Hologic Announces Financial Results for Third Quarter of Fiscal 2021

— Revenue of $1.168 Billion Increases 42.0%, 37.8% in Constant Currency —

— Organic Revenue Increases 38.4%, 34.2% in Constant Currency —

— Company Posts GAAP Diluted EPS of $1.04, Non-GAAP Diluted EPS of $1.33 —

Hologic, Inc. (Nasdaq: HOLX) announced today the Company’s financial results for the fiscal third quarter ended June 26, 2021.

“Hologic posted very strong financial results in our third fiscal quarter, with both revenue and EPS growth exceeding our guidance,” said Steve MacMillan, the Company’s chairman, president and chief executive officer. “Our base businesses showed strong momentum and we continued to make a big difference against the COVID pandemic. And we used our strong cash flows to strengthen the Company for the future by finalizing the Mobidiag acquisition.”

Recent Highlights

• Revenue increased 42.0% for the quarter, or 37.8% in constant currency. Excluding material acquisitions and divestitures, organic revenue in the third quarter increased 38.4%, or 34.2% in constant currency.
• Global revenue for the Company’s Breast and Skeletal Health and GYN Surgical divisions grew significantly compared to the prior year period, when sales were most negatively affected by the COVID-19 pandemic. Notably, both divisions also grew compared to the same period in 2019.
• Worldwide diagnostics revenue of $665.5 million increased 25.0%, or 20.3% in constant currency, despite lower demand for the Company’s two COVID assays that run on the Panther® and Panther Fusion® systems.
• Completed the acquisition of Finnish molecular diagnostics company Mobidiag for an enterprise value of approximately $808 million.
• The American College of Obstetricians and Gynecologists updated its guidance for the management of symptomatic uterine leiomyomas to support the use of laparoscopic radiofrequency ablation. And Cigna updated its medical policy to cover the Acessa laparoscopic radiofrequency ablation procedure as medically necessary.
• Launched Project Health Equality, which strives to address the structural and cultural barriers that prevent Black and Hispanic women in the U.S. from receiving the same quality health care as white women. Project Health Equality is a multiyear investment of more than $20 million to drive research, education and access to ensure women of color receive the care they want, need and deserve.
• Cash flow from operations was a very strong $662.9 million in the third quarter. In addition to closing the Mobidiag acquisition, the Company repurchased approximately 3.0 million shares of its common stock for $188 million in the quarter.

Key financial results for the fiscal third 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 business, as well as the acquired Acessa, Biotheranostics, Diagenode, and Mobidiag businesses. Revenue from acquired businesses is generally included in organic revenue starting a year after the acquisition.

Revenue Detail

Other Financial Highlights

• U.S. revenue of $749.9 million increased 13.5%. International revenue of $418.4 million increased 158.1%, or 137.0% in constant currency. Organically, U.S. revenue of $719.0 million increased 10.1%, while international revenue of $409.3 million increased 152.5%, or 131.4% in constant currency.
• GAAP gross margin of 60.1% increased 350 basis points. Non-GAAP gross margin of 66.1% increased 140 basis points. The increase in gross margin was largely due to a recovery in our base businesses.
• GAAP operating margin of 30.7% increased 750 basis points. Non-GAAP operating margin of 39.5% increased 650 basis points. The increase in operating margin was primarily due to the significant increase in revenues.
• GAAP net income attributable to Hologic of $268.4 million increased 94.6%. Non-GAAP net income attributable to Hologic of $344.8 million increased 77.1%. Adjusted non-GAAP earnings before interest, taxes, depreciation and amortization (EBITDA) was $483.1 million, an increase of 61.6%.
• Total principal debt outstanding at the end of the third quarter was $3.14 billion. The Company ended the quarter with cash and equivalents of $827.6 million, and a net leverage ratio (net debt over adjusted EBITDA) of 0.7.
• On a trailing 12 months basis, adjusted Return on Invested Capital (ROIC) of 34.7% increased 2,190 basis points compared to the prior year period.

Financial Guidance for the Fourth Quarter of Fiscal 2021

“As we wrap up Hologic’s best financial year in our fourth fiscal quarter, we expect strong growth in our base businesses, offset by declines in COVID testing revenue,” said Karleen Oberton, Hologic’s chief financial officer.

Hologic’s financial guidance for the fourth quarter of fiscal 2021 is shown in the table below. The guidance is based on a non-GAAP tax rate of approximately 21.5%, and 260 million diluted shares outstanding 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 fourth quarter of fiscal 2021. Organic revenue guidance is on a constant currency basis and excludes the divested Blood Screening business and the acquired Acessa, Biotheranostics, Diagenode, and Mobidiag businesses. Revenue from acquired businesses is generally included in organic revenue guidance starting a year after the acquisition.

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) adjustments to record contingent consideration at fair value; (iii) additional expenses resulting from the purchase accounting adjustment to record inventory at fair value; (iv) restructuring and divestiture charges and facility closure and consolidation charges, including accelerated depreciation, 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 the 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 foreign currency 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 business, and the acquired Acessa, Biotheranostics, Diagenode, and Mobidiag businesses.

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 third quarter of fiscal 2021. Interested participants may listen to the call by dialing 888-204-4368 (in the U.S. and Canada) or +1 323-994-2093 (for international callers) and referencing access code 5101679. Participants may also click here to join. Participants should dial in 5-10 minutes before the call begins. A replay will be available approximately two hours after the call ends through Friday, August 27, 2021. The replay numbers are 888-203-1112 (U.S.) or +1 719-457-0820 (international), access code 5101679, PIN 3270. 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.

Explanatory Notes to Reconciliations:

Reconciliation of GAAP to non-GAAP EPS Guidance:

(1) ROIC is presented on a TTM basis; non-GAAP effective tax rate for the three months ended September 26, 2020 was 22.75%, the three months ended December 26, 2020 was 21.75%, the three months ended March 27, 2021 was 21.22% and the three months ended June 26, 2021 was 21.50%.

(2) Calculated using the average of the balances as of June 26, 2021 and June 27, 2020.

(3) Adjusted (increased) to eliminate the effect of the impairment of intangible assets of $32.2 million in fiscal 2014, the impairment of goodwill of $685.7 million and an IPR&D asset of $46.0 million in fiscal 2018, the impairment of intangible assets and equipment of $685.4 million in fiscal 2019 and the impairment of intangible assets and equipment of $30.2 million in fiscal 2020. The impact of the intangible asset impairment charges is reflected net of tax.

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Hologic Announces Financial Results for Third Quarter of Fiscal 2021