Harmony Biosciences Holdings, Inc. Common Stock 12th Annual Cantor Fitzgerald Global Healthcare Conference

Yeah, thanks, Pete. On behalf of the Harmony team, thanks for the invitation to present today. I'm Jeff Dayno, CEO at Harmony Biosciences. Briefly, neurologist by training, 12 years clinical academic medicine, 28 years in the industry. Started at Merck, Cephalon, ViroPharma, and joined Harmony at the beginning in October 2017 with incredible opportunity on the heels of WAKIX. Now as we build out the pipeline with the focus on BP-205. Great to be here today, and Peter?

Yeah. First of all, thanks for pronouncing my name right. It takes a Greek to pronounce another Greek's last name, so thank you. I'm Peter Anastasiou. I'm the Chief Operating Officer. I've been with the company officially since April, but prior to that, I was on the board for 3 years. I've been in the industry 30 years. First half of it was at big companies like Eli Lilly and Company and Bristol Myers Squibb, and the last half has been with kind of smaller mid-size companies. I was President of Lundbeck North America. I was CEO of a company called Capsida Biotherapeutics right before I joined Harmony full time in April. It's a pleasure to be here.

Sure. Pete, let me first frame in addition to BD, the Harmony story and where we are. We feel that we're kind of emerging in our second chapter of growth. Obviously, on the heels of WAKIX, very successful in terms of commercial product, and the franchise continues to grow. On track for over $1 billion in revenue this year, and then the next generation programs also advancing. I think that has given us the ability in terms of very strong balance sheet, approaching $1 billion on the balance sheet, to really self-fund the entire enterprise. Our pipeline programs, we'll talk about BP-205 and in terms of our organic growth, and then in terms of business development, the ability to be competitive in the market with really interesting BD opportunities.

The plan is to continue to build out the pipeline, as well as look to diversify the commercial portfolio with potential on-market assets. I'll turn to Peter to frame the strategic lens that we look through in terms of BD opportunities.

Yeah. First of all, we want to do value-creating deals. We're very careful and cautious to make sure that when we evaluate, we're quite active in evaluating a number of BD opportunities and have been for quite a while. We want to do things that create value. The types of things that we are targeting are products that could bring revenues in the 2028-2032 timeframe. The reason for that is to help bridge the WAKIX LOE. That also helps us bridge to the significant revenues we expect from BP-205, our orexin agonist that we'll talk about hopefully here in a couple of minutes. Targeting revenues in that 2028-2032 timeframe implies something that is late stage in terms of phase III, something that's under regulatory review, or potentially even something that's on the market.

In terms of therapeutic focus and indications, clearly anything in the sleep space is something that we know we can do. We consider ourselves the leader in the sleep space. Anything there would be right in the center of the bullseye in our sweet spot. We also have an emerging capability and experience in the epilepsy space, particularly DEEs, with what we're doing in terms of the clinical trials with EPX-100. Also those types of indications are rare CNS disorders, and we've clearly demonstrated our ability to be successful with rare CNS disorders in what we're doing with narcolepsy. As we develop our orexin-2 agonist, we are committed to exploring a number of different potential indications for it, including outside the sleep-wake space.

We haven't disclosed what those indications are, but that certainly would be an important area of relatedness in terms of our strategy, those indications that we're thinking about with BP-205 to also be doing activities in the BD front. Last thing I'll say is we're agnostic to deal types. We're certainly looking at M&A, but we're also looking at licensing deals. I'll remind you that the billion-dollar business that we've built, it was built on a licensing deal. We're kind of agnostic to deal types. Also, we are unlikely to spend our entire dry powder on one transaction. It's likely we'll do two or three transactions. That gives you some color, Pete, about how we're thinking about BD.

Yeah. As I mentioned, I think what makes it attractive is the revenue timeframe in that 2032. We always want to do things that relate to things that are strengths of ours. As I mentioned, sleep-wake, but also rare CNS disorders. We clearly have the ability to do that, and so we've demonstrated that with what we've done with narcolepsy. Those are the areas of focus for us.

Yeah. In addition, as Peter Anastasiou said, building out the additional verticals with regards to the epilepsy business and with EPX-100 and looking at other potential assets in the epilepsy space. As we look to BP-205, the conversation's incredibly interesting, and it's accelerating pretty quickly. In addition to NT1, NT2, and IH, these broader CNS potential indications, yet unproven, but a lot of promise in that area that we will plan to pursue as well.

Hard to- No, please. When it comes to BD, hard to predict timing.