Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) Q2 2023 Earnings Call Transcript

So I think with our confidence in the strength of our IP, which we will vigorously defend any challenges. That is why we have confidence in WAKIX being a $1 billion-plus opportunity in adult narcolepsy and then, obviously, if successful in our current life cycle management programs could also contributed an additional $1 billion revenue to the franchise.

Graig Suvannavejh: Thanks very much.

Dr. Jeffrey Dayno: Yeah. Thanks, Graig.

Operator: Thank you. We’ll take our next question from Jason Gerberry with Bank of America.

Jason Gerberry: Hey. Good morning, guys. Thank you for taking my questions. First, just curious with the introduction of generic oxybate mindful that it’s not impacting WAKIX, but do you have any insights into what’s going on, is it expanding the market for pharmacotherapy for oxybate taking just share from Xyrem or taking share from other products? And then as my follow-up, I think, it’s to the Needham question. As you think about gen pitolisant, I guess, like, the curiosity is, why develop WAKIX for these follow-on indications, if the IP could be at risk towards the back end of this decade. Why not prioritize the next get pitolisant? So you could have visibility and sort of a product life cycle that last well into the 2030’s? Thanks.

Dr. Jeffrey Dayno: Good morning, Jason. Thanks for your question. In terms of — Jeff you want to expand in terms of the dynamics in the oxybate franchise and the new products.

Jeffrey Dierks: Sure. Yeah. So, Jason. What we’re seeing, and again, the Hickman [ph] data is visible within Symphony Health Claims and it looks like it’s simply just there’s a churn that’s exhibiting in the oxybate marketplace. As I’ve shared in my prepared comments and one of my earlier responses that, we haven’t seen any impact, obviously, on the generic on our launch or even the early introduction of the once nightly oxybate at the end of the second quarter on our business. So what I’m observing in the data is simply just a little bit of a churn that we’re seeing in the oxybate marketplace. I think what we see with WAKIX is that, we’ve had a branded version of oxybate available since our launch back in 2019 and we continue to see strong growth through that time period and really strong growth in the first quarter and second quarter this year in average number of patients.

We continue to add new prescribers and I think our ability to call on the approximate 9,000 narcolepsy treating healthcare professionals, approximately 5,000 of those are not enrolled in the oxybate REMS program really provides our ability to tap into that broad diagnosed adult narcolepsy patient population. It gives us a little bit of insulation as newer forms of oxybate come in. Obviously, the overall benefit risk profile of WAKIX the broad clinical utility, it appeals to a broader healthcare professional treating audience, as well as a broader patient base. So I think we have tremendous confidence in our business. There’s a significant unmet medical need in here. There’s a large diagnose and even undiagnosed patient population in here, and I think, what we’ve observed over the last couple of years is there is plenty of room for multiple therapeutic options in here.

So we feel really good about where WAKIX is. But to answer your question on the generic oxybate I haven’t really seen it expanding the market, it’s more so, just a change within the oxybate vertical.

Dr. Kumar Budur: Yeah. And Jason with to your, on your second question about the IP runway for WAKIX and the current life cycle management programs and new formulations. So really good question. And I think what we have done to-date, we’ve generated good momentum, obviously, in our IH program and the strong momentum and the pace of enrollment in that program with pitolisant and the same in terms of Prader-Willi syndrome in that program and where we are. But with regard to the longer term outlook, we do see the potential new formulations, where we would option potentially to take those development programs. Obviously, with longer patent protection longer runway and shift some of those to the new formulations of pitolisant depending on what we see in the clinic and as those programs advance.