Earnings Labs

Zevra Therapeutics, Inc. (ZVRA)

Q2 2017 Earnings Call· Thu, Aug 10, 2017

$9.95

+1.43%

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Transcript

Operator

Operator

Good day ladies and gentlemen and thank you for standing by. Welcome to the KemPharm second quarter 2017 corporate update conference call. [Operator Instructions]. I would now like to introduce your host for today's presentation Mr. Dan Cohen. Sir, please begin.

Dan Cohen

Analyst

Thank you and good afternoon everyone and thank you for joining our call today. At this time, I would like to remind our listeners that remarks are during this call may contain forward-looking statements that involve risks and uncertainties that are subject to changes at any time including, but not limited to, statements about KemPharm's expectations regarding future operating results. Forward-looking statements on this call are made pursuant to the Safe Harbor provisions of the Federal Securities Laws. Information contained in the forward-looking statements is management's beliefs based on current expectations and is subject to change. Actual results may differ materially from forward-looking statements. KemPharm disclaims any obligation to update such remarks, factors or announce publicly the results of any revisions to any forward-looking statements to reflect future events or developments, except as required by law. There is more complete information regarding forward-looking statements, risks and uncertainties in the reports KemPharm files with the SEC. These documents are available on KemPharm's website at www.kempharm.com under the Investor Relations section. We encourage you to review these documents carefully. Before I introduce today's speakers, I would like to note that KemPharm is using a slide presentation with the conference call. This presentation is also accessible via the Investor Relations section on KemPharm's website and is included with this webcast. Joining me on the call today will be Travis Mickle, President and CEO, who will provide an update on KemPharm's corporate and clinical development achievements and LaDuane Clifton, our CFO, who will review KemPharm's second quarter 2017 fiscal results. At that time we will conclude our remarks. There will be however no question-and-answer session today. I will now turn the call and the presentation over to Travis.

Travis Mickle

Analyst

Thank you Dan and welcome everyone to KemPharm's second quarter 2017 financial and business update conference call. As Dan mentioned, we have provided a brief slide presentation to accompany today's remarks. This second quarter continued what has been a very active 2017 for KemPharm and was highlighted by what we believe are important and significant advances with our ADJD portfolio which includes KP415 and the development of a new ADHD pro-drug candidate KP484. The progress we've have made with each product as well as our pain portfolio has been substantial and should set the stage for a busy second half of the year and early 2018. For KP415 we previously announced the successful completion of the end of Phase 1 meeting with the FDA and this morning we continued a strong momentum with an announcement of data from a confirmatory pharmacokinetic study of KP415 as well as additional pharmacokinetic data from studies to support both programs KP415 and KP484 including single dose and food effect with the normal breakfast with just the prodrug. These encouraging developments are the beginning of an extremely active productive clinical program for both KP415 and KP484 which will entail multiple operational and date announcements over the coming quarters. As stated previously we believe KP415 is our highest value pro-drug product and one that could potentially capture a significant share of the $13 million plus ADHD market should it be approved. However KP415 is no longer our only ADHD candidate. In June we also announced the development of a new product candidate KP484 which we plan to develop for ADHD indications that may benefit from an extended duration of treatment. Separate and apart from KP415, KP484 should enable KemPharm to now target the adult population of ADHD patients specifically with data suggesting an ability for this…

LaDuane Clifton

Analyst

Thank you, Travis and good afternoon everyone. I will provide a brief overview of our results for Q2 of 2017. Additional details are available on our press release which was published prior to the call. For the second quarter of 2017, we reported a net loss of $6.5 million or $0.44 per basic and diluted share as compared to a net income of $9.8 million or basic net income per share of $0.59 and diluted net loss per share of $0.58 for the second quarter of 2016. The net loss for Q2 2017 was primarily driven by an operating loss of $8.2 million and net interest expense and other items of $1.8 million which was offset by recognition of income from a non-cash fair value adjustment of $3.1 million during the quarter. As of June 30, 2017 total cash, cash equivalents, restricted cash, marketable securities and long term investments totalled 65.8 million which was a decrease in our cash position of about 6.6 million compared to March 31, 2017. Our updated forecast continues to show an expected cash burn rate of approximately 7 million to 9 million per quarter. This leaves KemPharm in a solid capital position with existing resources expected to fund our development and operating activities through the second quarter of 2019. Now I will return the call back to Travis.

Travis Mickle

Analyst

The second quarter of 2017 was an important step in the continued growth of KemPharm with the introduction of KP484 to our pipeline and the continued development of KP415. As noted earlier in the call these developments should enable KemPharm to meet multiple value building milestones through the remainder of 2017 and into 2018. It goes without saying that in the next several quarters will be an exciting time for KemPharm and should the various studies and data readouts prove favorable we could be in the position to file multiple NDAs in the coming years. As I've stated on previous calls KemPharm's ability to offer an accelerated and derisk development timeline as well as composition of matter protection on any new molecule we develop is we believe highly attractive considering we announced our updated clinical development strategy less than a year ago. It speaks volumes about the efficiencies of our prodrug platform and our ability to rapidly advance programs from IND to NDA. With that I would like to thank you for your time and listening to our call today and that would be the end of our call.

Operator

Operator

Ladies and gentlemen thank you for participating in today's conference. This concludes the program. You may not disconnect. Everyone have a wonderful day.