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

With respect to WAKIX and oxybate, what we’ve seen has been relatively consistent, it’s been a low double-digit percentage of the WAKIX, patients are also on an oxybate. Again you’re going to see as this category evolves a little bit, as you know, within managed care. There is likely going to be additional things that they’re looking to do to manage the category. But in a rare orphan space with not a lot of these individuals. You don’t see a lot of administrative steps with multiple products, managed care acknowledges that this was a polypharmacy market. And so with a low percentage of WAKIX patients also on an oxybate we see really good access for patients on the product and we’re really pleased with the strong payer coverage, that really remain unchanged, even with the introduction of new products.

And we believe we’re really well positioned Franc. It’s a differentiated product. It’s the only nonscheduled treatment option. And we’re well positioned today, as well as the evolving managed care landscape moving forward.

Francois Brisebois: Great. Thank you.

Dr. Jeffrey Dayno: Thanks, Franc.

Operator: Thank you. We’ll take our next question from Graig Suvannavejh with Mizuho Securities.

Graig Suvannavejh: Thanks. Good morning. Congrats on the continued progress. I’ve got two questions, one just on how to think about the third quarter and know that coming out of 350 new patient adds, which is a nice number. We’ve historically over the past several years seeing you report in the second quarter 400 patients and then they’ve kind of trickled down to 300, and I guess, that does reflect a certain element of summer seasonality. So, maybe Jeff Dierks, if I could just ask you kind of thoughts around the dynamic for the third quarter. Any changes relative to what we’ve seen in the past. I know you’ve got some nice new momentum in terms of new prescription starts. So just wanted to get additional color there. And then my second question is just on, I was hoping to get the company’s perspective on last week’s curious patent challenged by Scorpion Capital and kind of any response reply to that? Thanks.

Jeffrey Dierks: Sure, Graig.

Dr. Jeffrey Dayno: Good morning, Graig. Yeah. Jeff, I will answer the first question and then I’ll respond to your second question.

Jeffrey Dierks: Sure.

Dr. Jeffrey Dayno: So, Graig for Q3 dynamics. I mean, I think you’re thinking about Q3. The right way, we do anticipate the typical headwinds, the summer seasonality with fewer patient visits to healthcare professionals. We’ve got to your point, tremendous momentum coming out of Q2. Q2 was one of the strongest quarters in terms of topline prescription demand we’ve seen in three years, highest number of new patient starts ever in our launch and adding 350 patients in year four of our commercial launch. I think it’s really tremendous results and although we’re not providing forward looking guidance. I think you’re thinking about Q3 correctly. We continue to see growth in new prescribers. We see growth in average number of patients. We do expect sequential growth for WAKIX in average number of patients for the remainder of 2023 and we have extreme confidence in the long-term growth opportunity for WAKIX and being a potential billion dollar opportunity.

Jeffrey Dierks: Thanks, Jeff. And Graig, with regards to your second question regarding the petition for a reexamination of the patent for WAKIX that was filed, I believe on July 19th. I think as we’ve said before, we’re very confident in the strength of our IP. We believe strongly in terms of the enforceability and validity of the patent portfolio and it’s our feeling — our position that the petition for reexamination is without merit. With regards to the timing of the reexamination, so the PTAB has 90 days tighter deny or grant the petition from the date of submission and the majority of times the petition are granted, but that has no read through to the potential outcome of the reexamination by PTAB. And if the petition is granted, the reexamination is between PTAB and the patent holder and majority of times the patent status is often unusually upheld.