Invacare auditor submits third report

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Thursday, February 11, 2016

ELYRIA, Ohio – Invacare’s independent auditor this week issued its certification report for the third phase of the consent decree indicating substantial compliance to the FDA’s quality system regulation.

The report has been submitted to the FDA, announced Matt Monaghan, the company’s chairman, president and CEO, during a conference call to discuss financial results for the fourth quarter and year ended Dec. 31, 2015.

“The company cannot predict the acceptance of these reports by the FDA, nor any remaining work that may be needed to meet the FDA’s requirements, so while the third expert certification report is an important milestone, it is only one step forward in our ongoing journey toward an enhanced quality culture,” he said.

Invacare must now submit its own report to the FDA regarding its compliance status, as well as any observations to the auditor’s report. The FDA must accept both reports before the final phase of the consent decree, a re-inspection by the agency.

Invacare reported net sales of $283.3 million for the fourth quarter of 2015 compared to $318.2 million for the same period in 2014. It reported net sales of $1.14 billion for 2015 vs. $1.27 billion for 2014.

The company reported a net loss of $2.93 million for the fourth quarter of 2015 compared to $9.39 million for the same period in 2014. It reported a net loss of $26.2 million for 2015 vs. $56.1 million for 2014.

For North America HME, specifically, Invacare reported net sales of $115.4 million for the fourth quarter of 2015 compared to $124.8 million for the same period in 2014. It reported net sales of $474.2 million for 2015 vs. $507.9 million for 2014.

The company reported a net loss of $7.1 million for North America HME in the fourth quarter of 2015 compared to $8.8 million for the same period in 2014. It reported a net loss of $32.9 million for 2015 vs. $63.6 million for 2014.