Pfenex (NYSE: PFNX) reported Q4 EPS of ($0.22), $0.13 better than the analyst estimate of ($0.35). Revenue for the quarter came in at $3.35 million versus the consensus estimate of $4.4 million.

“We are excited about the opportunities before us in 2019 as we look to advance our key programs and expand our pipeline. This year we have multiple key milestones across our portfolio that hold the potential to transform Pfenex into a commercial stage biotech company and create significant value for our stockholders,” said Eef Schimmelpennink, Chief Executive Officer of Pfenex. “With the FDA acceptance of our 505(b)(2) New Drug Application for substantive review of PF708 and setting a PDUFA date of October 7, 2019, we are working with our development and licensing partner, Alvogen, to prepare for the commercialization of PF708 in the U.S. We believe that PF708 is on track for a potential launch in the U.S. market as early as the fourth quarter of 2019, subject to FDA approval and other factors. Building on this momentum, we have expanded our collaboration with Alvogen for PF708 to include Europe, MENA and ROW, which positions us to leverage Alvogen’s global supply chain and market access experience to maximize potential commercial success in these markets as well.”

“We have four key programs and partnerships in or nearing clinical studies or in regulatory review including PF708, our Jazz partnership, our anthrax vaccine candidates, and our CRM197 partnerships with Merck and Serum Institute of India. To ensure success we remain fully focused on the approval and commercialization of these core value drivers. In addition, we are exploring new pipeline and partnership opportunities that leverage our Pfēnex Expression Technology. This is an exciting time for the Company and our stockholders, and we look forward to a fruitful 2019,” concluded Schimmelpennink.

For earnings history and earnings-related data on Pfenex (PFNX) click here.