Pfenex Inc. (NYSE MKT:PFNX) Q2 2019 Earnings Conference Call Transcript

Aug 08, 2019 • 04:30 pm ET

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Pfenex Inc. (NYSE MKT:PFNX) Q2 2019 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Good afternoon, and welcome to the Pfenex Second Quarter Results and Business Update. [Operator Instructions]

At this time, I would like to turn the conference over to Eef Schimmelpennink, President and CEO. Please proceed.

Executive
Evert B. Schimmelpennink

Thank you, Chris, and good afternoon everyone. Welcome to Pfenex's second quarter 2019 results and business update conference call. Joining me on today's call is Susan Knudson, our Chief Financial Officer. During today's call, I will focus on discussing the status of the three lead programs in our clinical stage portfolio and how they have the potential to turn us into a commercial stage company in the near future. I will also provide an overview of our strategy to further leverage our proprietary Pfenex Expression Technology platform in order to expand our development pipeline, including a new milestone and royalty partnership that we have established. I believe this additional detail around our strategic expansion will provide greater insight into how we plan to build potential near and long-term shareholder value beyond our current advanced pipeline products. I will then turn the call over to Susan to discuss our second quarter 2019 financial results, after which we will open up the call for questions.

Let me start with our lead program, PF708, a therapeutic equivalent to Forteo that we believe has the potential to provide patients with a valuable alternative treatment option to Forteo, which achieved $1.6 billion in global product sales in 2018. Back in May, the FDA informed us that it had completed its mid-cycle review of our NDA for PF708 and had not identified any issues which require a advisory committee meeting. As such, they are continuing their review process, working toward the PDUFA date of 7 October, 2019.

Pfenex is also seeking an A therapeutic equivalence designation for PF708, which may permit PF708 to be automatically substituted for Forteo. Earlier in the year, Pfenex has submitted the protocol for the comparative human factor study for FDA feedback. Recently, the FDA informed Pfenex of its view that it might be premature to comment on the protocol until the details of PF708 labeling are agreed to, which may be near the PF708 PDUFA date of October 7, 2019. Pfenex has engaged in a discussion with the FDA around this position. Depending on the outcome, it may delay the start of the study and submitting the study results to the FDA, and potential therapeutic equivalence rating. As I mentioned, this process is separate from the NDA approval, and as such, we do not believe these discussions will impact the timing of the PDUFA date, which, as I mentioned earlier, is set for October 7, 2019.

Lastly, we are diligently moving forward with launch-readiness planning for PF708 with our partner Alvogen, which includes, among many other things, producing commercial materials and finalizing overall commercial strategy plans. We believe that all this puts us on track to launch PF708 into the US market as early as the fourth quarter of 2019, subject to FDA approval, final commercial strategic decisions