Dentsply Sirona voluntarily suspends sales of its teeth aligners
Adds details in paragraphs 5-8, analyst comment in paragraph 7
Oct 24 (Reuters) -Dentsply Sirona XRAY.O said on Thursday it was voluntarily suspending sales and marketing of its Byte teeth aligners and Impression Kits as it conducts a review of certain regulatory requirements related to these products.
Shares of the company fell 6.8% to $22.76 after the bell.
Dentsply Sirona said its decision was made in consultation with the U.S. Food and Drug Administration and it would work closely with the federal agency and other regulatory authorities.
The company said that certain state regulatory requirements have hurt its teeth aligner business model. It has begun to shift infrastructure and talent from Byte Aligner to other parts of its business.
Dentsply Sirona said it had suspended shipment and processing of new and recently placed orders for Byte Aligners and Impression Kits following the review.
The Impression Kit is used by patients to take molds of their teeth at home. Byte Aligners are clear-teeth aligners.
"Byte was typically a business line that investors had more negative views on given the direct to consumer channel, with potential for reining in operating expenditure depending on the future plans," said Leerink Partners analyst Michael Cherny.
Dentsply Sirona also provided preliminary third-quarter results. It expects third-quarter net sales of about $951 million and adjusted profit of between 49 cents and 51 cents per share.
Analysts were expecting sales of $937.91 million and adjusted profit of 47 cents per share, according to data compiled by LSEG.
Reporting by Sneha S K; Editing by Sriraj Kalluvila
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