Jazz Pharmaceuticals plc (NASDAQ:JAZZ) Q2 2023 Earnings Call Transcript

And we think we’ve established a great track record as a partner of choice to be able to do so as well.

Operator: Thank you. Our next question comes from the line of Gregory Renza with RBC Capital Markets. Your line is now open.

Gregory Renza: Great. Bruce and team, congrats on the quarter. Bruce, maybe just a little bit on Epidiolex and just with respect to Dan’s comments on the drivers for potential continued growth. Just curious if you can comment a bit on any particular areas or drivers that kind of outsized and help to propel the growth that you’re expecting certainly last quarter, first quarter, a little seasonality and seeing the momentum that you’re speaking about now? I’m just curious how you see that playing out in the near term.

Bruce Cozadd: Yes. Dan, do you want to take Epidiolex?

Dan Swisher: Yes. Thanks, Bruce. So with Epidiolex, there’s another quarter of double-digit growth with 15%, Greg. So really pleased to see the continued initiatives that we outlined on the call, continued face-to-face interactions, very important in the treatment centers, getting to more offices, more prescribers. We’ve been enhancing our focus on the adult setting. In particular, in the U.S., we’ve got after long-term care settings and seeing increasing penetration there. We’ve also been educating HCPs about the benefits of Epidiolex beyond seizure control. And that was highlighted in the become data, which was presented at the end of last year, which talks about cognitive and behavioral benefits and we look forward to continuing to lean into that area, both with caregiver surveys and even interventional studies.

And so we’ve got a real commitment to continuing to generate data, both within the indications and kind of outside those indications. Outside the U.S., the launches continue to go well. We’re at 23 countries globally. We’ve had six positive pricing reimbursement decisions to date in the U.S. — sorry, outside the U.S. And importantly, we’ve got a Phase III study and what we think could be a very significant market for us with Epidiolex in Japan. And so that’s enrolling nicely, and we look forward to providing updates in the coming quarters.

Operator: Thank you. The next question comes from the line of Annabel Samimy with Stifel. Your line is now open.

Annabel Samimy: Just a couple more on Epidiolex. So you mentioned a couple of times now expanded indications, the only indication we know that you’re working on is the EMA indication. So are there others that we don’t know about that you plan on expanding into? And also with the EU launch, we now have 23 countries approved, I guess, five in the major EU countries, but are all those countries on board? Should we now see a significant expansion in Epidiolex ex-U.S.

Bruce Cozadd: Rob, would you like to talk a little bit about some of the additional data we’re generating with Epidiolex? And then maybe, Kim, you could talk a little bit about the potential for broader use of the product over time?

Rob Iannone: Yes. So, you’re right that we’re evaluating EMA and the objective there is to generate data and yet another seizure type. Adding to the three indications we have, really trying to demonstrate that Epidiolex is broadly active across different seizure types, regardless of the underlying etiology. We also continue to provide evidence around the indications we have, both in terms of anti-seizure effectiveness, but also in terms of other potential benefits of Epidiolex. And you heard Dan refer to the caretaker survey, and we continue to support and do studies along those lines as well.