Rank: #6 (Last year: #8) $20.18 Billion
Prior Fiscal: $19.37 Billion
Percentage Change: +4.2%
R&D Expenditure: $1.2B
Best FY24 Quarter: Q4 $5.4B
Latest Quarter: Q2 $5.3B
No. of Employees: 74,000
Global Headquarters: Franklin Lakes, N.J.

Throughout medtech, companies are carefully assessing their product lines and clinical focus areas. They are separating from certain segments due to sagging sales, low growth potential, misalignment with core competencies, or another reason. At the same time, organizations are seeking to bolster product portfolios and enhance customer offerings to become a source for comprehensive solutions in specific technology and therapeutic spaces. To achieve this, they are making acquisitions of other companies (or pieces of them). Industry-wide, this practice has been prevalent for some time.

To this end, BD announced in 2021 it would spin out its diabetes business to stand alone. The organization would later be named Embecta, and it would become independent at the start of April 2022. Since then, the revenues for the new diabetes company stabilized with growth flat between 2023 and 2024. Time will tell if the business performs better once it truly gets settled and underway as an independent firm.

Recently, BD announced it was trying the strategy once more. This time, the separation would involve its Biosciences and Diagnostic Solutions Business. The decision was the result of a comprehensive business portfolio evaluation launched by the organization in early 2024. The intended goal of the move was twofold: first, to present BD as a focused medtech leader aligned to address essential needs and higher-growth trends in healthcare, and second, to create a leading firm offering life science tools and diagnostics.

“Our BD 2025 strategy has transformed the company into a faster-growing, more profitable organization positioned at the forefront of long-term growth trends in healthcare, and we believe today’s announcement is an exciting next step in unlocking significant potential value for all our stakeholders,” said Tom Polen, chairman, CEO, and president of BD. “We believe the separation will position New BD as a differentiated medtech leader and enable optimized investment to accelerate our innovation pipeline and ongoing margin enhancement through BD Excellence to further fund growth. We believe Biosciences and Diagnostic Solutions is expected to deliver substantial value as a pure-play leader in life sciences and will be well-positioned to execute on its unique and compelling solutions and growth opportunities. This transaction is designed to position both businesses to thrive in our respective sectors and deliver value for shareholders.”

For New BD, that vision materializes with the establishment of four operating segments:

•  Medical Essentials will be home to Medication Delivery Solutions and Specimen Management businesses, which manufacture tens of billions of devices each year and represent the backbone of healthcare delivery. BD will retain the latter business from its life sciences unit and not include it as part of the Biosciences and Diagnostic Solutions separation.
•  Medication Management Solutions and Advanced Patient Monitoring businesses—producing millions of smart devices that use automation, artificial intelligence, and analytics to improve the efficiency and effectiveness of patient care—would form Connected Care.
• Pharmaceutical Systems would be rebranded as BioPharma Systems to increase focus on the business unit responsible for developing and manufacturing biologic drug delivery solutions for the pharmaceutical industry.
• Interventional becomes the new name for Urology & Critical Care, Peripheral Intervention, and Surgery businesses, which advance the treatment of high-burden chronic conditions such as urinary incontinence, peripheral vascular disease, cancer, and hernias.

Meanwhile, the Biosciences and Diagnostic Solutions business was expected to post revenue of approximately $3.4 billion for its 2024 fiscal year (at the time of the separation announcement) in a market that could serve a more than $22 billion addressable market, growing at mid- to high-single-digits. Biosciences is a leader in immunology and cancer research solutions and related clinical diagnostics, including flow cytometry instruments and reagents, and has innovative single-cell multiomics tools. Diagnostic Solutions is a leader in microbiology and infectious disease diagnostics, including molecular diagnostics, cervical cancer screening, microbiology automation, and point-of-care offerings.

Another option for the business could be a sale to a current BD competitor or having it broken up to be sold as parts to private equity. An April 2025 report from Financial Times quoted “people familiar with the matter” as stating the organization was “engaging rivals including Thermo Fisher Scientific and Danaher.” The same parties also told Financial Times “it was possible sponsors could collaborate with a strategic buyer to break up the unit into several parts or form a consortium to buy the whole unit.” If sold, the business could be worth as much as $21.5 billion in market value, according to the report. One way or the other, it seems BD will undoubtedly split from the business and has stated it expects the transaction to be completed during its 2026 fiscal year.

Prior to announcing its second significant separation from a business unit this decade, BD made headlines for beefing up a different business. In June 2024, BD and Edwards Lifesciences revealed an agreement that would see the former acquire the latter’s Critical Care Product Group for $4.2 billion in cash. According to BD, the unit is a high-growth, innovative industry leader in advanced patient monitoring with AI algorithms serving millions of patients globally. Critical Care invented the hemodynamic monitoring category, and its solutions are currently used in more than 10,000 hospitals globally to better understand the cardiovascular condition in real-time for critically ill patients.

ANALYST INSIGHTS: To focus more on its medtech portfolio, BD is spinning off its Biosciences & Diagnostic Solutions division in 2026. The question becomes, “Can their new focus allow them to become a power player in medtech for years to come (organically and inorganically)?

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

“Critical Care expands BD’s portfolio of smart connected care solutions with its growing set of leading monitoring technologies, advanced AI-enabled clinical decision tools, and robust innovation pipeline that complement BD’s existing technologies serving operating rooms and intensive care units,” said Polen. “We believe the combination unlocks multiple new avenues for growth and value creation through BD’s broad global footprint, increased penetration across new and existing hospital customers, new innovation opportunities across data sets and platforms, and application of the BD Excellence operating system.”

At the time of the deal’s closing, which took place at the start of September, Katie Szyman was named worldwide president of BD Advanced Patient Monitoring, the new name for the segment. Szyman had served as corporate vice president of the business under Edwards since 2015.

While the deal’s closing was late in BD’s latest fiscal, Advanced Patient Monitoring was still able to make an appearance in the company’s annual reporting. It added $74 million to the company’s total of $20.18 billion. Undoubtedly, next year’s figure will be significantly more substantial.

The division’s sister units within the Medical Segment—BD’s largest revenue generator, accounting for approximately 50% of the firm’s total sales tally—carried the load to reach $10.07 billion for the year. That represented a 6% gain.

Among the three other divisions, Medication Delivery Solutions saw a modest 3.2% rise to finish at $4.43 billion. Leading the segment in percentage growth was Medication Management Solutions at 10.7%. That translated to $3.30 billion in total revenue for the fiscal year. At an increase of 2%, Pharmaceutical Systems contributed $2.27 billion to the company’s coffers.

The much-discussed Life Sciences Segment posted a $5.19 billion revenue haul, which represented a 1.1% gain. Integrated Diagnostic Solutions offered the lion’s share of that total with its $3.68 billion, a 1.5% expansion over the previous fiscal. The soon-to-be-jettisoned Biosciences unit was relatively flat, sharing its $1.51 billion with BD’s bottom line.

Just behind Life Sciences in terms of revenue, the Interventional Segment grew by 5.1% to fall just short of $5 billion for the fiscal year ($4.98 billion). Peripheral Intervention led with $1.93 billion, increasing by 3.7%. Urology and Critical Care ballooned by 13.1% to end with $1.55 billion in sales. Relatively flat, Surgery put $1.49 billion into the company bucket.

In addition to the larger strategic moves to reshape its company, BD was also active with organic initiatives involving the expansion of its product portfolio and offerings.

At the end of November 2023, BD launched an advanced ultrasound system designed to help improve clinician efficiency when placing peripherally inserted central catheters (PICCs), central venous catheters, IV lines, and other vascular access devices. The SiteRite 9 Ultrasound System is an all-in-one system designed with a user-friendly experience on an updated 15.6-inch touchscreen with enhanced image quality that provides catheter placement tools and technologies to support clinicians during the vascular access device insertion process. The system includes integrated visualization tools such as the Cue Needle Tracking System to provide nurses with continuous and real-time needle tracking, and the Sherlock 3CG+ Tip Confirmation System to ensure proper catheter tip navigation and location.

A week later, the company received 510(k) clearances from the U.S. FDA for a novel blood collection device. The BD MiniDraw Capillary Blood Collection System is less invasive than a traditional venous blood draw by using capillary blood collected from a patient’s finger by a trained healthcare worker, without the need for a phlebotomist to collect blood from a vein. The innovative design provides a sample that produces lab-quality blood test results from a fraction of the volume of traditional venous collections. It is less invasive than traditional venous blood collection methods and more convenient for the patient by expanding access to blood collection to new locations, including retail pharmacies. The device may provide a better patient experience and has the potential to transform diagnostic testing.

In April 2024, the BD FACSDiscover S8 Cell Sorters enjoyed a global commercial release. The systems feature BD CellView Image Technology and BD SpectralFX Technology, bringing to market breakthrough innovations in real-time imaging and spectral flow cytometry. The three- and four-laser additions to the BD FACSDiscover S8 Cell Sorter family complement the five-laser instrument launched the previous year.

A month later, BD enabled women in the U.S. to be able to collect their own cervical cancer screening sample through the FDA’s approval of its Onclarity HPV Assay. The agency’s okay was obtained for the use of self-collected vaginal specimens for human papillomavirus (HPV) testing when cervical specimens cannot otherwise be obtained. The approval of self-collected samples opened the door to a less invasive testing option, and it improved access to testing for individuals who face barriers to cervical cancer screening.

A single-cell research tool to help scientists better understand how the molecular machinery within a cell functions and how it regulates changes in a cell that can lead to cancer and other diseases was launched in June. The BD Rhapsody Single Cell ATAC-Seq (assay for transposase-accessible chromatin using next-generation sequencing) Assay enables scientists to perform single-cell analysis of the epigenome—the set of chemical marks, or epigenetic changes, on the DNA in a single cell that holds critical clues about mechanisms of disease. Adding an epigenomic layer-view plays a crucial role in helping researchers track and understand how environmental factors impact the DNA and corresponding cell function, ultimately aiding in the development of effective therapies.

A couple of weeks before the close of the 2024 fiscal (end of September), BD released the Neopak XtraFlow Glass Prefillable Syringe. The Neopak Glass Prefillable Syringe platform is designed to address key development needs for biologic drugs. BD customers have received approval to utilize the platform for more than 24 indications, including Crohn’s disease, atopic dermatitis, cardiovascular disease, and various rare diseases. This addition to the platform featured an eight-millimeter needle length and thinner wall cannula to optimize subcutaneous delivery of higher viscosity drug profiles by reducing the injection force and time required for a fixed solution viscosity.

In addition to the reshuffling of businesses, both previously and upcoming, BD reported several leadership changes as well. A number of senior executive positions had new faces taking on leading roles.

Executive vice president and president of BD’s Life Sciences segment, Dave Hickey, announced his retirement, effective July 1, 2024. He had served in the position since January 2021 and had been with the organization in other leadership roles since 2014.

Succeeding him almost two months after Hickey’s retirement was Michael Feld, who still holds the position. Feld left the Danaher spin-off, Veralto, where he was serving as president of Hach, a global leader in water quality products. Prior to that, he held several senior roles at Danaher, including senior vice president and general manager of Cepheid Europe, and president of several other Danaher businesses, including Mammotome, XOS, and Dover Motion.

Also during the fiscal year, Bridget Bagnato was named president of BD Specimen Management. She joined BD Integrated Diagnostic Solutions in July as vice president and general manager (VP/GM) of Specimen Management from the BD Surgery business. While at the company, Bagnato has had a variety of roles, including VP/GM for the Injection business in Diabetes Care, and senior business director for the Vascular Care platform in Medication Delivery Solutions.

Later, Nikos Pavlidis was announced as president of BD Diagnostic Solutions. He had been serving as acting president of Diagnostic Solutions since November 2023. Pavlidis previously served in roles including VP/GM for the Diagnostics business group and various global and regional marketing leadership roles for BD during his 25 years with the firm.

On April 1, 2024, Rian Seger took over as president of the BD Surgery business unit. He had been serving as VP/GM of the Medication Delivery Solutions business unit within the Medical Segment. Seger has been with BD for more than 18 years, joining the company through the Bard acquisition, and has held a variety of roles within BD Surgery before the latest move.

Six weeks later, Rima Alameddine was named worldwide president of the BD Peripheral Intervention business unit. She moved over from Urology and Critical Care, where she served as worldwide president since October 2021. Alameddine joined BD in 2015 as VP/GM for C. R. Bard in Latin America, and in 2019, was appointed VP/GM for the Oncology platform within BD Peripheral Intervention. Prior to BD, she spent 11 years at GE Healthcare in various leadership positions, including chief marketing officer for Latin America.

On Aug. 1, Patrick Jeukenne became worldwide president of the BD Pharmaceutical Systems business unit. He rejoins the company from Aptar Pharma where he was vice president of Strategy, Business Development, and Marketing, along with leading drug and patient services. Jeukenne previously spent 13 years at BD where he made significant contributions through successive roles in sales management, commercial development for new injection technologies, innovation project management, integration of the SSI acquisition, and led the Safety Devices platform as a member of the Pharmaceutical Systems leadership team.

In personnel news not involving a new president, Ronald Silverman, M.D., FACS, was named executive vice president and chief medical officer of BD, effective Dec. 4, 2023. In that role, he becomes responsible for leading the company’s Medical Affairs organization, which includes end-to-end medical affairs across BD’s business units, regions, and central team. Dr. Silverman replaced Dr. William Sigmund, who had the title since January 2018 and announced his intent to retire from the company in June 2023. Dr. Silverman came from 3M Health Care, where he had served as senior vice president and chief medical officer since 2021.

$19.37 Billion
Prior Fiscal: $18.34 Billion
Percentage Change: +6.6%
R&D Expenditure: $1.2B
Best FY23 Quarter: Q4 $5.2B
Latest Quarter: Q1 $4.6B
No. of Employees: 51,000

In recent years, BD has been quite active with tuck-in acquisitions. Its latest M&A activity involved Parata Systems, Medkeeper, Cytognos, and Venclose. While none of them generated the headlines the purchase of C.R. Bard did back in 2017, they were all deals intended to enhance the overall offering BD put forward to healthcare professionals.

Alongside those transactions, BD continued to evaluate its business to determine if all of its units aligned with its financial goals. The best example of this self-reflection was its decision to spin-out its diabetes division, named embecta following the split, believing the unit would fare better standing on its own. The move enabled BD to remain focused on what it envisioned as higher growth areas.

In fiscal 2023, the firm continued its internal evaluation, but M&A was conspicuously quiet following what had been regular annual acquisition activity. Perhaps executives wanted to take the time off from buying firms to inorganically grow its portfolio in anticipation of its large move in Q3 2024. The firm announced it was purchasing Edwards Lifesciences’ Critical Care product group for $4.2 billion.

The aforementioned self-reflection during the ’23 fiscal materialized in the form of the sale of its Surgical Instrumentation platform to STERIS for $540 million. The company explained the sale as aligning with its BD 2025 strategy as an example of the “Simplify” pillar. The BD 2025 plan focuses on three pillars of Grow, Simplify, and Empower with the goal of increasing value for shareholders.

The Surgical Instrumentation unit included three dedicated manufacturing sites and a portfolio of 20,000 SKUs. The company noted the cash proceeds would be used toward “a continued durable growth profile.” Undoubtedly, the Edwards buy was already on the radar for BD executives.

“The Surgical Instrumentation platform has a 120-year legacy of providing reliable and trusted high-quality products, and STERIS is well positioned to maximize the value of this extensive portfolio and is fortunate to be adding such a dedicated and talented team to its organization,” said Rick Byrd, president of the Interventional segment at BD. “This transaction further advances the BD Interventional segment’s focus on high-growth end markets. We look forward to continuing to address unmet needs in healthcare through a highly differentiated and innovative set of solutions and products.”

The deal was closed, as anticipated, during BD’s 2023 fiscal (August). It was the firm’s only transaction involving the sale or acquisition of a business during the 12-month period. That said, the firm was hardly quiet in its continued development of products to further grow its business via organic means.

Just after the start of the 2023 year (three months following the start of its 2023 fiscal), BD announced along with its partner, CerTest Biotec, that they had gained Emergency Use Authorization (EUA) from the U.S. FDA for a PCR assay for Mpox (i.e., monkeypox) virus detection. The VIASURE Monkeypox Virus Real Time PCR Reagents were made available for BD MAX System users. The BD MAX System is a fully integrated, automated platform that performs nucleic acid extraction and real-time PCR providing results for up to 24 samples across multiple syndromes in less than three hours.

Just days later, the organization launched the BD Kiestra 3rd Generation Total Lab Automation System. This technology allows laboratories to create a custom and flexible total lab automation configuration to connect multiple BD Kiestra modules and is scalable to meet labs’ unique and evolving needs. With multiple track options and choice of instruments to employ, labs can choose their automation entry point and configure the system to fit their individual workflow and physical lab space.

At the start of February, BD introduced the Rhapsody HT Xpress System, a single-cell analyzer. The product enables scientists to isolate, barcode, and analyze single cells at a high sample throughput—up to eight times more cells than prior versions of the firm’s analyzers. The system ensures no sample loss and gives scientists the flexibility to analyze multiple samples and different cell sizes and types, such as stem cells or cancer cells, at the same time, to obtain more insights in less time.

BD gained another EUA from the U.S. FDA—this time for its SARS-CoV-2, Influenza A + B, and RSV combination test. The test, developed for the BD MAX Molecular Diagnostic System, uses a single nasal or nasopharyngeal swab sample to identify and distinguish if a patient has COVID-19, the flu, RSV, or some combination of the three. Results are available in as short a time as two hours. The diagnostic helps eliminate the need for multiple tests or doctor visits and can help clinicians implement the right treatment plan quickly.

On Aug. 1, BD announced it had gotten the official U.S. FDA nod for the combination test via a 510(k) clearance. While the firm was able to market the test since it gained the EUA, it still needed to secure regulatory clearance to ensure the test could remain on the market following the end of the EUA period.

Still in February, the Onclarity HPV Assay gained U.S. FDA approval for use with the BD SurePath Liquid-based Pap Test and Hologic ThinPrep Pap Test. The vials for these tests are the two most common Pap vials used by labs in the U.S., according to BD. Inclusion of the Hologic test improves access to the BD human papillomavirus virus (HPV) assay, which is the only FDA-approved assay that tests for an extended set of HPV types individually, and particularly for HPV31—a specific type of HPV that poses a high-risk for causing cervical cancer.

With March came U.S. FDA clearance for a high-throughput diagnostic test for infectious vaginitis. The Vaginal Panel was developed for use with the BD COR System to detect multiple common types of vaginitis using only one swab for one test. It is the first PCR assay to use a single swab for the detection of multiple organisms.

In April, the organization rolled out an advanced ultrasound device developed to help ensure optimal IV placement. The BD Prevue II System features the BD Cue Needle Tracking System, offering a high-quality ultrasound image of the needle trajectory, and is compatible with BD Cue Needle Tracking-enabled catheters. Simulated studies demonstrate pairing a needle-tracking system with ultrasound guidance may help reduce the number of attempts and time to successful vessel access.

The U.S. FDA cleared BD’s Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) imaging application in May, which uses artificial intelligence (AI) to interpret bacterial growth and release negative specimens with minimal human interaction. The application can evaluate single specimens or group together a large volume of plates with non-significant growth for batch review and release of negative results.

That same month, BD launched its cell sorting instrument featuring two breakthrough technologies that enable researchers to uncover more detailed information about cells previously invisible in traditional flow cytometry experiments. The CellView Image Technology allows researchers to see detailed microscopic images of individual cells and sort at high speeds based on visual characteristics to confirm insights in real-time. With the BD SpectralFX Technology, researchers can achieve full-spectrum cell sorting, coupled with expanded performance enabled by a new modular optical architecture and system-aware algorithms, to perform high-parameter experiments within a simplified workflow.

Seeking to automate clinical flow cytometry, BD launched its FACSDuet Premium Sample Preparation System in June. The technology automates the sample preparation process for both in-vitro diagnostics and user-defined tests—including cocktailing, washing, and centrifuging—and then automatically transfers samples to the physically integrated BD FACSLyric Clinical Flow Cytometry System without human interaction.

The next month, the U.S. FDA granted a clearance to BD’s updated Alaris Infusion System. The clearance covered updated hardware features for the point-of-care unit, large-volume pumps, syringe pumps, patient-controlled analgesia pumps, respiratory monitoring, and auto-identification modules. It also covered a BD Alaris Infusion System software version with enhanced cybersecurity, along with interoperability features that enable smart, connected care with the most widely used electronic medical record systems.

The Alaris system was involved in a Class I recall in 2020 due to multiple system errors, software errors, and use errors.

“The 510(k) clearance of the updated BD Alaris Infusion System has been the number one priority for our teams who have been steadfast in their efforts to achieve this milestone, consistent with our commitment to quality,” said Tom Polen, chairman, CEO, and president of BD. “We are deeply committed to ensuring clinicians can continue to rely on our market-leading system to meet today’s most critical infusion needs. The features and enhancements incorporated into the updated BD Alaris Infusion System and subject to this clearance reinforce our advancements in smart, connected care, which deliver greater benefit to clinicians and patients and help improve healthcare system efficiency through better care coordination and utilization of actionable information.”

Perhaps related to its cybersecurity issues involving the Alaris system, BD began publishing a Cybersecurity Annual Report near the close of 2020. In January 2023, the organization offered its third annual report, which highlighted the challenge of cybersecurity within healthcare and the company’s commitment to transparency and collaboration.

“In healthcare, cybersecurity is about protecting patient safety and privacy, while also securing systems and data,” said Rob Suárez, chief information security officer of BD. “Patients receive medical care at some of the most critical and vulnerable moments in their lives. They trust the safeguards put in place to protect them. Upholding strong cybersecurity measures and continuing to advance cybersecurity is part of honoring that trust.”

In addition to the new products BD announced during the 2023 fiscal, it also shared a pair of partnerships it was a part of to help further technologies within its portfolio. The first such arrangement involved Biocorp, a medical device and delivery systems manufacturer based in France. To support biopharmaceutical companies in their efforts to improve the adherence and outcomes of injectable drugs, the two companies will integrate Biocorp’s Injay technology—a solution designed to capture and transmit injection events using Near Field Communication (NFC) technology—to the BD UltraSafe Plus Passive Needle Guard used with prefillable syringes. Biocorp’s Injay is a simple and cost-effective connected solution designed to monitor the use of pre-fillable syringes in clinical studies or routine care. Through NFC technology and specific sensors to identify the product, it can confirm a complete injection and easily transfer that information to a smartphone.

The second partnership involved Magnolia Medical Technologies Inc. in a co-exclusive commercial agreement aimed at helping U.S. hospitals reduce blood culture contamination to help improve testing accuracy and ultimately improve clinical outcomes. Under the agreement, BD and Magnolia Medical will both co-sell and co-market Magnolia Medical’s Steripath and Steripath Micro Initial Specimen Diversion Device platforms, complementing the BD specimen collection portfolio, including BD Vacutainer push button and BD Vacutainer UltraTouch blood collection sets. According to BD, Steripath is the only FDA 510(k)-cleared device platform specifically indicated to reduce blood culture contamination for sepsis testing accuracy. The Steripath Initial Specimen Diversion Devices divert and sequester the initial 1.5 to 2 mL of potentially contaminated blood from the sample and then collect blood for blood cultures.

In a different type of arrangement not specific to any BD product, the company partnered with Odense University Hospital, the Health Innovation Centre of Southern Denmark, Danish Technological Institute, and GMAF Circular Medico/EcoFitt. The collaboration involved a pilot program at the Odense University Hospital in Odense, Denmark. The goal was to evaluate the feasibility of recycling used blood collection tubes to reduce medical waste as part of the participants’ sustainability goals and Denmark’s Climate Action Strategy. The initiative modeled a circular economy, which reduces material use; redesigns materials, products, and services to be less resource intensive; and recaptures waste as a resource to manufacture new materials and products.

To help facilitate all of this, BD announced the opening of two new facilities—one dedicated to medication management manufacturing and the other to R&D. The Tijuana, Mexico, location involved a $38.6 million investment; it was the organization’s 12th manufacturing plant in the country. The site produces devices and technologies that help improve medication safety within healthcare settings. Opened in November 2022, the 15,775-square-meter facility was expected to add 500 new jobs over the following two years.

The second location—a €4 million R&D center in Dublin, Ireland—is a 10,600-sq.-ft. purpose-built R&D facility in Blackrock. It was designed to house 35 high-tech workers and complement BD’s R&D facility in Limerick, which employs more than 300 people. The location was intended to focus on the commercialization of BD’s first on-body injector device, known as the BD Evolve On-Body Injector.

At the grand opening ceremony, company officials also announced a €30 million investment to expand its existing manufacturing facility in Enniscorthy, Ireland, which was expected to create approximately 85 new jobs. The 40,000-sq.-ft. expansion would house operations to manufacture a new medical technology from BD’s Peripheral Intervention business unit.

In addition to changes at facility locations, the firm also shared news regarding two members of its executive team. Just days after the start of the 2023 fiscal period, it was revealed Eric Borin was named president of Medication Delivery Solutions (MDS) for BD. He succeeded Rick Byrd, who was promoted to EVP and president of the Interventional segment at the organization. Previously, Borin had been president of the Pharmaceutical Systems business since 2020. That role was then filled by Laura Boros in June 2023. Boros had previously served as senior vice president of global nutrition at Reckitt—a leader in hygiene, health, and nutrition brands. She also spent time with Procter & Gamble, Novartis, and GlaxoSmithKline.

All of these moves were conducted, of course, to bolster BD’s bottom line and maintain a growth trajectory moving forward. After experiencing a 1.4% dip in 2022’s fiscal year due primarily to the decrease in demand for COVID-19 diagnostics, BD enjoyed a nice bounce back in 2023 to finish the 12-month period at $19.37 billion. That was a 2.7% increase for the firm. While COVID-19 diagnostic demand continued to decline during the period, it was outweighed by strong sales among other products and units.

One such business was the Medical segment, which tallied $9.5 billion—a 7.5% gain. While Medication Delivery Solutions was relatively flat (just a 0.3% decline to end at $4.29 billion), the other two Medical units enjoyed double-digit increases. Medication Management Solutions rocketed 17.6% to finish just shy of $3.0 billion in revenue. Pharmaceutical Systems expanded 11.4% to contribute $2.23 billion to the company’s coffers.

Elsewhere, the Life Sciences segment saw a substantial shrinkage in revenue, dropping 7.8% to finish at $5.13 billion. As mentioned, the loss in COVID-19 diagnostic testing products continued to cause Integrated Diagnostic Solutions to tumble—this fiscal, by 13.4 %. That translated to a take of $3.62 billion for the unit. Unfortunately, Biosciences’ 9.4% gain couldn’t offset the loss, although it did provide $1.51 billion to the revenue total.

BD’s Interventional segment experienced mid-single-digit bumps for all three units that make it up. Overall, its 6.1% rise was reflected in a $4.74 billion revenue contribution. The Surgery unit flourished by 6.9% to post $1.5 billion in revenue. Peripheral Intervention rose 6%, reporting $1.87 billion from sales. Finally, Urology and Critical Care notched a 5.3% gain, finishing the fiscal with $1.37 billion.

$18.87 Billion
Prior Fiscal: $19.13 Billion
Percentage Change: -1.36%
R&D Expenditure: $1.25B
Best FY22 Quarter: Q2 $5.01B
Latest Quarter: Q2 $4.8B
No. of Employees: 77,000

The 140-acre wooded parcel at 41 degrees, 1 minute north latitude and 74 degrees, 12 minutes west longitude might look considerably different today if not for a chance encounter more than a century ago.

Its meticulously manicured lawns and shrubs might not exist, nor might the uniquely-shaped concrete structures that blend seamlessly with the land. There may not be two site walls rising from the vast lawn, or horizontal natural stone layers that call to mind the layered earth.

The camouflaged cafe, bank, dry cleaner, and loading dock might be in jeopardy, too.

Or, maybe not. Maybe nothing would be different at all.

In any case, the chance encounter that transformed the once-empty lot in Franklin Lakes, N.J., into an environmentally conscious self-sustainable community occurred 127 years ago between medical supply entrepreneur Maxwell Becton and paper salesman Fairleigh S. Dickinson.

Both men, according to unofficial historical accounts, were on extended sales trips—Becton for the company he co-founded just a few  years prior, and Dickinson for the Saugerties, N.Y.-based Baker Paper Company—when they crossed paths in a Texarkana, Texas, train station one bright sunny morning in 1896.

As the story goes, Becton, a naturally congenial man, adjusted the blinds in the station’s dining area to help Dickinson read the morning newspaper. Dickinson responded in kind by inviting Becton to join him for breakfast, and the pair quickly bonded over their commonalities: namely, their North Carolina origins and birthday (Aug. 22). In that moment, a lifelong friendship formed.

While traveling together to San Francisco, Dickinson became impressed with the portable nature of Becton’s medical supplies. He wanted to be part of his new friend’s company but Becton’s partner at the time opposed the idea.

So Becton bought out his partner and teamed with Dickinson, opening Becton, Dickinson and Co. in September 1897. The pair split the initial $8,000 investment.

ANALYST INSIGHTS: Another company facing difficult year-over-year comparables due to a slowdown in its post- COVID diagnostics business, BD is continuing its BD 2025 strategy of “Grow, Simplify and Empower.” A recent example is the sale of its surgical instrument line to Steris, which was simply a part of its portfolio, while allowing BD to focus on higher growth market segments.

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

“One might say they were destined to meet and partner,” Richard Kushnier, project manager, Communication Services, at Becton Dickinson and former informal company historian, told northjersey.com last fall. “As individuals, they may not have succeeded to the degree they did.”

Together, they succeeded to a degree neither one could have ever imagined.

Becton, Dickinson and Co.—now known simply as BD—has grown from a scrappy startup seller of glass syringes ($2.50 each) into a global medtech behemoth, manufacturing a cornucopia of medical supplies, devices, lab equipment, and diagnostics used by healthcare institutions, physicians, life science researchers, clinical laboratories, the pharmaceutical industry, and the general public. Its solutions improve medication management and patient safety, bolster infection prevention, equip surgical and interventional procedures, improve drug delivery, aid anesthesiology care, enhance infectious disease and cancer diagnoses, and advance cellular research and applications.

Such product/service diversification has prompted several address changes over the years: from third-floor office space in Manhattan to an East Rutherford manufacturing facility, and finally, the sprawling 140-acre corporate headquarters campus in North Jersey where BD conceives the products and solutions that have turned it into one of the world’s most profitable medtech companies.

“In fiscal year 2022, we built on our strong track record of execution, accelerated our shift into higher-growth and more impactful areas of healthcare, and simplified the company to focus on the products that matter most to customers and patients,” BD chairman/CEO/president Tom Polen said in the company’s latest annual report. “We exceeded our revenue, margin expansion, and earnings per share expectations…”

A commendable achievement, certainly, but many of those better-than-expected results still fell short of BD’s FY21 performance. Total fiscal 2022 revenue sank 1.36% to $18.87 billion, net income descended 14.9% to $1.77 billion, and basic earnings per share tumbled 14.3% to $5.93 amid the confluence of headwinds spawned by inflation, constrained logistics, geopolitical events (Russia-Ukraine war), transportation delays, foreign currency translation, and a skilled labor shortage.

FY22 wasn’t a total washout, though. Operating income was up 1.4% to $2.3 billion, gross profit margin increased to 45.1% (from 42.3%), and revenue improved in two of the company’s three business segments.

“We delivered consistent performance and durably strengthened our growth profile. Our FY22 results are on track with our long-range targets to deliver 5.5 plus top line and double-digit EPS growth with operating margin improvement back toward our pre-pandemic level,” Polen told analysts during a Q4/full-year conference call last fall. “Our execution in FY22 is a testament to our growth mindset at BD, where we firmly believe there’s nothing we can’t do, only things we haven’t done yet. And by navigating successfully the challenging macro environment, we are distinguishing BD and supporting our ability to consistently deliver strong performance.”

That strong (yet somewhat muted) performance was possible through solid growth in two of BD’s three business segments. The Medical segment was the clear frontrunner, increasing fiscal 2022 sales 5.7% to $8.8 billion on strong demand for catheters and vascular care products. Such desire was particularly driven by competitive gains for peripherally inserted intravenous catheter and flush products.

Also contributing to the Medical segment’s overall growth was robust gains in each of its three reporting units. Pharmaceutical Systems led the pack with a 9.5% revenue increase (to $2 billion), followed by Medication Delivery Solutions, which expanded sales 5.1% to $4.3 billion, and Medication Management Solutions, which boosted proceeds 4.2% to $2.53 billion.

Driving growth in the Pharmaceutical Systems unit in FY22 was high demand for BD’s pre-fillable solutions for biologic drugs and vaccines. Near the end of its fiscal year (Sept. 30, 2022), BD launched a next-generation glass pre-fillable syringe (PFS), Effivax. The syringe’s design enhancements are focused on fill/finish and container reliability to help the company’s biopharmaceutical customers meet stringent demands of vaccine manufacturing. Effivax reduces the risk of line stoppage and improves total cost of ownership, manufacturing capacity, and supply availability.

The Medication Management Solutions unit benefitted from strong growth in global placements of dispensing systems and BD’s $1.52 billion deal for Parata Systems last June. The Durham, N.C.-based firm provides medication adherence packaging technology and perpetual inventory management via its automation technology and software that enables pharmacists to focus more on clinical work and patient interactions.

BD also bolstered its Medical Management Solutions offerings last summer with the $93 million acquisition of MedKeeper from pharmaceutical giant Grifols, which bought the Colorado firm in 2020. MedKeeper added cloud-based pharmacy management applications to BD’s portfolio for supporting the preparation of compounded medications.

“Our revenue performance continues to be supported by our durable core portfolio,” executive vice president/CFO Christopher DelOrefice told analysts last fall, “and an increasing contribution from the transformative solutions we are bringing to the market through our innovation pipeline and tuck-in acquisitions.”

Two such transactions occurred within a week’s time during BD’s first fiscal quarter: the deal for catheter therapy developer Venclose Inc. on Dec. 2, 2021, and British surgical tech provider Tissuemed Ltd. a week later.

The Venclose acquisition provided BD with a new market for its venous therapy portfolio, enabling the company to offer treatment for chronic venous insufficiency, a malfunctioning valve disease that can cause varicose veins. Venclose’s technology—the compact Venclose System—provides two heating length sizes (2.5 cm and 10 cm) in one 6 Fr-sized catheter. It has 30% more heating length than the longest leading competitive radiofrequency ablation catheter, allowing physicians to skillfully ablate more vein during each heating cycle and reduce the total number of required in-vein ablations. The dual heating length also enables physicians to ablate both long and short vein segments with the same catheter, thus reducing inventory management compared to catheters with shorter and/or static heating length sizes. In addition, the system features a touchscreen display to deliver real-time procedure data and offers audible tones for thermal delivery.

The Tissuemed purchase also opened up a new market for BD—specifically, an international audience that may be unfamiliar with the company’s surgical innovations. BD intends to blend its own innovations with the acquired firm’s technology to create new surgical sealant solutions.

Overall, Tissuemed produces flexible, self-adhesive surgical sealant films. Its flagship product, TissuePatch, bonds to internal tissue to prevent surgical incisions from leaking and control internal bleeding. TissuePatch is designed to be used alongside sutures and surgical staples to minimize post-op leakages.

“This advanced sealant serves as a strategic complement to the BD products used in the operating room today—providing us with the opportunity to equip surgeons with a more robust, highly-integrated portfolio of surgical solutions,” said Kevin Kelly, BD’s president of Surgery. “Integrating Tissuepatch into our business aligns with our commitment to continuously innovate in our core portfolio to help support minimally invasive surgeries.”

Though both the Tissuemed and Venclose purchases expanded BD’s interventional solutions portfolio, only the latter really impacted FY22 sales. In its annual report, BD identified the Venclose deal as one of several factors that contributed to a 2.8% rise in Peripheral Intervention unit revenue (to $1.76 billion), with the others being strong oncology product demand and the Venovo system relaunch. However, supply constraints and hospital labor shortages during the second half of the year somewhat stymied overall unit growth.

The Surgery unit, meanwhile, leveraged a past acquisition to boost sales, leaning on the FY21 purchase of Tepha Inc. for a solid performance in fiscal 2022. A longtime BD partner, Tepha developed a resorbable polymer that is strong enough to act as scaffolding and can provide support during the natural tissue repair process. Robust demand for the Tepha-acquired polymer as well as BD’s advanced repair/reconstruction platform technology helped increase sales 8% to $1.4 billion.

Similarly, strong demand for acute urology products inflated Urology and Critical Care unit proceeds 5.9% to $1.3 billion. The increases in all three Interventional segment units triggered a 5.3% spike in total sales to $4.46 billion.

Such pecuniary perfection was lacking in BD’s Life Sciences segment, where waning coronavirus testing demand and a shrinking market for COVID-19-related solutions sent total revenue plummeting 14.8% to $5.56 billion and operating income declining 28.5% to $1.71 billion. COVID-19-only diagnostic testing sales of BD Veritor Plus, BD Veritor At-Home, and BD Max systems fell by nearly 75% from fiscal 2021, going from $1.95 billion that year to $511 million in FY22.

While mind-boggling, the descent was not as steep as BD had expected. In its fiscal 2022 projections, the company forecast a $200 million gain from COVID-19 tests, but later increased its prediction to $500 million based on strong Q1 sales.

Nevertheless, BD considerably pruned its crop of coronavirus-only test debuts in FY22, releasing to market the BD Veritor At-Home COVID-19 Test in late October 2021. The assay was the first over-the-counter COVID-19 rapid antigen test to use computer vision technology in a smartphone to interpret testing results. Available for purchase through Amazon, BD Veritor At-Home uses a mobile app (Scanwell Health, an eventual acquisition target) to interpret and digitally display testing results in 15 minutes. BD claims the test is one of the only at-home assays to fully automate results for reporting to federal and state public health agencies.

In an effort to ensure long-term growth and stay true to its 2025 Strategy, BD shifted its fiscal 2022 diagnostic focus from COVID-19-only testing to combination assays and an Mpox (Monkeypox) analytic.

In June 2022, the company won CE marking of the BD MAX Respiratory Viral Panel (RVP), a new molecular diagnostic combination test for SARS-CoV-2, Influenza A + B, and Respiratory Syncytial Virus (RSV). The assay uses a single nasal or single nasopharyngeal swab sample to test for COVID-19, the flu, or RSV. The BD MAX RVP is an RT-PCR assay that detects and differentiates the mRNA of SARS-CoV-2, flu A, flu B and RSV in about two hours.

“SARS-Cov-2, influenza and RSV are a triple threat, as patient symptoms and clinical presentation can be nearly identical,” Nikos Pavlidis, vice president of Molecular Diagnostics at BD, said upon the combination test’s regulatory approval. “A combined testing panel is key to enabling clinicians to quickly and efficiently diagnose, differentiate, and treat patients to help manage the spread of the infections.”

Roughly a month after receiving European authorization for the BD MAX RVP combination assay, Becton Dickinson launched a molecular polymerase chain reaction (PCR) test outside the United States for the monkeypox virus, a disease that can cause a painful rash, enlarged lymph nodes, and fever. Developed with CerTest Biotec in response to the global monkeypox outbreak, the Monkeypox PCR Detection Kit for the BD MAX System comes in a lyophilized format—i.e., a tube that snaps into the test-specific position on the BD MAX ExK TNA extraction strip, which is supplied by BD.

BD launched the monkeypox test in the United States in late September 2022.

In addition to the monkeypox and combination COVID-19/flu/RSV tests, BD further diversified its integrated diagnostics portfolio by purchasing Scanwell Health Inc. and Cytognos. Occurring within a six-week span in late 2021 and early 2022, the Scanwell deal provides BD with a platform for developing automated tests beyond COVID-19 (flu, strep throat) as well as other tests to diagnose chronic conditions.

The Cytognos purchase (from Vitro S.A.) expanded BD’s lineup of blood cancer diagnostics, immune assessment tests, and informatics to better meet patient, clinician, and care provider requirements. The transaction also gave the company exclusive access to advanced assays licensed from the EuroFlow Consortium, including scientists and researchers from more than 20 European universities and hospitals working in hematology and immunology.

“We are developing new solutions to address chronic disease outcomes, which represent one of the most significant healthcare and financial challenges facing societies in the 21st century,” Polen said in BD’s annual report. “By bringing forth new innovations…we are reinventing care for a new era and fulfilling our long-standing purpose of advancing the world of health.”

BD further advanced the world of health in fiscal 2022 by introducing nearly a half-dozen new products in its Integrated Diagnostic Solutions and Biosciences units.

Integrated Diagnostic Solutions rolled out two innovations within a 21-day span in December 2021 and January 2022. First up was the BD COR MX, which features a GX instrument to screen for HPV infections and a PX tool for preparing diagnostic samples. The MX instrument is based on the BD MAX System molecular PCR technology platform, a medium-throughput system used in hospital labs. BD intends to use the BD MAX System’s infectious disease test menu to create assays that can be performed in high-throughput central reference labs on the BD COR System.

The BD COR MX and its assay for sexually transmitted infections is CE marked to the IVD directive 98/79/EC and cleared by the U.S. Food and Drug Administration (FDA) for detecting Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in one test (the BD CTGCTV2 molecular assay).

In early January 2022, the company received FDA 510(k) clearance for the BD Kiestra IdentifA system, a tool designed to automate the preparation of microbiology bacterial identification testing.

BD Kiestra IdentifA is touted as the only FDA-cleared solution available under a track-connected system for lab automation to support specimen preparation workflows for regular and challenging isolate types. The system allows lab technicians to use BD Synapsys Informatics to select discrete bacterial colonies from a digital plate image. Robotics then choose the selected organisms and prepares the sample for specific identification testing.

By automating manual steps, the system is expected to minimize human error when preparing samples for bacterial identification and produce more precise diagnoses for patients.

Despite the innovations, Integrated Diagnostic Solutions sales fell 19.9% to $4.18 billion, due mainly to significantly lower coronavirus-only testing revenue. That dropoff was offset by wide clinical adoption of the company’s broader respiratory panel, as well as an expanded instrument base and higher specimen management product sales.

Biosciences, on the other hand, posted a 5.6% revenue spike to $1.37 billion. BD attributed the unit’s improved performance to strong reagent and instrument sales, and the continued adoption of its e-commerce platform.

The Bioscience unit welcomed two new products to its lineup in fiscal 2022, both of which occurred in the third and fourth quarters. The company in June launched the BD FACSDiscover S8 Cell Sorter featuring BD CellView Image Technology. It is the first cell sorter to combine advanced spectral flow cytometry with sort-capable image analysis to potentially enable researchers to yield more accurate data and sort cells that previously could not be identified, the company claims.

The novel BD CellView Image Technology captures images of individual cells flowing through the system and sorts them based on a detailed microscopic image analysis of each one at high sort speeds. This combination enables scientists to gain more accurate insights on cell populations and characteristics that can be visually confirmed in real-time, and interrogate and sort cells that could not be identified before, all in a simplified experimental workflow. The BD FACSDiscover S8 Cell Sorter is the first BD instrument to feature BD CellView Image Technology.

Three months after the BD FACSDiscover S8 unveiling, Becton Dickinson launched BD Research Cloud, a cloud-based software solution designed to streamline the flow cytometry workflow to enable higher quality experiments with faster time to insight for scientists working across a range of disciplines including immunology, virology, oncology, and infectious disease monitoring.

BD Research Cloud is built on an industry-standard cloud infrastructure and is specially optimized for BD instruments and reagents. As a cloud-based open system, future releases will provide users with even more intuitive and powerful capabilities, alongside growing resources from BD including panel design education sessions, e-books, and dedicated applications support.

$20.25 Billion
Prior Fiscal: $17.12 Billion
Percentage Change: +18.3%
R&D Expenditure: $1.34B
Best FY21 Quarter: Q1 $5.32B
Latest Quarter: Q2 $5.01B
No. of Employees: 75,000

What one company views as a high growth segment for their business, another sees as an expendable piece that can be divested or spun out to stand on its own. Neither company has an incorrect view of the division; rather, it’s a matter of focusing on core competencies. One company may see a unit as complementary while another views that same clinical focus as something just outside their true scope.

In May 2021, BD announced it thought it best to separate from its Diabetes Care business to allow the firm to “focus on innovation and priority growth markets.” Embecta Corp. (what would be announced as the new company’s name) has roots within diabetes care going back to 1924 when it introduced the world’s first specialized insulin syringe. According to BD, it is now responsible for producing approximately 8 billion devices annually and serves about 30 million patients; these figures put it near the top among companies providing technology for diabetes care.

In 2021, it was reported the unit took in revenues of $1.16 billion, originating almost 50/50 from U.S. customers versus international. According to the International Diabetes Foundation, in 2020, the estimated diabetic population was 463 million and that figure is anticipated to grow to 700 million by 2045.

“The decision to spinoff our Diabetes Care business is part of our active portfolio management and consistent with our BD 2025 strategy to Grow, Simplify and Empower,” said Tom Polen, chairman, CEO, and president of BD. “The spinoff will allow BD to strengthen its growth profile, enables a greater investment focus on our other core businesses and high-growth opportunities, and makes a greater impact for our customers and patients.”

At the time of the split announcement, the leadership team for Embecta was also introduced. Serving as president and CEO would be Devdatt Kurdikar. Kurdikar had been the worldwide president of BD Diabetes Care. He previously served as president and CEO of Cardiac Science before the company was sold to Zoll Medical, and also held positions at Boston Scientific and Baxter.

Coming from Teleflex where he served as former treasurer and head of investor relations, Jacob Elguicze was announced as a new hire and would become Embecta’s CFO. Elguicze began at accounting firm Coopers Lybrand before joining Motorola and, eventually, Teleflex.

ANALYST INSIGHTS: After successfully spinning off its diabetes business unit (named Embecta) in the first half of 2022, it was known that BD had cash for M&A to support its “BD 2025 Strategy.” They quickly flexed that muscle with a recent announcement to acquire Parata Systems, an innovative provider of pharmacy automation solutions, for $1.525 billion. Expect BD to continue to invest in Smart and Connected Care solutions to enhance its growth opportunities.

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

BD’s Board of Directors approved the transaction in February 2022 for an April 1 spinoff date, establishing one of the largest “pure-play” diabetes technologies firms in the world. “The completion of this spinoff is a significant achievement for both BD and embecta,” Polen said on the date of the spinoff’s completion. “While BD is proud of its heritage in the diabetes care category, we are just as excited to see our legacy advanced by Embecta as a newly independent, publicly-traded corporation.”

The Diabetes Care segment and its $1.16 billion revenue contribution leaves behind its former home within BD’s Medical Segment, which accounted for the largest portion of BD’s $20.25 billion 2021 fiscal revenue figure ($9.48 billion; a 9.2% gain year over year). Within this group, Medication Delivery Solutions notched the largest contribution at $4.06 billion, a 14% gain over 2020. The growth was attributed to strong demand for core offerings, including U.S. demand for catheters and vascular care products, as well as increased global demand for syringes resulting from COVID-19 vaccination efforts.

The Medication Management Solutions unit, on the other hand, decreased almost 1% compared to 2020. Its $2.43 billion in revenue reflected a loss due primarily to a decline in healthcare utilization, particularly in the United States, China, and Europe, according to BD.

The remaining segment of the division—Pharmaceutical Systems—ballooned by 15.2% to finish the fiscal at $1.83 billion. These gains were attributed to continued growing demand for pre-filled devices.

According to BD, demand for pre-filled devices is being aided by the vial to pre-filled device conversion for biologics, vaccines, and other injectable drugs. As such, in December 2020, the firm announced it was investing $1.2 billion in its manufacturing capacity for these technologies over a four-year period. The investment will impact six manufacturing locations and also add a new facility in Zaragoza, Spain. The new location is expected to be operational by the end of 2023 and will create approximately 600 jobs by 2030. The financial investment will also be put toward new product innovation, manufacturing technology enhancements, and business continuity improvements.

Further seeking to keep this division strong within the medical device space, the company announced it had submitted a 510(k) application for its BD Alaris System, a widely used infusion pump for acute care hospitals in the U.S. The regulatory submission was initiated to bring the technology “up to date, implement updated features, and address open recall issues, including through a new version of BD Alaris System software that will provide clinical, operational, and cybersecurity updates,” according to the firm’s news release from April 2021. The recall issues harken back to concerns that were brought to light during the prior year.

While Medication Delivery Solutions was the largest revenue-generating unit within the Medical Segment, the Life Sciences Segment was home to BD’s largest contributor. Integrated Diagnostic Solutions exploded by almost 48% in fiscal 2021 to close at $5.23 billion. Even Life Sciences sister division—Biosciences—enjoyed double digit gains (14.2%) to post $1.31 billion in revenue. While both saw a return of sales after pandemic-related declines in fiscal 2020, the enormous increases seen for the diagnostic unit were attributed primarily to COVID-19 testing solutions. Similarly, many of the company’s product announcements were related to this same area.

Soon after the start of the 2021 fiscal period, BD announced (alongside CerTest Biotec) a CE mark had been gained for the VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit adapted for the BD MAX System. The kit enables users to run a single module that tests concurrently for COVID-19, influenza (flu), and Respiratory Syncytial Virus (RSV).

In February, BD gained an FDA EUA (emergency use authorization) and CE mark for a combination molecular diagnostic to detect SARS-CoV-2, as well as influenza A+B in a single test. The EUA included updated information for the test to be used in detection of both U.K. and South African variants. Like the VIASURE test, this diagnostic is run on the company’s MAX system.

Just a month later, the organization gained another EUA for a similar test (detection of SARS-CoV-2, influenza A, and influenza B) in the form of a rapid antigen test that provided results in 15 minutes. This test was developed to run on the Veritor Plus System and provided definitive positive or negative individual digital display readouts for all three diseases.

Yet again, the firm gained an EUA for a COVID-related testing solution; this time for its rapid antigen test to be used for screening through serial testing (i.e., at least twice a week) of asymptomatic individuals. The Veritor Plus System supports this approach in everyday locations such as schools and businesses, along with serial testing in other situations, such as athletes and teams to ensure safe games and competitions.

In April 2021, CerTest and BD once again announced news regarding their collaborative development efforts. Saliva specimens were added to the CE mark the firms gained for testing with the VIASURE SARS-CoV-2 Kit on the MAX System. This marked the third type of specimen that could be run using these technologies (nasopharyngeal and oropharyngeal samples were the first two types).

In other efforts, BD teamed with organizations to leverage a digital health aspect alongside their testing solutions. In one such agreement, BD sought to pair an at-home lateral flow antigen test for the detection of SARS-CoV-2 with Scanwell Health’s (a provider of smartphone-enabled at-home medical tests) mobile app. The app provides step-by-step instructions on how to collect and transfer a nasal swab sample and use the mobile device’s camera to analyze and interpret results. The test result is displayed onscreen, and there were plans to develop functionality to assist in automated reporting to public health agencies. The at-home test gained an FDA EUA in late August 2021, and in December 2021 (FY2022), it was announced BD had completed the acquisition of Scanwell Health.

In a separate arrangement, ImageMover (a software platform that automates and simplifies medical data collection and management) was used by BD to create a companion mobile app that enabled more streamlined reporting of SARS-CoV-2 antigen testing results performed on its Veritor Plus System at everyday testing locations, such as schools and businesses. The ImageMover app empowered organizations performing point-of-care testing to efficiently capture required demographic details of those being tested, upload COVID-19 test results, report results to appropriate stakeholders, and automate reporting to federal and state agencies.

While the COVID testing solutions were the most prominent announcements regarding diagnostic solutions during the 2021 fiscal year, BD did provide news on a number of other testing-related products. A 510(k) clearance was granted for its FACSLyric Flow Cytometer with newly integrated FACSDuet Sample Preparation System. The technology enables clinical laboratories to fully automate the sample-to-answer process and improve their efficiency by reducing errors and limiting the manual user interactions required to run assays on the cytometer.

The firm also declared it obtained CE mark status for the self-collection of samples for HPV screening. This claim permitted laboratories and facilities to process self-collected samples via a BD diluent tube using the Onclarity HPV Assay on either the Viper LT or COR System. According to BD, adding at-home collection as an option to cervical cancer screening programs has been demonstrated to increase participation.

BD also announced the U.S. launch of a Urine Culture Application for use with its Kiestra lab automation incubation and imaging system. Designed using artificial intelligence and leveraging the quality of the firm’s BBL plated media, the application uses digital imaging and software algorithms to determine the amount of growth on a urine culture plate from clean caught and catheterized samples.

The BD FACSymphony A1 Cell Analyzer is a fluorescence-activated cell analyzer that offers advanced research capabilities in a compact design, which helps improve access to instrumentation for complex scientific research to more labs. The unit from the Biosciences division was launched in August 2021. Fluorescence-activated cell sorter technology enables the precise isolation of selected single cells from complex samples.

Within the same month, the company launched a fully automated, high-throughput diagnostic system using robotics and sample management software algorithms. The COR PX/GX System integrates and automates the complete molecular laboratory workflow from sample processing to diagnostic test result. The system is modular and scalable, and designed to address multiple needs within laboratories for expanding molecular testing and increasing test volumes. It gained a CE mark in 2019.

BD’s third segment—Interventional—also enjoyed auspicious gains due primarily to the return of more elective surgical procedures as the delays faced in 2020 began to subside. Its $4.24 billion contribution as a total segment represented a 12.7% increase over the prior fiscal. More specifically, each of the three units within the segment saw favorable growth. Surgery presented a final figure of $1.30 billion in revenue, representing a 15.7% rise. Next, Peripheral Intervention celebrated a 13.2% elevation to reach $1.71 billion for the fiscal. Finally, Urology and Critical Care enjoyed a high single-digit percentage gain in FY2021 to finish the 12-month period at $1.23 billion, a 9% expansion.

The segment made a couple of product declarations during the timeframe. One was the 510(k) clearance of its Pristine Long-Term Hemodialysis Catheter, which was developed with a unique side-hole-free symmetric Y-Tip distal lumen design. As a result, it can help minimize thrombus adhesion that can be associated with side-hole catheters and help facilitate blood clot aspiration prior to hemodialysis treatment.

The BD Surgiphor sterile wound irrigation system delivers simplified sterility and helps hospitals comply with national and international guidelines. According to the company, it is the first and only (at the time) ready-to-use aqueous povidone-iodine irrigation solution that mechanically loosens and removes wound debris. The product came to BD as part of its acquisition of Orthophor in November 2020.

BD announced several other acquisitions during its 2021 fiscal period. Also in November 2020, it purchased the Medical Business assets of CUBEX LLC, a privately-held company that developed cloud-based software offerings for advanced medication management. The deal expanded BD’s medication management offerings into the care continuum space and provided deeper integration with electronic health records.

In March 2021, the organization further expanded its medication management capabilities in a transaction for GSL Solutions Inc. A privately-held company, GSL developed smart medication devices for the storage and tracking of controlled substances and patient-specific medications that improve the security, efficiency, and compliance of medication storage. In addition, it provided analytic capabilities to further improve inventory management, including of controlled substances, regulatory compliance, and patient safety.

July 2021 saw the inclusion of Tepha Inc., a developer and manufacturer of a proprietary resorbable polymer technology. The technology platform provides additional innovation potential that can accelerate the growth of BD’s surgical mesh portfolio and drives the company into potential new areas within soft tissue repair, reconstruction, and regeneration.

$17.11 Billion
Prior Fiscal: $17.29 Billion
Percentage Change: -1%
No. of Employees: 72,000

Trail running etiquette is not quite as simple as it might seem.

There are no concrete rules or standards, only ambiguous protocols based primarily on common sense and social mores. Off-road running etiquette dwells within the gray area of governance, rendering it subject to interpretation and misunderstanding, and ultimately leading to a tapestry of different compliance practices.

Despite the variability, there are some basic principles most trail runners follow, the most important of which is following posted signs. Other generally accepted guidelines include yielding to hikers or walkers, passing on the left, staying on marked trails, being courteous, and never littering.

Accomplished endurance runner Tom Polen has observed these informal edicts so many times during his countless wilderness sprints that he’s added a few of his own to the mix. Polen’s “rules,” however, are just as applicable to business management as they are to the trail.

“When you’re following the light of your headlamp through the woods at 2 a.m., a lot of thoughts pop into your head,” BD’s president/CEO wrote in a brief LinkedIn blog two years ago, “and that’s when I realized that many of the strategies you use in a trail run are applicable to success in business.”

Those strategies became invaluable to Polen last year as he piloted BD through the world’s worst health crisis in a century. The new chief executive specifically employed three trail run strategies to address the enormous challenges wrought by COVID-19:

Look down the trail instead of down at your feet. Beginners tend to focus on the path directly in front of them, Polen wrote in his blog, while more experienced runners, with practice,” stop worrying about stumbling and begin to look further and further ahead, intuitively reading the trail and adjusting well ahead of time.”

ANALYST INSIGHTS: Buoyed by its COVID financial successes due to its Life Sciences businesses, BD has been making some portfolio decisions. They are divesting their Diabetes business segment to give it a chance to remain competitive with a renewed focus. In the meantime, BD will continue to grow thru a tuck-in M&A strategy.

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

Having been running the healthcare trail for 124 years now, BD has long mastered the art of strategic foresight. Accordingly, when the coronavirus first surfaced, the company rapidly shifted its focus and began developing diagnostic tests (BD MAX), safeguarded its critical care supplies (catheters, probe covers, needle-free connector tech), and increased production of injection devices for future vaccination efforts. BD also is priming itself for forthcoming pandemics by investing roughly $1.2 billion to expand and upgrade its manufacturing capacity for pre-fillable syringes and advanced drug delivery systems.

Obstacles can be turned into advantages. Rocks and roots that trip up novice runners often can become springboards for advanced sprinters, helping them traverse the bigger obstacles blocking their progress, Polen’s blog noted.

The rocks along BD’s bumpy path last year proved more of an advantage than liability, providing the firm with the necessary momentum to clear some serious COVID-19-induced financial hurdles. Specifically, BD compensated for declining Surgery sales (from elective procedure cancellations) by catering to demand for sample collection tools and increasing access to its automated in-vitro diagnostics molecular platform. The company also partnered with Birmingham, Ala.-based BioGX Inc. in March 2020 to develop and commercialize a diagnostic assay for on-site (hospital) coronavirus testing and detection, with results available in under three hours; the test won U.S. Food and Drug Administration (FDA) emergency use authorization last April.

Three months later, BD teamed up with BARDA (Biomedical Advanced Research and Development Authority) on a $70 million project to boost needle and syringe manufacturing operations and capacity in Nebraska, in conjunction with Operation Warp Speed.

You’re not alone out there. Polen relied on a seven-member team to complete a 135-mile charity race in the spring of 2019. Each member “owned” a part of the relay, and all participants supported each other. “We could feel the support of our teammates even when we weren’t together, which helped each of us power ahead,” Polen recalled in his blog.

Polen similarly depended on his 70,000-strong BD team to rapidly deploy the company’s capabilities, expertise, and scale to help customers diagnose, monitor, and care for COVID-19 patients, and prepare for mass vaccinations.

“…in 2020, few businesses in the world escaped the impact of the global pandemic. For some, it was an existential threat; for BD, it was a call to action as our more than 70,000 associates around the world rallied around our Purpose of advancing the world of health…” Polen told shareholders in BD’s 2020 annual report. “The perseverance of our associates—and the notable success of our BD Life Sciences-Integrated Diagnostic Solutions team in developing innovative COVID-19 diagnostic testing—allowed the business to return to revenue growth in the fiscal fourth quarter and finish the year with revenues down slightly on a year-over-year basis.”

Slightly indeed: Revenues slipped 1 percent to $17.1 billion compared with FY19 but gross profit and operating income fell more sharply, with the former tumbling 8.6 percent to $7.57 billion and the latter falling 15.7 percent to $1.48 billion. Basic EPS, meanwhile, declined by nearly one-third (31.4 percent) to $2.75.

A solid performance from BD’s Life Sciences Segment helped stave off further losses and kept the company’s FY20 revenue close to the previous fiscal year’s levels. Total Life Sciences proceeds rose 8.7 percent to $4.67 billion due to exceptional pandemic-triggered demand for diagnostics, especially tests. Interestingly, though, the coronavirus had a contradictory impact on the segment’s two business units.

Integrated Diagnostic Solutions revenue, for example, swelled 13.7 percent to $3.53 billion from robust sales of COVID-19 tests (the BD Veritor Plus and BD Max systems). Most of the increase can be attributed to the 32.1 percent growth in Diagnostic Systems proceeds (to $2 billion), offset only marginally by a 4.6 percent decline in Preanalytical Systems sales (to $1.48 billion).

The Biosciences unit suffered the opposite fate: Revenue shrunk 4.3 percent to $1.14 billion as the pandemic reduced demand for instruments and reagents, and slowed routine research and clinical lab activity.

Comparable COVID-19 paradoxes beset the business units in BD’s two other reporting segments. Interventional Segment sales fell 4.2 percent ($164 million) to $3.76 billion despite numerous product launches across its three business units.

New innovations from Peripheral Intervention failed to prevent a 4 percent ($63 million) revenue contraction to $1.51 billion. Products debuting during the fiscal year (Oct. 1, 2019-Sept. 30, 2020) included the LUTONIX Drug Coated Balloon (DCB) and LUTONIX 018 and 300 mm DCB; the Elevation Breast Biopsy System (featuring a TriConcave tip, an integrated coaxial cannula, and average nine-second sampling time); and the Caterpillar Micro Arterial Embolization device, available in three sizes (U.S.) to treat target artery diameters between 1.5 mm and 7 mm. The Caterpillar is BD’s first interventional oncology product, and has a dual-action design with opposing nitinol fiber segments and an occlusion membrane.

Surgery’s new products could not overcome the void left by thousands of elective procedure deferrals/cancellations last spring and summer; thus, unit sales fell 9.7 percent ($121 million) to $1.12 billion. The unit made a valiant effort to turn a profit though, releasing a new inguinal hernia mesh and an infection prevention solvent.

The robotic-compatible version of BD’s 3DMAX Light Mesh is an inguinal hernia solution that conforms to patients’ individual anatomies and retains its shape after laparoscopic insertion. PurPrep, on the other hand, is described as the “first and only fully sterile povidone- iodine plus isopropyl alcohol single-use antiseptic skin preparation commercially available in the United States.”

Only the Interventional Segment’s Urology and Critical Care business unit defied the odds and turned a profit in the wake of COVID-19, growing sales $20 million, or 1.8 percent, to $1.1 billion. Capitalizing on the company’s developing position in female incontinence, the unit launched drydock 2.0, a solution intended to facilitate home use of the PureWick Female External Catheter.

The financial dichotomy within the Life Sciences and Interventional segments existed in the Medical segment too, but its FY20 pecuniary woes cannot be blamed solely on COVID-19. Medication Delivery Solutions sales—down 7.6 percent to $3.55 billion—were partially impacted by a new volume-based procurement process adopted by several Chinese provinces. U.S. pricing pressures doomed Diabetes Care revenue, which slid 2.4 percent to $1.08 billion, and a Class I recall undermined Medication Management Solutions proceeds.

BD recalled its Alaris System infusion pumps in February 2020 over errors that could interrupt or delay infusion, and induce slower or faster medication delivery (under-infusion and over-infusion, respectively). The recall affected 774,000 units sold in the United States between July 2004 and October 2019.

“High-risk patient populations who are receiving life sustaining infusions are at the greatest risk of harm. For these patients, stopping or significantly lowering the infusion rate can lead to serious injury or death,” BD warned customers in a Feb. 4, 2020, recall notice.

Alaris pump system issues involving faulty keypads, outdated software, and hardware flaws prompted a flurry of recalls in FY20, many of which followed the FDA inspection of BD’s Medication Management Solutions facility in San Diego, and subsequent citation of potential violations in a Form 483.

Those recalls, and the suspension of Alaris infusion pump shipments, largely contributed to a 7.1 percent decline in FY20 Medication Management Solutions revenue (to $2.45 billion). The loss, however, was partially offset by international infusion pump sales and pandemic-related infusion pump orders placed in the United States with medical necessity certification.

The Medication Management Solutions shortfall also was somewhat counteracted by an 8.4 percent gain in Pharmaceutical Systems sales (to $1.58 billion). Growth was attributed to “continued strength in demand for prefillable products,” according to BD’s annual report.

Last May, BD issued $3 billion in equity to strengthen its balance sheet and reduce its net leverage. “At the same time,” Polen noted to shareholders, “we were also able to make prudent reinvestments into our business to strengthen our core and further advance our long-term growth initiatives, including tuck-in acquisitions.”

BD closed a half-dozen deals in FY20, including:

• • Adaptec, a Raleigh, N.C., startup developing an automated urine output measurement solution (Sensica UO). The technology captures hourly urine output measurements and integrates the data into the electronic health record through the BD HealthSight platform.

• • LifeBond Ltd., a 14-year-old Israeli company whose main product aims to minimize post-operative complications such as staple-line leakage in GI and bariatric surgeries.

• • NAT Diagnostics, an early-stage, privately held molecular diagnostics firm focused on rapid point-of-care testing. The NAT Dx isothermal technology will be further developed by BD, with the intent to offer customers decentralized molecular testing options in early 2023. “…we are very excited about the technology and our point-of-care diagnostics business more broadly,” Polen told industry analysts earlier this year, “and how this adds in a molecular capability to that.”

• • Straub Medical, a privately held firm that markets mechanical atherectomy and thrombectomy devices for peripheral arterial disease treatment. The acquisition expands BD’s portfolio of PAD and Venous Solutions within its Interventional segment.

$17.29 Billion
Prior Fiscal: $15.98 Billion
Percentage Change: +8.8%
No. of Employees: 70,093

Following a weeklong leak of the ethylene oxide (EtO) gas the company uses to sterilize medical devices from Sept. 17 to Sept. 24, Covington, Ga., mayor Ronnie Johnson asked Becton Dickinson to temporarily shut down its plant there. Air quality tests revealed “particularly high levels of ethylene oxide in the neighborhoods adjacent to [BD’s] facility” coinciding with a valve leak that released 54 pounds of EtO between Sept. 15 and Sept. 22. According to a Montrose Air Quality report, EtO levels reached 15.3 micrograms per cubic meter (µg/m3) in one neighborhood following the leak, and around 12 µg/m3 just outside the plant on Sept. 22.

The Covington facility shut down from Oct. 30 to Nov. 6 so the EPD could take ambient monitoring samples in the area when the plant was not in operation.

“We’re not jumping up and down over this court order today,” Cindy Jordan, a Newton County, Ga. resident told the Associated Press. “Their emission numbers have decreased. But we need to make sure the only thing that’s acceptable is zero ethylene oxide.”

To mitigate the issue, BD agreed to reduce capacity in Covington, not expand production in Madison, Ga., and implement operational modifications to reduce emissions. BD was also required by Oct. 31 to give the EPD an explanation on how they calculate fugitive emission levels and provide the formula’s certification by a third-party engineering firm. Modifications must capture 99 percent of all fugitive EtO emissions.

BD was slapped with a violation notice by Georgia’s EPD in December over a Covington warehouse leased last May to store EtO-sterilized devices that it had failed to disclose. State officials calculated the distribution center might emit 5,600 lbs. of EtO per year—any facility that can emit over 4,000 lbs. per year must apply for a state permit.

“These results are highly concerning, and we are demanding answers from [BD] to remedy this unlawful activity,” Georgia Gov. Brian Kemp said in a Dec. 18 tweet. “I have directed state officials to act as swiftly as possible to secure compliance.”

ANALYST INSIGHTS: With work to do on the device side on its infusion pump business, one might think BD would be more aggressive in its pharma business while it “reloads” internally within its medical device business units. New products will be necessary for future growth and may not be available in an impactful manner until later in 2021 or 2022.

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

BD was forced to stop storing EtO-sterilized devices in the warehouse from Dec. 23, 2019, through Jan. 6, 2020, and submit lists of products sterilized at facilities in Covington and Madison and non-BD facilities within and outside of Georgia. The company also had to list other warehouses where EtO-sterilized devices are stored, explain why fugitive EtO emissions are higher than the company’s estimate in air quality permits, and submit a plan to remove Foley catheter procedural trays from the Covington distribution center until the warehouse has the correct permit.

However, in March as COVID-19 began spreading in the United States, a swift change in policy took place. The heads of three federal agencies—HHS, the Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA)—supported loosening restrictions on sterilizing companies operating in Georgia, including BD. Medical gear shortages ignited the federal pressure as personal protective equipment demand exploded.

A particular BD Foley catheter was also in demand for COVID-19 patients, prompting loosened restrictions on operations on March 25.

“Foley catheters have consistently appeared on our list of products that our members have had challenges accessing during the COVID-19 pandemic,” Vizient, a medical products distribution company, told the Marietta Daily Journal. “These catheters are essential for patients who require a ventilator for care.”

“While we must take into account the risks from emissions of ethylene oxide, and addressing those risks remains a major regulatory priority for the agency, it’s important to bear in mind those risks are linked to exposure over an entire lifetime—over a 70-year period—however, COVID-19 poses an immediate threat to our nation during this crisis,’’ federal EPA administrator Andrew Wheeler said in a March 25 statement.

Last September, chairman and CEO Vincent Forlenza announced his January 2020 retirement from BD after nearly 40 years with the company. President and Chief Operating Officer Thomas Polen was promoted to BD president and CEO, and Forlenza continues as the executive chairman of the BD board of directors.

“As we head into the final year of the BD-Bard integration, the board and I have been focused on preparing for the next phase of the company’s growth, and we recognize this is the right time to appoint a successor with the vision, drive and capability to lead BD into the future,” Forlenza said of Polen.

“I am humbled by the trust Vince and the board have placed in me and honored to have this opportunity to lead such a dynamic company as we move into our next phase of growth and impact,” Polen told the press. “I am confident we have the right strategy, an exciting innovation pipeline, tremendous breadth of capabilities, and the most talented and dedicated team in healthcare.

Polen took the helm after another successful year following the company’s 2017 merger with C.R. Bard. BD earned $17.29 billion in its 2019 fiscal year, rising 8.8 percent over the previous year. Revenue was favorably affected by about 6 percent thanks to Bard.

The Medical segment’s fiscal 2019 revenue rose 5.2 percent over the previous year, coming to rest at $9.1 billion. Medication Delivery Solutions products acquired from C.R. Bard led the charge for this increase, supported by strong sales of vascular access devices. The Medication Delivery Solutions business accrued $3.9 billion, rising 5.9 percent. Infusion and dispensing systems installations and disposables sales boosted the Medication Management Solutions performance 6.4 percent to reach $2.6 billion. Pharmaceutical Systems revenue grew 4.8 percent to $1.5 billion thanks to strong prefillable product and self-injection system sales. Diabetes Care proceeds was flat at $1.1 billion—low growth in U.S. pen needle earnings offset strong sales in emerging markets.

BD’s second-generation Nano pen needle for subcutaneous injection earned an FDA nod last January. Its contoured needle base and variable injection force compensation supports more reliable 4mm target injection depth compared to other needles of the same length. The second-gen pen needle’s design also displayed an eight-fold reduction in calculated intramuscular injection risk, and its new ergonomic design makes for easier use and a more comfortable injection.

Life Sciences proceeds dropped 0.7 percent to $4.3 billion, primarily due to BD’s divestiture of its Advanced Bioprocessing unit to Thermo Fisher Scientific in September 2018. Preanalytical Systems revenue was flat with $1.6 billion in sales, though core products performed admirably in emerging markets. The BD Max molecular platform and growth in core microbiology sales stimulated the Diagnostic Systems portfolio’s slight 0.7 percent rise to $1.5 billion. The loss in Biosciences (down 3.8 percent to $1.2 billion in revenue) was tempered by robust research reagent and U.S. research instrument sales. Puneet Sarin, previously senior VP and GM of Beckman Coulter’s chemistry and immunoassay business, was also appointed as worldwide president of Biosciences last June.

BD gained CE-IVD certification for the FACSDuet automated flow cytometry system last March. A fully automated sample preparation instrument lets labs minimize manual steps that can cause errors. FACSDuet integrates with the FACSLyric clinical flow cytometer so technicians can load samples and reagents onto FACSDuet and receive data once samples are fully processed. The FACSLink middleware solution also grants bidirectional communication between instruments and connectivity with lab information systems.

BACTEC platelet quality control media launched last April. It allows microbiology labs, blood banks, and transfusion services to spot contaminated platelet units. The comprehensive solution leverages BACTEC FX technology and Synapsys microbiology informatics to meet culture-based platelet testing requirements. It can be used to test leukocyte reduced apheresis platelet units, both leukocyte reduced single and a pool of up to six units of leukocyte reduced whole blood platelet concentrates.

The ChloraPrep sterile chlorhexidine gluconate antiseptic skin preparation was also released in the U.S. last April. The process sterilizes the antiseptic solution inside the applicator’s sealed ampoules. ChloraPrep solutions undergoing the added level of sterility will be labeled as a sterile solution on all packaging.

BD achieved CE-IVD certification for the automated COR System for molecular testing last June. It integrates and automates molecular lab workflow from pre-analytical processing to diagnostic test result. The Onclarity HPV Assay will initially be available with COR. Samples can be processed directly from liquid-based cytology vials and creates molecular aliquot tubes and assay testing, replacing automating labor-intensive and error-prone manual processes. It has onboard capacity for reagents and samples that provide six to eight hours of system processing, eliminating multiple technologist interactions per shift.

The FDA OKed the Max Check-Points CPO (carbapenemase-producing organism) assay in October. It detects the five most common carbapenemase genes from the patient specimen in about 2.5 hours, as opposed to traditional methods that can take up to 24 hours to spot antibiotic-resistant bacteria. The assay will help hospitals implement programs to address antimicrobial resistance.

The Kiestra IdentifA automated preparation solution for microbial identification garnered a CE mark and Canadian approval in November. Sample processing steps needed to identify a microorganism are automated to reduce user error. It supports specimen preparation workflows for routine and challenging isolate types in combination with identification on the Bruker MALDI Biotyper and synchronizes with Synapsys microbiology informatics to speed communication of lab results.

Interventional segment proceeds skyrocketed 29.3 percent to $3.9 billion thanks to inclusion of Bard’s products in Q1 of the company’s fiscal 2019. Surgery revenue shot up 17.3 percent to $1.4 billion due to growth in biosurgery and infection prevention product sales. The Peripheral Intervention business’ sales ballooned 33 percent thanks to strong emerging market sales, and was partially offset by FDA guidance in March regarding use of paclitaxel-coated devices for peripheral artery disease that reduced drug-coated balloon sales. Urology and Critical care was the biggest winner, mushrooming 42.4 percent and reaching $1.1 billion.

BD received the FDA’s green light for the WavelinQ 4F EndoAVF (endovascular arteriovenous fistula) creation system last February. An alternative to open surgery, it creates an AV fistula in either the ulnar artery and vein or radial artery and vein for chronic kidney disease patients requiring hemodialysis. A slim profile increases anatomical AVF location options and enables additional venous access points, and reduces scarring or arm disfigurement that can occur with open surgical AV fistula creation.

The Venovo venous stent achieved FDA approval a month later. According to BD, Venovo is the first stent indicated to treat iliofemoral venous occlusive disease, obstructive or narrow blood flow specific to the iliac and femoral veins. Its balance of radial strength, compression resistance, and flexibility treats symptomatic post-thrombotic and non-thrombotic iliofemoral lesions. Broad stent sizing allows Venovo to treat large diameter veins and long lesion lengths.

“…it is purpose-built for application in veins, and engineered to address the special challenges of venous lesions that are very different than those posed by arterial narrowing,” commented Dr. Michael Dake, University of Arizona and the principal investigator for the Venovo IDE trial.

November saw FDA clearance for the Phasix ST Mesh with Echo 2 Position System for abdominal hernia repair. The long-lasting, bioresorbable mesh includes a hydrogel barrier for intraabdominal placement, creating a strong repair without a permanent implant. The Echo 2 pre-attached deployment and positioning device aids in accurate and consistent mesh placement in minimally invasive hernia repairs. According to preclinical testing, the positioning system can save up to 30 percent of time during placement compared to traditional flat mesh.

Last March, the FDA noted a potentially concerning signal of increased long-term mortality when using paclitaxel-coated devices. The agency said at the time the cause for increased mortality risk is unknown, and there is a limited amount of long-term data. BD reviewed data from the LEVANT2 study evaluating its Lutonix drug-coated balloon in response, and cited several known confounding factors for mortality over the five-year period. According to the company’s analysis, some causes of mortality couldn’t be reasonably attributed to paclitaxel. When excluding those deaths, the randomized portion of the study doesn’t cross the line to significance at five years.

The FDA held a circulatory system devices panel last June to further examine the possible increase in deaths using paclitaxel-coated devices, where BD presented data confirming that the benefits of the Lutonix drug-coated balloon outweigh the risks for superficial femoropopliteal artery procedures. The FDA updated recommendations in August, concluding that while a late mortality signal was present, paclitaxel-coated devices improve blood flow to the legs and decrease the chance of repeat procedures to reopen blocked blood vessels compared to uncoated devices. The agency also cautioned interpretation of the signal’s magnitude due to limitations in available data.

BD advised that stockholders reject an unsolicited mini-tender offer from TRC Capital Investment Corporation to purchase up to 500,000 shares of common stock at $234 per share in cash. TRC’s offer price was about 4.41 percent below the BD share market price on Nov. 8. The tender offer sought less than 5 percent of outstanding common stock, avoiding many disclosure requirements and SEC procedural protections. Investors were therefore not given the same protections in mini-tender offers as they would in private offers. The company recommended stockholders who haven’t responded to the offer take no action, and that common stockholders who already tendered their shares could withdraw them with a written notice.

COVID-19 Consequences

Q2 2020 Revenue: $4.25 Billion
Q2 2019 Revenue: $4.16 Billion
Percentage Change: +2.2%

Though BD posted increased Q2 2020 revenue over the same period in the prior fiscal year (ended Sept. 30), the Medical business—particularly Medical Delivery Solutions—was negatively impacted by declined hospital utilization in China due to stay-at-home measures. The segment declined 1.4 percent to $2.15 billion as a result. Life Sciences saw growth (up 5.8 percent to $1.11 billion) thanks to influenza and COVID-19 testing demand, though the pandemic slowed research lab activity, stifling instrument and reagent sales. Interventional proceeds grew 2.8 percent to $1 billion despite deferral of elective procedures.

CerTest BioTec’s ViaSure SARS-CoV-2 Real Time PCR Detection Kit was granted CE mark for use with BD’s Max system on March 10. The system performs nucleic acid extraction and real-time PCR, and provides results for up to 24 samples in less than three hours. Europe has a large installed base of BD Max systems, according to BD’s VP of molecular diagnostics and women’s health, Nikos Pavlidis.

On March 31, BD and N.C.-based clinical diagnostics firm BioMedomics released a point-of-care test that can spot antibodies in blood to confirm current or past exposure in as little as 15 minutes. However, BioMedomics withdrew its serology test from the market in May, and is currently working on submitting a newer version of its serology test for FDA review.

BD and biotech firm BioGX were granted FDA emergency use authorization for a SARS-CoV-2 diagnostic test that runs on the BD Max molecular diagnostic platform on April 2. The system can process 24 samples simultaneously with results in under three hours. The tests added capacity for 50,000 tests per week nationwide.

BD gained emergency authorization for an additional molecular COVID-19 diagnostic test that can provide results in two to three hours on April 13. On June 3, Canada signed a contract to purchase 37 million syringes from BD to prepare for an eventual COVID-19 vaccine. And on June 22, Baltimore County, Md., began a supply agreement with BD Integrated Diagnostic Solutions for thousands of COVID-19 testing collection and transport kits to bolster testing capacity, beginning with a first batch of 2,000 kits.

AT A GLANCE
$15.98 Billion
Prior Fiscal: $12.10 Billion
Percentage Change: +32.1%
No. of Employees: 76,032

Perhaps the most exciting medtech M&A news last year was that there wasn’t any. The industry had recently grown accustomed to nearly annual blockbuster deals—Zimmer and Biomet merged in 2014, with Medtronic and Covidien close on their heels; Abbott and St. Jude married in 2016; and right in MPO’s backyard, Becton, Dickinson and Company (BD) and C.R. Bard (Bard) formed their union in 2017. Although there were several small- to mid-sized deals keeping analysts’ interest up last year, they all lacked the gravity of the megamergers of recent years that were fast becoming a trend.

“…we are now seeing a new class of what I like to call ‘Super OEMs’—Medtronic, Abbott, and now BD. That’s a list that will continue to grow,” Mark Bonifacio, founder and president of Bonifacio Consulting Services, told MPO when the BD-Bard deal was announced.

Though significant, the $24 billion deal was considered “more of the same” in terms of medical device M&A. But whether the string of megamergers is healthy for the industry remains to be seen. Consolidation in this way can certainly help patients because of the clinical and procedural synergies created when joining complementary product portfolios. BD reaps the benefits of greater hospital buying group penetration with strong, high-margin products—particularly in urology and oncology, where it had lacked in market share. Combining two major companies also streamlines the supply chain as the merged companies look to consolidate supply base spending, which can be beneficial for product safety and eases the regulatory burden. However…

“As good as it is for BD (and Bard shareholders), I question how good this is becoming for the industry,” Covington Associates VP Perry De Fazio told MPO. “It is easy to foresee a day with a ‘Big Three’ in each of the major clinical sectors (e.g., orthopedics, cardiovascular, neurology, etc.) with a couple of others sprinkled here and there. The ‘too big to fail’ problems we saw in the financial, automotive, and insurance industries (and still do, to an extent) may soon befall the medical device sector.”

The worry is not without merit, as medical device industry trends typically lag a few years behind other industries. And it’s not just the greater economic system in danger—lifesaving technologies and treatments may also become more complicated to access should a “super OEM” crumble.

Thankfully, there appears to be no danger of that happening to BD—at least, not anytime soon. Thanks to Bard’s full integration, the firm’s sales nearly touched $16 billion last year, rising a monumental 32.1 percent from the year prior. A 24.5 percent gain was attributed to Bard, with the remaining growth covered by volume increase and favorable foreign currency transactions.

As a result of Bard’s full integration, BD’s business structure was reorganized into three segments: Interventional, Medical, and Life Sciences. Last April, former Life Sciences president Alberto Mas was appointed as Medical Segment president, and former Agilent senior VP Patrick Kaltenbach was named to fill Mas’ spot. Bard’s former Surgery business president Simon Campion became the Interventional Segment’s president last August.

The newly formed Interventional segment, which consists primarily of portfolios gained from Bard, posted $3 billion last year. Last year, surgery products brought in $1.2 billion, peripheral intervention solutions earned $1 billion, and urology and critical care offerings provided $800 million.

ANALYST INSIGHTS: With the CareFusion and Bard acquisitions behind it, as well as the divestiture of the CareFusion respiratory division (now Vyaire) to Apax Partners, BD is poised for its next move. As the top 10 medical device companies grow even larger and the healthcare landscape continues to change at a rapid pace, BD looks to remain as part of the medtech giants.

—Mark Bonifacio, Founder and President, Bonifacio Consulting Services

BD acquired Austin, Texas-based TVA Medical for an undisclosed sum last July. TVA Medical, which develops minimally invasive vascular access products for chronic kidney disease patients needing hemodialysis, won de novo clearance for its everlinQ endoAVF hemodialysis device just two weeks before the deal closed. The device uses a pair of thin, flexible magnetic catheters inserted into the ulnar vein and artery through a small puncture. An electrode from the venous catheter then delivers radiofrequency energy to the artery and vein’s connection to create an arteriovenous fistula, allowing hemodialysis access without open surgery. BD changed the device’s name to WavelinQ EndoAVF upon TVA’s integration into its peripheral intervention business.

The Medical franchise garnered $8.6 billion last year, rising 16.1 percent from the previous year. Medication delivery products (which posted $3.6 billion in sales last year, blossoming 29.6 percent) acquired from Bard were the main driver of the increase. Other underlying revenue growth arose from robust vascular access and vascular care sales, more dispensing and infusion system installations, prefillable syringe sales, and revenue from pen needles for diabetes.

BD completed the sale of its remaining stake in its respiratory solutions joint venture Vyaire Medical to joint partner Apax Partners to the tune of $435 million last April. BD and Apax formed Vyaire Medical in 2016 around BD’s respiratory diagnostics, vital signs, and AirLife businesses. Upon closing, Vyaire became an independent company, establishing itself as “the leading pure-play medical device company in the respiratory space,” according to an Apax press statement.

Medication management solutions gathered $2.5 billion of revenue last year, swelling 7.7 percent from 2017. The company launched new software to help identify drug diversion—a critical component of the opioid epidemic—at last November’s American Society of Health-System Pharmacists Midyear Meeting. The latest in the BD HealthSight platform for enterprise-wide medication management, the BD HealthSight diversion management application leverages data from the BD Pyxis ES system and electronic medical records to gather actionable insights for diversion investigations.

The diabetes care and pharmaceutical systems franchises respectively achieved sales of $1.1 billion and $1.4 billion, growing 4.6 and 11.2 percent.

The Life Sciences segment accrued $4.3 billion of proceeds last year, rising 8.6 percent. All three organizational units contributed to the gain. Improved sales of core microbiology products and the BD MAX molecular platform, research reagents and instruments, and a more severe influenza outbreak last year also padded this segment’s growth.

BD sold its Advanced Bioprocessing business to Thermo Fisher Scientific for $477 million last October. With revenue of about $100 million, the business includes a strong technical services program with a variety of peptones to enhance cell culture media formulations, which improve yield and reduce variability in biopharmaceutical applications.

Preanalytical systems posted a 5.5 percent revenue increase with $1.6 billion, but an FDA warning letter issued last January concerning modified BD Vacutainer blood collection tubes somewhat derailed sales. The letter cited that BD had marketed these tubes without proper clearance or approval and failed to submit medical device reports within the required timeframe. The violations were discovered through a July 2017 inspection of BD’s N.J. facility.

The inspection also revealed the company had not evaluated or investigated a complaint regarding inaccurate blood lead test results when the modified tubes were used with Magellan Diagnostics’ LeadCare test systems. The maligned modification concerned specific Vacutainer tubes’ rubber stoppers. As BD came to discover, Magellan LeadCare testing systems’ Anodic Stripping Voltammetry (ASV) technology is not compatible with thiuram, which is found in the aforementioned rubber stoppers. Last March, BD advised clinicians not to use BD Vacutainer EDTA Lavender, Pink, and Tan top tubes and BD Vacutainer Lithium Heparin Green top tubes when using assays employing the ASV methodology.

ANALYST INSIGHTS: Since its recent acquisition of Bard, BD seems to be highly internally focused to ensure its business units are focused on profitability to pay for the acquisition. While it’s unlikely BD will make major M&A deals in the near future, watch for the possibility of smaller, incremental deals to bolster its product lines.

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

The PAXgene Blood ccfDNA (circulating cell-free DNA) tube launched in Europe last February. Developed by PreAnalytiX GmbH, a joint BD-QIAGEN venture, the plastic blood collection tube for ccfDNA molecular diagnostic testing applications (for example, cancer and non-invasive prenatal tests) includes a sample stabilization additive and BD Vacutainer Hemoguard technology to protect healthcare worker safety. Clinical labs can use it to stabilize samples when a sample cannot be processed on the same day it was collected.

Diagnostics systems proceeds amounted to $1.5 billion last year, growing 11.5 percent. This area experienced more new product launch, approval, and clearance activity than any other franchise.

Last January saw CE mark clearance shared with Check-Points Health B.V. for the BD MAX Check-Points CPO assay, a molecular screening test for antibiotic-resistant CPOs (carbapenemase-producing organisms, which are resistant to carbapenem, an antibiotic used to treat severe or high-risk bacterial infections). The assay can detect the five most common carbapenemase genes in under 2.5 hours. The Check-Points CPO assay replaced an earlier version of the test from Check-Points.

The BD Onclarity HPV (human papillomavirus) assay obtained FDA approval last February. The test detects 14 types of high-risk HPV from specimens collected in a Pap test in a liquid-based cytology vial. The assay also identifies HPV genotypes associated with cervical cancers. Onclarity HPV is used as a primary screening test to triage patients with abnormal Pap test results, or can be used in conjunction with a Pap test. The test is run on the BD Viper LT benchtop molecular platform.

The company unveiled a suite of diagnostic informatics and automation innovations at last April’s European Congress of Clinical Microbiology and Infectious Diseases. The new informatics and automation solutions for clinical laboratories included:

• The BD Synapsys microbiology informatics solution for secure connectivity across instruments and locations
• The BD COR high-throughput molecular platform, which supports assays for women’s health, STIs, and GI applications
• BD Kiestra ID/AST modules that automate processing steps for bacterial identification and antibiotic susceptibility testing

Last October the firm introduced the BD MAX MDR-TB panel in Europe. The single PCR-based molecular test simultaneously detects tuberculosis-causing bacteria and determines that bacteria’s resistance to isoniazid and rifampicin, two first-line drugs. By adding the MDR-TB panel to BD’s BACTEC MGIT products, European clinicians can now test TB and multidrug resistance as a first line test, then provide broader drug susceptibility testing and patient monitoring.

The FDA cleared the BD Phoenix CPO detect test a month later. The test helps hospitals identify CPO infections in under 36 hours to implement infection control procedures, begin appropriate antibiotic therapies, and contain the spread of antimicrobial resistance. The CPO detect test is available in two configurations as part of the BD Phoenix automated microbiology system and is included on BD’s gram-negative panels.

The BD MAX enteric viral panel, a molecular test to detect viral gastroenteritis pathogens, acquired FDA clearance last December. The nod completed BD’s suite of molecular tests for GI infection, which now includes enteric panels for intestinal bacterial, viral, and parasitic infections. The BD MAX enteric viral panel returns results for norovirus, adenovirus, human astrovirus, and sapovirus infections in less than 3.5 hours.

The biosciences business grew 9 percent last year, earning $1.2 billion.

The BD FACSymphony S6 cell sorter hit the market last April. The new platform leverages the FACSymphony cell analyzer to sort cell populations and better understand cell phenotypes for immunology and multi-omics research. The S6 instrument offers six-way sorting and can support analysis up to 30 parameters, and its ultra-quiet electronics system was adapted from the defense industry.

BD made two notable investments in U.S. operations last year as well. About $150 million was invested last June in its existing Sumter, S.C., blood collection device manufacturing facility to create 125 jobs over the next few years. Last October, the firm also invested $200 million in its Nebraska facilities to create 300 jobs statewide. Over the last two years alone, BD has invested over $340 million in its Nebraska operations.

$12.1 Billion
GLOBAL HEADQUARTERS: Franklin Lakes, N.J.

Vincent Forlenza is obviously no stranger to blockbuster deals. Two years after claiming CareFusion for $12 billion, he decided it wasn’t quite enough to keep up with the string of megamergers rocking the medical device industry to counteract widespread slowdown in revenue growth as well as healthcare provider consolidation.

After all, he had elite (i.e., Top 30) companies to keep pace with. The medical device industry’s collective annual spit-takes began in April 2014, when orthopedic giants Zimmer and Biomet merged for a cool $13.4 billion. After medtech professionals had replaced their coffee-ruined computers, two months later, Medtronic made the announcement about a theretofore unheard of $43 billion-sized deal for Covidien. (Hopefully they had the wherewithal to turn their heads away from the screen this time.) A year later, Abbott made headlines for its $25 billion purchase of St. Jude Medical.

Last year, megamerger fervor came right into MPO’s backyard. Franklin Lakes, N.J.-based global medical technology firm Becton, Dickinson and Company (BD) proclaimed its intent to purchase Murray Hill, N.J. based C.R. Bard (Bard)—conveniently located about an hour’s drive apart without traffic—for $24 billion last April.

BD’s wide-ranging lineup includes products in diagnostics, diabetes care, injection, anesthesia, pharmacy, and laboratory automation. By bringing Bard into the fold, BD inherited a slew of oncology, vascular, urology, and specialty surgical offerings to tap into the market for devices used to treat vascular conditions and cancer.

ANALYST INSIGHTS: The BD and Bard integration is still underway, without a clear decision on the success of the merger. The slow process of integration is taking its time, as both companies were behemoths to begin with, and the critical synergies they were working towards have yet to be realized. Everyone is waiting to see which businesses and business units will start to operate separately or be sold off.

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

Vascular products were a particularly fruitful area for Bard. In 2016, they made up nearly a third of the company’s $3.7 billion in sales. BD has said that bringing Bard’s vascular products, particularly peripherally inserted central catheters, midlines, and drug delivery ports, together with its devices to prepare, dispense, and administer drugs, will help the combined company address a wider range of medication management needs. The companies together will also offer a more comprehensive lineup of products addressing surgical site infections and catheter-related bloodstream infections.

Bard’s portfolio will also empower BD to spread its treatment of disease states beyond diabetes. The combined company will be able to offer therapeutic products for diabetes, peripheral vascular disease, urology, hernia, and cancer.

“We will be able to partner (with providers) on fundamental treatment processes in a way that no one else can,” Forlenza told Reuters.

Both companies had historically garnered most of their sales from U.S. customers, but BD noted that Bard’s head start in international markets made it quite an attractive target. Bard currently has about 500 products already registered for sale overseas. Bard’s strong presence in vascular access and surgery will help to drive sales of the recently acquired CareFusion portfolio, and according to BD, Bard is among the fastest growing medical technology companies present in emerging markets.

“The combined company will have a large and growing presence in emerging markets, including $1 billion in annual revenue in China,” BD said upon the acquisition’s announcement.

Together, the companies have about $16 billion in revenue and is projected to enjoy annual revenue growth of 5 to 6 percent from this year to 2020, with earnings growth in the “mid-teens,” according to an investor presentation.

With the addition of Bard, BD created a third segment to join its Medical and Life Sciences businesses—BD Interventional. Timothy Ring, the previous chairman and CEO of Bard, joined BD’s Board of Directors when the transaction closed, along with an additional, unnamed Bard director. Tom Polen, previously executive vice president and president of BD’s Medical segment, was appointed president of BD the same day as the transaction. Polen joined BD in 1999, and will oversee all three businesses.

“This is an exciting time for BD,” he said in a company statement. “I am honored to serve in this new role as we continue our transformation into a medical technology leader focused on delivering solutions that advance the discovery, diagnostics, and delivery of healthcare globally and helping healthcare providers worldwide to improve both the process of care and the treatment of disease.”

ANALYST INSIGHTS: With the acquisition of Bard in its rearview mirror, BD is moving forward to strengthen its core portfolios in both Life Sciences and Medical Devices. It’ll be interesting to watch their next investments and which way they see their future unfolding.

—Dave Sheppard, Co-Founder and Principal, MedWorld Advisors

Under the deal, BD also said it expected to cut $300 million in annual costs by fiscal 2020. Naturally, some were worried about job cuts being a part of the cost-cutting process. Thankfully, BD spokesman Troy Kirkpatrick mollified those wary of getting the axe.

“There isn’t overlap in what we do and what Bard does,” he told USA Today. “So we are confident that the transaction will create career opportunities for their talented employees as part of a global industry leader.”

Let’s hope BD sticks to that plan.

The BD-Bard transaction closed three days before the end of 2017. Because BD’s fiscal year ends Sept. 30, Bard is not yet included in the company’s revenue. As such, even though BD stands poised to advance a few spaces forward in next year’s Top 30 report, the $12.1 billion of sales achieved in fiscal 2017 without Bard’s help actually represented a 3 percent loss from the year prior. The slight drop reflected the approximately 7 percent revenue decline due to BD’s shedding of its Vyaire Medical Respiratory Solutions business to private equity firm Apax Partners.

BD’s Medical Segment—comprised of medication and procedural solutions, medication management solutions, diabetes care, and pharmaceutical systems—fell 6 percent in 2017 revenue to reach $8.1 billion as a result of the Respiratory Solutions franchise divestiture. Apart from that, all remaining product categories posted increases last year. Medication and Procedural Solutions sales rose a slight 2.5 percent to $3.5 billion, driven by boosted proceeds from infusion disposables products, particularly in the international markets. Medication Management Solutions experienced a 4.4 percent hike with $2.3 billion in revenue. Pharmaceutical Systems grew 4.8 percent to $1.3 billion thanks to heightened self-injection systems sales. Diabetes Care expanded its revenue by 3.3 percent to post $1.1 billion, primarily as a result of improved pen needle sales in both the United States and emerging markets.

In a move that was overshadowed by the blockbuster Bard buy, BD closed the book on its purchase of Israeli infusion pump systems manufacturer Caesarea Medical Electronics (CME) last April. BD had previously gained a 40 percent ownership interest in CME upon acquiring CareFusion, and obtained the remaining 60 percent stake in the deal.

In November 2016, BD launched the U-500 Insulin Syringe, the first insulin syringe for diabetics taking Eli Lilly & Company’s Humulin U-500 insulin. It features a 6 mm x 31-gauge needle, the shortest of its kind available at the time of launch. The short needle minimizes risk of intramuscular injection and delivers the insulin into subcutaneous tissue. It also features clearly marked dosage labeling to prevent confusion and incorrect dosing.

The NeoPak 2.25 mL prefillable glass syringe hit the U.S., European, and Japanese markets a month later. It is specially designed for biopharmaceutical manufacturers making high-value, sensitive biologic drugs requiring higher quality levels and performance to treat chronic diseases like rheumatoid arthritis, psoriasis, lupus, and severe asthma. Neopak 2.25 mL was also designed to diminish unwelcome interactions, for example drug degradation or aggregation, between the primary container and drug.

Last January during the 53rd Annual Society of Thoracic Surgeons (STS) Meeting, the PleurX catheter system earned FDA 510(k) clearance to be used in specific non-malignant pleural effusions etiologies, including congestive heart failure. Initially approved in 1997 for managing malignant and recurrent pleural effusions, the new indication expanded the system to patients suffering from congestive heart failure and cardiogenic effusions.

“The system helps patients take control of their therapy by enabling them to manage fluid from pleural effusions outside of the hospital,” said Jim Leitl, BD’s worldwide vice president and general manager for Infection Prevention, V. Mueller, and Interventional Specialties. “Patients now have the option to potentially avoid the mental and physical toll of undergoing an additional hospital procedure.”

BD’s line of Snowden-Pencer 3.0 mm laparoscopic ergonomic take-apart instruments gained FDA clearance for laparoscopic surgery last June. The new instruments used in micro-laparoscopic surgery function like their 5.0 mm counterparts, with jaw lengths that mirror standard laparoscopic instruments. That way, surgeons can use a less invasive approach without compromising functionality. The new line’s launch gave BD one of the most customizable portfolios of 3.0 mm micro-laparoscopic instruments available—26 different jaw patterns, two different lengths (24 cm, 36 cm) and six take-apart handles, provide 312 combinations to target procedures in multiple specialties.

Last September, BD launched the Ultra-Fine micro pen needle 6 mm x 32G for leading pen injection devices. The shorter needle rounded out BD’s Ultra-Fine pen needle offering, which now includes 4mm x 32G, 5mm x 31G, 6mm x 32G, 8mm x 31G and 12.7mm x 29G. The needle helps prevent diabetic patients from injecting insulin into the muscle, and also ensures a comfortable injection experience due to micro-bonded needle lubrication for less friction.

BD’s Life Sciences business—which contains preanalytical systems, diagnostic systems, and biosciences offerings—rose a modest 4.2 percent to achieve $4 billion in 2017 revenue. Sales of preanalytical systems rose 4.4 percent to $1.5 billion. Diagnostics systems earned $1.4 billion, growing 5.9 percent from the year prior. Biosciences revenues posted $1.1 billion of sales, expanding 1.8 percent. Global sales growth was stimulated by boosted income from safety-engineered products, increased earnings from microbiology and molecular platforms (particularly in emerging markets), and augmented biosciences unit proceeds in developed markets.

On Halloween 2016, the MAX Vaginal Panel, a first-of-its-kind molecular test to detect the most common causes for vaginitis, won FDA market authorization. The assay is the first multiplex, real-time PCR test authorized to diagnose both vaginitis and vaginosis in women exhibiting vaginal infection symptoms. With the MAX Vaginal Panel’s introduction, labs and clinicians can use a single test to screen patients for microorganisms responsible for Bacterial Vaginosis, Trichomaniasis, and Vulvovaginal Candidiasis (yeast infection). The market authorization was granted under the de novo pathway.

Last January, BD launched Precise whole transcriptome analysis (WTA) kits to identify and quantify genetic information in individual cells for genomics-based research. WTA is usually used to determine if an under- or over-expression of certain genes are indicative of a specific set of physical characteristics, or phenotype. The kits include specialized agents to extract RNA molecules from individual cells, then “tag” each with a unique molecular signature to count individual instances of each molecule. Quantifying RNS cells comprising genes helps determine what makes healthy cells different from diseased cells.

The FACSVia flow cytometer system achieved FDA clearance last April. With a compact design that fits on a benchtop or within a hood, the system contains a leucocount reagent assay used in residual white blood cell enumeration. The BACSVia system provides blood banks and clinical labs with a cell analysis solution to help determine and quantify the presence of residual white blood cells in their blood products.

The company earned FDA 510(k) clearance for the MAX extended enteric bacterial panel last June. The molecular test targets infectious diarrhea by detecting harmful intestinal bacteria. It is the latest offering in the MAX enteric assays portfolio, which help to detect and diagnose acute gastroenteritis. It joins the MAX enteric bacterial and parasite panels to allow individualized testing based on the patient’s symptoms and health history.

A month later, the FACSLyric flow cytometer system won FDA clearance for use with the firm’s Multitest assays for immunological assessment of individuals and patients having or suspected of having immune deficiency. FACSLyric combines a benchtop-sized instrument with software, reagents, and services in order to ensure accurate, reliable, and repeatable results. FACSLyric supports the Multitest 4-Color assays and the Multitest 6-Color TBNK assay, whose metrics can be used together to evaluate the immunology of those who may have immune deficiency.

Four days before the close of BD’s fiscal year, it launched the Phoenix CPO (carbapenamase-producing organisms) detect test in Europe. CPOs, specifically carbapenem-resistant Enterobacteriaceae (CRE), are a prominent public health threat due to their resistance to nearly all available antibiotics, and are included on the World Health Organization’s priority pathogen list as critical threats. According to a 2015 study in the Journal of Antimicrobial Chemotherapy, rates of mortality associated with certain CPO infections vary widely from 22 to 72 percent. The Phoenix CPO detect test, included on Phoenix gram-negative panels, identifies CPOs and provides the Ambler classification of the enzyme produced in under 36 hours. That way, hospitals and labs can categorize antimicrobial resistance and rapidly implement infection control measures and select the appropriate antibiotics.

Last August, the FDA began an investigation that sought to determine a link between BD blood collection tubes and faulty results for Magellan Diagnostics’ LeadCare lead testing systems. Last May, Magellan had previously received an FDA warning for inaccurate results reported on blood samples. Prior to that, Magellan had said inaccurate results may be linked to a change in the composition of the tops of certain BD blood collection tubes. At the time, the FDA said they found several violations at BD’s New Jersey facility, but “have not determined that the BD tubes or any other brand of tube is linked to the cause of the inaccurate lead test results,” and “…are continuing to aggressively investigate the matter.”

The investigation ultimately led to a January 2018 warning letter citing that the company marketed certain BD Vacutainer blood collection tubes with significant changes to the rubber stoppers without required FDA clearance or approval, and failed to submit medical device reports to the FDA within the required timeframe. The inspection also revealed BD did not evaluate or investigate the previous complaints regarding Magellan’s lead testing systems. The company recalled the tubes in question this past March. The issue was discovered to be a chemical in the rubber tube stopper that interferes with the accuracy of Anodic Stripping Voltammetry testing methodology, which is used in Magellan’s LeadCare test.

$12.5 Billion
NUMBER OF EMPLOYEES: 50,928

Back in October 2014, BD made headlines when the company announced it was acquiring fellow MPO Top 30 perennial list member CareFusion for a purchase price of $12.2 billion. While the dust still hasn’t entirely settled on that transaction (although it did formally close in March 2015), BD made an even bigger splash in medtech M&A news in more recent months with the announcement that it would be gobbling up yet another member of MPO’s annual list. In April 2017, it was revealed that C.R. Bard would become the next acquisition for the medtech giant. At a purchase price of $24 billion, the transaction comes in just behind Abbott’s $25 billion price tag for St. Jude Medical Inc.—a deal that closed just days after the ball dropped to mark the start of 2017.

By comparison, BD’s 2016 fiscal year (which doesn’t follow the standard calendar, but instead runs from October through the following September) was relatively quiet in terms of acquisitions. Actually, BD ended up on the selling side a few times during the 12-month period.

Most notable, BD sold a controlling 50.1 percent of its Respiratory Solutions business to funds advised by Apax Partners. With the remaining 49.9 percent of the business, BD partnered with the global private equity firm in the formation of a new, stand-alone company of which Apax Funds is the majority owner. Vyaire Medical, the name of the new entity, was officially launched in October 2016 following the formal close of the transaction between BD and Apax.

“We have been proactively targeting the industry for respiratory devices and have been impressed with the continued progress the company has made over the past few years,” Steven Dyson, partner at Apax Partners, said in a release that first announced the sale. “We are pleased to have the opportunity to work with the entire team in further developing Respiratory Solutions’ position as a focused and leading global player. In order to take advantage of this opportunity, we are highly supportive of an investment program to further strengthen the business’s existing platform, both organically and through acquisitions.”

Vyaire Medical is made up of all the former BD Respiratory Solutions businesses, which included Ventilation, Respiratory Diagnostics, Vital Signs, and AirLife. At the time of the sale’s announcement, the combined estimated annual revenue of the individual pieces was $900 million.

“We are delighted to launch this new brand, Vyaire Medical, built on the foundation of excellent products, talented people, and the industry standard for service and support for our customers,” Dave Mowry, CEO of Vyaire Medical, said in a release announcing the launch of the new entity. “Our new company will be focused on providing improved patient outcomes and increased value to our customers through a collaborative partnership that brings innovation to these market segments.”

Analyst Insights: The core question for BD will be how to handle the CR Bard product portfolio. Bard struggled to gain meaningful global position with several of its smaller product lines and never matched the OUS position of its rivals. BD will need exceptional discipline to select which lines to keep and which to sell as well as building Bard into an international competitor of note.

—Tony Freeman, President, AS Freeman Advisors LLC

Further, BD performed two additional noteworthy divestitures during the 2016 fiscal year. In January, the company announced that it was selling its Rx business, including a pharmaceutical manufacturing plant in Wilson, N.C., along with the BD Simplist line of seven drugs that are provided in ready-to-administer, prefilled glass syringes, to Fresenius Kabi USA. In the same breath, the companies also declared that they signed a 10-year supply and distribution agreement under which Fresenius would supply BD with a portfolio of intravenous solutions. The other transaction alluded to previously was the sale of BD’s vertebral augmentation solutions business to Stryker. That transaction included the AVAmax, AVAtex, and AVAprep brand. The financial details and terms of the sales for both transactions were not disclosed.

BD did, however, have very positive financial news to disclose in terms of its 2016 fiscal year. The company moved up several spots on MPO’s Top Company list from the previous year, just as it had last year (No. 8 in 2016; No. 12 in 2015). With the official close of the CareFusion acquisition completed, the additional product offerings and revenue streams had a substantial impact on BD’s performance. The company’s revenues of $12.5 billion in 2016 reflected a 21.4 percent increase over 2015’s $10.3 billion (which had been a 21.7 percent increase over 2014’s $8.4 billion in revenues). Further, this performance was achieved in spite of the termination of a distribution agreement that was tied to the divested Respiratory Solutions unit and an unfavorable foreign currency translation impact of approximately 3.1 percent.

More specifically, looking at the volume growth that originated from specific units of BD, there were a number of areas that accounted for the overall gains the company saw in 2016.

The Medical segment experienced volume growth due to the Medication and Procedural Solutions unit’s sales of safety-engineered products, the Diabetes Care business’s sales of pen needles, and the Pharmaceutical Systems unit’s sales of self-injection systems. Life Sciences noted growth as a result of global sales of safety-engineered products from Preanalytical Systems, automated platform sales from Diagnostic Systems, and research instrument and reagent sales by the Biosciences unit. Infusion disposables and self-injection systems drove growth for the U.S. Medical segment. Internationally, safety-engineered and flush products drove growth for the Medical segment, while Life Sciences saw it from safety-engineered products, microbiology, women’s health platforms, and cancer platforms.

Examining the numbers for each segment of BD—Medical and Life Sciences—provides greater insight on where the company’s market strengths truly exist. The Medical segment, which accounted for $8.65 billion of the 2016 overall revenues, saw a 34 percent increase over 2015, a result of having the integrated CareFusion offerings as part of the company’s revenue streams for the full year (versus only half of the year in the 2015 fiscal year). Broken down further, by specific unit within the segment, the Medication and Procedural Solutions unit is the largest contributor to the company’s revenue, reporting $3.4 billion. The other units in the segment contributed revenue totals as follows: Medication Management Solutions—$2.2 billion; Diabetes Care—$1 billion; Pharmaceutical Systems—1.2 billion; and Respiratory Solutions—$824 million.

The Life Sciences segment contributed $3.8 billion to BD’s total revenues, a figure that was flat versus the prior year (up 0.2 percent). That segment is broken down into three, almost equal (in terms of revenue) units. Preanalytical Systems leads the segment with $1.4 billion, followed by Diagnostic Systems at $1.3 billion, and Biosciences posting $1.1 billion.

ANALYST INSIGHTS: Known for its solutions in cancer and diabetes, most were surprised when BD announced in May that it was acquiring CR Bard for $24 Billion. This acquisition will help BD leverage its global presence by accelerating end-to- end medication management and infection prevention, while creating new growth opportunities across a range of clinically impactful segments. It will also provide additional strength to BDs portfolio in the surgical arena. The key to success of this mega merger will very much be dependent on its execution of the post-merger integration.

—Dave Sheppard, Co-Founder and Principal, MedWorld Advisors

In terms of region, the company’s U.S. sales led revenue, representing $6.9 billion, compared to international sales that accounted for $5.6 billion. This was a reversal of 2015’s figures, which had international at $5.2 billion versus U.S. revenue of $5.1 billion. Again, the inclusion of CareFusion’s product lines had a direct impact on the increase in U.S. sales totals.

Enjoying increased sales revenues year over year from 2014 through 2016, the company mirrored those increases in its research and development spending. While a majority of the company’s R&D activity takes place within the United States, BD does conduct some internationally in China, France, India, Ireland, and Singapore. It also collaborates with universities and medical centers to further investigate potential new innovations. In total, BD spent $828 million on R&D in 2016. This represented a marked increase over 2015, during which $632 million was spent, and 2014, which saw R&D expenditures of $550 million.

Earlier investments in R&D are finally bearing fruit for the company as the 2016 fiscal year saw a fair number of notable product launches, FDA clearances/approvals, and CE mark notifications.

• • Genesis Low-Temperature Sterilization Containers: These surgical instrument sterilization containers are validated for the latest low-temperature processes, including STERIS’ V-PRO System and Advanced Sterilization Products’ STERRAD Systems. The containers have a visually differentiated set of orange components that make it unique compared to other Genesis containers. They also provide an environmentally friendly alternative to sterilization wrap.

• • FDA Clearance of New Syringe: This syringe was provided clearance for use with Humulin R U-500 insulin vials, required by diabetic patients requiring more than 200 units of insulin per day. The new syringe was developed to make it easier for users to draw the correct dose by reducing steps, avoiding potential errors.

• • Antimicrobial Vascular Dressings: BD teamed with Vancive Medical Technologies to launch a new line of transparent vascular dressings that contain a CHG antimicrobial preservative. The BD ChloraShield dressings are secured to a patient’s skin via Vancive’s BeneHold CHG adhesive technology. The dressings are easily applied and removed, and with the microbial growth inhibitor, they are suitable for catheter insertion sites.

• • Blood Collection and Separation Technology: BD received both a CE mark and FDA 510(k) clearance for its Vacutainer Barricor Tube. The system is a single-use, plastic evacuated tube used to collect, separate, transport, and process venous blood specimens to obtain high-quality plasma for in-vitro diagnostic use. The company claims the technology “improves sample quality, helps clinicians receive test results faster, and ultimately improves patient care and clinical efficiency.” It also states that the separator component reduces centrifugation time from 10 to three minutes.

• • Blood Collection Set: The company received FDA 510(k) clearance and a CE mark for the Vacutainer UltraTouch Push Button Blood Collection Set. The design employs the company’s PentaPoint Comfort 5-bevel needle technology, which studies have demonstrated reduces the chance of a painful injection. The flatter, thinner surface helps penetrate the skin with greater ease.

• • Automated Cervical Cancer Screening System: The BD Totalys MultiProcessor and BD Totalys SlidePrep instruments gained FDA approval during the 2016 fiscal year. These products, used in conjunction with BD’s FocalPoint SlideProfiler, compose the company’s Totalys System, “which further automates slide preparation, imaging, and review for use in cervical cancer screening, as well as providing ancillary testing aliquot capability.” The system is intended to be used by medium to high throughput cervical cancer screening labs, increasing workflow efficiency, reducing technician hands-on time and repetitive motion, and improving usability, user safety, quality, and functionality.

• • Wireless Rapid Diagnostic System: The BD Veritor Plus System is used to detect influenza A and B, respiratory syncytial virus (RSV), and group A strep. The system also offers traceability and secure patient health record documentation features and functionality. The technology enables lab-quality immunoassay test results within minutes without the need for a laboratory. The device can be used in physician offices, clinics, hospitals, and integrated delivery networks. When used in conjunction with BD’s Cloud Connectivity Solution, test data can be wirelessly and securely transmitted to a patient’s EMR or laboratory information system.

The Veritor system wasn’t the only example of BD’s interest in connected technologies in 2016. The company also announced a collaboration agreement with Edwards Lifesciences in which the two firms would enable interoperability between patient hemodynamic management and IV fluid administration. Specifically, the agreement leverages Edwards’ advanced hemodynamic monitoring systems and fluid management algorithms and BD’s (CareFusion) Alaris Infusion Systems.

“This collaboration builds on our history of innovation in patient monitoring infusion solutions and the investments we’ve made in our interoperability platform that integrates the Alaris Infusion System to HIT systems. We are excited to extend that interoperability capability to integration with patient monitoring. Our vision is to create interoperability with many different types of systems and devices to help improve the patient care, efficiency, and cost of IV therapy,” J.C. Kyrillos, worldwide vice president and general manager of Infusion Solutions for BD, said in a statement announcing the agreement.

Further addressing medtech connectivity, BD announced another “partnership” of sorts in which the company stated that it was using AT&T Internet of Things (IoT) services to connect its wireless health devices. At the 2016 Healthcare Information and Management Systems Society annual meeting, the company presented the aforementioned Veritor System, which leverages the AT&T technology. BD is continuing to work with the communications giant on wireless connectivity solutions for other products.

“This collaboration with AT&T further strengthens BD’s continued progress in health IT and is a significant step forward for the company in becoming a leader in medical IoT technology,” said David Feygin, vice president, Health IT and Strategic Innovation at BD. “We are continuing to evaluate how the addition of information technology to our current capabilities could further benefit our customers and patients.”

$10.3 Billion
NUMBER OF EMPLOYEES: 49,517

Quick pop quiz: Name the medical device OEM that owns GenCell Biosystems Ltd.

Hint: It’s the same company that purchased CRISI Medical Systems and Cellular Research Inc. last year.

Still stumped?

Here’s a final clue: This OEM was one of several that announced major, game-changing megadeals in 2014.

Give up?

The correct answer is Becton Dickinson and Company. The firm created quite a stir 21 months ago with its $12.2 billion bid for San Diego, Calif.-based CareFusion Corp., a manufacturer of patient safety-focused medical devices like smart infusion pumps and automated medication administration cabinets. The merger, in fact, was so consequential to the medtech industry that it overshadowed the company’s other acquisitions, which were equally as poignant to BD’s future as the CareFusion deal.

The GenCell Biosystems merger had virtually no chance of garnering any stage time, as it occurred merely a week after BD and CareFusion announced their union in October 2014. Nevertheless, the deal was a sound strategic investment for BD because it gave the company passage to the next generation sequencing (NGS) market, a sector slated to grow 20.8 percent annually over the next five years to reach $10.3 billion by 2021. The global NGS market currently is dominated by Illumina Inc., Thermo Fisher Scientific Inc., and Pacific Biosciences of California Inc., who together, claim a 94 percent stake in next generation sequencing platforms, according to online market research reports library ReportsnReports.com.

NGS is a new method for sequencing genomes at high speed, low cost, and great accuracy. “Next generation sequencing is a fast-growing space that represents a great opportunity for BD,” Becton’s Chairman, President, and CEO Vincent A. Forlenza told investors in an earnings conference call in November 2014. “As the NGS market moves to the clinic, BD is well-positioned with relevant experience in bringing products from research to clinical markets, pre-analytical sample collection, and sample preparation in Diagnostic Systems. BD will combine this experience with GenCell’s proprietary technology to meet unmet needs with upfront NGS workflow.”

GenCell’s Composite Liquid Cell (CLC) technology allows for open architecture microfluidics and smaller sample sizes, and eliminates plastic consumables, while being adaptable to various instrument configurations and applications.

At the time of its sale—the terms of which were not disclosed—the 3-year-old Irish firm had incorporated CLC on its fully automated genotyping platforms. GenCell won the 2013 Society for Laboratory Automation and Screening’s new product award for its Genotyper GT-Series, a device designed to enable continuous genotyping in miniaturized reaction volumes, sub 300 nL total volume with sample volumes of less than 100 nL (1 billion nanoliters equals one liter, or 1.06 quarts), allowing researchers to perform automated low-cost, high throughput applications.

“We want to build a capability that makes genomics a routine and easier-to-perform model. We have capabilities in the sector to enable researchers to acquire the exact type of cell they want to analyze,” Forlenza noted to India’s LiveMint blog in December 2015. “This [GenCell acquisition] provides an excellent platform to get into the genomics space.”

More of a foundation, really. BD followed the GenCell merger with the August 2015 purchase (terms undisclosed) of San Francisco Bay Area startup Cellular Research, a move that generated slightly more noise than its previous genomics deal, but still well below the decibel of the CareFusion acquisition.

Founded in 2011 by Stanford University and Silicon Valley entrepreneurs, Cellular Research created tools for massively parallel single-cell genetic analysis based on its proprietary molecular indexing technology. Similar to DNA barcoding techniques, molecular indexing encodes individual mRNA molecules within single cells at the time of reverse transcription, enabling the generation of highly multiplexed gene expression profiles.

The company’s molecular indexing science was not lost on BD—the two companies had collaborated for nearly a year before the merger on single-cell analysis workflows that operated with both entities’ tech platforms. The purchase, however, diversified BD’s integrated sample prep workflow offering for quantifying and studying individual gene cell expression.

Prior collaboration also prompted BD’s scantly-hyped takeover of Surgical Site Solutions Inc. and CRISI Medical Systems Inc. in the winter of 2015. Becton partnered with CRISI in June 2013 to jointly develop a medication management solution (dubbed Intelliport) for manual IV bolus injections. Surgical Site Solutions, contrarily, had teamed up with CareFusion (pre-BD merger) to create the ClipVac pre-surgical hair removal system. The device—an attachment to CareFusion’s surgical clippers—vacuums up 98.5 percent of hair and airborne contaminants, reducing the need for secondary cleanup measures in surgical and/or ancillary settings.

“While much of the spotlight this past year was on…the CareFusion acquisition, we also made strategic investments in life sciences, which remains an important growth driver as we aim to improve lab efficiency and outcomes from sample to diagnostic result,” Forlenza reminded shareholders in his annual letter. “During the [fiscal] year, we advanced our chronic disease management strategy, expanding our impact in diabetes management beyond products for insulin injection. By all measures, fiscal 2015 was a historic year for BD, unlike any other in our 118-year history.”

Indeed, the historic milemarkers were plentiful in FY15. The CareFusion deal was easily BD’s largest, most momentous purchase, doubling the size of its Medical segment and propelling total revenue past a record $10 billion. In addition, the company began the year with more products than ever in its pipeline, and it landed a spot on Fortune magazine’s inaugural “Change the World” list, which acknowledged companies that make a considerable impact on major social or environmental problems as part of their competitive strategy.

The company’s historic fiscal year haul resulted directly from the CareFusion acquisition. The deal—finalized on March 17, 2015—bumped up total revenue 21.7 percent to $10.28 billion and boosted the company’s gross margin 9.1 percent to $4.7 billion, according to BD’s fiscal 2015 annual report.

U.S. sales prospered from the merger as well—proceeds jumped 48.4 percent to $5.07 billion due to a virile flu season, growth in research reagent revenue and instrument placements, and the strength of BD’s overal medical product portfolio. International sales were somewhat stymied by volatile exchange rates, but still climbed 3.6 percent to $5.21 billion.

“We delivered strong growth in the U.S. region, and because CareFusion revenues are predominantly derived from developed markets, we will continue to see more balanced top-line contributions from the U.S. and international markets going forward,” Forlenza said in his shareholder letter. “Overall, our financial results for fiscal 2015 were very strong…”

Particularly in the Medical segment, the main beneficiary of the CareFusion inheritance. Expanding from three business units to five (Diabetes Care, Medication Management Solutions, Medication and Procedural Solutions, Pharmaceutical Systems, and Respiratory Solutions), segment revenue surged 41.3 percent to $6.46 billion and operating income swelled 18.5 percent to $1.53 billion. Executives attributed the increases to $1.5 billion in CareFusion’s U.S. product sales during the second half of FY15 (year ended Sept. 30) as well as strong demand for flush and safety-engineered devices.

The Medication and Procedural Solutions unit posted the largest financial gain in fiscal 2015, rising 23.5 percent to $2.85 billion. Revenue from the two new units, Medication Management Systems ($1.03 billion) and Respiratory Solutions ($419 million), helped offset losses in Diabetes Care and Pharmaceutical Systems. Diabetes sales slid 2.4 percent to $1.01 billion, while Pharmaceutical proceeds fell 5 percent to $1.16 billion.

Diabetes revenue may very well recover in FY16, as BD and Medtronic are jointly developing a new insulin infusion set with the novel FlowSmart technology, which was previously approved by the U.S. Food and Drug Administration (FDA) in May last year. The new set, designed for use with insulin pumps sold in the United States, features a smaller needle (30 gauge) that causes less insertion site trauma. Studies have shown that the technology has significantly fewer flow interruptions and blockages than regular sets.

BD’s Life Sciences segment will similarly benefit in fiscal 2016 from the late-year (2015) launch of the FACSseq high-throughput cell sorter, a device designed to solve “significant” unmet needs in single-cell analysis, and FDA approval of the MAX Enteric Parasite Panel. The latter product is the latest assay in the MAX suite that helps diagnose infectious gastroenteritis. It is a qualitative in-vitro test that detects DNA from Giardia lamblia Cryptosporidium (C. hominis and C. parvum), and Entamoeba histolytica in both unpreserved and 10 percent formalin-fixed stool specimens.

The BD MAX system automates sample preparation, extraction, nucleic acid amplification, and detection. The new panel, combined with the MAX Enteric Bacteria Panel, can detect the pathogens responsible for up to 95 percent of the bacteria that cause gastroenteritis.

“The BD MAX Enteric Parasite Panel addition to the menu will further streamline our workflow, improve turnaround time, and free up staff that were previously running EIA [enzyme-linked immunosorbent assay] testing manually,” Annette Monterrubio, microbiology and molecular biology system technical coordinator at St. Luke’s Health System in Boise, Idaho, said upon the product’s approval. “I believe this will greatly benefit patient care.”

So will the BD MAX CT/GC/TV and CT/GC assays, which received CE mark clearance in March 2015. The assays are used to detect sexually transmitted diseases like chlamydia, gonorrhea, and trichomonas vaginalis from a single specimen in one run. Urine samples can be used for testing, as well as self-collected vaginal swabs. Once loaded onto the BD MAX platform, results can be generated in less than three hours. The system, according to BD, combines automated extraction, real-time PCR amplification, and detection.

Though BD’s MAX platform proved popular with customers, it failed to significantly boost sales. Life Sciences revenue remained essentially flat, shrinking $50 million (1.3 percent) to $3.82 billion. Diagnostic Systems proceeds flatlined at $1.3 billion, though BD executives boasted of global sales growth in analytical platforms like Veritor, Kiestra, and BACTEC. Likewise, Preanalytical Systems revenue declined 1.5 percent to $1.39 billion despite solid gains in safety-engineered product sales. Segment operating income fell 2.5 percent to $839 million due to volatile exchange rates.

Despite Life Sciences’ sagging sales, Forlenza remained confident of BD’s future.

“With our progress in fiscal 2015 and our growth strategies for fiscal 2016 and beyond, we are very well positioned to become a more customer-centric provider of quality, innovative healthcare products and solutions,” he said. “A company focused on increasing access, improving outcomes, mitigating healthcare system cost pressures, and protecting patients and healthcare workers.”

$8.5 Billion
NO. OF EMPLOYEES: 30,619

Talk about foreshadowing.

In late 2013, Vincent A. Forlenza espoused the virtues of corporate evolution and adaptability to Becton Dickinson and Company shareholders. “…no matter where you are in the world, healthcare is under significant pressure and scrutiny. I strongly believe that by partnering with our customers and other industry stakeholders we are more effective in facing the pressure head-on, innovating and evolving to deal with such challenges,” the chairman/president/CEO wrote at the start of BD’s FY13 annual report. “Throughout BD’s entire history, we have always adapted to meet the needs of our customers and demands of the industry. In order to remain a relevant healthcare leader and help our customers address their biggest challenges, we are committed to evolving again.”

Partnering with industry stakeholders. Evolving…again.

Forlenza couldn’t possibly have fathomed the prescient nature of his words at that moment. Or maybe he did.

Mere days after FY14 ended, Forlenza announced his company’s $12.2 billion merger with San Diego, Calif.-based CareFusion Corp., manufacturer of patient safety-focused medical devices like smart infusion pumps and automated medication administration cabinets. The purchase price was nearly three times CareFusion’s value on its first day of trading, when it closed with a $4.2 billion estimated worth.

The deal is quite the coup d’état for Forlenza, as it allows the chief executive (who will lead the combined entity, of course) to meld both firms’ complementary product portfolios into a formidable patient safety solutions provider, offering hospital clients integrated systems to maximize patient outcomes in infection prevention, respiratory care and acute care procedural effectiveness.

“CareFusion focuses a lot on medication dispensing and targets cutting healthcare custs through efficiency,” Bloomberg Intelligence analyst Jason McGorman told The San Diego Union-Tribune. “That may help hospitals cut costs and reduce infections, both of which are goals from Obamacare [the Patient Protection and Affordable Care Act].”

Indeed, CareFusion is a departure from BD’s traditional growth strategy of smaller, tuck-in acquisitions and thus may present some integration challenges not posed by previous deals. But many potential benefits exist—not the least of which is the boost it most certainly will give to BD’s bottom line: Industry analysts expect the deal to be double-digit accretive to Becton’s cash earnings per share (EPS) as early as this current fiscal year (ending Sept. 30). The company also is likely to adopt cash EPS reporting, which will allow the stock to be valued on a higher earnings base, Leerink Swann & Co. Senior Equity Research Analyst Richard Newitter predicted last year.

To minimize its integration risk exposure and limit the firm’s total debt load, BD trimmed $250 million from its operating expenses through overhead cost-cutting, combining operations and scaling down certain manufacturing operations. Company executives said the savings would be fully realized by 2018.

A wise financial move, for sure, but the downsizing’s estimated savings nevertheless is dwarfed by the $13.8 billion debt BD listed on its second-quarter 2015 balance sheet (ended March 31), more than quadrupling the $3.97 billion it owed at FY14’s close (ended Sept. 30, 2014). Most of the increased debt stems from the $7.7 billion in bonds, term loans and cash the company is using to finance the CareFusion marriage (at a 2.6 percent average interest rate).

The spike in debt prompted Moody’s Investors Service, the credit rating agency of Moody’s Corporation, to downgrade Becton’s senior unsecured ratings to Baa2 from A3 after the deal was finalized in March. The credit agency cited BD’s weakened liquidity profile, its questionable strength in emerging markets, its ability to help reduce medication errors, and its increased vulnerability to America’s fickle market for hospital capital equipment as reasons for the lower ratings.

Shrinking sales surely was a determinant as well, though Moody’s didn’t specifically address the likelihood that BD’s 4.5 percent to 5 percent annual revenue growth rate will dip below 4 percent with CareFusion under its wing. Industry analysts, however, expect any sales decline to be offset by “turbo-charged” earnings as the combined entity morphs into a medication management enterprise, controlling the delivery of therapy to patients—inside and outside the hospital—from syringes to dispensing and drug infusion pumps.

JPMorgan Chase & Co. analyst Michael Weinstein predicts Becton’s bottom-line growth to jump 5 percent to 12.7 percent through 2018—”accretion [that] will be hard to ignore.” The earnings expansion more than compensates for the sales decrease; thus the sacrifice “is a trade-off investors will be willing to make,” Weinstein wrote in his upgrade of BD stock last fall.

By expanding its scale of operations and its product portfolio, the new and improved BD is expected to have a greater influence with the hospitals it supplies. A fair portion of the company’s lineup traditionally has been commodity-based disposables, while CareFusion’s offerings often have been more difficult for healthcare institutions to swap out.

“We see the customer base changing rapidly around the globe,” Forlenza said when the mega-merger was announced. “We see them consolidating, and we think that the low-hanging fruit in healthcare cost savings have been achieved by the customer base. That means hospitals have to do business differently and that requires the re-engineering of processes. [With] this deal, we’re able to put together and end-to-end process system and really attack, with great transparency, a process that is central to running a hospital—the medication management process. You can only do that if you have scale in the opportunity, and breadth. And when I say breadth, I’m not talking about more products in the bag, I’m talking about things that fit together as a solution that enables you to re-engineer a process. I think there are people who are going for solutions, I think there are other industry players that are going for breadth, and I would characterize that as more products in the bag. This [deal] is about solutions. We think that positions us very well in an industry where the buying process is moving up in the organization, and they’re looking for strategic partners.”

Obviously, the CareFusion purchase radically enhanced BD’s collaborative appeal, but it was not the company’s only hookup last year. Becton also acquired privately held diagnostic instrument firm Alverix Inc. for $40 million; the pair worked together since 2008, designing and developing the BD Veritor System, a device that can rapidly detect Flu A + B. In addition, Becton joined forces with Microsoft and Healthbox to help nurture medtech startups, and with Israel’s Office of the Chief Scientist to further develop the country’s medical device industry.

“These relationships give BD access to some of the world’s best science, technology and entrepreneurs—all with the goal of incenting the entrepreneurial community to consider and pursue early-stage business concepts that align with BD’s strategic interests,” Forleza explained in the FY14 annual report. “Our aim is to create a portfolio of partnerships comprised of small financial investments with opportunities for deep, hands-on engagement and strategic exploration.”

And profits, of course. Forlenza is hoping BD’s new partnerships will help the firm evolve well beyond FY14’s financial results, though it might take some time before the company reaps the full rewards of all its unions (particularly the CareFusion merger). BD had a fairly profitable year in fiscal 2014, growing total revenue 4.8 percent to $8.4 billion and expanding both its basic and diluted EPS by more than 28 percent. Gross margin climbed 3.1 percent to $4.3 billion but net income fell 8.3 percent to $1.18 billion.

Cash flow from operations remained solid, totaling $1.7 billion, and the company returned $800 million to shareholders through a combination of buybacks and dividends.

More than 60 percent of FY14 sales ($5 billion) were international transactions, with more than 25 percent originating in emerging markets, according to the annual report. China, Latin America and India accounted for nearly 15 percent of total revenue while the United States comprised 40.5 percent at $3.4 billion.

Becton’s three business segments gave flawless performances, with each achieving solid increases in their respective swan songs (the firm restructured its business units as of Oct. 1, reducing its reporting divisions from three to two—BD Medical and BD Life Sciences). The Medical segment led in growth, boosting sales 6.2 percent to $4.5 billion due to strong emerging market and international safety proceeds. Across-the-board increases in the segment’s three product divisions didn’t hurt either: Medical Surgical Systems sales rose 5 percent to $2.3 billion, while Diabetes Care and Pharmaceutical Systems revenue jumped 7 percent and 7.6 percent to $1 billion and $1.2 billion, respectively.

BD bigwigs attributed Diabetes Care growth to strong pen needle sales, particularly the BD Ultra-Fine Nano, BD PentaPoint and AutoShield Duo products, the latter of which is now sold in retail pharmacies. Pharmaceutical Systems, on the other hand, benefited mainly from the first-quarter 2013 purchase of Safety Syringes Inc., a Carlsbad, Calif.-based developer of needle guard products for prefillable syringes.

The Diagnostics segment followed a similar growth trajectory, expanding revenue through strong performances in both its divisions as well as higher diagnostic platform proceeds. Diagnostic Systems sales drivers included the BD Max, BD Affirm, BD BACTEC blood culture and tuberculosis systems and BD Phoenix automated microbiology system. Those gains, however, were somewhat offset by weaker sales of the company’s Women’s Health and Cancer platform—due mostly to U.S. guidelines for increased pap smear testing intervals—and share losses related to the BD ProbeTec and BD Viper systems.

Despite the setbacks, Diagnostic segment revenue climbed 2.5 percent to $2.7 billion compared with FY13. Preanalytical Systems proceeds rose 4.4 percent to $1.4 billion on strong sales of safety-engineered products, including the BD Vacutainer push button blood collection set. Diagnostic Systems sales rose 0.6 percent to $1.3 billion.

Biosciences segment revenue jumped 5.2 percent to $1.15 billion. Executives attributed the gain to double-digit emerging market sales growth, strong clinical reagent revenue worldwide and solid instrument placements in both Asia and the United States.

$8.05 Billion
NO. OF EMPLOYEES: 29,979

Charles Darwin would have made for a phenomenal entrepreneur. The English naturalist/geologist not only had the drive, determination and intelligence to succeed, he also conceived a winning business formula, though it originally was intended to explain the process of evolution by natural selection.

Darwin believed that life arose by common descent through a branching pattern of evolution, where species lineages—derived from common ancestral clans—changed over time through natural selection and other mechanisms. Survival, he famously theorized, depends not on strength or intelligence, but rather on adaptability to environmental factors.

Since its 1859 publication, business executives have used Darwin’s evolutionary thesis as the basis of their own survival strategies. “Over the past century, BD’s success depended on our ability to adjust to changes in the healthcare environment and continue to deliver value to our customers,” Becton Dickinson and Company Chairman/President/CEO Vincent A. Forlenza noted in his fiscal 2013 shareholders letter. “In order to remain a relevant healthcare leader and to help our customers address their biggest challenges, we are committed to evolving again.”

BD is ensuring its survival by partnering with customers, governments and other healthcare stakeholders to help solve the industry’s most pressing challenges. The company formed several new alliances in fiscal 2013, including a union with the prestigious Harvard Business School and non-profit consulting firm FSG to establish an executive training curriculum that helps enterprises create new opportunities for growth by focusing specifically on addressing unmet societal needs.

BD also aligned itself with Direct Relief and the National Association of Community Health Centers to expand healthcare services to America’s underserved and vulnerable populations. The company is funding care models for diabetes management and cervical cancer prevention at community clinics throughout the country, and supplying health centers with its insulin syringes to help treat uninsured and under-insured diabetics.

Additionally, BD teamed up with the College of American Pathologists to improve laboratory quality in China and India.
Specifically, the joint effort aims to improve access to external quality assurance/proficiency testing (PT), raise awareness of global practice standards, and help more labs achieve their quality improvement goals. BD has promised to manage PT distribution, including sales, shipping and first-line client service.

Perhaps the most notable collaboration, however, occurred in late September (near the end of BD’s fiscal year) with the World Health Organization agreement to develop and launch the Odon device, a new obstetrical instrument designed to gently maneuver fetuses through the birth canal during complicated second-stage labor. C-sections extensively are performed to address prolonged labor in high-income markets like the United States and Western Europe, but the procedure is far less accessible in developing countries, where most maternal and newborn deaths occur.

“Healthcare is often described as a stable industry, but I do not agree with that assessment,” Forlenza said. “What became abundantly clear to me in the last few  years is that no matter where you are in the world, healthcare is under significant pressure and scrutiny. I strongly believe that by partnering with our customers and other industry stakeholders we are more effective in facing the pressure head-on, innovating and evolving to deal with such challenges. I’m confident that despite the challenges and shifts in healthcare, we have positioned ourselves for ongoing success. Throughout BD’s entire history, we have always adapted to meet the needs of our customers and demands of the industry.”

Such adaptability helped BD grow sales 4.5 percent to $8 billion in fiscal 2013 (ended Sept. 30), boost net income 10.5 percent to $1.2 billion and increase its dividend to shareholders for the 41st consecutive year. In addition, gross margin climbed 5.5 percent to $4.1 billion and BD’s cash flow of $1.7 billion absorbed the impact of the 2.3 percent medical device excise tax mandated by the Affordable Care Act.

Emerging markets played a key role in BD’s overall fiscal 2013 growth, as revenues swelled 12 percent on strong performances from India, Latin America, the Middle East and certain Asian markets. China led the pack with a 20 percent year-on-year growth, bolstering Asia Pacific revenues 14 percent to $1 billion compared with FY12. Europe bolstered sales 5.6 percent to $2.5 billion while U.S. proceeds succumbed to weaker demand for women’s health and cancer products. Nevertheless, U.S. sales edged up 2 percent to $3.3 billion.

BD’s three business segments also fortified the firm’s FY13 sales gains, turning in solid performances compared with the previous year. The Medical segment made the largest contribution, growing its bottom line 5.3 percent to $4.3 billion due mostly to emerging market sales and a 3.5 percent revenue hike in safety-engineered products. Across-the-board increases within the segment’s three divisions didn’t hurt either: Medical Surgical Systems sales rose 4.3 percent to $2.1 billion, while Diabetes Care and Pharmaceutical Systems revenue both jumped 6.3 percent to $969 million and $1.1 billion, respectively.

Bigwigs attributed Diabetes Care growth to strong pen needle sales, particularly the BD UltraFine Nano and BD PentaPoint products as well as the AB AutoShield Duo Pen Needle. Pharmaceutical Systems, on the other hand, benefited mostly from the buyout of Safety Syringes Inc., a Carlsbad, Calif., company that develops and markets needle guard products for prefillable syringes (the tube is fitted with a safety that automatically locks into place). Analysts claim the buyout will help the company expand its prefilled syringes business.

In a nod to BD’s Business Darwinism corporate philosophy, the Medical segment secured its evolutionary survival through a handful of U.S. Food and Drug Administration (FDA) clearances and product launches, including the approvals of the BD UltraSafe Plus Passive Needle Guard, an anti-needlestick safety device; and the BD PhaSeal Closed System Transfer Device, a product designed to reduce healthcare workers’ exposure to hazardous, parenteral medications. The segment’s launches were spread throughout the year’s second half, with the UltraSafe Plus Passive Needle Guard hitting the market in April 2013, the Neopak Glass Prefillable Syringe System (specifically engineered to administer biopharmaceuticals) and BD UltraFine Nano 4mm Pen Needle with EasyFlow Technology debuting in June, and the BD Sterifill Advance first appearing in mid-August.

The Diagnostics segment followed a similar growth stratagem, boosting sales through strong performances in both of its divisions as well as higher safety-engineered product proceeds. Popular sales drivers included the BD Vacutainer Push Button Blood Collection Set, the BD Affirm system, the BD Bactec blood culture and TB (tuberculosis) systems, and the BD Phoenex ID/AST platform. The company also profited from a stronger flu season in 2013 and the FDA approvals of its BD Max Cdiff Assay in the United States, the BD ProbeTec Trichomonas Vaginalis Qx Amplified DNA Assay, and the nasopharyngeal wash, aspirate and swab in transport media specimens on the BD Veritor System for the rapid detection of respiratory syncytial virus.

The new device approvals and increased demand for safety-engineered products helped push Diagnostics segment sales to $2.6 billion, a 4.3 percent increase compared with FY12. Preanalytical Systems proceeds rose 3.9 percent to $1.3 billion, and Diagnostic Systems profit jumped 4.6 percent to $1.2 billion.

Biosciences segment sales climbed 2 percent to $1.1 billion, but profit was stymied by unfavorable foreign exchange rates and tepid demand in Western Europe.

“We announced a plan at the start of fiscal 2013 to continue delivering earnings growth through increased revenues and improved operating effectiveness,” Forlenza said in the annual report. “I am happy to report that we achieved our goals.”

Those achievements did not come without sacrifice, however. Ongoing legal drama sent FY13 diluted earnings per share (EPS) tumbling 11.8 percent to $4.67. The culprits included a $22 million pre-tax charge to settle four class-action lawsuits that accused the company of violating federal anti-trust laws in an effort to monopolize the market for hypodermic needles. The suits charged Becton Dickinson with crowding out competitors by offering discounts on a bundle of products in return for exclusivity in its hypodermic needle sales. Plaintiffs also argued that BD improperly gave warrants for company stock to group purchasing organizations, which negotiate prices for hospitals.

The other impediment to EPS growth came from a courtroom defeat in the company’s prolonged patent litigation battle with Little Elm, Texas-based Retractable Technologies Inc. A federal jury awarded Retractable Technologies damages after finding that BD attempted to monopolize the market for safety syringes and falsely advertised about the sharpness of its needles and the amount of waste space for its products. BD recorded a $341 million pre-tax charge in relation to the verdict, but Senior Vice President and General Counsel Jeffrey S. Sherman has vowed to appeal the decision.

$ 7.8 Billion
GLOBAL HEADQUARTERS: Franklin Lakes, N.J.

Becton Dickinson (BD) and Co.’s Medical, Diagnostics, and Biosciences divisions brought the company a total of $7.8 billion in sales, up 6.2 percent, for fiscal year 2011, (ended Sept. 30). Despite an uptick in sales for the year, net earnings were relatively flat. The company’s profit totaled $1.27 billion, down slightly from $1.31 billion in 2010. Almost $4.5 billion in sales were from international markets.

Sales for BD Medical (which includes products for anesthesia, infusion therapy, injection, sharps disposal and surgery; diabetes care; and surgical systems) increased 5.6 percent to $4 billion. BD Diagnostics (diagnostics and prenatal systems recorded earnings of just under $2.5 billion, an increase of 7 percent. BD BioSciences (cell analysis and discovery labware) grew sales by 6.7 percent to $1.3 billion.

BD made two strategic acquisitions during the fiscal year. In March it acquired Accuri Cytometers Inc., a company dedicated to manufacturing personal flow cytometers for researchers. Cytometry is the science of measuring and examining cells. The company was folded into BD’s Biosciences division, and Accuri’s signature product now is known as the BD Accuri flow cytometer, and has a variety of applications even outside the medical space such as environmental studies.

In September just before the close of the fiscal year, BD closed the acquisition of Carmel Pharma AB, a Swedish company that manufactures the BD PhaSeal system. The PhaSeal system is a closed-system drug transfer device for the safe handling of hazardous drugs that are packaged in vials. Carmel and the technology it brought with it were added to enable BD’s Medical Surgical Systems unit to “enter early stage market with significant long-term growth potential,” according to a letter to shareholders penned by CEO Vincent Forlenza (who became chief executive in June 2011 after successfully holding key leadership positions at the company throughout the years) and Chairman Edward Ludwig.

FY2011 also saw the release of a few new products.

The Vacutainer Rapid Serum Tube was released in October 2010. The blood collection device is designed to aid acute healthcare facilities in rapidly analyzing blood serum for patient diagnosis, and has 510(k) clearance from the U.S. Food and Drug Administration. The device is claimed to facilitate a five-minute clotting time and as little as three minutes of centrifugation, saving an alleged 32 minutes of laboratory time.

Some other notable products releases include: The BD AutoShield Duo Pen Needle, a next-generation product designed to protect healthcare workers from needlestick injuries and blood exposure at both the front and back ends of the needle launched by the Diabetes Care unit; The BD MAX System, a fully automated system designed for a range of molecular testing released by the company’s Diagnostic Systems unit; and the BD FACSVerse Flow Cytometer, introduced by the Cell Analysis unit. Overall, new products accounted for 8 percent of total revenues in FY2011.

The focus of FY2011 was research and development with an eye on the future, rather than contemporary product releases per se. FY2012 already is promising to be a much busier year in terms of technology, having already seen the release of three new products thus far, according to the company’s leadership.

“Our current product pipeline is the most robust in company history,” Forlenza and Ludwig told shareholders in the company’s annual report. “We have plans to launch more innovative products across our segments through fiscal years 2012 and 2013.” Future technologies are set to target diabetes, cancer, chronic and infectious diseases, and HIV/AIDS among other healthcare needs.

Becton Dickinson was among the companies affected by the Tohuku earthquake and tsunami of March 11, 2011, in Japan. The company’s Fukushima manufacturing plant closed down temporarily, while its Tokyo office was undamaged. No BD employees were injured or killed. The company donated $325,000 to relief efforts, being heavily invested in the Japanese device web. BD also matched donations from employees globally to the American Red Cross and the U.S. Fund for UNICEF.

BD’s company ethic of social responsibility did not end with Japan. During the fiscal year, BD sent human and monetary resources to Haiti to continue efforts one year after the earthquake of 2010; to Australia and New Zealand to help in flood recovery efforts; and to the Red Cross to aid in recovery following the Mississippi River flooding in the United States. Charitable donations also were made to help the victims of Hurricane Irene and the floods in the Northeast region.

$7.4 Billion
NO. OF EMPLOYEES: 28,803

It may not have been a banner year for Becton Dickinson and Company, but it most certainly was a solid year. In an overall rough financial market, Becton Dickinson managed to put out a steady stream of notable products and, for the 38th consecutive year, increase its dividend to shareholders. This continued tradition is one in which Director Emeritus Henry P. Becton, who died in October 2009 at age 95, would have been proud.

In FY10, which ended Sept. 30, 2010, Becton Dickinson’s board of directors declared a quarterly dividend of 41 cents per common share, an increase of 4 cents per share, or 10.8 percent from the previous quarter.

“We delivered against our own internal targets and against our commitments to our shareholders,” said Edward J. Ludwig, chairman and and CEO. “This is the 10th consecutive year Becton Dickinson has achieved its annual objectives….We are pleased to be able to continue to create value for our shareholders while also making strategic investments for Becton Dickinson’s future.”

Becton Dickinson reported total revenues of $7.4 billion in fiscal 2010, a 5.5 percent increase over fiscal year 2009 (5.6 percent on a currency-neutral basis). Business segments remained steady from FY09: BD Medical saw the biggest increase of 6.7 percent (6.2 percent on a currency-neutral basis) to $3.8 billion. In an earnings call with investors in November 2010, Chief Financial Officer and Executive Vice President David Elkins attributed the growth mainly to the diabetes care business. While this increase is extremely modest when compared with FY09, it more than accounted for the absence of the ophthalmic systems unit, which was sold to RoundTable Healthcare Partners in August 2010.

Becton Dickinson also unloaded its critical care and extended dwell catheter product platforms to Argon Medical Devices Inc., a portfolio company of RoundTable (the financial terms of these agreements were not disclosed). These platforms were classified as discontinued operations for all quarters, except for a portion of assets related to the extended dwell catheter product platform.

The company’s other segments increased at about the same rate: BD Diagnostics increased 4.2 percent (4 percent on a currency neutral basis), to $2.3 billion—but the segment took a 2 percent hit after the H1N1 flu pandemic caused sales to spike in the first half of the previous fiscal year.

“For the second half of the fiscal year (2010), the pandemic flu resulted in an almost 2 percent negative impact to our revenue growth, due to the international pandemic revenues that we recorded in the second half of fiscal year 2009 that did not repeat in the fiscal year 2010,” Elkins said. The net impact to revenues for the full year was about 20 basis points benefit, according to Elkins. Additional Biosciences stimulus and supplemental orders in the United States and Japan benefited FY2010 by about 50 basis points.

BD Biosciences, which was driven by strong instrument and reagent sales in the company’s cell analysis business, increased 4.4 percent (6.8 percent currency neutral) to $1.2 billion. Data showed a 4 percent to 7 percent decline in OB/GYN visits in the last two quarters, but the company offset that loss over the full year basis.

“We are proud of our accomplishments during 2010,” Ludwig said in the company’s 2010 published annual report. “We met our financial and operational goals despite the challenging macroeconomic climate facing our industry.”

Becton Dickinson kicked off FY2010 with its only acquisition of the year, of Ann Arbor, Mich.-based HandyLab Inc., a manufacturer of molecular and diagnostic assays and automation platforms, for $275 million.

The company’s fiscal 2010 operational goals also included expanding its presence globally. Becton Dickinson established new manufacturing facilities in San Luis Potosi, Mexico, in March; Tatabanya, Hungary, in April; and Mebane, N.C., in May.

Besides the opening of several new facilities, the year marked the launch of several notable products; the BD Vacutainer Push Button Blood Collection Set With Pre-Attached Holder debuted in the third quarter. The set was designed to protect healthcare workers from accidental needle stick injuries. The third quarter was a busy one for the segment—it also turned out the BD Max GBS Assay, the first U.S. Food and Drug Administration-cleared assay for the detection of Group B Streptococcus on the BD MAX System, and the BD Ultra-fine Nano, the world’s smallest pen needle, which provides a less painful injection experience for patients with diabetes while retaining the effectiveness of a larger needle.

Fiscal year 2010 also saw the promotion of President Vince Forlenza, who now is president and chief operations officer. Forelenza has overseen operations for each of the company’s business segments since January 2009. In January 2010 he also assumed responsibility for the Integrated Supply Chain and Information Technology functions.

“In addition, in 2010, we maintained consistent operational excellence across the P&L (profit and loss),” Ludwig explained. “We invested in capital expenditures, invested in emerging market infrastructure, increased our investment in R&D (research and development) and delivered steady predictable cash flow and return to shareholders through both dividends and share repurchases.”

10. Becton Dickinson

$7.2 Billion

KEY EXECUTIVES:
Edward J. Ludwig, Chairman and CEO
John R. Considine, Vice Chairman
Vincent A. Forlenza, President
Gary M. Cohen, Exec. VP
William A. Kozy, Exec. VP
David V. Elkins, Exec. VP and Chief Financial Officer
Scott P. Bruder, M.D., Ph.D., Sr. VP and Chief Technology Officer
David T. Durack, M.D., Sr. VP, Corporate Medical Affairs
Jeffrey S. Sherman, Sr. VP and General Counsel
William A. Tozzi, Sr. VP and Controller
Patricia B. Shrader, Sr. VP, Corporate Regulatory and External Affairs
Richard K. Berman, VP and Treasurer
Patti E. Russell, VP and Chief Ethics and Compliance Officer

NO. OF EMPLOYEES: 29,116

GLOBAL HEADQUARTERS: Franklin Lakes, N.J.

Becton Dickinson and Company belongs to an elite group of businesses that investors like to call “dividend aristocrats.” The moniker is not reserved for companies with old fashioned-sounding names, or those that have wealthy capitalists serving on their boards of directors. Rather, dividend aristocrat is the name given to companies that consistently have increased dividends to shareholders over the last 25 years.

Dividend aristocrats, according to the unofficial definition set forth by financial analysts and investors, have averaged annual total returns of 12.93 percent since 1989, beating the S&P 500 total return of 11.66 percent by 1.3 percent annually. These companies experience the economic peaks and valleys associated with any normal business cycle, but still manage to reward their shareholders with increasing payments through dividend growth.

Becton Dickinson consistently has rewarded its shareholders with dividend increases for 37 years, a distinction that undoubtedly has made it more attractive to investors. The honor certainly has made the company more attractive to billionaire Warren Buffett (chairman of Omaha, Neb.-based holdings firm Berkshire Hathaway Inc.), who recently purchased 1.2 million shares of Becton Dickinson stock worth an estimated $86.6 million.

Buffett’s shares are worth considerably more money now, thanks to a 12 percent dividend increase (to $1.48) announced in November 2009. Besides the dividend increase, shareholders also received $550 million in stock value through share repurchases. Truly an aristrocratic move.

Maintaining that perfect record of dividend increases has not been so easy, though, particularly in fiscal 2009, ended Sept. 30. The company reported a trivial 1 percent increase in revenue to $7.2 billion and an anemic 1.3 percent rise in its gross margin (52.6 percent).

“Fiscal 2009 was one of the most challenging years we have faced during our tenure as leaders at Becton Dickinson,” Chairman and CEO Edward J. Ludwig and President Vincent A. Forlenza told shareholders in a letter published in the company’s 2009 annual report. “We continued to experience a difficult global business environment and foreign exchange fluctuations which significantly impacted our revenues; however, our diversified portfolio steadied us and, as a result, we continued to grow.”
Some of that growth was explosive, too. Net income rose 9.2 percent to $1.2 billion, and earnings per diluted share jumped 11 percent to $4.99. Operating income swelled to $1.6 billion, a 7.4 percent increase compared with the $1.5 billion the company reported in fiscal 2008. And, revenue grew by the double digits in both Latin America and Asia Pacific.

Not all revenue grew by such leaps and bounds, though. Many of the company’s fiscal 2009 sales figures either were flat or barely reckonable.

The difficult business environment that Ludwig and Forlenza mentioned in their letter to shareholders was most evident in Becton Dickinson’s three business segments, which adversely were affected by foreign currency exchange rates, reduced inventories by U.S. companies and spending cuts by governments in developing markets. Executives did their best to put a positive spin on segment earnings, but the numbers could not mask the significant declines in revenue growth compared with fiscal 2008, when each of the sectors experienced double-digit increases (the mean growth in the sectors in fiscal 2008 was 13.3 percent, compared with 1.3 percent in fiscal 2009).

BD Medical—the segment that typically earns the most money for Becton Dickinson—generated only $11 million in additional revenue, collecting a total of $3.7 billion in fiscal 2009. Executives attributed the drop in revenue to foreign currency exchange rates, which impacted sales by 5 percentage points.

The medical surgical systems unit within the Medical segment reported $1.9 billion in sales, a 1 percent decrease compared with the $2 billion the unit posted in fiscal 2008. As in past years, the unit’s financial health was dictated by sales of safety-engineered products and pre-filled flush syringes. Safety-engineered product sales rose 2 percent in the United States and 13 percent internationally, though that growth was offset by an unfavorable foreign exchange rate impact of 12 percentage points.
Diabetes care products were the most profitable for the segment and perhaps prevented it from operating at a loss in fiscal 2009. The unit generated $715 million, a 3 percent increase compared with the $694 million it earned for the company in fiscal 2008. Sales were driven mainly by worldwide pen needle sales.

Demand for pharmaceuticals in Europe and the Asia Pacific region led the pharmaceutical unit to post nearly $1 billion in sales in fiscal 2009. That figure included $25 million from the sale of flu-related products during last year’s H1N1 pandemic. Ophthalmic systems product sales, meanwhile, remained flat at $79 million.

With medical sales flat, BD Diagnostics became the breadwinning segment in fiscal 2009, generating $2.2 billion in sales for the company. That figure represents a 3 percent increase compared with the previous fiscal year’s total revenue of $2.1 billion. Sales saviors included the molecular BD ProbeTec, BD Viper and BD Affirm systems, as well as BD Bactec blood culture and tuberculosis systems and the BD Pheonix ID/AST platform. Cervical cytology screening tests and those that detect MRSA (methicillin-resistant staphylococcus aureus) infections were popular as well: Revenue from the sale of TriPath products (cervical cytology) climbed $11 million to $130 million, while proceeds from GeneOhm products (MRSA detection tests) rose $9 million to $51 million.

Growth in BD Biosciences mimicked that of the Medical segment, rising a meager 1 percent to $1.2 billion or 2 percent on a currency-neutral basis. Revenue, according to the annual report, was impacted in the United States by cuts in research grant funding and internationally by dwindling demand for instruments in Latin America, Asia Pacific and Japan.

Such shrinking demand partly was responsible for flat sales outside of the United States in fiscal 2009. International sales revenue totaled $4 billion, with Western Europe, Asia Pacific and Latin America leading volume. Domestic sales, by contrast, grew 3 percent to $3.2 billion.

During the fourth quarter, Becton Dickinson received an infusion of $51 million from the sale of its Ace brand and elastic bandage product lines to 3M, a global technology company based in St. Paul, Minn. 3M executives said the Ace product line would broaden the company’s consumer product choices. Becton Dickinson’s Ace product brand dates back to 1914, when the company manufactured the first elastic bandages in the United States.

$7.2 Billion
NO. OF EMPLOYEES: 28,000

Franklin Lakes, N.J.-based Becton Dickinson always has been a steady financial performer. Despite difficulty in financial markets at the end of the year and increased raw material costs, fiscal 2008 (ended Sept. 30) was no exception to the firm’s historically solid results.

One of the company’s mottos is: “Helping all people live healthy lives.”

It seems that positioning the company to respond to this directive also results in a healthy bottom line.
Company revenues of $7.2 billion for the year represented an increase of 13 percent compared to fiscal 2007, which reflects an overall estimated 6 percent favorable impact from foreign currency translation that affected all three of the company’s product segments—Medical, Biosciences and Diagnostics. Income from continuing operations rose significantly to $1.1 billion, up 31.7 percent.
“We are pleased to report another strong year for BD, one in which we exceeded our strategic and financial goals despite a challenging business environment,” said Edward J. Ludwig, chairman and CEO. “All segments contributed to our success and growth. Implementation of disciplined spending controls enabled us to expand our operating margins as we continued to make significant capital and R&D [research and development] investments to support our innovation strategy.”

Revenue for BD Medical (the largest slice of the company’s sales pie) rose by 11 percent over 2007 to $3.8 billion, which reflects an estimated 6 percent favorable impact from foreign currency translation. Key growth contributors, according to the company, were Pharmaceutical Systems and Diabetes Care products. Safety-engineered devices continued to be an important contributor, increasing by 10 percent globally, with an estimated 2 percent favorable impact from foreign currency translation, company officials noted. Sales in the United States of safety-engineered devices grew 5 percent to $1 billion in 2008, from $987 million in 2007.

International sales of safety-engineered devices grew 29 percent to $534 million in 2008 from $414 million in 2007, with an estimated 11 percentage points of such growth coming from the favorable impact of foreign currency translation. In 2009, the company expects sales of safety-engineered devices to increase about 5 to 6 percent in the United States and 11 to 12 percent internationally, after taking into account an estimated unfavorable foreign exchange impact of about 9 percent.

The Medical division’s principal product lines include needles, syringes and intravenous catheters for medication delivery; pre-filled IV flush syringes; syringes and pen needles for the self-injection of insulin and other drugs used in the treatment of diabetes; pre-fillable drug delivery devices provided to pharmaceutical companies and sold to end-users as drug/device combinations; surgical blades/scalpels and regional anesthesia needles and trays; critical care monitoring devices; ophthalmic surgical instruments; sharps disposal containers; and home healthcare products such as ACE brand elastic bandages.

Revenue for the company’s Diagnostics unit grew 13 percent compared to 2007, reaching $2.2 billion in sales, including a 5 percent favorable impact from foreign currency translation. The Pre-analytical Systems unit grew 12 percent to $1.1 billion, with an estimated 5 percent favorable impact from foreign currency translation. Global sales of safety-engineered products increased 14 percent, with an estimated 4 percent favorable impact from foreign currency translation, due, in large part, to strong sales of BD Vacutainer Push Button Blood Collection Sets, the company noted. Revenues for the Diagnostic Systems product group increased 15 percent, with an estimated 4 percent favorable impact from foreign currency translation, and reflected growth from cancer diagnostics products and infectious disease testing systems.

BD’s Biosciences revenues rose by 16 percent to $1.2 billion. As with the other sectors, the figure includes roughly a 6 percent favorable impact from foreign currency translation. The Cell Analysis unit of the division grew 19 percent. Sales of the BD FACSCanto II (clinical analyzer) and BD FACSAria II (research sorter) and clinical reagents significantly contributed to the strong growth.

Part of the company’s growth is attributable to solid research and development efforts, and an eye toward strategic expansion. In 2008, BD, which is more than 110 years old, invested nearly $1 billion in new capital investments and R&D. In April 2008, the company opened a new manufacturing facility in Suzhou, China, to produce rapid diagnostic products. In June, it opened yet another plant—a $34 million expansion—in Quebec, Canada. A $53 million facility to produce cell culture media is under way in Florida. In addition, a large state-of-the-art facility to produce pre-fillable syringes is under construction in Tatabánya, Hungary.

The plant, which is more than a $100 million investment for BD, is expected to open in 2010. Also noted for its numerous philanthropic activities, including helping to fight HIV/AIDS in Africa, in 2008 it was named one of America’s most admired companies by Forbes magazine, as well as one of the world’s most ethical companies by Ethisphere magazine.
BD kicked off 2009 with new faces in the front office. Vincent A. Forlenza was named president, and David V. Elkins became executive vice president and chief financial officer (replacing John Considine, who remains vice chairman).

Forlenza will oversee BD’s three business segments in addition to International and Quality. He will continue to be a member of the Office of the CEO, along with Considine, Executive Vice Presidents Gary Cohen, John Hanson and William Kozy, and Elkins, who will join the office of the CEO. Forlenza joined BD in 1980.

He was named executive vice president in 2006 and was most recently responsible for leading BD Diagnostics. Elkins will be responsible for executive management and oversight of BD’s global financial operations. He joins BD from AstraZeneca, where he has served since 2006 as vice president, chief financial officer, North America and Global Marketing, a $13 billion business.

Considine continues his oversight of the company’s Integrated Supply Chain department; Information Technology; Environment, Health and Safety; Project Management and Engineering Services; and Security.

So far, for the six months of fiscal 2009 (ended March 31), reported diluted earnings per share from continuing operations were $2.32, an increase of 12.5 percent compared to diluted earnings per share from continuing operations of $2.16 from 2008.

For the first half of the year, revenues in the United States were $1.6 billion, an increase of 1 percent from the prior year period. Revenues outside of the United States were $1.9 billion, representing an increase of 0.5 percent from FY08 (including an estimated 6 percentage points of unfavorable impact from foreign currency translation).

$6.4 Billion
NO. OF EMPLOYEES: 28,000

For the 2007 fiscal year (ended Sept. 30), Becton Dickinson & Co. continued the steady growth and performance the industry has come to expect from this 110-year-old medical device maker. According to Ed Ludwig, chairman, president and CEO, in the past eight years, BD’s revenue and profit base has more than doubled.

Headquartered in Franklin Lakes, NJ, BD, which is comprised of three major segments (Medical, Diagnostics and Biosciences), has operations in more than 50 countries.

The company bested its 2006 financial performance by 11%. Total revenue for the year was $6.4 billion, compared with $5.7 billion for the prior year. The total reflects an overall estimated 3% favorable impact from foreign currency translation that affected all segments. Income from continuing operations was $856 million, or $3.36 per diluted share, in 2007, as compared with $815 million, or $3.18 per diluted share, in 2006

The Medical segment—the largest slice of the BD revenue pie—reported 10% revenue growth to $3.4 billion. Strong sales in the Medical division’s Pharmaceutical Systems unit continued to significantly contribute to the growth of the segment, the company said, along with the continued global conversion to safety-engineered products. The Pharmaceutical Systems unit grew by 24%, reflecting the increased use of pre-fillable syringes by pharmaceutical companies to market new vaccines and biotech drugs, especially in the United States. Revenue growth in the Medical Surgical Systems unit primarily was driven by the growth in safety-engineered products and pre-filled flush syringes, according to company officials. Sales of safety-engineered products increased 6% in the United States and 30% internationally. For 2008, the company said it expects full-year revenue growth for the Medical division to be about 8%.

The Medical division’s principal product lines include needles, syringes and intravenous catheters for medication delivery; pre-filled IV flush syringes; syringes and pen needles for the self-injection of insulin and other drugs used in the treatment of diabetes; pre-fillable drug delivery devices provided to pharmaceutical companies and sold to end-users as drug/device combinations; surgical blades/scalpels and regional anesthesia needles and trays; critical care monitoring devices; ophthalmic surgical instruments; sharps disposal containers; and home healthcare products such as ACE brand elastic bandages.

For the BD Diagnostics segment, there was revenue growth of 11% to $1.9 billion, which includes $88 million of revenues from TriPath Imaging, a maker of innovative solutions to improve the clinical management of cancer, which was acquired at the end of the first quarter of fiscal 2007 for approximately $350 million. Sales of safety-engineered products rose by 25% internationally and 9% in the United States, due in large part to BD Vacutainer Push Button Blood Collection Set conversion activity, the company said.

Principal products and services for the Diagnostics business include integrated systems for specimen collection; an extensive line of safety-engineered blood collection products and systems; plated media; automated blood culturing systems; molecular testing systems for sexually transmitted diseases and hospital-acquired infections; microorganism identification and drug susceptibility systems; liquid-based cytology systems for cervical cancer screening; and rapid diagnostic assays.

At the beginning of fiscal 2008, BD received FDA clearance for the BD GeneOhm StaphSR assay. According to the company, the new assay is the first test available to rapidly and simultaneously identify two deadly healthcare-associated infections—Staphylococcus aureus and methicillin-resistant Staphylococcus aureus—from patients with positive blood cultures. It will help enable physicians to implement the right treatment quickly and more cost effectively for patients with bloodstream infections.

In June, BD officially opened the GeneOhm manufacturing facility in Québec, Canada for its Diagnostic business. The $34 million facility will manufacture and develop diagnostic tests that provide rapid detection of bacterial organisms, including those known to cause healthcare-associated infections. The 64,500-square-foot facility includes 30,200 square feet of new manufacturing space.

The company’s Biosciences segment reported 13% revenue growth to $1 billion, resulting from continued strong sales of flow cytometry and bioimaging instruments, flow cytometry reagents and advanced bioprocessing products. Principal product lines include fluorescence-activated cell sorters and analyzers; cell imaging systems; monoclonal antibodies and kits for performing cell analysis; reagent systems for life-sciences research; tools to aid in drug discovery and growth of living cells and tissue; cell culture media supplements for biopharmaceutical manufacturing; and diagnostic assays.

In May, BD acquired all of the outstanding stock of Cytopeia, a privately held Washington corporation based in Seattle that develops and markets advanced flow cytometry cell sorting instruments. Terms of this transaction were not disclosed.

The steady financial gains appear to continue into 2008. For the first six months of fiscal 2008, overall revenues for the six months ended March 31 were $3.5 billion, an increase of 12%. Both the Biosciences and Diagnostic business segments posted 15% revenue increases. The Medical segment, still the largest sales generator at $1.8 billion, grew 9.6% for the first half of the year.

Notably, one way BD has distinguished itself over the past few years has been through many of its humanitarian projects. For example, to help fight the HIV/AIDS crisis in sub-Saharan Africa, the company, along with the International Council of Nurses, is establishing wellness centers in four countries hardest hit by the HIV/AIDS pandemic and healthcare worker shortages. The centers will provide comprehensive health services for thousands of healthcare workers and their families. According to BD officials, the goal is to sustain a healthy and productive healthcare workforce, leading to a stronger regional healthcare delivery system. The centers offer testing, counseling and treatment for HIV/AIDS and tuberculosis; prenatal services; stress management; screening for chronic conditions; and training for continuous professional development, including prevention of occupational exposures. BD is providing $120,000 in cash support to help fund the wellness centers, as well as training in safe injection and phlebotomy practices valued at more than $200,000.

$5.8 Billion

Key Executives:
Edward J. Ludwig, Chairman, President and CEO
John R. Considine, Sr. Exec. VP and CFO
Gary M. Cohen, Exec. VP and President, Medical
William A. Kozy, Exec. VP and President, Diagnostics
David T. Durack, Sr. VP, Corporate Medical Affairs

No. of Employees: 27,000

World Headquarters: Franklin Lakes, NJ

According to Ed Ludwig, chairman, president and CEO of Beckton, Dickinson and Co. (BD) in Franklin Lakes, NJ, his company’s revenue and earnings growth for fiscal year 2006 exceeded expectations and provided “continuing confidence that our strategy is sound and our implementation disciplined.”

BD manufactures medical surgical systems, including anesthesia and infusion therapy devices, injection products, sharps disposal products and surgical products. The company also produces a wide range of diabetes care devices, diagnostic systems, and has been a leading manufacturer of engineered-safety devices to protect healthcare workers.

For fiscal 2006 (ended Sept. 30), BD reported record revenues of $5.8 billion, representing an 8% increase compared to fiscal year 2005. Of the company’s three divisions—Medical, Diagnostics and Biosciences—the Medical Division was the clear revenue driver at $3.2 billion, which is an increase of 8%. The division is comprised of four units: Medical Surgical Systems, Diabetes Care, Pharmaceutical Systems and Ophthalmic Systems. BD attributes strong sales in the Pharmaceutical Systems and Diabetes Care units as two of the most significant contributors to the division’s success for 2006—both grew at 14% and 12%, respectively, for fiscal 2006.

Overall, international sales marginally outpaced US sales. Revenues in the United States were $2.8 billion, a 9% increase compared to last year’s sales, while international sales were $3 billion, an increase of 6%.

According to BD, revenue growth in the Medical Surgical Systems unit primarily was driven by the growth in safety-engineered products and pre-filled flush syringes. The Diabetes Care unit’s revenue growth reflected strong sales of pen needles worldwide.

In September, BD announced its plan to exit the blood glucose monitoring (BGM) market. The company said the move would impact its distribution of blood glucose meters in addition to sales of related test strips, which will continue to be distributed until December of this year. BD said the decision to exit the market would not affect other Diabetes Care products, including insulin syringes, pen needles and lancets, but added that it has made a commitment to provide test strips until patients find alternative products. BD entered the blood glucose monitoring market in early 2003 with the introduction of the BD Logic blood glucose monitor.

“After careful consideration, we concluded that our future outlook in the increasingly competitive BGM market did not justify the levels of investment and additional resources necessary to continue,” Ludwig said in a letter to shareholders. “We remain solidly committed to our overall Diabetes Care business, as we have been since pioneering the development of insulin injection devices in 1924. Revenue derived from insulin delivery products exceeds $500 million annually and grew more than 9% this year over fiscal 2005.”

The company’s Diagnostics Division reported sales of $1.8 billion, a 6% increase from 2005. The BD Biosciences segment reported revenues of $877 million. The company cited flow cytometry instruments and reagents and a recently discontinued distribution agreement as the strongest growth factors.

In September, BD announced plans to purchase TriPath Imaging, based in Burlington, NC. TriPath, which manufactures cancer diagnostic products, is expected to broaden BD’s line of diagnostics. The deal, worth $350 million, was completed in December.

Facility expansion seems to be part of BD’s game strategy for 2007. The company is planning a $34 million capital investment in a 64,500-square-foot facility in Québec, Canada, where it currently leases space. The facility is intended to meet growing demand for its molecular diagnostic tests for the rapid detection of bacterial organisms, including those known to cause healthcare-associated infections. Construction is scheduled for completion in May 2008.

BD also recently announced plans to expand its Treyburn facility in Durham, NC to consolidate and increase US manufacturing capacity for its Discovery Labware products, including BD Falcon products. The $25 million capital investment project is expected to create 28 new positions in 2007 and a total of 100 by the end of 2008, building on the 285 employees at present. Approximately 50,000 square feet of manufacturing space will be added.

Financially, the first half of 2007 also is in expansion mode and on track to meeting company and analyst expectations. For the first two quarters, the company reported $3 billion in net sales. The first quarter was an 8% rise compared to the same quarter for 2006. Second quarter was an 11% increase. For the six-month period ended March 31, the BD Medical segment reported 10% revenue growth.

$3 Billion ($41.3B Total)
No. of Employees: 25,600

Becton, Dickinson and Co.’s medical device segment registered double-digit increases in revenues last year as its sales of safety-engineered products and blood glucose monitoring products were strong drivers in growth. The safety-engineered products leaped 28% outside of the United States while growing 7% domestically. Blood glucose monitoring products brought in $76 million in 2005.

In addition to those two product lines, BD Medical boosted its revenues by 11% with the help of pre-filled IV flush syringes, pen needles for insulin injection and pre-fillable syringes sold to pharmaceutical companies. BD Medical encompasses four units: Medical Surgical Systems, Diabetes Care, Pharmaceutical Systems and Ophthalmic Systems. The Diabetes Care unit had the biggest gain in 2005 with a 17% jump to $182 million that included double-digit increases both internationally and domestically. Medical Surgical Systems is the largest unit of the four with $429 million in sales, a 9% rise in 2005. BD Medical is just one third of the entire BD company, which also includes Diagnostics and Biosciences divisions. Overall, the company’s sales rose 10% in 2005 along with the profit, which grew by 54% with the help of increased revenue and productivity.

“Our excellent results this year were driven, in particular, by our strong international performance, new product revenue growth and significant margin improvement,” said CEO Edward J. Ludwig, whose company increased its spending on R&D by 13%. “Our Asia Pacific/Japan, Canada, Europe and Latin American regions contributed double-digit revenue growth, and the combination of higher margin products and increased operating effectiveness drove margin expansion.”

The division was also helped by the launch in the United States and Europe of the BD Nexiva Closed IV Catheter System to improve the way infusion therapy is delivered and to enhance safety for both patients and healthcare workers.

In 2005, some of the more popular products in the BD Medical division were the BD Hypak prefilled syringe with the BD Preventis automatic needle shielding system, BD SoloMed syringe, BD PosiFlush Saline and Heparin Lock Flush Syringes and the BD Logic Blood Glucose Monitor.

The company did experience a recall in the first half of fiscal 2006. In February, BD Medical announced a voluntary recall for its blood glucose meters after a malfunction was reported that would affect the units of measure displayed on the meters. If the malfunction occurs and goes unnoticed, it is possible that users may misinterpret test results and change their diet or medication in a way that can result in temporary periods of high or low blood glucose and subsequently may require medical intervention.

In the most recent quarter, the second quarter of fiscal 2006, the Medical division continued its strong surge with a 9% rise in revenues to $795 million, while in the first six months of 2006 the Medical unit reported a 10% jump. The second quarter was bolstered by a strong showing in Diabetes Care and Pharmaceutical Systems units.