MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic, Inc. (Nasdaq: HOLX) announced today that the Company will present at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024, at 1:30 p.m. Pacific Time.The presentation and Q&A session will be webcast live and may be accessed through a link on the Investors section of Hologic’s website at http://investors.hologic.com. The webcast will be available for 30 days following the event.About Hologic, Inc.Hologic, Inc. is an innovative medical tech ...

FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: September 30, 2023 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________________________ or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 1-36214 _________________________________________________ ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________________________ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended July 1, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 1-36214 __________________________________________________________ HOLOGIC ...

Hologic, Inc. (NASDAQ:HOLX) Q2 2023 Earnings Conference Call May 1, 2023 4:30 PM ET Company Participants Ryan Simon - VP, IR Stephen MacMillan - Chairman, President and CEO Karleen Oberton - CFO Conference Call Participants Patrick Donnelly - Citi Tim Daley - Wells Fargo Casey Woodring - JPMorgan Anthony Petrone - Mizuho Group Elizabeth Garcia - UBS Andrew Cooper - Raymond James Jack Meehan - Nephron Research Puneet Souda - SVB Securities Jack Meehan - Nephron Research Max Masucci - Cowen & Company Tejas Sa ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________________________ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended April 1, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 1-36214 __________________________________________________________ HOLOGI ...

Hologic, Inc. (NASDAQ:HOLX) Q1 2023 Earnings Conference Call February 1, 2023 4:30 PM ET Company Participants Ryan Simon - VP, IR Stephen MacMillan - Chairman, President and CEO Karleen Oberton - CFO Conference Call Participants Patrick Donnelly - Citi Jack Meehan - Nephron Research Max Masucci - Cowen & Company Puneet Souda - SVB Securities Vijay Kumar - Evercore ISI Tim Daley - Wells Fargo Tejas Savant - Morgan Stanley Derik de Bruin - Bank of America Dustin Scaringe - William Blair Navann Ty - BNP Pariba ...

Millions • 14.7% constant currency organic Strong Balance Sheet for Future Capital Deployment Opportunities • No near-term debt maturities, no balance outstanding on revolver 25 *Net debt is total debt minus cash in $ billions; leverage ratio is principal debt minus cash to TTM adjusted EBITDA Introduction Results Driven 26 • Purpose Driven, Results Driven ...with Leadership Across the Continuum of Care SUP 23 24 • Stability in NovaSure Non-COVID Panther Utilization Metrics • Panther non-COVID utilization g ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________________________ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 1-36214 __________________________________________________________ HO ...

3 Introduction Elevating Global Women's Health… • 4th for large companies in San Diego County by The San Diego Union-Tribune 2 Non-GAAP Financial Measures The Company has presented the following non-GAAP financial measures in this presentation: constant currency revenues; organic revenues; non-GAAP gross margin; non-GAAP operating expenses; non-GAAP operating margin; non-GAAP effective tax rate; non-GAAP net income; non-GAAP net margin; non-GAAP EPS; and adjusted EBITDA. Constant currency calculations show ...

Business Segments - The company operates in four segments: Diagnostics, Breast Health, GYN Surgical, and Skeletal Health, focusing on women's health and well-being through early detection and treatment [20]. - The Diagnostics segment includes molecular diagnostic assays for STDs, HPV, and viral load tests for Hepatitis B and C, with the Aptima SARS-CoV-2 assay launched in response to the COVID-19 pandemic [21]. - The Breast Health segment offers advanced solutions for breast cancer care, including 3D digital mammography systems and AI-driven image analytics software [22]. - The GYN Surgical products include the NovaSure endometrial ablation system and MyoSure hysteroscopic tissue removal system, targeting abnormal uterine bleeding and uterine pathology [23]. - The Skeletal Health segment features the Horizon DXA system for bone density evaluation and the Fluoroscan Insight FD mini C-arm for minimally invasive orthopedic procedures [24]. Product Development and Innovation - The company has developed new molecular assays, including the Panther Fusion EBV Quant and BKV Quant assays, expanding its transplant monitoring capabilities [21]. - The ThinPrep System is the most widely used method for cervical cancer screening in the U.S., automating the preparation of cervical slides for examination [36]. - The Panther Fusion system enhances the capabilities of the Panther system by adding PCR functionality, allowing for a broader range of diagnostic tests [35]. - The company emphasizes the integration of proprietary technologies in its assays, such as target capture and transcription-mediated amplification, to improve test sensitivity and specificity [30][31]. - The company continues to expand its product offerings and market presence through innovation in diagnostics and surgical solutions for women's health [20]. - The Genius Digital Diagnostics System, launched in November 2020, utilizes AI to analyze ThinPrep Pap test images, narrowing down tens of thousands of cells to the most diagnostically relevant images [41]. - The acquisition of Biotheranostics in February 2021 introduced two proprietary laboratory developed tests: the Breast Cancer Index test and the CancerTYPE ID test, enhancing cancer treatment support [43]. - The Rapid Fetal Fibronectin Test is a single-use test that assesses the risk of pre-term birth by detecting fetal fibronectin in vaginal secretions [42]. - The acquisition of Mobidiag in June 2021 aims to expand PCR-based tests for acute care conditions, with plans to seek U.S. clearance for the Novodiag instrument and related assays [45]. - The 3DQuorum technology reduces the number of 3D mammography images to review by two-thirds, saving an estimated one hour per eight hours of daily image interpretation time [47]. - The NovaSure CLASSIC endometrial ablation system features Smart-Depth technology for customized treatment of abnormal uterine bleeding, improving patient outcomes [53]. - The Horizon line of x-ray bone densitometers provides advanced features for bone health screening and body composition assessment, crucial for diagnosing osteoporosis [59]. - The Fluoroscan Insight FD mini C-arm imaging system offers high-resolution imaging at lower radiation levels, primarily used in orthopedic surgeries [60]. Market Dynamics and Competition - The company maintains distinct sales teams for Diagnostics, Breast Health, GYN Surgical, and Skeletal Health markets, targeting clinical laboratories and healthcare providers [62]. - In fiscal 2020, two customers accounted for 12.5% and 10.9% of the Diagnostics segment revenue, reflecting industry consolidation, with no other customer exceeding 10% in subsequent years [61]. - The healthcare industry is highly competitive, with numerous companies developing products that may compete with the company's offerings [65]. - The company faces pressure on average selling prices and overall procedure rates due to increased competition and declining reimbursement rates [66]. - The success of the company's products relies on their ability to demonstrate clinical and operational superiority, including efficacy, reliability, and cost-effectiveness [67]. - The ThinPrep liquid-based cytology product competes with Becton, Dickinson and Company and conventional Pap smears, with international competition from various non-FDA approved tests [68]. - The Rapid Fetal Fibronectin Test is currently the only in vitro diagnostic test for predicting pre-term birth risk in the U.S., facing competition from Actim Partus and PartoSure internationally [69]. - The molecular diagnostics market is rapidly evolving, with over 400 COVID-19 assays receiving Emergency Use Authorization from the FDA, increasing competition [70]. - The Aptima Combo 2 test competes against major companies like Abbott Laboratories and Roche Diagnostics in the U.S. clinical diagnostics market [71]. - The company’s mammography systems face competition from General Electric, Siemens, and Philips, among others, in both the U.S. and international markets [72]. Financial Performance and Challenges - Diagnostics product revenues decreased by 18.7% in fiscal 2022, primarily due to a reduction of $729.0 million in sales of SARS-CoV-2 assays, resulting in total molecular diagnostics revenue of $2,427.5 million [211]. - Breast Health product revenues fell by 16.5% in fiscal 2022, attributed to supply chain constraints affecting the production of digital mammography systems and biopsy systems, with significant back orders remaining [212]. - GYN Surgical product revenues increased by 7.1% in fiscal 2022, driven by higher sales volumes of Fluent Fluid Management products and Bolder products, despite a decline in NovaSure system sales [214]. - Skeletal Health product revenues decreased by 6.6% in fiscal 2022, primarily due to lower sales volumes of Horizon DXA systems and Insight FD Fluoroscan systems, linked to supply chain issues [215]. - The company reported a total product revenue decrease of 15.6% in fiscal 2022, largely due to declines in Diagnostics and Breast Health segments [210]. - Supply chain shortages, particularly in semiconductor chips, are impacting the production capabilities of Breast Health capital equipment products, potentially leading to lower sales in fiscal 2023 [204]. - The company expects continued declines in sales of COVID-19 assays in fiscal 2023 as the pandemic situation improves and vaccination efforts continue [211]. Regulatory and Compliance Issues - The company is engaged in intellectual property litigation, which may impact product availability and market demand [92]. - The FDA classifies medical devices into three classes based on risk, with Class II and III requiring pre-market notifications or approvals [94]. - The company has received Emergency Use Authorizations (EUA) for its COVID-19 assays, including the Panther Fusion SARS-CoV-2 assay and Aptima SARS-CoV-2 assay [96]. - The regulatory environment in China is evolving, which may affect the company's operations and product introductions in that market [104]. - Compliance with international regulations, such as the EU Medical Device Regulation, requires significant expenditures and may impact business operations [102]. - The company anticipates ongoing scrutiny from governmental authorities, which may lead to increased compliance costs and operational uncertainties [105]. - Changes in healthcare laws and regulations may increase compliance costs and expose the company to litigation risks [156]. - The company is subject to product liability claims, which could result in substantial damages and affect its reputation [161]. - The company relies on licenses for key technologies, and loss of these licenses could limit product development capabilities [167]. - The company may face challenges in obtaining necessary intellectual property rights to commercialize products, impacting its business [169]. - Compliance with evolving privacy and data security laws may require significant changes to products and incur penalties, impacting operations [149]. Employee and Community Engagement - As of September 24, 2022, the company employed 6,944 full-time employees, with 4,045 in the U.S. and 2,899 outside the U.S. [110]. - The company emphasizes the importance of employee engagement, conducting annual surveys since 2015 to enhance workforce performance [111]. - The company has a diverse board, with 38% of directors being women and a commitment to promoting diversity within its workforce [114]. - In fiscal 2022, the company pledged to donate $5 million from its charitable fund to support community initiatives [120]. - The company awarded extraordinary financial bonuses to front-line employees who worked during the COVID-19 pandemic [117]. - The company has developed several employee-focused initiatives to support well-being, including enhanced insurance and access to telehealth services [118]. Financial Position and Debt - As of September 24, 2022, the company had approximately $2.85 billion in aggregate principal of indebtedness outstanding, which limits operational flexibility [173]. - Approximately $1.5 billion of the company's indebtedness is subject to floating interest rates, increasing vulnerability to economic downturns and interest rate hikes [177]. - The company has a hedging arrangement in place to mitigate higher interest rates, but there is no assurance it can be extended at favorable terms [177]. - The company has never declared or paid cash dividends and plans to retain earnings for growth, debt repayment, and stock repurchase [190]. - A total of 3,917 shares were repurchased at an average price of $70.36 per share, with a remaining authorization of $1.0 billion for stock repurchase [192]. - The company faces risks related to its significant indebtedness, which may impair its ability to respond to changing business conditions [174]. - The stock price has been highly volatile, influenced by various factors including market conditions and technological innovations [179]. - The company may need to adopt alternative strategies such as asset sales or restructuring debt if it cannot generate sufficient cash flow to meet obligations [176]. Supply Chain and Economic Factors - The company faces significant supply chain disruptions and inflationary pressures, impacting its ability to procure raw materials and meet customer demand [130]. - The company relies on sole source manufacturers for certain product lines, increasing risks associated with production delays and quality control [131]. - Economic uncertainties, including inflation and rising interest rates, may adversely affect the company's sales volume and pricing strategies [124]. - The markets for the company's products are intensely competitive, with rapid technological changes and potential new product introductions affecting demand [134]. - The company has seen significant demand for its COVID-19 assays, but faces competition from other companies producing similar tests [135].