Harmony Biosciences Holdings Inc (HRMY) Q1 2024 Earnings Call Transcript Highlights: Strong ...

• Net Revenue: $154.6 million for Q1 2024, a 30% year-over-year growth.

• Net Revenue Guidance for 2024: Projected to be between $700 million to $720 million.

• Net Income: Non-GAAP adjusted net income for Q1 2024 was $50.7 million, or $0.88 per diluted share.

• Cash Position: $453.6 million in cash, cash equivalents, and investments as of the end of Q1 2024.

Release Date: April 30, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Q & A Highlights

Q: Hey, good morning, Chip and team. Thanks for taking our questions and congratulations on a good commercial quarter as well as recent it's development deals in compressive activity and it could include Europe so on. And a quick question for Chapter six. In terms of the commercial business, nice growth year on year, appreciating the seasonal issues. But in terms of the number of patient adds. And let me let me ask you about how you feel about that as well as one of the things that Kumar mentioned is in the next generation and ability to titrate more rapidly. And I guess I'm wondering if you look at the current patient population taking weight Qix on, you know, how do you how do you feel that's impacting the use of a weaker mix will be improved titration rate. And I'll make a difference in terms of the persistence with it within weight. A: Charles, thank you. For your question, Jeff. Yes, thanks for the question. Charles, on to answer your question on the average number of patient adds in the first quarter, first off, I'll tell you we're extremely pleased with the durable growth that we're seeing in the average number of patients. It grew 150 patients sequentially from what we reported in Q4, we continued to see strong top line demand and new patient starts and trials. As you know, like the 150 average patient growth is well in line with our past to Q1 average patient growth in the last two years. And as you cited, we typically have the Q1 seasonal payer dynamics, the reauthorizations that prescriptions on a reminder coming into 2024, we had a larger established patient base. We had 61 hundred and 50 average patients coming into '24. Whereas a year ago, we only had about 49 hundred. And all of those established patients are exposed to those reauthorizations that occur every January for specialty and branded products. And certainly trial, as you know, those reauthorizations just simply add time. So about 25% more of our patients were exposed to that. And then on top of that, we did have the additional headwind of Change Healthcare but as you know, we've got a great commercial model. We have a closed distribution network and the outstanding work of our team. We did a tremendous job in navigating those dynamics and we've continued to been able to demonstrate growth every single quarter and average patients are going to continue to tap into that large patient opportunity as the market allows each quarter and we're confident, as Sandip shared in his prepared comments to see quarter over quarter growth for remainder of '24 and beyond.

Q: That's helpful, if I could ask one development question that is regarding the new assets at the Agennix. Congratulations on that Kumar. You mentioned 26 being data with YPX. 100. I guess I'm wondering what is really modulating that timing of of 26. I know these are difficult studies to enroll, but what could that prove to be an overly conservative estimate of time to top line data on EPX. 101. A: Good morning, Charles. Thanks for the question. Look, we just acquired this asset and right now, we believe 2026 is when we will be able to come out with the top line data. Obviously, as the study progresses, as we are able to bring in Hoffman the resources, the expertise in R&D and especially the advocacy support group that we have very well established tier companies who work hand in glove with patient communities. So all of these things will definitely help with the recruitment and you're right recruiting these patients is not necessarily easy, but I think we have a really A-plus team to recruit these patients. And as we make progress with the clinical trials we will provide more granularity for the time line.

Q: And I apologize if the question was already asked, I got dropped off the call for a sec there. But I was just wondering in terms of the acquisition, the epigenetics acquisition, is there any data that share that you intend to share soon about further past readouts, just given it's a private company and people might not be familiar with the story? A: Good morning, Franc. Thank you for your question. I think Kumar can talk about on data generated and what we'll be sharing going forward here. So thank you, Franc. You have some implements own hydrochloride of CHF because of first-generation antihistamines that was introduced in 1958 and sunset in 1970s, introduction of second and third-generation antihistamine. Our there is some safety data from that period of time, which is very benign. And then on the fee and one year mutation model of the superficial premise of hydrochloride was studied. Our He's published extensively our BIS card in Pottery Barn, who's a professor Highstar University of California in San Francisco are the mechanism of action front is a potent centrally acting serotonergic drug, and this is proven mechanism of action when it comes to developmental epileptic encephalopathies and that alongside with the robust data that we observed in FY 1 million mutation. The Proficient model and safety data that we have from Clemens. All most of it is available in the public domain and within the clinical trial. This is a Phase three registrational clinical trials, and we have asked us to build long-term open-label data that has not been published yet. Obviously, we don't know the double-blind data. It is double-blind, but the open-label long-term study data is available and we will be discussing gone what will be the appropriate time to put those data in the public domain.

Q: Okay, perfect. And then just a question in terms of and again, sorry, if you mentioned this, but the 150 new patient adds, is there any seasonality impact here on the number of patient adds? Or is it mostly with gross-to-net and that impact on the inventory also having an impact or does the number of patient adds also impacted by seasonality in the first quarter? We have seen it a few years ago is only 100 patients, I think, in Q1 '22. So just wondering about that. And then, you know, you mentioned the 700 to 720 guidance for you and I think you mentioned the 7,000 patients on drug. Is that still something do we should expect or are we getting away from that 7,000 number here? A: Thank you. Sure. And Frank, thanks for the question. And yes, from a Q1 perspective, we do see seasonal payer headwinds that do have an influence on the number of patient adds in the first quarter and you cited the 150 patient adds we had this quarter is in line with the last two years. We had 200 last year. We had 102 years ago. So very consistent as we get reauthorization headwinds on prescriptions. And the one thing take into account this year, Frank, as we had a larger established patient base coming into 2024, we had about

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

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