Hologic is like:

• The 'GE Healthcare' or 'Siemens Healthineers' primarily for breast health imaging and women's diagnostic solutions.
• A specialized 'Quest Diagnostics' or 'LabCorp' with a strong focus on women's health and molecular screening technologies.
• An 'Abbott Laboratories' or 'Becton Dickinson' specifically dedicated to advanced diagnostics and medical devices for women's health.

• 3D Mammography Systems: Advanced imaging systems like the Hologic 3Dimensions™ and 3D™ Mammography™ for early detection of breast cancer.
• Breast Biopsy Devices: Systems such as Affirm® and Brevera® that assist in the precise sampling of breast tissue for diagnostic purposes.
• Molecular Diagnostic Assays & Systems: Comprehensive tests, including Aptima® assays run on the Panther® System, for detecting infectious diseases like HPV, STIs, and respiratory viruses.
• Cervical Cytology Products: Products like the ThinPrep® Pap Test and related imaging systems for screening and early detection of cervical cancer.
• Blood Screening Solutions: Diagnostic assays and instruments used to screen donated blood for various infectious agents.
• Endometrial Ablation Systems: Surgical devices such as the NovaSure® System used to treat heavy menstrual bleeding by ablating the uterine lining.
• Hysteroscopic Tissue Removal Systems: Instruments like the MyoSure® System designed for the minimally invasive removal of uterine fibroids and polyps.

Hologic (HOLX) primarily sells its products and services to other companies and institutions within the healthcare sector, rather than directly to individual consumers.

Due to the highly fragmented nature of the global healthcare market and common industry practices for medical technology companies, Hologic does not publicly disclose specific named "major customer companies" that represent a material portion of its revenue. Its sales are distributed across a broad base of institutional clients worldwide.

However, the categories of customers that regularly purchase and utilize Hologic's products and solutions include:

• Hospitals and Hospital Systems: These institutions are key customers for Hologic's medical imaging systems (e.g., mammography, bone densitometry), diagnostic equipment, and surgical products used in patient care.
• Clinical and Reference Laboratories: These facilities utilize Hologic's diagnostic instruments and assays for various tests, particularly in women's health (e.g., HPV testing, STI testing, cytology).
• Physician Offices and Clinics: This category includes specialized practices such as gynecologists, obstetricians, imaging centers, and primary care providers who employ Hologic's devices for diagnostics and and treatments.
• Government Agencies: Healthcare facilities operated by government entities (e.g., military hospitals, public health clinics) also purchase Hologic's products.
• Group Purchasing Organizations (GPOs): While not end-users, GPOs act as intermediaries, negotiating contracts and facilitating purchases for their member healthcare providers across the categories mentioned above.

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Stephen P. MacMillan, Chairman, President and Chief Executive Officer

Mr. MacMillan joined Hologic in December 2013 as President and CEO, and was elected Chairman of the Board of Directors in June 2015. He is credited with leading a dramatic turnaround at the company, including doubling revenue by expanding Hologic's positions in 3-D mammography, molecular diagnostics (including COVID-19 tests), and the gynecological surgical business. Before Hologic, from 2005 to 2012, Mr. MacMillan served as President and Chief Executive Officer of Stryker Corporation, where he had been President since 2003. During his tenure at Stryker, he successfully led the company through strategic acquisitions and product launches, tripling revenue from $2.8 billion to $8.3 billion. Prior to 2003, he was a senior executive with Pharmacia Corporation, overseeing five global businesses, including one in diagnostics, with revenues exceeding $2 billion. He also spent 11 years with Johnson & Johnson in various senior roles, including President of the joint venture between Johnson & Johnson and Merck, and began his career with Procter and Gamble in 1985. After leaving Stryker, he joined sBiomed, a small startup, as CEO in November 2012, before joining Hologic.

Karleen M. Oberton, Chief Financial Officer

Ms. Oberton became Hologic's Chief Financial Officer in August 2018. She initially joined Hologic in 2006 as corporate controller, was promoted to Chief Accounting Officer in 2014 (or 2015 by some accounts) and joined the Global Leadership Team in 2017. Before her time at Hologic, Ms. Oberton served as Senior Corporate Controller of Immunogen from 2004 to 2006. Earlier in her career, she was a Senior Audit Manager in Ernst & Young's Life Science practice and in Arthur Andersen's High Technology practice. She was an active Certified Public Accountant for over 18 years.

Essex Mitchell, Chief Operating Officer

Mr. Mitchell was promoted to Chief Operating Officer in January 2024. He joined Hologic in 2017 as the Vice President of Sales and Commercial Excellence for the GYN Surgical Division, and was subsequently promoted to Division President in 2020. Mr. Mitchell brings nearly 20 years of medical device and pharmaceutical experience. Prior to Hologic, he worked for Stryker Corporation from 2006 to 2017 in various commercial roles, and before that, held commercial positions with Merck and Abbott Laboratories.

Jan Verstreken, Group President, International

Mr. Verstreken serves as Hologic's Group President, International, overseeing the company's global operations.

Jennifer Schneiders, President, Diagnostic Solutions

Dr. Schneiders was promoted to President, Diagnostic Solutions in April 2023. She joined Hologic in March 2008 following the company's acquisition of Third Wave Technologies. Throughout her tenure at Hologic, she has held various roles of increasing responsibility, including Vice President, Diagnostic Laboratory Solutions and Senior Director of Clinical Solutions, and has been instrumental in driving Hologic's market leadership in women's health diagnostics.

The public company Hologic (HOLX) faces several key business risks, primarily stemming from regulatory scrutiny, intense market competition, and geopolitical and macroeconomic factors.

The most significant risk for Hologic lies in Regulatory and Compliance Challenges. The company operates in a highly regulated industry, and any failure to obtain necessary regulatory clearances or approvals for its products can negatively impact its business. Recent concerns include an FDA warning letter and over 100 lawsuits related to its BioZorb product, highlighting potential gaps in regulatory oversight and patient safety documentation for surgical devices. The evolving regulatory landscape, particularly concerning artificial intelligence in medical devices, also presents an increased risk of enforcement and litigation. These issues can lead to substantial financial penalties, reputational damage, and restrictions on product sales.

Another key risk is Intense Competition and Market Volatility. Hologic competes with major players like GE Healthcare and Siemens Healthineers in dynamic markets, particularly in breast imaging and diagnostics. Competitors continuously introduce new products and technologies, intensifying competition and potentially leading to market saturation or the need for price reductions and increased investment in product improvements. The Breast Health segment, for instance, has experienced volatility with soft gantry sales. The markets for newly developed products may also not develop as expected, and Hologic's return on invested capital (ROIC) has reportedly decreased, suggesting fewer profitable growth opportunities. Additionally, the Diagnostics segment relies on a small number of customers for a large portion of its sales, and the loss of any of these customers could substantially lower revenue.

Finally, Geopolitical and Macroeconomic Headwinds pose a notable risk. Hologic has faced increased costs due to U.S. tariffs and has seen sales projections cut due to a slowdown in healthcare spending in China. The company also experienced a loss of HIV testing revenue in Africa due to USAID funding cuts. Broader macroeconomic pressures and geopolitical risks, which account for a higher percentage of Hologic's risk factors compared to the sector average, can significantly impact the company's profitability and growth trajectory.

The emergence and advancement of liquid biopsy technologies for multi-cancer early detection (MCED) represent a clear emerging threat to Hologic's core businesses in breast and cervical cancer screening. Hologic is a leading provider of 3D mammography systems and diagnostic tests for HPV and cytology (Pap tests), which are foundational for early detection of these cancers. Should liquid biopsies achieve sufficient sensitivity, specificity, and cost-effectiveness to be widely adopted for routine screening of breast and cervical cancers, they could fundamentally disrupt the current screening paradigms, potentially diminishing the demand for Hologic's established imaging and diagnostic products.

Hologic (HOLX) operates in several key markets within women's health, including diagnostics, breast health, GYN surgical, and skeletal health. The addressable market sizes for their main products and services are outlined below, with market sizes generally representing global figures unless otherwise specified:

• Women's Health Diagnostics: The global women's health diagnostics market is estimated at approximately USD 30.73 billion in 2025, with projections to reach USD 41.93 billion by 2030. Another estimate for the global market size is USD 36.6 billion by 2025.
• Hologic Mammography: The global Hologic mammography market is projected to reach a valuation of USD 3.27 billion in 2025 and is anticipated to grow to USD 7.87 billion by 2034.
• Breast Biopsy Devices: The global breast biopsy devices market is projected to be valued at USD 2.47 billion in 2025 and is expected to reach USD 4.21 billion by 2035.
• Cervical Cancer Screening/Diagnostics: The global cervical cancer diagnostic market size is calculated at USD 9.82 billion in 2025 and is predicted to surpass approximately USD 15.37 billion by 2034. The global cervical cancer screening market was estimated at USD 7.9 billion in 2024 and is expected to reach USD 14.5 billion by 2033.
• Gynecological Surgical Devices: The global gynecological surgical devices market is projected to reach an estimated USD 18.5 billion by 2025 and is anticipated to surge to approximately USD 26.0 billion by 2033.
• Molecular Diagnostics: The global molecular diagnostics market size is valued at USD 45.11 billion in 2025 and is expected to hit around USD 63.86 billion by 2034. Another estimate places the global molecular diagnostics market at USD 15.78 billion in 2025, growing to USD 21.21 billion by 2032.

Hologic (HOLX) is anticipated to drive future revenue growth over the next 2-3 years through several key strategies and market dynamics:

1. New Product Innovation and Launches: The company expects growth from new product introductions, particularly in its Breast Health and Diagnostics segments. Key upcoming products include the Envision mammography platform, expected to be a significant driver in fiscal years 2027-2029. Hologic also recently introduced its next-generation Genius AI Detection PRO solution for enhanced breast cancer screening accuracy and efficiency. In breast surgery, the next-generation Sentimag Gen 3 device was launched in Europe in 2025. In diagnostics, the expansion of the Panther platform with the Fusion add-on is expected to provide five years of growth by increasing menu and PCR capabilities, with new Fusion assays contributing in 2027-2028. The BVCV assay is also identified as a major growth driver with strong competitive positioning and international market potential.
2. International Market Expansion: Hologic anticipates mid-single-digit organic revenue growth in fiscal year 2026, partly driven by its expanding international market reach. The Diagnostics market is expected to grow with the continued decentralization of testing and increased adoption of the Panther platform in international markets. Furthermore, the international breast health market is considered underdeveloped, presenting a substantial opportunity for 3D mammography adoption and policy-driven growth.
3. Rebound and Strength in the Breast Health Business: A significant driver of future optimism is the continuous rebound in Hologic's Breast Health business. The company expects to achieve solid mid-single-digit organic revenue growth partly due to this segment's recovery. Recent performance in the third quarter of fiscal year 2025 showed sequential improvement, supported by innovations in mammography and a restructured breast health sales force leading to improved execution. Analysts also link future margin recovery to innovation and premium product upgrades within this segment.
4. Continued Growth of the Diagnostics Business and Panther Platform: The Diagnostics business remains a strong growth engine, consistently delivering high-single-digit revenue growth and increased utilization of its Panther platform. The expansion of the Panther molecular diagnostic system has led to a substantial increase in installed units globally, generating recurring revenue through assay sales. Hologic has also significantly broadened its menu of FDA-cleared assays available on the Panther system. This segment is projected to contribute to mid-single-digit growth in 2026.
5. Strategic Acquisitions: Acquisitions are expected to contribute to revenue growth. The Endomagnetics (Endomag) acquisition, for instance, has been performing ahead of expectations and is contributing to growth, adding $20 million in the third quarter of fiscal year 2025 and becoming part of organic revenues from August 2025. Hologic also signed a definitive agreement in October 2024 to acquire Gynesonics, which is anticipated to close in the first half of calendar year 2025, further pursuing growth opportunities.

Share Repurchases

• In recent years, Hologic has allocated approximately $3.6 billion to share repurchases.
• In September 2024, the company authorized a new share repurchase program of up to $1.5 billion over five years.
• Between March 30 and June 28, 2025, Hologic repurchased 667,618 shares for $35.62 million, contributing to a total of nearly 8 million shares at a cost of $562.74 million under the September 2024 program.

Inbound Investments

• In October 2025, private equity firms Blackstone and TPG announced an agreement to acquire Hologic for $18.3 billion, taking the company private.

Outbound Investments

• Hologic allocated approximately $2 billion to mergers and acquisitions in recent years.
• Notable acquisitions include Gynesonics in October 2024 for $350 million, focused on minimally invasive uterine fibroid treatment.
• In April 2024, Hologic acquired Endomag for approximately $310 million, enhancing its breast cancer surgery technologies.
• Other significant acquisitions in the last three to five years include Mobidiag for $795 million and Biotheranostics for $230 million, both in 2021.

Capital Expenditures

• Hologic's capital expenditures averaged $148.3 million annually for fiscal years ending September 2020 to 2024.
• Capital expenditures for the latest twelve months ending June 28, 2025, were $136.9 million.
• Expenditures peaked at $177.7 million in September 2021 and reached a 5-year low of $127.2 million in September 2022.