Jazz Pharmaceuticals plc (NASDAQ:JAZZ) Q3 2022 Earnings Call Transcript

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Kim Sablich: Yes, I’d be happy to take that one because we are incredibly pleased that Rylaze sales have exceeded prior U.S. peak sales of Erwinaze and that we believe this is a strong signal that the unmet needs of the market had never really been fully met before Erwinaze started to have supply issues. So I’ll point to a number of things. We now have robust brand awareness among customers and prescribers. We’ve created high confidence in the high-quality and reliable supply of the product. And right now, we enjoy the position as the only available therapy to patients in the US, who have a hypersensitivity reaction to E. coli-derived asparaginase. We’re continuing to hear from customers that based on the availability of Rylaze that they are returning to that clinical practice and switching to non-E.

coli derived asparaginase earlier than they previously were during the supply shortage when they see initial hypersensitivity reaction observed. At this point, Rylaze has been adopted, as you kind of said, almost universally in the pediatric oncology protocols. But we’re also encouraged to see that there is increasing use of Rylaze in the treatment of adolescents and young adults. Now, the majority of the patients out there are pediatric. And it’s important to note that many adolescent and young adult patients are actually treated in pediatric centers under the really strong pediatric protocol. So that’s a good driver of the growth. Our launch was focused in the last year on establishing Rylaze with our existing asparaginase prescribers who, again, were predominantly in the pediatric setting.

And next year in 2023, we aim to increase our efforts to driving — prescribing in the adolescent young adult population and seeing if we can further expand the market. So again, that’s just inside the US. And certainly, there’s lots of growth opportunity ex-US for Dan to talk about.

Dan Swisher: Yes. Thanks, Kim. On the outside of the US, as we’ve mentioned, we filed with the EMA, and we’re hoping for a potential approval in 2023, depending on how long that takes and to answer questions, et cetera. It’s a different market over there. Of course, pricing is lower and also Erwinaze is on the market in the European setting. That being said, the experience we’ve had within the US and having really optimized, particularly the Monday, Wednesday, Friday dose with a bigger dose on Friday to ensure full coverage for these patients. And then there’s other advantages in terms of the concentration, the ready till fully recombinant, no particulates in the solution. So we do look forward to giving another treatment option to those physicians.

Outside of Europe, there are some countries where Erwinaze is not yet on the market. Japan is one. And we do — we’re actively considering what the opportunity there is, and we’ll be working with the regulators to see, is there an expedited path to get this important medicine to patients who could benefit from it.

Operator: Please stand by for our next question. Our next question comes from Gregory Renza with RBC Capital. Your line is open.

Gregory Renza: Hey, good evening, Bruce and team. Congrats on the quarter and thanks for taking my question. Bruce, I just wanted to ask a specific one on Vyxeos. Perhaps you can just give us some updated color on the Vyxeos performance and view and trajectories from here? And maybe related to that, it’s super helpful to hear Renée and the team’s color elaborating on BD and zani as a potential blueprint. I’m just curious, as you reflect on Celator from few years ago and with Vyxeos now under Jazz, how that potentially juxtaposes as far as the strategy back then to how you’re looking at deals like zani going forward? Thank you, very much.

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