Mickle Puns

CEO Dr. Travis Mickle

We expect to get the SDX data before the end of the year. Once that's available, that will tell us the development path for SDX related compounds.

Selection of a lead SDX product development candidate as early as January 2022.

Clinical and Business Criteria will Guide Decisions on SDX Opportunities.

I think it will be a fairly quick program, whatever we pick.

With GPC (Gurnet Point Capital) having an option on KP879, what is the ultimate hold that they have in negotiating for a partner?

Are they going to get the last call on any offers? Sometimes we see a party with an ongoing ROFR drag out negotiations.

What's your thoughts on this?

We've learned through good and bad experiences you can't be tied down too hard. They had a valid right to have some sort of right of first negotiation on the product because SDX is a major component in their licensed product.

So, when we negotiated this, when we actually worked it out, we said, “okay after the first study let's do a right of first negotiation and that will go on for some time period.” If you pass or we can't come to any terms, none of those have been set yet either.

That's another big thing is, we can ask for something ridiculous if we really want to keep it. And if they match it, that's great, we'll take it. But at the end of the day, it does switch to a ROFR. But that's not forever, it's a one-time thing, somebody else can come in and do it. We are free to develop it and commercialize it as we see fit without ever asking them again. And it does expire when the NDA is finally accepted, not approved, but that initial FDA acceptance.

You've been answering a lot of phone calls from other companies voicing interest in, and at least talking to you about KP879 or it’s too early for this?

I was shocked after, right after the approval I got so much inbound interest in really our entire pipeline. It was great, you know? It's almost an affirmation after you get something approved where folks finally realize, “oh, hey maybe they're for real.”

So we have a lot of interest; it's really nice.

We literally have dozens of candidates we could boil to the top. It's usually about resource allocation and finding the right ones that are going to be the highest value at that moment. Right? To work in abuse-deterrant opioids. Well maybe that didn't work out but now ADHD is certainly very hot still.

And then moving beyond that into rare diseases. We could work in oncology

Our biggest news of course, was the launch of AZSTARYS and as most of you are certainly very focused on the launch of the product and the near term here, while we can't give a lot of details based on our agreement with Corium. We are certainly excited to share with you what has been passed along, is that within the first 100 days into the launch, they now have access to over 50 million lives that are covered by both commercial and Medicaid insurance.

Rich Pascoe, has joined as our Executive Chairman, helpful here in the office, as well as with the Board.

He's here to help guide our organization in the future. Our goal is truly to create opportunity for our shareholders to grow, to build value in the company and to do that by building a profitable, fully integrated biopharmaceutical company with multiple assets that we can take into the market.

We recently initiated a trial with SDX. Under our KP879 IND, now if you recall, 879 is our program for stimulant use disorder. It's at least where we want to investigate that sort of indication. And it's looking at the pharmacokinetic safety and some of the exploratory effects of what happens with SDX at high doses, data release still on track for the end of the year.

We have a number of SDX candidates. Gurnet Point does have a right of first negotiation. And that right of first negotiation is triggered after we have our first proof-of-concept trial in.

After 150-day window, then flips to ROFR. So Right of First Refusal on any valid third party offer and terminates to one-time ROFR and terminates upon an NDA acceptance. So if we do decide to pursue our own programs, we would do so without hindrance or impedance from GPC.

We do expect still to have the data from the SDX trial before year end. We also expect to be able to provide a pathway forward with that based on that data.

We should be able to certainly outline as early as January, perhaps hopefully early January, right after the data comes out and then ongoing evaluation of non-SDX candidates and external opportunities is ongoing and certainly cash and future revenue, all the great data that we have will support those efforts.

I expect that this year will continue to be a banner year for KemPharm.

In after-time, a sage of mickle lore

Y-cleped Typographus, the Giant took,

And did refit his limbs as heretofore,

And made him read in many a learned book,

And into many a lively legend look;

Thereby in goodly themes so training him,

That all his brutishness he quite forsook,

When, meeting Artegall and Talus grim,

One he struck stone-blind, the other’s eyes wox dim.

(Keat’s final poem, a Spenserian stanza written in his copy of Edmund Spenser during July of 1820)

What's nice about KemPharm?

We have this technology, right, we have the two approved products,but they are both licensed. So, we're not taking on the commercial risk, we're not taking on the commercial cost at this time.

AZSTARYS of course, I've mentioned, that was actually partnered with an affiliate of GurnetPoint Capital. Of course, this is a large private equity fund located in Boston. They own a number of various organizations. One of them happens to be Corium, which is the commercial partner in this case, which they assigned those rights to.

Some positive signs that we have heard from payers and – our prescribers and patients is that, they believe in the clinical profile. They see it in their day to day. They know what's going on. We can see from our tracking data that prescribing is going through and getting repeat prescribing with the same physicians, as well as refills with the same patients.

We're here to support Corium and provide whatever they need. And we believe that this is a much bigger opportunity than even we thought initially.

Corium has led their CEO is former head of the Neuroscience Business Unit at Shire. The team that really brought Vyvanse to market and made it the multi-billion-dollar ADHD treatment that it is, this deal is worth to us in regulatory and sales milestones up to $590 million. It's a significant amount. We believe most of its attainable.

It's not those biobucks that most folks get. We really see that it is a real opportunity here for KemPharm shareholders.

Great cash position. For the first time in our history, we actually have a solid financial position tosit on. Cash on hand $132 million. We had net income in the second quarter, and we just expect things to continue to improve as we bring in royalties and sales-based milestones on our two products.

Talk about SDX's pro-drug and methylphenidate, and I really want to kind of hit home here. Having a schedule formethylphenidate is highly valuable. There are so many opportunities for methylphenidate-basedproducts, now with a completely different pharmacokinetic profile, that's not reproducible,something that's inherently already now a schedule for product really means that the opportunitiesfor SDX are huge.

KP879

This is a huge issue, and it's in fact actually bigger and surprisingly so when I saw this data than opioid abuse, and those people seekingtreatment, that's a bigger market than opioid abuse. And I don't think it's something that gets as mu

Thanks to Matt (NiightTrain)

Hello KMPH LONGS. I hope Dr. Mickle doesn’t mind that I share his response with everyone.

I know I get saucey and frustrated- but for him to respond - and promptly- speaks of his character- and care for the shareholders.👍🏻

Also - MOST importantly- it shows that Dr. Mickle IS AWARE of the Manipulation of the SP as of late.

Note from myself I can add to this: "When the official launch for AZSTARYS occurs, rest assured, it will be announced via a press release given its materiality to KemPharm".

Have a great weekend everybody!

https://preview.redd.it/uwsyv84hyrb71.png?width=670&format=png&auto=webp&s=12d0841a49ce1ec1c802f48d49e48105166884db

Ayo, I have my first exam for PB360 (Ecology) with Prof. Mickle on the 13th and I am wondering how the exams are? How much studying does it usually require...? pff pray for me

Travis Mickle

We do expect to see royalties and sales milestones in 2022 and beyond. But as you'll hear in further update, that is probably the extent of any sort of projections that we can give at this time. Just as you may recall, the royalty rates on US sales go from the high single digits up to the mid 20s. And our AZSTARYS patents run until 2037. So sitting here in 2021 with a product that just launched, now we have a 16 year product life just a tremendous opportunity in front of us for AZSTARYS.

We also heard in the second quarter, received notice that the DEA did take a recommendation from the FDA as to schedule SDX, or Serdexmethylphenidate, as a Schedule IV controlled substance. All methylphenidate products right now are Scheduled II. This is the only methylphenidate containing product that is a Schedule IV. It is remarkably beneficial. It means it has a lower potential for abuse when compared to other d-methylpenidate products and, in fact, lower than Schedule III product, and it's a key differentiator for AZSTARYS. Not only that, it's also a key value proposition for our other SDX based product candidates.

I'm going to turn it over to LaDuane Clifton

We did issue a small amount of inducement warrants. But those have an exercise price of 16.50.

So really a higher price, which indicates what we believe is where we're headed.

And as you know, and many of you have followed, we have completely restructured and recapitalized our balance sheet. This not only provides for operating requirements, but it also allows us to look at how to allocate resources towards our internal development opportunities, and we also can look at other potential external investments and fee.

For now, our cash burn rate remains at $1 million to $1.5 million per quarter. But obviously, as we make some of those strategic decisions around development opportunities that will change the cash burn rate as we get those development plans in place.

Another item that we received a number of questions related to has been around the shelf registration that we completed, which was just after the end of the quarter, but still certainly inside the area of interest here. It's important to note that we actually had an S-3 previously. So this was really -- we just increased the size of the S3 to really be in line with what our new balance sheet looks like. And so certainly, keeping and maintaining a shelf registration on Form S-3 is very much a housekeeping step. I would say t

The audio interview is available at hpr.com and on youtube.

https://healthprofessionalradio.com.au/kempharm-new-adhd-drug/

https://www.youtube.com/watch?v=hpWglHc7AI4

One of the highlights was Travis' explanation of how they listened to the market research, how they listened to physicians that said patients needed a medication that 1) takes effect quickly and 2) lasts through the day.

Then he laid out the day in the life:

1. You take the medication at 7:00am
2. It starts to take effect at about 7:30am
3. It lasts until 8pm

This reiterates the 30/13 efficacy of the FDA label for Azstarys. It takes effect in 30 minutes and lasts 13 hours. One of the primary qualifications for KMPH receiving a $48m milestone payment for Azstarys is this 30/13 label. We expect the receipt of the milestone payment to come this week. With current cash at $77m this is a significant financial event for Kempharm.