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

Page 5 of 11

We also see that as physicians gain experience and they push up the doses that, that also generally leads to better efficacy. And so continuing to titrate up, and I think in some of the markets, we feel we’re under-dosed. So that’s going to be an area of growth. And then we’ve got a broad indication for starting at a young age going all the way up and I think we’ve done a good job with the pediatric settings in most markets. But there’s still an opportunity to transition those pediatrics as they become young adults and even adults with these lifelong conditions and also addressing the adult patient population. And then, there’s still additional geographic opportunities in some of the countries we haven’t been in. And longer term, we’re investing in data generation for new seizure types such as EMAS but we’re also looking to address new significant markets like Japan and Asia.

David Amsellem: Good. Thank you.

Operator: Please standby for our next question. Our next question comes from Marc Goodman with SVB. Your line is now open.

Marc Goodman: Yes. I’m sorry to keep it on Epidiolex more, but maybe you could just help us a little bit here. Last year, in the third quarter, it was kind of a weak quarter and then fourth quarter was extremely strong. And so the question was there a little bit of one quarter taking away from the other, any inventory movements and stuff like that. And so — can you help us understand if there was any of that in this quarter, obviously, a very big quarter, and we’re just trying to understand it. Maybe you can help tease out like is this all just European regions just getting added on or was there actually real growth in the United States? Like, can you confirm there was double-digit growth in the United States year-on-year, something like that?

Was there any inventory change? And then just lastly, you talked about the Japan study. I was just curious, before Epidiolex was approved in US and Europe, there was a lot of CBD usage, buy them in the Bodega, all over the place. It was just the thing to do, and it was pretty well understood. Is it the same over there in Japan? Do you expect the same type of ramp up over there and that type of excitement? Thanks.

Bruce Cozadd: Yes. Mark, this is Bruce. I’ll take the first part of your question and then maybe have Dan make a couple of comments on Japan. It’s going to be a short answer. The growth you saw in Epidiolex is real. Yes, it’s in the US as we continue to roll out in new countries and new indications as Dan described in Europe, we are seeing solid growth in the US and no, it’s not due to changes in inventory. Dan, you want to take Japan?

Dan Swisher: Yes. On the Japan side, we’re super excited for that market and to now have launched our official study and so worked very closely with the regulatory agency and developing thought leaders who needed we’re very interested in the data that was coming out of Epidiolex. But unlike other markets, there is really no cannabis allowed vector, the Cannabis Control Act, which prevents use of whether it’s regulated or non-regulated. And so we’re also working in parallel as GW had done successfully in other geographies with government officials to allow for exceptions to the Cannabis Control Act for regulated medicines that have gone through a safety and efficacy evaluation. And we’re feeling confident we’ll be able to do that change of law and sort of change of practice. And then meanwhile, so enroll and get the experience within Japan from the clinical study. So that’s where we are with Japan.

Marc Goodman: Thanks.

Operator: Our next question comes from Ami Fadia with Needham. Your line is now open.

Page 5 of 11