07.20.22
Rank: #22 (Last year: #25)
$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
Global Headquarters: Marlborough, Mass.
KEY EXECUTIVES:
Stephen P. MacMillan, Chairman, President, and CEO
Karleen Oberton, CFO
Sean S. Daugherty, Group President, Breast/Skeletal Health and GYN Surgical Solutions
Kevin R. Thornal, Group President, Global Diagnostic Solutions
Erik Anderson, President, Global Services
Michelle Garsha, President, Diagnostic Solutions
Jennifer Meade, Division President, Breast &
Skeletal Health Solutions
Essex Mitchell, Division President, GYN Surgical Solutions
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.
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.
$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
Global Headquarters: Marlborough, Mass.
KEY EXECUTIVES:
Stephen P. MacMillan, Chairman, President, and CEO
Karleen Oberton, CFO
Sean S. Daugherty, Group President, Breast/Skeletal Health and GYN Surgical Solutions
Kevin R. Thornal, Group President, Global Diagnostic Solutions
Erik Anderson, President, Global Services
Michelle Garsha, President, Diagnostic Solutions
Jennifer Meade, Division President, Breast &
Skeletal Health Solutions
Essex Mitchell, Division President, GYN Surgical Solutions
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.