BEDFORD, Mass., Nov. 5, 2014 /PRNewswire/ -- Hologic, Inc. (NASDAQ: HOLX) announced today its results for the fourth fiscal quarter ended September 27, 2014.
Fourth Quarter Financial Highlights and Recent Developments:
- Reported revenues of $660.6 million increased 6.2% compared to the prior year and included a one-time revenue benefit of $20.1 million related to an amended license agreement with Roka Bioscience.
- Net of the one-time revenue benefit, revenues from the Company’s underlying business were $640.5 million, an increase of 3.0%, with operational growth of 2.8%.
- Revenues grew in all four business segments.
- Diagnostics grew 2.4% (net of the one-time revenue benefit).
- Breast Health grew 3.1%.
- GYN Surgical grew 2.3%.
- Skeletal Heath grew 10.4%.
- Non-GAAP earnings per share (EPS) were $0.43, which included $0.05 from the one-time revenue benefit. Net of this one-time benefit, non-GAAP EPS was $0.38, a decline of 3.6% compared to the prior year, but above the guidance range of $0.36 to $0.37.
- GAAP EPS was $0.10 per diluted share compared to a loss of $4.11 in the prior year.
- Installed the 2,000th Hologic 3D mammography system worldwide and surpassed the fiscal 2014 U.S. placement goal.
- On October 31, the Centers for Medicare and Medicaid Services (CMS) released reimbursement rates for 3D mammography screening and diagnostic services. The new rule also creates a pathway for private insurers to explore broader coverage and payment options.
“Our fourth quarter provides further evidence that our turnaround is strengthening and our outlook is improving,” said Stephen MacMillan, President and Chief Executive Officer. “Although we began the year with declining performance, this quarter we achieved growth in all four franchises and transitioned to a company on a clear path to sustainable organic growth. While we still have work to do, we have put the pieces in place to drive accelerating growth and are much better positioned as we head into fiscal 2015.”
Fourth Quarter Fiscal 2014 Revenue Overview by Segment (Compared to the Fourth Quarter Fiscal 2013):
- Diagnostics revenues of $297.1 million increased 2.4%, net of the one time revenue benefit of $20.1 million. The increase was primarily due to an increase in the Company’s molecular diagnostics franchise and blood screening franchise, primarily from the Japanese Red Cross deal. Partially offsetting these increases was a continued decrease in U.S. ThinPrep pap test sales due to interval expansion.
- Breast Health revenues of $241.5 million increased 3.1% driven by strong growth in 3D mammography system sales, as well as service revenue growth from the growing installed base of digital mammography systems. Partially offsetting these increases was the expected overall sales decline of 2D mammography systems as customers continue to transition to the Company’s 3D systems.
- GYN Surgical revenues of $78.5 million increased 2.3%, driven by strong growth in worldwide MyoSure system sales, partially offset by declines of U.S. NovaSure system sales.
- Skeletal Health revenues of $23.4 million increased 10.4%, driven by growing sales of the Company’s new Horizon platform and to a lesser extent, an increase in mini C-arm system sales.
Financial Guidance:
The Company’s guidance includes current operations, including revenues from its approved and cleared products. The fiscal 2015 growth rates exclude the one-time revenue benefit of $20.1 million in fiscal 2014.
Fiscal 2015 (Year Ending September 26, 2015)
The Company expects fiscal 2015:
- Operational revenue growth, excluding the impact of foreign currency, of approximately 2% to 3.5% over fiscal 2014. Including an expected 1% negative impact from foreign currency, the Company expects reported growth of approximately 1% to 2.5%, resulting in reported revenues in the range of $2.54 billion to $2.57 billion. The Company expects growth in all four business segments, as well as internationally.
- Non-GAAP EPS in the range of $1.50 to $1.54. Compared to $1.46 in fiscal 2014, this represents year-over-year growth of approximately 3% to 5.5%.
First Quarter Fiscal 2015 (Quarter Ending December 27, 2014)
The Company expects first quarter fiscal 2015:
- Operational revenue growth, excluding the impact of foreign currency, of approximately 3% to 4.5% over the first quarter of fiscal 2014. Including an expected 1% negative impact from foreign currency, the Company expects reported growth of approximately 2% to 3.5%, resulting in reported revenues in the range of $625 million to $635 million.
- Non-GAAP EPS in the range of $0.35 to $0.36. Compared to $0.34 in the first quarter of fiscal 2014, this represents year-over-year growth of approximately 3% to 6%.
Hologic may not generate expected revenues and may incur expenses or charges, realize income or gains, or execute transactions in fiscal 2015 that could cause actual results to vary from the guidance above. In addition, the Company is continuing to monitor the effects of the U.S., European and general worldwide economic and regulatory conditions and related uncertainties, including the implementation of healthcare cost containment measures and healthcare reform legislation, as well as foreign currency fluctuations, which, along with other uncertainties facing the Company’s business including those referenced elsewhere herein and in its filings with the Securities and Exchange Commission, could adversely affect anticipated results.
The Company includes non-GAAP financial measures in this press release. Definitions of these non-GAAP financial measures and the reconciliations to the Company’s comparable GAAP financial measures (calculated in accordance with U.S. generally accepted accounting principles) for the periods presented, are included in this press release.
Conference Call and Webcast:
Hologic’s management will host a conference call on Wednesday, November 5, 2014, at 4:30 p.m. (Eastern) to discuss fourth quarter fiscal year 2014 operating results. Interested participants may listen to the call by dialing 877-718-5098 or 719-325-4925 for international callers and referencing participant code 5099577 15 minutes prior to the call. For those unable to participate in the live broadcast, a replay will be available two hours after the call ends through Wednesday, November 26, 2014, at 888-203-1112 or 719-457-0820 for international callers, access code 5099577. The Company will also provide a live webcast of the call. Interested participants may access the webcast on the Company’s website at www.investors.hologic.com/investors-overview. A PowerPoint presentation related to the conference call will be posted to the site.
About Hologic, Inc.:
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products. The Company’s core business units focus on diagnostics, breast health, GYN surgical, and skeletal health. With a unified suite of technologies and a robust research and development program, Hologic is dedicated to The Science of Sure. For more information on Hologic, visit www.hologic.com.
Hologic, 3D mammography, Aptima, Gen-Probe, Horizon, mini C-arm, MyoSure, NovaSure, and ThinPrep 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 Statement Disclaimer:
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 included herein 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 ability of the Company to successfully manage recent and ongoing leadership and organizational changes, including the ability of the Company to attract, motivate and retain key employees; U.S., European and general worldwide economic conditions and related uncertainties; 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; uncertainties regarding the recently enacted or future healthcare reform legislation, including associated tax provisions, or budget reduction or other cost containment efforts; 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, 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; manufacturing risks, including the Company’s reliance on a single or limited source of supply for key components, and the need to comply with especially high standards for the manufacture of many of its products; 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 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; 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.
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