3/11/2021

speaker
Operator
Conference Operator

Ladies and gentlemen, thank you for standing by, and welcome to the ChemPharm fourth quarter and year-end 2020 results conference call. At this time, all participants are in a listen-only mode. Please be advised that today's conference call is being recorded, and if you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Mr. Jason Randall from Timberland Strategic Advisors. Thank you. Please go ahead, sir.

speaker
Jason Randall
Timberland Strategic Advisors (Moderator)

Good afternoon, and thank you for joining our call today to discuss ChemPharm's fourth quarter and full year 2020 financial and corporate 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 ChemPharm'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. ChemPharm disclaims any obligation 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 ChemPharm's filings with the SEC. which are available on ChemFarm's website under the Investor Relations section. Speaking on today's call will be Travis Mickel, ChemFarm's President and CEO, and LaDwayne Clifton, CFO. Following the remarks, there will be a question and answer session during which ChemFarm's management will respond to questions that have been submitted during the past week since that company's call regarding the approval of the STARS. With that, it is my pleasure to introduce Travis.

speaker
Travis Mickel
President and Chief Executive Officer, ChemPharm

Thanks, Jason, and thanks, everyone, for joining this afternoon, this evening. I wanted to just quickly provide some updates, really just recaps from what we've discussed over the past few months. I think most of our questions that we've received and most of the focus will be around the financial position of the organization since now we're able to actually report that out. So I think the focus of today's call will center around very much so the financial position of the organization. So to start out, of course, hopefully every single person is aware that's on this call or will be listening to it that the FDA approved our product of Starus last week. That is, of course, partnered with an affiliate of Gernot Point Capital, and the commercial partner in that case is also Quorium. Under the license agreement, we're eligible to receive regulatory sales-based milestones totaling up to $468 million and also includes tiered royalties up to the mid-20s. These milestones are broken up into various amounts, but they include an approval and, of course, sales-based milestones. Coriam has issued a press release regarding the approval of Astaris. I encourage you, if you want to hear a little more from them on the product, please seek out their press release to read more about Astaris. Updates on the partnership. Again, we've entered into a consulting agreement with Corium on other projects other than KB415 slash Astaris. This provides us additional revenue. And we have, of course, our ongoing collaboration with KVK Tech and for the launch of APIDAS and the pilot program there that just launched in Alabama. A greatly improved financial position. I will let LeDwayne really talk through all of this. I think everybody on the call or listening can see the tremendous turnaround from a year ago, two years ago, even before that, and I'll let him go through that in detail. And then kind of looking forward, we have this great achievement. I do want to spend a little bit of time, mostly towards the end, kind of outlining for everybody where we believe the product is differentiated, help point to the value proposition a little bit more, and provide some context that I think will be very, very helpful for you as you assess the future of the product, the future value proposition of the product, as well as the value to this organization. So with that, I will jump right in to talk a little bit about the approval of Astaris. Of course, this was approved on the 2nd. This was actually a very late night event. There was no pizza party, just so everybody knows. In fact, many of us had already gone home for the day waiting for that event to happen, the official letter from the FDA. Coriam does expect to make Astaris available in the U.S. as early as the second half. I think in general, for anybody that would launch an ADHD product, a great time to do so is at the very beginning of the school year. So if I was in Perry Sternberg's shoes over there at Coriam, that would be where I would focus my most attention. A Starus NDA approval not only validates the prodrug approach, the LAT approach that we've developed here at ChemPharm, but also the value potential of each one of our prodrugs that we do spend a lot of time and effort on to get these products approved. This goes far beyond a Starus. This goes into KP484. It's the same active, the only active ingredient in KP879. So with this, it's really a pivotal point in our organization's history. Turning to the partnership a little bit more. For those that aren't really familiar with this license, again, it started off back in September of 2019. It's with a portfolio company directly of GPC who has then assigned the commercialization rights to Quorium. Quorium is headed by Perry Sternberg. I mentioned him already. This is the guy who really made Vyvanse what it was commercially, and much of the team that worked with him there is now at Quorium, and we are very excited to have such a great commercial partner, literally very complementary to this great development team that we have here at Kim Farms. The milestones and royalties I've already mentioned. So, just briefly, I did want to touch on the marketplace. And this is really a prelude to some of the discussion I'll have related to some questions. You know, this is a very big and growing market. I think we really underestimate when we think about ADHD, it's so well understood. You know, a $17.5 billion market in this particular case divided up, yeah, sure, in a number of different products, but two major categories, stimulant, non-stimulant, with only really two stimulant-based types of products. We believe that our product has met many of these, if not all, the key advantages that we intended to go out and demonstrate as far as how we can improve methylphenidate-based products. So with that, I'm actually going to turn it back over to LeDwane, and he'll go through the financial update.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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