Earnings Labs

Zevra Therapeutics, Inc. (ZVRA)

Q2 2016 Earnings Call· Wed, Aug 10, 2016

$9.95

+1.43%

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the KemPharm Second Quarter 2016 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] As a reminder, this call maybe recorded. I would now like to introduce your host for today's conference, Jason Rando of Tiberend Strategic Advisors. Please go ahead.

Jason Rando

Analyst

Good morning everyone. Thank you for joining our call today. At this time, I would like to remind our listeners that remarks made during this call may contain forward-looking statements that involve risks and uncertainties, and 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. And actual results may differ materially from forward-looking statements. KemPharm disclaims any obligation to update any such factors or to announce publicly the results of any revisions to any of the forward-looking statements to reflect future events or developments, except as required by law. There is more complete information regarding the forward-looking statements, risks, and uncertainties in the reports KemPharm files with the SEC. These documents are available on KemPharm's Web site at www.kempharm.com, under the Investor Relations section, and we encourage you to review these documents carefully. Speaking on today's call will be Travis Mickle, President and CEO, who will provide an update on KemPharm's corporate and clinical development achievements including the recent regulatory events involving Apadaz. Following Dr. Mickle, LaDuane Clifton, CFO, will review KemPharm's second quarter 2016 financial results. At the conclusion of the remarks, we will then proceed to a question-and-answer session. I will now turn the call over to Travis.

Travis Mickle

Analyst

Thank you, Jason. And welcome everyone. This has been a significant period for KemPharm, not only regarding Apadaz, but also with respect for advancing pipelines and broader development strategy. As disclosed in our press release this morning, KemPharm and representatives from the FDA held an end-of-review meeting for Apadaz on August 3. We requested this meeting following the complete response letter for Apadaz that was issued in June. Our rationale for the end-of-review meeting was to discuss the issues identified by the FDA in the Apadaz NDA, and to discuss the NDA amendment request that was filed in conjunction with the June 9 PDUFA. I can report that the end-of-review meeting clarified several of the issues that first arose during the Apadaz AdCom, and were subsequently reflected in the CRL particularly related to abuse-deterrent labeling. We were able to have an open discussion of fundamental issues pertaining to hydrocodone-acetaminophen combination products, abuse-deterrents in relation to the broader immediate-release prescription opioid market, and published industry guidance from the FDA concerning the evaluation and labeling of abuse-deterrent opioid. Additionally, while the FDA was unable to respond to our NDA amendment when it was submitted, we were pleased to learn that the end-of-review meeting that our proposed -- at the end-of-review meeting, sorry, that our proposed short duration blister packaging for Apadaz was well-received and aligned with suggestions provided prior to our filing to amendment. As described in our press release this morning, the short duration blister packaging was proposed in accordance with the CDC guidelines for prescribing opioids for chronic pain, which advises that clinicians should prescribe the lowest effective dose of immediate-release opioids, and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. The Apadaz AdCom and subsequent CRL were disappointing. At…

LaDuane Clifton

Analyst

Thank you, Travis, and good morning everyone. Just a quick review of our financials for Q2, we reported net income of $9.8 million or $0.59 per basic share. That was driven solely by a $20.8 million decrease in the fair value of our derivatives and warrant liability. Our operating loss for Q2 was $9.3 million, versus $6 million in the same quarter of 2015. The increase in the operating loss compared to Q2 of 2015 was driven by a $2.2 million increase in R&D spending related to KP511 and KP415, and a $1.1 million increase in G&A expenses due to increased headcount and commercial activities during the quarter. Total cash, as of June 30, was $102.6 million, which was a decrease of $8.4 million from March 31. We remain well-positioned with resources to support our ongoing development efforts that Travis has outlined, and so we look forward to continuing to allocate those resources judiciously. And so with that, I will turn the call back over to Travis.

Travis Mickle

Analyst

Thank you, LaDuane. Again, I appreciate your time this morning. And now I'd like to open it up for any questions that you may have.

Operator

Operator

Thank you. [Operator Instructions] Our first question comes from the line of Randall Stanicky with RBC Capital Markets. Your line is open. Please go ahead.

Unidentified Analyst

Analyst

Great, thanks. This is Aishwarya [ph] on for Randall, thanks for taking my question. So just to clarify, given the issue with CRL, can we take this to mean that both you and the FDA are in agreement over what the label could look like. And if so, can we get a little bit more color around the type of abuse-deterrent language you see potentially [ph] on the label? And I just have a quick follow-up after that.

Travis Mickle

Analyst

Hi. The first part of your question about the agreement between what the company and FDA could agree on a label, we are in agreement on everything except for the abuse-deterrent claims, as I stated on the call. And the second part of your question, I can't really give you any details there because we don't know where the different options lie. We know that there are several options, and we continue to explore those with the FDA.

Unidentified Analyst

Analyst

Okay. And what's the potential timeline that you guys are expecting for a CRL resolution; will it be a Class 1 or Class 2 resubmission?

Travis Mickle

Analyst

Again, that's one of the options that we're exploring. There's certainly a number of different paths we can take, some more formal and some less formal. Many of those don't have bound timeline. So, I can't really give you any insight as to how long that may take.

Unidentified Analyst

Analyst

Okay, got it. Thank you.

Operator

Operator

Thank you. [Operator Instructions]

Operator

Operator

And I'm showing no additional questions. At this time, I'd like to turn the call back over to Travis Mickle, President and CEO, for any closing remarks.

Travis Mickle

Analyst

I appreciate everyone's time for being on the call this morning again. And look forward to updating you on the continued progress of our products and our pipeline, as well as any developments that may occur with Apadaz. Thanks again.

Operator

Operator

Ladies and gentlemen, thank you for participating in today's conference. This does conclude today's program. You may all disconnect. Everyone have a great day.