Transcript of Dan's Q&A at Bloom Burton - Apr. 21, 2021 https://wsw.com/webcast/bloomburton6/ate.to/3077571 might get taken down soon
Transcripts of the Q&A Section (starts at 21:45) (edited out the pauses and stuttering); Feel free to share this
Question (21:45): How will otenaproxesul compare with intra-articular injectables for osteoarthritis?
Dan: Well they’re going after different things really. A lot of the injectables are trying to be disease modifiers, whereas our drug is going after the pain and it is the dominant treatment. Plus it’s an oral once a day pill. All main commercial studies (not just the ones that we commissioned), but many of the larger studies in general, have shown that over the next 20 years, NSAIDS will be a major slice of the pie for osteoarthritis in particular and other forms of pain. I would suggest to our investors and listeners that more of the risk is the standard biotech risk as opposed to competitive risk.
Question (23:00): In your press release with your Chinese partner you indicated that you had sufficient cash to get through phase 3, yet you just completed a recent financing, so why did you feel the need to do that financing?
Dan: Well for two reasons, and I suspect that the press release said that we had sufficient to get through our first phase 3 study, but it’s more involved than that, now we have the money for all of our studies. It provides negotiating leverage for partnering activity. The more money you have, the stronger position you are in, that’s a well known phenomenon. Plus it give us that calm strength to uplist onto NASDAQ. Our board and myself were feeling that, even just after the Nuance deal, we’d still be in a lot stronger position than desirable to do that NASDAQ uplist (personal comment: he was stuttering a lot, that last sentence as written doesn’t make sense, but I believe he was implying that the financing made them into a stronger position to then uplist to NASDAQ).
Question (24:00): Based on your stage of development, pipeline and cash, it does looks like you should be on NASDAQ, and you did briefly mention that, so what are your plans in regards to timing and listing on NASDAQ?
Dan: We have been well received by the sell side or the NY investment banks and that’s been a pleasure. We’re in the midst of buy side or institutional investor outreach, we now have a number of US institutions who are shareholders of ours, so that is going to continue. It’s really a matter of strategy and tactics and timing. You don’t really want to do an uplist in the summertime and there’s also the pandemic has been planning into it a little bit. We took advantage of a really nice capital market winter situation, by doing our financing so we’re in a nice position. So we’re looking towards the fall as an opportune time. Together with our advisors, we will shortly be able to decide the time and then build up momentum leading into it. So it is a near term phenomenon, but I don’t have any more specific information than that for you.
Question (25:30): Could you talk some more about potential pricing for your lead program, it’s a massive market it seems, but there’s also a lot of generic drugs out there, so how price sensitive do you think the market will be?
Dan: Well that’s a very great and sophisticated question. The NSAID market is forecast to continue for several more decades, but it is essentially a generic market, so these are lower priced drugs. The pricing behind the slide that I showed you on our peak sales, is at $6 a day US, for the United States with this corresponding fall off for other countries. We’re likely to obtain a $6-10 price with little or no reimbursement issues, which is excellent. At $6 / day the value of our drug is immense and we would have very few reimbursement issues, if any. And we could compete very favourably with the generics. We could even go way lower than that. Our cost of goods is about $0.15 / day and trending lower at scale. So of course we have all kinds of room. We’re in nice shape on pricing. We paid a lot of attention to pricing in the commercial studies in Japan and the other markets that I mentioned. We’re very profitable at much lower than $6, but we chose $6 for the purpose of the studies, instead of $10 or $2.
Question (27:30): What’s the status of the holding company IP transaction?
Dan: That is proceeding. We hope to have news soon. It just takes time, just the human dynamics. We’re trying to do this with proper governance. Each company has formed independent board committees, John Wallace and myself are conflicted so we’re not involved. They’ve each hired their own counsel, so that’s 4 sets of lawyers and each company has hired independent investment banks for fairness opinions. That’s just modestly bureaucratic, but it’s been proceeding for the past 2.5 months and proceeding well. I don’t have any more news than that, other than to say that I hope to have news soon.
Question (28:30): Your PK profile is quite different than the existing pain and inflammation products like naproxen, ibuprofen and that type of thing. Do you foresee your safety profile taking you to the once a day chronic usage case for broader indications than osteoarthritis?
Dan: Our PK profile, it has turned out, for a whole number of years now, we’ve realized is central to our effectiveness and to our safety profile and it is quite fascinating science. But it is very dependent on the make up of the molecule. The 3 pipeline drugs use the same donor molecule attached to different parent NSAIDS and they exhibit similar PK. Effectiveness and safety profile are dependent upon that. We’re working, as I mentioned on inflammatory bowel disease, but with completely new donors and we don’t have a handle yet on the PK, that is coming up relatively soon, but PK plays an essential role. (personal comment: PK stands for pharmacokinetic)
(Feel free to share this, I believe they said the video would only be up for 24 hours after the end of the conference, so might get taken down soon)