Avadel Pharmaceuticals plc (NASDAQ:AVDL) Q4 2022 Earnings Call Transcript

Greg Divis: Yes, thanks, David. Well, Jen, I’ll let you go first.

Jennifer Gudeman: Sure. That’s great. We have conducted two relative bioavailability studies comparing LUMRYZ to twice-nightly oxybate. And what we have shown is that our concentration eight hours after taking the dose is actually a little bit lower than twice-nightly oxybate. So based upon those blood levels there would not be any sort of expectation of impairment the next day, and that certainly is not something we’ve seen in our pivotal clinical trial or in our open label study. I think it’s also really, really important to note that with any oxybate you shouldn’t drive or operate heavy machinery six hours after taking the dose. When you think about LUMRYZ that covers the nocturnal sleep period. When you think about twice-nightly and that 90-minute window when you can take your second dose, when patients are waking up later that is a restriction with that additional six hours that oftentimes does interfere with next day functioning.

Greg Divis: Thanks Jen. Richard, anything you want to comment?

Richard Kim: Yes. Hey David, I just would sort of add, you know, it’s quite interesting €“ oh, we hear bit of background noise, David. There we go. Hey thanks. So David, your question as far as some of the counter messaging is concerned, so I think for us the one thing we have realized over the last 20 years is I don’t think anyone has really thought making patients wake up during the middle of night has been normal. And where we see that most predominantly in our market research around de novo patients, we’re absolutely consistently physicians will state that they would want to start patients on LUMRYZ. Why would they offer a therapy where you have to get up during the middle of the night? And to Jen’s point, we also know that the €“ and if there’s any tolerability issues with oxybate, they generally tend to subside over time as well.

But I think for us where we sort of see it is physicians are speaking sort of with their, both as far as the need to not or the ability to not offer that second dose is an intuitive proposition for new patients that we believe will aptly spillover into existing patients as well. So we €“ if that €“ if those are the counter messages that come up, we’re more than prepared to deal with them and we believe our campaigns will address them head on.

David Amsellem: That’s helpful. If I may just sneak in a follow-up; do you think you’re going to be able to pull in patients who have gone to low sodium already?

Greg Divis: Yes. So David, when we do our patient research, what we find about patients who have gone to the mixed-salt version of the twice-nightly oxybate, they tend to be patients who have been diagnosed with narcolepsy for a shorter period of time, and they tend to be earlier adopters of therapy. They’re generally not satisfied as treatment and seeking more. So even though they have switched to the mixed-salt version they are €“ all of our patient segments show an extremely high level of interest in learning about LUMRYZ or potentially switching. Ironically, the highest group just nudging out the Xyrem patient are those on the mixed-salt, and our belief there is because they are the ones who are going to most often seek more that they can do to manage their narcolepsy.

David Amsellem: Thank you.

Greg Divis: Thanks David.

Operator: Our next question comes from the line of Marc Goodman with SVB Securities.

Unidentified Analyst: Hi, thanks for taking my question. It’s Rudy on the line for Marc. Congrats on the progress. We can talk about your operating expenses in 2023 based on your current commercial launch funding. Now, we’ll raise another, around maybe $200 million, do you need additional funding before breakeven? Thanks.

Greg Divis: Yes. Thanks for the question. We’re really pleased, we made a capital rise. We’re not providing guidance on operating expenses. We’re heading into 2023, but from our standpoint with the capital that we now have we’re quite frankly good to go for a launch.