Harmony Biosciences Q4 2025 Earnings Report

Harmony Biosciences EPS Results

• Actual EPS: $0.38
• Consensus EPS: $0.84
• Beat/Miss: Missed by -$0.46
• One Year Ago EPS: $0.85

Harmony Biosciences Revenue Results

• Actual Revenue: $243.78 million
• Expected Revenue: $240.04 million
• Beat/Miss: Beat by +$3.74 million
• YoY Revenue Growth: +21.10%

Harmony Biosciences Announcement Details

• Quarter: Q4 2025
• Date: 2/24/2026
• Time: Before Market Opens
• Conference Call Date: Tuesday, February 24, 2026
• Conference Call Time: 8:30AM ET

Harmony Biosciences (NASDAQ:HRMY) is a commercial‐stage biopharmaceutical company focused on developing and delivering therapies for people with rare neurological and endocrine diseases. Founded in 2017 and headquartered in Plymouth Meeting, Pennsylvania, Harmony Biosciences went public in 2020 and trades on the Nasdaq under the ticker HRMY. The company’s mission centers on identifying and advancing medicines that address critical unmet needs in patient populations underserved by existing treatments.

The company’s flagship product is WAKIX (pitolisant), the first and only histamine H3 receptor antagonist/inverse agonist approved by the U.S. Food and Drug Administration for the treatment of excessive daytime sleepiness and cataplexy in adult patients with narcolepsy. WAKIX was granted approval in August 2019 following pivotal Phase III clinical trials demonstrating its efficacy and tolerability profile. Harmony Biosciences has established a commercial infrastructure across the United States to support patient access, education, and ongoing research into expanded indications.

In addition to its marketed therapy, Harmony Biosciences maintains a clinical development program to evaluate pitolisant in other sleep disorders and cognitive conditions, leveraging its expertise in histaminergic modulation. The company collaborates with academic institutions, patient advocacy groups, and specialty pharmacies to facilitate real‐world data collection and to enhance support services for patients and healthcare providers. Harmony continues to explore strategic partnerships and licensing arrangements to extend its reach into international markets.

Harmony Biosciences is led by President and Chief Executive Officer Joseph P. Woody, whose leadership team brings together experience in specialty pharmaceuticals, regulatory affairs, and commercial operations. With a focus on patient‐centric innovation and long‐term value creation, Harmony Biosciences aims to address unmet needs in rare disease communities while expanding its pipeline and geographic footprint.

Harmony Biosciences Q4 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: WAKIX commercial momentum: Q4 net product revenue was $243.8M (FY2025 $868.5M), the franchise added ~400+ average patients for a third consecutive quarter, and management is guiding 2026 WAKIX net revenue to blockbuster range of $1.0B–$1.04B.
• Neutral Sentiment: IP and litigation update: Harmony has settled with 6 of 7 ANDA filers and says generic entry would be no earlier than March 2030 if pediatric exclusivity is granted, but a trial and potential appeals remain outstanding.
• Positive Sentiment: Pipeline and near-term catalysts: five ongoing Phase 3 registrational programs across CNS indications, Pitolisant GR NDA expected in Q2 2026 (PDUFA target Q1 2027), Pitolisant HD top-line planned for 2027 (PDUFA 2028), plus EPX-100 and an orexin‑2 agonist advancing toward readouts.
• Negative Sentiment: Rising spending and margin pressure: Q4 operating expenses rose to $136.7M (from $91.1M YoY) driven by R&D, commercialization and litigation costs, and non‑GAAP adjusted net income fell to $33.4M ($0.57/sh) versus prior quarter levels.
• Positive Sentiment: Strong balance sheet and cash generation: $882.5M in cash and investments and $348.2M cash from operations in 2025, which management says funds ongoing development, business development opportunities, and a $150M buyback capacity.

Presentation

[Operator]

I will now turn the call over to Matthew Beck from Astor Partners. Please go ahead.

[Matthew Beck, Investor Relations at Astor Partners]

Thank you, operator. Good morning, everyone, and thank you for joining us today as we review Harmony Biosciences' Fourth Quarter 2025 Financial Results and provide a business update. Before we start, I encourage everyone to go to the investor section of our website to find the materials that accompany our discussion today, including a reconciliation of our GAAP to non-GAAP financial measures. At this stage of our life cycle, we believe the non-GAAP financial results better represent the underlying business performance. Our speakers on today's call are Dr. Jeffrey Dayno, President and CEO, Adam Zaeske, Chief Commercial Officer, Dr. Kumar Budur, Chief Medical and Scientific Officer, and Sandeep Kapadia, Chief Financial and 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.

[Matthew Beck, Investor Relations at Astor Partners]

Our actual results may differ materially. We undertake no obligation to update these statements even as 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 our CEO, Dr. Jeffrey Dayno. Jeff?

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Thank you, Matt. Good morning, everyone, and thanks for joining our call today. I want to start off by recognizing the entire Harmony team for another outstanding quarter and a remarkable year in 2025. Our fourth quarter results reflect strong, sustained execution and have positioned us to achieve blockbuster status for WAKIX this year. In Q4, we delivered $243.8 million in net product revenue, up from $201.3 million in the same period last year, driven by continued strong demand for WAKIX based on its broad clinical utility and ongoing executional excellence by our commercial team. Q4 2025 marked the third consecutive quarter with approximately 400-plus average patient adds, the first time in franchise history. This quarter's net patient adds brings us to approximately 8,500 average patients on WAKIX.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

With 80,000 diagnosed patients with narcolepsy, there continues to be a large market opportunity to support strong growth. For full year 2025, WAKIX generated $868.5 million in net product revenue, representing strong year-over-year growth and extending to six consecutive years of revenue growth and profitability. Looking ahead to 2026, we are guiding WAKIX net revenue to blockbuster status of $1 billion-$1.04 billion for the first time in franchise history, underscoring the durability of the WAKIX brand and the strength of our commercial engine. On the IP front, we have made good progress toward the goal of securing the WAKIX franchise. We recently settled with three generic filers, resulting in us having settled with six of the seven ANDA filers.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Based on these settlements, generic entry would occur no sooner than March of 2030 if we are granted pediatric exclusivity, which we are on track to obtain. As for last week's trial, we remain confident in the strength of our IP and will continue to vigorously defend it as the legal process and trial continues. In addition to the strong growth of WAKIX, we are advancing the next generation pitolisant franchise. Pitolisant GR will extend the WAKIX franchise and our leadership in narcolepsy as a line extension of WAKIX with its broad clinical utility. We are on track for NDA submission in Q2 this year, with a target PDUFA date in Q1 2027. Pitolisant HD is designed to expand the pitolisant franchise into unique indications in orphan rare diseases, addressing unmet medical needs.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

We now have an opportunity to explore a new pitolisant formulation to pursue broader indications in CNS patient populations in which fatigue is a prominent symptom. This strategy is a mechanism-based approach, as fatigue is mediated through histamine circuits in the brain, and pitolisant works by upregulating histamine transmission in the brain, along with other neurotransmitters. This work is supported by newly licensed IP with patent protection until 2042, and we are excited for the opportunity to explore broader CNS indications with pitolisant. Kumar will provide more color on this opportunity later in the call. Our robust late-stage pipeline continues to advance, with five ongoing phase 3 registrational trials toward five distinct CNS indications, and we are making good progress. These trials set us up for multiple catalysts over the next few years and, if successful, meaningful long-term value creation.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Kumar will provide more details on the progress of our pipeline programs and the timing of these important catalysts during his R&D update. In summary, Harmony enters 2026 with powerful momentum, a clear path to blockbuster status for WAKIX in narcolepsy alone, record revenues and a large market opportunity that remains in narcolepsy for continued growth of WAKIX. A lifecycle management strategy that we are advancing to extend the success of WAKIX, expand next generation pitolisant into unique indications in orphan rare CNS disorders, along with our new opportunity to explore broader CNS indications with a new formulation of pitolisant, driven by a mechanism-based approach. A robust late-stage pipeline with five ongoing Phase 3 registrational trials towards five distinct CNS indications.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

All of this reinforces our belief that we have built something rare in this industry, a profitable, self-funding biotech company with a strong balance sheet, well-positioned to build out our pipeline and expand our commercial portfolio to drive long-term value creation. With that, I'll turn the call over to Adam Zaeske, our Chief Commercial Officer, for an update on our outstanding commercial performance. Adam?

[Adam Zaeske, EVP and Chief Commercial Officer at Harmony Biosciences]

Thank you, Jeff. 2025 marked a year of unprecedented and record-setting performance for WAKIX. That performance continued in the fourth quarter. In Q4 of 2025, WAKIX continued its remarkable trajectory with a third consecutive quarter of approximately 400 or more average patient adds. The first time this has been achieved in the history of the franchise. This level of sustained momentum speaks directly to the strength of the brand and the consistency of our execution. What's driving this performance is clear. WAKIX maintains a unique, highly differentiated position as the only non-scheduled treatment option, which continues to fuel broad clinical adoption. Brand awareness, perceived efficacy, tolerability, and stable payer coverage remain exceptionally strong. We've sharpened our commercial fundamentals from field deployment and call planning to refined messaging, targeted promotion, new payer wins, and better patient support processes that shorten time to dispense and boost conversion.

[Adam Zaeske, EVP and Chief Commercial Officer at Harmony Biosciences]

The compelling value proposition of WAKIX, combined with continued strategic adjustments and strong operational execution, are delivering results, giving us confidence heading into 2026. In addition, right now, we are expanding our field-based teams by almost 20% across our field sales, field reimbursement, and remote sales teams, and we've already made progress in hiring for these roles. This investment will increase our presence in the market and demonstrates confidence in our continued growth. We will launch a new online portal to enable easier and faster access for patients, and we're continuing to deploy process improvements to further improve time to dispense and success rate. We'll continue to look for opportunities for additional improvements and efficiencies moving forward. We're also extremely excited about the recent FDA approval of WAKIX for the treatment of cataplexy in pediatric patients six years of age and older with narcolepsy.

[Adam Zaeske, EVP and Chief Commercial Officer at Harmony Biosciences]

This approval further demonstrates the clinical value of WAKIX for pediatric patients who experience cataplexy and gives their healthcare providers the option of prescribing WAKIX to address excessive daytime sleepiness, cataplexy, or both in people six years of age and older living with narcolepsy. Our commercial teams were well prepared ahead of this approval with robust promotional strategy and began executing on those plans from the day of approval. With all of this momentum, we've announced full-year revenue guidance for WAKIX to achieve blockbuster status of between $1 billion and $1.04 billion in revenue in narcolepsy alone. Looking ahead, pitolisant GR and pitolisant HD give us the opportunity to extend and expand the franchise with differentiated formulations that address important unmet needs while fully leveraging the commercial engine we've built.

[Adam Zaeske, EVP and Chief Commercial Officer at Harmony Biosciences]

Early feedback from market research with healthcare providers and payers has been highly encouraging, and we're preparing the organization to drive the next phase of growth as these assets come to market. In short, our commercial performance has never been strong, execution is disciplined, and we have a clear path to sustained growth. Now, I'd like to turn the call over to our Chief Medical and Scientific Officer, Kumar Budur, to discuss the advancements in our clinical development programs. Kumar?

[Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences]

Thank you, Adam. Good morning, everyone, and thank you for joining us today. Q4 2025, significant clinical progress for Harmony, and we are entering 2026 with one of the most robust late-stage CNS pipelines in the industry. We now have five ongoing phase 3 registrational clinical trials across five distinct CNS indications, underscoring the breadth and depth of our development programs. I'll start with updates for our sleep-wake franchise. I'm pleased to highlight a new indication for WAKIX that the FDA approved on February thirteenth. The FDA approved WAKIX for cataplexy in patients six years of age and older. This is another important milestone for WAKIX, and it is now approved for both excessive daytime sleepiness and cataplexy in adults and children six years of age and older. This approval also advances our efforts towards achieving pediatric exclusivity for WAKIX.

[Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences]

which is an additional six months of regulatory exclusivity at the back end of the longest patent for WAKIX. The data from the ongoing phase III study in Prader-Willi syndrome, the TEMPO study, is the other requirement for pediatric exclusivity. We are on track for the top-line data from the TEMPO study in second half of this year. Across our next-gen pitolisant program, pitolisant GR continues to advance as a fast-to-market strategy after demonstrating bioequivalence to WAKIX in a pivotal bioequivalence study, and has the ability to initiate treatment at the therapeutic dose range at 17.8 mg, eliminating the need for titration, which is an important differentiation. We remain on track for an NDA submission in Q2 2026 and target PDUFA in Q1 2027.

[Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences]

Pitolisant HD, our enhanced formulation with an optimized PK profile and a higher dose, remains on track for top-line data in 2027 and PDUFA in 2028. The Phase 3 registrational clinical trials in narcolepsy and IH, that is the ONSTRIDE 1 and ONSTRIDE 2 studies, are ongoing. ONSTRIDE 1 is a prospective, placebo-controlled, parallel-arm, double-blind, randomized clinical trial comparing Pitolisant HD and placebo. This is an eight week study evaluating excessive daytime sleepiness via subjective and objective endpoints, that is ESS and MWT, and we are also evaluating cataplexy and fatigue in this study. ONSTRIDE 2 is also a prospective, placebo-controlled, parallel-arm, double-blind, randomized clinical trial comparing Pitolisant HD and placebo. This is an 8 eight week study evaluating symptoms of idiopathic hypersomnia via IHSS and sleep inertia via sleep inertia scale.

[Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences]

The sample size for each of these studies is approximately 200 patients. Both programs are pursuing differentiated labels: fatigue in narcolepsy and sleep inertia in idiopathic hypersomnia. Both GR and HD formulations have utility patents filed, extending and expanding the pitolisant franchise potentially into the 2040s. We are also very excited to announce the opportunity to explore broader CNS indications with a new formulation of pitolisant, with an issued patent until 2042. As we have discussed in the past, the histaminergic mechanism of action of pitolisant is uniquely positioned to address all three different dimensions of fatigue: physical, emotional, and cognition. We have already generated clinical data to support the utility of pitolisant to treat fatigue.

[Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences]

We plan to evaluate this new formulation for fatigue in broader indications, with fatigue in multiple sclerosis as the lead indication, and explore other opportunities such as post-stroke fatigue and fatigue in Parkinson's disease. Our current efforts are focused on formulation optimization and new modes of delivery and towards the phase 1 PK study. Beyond pitolisant, our orexin 2 receptor agonist, BP1.15205, is enrolling in our phase 1 clinical study. We are on track for phase 1 PK data in mid-2026. As we have previously shared, BP1.15205 has demonstrated compelling preclinical potency, selectivity, safety, and efficacy, positioning it as a potential best-in-class orexin 2 receptor agonist. Moving on to our epilepsy franchise, EPX-100 continues to advance in 2 global phase 3 registrational programs.

[Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences]

Enrollment is ongoing in both the Dravet syndrome and the Lennox-Gastaut syndrome programs, that is the ORCHEST study and the LIGHTHOUSE study, respectively. The top-line data is expected in first half of 2027 and PDUFA in 2028. We recently presented the data from the open label extension part of the Phase 3 study in Dravet syndrome at the AES meeting in December 2025, which supported a differentiated product profile for EPX-100. The effectiveness data in patients who had at least six months of exposure to EPX-100 showed clinically meaningful reduction in seizures, approximately 50% median reduction in seizures as measured by CMS-28. In addition, we saw at least 50% reduction in seizures in half of the patients.

[Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences]

EPX-100 was found to be generally well-tolerated, with no additional laboratory or special monitoring requirements, with some participants exposed to EPX-100 for more than two years and approaching three years. Finally, on behalf of Harmony, I would like to thank all the patients and their families who are participating in our clinical trials, as well as the clinical investigators and site personnel for their efforts and commitment in helping us to advance our development programs. I'll now turn the call over to our CFO, Sandip Kapadia, for an update on our financial performance. Sandip?

[Sandip Kapadia, CFO and Chief Administrative Officer at Harmony Biosciences]

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 2025 financial and operating results. Our financial performance is also shown on slides 15 through 17. We finished the year with great momentum across the business, delivering strong growth across several of our key metrics, positioning us well as we head into 2026. We delivered another year of double-digit top line growth as we reported net revenues above the top end of our previous guidance range. We continue to be a profitable, cash-generating company, funding the growth and advancement of our pipeline fully with the strength of our balance sheet.

[Sandip Kapadia, CFO and Chief Administrative Officer at Harmony Biosciences]

Our strong financial performance, combined with a solid balance sheet, including approximately $882.5 million in cash equivalents, and investments, positions us well as we continue to invest in the advancement of our robust late-stage pipeline and look for additional value-enhancing opportunities to further build out our pipeline and add to our commercial portfolio. We reported net revenues of $243.8 million, compared to $201.3 million in the prior year quarter, representing a growth of 21% and also our highest quarterly revenues to date. Performance in the quarter reflects the sustained strong underlying demand for WAKIX. We reported total operating expenses for the fourth quarter of $136.7 million, compared to $91.1 million for the same quarter in 2024.

[Sandip Kapadia, CFO and Chief Administrative Officer at Harmony Biosciences]

The growth in expenses, which were related to investments in our R&D to advance our late-stage pipeline, investments in the commercialization of WAKIX and narcolepsy, as well as ANDA litigation and settlement expenses during the fourth quarter of 2025. Non-GAAP adjusted net income for the fourth quarter of 2025 was $33.4 million, or $0.57 per diluted share, compared to $64.2 million, or $1.10 per diluted share in the prior quarter. We believe non-GAAP adjusted net income better reflects the underlying business performance. Please see our press release for a reconciliation of GAAP to non-GAAP results. We ended the fourth quarter with $882.5 million in cash equivalents, and investments.

[Sandip Kapadia, CFO and Chief Administrative Officer at Harmony Biosciences]

The balance reflects robust cash generation of $348.2 million from operations in 2025, providing us with the financial flexibility to execute on our growth strategy. Looking ahead to our expectations for 2026, as previously disclosed, we are reiterating our guidance for WAKIX net revenue of $1 billion-$1.04 billion. We believe this guidance reflects our strong expectations for 2026 and demonstrates that we are on track to achieving blockbuster potential for WAKIX in narcolepsy alone. As you think about phasing of revenues for the first quarter of 2026, we expect to see the typical seasonal dynamics that the industry as a whole experiences each year in Q1. This includes higher gross to net deductions due to insurance plans resets and higher copay obligations, along with potential for drawdown in trade inventories.

[Sandip Kapadia, CFO and Chief Administrative Officer at Harmony Biosciences]

With respect to expenses, we expect significant increases in investments in R&D as we advance our pipeline with five ongoing registrational phase III programs, along with plans for a sixth phase III study anticipated to start later this year. Finally, business development is a high priority, and our intention is to deploy capital to expand our pipeline and commercial portfolio. In summary, I'm pleased with our strong financial performance in 2025. We've once again delivered a year with strong top-line growth, maintained healthy operating margins while continuing to generate significant cash. This positions us well as we enter 2026 with a potential for significant value generation. With that, I'd like to turn the call back over to Jeff for his closing remarks. Jeff?

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Thank you, Sandeep. In closing, I'm incredibly proud of what the Harmony team accomplished in 2025, but that is behind us, and we are now focused on 2026 and excited for what is ahead. Growth of the WAKIX franchise, guiding WAKIX to blockbuster status in 2026. Extending the WAKIX franchise with Pitolisant GR's target PDUFA date in Q1 2027. Expanding the Pitolisant franchise with the advancement of the phase III trials with Pitolisant HD in unique orphan rare CNS indications. A new opportunity to explore broader CNS indications with newly licensed IP and a new formulation of Pitolisant. Advancing our robust late-stage pipeline with five ongoing phase III registrational trials toward five distinct CNS indications. It is because of these achievements that we continue to operate from a position of strength and drive significant momentum.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

This momentum reinforces our confidence that we have built something rare in this industry: a profitable, self-funding biotech company with a strong balance sheet, blockbuster commercial product, a pipeline positioned to deliver significant long-term value, and the capacity, experience, and commitment to generate even greater value through the pursuit of smart business development opportunities. Thank you. I will now turn the call back over to the operator for Q&A. Operator?

[Operator]

Thank you. At this time, if you would like to ask a question, please press star one on your telephone keypad. If you wish to remove yourself from the queue, you may do so by pressing star two. We remind you to please pick up your handset and please limit yourself to one question and one follow-up question. We'll take our first question from Peter Stavropoulos with Cantor Fitzgerald. Your line is now open. Please go ahead.

[Pete Stavropoulos, Analyst at Cantor Fitzgerald]

Hi, thank you for taking the question. I'm going to go to one of your earlier stage assets, EPX-100 for Dravet, and the clinical data disclosed at AES in December. Can you just comment on the baseline seizure rates and the baseline anti-seizure med use? You know, how do they sort of compare to the real-world patients, and how do you compare to patients in other Dravet clinical trials? With the interim OLE efficacy and safety data at hand for those that have at least six months of exposure, what's your view on the emerging benefit risk profile? How competitive do you believe the emerging profile is, and where do you see it fitting into the current landscape?

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Good morning, Pete. Thanks for your question, and I'll turn it over to Kumar to respond.

[Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences]

Hey, good morning, Pete. Thank you for the question. These patients who participated in our Dravet syndrome study had treatment-resistant seizures, basically about four anti-seizure methods. Their baseline seizures, I don't remember the exact number, what the baseline seizure was, but I can provide that information, but that was comparable to what we have seen in other studies as well. In terms of the value proposition, Pete, I mentioned on the call, the efficacy that we saw in this study. The effectiveness data showed that we had at least about approximately 50% median reduction in seizures, and we also saw 50% reduction in seizures in about 50% of these patients. What's important is to see this alongside the safety and tolerability profile.

[Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences]

We did not see significant nausea, vomiting, abdominal pain, diarrhea, that is commonly seen with other medicines, including suppression of appetite. In fact, the only GI AE of note was diarrhea, which was seen in about 2% of the patients. Liver function tests also remained normal, which is an issue with some of the approved drugs. EPX-100 doesn't require any special monitoring. The ease of use is also very important here. A liquid formulation, BID dosing regimen is much more better suited in this patient population for patients and caregivers, compared to some of the other drugs that are in development, which have a TID dosing regimen. Thank you, Pete.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Thanks, Kumar.

[Pete Stavropoulos, Analyst at Cantor Fitzgerald]

1 follow-up, if okay. a question on the orexin 2.

[Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences]

Go ahead, Pete.

[Pete Stavropoulos, Analyst at Cantor Fitzgerald]

Can you hear me?

[Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences]

Yes.

[Pete Stavropoulos, Analyst at Cantor Fitzgerald]

Yeah. For the orexin 2 receptor agonist, you know, you're going to have data midyear-ish. What's the PK, PD, and safety bar that you look for in the phase 1 to move this program into a later stage studies? Where do you sort of see your orexin 2 receptor agonist fitting into the emerging landscape?

[Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences]

We are dosing subjects right now in our phase 1 PK study. By mid-2026, we will see clinical PK data, safety, and tolerability data. We don't anticipate to see anything different than what is already seen with other orexin receptor agonists in this class. We are making progress on advancing this to the next stage of development, which is the sleep-deprived healthy volunteer study, we plan to commence in the second half of this year. In terms of how it fits with the competitive landscape, look, Takeda is ahead. They have submitted an NDA, the others are in phase 1 and phase 2 studies.

[Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences]

Our goal is to really accelerate the clinical development by leveraging some of the learnings, that we have from other development programs that are ahead of us without compromising the quality of data.

[Pete Stavropoulos, Analyst at Cantor Fitzgerald]

All right, thank you, and thank you for taking my questions, and congrats on the quarter.

[Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences]

Thank you, Pete.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Thanks, Pete.

[Operator]

Thank you. We'll move next to David Amsellem with Piper Sandler. Your line is now open.

[David Amsellem, Analyst at Piper Sandler]

Thanks. two for me. One on the orexin, just wanted to clarify, are we going to get multiple ascending dose data in the, in the second half in sleep-deprived healthies? How are you thinking about indications here, given that you have a number of companies that are looking at narcolepsy and IH? Are you thinking beyond narcolepsy and IH, or, is that going to be your core focus for the orexin program? That's number one.

[David Amsellem, Analyst at Piper Sandler]

Number two is sort of a hypothetical here, but just to the extent that, with the, with the patent case, if you were to not prevail, and there was an earlier than expected loss of exclusivity, how do you think about cash conservation, and ultimately, trying to bridge from the LOE to your next set of development stage assets and commercialization of them? Thanks.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Good morning, David. Thanks for your questions. With regards to the orexin two agonist, just to comment. In terms of, you know, target indications. I think, you know, we're contemplating broadly, you know, in addition to the primary targets, you know, in terms of our overall orexin two program, you know, other opportunities beyond, you know, primary disorders of hypersomnia. I think, you know, that is part of an overall development strategy. With regards to the emerging data, first, I just want to clarify. In terms of the PK profile, you know, the, in healthy volunteers, single dose study, you know, we are looking to confirm the expected profile of, you know, once-daily dosing with regards to the initial data that we'll read out. Kumar, multiply ascending dose on sleep-deprived, healthy volunteers?

[Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences]

Yeah. The multiple ascending dose study, David, will follow the single ascending dose study. In parallel, we plan to conduct a sleep-deprived healthy volunteer study. In terms of the indications, as Jeff was mentioning, we are keeping an open eye and looking at everything, not just central disorders of hypersomnia, but other potential neuropsychiatric disorders, including several aspects of cognition, mood, and other things. We will pursue single ascending, multiple ascending dose study because that's something that we need to do regardless. Then we will evaluate the competitive landscape and decide which way to go.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

David, with regards to your second question, with regards to the ongoing litigation, I think as you're aware, I think it's premature, and I'm not going to speculate on the future outcome of the trial. I point you to the recent progress that we made in settling with three of the generic filers. That currently brings the total number of settlements to six of the seven ANDA filers. We feel good about how that positions us going forward. Based on these settlements, generic entry stands at March of 2030 if we're granted pediatric exclusivity, which we're on track to obtain. With regards to our cash position and how we stand on funding?

[Sandip Kapadia, CFO and Chief Administrative Officer at Harmony Biosciences]

Look, I think we're in a very strong cash position. You saw, we generated close to $348 million cash last year, where we have $880 million cash on the balance sheet. I think we're really well-positioned to continue to drive innovation, try to build our pipeline, and be able to fund many of all the programs that we spoke about today, generally. We continue to have a solid position as a company.

[Operator]

Thank you. We'll move next to Jay Olson with Oppenheimer.

[Jay Olson, Analyst at Oppenheimer]

Oh, hey, congrats on the progress, and thank you for taking the questions. Can you talk about any gating factors to filing the pitolisant GR NDA next quarter? Separately, can you just talk about the pace of enrollment in your phase 3 narcolepsy and IH studies for pitolisant HD, considering, you've got some competitors also enrolling their studies? Thank you.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Good morning, Jay. Thanks for your question. We're excited about Pitolisant GR. You know, it's sort of right around the corner in terms of NDA submission. Kumar, any gating items to that, or how are things looking?

[Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences]

Yeah, things are looking good. Good morning, Jay. We are on track to submit the pitolisant GR NDA in second quarter of this year. As always, the final things that are needed for NDA submission, that's what we are working on. We are on target for PDUFA in Q1 of 2027. In terms of your question regarding the enrollment for pitolisant HD in narcolepsy and idiopathic hypersomnia studies, you're absolutely right, Jay. There is competition for patients. We are very much aware of it. We also have been in this field for a long time. We know the sites, we know the investigators. We have conducted studies in this patient population. We are confident with our current timeline, which is top line in 2027, and PDUFA in 2028.

[Jay Olson, Analyst at Oppenheimer]

Yep. Thanks, Kumar.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

With regards to Pitolisant GR, I just want Adam to, you know, comment on how he sees the opportunity and how the commercial team is preparing for that.

[Adam Zaeske, EVP and Chief Commercial Officer at Harmony Biosciences]

Great. Thanks, Jeff. Preparation is definitely underway, looking for PDUFA in 1Q 2027. That'll have us launching several years before LOE with an opportunity to extend the WAKIX franchise. This is a fast-to-market line extension strategy that provides a GR coating to pitolisant and allows patients to start right at a therapeutic dose. Another layer of additional protection for a product that's already perceived as highly well-tolerated, and the addition of starting at a therapeutic dose, which has hopefully the benefit of securing faster patient outcomes. The strategy here is really focused on new patients that would have been prescribed WAKIX, as well as previous patients, that we have the ability to recontact because we secure consent right up front anytime there's a patient referred for WAKIX therapy.

[Adam Zaeske, EVP and Chief Commercial Officer at Harmony Biosciences]

Both of those are tremendous opportunities, and we look forward to executing on that launch beginning in 1Q 2027 next year.

[Jay Olson, Analyst at Oppenheimer]

Thank you, Adam.

[Operator]

Thank you. We'll take our next question from Graig Suvannavejh with Mizuho. Your line is now open.

[Analyst at Mizuho]

Hi, everyone. This is Ryan on for Greg today. A couple of quick questions for me. I'm wondering if you could comment on the increase in SG&A that we saw in the fourth quarter, the dynamics behind that, and then any updates that you might have on EPX-200, and when we might hear more about that program. Thank you.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Okay, Sandip?

[Sandip Kapadia, CFO and Chief Administrative Officer at Harmony Biosciences]

Yeah, just regarding the expenses in the fourth quarter, I mean, as I mentioned on the call, I mean, we did see an increase in expenses, largely driven by the R&D investments as we start up our phase threes for both IH and narcolepsy, in the HD program. You know, continued costs in terms of investments for WAKIX in narcolepsy commercialization there. I also mentioned that we did have a hand on litigation and settlement expenses in the fourth quarter, so that the team could be prepared for the trial, which happened a few days ago as well. Again, those are the key drivers for our expenses.

[Sandip Kapadia, CFO and Chief Administrative Officer at Harmony Biosciences]

As I mentioned, going forward, I think the key thing to note in terms of expenses is as we'll have five registrational studies ongoing this year and potentially six months planned for later this year, we will see some increases also in the R&D expenses as we go into 2026.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Thanks, Sandeep. Kumar?

[Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences]

Hey, Ryan. Good morning. Regarding liquid lorcaserin, which is EPX-200, we are doing some pre-IND-related work right now. Ryan, as you know, lorcaserin is more selective for 5-HT2C, and that this drug probably has one of the largest safety and tolerability database out there, including a long-term cardiovascular outcome study. Also, there is a lot of efficacy data in several DEEs with this compound. Our goal is to leverage all of the data that is already available and pursue an accelerated development program and hopefully bring a new medication to patients with Developmental and Epileptic Encephalopathies.

[Analyst at Mizuho]

Thanks, Kumar.

[Operator]

Thank you. We'll go next to Danielle Brill with Truist Securities. Your line is now open.

[Analyst at Truist Securities]

Hey, guys. This is Alec on for Danielle. Thanks for the question. two little detailed questions.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Yeah.

[Analyst at Truist Securities]

One follow-up on Jay's question on ONSTRIDE 1 and 2. Have those begun enrolling patients? Just we haven't seen any in indication in ClinicalTrials.gov. On the OpEx expenditure, you mentioned the impact of some of the settlements and litigation. Was that primarily in the General and Administrative line item? Just kind of curious how that run rate we should expect moving forward. Thanks so much.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Kumar?

[Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences]

Good morning, Alex. ONSTRIDE 1 and 2 studies. As we had mentioned in the past, we started initiating sites towards the end of last year, and it will be posted on ClinicalTrials.gov, typically within 21 to 30 days after the first subject is enrolled. We are at different stages of site initiation, site activation. Sites are getting prepared to enroll the patients.

[Sandip Kapadia, CFO and Chief Administrative Officer at Harmony Biosciences]

Regarding the expenses, most of them, they were all under G&A in terms of the end of litigation and settlement expenses. Some of it tends to be one-time expenses, and some will continue as we continue with the litigation process.

[Analyst at Truist Securities]

Great. Thanks so much.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Thanks, Alex.

[Operator]

Thank you. We'll move next to Corinne Johnson with Goldman Sachs. Your line is now open.

[Corinne Johnson, Analyst at Goldman Sachs]

Thanks. Good morning. Too much about the details of ongoing litigation, you could help us understand kind of the timeline for decisions that are expected next, what process you kind of could anticipate for appeal for a situation like this, and also kind of remind us the regulatory exclusivity timelines that you have. I know you talked about the litigation or the settlements you have, kind of with six of seven of these other generic manufacturers, can you clarify what the impact this litigation might have on potentially, like, acceleration clauses in those settlements? I think those are pretty standard, not sure if they're included here. Thanks.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Yeah, Corinne, thanks for your question. With regards to, you know, the timing of the judge issuing a ruling. You know, it's really hard to know and can't really speculate. You know, this is an ongoing legal process, and it's hard to know, you know, when that will complete and, you know, come to final decision. As a reminder, you know, there is in the meantime, there is a stay, you know, that's in place that extends to February of 2027. Based on the outcome of the trial, obviously an appeals process is available to both sides. I think we know that the litigation process as well as the appeals process, you know, takes time.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

You know, with that, while this was happening, again, I think pointing back to the progress we've made, you know, on the settlements in terms of the six of the aeven generic filers, being settled, we feel that, you know, positions us well going forward, you know, with regards to the overall process. In the meantime, you know, there are other things going on with regards to, as we just spoke to, you know, Pitolisant GR in extending, you know, the franchise. You know, that's, we remain, you know, with regards to last week's trial, you know, we remain confident in the strength of the IP, and we will continue to vigorously defend it, you know, as, the legal process, plays out, you know, after the trial.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Kumar, in terms of regulatory exclusivities. In terms of our regulatory exclusivities of, you know, where we are with regards to, I mean, ODE, with regards to EDS, you know, takes us to March of 26, and for cataplexy to October of 27.

[Corinne Johnson, Analyst at Goldman Sachs]

Thank you.

[Adam Zaeske, EVP and Chief Commercial Officer at Harmony Biosciences]

August twenty-fifth.

[Operator]

Thank you. We'll take our next question from Patrick Trucchio with H.C. Wainwright. Please go ahead.

[Patrick Trucchio, Managing Director of Equity Research at H.C. Wainwright]

Hi, good morning. Just a couple of clarification questions and then a follow-up. First, I think you reiterated 2026 WAKIX guidance of $1 billion-$1.04 billion. What level of average patient growth is embedded in that range? How much incremental contribution do you expect from the newly approved pediatric cataplexy indication in 2026?

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Good morning, Patrick. Thanks for your question. Adam, what.

[Adam Zaeske, EVP and Chief Commercial Officer at Harmony Biosciences]

Yeah.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

the patient supporting that?

[Adam Zaeske, EVP and Chief Commercial Officer at Harmony Biosciences]

Yeah. Thanks for the question. For 2026 guidance, you know, exceeding basically $1 billion or blockbuster status, the underlying patient growth is consistent with what we've seen this year. We expect that momentum to continue. We're really excited to see the third consecutive quarter of, you know, more than 400 patient adds in a quarter. We've never seen that before in the brand. We believe that's a strong foundation and momentum carrying us into 2026, and we expect that to continue. You're going to see the regular and normal seasonality that you're going to, that we've seen over the last several years. You know, Q1 tends to be a little bit slower as the, you know, start of the calendar year with payer resets and what have you.

[Adam Zaeske, EVP and Chief Commercial Officer at Harmony Biosciences]

We expect that seasonality to continue, but the underlying sort of average performance, we'd expect to continue the momentum we saw in 2025. Hopefully that covers the question.

[Patrick Trucchio, Managing Director of Equity Research at H.C. Wainwright]

Yeah. That's helpful. Just as it regards the broader CNS strategy of MS fatigue, I'm wondering, first, can you elaborate on what existing clinical data supports pitolisant's efficacy in fatigue? What is the development timeline to the phase 1 PK study?

[Adam Zaeske, EVP and Chief Commercial Officer at Harmony Biosciences]

Hey, good morning, Patrick. Regarding this new formulation, this is something we are very excited about. It's a new formulation with an issued patent until 2042. We have mentioned in the past about our interest to pursue fatigue based on the histaminergic mechanism of action. We have also said that fatigue is not a unidimensional construct, it's a multidimensional construct with physical, somatic, and cognition symptoms, and how pitolisant, with its unique mechanism of action, working at tuberomammillary nucleus and the downstream effects on serotonin and norepinephrine, is uniquely positioned to treat fatigue. To your question about clinical data, Patrick, we actually showed the efficacy data in fatigue with pitolisant in our myotonic dystrophy study, where we saw clinically meaningful improvement in symptoms of fatigue, and we also saw dose response.

[Adam Zaeske, EVP and Chief Commercial Officer at Harmony Biosciences]

Similarly, we also saw clinical efficacy data in fatigue in patients with residual excessive daytime sleepiness with OSA. Armed with all of these data points, we plan to pursue broader CNS indications, where fatigue is a prominent symptom, and we have identified fatigue in MS as a lead indication because it's very well characterized, very well known, and about 80% of patients with MS have fatigue, with more than 50% having clinically significant fatigue. In terms of where we are with the development program, right now, the focus is on formulation optimization and looking at potentially other modes of delivery and prepare for a PK study, clinical PK study. That's where we are. Thank you.

[Patrick Trucchio, Managing Director of Equity Research at H.C. Wainwright]

Great. Thanks so much.

[Adam Zaeske, EVP and Chief Commercial Officer at Harmony Biosciences]

If I could just jump in, I neglected to answer the second part of your question around the pediatric.

[Patrick Trucchio, Managing Director of Equity Research at H.C. Wainwright]

Okay.

[Adam Zaeske, EVP and Chief Commercial Officer at Harmony Biosciences]

cataplexy opportunity. Just a quick couple of words on that. We're really excited about the approval of pediatric cataplexy. We now have approval for EDS and cataplexy in both adult and pediatric populations, basically anyone over six years of age. The pediatric patient population represents about 5% of the total narcolepsy population, just to give you an idea around scale of the opportunity. Really, we see this as, look, this is a, this is an important addition to the label. It provides greater flexibility for healthcare providers in their ability to treat these patients. It's important new information that we will educate those healthcare providers on. It, I think, reinforces WAKIX as an appropriate treatment for Peds, as well as having just broad clinical utility across almost all patients with narcolepsy.

[Adam Zaeske, EVP and Chief Commercial Officer at Harmony Biosciences]

Our teams were really well prepared ahead of the approval. As I mentioned, we had a robust promotional and execution strategy ready to go, and we began executing on those plans really from the day of approval. Thank you for the question.

[Patrick Trucchio, Managing Director of Equity Research at H.C. Wainwright]

Terrific. Thank you so much.

[Operator]

Thank you. We'll go next to Jason Gerberry with Bank of America. Please go ahead.

[Bhavin Patel, Analyst at Bank of America]

Hey, guys. This is Bhavin Patel on for Jason Gerberry. Just a couple questions for us. The first is, I know you guys mentioned expanding the field sales and reimbursement teams in 2026. Maybe if you can just help us understand how much of this investment is dedicated to the core narcolepsy market versus preparing for new launches like Pitolisant GR in the future. The second question is with regards to the DD as a capital allocation priority versus share repurchases or other things, how you're planning to diversify beyond the pitolisant franchise ahead of an important IP outcome providing clarity on the sole commercial asset. Thank you.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Yeah, I didn't catch the first part of the question, if you could repeat that.

[Adam Zaeske, EVP and Chief Commercial Officer at Harmony Biosciences]

I did.

[Bhavin Patel, Analyst at Bank of America]

Yeah.

[Adam Zaeske, EVP and Chief Commercial Officer at Harmony Biosciences]

Jeff, I did the first-.

[Bhavin Patel, Analyst at Bank of America]

Yeah. You know. Yeah, go ahead.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Okay, Adam. Go ahead.

[Adam Zaeske, EVP and Chief Commercial Officer at Harmony Biosciences]

Yeah, the first part of the question was around the expansion. You know, what does that look like, and how much of that is related to core? Basically growing WAKIX versus preparing for GR. I mean, the short answer on that last piece is 100% of the investment expansion is around continuing to grow WAKIX today. You know, our plans for how we will launch GR will take form kind of as we progress through the calendar year this year and approach that PDUFA date in 1Q27. I'll remind that, you know, we were really pleased with the performance we saw in 2025, really record-setting performance. That was based on continuing to tweak some of the fundamentals around our sales execution, marketing, promotional mix, and messaging, adding some payer wins and supporting patients.

[Adam Zaeske, EVP and Chief Commercial Officer at Harmony Biosciences]

As we enter 2026, we triggered an expansion of our field-based teams. That's what you were asking about. Overall, it's about a 20% increase in total field-based personnel. We see that as a really significant and meaningful increase in our share of voice. Also gives us the opportunity to rebalance territories that you want to do about every 18 months to two years. With our field sales teams, we're seeing that expansion more than 10%, field reimbursement, more than 50%, our remote sales teams, more than 10%. It's really meaningful, and we're excited about that opportunity. We've posted those roles. We're already in the process of hiring. We've already identified several of those candidates. We expect those folks to be in place by the end of this quarter. That's our plan. Thanks for the question.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Great. Thanks, Adam. Yeah, thanks, Adam. With regard to the second question on business development, you know, business development, you know, remains a high priority for us, obviously, you know, with a very strong balance sheet, and we want to deploy that capital and, you know, invest in the business. As we said, you know, the sweet spot, the focus continues to be orphan rare CNS opportunities, late-stage development, as well as commercial on-market. We have the capacity to do that. Obviously, we have a strong commercial engine. We'd like to build out, you know, the commercial portfolio. Dedicated business development team, and we're also, you know, looking, and we've said this before, you know, adjacencies, broader CNS indications.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Obviously, we shared today a new opportunity that we're very excited about based on newly licensed IP, with a new formulation of pitolisant, where we see a significant opportunity around fatigue and in broader CNS populations. We are focused and committed to those efforts, deploy our capital towards business development. Sandip, any thoughts on capacity?

[Sandip Kapadia, CFO and Chief Administrative Officer at Harmony Biosciences]

Yeah, look, I think, we're in a very strong position. We have over $880 million in cash on the balance sheet as of last quarter. Just to your question, I mean, not only obviously we're looking at business development, but of course, we also have $150 million capacity on the share buyback. We're always looking at opportunities, to drive value for shareholders, and that's something that, you know, we think we have the optionality as a company and to move forward there.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Very good. Thanks, Sandip. Yep, thank you.

[Operator]

Thank you. We'll go next to Soyun Shin with UBS. Please go ahead.

[Soyun Shin, Analyst at UBS]

Good morning. Thank you for taking my question, and congrats on the great year. I have two questions, if I may. First, things like the settlement for generic entry with the three additional and the filers are now four months early, March 2030, if pediatric exclusivity is granted from the trial settlement agreement of July 2030. Just wanted to check if I'm understanding it correctly. Does it mean without the pediatric exclusivity, the generic entry would start no earlier than September 2029 now? My second question is on Prader-Willi syndrome indication for WAKIX. The phase 3 reading out second half of this year, potential PDUFA in 2028. Here, I was wondering, what are you envisioning opportunities from the PWS?

[Soyun Shin, Analyst at UBS]

It would support the pediatric exclusivity for WAKIX and delay generic entry too, but on just the PWS indication itself, the runway would just be about two years from launch if approved. Are you thinking of trying the PWS with the pitolisant HD as well?

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Soyun Shin, thanks for your questions. With regards to your first one about the timing of the settlements, you are correct in terms of without the pediatric exclusivity, market entry would be September 2029. We are, you know, we are on track, making very good progress towards pediatric exclusivity, which should take it to March of 2030. One of the important components of that, obviously, after the Peds narcolepsy data, is the Prader-Willi program, both for potential indication, you know, the larger market opportunity, I think, as you're aware, is the six months extension with the pediatric exclusivity. Kumar, further thoughts on that?

[Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences]

Good morning, Soyun. With the PWS in the U.S. alone, there are approximately 15,000 patients with Prader-Willi syndrome. About half of these patients have significant excessive daytime sleepiness, for which there are no drugs approved. If we are successful with this study, we will go for an indication, really addressing high unmet need in this patient population. In terms of Pitolisant HD being a potential option to pursue PWS, that's not how we are thinking right now, but that option is always open to us. Thank you.

[Soyun Shin, Analyst at UBS]

I see. Thank you.

[Operator]

Thank you. We'll take our next question from David Huang with Deutsche Bank. Your line is now open.

[David Huang, Equity Analyst at Deutsche Bank]

Hi. Good morning. Thanks for taking my questions. Maybe on the new pitolisant formulation, could you talk a little bit about what characteristics and profile you expect to see with that product? How is it, you know, different from, let's say, Pitolisant HD? Are there characteristics that lend itself to MS and related conditions? And then maybe a second question just around the IP estate for some of these life cycle management products. If you just summarize again for us, the IP that you either currently have or expect to obtain for Pitolisant GR, HD, and then the new formulation. Thank you.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Good morning. On the new opportunity?

[Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences]

Yeah. Hey, good morning, David. Thanks for the question. Regarding the new formulation, as we evaluated this opportunity, there might be some potential options for us with this new formulation that will that could potentially differentiate itself in terms of the PK parameters, that probably will lend itself better for the treatment of fatigue in larger indications. Once we complete the human PK study, that's when we will get to know how exactly this will play out in humans, and that will help us determine the next step. For now, we are really excited about this particular formulation because as I mentioned earlier, to the other question, this is a very unique opportunity for us to pursue fatigue in broader CNS indication.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

David, in terms of your second question about the IP estate, just briefly as a reminder, pitolisant GR and pitolisant HD, utility patents filed out to 2044. This new formulation of pitolisant, the opportunity there is actually an issued patent that we have a license to out to 2042. Formulation work continues on. As Kumar mentioned, the potential of other modes of administration, looking at, you know, the potential, some of these patient populations where there's swallowing dysfunction and other methods of delivery, but an issued patent out to 2042.

[Operator]

Thank you. We'll take our last question from Ami Fadia with Needham & Company. Your line is now open.

[Poorna Kannan, Biotech Equity Research Associate at Needham and Company]

Hi, this is Poorna in for Ami. Thank you for taking our question. Are there any recent updates for the enrollment from the ARGUS and the LIGHTHOUSE studies? Just in case I missed this, what are the targets for the recent sales force expansion? When do you see that impact coming through? Thank you.

[Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences]

Hey. Good morning, Poorna. ARGUS and LIGHTHOUSE Study, they continue to enroll, and we continue to make progress. We are on track for top-line data in first half of 2027 and PDUFA in 2028.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

The second question, just to clarify, the...

[Poorna Kannan, Biotech Equity Research Associate at Needham and Company]

Just want to understand, when do you see the impact from the sales force expansion coming through?

[Adam Zaeske, EVP and Chief Commercial Officer at Harmony Biosciences]

Yeah, and thank you, Ami. Yeah, there was a question around the targets as well.

[Poorna Kannan, Biotech Equity Research Associate at Needham and Company]

Yes.

[Adam Zaeske, EVP and Chief Commercial Officer at Harmony Biosciences]

We did add some targets, but let's say it was about 5%, so not a huge add. It's really improving our share of voice and rebound from territories targeted at the existing target base that we've been targeting for some time. When would we expect to see that impact? Obviously, as I mentioned, we'd like to get those folks on board and in place by, you know, by the end of this quarter. From the impact standpoint, I guess you would expect to see the impact from that point forward.

[Poorna Kannan, Biotech Equity Research Associate at Needham and Company]

Thanks.

[Operator]

Thank you. I'm showing no further questions. I would now like to turn the call back over for any closing remarks.

[Jeffrey M. Dayno, President and CEO at Harmony Biosciences]

Thank you, operator. Thanks, everyone, for joining our call this morning, for your interest in Harmony Biosciences, and have a great rest of your day. Thank you.

[Operator]

This does conclude today's Harmony Biosciences Fourth Quarter and Full Year 2025 Financial Results Conference Call. You may now disconnect your line and have a wonderful day.

Participants

Executives

• Adam Zaeske, EVP and Chief Commercial Officer
• Jeffrey M. Dayno, President and CEO
• Kumar Budur, Chief Medical and Scientific Officer
• Sandip Kapadia, CFO and Chief Administrative Officer

Analysts

• Bhavin Patel, Analyst at Bank of America
• Corinne Johnson, Analyst at Goldman Sachs
• David Amsellem, Analyst at Piper Sandler
• David Huang, Equity Analyst at Deutsche Bank
• Jay Olson, Analyst at Oppenheimer
• Matthew Beck, Investor Relations at Astor Partners
• Patrick Trucchio, Managing Director of Equity Research at H.C. Wainwright
• Pete Stavropoulos, Analyst at Cantor Fitzgerald
• Poorna Kannan, Biotech Equity Research Associate at Needham and Company
• Soyun Shin, Analyst at UBS
• Analyst at Mizuho
• Analyst at Truist Securities