Stephen P. MacMillan, Chairman, President, and CEO
Robert W. McMahon, CFO
Eric B. Compton, COO
Michael Davin, Division President, Cynosure
Thomas P. O’Neill, Division President, GYN Surgical Solutions
Peter J. Valenti III, Division President, Breast and Skeletal Health Solutions
Thomas A. West, Division President, Diagnostics Solutions
NUMBER OF EMPLOYEES: 5,333
GLOBAL HEADQUARTERS: Marlborough, Mass.
After being diagnosed with breast cancer in 2006, singer/songwriter Sheryl Crow continues to raise her voice in search for a cure. In June 2016, almost 10 years since her diagnosis, she became the national spokesperson to educate women about The Genius 3D Mammography exam, Hologic’s breast cancer exam proven to detect the disease 15 months earlier than traditional 2D exams.
“Early detection saves lives—it’s that simple,” Crow said in Hologic’s announcement of her spokesperson role. “Women need to be advocates for their health, and that means getting annual mammograms starting at age 40 and taking advantage of the best, and most accurate, technologies available. I opted for a Genius exam because early detection is what saved my life—it’s a woman’s best chance at survival, and it’s a chance we all deserve.”
In addition to digital mammography systems like Genius 3D, Hologic’s Breast Health portfolio includes a number of technologies to aid early diagnosis like computer-aided detection for mammography, minimally invasive breast biopsy devices, breast biopsy site markers, and breast biopsy guidance systems. With fiscal year 2016 revenue (ended Sept. 24, 2016) of $720 million—up 5 percent from the year prior—the segment contributed a quarter of Hologic’s $2.8 billion in revenue, which was also a 5 percent increase from 2015.
The bump was almost entirely a result of higher worldwide sales of the company’s 3D Dimensions digital mammography systems, which rose $57 million from 2015. The growth was also partly a result of increased sales of C-View, the software powering Hologic’s Low Dose 3D Mammography exam. Diminished sales of the 2D Selenia system and interventional breast solutions products and no sales of the MRI breast coil line (which was discontinued in 2015) did not offset the emboldened digital mammography sales. Further expanding the Breast Health product mix, in April 2016 Hologic launched its U.S. Food and Drug Administration (FDA)-cleared Affirm Prone Biopsy System, the first 2D/3D imaging-guided dedicated prone biopsy system. The minimally invasive, stereotactic breast biopsy technology pairs 360-degree breast access with the company’s newly-developed 2D/3D imaging.
ANALYST INSIGHTS: Hologic is another industry leader that realizes it needs to acquire to grow. Its recent $1.65 billion acquisition into women’s health aesthetics (Cynosure) was a significant step for a $3B company. They now need to integrate that while they determine how to grow in their core diagnostics and imaging businesses.
—Dave Sheppard, Co-Founder and Principal, MedWorld Advisors
Hologic’s Diagnostics segment, which aids in disease detection as well as screening blood plasma, is its largest business with $1.2 billion in sales, a slight 2 percent bump from the previous year. The rise was attributable to heightened cytology and perinatal and molecular diagnostics sales—the latter of which introduced a number of new products among its Aptima assay line in FY16.
In October 2015, Hologic earned CE-IVD clearance for its Aptima HCV (hepatitis C virus) Quant Dx assay. Certified to both confirm active infections in patients with a positive HCV antibody result and for viral load monitoring, it complements the previously cleared Aptima HIV-1 Quant Dx assay as well as an extensive menu of women’s health assays running on the company’s automated Panther system in Europe. The Aptima HBV (hepatitis B virus) Quant Dx assay and Aptima Mycoplasma genitalium test for the M. genitalium STI were added to this European product mix in December 2015. In November 2015, the company launched the ThinPrep 5000 Processor and ThinPrep 5000 with Autoloader System for automated gynecological sample processing, providing labs with automation and productivity to prepare cytology slides.
Following the widely publicized Zika virus outbreak, in June 2016 Hologic added the Aptima Zika Virus assay to the Panther system’s capabilities, which was granted emergency use authorization by the FDA. (This means the assay has not been FDA-cleared or approved and is only authorized for use for the duration of the declaration that circumstances exist, justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection.)
June’s clearance enabled qualitative detection of RNA from Zika in human serum and plasma specimens. A few days following that, the Procleix Zika virus assay was cleared to screen the U.S. blood supply under the FDA’s Investigational New Drug (IND) study protocol. In September, the Aptima Zika assay’s emergency use authorization was expanded to process urine samples as well, which lengthened the time during which patients could be tested from one week to two weeks.
The GYN (gynecologic) Surgical segment achieved the most significant amplification in 2016 with a healthy 17 percent hike to $392 million. This was invigorated by strong MyoSure (a hysteroscopic tissue removal system) and NovaSure (an endometrial ablation system) sales, which advanced $38 million and $19 million respectively from 2015. In its annual report, Hologic asserted that the increase in domestic NovaSure sales resulted from a competitor’s recent market withdrawal. (The competitor was not named.) In May 2016, Hologic augmented the MyoSure suite of gynecological surgical products with the REACH device, which permits entry into the difficult-to-reach upper third of the uterine cavity.
Skeletal Health represented Hologic’s only declining business, falling 6 percent to $62 million in FY16 sales. This was mainly due to diminished sales of the company’s older Discovery osteoporosis detection and mini C-arm products. The remaining revenue was generated by Hologic’s service business (comprised of field service), which rose 4 percent in FY16 sales to $456 million, mainly in the Breast Health segment.
Although outside of fiscal year 2016 activities, Hologic made a major acquisition and divested a core business in early 2017. At the end of January, the company dispossessed its blood-screening business to longtime commercial partner Grifols for $1.9 billion. Two weeks later, the company announced the agreement to purchase women’s health medical aesthetics and technologies firm Cynosure for $1.7 billion. The acquisition built on Hologic’s strong women’s health and OB/GYN businesses, and allowed the company entry into the fast-growing medical aesthetics segment.