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: Brandon Richard Folkes - Cantor Fitzgerald & Co., Research Division - Analyst
: Great. Thanks so much, Renee. And then the sodium oxybate franchise is obviously remains extremely important, right? And I'm sure we all get
asked a lot of questions about the Xyrem, Xywav switch in narcolepsy. But I do want to focus this discussion on this innovation you called out that
we've been seeing at Jazz and just the differentiated Jazz we see today. So starting on Xywav, this is a product -- and digging into the idiopathic
hypersomnia opportunity, right? You mentioned this is a product developed fully in-house. Maybe without giving too much away before the
October call that you are hosting regarding the launch strategy, can you just talk maybe about the market that you're launching into? What is the
patient population? How should we think about reimbursement coverage here and that launch trajectory in IH?
Question: Brandon Richard Folkes - Cantor Fitzgerald & Co., Research Division - Analyst
: Great. And then Xywav has been on the market for narcolepsy, right? And I think over 5,000 active patients already on therapy. So can you just talk
about the brand recognition of Xywav that's already out there in the market? And maybe this excitement you have this safe alternative in the
market for narcolepsy, but also now to have that product with a label for IH?
Question: Brandon Richard Folkes - Cantor Fitzgerald & Co., Research Division - Analyst
: Great. And then switching gears to Epidiolex. So I wanted to talk about what you're seeing since taking over this product. I think we're looking at
3Q is maybe the first full quarter of Jazz promoting the product and getting some sort of indication on how this is going, but up pop up the COVID
variance right, and I don't think they've made things very smooth for anyone, right? So maybe just taking a step back, I think something that's
probably important is any color on the retention of the GW commercial team, I think, how has that gone? And then maybe secondly, can you just
elaborate on the challenges of switching to patients to Epidiolex with these outbreaks? Maybe a concern of switching patients on a polypharmacy
routine. When parents may want to keep their children out of the ER physician offices. Just any color would be fantastic?
Question: Brandon Richard Folkes - Cantor Fitzgerald & Co., Research Division - Analyst
: Great. And now just digging deeper into that comment you made Dan. If I'm a parent and I am concerned about changing therapies in this COVID
backdrop. Should we think of those patients has really just been pushed out in terms of when they'll come on to Epidiolex as maybe a better therapy
in terms of what they've been treated with now? Or are those patients lost to -- I don't say the conversion, but coming on to Epidiolex?
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
SEPTEMBER 27, 2021 / 8:40PM, JAZZ.OQ - Jazz Pharmaceuticals PLC at Cantor Fitzgerald Global Healthcare
Conference (Virtual)
Question: Brandon Richard Folkes - Cantor Fitzgerald & Co., Research Division - Analyst
: Great. And maybe staying on the potential for broad application of the drug. Can you talk about the EMAS trial, right? What does this do to the
addressable market? And are there some patients already on therapy out there?
Question: Brandon Richard Folkes - Cantor Fitzgerald & Co., Research Division - Analyst
: Right. And just continuing on the pipeline, seeing historical GW, do you remain on track with the nabiximols trial for MS in spasticity?
Question: Brandon Richard Folkes - Cantor Fitzgerald & Co., Research Division - Analyst
: Great. And then bringing it back to another Jazz in-house developed product Rylaze. Any color on that launch to date? And then, I guess, similar
along those lines, just looping in, what's your ability to supply the demand to date? And then also longer term, anything we should think about
here? Or now that the process is a reliable one compared to what Erwinaze was, should there be no concerns in terms of ability to supply market
demand?
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
SEPTEMBER 27, 2021 / 8:40PM, JAZZ.OQ - Jazz Pharmaceuticals PLC at Cantor Fitzgerald Global Healthcare
Conference (Virtual)
Question: Brandon Richard Folkes - Cantor Fitzgerald & Co., Research Division - Analyst
: Great. And then in terms of the competitive dynamic, is Erwinaze now out of the market until Clinigen's BLA approval? Or what is that market
dynamic?
Question: Brandon Richard Folkes - Cantor Fitzgerald & Co., Research Division - Analyst
: Great. And there's one more on Rylaze before we move on. Any update on the IV formulation?
Question: Brandon Richard Folkes - Cantor Fitzgerald & Co., Research Division - Analyst
: Great. And then moving on to another product that's done tremendously, while since taking over Zepzelca. And any color in terms of how we
should think about the revenue? How far we are from a steady-state run rate of revenue within the current label? And then beyond that, can you
just remind us of the time lines for potential label expansion as well as a confirmatory trial?
Question: Brandon Richard Folkes - Cantor Fitzgerald & Co., Research Division - Analyst
: Great. And now bringing it back to the sleep franchise almost where we began. But we do have the approval of a once-nightly high sodium version,
potentially next month, right? So maybe just two questions there. Starting off, as you go out into the market now, what is the prescriber reception
being to understanding the concerns around the Sodium levels in Xyrem and thus potentially -- well, well, in FT218, potentially, should it be
approved?
Question: Brandon Richard Folkes - Cantor Fitzgerald & Co., Research Division - Analyst
: Great. And you touched on that orphan drug designation. Maybe just any color or how should we think about that impacting the ability for FT218
to come to market?
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
SEPTEMBER 27, 2021 / 8:40PM, JAZZ.OQ - Jazz Pharmaceuticals PLC at Cantor Fitzgerald Global Healthcare
Conference (Virtual)
Question: Brandon Richard Folkes - Cantor Fitzgerald & Co., Research Division - Analyst
: Great. And we are just about out of time. But given that it's the launch session of the day, I'm going to sneak one more in, just because there is so
much to talk about at Jazz these days. JZP-358 for essential tremor. Is this something that remains on track and remains a priority?
|