Prior Fiscal: $15.98 Billion
Percentage Change: +8.8%
No. of Employees: 70,093
Global Headquarters: Franklin Lakes, N.J.
Tom Polen, President and CEO
Christopher R. Reidy, Exec. VP, CFO, and Chief Administrative Officer
John A. DeFord, Ph. D., Exec. VP and Chief Technology Officer
Simon D. Campion, Exec. VP and President, Interventional
Patrick Kaltenbach, Exec. VP and President, Life Sciences
Alberto Mas, Exec. VP and President, Medical
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.
Q2 2020 Revenue: $4.25 Billion
Q2 2019 Revenue: $4.16 Billion
Percentage Change: +2.2%
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.