Avadel Pharmaceuticals PLC at Needham Healthcare Conference (Virtual) Transcript

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

Question: Ami Fadia - Needham & Company, LLC - Analyst : Okay. Lot of the recent developments of the company. Thank you for the overview. Perhaps, let's talk about the FDA approval. You indicated that you've submitted the sort of adjustments to your NDA. Can you talk about what are the outstanding questions from FDA standpoint? Obviously, you no longer have to attest to the REMS patent because that patent no longer exists. But outside of that, other outstanding topics that the FDA needs to sort of think through before converting to an approval from your standpoint?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Got it. Okay. I think a lot of investors have asked us kind of a question around the FDA deciding to allow the company to import the drug. What does that sort of indicate in terms of FDA's sort of willingness or expectation that they are moving towards an approval. Can we simplistically make that conclusion that obviously the FDAs would not have asked for the drug to be imported unless they were expecting to approve the drug sometime soon. Is that a fair conclusion to make?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Got it. I also want to talk about the orphan drug exclusivity of Xywav. And one of the sort of considerations for investors was that would that be something that potentially could block approval of any other sodium oxybate in the market? Can you talk about FDA's review of the LUMRYZ clinical profile in this context? And do you think that they have conducted their review of this already? Or is that something that's going to be forthcoming?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Okay. That sounds good. Let's shift gears a little bit. Let's talk about the narcolepsy market. At least within the sodium oxybate, Xyrem was the only product in the market for many years. And then came along Xywav, which is the low sodium version for the last couple of years. And now recently, authorized generics have been launched. In this context, can you talk about where the opportunity for LUMRYZ is? And then where do you see it taking market share? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 17, 2023 / 1:30PM, AVDL.OQ - Avadel Pharmaceuticals PLC at Needham Healthcare Conference (Virtual)

Question: Ami Fadia - Needham & Company, LLC - Analyst : Okay. Can you talk about sort of two of the segments. One is the 16,000 or so patients that had been on a sodium oxybate over the last two to three years. How easy would it be to sort of go back to those patients and present them with this once-nightly alternative? And secondly, can you talk about patients that have switched from Xyrem and Xywav recently? And then how do you sort of activate those patients to explore another alternative?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Understood. Okay. Can you talk about how the entry of generics is likely to impact the utilization of LUMRYZ? We have Hikma and then we'll have additional generics enter the market later on. To what extent could payers potentially require patients to step through a generic before trying LUMRYZ?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Got it. So I want to just round up this discussion as we think about the launch, and I want to talk a little bit more about launch readiness. But as we think about the adoption of LUMRYZ, what would you characterize as the lowest hanging fruit? And what is the market segment that's probably going to take the longest? I think what I heard you say was perhaps patients who switch to Xywav are the ones who're more likely to consider switching first, followed by perhaps patients who are on the traditions that the older Xyrem or the generic and then patients had been on a sodium oxybate in the last couple of years. Is that the right way to think about it? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 17, 2023 / 1:30PM, AVDL.OQ - Avadel Pharmaceuticals PLC at Needham Healthcare Conference (Virtual)

Question: Ami Fadia - Needham & Company, LLC - Analyst : Fair enough. Okay. Let's switch gears and talk a little bit about launch readiness. I think Greg just mentioned earlier that the product will be available in about four weeks of an expected FDA decision in early May. So that puts us in early June. So can you talk about your launch readiness from a sales force team perspective? How many sales reps have you identified and given offers to? And when would the entire team be ready to hit the ground post-launch?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Okay. Can you talk a little bit about the targeting strategy of these sort of 5,000 physicians with your sales team. Maybe help sort of break down for us. How many of these 5,000 target physicians are kind of the biggest prescribers of the sodium oxybate? And how do you plan to target them?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Okay. So, I just want to clarify. So about just under 500 physicians drive 50% of the current sodium oxybate scripts. And those would be of focus and the time of the launch. Is that correct, Greg?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Okay. Can you talk about the REMS program. That's a big part of how patient will get the drug. How is it similar or different to that of Xyrem and Xywav? And what needs to get done in order for physicians to be trained on the new REMS for LUMRYZ and be ready to really prescribe a patient?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Got it. Okay. Let's talk about from a payer coverage perspective. What do you think payers are going to require for a physician to sort of fill out from a paperwork standpoint that the patient needs in once nightly or-- Do they need to establish that for a certain time period, they could not comply with the twice-nightly product or put out some other type of criteria because a large portion of your target market is patients that have been prescribed twice nightly. So do they just need to say that they can no longer comply with it? Or what would be the requirement from a peer perspective?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Understood. Okay. I want to talk a little bit about your pricing strategy. You guys announced that LUMRYZ would be priced at parity with the existing brands. I guess I wanted to understand why you chose to not price it at a discount. Was that not sort of an advantage in being a slightly lower priced product in the market to be able to drive market share?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Okay. So as we have a launch around the corner, what would you say would be the right analog in terms of how we should think about the ramp of the product? Xyrem was launched too many years ago to think about that as a comparable. But how do we think about maybe the recent launch of WAKIX or the launch of Xywav as potential analogs for how we should think about LUMRYZ's launch?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Okay. Fair enough. Look for more as time goes. Let me switch gears off the LUMRYZ current indication. And we do have just a couple of minutes. But beyond this expected launch, what is sort of -- what are you thinking about in terms of next? Where do you develop FT218 in terms of other indications or formulations? Maybe if you could talk a little bit about that.

Question: Ami Fadia - Needham & Company, LLC - Analyst : Okay. I can't let you go without asking Tom, a question on the cash runway. Obviously -- Tom, congratulations on the recent financing initiatives. But in the context of the launch and some of the other R&D projects that Greg just mentioned, how should we think about the cash runway if you could sort of talk about that?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Hey, Tom, maybe one quick follow up. You mentioned the second tranche on the milestone. It's sort of dependent on achieving about $25 million in quarterly revenues. How comfortable do you feel in being in a position to kind of hit that benchmark? And also, would you draw on that? How do you think about 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. APRIL 17, 2023 / 1:30PM, AVDL.OQ - Avadel Pharmaceuticals PLC at Needham Healthcare Conference (Virtual)

Question: Ami Fadia - Needham & Company, LLC - Analyst : Understood. That's very helpful. With that, I'm being told that we are out of time. So thank you so much to the team for taking the time to be with us today. And thanks to all our listeners.