Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) Q3 2023 Earnings Call Transcript

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So we’ve engaged expert IP counsel to represent both Harmony and Bioprojet in the patent litigation. And we are confident in the strength of our IP, prepared to vigorously defend it. And we’ll provide updates as that process moves forward.

Operator: Thank you. We’ll take our next question from Corinne Jenkins with Goldman Sachs. Please go ahead.

Corinne Jenkins: Good morning, everyone. Could you just maybe clarify, I think, for formulation 2, you highlighted an abbreviated development program. So what does that actually mean in terms of the need for in size of Phase 1, Phase 2, and Phase 3 studies? And how quickly do you think you can kind of get a program like that to market? And then, I guess as a follow-on to that question, do you primarily see this launch would be a switch campaign ahead of generic and launches? And what lessons can you win for other switch campaigns that you would apply there?

Jeffrey Dayno: Good morning, Corinne. I’ll have Kumar sort of comment on the approach to the second formulation quick-to-market strategy. From a commercial perspective, I’ll ask Jeff Dierks to share thoughts on what that could offer to the market.

Kumar Budur: Good morning, Corinne. The formulation 2 is the pitolisant-based modified formulation, and we are on start to get into the clinic in the second half of this quarter. In terms of the attributes and the potential clinical differentiation, we do believe that this particular formulation will have different attributes and several different clinical differentiation, but we are not in a position to comment on that one because the rate of the formulation or the differentiation because of the IP and competitive reasons. But this will be a fast-to-market strategy, and we anticipate to launch within the Wakix life cycle.

Jeffrey Dayno: Jeff?

Jeffrey Dierks: And Corinne, from the commercialization strategy with the new formulation 2, it will not be a switch strategy. This is a brand-new product. And given the level of dissatisfaction that we see in the marketplace, the significant unmet need, people living with narcolepsy need new treatment options. And so we see this as a unique option that will be differentiated from Wakix and providing a new therapeutic option for patients. So we see Wakix and this new formulation being able to coexist and provide two unique options to people looking for a therapeutic treatment for EDS or cataplexy and adult narcolepsy.

Corinne Jenkins: And just to clarify, when you say within the Wakix life cycle, I assume you mean your base case, which is late mid-2030?

Jeffrey Dayno: That’s correct. Yeah, that’s correct, Corinne.

Corinne Jenkins: Okay. Thanks.

Operator: I’m showing no further questions. At this time, I would like to turn the call back to management for closing remarks.

Jeffrey Dayno: Thank you, operator, and thanks, everyone, for joining our call today and for your interest in Harmony. As you heard from us this morning, our business remains strong, and we have confidence in the long-term growth potential of our company. We look forward to providing updates as our business advances. Thank you, and have a great day.

Operator: Thank you. This does conclude today’s Harmony Biosciences third quarter 2023 financial results conference call. You may now disconnect your lines, and have a wonderful day.

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