KemPharm, Inc.

Good afternoon, ladies and gentlemen, and welcome to ChemPharm Q3 2020 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. If anyone should require assistance during the conference, please press star zero on your touchtone telephone. As a reminder, this conference call may be recorded. I would now like to turn the conference over to your host, Mr. Jason Randall, Tiburant Strategic Advisor. Sir, the floor is yours.

Good afternoon and thank you for joining our call today to discuss ChemFarm's third quarter 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 ChemFarm'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 reports ChemPharm files with the SEC, which are available on ChemPharm's website at www.chempharm.com under the investor relations section. We encourage you to review these documents carefully. Speaking on today's call will be Travis Mikkel, ChemPharm's President and CEO, and LaDwayne Clifton, CFO. Following remarks will open the call to questions. With that, it is my pleasure to introduce Travis.

Thank you, Jason, and thank you everyone for joining this afternoon. I want to run through the PIMFARM highlights here on slide four. Just a few things of note, we continue to execute on our plan as we've stated all along, continue to meet the obligations with our partners, continue to push forward with our NDA and development programs, and continue to address the base business, including the revenue as well as expenses, and continue to work on our debt. So as you can see from the highlights of our last quarter, that's very much what we've done. The FDA continues to review the NDA for KP415. We have a PDUFA date for March 2nd, 2021, which many of you are already familiar with. And to date, there's been no new safety issues, no safety issues, and no substantive issues identified as far as that review of the KP415. NDA. We announced recently the expansion of a consulting arrangement with Corium, our partner, commercial partner for KP415, as well as a collaboration intended to really launch off the APRDAS program between KVK and SureMed. I'll discuss a little bit more in detail soon. Also going to be presenting our financial results. Continue to have revenue based on our services to our partner. And we see that continuing for the foreseeable future. And all of this at the same time while trying to address maybe the only issue left to address for us, which is our outstanding debt. Turning to the next slide, looking more specifically at KP415. As I mentioned, there was no substantial issues or safety concerns that were raised on our last meeting with the FDA on August 13th. We do have a tentative date, December 1st of this year, in which we could also meet with the agency for a late cycle review meeting. This meeting would only be called if it was necessary to do so. So that would be to identify any approvability issues or just to confirm, you know, that there are no issues. So either way, we'll be explaining and sending along what happens at that meeting. along to investors and shareholders in order for you to know essentially how that is progressing. That is effectively the approvability point with the FDA is supposed to know whether the product would be approvable or not from then on. We also have announced and really working ahead with Corium on their commercial activities. They are targeting a mid-year a second half 2021 date for the product launch. This is after what would be expected to be a roughly 90-day process to achieve DEA scheduling and quota generation in order to be able to have that launch at that point. We do plan to still have a call with Coriam to provide an overview of the commercial plans and market dynamics related to ADHD, their viewpoints on KP415, Again, scheduling has been a challenge for multiple reasons, all of them good, so the date to be announced as soon as possible. Turning now to that agreement on slide six here, the agreement between Corium and ChemPharm, continue to build on the relationship that has put us in the position that we're in with this great partnership on KB415. Now adding additional services from our R&D staff able to support Corium in their endeavors, internal endeavors to develop other products not related to our prodrugs. So this is already an expansion upon what we were already doing to support them in their commercial activities, which include manufacturing, medical affairs, scientific publications, and such. So you can see the relationship there, the kind of co-support trust, as it were, is continuing to build. This is a fairly substantial financial commitment based on the relationship here. Our support is up to $15.6 million past the PDUFA date for a full year. Certainly that shows a commitment on both parties' side and one that we're very excited about as we expand that relationship. On the next slide, referring to SHERMED and KDK agreement. Excuse me. The newly announced program actually has a new name. It's referred to as Perspectives in Care. This is a tool that will be used to educate physicians as well as to create research in which we will be able to identify and look for more information about the abuse patterns, potential abuse patterns, sorry, for products like APIDAS. And this particular effort will be focused very much on the research around what would happen in the appropriate switching situation where a product is switched from a hydrocodone product to something like APIDAS when it's an appropriate script to do that with. This pilot program is intended to measure or gauge these abuse-related outcomes with Avidaz, and then expand those efforts further once those are successful. So the launch officially has a date, so the program will launch on December 1st in Alabama. This is actually, Alabama is a unique situation. It has the highest utilization per capita in the United States for the hydrocodone acetaminophen type products. And you can see here, as we've described, it's more than 129 million tablets dispensed annually in 2019. Certainly a great opportunity and hopefully some good momentum now with the APIDAS project. And with that, I'm actually going to turn the rest of the call over, except for wrapping up, some summary comments to Edwin Clifton, our CFO. Edwin?