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

Sandip Kapadia: Sure. What I’d say is, look, it’s a natural evolution of the company, right? We have a very strong balance sheet, continued cash generation. So we have the opportunity to opportunistically return capital to shareholders, while still maintaining sufficient capital for other important priorities including business development. So this is not an either or this is in addition, I would say, overall, and certainly, given our stock price right now, it’s really accretive use of capital to execute to really drive maximize shareholder value from that perspective. So hopefully that gives you a little bit of color in terms of, we don’t really see that either or. So I think, it’s really just a natural evolution of the company, we are $430 million on the balance sheet and we have capacity to do business development as well.

And to your other question, as you know, we also did a recent financing as well that we announced last week, about $185 million led by very syndicate banks, which again gives us continued access to capital if needed to — for potential business development in the future as well.

Dr. Jeffrey Dayno: Yeah. And David, just to reinforce in terms of business development, as I’ve mentioned before, it continues to be a high priority for us, and obviously, since I took on the CEO role at the beginning of the year, we’ve been actively engaged. The team and looking at opportunities, we’ve gone deep on several. So it continues to be a high priority. We have optionality and access to capital and that’s how we look sort of deploying that in addition to the potential for share repurchase.

Dr. Kumar Budur: Good morning, David. Just on the pitolisant based assets. We are working very closely with the Bioprojet on this effort and the formulation work is ongoing. These are pitolisant based assets with the potential for generating new IP and the potential to extend the pitolisant franchise well beyond 2040. We do expect to provide an update later this year on this pitolisant — new pitolisant based assets.

Dr. Jeffrey Dayno: Okay. Yeah. Thanks Kumar. So they are — yeah, they are not new molecular entities, the new formulations, enhanced formulations of pitolisant and as Kumar said, updates coming later this year on our progress on those programs.

David Amsellem: Okay. Helpful. Thanks, guys.

Dr. Jeffrey Dayno: Thanks, Dave.

Operator: Thank you. We’ll take our next question from Ami Fadia with Needham & Company.

Unidentified Analyst: Hi. This is Poonam [ph] for Ami Fadia. Thank you for taking my question. I guess, just wanted to ask if you can talk a little bit about where you are in your — on your walk in the life cycle management for WAKIX, like what initially completed before we’re ready to give strategic update by end of the year and if the new formulation that you mentioned could be used in any indications that you are procuring?

Dr. Jeffrey Dayno: Sure. So in terms of our life cycle management updates, Kumar can provide color on that. But I think as we shared all of our current life cycle management programs, we’re looking ahead to milestones later this year in the fourth quarter and advancing those leading with IH idiopathic hypersomnia and the Phase III registrational trial there. Kumar can provide more color on each of those with regards to where we are.

Dr. Kumar Budur: Good morning. Thank you for the question. In terms of life cycle management, as we mentioned earlier, we have a catalyst rich second half of this year. Let’s start with idiopathic hypersomnia. We are on track for topline resulting idiopathic hypersomnia in the fourth quarter of this year. On DM1 we are also on track for topline results in the fourth quarter of this year. Just as a reminder, the DM1 study. It’s a small signal detection proof-of-concept study that is not powered for statistical significance. In terms of PWS, we had a good meeting with the FDA, the end of Phase II meeting and we aligned on the study design. We plan to initiate this study in the fourth quarter of this year and also we are planning to submit pediatric narcolepsy sNDA in the fourth quarter of this year. So, really a lot of activities happening in the second quarter of — second half of this year, in terms of life cycle management of WAKIX.