Sandoz takes further steps to resolve legacy US Generic Drug Antitrust Class Action Litigation
Sandoz has announced significant steps to resolve the US Generic Drug Antitrust Class Action Litigation. The company has reached a $275 million settlement with end payer plaintiffs' class, to be paid by December 31, 2024. Additionally, Sandoz has established a $265 million provision for outstanding claims from opt-out plaintiffs and State Attorneys' General.
The settlement with end payer plaintiffs includes no admission of wrongdoing and covers alleged conduct between 2009 and 2019. Class members can opt out, potentially reducing the settlement by up to $45 million. The agreement follows previous settlements with the US Department of Justice (2020-2021) and direct purchaser plaintiffs (February 2024).
These financial commitments will be reflected in Sandoz's 2024 financial results but will not affect the company's full-year 2024 and mid-term guidance.
Sandoz ha annunciato importanti passi per risolvere il processo collettivo antitrust sui farmaci generici negli Stati Uniti. L'azienda ha raggiunto un accordo di $275 milioni con la classe dei querelanti destinatari, da pagare entro il 31 dicembre 2024. Inoltre, Sandoz ha istituito un accantonamento di $265 milioni per le richieste pendenti dei querelanti che hanno scelto di uscire dal gruppo e degli Procuratori Generali degli Stati.
L'accordo con i querelanti destinatari non implica alcun riconoscimento di colpa e copre condotte presunte avvenute tra il 2009 e il 2019. I membri della classe possono decidere di uscire, riducendo potenzialmente l'accordo fino a $45 milioni. L'accordo segue precedenti intese con il Dipartimento di Giustizia degli Stati Uniti (2020-2021) e con i querelanti acquirenti diretti (febbraio 2024).
Questi impegni finanziari saranno riflessi nei risultati finanziari di Sandoz per il 2024, ma non influenzeranno le previsioni per l'intero anno 2024 e per il medio termine.
Sandoz ha anunciado pasos significativos para resolver la litigación colectiva antimonopolio sobre medicamentos genéricos en EE. UU. La compañía ha alcanzado un acuerdo de $275 millones con la clase de demandantes finales, el cual se pagará antes del 31 de diciembre de 2024. Además, Sandoz ha establecido una provisión de $265 millones para las reclamaciones pendientes de los demandantes que optaron por salir y de los Fiscales Generales de Estado.
El acuerdo con los demandantes finales no implica una admisión de culpabilidad y cubre conductas presuntas entre 2009 y 2019. Los miembros de la clase pueden optar por salir, lo que podría reducir el acuerdo en hasta $45 millones. Este acuerdo sigue a acuerdos previos con el Departamento de Justicia de EE. UU. (2020-2021) y con los demandantes compradores directos (febrero de 2024).
Estos compromisos financieros se reflejarán en los resultados financieros de Sandoz para 2024, pero no afectarán las previsiones anuales completas y de medio plazo de la compañía para 2024.
산도즈는 미국 제네릭 약물 반독점 집단 소송을 해결하기 위한 중요한 조치를 발표했습니다. 회사는 최종 지급 청구인 집단과 2억 7500만 달러의 합의에 도달했으며, 이는 2024년 12월 31일까지 지급될 예정입니다. 또한, 산도즈는 선택적으로 제외한 청구인 및 주 검사들로부터의 미결 청구를 위한 2억 6500만 달러의 충당금을 설정했습니다.
최종 지급 청구인과의 합의는 잘못을 인정하지 않으며, 2009년에서 2019년 사이의 연관된 행위를 포함합니다. 집단의 구성원들은 선택적으로 제외될 수 있으며, 이는 최대 4500만 달러까지 합의를 줄일 수 있습니다. 이 합의는 미국 법무부와의 이전 합의(2020-2021)와 직접 구매자 청구인과의 합의(2024년 2월)에 이어집니다.
이러한 재정적 약속은 산도즈의 2024년 재무 실적에 반영되지만, 회사의 2024년 전체 연도 및 중기 가이던스에는 영향을 미치지 않을 것입니다.
Sandoz a annoncé des étapes significatives pour résoudre le litige collectif antitrust sur les médicaments génériques aux États-Unis. L'entreprise a conclu un accord de 275 millions de dollars avec la classe des plaignants finaux, qui sera versé d'ici le 31 décembre 2024. De plus, Sandoz a établi une provision de 265 millions de dollars pour les réclamations en cours des plaignants ayant choisi de sortir et des Procureurs Généraux des États.
L'accord avec les plaignants finaux n'implique aucune reconnaissance de faute et couvre des comportements présumés entre 2009 et 2019. Les membres de la classe peuvent choisir de se retirer, ce qui pourrait réduire l'accord jusqu'à 45 millions de dollars. L'accord fait suite à des règlements antérieurs avec le Département de la Justice des États-Unis (2020-2021) et avec les plaignants acheteurs directs (février 2024).
Ces engagements financiers seront reflétés dans les résultats financiers de Sandoz pour 2024, mais n'affecteront pas les prévisions pour l'année entière 2024 et les prévisions à moyen terme de l'entreprise.
Sandoz hat bedeutende Schritte zur Lösung der US-Kartellklage gegen Generika angekündigt. Das Unternehmen hat eine Einigung über 275 Millionen Dollar mit der Klasse der Endzahlungskläger erzielt, die bis zum 31. Dezember 2024 zu zahlen ist. Darüber hinaus hat Sandoz eine Rückstellung von 265 Millionen Dollar für ausstehende Ansprüche von Klägern, die opt-out gewählt haben, und von Staatsanwälten eingerichtet.
Die Einigung mit den Endzahlungsklägern beinhaltet kein Eingeständnis von Fehlverhalten und deckt angebliches Verhalten zwischen 2009 und 2019 ab. Klassenmitglieder können opt-out wählen, was die Einigung um bis zu 45 Millionen Dollar reduzieren könnte. Die Vereinbarung folgt früheren Einigungen mit dem US-Justizministerium (2020-2021) und direkten Käuferklägern (Februar 2024).
Diese finanziellen Verpflichtungen werden sich in den Finanzberichten von Sandoz für 2024 widerspiegeln, jedoch keinen Einfluss auf die Gesamtjahresprognose 2024 und die mittelfristige Prognose des Unternehmens haben.
- Settlement provides clarity and resolves significant legal uncertainty
- No impact on company's 2024 and mid-term financial guidance
- Settlement includes broad release of claims covering 2009-2019 period
- USD 275 million payment required for end payer settlement
- Additional USD 265 million provision needed for remaining claims
- Potential for opt-outs could lead to further legal challenges
- Ongoing litigation with US States and other plaintiffs continues
Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules
Sandoz takes further steps to resolve legacy US generic drug antitrust class action litigation
- Sandoz US has entered into a settlement agreement with the class of end payer plaintiffs for USD 275 million
- Provision of USD 265 million taken to cover potential additional settlement costs with regard to the US generic drug industry antitrust litigation
- No impact on current Sandoz full-year 2024 and mid-term guidance
Basel, December 17, 2024 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced a number of steps to resolve the US Generic Drug Antitrust Class Action Litigation. Following the previously announced settlements with the US Department of Justice in 2020 and 2021 and with the direct purchaser plaintiffs’ class in February 2024, Sandoz has now also entered into a settlement agreement with the end payer plaintiffs’ class for a total of USD 275 million, which is expected to be paid before December 31, 2024. The company has also taken a provision of USD 265 million for the outstanding claims brought by opt-out plaintiffs and State Attorneys’ General. The settlement payment and the provision will be included in the company’s 2024 financial results. This does not affect current Sandoz full-year 2024 and mid-term guidance.
End payer plaintiffs class settlement
Sandoz Inc. and its subsidiary Fougera Pharmaceuticals Inc. – both indirect subsidiaries of Sandoz Group AG – have entered into a settlement agreement with the class of end payer plaintiffs in the multi-district litigation entitled In re Generic Pharmaceuticals Pricing Antitrust Litigation in the US District Court for the Eastern District of Pennsylvania. This agreement, which contains no admission of wrongdoing by Sandoz US, resolves all of the damages claims of the end payer class, which is comprised generally of certain consumers, insurers, health and welfare funds, employee benefit plans, and other entities that paid for and reimbursed the sales of drugs. Under the terms of the agreement, Sandoz US will pay USD 275 million in exchange for a full release of all claims asserted against it in the end payer class action by the settlement class members.
This settlement underscores Sandoz commitment towards integrity and sound governance, and it is an encouraging step toward resolving allegations of legacy conduct. Beyond the payment, settlement terms include:
- A broad release of claims that covers alleged conduct between 2009 and 2019 as well as all medicines at issue in the end purchaser class claims
- Class members have the right to opt out of the settlement, which could result in the settlement amount being reduced by up to USD 45 million
The settlement is subject to Court approval, as is required for class settlements under US law. If the Court preliminarily approves the settlement, class members will be notified of the settlement and given an opportunity to opt out of the class, object to the settlement, and file a claim to receive a settlement payment.
Remaining claims related to the US generic antitrust litigation
The remaining claims are seeking damages for alleged anticompetitive conduct in the US market. These claims are brought by certain US States and Territories as well as the indirect reseller plaintiff class and individual plaintiffs in the multidistrict litigation. Sandoz US continues to defend itself vigorously in those cases, and has raised a number of defenses, including whether downstream purchasers were actually damaged due to the alleged conduct. Based on its current assessment of these remaining claims, Sandoz set up a provision of USD 265 million. As the litigation progresses, Sandoz will continue to assess the overall situation and may increase or decrease the provision as appropriate.
Other generic antitrust litigation
In addition to the US generic antitrust litigation, as previously disclosed, Sandoz Inc., Sandoz Canada Inc., and Fougera Pharmaceuticals Inc. have been named in a class action in Ontario, Canada alleging price fixing in the Canadian generic pharmaceutical market. The claims are being vigorously contested.
DISCLAIMER
This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law.
ABOUT SANDOZ
Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 800 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2023, Sandoz recorded net sales of USD 9.6 billion.
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FAQ
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