Rank: #27 (Last year: #24)
Prior Fiscal: $3.06 Billion
No. of Employees: 6,252
Global Headquarters: Marlborough, Mass.
Stephen P. MacMillan, Chairman, President, and CEO
Karleen Oberton, CFO
Jay A. Stein, Co-Founder, Chairman Emeritus, Sr. VP, and CTO
Sean S. Daugherty, Division President, GYN Surgical Solutions
Kevin R. Thornal, Division President, Cynosure
Peter J. Valenti III, Division President, Breast and Skeletal Health Solutions
Jan Verstreken, Regional President, EMEA & Canada
Sanjay Prabhakaran, Regional President, Asia Pacific
Patrick Brady, Sr. VP, Global Supply Chain, Quality, and Regulatory
After making a big splash in M&A news with its acquisition of Cynosure in early 2017, Hologic pressed pause on being included in any substantial headlines during its 2018 fiscal year (which ran through Sept. 29, 2018) and instead, focused on a couple of small tuck-ins and a bevy of product announcements.
In its latest annual period, Hologic was essentially flat against its 2017 fiscal revenue total. The firm ended with $3.22 billion compared to 2017’s $3.06 billion. The majority of those sales (82.2 percent) originate from the firm’s products, which are divided into five segments. The largest segment (34.9 percent), Diagnostics, posted $1.12 billion in fiscal 2018. That represented a decrease of 3.6 percent, which was attributed primarily to the decrease in blood screening revenues—the result of a divestiture of the business in 2017. The losses experienced by Diagnostics were, fortunately, the largest for the company with other product segments offsetting the difference.
Breast Health (23.6 percent of the company’s revenue) finished the fiscal year at $759 million, which represented a 7.1 percent increase. The gains were due to several successes in the segment, including increased unit volumes of 3Dimensions and 3D Performance systems, rising sales volume of the Affirm Prone table and Brevera breast biopsy system, and a gain in Eviva and ATEC volumes internationally.
Ballooning revenue experienced by the Medical Aesthetics portion (8.7 percent of the revenue total) resulted in a final figure of $278 million for fiscal 2018, which translated to a 56.1 percent rise compared to the 2017 total. This new unit came about as a result of the aforementioned Cynosure acquisition in 2017. Benefiting from sales throughout a full year, increases were enjoyed with product sales for body contouring, skin, women’s health, and other technologies tied to the segment.
Revenues could have been even greater if it wasn’t for one stumble during the year. In August, the company announced via a filing with the U.S. Securities and Exchange Commission that it would voluntarily suspend marketing and distribution of the TempSure Vitalia and related products as a result of FDA concerns over a similar device. The agency had expressed doubts over the effectiveness of vaginal rejuvenation tools and also indicated it had questions about safety. The devices leverage heat and deliver it to vaginal tissue via laser to treat symptoms associated with several conditions, including menopause, urinary incontinence, and sexual function. Hologic did not, however, remove its MonaLisa Touch laser indicated for vaginal dryness from the market as it noted the Vitalia had “much less clinical data.” The MonaLisa Touch was still the subject of an FDA letter, which inquired about several inconsistences between the device’s approved uses and some applications noted on the technology’s website.
The Skeletal Health business, which is the smallest unit—2 percent of the firm’s total revenue—saw a modest 3.1 percent gain primarily as a result of increased sales of the Horizon osteoporosis assessment product in the U.S. The segment posted $62.3 million in revenue.
The other business to experience a decrease in fiscal 2018 was GYN Surgical, which fell 1.2 percent to close at $421 million. Hologic noted this loss was primarily attributed to lower NovaSure system sales due to “increased competition and a stagnant market for endometrial ablation.”
The other portion of Hologic that accounts for the remaining percentage of its total in the 2018 fiscal year is “Service and Other Revenues.” This is comprised of the firm’s ongoing service, installation, and repair of its products—the majority of which involves the Breast Health segment. This area saw $574 million toward the revenue total, which was 10 percent higher than 2017’s fiscal total of $521 million.
To help stimulate revenue growth in years to come, the company also examined strategic acquisition targets and made two noteworthy buys during fiscal 2018. In July, the firm expanded the scope of offerings from its Breast Health business with an $85 million purchase of Faxitron Bioptics. The organization’s product technology revolved around digital specimen radiography, breast lesion localization, and sentinel lymph node biopsy. Specifically, the company’s capabilities allow Hologic “to play a larger role in breast conserving surgery,” according to the statement announcing the acquisition.
“Acquiring Faxitron is consistent with our capital deployment goals,” explained Steve MacMillan, Hologic’s chairman, president, and CEO. “This is a great tuck-in acquisition that leverages our existing strength in the breast health channel, while providing attractive growth and return on invested capital.”
ANALYST INSIGHTS: To stimulate its growth rates, Hologic continues to focus on small- to medium-size M&A in its core markets. However, it continues to struggle somewhat with its Cynosure business. It will be interesting to watch whether Hologic decides to build on that franchise or divest it altogether.
—Dave Sheppard, Co-Founder and Managing Director, MedWorld Advisors
Then in September, Hologic communicated an agreement to obtain Focal Therapeutics for $125 million. Among the technologies that come as part of the transaction, Focal’s BioZorb marker was added to Breast Health’s product portfolio. According to Hologic, BioZorb is an implantable three-dimensional marker that helps clinicians overcome challenges in breast conserving surgery, or lumpectomy. The marker, placed by the surgeon, is used to mark the tumor excision site for monitoring and future treatments, and its unique, open design allows for tissue ingrowth during the healing process.
“We are very excited to become part of Hologic,” said Dr. Gail Lebovic, Focal’s co-founder and chief medical officer. “Hologic’s long-standing commitment to early cancer detection is key for success in breast conserving surgery. Hologic is the perfect fit for our company.”
Realizing that product innovation is the lifeblood of any company’s primary successes, Hologic certainly did not rest on its laurels in its quest for organic growth through new technology introduction. The company announced a healthy stable of additions to its portfolios across many of the firm’s businesses:
- Launched Fluent Fluid Management System—to simplify hysteroscopic operations, the Fluent system features a single waste bag design and unique FloPak technology to effectively control fluid use throughout the procedure.
- FDA clearance of the Panther Fusion GBS Assay—the screening is important to help prevent the spread of the bacterium from mother to baby during labor, which can lead to serious health consequences for the newborn.
- CE mark of the Panther Fusion MRSA Assay—brings full automation, efficiency, and excellent assay performance to MRSA screening.
- FDA approval of ThinPrep Integrated Imager—makes automated imaging of Pap tests more broadly available to laboratories and cytologists in the United States.
- FDA approval of new innovations on the 3Dimensions Mammography System—Clarity HD high-resolution 3D imaging and Intelligent 2D imaging technology were made available on the breast tomosynthesis system.
- PMA approval of the Aptima HBV Quant Assay—enables quantitation of hepatitis B viral load on the fully automated Panther system.
- Launch of the Fluoroscan InSight FD Mini C-Arm Extremities Imaging System—offers a variety of improved features designed to arm orthopedists, podiatrists, and clinicians with diversified imaging options, more flexible storage and transport, and an enhanced interface.
- Launch of Cynosure’s TempSure Envi—an advanced radiofrequency device that minimizes facial fine lines and wrinkles, tightens skin through soft tissue coagulation, and improves the appearance of cellulite.
- CE mark for Brevera Breast Biopsy System with CorLumina Imaging Technology—a real-time breast biopsy and verification system that improves the patient experience and streamlines the biopsy process from start to finish.
- CE mark and U.S. launch of the MyoSure MANUAL Device—the MyoSure suite of gynecologic surgical products offer simple and effective solutions to resect and remove tissue.
- FDA clearance of the Paraflu Assay for the Panther Fusion System—detects and differentiates Parainfluenza viruses 1, 2, 3, and 4.
- FDA clearance of the Flu A/B/RSV Assay for the Panther Fusion System
Finally, Hologic came out on the positive side of two patent disputes with other firms. A U.S. International Trade Commission judge ruled in favor of Hologic in a case involving a patent infringement complaint filed by the organization against Fujifilm. The patents in question were tied to X-ray mammography with tomosynthesis and other related mammography technologies found in Hologic’s Selenia Dimensions and 3Dimensions systems. As a result of the ruling, the judge recommended an exclusion order that prevents the importation of infringing Fujifilm products into the U.S., as well as a cease-and-desist order preventing the further sale and marketing of infringing Fujifilm products in the country. In early 2019, it was announced that the two entities settled the dispute, signing an agreement that would enable both to continue selling their products in the U.S. and worldwide.
In July 2018, a federal court in Delaware awarded Hologic $4.8 million in a patent infringement lawsuit against Minerva Surgical. The court had ruled Minerva’s endometrial ablation system infringed U.S. patents held by Hologic. Legal disputes between the two companies seem to be ongoing, however, with a more recent ruling cast against Hologic with regard to patents it owns related to detecting perforations in body cavities during ablation.