Good morning. My name is Brittany, and I will be your conference operator today. At this time, I would like to welcome everyone to the Harmony Biosciences Fourth Quarter and Full Year 2023 Financial Results Conference call. All participant lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session [Operator Instructions]. Please be advised that today's conference may be recorded [Operator Instructions]. I would now like to turn the call over to Luis Sanay, Head of Investor Relations. Please go ahead.

Thank you, operator. Good morning, everyone. And thank you for joining us today as we review Harmony Biosciences fourth quarter and full year 2023 financial results and provide a business update. Before we start, I encourage everyone to go to the investors section of our Web site to find the materials that accompany our discussion today, including the reconciliation of our GAAP to non-GAAP financial measures. At this stage of our life cycle, we believe non-GAAP financial results better represent the underlying business performance. Our speakers on today's call are Dr. Jeffrey Dayno, President and CEO; Jeffrey Dierks, Chief Commercial Officer; Dr. Kumar Budur, Chief Medical Officer; and Sandip Kapadia, Chief Financial Officer and Chief Administrative Officer. As a reminder, we will be making forward looking statements today, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties. Our actual results may differ materially and we undertake no obligation to update these statements, even if circumstances change. We encourage you to consult the risk factors referenced in our SEC filings for additional details. I would now like to turn the call over to Dr. Jeffrey Dayno. Jeff.

Thank you, Luis. And thanks everyone for joining our conference call today. Harmony continues to be a growth story as demonstrated by our team's accomplishments throughout 2023. We delivered another strong year of performance across the organization, growing revenue and average number of patients on WAKIX. We advanced all our clinical development programs for pitolisant, moved the next generation or next gen formulations of pitolisant into the clinic and expanded our pipeline and diversified our portfolio with the acquisition of Zynerba and the ongoing Phase 3 clinical trial in patients with Fragile X syndrome. Yesterday, we announced that FDA granted priority review for our supplemental NDA or sNDA for WAKIX in pediatric narcolepsy with a PDUFA date of June 21st. Earlier this week, we also shared that FDA granted orphan drug designation for pitolisant for the treatment of Prader-Willi Syndrome or PWS, as we are preparing to initiate our pivotal Phase 3 TEMPO study in patients with PWS down to age six. All of this reflects momentum across our organization from our commercial business with WAKIX in narcolepsy to our clinical development programs, as well as positive interactions with FDA related to these programs. These outcomes also reflect excellence and execution, and the dedication of our team to deliver on the strategy we have laid out and are executing on. In addition, we have returned capital to shareholders via our share repurchase program and will continue to take an opportunistic approach to this program throughout this year. I am very excited for the year ahead and believe that Harmony is poised to accelerate our growth in 2024. For the fourth quarter, we reported WAKIX net revenue of $168.4 million and full year net revenue was $582 million, representing growth of 31% and 33% respectively. This result demonstrates the significant underlying…

Thank you, Jeff. 2023 was a strong year of growth for WAKIX and year four of our commercialization in adult narcolepsy. The fourth quarter represented the strongest revenue quarter in our history with continued growth and momentum in our underlying business fundamentals and top line performance metrics. Net revenue for the fourth quarter was $168.4 million, representing 31% growth from the same quarter prior year and our second consecutive quarter of over $150 million in net revenue. Full year 2023 net revenue was $582 million, a 33% increase from full year 2022. We continue to see strong double digit growth in net revenue for WAKIX heading into year five of our commercialization, reflecting continued high interest of WAKIX in the narcolepsy market. The solid performance and continued growth reinforces our long term belief that WAKIX represents a potential a billion dollar plus opportunity in adult narcolepsy alone. I'd like to share a few key highlights from our performance in the fourth quarter on Slide 5. The average number of patients on WAKIX in the fourth quarter increased to approximately 6,150, an increase of approximately 350 average patients sequentially from what we reported last quarter. The impressive growth in average patients in the fourth quarter was driven by strong top line demand and new patient starts and speaks to continued product adoption. And more importantly, it highlights the remaining large diagnosed patient opportunity that we continue to tap into each quarter as the market allows. In addition to the strong growth in average number of patients on WAKIX, we also saw continued product adoption of WAKIX by the narcolepsy healthcare community, both in new and existing prescribers. The number of unique prescribers of WAKIX increased again in the fourth quarter. And importantly, we continue to see growth in product adoption of…

Thank you, Jeff. Last year was a defining year for Harmony R&D. We made great progress in advancing, expanding and diversifying our portfolio, working on nine different development programs across five different assets, several of which are in late stage development. It is not just the numbers but also the complexity of the program as we target a broad set of indications in rare disease patient population with significant unmet medical needs. As we grew our portfolio, we also built a strong, experienced and dedicated R&D organization, ready to take on new opportunities as we continue to build our existing portfolio with new assets via business development. I'm proud of the work that our team does every day and to look forward to delivering potential new treatment options for patients with rare diseases with high unmet needs. Our full clinical development pipeline is shown on Slide number 7. Starting with pediatric narcolepsy. We submitted a supplemental NDA to the FDA for an indication in pediatric narcolepsy in the fourth quarter and we are pleased with the FDA's decision to grant a priority review. This decision highlights the need for new treatment options for the approximately 4,000 pediatric patients living with narcolepsy. The FDA has set a PDUFA date of June 21st. We look forward to working with the FDA to potentially bring a non-scheduled treatment option administered once a day in the morning for pediatric patients with narcolepsy. Moving on to our development program in idiopathic hypersomnia. We completed our review of the full data set and submitted an FDA meeting request in the fourth quarter to discuss the path forward and the meeting is scheduled for March. We are optimistic that we'll be able to find an efficient path forward to bring pitolisant to patients with idiopathic hypersomnia. Our…

Thank you, Kumar, and good morning, everyone. This morning, we issued our fourth quarter earnings release and filed our 10-K where you'll find the details of our fourth quarter and full year 2023 financial and operating results. Our financial performance is also shown on Slides 10 through 13. We finished the year with strong momentum across the business, helping us deliver solid growth across several key metrics. We reported $582 million in annual WAKIX net revenue, achieved our third year of profitability along with robust cash generation. In addition, we advanced our pitolisant life cycle management program and executed on business development with the acquisition of Zynerba. We also deployed capital towards our share repurchase program. Overall, we remain well positioned to execute on our growth strategy moving forward. So let me take a moment to review our financial results in more detail. For the fourth quarter of 2023, we reported our strongest revenue quarter in company history with net revenues of $168.4 million compared to $128.3 million in the prior year quarter, representing a growth of 31%. Performance in the quarter reflects the strong continued underlying demand for WAKIX. In the fourth quarter of 2023, operating expenses were $85.1 million compared to $53.8 million in the prior year quarter. The higher operating expenses were primarily driven by our advancement of our clinical development programs, including ZYN002, expenses related to the commercialization of WAKIX and one-time Zynerba transaction related costs of $9.8 million. Operating income for the fourth quarter of 2023 was $40.2 million compared to $47.6 million in the prior year quarter. Non-GAAP adjusted net income for the fourth quarter of 2023 was $42.8 million or $0.73 per diluted share compared to $61.9 million or $1.01 per diluted share in the prior year quarter. We believe non-GAAP adjusted net…

Thank you, Sandip. In summary, Harmony continues to be a growth story as evidenced by the significant progress our team made in 2023. Looking ahead, we see durability in our core business, strong momentum in our development programs and remain focused on continuing to grow our WAKIX business and helping even more adult patients living with narcolepsy; advancing our pipeline across both our pitolisant and ZYN002 clinical development programs; working with our partner Bioproject on next gen formulations to extend the pitolisant franchise to help even more patients living with rare neurological diseases; continuing to build out our pipeline through business development to create a robust portfolio of rare disease assets, covering all stages of development; and deploying capital to maximize shareholder value through our share repurchase program and business development opportunities. I am excited for what is to come this year and believe that we are poised to accelerate Harmony's growth in 2024. This concludes our planned remarks for today. Thank you for joining our call. And I will now turn the call back over to the operator to facilitate the Q&A session. Operator, can you please open the call to questions?

[Operator Instructions] We'll take our first question from Ami Fadia with Needham & Company.

Thank you for giving all the updates on the pipeline. Firstly, I have two questions. First, can you talk about the two new pitolisant formulations on which you're going to be sharing data in the first half. What should we expect to see from the data? And just to set up expectations for investors, will we be able to get visibility into how these formulations may be differentiated from WAKIX based on that data? And then the second question is regarding idiopathic hypersomnia. If you could share any additional color on the analysis that you've put together for your meeting with the FDA? And if you could comment on whether there's any possibility of generating any additional data from the open-label portion of the study to support an approval?

I'll ask Kumar to comment on the next gen formulations and some visibility there and as well as our preparation for the FDA meeting on IH. Kumar?

In terms of next gen formulation, as we mentioned, we made significant progress on next gen formulations last year, and we were really pleased to bring both of those two formulations into the clinic in the fourth quarter. And as we previously said, we will provide data from the next gen formulations in the first half of this year. In terms of Next Gen 1 or NG1, it's a modified pitolisant formulation with the potential for clinical differentiation first to market strategy by demonstrating bioequivalence alongside a clinical study that will offer a meaningful clinical differentiation for patients. The nature of the clinical study and the potential differentiation that will be offered will be discussed at the next earnings call along with the PK data. With the next gen 2 or NG2 formulation, it's an enhanced formulation of pitolisant designed to deliver optimized PK and also an ability to go to a higher dose strength. This is the formulation that will have a full development program and new IP, and it will extend the pitolisant franchise well beyond 2040. and we plan to provide the PK data from these formulations at our next earnings call. Regarding your question about the idiopathic hypersomnia, Ami, the totality of the data from the open-label study from the randomized withdrawal period of the study and the long term extension study supports pitolisant's efficacy in patients with idiopathic hyperphromia. And in terms of the arguments or the discussions that we will be having with the FDA, it's the totality of the data, the non-scheduled start-up of pitolisant, the ease of administration, relatively benign safety profile, especially in the context of only one drug that happens to be a Schedule III controlled substance and the off label use of Class II controlled substance drugs that have their own safety profile. So all these factors offer a strong benefit risk proposition to bring pitolisant for patients with idiopathic hyperphromia and we hope to have good discussions with the FDA and find an efficient path forward to bring pitolisant to patients with the idiopathic hyperphromia as soon as possible.

We’ll take our next question from Charles Duncan with Cantor Fitzgerald.

Congratulations on a good year in '23. I have one commercial question and then a pipeline question to follow. So regarding the commercial question, absolutely appreciate the ‘25 rev guide. Looks good to me. I note that you've added about 350 patients on WAKIX per quarter for the last three quarters, and that seems to be just a really consistent number. And I guess I'm wondering if you could speak to anything in the market dynamics or prescriber access that results in that 350 or is that just serendipity?

I think, you know, Jeff Dierks can provide some color on the patient adds and the continued market opportunity for WAKIX.

We've been extremely pleased with the durable growth that we've seen in the average number of patients on WAKIX. And I think some of the things that we're seeing Charles is given the unique and meaningfully differentiated product profile, WAKIX has the ability and our sales team has the ability to engage with the broad 9,000 approximate healthcare professionals that see and treat the narcolepsy patients. And what that does is that affords us the opportunity to tap into the full diagnosed patient opportunity, both those individuals and healthcare professionals outside the oxybate REMS program, which we continue to see meaningful growth in the number of unique writers every quarter but even within the oxybate REMS enrolled healthcare professionals, even with the availability of generic and once nightly oxybate launches this year, we're seeing meaningful growth in terms of depth of prescribing in that audience. So I think really what we're seeing is the unique nature of the meaningfully differentiated product profile, the non-scheduled status, the broad clinical utility that Jeff Dayno spoke about. That really affords us the ability to continue to tap into that broad diagnosed patient opportunity as the market allows around the traditional quarterly dynamics that we speak about each earnings call. But Charles, we're extremely pleased with what we're seeing, as I'm hearing from you as well, and we're confident in continued growth in the average number of patients as we move into ‘24.

Quick question on the pipeline, actually a multi-part question. Sorry about that. And that is, appreciate the Phase 3 TEMPO study data, or not data, details. I'm wondering when you would anticipate data, how rapidly do you think that study can enroll, given some competing programs? And then is the NDA, sNDA timing, I assume it would be, gated by the open label extension or would you file perhaps before that's completed? And then the second part of the question is regarding the pediatric narcolepsy and priority review. It seems to say something about the agency's perspective on the safety of the product. So I'm wondering if you could provide any thoughts on that and recent priority review being granted?

Charles, first let me say, I think that we're excited to be initiating the Phase 3 TEMPO study in patients with Prader-Willi. I'll have Kumar comment on that and then I'll circle back on some thoughts about the priority review for the pediatric narcolepsy sNDA. Kumar?

Regarding the PWS study, first of all, we are very pleased to have the orphan drug designation from the FDA for PWS program. In terms of recruitment, we anticipate to complete enrollment in about two years. It is true, Charles, that there are multiple programs in this space but then we are the only ones who are looking at excessive daytime sleepiness and the behavioral symptoms in PWS. The other programs are targeting more towards the hyperphagia in PWS. And as we have mentioned previously, more than half of the patients with PWS have excessive daytime sleepiness and almost all of these patients have behavioral disturbances. And from our proof-of-concept study, we showed strong data supporting pitolisant's efficacy both in excessive daytime sleepiness [Technical Difficulty].

And Charles, can you repeat that second question about the [pediatric] narcolepsy sNDA?

The pediatric narcolepsy, PDUFA and rapid time to respond just seems to say something about the safety of the product or the agency's perspective on that, and I'm not speaking for the agency, of course, but that combined with the priority review. I guess do you have any thoughts about the perspectives on that?

Charles, I mean what I would say, I think that as we've shared this week, we're very pleased with the interactions we've had with FDA with regards to the orphan drug designation for pitolisant for Prader-Willi and then followed by the decision priority review for the pediatric narcolepsy sNDA. I think that it reflects with regards to the overall benefit risk profile of pitolisant and what we have said all along and advancing the development programs. We don't have any concern with regards to -- the safety profile has been consistent from the original pivotal development program in narcolepsy and on through the life cycle management programs that we've been conducting with no real change in the overall safety profile and the favorable benefit risk profile. I think that reflects the positive interactions we've had with the agency, the decisions that we've received. And we remain focused on the execution and advancement of those development programs to bring potential new treatment options to those patient populations.

We'll take our next question from Francois Brisebois with Oppenheimer.

So just wondering in terms of the guidance, can you help us understand what the thought process was behind giving guidance for the first time here? And how should we be thinking about the revenue for patients in 2024?

Sandip?

I mean, our guidance represents what I'd say is a thoughtful and balanced approach, especially the first year as we've given guidance. I think we certainly look for opportunities to provide an update as we go throughout the year with respect to the guidance.

How we should think about pricing or maybe revenues per patient's…

I think, we did take our price increase earlier this year, it was about 7%, a good portion of that usually follows through the bottom line. So I think generally, you'll see an impact from that as we go throughout the year. Obviously, in the first quarter, there's usually headwinds regarding gross-to-net pressure and normal things that happen typically in the seasonality that happened. So you generally don't see as much of that in the first quarter. But generally as we go throughout the year, you'll see the the benefit. It's very similar to the pattern that we've had over the last three or four years.

We'll take our next question from David Amsellem with Piper Sandler.

So just a couple first, regarding business development. I wanted to get more detailed thoughts on the extent to which you do a larger scale transaction versus something smaller scale along the lines of Zynerba. Just philosophically, how are you thinking about acquisitions in general? And tied to that question is also would you lever up and lever up significantly to do something? So that's number one. And then number two, wanted to pick your brain on the orexins. We've seen some data from Takeda, from [Alchemies]. There are others of course. Wanted to get your view on the potential long term impact of the orexin to receptor agonists, to the extent one or more reach the market?

I think with regards to business development, we are assessing the landscape very actively and we're open to sort of all opportunities. And with regards to a deal similar to Zynerba, that's a good strategic fit, as well as something more transformational. We're in a strong sort of financial position to transact. So we first looked for good strategic fit, prefer sort of late stage assets but open to earlier stage, and those that could launch both during the WAKIX life cycle and after. In terms of capacity, I'll ask Sandip to comment on that.

We have good financial strength and flexibility to execute on business development. We also have access to debt if appropriate as well as the capital markets. As also we mentioned we had over $425 million of cash and cash equivalents available. We're generating significant positive cash flow. Last quarter was about $77 million in cash flow generation, as well as almost over $219 million last year in cash generation. So I think we have a good flexibility, as Jeff mentioned, to look at, both small add-on transactions as well as potentially something that's more larger and transformative. But I think the important thing is the filter that Jeff mentioned upfront in terms of making sure it's a good strategic fit for the company. And I think from a capital perspective, we have broad flexibility.

And David, turning to question about the orexin agonist, I mean, you know this space well as do we and we following it closely. So obviously, a lot of attention lately given some of the data that has come out. I think at a high level the programs are still early and they're obviously advancing. I think questions are being generated, both on the safety side and the efficacy side based on the data that has been coming out. Obviously, the target is interesting in terms of the next potential novel mechanism of action for narcolepsy and other central disorders of hypersomnolence. So I think we following the space closely as the data come out, as more questions have been generated. And I think that they likely come to market as successful towards the end of the decade, towards the end of the WAKIX life cycle. But importantly, it's our belief that narcolepsy will continue to be a polypharmacy market, new entrants can only help the space and more share of voice, more education. So interesting novel target, I think ways to be seen as these development programs advance. And we'll continue to be a polypharmacy market and we'll follow them as things go forward.

We'll take our next question from Jason Gerberry with Bank of America.

This is Bhavan on for Jason. Our first question is with regards to Zygel assets. Where are you at with enrollment for the Phase 3 Fragile X syndrome study? And any added clarity as to what assumptions shape your view on mid-2025 readout timing? And then the second commercial question, what are your assumptions for average revenue per WAKIX patient? Is that a meaningful tailwind for revenue growth in 2024 in your guidance or is growth mainly driven by volume?

I'll ask Kumar to comment on the ZYN002 Phase 3 RECONNECT trial. Very exciting opportunity for us and to provide kind of some more color on where we are there.

So we looked at the timeline as we've mentioned previously that we will. And based on the historical recruitment plan and the anticipated recruitment in this particular patient population, we arrived that we will complete enrollment in the first quarter of 2025 and the top line will be in mid-2025. Now that the asset is within the half, obviously, we will bring all the additional resources and the expertise not just from a clinical development perspective but also from the advocacy group perspective as well to try and accelerate the recruitment.

In terms of revenue per patient, Jeff Dierks, do you want to comment on that?

So in looking ahead in '24, question in terms of just price volume or average revenue per patient. As Sandip shared, we took a 7% price increase in the beginning of the year. And as with previous years, we would expect to capture most of that price increase. And as you're looking at our guidance right from 700 to 720, you could see that we're expecting 20 plus percent growth. So you could see that the vast majority of the growth we're expecting in '24 is driven by volume. We've talked a lot about the large remaining diagnosed patient opportunity, the meaningfully differentiated product profile for WAKIX. So we see significant opportunity and room for growth. But hopefully that provides a little bit of context and helps you think about price versus volume assumptions in the average revenue per patient at '24.

And if I could have one follow-up question. What does the appetite for share buybacks in 2024 look like relative to the $100 million in share buybacks that you guys did in 2023?

I think as we said, we're looking to take an opportunistic approach. And Sandip, do you want to comment further?

We're very pleased last year that we were able to do approximately $100 million share repurchase activities over the last couple of quarters. And I think it's really not a question of either or, we have the flexibility to do both. And with respect to business development, we obviously talked about our strategy there. And then in terms of the share buyback, again, we'd look at it more opportunistically and at the appropriate level we would certainly in a great cash position to be able to execute. And we have approximately $150 million of capacity still remaining.

We'll take our next question from Danielle Brill with Raymond James.

I was also hoping you could provide some more color on the assumptions that went into your ‘24 guidance, specifically around expectations for patient adds. It looks like you're expecting a slowdown in net patient adds each quarter. Are you just being conservative here or is growth starting to moderate? And then as a follow up, can you remind us what impact label expansion into the pediatric narcolepsy population will have on the overall TAM for WAKIX?

With regards to -- I think that in terms of revenue and the revenue guidance, Sandip do you want…

I think as we mentioned, we've taken a thoughtful and balanced approach in terms of providing guidance for the first year. We certainly look to provide an update as we go throughout the year. We're not in any way indicating, we see great momentum coming out of the fourth quarter and we expect that momentum to sort of carry through for the year. I mean, Jeff Dierks, do you want to comment at all in terms of just overall growth, what you're seeing?

And Danielle, in terms of looking at average patient growth and sort of the assumptions in the ‘24 guidance. I mean, as you've seen, we've seen demonstrated durable growth in an narcolepsy market and we've grown average patients every quarter since launch, even with availability. But within that durable growth, that growth has evolved every year. And entering our year five of our orphan launch, we're going to expect that growth to continue to evolve, but follow the previous year's cadence of the quarterly growth as we tap into that large diagnosed patient opportunity. So you'll see the traditional payer headwinds in the first quarter that impact all brands and specialty products. You'll see the traditional fewer patient visits associated with chronically managed conditions and diseases in Q3. And then typically in previous years, we expect to have the traditional tailwinds in the second and the fourth quarter with stronger prescription demand again. But I think though the takeaway is we're extremely pleased with what we're seeing, confident continued growth and we really believe that WAKIX is well positioned for future growth in ‘24.

And your next question on…

It was on pediatric TAM and how that expands the WAKIX opportunity…

I think Jeff can speak to that. I think obviously, positive signals from the agency on the importance of that indication in pediatric narcolepsy patients. So Jeff, what's the opportunity look like?

So I mean, Danielle, we estimate there's about 4,000 pediatric narcolepsy patients in the US. And although, it's not a large opportunity, it's an important one and it's a very underserved patient population with only one FDA approved treatment option being sodium oxybate being a Schedule III REMS product right now. And I think we're very excited about the potential if successful to bring a non-scheduled treatment option given what we've seen the impact of narcolepsy on these individuals' lives.

And Danielle, let me just also add. With regards to the pediatric narcolepsy, that sNDA. It's also important that those data, we're also pursuing pediatric exclusivity, which is obviously an important commercial opportunity with regards to an additional six months of regulatory exclusivity. So those data are one component of that along with the data that we’ll be generating in the Phase 3 Prader-Willi TEMPO study. So both of these components are important. And we are advancing both of these and making progress in terms of pediatric narcolepsy data through that submission and then the initiation of the Phase 3 trial in Prader-Willi syndrome. And both of those components are sort of what would be required as we pursue pediatric exclusivity and additional six months of protection.

We'll take our next question from Graig Suvannavejh with Mizuho.

This is Avantika on for Graig. I just have a question about the -- one about the Fragile X opportunity. I know you said that the time line has been pushed a little bit due to enrollment. But were there any changes in the trial design as there originally were, which also caused delays? And then also on the pediatric opportunity, I know you said it's a pretty small opportunity. But do you anticipate growing the WAKIX sales force at all if approved?

With regards to the Fragile X study, Kumar?

With Fragile X syndrome, the time lines were not pushed out with that. We had mentioned that we will evaluate the time lines once the asset is in house and we had an opportunity to evaluate the time lines. And based on the historical recruitment plan and the anticipated recruitment in this patient population, we arrived at completing the enrollment in the first quarter of 2025 with top line anticipated in wake of mid-2025. And there is no change in the study design.

And I would just add. I think that the opportunity is for Harmony, for us to put our resources towards driving the Phase 3 RECONNECT trial forward. With regards to the experience of the clinical development team, more capacity from an operational perspective and really engaging with the patient community through our patient advocacy efforts as well to drive that forward towards a significant market opportunity of 80,000 diagnosed patients in the US. Turning to pediatric narcolepsy, we keep here in sort of small market opportunity but an important one. And I think Jeff sort of alluded to this, an important one in terms of potential new non-scheduled treatment option for pediatric patients with narcolepsy rather than Schedule II stimulants. So we are looking forward to working with the agency towards that. And then with regards to the impact on the market opportunity, Jeff?

So in looking at the sales force coverage for pediatric narcolepsy, we believe that we're optimized for the narcolepsy opportunity with our existing sales force footprint. There will be some new prescribers that we’ll be adding to our target list if successful. But we believe that our current team that is very excited about the potential to bring this forward is optimized to be able to take on this new opportunity with these additional patients. And with the addition of a handful of healthcare professionals, there's a high overlap between adult narcolepsy prescribing and pediatric narcolepsy prescribing. So we believe we've got relationships established with a good portion of those prescribers but we are absolutely optimized with our team and if successful, very excited to bring this new indication forward.

And can I just squeeze in one more. For gross to net, I know you said that there will be headwinds in first quarter. But can you just quantify what you think it will be for the full year?

Sandip?

As I mentioned, typically in the first quarter across the industry, there are general headwinds from just higher copay obligations and insurance plans resets in the first quarter. So we'll see a couple of percentage points impact from that typically is what we've seen in the past in the first quarter, and that sort of improved as we go throughout the year generally.

Thank you. I am showing no further questions. I would now like to turn the call back to management for closing remarks.

Thank you, Brittany. And thanks everyone for joining our call today and for your interest in Harmony. As you heard from us this morning, our strong execution in 2023 and solid momentum going into this year positions Harmony well for continued growth in 2024. We look forward to providing updates as we execute on our growth strategy. Thank you, and have a great day.

This does conclude today's Harmony Biosciences fourth quarter and full year 2023 financial results conference call. You may now disconnect your line, and have a wonderful day.