PLx Pharma Inc. (NASDAQ:PLXP) Q2 2019 Earnings Conference Call - Final Transcript

Aug 09, 2019 • 08:30 am ET

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PLx Pharma Inc. (NASDAQ:PLXP) Q2 2019 Earnings Conference Call - Final Transcript

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Presentation
Operator
Operator

Good day, ladies and gentlemen, and welcome to the PLx Pharma's Second Quarter 2019 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded.

I would now like to introduce your host for today's call, Lisa Wilson, Investor Relations for PLx Pharma. Please go ahead.

Executive
Lisa M. Wilson

Thank you, Johanda. Welcome to PLx Pharma's Q2 2019 earnings results call. This is Lisa Wilson, Investor Relations for PLx. With me on today's call are Natasha Giordano, President and Chief Executive Officer; and Rita O'Connor, Chief Financial Officer of PLx. You can also access the webcast of this call through the Investors Section of the PLx website at plxpharma.com.

Before we get started, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation or intent regarding future events and the Company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to PLx Pharma's management as of today and involve risks and uncertainties, including those noted in our press release issued this morning and our filings with the SEC. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements.

PLx specifically disclaims any intent or obligation to update these forward-looking statements except as required by law. An archived webcast of this call will be made available for 30 days on our website, plxpharma.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on August 9th, 2019. Since then, PLx may have made announcements related to the topics discussed, so please reference the Company's most recent press releases and SEC filings.

And with that, I'll turn the call over to PLx's CEO, Natasha Giordano.

Executive
Natasha Giordano

Thank you, Lisa. Good morning, everyone, and thank you for joining our call. I'm pleased to share some updates with you today as we continue to make progress toward our planned launch of VAZALORE in the middle of next year. As we advance VAZALORE through the regulatory process, we are tracking well on all our key milestones.

We conducted a Type C meeting with the FDA, in a written response-only format, regarding our April briefing package submission for VAZALORE. The Type C meeting confirmed the information we need to provide for the approval of VAZALORE. We completed the manufacture of registration batches at the end of June and are now gathering stability data to support the sNDA submission for VAZALORE planned for year-end. We continue our pre-commercial activities, and we're on track to launch VAZALORE in mid-2020.

I'll now turn the call over to our CFO, Rita O'Connor, to discuss second quarter results and our progress in manufacturing. Rita?

Executive
Rita O'Connor

Thank you, Natasha. We recognized revenue of approximately $183,000 in the second quarter of 2019 compared to revenue of $167,000 in the second quarter of 2018. All the revenue recognized