Since the start of June, Ocular Therapeutix‘s (NSDQ:OCUL) stock price has fallen more than -45%. The company’s founder and chief executive, Amar Swahney, has stepped down, assuming the role of executive chairman, and the FDA has rejected Ocular’s resubmitted new drug application for its hydrogel plug, Dextenza.
Amidst regulatory troubles, Ocular tapped former Mundipharma exec Antony Mattessich to serve in the company’s corner office.
Mattessich has worked for an array of pharma giants, including Novartis (NYSE:NVS) and Bristol-Myers Squibb (NYSE:BMY). In a call today with analysts, Mattessich gave his first comments on how he plans to redirect the Bedford, Mass.-based company.
The pharma veteran wouldn’t detail the company’s timeline for the resubmission of the NDA for Dextenza, but said that “Ocular needs to enhance its credibility,” and that the company was working with the FDA to validate Dextenza’s manufacturing process.
“This is just the beginning of my second full week and I will not commit the organization to any timeline until I understand, with great clarity, the path forward,” Mattessich said. “I will say though that I believe the issues played out in the 483 can be resolved. Regardless, our intention going forward is to under-promise and over-deliver.”
He also declared his intentions to “aggressively seek new parterships.” Besides a collaboration with Regeneron, Ocular has largely remained an isolated player in the biopharmaceutical arena.
“While we may still wind up taking some of our products through to market, particularly within the ophthalmology in the U.S., we need partnerships in order to access the capital and novel molecules to fully leverage the potential of our platform,” Mattessich said. “We hope to become the go-to technology for any company with a valuable molecule that can benefit from a depot formulation.”
He signaled that Ocular would also shift its focus to the global market.
“While the U.S. has been our focus to date, we will be looking at all of our projects on a global basis going forward. Another of the key benefits of the hydrogel platform is the low production cost, allowing potential bottom of the pyramid plays in nearly any market or market segment in the world,” Mattessich said. “My experience in both the international and established brand markets will add to Ocular’s capabilities in this area.”
The company posted a net loss of -$18.7 million in the second quarter, on sales of $438,ooo for the 3 months ended June 30, for bottom-line loss of -63% on sales loss of -0.7% compared with the same period last year.
Adjusted to exclude 1-time items, earnings per share were -64¢, behind consensus on The Street, where analysts were looking for sales of $490,000.
OCUL shares were trading at $5.83 apiece today in afternoon activity, down -2%.
Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.