Ladies and gentlemen, thank you for standing by and welcome to KemPharm's First Quarter 2020 Corporate Update Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] Now I would like to turn the call to Jason Rando.

Good afternoon, and thank you for joining our call today to discuss KemPharm's first quarter 2020 corporate and financial results. Before we begin, 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 are made pursuant to the safe harbor provisions of the federal securities laws and represent management's current expectations. Actual results may differ materially. KemPharm disclaims any obligations to update or revise its forward-looking statements, except as required by law. More complete information regarding forward-looking statements, risks and uncertainties can be found in the reports KemPharm files with the SEC, which are available on KemPharm's website at www.kempharm.com, under the Investor Relations section. We encourage you to review these documents carefully. Speaking on today's call will be Travis Mickle, KemPharm's President and CEO; and LaDuane Clifton, CFO. Following the remarks, we will open the call to your questions. With that, it is my pleasure to introduce Travis.

Thank you, Jason and thanks everyone for taking the time to be with us today. There are certainly a number of updates to provide, so I'll jump right into those. First, as many of you seen the KP415 NDA was accepted for review by the FDA on May 1. This acceptance triggered a $5 million payment obligation from our partner GPC as part of our license agreement, and I believe that at least some recognition of the relative importance of this milestone. We also announced that Corium, which is a GPC portfolio company will be commercializing KP415 and eventually KP484. KemPharm actually has a long history with the Corium team, but I'll get more into that in a minute. I'm also happy to report our third consecutive quarter with development services revenue from our partners, GPC and Corium. I think this is an underappreciated aspect of our partnership, but certainly one that highlights the value that KemPharm brings to the table. As is the case it will be until approval, our cash reserves will remain skinny as we aggressively manage revenue expenses, as well as balancing with risks with any potential financing needs. The goal ultimately is to address the company's needs in the most balanced fashion available to us. You can see that this has led to the position where we've addressed our debt in the near term and brought in additional revenue that has pushed our forecast out past the potential PDUFA date for KP415. As some of you may be not as familiar with the whole KemPharm story, there is just a few spikes here that I'd like to run through quickly as a little bit of a background. First, I want to remind our listeners today of the general terms of the license agreement with GPC…

Thank you, Travis and good afternoon everyone. For Q1 of 2021, we've reported excuse me of 2020 this quarter, we reported $2.1 million in services revenue as compared to Q4, 2019 revenue of $1.4 million. As Travis mentioned, this is KemPharm’s third sequential quarter of reporting revenue. And we expect this trend to continue as we continue to work with our partners on the development of KP415 and our other product candidates. We reported a net loss of $5.8 million or $0.12 per basic and diluted share for the quarter. This is a significant improvement compared to the Q1, 2019 net loss of $12.3 million or $0.46 per basic and diluted share. Over the past year, we have undertaken a number of measures to improve our financial position, including a 36% reduction in our workforce, as well as other G&A cost reductions, shifting development costs to our partners and adding services revenue. Considering that net loss includes a number of non-cash items such as interest expense accruing the principal of $2.2 million, non-recurring severance expense of $800,000 and stock compensation expense of $600,000 during the quarter. You can see that we have made substantial progress in improving our financial position. Returning to the balance sheet, as of March 31, 2020 we had total cash of $2.5 million, which was a decrease of about $1.1 million compared to December 31, 2019. I'm glad to report that based on our current operating forecast, along with the expected revenues and our existing resources, our cash runway is expected to extend past the potential PDUFA date for KP415 and up to the debt maturity date of March 31 2020. We expect that our cash burn rate will be approximately $1 million per quarter, but we're working to reduce that as much as we can.…

Thanks LaDuane. So as, we look ahead now that the NDA acceptance is behind us, and look forward to the potential PDUFA in March of 2021. There's a lot of work in front of us. We'll certainly let you know what the exact date is once the FDA confirms it and we received that actually in a day 74 letter, which we don't expect to get until later this week. We will continue along the way to support the approval of KP415 as well as work closely with Corium among commercial supply and launch. They are ramping up full sales and marketing organization and we are prepared and ready to support their needs at any point. As I mentioned previously, we do hope to provide an update directly from Corium on the KP415 opportunity and ADHD market. I suspect within, currently jumping in with both feet to get everything up to speed, and the current kind of COVID environment that we are experiencing. This may not be until later this year, not something that we view it will be imminent, but at this time, this is just my best guess. I mentioned upfront, the need to balance risk, cash and dilution. We believe by managing those factors closely. We have mitigated risk related to potential factors outside our control, like the NDA filing timing that was delayed from what we had thought, any potential acceptance risks, and then factors that we're currently all experiencing, related to COVID virus as well as market conditions. As we plan ahead, we look to be able to open this resource up and look towards our milestones and potential revenue as positive factors in that direction. With that we're not blind to the issues in front of us and with the NDA acceptance behind us.…

[Operator Instructions] And our first question is from Oren Livnat with H.C. Wainwright. Please go ahead.

Congrats on that long awaited NDA filing. I have a few questions first of all, you've highlighted as advised several times that people are missing, I guess the relevance of Corium in the ADHD space, given their history and current makeup. And I'm just, and you pointed to the fact that they probably will have some kind of coming out party, before the PDUFA, but is there anything holding you and them back now about talking more about this asset? There hasn't been a ton of innovation in this space? And I'm just wondering, is it for competitive reasons that we're not talking about this asset more publicly yet that they aren't or are we waiting to see this label, and I have a couple follow-ups?

No, yes we're certainly not going to wait to see the label like I think, they fully believe as we do that the label is going to be what we've said all along, it's going to be with the onset and duration and abuse features that we have seen in our clinical studies. Really, it's been multiple factors here, I think, until the NDA was accepted, this was really managed by GPC, which is kind of the mothership, as it were to Corium. And so Corium is now the official - it has the official handoff. They are now the commercial partner, and it's going to take them some time to evaluate all the different opportunities. They're very familiar with ADHD. But until recently, we couldn't even announce that they would be the intended commercial partner. So we'd like to do it as soon as possible. I think they fully get what the value proposition is. We'd like to do it in the best form possible. And I think at this point, that it's not the ultimate timing that both Corium and KemPharm would like to see for that discussion.

Okay. And you mentioned that label, obviously, that's a huge issue. And I'm just curious, since, you guys been working for several extra months with GPC on this NDA, what sort of process have you guys pursued to maximize your chances of getting that best case onset duration claim? Have you been conducting any other analysis? Did you submit data to the FDA that we haven't seen? Is there anything color you can give us there?

No, we haven't submitted anything extra. We didn't do any additional analysis. It's really what everybody has seen publicly. Of course, that all has to be put in the context of the rest of the product and how it all makes sense for potential approved product. And again, I think it did take a little bit longer for GPC to get their consultants up to speed and then get through all their subsequent reviews. Ultimately, it made the NDA better, but there really wasn't any additional work that was done. It was really already all baked into the data packages we provided and work with them to formulate the NDA together on.

Okay. And just lastly, if I may on that milestone for approval, clearly, it's going to be dependent on the labeling. Have you ever given us bookends around that with regards the best and worst case?

I mean you can't, but it'd be a little bit facetious because the $58 million is the most it could be for both KP415 and 484 and zero as if you don't get approval, right. That's really the best we can do right now. As things materialize and get closer, GPC has been more willing to allow us to kind of disclose more. We did that as well, folks that had thought about the $10 million upfront, they didn't realize there was another $8 million that was actually paid out in reimbursements or in very well that typically organizations that receive upfronts, that money is intended to go for those additional fees and anything that the organization would need to pass through. So in this particular case, I think it didn't show the full story. They really - today we've had $23 million roughly of reimbursements in milestones, and there is more to come that's not subject to that restriction. So we certainly think that there is better economics here for us than people can really appreciate the face value.

Thank you. And now I would like to turn the call back to Travis Mickle for his final remarks.

I just want to thank all of you again for your time today and greatly appreciate your continued patience and support. We will continue to press forward to optimize the value of these agreements and address our issues as judiciously as possible. Thanks again.

Thank you. Ladies and gentlemen, this concludes today's conference. Thank you for participating. You may now disconnect.