07.22.21
Rank: #25 (Last year: #27)
$3.78 Billion
Prior Fiscal: $3.37 Billion
Percentage Change: +16.4%
No. of Employees: 5,814
Global Headquarters: Marlborough, Mass
KEY EXECUTIVES:
Stephen P. MacMillan, Chairman, President, and CEO
Jay A. Stein, Co-founder, Chairman Emeritus, Sr. VP, CTO
Karleen Oberton, CFO
Erik Anderson, President, Global Service and Breast & Skeletal Health Service
Monica Aguirre Berthelot, Chief of Staff
Patrick Brady, Sr. VP, Global Supply Chain, Quality and Regulatory
Sean S. Daugherty, Group President, Breast/Skeletal Heath and GYN Surgical Solutions
Jennifer Meade, Division President, Breast & Skeletal Health Solutions
Essex Mitchell, Division President, GYN Surgical Solutions
Kevin R. Thornal, Division President, Diagnostic Solutions
Jan Verstreken, Group President, International
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.
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.
$3.78 Billion
Prior Fiscal: $3.37 Billion
Percentage Change: +16.4%
No. of Employees: 5,814
Global Headquarters: Marlborough, Mass
KEY EXECUTIVES:
Stephen P. MacMillan, Chairman, President, and CEO
Jay A. Stein, Co-founder, Chairman Emeritus, Sr. VP, CTO
Karleen Oberton, CFO
Erik Anderson, President, Global Service and Breast & Skeletal Health Service
Monica Aguirre Berthelot, Chief of Staff
Patrick Brady, Sr. VP, Global Supply Chain, Quality and Regulatory
Sean S. Daugherty, Group President, Breast/Skeletal Heath and GYN Surgical Solutions
Jennifer Meade, Division President, Breast & Skeletal Health Solutions
Essex Mitchell, Division President, GYN Surgical Solutions
Kevin R. Thornal, Division President, Diagnostic Solutions
Jan Verstreken, Group President, International
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.