Thank you Brentie.
Comments on what Mike said.
1. Mike, we always have a new team. Anew team every time is our motto.
2. Old men business cults. The keep them stupid theory of education. Change is difficult.
Interviewer "Inhaled insulin was a less successful product before you and you know obviously
insulin has run 90-something years or 100 years at this point. So it's a tough small change in practice.
Mike: some of these
doctors, 65 to 75 years old, talking about they are
going to be treating patients till they are 85 and they have been treating diabetes for
40, 50 years. So they have been around half the time as much as insulin has been around and in their entire career, they have never had a physiologic insulin."
3. I haven't been to the Afrezza facebook group lately, however things have changed and the barriers you reported to getting insurance approval were only perceived as in imaginary. Really?
"We just ran 100 tests the other today just to see where the patients are. 30% go through now with no prior auth, 70% have a prior auth. The majority of those get approved in a couple days. So we don't see that being the biggest barrier. It's a perceived barrier, but not a real barrier. So I think you will see some nice things we are launching here in Q4 that will overcome those barriers."
4. "What people don't realize is,
40% to 60% of all the price of a drug goes to the middle men.
And I think that's when they increase is the wholesalers are taken up $0.22 on $1. There is no reason the wholesale channel should be making $0.22 on $1. They don't innovate anything. And how do we change that distribution model so that we can pas those savings along ultimately to the patients and that's really what we are doing."
5. So we were able to build out a small specialty pharmacy network that's local and national in nature. And we saw those sales double this year. So we went from 7% in January to 16% in June. And that's continued to grow throughout Q3. So we haven't released those figures publicly. But we do see that specialty channel, that distribution, I think, will provide nice economic upside as we go out, not just this year but for the years out.
Because if we save 5% or 10% on the wholesale fees that drops directly to the bottomline. And so when you are giving away 40% gross to net, we do almost what $16 million to $18 million a quarter of gross sales. So if you can save 10% of that, that's huge to the bottomline each quarter.
6. "So the last thing is the BREEZE study. But when you think about the BREEZE study, that was a two weeks switch study for safety. And so now we got patients almost on the product for a year. We are able to see their dosing. We are able to see it's safe and effective. So we are pretty excited about where that product is going to go. And I think everything related to that filing should be wrapped up by the second half of this year, by December, which sets us up for an early filing in 2021. So that's going to be really exciting."
7. "But there is multiple other products that we are working on right now, not all of them are on our website, really looking at orphan lung disease. And we think that as you look at the company, there will be a metabolic division and an orphan lung division. And really, we are excited because this is where we are going to transform people's lives. It's really exciting what we are hearing, what we are seeing in that space."
8.
BINGO. "The migraine space, as you know, has been around a long time. It's really heated up lots of competition. But there is still an unmet need in the acute space, right. And that's where people try and fail multiple products. But sumatriptan has been the gold standard for, I don't know, 20-plus years now. And that, when you look at our profile, we released this data publicly in one of our investor decks, but you got like almost like an IV-like response in that first of couple minutes here soon as you inhale. But you don't have that lag effect that you get with the oral which you got that oral that's hanging in there for a little bit of time because it gets some time to get absorbed. So you get the fast throw and you get the fast ball, just like you see in our insulin."
9. And then just back on the United Therapeutics that, to me, they also licensed our technology exclusively for PAH. So we are looking for additional assets to work with them so that we can hopefully bring more forward because every asset they put on the platform, we will get $10 million upfront and $30 million milestone. So I don't expect UT to be a single one and done product.
10.
CASH> "Yes. So I think the good news is, we have enough cash to kind of get TreT on the right track and see Afrezza continue to grow and invest in opportunities for faster growth. So that's all positive. We finished Q2 with about $63 million in cash. And then we have about $37.5 million in accessible capital between a $12.5 million milestones from UT here in Q4 and we have a $25 million third tranche in our debt available to us between now and June of next year. So when you all-in, call it roughly $100 million in accessible capital between now and June of next year. And in the first half of this year, we have earned about $27 million."
"They are pretty good at making the powders pretty efficiently and the Phase 1 sites aren't that expensive. So we feel like we can move multiple assets in and then by the time we start to need to funds the Phase 2 or Phase 3, Treprostinil will then hit the market by then launched and that will help fund our innovation."
"We just modified our debt covenant to make we didn't trip on paying up the debt. So that's in good shape now. And we have a Q4 milestone we expect to hit publicly, we stated, for TreT. So that will be our last and fourth milestone. And that's in our control."
