The company is facing a slew of class action suits from investors, as well as a probe by the Securities and Exchange Commission regarding its post-surgical pain relief implant, Dextenza.
Ocular’s device is designed to deliver a sustained dose of dexamethasone over four weeks following eye surgery. But the company has faced several hurdles getting its product to the market in the U.S. – it has twice received the FDA’s dreaded complete response letter.
Ocular plans to resubmit its application for Dextenza to the FDA in the first half of this year.
In July last year, the FDA denied approval for Ocular’s hydrogel plug after it discovered ‘deficiencies in manufacturing process and controls’ in a pre-new drug application approval inspection.
Ocular’s 2017 annual report detailed three class action securities suits and four shareholder derivative suits filed against the company and former executives, alleging that Ocular misled investors after the FDA found problems with the company’s manufacturing process for Dextenza.
The company also revealed that it was subpoenaed by the SEC in December last year. The Bedford, Mass.-based company did not specify what the SEC was asking for, but noted that the request covers communications between Ocular and the FDA, as well as investors.
For the three months ended Dec. 31, the company posted a net loss of -$13.1 million on sales of $487,000, for bottom-line loss of-2.2% on sales loss of -4.7% compared with the same period last year.
Adjusted to exclude 1-time items, earnings per share were -44¢, ahead of consensus on The Street, where analysts were looking for sales of $520,000.
For the full year, Ocular posted a net loss of -$63.4 million on sales of $1.9 million, for bottom-line loss of -41.8% on sales growth of 4.2% compared to the same period last year.
“It gives me great pleasure to turn the page on 2017 and look forward to 2018 with a rebuilt team in place and an exciting set of near-term opportunities before us,” president & CEO Antony Mattessich, who took over the corner office after founder Amarpreet Sawhney stepped down, said in prepared remarks.
“We have gained significant momentum in making the changes we believe are necessary to resubmit our New Drug Application for Dextenza and advance our pipeline. Based on this momentum, we can reaffirm our guidance that we are on track for a resubmission of our Dextenza NDA in the first half of 2018,” he added.
OCUL shares were trading at $5.96 apiece today in morning activity, up 0.2%.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
At DeviceTalks Boston, MacMillan will provide exclusive insights into the Massachusetts-based company and its evolving definition of women's healthcare. You don't want to miss it!
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