Rank: #29 $4.03 Billion
Prior Fiscal: $4.03 Billion
Percentage Change: 0%
R&D Expenditure: $272.8M
Best FY24 Quarter: Q2 $1.01B
Latest Quarter: Q2 $1B
No. of Employees: 7,063
Global Headquarters: Marlborough, Mass.

Women are strong. Arguably, even stronger than men in certain circumstances.

The warmer, more nurturing half of the human race has proven it can brave almost any challenge, be it professional inequity, poverty, workplace discrimination, politics, or poor educational access, among others. To parrot an old adage (with a twist): When the going gets tough, women get tougher.

That strength, however, is not without its own trials.

Uterine health issues, for example, can be a serious strength buster, yet most women are hesitant to discuss disruptive menstrual cycle symptoms with their doctors.

To combat such reluctance and empower more women to take charge of their menstrual health, Hologic launched a new education/awareness campaign last year called “Better is Possible.”

The initiative was designed to boost awareness around “quality of life challenges” in uterine health, including heavy and disruptive periods, pelvic pain, and fibroids. The campaign also aims to educate women about available treatment options.

“Roughly two-thirds of women say that their period has impacted their day-to-day life, but until now, there’s been a glaring absence of discussion around solutions. Through this campaign, we want to show women who experience painful periods, uncontrolled bleeding, or other uterine health issues, that they don’t have to suffer in silence,” Mary Byerly, VP of Marketing for Hologic’s GYN Surgical Solutions division, said in announcing the campaign. “When it comes to periods, it can be so difficult to differentiate between what is normal and what isn’t. We’re proud to equip women with the resources they need to start the conversation and feel empowered when talking to their doctor about their periods and play an active role in their treatment plan.”

Hologic’s Better is Possible campaign included a video highlighting the experiences of women living with uterine health issues. A website, BetterIsPossible.com, offers visitors downloadable materials like a symptom quiz, discussion guides, and information about Hologic’s treatment options for better uterine health.

“We’ll be the first to put on a smile and say, ‘oh I’m fine.’ But what about when that strength is stretched to its limits?” the female-narrated Better is Possible video states. “…when all you want to do is feel better and just can’t…You need a healthcare partner that’s a strong as you and your uterus. At Hologic, we believe better is possible. Better care. Better options. Better relationships with your healthcare provider, and a better life with less debilitating pain. Better is possible with Hologic.”

Better may indeed be possible with Hologic’s uterine treatment offerings, but the same cannot be said for the company’s FY24 financial performance. Overall sales stalled at $4.03 billion despite astronomical increases in net income (73.1%) and earnings per share (81.1%), and solid gains in half of its product segments.

ANALYST INSIGHT: “Utilizing its leadership in women’s health and molecular diagnostics, Hologic has done very well since the pandemic. Unfortunately, the current tariff volatility seems to have some immediate negative impacts on their business. However, for the mid-to-long term, I expect them to re-gain their growth and dominance in their core markets.”

—Dave Sheppard, co-founder and managing director, MedWorld Advisors

Breast Health revenue climbed 6.3% to $1.52 billion due to higher sales volumes of Hologic’s digital mammography systems, and a $21.6 million sales increase in interventional breast solutions products driven by robust demand for Brevera disposables and Somatex Tumark markers, according to the company’s 2024 annual report. Sales also benefited from higher average selling prices of ATEC disposable devices, and the $310 million purchase of U.K.-based Endomagnetics in April 2024. The deal added Endomagnetics’ wireless breast surgery localization and lymphatic tracing solutions to Hologic’s breast surgery portfolio.

The increases in various Breast Health product revenue were partially offset by a $14.6 million shortfall in SSI ultrasound imaging sales and tepid demand for Localizer consumables.

GYN Surgical’s FY24 performance followed the same pattern as its Breast Health brethren: Proceeds rose 6.1% to $641.3 million from higher sales volume of MyoSure devices and Fluent fluid management products but the increase was tempered by lower demand for and average selling prices of NovaSure devices in the United States. The U.S. drop-off, however, was partially offset by better demand in Western Europe. 

“We delivered strong fiscal 2024 results, reinforcing our track record of durable performance with another solid quarter of growth,” Hologic Chairman/President/CEO Steve MacMillan said of the company’s FY24 performance. “Each year we grow stronger, leveraging our leading brands to drive diverse revenue growth and industry-leading margins, while generating exceptional cash flow.”

In touting Hologic’s industry-leading margins, MacMillan focused entirely on fourth-quarter earnings in a company-issued news release, shunning the full-year losses posted by the Diagnostics and Skeletal Health segments.

Diagnostics revenue declined 5.2% to $1.78 billion, driven by a $100.8 million drop in Molecular Diagnostics sales—largely due to a $169.6 million sales decrease for two SARS-CoV-2 assays, according to Hologic. The company attributed the lower volume to waning demand for COVID-19 tests. Diagnostics proceeds also suffered from a reduction in CT/GC revenue, slightly lower average selling prices, and a reduction in legacy Mobidiag products. The decreases were somewhat offset by higher sales of BV/CV assays, Fusion respiratory devices, and cytology instruments and related products internationally.

The newest addition to Hologic’s cytology lineup arrived in February 2024 with the U.S. Food and Drug Administration (FDA) clearance of the Genius Digital Diagnostics System with the Genius Cervical AI algorithm. The company claims its Genius solution is the first and only FDA-cleared digital cytology system to combine deep learning-based artificial intelligence with advanced volumetric imaging technology to help identify pre-cancerous lesions and cervical cancer cells.

Cervical cancer screenings usually include a Pap test, where a sample is generally collected and the cervical cells are sent to a laboratory, where they are transferred to a glass slide and examined under a microscope. With the Genius Digital Diagnostics System, the glass slides are digitally imaged and an AI algorithm is applied to pinpoint the cells that cytologists and pathologists should review for further analysis.

The Genius Digital Diagnostics System also offers the opportunity for greater collaboration across lab and other healthcare settings. The system allows cytologists and pathologists to securely review cases remotely, so patients can benefit from the collective knowledge of geographically dispersed experts.

The Genius Digital Diagnostics System consists of the Genius Digital Imager for image acquisition, the Genius Cervical AI algorithm for image analysis, the Genius Image Management Server for image storage, and the Genius Review Station for local or remote case review. The complete system is scalable and designed to fit labs’ present and future needs. The Genius Digital Diagnostics System had already been commercially available in Europe, Australia, and New Zealand at the time of the FDA’s clearance. 

Hologic’s other product segment that failed to turn a profit in FY24 (ended Sept. 28) was Skeletal Health. Proceeds plummeted 25.8% to $84.1 million due primarily to a temporary stop-shipment placement on Horizon DXA systems during Q3. Hologic blamed the stop shipment order on a “non-conformance matter pertaining to electromagnetic compatibility requirements.”

$4.86 Billion
Prior Fiscal: $5.63 Billion
Percentage Change: -13.68%
R&D Expenditure: $283.4M
Best FY22 Quarter: Q1 $1.47B
Latest Quarter: Q2 $1.02B
No. of Employees: 6,944

“In the midst of every crisis, lies great opportunity.”

Pithy but factual, yet mysterious and complicated.

Such are the elements of this well-known adage cited often throughout history by philosophers, scholars, politicians, entrepreneurs, and military leaders alike. It’s typically referenced during crises as a reminder of the potential benefits obscured within challenges, and has repeatedly proven its worth as an effective solutions mechanism.

Yet the maxim remains steeped in confusion. Its origins are murky, with credit given to Chinese military general Sun Tzu, German physicist Albert Einstein, Greek philosopher Plato (“necessity is the mother of invention”), and Japanese Kanji (the word for crisis is supposedly written with two characters, one representing danger; the other, opportunity). Einstein is most widely endorsed as its creator, but there is no real evidence linking him to the axiom—no backstory, no documentation (written or otherwise), no corroboration (personal or professional).

Nothing.

Nevertheless, the saying has become an effective strategy for managing and surviving any crisis or extreme threat. Countless individuals and businesses, for example, found great opportunities lurking in the COVID-19 pandemic: Disgruntled employees either changed careers or left the workforce, while companies profited from pandemic-induced diagnosis and treatment solutions.

Among the organizations that successfully leveraged the pandemic’s opportunities was Hologic Inc., a Marlborough, Mass.-based women’s healthtech firm that was one of the first to develop a COVID-19 test [its Panther Fusion assay received U.S. Food and Drug Administration (FDA) Emergency Use Authorization on March 16, 2020—the day the world began to shut down].

“We make tens of millions of tests every year for sexually transmitted infections, cervical cancer screening, and viral load monitoring,” Kevin Thornal, Hologic’s former Diagnostic Solutions Division president (current Nevro CEO/president), recalled in an online post. “It’s routine for us, so we knew we had to make a test for Panther, and make it as rapidly as possible.”

ANALYST INSIGHTS: Hologic did an amazing job of maximizing its pandemic cash from its diagnostic solutions to rapidly acquire new business to enhance its product portfolio in the last few years. Based on these investments, it’s in good shape for future growth. The question is, “Do they stand still with organic growth or do they continue to strategically enhance their solutions with inorganic activity?”

—Dave Sheppard, Co-Founder and Managing Director, MedWorld Advisors

Hologic’s top executives also knew that more than one test would be needed to diagnose and track the rapidly spreading disease. Consequently, the firm’s R&D, manufacturing, and regulatory affairs teams worked at a furious pace, compressing an average two-year process into two months to develop the Aptima SARS-CoV-2 assay, which was cleared for U.S. and European use in May 2020. By the end of that year, Hologic had shipped approximately 68 million COVID-19 tests worldwide.

The Panther and Aptima assays’ meteoric turnaround clearly is a testament to Hologic’s capacity to pivot and fast-track diagnostic technology deployment. But it also demonstrates its leaders’ acumen for recognizing (and leveraging) opportunities in a crisis.

“…what we have said at the beginning was we thought that this [COVID-19] long-term would create a new assay for us that would be far more enduring then, I think, anybody ever thought it would be back in 2020—back…when everybody thought this was going to go away in a hurry or it was going to go away as soon as vaccines arrived or molecular testing was going to go away as soon as antigen tests came along,” Hologic Chairman, President, and CEO Stephen P. MacMillan told analysts during a Q4 earnings call last fall. “What we’ve learned is this thing is going to be around…we always said in the beginning, this is a respiratory virus that will mutate. Herd immunity was never going to be achieved. And we thought we would end up with an enduring business. Whether that enduring business ends up being $50 million, $100 million, $150 million, $200 million, we really don’t know, but we feel really good that we’re in that business.”

Those feelings certainly are warranted: Hologic’s Molecular Diagnostics revenue nearly doubled in the pandemic’s first year, going from $1.64 billion in fiscal 2020 to $3.17 billion in fiscal 2021. However, ebbing demand for coronavirus tests—courtesy of waning infection rates—reversed the firm’s diagnostics fortunes in FY22 (ended Sept. 24, 2022), as Molecular Diagnostic revenue descended 20.8% ($660.1 million) to $2.51 billion, according to Hologic’s latest annual report. The company attributed the deficit to a $729 million loss in Aptima and Panther Fusion SARS-CoV-2 assay sales (from $2.16 billion in fiscal 2021 to $1.43 billion in fiscal 2022), as well as the impact of at-home testing alternatives and lower average selling prices globally.

COVID-19’s slow retreat from pandemic status also curtailed Hologic’s Panther and Panther Fusion instrument revenue in FY22, but the losses were somewhat offset by a $53.6 million spike in worldwide sales of Aptima assays and STD collection kits (primarily for the CTGC, Bacterial Vaginosis, and CV Candida tests). Yet that particular increase was tempered by lower HPV assay volumes and lower average selling prices.

Further contributing to the Molecular Diagnostics financial seesaw was a $32.6 million increase in global Quant Viral assays and Fusion respiratory product sales, and $13.3 million in incremental product revenue from the inclusion of Hologic’s Diagenode and Mobidiag brands in fiscal 2022. But those gains were neutralized by volatile foreign currency exchange rates.

Hologic complemented its Mobidiag portfolio in October 2021 with the European debut of the Novodiag system, a fully automated molecular diagnostic solution for on-demand molecular testing of infectious diseases and antimicrobial resistance. The solution combines real-time polymerase chain reaction with microassay capabilities to identify multiple pathogens in a single sample. Novodiag is precision engineered for affordability, simplicity, and accuracy across a broad menu of high and low plex tests.

“The addition of the Novodiag system to our diagnostic molecular scalable solutions portfolio will offer more customers in Europe a wider choice of solutions that meet their needs, from single patient rapid testing to population-level screening,” Jan Verstreken, group president, International, said upon the product’s launch.

Joining Novodiag on the European market in November 2021 was the Genius Digital Diagnostic System, a screening tool that uses deep learning artificial intelligence and volumetric imaging technologies to spot pre-cancerous lesions and cancer cells, enabling earlier cervical cancer diagnosis. The Genius system received CE mark approval in late 2020; it is not available in the United States, but another version of the Genius software designed to detect breast cancer in mammography images was cleared by the FDA in December 2020.

Hologic added to its Panther scalable solutions portfolio near the end of Q1, introducing Panther Trax to the United States, Europe, Canada, Australia, and New Zealand. Panther Trax enhances laboratory automation by physically linking multiple Panther instruments into a single workcell, thereby enabling increased testing volumes without increasing staff.

The procession of new Molecular Diagnostics products continued in the second half of fiscal 2022 with regulatory consents for two transplant-focused assays and two COVID-19-flu-RSV tests. The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay and Novodiag RES-4 molecular diagnostic test launched in Europe in early July 2022—well before the start of the northern hemisphere’s respiratory viral season.

Both transplant-focused assays passed regulatory muster two weeks apart in May 2022. First up was FDA approval of the Aptima CMV Quant assay, which measures the viral load of cytomegalovirus (CMV) in organ or stem cell transplant patients. Running on Hologic’s Panther system, the test merged into the company’s existing portfolio of diagnostic and viral load tests for HIV-1, Hepatitis C and Hepatitis B. It reportedly is the first test to commence in the United States for detecting and monitoring post-transplant pathogens on the Panther system.

Hologic followed the Aptima CMV Quant approval with CE mark approval of two new molecular assays that monitor for Epstein-Barr virus (EBV) and BK virus (BKV) in transplant patients. Panther Fusion EBV Quant Assay and Panther Fusion BKV Quant Assay quantify the viral load of the respective viruses with the aim of aiding in diagnosing and managing solid organ transplant and hematopoietic stem cell transplant patients. The in-vitro nucleic acid amplification tests run on Hologic’s automated Panther Fusion system using real-time PCR technology. The EBV assay is validated for use with whole blood and plasma samples, and the BKV assay is validated for use with human plasma and urine samples.

The cavalcade of new Molecular Diagnostics innovation, however, failed to boost Diagnostics segment revenue in FY22. Total sales sank 18.3% to $3.02 billion due to losses in both Molecular Diagnostics and Blood Screening (down a staggering 34.7% to $32.4 million) but an $800,000 increase in Cytology & Perinatal proceeds helped curb the segment’s fiscal decline.

Two of Hologic’s three other product segments also posted sales losses in fiscal 2022. Breast Health revenue fell 9.2% to $1.23 billion due to lower digital mammography system volumes (mostly 3D Dimensions), related software and workflow products, Affirm biopsy systems, and Brevera biopsy systems. The company blamed the reduced volume on the global semiconductor chip shortage, which consequently impacted its ability to manufacture enough mammography systems to meet customer demand. Breast Imaging proceeds tumbled 12.2% to $951.6 million, but the decline was partially offset by a 2.7% increase in Interventional Breast Solutions revenue (to $276.2 million), which was driven by higher sales of ATEC and Brevera disposables. Foreign currency exchange rates negatively impacted segment revenue.

Foreign currency exchange rates also worked against Hologic’s GYN Surgical and Skeletal Health sales as well, though the former segment still managed to turn a profit in fiscal 2022. Revenue jumped 7.1% to $522.9 million, thanks mostly to higher sales of the company’s Fluent Fluid Management solutions, its MyoSure system, Accessa Pro Vu system, and Bolder products (including the CoolSeal vessel sealing devices and JustRight surgical staplers). The Bolder products are a relatively new addition to Hologic’s GYN Surgical lineup, having been incorporated via acquisition ($160 million, Bolder Surgical) in October 2021.

GYN Surgical’s gains, however, were somewhat tempered by weak demand for the NovaSure V5 endometrial ablation device. The product delivers radiofrequency energy to ablate the uterus’ endometrial lining to reduce or stop abnormal menstrual bleeding.

Skeletal Health product revenue slipped 3.4% to $93.6 million due to lower sales of the Horizon DXA and Insight FD Fluoroscan systems, largely attributable to supply chain constraints. “We have confidence the worst of the chip shortage is behind us,” MacMillan said during the earnings call.

An improving chip supply would certainly be heralded by Hologic and other companies that depend on the electronic components for their products. A free-flowing supply also would help the company’s finances rebound from a particularly rough fiscal year. Overall FY22 sales fell 13.6% to $4.86 billion and gross profit deteriorated 21% to $2.99 billion, owing to pandemic-induced declines in the Diagnostic business, lower Breast Health revenue, and volatile foreign exchange rates. Income from operations plummeted 34% to $1.64 billion and basic net income per share dropped 28.5% to $5.18.

$5.63 Billion
Prior Fiscal: $3.78 Billion
Percentage Change: +48.9%
R&D Expenditure: $276M
Best FY21 Quarter: Q1 $1.61B
Latest Quarter: Q2 $1.44B
No. of Employees: 6,705

The M&A activity in the medical device industry has been dramatic. It’s the subject of many articles, conference sessions, and social media discussions. While the big names dominate headlines when they absorb a reasonably large-sized peer within the marketplace, there are those that seemingly fly under the radar due to the lack of a “big splash” or price tag. The number of transactions, however, and the consistency is still no less impressive. Hologic is one of those that have been aggressive without making much noise about it.

During its 2020 fiscal, Hologic engaged in a fair amount of M&A activity to help bolster its product offerings going forward. In the most recent fiscal year, the firm didn’t slow its pace.

It wrapped the 2020 year (Hologic’s fiscal began on Sept. 26, 2020) with the completion of a $64 million transaction for SOMATEX Medical Technologies GmbH, a provider of biopsy site markers and localization technologies. The company was previously owned by E-Med Solutions GmbH Berlin, a group of investors led by German private equity company Westlake Partners. The deal supports Hologic’s strategy to provide a comprehensive suite of solutions across the continuum of breast healthcare.

Just a few days later, it was announced Biotheranostics would be brought into the fold. The organization develops and markets two highly differentiated molecular diagnostic tests for breast and metastatic cancers—Breast Cancer Index (BCI) and CancerTYPE ID (CTID). The BCI test is recommended for prediction of which early-stage hormone receptor positive breast cancer patients are likely to benefit from extended endocrine therapy. The CTID test, on the other hand, provides a molecular diagnosis for patients with uncertain or unknown cancers. The deal was valued at approximately $230 million and closed the next month.

On March 1, Hologic made yet another acquisition announcement. This time, the news was regarding a European molecular diagnostic company—Diagenode—being bought for about $159 million. Diagenode offers more than 30 real-time PCR tests that are CE-marked for the detection of bacteria, parasites, and viruses involved in sexually transmitted infections, respiratory diseases, meningitis, and gastroenteritis. The firm previously collaborated with Hologic to develop Panther Fusion assays for group B Streptococcus and Bordetella.

ANALYST INSIGHTS: Hologic continues to be THE women’s health market leader. And they have propelled themselves forward even more as a result of the pandemic and their assay systems. But I’m curious to see how they will continue to innovate, grow forward past acquisitions, and utilize the windfalls of the pandemic to further women’s health on a global scale.

— Marissa Fayer, CEO, HERhealthEQ

The largest transaction of the fiscal year was also the last (but not the last of the calendar year; Hologic continued its shopping spree into its 2022 fiscal period). This deal, announced in June, saw the absorption of Mobidiag Oy—a privately held, commercial-stage Finnish-French developer of innovative molecular diagnostic tests and instrumentation—into Hologic. It was concluded later the same month and had an enterprise value of approximately $808 million.

“Closing the acquisition of Mobidiag enables us to become a broader, more diversified global diagnostics leader,” said Jan Verstreken, group president, International, at Hologic. “Together, we can accelerate development and adoption of Mobidiag’s innovative products globally and drive Hologic’s growth.”

Mobidiag provides near-patient, molecular diagnostic instruments and tests for acute care conditions including gastrointestinal and respiratory infections, antimicrobial resistance management, and healthcare-associated infections. Its Amplidiag and Novodiag testing platforms deliver results in 50 minutes to two hours. The Novodiag platform combines real-time PCR and microarray capabilities to provide high-level multiplexing.

Expansion of its testing offerings seems to be a logical path forward for Hologic as the organization saw huge gains year-over-year in diagnostics. In fact, the company has stated the 53.9% explosion in total revenue was a direct result of the full-year sales period of its two COVID-19 assays. Beyond those, product revenues began to return following the decreased demand experienced during the early stages of the pandemic. As such, gains were seen across all product categories, but not nearly as dramatically as those observed for diagnostics. However, the organization did see a decrease in comparative revenue between the two fiscal periods from the divestiture of its Medical Aesthetics business, which occurred during the 2020 fiscal year.

Ultimately, Hologic finished its 2021 fiscal with $5.63 billion in total revenue, as compared to its $3.78 billion total during the previous period. As mentioned, the diagnostics business (63.9% of all company sales), far and away, led in the firm’s gains. Its astonishing 73.4% growth translated to a $3.60 billion contribution.

While it achieved those incredible figures via primarily from the two COVID-19 tests, the company continued progress on an array of other diagnostic solutions to ensure future growth is not curbed substantially after the pandemic.

Days after the start of the 2021 fiscal, the organization announced its Panther Fusion SARS-CoV-2 assay received Emergency Use Authorization (EUA) from the FDA for testing of individuals without symptoms or other reasons to suspect COVID-19 infection. The availability was expected to play a key role in identifying early infection in exposed individuals, as well as reopening schools, workplaces, and the economy in general.

Just a week later, Hologic stated its Aptima SARS-CoV-2 assay, which initially received an EUA from the FDA in May, was additionally authorized for testing of individuals without symptoms or other reasons to suspect COVID-19 infection.

Later that month (October 2020), the firm was awarded a $119 million contract from the U.S. government to expand its production capacity for COVID-19 molecular tests. The contract was reported to support capital and labor investments, enabling Hologic to provide 13 million COVID-19 tests per month for the U.S. market by January 2022.

Then in July the following year, Hologic obtained a CE Mark for the use of saliva samples with the Aptima SARS-CoV-2 molecular assay in Europe. The test runs on the fully automated Panther system. According to the company, certain European health authorities had determined the established assay performance with saliva and the ease of obtaining the sample made saliva suitable for programs that use repeated screenings.

While the firm continued its development and launch of diagnostics solutions used for COVID-19 throughout its 2021 fiscal, these products were not the only testing offerings to generate newsworthy announcements.

November brought FDA approval of a diagnostic claim for Hologic’s HIV-1 viral load monitoring assay. The Aptima HIV-1 Quant Dx assay, which was approved in late 2016 for viral load monitoring, became the first dual-claim assay in the U.S. with the addition of diagnosis. The molecular diagnostic test runs on the fully automated, sample-to-result Panther system and is also CE IVD-marked for both claims.

Within the same month, the Genius Digital Diagnostics System was given a CE mark in Europe. Genius Digital Diagnostics is the first digital cytology platform to combine an artificial intelligence algorithm with advanced digital imaging to help cytotechnologists and pathologists identify pre-cancerous lesions and cancer cells in women.

FDA approval for the organization’s ThinPrep Genesis processor for cytology processing and specimen transfer for downstream applications was gained in May 2021. The new instrument streamlines these workflows with advanced automation capabilities including chain of custody verification, which prevents sample misidentification and allows for more confidence in results.

A month later, a CE mark was acquired for the Aptima CMV Quant assay, which quantifies the viral load of human cytomegalovirus (CMV). It is intended for use to aid in the diagnosis and management of solid-organ transplant patients and hematopoietic stem cell transplant patients. This in-vitro nucleic acid amplification test uses real-time transcription-mediated amplification technology on the Panther system and can be used with human plasma and whole blood samples.

Hologic isn’t putting all its eggs into one basket, however, as it remains an industry leader in women’s health technologies as well. Its Breast Health segment provided $815 million to the company’s coffers (14.5% of total revenue), representing a rise of 21.3% over the prior fiscal. Similar to diagnostics, a number of product announcements were shared throughout the 12-month period.

Its 3DQuorum Imaging Technology, powered by Genius AI, was made available in Europe in October 2020. The innovation was designed to help improve mammography efficiency and workflow—an important offering as healthcare facilities were trying to manage the backlog of women whose routine breast screening was delayed due to the COVID-19 lockdown.

The next month, Hologic announced updates to its Unifi Analytics platform, a business intelligence tool that provides mammography centers insights into technologist performance, proactive device maintenance, and business considerations. Version 1.2 enables users to better understand and improve daily mammography workflow by providing valuable insights regarding volume and time spent on screening, diagnostic, and biopsy studies.

FDA granted clearance and commercial availability was announced in December for Hologic’s Genius AI Detection technology—a deep learning-based software designed to help radiologists detect subtle potential cancers in breast tomosynthesis images. The technology highlights areas with subtle potential cancers that can be difficult to detect for further examination by the radiologist.

Near the close of the calendar year, the firm declared 3D ultrasound imaging was available on the SuperSonic MACH 40 ultrasound system. The advance enabled access to high-resolution B-mode and ShearWave PLUS elastography 3D volumes, which are designed to enhance diagnostic certainty. In January, the company announced the same technology was available in Europe on the SuperSonic MACH 30 and 20 ultrasound systems. (The “formal” announcement of the MACH 20’s availability came a week later.)

Following Breast Health (from a revenue contribution standpoint) was GYN Surgical with a final figure of $487 million. Sales from this segment provide 8.6% of the company’s total, and its 2021 figure reflected a 29.8% gain over the prior fiscal.

Innovation news from this segment began with a November announcement regarding the launch of the Omni Suite, a comprehensive surgical offering designed to optimize diagnostic and operative hysteroscopy. The offering includes a versatile Omni 30° hysteroscope and Omni 4K video technology to complement the company’s existing portfolio of GYN surgical solutions.

Hologic also marked the European launch of its CE-marked Fluent fluid management system in January 2021. Fluent features innovations designed to provide healthcare professionals performing hysteroscopic procedures simpler, more effective fluid management. The system is designed to give clinicians clinical confidence by providing consistent intrauterine pressure and accurate fluid deficit readings.

Rounding out the company’s 2021 fiscal figures was its Skeletal Health segment, which enjoyed a 22.7% rise. It posted $69.3 million in sales, only 1.2% of the total company sales. Meanwhile, Services and Other Revenues accounted for 11.8% of the firm’s revenue; that tally saw a 21% gain to finish at $665 million.

$3.78 Billion
Prior Fiscal: $3.37 Billion
Percentage Change: +16.4%
No. of Employees: 5,814

Hologic is a company that seems to be a bit uncertain of its actual identity. The firm is decidedly focused on providing technologies to improve women’s health. At the same time, however, its diagnostics were aiding in the fight against COVID-19. This segment also represented its greatest revenue during the 2020 fiscal (by far), while all other segments saw declines (undoubtedly a direct result of the same pandemic). Meanwhile, during the same 12-month period, the firm finalized the divestiture of a business unit.

Regardless of its true identity, Hologic saw great success during its 2020 fiscal. While due to unfortunate circumstances (i.e., the COVID-19 pandemic and increased demand for diagnostics), the organization weathered the storm rather well, experiencing a 16.4 percent rise in revenue compared to the previous period. Since Hologic’s fiscal year begins and ends near the close of September, the non-diagnostic business segments did not have much chance to experience a recovery as more patients sought care for non-COVID-19-related concerns, which makes the growth even more impressive.

The firm finished its 2020 fiscal on Sept. 26, 2020, with $3.78 billion in revenue compared to $3.38 billion during the previous period. As mentioned, Diagnostics was the clear front runner in terms of revenue generation companywide. Its $2.07 billion accounted for more of the firm’s total than all other segments combined. That figure represented a 75.8 percent increase over the prior year’s $1.18 billion. The dramatic increase was directly attributed to demand for Hologic’s two COVID-19 assays and increased sales of its Panther and Panther Fusion instruments to increase testing capacity for COVID-19.

Specifically, Hologic gained Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the first of two molecular tests for COVID-19 early in the pandemic (i.e., mid-March 2020). This first test was for the Panther Fusion SARS-CoV-2 assay, which detected the virus that causes COVID-19. Each Panther Fusion system could provide results in less than three hours and process up to 1,150 coronavirus tests in a 24-hour period.

Hologic was the first company to receive support for coronavirus test development from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA). “Making rapid and accurate diagnostic tools available to healthcare providers is critical for early detection and control of COVID-19,” said BARDA Director Rick A. Bright, Ph.D. “The speed at which this assay was developed, validated, and issued EUA—less than two months—is a testament to Hologic’s commitment to helping reduce the global COVID-19 burden.”

The second test, granted an EUA in mid-May, was for the firm’s Aptima SARS-CoV-2 assay. This test was able to be run on Hologic’s fully automated Panther system, more than 1,000 of which were already installed in clinical laboratories throughout the U.S. As was the case with the first test, each Panther system provided initial results in approximately three hours and processed more than 1,000 coronavirus tests in 24 hours.

ANALYST INSIGHTS: Taking advantage of its Diagnostics business, Hologic has executed well and flourished during COVID. Flush with cash from the Diagnostics profits, Hologic has been aggressive in expanding its portfolio thru M&A. Expect Hologic to continue to be aggressive with M&A. However, the deals may be smaller for a period of time.

—Dave Sheppard, Co-Founder and Managing Director, MedWorld Advisors

Later in the year, the organization gained an EUA from the FDA for a Panther Fusion SARS-CoV-2 assay for testing of individuals without symptoms or other reasons to suspect COVID-19 infection. According to the company, the assay was the first widely available, high-throughput molecular diagnostic test specifically authorized for screening asymptomatic people. The availability was anticipated to play a key role in identifying early infection in exposed individuals, as well as in reopening schools, workplaces, and the economy in general.

Further, Hologic announced it validated use of its Aptima and Panther Fusion molecular diagnostic COVID-19 assays with pooled patient samples. By allowing samples from multiple individuals to be tested simultaneously, pooling was expected to help laboratories deliver increasing numbers of highly accurate molecular test results more quickly.

The declines in sales of all other units were blamed on the pandemic—which bolstered the Diagnostic segment’s figures—such as the almost 20 percent losses experienced by its Breast Health business. This translated to a final tally of $672 million after 2019’s $837 million. Similarly, GYN Surgical declined by 14.1 percent year over year, going from $436 million to $375 million. Skeletal Health followed suit with a 13.7 percent drop to stop at $57 million from its previous fiscal of $66 million.

Hologic’s Medical Aesthetics unit Cynosure, however, did not experience a substantial loss in revenue contribution due to the virus. Rather, the 80 percent difference between 2019 and 2020 was due to the fact the company sold the business to an affiliate of investment funds managed by Clayton, Dubilier & Rice. The deal was finalized on Dec. 30, 2019, and Hologic didn’t see any additional revenue from the unit beyond the $50 million it had recorded to that point.

The actual sale did make for a curious one, however, since in the company’s Q1 2020, the unit accounted for the aforementioned $50 million in revenue, yet the purchase price was $205 million in cash.

Further, net cash proceeds after closing was approximately only $142 million. Hologic originally purchased Cynosure in February 2017 for $1.65 billion.

The organization made several moves later during its fiscal year to fill the hole left by the jettisoned Medical Aesthetics business. In a cash transaction valued at $80 million (plus contingent payments based on future revenue growth), Hologic acquired Acessa Health Inc., a privately-held innovator in minimally invasive treatment of fibroids. The deal brought to Hologic the Acessa ProVu system, a fully integrated laparoscopic system that combines radiofrequency ablation with advanced intra-abdominal ultrasound visualization and guidance mapping, enabling physicians to effectively and safely treat women with symptomatic, benign uterine fibroids. Clinical studies demonstrated the Acessa ProVu system is a safe and minimally invasive alternative to hysterectomy and myomectomy.

In February 2020, Hologic completed a transaction for Health Beacons Inc. for $19.7 million, which included holdbacks of $2.3 million payable up to 18 months from the date of acquisition. Health Beacons was the manufacturer for the LOCalizer product, a wire-free guidance system designed to mark and guide to non-palpable breast lesions using a miniature radiofrequency identification (RFID) Tag. The RFID breast localization system can be placed in the breast any time prior to or on the day of surgery and has a unique identification number that is displayed on the reader.

Just about the same time as the shedding of Cynosure, Hologic took in Alpha Imaging LLC. That deal was valued at $18 million. The firm was a long-standing distributor of Hologic’s Breast and Skeletal products in the U.S. According to the organization’s website, Alpha Imaging is the exclusive distributor for several major manufacturers of medical imaging equipment. Its product portfolio consists of low-dose CT scanners; cardiovascular and interventional imaging labs; digital radiographic and fluoroscopic systems; image management and sharing software solutions; and women’s healthcare products. Vendor partners include Shimadzu Medical Systems, Neusoft Medical, Del Medical, Konica Minolta Healthcare, Medicom, and CMR-MBI.

Working toward future growth post-pandemic, Hologic announced news about a number of non-COVID-19-related products during the year despite its rapid deployment of diagnostic solutions to help fight the virus.

The CE-marked Aptima HIV-1 Quant Dx assay was awarded prequalification for testing of dried blood spot (DBS) samples by the World Health Organization. The assay can be used with DBS samples to monitor viral load and disease progression among HIV-1 infected individuals, and to aid in the diagnosis of HIV-1 infected infants under 18 months. It is the first and only dual-claim assay for both viral load and early infant diagnosis.

Hologic also announced improvements to its Brevera Breast Biopsy System with CorLumina Imaging Technology, the world’s first and only breast biopsy solution to combine vacuum-assisted tissue acquisition, real-time imaging verification, and advanced post-biopsy handling in one, integrated system. To better meet clinician needs, the Brevera system features a reusable device driver and disposable needles to simplify storage and improve waste management. The system also features improvements that allow radiologists and technologists to better separate and verify target samples automatically, then transfer seamlessly to pathology with minimal handling to help maintain core integrity.

The SuperSonic MACH 40 ultrasound system was launched in the U.S., expanding the company’s suite of ultrasound technologies with its first premium, cart-based system. The new system features excellent image quality, standard-setting imaging modes, and is designed to enhance efficiency and accuracy. It leverages UltraFast imaging technology—inspired by cutting-edge graphics innovations from the video gaming industry—to provide greater frame rates of up to 20,000 images per second. The technology also enables innovative imaging modes, without the trade-offs present in conventional systems.

The aforementioned LOCalizer RFID tag had its CE mark extended for long-term placement, enabling it to be implanted more than 30 days prior to a breast-conserving surgery, providing even greater flexibility and convenience to patients and providers. Following its earlier placement, the miniature implantable tag can be detected on the day of surgery by a portable, handheld reader that indicates the location and distance in millimeters to the lesion, enabling the surgeon to pinpoint the correct area of breast tissue for removal.

The FDA approved 3DQuorum Imaging Technology, powered by Genius AI. The technology works in tandem with Hologic’s Clarity HD high resolution imaging technology to reduce tomosynthesis image volume for radiologists by 66 percent. 3DQuorum technology uses Genius AI-powered analytics to uniquely reconstruct high-resolution 3D data to produce 6-mm “SmartSlices.” These analytics identify clinically relevant regions of interest and preserve important features during reconstruction of the SmartSlices.

The organization launched the Definity cervical dilator, a major advancement for gynecological procedures that uses SureAccess balloon technology to gently and effortlessly access uterine cavities without a tenaculum, lessening patient discomfort and reducing risk of perforation during dilation.

Hologic also launched the Omni Lok cervical seal, part of its growing portfolio of hysteroscopic devices. The first-in-its-class product is designed to help maintain uterine distention and improve procedural efficiency in the operating room by minimizing fluid leakage during hysteroscopic procedures.

Prior Fiscal: $3.21 Billion
Percentage Change: +4.6%
No. of Employees: 6,478

The odds were not good.

Actually, they were worse than that: They were awful. Downright frightful, even.

Lindsay was aware of the odds. She was cognizant of the tainted family history (both sides) that made her more vulnerable than others to breast and ovarian cancers. She knew about the maternal aunts that succumbed to malignancies, one of them being just 22.

Lindsay watched her mother battle Stage 0 breast cancer. She was well-versed in BRCA1 and BRCA2 knowledge, and had heard about Hereditary Breast and Ovarian Cancer Syndrome (HBOC).

Indeed, Lindsay was keenly aware of the risks she faced from her genetic family tree. Hence her request (more like a fight, really) for a mammogram at age 35—10 years before the recommended cancer screening age for average-risk women and five years before the suggested age for higher-risk females.

Lindsay’s first mammogram was normal. But as her second screening approached, she discovered a lump, prompting her to dutifully schedule a diagnostic mammogram and ultrasound. Only one test was needed, however, to confirm Lindsay’s worst fears.

“Before I got to do the ultrasound, they asked me to come back in for more mammogram pictures,” the mother of two recalls in a YouTube video. “I was like, ‘oh s*it, this is not good.’ The doctor came in and told me right then that it was a 99 percent chance that this was cancer. I just was in shock. Like, I couldn’t die.”

It wasn’t death that Lindsay was afraid of, though. Rather, she was frightened to leave her husband and two young children, ages 5 and 7 at the time of diagnosis.

Fortunately, doctors caught Lindsay’s cancer early and she successfully beat the disease, becoming one of the few survivors to overcome her doomed destiny. Though Lindsay’s mother Deidre credits her daughter’s survival to determination and persistence, Lindsay attributes her success to the 3D mammogram she underwent after finding the lump.

ANALYST INSIGHTS: Hologic had some timely COVID related portfolio platforms that allowed it to be “opportunistic” in creating growth during a quarter (Q2 2020) in which it might ordinarily have had a difficult time. With more strength in its diagnostic business now established, expect Hologic to combine that momentum with its Women’s Health position to find momentum for a positive 2020/2021.

—Dave Sheppard, Co-Founder and Managing Director, MedWorld Advisors

3D mammograms combine multiple breast X-rays to create a three-dimensional picture of the breast. While they generally are used to detect cancer in patients with no signs or symptoms, 3D mammograms also can help clinicians investigate the cause of problems like breast masses, pain, and nipple discharge.

3D mammogram machines create both 3D and standard two-dimensional breast images. On average, 3D screenings may slightly increase cancer detection rates, finding about one extra breast tumor for every 1,000 U.S. women screened, according to a 2018 analysis in the Journal of the National Cancer Institute. Most studies also show that 3D screenings cause fewer “false alarms,” in which women are called back for procedures they don’t need. But more research is needed to determine whether 3D mammograms reduce breast cancer death risk significantly more than their two-dimensional counterparts alone.

Either way, Lindsay is grateful to have had access to 3D mammography. “I feel extremely lucky that I had the 3D mammogram accessible to me,” she said in the YouTube video. “I was able to be diagnosed quickly and I was still early stage. And that really saved my life.”

3D mammography also has been a lifesaver of sorts for Marlborough, Mass.-based Hologic Inc., which has installed nearly 7,000 three-dimensional imaging systems throughout the United States. Stronger sales of the company’s 3Dimensions and 3D Performance systems in FY19 improved total revenue 4.6 percent to $3.36 billion and helped drive a 10.3 percent surge in Breast Health product proceeds.

“Our core 3D mammography business remains rock solid and we are building on it with an increasingly diversified product portfolio that spans the continuum of Breast Health care. In U.S. Breast Health, we are using internal R&D and external acquisitions to build on an incredibly strong domestic leadership position in 3D mammography,” Hologic Chairman, president, and CEO Stephen P. MacMillan told investors on a fourth-quarter earnings call last fall. “By leveraging our installed base we are creating a steadier more diversified growth engine across the continuum of breast healthcare.”

Fueling that engine in FY19 was the previous fiscal year’s purchases of Faxitron Bioptics and Focal Therapeutics, which together contributed $44.7 million to the Breast Health division’s $758.5 million total. Other growth stokers included newer workflow products like Intelligent 2D, Clarity HD, and SmartCurve upgrades, though gains were somewhat stymied by fluctuating foreign currency rates, 3D software upgrades, and lower sales of Brevera breast biopsy systems (supply constraints), Affirm Prone Breast Biopsy tables, and various software features.

Similar forces were at play in Hologic’s Skeletal Health division, where the Faxitron and Focal integration combined with higher demand for Horizon DXA systems to bump up sales 5.1 percent to $65.5 million. In FY19, the division garnered 74.6 percent of its product revenue in the United States, 12 percent in Europe, 8.8 percent in Asia-Pacific, and 4.6 percent in other international markets.

Diagnostics more or less mimicked that geographic sales apportionment in FY19, generating 76.4 percent of sales in the United States and 23.6 percent internationally. Total division revenue rose 5 percent to $1.17 billion, driven largely by a $64.2 million uptick in Molecular Diagnostics sales (excluding blood screening products). That uptick was triggered by a $41.9 million increase in worldwide Aptima assay sales (itself fueled by an expanded Panther instrument base), as well as robust demand for virology and Fusion devices.

Hologic expanded its Aptima and Fusion portfolios during the fiscal year with regulatory approvals in the both the United States and Europe. In October 2018, the company won CE marking for its Panther Fusion Bordetella Assay, a real-time PCR test for detecting and differentiating Bordetella pertussis and Bordetella parapertussis, the bacteria most commonly associated with Whooping cough.

Four months after that approval (February 2019), Hologic received two CE marks for its Aptima HIV-1 Quant Dx Assay for use in testing dried blood spots and early diagnosis of the disease in infants. The two CE marks gave the company the right to use the assay in European and African countries to qualitatively detect HIV type 1 RNA in infants younger than 18 months. Clinicians in those countries also can use the assay in testing dried blood spots to monitor viral load and disease progression in HIV-1 infected patients.

Stateside consent came last spring with the U.S. Food and Drug Administration (FDA) clearances of the Aptima BV assay for bacterial vaginosis detection and the Aptima CV/TV assay for Candida vaginitis and Trichomonas vaginalis identification. “Vaginitis is one of the most common reasons women visit a healthcare provider, and Hologic’s new molecular assays have the potential to transform how these infections are diagnosed in that very first appointment,” Edward Evantash, M.D., medical director and vice president of medical affairs, Hologic, said in publicizing the clearances. “The improved sensitivity and specificity of Hologic’s molecular assays over traditional methods in determining the underlying cause of vaginitis not only means identifying the right infection, but enabling the right treatment and, in turn, reducing the potential for recurrent or persistent infections.”

Aptima’s two U.S. authorizations raised Hologic’s FDA-cleared assay total to 16.

Hologic expanded its Cytology & Perinatal product platform as well in fiscal 2019 (ended Sept. 28, 2019), but the new additions failed to plug an $8.6 million deficit stemming from lower Perinatal volumes. A number of factors reduced Perinatal demand, including a shift in ordering patterns and lower domestic ThinPrep test volume; intriguingly though, the company’s ThinPrep test portfolio received a boost overseas with the CE marking last April of the ThinPrep Genesis processor, an instrument that prepares slides for cytology and aliquot samples for molecular testing. Compared to older instruments, the ThinPrep Genesis processor has increased automation capabilities and provides ergonomic and chain-of-custody benefits. It also provides automated sample barcoding, helping to ensure accurate sample tracking and reducing manual steps.

Hologic attributed the lower ThinPrep test volumes in the United States to screening interval expansion and a decline in average selling prices.

The Cytology & Perinatal product lineup was not the only unprofitable portfolio, though. Women’s Health finished fiscal 2019 with a deficit due to lower MonaLisa Touch gynecologic laser sales, which fell victim to an FDA crackdown on “vaginal rejuvenation” devices. These products use lasers and other energy-based devices to remove or reshape vaginal tissue in an effort to treat conditions and symptoms of menopause, urinary incontinence, or sexual function. But clinical evidence on such devices is lacking, and the FDA has identified numerous cases of vaginal burns or scarring tied to vaginal rejuvenation, as well as post-procedural pain during sexual intercourse or recurring chronic pain.

As a result of the FDA’s concerns, Hologic temporarily suspended sales of its TempSure Vitalia handpieces and single-use probes. The products re-entered the market in Q1 of fiscal 2019.

The loss in Women’s Health sales was partly responsible for the FY19 deficit in Medical Aesthetics product revenue. Other contributors to the 9.2 percent sales decrease (to $252.9 million) included lower body contouring product demand; fewer sales of SculpSure lasers, Submental upgrades, and related PAC keys, increased competition in non-invasive fat-reduction technology, and fluctuating foreign currency exchange rates.

Offsetting the Medical Aesthetics division’s profit-busters was higher skin product revenue, driven mainly by robust Icon and TempSure system sales.

Similarly, increased MyoSure and Fluent systems volume helped boost GYN Surgical product revenue 3.6 percent in FY19 to $436.2 million. MyoSure contributed $9.7 million to the total, while Fluent chipped in $10.8 million. Also supporting GYN Surgical’s overall sales increase was the first-quarter U.S. launch of the Omni hysteroscope, a three-in-one modular scope with advanced visualization capabilities designed for both diagnostic and therapeutic procedures. Approved by Canadian and European regulators in March 2019, the Omni scope can be used in doctors’ offices, surgical centers, or operating rooms.

The increases realized through Fluent, MyoSure, and Omni sales were partially neutralized by a $14 million loss in NovaSure systems revenue. Hologic attributed that shortfall to increased competition, a stagnant market for endometrial ablation, and lower average selling prices.

Another profit-maker for Hologic in fiscal 2019 was its Service and Other Revenues division, comprised primarily of sales generated by the firm’s field service organization for ongoing product service, installation, and repair. Most of the proceeds in this division come from the Breast Health segment, and to a lesser extent, the Medical Aesthetics business. Service and Other Revenues rose 3.8 percent to $596 million on higher installation rates, spare parts, and service contract conversion and license renewal rates for the Breast Health business.

Hologic bolstered the Breast Health business in FY19 with its purchase of a 46 percent stake in French firm SuperSonic Imagine. SuperSonic’s products complement Hologic’s wireless, handheld ultrasound scanner Viera, which is commercialized through a development and distribution agreement with Clarius Mobile Health.

Upon purchase of the SuperSonic stake, MacMillan said: “SuperSonic Imagine provides best-in-class ultrasound technology that is strategically important to the long-term growth of our Breast Health business.”

A slew of product launches and approvals throughout FY19 helped foster the growth of Hologic’s other businesses. Those actions included:

• Cynosure’s (which was divested in late 2019) North American launch of TempSure Surgical RF Technology, a new platform offering that allows clinicians to perform both surgical and non-surgical aesthetic procedures across various specialties, on one device.
• The launch of the Unifi Analytics software tool, intended to help healthcare facilities manage mammography usage and performance. The system tracks installed mammography devices and provides efficiency and accuracy analyses for devices and technologists.
• The U.S., Canadian, and European launch of the Trident HD Specimen Radiography System. The product delivers enhanced image quality and improved workflow with instant sample verification during breast-conserving surgeries and stereotactic breast biopsies. The Trident system features a bigger detector that gives clinicians a complete image of larger breast surgical specimens and various surgical and biopsy samples.
• FDA clearance of the LOCalizer radio frequency identification lesion localizing system for tagging and pinpointing breast lesions during surgeries. The LOCalizer does not emit ionizing radiation and can be implanted via syringe up to a month before surgery without anything remaining protruding through the skin.

COVID-19 Consequences

Q2 2020 Revenue: $756 Million
Q2 2019 Revenue: $818 Million
Percentage Change: -7.6%

Hologic Inc. wasted no time in tackling the global coronavirus pandemic. In mid-March, before shutdowns became widespread throughout the world, the Marlborough, Mass.-based company received FDA Emergency Use Authorization (EUA) for the Panther Fusion SARS-CoV-2 assay to detect the virus. The test is conducted on Hologic’s Panther Fusion fully automated and molecular diagnostic platform, which is used across much of the United States.

Two months after securing that authorization, Hologic won a second EUA from the FDA (May 15) for its Aptima SARS-CoV-2 virus detection assay. This test runs on Hologic’s fully automated Panther system, more than 1,000 of which are installed in U.S. clinical laboratories. Each Panther system provides initial results in roughly three hours and can process more than 1,000 COVID-19 tests in 24 hours. More than 1,800 Panther systems have been installed in 60 countries, according to the company.

AT A GLANCE
$3.22 Billion
Prior Fiscal: $3.06 Billion
Percentage Change: +0.5%
No. of Employees: 6,252

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.

$3.1 Billion
NO. OF EMPLOYEES: 6,233

To the relative indifference of anyone outside the medical device industry, Hologic’s first quarter of fiscal year 2017—ended Sept. 30—culminated in bloodshed.

Miraculously, no Hologic employees lost their lives due to the blood loss, which ultimately amounted to approximately $1.85 billion in cash. Longtime commercial partner Grifols, however, was sanguine at the news that it would be inheriting the Massachusetts-based diagnostic, imaging, surgical, and aesthetics firm’s shares of its blood screening business. Hologic and Grifols had collaborated since 1998 to provide molecular blood screening, with Hologic supplying the Procleix blood screening products, and Grifols leading commercialization efforts worldwide. The molecular assays and instruments were utilized around the world to screen blood for HIV, hepatitis B and C, West Nile, and Zika prior to transfusion.

The companies had shared revenue from the products, but Hologic’s share of the business was completely divested to Grifols at the close of last January. Two weeks later, Hologic began the $1.6 billion acquisition ostensibly funded by shedding its blood screening business—medical aesthetics systems and technologies firm Cynosure Inc.

Already a strong contender in women’s health and OB/GYN, Cynosure added non-invasive body contouring, hair removal, skin revitalization, and other women’s health products to Hologic’s GYN Surgical portfolio and newly established Medical Aesthetics segment. According to Hologic, as of last year the medical aesthetics market exceeded $2 billion globally and will grow at a low-double-digit rate over the next few years, making it one of the fastest growing segments within the medical technology industry.

As the American population continues to age and more effective non-surgical products hit the market, Cynosure’s business had generated double-digit revenue growth the past seven years. Growth is being provoked by physicians’ ambition to increase their cash-based procedures as well—a large portion of aesthetics is not subject to reimbursement risks, which makes it less cyclical, according to William Blair analyst Margaret Kaczor. Because of this, she told Reuters, “Larger acquirers [like Hologic] can access a fast growing, profitable market that is just in the first quarter of the game.”

Cynosure’s revenue was $433.5 million, and accounted for $178 million of Hologic’s 2017 revenue, a mere 5.8 percent of the company’s fiscal 2017 sales of $3.1 billion. The acquisition and integration of Cynosure’s portfolio as the Medical Aesthetics segment is primarily responsible for the company’s 7 percent revenue boost from the previous year.

The Medical Aesthetics segment was further augmented by two fourth-quarter FDA clearances granted to the SculpSure non-invasive body contouring (lipolysis) product, which permanently eliminates fat cells in problem areas via a selective wavelength laser that targets and heats subdermal fat cells. Last June, SculpSure was approved to treat the back and inner and outer thighs. Last September, SculpSure’s treatment area was expanded to the submental area—also known as a double chin. The latest clearance marked the sixth available body treatment area.

ANALYST INSIGHTS: Hologic continues to be a strong company, bolstered by several recent acquisitions into tangential markets, still staying core to women’s health. Their core focus sets them apart from many other competitors and strengthens their company image and name.

—Marissa K. Fayer, CEO and Founder, Health Equity for Women and HERHealthEQ

Hologic’s Diagnostics business—its chief revenue generator, accounting for 38 percent of total sales—fell 3.3 percent from the previous year to reach $1.2 billion. The shedding of the blood screening business to Grifols was primarily responsible for the loss, dropping $94.6 million from the segment’s proceeds. Excluding the divestiture, molecular diagnostic products yielded a year-over-year increase of $57.5 million due to a boosted installed base of the company’s Panther instruments, driving higher volumes of assay testing in Hologic’s Aptima assays in particular.

The Aptima HSV 1 & 2 assay, a nucleic amplification test conducted via swab specimens from skin lesions to detect herpes simplex virus (HSV) RNA, earned CE mark approval in November 2016, and subsequently achieved FDA clearance last June. Run on Hologic’s fully automated Panther system and five times more sensitive than live culture samples, the HSV 1 & 2 assay qualitatively spots and differentiates between HSV-1 and HSV-2. Patient specimens collected in a broad range of commercially available transport media can be tested with the assay.

Hologic was granted two FDA PMA approvals for its Aptima assay portfolio last year. The Aptima HIV-1 Quant assay, a nucleic acid amplification test for the quantitative detection of RNA from HIV in plasma specimens, was approved last January. The assay uses a dual target approach against highly reserved regions in the HIV genome to reliably and consistently quantify HIV-1 groups and subtypes. The Aptima Hepatitis C Quant Dx assay was awarded PMA approval last February. This assay quantifies hepatitis C virus viral load and confirms active infection by way of real-time transcription-mediated amplification (TMA), which is proven to reliably quantify the determination of sustained antiviral response across all major genotypes and a wide linear range.

Across the pond, the Aptima assay line achieved a number of CE mark clearances in fiscal 2017. Responding to the Zika outbreaks dominating last year’s headlines, the Aptima Zika Virus molecular test gained EU approval last February for patients at risk of exposure to Zika or with signs and symptoms of the virus. It identifies Zika RNA in human serum, plasma, and urine specimens, and can be used up to 14 days following symptom onset. In June, the Aptima Combo 2 assay for chlamydia and gonorrhea received new CE-marked claims, expanding the testing method to both clinician- and patient-collected throat and rectal swabs. About a week later, the Panther Fusion system and assays for flu and respiratory testing won CE mark clearance. The Panther Fusion module is an in-lab upgrade to the Panther instrument, offering multiple chemistries on a single platform as well as a higher throughput of up to 335 Panther Fusion tests in eight hours, or up to 500 Fusion and Aptima tests.

The firm’s Breast Health sales dropped 1.6 percent to $708 million in 2017, mainly due to lower sales volume of the 3D Dimensions systems and components and discontinuation of the Selenia system in 2016. This was somewhat offset by 3D upgrades and an international revenue increase as a result of the 2017 acquisition of Hologic’s Breast and Skeletal Health products distributor in Germany, Austria, and Switzerland, MMS Medicor Medical Supplies GmbH.

Hologic’s Genius 3D Mammography exam earned FDA approval  last June as the only mammogram superior to standard 2D mammography for routine breast cancer screening of women with dense breasts. A subgroup analysis from a previously published (JAMA 2014) retrospective multicenter clinical study made available shortly after the announcement also showed that with the addition of tomosynthesis to digital mammography, detection rates for invasive cancer increased significantly for women ages 40 to 69.

“Patients, and even referring physicians, have been confused about the current recommendations on when to start screening for breast cancer given the conflicting guidance from medical societies,” said Elizabeth Rafferty, M.D., lead author of the study. “The fact that tomosynthesis offers specific benefit to women in their 40s is not surprising, but the magnitude of that benefit was unexpected. We needed a better screening tool, and tomosynthesis fills that void. The substantial increase in cancer detection, along with fewer false positive studies, should address any concerns that have lingered over screening this population of women. The time has come for tomosynthesis to be viewed as the standard of care for breast cancer screening, beginning at age 40.”

In the final month of the company’s 2017 fiscal year, Hologic launched two Breast Health products. The Brevera breast biopsy system hit the U.S. market in late August. Designed for 2D and 3D breast biopsy, the system lets radiologists obtain and image tissue samples in the procedure room in a few seconds. Previously, radiologists performing stereotactic breast biopsy procedures to diagnose breast cancer were often required to leave the patient under compression while moving to another room to image and verify samples. A week and a half later, the 3Dimensions mammography system, which provides higher quality 3D images, enhanced workflow for technologists, a more comfortable experience, and low-dose options, became available to the European market.

Hologic’s ever-dwindling Skeletal Health business dropped 3.5 percent to $60 million in fiscal 2017 revenue, provoked by competitive pressures stifling U.S. mini C-arm sales. The drop was slightly offset by increased global sales volume of the Horizon osteoporosis assessment product.

The firm’s GYN Surgical revenue rose a moderate 8.7 percent in 2017 sales, reaching $426 million primarily as a result of increased MyoSure tissue removal system sales, somewhat offset by lower NovaSure ablation system revenues. The NovaSure Advanced 6mm global endometrial ablation system, which reduces abnormal uterine bleeding by applying radiofrequency energy to the endometrium and gently removing the lining of the uterus in two minutes or less, was launched in Europe, Canada, and Australia in November 2016, and was released in the United States last February. The new GEA device’s smaller sheath size requires less cervical dilation, reducing patient discomfort, and comes equipped with an acorn-shaped cervical seal to create an increased sealing surface.

Redwood City, Calif.-based startup Minerva Surgical hit Hologic with a lawsuit last April alleging the NovaSure Advanced GEA system infringed on its patented technology—specifically Patent No. 9,186,208, covering systems for endometrial ablation. The complaint, filed in San Francisco federal court, sought an injunction blocking U.S. sales of NovaSure Advanced. Minerva’s rival device, by comparison, won FDA PMA approval in July 2015, but had not been launched at the time the allegations arose.

However, a ruling that took place this past January determined Minerva isn’t entitled to an injunction barring sales of NovaSure Advanced. According to Bloomberg BNA, Judge James Donato of the U.S. District Court for the Northern District of California declared halting NovaSure advanced sales would limit women’s access to a device that would offer them “a greater degree of effectiveness and comfort than other options on the market.”

$2.8 Billion
NUMBER OF EMPLOYEES: 5,333

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.

$2.7 Billion
NUMBER OF EMPLOYEES: 5,290

Before examining Hologic Inc.’s 2015 finances, let’s first wish the company a very happy birthday. The multinational firm turned 30 last year, and even if the company leaving young adulthood doesn’t tickle your fancy, it’s an excellent excuse to celebrate with some cake.

Hologic’s Selenia Dimensions breast tomosythesis cancer screening system—featuring the company’s Genius 3D Mammography exam—was approved by the U.S. Food and Drug Administration (FDA) in 2011. Since then, the technology has begun to draw attention with celebrity spokeswomen to sing its praises, as well as generate awareness for the importance of breast cancer screening in general.

In June 2015, award-winning actress, singer, and Broadway veteran Kristin Chenoweth became the first celebrity to represent Genius 3D’s national campaign.

Chenoweth is the daughter of a two-time breast cancer survivor, so she fully understands how critical an accurate breast cancer screening tool can be. “Every woman knows that early detection is crucial when it comes to fighting breast cancer, but what so many don’t realize is that not all mammograms are the same,” she said in a company press release. “That’s why I’m partnering with Hologic and urging women across the country to demand that their hospitals or facilities offer the Genius 3D Mammography exam. Women need to take advantage of this more accurate screening—but that’s only possible if they have access to it.” Nothing garners attention for a campaign like a Broadway star.

That is, except for Grammy award-winning singer/songwriter and breast cancer survivor Sheryl Crow, who was named national spokesperson for the campaign in early June 2016. “Early detection saves lives—it’s that simple,” said Crow. “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.”

Financial Landscape

Fiscal 2015 (year ended Sept. 26) brought $2.7 billion in revenue, representing a 6.8 percent increase from FY14. An increase in both product and service revenue are responsible, according to the company. 2015’s net product sales of $2.27 billion (accounting for 83.9 percent of total revenue) showed an 8.4 percent bump over 2014. The company’s net service revenue, mainly generated within its Breast Health segment, of $434.6 million (accounting for 16.1 percent of total revenue) displayed a 0.3 percent decrease from 2014. Most of Hologic’s revenue was gained domestically—the U.S. market represented 76 percent of fiscal 2015’s total revenues. For the rest of the world, the European region was responsible for 11.8 percent of total net sales, the Asian-Pacific for 8.5 percent, and all other regions for the remaining 3.7 percent.

Hologic’s business is divided into four segments: Diagnostics, Breast Health, GYN Surgical, and Skeletal Health. All four segments generated an increase in product revenues in FY15, on both a domestic and worldwide basis, though growth was partially offset by the impact of negative foreign currency exchange due to the strengthening of the U.S. dollar.

The $1.2 billion in Diagnostics product revenue represented a 4.2 percent increase from fiscal 2014. Much of this can be attributed to the increase in Hologic’s Molecular Diagnostics family of products, particularly in the company’s Aptima family of assays for increased volumes based on an increased installed base of its Panther instruments. Also responsible for the increase is the company’s higher HPV screening assay sales volumes, also used in the Panther system. However, these increases were partially offset by the company’s lower Cervista HPV revenues resulting from customer transition to the aforementioned Aptima assay and Panther system. Lower instrumentation sales also occurred in FY15 due to Quest’s purchases in the first quarter of fiscal 2014.

Breast Health’s $685.1 million in net sales represents an impressive 16.5 percent hike over 2014. Most of this bump comes from the company’s digital mammography and related products increase, specifically the larger number of 3D Dimensions units sold on a worldwide—but primarily domestic—basis. Somewhat marring this growth was lower average selling prices, as well as a product mix shift within 3D offerings to systems with fewer features. Though not occurring during fiscal year 2015, it must also be noted that in October 2015, the American Cancer Society introduced new guidelines for mammograms, which recommends that women begin annual screening at 45 rather than 40, and that women be screened every two years instead of annually. Fewer overall mammograms may result in a decrease in purchases of Hologic’s mammography systems.

The GYN Surgical segment reported 2015 net sales of $334.6 million, a 9.1 percent increase from 2014. Mainly responsible for the gain are the MyoSure and NovaSure devices; however, MyoSure’s sales increase was offset by a decline in Novasure revenue—largely due to the negative impact of foreign currency exchange rates.

Skeletal Health’s $66.6 million in FY15 revenue represents a 4.9 percent increase over 2014, mainly due to volume increases in Hologic’s Horizon osteoporosis

assessment product sales on a worldwide basis. During the third quarter of fiscal 2015, Hologic decided to close its Bedford, Mass. facility where it manufactures its Skeletal Health products and supports select manufacturing services for its Breast Health segment. Henceforth, manufacturing of Skeletal Health products will be outsourced to a third party. Breast Health manufacturing services—along with research and development, sales and services support, and administrative functions—will be dispersed among its Danbury, Conn., and Marlborough, Mass., facilities. The transaction should be completed by the end of fiscal 2016.

Product and People News

In November 2014, Hologic announced the launch of its NovaSure 6mm global endometrial ablation system, designed to deliver radiofrequency energy to the endometrium and gently remove the uterus lining in two minutes or less. Used to treat women with abnormal uterine bleeding or heavy periods, the procedure can be done once in the doctor’s office in about five minutes. The new NovoSure offering adds to the company’s growing GYN Surgical portfolio. However, although over 2 million NovaSure endometrial ablation procedures have been performed to date and full market release occurred in both the domestic and international markets in December 2014, the company experienced a decline in domestic NovaSure sales.

The company also received CE mark clearance for its Aptima HIV-1 Quant Dx assay for use on its Panther molecular diagnostics system in December 2014. Using real-time transcription-mediated amplification technology, Hologic claims the product is the first viral load assay with both diagnosis and treatment monitoring capabilities.

Aptima’s launch in Europe was a large factor in the increased revenue for its Diagnostics sector. The assay is not yet approved for use in the U.S.

In June 2015, it was announced that David LaVance would resign as chairman of Hologic’s board of directors, to be replaced by president and CEO Steve MacMillan. “It has been a great honor to contribute to Hologic’s growth and development since 2002,” LaVance said. “The company’s future is bright, so this is the right time for me to transition leadership to the experienced team that’s now in place.” Another notable addition was the appointment of John Griffin, former vice president and deputy general counsel for Covidien plc, as general counsel, bringing nearly 30 years of experience across a wide variety of legal matters. In addition to his stint with Covidien, Griffin served as an assistant U.S. district attorney in Massachusetts.