BD Reports Third Quarter Fiscal 2023 Financial Results

2023-08-03

财报

Continues Strong Performance and Progress Toward Achieving BD 2025 Strategy; Advances Innovation Pipeline and Receives Clearance for Updated BD Alaris™ Infusion System

Revenue of $4.9 billion increased 5.1% as reported and 6.3% on a currency-neutral basis

Revenue from base business (which excludes COVID-only diagnostic testing) grew 6.7% as reported, 7.9% currency-neutral or 6.3% organic

GAAP and adjusted diluted EPS from continuing operations of $1.36 and $2.96, respectively

Company raises full-year base organic revenue growth guidance; maintains full-year adjusted EPS guidance

FRANKLIN LAKES, N.J., Aug. 3, 2023 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced results for its third quarter of fiscal 2023, which ended June 30, 2023.

"We continue to deliver strong results and this quarter is another reflection of our consistent execution against our BD 2025 goals." said Tom Polen, chairman, CEO and president of BD. "Our teams are working unwaveringly to achieve key milestones that set us up for continued growth and consistent performance. We are very pleased to deliver our number one priority since launching BD 2025 – achieving 510(k) clearance for the updated BD Alaris™ Infusion System – allowing us to bring this updated system to our customers and their patients."

Recent Business and ESG Highlights

Received FDA 510(k) clearance for the updated

BD Alaris™ Infusion System.

Completed the sale of the

Surgical Instrumentation platform in the

Surgery business unit of the BD Interventional segment to STERIS for $540 million.

BD Medical:

The

Medication Delivery Solutions business unit announced expanded customer availability of

BD PosiFlush™ SafeScrub, an all-in-one prefilled flush syringe. The innovation is part of the company's

vascular access management portfolio and further drives the BD

"One-Stick Hospital Stay" vision.

BD Life Sciences:

The

Biosciences business unit announced the worldwide commercial launch of the

BD FACSDiscover™ S8 Cell Sorter, the world's first spectral cell sorter with high-speed real-time cell imaging. The new-to-world instrument features two breakthrough technologies,

BD CellView™ Image Technology and

BD SpectralFX™, that enable researchers to uncover more detailed information about cells that was previously invisible in traditional flow cytometry experiments.

The

Biosciences business unit launched the

BD FACSDuet™ Premium Sample Preparation System, a new robotic system to automate

clinical flow cytometry and improve standardization and reproducibility in cellular diagnostics.

The

Integrated Diagnostics Solutions business unit received FDA 510(k) clearance for the new

BD Kiestra™

MRSA imaging application that uses artificial intelligence powered by

BD Synapsys™ Informatics Solution to interpret bacterial growth.

Opened a new R&D facility in Dublin, which will focus on the commercialization of the

Pharmaceutical Systems business unit's first on-body injector device, known as the

BD Evolve™ On-Body Injector.

Issued

FY 2022 ESG Report, with notable progress in energy and waste reduction, health care access and diversity.

Earned

HIRC Transparency Partner Badge from the Healthcare Industry Resilience Collaborative (HIRC), demonstrating BD's commitment to transparency as a foundation of supply chain resiliency and progress toward the company's 2030+ ESG goals.

Named a "Noteworthy Company" in DiversityInc's annual ranking of the

top U.S. companies for diversity.

Recognized as a

Best Place to Work for Disability Inclusion for the fifth consecutive year. Top score on 2023 Disability Equality Index® demonstrates ongoing progress in creating employment opportunities for people with disabilities.

Named to U.S. News & World Report's inaugural

"Best Companies to Work For" list.

Third Quarter Fiscal 2023 Operating Results

Geographic Results

Segment Results

The

BD Medical segment includes the Medication Delivery Solutions (MDS), Medication Management Solutions (MMS), and Pharmaceutical Systems (PS) business units. BD Medical revenue growth was driven by strong double-digit growth in MMS and PS.

MDS performance reflects continued execution of our comprehensive Vascular Access Management strategy, which drove strong performance in BD Posiflush™ and our Catheter Solutions in both the US and international markets. The unit's performance also reflects a favorable comparison to prior-year COVID restrictions in China that was partially offset by negative impacts from the comparison to prior-year COVID vaccination device demand and planned strategic portfolio exits in the current quarter.

MMS performance reflects strong growth in Pharmacy Automation, led by our Parata and BD ROWA™ solutions. The unit's performance also reflects double-digit growth in Dispensing driven by our continued focus on innovation to improve workflows and efficiencies, evidenced by performance of our BD Pyxis™ and BD HealthSight™ portfolio.

PS performance reflects our strong leadership position in pre-fillable solutions such as BD Hypak™ and innovative products like BD Neopak™, BD Effivax™ and BD Hylok™, which drove another quarter of double-digit growth while supporting increased demand in high-growth categories like biologics.

The BD Life Sciences segment includes the Integrated Diagnostic Solutions (IDS) and Biosciences (BDB) business units. BD Life Sciences performance reflects a decline in COVID-only diagnostic testing revenues and performance in the segment's base business that was about flat. The segment's base business performance reflects high-single digit growth in BDB that was offset by a decline in base IDS revenues due to the comparison to higher prior-year flu/COVID respiratory testing revenues, which impacted the segment's base business revenue growth by approximately 400 basis points, and the impact of US distributor de-stocking in Specimen Management.

IDS performance reflects the decline in COVID-only diagnostic testing revenues as well as the impacts in the base business from higher prior-year respiratory testing revenues and distributor de-stocking. Partially offsetting these declines was double-digit growth in our Microbiology platform driven by continued adoption of our BD Kiestra™ IdentifA and Total Modular Track solutions, and strong demand for blood culture and ID/AST reagents. IDS base business performance also reflects continued strong growth from Molecular IVD assays leveraging the BD COR™ System and the incremental BD Max™ System installed base.

BDB performance reflects double-digit growth in Cancer reagents leveraging our growing installed base of FACSLyric™ analyzers, adoption of FACSDuet™ sample preparation automation and continued strong growth in research reagents enabled by our innovative and differentiated BD Horizon™ dyes.

The BD Interventional segment includes the Surgery, Peripheral Intervention (PI), and Urology & Critical Care (UCC) business units. BD Interventional performance was driven by strong growth across the segment.

Surgery performance reflects double-digit growth in Advanced Repair and Reconstruction, driven by continued market adoption of the Phasix™ hernia resorbable scaffold and double-digit growth in Biosurgery, aided by TissuePatch™ and Avitene™ hemostat in Greater Asia.

PI performance reflects double-digit growth in Peripheral Vascular Disease that was driven by broad-based strength across the portfolio including global penetration of the Rotarex™ Atherectomy System. PI growth was tempered by planned strategic portfolio exits and Venclose™ RF Ablation System supplier constraints.

UCC performance reflects double-digit growth in our PureWick™ solutions for chronic incontinence, driven by continued adoption in both the acute care and alternative care settings. The unit's performance also reflects double-digit growth in Targeted Temperature Management as well as Endourology which reflects the success of the Aptra™ Digital Endoscope System launch and improved supplier performance.

Assumptions and Outlook for Full Year Fiscal 2023

The company raised its full-year base organic revenue growth guidance. Adjusted EPS guidance remains unchanged but reflects increased base business earnings offset by the Surgical Implementation platform divestiture and foreign currency headwinds.

The company now expects fiscal year 2023 revenues to be approximately $19.3 billion compared to $19.2 billion to $19.3 billion previously announced.

Revenue guidance now assumes base business currency-neutral revenue growth of 6.8% to 7.1% before the impact of the Surgical Instrumentation platform divestiture. This reflects an increase of 25 basis points at the mid-point to 7.0%, driven by strong third quarter performance.

Base organic revenue growth is now expected to be 5.5% to 5.8%, compared to 5.25% to 5.75% previously announced, and continues to reflect fourth quarter organic revenue growth of about 6%.

Adjusting for the impact of the Surgical Instrumentation platform divestiture lowers the updated base revenue growth guidance by 20 basis points to a range of 6.6% to 6.9%. Increased base organic revenue growth guidance of 5.5% to 5.8% is not impacted.

Revenue guidance includes $56 million in year-to-date COVID-only diagnostic testing revenues.

Based on current rates, foreign exchange continues to represent a reduction of approximately 200 basis points, or approximately $370 million, to total company revenue growth.

The company's fiscal year 2023 adjusted diluted EPS guidance of $12.10 to $12.32 remains unchanged but reflects absorbing a $0.02 negative impact from the divestiture of the Surgical Instrumentation platform and a $0.05 negative impact from the latest foreign currency rates. Adjusted EPS guidance also reflects an increase to base business earnings of $0.07, which is offsetting the impact of the divestiture and foreign currency.

On a currency-neutral basis, adjusted diluted EPS guidance now represents growth of approximately 10% to 11.5%, an increase of 50 basis points from the company's prior expectation.

Adjusted diluted EPS guidance now includes an estimated headwind from foreign currency of approximately 320 basis points based on current rates, compared to 270 basis points previously.

BD's outlook for fiscal 2023 reflects numerous assumptions about many factors that could affect its business, based on the information management has reviewed as of this date. Management will discuss its outlook and several of its assumptions on its third fiscal quarter earnings call.

The company's expected adjusted diluted EPS for fiscal 2023 excludes potential charges or gains that may be recorded during the fiscal year, such as, among other things, the non-cash amortization of intangible assets, acquisition-related charges, spin related costs, and certain tax matters. BD does not attempt to provide reconciliations of forward-looking adjusted diluted non-GAAP EPS guidance to the comparable GAAP measure because the impact and timing of these potential charges or gains is inherently uncertain and difficult to predict and is unavailable without unreasonable efforts. In addition, the company believes such reconciliations would imply a degree of precision and certainty that could be confusing to investors. Such items could have a substantial impact on GAAP measures of BD BD's financial performance. We also present our estimated revenue, base business revenue growth, base organic revenue growth and adjusted diluted EPS growth for our 2023 fiscal year after adjusting for the anticipated impact of foreign currency translation. BD believes that this adjustment allows investors to better evaluate BD's anticipated underlying earnings performance for our 2023 fiscal year in relation to our underlying 2022 fiscal year performance.

Conference Call and Presentation Materials

BD will host an audio webcast today for the public, investors, analysts, and news media to discuss its third quarter results. The audio webcast will be broadcast live on BD's website, www.bd.com/investors at 8 a.m. (ET) Thursday, August 3, 2023. Accompanying slides will be available on BD's website, www.bd.com/investors at approximately 6:30 a.m. (ET). The conference call will be available for replay on BD's website, www.bd.com/investors. Alternatively, you can dial into the replay at 800-695-1564 (domestic) and 402-530-9025 (international) through the close of business on Thursday, August 10, 2023. A confirmation number is not needed to access the replay.

Basis of Presentation — Continuing Operations

On April 1, 2022, the Company completed the spin-off of its Diabetes Care business as a separate publicly traded company named Embecta Corp. The historical results of the Diabetes Care business are now accounted for as discontinued operations.

Non-GAAP Financial Measures/Financial Tables

This news release contains certain non-GAAP financial measures. These include revenue growth rates on a currency-neutral basis, adjusted diluted earnings per share, base revenue, base revenue growth rates and base organic revenue growth rates on a currency-neutral basis. These non-GAAP financial measures are not in accordance with generally accepted accounting principles in the United States. BD management believes that the use of non-GAAP measures to adjust for items that are considered by management to be outside of BD's underlying operational results or that affect period to period comparability helps investors to gain a better understanding of our performance year-over-year, to analyze underlying trends in our businesses, to analyze our base operating results, and understand future prospects. Management uses these non-GAAP financial measures to measure and forecast the company's performance, especially when comparing such results to previous periods or forecasts. We believe presenting such adjusted metrics provides investors with greater transparency to the information used by BD management for its operational decision-making and for comparison to other companies within the medical technology industry. Although BD's management believes non-GAAP results are useful in evaluating the performance of its business, its reliance on these measures is limited since items excluded from such measures may have a material impact on BD's net income, earnings per share or cash flows calculated in accordance with GAAP. Therefore, management typically uses non-GAAP results in conjunction with GAAP results to address these limitations. BD strongly encourages investors to review its consolidated financial statements and publicly filed reports in their entirety and cautions investors that the non-GAAP measures used by BD may differ from similar measures used by other companies, even when similar terms are used to identify such measures. Non-GAAP measures should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures.

We present adjusted diluted earnings per share for the third quarter and the first nine months of fiscal year 2023, and the corresponding prior periods, after eliminating items we believe are not part of our ordinary operations and affect the comparability of the periods presented. Adjusted diluted earnings per share includes adjustments for the impact of purchase accounting adjustments, integration and restructuring costs, spin related costs, certain regulatory costs, certain product remediation costs, certain product liability and legal defense costs, certain investment gains and losses, certain asset impairment charges and the impact of the extinguishment of debt. In particular, current and prior-year adjusted diluted earnings per share results exclude European regulatory initiative-related costs, which represent costs incurred to develop processes and systems to establish initial compliance with the European Union Medical Device Regulation and the European Union In Vitro Diagnostic Medical Device Regulation (collectively, the "New EU Medical Devices Regulations"), which represent a significant, unusual change to the existing regulatory framework. We consider the excluded European regulatory initiative-related costs to be duplicative of previously incurred costs and/or one-off costs related to establishing initial compliance with such regulatory regimes, and in each case are limited to a specific period of time. These expenses relate to establishing initial compliance with the New EU Medical Devices Regulations and include the cost of labor, other services and consulting (in particular, research and development and clinical trials) and supplies, travel and other miscellaneous costs. These costs were recorded in Cost of products sold and Research and development expense.

We also present revenue growth rates for the third quarter and first nine months of fiscal year 2023 over the corresponding prior periods on a currency-neutral basis after eliminating the effect of foreign currency translation, where applicable. We also show the growth in adjusted diluted earnings per share compared to the prior year periods after eliminating the impact of foreign currency translation to further enable investors to evaluate BD's underlying earnings performance compared to the prior periods. We calculate foreign currency-neutral percentages by converting our current-period local currency financial results using the prior period foreign currency exchange rates and comparing these adjusted amounts to our current-period results. As exchange rates are an important factor in understanding period-to-period comparisons, we believe the presentation of results on a foreign currency-neutral basis in addition to reported results helps improve investors' ability to understand our operating results and evaluate our performance in comparison to prior periods.

Reconciliations of these and other non-GAAP measures to the comparable GAAP measures are included in the attached financial tables. Within the attached financial tables presented, certain columns and rows may not add due to the use of rounded numbers. Percentages and earnings per share amounts presented are calculated from the underlying amounts.

About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 77,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/ and Twitter @BDandCo.

This press release and accompanying audio webcast on August 3, 2023 contain certain estimates and other forward-looking statements (as defined under Federal securities laws) regarding BD's future prospects and performance, including, but not limited to, future revenues and earnings per share. All such statements are based upon current expectations of BD and involve a number of business risks and uncertainties. Actual results could vary materially from anticipated results described, implied or projected in any forward-looking statement. With respect to such forward-looking statements, a number of factors could cause actual results to vary materially. These factors include, but are not limited to, risks relating to the macroeconomic environment on our operations and healthcare spending, including any impact of the current disruptions in the global supply chain on our ability to source raw materials, components and energy sources needed to produce our products, labor constraints, inflationary pressures, currency rate fluctuations and increased interest rates and borrowing costs; geopolitical developments such as the ongoing Russia and Ukraine conflict and the evolving conditions in Asia, which could adversely impact our operations; increases in energy costs and their effect on, among other things, the cost of producing BD's products; product efficacy or safety concerns resulting in product recalls or actions being taken with respect to our products; new or changing laws and regulations impacting our business (including the imposition of tariffs. sanctions, changes in tax laws, new environmental laws and regulations (such as those related to climate change), new cybersecurity or privacy laws or changes in laws impacting international trade), or changes in enforcement practices with respect to such laws; increased labor costs and labor shortages; our suppliers' ability to provide products needed for our operations and BD's ability to maintain favorable supplier arrangements and relationships; legislative or regulatory changes to the U.S. or foreign healthcare systems, potential cuts in governmental healthcare spending or governmental or private measures to contain healthcare costs (including China's volume-based procurement tender process), including changes in pricing and reimbursement policies, which could result in reduced demand for our products or downward pricing pressure; adverse changes in regional, national or foreign economic conditions, particularly in emerging markets, including any impact on our ability to access credit markets and finance our operations; the adverse impact of cyberattacks on our information systems or products; competitive factors including technological advances and new products introduced by competitors; risks relating to our overall indebtedness; the possible impact of COVID-19, including any resurgence or new strains, or other health crises on our business and the global healthcare system, which could result in decreased demand for our products, disruptions to our operations or the operations of our suppliers and customers and our supply chain; interruptions in our manufacturing or sterilization processes or those of our third-party providers, including any restrictions placed on the use of ethylene oxide for sterilization; pricing and market pressures; difficulties inherent in product development, delays in product introductions and uncertainty of market acceptance of new products; the overall timing of the replacement or remediation of the BD Alaris™ Infusion System and return to market in the U.S., which may be impacted by, among other things, customer readiness and our continued engagement with the FDA; our ability to achieve our projected level or mix of product sales; our ability to successfully integrate any businesses we acquire; uncertainties of litigation and/or investigations and/or subpoenas (as described in BD's filings with the Securities and Exchange Commission ("SEC")); and the issuance of new or revised accounting standards, as well as other factors discussed in BD's filings with the SEC. In addition, we have made certain assumptions in making these forward-looking statements. If any of these assumptions are incorrect, BD's actual results could differ materially from those described in these forward-looking statements. We do not intend to update any forward-looking statements to reflect events or circumstances after the date hereof except as required by applicable laws or regulations.

Contacts:

Investors: Francesca DeMartino, SVP, Head of Investor Relations - 201-847-5743

Media: Troy Kirkpatrick, VP, Public Relations - 858-617-2361

SOURCE BD (Becton, Dickinson and Company)