liquidia technologies inc (NASDAQ:LQDA) Q4 2018 Earnings Conference Call Transcript

Feb 26, 2019 • 08:00 am ET

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liquidia technologies inc (NASDAQ:LQDA) Q4 2018 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Good day, ladies and gentlemen, and welcome to the Liquidia Technologies 2018 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time.

(Operator Instructions)

I would like to remind everyone that this conference call is being recorded. I'll now hand the call over to Jenny Kobin, who is supporting the Liquidia's Investor Relations activities while Jennifer Almond, is on maternity leave.

Executive
Jenny Kobin

Thank you, and good morning. Welcome to Liquidia Technologies fourth quarter and full year 2018, financial results and corporate update.

Today's call will include forward-looking statements pursuant to the Private Securities Litigation Reform Act of 1995 based on current expectations. Such statements represent management's judgment as of today and may involve significant risks and uncertainties that could cause actual results to differ materially from expected results. Please refer to Liquidia's filings with the SEC, which are available from the SEC or at liquidia.com, for information concerning risk factors that could cause such differences and otherwise affect the Company.

I would now like to turn the call over to Neal Fowler, CEO.

Executive
Neal Fowler

Good morning, and thank you for joining us as we summarize Liquidia's results for the fourth quarter and year-ended December 31, 2018. Joining me today are Kevin Gordon, President and Chief Financial Officer; and Dr. Robert Roscigno, Senior Vice President of Product Development and Program Lead for LIQ861.

This morning, I will update you on our pipeline progress, which includes our lead product candidate LIQ861 for pulmonary arterial hypertension or PAH, currently being evaluated in a Phase 3 study. And LIQ865, our injectable sustained release formulation of the non-opioid anesthetic bupivacaine to treat local post-operative pain.

Kevin will provide highlights of our financial results for the fourth quarter and full year 2018. And then I will wrap up with an update on our upcoming key milestones in 2019. After our prepared remarks, we will open the call for your questions.

We will begin with our lead program LIQ861, an inhaled dry powder formulation of treprostinil designed using Liquidia's proprietary PRINT technology to enhance deep lung delivery, using a convenient palm-sized disposable device for the treatment of PAH. Given that PAH is a rare chronic and progressive disease, we believe LIQ861 has the potential to improve a patient's overall quality of life. As an inhaled product, we believe LIQ861 will minimize the systemic side effects seen with oral and infused prostacyclin based products, while also overcoming the limitations of current nebulized therapies to safely deliver higher doses into the lungs.

In January of this year, we reported positive interim safety data from our pivotal Phase 3 clinical trial known as INSPIRE. LIQ861 was observed to be well tolerated in 109 PAH patients at the two-week time point. The period, which addresses the FDA's request for data inclusion in our NDA submission. LIQ861 was evaluated at doses up to a 125-microgram capsule strength with no study-drug related serious adverse events