BD Resolves Previously Disclosed SEC Investigation
BD (BDX) has reached a settlement with the SEC regarding an investigation into previous disclosures about the BD Alaris™ System, acquired from CareFusion in 2015. The company will pay $175 million to resolve the matter, an amount already reserved and disclosed in their FY2024 Form 10-K. The settlement, which involves events from over four years ago, requires no financial restatements and won't affect BD's innovation investments or capital allocation strategy.
The company maintains that the BD Alaris™ System is safe and effective, noting its critical role in healthcare delivery, including during the COVID-19 pandemic. The system received FDA 510(k) clearance in July 2023. BD has implemented improvements to its operational and governance processes, affirming its commitment to ethical standards and product quality.
BD (BDX) ha raggiunto un accordo con la SEC riguardo a un'indagine su precedenti divulgazioni relative al BD Alaris™ System, acquisito da CareFusion nel 2015. L'azienda pagherà 175 milioni di dollari per risolvere la questione, un importo già riservato e divulgato nel loro Modulo 10-K per l'anno fiscale 2024. L'accordo, che coinvolge eventi risalenti a oltre quattro anni fa, non richiede rettifiche finanziarie e non influenzerà gli investimenti in innovazione di BD né la strategia di allocazione del capitale.
L'azienda sostiene che il BD Alaris™ System è sicuro ed efficace, sottolineando il suo ruolo fondamentale nella fornitura di assistenza sanitaria, anche durante la pandemia di COVID-19. Il sistema ha ricevuto l'approvazione FDA 510(k) a luglio 2023. BD ha implementato miglioramenti nei suoi processi operativi e di governance, riaffermando il proprio impegno verso standard etici e qualità del prodotto.
BD (BDX) ha alcanzado un acuerdo con la SEC con respecto a una investigación sobre divulgaciones anteriores relacionadas con el BD Alaris™ System, adquirido de CareFusion en 2015. La compañía pagará 175 millones de dólares para resolver el asunto, una cantidad que ya se había reservado y divulgado en su Formulario 10-K del año fiscal 2024. El acuerdo, que involucra eventos de hace más de cuatro años, no requiere ajustes financieros y no afectará las inversiones en innovación de BD ni su estrategia de asignación de capital.
La compañía sostiene que el BD Alaris™ System es seguro y efectivo, destacando su papel crítico en la prestación de atención médica, incluso durante la pandemia de COVID-19. El sistema recibió la autorización 510(k) de la FDA en julio de 2023. BD ha implementado mejoras en sus procesos operativos y de gobernanza, reafirmando su compromiso con los estándares éticos y la calidad del producto.
BD (BDX)는 2015년 CareFusion으로부터 인수한 BD Alaris™ 시스템에 대한 이전 공시에 관한 조사와 관련하여 SEC와 합의를 도달했습니다. 회사는 문제 해결을 위해 1억 7500만 달러를 지불할 예정이며, 이는 이미 FY2024의 10-K 양식에서 예약 및 발표되었습니다. 4년 이상 전에 발생한 사건과 관련된 이번 합의는 재무 재조정이 필요 없으며 BD의 혁신 투자 또는 자본 배분 전략에 영향을 미치지 않습니다.
회사는 BD Alaris™ 시스템이 안전하고 효과적이며 COVID-19 팬데믹 기간 동안 의료 서비스 제공에서 중요한 역할을 했다고 주장합니다. 이 시스템은 2023년 7월 FDA의 510(k) 허가를 받았습니다. BD는 운영 및 거버넌스 프로세스 개선을 구현하여 윤리 기준과 제품 품질에 대한 헌신을 재확인하고 있습니다.
BD (BDX) a conclu un accord avec la SEC concernant une enquête sur d'anciennes divulgations liées au BD Alaris™ System, acquis de CareFusion en 2015. L'entreprise paiera 175 millions de dollars pour résoudre cette affaire, un montant déjà réservé et divulgué dans son Formulaire 10-K pour l'exercice 2024. L'accord, qui concerne des événements d'il y a plus de quatre ans, ne nécessite pas de retraitements financiers et n'affectera pas les investissements en innovation de BD ni sa stratégie d'allocation de capital.
L'entreprise soutient que le BD Alaris™ System est sûr et efficace, soulignant son rôle essentiel dans la fourniture de soins de santé, y compris pendant la pandémie de COVID-19. Le système a reçu l'autorisation 510(k) de la FDA en juillet 2023. BD a mis en œuvre des améliorations de ses processus opérationnels et de gouvernance, réaffirmant son engagement envers des normes éthiques et la qualité des produits.
BD (BDX) hat eine Einigung mit der SEC bezüglich einer Untersuchung von früheren Offenlegungen zum BD Alaris™ System, das 2015 von CareFusion erworben wurde, erzielt. Das Unternehmen wird 175 Millionen Dollar zahlen, um die Angelegenheit zu klären, ein Betrag, der bereits in ihrem FY2024 Form 10-K reserviert und offengelegt wurde. Die Einigung, die Ereignisse aus vor über vier Jahren betrifft, erfordert keine finanziellen Nachbesserungen und wird die Innovationsinvestitionen von BD oder die Kapitalallokationsstrategie nicht beeinträchtigen.
Das Unternehmen betont, dass das BD Alaris™ System sicher und effektiv ist, und hebt seine entscheidende Rolle in der Gesundheitsversorgung hervor, einschließlich während der COVID-19-Pandemie. Das System erhielt im Juli 2023 die FDA 510(k)-Zulassung. BD hat Verbesserungen in seinen Betriebs- und Governance-Prozessen umgesetzt und bekräftigt sein Engagement für ethische Standards und Produktqualität.
- Settlement resolves long-standing SEC investigation without admission of wrongdoing
- No impact on FY2025 guidance or capital allocation strategy
- No financial restatements required
- BD Alaris System received FDA 510(k) clearance in July 2023
- $175 million settlement payment to SEC
- Disclosure and reporting issues with BD Alaris System
Insights
The
The resolution eliminates regulatory uncertainty and potential future litigation risks related to these historical disclosure issues. This clean break, combined with the recent FDA clearance for the updated Alaris System, positions BD to move forward without this regulatory overhang.
The settlement's financial impact appears well-contained, with BD having already reserved the
The resolution removes a significant regulatory uncertainty without disrupting BD's core business operations or growth initiatives. The Alaris System's continued market presence and recent FDA clearance indicate sustained revenue potential from this product line, supporting long-term business stability.
BD has reached an agreement with the
The SEC Order, the findings of which BD neither admits nor denies, relate to matters concerning BD Alaris that occurred more than four years ago. As part of the settlement, BD has agreed to pay
The BD Alaris™ System is safe and effective and is a critical part of health care in
BD has implemented a number of improvements to its operational and governance processes and related disclosure practices. BD is committed to operating with integrity and the highest ethical standards to produce high-quality, safe and effective products and serve as a trusted partner for its customers and their patients.
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 more than 70,000 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/, X (formerly Twitter) @BDandCo or Instagram @becton_dickinson.
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SOURCE BD (Becton, Dickinson and Company)
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