Good day, ladies and gentlemen, and welcome to the KemPharm’s Second Quarter 2018 Corporate Update 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 conference is being recorded. I’d now like to introduce your host for today’s conference Dan Cohen, Executive Vice President. You may begin.

Thank you, and good afternoon, everyone. Thank you for joining our 2018 second quarter financial and corporate results phone call this afternoon. At this time, I would like to remind all of our listeners that remarks made during this call, may contain forward-looking statements those 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 Federal Securities Laws. Information in the forward-looking statements is management’s beliefs based on current expectations and is subject to change and it may actually differ materially from actual results from the forward-looking statements themselves. 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 forward-looking statements, risks and uncertainties in the reports KemPharm files with the SEC. These documents are available at KemPharm’s website at www.kempharm.com under the Investor Relations section, and we encourage you to review these documents carefully. Before I introduce today’s speakers, I would like to remind all listeners that KemPharm is using a slide presentation with the conference call. The presentation is accessible via the Investor Relations section on KemPharm’s website and is also included within the webcast. Joining me on today’s call is Travis Mickle, President and Chief Executive Officer; and LaDuane Clifton, our Chief Financial Officer. We will begin this call by reviewing our corporate achievements and recent clinical developments involving our prodrug portfolio followed by a review of our financial results. I will now turn the call and the presentation over to Travis.

Thank you, Dan, and thanks everyone for joining the call. As discussed on prior quarterly conference calls, KemPharm’s mission is to build a portfolio of prodrugs that are an improvement on currently approved drugs and address unmet medical needs in large, established markets, or in treatment indications that are significantly underserved. Our pipeline consists of multiple products at varying stages of development, targeting both large market and orphan indications that address patient populations where a prodrug can offer better treatment outcomes and alleviate unwanted or unintended side effects. The depth and diversity of our pipeline is uncommon for a company our size, and the progress we've made and expect to make should enable us to build both near-term and longer-range value. Our ADHD portfolio, let by KP415, exemplifies this strategy and the potential advantages that prodrug products can offer. The second quarter was highlighted by two key clinical advances with our KP415 program, which we believe continues to demonstrate the potential of our ADHD prodrug pipeline. On July 9, we announced topline data from the efficacy and safety trial of KP415. I will discuss the results in greater detail shortly, but in summary, KP415 was shown to be an effective treatment, with the overall data package suggesting an onset of action at 30 minutes and a duration of effect of 13 hours. We believe these properties represent important points of differentiation when compared to current methylphenidate-based treatments for ADHD. In addition, another highly differentiating property of KP415 was highlighted during the second quarter, with the announcement of topline data from the intravenous human abuse potential trial of our prodrug of d-methylphenidate that is found in both KP415 and KP484. Results from the IV HAP study were outstanding, indicating that SER dexmethylphenidate, the prodrug for both of these products, produces pharmacodynamic…

Thank you, Travis, and good afternoon, everyone. I will provide a brief overview of our results for second quarter 2018. Additional details are available in our press release, which was published just prior to the call. For the quarter ended June 30, 2018, KemPharm reported a net loss of $10 million or $0.65 per basic share and $0.91 per diluted share, compared to a net loss of $6.5 million or $0.44 per basic and diluted share for the same period in 2017. Net loss for Q2 of 2018 was driven primarily by a loss from operations of $13.9 million and net interest expense and other items of $1.7 million, partially offset by non-cash fair value adjustment income of $5.6 million. Loss from operations increased to $13.9 million for Q2 2018 compared to $8.2 million for Q2 2017. The increase was primarily due to an increase of $5.8 million in research and development expenses, partially offset by about $100,000 in general and administrative expense. As of June 30, 2018, total cash and security-related amounts, which is comprised of cash, cash equivalents, restricted cash, marketable securities, and trade day receivables was $29.3 million. This was a decrease of approximately $7.9 million, as compared to the end of Q1 2018. Based on the Company’s current operating forecast, existing resources are expected to fund operating expenses and capital expenditure requirements into but not through the first quarter of 2019. I want to leave you with one additional thought related to our cash forecast as we progress toward a commercial partner for Apadaz. As we have discussed in a previous call earlier this year, there are certain costs included in our cash forecast related to preparing for the Apadaz launch, such as API purchases, other raw material purchases, and costs related to commercial scale validation batches. We believe there is the potential that all or a portion of these expenses could be shifted to a commercial partner. This would allow us to avoid approximately $8 million to $10 million in costs that are currently included in the forecast, and potentially extend our cash forecast into Q2 of 2019. We will keep you posted as the partnering process for Apadaz progresses. Now I will turn the call back over to Travis.

Overall, the second quarter of 2018 was a period of great progress for KemPharm, and in particular, the KP415 program. As we hope you can now appreciate, our outlook for KP415 is extremely optimistic. Looking ahead, we foresee several potential value-enhancing milestones over the next several quarters, including the KP415 and KP484 oral and intranasal HAP data in the second half of this year, initiation of the KP484 pivotal efficacy study, an announcement of an Apadaz partnership before year-end, as well as an announcement of a KP415 partnership before year-end, and then a submission of a KP415 NDA in early 2019. These events, combined with the ability to harness our LAT program to develop additional products for either our development efforts or for that of other companies offer KemPharm an abundance of growth opportunities both near and long term. With that, I will now open the call to your questions.

[Operator Instructions] Our first question is from Randall Stanicky from RBC. Your line is now open.

Great. Thanks, guys. Travis, just a couple up front on KP415, and then I want to ask one on Apadaz. But have you spoken or had any communication with FDA since putting out the data? And then the second question is just on tone or any discussions that you’re having with partners, and has anything changed there in terms of how they’re thinking about the opportunity or the ad hoc data? Any color that you can provide from that front, then I’ve got a couple more.

Sure, turning your question about the FDA. No, I mean, they don’t have a turnaround that quickly for what would be traditionally a Type C type request for a meeting. There is an opportunity to have a more in depth discussion at a, say, a pre-NDA, but we have that planned with several very key questions later in the year, early next year. So for us, as I said on the data call, I think it best, even if we do have say two meetings between now and NDA filing, we could expect maybe they’d be receptive to it, but they would only consider a final decision at review, and I think that’s really still what our expectations are. But of course, we’ll let everybody know if we hear even any indication of receptivity. Our belief is very strong that this data would represent their interpretation. As far as the partnership discussions, I can’t give specific details or anything. I will say that we have definitively said that we will anticipate reaching a agreement with a partner on KP415 by year-end, and I think that indicates not only our confidence but probably the confidence of those that we’ve been speaking to.

And presumably, that would be – 404 would be part of that. Maybe just talk to us about two things. One, it sounds like the timeline for 404 is unchanged, but remind us how the KP415 learnings are helping inform that path forward.

As far as for KP484 and 415, yes, they’re related to the same IP. It’s the same prodrug in both products, so those essentially would have to go together. It would be difficult to license them to two different individual parties. You’re right, we’ve been able to track alongside of KP415. In this particular case, that’s an adult-focused market, so you don’t have classroom study designs and you don’t have the same issues. But there was a lot of learnings about secondary endpoints and such that we’ll be using here, as well as the general design of the program and the efficacy study. So that’s really why we waited for the data to get started in earnest with KP404.

And my last question on Apadaz. We’ve been anticipating a possible deal for some time. We’re getting closer to year-end. I guess, to the extent that you can, remind us what type of deal that you’re thinking about. You’ve talked about a possible PBM, possible manufacturer partner. Has the type of structure of deal and partner evolved or changed, or should we be thinking about it the same way? Thanks.

No, that's still our plan. I think the evolution here has been as we proceed kind of down both pathways, we kind of expect one to happen before the other. And I think our expectation right now is that having a generic partner, a manufacturer in place first, will really help overcome supply questions that can give plans more confidence that we can supply the marketplace. So I think that's kind of where our priority is set, and it's still our same expectations that this is the pathway for Apadaz that we plan to now partner with a generic manufacturer first, followed by various plans, PBMs, in order to have them prefer or substitute completely generics for Apadaz.

Okay, great. Thanks, Travis.

Thank you. Our next question is from Bill Maughan from Cowen and Company. Your line is now open.

Hi, guys. Good afternoon. So just very generally, what kind of structure should we be expecting in a 415 partnership deal? And then, you mentioned a precedent earlier. What specific precedent can you point us to where the FDA has shifted their analysis based on a study design issue like this one? And then, even if the FDA adheres to, say, Visit 5 baseline, would this still then just be approvable and then it would be in the hands of the doctors and patients to find the differentiation for themselves? Thanks.

Yes, so starting with the partnership discussion, we don't have an exact structure that I can share with you today. Again, a lot of this would be focused on a licensing agreement. I could point you back to what we did with Vyvanse. Again, that was a $50 million upfront with various milestones afterwards, culminating in about a $500 million deal with up to a 50/50 profit split post-commercialization, post-approval. So I think those are along our thoughts because we would like to see, ultimately, the best economics for what we feel is a $1 billion-plus opportunity for these products in ADHD. As far as precedent for FDA and kind of analogous to KP415, we don't have a direct comparison, but if you can look at what the division has directly done with various ADHD products, you can look at Cotempla, you can look at Aptensio, and you can look at Quillivant as three examples where there has been statistical issues that they have addressed along the way and either used a change to the SAP, used an alternative analysis, or used the sponsor's analysis to guide, ultimately, what the label said. And the last question, using the Visit 5, yes, this an approvable product. We met the primary endpoint. We met all the secondary endpoints that show this is effective. Ultimately, if the label is silent on onset and duration, you could do a second study, or you can use this data as-is, which we believe is the correct way to do, to generate some of that initial thoughts around onset and duration. And of course, this would always be left up to the physicians in the real-world practice to see how it actually performs, which again, we believe is very comparable to Vyvanse in its duration.

All right. Thank you for the response.

Thank you. Our next question is from Ken Trbovich from Janney. Your line is now open.

Thanks for taking the question. Travis, I guess couple questions specifically on 484. Is there any additional thought with regard to perhaps delaying the start of that study until after you have the pre-NDA meeting with the agency and get more feedback in general about the overall program?

No, because that's a separate program altogether, so before we would initiate any efficacy study, I'm sure we would request a meeting along that direction, just like we did for KP415. So, again, this is an adult product. It doesn't have the same designs or consideration. But we would want to be in front of that with its own sort of set of meetings, specifically to KP484.

Sure, and I guess just specifically then, with data in hand do you have confidence on timing for when you would be getting 484 done?

Again, as I said on the call, I think we’re still focused on initiation of the clinical study by year-end. I think it’s kind of again timed about a year behind. We imitated very late last year the KP415 and announced data in July, and I think that’s reasonable to assume here, but I don’t have the exact details at all.

Sure. And then just as it relates to the partnership, and I know you alluded to this earlier at partnership discussions, can you give us a sense as to what that process was like with regard to start-to-finish regarding new River and Vyvanse? My recollection was it was an agreement that was signed in late summer, early fall with an investment bank that helped to facilitate that transaction with Shire, and I’m just curious if you help us to sort of comparative trust where you’re at in that timeline relative to the process that you went through with New River?

Yes, no, that’s a great question. One thing I would like to kind of add to that a little bit, Ken, is that New River was at a much earlier stage. They had a single completed pharmacokinetic study and an efficacy study that was underway but did not have any data readouts by the time they signed a terms sheet and led to a definitive agreement with Shire. So the group that we actually worked with when I was at New River, you might know one the gentleman, he works for the company here, Rusty Johnson. He was the head of the banking group that led that partnering process. We started it in August of 2004. There was a binding terms sheet by year-end, and the agreement was inked in February of 2005, early, very rapid process. We are already much further along and have a multitude of additional data that New River never had during that process. So that’s why we feel this is such a healthy opportunity and we should take advantage of it.

Makes sense. Appreciate the clarity.

Thank you. [Operator Instructions] Our next question is from David Solomon from Roth Capital Markets. Your line is now open.

Hey guys, congrats on the progress and thanks for taken my questions. Just getting started related to the partnership discussion we just heard, and thanks for all the color related to it, how critical is the information that you're going to learn near-term on the oral and nasal HAL studies for these discussions?

Intravenous is the most extreme route, and we've shown really zero effect there. I think those are additional points. I don't think they're critical to have those before you get this active process underway, which we already have underway. So, clearly, we haven't seen a lot of resistance, but we'll update everybody that's in the process along that path.

Thanks. But coming along those lines, is it something where you guys potentially may be waiting to have that data? Is it something that could have significant upside to the negotiations or the value that you're looking to maybe have?

Yes. I mean we agree that’s a huge value driver here is abuse potential and having much lower abuse potential than kind of the best lower abuse potential, like Vyvanse, would be great. But this provides us, as the data reads out over the next couple months, opportunities to keep everybody more informed of what the data is. Of course, before we think anything and get through, we want to make sure we maximize the value as much as possible and have that data available to the partner.

Great, thanks. And just regarding the efficacy study and the post hoc analysis, how should we be thinking about those two endpoints and why maybe at those final time points, it was significant on Day 5, but they were so for the other? Just, if we get some color more on how those two are compared.

Well, there was a fundamental shift in the scores from Visit 5 to Visit 6 because the patients themselves underwent different conditions. So prior to Visit 5, everybody had run in on KP415 for a number of weeks to their optimized dose. Then they were all washed out for two days, and then the baseline was taken on Visit 5. During Visit 5, everyone was randomized and placed into two different groups either on their optimized dose of KP415 or on placebo. And so, essentially, if you think about that, there was one group that was now kind of completely treated differently, and so what happened is the scores pre-dose for the placebo change that really could not be expected to be different than after a two-day washout. So that's fundamentally what happened there and why the scores were so different from Visit 5 to Visit 6.

Great. And then just between the two endpoints, how come it was significant? I guess you were starting to see slightly greater P values, but they were still highly significant for the PERMP score at those time points. I'm just trying to understand the two endpoints between themselves.

Sure, and I guess I didn't understand your question the first time, so I'm glad you restated it. The difference was at Visit 5, they were all identical because everybody had been treated the same way and everybody was basically in the same group. When Visit 6 was accounted for, there was a shift where placebo and drug had a difference, and that difference then was not accounted for. And so, when you'd use the Visit 5 baseline you didn't see statistically significant differences early and late in the study because you weren't accounting for the placebo. Once you account for the placebo, that's when the true data splits out. Now, for the PERMP, the shift or the change was exactly the same because there really wasn't any additional change in the study conditions for those individual subjects. So I think that's the difference there, the PERMP itself saw a difference, but it was consistent between Visits 5 and 6, while for the SKAMP you saw this crossover difference.

Great. That's really helpful. And then, just regarding that 13th hour, how critical is it for the label, do you think?

Again, you might want to go back and look at some of the different labels for ADHD products. Some of them are actually silent on said and duration, so as far as the label goes, you can have both it on there and off there. We've been looking at some examples. I think the marketing materials ultimately would include the data that we have, and we believe strongly that this data will be used by the FDA. This is not something that they really are going to take lightly as far as Visit 6 data.

I understand. And then, just lastly on Apadaz, so you discussed things that you could be doing, but there could be a partnership coming that they may be doing things. What are the things that you're kind of planning to do near term, or is it mainly just waiting for the partnership?

No, we have several manufacturing activities as [indiscernible] doing outline that were both planned and yet to be done, and things that we have gone under since approval. So a lot of it's regulatory and commercial planning, manufacturing, and so forth. But a lot of that cost that LaDuane was referring to will be pushed onto our partner once that happens. We believe that's going to happen as rapidly as possible.

Great. Thanks for taking my questions.

You welcome.

Thank you. Our next question is from Dewey Steadman from Canaccord. Your line is now open.

Hi guys, and thanks for taking the question. I guess on the earlier program, so you've got some other programs outside of ADHD and some pain programs. Can you just remind us of the status of those, and are those progressing sort of behind the scenes as ADHD comes to fruition?

Yes, we have things we haven't disclosed. Of course there's the other opioid programs that we have clinical data for. We did highlight in our recent pipeline that as far as the other opioids go, they'll follow the path of the Apadaz. So as that becomes a successful commercial program with partners, we'll decide kind of how to prioritize those. Beyond that, we have again a product that we in-licensed with Genco that we're preparing a project for that we announced last year in the pediatric rare disease area of Tourette's. You know, these are very interesting components. Just to remind everybody, you know, we're sitting here with a culmination of a huge amount of data for KP415. Last year at this time, we had a single pharmacokinetics study. So roughly in a year's time, we've been able to do about 16 to 18 clinical studies, wrap up all our nonclinical work with the exception of one study, so tremendous amount of progress that can be made very rapidly with our approach.

Thanks, and then on the potential for duration, if FDA doesn't agree with you and you get a label that shows 10 or so hours of duration, would you consider doing potentially a head-to-head study against maybe an older ADHD product to show superiority of duration over the last generation of products?

I guess we really haven't considered that type of study. Those are always fraught with all sorts of clinical and regulatory risks if you do those types of studies. But you know, I think it's really our belief that the probability of them accepting the one to 10 hour analysis of Visit 5 is very, very low. So if they do that, I would rather spend time and effort, and I think a partner who would put that effort in, in doing a study that could be used on the label. A very similar approach is what we did with Vyvanse--get the product approved. It had a duration of two to 12 hours, and then do another study to add in that additional hour post-approval, and that's exactly what we did with Vyvanse.

Great guys. Thanks a lot.

Thank you. At this time, I'm showing no further questions, I would now like to turn the call back over to Travis Mickle, CEO for closing remarks.

In closing, I appreciate your time today and attention and look forward to future updates as we continue to advance our pipeline and anticipate multiple value building milestones. Thanks everyone.

Ladies and gentlemen, thank you for your participation in today's conference. This concludes the program. You may now disconnect.