DURECT Corporation (NASDAQ:DRRX) Q4 2022 Earnings Call Transcript

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Norman Sussman: Yes, I agree with what Jim just said. We’re — the activities we’re — the trial is proceeding at a decent pace. I don’t think — I’m more optimistic than your projection because typically during the holidays, most trials slow down a little bit. So we have picked up the pace again. And I’m pretty confident that we will finish on time. In terms of what to do, we’re preparing for the final analysis. So we’re — at the moment, we’re preparing all of the reporting shelves and all of the — the sort of the tables are ready to be populated there. As you can imagine, a trial of this size, there are thousands of data points. And then as Jim says, we want to make sure that we decided on all of our analysis. You can always do a post-hoc analysis, but doing it prospectively gives everyone a lot more confidence. And so we’re trying to make sure we haven’t left anything out before we do the data lock.

Antonio Arce: Great. That’s very helpful. Maybe just a couple more for me, more on the commercial side. And I’ll open it up to anyone, but of course, wants to give some comments, I appreciate that. So as you had mentioned earlier, I think, Jim, — there’s a wide recognition of the problem in the hospital or I think actually it was Norman. And also no hepatologists in the U.S. is unaware of either AH or larsucosterol, which is also, of course, very encouraging from the prescriber’s perspective. So given that background, I was just wondering if you could comment on the 85% of patients that have insurance? What breakdown do you think that sits at? And to the degree that you’ve had any sort of interactions, even just tangentially, what are your thoughts about the degree of receptivity on the payer side?

James Brown: Yes. Well, I’ll let speak — Keith speak to the payer piece. But as far as the percentage of patients who have insurance of the 150-some-odd thousand hospitalizations per year, I would say, the vast majority. From what we can glean, it’s north of 80%, maybe north of 85% of those patients. And so that would put them in the right place from that standpoint. And the cost of this disease, unfortunately, is horrific. When you take that number of 150,000. And you multiply it by a number that’s somewhere between 50,000 and 150,000, you’re clearly running a huge bill. It’s in the $5-plus billion range. And that’s not taking into account at all the cost of liver transplant, which, as Norman tells us, there aren’t that many livers available.

There’s maybe 4,000-some odd, but that’s 4,000 almost 1 million each. So that’s a very expensive component as well. So you add all this together and you’re talking about a substantial cost to the health care system in the United States. Somewhat less than that in Europe, but not much. It’s still quite large in Europe as well because the patient population is a little bit bigger, I think, and other markets around the world. So we think that sets us up very well to have a product that can save lives. Remember, about 30% of these people are dying and can be very rewarding to our shareholders as well. So we think that we can create a very successful product for DURECT, save the health care system an equal amount of money in that range, and still be there to be able to save lives.

But maybe, Keith, you can speak more specifically to enhancing awareness in payers.

Keith Lui: Ed, this is Keith. Good question. And of that 80% or so that are insured, I would say it’s a mix of Medicare, Medicaid and private insurance, probably being a little bit more heavily towards the Medicare and Medicaid when we look at the NIS 2019 data that we published on previously. But I think the value proposition to the hospitals, we are certainly doing a lot of research around that and building our case. But just going back to the primary endpoint of a firm being a statistically significant reduction in mortality and liver transplant that in and of itself would be a huge benefit to deter people and have them take them off of the wait list and off the liver transplant list because, as Norman stated previously, there’s way too much demand for the limited supply of livers for transplant.

But in addition to that primary endpoint, obviously, there’s a number of market access and reimbursement factors in the hospital that I think larsucosterol could help offset things like decreasing length of stay, decreasing diagnostics and health care — other health care realization, hopefully, decreasing the time spent in ICU that these severe AH patients typically comprise. So I think there are a number of potential cost upsets that we are investigating in depth between now and top line data. And obviously, after top line data, the market access and reimbursement division of our commercial team will certainly be one that is active now and will certainly ramp up after top line results.

Operator: Thank you. There are no further questions at this time. I’ll hand the floor back to management for closing remarks.

James Brown: With that, we’d just like to thank you for your time. And as always, please feel free to give us a call or contact us. We look forward to catching up. Take care.

Operator: Thank you. This concludes today’s conference. All parties may disconnect. Have a great evening.

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