The Bedford, Mass.-based company posted losses of -$-12.8 million, or -52¢ per share, on sales of $0.5 million for the 3 months ended Dec. 31, for bottom-line loss of -20.5% on sales growth of 17% compared with the same period last year.
Adjusted to exclude 1-time items, earnings per share were -52¢, behind consensus on The Street, where analysts were looking for sales of $0.48 million.
“We continue to execute our diversification strategy as we seek to improve the standard of care across many ophthalmic indications using our proprietary hydrogel platform technology,” chairman, president & CEO Amar Sawhney said in prepared remarks. “With the July 19 PDUFA date for Dextenza fast approaching, pre-commercialization activities are well underway as Dextenza has the potential to become the first approved non-invasive extended release drug product that can provide a full post-operative course of therapy following ocular surgery with a single administration. We also continue to make substantial progress across our additional drug product development programs targeting common causes of blindness such as glaucoma and wet AMD. Together, our programs comprise a potential market opportunity of more than $11 billion in the United States. We look forward to the further advancement of these product candidates towards potential commercialization.”
OCUL shares were trading at $8.49 apiece today in afternoon trading, down -4.2%.
In January, the company launched a $25 million underwritten public offering of its common stock. Ocular did not provide any specific pricing details for the offering.
Cantor Fitzgerald & Co. is the sole bookrunner for the offering, according to regulatory filings.
In the same month, Ocular resubmitted a New Drug Application to the FDA for its post-surgical ocular pain reliever. The hydrogel plug, inserted into a patient’s tear duct, is designed to deliver a sustained dose of dexamethasone over 4 weeks following ophthalmic surgery.
Ocular has had trouble gaining regulatory approval for the pain relief drug-device combo – in July last year, the FDA denied approval for Ocular’s Dextenza, citing concerns related to “deficiencies in manufacturing process and controls” which were identified during a pre-New Drug Application approval inspection of its manufacturing facility.