Dentsply Sirona announced on October 24, 2024, the voluntary suspension of sales and marketing for its Byte Aligners and Impression Kits. This decision was made in consultation with the U.S. Food and Drug Administration (FDA) as the company conducts a review of certain regulatory requirements related to these products.
In connection with this review, Dentsply Sirona has suspended shipment and processing of new and recently placed orders for Byte Aligners and Impression Kits. The company stated that the state regulatory environment had already adversely impacted the Byte Aligner business model, leading to declining conversion rates and new documentation requirements.
The company expects to record non-cash charges for the impairment of goodwill within the range of $450 million to $550 million, net of tax. These charges pertain to its Orthodontic Aligner Solutions and Implants & Prosthetic Solutions reporting units, which together form the Orthodontic and Implant Solutions segment. Preliminary third quarter 2024 net sales are expected to be approximately $951 million, with adjusted EPS between $0.49 and $0.51.
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