07.20.23
Rank: #5 (Last year: #5)
$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
Global Headquarters: Franklin Lakes, N.J.
KEY EXECUTIVES:
Thomas E. Polen, Board Chairman, CEO, and President
Christopher J. DelOrefice, Exec. VP and CFO
Michael Garrison, Exec. VP and President, Medical Segment
Richard Byrd, Exec. VP and President, Interventional Segment
David B. Hickey, Exec. VP and President, Life Sciences Segment
Vishy Kanda, Sr. VP and Chief Strategy Officer
Elizabeth McCombs, Exec. VP, Chief Technology Officer
David Shan, Exec. VP and Chief Quality Officer
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.
“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.
$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
Global Headquarters: Franklin Lakes, N.J.
KEY EXECUTIVES:
Thomas E. Polen, Board Chairman, CEO, and President
Christopher J. DelOrefice, Exec. VP and CFO
Michael Garrison, Exec. VP and President, Medical Segment
Richard Byrd, Exec. VP and President, Interventional Segment
David B. Hickey, Exec. VP and President, Life Sciences Segment
Vishy Kanda, Sr. VP and Chief Strategy Officer
Elizabeth McCombs, Exec. VP, Chief Technology Officer
David Shan, Exec. VP and Chief Quality Officer
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.