Avadel Pharmaceuticals PLC at Stifel CNS Days (Virtual) Transcript

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

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Yeah. Okay. Great. Thank you, Greg. I guess maybe to start. So you had some labeling interactions in January, it sounds like. How far have you come along with the label since late October? Because I think at that time, it sounded like you are already pretty close and already refined some of the key labeling language related to the (technical difficulty) controversies on DDI and things like that. 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 29, 2022 / 4:00PM, AVDL.OQ - Avadel Pharmaceuticals PLC at Stifel CNS Days (Virtual)

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Yeah, okay. And when you talk to your regulatory consultants and you convey to them, hey, look, the FDA said the issue is administrative. How do they translate that into [a layperson speaking]? Because I hear administrative and I think, oh, it's a resources issue or someone was out sick, but I also could see how administrative could be completely subjective and mean almost anything. How do you interpret it?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Yeah, okay. From your seat, who did you guys interact with, higher-up at the FDA?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Okay. And have you received specific questions or had interaction related to your justification for FT218 orphan drug exclusivity? 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 29, 2022 / 4:00PM, AVDL.OQ - Avadel Pharmaceuticals PLC at Stifel CNS Days (Virtual)

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Yeah, okay. Can you help clarify what the scenarios are related to orphan drug exclusivity as it relates to whether or not FT218 gets it and then the relationship of that or not with Xywav's OD and I guess for full approval, tentative approval transcending that, not transcending that?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Okay. To clarify the tenor of your labeling discussions with the FDA, I guess probably in a more typical case, you enter labeling discussions six weeks-ish before the PDUFA and you probably have a pretty regular back and forth. Given that you were in labeling discussions in later October, how long is the FDA generally taking to get back to you in this ongoing discussion around the FT218 label?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Yeah. Okay. All right. I don't want to beat a dead horse here. Is there anything else we can say, I guess if you were giving advice to an investor or retail channels, like what -- is this a researchable situation?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Yeah, okay. Okay. A couple of questions that have come in from people listening in. The ODE comparator, it is Xywav, correct, not Xyrem?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Okay. Have you had any additional dialog around the REMS or has that essentially been finalized?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Yeah, okay. And how have you been navigating this process while thinking about hiring a sales force and I guess getting your REMS ready to be set up for real world, you said?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Okay, great. Sorry. I keep muting myself. It's embarrassing, but thank you. I have a few other questions that have come in, Greg. I hope you don't mind.

Question: Paul Matteis - Stifel Financial Corp. - Analyst : I think one is maybe could you dive a little bit deeper on why you could launch without ODE? Why isn't, I guess, getting full approval intertwined with ODE? Aren't they functionally a decision on the same thing? 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 29, 2022 / 4:00PM, AVDL.OQ - Avadel Pharmaceuticals PLC at Stifel CNS Days (Virtual)

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Yeah, yeah. Okay, okay. All right, great. I guess switching gears, what is your lifecycle expansion plans as you relate to next-gen products and other indication?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Yeah. Okay, okay. A couple more questions just around the approvability stuff before we wrap up. Do you have a sense of who besides the folks that would be typical at the Neurology Division have been engaged at FDA on the FT218 application, like what other parties? 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 29, 2022 / 4:00PM, AVDL.OQ - Avadel Pharmaceuticals PLC at Stifel CNS Days (Virtual)

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Okay, okay. And is there any update on when an injunction hearing could occur?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Okay. Okay, all right. And then we try to get out from a lot of angles. Anything else you can add, Greg, before we wrap things up?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Okay. I just want to clarify one quick thing to make sure it's not misunderstood, if you don't mind. So on the earnings call, I think you said you were going to get comments on the label from FDA soon. So did that already happen?

Question: Paul Matteis - Stifel Financial Corp. - Analyst : Okay. And they said that they were going to take an action soon or give you labeling comments soon, just to clarify it?