Avadel Pharmaceuticals PLC at Oppenheimer Healthcare Conference (Virtual) Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : Of course, that's great. So, this morning -- you just had your earnings call. And it seems like there's more -- even from, I think, the press release here, I think there was recent interaction with the FDA. Can you just maybe frame -- maybe I guess frame as much as you can about when these interactions happened and, just on this last one, what's the update, I guess?

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : Right, okay. If the FDA was to reach out and say, look, we still have a lot of work to do, we cannot tell you sooner. Now I think the first time you guys mentioned it, it was like this probably won't be done by -- was it end of October or November? There were just a few weeks left and they basically gave an idea of the timeline, I guess. But now, if you thought this would last many months and stuff, would you have to disclose something or how does that work?

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : And when you reach out to people at higher levels at the FDA, like you mentioned, so there's a review -- is this the same people as the office of orphan drug and the people that refused this altogether or --? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 17, 2022 / 2:40PM, AVDL.OQ - Avadel Pharmaceuticals PLC at Oppenheimer Healthcare Conference (Virtual)

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : Okay. And if anyone is not familiar with the market or anything, when people ask about -- or maybe investors, anyone asks about a potential discussion around orphan exclusivity, who are we talking about? Who could we be potentially having issues with there?

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : Okay. It doesn't take much research to -- the once nightly, the first one is Xyrem, now XYWAV, mix salt, low salt version. But is this -- because Xyrem has been around for a long time, just for listeners here that may be new to the story. Is there still exclusivity on the original Xyrem or is this just the new XYWAV?

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : Okay, so it's more on the newer version. Okay. Okay, so still no certification Paragraph 4. Okay, and I guess there's a litigation from Jazz. And just maybe help us understand, I think we had an idea on the timeline that things would be resolved based on its original PDUFA. What's going on there? Maybe a refresher on how quickly would you expect this to be dealt with.

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : Okay. And what you mean by that is if the PDUFA came -- let's say the PDUFA came tomorrow, gets approved, you guys aren't launching next week? There's still preparations to do before launch. And that if there was a PI, it would probably be in that timeframe. So, I guess can you tell us what you think -- how much time -- if this was tomorrow, how much time do you need for more preparation before an official launch?

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : Okay. What's nice though based on (multiple speakers).

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : Okay and --.

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : What's nice too is it's not -- sodium oxybate has been out there in terms of physicians -- this is, to dumb it down a little bit, once nightly versus twice nightly should not be an extremely hard education process, is my feeling. And then the -- all right, so the commercial efforts, so you haven't paused really since October. We've still been going. So, what have you done since to kind of do everything we possibly can to make sure that five-, six-month window could not be extended here?

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : So, were you guys present at the World Sleep conference?

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : Interesting. And is this something -- obviously you guys are probably more focused on the US now. But is this something you see growing interest ex US for these kind of products or --?

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : Interesting. Have you ever thought about maybe using FT218 to get outside of rare disease? If excessive daytime sleepiness is something that could be a symptom of a much larger -- whether it's treatment course or interaction, has there been any thought or we're very much focused on rare disease and this is what the company's been doing and so we are going to stick to it?

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : Okay. I think a logical indication that people have looked at in the space is the IH or the idiopathic hypersomnia. And I think the diagnosis is more by exclusion a little bit, that it's not narcolepsy. But if you guys thought about this when you talk about lifecycle management as a thought? Or right now it's like we're just ready to go on -- and let's get this PDUFA going here? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 17, 2022 / 2:40PM, AVDL.OQ - Avadel Pharmaceuticals PLC at Oppenheimer Healthcare Conference (Virtual)

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : Okay, great. And when you've looked at IH though, in terms of the market, obviously narcolepsy is a growing market, but there's a lot of patients that aren't diagnosed. We think there's narcolepsy and then there's the diagnosis patients, then even smaller diagnosed and treated patients in terms of lowest hanging fruit. But any idea, hypersomnia, what kind of market that is? And are patients -- is it similar where there's probably just a small percentage or maybe half percentage of patients out there that are actually diagnosed with IH?

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : Okay, great. And then you came back from Rome with the sleep conference. And just wondering, the data you presented, I think there's a new interim look there. So, just maybe if you can walk us through what you presented and the reception that you got.

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : Okay, great. And in terms of -- so, on the commercial side, I assume commercially all this extra data too, the time that you have to present extra data can probably help with awareness in the medical community. But in terms of reps here, how many docs are you targeting? Are you targeting the sodium oxybate docs or do you go on broader? And how many reps are you going to need? I guess to finalize that, where do you stand in terms of conditional job acceptance, I guess, until the PDUFA?

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : Yes, and what kind of docs are these? Are the sleep specialists? Who's prescribing these?

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : Great. And I guess every patient is important. It seems to me, and tell me if I'm wrong here, but it seems like 1,000 patients equates to almost $100 million in topline revenue here in this market. So, targeting the correct docs is definitely important. And then just lastly, I think we're running up on time, is -- this morning on the earnings I saw that there was a -- can you just talk about your financial situation, where did you finish in cash? And I saw there was a change to the convert out there, so maybe you can touch on that.

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : Okay and that maturity due in a lump-sum payment or --? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 17, 2022 / 2:40PM, AVDL.OQ - Avadel Pharmaceuticals PLC at Oppenheimer Healthcare Conference (Virtual)

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : Okay. Well, great. Sorry, say that again.

Question: Frank Brisebois - Oppenheimer & Co. - Analyst : That's right, that's right. Great. Well, Greg, thank you so much. I know we went just over time and best of luck. Hopefully we hear soon, but thank you for joining.