Hologic Announces Financial Results for First Quarter of Fiscal 2021

– Revenue of $1.61 Billion Increases 89.3%, 86.5% in Constant Currency –

– Organic Revenue Increases 107.0%, 104.0% in Constant Currency –

– Company Posts GAAP Diluted EPS of $2.50, Non-GAAP Diluted EPS of $2.86 –

MARLBOROUGH, Mass.–(BUSINESS WIRE)–#earnings–Hologic, Inc. (Nasdaq: HOLX) announced today the Company’s financial results for the fiscal first quarter ended December 26, 2020.

“Hologic had a strong start to fiscal 2021 across all our businesses and major geographies,” said Steve MacMillan, the Company’s Chairman, President and Chief Executive Officer. “Our Diagnostics division continued to deliver incredible performance by making a massive impact against COVID-19. Furthermore, our Breast Health and Surgical businesses continued to strengthen, with each returning to growth in the United States, Europe and Asia-Pacific.”

Recent Highlights

• Revenue increased 89.3% for the quarter, or 86.5% in constant currency, including revenue from the divested Medical Aesthetics business in the prior year period. Excluding material acquisitions and divestitures, organic revenue in the first quarter increased 107.0%, or 104.0% in constant currency.
• Worldwide molecular diagnostics revenue of $995.3 million increased 457.6%, or 448.7% in constant currency, exceeding expectations based on increased production of, and strong global demand for, the Company’s two SARS-CoV-2 assays that run on the fully automated Panther® and Panther Fusion® systems.
• In early January, announced an agreement to acquire Biotheranostics, a privately held, commercial-stage company that provides molecular diagnostic tests for breast and metastatic cancers, for approximately $230 million.
• On December 31, completed the acquisition of SOMATEX Medical Technologies GmbH, a leader in biopsy site markers and localization technologies, for approximately $64 million.
• Recent regulatory clearances:
  • U.S. FDA clearance of Genius AI™ detection technology, a deep learning-based software designed to help radiologists detect subtle potential cancers in breast tomosynthesis images.
  • U.S. FDA approval of a diagnostic claim for the Company’s Aptima® HIV-1 Quant Dx viral load monitoring assay, making it the first dual-claim assay for both diagnosis and viral load monitoring in the United States.
  • European CE Mark of the Genius™ digital diagnostics system, the first digital cytology platform to combine a new artificial intelligence algorithm with advanced digital imaging to help identify cancerous and pre-cancerous cells in women.
• Cash flow from operations was $650.0 million in the quarter. Based on this strong cash flow, the Company announced the Biotheranostics and SOMATEX acquisitions, repaid $250 million of debt under its revolving credit facility, and repurchased 1.5 million shares of its common stock for $101 million.

Key financial results for the fiscal first quarter are shown in the table below.

Throughout this press release, all dollar figures are in millions, except EPS, unless otherwise noted. Some totals may not foot due to rounding. Unless otherwise noted, all results are compared to the corresponding prior year period. Non-GAAP results exclude certain cash and non-cash items as discussed under “Use of Non-GAAP Financial Measures.” Constant currency percentage changes show current period revenue results as if the foreign exchange rates were the same as those in the prior year period. Organic revenue is on a constant currency basis and excludes the divested Blood Screening and Medical Aesthetics businesses, as well as the acquired Acessa business.

* Hologic completed the divestiture of its Medical Aesthetics business on December 30, 2019.

Other Financial Highlights

• U.S. revenue of $1,137.8 million increased 79.8%. International revenue of $472.0 million increased 116.7%, or 106.0% in constant currency. Organically, U.S. revenue of $1,128.4 million increased 91.3%, while international revenue of $472.0 million increased 157.5%, or 144.7% in constant currency.
• GAAP gross margin of 73.3% increased 2,230 basis points. Non-GAAP gross margin of 77.2% increased 1,560 basis points, primarily due to sales of SARS-CoV-2 tests and the divestiture of the lower margin Medical Aesthetics business.
• GAAP operating margin of 55.0% increased 4,030 basis points. Non-GAAP operating margin of 60.2% increased 3,270 basis points, primarily due to sales of SARS-CoV-2 tests and the divestiture of the lower margin Medical Aesthetics business.
• GAAP net income attributable to Hologic of $654.4 million increased 69.5%. Non-GAAP net income attributable to Hologic of $749.6 million increased 356.8%. Adjusted non-GAAP earnings before interest, taxes, depreciation and amortization (EBITDA) was $1,000.7 million, an increase of 282.1%.
• Total principal debt outstanding at the end of the first quarter was $2.8 billion. The Company ended the quarter with cash and equivalents of $868.7 million, and a net leverage ratio (net debt over adjusted EBITDA) of 0.8 times.
• On a trailing 12 months basis, adjusted Return on Invested Capital (ROIC) of 26.7% increased 1,440 basis points compared to the prior year period.

Financial Guidance for the Second Quarter of Fiscal 2021

“We expect our strong financial performance to continue in the second quarter of fiscal 2021,” said Karleen Oberton, Hologic’s Chief Financial Officer.

Hologic’s financial guidance for the second quarter of fiscal 2021 is shown in the table below. The guidance is based on a non-GAAP tax rate of approximately 21.75%, and diluted shares outstanding of 262 to 263 million for the quarter. Constant currency guidance assumes that foreign exchange rates are the same in fiscal 2021 as in fiscal 2020. Current guidance assumes that recent foreign exchange rates persist for all of the second quarter of fiscal 2021. Organic revenue guidance is on a constant currency basis and excludes the divested Blood Screening and the acquired Acessa businesses. The guidance does not include the impact of the pending Biotheranostics acquisition, which has not closed.

Use of Non-GAAP Financial Measures

The Company has presented the following non-GAAP financial measures in this press release: 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. The Company defines its non-GAAP net income, EPS, and other non-GAAP financial measures to exclude, as applicable: (i) the amortization of intangible assets and impairment of goodwill, intangible assets and equipment; (ii) accelerated depreciation related to consolidation and closure of facilities; (iii) additional expenses resulting from the purchase accounting adjustment to record inventory at fair value and adjustments to contingent consideration; (iv) restructuring and divestiture charges and facility closure and consolidation charges and costs incurred to integrate acquisitions (including retention, transaction bonuses, legal and professional consulting services) and separate divested businesses from existing operations; (v) expenses related to its divested Cynosure business incurred subsequent to the disposition date primarily related to indemnification provisions for legal and tax matters; (vi) transaction related expenses for divestitures and acquisitions; (vii) third-party expenses incurred related to implementing the European MDR/IVDR requirements and obtaining the appropriate approvals for its existing products; (viii) debt extinguishment losses and related transaction costs; (ix) the unrealized (gains) losses on the mark-to-market of forward foreign currency contracts and foreign currency option contracts for which the Company has not elected hedge accounting; (x) litigation settlement charges (benefits) and non-income tax related charges (benefits); (xi) other-than-temporary impairment losses on investments and realized gains and losses resulting from the sale of investments; (xii) the one-time discrete impacts related to internal restructuring and non-operational items; (xiii) other one-time, non-recurring, unusual or infrequent charges, expenses or gains that may not be indicative of the Company’s core business results; and (xiv) income taxes related to such adjustments. The Company defines adjusted EBITDA as its non-GAAP net income plus net interest expense, income taxes, and depreciation and amortization expense included in its non-GAAP net income. The Company defines organic revenue to exclude the divested Blood Screening and Medical Aesthetic businesses, and the acquired Acessa business.

These non-GAAP financial measures should be considered supplemental to, and not a substitute for, financial information prepared in accordance with GAAP. The company’s definition of these non-GAAP measures may differ from similarly titled measures used by others.

The non-GAAP financial measures used in this press release adjust for specified items that can be highly variable or difficult to predict. The company generally uses these non-GAAP financial measures to facilitate management’s financial and operational decision-making, including evaluation of Hologic’s historical operating results, comparison to competitors’ operating results and determination of management incentive compensation. These non-GAAP financial measures reflect an additional way of viewing aspects of the company’s operations that, when viewed with GAAP results and the reconciliations to corresponding GAAP financial measures, may provide a more complete understanding of factors and trends affecting Hologic’s business.

Because non-GAAP financial measures exclude the effect of items that will increase or decrease the company’s reported results of operations, management strongly encourages investors to review the company’s consolidated financial statements and publicly filed reports in their entirety. A reconciliation of the non-GAAP financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this release.

Conference Call and Webcast

Hologic’s management will host a conference call at 4:30 p.m. ET today to discuss its financial results for the first quarter of fiscal 2021. Approximately 10 minutes before the call, dial 888-204-4368 (in the U.S. and Canada) or +1 323-994-2093 (international) and enter access code 2632110. A replay will be available approximately two hours after the call ends through Friday, February 26, 2021. The replay numbers are 888-203-1112 (U.S.) or +1 719-457-0820 (international), access code 2632110, PIN 7018. The Company will also provide a live webcast of the call at investors.hologic.com

About Hologic, Inc.

Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.

Hologic and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.

Forward-Looking Statements

This news release contains forward-looking information that involves risks and uncertainties, including statements about the Company’s plans, objectives, expectations and intentions. Such statements include, without limitation: financial or other information based upon or otherwise incorporating judgments or estimates relating to future performance, events or expectations; the Company’s strategies, positioning, resources, capabilities, and expectations for future performance; and the Company’s outlook and financial and other guidance. These forward-looking statements are based upon assumptions made by the Company as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those anticipated.

Risks and uncertainties that could adversely affect the Company’s business and prospects, and otherwise cause actual results to differ materially from those anticipated, include without limitation: the severity and duration of the COVID-19 pandemic and its impact on the U.S. healthcare system, the U.S. economy and worldwide economy; the timing, scope and effect of further U.S. and international governmental, regulatory, fiscal, monetary and public health responses to the COVID-19 pandemic; continued demand for the Company’s COVID-19 TMA assay; the Company’s ability to manufacture, on a scale necessary to meet demand, its COVID-19 TMA assay as well as the Panther systems on which the assay runs; U.S., European and general worldwide economic conditions, trade relations, and related uncertainties; manufacturing risks, including the Company’s reliance on a single or limited source of supply for key components, the need to comply with especially high standards for the manufacture of many of its products and risks associated with utilizing third party manufacturers; the Company’s ability to predict accurately the demand for its products, and products under development, and to develop strategies to address its markets successfully; the ability of the Company to successfully manage leadership and organizational changes, including the ability of the Company to attract, motivate and retain key employees and maintain engagement and efficiency in remote work environments; the Company’s reliance on third-party reimbursement policies to support the sales and market acceptance of its products, including the possible adverse impact of government regulation and changes in the availability and amount of reimbursement and uncertainties for new products or product enhancements; changes to applicable laws and regulations, including tax laws, global health care reform, and import/export trade laws; changes in guidelines, recommendations and studies published by various organizations that could affect the use of the Company’s products; uncertainties inherent in the development of new products and the enhancement of existing products, including FDA approval and/or clearance and other regulatory risks, technical risks, cost overruns and delays; the risk that products may contain undetected errors or defects or otherwise not perform as anticipated; risks associated with strategic alliances and the ability of the Company to realize anticipated benefits of those alliances; risks associated with acquisitions, including, without limitation, the Company’s ability to successfully integrate acquired businesses, the risks that the acquired businesses may not operate as effectively and efficiently as expected even if otherwise successfully integrated, and the risks that acquisitions may involve unexpected costs or unexpected liabilities; the risks of conducting business internationally; the risk of adverse exchange rate fluctuations on the Company’s international activities and businesses; the early stage of market development for certain of the Company’s products; the Company’s leverage risks, including the Company’s obligation to meet payment obligations and financial covenants associated with its debt; cybersecurity risks; risks related to the use and protection of intellectual property; expenses, uncertainties and potential liabilities relating to litigation, including, without limitation, commercial, intellectual property, employment and product liability litigation; technical innovations that could render products marketed or under development by the Company obsolete; and competition.

The risks included above are not exhaustive. Other factors that could adversely affect the Company’s business and prospects are described in the filings made by the Company with the SEC, including its most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such statements are based.

SOURCE: Hologic, Inc.

Contacts

Michael Watts

Vice President, Investor Relations and Corporate Communications

(858) 410-8588

Michael.watts@hologic.com

Read full story here