The news of the shipment hold’s end was enough to counteract Q2 earnings misses, sending OM shares up 21.5% at $18.77 per share in midday trading. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 0.6%.
In June, the company announced that it was holding shipments of its Tablo hemodialysis system for home use as a result of a pending FDA review and clearance of a 510(k) submitted for changes made since the Tablo system’s original March 2020 clearance.
Last month, it was revealed that the company would face a shareholder lawsuit claiming that the company and its top executives made false and misleading positive statements leading up to the shipment hold announcement.
However, in announcing its second-quarter results, Outset confirmed that the FDA has cleared the system changes, allowing shipments of Tablo for home use to resume.
For the quarter, the San Jose, California–based company posted losses of $43.8 million, or 92¢ per share, on sales of $25.1 million for the three months ended June 30, 2022, for a more than $13 million bottom-line slide on a sales dip of 0.6%.
Adjusted to exclude one-time items, losses per share were 77¢, 7¢ behind Wall Street, where analysts were looking for sales of $27.5 million.
“We are pleased to begin supporting new patients in the home again and helping them achieve autonomy and control over where and when they dialyze,” Outset Chair and CEO Leslie Trigg said in a news release. “As we look to the second half of the year, we see no change in underlying demand for Tablo. However, we have reflected in our guidance the staffing and inflationary pressures our provider customers are facing, as well as the work we need to do to regain commercial momentum following release of the Tablo ship hold.”
Outset said it now expects to bring in revenues between $105 million and $110 million, representing growth of 2% to 7% year-over-year.