The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Andrew Tsai - Jefferies & Company, Inc. - Analyst
: Fantastic. So maybe a check-the-box type of question. In the label itself anything you'd highlight from LUMRYZ in general from the label?
Question: Andrew Tsai - Jefferies & Company, Inc. - Analyst
: Great and I just want to then ask on that statement. It is very intriguing to me personally because what does the FDA mean when they say clinically
superior? It's not -- is it the safety part or is it less discontinuations? How do you interpret that? How do doctors interpret that?
Question: Andrew Tsai - Jefferies & Company, Inc. - Analyst
: Makes sense. Okay, so on my side, investor discussions are naturally about the launch, how big can this be. So help us frame the market opportunity
in your view for LUMRYZ. You've mentioned there may be three major subsegments. Maybe describe that for us an opportunity.
Question: Andrew Tsai - Jefferies & Company, Inc. - Analyst
: Great. And so then the question is how much from -- how much market share within patients currently on twice-nightly oxybates can you take?
And so what would the other -- aside from twice-nightly dosing, is there any other angle that you will be messaging to doctors or what will be your
messaging within that group? And is that also the low-hanging fruit in your view?
Question: Andrew Tsai - Jefferies & Company, Inc. - Analyst
: Thanks and maybe you said another way, Jazz has XYREM and XYWAV. So you guys are pretty confident you can take market share also from XYWAV
not only XYREM just to be clear?
Question: Andrew Tsai - Jefferies & Company, Inc. - Analyst
: Interesting. Okay. Thanks. And so you launched earlier this week. Have you dosed your first patient?
Question: Andrew Tsai - Jefferies & Company, Inc. - Analyst
: Okay. And in terms of the cadence, the launch cadence of Q3 and Q4, should investors thinking -- be thinking this is going to be a fast ramp? Can
you give us some color how you're thinking about the pace of launch?
Question: Andrew Tsai - Jefferies & Company, Inc. - Analyst
: Okay. And does the team have any kind of internal view on in terms of launch comps? Because we're all wondering is there a relevant launch comp
comparison or something like this?
Question: Andrew Tsai - Jefferies & Company, Inc. - Analyst
: Right. We'll just have to be patient, then. I know to the audience and when I looked it up 20 years ago, XYREM was able to get thousand prescriptions
in the first quarter, so I think it bodes well for you guys. So we'll stay patient.
Okay. So speaking of payer access on price, how did you price LUMRYZ? How does that compare to the other branded drugs? And how should we
be thinking about that price?
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JUNE 08, 2023 / 5:00PM, AVDL.OQ - Avadel Pharmaceuticals PLC at Jefferies Healthcare Conference
Question: Andrew Tsai - Jefferies & Company, Inc. - Analyst
: Makes sense. And leading indicators how should we be tracking the progress of your ramp other than quarterly sales if there's anything for us to
track? Or what are you guys looking at?
Question: Andrew Tsai - Jefferies & Company, Inc. - Analyst
: Got it. And should we be expecting, let's just say you were to report your Q2 sales number and let's just say August, which is one month, should
we be expecting inventory stocking or is a pretty specialty drug launch where there's not much inventory. How should we think about that?
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JUNE 08, 2023 / 5:00PM, AVDL.OQ - Avadel Pharmaceuticals PLC at Jefferies Healthcare Conference
Question: Andrew Tsai - Jefferies & Company, Inc. - Analyst
: Okay. And then the discontinuation rates for your product. I guess what does your open-label data show, long-term data? How should we be
thinking about your discontinuation rates relative to the other oxybates?
Question: Andrew Tsai - Jefferies & Company, Inc. - Analyst
: Got it. And there's one more dynamic I'm monitoring in the near term that's the availability of generic XYREM. I think July 1 maybe three more
generics after Hikma can join. So why does that not deteriorate the price of LUMRYZ? And secondly, how are payers thinking about generic XYREM?
Question: Andrew Tsai - Jefferies & Company, Inc. - Analyst
: Thanks. And maybe, I believe, these four generics have limit can launch at limited quantities of generics arm for the next three years. But let's just
say 2026 time frame, how should we then think about that dynamic compared to LUMRYZ?
Question: Andrew Tsai - Jefferies & Company, Inc. - Analyst
: Got it. And so bigger picture question back to the launch is I'll say this -- I'll ask this another way, what more needs to be done to ensure a fast and
rapid launch? What are the bottlenecks and how are you addressing those bottlenecks?
Question: Andrew Tsai - Jefferies & Company, Inc. - Analyst
: Okay. I should have asked us earlier but remind us how many sales reps you're planning. Are they ready to go today, all of them? And are you
planning to do a DTC?
Question: Andrew Tsai - Jefferies & Company, Inc. - Analyst
: And maybe a corollary to that remind us your cash balance. How much your financial structure? How much debt you have? Are you -- I mean, do
you have enough cash? (inaudible)
Question: Andrew Tsai - Jefferies & Company, Inc. - Analyst
: Great and maybe one last question, want to be respectful of everyone's time is what else are you working in the pipeline, if you're doing anything
any lifecycle management opportunities? How should we think about the tail, the patent life of LUMRYZ?
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JUNE 08, 2023 / 5:00PM, AVDL.OQ - Avadel Pharmaceuticals PLC at Jefferies Healthcare Conference
Question: Andrew Tsai - Jefferies & Company, Inc. - Analyst
: Makes sense. Okay, that's all the time we have. Thank you, Greg and Richard, for joining us today, and thank you, our audience.
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