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2200 Pennsylvania Ave NW 800 W Washington, District of Columbia 20037 US
Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what
Rank: #14 (Last year: #14) $9.79 Billion ($23.88B total) Prior Fiscal: $9.58 Billion Percentage Change: +2.0% R&D Expenditure: $1.6B Best FY24 Quarter: Q4 $2.6B Latest Quarter: Q1 $2.4B No. of Employees: 63,000 (total) Global Headquarters: Washington, D.C.
Continuity of leadership is an important goal of most firms. A smooth transition from one leader to the next can be critical to continuing growth initiatives and strategic planning. While it’s not always possible to orchestrate, Danaher’s Diagnostics unit was able to set up a seamless switch due to the retirement of one executive and the promotion of another.
Midway through its 2024 fiscal year, it was announced Joakim Weidemanis would leave his post as executive vice president, Diagnostics, on Sept. 30. Prior to his departure, he would work with his replacement in support of the transition for three months before formally retiring from Danaher.
Weidemanis’ 13 years of service were spent overseeing Diagnostics as well as the organization’s previously owned Product Identification and Water Quality platforms, now part of Veralto Corporation. “It has been a privilege to work alongside Joakim for the past 13 years. His contributions have been pivotal in evolving strategy, furthering growth, innovation, operational excellence, and developing leaders across our businesses. On behalf of our Board of Directors, associates, and shareholders, I want to thank Joakim for helping to make Danaher a better, stronger company,” President and CEO Rainer Blair said in prepared remarks.
Moving into the position was Julie Sawyer Montgomery, then vice president and group executive of Danaher’s Clinical Diagnostics businesses, where she was responsible for providing strategic leadership across the diagnostic businesses. Montgomery also served as president of Beckman Coulter Diagnostics. She joined the firm in 2017.
“Julie’s exceptional leadership has been instrumental in driving growth and improving performance at Beckman Coulter Diagnostics and, more recently, across our Clinical Diagnostics businesses. During her tenure Julie has shown tremendous commitment to supporting our customers, building winning teams, driving innovation, and leading with the Danaher Business System. I look forward to seeing Julie apply her skills and experiences to help ensure the ongoing success of our entire Diagnostics franchise, as we work to improve outcomes for patients with faster, more accurate diagnoses,” stated Blair.
Following Montgomery’s promotion from the leader of Beckman Coulter to VP of the diagnostics businesses, which took place earlier that same year (February), Kevin O’Reilly was announced as her replacement. O’Reilly joined the firm from Varian Medical Systems where he was serving as president of Radiation Oncology Solutions. He had been with the organization for 15 years and was involved in varied roles, including those in R&D, product strategy, sales, supply chain, and manufacturing.
Beckman Coulter is just one of the many businesses that make up the Danaher Diagnostics unit. During the 2024 fiscal, the company remained focused on organic growth initiatives, similar to its sister organizations under the Diagnostics flag. With the deal to acquire Abcam still settling, expansion would be sought through portfolio expansion and partnership opportunities.
To that end, the business unveiled its DxC 500 AU Chemistry Analyzer, an automated clinical chemistry analyzer, at Medlab Middle East in Dubai, in February. It features advanced automation technology, onboard guided workflows, and standardized reagents for use across healthcare networks for more than 120 assays.
A month later, it expanded its partnership with Fujirebio, a leader in neurological markers and in-vitro diagnostic manufacturing, to focus on the development, manufacturing, and clinical adoption of neurodegenerative disease assays. The assays were developed for use on Beckman Coulter’s DxI 9000 Immunoassay Analyzer. (The analyzer generated headlines again in April when tests for Hepatitis B and C viruses—namely Access anti-HCV, Access HBsAg, and Access HBsAg Confirmatory assays—received CE marks.)
May saw the launch of a collaboration with Johns Hopkins University with the goal of developing new methods for diagnosing mild traumatic brain injury. As part of the Danaher Beacons program, researchers at the University would leverage technology from Beckman Coulter Diagnostics to potentially establish correlations between a new biomarker panel and clinical outcomes. If effective, the approach could potentially be adapted for the diagnosis of other types of brain injury or neurodegenerative diseases. The Danaher Beacon for Brain Injury Diagnostics is the sixth collaboration in the Danaher Beacons program, which funds product-driven scientific research with globally recognized academic investigators.
FROM THE TOP: “We believe Danaher is better positioned than at any point in our 40-year history. The transformation in our portfolio over the last five years has shaped us into a focused life sciences and diagnostics innovator, with improved revenue growth, margin, and cash flow profiles. While our 2024 results did not fully demonstrate the power of our portfolio given challenging end-market conditions, a steadily improving operating environment—paired with our team’s commitment to leading with the Danaher Business System—reinforces our confidence in the bright future ahead for Danaher.”
—Rainer M. Blair, President and CEO
Before the end of that month, a U.S. FDA clearance was obtained for the Access NT-proBNP (N-terminal Pro B-type Natriuretic Peptide) assay for the assessment of heart failure in less than 11 minutes on the DxI 9000 Immunoassay Analyzer. The assay aids in diagnosing patients suspected of having acute heart failure in emergency departments as well as assessing the severity and risk stratification of patients with heart failure and acute coronary syndrome.
Just before August, Biogen joined the aforementioned duo of Beckman Coulter and Fujirebio to potentially identify and develop blood-based biomarkers for tau pathology in the brain and to potentially clinically advance and commercialize new tests for tau pathology in Alzheimer’s disease.
Expanding on another partnership, Beckman Coulter and Scopio Labs, a medtech company that develops digital cell morphology workflow solutions, announced a global distribution agreement of the latter’s Full-Field Bone Marrow Aspirate Application, which is CE marked in conjunction with the firm’s X100/X100HT.
Danaher’s other leading diagnostic business, Cepheid, offered a number of product announcements itself. First, it received U.S. FDA clearance with a CLIA waiver for its Xpert Xpress MVP. This multiplex vaginal panel can be performed in near-patient settings, enabling results within 60 minutes from a single specimen for bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis. The test runs on Cepheid’s GeneXpert Xpress instruments and has been approved for testing women 14 years of age and older.
In March, U.S. FDA clearance was secured for the Xpert Xpress GBS, a dual-target molecular diagnostic test for the qualitative intrapartum detection of Group B Streptococcus (GBS). This next-generation test incorporates new dual targets in highly conserved regions of the GBS genome to improve sensitivity and bacterial strain coverage.
During the summer, a De Novo marketing authorization and CLIA waiver approval was obtained for the Xpert HCV, the only molecular test in the U.S. to detect hepatitis C virus RNA directly from a human capillary whole blood (fingerstick) sample, according to the firm. The Xpert HCV test is performed on the GeneXpert Xpress System and provides results in approximately an hour.
In the effort to combat antimicrobial resistance (AMR), Cepheid teamed with the Fleming Initiative, a global collaboration established by Imperial College Healthcare NHS Trust and Imperial College London. The Fleming Initiative brings together research scientists, policymakers, clinicians, behavioral experts, and public and commercial partners to provide the networks, expertise, and skills to provide equitable solutions to AMR at the global scale.
With November came The World Health Organization’s (WHO) listing of Cepheid’s Xpert Mpox under its Emergency Use Listing (EUL) procedure. The EUL process assesses the quality, safety, and performance of essential health products, such as diagnostic tests, to guide procurement agencies and WHO Member States in making informed decisions for time-limited emergency procurement. In 2024, 18 countries reported more than 40,000 suspected mpox (a.k.a., monkeypox) cases with most remaining unconfirmed due to limited testing capacity, especially in low and middle-income countries. In the Democratic Republic of the Congo—the hardest-hit country—testing significantly increased in 2024, according to Cepheid.
At another sister business under the Diagnostics purview, Leica Biosystems contributed its own product portfolio news announcements. Its flagship digital pathology system, Aperio GT 450 DX, received 510(k) clearance from the U.S. FDA. Previously sold into the clinical market under enforcement discretion due to the COVID-19 pandemic, Aperio GT 450 is a proven technology that consistently delivers high-quality images at a fast turnaround time of less than 32 sec/slide.
Toward the end of July, Leica Biosystems opened the doors of its new research and development facility in Newcastle Upon Tyne, U.K., to accelerate the development of Companion Diagnostics. The new Center for Enabling Precision Medicine also has a strong focus on environmental consciousness: Ahead of the opening, it received certification from My Green Lab, an organization considered to be the gold standard for laboratory sustainability best practices around the world.
Perhaps as an early holiday gift, the company announced it was dropping enforcement of their Digital Pathology DICOM (digital imaging and communications in medicine) patent portfolio to accelerate the usage of DICOM and standardization of digital pathology. As such, a patent license agreement would no longer be required, empowering companies to optimize and utilize the standard. Leica sought to foster greater innovation and cooperation within the industry to shape a brighter future for digital pathology.
Before the end of the year, a new printing solution to optimize laboratory workflow using laser technology was announced. The HistoCore LIGHTNING S is an on-demand, batch laser printer optimized for use with Leica Biosystems’ staining solutions. The laser etching technology in the printer delivers consistent print quality, enhanced efficiency, and strong uptime.
Focused on breast care, Mammotome expanded its product portfolio as well. A 510(k) clearance was obtained for the LumiMARK Biopsy Site Marker, a tissue marker line designed with visibility top of mind. The LumiMARK markers are distinct from every angle under ultrasound, mammography, and magnetic resonance.
The company then added to its previously launched HydroMARK Plus Breast Biopsy Site Marker line. A new shape—the Hummingbird marker—was introduced, providing clinicians with a second unique option within the line.
In November, the Mammotome AutoCore Single Insertion Core Biopsy System, the first automated spring-loaded core needle device on the market, was launched. The system features single-button functionality with automated arming, allowing the user to perform all sampling steps with one click. This eliminates manual arming and enables easy one-handed operation.
All of these product portfolio expansions will certainly give a boost to the Diagnostics segment’s revenue tally, which finished at $9.79 billion in 2024. This represented a modest 2% increase over the previous year, but was still well short of its 2022 total of almost $11 billion.
$9.58 Billion ($23.89B total) Prior Fiscal: $10.85 Billion Percentage Change: -11.5% R&D Expenditure: $1.5B Best FY23 Quarter: Q4 $2.72B Latest Quarter: Q1 $2.53B No. of Employees: 63,000 (total)
While Danaher’s Diagnostics unit may have finished 2023 down in revenue by more than 11%, the organization emerged with a new look. In addition, its revised appearance was not just due to a rebranded logo (although that was the most obvious), but rather, its new look was due to several factors.
As mentioned, the company debuted a new logo in 2023. Lippincott took on the task of revitalizing the organization’s image. On its website, Lippincott explained the idea for the new look originated out of a single idea—Innovation at the speed of life. With that, the concept developed into the formation of “an ‘acceleration curve’ with every component, from the logo and voice to illustration and motion, conveying dynamism and forward momentum.” The logo also retained the subtle “D” from the previous version of the logo, which was a nice touch.
In addition to the visual update, the company gained a significant business injection via the $5.7 billion acquisition of Abcam plc, a global supplier of protein consumables, including reagents, biomarkers, and assays used in diagnostics. Announced in late August 2023, the deal was finalized in December.
“We couldn’t be more excited to have Abcam join Danaher. Abcam’s long track record of innovation, outstanding product quality, and breadth of antibody portfolio positions them as a key partner for the scientific community,” explained Rainer M. Blair, Danaher’s president and CEO. “We look forward to welcoming Abcam’s innovative and talented team to Danaher as we continue to help our customers solve some of the world’s biggest healthcare challenges.”
Further reshaping the company, it was announced in February 2023, the unit being spun out from the organization—the Environmental and Applied Solutions (EAS) segment—would be named the Veralto Corporation. The stand-alone entity would be comprised of Danaher’s brands Hach, ChemTreat, Trojan, OTT HydroMet, and McCrometer from the Water Quality Platform and Videojet, Esko, X-Rite Pantone, and Linx from the Product Identification Platform. The separation was completed in September 2023, leaving the remaining company to focus primarily on life sciences-related industries across the three remaining business units—Biotechnology, Life Sciences, and Diagnostics.
Specifically within that Diagnostics unit, as mentioned previously, the company saw a loss of 11.5% compared to the prior fiscal, ending with $9.58. The total was also lower than the 2021 total, similar to many companies that provided diagnostics to detect COVID-19 during the pandemic. The company confirmed as much within its annual report; it also cited the impact of changes in currency exchange rates. On a positive note, there was a more than 20% increase in non-respiratory disease tests, but it wasn’t enough to offset the losses of reduced COVID-19 tests.
With a new look for the coming years, the company’s multiple diagnostics businesses shared information on new offerings that would help bolster the firm’s overall revenue take. The following news on offerings was shared during the 12-month fiscal period.
From Beckman Coulter, the DxI 9000 Access Immunoassay Analyzer was revealed in May. The system can run up to 215 tests per hour per square meter (tests/hr/m²). In addition, its ZeroDaily Maintenance feature, which reduces annual maintenance routines by up to 96%, is one of the well-received aspects based on beta-user feedback.
July saw news regarding two of the business’ offerings. First, a partnership with Fujirebio was conceived to increase access to a blood-based Alzheimer’s Disease test. The agreement addressed the global unmet clinical need for those diagnostics through continued menu expansion on Beckman Coulter’s Access Family of Immunoassay Analyzers leveraging Fujirebio’s assay technology. The initial focus was on the previously mentioned Dxl 9000 analyzer.
About a week later, the company gained FDA clearance for its DxC 500 AU Chemistry Analyzer, an automated chemistry analyzer. The unit uses standardized assays and reagents found across Beckman Coulter’s portfolio of AU clinical chemistry analyzers.
Cepheid shared several announcements on products in 2023 as well. Its first was from February when it gained U.S. FDA Emergency Use Authorization (EUA) for its Xpert Mpox (commonly referred to as monkeypox) point-of-care test. The test was authorized for use in moderately complex settings and was considered authorized for use in point-of-care settings under the EUA for use on GeneXpert Xpress systems.
The business also received a medical device license from Health Canada for its Xpert Xpress CoV-2plus, a rapid molecular diagnostic test for qualitative detection of the virus that causes COVID-19. Since multiple variants of the virus have been documented globally, Cepheid proactively addressed this increasing genetic diversity by enhancing gene coverage. The plus version of the test incorporated a 3rd conserved genetic target for SARS-CoV-2 detection to meet the challenge of future viral mutations and optimized nucleocapsid gene probes to enable consistent virus detection.
A CE mark was achieved for the Xpert NPM1 Mutation, a molecular in-vitro diagnostic test for the quantification of mutant NPM1 mRNA transcripts (types A, B, and D in exon 12) in peripheral blood specimens from patients with Acute Myeloid Leukemia. The test utilizes automated real-time reverse transcription polymerase chain reaction and reports the percent ratio of mutant NPM1 to ABL1 endogenous control mRNA transcripts.
In September, Danaher stated it would provide Cepheid’s Xpert MTB/RIF Ultra diagnostic test cartridges for tuberculosis (TB) at Cepheid’s cost of $7.97 each to the Global Fund to Fight AIDS, TB and Malaria and to less-developed countries eligible for Cepheid’s Global Access Program to support greater access to high-quality TB testing. The agreement significantly expands a longtime partnership between Cepheid and the Global Fund to improve access to testing where it matters most.
At Leica Biosystems, an expanded partnership with Paige to enhance the use of image management and artificial intelligence (AI) technology in global digital pathology workflows was announced. Paige is a global leader in end-to-end digital pathology solutions and clinical AI applications. Leica selected the partner to be the preferred provider of software-as-a-service digital pathology image management and viewing software along with diverse embedded AI solutions for its line of Aperio GT 450 digital pathology slide scanners. While the expansion was announced in early 2023, the launch of the technology occurred in late October.
In April, a U.S. FDA clearance was achieved for the BOND MMR Antibody Panel, providing customers with a high-performing immunohistochemistry Mismatch Repair option when screening colorectal cancer patients for the identification of probable Lynch syndrome. A result can be provided after only 2.5 hours with the panel.
June saw the launch of the BOND ChromoPlex II Dual Detection, a plug-and-play dual detection system designed to deliver in situ hybridization and immunohistochemistry dual staining on BOND-MAX and BOND-III. Dual staining enables clinicians or researchers to stain a single tissue sample with multiple markers, providing new insights into what is occurring at the cellular level.
The business also released three software features for the Aperio GT 450 Digital Pathology scanner. The new enhancements—Z-Stack Scanning, Automatic Narrow Stripe Scanning, and 20x Magnification—were provided to help improve image quality and flexible scanning solutions in research settings.
Mammotome launched its HydroMARKT Plus Breast Biopsy Site Marker in August, designed to enhance ultrasound visibility, improve ease of locating, and mitigate displacement during surgical procedures. The hydrogel-based carrier hydrates more than 200% of its original size and becomes strikingly anechoic within 24 hours, and lasts up to 12 months, enabling long-term ultrasound visibility, even in patients undergoing Neoadjuvant Chemotherapy.
In addition to rolling out new products in 2023, one of the businesses also introduced a new leader. Coming over from Philips North America where he was CEO and also CEO of the Global Ultrasound Business, Vitor Rocha joined Cepheid as president in May. Prior to Philips, Rocha worked at GE HealthCare for more than a decade in various leadership roles, including management of sales operations across 32 countries.
$10.85 Billion Prior Fiscal: $9.84 Billion Percentage Change: +10.3% R&D Expenditure: $1.75B Best FY22 Quarter: Q4 $8.4B Latest Quarter: Q1 $7.2B No. of Employees: 81,000
Danaher proclaimed its intention to separate its Environmental & Applied Solutions (EAS) business into the Veralto company this past September. It will be comprised of the company’s Water Quality and Product Identification businesses, with the aim to launch in Q4 2023.
“We believe that EAS will be advantaged as a standalone company with greater opportunities to pursue high-impact organic and inorganic investments,” CEO Rainier Blair said in a press release. “The combination of a resilient business model—with more than 50% recurring revenue—and a talented team with a foundation built on the Danaher Business System will position [Veralto] to continue delivering the same results it has as part of Danaher.”
Veralto’s operating companies will include Hach, ChemTreat, Trojan, OTT, and McCrometer in Water Quality and Videojet, X-Rite Pantone, Esko and Linx in Product Identification. Jennifer L. Honeycutt, who joined Danaher in its 1999 acquisition of Hach and is an executive vice president with responsibility for the EAS segment, will become president and CEO upon the transaction’s completion.
“I am honored and humbled to be selected to lead EAS as a standalone public company,” said Honeycutt. “As a leading water quality and product identification franchise we will be well-positioned to pursue our strategic priorities and create long-term value for our shareholders, customers, and associates.”
Danaher’s Diagnostics business grew just over 10% in its fiscal year 2022, accruing revenue of $10.85 billion. The company’s annual report cites increased core sales in the molecular diagnostics business, led by North America and Western Europe as the business demonstrated healthy growth in the sale of diagnostic consumables. This increase was mainly driven by higher sales of COVID-19 diagnostic test solutions and high demand for non-respiratory disease tests. Further production capacity in 2021 let the business make more diagnostic tests in 2022 and meet continued, strong demand from private and government investors.
Core sales in the segment’s clinical lab business also grew because increased demand in North America and Japan tempered weaker demand in China, where COVID-19 restrictions reduced patient volumes. Acute care diagnostic business sales also grew thanks to increased demand for Danaher’s blood gas products. Demand here was driven by Western Europe, North America, and China. Pathology business sales rose as well across all geographies, provoked by further demand for core histology, advanced staining, and pathology imaging products.
Danaher’s Cepheid business earned FDA emergency use authorization (EUA) for its Xpert Xpress COV-2plus rapid molecular test to detect COVID-19 in May, the same month it also began shipping. It incorporates a third, conserved genetic target for SARS-CoV-2 detection to spot future viral mutations, as well as optimizes nucleocapsid gene probes to enable consistent virus detection. The test earned CE mark certification about a week later.
The Xpert Xpress GBS (Group B Steptococcus) molecular diagnostic test for qualitative, intrapartive detection in pregnant females gained CE-IVD mark status in November. The upgraded test enhances gene coverage and incorporates new dual targets in highly-conserved GBS genome regions. The test produces positive results as early as half an hour and allows testing at the time of neonatal delivery for real-time GBS status.
Also in November came the launch of Cepheid’s XpertXpress MVP (multiplexed vaginal panel) PCR test to detect bacterial vaginosis (BV), vulvovaginal candidiasis, and trichomoniasis from a single sample. The test can address co-ocurrances from a single sample, with detection time within an hour to narrow the test-to-treatment gap and support outcomes. The Xpert Xpress GBS LB XC (extended coverage) molecular test for Group B Streptococcus using enriched Lim borth cultures of patient samples was also launched that day. The test can generate positive results for GBS in as soon as 27 minutes.
Danaher’s Beckman Coulter Diagnostics business began a partnership in July with Massachusetts General Hospital—greased with funds from the Biomedical Advanced Research and Development Authority (BARDA)—to validate its Monocyte Distribution Width (MDW) hematology biomarker as a screening tool to measure severity of infection in children presenting with high fevers. MDW is a regulatory-cleared parameter for adults presenting to the emergency department and is available as a standard component of a CBC performed on the company’s DxH 900 and 690T hematology analyzers.
Beckman Coulter acquired artificial intelligence firm StoCastic in October. StoCastic offers evidence-based decision support for emergency departments—its TriageGo decision support tool integrates electronic health record systems and routine emergency department workflow. TriageGo has been shown to lower door-to-clinical decision time by 20-30 minutes, door-to-ICU times by 40-80 minutes, and door-to-ED departure for those undergoing emergency surgery by 30–60 minutes.
Danaher’s Radiometer America business gained authorization in July from the Cybersecurity Logistics (CyberLOG) branch of the Defense Health Agency (DHA) Medical Logistics division for its ABL90 Flex Series Version 3.x_AI. CyberLOG is responsible for conducting the Risk Management Framework process and centralized oversight of continuous monitoring activities. Radiometer America’s ABL90 FLEX PLUS blood gas analyzer is designed for point-of-care testing in busy clinical environments, like the emergency department, intensive care unit, neonatal intensive care unit, and operating room. The authorization gives the company clearance until July 2025.
$9.84 Billion ($29.45B total) Prior Fiscal: $7.4 Billion Percentage Change: +33% R&D Expenditure: $1.74B Best FY21 Quarter: Q4 $2.88B Latest Quarter: Q1 $2.64B No. of Employees: 80,000 (total)
Ultimate Gray+Illuminating.
An unlikely pairing, this union of dark and light, of drab and vivid.
Yet somehow, it works. The flat, neutral Ultimate Gray—think concrete slab—is a calming counterpart to Illuminating’s vitality and brilliance (think sunshine).
“The contrast between Ultimate Gray and Illuminating is stark,” Jacob Olesen, founder of Color Meanings, a website about color symbolism and design, wrote in an undated post. “While Ultimate Gray offers a reassuring, calm presence, Illuminating is bursting with energy. This cheerful yellow also has some power to it. It’s reminiscent of sunlight…”
And sunlight is associated with warmth, joy, positivity, and hope. That explains—at least partially—the decision to name Illuminating and Ultimate Gray as the Pantone Color of the Year 2021.
Last year’s complementary tones clearly were a metaphorical choice, intended to convey a message of resilience and optimism after a particularly challenging 2020. “The union of an enduring Ultimate Gray with the vibrant yellow Illuminating expresses a message of positivity supported by fortitude,” Pantone Color Institute Executive Director Leatrice Eiseman said in a December 2020 news release. “Practical and rock solid but at the same time warming and optimistic, this is a color combination that gives us resilience and hope.”
Indeed, the pairing of Ultimate Gray and Illuminating served as a beacon of hope last year to a world grown weary of a (seemingly) interminable pandemic, racial unrest, climate change-fueled natural disasters, and political extremism. Their complementary nature, in fact, exemplified the importance of human connection in overcoming great challenges.
“It became apparent there was never going to be one color that could express everything that needed to be expressed—that it was, instead, critical to have two independent colors that could come together,” Pantone Color Institute Vice President Laurie Pressman explained. “Not only to subliminally convey the message that we can’t do this alone—that we all need each other—but because it is the combination of the qualities of these colors that tells the story.”
One of many stories, actually.
Ultimate Gray and Illuminating also tell a tale of resilience, unity, and fortitude at Pantone’s parent company, Danaher Corporation. Through its various subsidiaries, the multinational firm became a pillar of endurance, strength, and sanguinity last year as SARS-CoV-2 continued its deadly rampage, with Beckman Coulter Diagnostics and Cepheid providing a solid base of assays and Cytiva and Pall Corporation supporting vaccine development.
Beckman Coulter’s two new COVID-19 antigen tests premiered last spring. Its Access SARS-CoV-2 Antigen assay can deliver results in 30 minutes and runs on the company’s immunoassay analyzers, including the DxI 800, a high-throughput analyzer capable of processing 200 samples an hour.
The Access SARS-CoV-2 Antigen assay has proven 93% positive percent agreement within seven days post-symptom onset and 100% negative percent agreement. The assay also has a 33 TCID50/mL detection limit, which is two to 200 times lower, and more sensitive than the reported detection limits for most available point-of-care antigen tests.
Beckman Coulter priced the assay at $4 for all healthcare providers to enable frequent testing. Access SARS-CoV-2 Antigen test samples are collected with a nasopharyngeal or nasal swab and can be store at room temperature for up to 24 hours and 48 hours refrigerated (2 degrees to 8 degrees Celsius) with one freeze/thaw cycle.
On the heels of the Access test’s general availability was FDA Emergency Use Authorization of Beckman Coulter’s semi-quantitative Access SARS-CoV-2 IgG II antibody assay. That test measures COVID-19 antibody levels, measuring IgG antibodies directed to the receptor-binding domain of the coronavirus’s spike protein. Offered in random access mode, the test has a confirmed 98.9% positive percent agreement (sensitivity) and 100% negative percent agreement (specificity) at 15 or more days upon symptom onset.
“Antibody assays like our Acess SARS-CoV-2 IgG II test can help researchers quantitatively determine the levels of IgG antibodies and enable them to access the relative changes of an individual’s immune response to the virus over time,” Shamiram R. Feinglass, M.D., Beckman Coulter’s chief medical officer, said. “This information is essential because it helps continually inform therapeutics and vaccine development. Effective and high-quality diagnostic solutions are essential in the fight against COVID-19.”
Cepheid contributed to the global fight by developing tests for Omicron and future variants, as well as assays for differentiating/detecting SARS-CoV-2, flu, and RSV (respiratory syncytial virus).
The latter tests augmented Cepheid’s Xpert Xpress portfolio. Canadian regulators sanctioned Xpert’s four-in-one SARS-CoV -2/Flu/RSV rapid molecular assay in mid-January last year as the flu season reached its peak. The test can distinguish between the viruses causing COVID-19, Flu A, Flu B, and RSV infections from a single patient blood sample. Designed for laboratory and point-of-care use, the assay and delivers results in about 36 minutes.
Cepheid developed an expanded combination COVID-19 test that received both FDA emergency use authorization and CE Mark approval last fall. Besides deciphering between the four respiratory illnesses, the Xpert Xpress SARS-CoV-2/Flu/RSV plus adds a third gene target for COVID-19 detection to “meet the challenge of future viral mutations.” The test can be used on any Cepheid GeneXpert system and provides results in roughly 36 minutes.
Cepheid’s Xpert testing line has proven resilient to the Omicron variant, based on computer-based analysis, according to the company. “RNA viruses are well known to naturally undergo genetic variation, and thus are well-poised to emerge in the face of new selective pressures—it is how they thrive,” David Persing, M.D., Ph.D., executive vice president and chief science officer at Cepheid, said last December. “From the beginning of the pandemic, we have been keenly focused on staying ahead of SARS-CoV-2 genetic drift and have designed our tests in anticipation of variants like Omicron and potential future variants.”
That foresight helped boost demand for Cepheid’s PCR respiratory test and its four-in-one combination assays late last year as Omicron become the dominant coronavirus variant and the flu began its seasonal march through the Northern Hemisphere.
“At Cepheid, we have increased our manufacturing capacity for respiratory tests—including our four-in-one combination test for COVID-19, Flu A, Flu B, and RSV—by 10-fold over the last two years,” Danaher President and CEO Rainer M. Blair said in the company’s 2021 annual report. “Near-term, these investments have been critical to meet customer demand and we believe they are driving meaningful market share gains.”
They’re certainly driving meaningful sales gains. Diagnostic segment proceeds skyrocketed 33% to $9.84 billion in FY21, nearly matching Danaher’s overall 32.2% revenue rise (to $29.45 billion). Diagnostic operating profit mushroomed 50.4% to $2.31 billion—significantly less than Life Sciences’ two-fold gain in operating profit but far more than the 7.6% increase recorded by Environmental & Applied Solutions.
Diagnostics’ stellar showing last year can primarily be attributed to sales gains in each of its three product franchises, higher SARS-CoV-2 molecular test volume, and demand for non-coronavirus products, such as Cepheid’s advanced, extended-coverage HIV tests, Xpert HIV-1 Viral Load XC and Xpert HIV-1 Qual XC, both of which received CE-IVD clearance last summer. Xpert HIV-1 Viral Load XC analyzes the viral load levels used for monitoring anti-retroviral treatment efficiency; it adds a second target for identifying HIV-1, offering expanded strain coverage to boost performance and alleviate the risk of false-negative results due to gene mutations or deletions.
Xpert HIV-1 Qual XC adds a second target as well for quicker HIV-1 infection detection—up to seven to 10 days before seroconversion. The Qual XC assay can be used in both laboratory and near-patient testing environments.
Increased demand for chemistry and immunoassay products helped boost sales in Diagnostics’ clinical lab business, though new innovations likely contributed too. Beckman Coulter debuted a tabletop analyzer and workflow automated solution last winter and spring, expanding the company’s solutions for small and medium-sized laboratories.
The DxH 560 AL analyzer features auto-loading, closed-tube aspiration, and walkaway capabilities. Designed to reduce the time and resource constraints faced by small to mid-size labs, the analyzer uses a 17µL sample, one of the smallest sample volumes on the market; users can continually load up to 50 samples, and results are delivered in 60 seconds or less.
The DxH 560 AL provides privacy and security features including customizable user login, paperless data management, and fully traceable automated timeoouts that guard patient electronic personal health data.
The DxA 5000 Fit is a workflow automation solution for medium-sized labs running less than 5,000 tests daily. Its workflow automation solution can reduce up to 80% of manual steps through pre-analytical, analytical, and post-analytical automation. The DxA 5000 features intelligent routing and calculated route planning for rapid and consistent turnaround time, with statistics prioritized to deliver results faster, and a flexible design that can be adapted to meet a mid-volume lab’s space and infrastructure constraints.
Robust demand for blood gas consumables and immunoassay products lifted acute care diagnostic sales in 2021, though the hike partially was offset by lower instrument revenue (not surprising, considering the pandemic-induced demand for blood gas instruments in 2020).
Pathology business sales rose amid higher demand for core histology, advanced staining, and pathology imaging products. Leica Biosystems and Mammotome both introduced new solutions last year: Leica worked with Leeds Teaching Hospital NHS to develop a DICOM implementation solution for its next-generation Aperio GT 450 DX scanner. The product now produces DICOM Whole Slide Images natively, thus meeting industry standards to enable compatibility with PACS and tighter integration of digital pathology into the diagnostic pathway.
Mammotome, meanwhile, unveiled new flexible HydroMARK Breast Biopsy Site Marker applicators last April. Intended to simplify and improve user intuitiveness, the new applicator line expands compatibility with vacuum-assisted breast biopsy systems, including the Mammotome Revolve dual Vacuum-Assisted Breast Biopsy System. The hydrogel technology hydrates, reaching more than 90% water in less than 24 hours, and the new flexible applicator design allows for easier deployment in upright biopsies.
$7.40 Billion ($22.28 Billion) Prior Fiscal: $6.56 Billion Percentage Change: +12.8% No. of Employees: 69,000 (total)
B+C+S
Those letters represent the three main components of entrepreneurial success: Brand, Culture, Strategy.
The ideologically simple formula is more or less a philosophy rather than a hard-and-fast rule. Corporate disciples of this doctrine have been rewarded handsomely for their loyalty, both financially and socially.
While straightforward, the formula will only produce results when all three elements are aligned—a feat that is not so simple to achieve. It requires the right mix of branding, along with corporate cultural awareness, social responsibility, stakeholder value, service standards, an “employee-first” tenet, and core company values.
“I created the formula for myself in business years ago to try and figure out how all these things fit in,” independent business consultant Kenneth C. Bator recalled in a podcast (the theorem is detailed in his 2015 book, “The Formula for Business Success = B+C+S”). “In the 1990s when I was in the corporate world, I would run to a seminar about empowerment, then I would pick up a book about re-engineering, and maybe read an article on Six Sigma, and I always thought that in and of itself, this is a great concept, but how do we align and put all these things together? What eventually came to my head was everything seemed to fall into one of three buckets—either branding, culture, or strategy.”
Bator devotes a considerable portion of his book to branding, noting that a company’s mission statement is a vital ingredient within the “B” part of the formula.
Mission statements (sometimes referred to as credos) are relatively common in the business world, as they create a clear identity for companies, and help convey its values and purpose to both employees and the public. Mission statements also provide an ideal vision for an organization and directs its future growth.
Obviously, not all mission statements are created equal. Some are longer than others, some are more explicit than others, and some are more abstract. InVisionapp, for example, is guided by phrases: “Question Assumptions. Think Deeply. Iterate as a Lifestyle. Details, Details. Design is Everywhere. Integrity.” Starbucks’ vision, on the other hand, is more straightforward: “To inspire and nurture the human spirit—one person, one cup and one neighborhood at a time.”
Most mission statements, however, fall between the two extremes, mixing Starbucks-style clarity with InVisionapp-type ambiguity. Case in point: Ford Motor Company pledges to “go further to make our cars better, our employees happier, and our planet a better place to be.” Similarly, Nike vows to “bring inspiration and innovation to every athlete in the world” and Danaher Corporation is devoted to “Helping Realize Life’s Potential.”
The latter mission was particularly fitting last year as the Fortune 500 science and technology innovator helped the world realize life’s potential through critical COVID-19 diagnostics, treatments, and vaccines.
“The COVID-19 pandemic changed our lives and businesses, suddenly and substantially. We had to invent new ways to support each other and serve our customers while safeguarding our associates’ health and safety,” Danaher president and CEO Rainer M. Blair told shareholders at the start of the company’s 2020 annual report. Blair succeeded former president and CEO Thomas P. Joyce Jr. on Sept. 1.
“…unified by our Shared Purpose, Helping Realize Life’s Potential, we have worked hard to navigate these unprecedented times from a position of strength,” he continued. “Since the onset of the pandemic, our team has met the challenges presented and turned them into impactful opportunities to help our customers and the global community.”
Those opportunities benefited Danaher, too. Total sales jumped 24.4 percent last year to $22.3 billion and gross profit swelled 25 percent to $12.5 billion. Net earnings and basic net earnings per share each grew by 50 percent, to $3.64 billion and $4.97, respectively.
Danaher’s annual report attributes the sales growth to overall increased demand for the company’s products and services, as well as an 18 percent boost from the $21.4 billion addition of General Electric Co.’s biopharmaceutical business. Danaher purchased the business to gain a competitive edge in the global bioprocessing market, a sector forecast to grow 17 percent annually over the next five years.
The deal likely will help Danaher become a major competitor in the biopharmaceutical arena, as it now retains the ability to develop and manufacture both equipment and software used in biopharmaceutical research. Upon closing the transaction in March 2020, Danaher renamed the business (Cytiva) and established it as a standalone company within its Life Sciences segment.
And that new company helped significantly improve segment sales. Total Life Sciences revenue skyrocketed 52.2 percent last year to $10.57 billion, partly due to a 30 percent increase in core Cytiva proceeds between March 31 and Dec. 31, 2020, according to Danaher.
“With the addition of Cytiva, we doubled our annual revenue in the highly attractive biopharmaceutical end-market, which now represents more than 50 percent of our Life Sciences platform’s annual revenue,” Blair wrote in the annual report. “Cytiva achieved more than 25 percent core revenue growth and over $4 billion in revenue. We could not be more pleased with Cytiva’s early results…”
Such delight also was justified within the Diagnostic segment, where total sales rose 13 percent to $7.4 billion and operating profit ballooned 35.6 percent to $1.54 billion.
COVID-19 proved to be a double-edged sword for the segment—while it increased demand for molecular diagnostics and acute care instruments and consumables, lockdowns and other virus-induced restrictions reduced the need for clinical lab instruments and consumables.
Higher demand for blood gas instruments and consumables, partially driven by increased COVID-19 hospitalizations, bolstered acute care diagnostic sales last year. Demand was strong throughout the world, according to Danaher.
Conversely, core clinical lab revenue fell due to lower demand, despite the May 2020 launch of Beckman Coulter’s DxH 690T hematology analyzer, and the U.S. Food and Drug Administration (FDA) 510(k) clearance of the PK7400 Automated Microplate System last July. The clinical lab deficit, however, was somewhat offset by higher molecular diagnostic revenue, which itself was driven by robust growth of infectious disease instruments and consumable products as well as the development of COVID-19 tests by the company’s Beckman Coulter business.
The pandemic-induced tests included:
Beckman Coulter also began working last year on a federally-funded coronavirus-related sepsis detection algorithm and a rapid diagnostic test for pediatric COVID-19 patients.
The company is collaborating with San Francisco-based algorithm software developer Dascena Inc. on the sepsis diagnostic; the solution would combine clinical data from Beckman Coulter’s monocyte distribution width laboratory tests and patient data from electronic health records in a predictive machine learning algorithm to better and more accurately detect sepsis early. The diagnostic seeks to build on Beckman Coulter’s existing Early Sepsis Indicator, which received FDA 510(k) clearance in April 2019.
“Until recently, the majority of sepsis cases have been thought to be caused by bacterial pathogens,” Shamiram R. Feinglass,M.D., chief medical officer at Beckman Coulter, said in prepared remarks last May. “COVID-19 is changing that, and causing a paradigm shift in how we think about sepsis. The aim…is to determine whether MDW, as part of the sepsis prediction algorithm, will be able to aid in the detection of sepsis regardless of whether it is bacterial or viral-induced.”
Beckman Coulter also will build upon its MDW measurement technology to develop a COVID-19 test for children. The company currently is working to create a blood-based biomarker for measuring MDW, or variations in certain white blood cell sizes, which can indicate a systemic infection.
Funding from BARDA (Biomedical Advanced Research and Development Authority) will help support a clinical trial of the test that eventually will be administered by Beckman Coulter and researchers at Massachusetts General Hospital, Johns Hopkins University School of Medicine, and the University of Florida.
Further advancing Beckman Coulter’s sepsis diagnostic capabilities last year was the FDA’s late January 510(k) clearance of the Access PCT assay, an in-vitro analytical test that measures the blood’s procalcitonin levels to determine critically ill patients’ risk of developing severe sepsis or septic shock.
The assay integrates procalcitonin testing into routine sepsis workups on core laboratory analyzers as a primary or reflex test programmed through Beckman Coulter’s Remisol Advance middleware, according to the company. Access PCT is available for use on the company’s Access family of immunoassay systems, including the Access 2, UniCel Dxl 600, and UniCel Dxl 800.
Sepsis was not the only diagnostic capability Danaher (through its various standalone businesses) augmented last year.
Higher demand for advanced staining consumables and pathology imaging products prompted Buffalo Grove, Ill.-based Leica Biosystems Inc. to enhance its Aperio product line throughout the year. Major developments included:
$6.56 Billion ($17.91B total) Prior Fiscal: $6.25 Billion Percentage Change: +4.95% No. of Employees: 60,000 (total)
Success is hardly ever attained easily.
It usually is hard fought, obtained through great sacrifice, risk, hard work, and failure (the latter being an “essential prerequisite” for achievement, according to researchers).
Success almost never arrives unescorted, either—it typically is ushered in by any number of attendants: determination, perseverance, faith, honesty, flexibility, loyalty, courage, etc.
Luck can play a part too, though many of the world’s most successful people scoff at such a suggestion. They believe there is a “science” to luck—i.e., that good fortune occurs not through serendipity but rather by invitation or permission.
“When you ask highly successful people for their best success story you almost never hear a tale of a step-by-step plan executed to perfection,” August Turak, one of MTV’s founding members, wrote in a Forbes column last fall. “Instead serendipity or what seems like just pure dumb luck always seems to play the starring role. I see that same serendipitous thread in my own life. But as contradictory as it may sound, I also believe there is a bit of ‘science’ to serendipity. In other words, being a lucky person is not just a function of being lucky. While luck can never be willed or forced, it can be ‘invited’ and ‘allowed’…”
Maybe. Or maybe not.
Maybe luck has nothing at all to do with success.
Thomas P. Joyce Jr. would likely support this theory as head of Danaher Corporation, a multinational science and technology conglomerate that claims to have developed a “proven system” for achieving success through continuous improvement, quality management, and accountability.
ANALYST INSIGHTS: After adding to its Life Sciences Business in the past year through the acquisition of GE’s Life Sciences Business Unit, expect Danaher to continue to “pour gas” in this segment of their business through both internal growth efforts and bolt-on M&A. It’s rare that Danaher stays silent on the sidelines and the next year will be no different.
—Dave Sheppard, Co-Founder and Managing Director, MedWorld Advisors
“Success at Danaher doesn’t happen by accident. We have a proven system for achieving it,” the company states on its website. “We call it the Danaher Business System (DBS), and it drives every aspect of our culture and performance.”
Danaher’s “proven” method for securing success dates back virtually to its mid-1980s founding. Faced with intense competition, the young company launched a process improvement effort based on Lean manufacturing principles (enhancing efficiency, effectiveness, and profitability).
As it grew, Danaher augmented its continuous improvement program with homegrown approaches to innovation, commercialization, and leadership development that involved all levels of management and were led directly by the company’s successive CEOs.
Today, more than three decades after its birth, the DBS continues to be the focus of Danaher’s long-term growth strategy. “The Danaher Business System remains the driving force in our pursuit of a better, stronger Danaher. DBS is our core—it’s who we are, and how we do what we do,” Joyce, Danaher’s president and CEO, said in the company’s 2019 annual report. “At the heart of DBS is kaizen, ‘continuous improvement.’ We challenge ourselves to be better every day, and the tools and processes of DBS are uniquely impactful in this endeavor. The team’s daily commitment to DBS and our Core Values is what differentiates us. DBS is our competitive advantage…”
Indeed, DBS has given Danaher quite an advantage over the years: Since its 1984 inception, the company has consistently beat the S&P 500 in total shareholder return (TSR). Its 35-year TSR is 100,000 percent, a 25-fold increase over the 4,000 percent TSR posted by the S&P 500 during that period, and Danaher’s TSR since 2015 is double that of the well-known stock index (144 percent). In addition, Danaher claims to stand alone among publicly traded companies in outperforming the S&P 500 in every five-year period since 1984.
No luck involved there.
The DBS advantage maintained its edge last year too, increasing sales, capital investment returns, and operating profit margins for both Danaher and many of its 24 member companies. Beckman Coulter Life Sciences and Cepheid, for example, each topped $1 billion in revenue last year (a first for both), and water quality analytics firm Hach surpassed a 20 percent return on invested capital.
“Since we acquired Beckman in 2011, the team has focused on implementing DBS Growth tools and processes to increase the cadence of innovation,” Joyce stated in the annual report. “These initiatives have been a key contributor to Beckman’s enhanced growth trajectory and market share gains—going from flat core revenue growth at the time of acquisition to mid-single digit or better core revenue growth each of the last five years. DBS…continued to be the primary driver of our strong performance in 2019.”
Luck took a back seat this time.
DBS proved to be quite the leadfoot in fiscal 2019, raising total sales 5.1 percent to $17.91 billion, expanding operating profit 7 percent to $3.26 billion, and boosting net earnings 13.5 percent to $3.01 billion. Net earnings per common share also improved, jumping 8.7 percent (basic) and 8.3 percent (diluted).
Danaher’s three business reporting segments hitched a ride on the DBS express last year to reach profitability: Environmental & Applied Solutions sales rose 1.8 percent to $4.39 billion, Diagnostics revenue swelled 4.9 percent to $6.56 billion, and Life Sciences proceeds jumped 7.4 percent to $6.95 billion. Segment operating profit improved as well, with Environmental & Applied Solutions posting a 6.4 percent increase and Life Sciences generating 13.9 percent growth.
Diagnostics operating profit rose 10 basis points, or 5.6 percent to $1.13 billion, due to higher core sales volumes, cost savings measures, service and marketing investments, and foreign currency exchange rates.
Serendipity be damned.
Any lucky break or “happy accident,” actually, was damned last year, as the DBS extended its influence into each Diagnostics product division. Acute care diagnostics sales growth, for instance, was fueled by strong demand for blood gas and immunoassay products in China, Japan, Western Europe, and North America.
Three of those four regions—China, Western Europe, and North America—helped drive core revenue growth last year in the pathology diagnostics business, though sales also benefited from increased demand for advanced staining and core histology products. The division fed that demand with the U.S. Food and Drug Administration (FDA) approval of the Aperio AT2 DX System, used for clinical diagnosis.
Marketed by Leica Biosystems, the Aperio AT2 System features clinical image management software for an integrated digital pathology workflow solution.
Leica Biosystems announced FDA approval of its Aperio AT2 System on the same day Cepheid revealed U.S. regulatory clearance of its Xpert CT/NG test for Chlamydia and Gonorrhea. Operating on Cepheid’s GeneXpert system, the assay enables same-day patient consultation and treatment of the two most common sexually transmitted bacterial infections in the United States. Xpert competes with Hologic’s Gen-Probe for market share.
“We are bringing to market a true next-generation molecular diagnostic product for detection of CT/NG—a test we designed from the ground up to provide accuracy, ease of use, and results availability,” Cepheid CEO John Bishop said in announcing the FDA clearance in late May 2019. “We expect this diagnostic test to deliver new levels of confidence to clinicians, in addition to enabling same-day decisions about treating their patients—the critical first step in effectively managing these epidemics.”
Cepheid’s Xpert product line underwent further diversification in early October 2019 with the FDA clearance of its BCR-ABL Ultra test for chronic myeloid leukemia (blood cell cancer). The in-vitro diagnostic, designed to be run on demand, delivers results from whole blood samples in less than three hours. The automated assay is Cepheid’s first FDA-cleared oncology application.
Cepheid’s regulatory clearances and its $1 billion sales club accession last year helped boost core revenue in Danaher’s molecular diagnostics business.
Clinical lab proceeds rose as well, driven by robust demand in China and North America for immunoassay, chemistry, and automation products; those gains, however, were partially offset by modest sales declines in Western Europe.
Danaher kept those losses to a minimum through a bevy of FDA clearances and product releases within the Beckman Coulter Diagnostics business. The new portfolio additions included:
Perhaps as a testament to its fiduciary forte, Danaher ended FY19 by completing the IPO (initial public offering) and spinoff of its Dental business into an independent, publicly traded company, Envista. Initially announced in July 2018, Envista closed its IPO in September 2019 at $677 million, including more than $88 million from underwriters. The spinout unites the Nobel Biocare, KaVo Kerr, and Ormco dental brands under Envista.
COVID-19 Consequences
Q1 2020 Revenue: $4.34 Billion Q1 2019 Revenue: $4.22 Billion Percentage Change: +2.8% (total)
Danaher Corporation has contributed to the coronavirus war effort through the supply of diagnostic tools, personal protection equipment (PPE), and a potential vaccine.
Cepheid’s Xpert Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative virus detection, received FDA emergency use authorization (EUA) on March 21—the first point-of-care assay to be awarded such designation. Designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems worldwide, the test boasts a 45-minute detection time.
The Sunnyvale, Calif.-based firm is now working to develop a single test to detect SARS-CoV-2, Flu A, Flu B, and RSV (respiratory syncytial virus) in time for the 2020-21 flu season. Cepheid plans to pursue the FDA’s EUA pathway for the four-in-one combination test, and is aiming for a detection time of 35 minutes. The assay will be designed for use on the company’s cartridge-based GeneXpert System, with instruments configured for either patient point-of-care or high-volume laboratory testing.
Beckman Coulter is developing assays to identify IgM (immunoglobulin M) and IgG (immunoglobulin G) antibodies to the coronavirus. The firm’s Access SARS-CoV-2 IgG antibody test won CE mark approval in mid-June and is currently commercially available in Europe. Beckman Coulter’s IgM and IgG serology assays are designed to determine whether a patient has developed an immune reaction to the coronavirus; such tests can help virologists and epidemiologists better understand individual immunity levels and health officials identify prospective vaccine candidates.
Leica Biosystems added to the COVID-19 diagnostics repository in early April with emergency regulatory clearance of its Aperio ImageScope DX Viewer for remote SARS-CoV-2 diagnosis. The product’s software enables pathologists to safely view images acquired through the Aperio AT2 DX Scanner and remotely diagnose cases. “This remote use capability will be transformative—and help alleviate the pressure that the emergence of the COVID-19 outbreak has put on healthcare facilities,” Melissa Aquino, Leica Biosystems president, said in announcing the clearance.
HemoCue, meanwhile, is repurposing scrapped pallets of plastic film originally used in microcuvette production to create head visors for front-line healthcare workers.
Finally, Pall Corporation—as part of a consortium led by the University of Oxford (England)—is scaling up the manufacturing of ChAdOx1, which has been fast-tracked as a leading COVID-19 vaccine candidate. A single dose of the investigational ChAdOx1 vaccine protected six rhesus macaques from pneumonia caused by the virus, National Institutes of Health scientists and University of Oxford collaborators reported in mid-May. ChAdOx1 has been used to develop investigational vaccines against several pathogens, including a closely related coronavirus that causes Middle East respiratory syndrome.
AT A GLANCE $9.10 Billion ($19.9B total) Prior Fiscal: $8.60 Billion Percentage Change: +5.81% No. of Employees: 71,000 (total)
Westslope cutthroats run big in the South Fork. So do bull trout, which can grow as large as 25 pounds from a steady diet of scuds, minnows, mayflies (depending on river currents), kokanee (a.k.a., sockeye) salmon, and, ironically enough, cutthroats.
Trout bite all year long in the South Fork. Big Sky biologists say the river contains 400 to 1,000 fish per mile, with cutthroats ranging from 12 to 18 inches and bulls averaging more than 20 inches (some can reportedly reach two and a half feet!). It’s not unusual to find larger-than-normal fish in this part of North America, as the cool, nutrient-rich water flow from mountain streams creates an ideal breeding ground for trout prey. These food factories are often so prolific that trout can get bigger simply by staying in one spot and feeding on their surroundings.
The 98-mile South Fork of western Montana’s majestic Flathead River begins deep within the Bob Marshall Wilderness Complex, a 1.53 million-acre tract of Congressionally-designated wild land flanking the Continental Divide. The South Fork begins at the junction of Danaher and Young’s creeks; fed by dozens of small tributaries, it runs for 45 miles due north before exiting The Bob near Spotted Bear Ranger Station.
South Fork is the site of the world’s highest morning glory spillway (water cascades 490 feet off the 66-year-old Hungry Horse Dam). It’s also the site of inspiration for Steven and Mitchell Rales’ entrepreneurial aspirations: During an early 1980s fishing trip on the river, the Bethesda, Md., brothers envisioned starting a new kind of manufacturing company—an entity committed to continuous improvement and customer satisfaction. Using their favorite fishing spot as a muse, the Rales decided their organization would operate much like the South Fork: continuously moving forward but able to quickly change flow.
The Rales’ new company began as a real estate investment trust but assumed its true mission after refocusing on manufacturing and adopting kaizen, the Japanese business philosophy of continuous improvement. In a nod to their muse, the brothers renamed the firm Danaher (quite appropriate, considering “dana” actually is an ancient Celtic word for “swift-flowing”).
Danaher spent its formative years as a group of individual manufacturing businesses. Over the past quarter century, however, the Rales have become renowned for their unique approach to business growth; the strategy involved buying other companies’ discards and subjecting them to the Danaher Business System (a set of lean manufacturing and continuous improvement principles) to raise their margins and capital returns. That method has worked rather well for the company in its evolution into a multi-billion-dollar conglomerate with operations in life sciences, diagnostics, dental, environmental services, and industrial tools.
“We have never strayed from the clarity of our intention or the inspiration of that swift-flowing river,” the company states in a brief autobiography on its home page. “We adapt quickly to the changing flow of business and the evolution of technology, but our guiding principles—continuous improvement and customer satisfaction—remain rock solid.”
Those guiding principles, though, have largely dictated Danaher’s ever-changing business flow throughout its lifetime. Case in point: The company entered the medtech industry in the early part of the millennium to offset saturation and low growth rates in its capital-intensive and cyclical industrial platform. Upon diversifying its healthcare offerings (through acquisition), Danaher spun off its industrial businesses into an independent, publicly-traded firm (Fortive) focusing on professional instrumentation, automation, sensing, and transportation technologies.
The Fortive spinoff turned Danaher into a predominantly healthcare-focused business with offerings in acute care, pathology diagnostics, life sciences instrumentation, and dental technology. The split also has created significant shareholder value for both companies—since the July 2016 breakup, Fortive and Danaher have provided total returns of nearly 70 percent and 61 percent, respectively, (through February this year).
Sales and profits have benefitted from the spinoff as well: Fortive’s 2018 revenue grew 12 percent to $6.45 billion, and profits swelled 3.1 percent to $1.17 billion. First-quarter sales this year jumped 6.7 percent, with core revenues rising 3.7 percent. Danaher’s finances experienced a similar boost, with fiscal 2018 sales climbing 8.5 percent to $19.89 billion and profits surging 13.8 percent to $3.4 billion, according to the company’s 2018 annual report. First-quarter 2019 sales rose 3.9 percent and gross profit advanced 2.8 percent to $2.71 billion.
The Rales brothers are hoping history repeats itself with the spinout of Danaher’s dental segment, announced last July. The dental unit has been a monetary millstone for the company in recent years due to inventory restocks and product manufacturing/distribution realignments. Dental segment revenue has barely moved since fiscal 2016, edging up only $59.1 million to $2.84 billion through Dec. 31, 2018. Operating profit, meanwhile, has nosedived, falling 4.4 percent in 2017 (to $400.7 million) and a staggering 13.5 percent last year to $346.7 million.
“The dental unit has been a sore spot for Danaher amid otherwise strong organic growth and profitability,” Bloomberg opinion columnist Brooke Sutherland wrote upon learning of the spinoff. “Talking about and trying to fix that business sucked up an increasing amount of executives’ time. And while there are signs that efforts to cut costs and invest in new growth initiatives at the dental unit are yielding results, the turnaround efforts had undoubtedly become a distraction and both companies should be better off as separate entities.”
Danaher executives agree. Commenting on the spinoff last summer, Danaher president/CEO Thomas Joyce Jr. predicted the move would cultivate more focused, savvy investments that eventually will boost long-term shareholder value for both companies.
ANALYST INSIGHTS: Danaher is a company very adept at portfolio management. Watch for them to continue that focus with incremental M&A activities. Don’t be surprised if it decides to either make a large opportunistic acquisition or divest one of its current businesses or both. It’s a rare year when Danaher stands still.
—Dave Sheppard, Co-Founder and Managing Advisor, MedWorld Advisors
“This is an important step towards realizing even greater potential for both Danaher and our Dental business,” Joyce said. “[The] announcement demonstrates our commitment to maximizing long-term value for all of our shareholders, customers, and associates. We believe that our Dental business can be more effective as a standalone company, with greater focus around both organic and inorganic investment opportunities.”
Danaher’s DentalCo (a new name is forthcoming) is expected to be completely free of its parent firm in the second half of 2019. The company will be tax free to shareholders and comprise the KaVo Kerr, Nobel Biocare, and Ormco businesses. It will employ 12,000 workers and be led by president/group executive Amir Aghdaei.
DentalCo’s diverse product offerings should help the firm succeed upon its independence. All three business divisions debuted new innovations last year, beginning with the winter premiere of KaVo Kerr’s flexible digital intraoral X-ray sensor (DEXIS FS Ergo), X Pro intraoral scanner, and Dex Voice.
Danaher branded the FS Ergo as a “new category” of intraoral sensors designed to improve patient comfort and diagnostic detail. The Dex Voice, unveiled at the 2018 Chicago Midwinter dental meeting, is built on the Amazon Echo/Alexa platform and fully integrates with the company’s Dexis software. Its smart speaker enables clinicians to deliver voice commands to Alexa to perform Dexis actions that normally would require keyboard or other manually entered commands.
Over the summer, KaVo Kerr introduced a handheld X-ray system (the NOMAD Pro 2), cross-cut carbide burrs, a titanium sensor featuring motion detection capabilities, and a composite system (SonicFill 3) designed to fill cavities in seconds. The SonicFill 3 SingleFill system contains a nanoscale zirconsil (zirconium oxide plus silica oxide) composite filler, which provides effective blending, wear resistance, strength, and reliability for lasting restorations, according to Danaher.
Nobel Biocare timed its only product launch for the summer as well, releasing to market a two-piece ceramic implant featuring a cement-free connection to support natural soft tissue appearance. Made of zirconia, the NobelPearl is designed to encourage excellent soft tissue attachment and minimize inflammation. The product is particularly useful in thin gingival biotype cases.
Ormco debuted the bulk of its new technologies last spring and fall, including a ceramic twin bracket system, a self-litigating bracket (with twice the rotational control and more space under the tie-wing than its predecessor), and a line of stainless-steel instruments (45 pliers, 12 cutters).
“We are building a better, stronger Danaher,” Joyce wrote in his annual shareholder letter last year. “With the Danaher Business System as our driving force, we strengthened our footholds in attractive, fast-growing markets and enhanced our competitive positions. We accelerated our core revenue growth rate, led primarily by the impact of new product innovation and sales and marketing initiatives. Financially and strategically, 2018 was an outstanding year.”
Indeed, it was—for Danaher’s non-dental business segments. Sales in the company’s Life Sciences, Diagnostics, and Environmental & Applied Solutions units posted solid gains, rising 13.3 percent, 7.1 percent, and 8.8 percent, respectively.
Diagnostics revenue, which totaled $6.25 billion, was fueled by strong growth in each product division. Molecular diagnostics, for example, experienced robust infectious disease commodity sales upon the outbreak of a severe flu season last winter as well as the additions of new assays to its portfolio. The unit’s Cepheid business won U.S. Food and Drug Administration (FDA) approval for rapid flu A/B, Strep A, and carbapenem non-susceptible bacteria tests, and CE IVD marking for Hepatitis B and Hepatitis C tests.
Acute Care Diagnostics profited from strong sales of blood gas and immunoassay products across most major geographies, while new innovations in advanced staining and core histology bolstered Pathology Diagnostics sales.
Clinical Lab Diagnostics proceeds rose on higher 2018 sales in China and stronger demand for immunoassay products. The business met that demand in part last year by commercializing solutions like Access Sensitive Estradiol, a test for measuring estradiol levels in blood (for diagnosing fertility, menstruation, or puberty problems).
The E2 (estradiol) test was just one of a number of products the Clinical Lab Diagnostics business marketed last year (through Danaher’s Beckman Coulter Diagnostics arm). Other commercialized innovations included:
In addition to commercialization efforts, Beckman Coulter secured CE mark approval for its Early Sepsis Indicator and DxH 520 Hematology analyzer. The Early Sepsis Indicator identifies patients who either have developed sepsis or are at risk of developing it. It is the first early sepsis warning test to be offered as part of a complete blood count with differential, according to the company.
The 520 Hematology analyzer is made to enhance doctor office laboratory efficiency and resource management through the automation of daily tasks. Using two aqueous-based cyanide-, azide- and formaldehyde-free reagents, the system reduces the amount of time spent on lab operations and frees up time for patient care.
Two months after receiving the CE mark for the 520 Hematology analyzer Beckman Coulter scored a double regulatory victory in June 2018 with back-to-back clearances in Canada and the United States for its high-sensitivity troponin (hsTnl) assay, Access hsTn1, a test for detecting troponin l—a protein present in circulation during myocardial infarction. The FDA cleared the assay for use on the Access 2, DxI, and the entire Access family of immunoassay systems.
$8.6 Billion ($18.3B total) NO. OF EMPLOYEES: 67,000 (total)
Hurricane Harvey, the 280 mile-diameter Category 4 August 2017 catastrophe that broke single storm rainfall records in the United States, was the strongest storm coastal Texas had seen in many years. A few unfortunate statistics from CNN about the behemoth: It dumped 26 inches of rain on the coastal cities of Beaumont and Port Arthur in 24 hours, caused $75 billion of estimated damage, and drove 30,000 people out of their homes to seek temporary shelter once the storm had petered out. Huge swaths of Houston—the fourth-largest U.S. city—were underwater following the storm, and many areas of the city were uninhabitable for weeks.
Leaving many Houstonians with nothing but the clothes on their backs, an organization called Operation BBQ Relief worked tirelessly to provide hot meals to those in need. And one of those helping the cause was Jon Hansel, a territory manager for Nobel Biocare, a business within globally diversified conglomerate Danaher Corporation that manufactures dental implants and personalized prosthetics.
Jon landed in Houston on Sept. 2, and immediately set up and started grilling over 800 pounds of North Carolina style BBQ. His pace increased as time went on, as Hansel cooked around 1,600-1,800 pounds of meat over 12 hours. His following week was spent feeding and assisting those in need.
“We’ve cooked everything we could and it was wonderful,” Jon said. Jon’s day job as a Nobel Biocare territory manager has nothing to do with cooking, but in his spare time, he’s a pit master for competition and charity.
“When you hand somebody a plate of food you see it in their eyes that this is something important to them,” he said.
ANALYST INSIGHTS: Watch for Danaher to surprise us with an M&A play in 2018/2019. While they have been aggressive with bolt-on acquisitions, it’s been a while since Danaher has executed on a larger portfolio play. This may be the year that happens.
—Dave Sheppard, Co-Founder and Principal, MedWorld Advisors
The multinational conglomerate already extensively contributes to public health through diagnostic and dental offerings, but it’s nice to see company representatives in the field offering a service that doesn’t contribute to revenue gains. Not that Danaher needed a gimmick to boost business—the firm earned $8.6 billion in 2017 diagnostics and dental sales, rising a respectable 10 percent over the previous year.
Danaher’s Diagnostics business, which makes up the majority of its medical device returns, achieved $5.8 billion in 2017 sales, rising a remarkable 16 percent over the previous year’s proceeds. The late 2016 acquisition of diagnostics firm Cepheid was an enormous driver for the impressive gains—in Cepheid’s first full year with Danaher, core revenue rose about 20 percent. Provoking this was a strong commercial execution and bolstered installed base of molecular diagnostics instrumentation.
In the clinical lab business, core sales rose over the previous year, prompted by increased demand for immunoassay products. These were partially offset by declines in the Western European and Japanese markets. The acute care diagnostic segment also flourished in 2017 as a result of strong global diagnostic consumable sales. Meanwhile, amplified global demand for advanced staining, core histology instruments, and related consumables stimulated revenue growth in the pathology diagnostics business.
Rather than marketing its product portfolios under the Danaher name, each separate business brands and markets its own products. Danaher’s Diagnostic business operates under four brands: Beckman Coulter Diagnostics (BEC Diagnostics), Leica Biosystems, Radiometer, and the recently acquired Cepheid.
Brea, Calif.-based BEC Diagnostics develops products to advance and optimize the clinical laboratory. The firm’s diagnostic offerings, scalable instruments, clinical data management tools, and process management solutions help healthcare professionals assess, diagnose and monitor conditions from cardiac disease to metabolic functions, blood disorders, infectious disease, cancer, and more.
Last June, as a result of a partnership with cGMP and ISO 13485 certified medical device manufacturer Diazyme Laboratories, the company achieved FDA clearance for a procalcitonin (PCT) assay to manage bacterial infections and sepsis. It is the first homogenous PCT assay for use on Beckman Coulter’s AU model chemistry analyzers and removes the need for costly dedicated instrumentation. The assay features a latex-enhanced immunoturbidimetric methodology, which uses multiple monoclonal antibodies for enhanced assay sensitivity and specificity.
A month later, BEC Diagnostics launched its DxOne information management solution, a cohesive and integrated system of products to improve workflow efficiency, provide insight into operations, and gain a more comprehensive understanding of laboratory performance. DxOne contains an automatic and electronic inventory manager, a command center to monitor multiple instruments, and insights for greater access to cloud-based analytics.
Last November, the firm’s high-sensitivity troponin (hsTnl) assay earned EU approval. The hsTnl assay helps diagnose myocardial infarction for patients experiencing chest pain or other ischemic systems by measuring cardiac troponin, a biomarker that aids in heart attack detection. The hsTnl assay can detect lower levels of troponin than previous tests, and allows clinicians better confidence in interpreting emergency room chest pain cases.
Last December, the FDA cleared the automated Access AMH (Anti-Müllerian Hormone) immunoassay for in-vitro diagnostic use. Access AMH is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of AMH levels, which help assess a woman’s ovarian reserve to guide clinical management of women struggling with fertility or those planning to become pregnant later in life.
Buffalo Grove, Ill.-based Leica Biosystems develops and supplies clinical diagnostics to the pathology market. Last March, Leica introduced RNAscope, a reagent for use with the BOND-III clinical instrument. Born out of the partnership between Leica and Advanced Cell Diagnostics, the automated technology detects RNA that fits into the existing anatomic pathology workflow.
Last September, Leica released the HistoCore Peloris Premium Tissue Processor, the world’s first tissue processor incorporating an easy-to-use solution for track and trace. An integrated bar code scanner and onboard reporting module associate samples with the correct processing program, reagent details, and user information, helping to eliminate manual records and increase specimen safety.
Brea, Calif.-based Radiometer is a developer of blood sampling, blood gas analysis, transcutaneous monitoring, and POC data management equipment. Last March, the company launched the ABL90 Flex Plus point-of-care blood analyzer, the latest in the ABL90 Flex family of analyzers. It can measure 17 parameters in 35 seconds using only 65 µL of blood and comes equipped with an automated intel to minimize manual processes.
The recently acquired Sunnyvale, Calif.-based molecular diagnostics firm Cepheid won FDA clearance for its Xpert Xpress Flu and Xpert Xpress Flu/RSV tests last February. Designed to deliver reference-quality molecular results to diagnose influenza and respiratory syncytial virus infection in 20 minutes, the tests are Cepheid’s first Xpress branded products, all of which produce results in a half hour or less. The new tests employ multiple targets for each virus and feature built-in redundancy to reduce the impact of seasonal genomic drift.
In collaboration with Rutgers New Jersey Medical School and FIND, last March Cepheid released the Xpert MTB/RIF Ultra test to diagnose tuberculosis (TB) and resistance to rifampicin, a critical first-line TB drug. In a World Health Organization (WHO) evaluation, the Ultra test showed better performance than Xpert MTB/RIF in detecting TB in difficult-to-diagnose and vulnerable populations, such as children and people living with HIV, and in those with extra-pulmonary TB. However, as a result of the test’s increased sensitivity, Ultra’s use also exhibited a higher rate of false positives. A WHO expert group then identified the need for further discussion on implementation challenges, which will explore the willingness to balance increased test sensitivity with decreased specificity in different settings.
Danaher’s Dental segment is comprised of the KaVo Kerr, Nobel Biocare, Ormco, and Implant Direct businesses. The Dental franchise’s 2017 revenue change was relatively flat compared to the previous year, rising a paltry 1 percent to $2.8 billion. Several high-growth markets like China and Russia were not able to compensate for lower demand in the United States and Western Europe. Specialty consumables—which consist of implant solutions and orthodontic products—demonstrated strong year-over-year growth.
The Dental business grew double digits in China core revenue for the fifth straight year, extending its position in 2017 by acquiring a digital lab service company that provides implant, orthodontic, and prosthetic treatment planning to Chinese dentists. The segment has also increased R&D spending as a percentage of sales by 100 basis points over the last two years to position it for growth.
The KaVo Kerr business was formed as a result of the October 2017 merger of KaVo (which develops dental instruments, imaging solutions, and dental treatment units) and Kerr Corporation (a developer of restorative, endodontic, and restorative dental products). Last February—prior to the merger—Kerr Endodontics launched OptiDam, a three-dimensional, low radiopacity rubber dam that helps dental professionals position the device more freely and is more comfortable to patients.
Last February, KaVo brought its Estetica treatment unit line—the KaVo Estetica E70/E80 Vision and KaVo Estetica E50 Life units—to the North American market. Both tout integrated functions that optimize dentists’ workflow with features like an integrated sanitation function to quickly clean suction hoses and lines. They also share ergonomic design, facilitating natural, intuitive movement to assist in keeping health posture while performing dental procedures.
Last August, KaVo introduced the Electromatic line of electric systems to help dentists more easily transition to electric handpieces without compromising performance. In combination with KaVo handpieces, KaVo electric systems provide stable control from 2-200,000 rpm, an intuitive user interface, and simple adjustment of speed on the control system display for a wide range of indications. A plug and play system also connects to standard air tubing and automatically adjusts to the air pressure of the existing dental unit.
A month later, KaVo released the entry-level 3D imaging system KaVo OP 3D. With programs for both panoramic and 3D imaging, general dental practitioners, craniofacial surgeons, and airway specialists can find use with OP 3D. The OP 3D also offers efficient tools for optimizing patient dose by allowing the clinician to select the best resolution, fields of view size, and region of interest.
Kloten, Switzerland-based Nobel Biocare manufactures dental implants and CAD/CAM-based individualized prosthetics. The company posted mid-single digit core revenue expansion that Danaher attributes to a 20 percent R&D spending increase, 25 new products launched, and a 15 percent increase in its sales force over the last two years.
Last March at the International Dental Show in Cologne, Germany, Nobel Biocare and KaVo Kerr unveiled the DTX Studio, a single digital platform connecting diagnostics and treatment for dental patients. The open system launched in fall 2017. DTX Studio connects to not only KaVo imaging devices, but also has the ability to import images from any X-ray device, intraoral scanner, or desktop scanner. The system’s diagnostics module features multiple workspaces, and the implant module facilitates visualization of critical information for precise implant planning according to the desired prosthetic outcome.
Last October at the Annual Scientific Meeting of the European Association for Osseointegration (EAO), Nobel Biocare launched the Trefoil system, which treats edentulous patients and patients with failing dentition, enabling the fixed, definitive, full-arch restoration of the mandible in one day. A passive fit is made possible with a fixation mechanism that compensates for deviation in implant placement, enabling shorter time-to-teeth and reduced chair time in comparison with conventional treatments that require provisional restorations.
Nobel Biocare also launched a new metal-free, two-piece ceramic implant solution at the EAO congress, in partnership with ceramic implant maker Dentalpoint AG. Dentalpoint AG is the developer of the first completely metal-free two-piece bone level implant system with internal connection that is not dependent on cement. Screw-retained with a metal-free screw, the two-piece nature of the system means clinicians can treat patients with a zirconia implant using protocols similar to those they are familiar with for traditional implants.
$7.8 Billion ($16.9B total) NUMBER OF EMPLOYEES: 62,000 (total)
One business leaves, and another enters.
Washington D.C.-based Danaher Corp. first broke the news that Fortive Corporation—a conglomerate of its Test & Measurement, Industrial Technologies, and Retail/Commercial Petroleum businesses—would be spun off in 2015. The separation was completed July 2, 2016, and Fortive commenced trading on the New York Stock Exchange three days later under the ticker “FTV.” With 20,000 employees worldwide, Fortive is comprised of two segments, Professional Instrumentation and Industrial Technologies, and is headquartered in Everett, Wash. The company enters the market in a strong position, with a sizeable share of the professional instrumentation, automation, and sensing and transportation technologies businesses. Fortive generated $6.2 billion in sales in 2015.
“This is an exciting day for Danaher. The successful spin-off of Fortive is an exceptional opportunity for both Danaher and Fortive to independently build greater shareholder value, to serve customers and to deliver on strategic priorities by investing in high-impact organic and inorganic growth opportunities,” Danaher President and CEO Thomas P. Joyce Jr. said in a company press release proclaiming the separation’s culmination.
About two months later, Danaher declared it would be purchasing global molecular diagnostics firm Cepheid for $4 billion—the latest in the company’s annual multi-billion dollar buys. (Danaher acquired its Beckman Coulter diagnostics business for $5.9 billion in 2011, dental implants firm Nobel Bioservices AG for $2.2 billion in 2014, and filtration, separation, and purification solutions company Pall Corporation for $13.8 billion in 2015.)
Cepheid added a suite of accurate and easy-to-use molecular systems and tests to Danaher’s Diagnostics business. Cepheid’s fully automated GeneXpert systems provide rapid genetic testing and results to manage infectious diseases, and the company touts a large global installed base of instruments and test menus for molecular diagnostics. Headquartered in Sunnyvale, Calif., Cepheid joins the Diagnostic segment’s Beckman Coulter, Leica Biosystems, and Radiometer businesses.
“We expect Cepheid to be an excellent complement to our existing Diagnostics businesses and to expand our runway for growth across the platform,” Joyce commented in a press release detailing the buy. “Cepheid’s extensive installed base, test menu, and innovative product offering contribute to its market leadership in molecular diagnostics and we expect it to strengthen our position in this high-growth segment. By applying the Danaher Business System and combining Cepheid with our existing $5 billion revenue position in the diagnostics industry, we believe that Cepheid will be well-positioned to improve operational efficiencies, significantly expand margins, and drive long-term growth. We look forward to welcoming the Cepheid team to Danaher.”
The acquisition closed on Nov. 4, 2016, establishing Cepheid as an indirect wholly owned subsidiary of Danaher’s Copper Merger Sub Inc. subsidiary.
ANALYST INSIGHTS: Danaher is a master at smart portfolio management. After building a large multi-industry conglomerate, the company spun off its industrial businesses last year to increase the focus on life sciences. Unlike some other companies, they won’t just “bolt-on” acquisitions; they will acquire to gain a presence in new categories. It makes them exciting to watch.
Danaher’s Diagnostics business became a separate business unit in 2016, previously part of the company’s Life Sciences & Diagnostics segment. [Editor’s note: The drop in medical device revenue from 2015’s $10.9 billion is not reflective of the fiscal 2016 (ended Dec. 31) performance due to the split—Danaher’s revenue as reported in last year’s top company report had previously included the Life Sciences segment.] Danaher as a whole performed quite admirably in 2016, achieving double-digit sales growth with $16.9 billion in total revenue.
The Diagnostics business—which offers analytical instruments, reagents, consumables, software, and services to diagnose disease and make treatment decisions—rose 4 percent in sales from the previous year to $5 billion. Heightened demand for immunoassay products stimulated the majority of this growth, combined with substantial consumable sales for acute care diagnostics in the Chinese, Western European, North American, and Japanese markets. Further expansion was prompted by increased North American and Chinese demand for staining consumables, as well as strong Chinese core histology equipment sales. Somewhat contributing to growth, in 2016 Danaher’s Radiometer business launched the TCM5 Flex, a transcutaneous monitor that measures ventilation for patients in critical condition.
The Cepheid acquisition was completed late in the year, so while it promises to invigorate Danaher’s molecular diagnostics sales and earnings in 2017, it did not make a major impact on 2016.
Danaher’s Dental business is a worldwide provider of a broad range of dental consumables, equipment, and services used to diagnose, treat, and prevent disease and ailments of the teeth, gums, and supporting bone, as well as to improve the aesthetics of the human smile. According to Danaher, its dental products are used in over 95 percent of dentist offices worldwide. The segment was basically flat from 2015 (increasing less than 2 percent) with revenues of $2.8 billion. This slight bump was provoked by strong Chinese and North American implant solutions demand, combined with solid Chinese and Russian orthodontics sales. China’s annual dental revenue has proven to be an incredibly productive area for the business—it has escalated tenfold since 2010, posting sales of $150 million.
Equality in the workplace is an important facet of company performance and culture. At the end of 2016, Danaher was awarded a perfect score of 100 percent on the 2017 Corporate Equality Index (CEI), a national report on LGBT workplace equality corporate policies and practices. The 2017 CEI evaluated 1,043 businesses in the report for LGBT-related policies and practices including non-discrimination workplace protections, domestic partner benefits, transgender-inclusive healthcare benefits, competency programs, and public engagement with the LGBT community.
“We are working hard to continuously improve our culture to ensure our associates are truly engaged, where they feel empowered to deliver results for the business, and where they are able to come to work every day as themselves,” said Ernest Adams, Danaher’s global diversity and inclusion leader. “The Human Rights Campaign’s recognition of Danaher as a Best Place to Work for LGBT Equality reflects our continued commitment to building diverse and inclusive communities around the world.”
$10.9 Billion NUMBER OF EMPLOYEES: 81,000 (total)
Danaher has a long history of growth through acquisitions. In fact, the company has made over 400 purchases since 1984 to enhance its offerings within its identified key focus business sectors. More recent buys that impacted its medical technologies footprint included Beckman Coulter Inc., a medical diagnostics manufacturer, for $5.87 billion in 2011, and Nobel Biocare Services AG, a then-leading provider of dental implants, for $2.2 billion in 2014. Both moves immediately positioned Danaher as a leader in these respective healthcare technology sectors.
Following in the footsteps of those acquisitions, Danaher made one of its largest purchases in 2015. In May, it was announced that the company had agreed to buy Pall Corporation, a global provider of filtration, separation, and purification solutions for an array of industries, including many to which Danaher was already providing products. The purchase price for Pall was $13.8 billion; the company saw revenues in 2014 of $2.8 billion—$1.5 billion from the life sciences segment and $1.3 billion from industrial. While the life sciences sector of Pall primarily sold into the biopharmaceutical market, it also supplied medical device manufacturers. Given Danaher’s strength in the diagnostics technologies sector, synergies between the two must have been apparent.
“Pall is a highly attractive business, with approximately 75 percent recurring revenues, mid-single digit organic growth, and a solid margin profile. Its best-in-class technology, combined with the broadest, most technically advanced solutions, make it the premier brand in the filtration industry,” Thomas P. Joyce Jr., Danaher’s president and CEO said in a press release that initially announced the acquisition. “Pall will provide us a leading business with significant runway for expansion and strengthens our life sciences position in the strategically attractive, high-growth biopharmaceutical market. With the Danaher Business System as a foundation, Pall associates will have the tools to accelerate new product development and improve operational efficiency in the years to come. We look forward to welcoming the Pall team to Danaher.”
In addition to the Pall purchase, Danaher acquired 11 other companies to further its capabilities across its five main business segments. In total, the company’s 2015 M&A activity significantly outpaced 2014’s moves (financially), which totaled more than $3 billion and 17 businesses, including Nobel Biocare. Company executives insist that its acquisition strategy will remain in place through 2016, but as of yet, there haven’t been any significant buys by Danaher since the Pall purchase. This may be due to the company’s strategy to split Danaher into two unique business entities—a science and technology focused growth company, and a diversified industrial firm.
Danaher and Fortive
In contrast to the consolidation trend among medical device OEMs that have firms growing rapidly while becoming a “one-stop-shop” to address a particular therapy application such as diabetes or orthopedics, this year’s Top 30 list features a number of examples of companies that are splitting into separate business entities. In several instances, where a company maintains dissimilar divisions that serve very different market segments, the company is going through a significant transformation to become two stand-alone entities. Danaher is yet another example of this trend.
In what must have been the biggest news cycle for the company in its history, on the same day the Pall acquisition announcement was made, Danaher also made it known that it would separate to become two independent, publicly traded firms.
Danaher would continue on to be the company name for the firm that executives described as “a science and technology growth company united by common business model characteristics, including significant recurring revenue and an attractive margin profile.” This entity would be made up of the Pall Corporation, along with the existing segments of life sciences and diagnostics, as well as dental. Rounding out this business would be the water quality and product identification platforms. The collective businesses posted approximately $16.5 billion in revenues in fiscal 2014.
The then-unnamed spin-off firm (since launched under the name Fortive) would be made up of Danaher’s industrial divisions, providing offerings that address needs in test and measurement, retail fueling, telematics, and automation. These business units saw revenues of approximately $6 billion in fiscal 2014.
“This is an exciting day for Danaher and an important step in our company’s history. Danaher has always been at its best when all platforms have the ability to invest in the highest impact organic growth opportunities, pursue meaningful acquisitions, and use the Danaher Business System to continuously improve performance,” Joyce said in the release that officially announced the split. “The pending strategic acquisition of Pall Corporation offers us the unique opportunity to drive greater shareholder value going forward as two stronger and better companies. Each company will be more focused with access to the capital necessary to pursue organic and inorganic growth opportunities. DBS will remain the foundation of both companies, allowing each to further strengthen their market leading positions while continuously improving growth, margins and cash flow.”
Leading Danaher will continue to be Joyce as president and CEO and Daniel L. Comas, executive vice president and chief financial officer. At the helm of Fortis is President and CEO James A. Lico, formerly the executive vice president of the Danaher Test & Measurement and Gilbarco Veeder-Root businesses.
“I am honored and humbled that the board has selected me to lead this new diversified industrial growth company,” Lico said in the announcement release. “As a standalone company, we will have the opportunity to pursue a more focused growth strategy with a renewed emphasis on M&A for many of these businesses. We have an outstanding team that will ensure this separation goes smoothly and that the company will continue to win in the markets in which we compete. I am committed to building and reinforcing the DBS culture and ensuring the company exceeds our customers, shareholders, and associates’ expectations.”
Figures
Regardless of the roller coaster ride that was 2015 for Danaher, with the start of a company split coupled with bringing a substantial acquisition into the fold (not to mention the incorporation of the other 11 company buys that were also brought aboard), numbers looked good for the business. Sales in 2015 (year ended Dec. 31) for medical device related businesses (life sciences & diagnostics, and dental) were $10.95 billion. This represented a 16.8 percent increase over 2014’s total for the same segments, which was $9.37 billion.
Broken out separately, the life sciences & diagnostics sector was credited with sales of $8.21 billion, a 14.3 percent increase over the $7.19 billion reported in 2014. According to Danaher, this business sector offers analytical instruments, reagents, consumables, software, and services that hospitals, physicians’ offices, reference laboratories, and other critical care settings use to diagnose disease and make treatment decisions. It also includes the filtration products and capabilities of the acquired Pall Corporation. Part of the increase in sales was attributed to price increases. Strong demand in China and other high-growth regions for urinalysis and immunoassay consumable products was another contributor. Another factor behind the increase was consumable sales to support an installed base of blood gas instruments, primarily in China and the Middle East.
The dental segment, which provides products used to diagnose, treat, and prevent disease and ailments of the teeth, gums, and supporting bone, as well as to improve the aesthetics of the human smile, saw even more dramatic growth. Sales in 2015 were $2.73 billion, a 25 percent increase over 2014’s $2.19 billion revenue. Again, a small portion of the increase can be attributed to price increases. The Nobel Biocare purchase in December 2014 had the greatest impact on sales, increasing the company’s overall dental line and providing new and complementary products and services.
$9.4 Billion ($19.9B total) NO. OF EMPLOYEES: 71,000 (total)
Conglomerate. noun. /kƏn’glämƏrƏt/ 1. a number of different things or parts that are put or grouped together to form a whole but remain distinct entities.
Washington, D.C., certainly isn’t a medical device hub. Aside from the lobbying that takes place in the city on the industry’s behalf and the laws enacted that impact how the sector does business, D.C.’s not a hotbed of medtech innovation. A block away from George Washington University Medical Center and roughly seven blocks from the White House in the heart of D.C.’s Foggy Bottom neighborhood, however, is headquartered Danaher Corp. You won’t find the Danaher name or logo on many, if any, life-science technology products, but you’ll find plenty of venerable company monikers familiar to life-sciences professionals under the Danaher corporate umbrella. Danaher is a true conglomerate, owning subsidiaries and their respective brands in the following five sectors: Test & Measurement, Dental, Industrial Technologies, Environmental, and Life Science & Diagnostics.
The company has made careful, solid acquisitions its business, from which—company officials, of course, hope—follows organic growth. In that respect, so far, so good.
The company’s Life Science & Diagnostics division had $7.19 billion in sales for fiscal 2014 (ended Dec. 31, 2014), up from $6.86 billion in 2013. Dental revenue was $2.19 billion, up slightly from $2.09 billion. Profit for Life Science & Diagnostics was $1.11 billion, up from $1.01 billion for fiscal 2013. Dental division earnings were $304.4 million, down slightly from $304.9 million. (For the purposes of MPO’s list of top companies, we include the 2014 performances of both the Life Science & Diagnostics and Dental sectors.)
Of the 5 percent growth recorded from fiscal 2013 to 2014 for the Life Science and Diagnostic sector, existing businesses grew 4.5 percent; acquisitions were responsible for 2 percent growth; and currency exchange rates slowed revenue growth by 1.5 percent. In the Dental sector, existing businesses accounted for 3 percent of the sector’s 4.5 percent year-over-year growth; acquisitions drove revenue gains 3 percent; and currency exchange rates hurt top-line expansion by 1.5 percent.
Sales for the Life Science & Diagnostic segment by geographic destination were: North America, 37 percent; Europe, 29 percent; Asia/Australia, 27 percent; and all other regions, 7 percent. In fiscal 2014, sales for the company’s Dental division holdings by geographic destination were: North America, 51 percent; Europe, 32 percent; Asia/Australia, 11 percent; and all other regions, 6 percent.
Company revenues across all divisions for fiscal 2014 increased 4 percent to $19.9 billion. Net earnings were $2.6 billion, or $3.63 per share on a diluted basis.
The company’s diagnostic businesses offer a range of analytical instruments, reagents, consumables, software and services that hospitals, physician offices, reference laboratories and other critical-care settings use to diagnose disease and make treatment decisions. Life-sciences businesses provide research and clinical tools that scientists use to study cells and cell components to understand the causes of disease, identify new therapies and test new drugs and vaccines. Danaher’s dental businesses focus on consumables, equipment and services that are used to diagnose, treat and prevent disease and ailments of the teeth, gums and supporting bone, and to improve smile aesthetics.
The Buys Have It
For 2014, acquisitions played a big part, as usual, in the story of Danaher’s life-science businesses. The company made two high-profile acquisitions toward the end of the year.
In October, Danaher’s Leica Biosystems, a manufacturer of anatomic pathology laboratory solutions and instruments, agreed to acquire Devicor Medical Products Inc., a maker of breast biopsy instruments and consumables, with annual revenues of approximately $170 million. Devicor, headquartered in Cincinnati, Ohio, has more than 550 employees and sells products in more than 50 countries around the world. Financial terms and conditions of the deal were not disclosed.
The acquisition of Devicor moves Leica Biosystems “further upstream in anatomical pathology to the biopsy, providing better sample control and delivering higher levels of diagnostic quality and confidence,” company officials said.
“Leica Biosystems’ products and solutions address the key steps across the anatomic pathology workflow. The addition of Devicor’s market leading breast biopsy products, especially Mammotome, allows us to further integrate that workflow from the source, starting with the patient and the biopsy sample,” said Matthias Weber, M.D., president of Nussloch, Germany-based Leica Biosystems. “This acquisition supports our mission of advancing cancer diagnostics to improve lives by adding products that will have direct benefits for the patients and the clinicians who care for them.”
Among Devicor’s products is the Original Mammotome Breast Biopsy System, which, to date, has enabled more than four million women to have a minimally invasive breast biopsy. Devicor’s product portfolio also includes the Mammotome revolve, the tether-less Mammotome elite, Neoprobe Gamma Detection System, Mammotome MammoTest stereotactic biopsy table, as well as a comprehensive portfolio of tissue markers used in breast disease diagnostic sampling and management.
Devicor now operates as a standalone business within Leica Biosystems and continues to be led by Tom Daulton, CEO of Devicor. “Our portfolio of products is highly complementary with Leica’s. We are excited about our future as part of Leica. Integrating the pathology workflow will open the door to further improve efficiency, diagnostic quality and patient outcomes,” said Daulton.
In September, Danaher Corp. agreed to acquire Nobel Biocare Holding AG for $2.2 billion. Nobel Biocare, a Swiss maker of dental implants, had been searching for a buyer amid the recent wave of consolidation in the medical technology industry. The deal was completed by December. Nobel Biocare became part of Danaher’s Dental segment. Henk van Duijnhoven, senior vice president of Danaher’s Dental segment, said at the time of the acquisition: “Nobel Biocare has a very strong track record as an innovator and leader in the attractive market for dental implant and prosthetic solutions. Bringing Nobel Biocare’s deep expertise in implant dentistry, digital prosthetics and software together with our extensive knowledge in 3-D imaging, intraoral scanning and digital restorative solutions will further enable us to optimize clinical workflows to the benefit of patients and dental practitioners. This combination will help us build a strong platform for future growth.”
Danaher paid 17.10 Swiss francs a share in cash, creating—according to Danaher officials—the world’s largest maker of premium dental implants. Danaher bought a business with sales that still hadn’t recovered from the recession and financial crisis that began in 2008. After peaking at 90.75 francs in 2007, Nobel Biocare traded below 20 francs for more than three years. As unemployment soared, people cut back on implants because they often aren’t covered by insurance.
Danaher officials said the firm’s annual sales from the dental industry will approach $3 billion after the purchase, giving it an “unmatched position” in dental implants as Nobel Biocare will expand the company’s presence in the premium segment of the market. The company expects the purchase of Nobel Biocare to return 10 percent on invested capital by 2019 and add 5 cents a share to earnings in 2015 and 10 cents a share the following year.
“Nobel Biocare’s broad reach and leadership position make it one of the strongest global brands in the dental industry today,” said Danaher’s president and CEO, Thomas P. Joyce Jr. “We believe that application of the Danaher Business System will provide Nobel Biocare with a unique opportunity to further accelerate growth, expand margins, strengthen its market presence and develop innovative solutions for dental patients and practitioners around the world.”
Danaher is likely to continue hunting for deals, Chief Financial Officer Daniel Comas said on a conference call, and the company has more than $8 billion for acquisitions.
Leadership Transition
Fiscal 2014 also was a period of leadership change for Danaher.
In September, Danaher’s board of directors appointed Joyce as president and CEO and a member of the board. Joyce’s predecessor, H. Lawrence Culp Jr., took on a senior advisory role. The transition had been announced in April and originally wasn’t slated to take place until 2015, but the move happened sooner than previously planned. Joyce began his career at Danaher in 1989 as a marketing project manager in the Danaher Tool Group. From 2006 until his CEO appointment, he was an executive vice president, with responsibility for more than $9 billion of annual revenues, including Danaher’s Life Sciences & Diagnostics and Water Quality businesses. He led the acquisition and integration of many of Danaher’s leading brands, including Beckman Coulter Inc., AB Sciex and ChemTreat.
During Culp’s tenure, Danaher’s revenues increased approximately five-fold to nearly $20 billion and its market capitalization grew to more than $50 billion. At the same time, shareholder returns have outpaced the S&P 500 Index by a factor of five, according to the company. Under his leadership, Danaher greatly expanded its global reach with particular emphasis in the high growth markets, increasing sales in these markets ten-fold to $5 billion. Culp began his career at Danaher in 1990 and served as president and CEO beginning in May 2001. He will serve as a senior advisor to Joyce, the board and the rest of the leadership team until March 2016.
Earlier in the year, in March, Danaher promoted Rainer Blair to vice president and group executive with responsibility for Danaher’s $2.5 billion Life Sciences platform, which includes AB Sciex, Leica Microsystems, Beckman Coulter Life Sciences and Molecular Devices. Blair served as the president of AB Sciex since February 2011. Jean-Paul Mangeolle was hired as president at AB Sciex in July 2014. Arnd Kaldowski was promoted to vice president and group executive with responsibility for Danaher’s $4.5 billion Diagnostics platform, which includes Beckman Coulter, Leica Biosystems and Radiometer. Kaldowski remains president, diagnostics, for Beckman Coulter.
$8.96 Billion ($19.1 B total) NO. OF EMPLOYEES: 66,000 (total)
High-tech entrepreneur and billionaire Elon Musk once equated the practice of forming a successful company to the science of baking.
“If you’re trying to create a company, it’s like baking a cake,” said the co-founder of PayPal, SpaceX and Tesla Motors, among others. “You have to have all the ingredients in the right proportion.”
To take the analogy one step further, to get the best results out, the best ingredients need to go in.
That’s a philosophy that seems to be driving Washington, D.C.-based Danaher Inc. The multi-billion-dollar, multinational firm is an amalgam of different companies, brand names and technologies serving varied industries—in just the right amounts it seems, following a secret corporate recipe for successful bottom-line growth.
The company breaks its focus areas into five primary sectors: Test & Measurement, Dental, Industrial Technologies, Life Sciences & Diagnostics, and Environmental. For the purposes of MPO’s list of top companies, we include the performance of the Life Science & Diagnostics and Dental sectors.
For the year, Danaher’s overall sales were $19.1 billion, up from $18.3 billion last year. The company’s Life Sciences & Diagnostics division reported sales of $6.86 billion, up from $6.49 billion in 2012, and the Dental unit grew marginally—$2.09 billion from $2.02 billion in fiscal 2012. Operating profit for Life Sciences & Diagnostics was $1.01 billion, up from $861 million. For dental, operating profit was $305 million, an increase from $293 million. Danaher’s overall operating profit was $3.3 billion, up from $3.2 billion.
The company’s life-sciences and diagnostics businesses accounted for 36 percent of revenue, while dental extracted dollars worth 11 percent of sales. Together, they represent nearly half of the company’s topline results for the year.
Growth Drivers In the Dental business, single-digit sales growth for fiscal 2013 primarily was the result of increased sales of professional dental consumables and implant products. On a year-over-year basis, sales of dental consumables were strong in North America, China and other high-growth markets, and contracted slightly in Western Europe. In addition, sales from existing businesses in the segment’s dental technologies businesses grew at a low-single digit rate on a year-over-year basis primarily as a result of increased demand for imaging products and treatment units. Geographically, increased sales in North America, China and certain other high-growth markets more than offset lower demand in Europe, Danaher officials reported. North America accounted for 51 percent of sales, while Europe was 32 percent, Asia/Australia 10 percent, and all other regions 7 percent. Operating profit margins increased 10 basis points during 2013 as compared to 2012. Market penetration for the firm’s dental products is strong. For example, Danaher’s KaVo-Kerr Group, which includes 17 brands and makes a wide range of instruments and dental consumables, serves 99 percent of dental practices in the United States.
On the diagnostics side, sales from existing businesses grew at a mid-single digit rate during 2013 thanks to increased demand in the clinical, acute care and pathology diagnostic sectors. The clinical diagnostics business experienced strong sales of consumables and automation hardware in such high-growth markets as China, which more than offset slightly negative year-over-year sales performance in North America and Europe. Sales growth in the acute-care diagnostic business primarily was the result of “continued robust global consumables sales” related to the business’ growing installed base of instrumentation, which is expected to continue to grow in 2014, as well as strong demand for compact blood gas analyzers and cardiac care instruments, officials predicted. The year-over-year sales growth in the pathology diagnostics business was driven by strong demand for advanced staining systems and consumables in North America, China and Japan and increased demand for core histology instruments and consumables in North America and China.
Sales from existing life-sciences businesses grew at a mid-single-digit rate during 2013 primarily to strong demand for new product introductions across the life-sciences businesses. Sales of the business’ broad range of mass spectrometers grew on a year-over-year basis as strong sales growth in the applied and clinical research markets and the pharmaceutical market were partially offset by sales declines in the academic research market. Geographically, year-over-year sales growth in the mass spectrometry business was strong in high-growth markets and in the second half of 2013 the business also experienced strong demand in Europe and Japan. The business’ confocal microscopy, flow cytometry and sample preparation product lines also contributed to year-over-year growth, officials reported, principally from demand in high-growth markets.
Overall, for the Life Sciences & Diagnostics business, North America accounted for 38 percent of sales in 2013, Europe was 29 percent, Asia/Australia brought in 27 percent, and all other regions were 6 percent.
Division News Worth Noting In December 2013, Leica Biosystems, one of Danaher’s diagnostic divisions, increased its ownership of Jung Feintechnik from 50 to 100 percent. Jung Feintechnik—based in Eisfeld, Germany—is a developer and manufacturer of sectioning products for the histology process. Terms of the deal were not disclosed.
In October of fiscal 2013, Danaher’s Brea, Calif.-based Beckman Coulter Life Sciences business received 510(k) clearance from the U.S. Food and Drug Administration and an Import Medical Device Registration Certificate from the China Food and Drug Administration for the in-vitro diagnostic use of the Navios flow cytometry system. In the United States, the Navios flow cytometer is intended for immunophenotyping (a technique used to study the protein expressed by cells) in conjunction with proprietary Navios tetra software and Cyto-Stat TetraChrome reagents.
The company’s AB-Sciex division, headquartered in Framingham, Mass., which makes analytical technologies, introduced the AB-Sciex API 3200MD and 3200MD QTrap LC/MS/MS systems, two devices that can be used to analyze trace levels of multiple compounds in human samples for diagnostic purposes.
“Clinical diagnostics is the new frontier for mass spectrometry,” said Rainer Blair, president of AB-Sciex. “The introduction of the 3200MD series is a major milestone for AB-Sciex itself in response to the demand in clinical settings for mass spectrometers as medical devices that meet regulatory requirements.”
It is the first in-vitro device for AB-Sciex and the first of a family of in-vitro diagnostic devices the company plans to roll out.
In 2013, a unit of Danaher’s Dental division—Implant Direct—recorded 18.8 percent overall sales growth compared to 2012. Growth for the company in North America was 25.8 percent. Danaher owns 75 percent of the Implant Direct, which competes with dental implant industry heavyweights such as Switzerland’s Straumann Group and Zimmer Dental Inc., a division of Warsaw, Ind.-based orthopedic company Zimmer Holdings Inc. Headquartered in Calabasas Hills, Implant Direct reported in November 2013 that the company’s founder and president, Gerald Niznick, DMD, planned to retire and would be succeeded by Tom Stratton, who joined the company in January 2013 as executive vice president of global sales and business development. Niznick’s career has spanned more than 32 years. He sold his first dental implant company for $100 million in 2000 to Sulzer Medica AG (which later was acquired by Zimmer).
$6.6 Billion ($16.1B total) NO. OF EMPLOYEES: 59,000 (total)
Washington, D.C.-based Danaher Corp. goes about its business quietly. Or perhaps that’s better phrased as businesses (plural). Chances are that people are more familiar with the brands that Danaher makes than they are with the parent company. Danaher’s diverse brands are broken down into five categories: Test & Measurement; Environmental; Life Sciences & Diagnostics; Dental; and Industrial Technologies.
In the medical device space, the company’s Dental and Life Sciences & Diagnostics divisions are of interest to the Medical Product Outsourcing (MPO) audience. Danaher’s Life Sciences and Diagnostics units provide technology for clinical histopathology laboratories, hospital central labs and point-of-care locations, as well as government, academic and pharmaceutical research laboratories. The Dental division provides devices for dental operatory, including dental consumables, digital imaging products, precision dental hand pieces, treatment units and diagnostic systems. On the medical device side, Danaher more likely is known for its varied product lines than its company moniker. Divisions include such brands as AB Sciex, Dexis, Gendex, Imaging Sciences International, Instrumentarium Dental, Invetech (a contract manufacturer with which MPO readers may be familiar), KaVo, Dessert, Kerr, Leica Microsystems, Ormco, Pelton & Crane, Radiometer, Soredex and SybronEndo.
For the 2011 fiscal year (ended Dec. 31) revenues for everything under the Danaher corporate umbrella were $16.1 billion compared to $12.6 billion in 2010, an increase of 28 percent. The significant increase was due in large part to the acquisition of diagnostic firm Beckman Coulter in early 2011 for $6.8 billion, which Danaher added to its Sciences & Diagnostics division. The deal was completed in June 2011. Overall net earnings were $1.9 billion, or $2.77 per share on a diluted basis, compared with net earnings of $1.7 billion, or $2.53 per share on a diluted basis for 2010. The company divested a number of non-life-science-related firms in 2011, which has been part of an ongoing corporate strategy to focus on existing operations or to acquire faster-growing, more profitable businesses that are less dependent on cyclical demand. A total of 13 companies across all product categories were acquired. Notably, research and development spending topped the $1 billion mark for the first time in Danaher’s history. For the company overall, emerging market revenues grew more than 12 percent in 2011 compared to 2010. The company also has doubled its low-cost region sourcing to nearly 30 percent from 2005 to 2011.
H. Lawrence Culp, Jr., president and CEO called 2011 a “tremendous” year for the company.
The Life Sciences & Diagnostics sector recorded $4.6 billion in sales, up from $2.3 billion in 2010. Operating profit was $402 million, a significant increase compared with $228 million for fiscal 2010. Acquisitions (the Beckman Coulter buyout) were responsible 91 percent of sales growth. Sales for this segment in 2011 by geographic destination were: Europe, 37 percent; North America, 31 percent; Asia/Australia, 27 percent; and other regions, 5 percent. Sales by geographic destination in 2012 are expected to differ from sales by geographic destination during 2011 as a result of the June 2011 acquisition of Beckman Coulter. More of the segment’s 2012 sales are anticipated to be in North America.
Sales from existing businesses in the segment’s acute care diagnostics business grew at a high single-digit rate during 2011 as a result of strong consumable sales related to the business’ installed base of acute care diagnostic instrumentation and new instrument placements, primarily in Europe, China and other Asian markets. Demand for the business’ compact blood gas analyzer also remained strong, particularly in emerging markets, the company reported. Increased European and emerging market demand for the business’ cardiac care instruments also contributed to growth. Sales from existing businesses in the pathology diagnostics business also grew at a high single-digit rate during 2011 due to increased demand for advanced staining instruments and consumables, as well as higher sales of core histology systems and consumables, primarily in North America and emerging markets, and to a lesser extent, Europe. The acquisition of Beckman Coulter significantly expanded the segment’s product portfolio in the area of clinical diagnostics through the addition of new and complementary product and service offerings. Sales from existing businesses in the segment’s microscopy business grew at a mid single-digit rate during 2011 due to demand for confocal and compound instrumentation serving the life-sciences research and industrial markets, particularly in China and other emerging markets. Strong demand for mass spectrometers serving both the academic and proteomic research markets as well as the applied markets resulted in a low double-digit growth rate from sales from existing businesses. Sales from existing businesses in the mass spectrometry business grew in all major geographies during 2011 led by strong performance in the Asia-Pacific region and North America. Company officials expect “significant cost synergies” by applying existing Danaher business models to Beckman Coulter and the combined purchasing power of the company and Beckman Coulter.
Danaher’s Dental division businesses took a $2 billion bite out of the market in terms of sales. That’s up compared to $1.8 billion in 2010. Total operating profit was $236 million, compared to $203 million for the previous fiscal year. Dental segment sales by location were: North America, 49 percent; Europe, 34 percent; Asia/Australia, 10 percent; and other regions, 7 percent. Price increases throughout the Dental segment contributed 1 percent to sales growth during 2011. Sales from existing businesses in the dental consumables business grew at a mid single-digit rate in 2011 driven primarily by increased demand for general dentistry consumables and orthodontic products and, to a lesser extent, infection control products, the company reported. Sales in the dental consumables business grew in all major geographies. Increased sales of imaging products were led by North America, and to lesser extent, the emerging markets, while instrument sales growth was driven largely by North America and Europe.
$4.1 Billion ($13.2B total) NO. OF EMPLOYEES: 46,600 (total)
After a challenging fiscal 2009, 2010 was a bit of a rebound for Danaher Corp. The manufacturer of everything from environmental testing equipment to dental tools has remade its portfolio in recent years through both acquisitions and asset sales to focus on faster-growing, more profitable businesses that are less dependent on cyclical demand.
Some of that strategy may have paid off last year. Revenues for 2010 (fiscal year ended Dec. 31) were $13.2 billion compared with $11.2 billion for 2009, an increase of 18 percent. Earnings were $1.8 billion, compared with $1.2 billion in fiscal 2009.
During the fourth quarter of 2010, the company changed the composition of its reportable segments to reflect changes in its internal organization. It now reports results in five separate business segments consisting of Test & Measurement; Environmental; Life Sciences & Diagnostics; Dental; and Industrial Technologies. Danaher previously reported its operations under four segments: Professional Instrumentation; Medical Technologies; Industrial Technologies; and Tools & Components.
Danaher’s Life Sciences and Diagnostics units provide technology for clinical histopathology laboratories, hospital central labs and point-of-care locations, as well as government, academic and pharmaceutical research laboratories. The Dental division provides devices for dental operatory, including dental consumables, digital imaging products, precision dental hand pieces, treatment units and diagnostic systems. On the medical device side, Danaher more likely is known for its varied product lines than its company moniker. Divisions include such brands as AB Sciex, Dexis, Gendex, Imaging Sciences International, Instrumentarium Dental, Invetech (a contract manufacturer with which Medical Product Outsourcing readers may be familiar), KaVo, Dessert, Kerr, Leica Microsystems, Ormco, Pelton & Crane, Radiometer, Soredex and SybronEndo.
The company’s Life Sciences & Diagnostics segment earned almost $2.3 billion for fiscal 2010, up sharply from nearly $1.5 billion in 2009, due in large part to the acquisitions of AB Sciex and Molecular Devices (announced in 2009 and completed in February 2010). The acquisitions were responsible for 46 percent of revenue growth. Without them, sales for the division grew 9 percent. Increased European demand for the business’ cardiac care instruments as well as continued strong consumable sales related to the business’ installed base of acute care diagnostic instrumentation also contributed to year-over-year sales growth, officials noted.
The company’s dental business earned $1.8 billion in fiscal 2010, up from approximately $1.7 billion. Life-sciences businesses profited the firm by $228 million, up from $180 million in fiscal 2009. Net earnings for the dental business dipped by 5.6 percent to $203 million from $215 million in 2009. Research and development spending for life sciences and diagnostics businesses was $193 million, up significantly from $117 in 2009. Dental R&D also rose to $73 million from $52 million.
Early in 2011, Danaher added a high-profile name to its portfolio of diagnostic brands housed under its Life Sciences & Diagnostics division and another company on this year’s Top 30 list: Beckman Coulter. The purchase price was $6.8 billion, with the deal completed in late June this year. The purchase raised Danher’s stock price to its highest level since the 1980s when the company was founded. Last year, Beckman hired investment firm Goldman Sachs to help with the possible sale of the company. Prior to that, Beckman Coulter had experienced a volatile year in which CEO Scott Garrett abruptly resigned following a product recall and troubles with the U.S. Food and Drug Administration.
For the immediate future, medical technology businesses will make up about 47 percent of Danaher’s sales after the acquisition, though CEO H. Lawrence Culp said that figure probably would drop to 40 percent over time.
“Beckman Coulter is an iconic company with a great brand, broad reach and technology leadership; well positioned in the markets it serves. Beckman provides an excellent complement to our existing Life Sciences & Diagnostics businesses,” said Culp. “Being part of Danaher, Beckman associates will have the opportunity to leverage the power of the Danaher Business System, including the processes by which Danaher accelerates growth through new product innovation and driving sales, marketing and service, as well as its strength in continuously expanding margins.”
Across all five business segments, company officials claim the firm launched more than 1,800 new products. Notably, in the diagnostics sector, the company’s Radiometer division launched the ABL90 FLEX blood gas analyzer targeting mid-volume point-of-care testing in clinical applications and the ABL80 FLEX designed for the emerging markets. Overall Danaher sales in emerging markets expanded by 20 percent in fiscal 2010.
The name Danaher comes from the ancient Celtic word “Dana,” which means “swift flowing.” It certainly seems as if the company has moved swiftly throughout 2010 and the beginning of 2011 to grow its presence in medical technology.
$3.1 Billion ($11.2B total) NO. OF EMPLOYEES: 46,600 (total)
There’s power in numbers, so the old saying goes. Part of Danaher’s success in the medical device areas has come not from one parent brand, but from a number of discrete divisions.
Danaher’s Life Sciences and Diagnostics units provide technology for clinical histopathology laboratories, hospital central labs and point-of-care locations, as well as government, academic and pharmaceutical research laboratories. The Dental division provides devices for dental operatory, including dental consumables, digital imaging products, precision dental hand pieces, treatment units and diagnostic systems. Divisions include such brands as AB Sciex, Dexis, Gendex, Imaging Sciences International, Instrumentarium Dental, Invetech (a contract manufacturer with which MPO readers may be familiar), KaVo, Dessert, Kerr, Leica Microsystems, Ormco, Pelton & Crane, Radiometer, Soredex and SybronEndo.
Unfortunately, no number of subsidiaries could keep the company completely protected from the past year’s economic downturn.
Overall, the company experienced a decline in revenue compared with fiscal 2008. For fiscal 2009 (ended Dec. 31), sales were $11.2 billion, compared with $12.7 billion the year before. Net profit also was down marginally to $1.2 billion from $1.3 billion. For medtech specifically, the company recorded sales of $3.1 billion (28 percent of the company’s overall revenue), down from approximately $3.3 billion for 2009. Despite the lower figures overall, operating profit for the company’s medical segment was up for fiscal 2009 to $396 million from $371 million, in part, according to company officials, due to a favorable ruling in a litigation settlement.
According to the firm, sales growth in acute care diagnostic and pathology diagnostic businesses was more than offset by sales declines in the life-sciences instrumentation and dental businesses. Price increases contributed 1 percent sales growth during the year. Ongoing restructuring activities are credited with keeping costs and material expenses down throughout the year. Increased sales of the company’s cardiac marking instrument also contributed to the year-over-year growth and are expected to further benefit sales in 2010. Sales for the firm’s dental businesses declined at a high single-digit rate.
Increased sales of orthodontia and infection control products during 2009 were offset by weaker demand for implants, endodontic products and general dentistry consumables. Lower capital spending by customers and inventory reductions in certain distribution channels drove year-over-year sales declines around 15 percent in the dental technologies businesses, according to the company. Danaher’s leadership expects that the acquisition of PaloDEx, a leading manufacturer of dental imaging products, in the fourth quarter of 2009, will provide additional sales growth for dental imaging business in 2010.
Across all divisions, the company spent nearly $2 billion on 18 acquisitions that were announced or closed in 2009, bringing in about $1.1 billion of new revenue. The largest transactions were in the firm’s life-sciences sector, with the acquisition of AB Sciex and MDS Analytical Technologies (for $450 million and $650 million in cash, respectively.)
Spending on medtech research and development dipped slightly for 2009 to $169 million from $190 million in 2008.
International sales helped the bottom line, with double-digit growth reported in China and the emerging economies of Latin America, officials said, while combined Europe and North America sales were flat. International sales made up 65 percent of the company’s medtech revenue.
“While 2009 was a year we hope not to see again any time soon,” said President and CEO Lawrence Culp, he said the company is off to an “encouraging start” in 2010. “We believe we are moving beyond stabilization to the early signs of growth, and with that the organic and inorganic investments we made throughout 2009 should position us well, as we strive to outperform again in 2010,” he said.
$3.3 Billion ($12.7B total) NO. OF EMPLOYEES: 50,300 (companywide)
As far as medical device companies go, Danaher seems to fly under the radar, better known perhaps by its brand names in the device space (companies such as DEXIS, Gendex, Imaging Sciences International, Invetech, KaVo, Leica Microsystems and SybronEndo) rather than recognized by the parent company’s moniker.
However, despite a global economic slowdown that accelerated through the second half of the year, the company’s bottom-line performance is anything but subtle. Danaher categorizes its sales according to four major business segments: Professional Instrumentation, which encompasses environmental and test and measurement products and services; Industrial Technologies, which accounts for products for motion and product identification; Tools and Components, which offers mechanical hand tools and products; and the Medical Technologies segment, which encompasses three key businesses: Dental Equipment and Consumables, Life Sciences, and Acute Care Diagnostics.
For fiscal 2008 (ended Dec. 31) the company’s overall revenue increased 15 percent to $12.7 billion, and adjusted earnings per share grew 10.5 percent. Net earnings for the year were $1.3 billion, down from $1.4 billion last year. Sales for the company’s medical products division (26 percent of the company’s total sales) grew to $3.3 billion, up from $3 billion last year—though sector profits were slightly off, down to $370 million from $393 million in fiscal 2007.
Sales growth for Medical Technologies primarily was driven by the segment’s acute care diagnostics, life sciences instrumentation and pathology diagnostics businesses, the company reported. Price increases accounted for approximately 1 percent of sales growth, which is reflected as a component of the sales from existing businesses. Company officials noted that fourth quarter 2008 restructuring activities adversely impacted operating profit margins for the division. In addition, a decline in demand for certain products in the dental technologies business, as well as increased sales force investment and research and development costs within the life-sciences business (R&D costs rose to $190 million in 2008 from $168 million in 2007), also adversely impacted year-over-year operating margin profit comparisons.
Revenues in the segment’s acute care diagnostics business grew at mid-single-digit rate in 2008 as compared to 2007. The year-over-year growth was primarily attributable to strong aftermarket consumables sales for the business-installed base of acute care diagnostic instrumentation, sales of the business’ compact version of its blood gas analysis instrument, as well as sales resulting from the launch of the business’ AQT cardiac marker during 2008.
The segment’s life science instrumentation business experienced high-single digit revenue growth in 2008 as compared to 2007. Continued strong sales of the business’ pathology diagnostics instrumentation and consumables offerings, as well as compound microscopy product offerings, drove the majority of this growth. All major geographic regions experienced growth. The acquisition of Surgipath Medical Industries in the fourth quarter of 2008 is expected to provide additional sales and earnings growth opportunities for the pathology diagnostics business. Surgipath, based in Richmond, Ill., is a provider of consumables and medical device accessories for clinical histology and research laboratories. Terms of the deal were not disclosed.
The company’s dental business revenue in 2008 was essentially flat as compared to 2007. Revenues in the dental technologies business grew at a mid-single digit rate through the first nine months of 2008 primarily driven by strong demand for imaging equipment.
However, a significant decline in demand in the fourth quarter for the majority of the products in the dental technologies’ business, including imaging equipment, more than offset this earlier growth resulting in low-single digit sales declines for the year, the company reported. Danaher officials attributed the decline in demand to customer decisions to cancel or delay capital spending, as well as inventory reductions in certain distribution channels. Offsetting the 2008 sales declines in the dental technologies business was low-single digit growth in the dental consumables business. Sales growth in the dental consumables’ businesses was primarily due to strong sales of general dentistry consumables and increased demand for endodontic and infection control products, offset by lower demand in the orthodontia product line.
Sales growth was experienced in all major geographic regions during the year. Particularly strong growth in emerging markets during the first nine months of the year moderated during the fourth quarter as a result of currency exchange rate volatility and economic uncertainty. Overall, a breakdown of annual sales were as follows: Europe, 41 percent; North America, 39 percent; Asia/Australia, 15 percent; and other regions, 5 percent.
Despite sales growth, Danaher officials did report some restructuring in the form of layoffs and work force reductions. The company, did not, however, detail which of its subsidiaries would be affected—though the Medical Technologies business incurred approximately $26 million in restructuring charges for the year. In the fourth quarter of 2008, restructuring activities resulted in net work force reductions of approximately 1,800 associates and 13 facility closures, the majority of which were completed as of Dec. 31. According to the company, remaining work force reductions and facility closure activities associated with the fourth quarter’s restructuring activities to be completed during 2009 “are not significant.”
“We have taken significant steps to prepare our businesses for what we believe will be a difficult year ahead. However, despite the current economic backdrop, we believe we are well positioned for 2009,” said H. Lawrence Culp Jr., president and CEO.
“$3 Billion ($11B total)
Steven M. Rales, Chairman H. Lawrence Culp, Jr., President and CEO Daniel L. Comas, Exec. VP and CFO Jonathan P. Graham, Sr. VP—General Counsel Frances B. L. Zee, VP—Regulatory Affairs/Quality Assurance Daniel A. Raskas, VP—Corp. Development
50,000
Washington, DC
As an industrial company immersed in diverse markets, Danaher’s name is rooted in the Celtic word “Dana,” a term dating from before 700 BC that means “swift flowing.” Thus, it is fitting that the manufacturer was formed in the 1980s during a fishing trip on a river in western Montana bearing its namesake. In accordance with its concept of flow, Danaher has branded itself as a business focused on continuous improvement and customer satisfaction. And as a result, it has evolved in a multibillion-dollar, global enterprise in a relatively short period, operating more than 200 manufacturing facilities in more than 20 countries (with sales within more than 125 countries).
The proof of success is most evident in net sales figures, which totaled $11 billion for 2007. This amount marks 16.5% growth from nearly $9.5 billion recorded in 2006 and 40% growth compared with nearly $7.9 billion reported in 2005. Furthermore, free cash flow exceeded $1.5 billion and net earnings for 2007 were $1.2 billion.
Danaher categorizes its sales according to four major business segments, including Professional Instrumentation, which encompasses environmental and test and measurement products and services; Industrial Technologies, which accounts for products for motion and product identification; Tools and Components, which offers mechanical hand tools and products; and Medical Technologies, which consists of businesses that offer products and services to dentists, other doctors, hospitals and research professionals in the life sciences sector.
The latter segment, Medical Technologies, was a newer entrant into Danaher’s portfolio after the company acquired Kaltenback & Voigt GmbH & Co. KG (KaVo), the Gendex business of Dentsply International Inc. and Radiometer A/S in 2004. The company has continued to strengthen this division’s offerings through the acquisitions of Leica Microsystems in 2005 and Sybron Dental Specialties and Vision Systems Ltd. in 2006. Medical Technologies serves three main markets: dental products ($1.7 billion), acute care diagnostics ($400 million) and life sciences ($900 million). Total net sales for this segment in 2007 were $2.998 billion, a 35% increase from 2006 annual sales and 154% growth from 2005.
In just a few short years, Medical Technologies clearly has become a strong contributor to overall sales, given that Professional Instrumentation, Industrial Technologies, and Tools and Components reported 2007 sales of $3.5 billion, $3.2 billion and $1.3 billion, respectively, and Medical Technologies’ sales contributed 27% of the company’s total revenues in 2007.
More than half of Danaher’s total sales come from outside the United States, and this applies to the Medical Technologies segment as well. Last year, 37% of sales came from North America, 41% from Europe, 14% from Asia and other regions accounted for the remaining portion.
Looking specifically at some of the businesses within the Medical Technologies segment, much of the growth for the overall segment came from a mid-teens increase for Leica Microsystems, driven by microscopy demand. Leica, whose operations are in Europe, Australia, Asia and the United States, is a provider of high-precision optical instruments and other products for life-sciences and medical applications such as laboratory and surgical microscopes as well as diagnostics products. Australia-based Vision Systems Ltd., a manufacturer of automated instruments, antibodies and biochemical reagents used for cancer and other disease detection, was integrated with Leica Microsystems after it was acquired, forming Leica Biosystems. Vision’s revenue grew about 30% in 2007, compared with when it was a standalone company in 2006.
Dental core revenues grew at a mid-single-digit rate, with increased sales volumes coming from restorative and orthodontia products, as well as instrument and treatment products. Within the dental portfolio are products made by KaVo, a manufacturer of digital dental imaging products, precision dental hand pieces, treatment units and diagnostic systems; and Sybron Dental Specialties, a provider of dental consumables and small equipment for the professional dental market. Some of the brands under the dental umbrella include Gendex, Dexis, Pelton & Crane, Ormco, Kerr and Imaging Sciences International.
Finally, Radiometer’s core sales increased at a high-single-digit rate as a result of strong instrument placements globally. Radiometer is a provider of diagnostic equipment such as blood gas analyzers, with manufacturing facilities in North America and Europe. Growth for Radiometer was fueled by increased sales of diagnostic instruments in Europe (particularly Russia) and, to a lesser extent, sales in North American and Asia-Pacific markets.
Danaher’s first quarter of 2008, ended March 28, showed total revenues of $3.03 billion, 20% higher than the $2.52 billion reported for the same period in 2007. Medical Technologies revenues totaled $758 million, an 11% increase from $684 million in the first quarter of 2007.”
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