unregistered Securities. We did not sell unregistered securities during the fourth quarter of fiscal 2025.
The following graph compares cumulative total shareholder return on our common stock since September 28, 2019 with the cumulative total return of the Standard & Poor’s 500 Index and the S&P Health Care Supplies Index. This graph assumes the investment of $100 on September 28, 2019 in our common stock.
The following graph compares cumulative total shareholder return on our common stock since September 26, 2020 with the cumulative total return of the Standard & Poor’s 500 Index and the S&P Health Care Supplies Index. This graph assumes the investment of $100 on September 26, 2020 in our common stock.
We have never declared or paid cash dividends on our capital stock, and we currently have no plans to do so. Our current policy is to retain all of our earnings to finance future growth (including acquisitions), pay down our existing indebtedness and repurchase our common stock.
We have never declared or paid cash dividends on our capital stock, and we currently have no plans to do so. Our policy has been to retain all of our earnings to finance future growth (including acquisitions), pay down our indebtedness and repurchase our common stock.
As of November 21, 2024, there were approximately 703 holders of record of our common stock, including multiple beneficial holders at depositories, banks and brokers listed as a single holder in the street name of each respective depository, bank or broker. Dividend Policy .
As of November 13, 2025, there were approximately 617 holders of record of our common stock, including multiple beneficial holders at depositories, banks and brokers listed as a single holder in the street name of each respective depository, bank or broker. Dividend Policy .
These programs do not obligate the Company to acquire a minimum number of shares. Under these programs, shares may be repurchased in privately negotiated and/or open market transactions, including under plans complying with Rule 10b5-1 under the Exchange Act.
As of September 27, 2025, $937.5 million remained unused under this program. The repurchase program does not obligate the Company to acquire a minimum number of shares. Shares may be repurchased in privately negotiated and/or open market transactions, including under plans complying with Rule 10b5-1 under the Exchange Act.
Removed
This new stock repurchase authorization is in addition to the Company’s prior stock repurchase authorization. As of September 28, 2024, $1.5 billion remained unused under this program.
Removed
(2) On September 22, 2022, the Board of Directors authorized a stock repurchase program, with a five-year term, to repurchase up to $1.0 billion of the Company’s outstanding common stock, effective as of the close of trading on September 23, 2022. As of September 28, 2024, $190.3 million remained unused under this program.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

110 edited+48 added−74 removed56 unchanged
Biggest changeThese decreases were partially offset by a lower principal balance outstanding under our 2021 Credit Agreement as we voluntarily prepaid $250.0 million during the first quarter of fiscal 2024. 42 Table of Contents Other Income (Expense), net Years Ended September 28, 2024 September 30, 2023 Change Amount Amount Amount % Other Income (Expense), net $ (4.1) $ (1.7) $ (2.4) 141.2 % In fiscal 2024, this account primarily consisted of net foreign currency exchange losses of $21.0 million, primarily from the mark-to-market of foreign currency contracts used to hedge operating results and to a lesser extent losses of $3.6 million from our Maverix strategic investment that is accounted for under the equity method, partially offset by a gain of $14.9 million from the change in cash surrender value of life insurance contracts related to our deferred compensation plan driven by stock market gains and a gain of $6.3 million from a change in control provision related to a license agreement.
Biggest changeOther Income (Expense), net Years Ended September 27, 2025 September 28, 2024 Change Amount Amount Amount % Other Income (Expense), net $ 9.6 $ (4.1) $ 13.7 (334.1) % In fiscal 2025, this account primarily consisted of net foreign currency exchange gains of $11.6 million, primarily from the mark-to-market of foreign currency contracts used to hedge operating results and a gain of $7.5 million from the change in cash surrender value of life insurance contracts related to our deferred compensation plan driven by stock market gains, partially offset by losses of $9.0 million from our Maverix strategic investment that is accounted for under the equity method. 44 Table of Contents In fiscal 2024, this account primarily consisted of net foreign currency exchange losses of $21.0 million, primarily from the mark-to-market of foreign currency contracts used to hedge operating results and to a lesser extent losses of $3.6 million from our Maverix strategic investment that is accounted for under the equity method, partially offset by a gain of $14.9 million from the change in cash surrender value of life insurance contracts related to our deferred compensation plan driven by stock market gains and a gain of $6.3 million from a change in control provision related to a license agreement.
These solutions include 3D digital mammography systems, image analysis software utilizing artificial intelligence, reading workstations, minimally invasive breast biopsy guidance systems, breast biopsy site markers, localization, and specimen radiology systems. Our most advanced breast imaging platforms, Selenia 3D Dimensions and 3Dimensions systems, utilize tomosynthesis to produce 3D images that show multiple contiguous slice images of the breast.
These solutions include 3D digital mammography systems, image analysis software utilizing artificial intelligence, reading workstations, minimally invasive breast biopsy guidance systems, breast biopsy site markers, localization, and specimen radiology systems. Our most advanced breast imaging platforms, Selenia Dimensions and 3Dimensions systems, utilize tomosynthesis to produce 3D images that show multiple contiguous slice images of the breast.
During the third quarter of fiscal 2024, the Federal Drug Administration classified a prior safety notice for the BioZorb Marker as a Class I recall. This was a technical classification of a prior safety notice only, not a product removal. Following this, we lowered our forecast for this product line, which is an indicator of impairment.
During the third quarter of fiscal 2024, the Federal Drug Administration classified a prior safety notice for the BioZorb Marker as a Class I recall. This was a technical classification of a prior safety notice only, not a product removal. Following this, we lowered our forecast for this product line, which was an indicator of impairment.
Our longer-term liquidity is contingent upon future operating performance. We may also require additional capital in the future to fund capital expenditures, repayment of debt, acquisitions, strategic transactions or other investments. As described above, we have significant indebtedness outstanding under our 2021 Credit Agreement, 2028 Senior Notes, and 2029 Senior Notes. These capital requirements could be substantial.
Our longer-term liquidity is contingent upon future operating performance. We may also require additional capital in the future to fund capital expenditures, repayment of debt, acquisitions, strategic transactions or other investments. As described above, we have significant indebtedness outstanding under our 2025 Credit Agreement, 2028 Senior Notes, and 2029 Senior Notes. These capital requirements could be substantial.
The 2021 Credit Agreement contains affirmative and negative covenants customarily applicable to senior secured credit facilities including the requirement we maintain two financial covenants (a total net leverage ratio and an interest coverage ratio) measured as of the last day of each quarter for the previous twelve-month period.
The 2025 Credit Agreement contains affirmative and negative covenants customarily applicable to senior secured credit facilities including the requirement we maintain two financial covenants (a total net leverage ratio and an interest coverage ratio) measured as of the last day of each quarter for the previous twelve-month period.
To estimate the fair value of the asset group, we utilized the income approach, which is based on a discounted cash flow (DCF) analysis and calculated the fair value by estimating the after-tax cash flows attributable to the asset group and then discounting the after-tax cash flows to present value using a risk-adjusted discount rate.
To estimate the fair value of the asset groups, we utilized the income approach, which is based on a discounted cash flow (DCF) analysis, and calculated the fair value by estimating the after-tax cash flows attributable to the asset groups and then discounting the after-tax cash flows to present value using a risk-adjusted discount rate.
In addition, subject to the terms and conditions set forth in the 2021 Credit Agreement, we may be required to make certain mandatory prepayments from the net proceeds of specified types of asset sales (subject to certain reinvestment rights), debt issuances (excluding permitted debt) and insurance recoveries (subject to certain reinvestment rights).
In addition, subject to the terms and conditions set forth in the 2025 Credit Agreement, we may be required to make certain mandatory prepayments from the net proceeds of specified types of asset sales (subject to certain reinvestment rights), debt issuances (excluding permitted debt) and insurance recoveries (subject to certain reinvestment rights).
We believe we used reasonable estimates and assumptions about future revenue, cost projections, cash flows, discount rates and market multiple as of the measurement date. As a result of completing this analysis, all of our reporting units had fair values exceeding their carrying values.
We believe we used reasonable estimates and assumptions about future revenue, cost projections, cash flows, and discount rates as of the measurement date. As a result of completing this analysis, all of our reporting units had fair values exceeding their carrying values.
The MyoSure suite of devices offers four options to provide incision-less removal of fibroids, polyps, and other pathology within the uterus. The NovaSure portfolio is comprised of the NovaSure ADVANCED device and the NovaSure V5 device for the treatment of abnormal uterine bleeding. The Fluent and Fluent Pro fluid management system provides liquid distention during diagnostic and operative hysteroscopic procedures.
The MyoSure suite of devices offers four options to provide incision-less removal of fibroids, polyps, and other pathology within the uterus. The NovaSure portfolio is comprised of the NovaSure ADVANCED device and the NovaSure V5 device for the treatment of abnormal uterine bleeding. The Fluent and Fluent Pro fluid management systems provide liquid distention during diagnostic and operative hysteroscopic procedures.
In connection with these legal proceedings and claims, management periodically reviews estimates of potential costs to be incurred by us in connection with the adjudication or settlement, if any, of these proceedings. These estimates are developed, as applicable in consultation with outside counsel, and are based on an analysis of potential litigation outcomes and settlement strategies.
In connection with these legal proceedings, claims, inspections, inquiries or investigations, management periodically reviews estimates of potential costs to be incurred by us in connection with the adjudication or settlement, if any, of these proceedings. These estimates are developed, as applicable in consultation with outside counsel, and are based on an analysis of potential litigation outcomes and settlement strategies.
At the end of any of our fiscal quarters and years, there remain open orders, primarily related to consumable products, that are not fulfilled until the beginning of the subsequent quarter or year, depending on a number of factors, including but not limited to management discretion to defer shipping orders based on achieving certain financial targets, customer ordering patterns, and various operational and logistical issues.
At the end of any of our fiscal quarters and years, there remain open orders, primarily related to consumable products, that are not fulfilled until the beginning of the subsequent quarter or year, depending on a number of factors, including but not limited to customer ordering patterns, various operational and logistical issues, and in periods prior to fiscal 2025 management discretion to defer shipping orders based on achieving certain financial targets.
Borrowings under the 2021 Credit Agreement are secured by first-priority liens on, and a first priority security interest in, substantially all of our and our Subsidiary Guarantors’ U.S. assets.
Borrowings under the 2025 Credit Agreement are secured by first-priority liens on, and a first priority security interest in, substantially all of our and our Subsidiary Guarantors’ U.S. assets.
During the first quarter of fiscal 2024, we further refined our strategy for the Mobidiag business and decided to discontinue the manufacture and sale of certain products. This decision resulted in the closure of facilities in Finland and France and moving the development activities and operations to our San Diego, California location.
During the first quarter of fiscal 2024, we further refined our strategy for the Mobidiag business and decided to discontinue the manufacture and sale of certain products. This decision resulted in the closure of facilities in Finland and France as we moved the development activities and operations to our San Diego, California location.
Since the fair value of our reporting units was determined by use of the DCF, and the key assumptions that drive the fair value in this model are the WACC, terminal values, growth rates, and the amount and timing of expected future cash flows, 49 Table of Contents significant judgment is applied in determining fair value.
Since the fair value of our reporting units was determined by use of the DCF, and the key assumptions that drive the fair value in this model are the WACC, terminal values, growth rates, and the amount and timing of expected future cash flows, significant judgment is applied in determining fair value.
In general, estimates of variable consideration and constraints are not material to our financial statements. We also place instruments (or equipment) at customer sites but retain title to the instrument (for example, the ThinPrep Processor, ThinPrep Imaging System, and the Panther and Panther Fusion systems).
In general, estimates of variable consideration and constraints are not material to our financial statements. We also place instruments (or equipment) at customer sites but retain title to the instrument (for example, the ThinPrep Processor, ThinPrep Imaging System, Genius Digital Diagnostics System and the Panther and Panther Fusion systems).
Subject to the “Risk Factors” set forth in Part I, Item 1A of this Annual Report and the general disclaimers set forth in our Special Note Regarding Forward-Looking Statements at the outset of this Annual Report, we believe that our 47 Table of Contents cash and cash equivalents, short and long-term investments, cash flows from operations, and the cash available under our 2021 Revolver will provide us with sufficient funds in order to fund our existing commitments and our expected normal operations and debt payments over the next twelve months.
Subject to the “Risk Factors” set forth in Part I, Item 1A of this Annual Report and the general disclaimers 48 Table of Contents set forth in our Special Note Regarding Forward-Looking Statements at the outset of this Annual Report, we believe that our cash and cash equivalents, short-term investments, cash flows from operations, and the cash available under our 2025 Revolver will provide us with sufficient funds in order to fund our existing commitments and our expected normal operations and debt payments over the next twelve months.
Business Combinations We record tangible and intangible assets acquired and liabilities assumed in business combinations under the purchase method of accounting. Amounts paid for each acquisition are allocated to the assets acquired and liabilities assumed based on their fair values at the dates of acquisition.
Business Combinations 49 Table of Contents We record tangible and intangible assets acquired and liabilities assumed in business combinations under the purchase method of accounting. Amounts paid for each acquisition are allocated to the assets acquired and liabilities assumed based on their fair values at the dates of acquisition.
As a result, we recorded impairment charges, accelerated depreciation and severance benefits totaling $31.6 million in fiscal 2024. For additional information, please refer to Note 8 to our consolidated financial statements.
As a result, we recorded impairment charges, accelerated depreciation and severance benefits totaling $31.6 million in fiscal 2024 and $3.4 million in fiscal 2025. For additional information, please refer to Note 8 to our consolidated financial statements.
The customer has the right to use the instrument for a period of time, and then we recover the cost of providing the instrument through the sales of disposables, namely tests and assays in Diagnostics and handpieces in GYN Surgical.
The customer has the right to use the instrument for a period of time, and then we recover the cost of providing the instrument 51 Table of Contents through the sales of disposables, namely tests and assays in Diagnostics and handpieces in GYN Surgical.
Our primary Diagnostics products include our molecular diagnostic assays, which run on our advanced instrumentation systems (Panther and Panther Fusion), our ThinPrep cytology system, including our Genius Digital Diagnostics System, and the Rapid Fetal Fibronectin Test.
Our primary Diagnostics products include our molecular diagnostic assays, which run on our advanced instrumentation systems (Panther and Panther Fusion), our cytology systems, including the ThinPrep System and the Genius Digital Diagnostics System, and the Rapid fFN Test.
If the product or service does not have a history of sales or if sales volume is not sufficient, we rely on prices set by our pricing committees or applicable marketing department adjusted for expected discounts. 50 Table of Contents We exercise judgement in estimating variable consideration, which includes volume discounts, sales rebates, product returns and other adjustments.
If the product or service does not have a history of sales or if sales volume is not sufficient, we rely on prices set by our pricing committees or applicable marketing department adjusted for expected discounts. We exercise judgment in estimating variable consideration, which includes volume discounts, sales rebates, product returns and other adjustments.
Based on this analysis the undiscounted cash flows were not sufficient to recover the carrying value of the long-lived assets. Therefore, we were required to perform Step 3 of the impairment test and determine the fair value of the asset group.
Based on this analysis the undiscounted cash flows were not sufficient to recover the carrying value of the long-lived assets. Therefore, we were required to perform Step 3 of the impairment test and determine the fair value of the asset group. To estimate the fair value of the asset group, we utilized a DCF analysis.
We have the option to redeem the 2028 Senior Notes on or after: February 1, 2024 through February 1, 2025 at 101.541% of par; February 1, 2025 through February 1, 2026 at 100.770% of par; and February 1, 2026 and thereafter at 100% of par.
We have the option to redeem the 2028 Senior Notes on or after: February 1, 2025 through February 1, 2026 at 100.770% of par; and February 1, 2026 and thereafter at 100% of par.
The following is a discussion of what we believe to be the more significant critical accounting policies and estimates used in the preparation of our consolidated financial statements. Inventory Our inventories include material, labor and overhead, and are stated at the lower of cost (first-in, first-out) or net realizable value.
The following is a discussion of what we believe to be the more significant critical accounting policies and estimates used in the preparation of our consolidated financial statements. Inventory The valuation of inventory includes material, labor and overhead, and is stated at the lower of cost (first-in, first-out) or net realizable value.
Based on this analysis, the fair value of the BioZorb asset group was below its carrying value and we recorded an aggregate impairment charge of $26.8 million. The impairment charge was allocated to the BioZorb long-lived assets, of which $25.9 million was allocated to developed technology.
Based on this analysis, the fair value of the BioZorb asset group was below its carrying value, and we recorded an impairment charge of $26.8 million of which $25.9 million of the charge was allocated to developed technology.
The remaining scheduled balance of $1.085 billion (or such lesser aggregate principal amount of the Term Loans then outstanding) on the 2021 Term Loan and any amounts outstanding under the 2021 Revolver are due at their respective maturities.
The remaining scheduled balance of $1.04 billion (or such lesser aggregate principal amount of the Term Loans then outstanding) on the 2025 Term Loan and any amounts outstanding under the 2025 Revolver are due at their respective maturities.
Our GYN Surgical products include our MyoSure hysteroscopic tissue removal system, our NovaSure endometrial ablation system, our Fluent fluid management system, our Acessa ProVu laparoscopic radiofrequency ablation system, as well as our CoolSeal vessel sealing portfolio and our JustRight surgical stapler.
Our GYN Surgical products include our MyoSure hysteroscopic tissue removal system, our NovaSure endometrial ablation system, our Fluent fluid management system, our Sonata transcervical radiofrequency ablation system, our Acessa ProVu laparoscopic radiofrequency ablation system, and our CoolSeal vessel sealing portfolio and our JustRight surgical stapler.
Endomag’s results of operations are reported in our Breast Health segment. SuperSonic Imagine Ultrasound Imaging On September 28, 2023, we entered into a definitive agreement to sell our SSI ultrasound imaging business to SSH Holdings Limited for a sales price of $1.9 million in cash. The sale was completed on October 3, 2023.
Endomag’s results of operations are reported within our Breast Health segment. SuperSonic Imagine Ultrasound Imaging On September 28, 2023, we entered into a definitive agreement to sell our SSI ultrasound imaging business to SSH Holdings Limited for a sales price of $1.9 million in cash.
We have the option to redeem the 2029 Senior Notes on or after: September 28, 2024 through September 27, 2025 at 100.813% of par; and September 28, 2025 and thereafter at 100% of par.
We have the option to redeem the 2029 Senior Notes on or after: September 28, 2025 and thereafter at 100% of par.
Partially offsetting these uses of cash was $37.8 million from our equity plans from the exercise of stock options and issuance of shares under our employee stock purchase plan.
Partially offsetting these uses of cash were proceeds of $38.8 million from our equity plans from the exercise of stock options and issuance of shares under our employee stock purchase plan.
Our assay portfolio also includes diagnostic tests for a range of acute respiratory infections, including SARS-CoV-2, various strains of influenza and parainfluenza, and respiratory syncytial virus, as well as a test for the detection of Group B Streptococcus, or GBS, that are run on the Panther Fusion system, a field upgradeable instrument addition to the base Panther system.
Our assay portfolio also includes diagnostic tests for a range of acute respiratory infections, including SARS-CoV-2, various strains of influenza and parainfluenza, and respiratory syncytial virus, as well as a test for the detection of Group B Streptococcus, or GBS, as well as two assays that detect several bacterial gastrointestinal (GI) pathogens that commonly cause acute gastroenteritis; all of which are run on the Panther Fusion system, a field upgradeable instrument addition to the base Panther system.
Our operating performance may also be affected by matters discussed under the above-referenced Risk Factors set forth elsewhere in this report. These risks, trends and uncertainties may also adversely affect our long-term liquidity. Legal Contingencies We are currently involved in certain legal proceedings and claims.
Our operating performance may also be affected by matters discussed under the above-referenced Risk Factors set forth elsewhere in this report. These risks, trends and uncertainties may also adversely affect our long-term liquidity. Legal Contingencies We are currently involved in certain legal proceedings, claims, governmental and/or regulatory inspections, inquiries and investigations arising out of the ordinary course of business.
At September 28, 2024, we believe that our reporting units, with goodwill aggregating $3.4 billion, were not at risk of failing the goodwill impairment test based on our current forecasts and qualitative assessment.
At September 27, 2025, we believe that our reporting units, with goodwill aggregating $3.6 billion, were not at risk of failing the goodwill impairment test based on our current forecasts and quantitative assessment.
Debt We had total recorded debt outstanding of $2.53 billion at September 28, 2024, which was comprised of amounts outstanding under our 2021 Credit Agreement of $1.20 billion (principal of $1.20 billion), 2029 Senior Notes of $940.8 million (principal of $950.0 million), and 2028 Senior Notes of $397.6 million (principal of $400.0 million). 2021 Credit Agreement On September 27, 2021, we refinanced our existing term loan and revolving credit facility with Bank of America, N.A. in its capacity as Administrative Agent, Swing Line Lender and L/C Issuer, and certain other lenders from time to time party thereto (the “2018 Credit Agreement”) by entering into Refinancing Amendment (the “2021 Credit Agreement”).
Debt We had total recorded debt outstanding of $2.51 billion at September 27, 2025, which was comprised of amounts outstanding under our 2025 Credit Agreement of $1.167 billion (principal of $1.169 billion), 2029 Senior Notes of $942.9 million (principal of $950.0 million), and 2028 Senior Notes of $398.3 million (principal of $400.0 million). 2025 Credit Agreement On July 15, 2025, we refinanced our existing 2021 Term Loan and 2021 Revolver with Bank of America, N.A. in its capacity as Administrative Agent, Swing Line Lender and L/C Issuer, and certain other lenders from time to time party thereto (the “2021 Credit Agreement”) by entering into Refinancing Amendment (the “2025 Credit Agreement”).
The other significant factor in the DCF is our projected financial information (i.e., amount and timing of expected future cash flows and growth rates) and if these assumptions were to be adversely impacted, this could result in a reduction of the fair value of a reporting unit.
The other significant factor in the DCF is our projected financial information (i.e., amount and timing of expected future cash flows and growth rates) and if these assumptions were to be adversely impacted, this could result in a reduction of the fair value of a reporting unit. 50 Table of Contents Intangible Assets Intangible assets are initially recorded at fair value and stated net of accumulated amortization and impairments.
Based on this analysis the undiscounted cash flows were not sufficient to recover the carrying value of the long-lived assets. As a result, we were required to perform Step 3 of the impairment test and determine the fair value of the asset group.
Based on these analyses, the undiscounted cash flows were not sufficient to recover the carrying value of the long-lived assets. Therefore, we were required to perform Step 3 of the impairment test and determine the fair value of the asset groups.
As of September 28, 2024, there were no borrowings under the 2021 Revolver. Borrowings under the 2021 Credit Agreement, other than Swing Line Loans, bear interest, at our option, at the Base Rate, at the Term SOFR Rate, at the Alternative Currency Daily Rate, or at the Daily SOFR Rate, in each case plus the Applicable Rate.
As of September 27, 2025, there were no borrowings under the 2025 Revolver. 47 Table of Contents Borrowings under the 2025 Credit Agreement, other than Swing Line Loans, bear interest, at the Company’s option, at the Base Rate, the Daily SOFR Rate, the Term SOFR Rate, the Alternative Currency Daily Rate, and the Alternative Currency Term Rate, in each case plus the Applicable Rate.
Intangible Assets Intangible assets are initially recorded at fair value and stated net of accumulated amortization and impairments. We amortize intangible assets that have finite lives using either the straight-line method, or if reliably determinable, based on the pattern in which the economic benefit of the asset is expected to be utilized.
We amortize intangible assets that have finite lives using either the straight-line method, or if reliably determinable, based on the pattern in which the economic benefit of the asset is expected to be utilized.
The credit facilities (the “2021 Credit Facilities”) under the 2021 Credit Agreement consist of: • A $1.5 billion secured term loan (“2021 Term Loan”) with a stated maturity date of September 25, 2026; and • A secured revolving credit facility (the “2021 Revolver”) under which the Borrowers may borrow up to $2.0 billion, subject to certain sublimits, with a stated maturity date of September 25, 2026.
The credit facilities (the “2025 Credit Facilities”) under the 2025 Credit Agreement consist of: • A $1.169 billion secured term loan (“2025 Term Loan”) with a stated maturity date of July 15, 2030; and • A secured revolving credit facility (the “2025 Revolver”) under which the Borrowers may borrow up to $1.25 billion, subject to certain sublimits, with a stated maturity date of July 15, 2030.
As a result, we recorded a charge of $51.7 million in the fourth quarter of fiscal 2023 to record the asset group at its fair value less costs to sell pursuant to ASC 360, Property, Plant and Equipment—Impairment or Disposal of Long-Lived Assets . 36 Table of Contents RESULTS OF OPERATIONS Fiscal Year Ended September 28, 2024 Compared to Fiscal Year Ended September 30, 2023 Product Revenues Fiscal Years Ended September 28, 2024 September 30, 2023 Change Amount % of Total Revenue Amount % of Total Revenue Amount % Product Revenues Diagnostics $ 1,658.3 41.1 % $ 1,764.4 43.8 % $ (106.1) (6.0) % Breast Health 912.9 22.7 % 836.6 20.8 % 76.3 9.1 % GYN Surgical 635.0 15.8 % 600.0 14.9 % 35.0 5.8 % Skeletal Health 48.9 1.2 % 78.9 2.0 % (30.0) (38.0) % $ 3,255.1 80.8 % $ 3,279.9 81.4 % $ (24.8) (0.8) % We had a decrease in product revenues of 0.8% in fiscal 2024 compared to fiscal 2023.
As a result, we recorded a charge of $51.7 million in the fourth quarter of fiscal 2023 to record the asset group at its fair value less costs to sell pursuant to ASC 360, Property, Plant and Equipment—Impairment or Disposal of Long-Lived Assets . 38 Table of Contents RESULTS OF OPERATIONS Fiscal Year Ended September 27, 2025 Compared to Fiscal Year Ended September 28, 2024 Product Revenues Fiscal Years Ended September 27, 2025 September 28, 2024 Change Amount % of Total Revenue Amount % of Total Revenue Amount % Product Revenues Diagnostics $ 1,693.3 41.2 % $ 1,658.3 41.1 % $ 35.0 2.1 % Breast Health 829.5 20.2 % 912.9 22.7 % (83.4) (9.1) % GYN Surgical 668.8 16.3 % 635.0 15.8 % 33.8 5.3 % Skeletal Health 64.5 1.6 % 48.9 1.2 % 15.6 31.9 % $ 3,256.1 79.4 % $ 3,255.1 80.8 % $ 1.0 — % Product revenues remained relatively flat in fiscal 2025 compared to fiscal 2024 due to an increase in Diagnostics, GYN Surgical, and Skeletal revenues offset by a decrease in Breast Health revenues.
Cost of Service and Other Revenues Years Ended September 28, 2024 September 30, 2023 Change Amount % of Service and Other Revenues Amount % of Service and Other Revenues Amount % Cost of Service and Other Revenues $ 376.6 48.6 % $ 389.4 51.9 % $ (12.8) (3.3) % Service and other revenues gross margin was 51.4% in fiscal 2024 compared to 48.1% in fiscal 2023.
Cost of Service and Other Revenues Years Ended September 27, 2025 September 28, 2024 Change Amount % of Service and Other Revenues Amount % of Service and Other Revenues Amount % Cost of Service and Other Revenues $ 376.3 44.6 % $ 376.6 48.6 % $ (0.3) (0.1) % Service and other revenues gross margin was 55.4% in fiscal 2025 compared to 51.4% in fiscal 2024.
For additional information, please refer to Note 7 to our consolidated financial statements. Restructuring Charges. We have implemented various cost reduction initiatives to align our cost structure with our operations and related integration activities. These actions have primarily resulted in the termination of employees and the shutdown of certain facilities.
We have implemented various cost reduction initiatives to align our cost structure with our operations and related integration activities. These actions have primarily resulted in the termination of employees and the shutdown of certain facilities.
In May 2022, we obtained CE-marking for two new molecular assays, Panther Fusion EBV Quant assay for quantitation of Epstein-Barr virus, and the Panther Fusion BKV Quant assay for quantitation of the BK virus.
We also offer two CE-marked molecular assays, the Panther Fusion EBV Quant assay for quantitation of Epstein-Barr virus, and the Panther Fusion BKV Quant assay for quantitation of the BK virus.
GYN Surgical Years Ended September 28, 2024 September 30, 2023 Change Amount Amount Amount % Total Revenues $ 641.3 $ 604.2 $ 37.1 6.1 % Operating Income $ 185.5 $ 188.9 $ (3.4) (1.8) % Operating Income as a % of Segment Revenue 28.9 % 31.3 % GYN Surgical revenues increased in fiscal 2024 compared to fiscal 2023 due to the increase in product revenues discussed above.
GYN Surgical Years Ended September 27, 2025 September 28, 2024 Change Amount Amount Amount % Total Revenues $ 679.8 $ 641.3 $ 38.5 6.0 % Segment Operating Income $ 204.6 $ 224.5 $ (19.9) (8.9) % Operating Income as a % of Segment Revenue 30.1 % 35.0 % GYN Surgical revenues increased in fiscal 2025 compared to fiscal 2024 due to the increase in product revenues discussed above.
Operating income for this business se gment decreased in fiscal 2024 compared to fiscal 2023 primarily due to an increase in operating expenses partially offset by an increase in gross profit. Gross margin was 67.3% in the current year, compared to 67.7% in the prior year.
Operating income for this business se gment decreased in fiscal 2025 compared to fiscal 2024 primarily due to an increase in operating expenses partially offset by an increase in gross profit.
The 2028 Senior Notes mature on February 1, 2028 and bear interest at the rate of 4.625% per year, payable semi-annually on February 1 and August 1 of each year.
The 2028 Senior Notes are general senior unsecured obligations and are guaranteed on a senior unsecured basis by certain of our domestic subsidiaries. The 2028 Senior Notes mature on February 1, 2028 and bear interest at the rate of 4.625% per year, payable semi-annually on February 1 and August 1 of each year.
Our annual impairment test date is the first day of our fiscal fourth quarter. In performing the test, we either use the qualitative assessment permitted by ASC 350, Intangibles — Goodwill and Other, or the single step quantitative approach prescribed under ASC 350 including amendments under ASU 2017-04.
Our annual impairment test date is the first day of our fiscal fourth quarter. In performing the test, we use the single step quantitative approach prescribed under ASC 350, Intangibles — Goodwill and Other, and related amendments under ASU 2017-04. Under the quantitative impairment test, we perform a comparison of the reporting unit’s carrying value to its fair value.
Certain of the mandatory prepayments are subject to reduction or elimination if certain financial covenants are met. Subject to certain limitations, we may voluntarily prepay any of the 2021 Credit Facilities without premium or penalty. As of September 28, 2024, the outstanding principal balance of the 2021 Term Loan was $1.2 billion.
Certain mandatory prepayments are subject to reduction or elimination if certain financial covenants are met. Subject to certain limitations, we may voluntarily prepay any of the 2025 Credit Facilities without premium or penalty.
Cost of Product Revenues Years Ended September 28, 2024 September 30, 2023 Change Amount % of Product Sales Amount % of Product Sales Amount % Cost of Product Revenues $ 1,206.2 37.1 % $ 1,184.3 36.1 % $ 21.9 1.8 % Amortization of Acquired Intangible Assets 180.5 5.5 % 205.7 6.3 % (25.2) (12.3) % Impairment of Acquired Intangible Assets and Equipment 39.2 1.2 % 179.5 5.5 % (140.3) ** $ 1,425.9 43.8 % $ 1,569.5 47.9 % $ (143.6) (9.1) % ** Percentage not meaningful Product gross margin was 56.2% in fiscal 2024 compared to 52.1% in fiscal 2023.
Cost of Product Revenues Years Ended September 27, 2025 September 28, 2024 Change Amount % of Product Sales Amount % of Product Sales Amount % Cost of Product Revenues $ 1,246.4 38.3 % $ 1,206.2 37.1 % $ 40.2 3.3 % Amortization of Acquired Intangible Assets 176.5 5.4 % 180.5 5.5 % (4.0) (2.2) % Impairment of Acquired Intangible Assets and Equipment 183.4 5.6 % 39.2 1.2 % 144.2 ** $ 1,606.3 49.3 % $ 1,425.9 43.8 % $ 180.4 12.7 % ** Percentage not meaningful Product gross margin was 50.7% in fiscal 2025 compared to 56.2% in fiscal 2024.
Skeletal Health Years Ended September 28, 2024 September 30, 2023 Change Amount Amount Amount % Total Revenues $ 84.1 $ 113.4 $ (29.3) (25.8) % Operating Income (Loss) $ (0.5) $ 12.6 $ (13.1) 104.0 % Operating Income (Loss) as a % of Segment Revenue (0.6) % 11.1 % Skeletal Health revenues decreased in fiscal 2024 compared to fiscal 2023 primarily due to the decrease in product revenues discussed above.
Skeletal Health Years Ended September 27, 2025 September 28, 2024 Change Amount Amount Amount % Total Revenues $ 109.4 $ 84.1 $ 25.3 30.1 % Segment Operating Loss $ (3.7) $ (0.5) $ (3.2) (640.0) % Operating Loss as a % of Segment Revenue (3.4) % (0.6) % Skeletal Health revenues increased in fiscal 2025 compared to fiscal 2024 primarily due to an increase in product revenues discussed above.
In fiscal 2024, our financing activities used cash of $1,108.6 million, primarily due to $835.1 million for repurchases of our common stock, including a $500 million accelerated share repurchase program, $287.5 million for debt principal payments under our 2021 Credit Agreement, including a $250.0 million voluntary prepayment, and $17.4 million for the payment of employee taxes withheld for the net share settlement of vested restricted stock units.
In fiscal 2025, our financing activities used cash of $777.2 million, primarily due to $752.9 million for repurchases of our common stock, including a $250 million accelerated share repurchase program completed in the first quarter of fiscal 2025, $28.5 million for debt principal payments under our 2021 Credit Agreements, and $22.2 million for the payment of employee taxes withheld for the net share settlement of vested restricted stock units.
The Applicable Rate in regard to the Base Rate, the Term SOFR Rate, the Alternative Currency Daily Rate, the Alternative Currency Term Rate and the Daily SOFR Rate is subject to change depending on the Total Net Leverage Ratio (as defined in the 2021 Credit Agreement).
The Applicable Rate with respect to the Base Rate, Daily SOFR Rate, Term SOFR Rate, the Alternative Currency Daily Rate and the Alternative Currency Term Rate is subject to specified changes depending on the Total Net Leverage Ratio (as defined in Refinancing Amendment No.4).
Service and Other Revenues Years Ended September 28, 2024 September 30, 2023 Change Amount % of Total Revenue Amount % of Total Revenue Amount % Service and Other Revenues $ 775.2 19.2 % $ 750.5 18.6 % $ 24.7 3.3 % Service and other revenues are primarily comprised of revenue generated from our field service organization to provide ongoing service, installation and repair of our products.
Service and Other Revenues Years Ended September 27, 2025 September 28, 2024 Change Amount % of Total Revenue Amount % of Total Revenue Amount % Service and Other Revenues $ 844.4 20.6 % $ 775.2 19.2 % $ 69.2 8.9 % Service and other revenues are primarily comprised of revenue generated from our field service organization to provide ongoing support and maintenance services, installation and repair of our products.
Impairment of Intangible Assets and Equipment. During the second quarter of fiscal 2024, in connection with commencing our company-wide annual strategic planning process, we identified indicators of impairment in our BioZorb product line, which was part of the Focal acquisition and included in our Breast Health reportable segment.
During the second quarter of fiscal 2024, in connection with commencing our company-wide annual strategic planning process, we identified indicators of impairment in our BioZorb product line, which was part of the Focal acquisition. As a result, we performed an undiscounted cash flow analysis.
Our effective tax rate for fiscal 2023 was a provision of 32.6%.
Our effective tax rate for fiscal 2024 was a provision of 8.7%.
The JustRight 5 mm stapler features a smaller instrument profile and is used for laparoscopic general and pediatric surgery.
The CoolSeal portfolio includes the CoolSeal Trinity, CoolSeal Reveal, and CoolSeal Mini advanced bipolar vessel sealing devices. The JustRight 5 mm stapler features a smaller instrument profile and is used for laparoscopic general and pediatric surgery.
Skeletal Health product revenues decreased 38.0% in fiscal 2024 compared to fiscal 2023 primarily due to a decrease in sales volume of our Horizon DXA systems as a temporary stop-ship was implemented during the third quarter of fiscal 2024 due to a non-conformance matter pertaining to electromagnetic compatibility requirements.
Skeletal Health product revenues increased 31.9% in fiscal 2025 compared to fiscal 2024 primarily due to an increase in sales volume of our Horizon DXA systems from pent up demand as the temporary stop-ship implemented during the third quarter of fiscal 2024 due to a non-conformance matter pertaining to electromagnetic compatibility requirements was fully resolved for all Horizon DXA models in the third quarter of the current fiscal year.
Our cash and cash equivalents balance decreased by $595.5 million during fiscal 2024 principally due to cash used in investing and financing activities primarily related to repurchases of our common stock, debt payments, purchases of available-for-sale securities and a payment made to acquire Endomag, partially offset by cash generated from operating activities.
Our cash and cash equivalents balance decreased by $200.7 million during fiscal 2025 principally due to cash used in investing and financing activities primarily related to repurchases of our common stock, cash paid to acquire Gynesonics, capital expenditures and strategic investments, partially offset by cash generated from operating activities and net maturities of available-for-sale securities.
Final settlement of the transaction is expected to be completed in the second quarter of fiscal 2025. The timing of any future share repurchases will be based upon our continuing analysis of market, financial, and other factors.
The timing of any future share repurchases will be based upon our continuing analysis of market, financial, and other factors.
Fiscal Year Ended September 30, 2023 Compared to Fiscal Year Ended September 24, 2022 Discussions of year-to-year comparisons between fiscal 2023 and 2022 that are not included in this Form 10-K can be found in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part II, Item 7 of the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2023.
Fiscal Year Ended September 28, 2024 Compared to Fiscal Year Ended September 30, 2023 Discussions of year-to-year comparisons between fiscal 2024 and 2023 that are not included in this Form 10-K can be found in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part II, Item 7 of the Company’s Annual Report on Form 10-K for the fiscal year ended September 28, 2024. 46 Table of Contents LIQUIDITY AND CAPITAL RESOURCES At September 27, 2025, we had working capital of $2,690.9 million, and our cash and cash equivalents totaled $1,959.5 million.
Provision for Income Taxes Years Ended September 28, 2024 September 30, 2023 Change Amount Amount Amount % Provision for Income Taxes $ 75.6 $ 220.1 $ (144.5) (65.7) % Our effective tax rate for fiscal 2024 was a provision of 8.7%.
Provision for Income Taxes Years Ended September 27, 2025 September 28, 2024 Change Amount Amount Amount % Provision for Income Taxes $ 115.5 $ 75.6 $ 39.9 52.8 % Our effective tax rate for fiscal 2025 was a provision of 17.0%.
We also offer viral load tests for the quantitation of Hepatitis B virus, Hepatitis C virus, human immunodeficiency virus, or HIV-1, and human cytomegalovirus, or CMV, for use on our Panther instrument system. In addition, we offer bacterial vaginosis and candida vaginitis assays for the diagnosis of vaginitis, a common and complex ailment affecting millions of women a year.
We also offer viral load tests for the quantitation of Hepatitis B virus, Hepatitis C virus, human immunodeficiency virus, or HIV-1, and human cytomegalo virus, or CMV, for use on our Panther instrument system.
As a result, we performed an undiscounted cash flow analysis to determine if the cash flows expected to be generated by the BioZorb product line over the remaining estimated useful life of the primary asset were sufficient to recover the carrying value of the asset group.
As a result, we performed undiscounted cash flow analyses pursuant to ASC 360, Property, Plant and Equipment - Overall , to determine if the cash flows expected to be generated by these product lines over the remaining estimated useful lives of their primary assets were sufficient to recover the carrying value of the asset groups.
In fiscal 2024, our operating activities provided cash of $1,285.2 million, primarily due to net income of $789.5 million, non-cash charges for depreciation and amortization aggregating $309.0 million, stock-based compensation expense of $82.3 million, intangible asset impairment charges of $44.8 million, and other adjustments and non-cash items of $45.9 million.
In fiscal 2025, our operating activities provided cash of $1,057.1 million, primarily due to net income of $565.7 million, non-cash charges for depreciation and amortization aggregating $299.8 million, intangible asset impairments of $225.9 million and stock-based compensation expense of $84.3 million.
Endomag, located in the U.K., develops and sells breast surgery localization and lymphatic tracing technologies. Based on our preliminary valuation, we allocated $197.8 million of the purchase price to the value of intangible assets and $138.9 million to goodwill. The allocation of the purchase price is preliminary as we continue to gather information supporting the acquired assets and liabilities.
Endomag On July 25, 2024, we completed the acquisition of Endomagnetics Ltd (“Endomag”) for a purchase price of $313.9 million. Endomag, located in the U.K., develops and sells breast surgery localization and lymphatic tracing technologies. Based on our valuation, we allocated $197.8 million of the purchase price to the value of intangible assets and $140.1 million to goodwill.
These adjustments to net income were partially offset by a decrease in net deferred taxes of $72.1 million primarily due to the amortization of intangible assets and to a lesser extent the capitalization of research expenditures under the tax rules. Cash provided by operations included a net cash inflow of $84.1 million from changes in our operating assets and liabilities.
These adjustments to net income were partially offset by a decrease in net deferred taxes of $141.6 million primarily due to the amortization of intangible assets and impairments of acquired intangible assets recorded in the second quarter in fiscal 2025. Cash provided by operations included a net cash outflow of $20.4 million from changes in our operating assets and liabilities.
As of September 28, 2024, the interest rate under the 2021 Term Loan was 5.96% per annum. We are required to make scheduled principal payments under the 2021 Term Loan in increasing amounts, which currently range from $9.375 million per three-month period to $18.75 million per three-month period commencing with the three-month period ending on December 26, 2025.
We are required to make scheduled principal payments under the 2025 Term Loan in increasing amounts, which currently range from $2.92 million per three-month period to $14.61 million per three-month period commencing with the three-month period ending on September 25, 2026.
Amortization of Acquired Intangible Assets. Amortization of intangible assets included in cost of product revenues relates to acquired developed technology, which is generally amortized over its estimated useful life of between 5 and 15 years using a straight-line method or, if reliably determinable, based on the pattern in which the economic benefits of the assets are expected to be consumed.
Amortization of intangible assets included in cost of product revenues relates to acquired developed technology, which is generally amortized over its estimated useful life of between 10 and 15 years.
During the first quarter of fiscal 2024, as discussed in Note 2 to the consolidated financial statements, we recorded an impairment charge of $4.3 million to record our only IPR&D asset from the Mobidiag acquisition to fair value.
During the first quarter of fiscal 2024 we recorded an impairment charge of $4.3 million to record our IPR&D asset from the Mobidiag acquisition to fair value. The reduction in fair value was primarily due to a reduction in forecasted revenues and timing of completing the project. Restructuring Charges.
As of September 28, 2024, $190.3 million remained authorized for repurchase. Subsequent to September 28, 2024, we repurchased 2.7 million shares of our common stock for total consideration of $217.2 million. On September 12, 2024, our Board of Directors authorized a new stock repurchase program, with a five-year term, to repurchase up to $1.5 billion of our outstanding stock.
Stock Repurchase Program On September 12, 2024, our Board of Directors authorized a new stock repurchase program, with a five-year term, to repurchase up to $1.5 billion of our outstanding stock. As of September 27, 2025, $937.5 million remained unused under this authorization.
Interest Income Years Ended September 28, 2024 September 30, 2023 Change Amount Amount Amount % Interest Income $ 108.7 $ 120.5 $ (11.8) (9.8) % Interest income in fiscal 2024 decreased compared to fiscal 2023 due to lower average cash and investment balances in the current year compared to the prior year, partially offset by higher interest rates in the current year as the U.S.
Interest Income Years Ended September 27, 2025 September 28, 2024 Change Amount Amount Amount % Interest Income $ 74.4 $ 108.7 $ (34.3) (31.6) % Interest income in fiscal 2025 decreased compared to fiscal 2024 due to lower average cash and investment balances and lower interest rates as the U.S.
Future Liquidity Considerations We expect to continue to review and evaluate potential strategic transactions that we believe will complement our current or future business.
Pursuant to the Merger Agreement, we are restricted from initiating share repurchases without the prior written consent of Blackstone and TPG. Future Liquidity Considerations We expect to continue to review and evaluate potential strategic transactions that we believe will complement our current or future business.
Diagnostics Years Ended September 28, 2024 September 30, 2023 Change Amount Amount Amount % Total Revenues $ 1,782.0 $ 1,880.1 $ (98.1) (5.2) % Operating Income $ 303.1 $ 193.9 $ 109.2 56.3 % Operating Income as a % of Segment Revenue 17.0 % 10.3 % Diagnostics revenues decreased in fiscal 2024 compared to fiscal 2023 primarily due to the decrease in product revenues discussed above, partially offset by higher lab testing revenue from our Biotheranostics business. 43 Table of Contents Operating income for this business segment increased in fiscal 2024 compared to fiscal 2023 primarily due to an increase in gross profit and a decrease in operating expenses.
Diagnostics Years Ended September 27, 2025 September 28, 2024 Change Amount Amount Amount % Total Revenues $ 1,827.2 $ 1,782.0 $ 45.2 2.5 % Segment Operating Income $ 599.9 $ 509.5 $ 90.4 17.7 % Operating Income as a % of Segment Revenue 32.8 % 28.6 % Diagnostics revenues increased in fiscal 2025 compared to fiscal 2024 primarily due to the increase in product revenues discussed above and higher lab testing revenue from our Biotheranostics business.
These estimates require significant judgment and adverse changes in assumptions could result in a lower fair value. Revenue Recognition We generate revenue from the sale of our products, primarily medical imaging systems and diagnostic and surgical disposable products, and related services, which are primarily support and maintenance services on our medical imaging systems.
To estimate the fair value of the assets, the Company uses market participant assumptions pursuant to ASC 820, Fair Value Measurements . Revenue Recognition We generate revenue from the sale of our products, primarily medical imaging systems and diagnostic and surgical disposable products, and related services, which are primarily support and maintenance services on our medical imaging systems.
The Acessa ProVu system is a fully integrated system that uses laparoscopic ultrasound, guidance mapping and radiofrequency ablation to treat nearly all types of fibroids. The CoolSeal portfolio includes the CoolSeal Trinity, CoolSeal Reveal, and CoolSeal Mini advanced bipolar vessel sealing devices.
The Sonata system uses transcervical, intrauterine ultrasound guidance to treat a wide range of fibroid types without the need for incisions. The Acessa ProVu system is a fully integrated system that uses laparoscopic ultrasound, guidance mapping and radiofrequency ablation to treat nearly all types of fibroids.
The valuation is based upon expected future discounted operating cash flows of the reporting unit as well as analysis of recent sales and ratio comparisons of similar companies. We base the discount rate on the weighted average cost of capital, or WACC, of market participants.
We consider a number of factors to determine the fair value of a reporting unit, including an independent valuation to conduct this test. The valuation is based upon expected future discounted operating cash flows of the reporting unit . We base the discount rate on the weighted average cost of capital, or WACC, of market participants.
This decrease was partially offset by an increase in sales of our 3D Dimensions systems and related workflow products, and an increase in GYN Surgical sales in the U.S. The increase in Europe was primarily due to an increase in sales of our GYN Surgical products, specifically our MyoSure and NovaSure devices.
The decrease in the United States was primarily due to a decrease in sales of our Breast Health products, specifically our 3D Dimensions systems and related workflow and workstation products and to a lesser extent Trident HD systems, and a decrease in our GYN Surgical NovaSure devices.
Acquisition On October 11, 2024, we entered into a definitive agreement to acquire Gynesonics, Inc. (“Gynesonics”) for a purchase price of approximately $350.0 million, subject to working capital and other customary adjustments. Gynesonics, located in Redwood, California, develops a technology intended for diagnostic intrauterine imaging and transcervical treatment of certain symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
Gynesonics, located in Redwood City, California, develops and sells a technology intended for diagnostic intrauterine imaging and transcervical treatment of certain symptomatic uterine fibroids, including those associated with heavy menstrual bleeding. Based on our valuation, we allocated $146.1 million of the purchase price to the value of intangible assets and $191.0 million to goodwill.
These two assays are the first quantitative real-time PCR assays on the Panther Fusion system, and, together with the Aptima CMV Quant assay, expand our menu of transplant monitoring assays. The ThinPrep System is primarily used in cytology applications, such as cervical cancer screening, and the Rapid Fetal Fibronectin Test assists physicians in assessing the risk of pre-term birth.
These two assays are the first quantitative real-time PCR assays on the Panther Fusion system, and, together with the Aptima CMV Quant assay, comprise our menu of transplant monitoring assays.
The reduction in fair value was primarily due to a reduction in forecasted revenues and an extension in the timing of completing the project. During the third quarter of fiscal 2023, as discussed above, we recorded an aggregate impairment charge of $197.4 million related to our Mobidiag acquisition and $26.4 million related to our SSI ultrasound imaging assets.
We also recorded an impairment charge of $16.9 million to record our IPR&D asset from the Mobidiag acquisition to fair value. The reduction in fair value was primarily due to a reduction in forecasted revenues and timing of completing the project.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

10 edited+3 added−10 removed1 unchanged
Biggest changeSince this debt obligation is a variable rate instrument, our interest expense associated with the instrument is subject to change. A hypothetical 10% adverse movement (increase in the SOFR rate) would increase annual interest expense by approximately $3.4 million, which is net of the impact of our interest rate swap hedge.
Biggest changeA hypothetical 10% adverse movement (increase in the SOFR rate) would increase annual interest expense by approximately $2.8 million, which is net of the impact of our interest rate swap hedge. We have entered into interest rate swap agreements to help mitigate the interest rate volatility associated with the variable rate interest on the amounts outstanding under our credit facilities.
A hypothetical 100 basis point change in market rates would change annual interest income by approximately $10.4 million based on our current cash and investment balances. Foreign Currency Exchange Risk.
A hypothetical 100 basis point change in market rates would change annual interest income by approximately $17.9 million based on our current cash and investment balances. Foreign Currency Exchange Risk.
We designated these derivative instruments as a cash flow hedge of the variability of the Term SOFR-based interest payments on $500 million of principal. The return from cash and cash equivalents, and our short and long-term investments, which are available-for-sale debt securities, will vary as short-term interest rates change.
We designated these derivative instruments as a cash flow hedge of the variability of the Term SOFR-based interest payments on $500 million of principal outstanding under the 2025 Credit Agreement. 52 Table of Contents The return from cash and cash equivalents, and our short-term investments, which are available-for-sale debt securities, will vary as short-term interest rates change.
Amounts outstanding under our 2021 Credit Agreement of $1.2 billion aggregate principal as of September 28, 2024 are subject to variable rates of interest based on current market rates, and as such, we believe the carrying amount of these obligations approximates fair value. Primary Market Risk Exposures .
Amounts outstanding under our 2025 Credit Agreement of $1.17 billion aggregate principal as of September 27, 2025 are subject to variable rates of interest based on current market rates, and as such, we believe the carrying amount of these obligations approximates fair value. Our primary market risk exposures are primarily related to interest rate risk and foreign currency exchange risk.
We believe that the operating expenses of our international subsidiaries that are incurred in local currencies will not have a material adverse effect on our business, results of operations or financial condition.
We believe that the operating expenses of our international subsidiaries that are incurred in local currencies will not have a material adverse effect on our business, results of operations or financial condition, and accordingly, foreign currency exchange risk is not significant to the Company.
Except for our outstanding 2028 and 2029 Senior Notes, the fair value of these financial instruments approximate their carrying amount. The fair value of our 2028 and 2029 Senior Notes was approximately $393.1 million and $882.2 million, respectively, as of September 28, 2024.
Except for our outstanding 2028 and 2029 Senior Notes, the fair value of these financial instruments approximate their carrying amount. The fair value of our 2028 and 2029 Senior Notes was approximately $397.9 million and $916.8 million, respectively, as of September 27, 2025.
However, we believe that the foreign currency exchange risk is not significant. We believe a hypothetical 10% increase or decrease in foreign currencies that we transact in would not have a material adverse impact on our financial condition or results of operations.
We believe a hypothetical 10% increase or decrease in foreign currencies that we transact in would not have a material adverse impact on our financial condition or results of operations. Item 8. Financial Statements and Supplementary Data Our Consolidated Financial Statements and Supplementary Data are set forth under Part IV, Item 15, which is incorporated herein by reference. Item 9.
Our primary market risk exposure is in the areas of interest rate risk and foreign currency exchange rate risk. We incur interest expense on borrowings outstanding under our 2028 and 2029 Senior Notes, and 51 Table of Contents 2021 Credit Agreement. The 2028 and 2029 Senior Notes have fixed interest rates.
Interest Rate Risk . We incur interest expense on borrowings outstanding under our 2028 and 2029 Senior Notes, and 2025 Credit Agreement. The 2028 and 2029 Senior Notes have fixed interest rates. Borrowings under our 2025 Credit Agreement bear interest at the SOFR Rate plus 1.10% per annum.
We conduct business worldwide and maintain sales and service offices outside the U.S. as well as manufacturing facilities in Costa Rica and the United Kingdom. Our international sales are denominated in a number of currencies, primarily the Euro, U.S. dollar, U.K. Pound, Australian dollar, Canadian dollar, Chinese Yuan and Japanese Yen.
We conduct business worldwide and due to the global nature of our operations, we are exposed to currency exchange rate changes, which may cause fluctuations in earnings and cash flows in a number of currencies, primarily the Euro, U.K. Pound, Australian dollar, Canadian dollar, Chinese Yuan and Japanese Yen.
Financial Statements and Supplementary Data Our Consolidated Financial Statements and Supplementary Data are set forth under Part IV, Item 15, which is incorporated herein by reference. Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None.
Removed
Effective September 25, 2022 (the first day of fiscal 2023), borrowings under our 2021 Credit Agreement bear interest at the SOFR Rate plus SOFR Adjustment of 0.10% plus the applicable margin of 1.00% per annum. As of September 28, 2024, there was $1.20 billion of aggregate principal outstanding under the 2021 Credit Agreement.
Added
As of September 27, 2025, there was $1.169 billion of aggregate principal outstanding under the 2025 Credit Agreement. Since this debt obligation is a variable rate instrument, our interest expense associated with the instrument is subject to change.
Removed
We previously entered into interest rate swap agreements to help mitigate the interest rate volatility associated with the variable rate interest on the amounts outstanding under our credit facilities.
Added
Fluctuations in the currency exchange rates of currency exposures that are unhedged, such as in certain emerging markets, may result in future earnings and cash flow volatility. We have executed forward foreign currency contracts to hedge a portion of results.
Removed
The critical terms of the interest rate swaps were designed to mirror the terms of our SOFR-based borrowings under the 2021 Credit Agreement, and therefore the interest rate swap is highly effective at offsetting the cash flows being hedged.
Added
Additional information regarding our currency exchange rate derivative instruments is included in Note 2 to the current period’s consolidated financial statements.
Removed
Our international business is subject to risks, including, but not limited to: unique economic conditions, changes in political climate, differing tax structures, other regulations and restrictions, and foreign exchange rate volatility. Accordingly, our future results could be materially adversely impacted by changes in these or other factors.
Removed
The majority of our foreign subsidiaries functional currency is the local currency, although certain foreign subsidiaries functional currency is the U.S. dollar based on the nature of their operations or functions. Our revenues denominated in foreign currencies are positively affected when the U.S. dollar weakens against them and adversely affected when the U.S. dollar strengthens.
Removed
Fluctuations in foreign currency rates could affect our sales, cost of goods and operating margins and could result in exchange losses. In addition, currency devaluations can result in a loss if we hold deposits of that currency.
Removed
We have executed forward foreign currency contracts and foreign currency collars (principally the Japanese yen) to hedge a portion of results denominated in the Euro, U.K. Pound, Australian dollar, Japanese Yen, Canadian dollar and Chinese Yuan. These contracts do not qualify for hedge accounting.
Removed
As a result, we may experience volatility in our Consolidated Statements of Income due to (i) the impact of unrealized gains and losses reported in other income, net on the mark-to-market of outstanding contracts and (ii) realized gains and losses recognized in other income, net, whereas the offsetting economic gains and losses are reported in the line item of the underlying cash flow, for example, revenue.
Removed
Our operating results and certain assets and liabilities that are denominated in foreign currencies are affected by changes in the relative strength of the U.S. dollar against those currencies. Our expenses, denominated in foreign currencies, are positively affected when the U.S. dollar strengthens against those currencies and adversely affected when the U.S. dollar weakens.
Removed
During fiscal 2024, we incurred net foreign exchange losses of $21.0 million, net foreign exchange losses of $7.9 million in fiscal 2023 and net foreign exchange gains of $48.5 million in fiscal 2022. Item 8.