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Please stand by. Your meeting is about to begin. Good morning. My name is Nikki, and I will be your conference operator today. At this time, I would like to welcome everyone to Harmony Biosciences' third quarter 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. If you would like to ask a question at that time, please press Star 1 on your telephone keypad. Please be advised that today's conference is being recorded. Lastly, if you should require operator assistance, please press Star 0. I will now turn the call over to Brennan Doyle, 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' third quarter 2026 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 today's discussion. Our speakers on today's call are Dr. Jeffrey Dayno, President and CEO, Peter Anastasiou, Senior Executive Vice President, Chief Operating Officer and incoming President and CEO, Adam Zaeske, Chief Commercial Officer, Dr. Kumar Budur, Chief Medical and Scientific Officer, Steve Mollichella, Interim Principal Financial 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 risk 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 our CEO, Dr. Jeffrey Dayno. Jeff.

Thank you, Brennan. Good morning, everyone, and thank you for joining our call today. Before I get into the quarter, I first want to say a few words about the CEO transition we announced last month. I will be stepping down at the end of the year, and Peter Anastasiou, our Senior Executive Vice President and Chief Operating Officer, will succeed me as President and Chief Executive Officer, effective January 1, 2027. I am confident that Harmony is in very good hands with Peter, and you will hear from him next. The main themes regarding the CEO transition are continuity, strength, and growth. This leadership transition does not signal any change in our overall business or our strategic priorities. We are doing this from a position of strength and executing a well-coordinated plan. Harmony continues to be a growth story and during Q3, We move that story forward in each of our four priorities of value creation. Continue to grow WACICS in an evolving market, advancing a novel and robust clinical stage pipeline, transact on strategic business development deals, and protect the Petolitan franchise. I will provide some more color on our first two strategic priorities of value creation, and then turn it over to Peter to expand on our other two strategic priorities. The key highlights that I want you to take away from today's call are sustained patient demand-driven growth for AWAKENs in its seventh year on the market, keeping us firmly on track to exceed $1 billion in net revenue this year, and preliminary multiple ascending dose data for our orexin 2 agonist, BP205, that further strengthened its emerging best-in-class profile. First, growing the WACIX franchise. In the third quarter, WACIX delivered $269 million in net revenue with 400 net patient ads, resulting in approximately 9,350 average patients on WACIX in the quarter. For the first time in company history, we expect to exceed $1 billion in revenue per WACIX this year. We want to recognize our commercial team for their executional excellence, and Adam will take you through our commercial performance in more detail later in the call. Our second strategic priority is advancing our novel clinical stage pipeline. The strength and durability of the Pitocin franchise gives us the flexibility to fund our pipeline, creating new growth drivers for the company. The centerpiece of our pipeline is BP205, and we continue to have firm conviction in its best-in-class potential. Today, we announce preliminary results from the multiple ascending dose portion of our Phase 1 study for BP205. After 14 days of once-daily dosing, The safety, tolerability, and PK profile was consistent with what we saw in the single ascending dose study, giving us confidence in the emerging best-in-class profile of BP205. We initiated a study in sleep-deprived healthy volunteers in the third quarter, with data expected in the first quarter of 2027. And Phase II studies across multiple CNS indications are planned to initiate in mid-2027. There is a clear line of sight to the multiple data catalysts for BP205, and they are right around the corner. Kumar will provide more color on BP205 and the rest of our pipeline programs during his R&D update. Peter will now walk you through our two other value creation priorities related to business development and protecting the Petolitan franchise. Peter?

Thank you, Jeff, and good morning, everyone. First, I want to thank Jeff for his leadership and for everything he has done for Harmony over the last nine years. WAKIX is on track to exceed a billion in net revenues this year. We have a novel pipeline led by BP 205, and we have a strong balance sheet to fund our business development efforts. That is the foundation I get to build on, and I am honored to become Harmony's next CEO. Our ambition is to build harmony into an enduring, leading CNS company with multiple products across multiple franchises. And our strategic priorities will enable us to achieve this ambition. You heard Jeff speak to our first two strategic priorities regarding our strength in the WakeX business and the advancement of our pipeline. Our third strategic priority is transacting on business development. With over $1 billion on our balance sheet, we have both the capacity and the conviction to execute on meaningful transactions. We are pursuing assets that can add near-term revenues to support our self-funded model and assets that can continue to drive long-term value creation. Our fourth strategic priority is protecting the Pitollasen franchise. We have settled with six of the seven antifilers and our multi-layered IP strategy across active legal proceedings reinforces our confidence in weight exclusivity to March 2030, inclusive of six months of pediatric exclusivity. In summary, Harmony is a growth story, and we are executing on all four strategic priorities. To tell you more about our first strategic priority of growing the WAKIX franchise, I'll turn it over to our Chief Commercial Officer, Adam Zaeske. Adam?

Thank you, Peter, and good morning, everyone. We continue to see extremely strong demand-driven growth for WAKIX this quarter. WAKIX achieved estimated average patients of 9,350, An increase of 400 patients in the quarter. WAKIX has now demonstrated a meaningful acceleration in growth in year seven on the market, with 400 net patient additions in five of the last six quarters. Prior to 2025, WAKIX had achieved 400 net patient additions only twice in the history of the brand. As a result, WAKIX delivered $269 million in net product revenue which was right in line with our internal expectation. And we remain on track to achieve our full year guidance of 1 to 1.04 billion. The drivers of this growth and performance are clear. WAKIX holds a unique position as the only non-scheduled treatment option for excessive daytime sleepiness and cataplexy in adults and pediatric patients with narcolepsy. With more than seven years of clinical experience, healthcare providers are highly aware at WAKIX and believe in its unique combination of efficacy, safety and tolerability with low drug-drug interactions as well as its broad payer coverage with more than 80% of lives covered. This makes WAKIX a familiar go-to option for any adult and pediatric patients with narcolepsy type 1 and type 2 and in any combination with other therapies in a highly polypharmacy market. and this will continue to remain true as the market continues to evolve, including with the introduction of orexins. We executed the expansion of our field sales, remote sales, field reimbursement and patient outreach teams in the second quarter and are seeing higher levels of HCP engagement, fueling a strengthening of top-line demand. We also implemented changes to our reimbursement and patient support programs which are decreasing the time required and increasing the success rate of patients filling prescriptions. In addition, significant growth opportunity remains. Approximately 170,000 people in the U.S. are living with narcolepsy, fewer than 50% are diagnosed, and brand penetration is approximately 20%. Looking ahead, we're excited about our two lifecycle programs to extend and expand the franchise. Petolacin GR is on track to launch in the first half of 2027 with a PDUCA date of April 1, 2027 and builds on the WAKIX safety and tolerability profile while enabling patients to start at a therapeutic dose. Petolacin HD offers an opportunity to extend the Petolacin franchise with differentiated labeling for fatigue and narcolepsy and sleep inertia NIH. with up to two times the highest labeled dose of WAKIX and all the benefits of the GR formulation. Finally, our orexin program gives us the opportunity to deliver on the promise of efficacy with a favorable safety and tolerability profile, once-a-day dosing, and potential use across MT1, MT2, and IH, in addition to a broad range of CNS indications. To summarize, WAKIX performance has never been stronger. We are on track to achieve more than $1 billion in net sales this year, and our pipeline is positioned to extend our leadership in sleep-wake for at least the next decade. I'll now turn the call over to our Chief Medical and Scientific Officer, Dr. Kumar Budur, to discuss the advancements in our clinical development programs. Kumar?

Thank you, Adam. Good morning, everyone, and thank you for joining us today. We continue to make good progress across our robust clinical state pipeline, including five Phase III registrational studies in five distinct rare neurological disorders and BP205, our potential best-in-class RxN2 receptor agonist. The headline for R&D this quarter is again BP205, so let me start there. BP205 is discovered by Casing Pharma and developed in partnership with Bioproject. It is designed to deliver a differentiated profile with high potency, excellent selectivity, emerging strong PK, and favorable safety tolerability, all supportive of a best-in-class profile. DP205 is built on a unique chemical scaffold and has the highest potency among known orexin agonist in clinical development and has demonstrated excellent selectivity for orexin-2 receptors over orexin-1 receptors and over 150 other Receptors of Interest. As a reminder, we reported top-line data from the single ascending dose or SAD portion of the study in August. Today, we announced preliminary results from the multiple ascending dose or MAD portion of the Phase I studies. The multiple ascending dose study was a 14-day randomized double-blind placebo-controlled study evaluating once daily doses of 0.1 0.6, 1, and 3 milligrams across six cohorts, four male and two female, of healthy volunteers. A total of 94 healthy volunteers participated. The preliminary data shows that the PK profile is consistent with what was expected based on the preclinical and the SAD data. The mean Tmax was approximately 60 minutes with a range of 30 to 90 minutes pointing to the potential for rapid onset of efficacy. The mean effective half-life was approximately 29 hours, not meaningfully different from the SAD study, and it supports one steady dosing and the potential for durable efficacy throughout the day and potentially with no troublesome insomnia as evidenced by the tolerability profile of BP205 from the SAD and the MAD data. Exposure was dose-related, and we saw target engagement adverse events, which further highlights its potential to deliver meaningful efficacy at low clinical doses. The most common adverse event was headache, observed in approximately 25% of participants. On-target adverse events of insomnia were reported in less than 20% of participants at all doses evaluated. These events were mild in severity and did not lead in any discontinuation. On target adverse events of urinary frequency and urgency were reported in less than 20% of participants and only at the 1mg and 3mg doses. These events were also mild in severity and did not lead to any discontinuation. BP205 was generally well tolerated with no serious or severe treatment emergent adverse events. In addition, no liver or visual adverse events were reported and no clinically significant cardiovascular events or EKG abnormalities were recorded. These data strengthen our conviction of PP205's emerging best-in-class profile and will inform our dosing strategy as we accelerate the development program. The complete MAG datasets will be presented at an upcoming medical meeting. We initiated the Phase 1B study in sleep-deprived healthy volunteers in the U.S. in the third quarter with top-line data expected in the first quarter of 2027. That study is the one to watch because it will provide the first signals of efficacy for BP to offline. Reflecting our commitment to investing in a robust development program for BP205, we expect to initiate Phase 2 studies across multiple CMS indications by mid-2027. Before I move on to the rest of the portfolio, we have highlighted the potential synergistic effects of orexin and histaminic mechanisms of action based on the neurocircuitory and orexin neurons, resulting in downstream effects on various neurotransmitters, including histamine. At the recently concluded SLEEP-EU2026 meeting, Bioprocess presented a poster showing an in vivo synergistic effect of orexin and in an narcoleptic mouse model. Specifically, pitolocent added to BP205 drove maximum histamine release versus BP205 or pitolocent alone, and this translated into increased duration of wakefulness in this model. The relevance of these data is that they suggest combining an RXL2 agonist with a treatment that works through histamine could be a new therapeutic approach for patients with narcolepsy and other central disorders of hyposomnolence. Of note, WAKIX, along with Pitolacine, GR, and HD, are the only agents that work through histamine that is either approved or in late-stage clinical development. Speaking of Pitolafen, starting with Pitolafen-GR, we are on track to launch in the first half of 2027. The NDA was accepted by the FDA with the put to date of April 1st, 2027. Pitolafen-GR has enteric coating, enables patients to initiate treatment at a therapeutic dose of 17.8 milligrams without titration, and important clinical differentiation. Petrolofent HP is our key value driver to extend the Petrolofent franchise with differentiated labeling. It's an enhanced formulation of Petrolofent with an optimized PK profile, enteric coating, and a higher dose to drive greater efficacy. Our Phase III registration of clinical trials Onstrite 1 in narcolepsy and Onstrite 2 in idiopathic hypersomnia are ongoing with top-line data expected in 2027 and anticipated to do for date in 2028. Utilized patents are filed for both Pitocin-GR and Pitocin-HD to extend the Pitocin franchise into the 2040s. For VATICS, the Phase III TEMPO study We remain on track for pediatric exclusivity. Completion of the TEMPO study fulfills the second and last requirement agreed with the FDA for vaguex pediatric exclusivity, which would provide an additional six months of regulatory exclusivity for vaguex. We are also exploring the amorphous form of ptolephant to pursue broader CNS indications. This opportunity is based on our exclusive license to Norwegian-issued amorphous form of ptolephant patent with protection until 2042. Current efforts are focused on formulation optimization and new modes of delivery. Finally, our epilepsy franchise. and Alex 100 is actively enrolling patients in two global phase III registrational trials in rare epilepsies, the Lighthouse Study in Lennart's Gestalt syndrome and the Orgaz Study in Dravet syndrome. The top-end data are expected in mid-2027 and anticipated to do for dates in 2028. In December, we will present updated 18-month data from the open-label extension of the ORCIS study at the American Epilepsy Society Annual Meeting. In summary, the MAD data further strengthen the emerging profile of BP205 as a potential best-in-class Oryxin-2 agonist, and our next data readout from the Sleep-Deprived Healthy Volunteer Study comes in the first quarter of 2027. We also continue to make progress on the five phase three registration of clinical trials across our other pipeline programs, which will continue to additional data catalyst in 2027 and target to do for dates in 2028. On behalf of Harmony, I want to thank the patient and the families for participating in our clinical trials, along with the investigators and the site personnel for their dedication in advancing our clinical trials. I'll now turn the call back over to Peter. Peter?

Thank you, Kumar. I'll now provide further color on our final two strategic priorities of value creation, transacting on business development and protecting the Patolasin franchise. Let me start with business development. We are pursuing two types of opportunities. The first is assets that can add near-term revenue in the 2028 to 2032 timeframe. to support our self-funded model. For this category, we are prioritizing assets in phase three in registration or on the market. The second category is innovative pipeline assets that drive long-term value creation the way we believe BP205 can. Our therapeutic areas of interest include sleep disorders, epilepsy, rare orphan CNS, and broader CNS indications. We see the opportunity to broaden our reach beyond orphan rare into larger CNS patient populations through both our erection strategy and business development efforts. We are directing our search and evaluation efforts accordingly and we are considering a variety of deal types including M&A and licensing. We have a strong balance sheet with over a billion dollars. We will be good stewards of capital, seeking value creating opportunities. You should not expect that we will allocate all of that capital on one transaction. Instead, we will likely engage in multiple transactions. Together, they can be transformative for harmony and drive long-term value creation. With regard to our fourth strategic priority of protecting the and many more. Harmony is asserting its Catolysin IP in active legal proceedings. First, the Polymorph 197 and Method of Use 947 patents. The bench trial in the AET and the litigation has concluded and closing arguments were held on October 22nd. Harmony believes AET's proposed product infringes the 197 Polymorph patent and that the 947 patent is valid. We expect a ruling from the judge around the time of the 30-month stay expiring in February 2027. Second, the amorphous form 920 patent. Harmony and Novidium filed a lawsuit alleging patent infringement in April against AET Pharma U.S. and its marketing partner, Sandoz. The licensed Novidium patent provides protection to 2042. A scheduling conference was held on October 21st. The amorphous 920 patent trial has not yet been scheduled, but would be expected to be scheduled for some time in 2029. Yesterday, November 3, the judge scheduled a preliminary injunction hearing on January 26, 2027, with an expected decision by February 14, 2027, when the 30-month stay expires. This schedule is identical to the preliminary injunction schedule Harmony proposed to the judge on October 26. In Q1 this year, we obtained the exclusive rights to a patent covering methods of making amorphous pitolis and hydrochloride from our licensee MSN Labs. That patent was issued by the PTO in Q3. The patent strengthens our patent portfolio and protects our development efforts for a new amorphous Catolysin Hydrochloride product. Together with our settlements, with the six other ANDA filers, these actions reinforce our confidence in WCAG's exclusivity to March 2030. I will now turn the call over to our Interim Principal Financial Officer, Steve Mollichella, to walk through our financial results for the quarter.

Steve? Thank you, Peter, and good morning, everyone. This morning, we issued our third quarter 2026 earnings release and filed our 10-Q, where you can find details of our financial and operating results. We continue to deliver financial results that reflect strong underlying demand for WACICs, as well as our disciplined approach to managing expenses across the business. For the third quarter of 2026, we reported net revenue of $269 million compared to $239 million in the prior year quarter. Our performance this quarter reflects continued strong demand for Wakex within the large narcolepsy market, coupled with typical quarter-to-quarter buying patterns that the industry as a whole experiences. Cost of products sold was 30% of net revenue and many more. We reported total operating expenses of $134 million for the third quarter, compared to $114 million in the prior year quarter. The increase in expenses was primarily driven by a $25 million charge related to a milestone achieved by MSN Labs, continued investments in R&D, and the expansion of our field-based team, which we completed earlier this year. These increases were partially offset by a $15 million charge related to a clinical milestone for ZYN002 in the prior year quarter. Net income for the third quarter was $48 million, or 81 cents per diluted share. and many more. We ended the third quarter with over $1 billion of cash, cash equivalents and investments and $150 million in debt. Looking forward, we continue to expect our operations to generate cash, for maintaining our strong balance sheet. Our capital allocation priorities include investment in R&D, driven by our BP205 development plans, along with potential business development opportunities and contractual milestones, which may be triggered by continued success in our pipeline. Finally, we are reiterating our four-year guidance of $1 billion to $1.04 billion for WCAG's net revenue. I will turn the call back to Jeff for his closing remarks. Jeff? Thanks, Steve.

In closing, this was another productive quarter for Harmony centered around two key accomplishments, sustained patient demand-driven growth for WACATS that keeps us firmly on track to exceed $1 billion in net revenue this year, and preliminary MAD data that further strengthened the emerging best-in-class profile of our orexin-2 agonist, BP205. We have been leaders in the sleep disorder space for almost a decade now and are leveraging our expertise to accelerate our BP205 development program toward multiple CNS indications to become a leader in the orexin space. We believe that when we execute on our four strategic priorities of value creation, Harmony is well-positioned to become an enduring, leading CNS company with multiple products across multiple franchises, bringing innovative treatments to patients living with CNS diseases while driving sustained long-term value for our shareholders. I would like to end this call today on a personal note before I step down as CEO at the end of the year. It has been my honor and privilege to have been a part of building Harmony Biosciences from the beginning over the past nine years and leading the organization as the CEO these past four years. I am grateful to our board of directors for the confidence they had in me and the opportunity to have served in the CEO role as well as staying on it as an advisor to the company throughout 2027. I want to thank the analysts I have worked with and members of the investment community for your interest in what we have been building at Harmony and recognizing the value of the enterprise that we are advancing. Lastly, I want to thank the entire Harmony organization for their dedication, commitment, and their passion for why we do what we do That is what I am most proud of, because when empathy and innovation meet, a better life can begin for patients with unmet medical needs. I wish Peter all the best of success in the role of CEO, and I am confident in his leadership and the entire organization in driving Harmony's next chapter of growth. Thanks, everyone, and I will now turn the call back over to the operator for Q&A. Operator?

Thank you. At this time, if you would like to ask a question, please press Star 1 on your telephone keypad. If you wish to remove yourself from the queue, you may do so by pressing Star 2. We remind you to please pick up your handset and please limit yourself to one question and one follow-up. We will take our first question from Ami Fadia with Needham. Please go ahead. Your line is open.

Hi, good morning. Thanks for taking my question. Firstly, Jeff, congrats on a fantastic career and it's been great working with you. So my first question is, thank you. With regards to the NAD data, while this was a safety study, can you give your preliminary thoughts on the therapeutic index across the doses studied based on target engagement? and what are your thoughts around being able to explore a dose even higher than the range that you studied in the MAD study because you went up to six milligrams in the SAD study. And then I have one more question.

Good morning, Ami. Thank you for the question. In terms of the therapeutic index, we do have a wide range of therapeutic index with the BP205. Regarding your question about limiting the dose to 3 mg in the multiple ascending dose study, and in the SAD study, we went all the way up to 6 mg. The repeat dose of 3 mg at steady state and many more. So, in terms of could we have gone higher on the dose? Absolutely, yes, we could have. We limited the MAD at 3 milligrams starting at 0.1 milligram because based on our preclinical PK3D modeling and the modeling that we have from the single ascending dose study, a 3 milligram We saw target engagement at a very low dose of 0.1 mg where we saw insomnia, which is a class-related AE. and we saw other target engagement AEs like urinary frequency and urgency at 1 and 3 mg. So what it says is in the dose range that we have evaluated, the drug crosses the blood-brain barrier, interacts with Oroxyl-2-saccharogenase and is doing what is expected to do. So with this, this data supports the potency of the P205 which is highest compared to other orexin two-receptor agonists in clinical development and gives us an opportunity to explore doses, low doses, to treat all three central disorders of hypersomnolence.

Got it. Thank you. One other quick question. You know, the half-life obviously supports one steady dosing. However, based on what we've seen from the other orexin programs, what are your thoughts around exploring a split dosing when you initiate the Phase II planned middle of next year. Thanks.

Yes, a great question, Ami. In terms of what we have seen with the half-life and the target engagement age that we are seeing, we remain confident that once-a-day dosing is what's going to work with BP205.

Yeah, I would add to that. I think that the data from the Sleep Surprise Healthy Volunteers study on me will inform that in terms of the ability to demonstrate sustained wakefulness, you know, throughout the day and into the late day, early evening. So that, you know, that data set will also inform the potential that we believe, you know, could be once daily dosing.

And there are also other factors other than half-life, like the ability to cross blood-brain barriers, the potency, the selectivity, the features that we have talked about, especially that are very unique for BP205. Got it.

Thank you. Thank you, Amit.

Thank you. We will move next with Greg Silvanovich with Misuho. Please go ahead.

Good morning. Thanks for taking my questions. Jeff, congrats on a great career. Look forward to connecting with you on whatever might be next for you. But that being said, I have two questions, if I could. One, just on the existing business, WACIC seems to be in a good place, but I think we're within the month that Takeda Zorzaful may be launching and maybe this is a question for Adam, but how should we think about that launch and what the impact might be to WCAG both in the very near term or perhaps in the midterm? Just thinking about, you know, you're getting good traction on new patient ads, but just if you could give some other higher level comments because we are pretty much here and we've been talking about it for a while now and then Second, if I could just revisit the patent litigation, it is very complex. I know you had mentioned that the amorphous patent litigation, the timing there would be perhaps a trial start in 2029, but if we get to a final decision in the original ANDA-based litigation, which could come, I guess, in February, if you end up Losing on that, could you just remind us around the risks around really a potential launch at risk? I know you've got the PI hearing, but just trying to think about how we all should be thinking, given the many moving parts of this multilayered IP strategy that you have. Thanks. Thanks.

Yeah, sure, Greg. Good morning, Greg. Thanks for your kind words. Over to Adam first for thoughts on potential impact of the Orzefa launch.

Adam? Yeah, hi, Greg. We're thrilled with the results that we saw this quarter. Another now five out of the last six quarters of 400-plus patient ads. Really, really excited and enthusiastic about that continued growth. We expect Orzefa launch probably this month. It's looking like will be wrapped up potentially this week. We expect Orzapil to be scheduled for. So what that means for WCAGS, you know, and Orzapil will be indicated only in NT1. So for WCAGS, we expect everything that's driven the performance today will continue to drive our performance in the future. And we're confident in continued growth through the end of this year and into next year. WCAGS will remain The only non-scheduled treatment option, broad clinical utility across NT1 and NT2 pediatric and adult patients with EDS and cataplexy. So broad indications and broad utilization with strong efficacy, very clean safety and tolerability profile, which really differentiates it and makes it a great addition for any combination of treatments in a highly polypharmacy market. We continue to enjoy broad coverage with more than 80% of lives covered. and we believe all of that will remain unchanged with the launch of Orzaful and will continue to propel our growth through 2027. Thanks, Peter.

Yeah, and on your second question about the patent litigation, you're right, it is complicated, Greg. And I'll try to make it as simple as possible. The headline basically is that the schedule is proceeding exactly as we expected and actually even proposed. So there is a scheduled, yesterday the judge issued a scheduling order, that there is a scheduled preliminary injunction hearing. To be clear, we're the ones asking for the preliminary injunction. and she granted that. We proposed it in two forms. We proposed it on October 26th in a letter that she asked us to provide on our proposed schedule and we actually proposed it yesterday again in the morning in a letter we sent to the judge and then in the afternoon she issued the schedule. So this is progressing exactly the way we expected and wanted. So this is a positive for us and so the scheduling or the Thank you for joining us. The amorphous case still has not been scheduled. And as you pointed out, just based on past history, those things typically get scheduled a couple of years out. So we expect it to be scheduled in 2029 and then a ruling from the judge sometime after that. So this is progressing exactly as we had proposed, and we are looking forward to the upcoming PI hearing. and stating our case. And we continue to reiterate the confidence that we have in March of 2030 when you look at both the ANDA case, the still outstanding amorphous case, and our requested preliminary injunction hearing.

Just a quick follow-up. I mean, just the request for the preliminary injunction, which sounds like it's going the way that you had proposed, I guess From a more bearish perspective, it gives a sense that you're already anticipating that you could lose in the final ruling. So could you just address how those who are trying to think about all the implications, the fact that you did request a hearing for the preliminary injunction, how people may interpret that, whether rightfully or wrongfully?

Yeah, I mean, no one should interpret that as our belief that we won't prevail in the ANDA trial. We still have very strong confidence that we will prevail in the ANDA trial. But as you've seen, we've vigorously defended our IP, and we're going to take advantage of every opportunity we have to continue to defend our IP. So it's well within our rights to ask for a preliminary injunction, and we asserted that right. and you also have seen that we asserted our rights by suing AET and Sandoz with the amorphous trial. So it just is consistent with the very assertive approach that we have taken to defend WAKIX-IP and we believe we will prevail ultimately, but we also believe we'll prevail specifically on the ANDA trial. Thank you very much. Thanks, Craig.

Thank you. We will move next with Jay Olson with Oppenheimer. Please go ahead.

Thank you, Jeff, for your leadership over the years, and congrats on all the impressive progress you've made on behalf of patients. Thank you, Jay. Thank you. We look forward to staying in touch with you. We have a question about BP205, which is already demonstrating clear points of differentiation based on the clean safety and Can you talk about what to expect from the sleep-deprived volunteer study beyond demonstrating wake-promoting activity? Will you assess late-day efficacy, attention, next-night sleep, or other points of differentiation? And then as a follow-up, how will those findings factor into your clinical development plan, especially in terms of potential indications you would pursue? Thank you.

Jay, thank you for your question. I'll turn it over to Kumar, but I think you're highlighting the multiple catalysts for BP205 that are coming right around the corner, and the important one, the sleep-deprived healthy volunteer study data. And Kumar can provide sort of more color on what we anticipate, how that will inform

Thank you for the question and thank you for highlighting some of the features that we discussed today in terms of the PK differentiation, in terms of safety and tolerability differentiation for BP205. Regarding sleep-deprived healthy volunteer study, the goal is we anticipate wakefulness that is expected from this class of drugs, that's RxA2. and a favorable safety and tolerability profile. This is going to be a single dose in sleep-deprived healthy volunteers. As long as we hit the benchmark or the ballpark, what we anticipate in terms of efficacy for this class of compounds, that's good for us, for us to move to the next stage of development. What the sleep-deprived healthy volunteers study also does is it will help us to bracket the dose range that we'll be taking into Phase 2 studies. We already have an idea based on what we saw with our single ascending dose study, especially with the multiple ascending dose study based on the target engagement age that we have seen with very small doses, doses ranging from 0.1 to 3 milligrams in multiple ascending doses. So the data from the Sleep Deprived Healthy Volunteers will add to the data that we are generating, and that will help us to determine the dose ranges and the design of our multiple phase II clinical trials that we plan to initiate in mid-2027 in multiple CNS indications. Great. Thank you.

Thanks, Jay.

Thank you. We will move next with Rudy Li with Wolf Research. Please go ahead.

Rudy Li, Wolf Research, Bp205 Bp205, can you provide more color on the headache AEs? Are they dose-dependent? to have any patient discontinued because of ADHC-AIDS. And what doses will be passing the sleep deprived subjects? Are you dosing just QD or include speed dosing? So what do you think would be the right therapeutic dose?

Thanks. Hey, good morning, Grody. Thank you for the question. In terms of headache, about 25% of the participants experienced headache. They were mild in severity and that did not lead to any discontinuation. So headache did not lead to any discontinuation. In terms of headache itself, it's actually very common in any phase one studies to see headache raised to the top one, two, or three most commonly reported because all these studies are done in an inpatient unit. The healthy volunteers are in the unit sometimes for up to 10 days. and it's actually very common for these healthy volunteer participants to report headache. And the second question in terms of QD, BID, split dosing, the data that we have generated, Rudy, thus far, in terms of terminal half-life from our single ascending dose study, in terms of effective half-life in our multiple ascending dose study, and the target engagement AEs that we saw with the QD dosing, mind you, the multiple ascending dose study was dosed every day in the morning for 14 consecutive days. Based on everything that we are seeing, we are confident that the BP205 will be QD dosing at this point in development.

Thanks. Very helpful. Thanks, Rudy.

Thank you. We will move next with Patrick Trucchio with HC Wainwright. Please go ahead.

Good morning. A question on WACICs. Just wondering, Steve, where should we be modeling the cost of sales going forward? And did this quarter include passive charges or royalty-tier effects? Is it approximately 30% appropriate going forward? And as far as WACICs buying patterns, Could you quantify the third quarter revenue impact of the buying patterns that you referenced and clarify whether you expect the effect to reverse in the fourth quarter?

Yeah, Patrick, thanks for your question. I think Adam can respond in terms of the buying patterns, and Steve can comment on the other impact.

Yeah, sure. Hi, Patrick. I mean, the short answer is we really saw no impact from inventory fluctuations for our third quarter results. Steve, over to you on cost of sales.

Yeah, hi, Patrick. On cost of sales, third quarter represents the full impact of the new royalty from the NVIDIA agreement we signed in Q3, so I would expect that you would see that kind of going forward.

Great. And then, if I could, just on BT205, Kumar, separately from the single-dose sleep-derived study, were any objective overnight sleep measurements collected during the MAD portion of the program, or was the nighttime palatability assessment based on participant-reported insomnia?

Patrick, we did not collect any information like attention, concentration, things like that. It's in Healthy Volunteers. And in terms of AE collection, obviously we collected the AEs based on the standard format that is used in Phase 1 studies. And that's where we noticed insomnia in less than 20% of the participants. We saw urinary urgency and frequency, less than 20% of participants only at one and three milligram doses. Both of these AEs were mild in severity, and importantly, importantly to note, neither of these target engagement AEs led to any discontinuation.

Thank you so much. Thanks, Patrick.

Thank you. We will move next with David Amsalem with Piper Sandler. Please go ahead.

Thanks. First, Jeff, I just want to wish you all the best. I've really enjoyed working with you over the years, so all my best to you. And now to my questions, just a couple. First, on 205, as you think about... Evaluation of the drug in orexin-deficient patients. How do you think it will behave from a tolerability perspective? In other words, insomnia, polychorea. I know that you have the data in Healthies, but do you expect it to behave differently once you're putting it into actual orexin-deficient patients as you think about tolerability, particularly insomnia and polychorea? So that's number one. and then secondly, appreciate Peter the transparency on business development M&A. You did talk about a broader aperture within CNS and that sort of leads me to wonder, are you thinking about Thank you.

David, good morning, David. Thanks for your questions. Thanks for your kind words. I've enjoyed working with you as well over the years. First, let me frame in terms of, you know, BP205 and disorders beyond erection deficiency. I think, you know, as we said, it starts with regards to the potential, the high potency. So I think, you know, framing this opportunity is, you know, the most potent erection to agonists in the clinic. and the opportunity for lower clinical doses, overall achieving driving towards a favorable risk-benefit profile. And that's, I think, the opportunity that we're seeing in the emerging data. I think Kumar can expand on that. But, you know, that is what we believe is the real opportunity in the high potency of BP205.

Thank you, Jeff. Hey, good morning, David. Thank you for the question. That's a great question. Look, from a clinical development perspective, what happens is, in general, I'm not talking specifically for PP2 or fire narcolepsy, in general, the tolerability profile is much better in patients compared to healthy volunteers. That's what we have seen. But specifically in NT1, that's a question that I don't know the answer, to be honest with you, because these are also the patients whose physiological system has never ever been exposed to any meaningful exposure to orexins. So we just need to see what happens in the clinical setting. But outside of NT1, David, in NT2, IH, in broader CNS indications, these individuals have intact orexin physiology and the healthy volunteers also have health-impact orexin physiology. So I'm actually pretty confident that the safety and tolerability profile, which is very favorable, that we saw in the MAD dose, extends to patient population who have impact orexin physiology that is linked to IH and product CLS indications.

Peter on non-business development. Yeah, thanks for the question, David. First of all, just to reiterate, sort of our priority areas are where we have franchises now and emerging franchises. So clearly, sleep is a high priority given our leadership in the sleep space. We have an emerging franchise in epilepsy, so that's a high area of interest. In terms of those broader indications that you asked about, we've been silent to date on what specific indications we're pursuing with orexin, but we have said that the broad categories of interest are things that relate to areas of orexin's role in various disease processes, and those include cognition, attention, mood, fatigue, just as broad categories. And so as we continue to move forward our planning for our erection strategy, those final indications that we ultimately start studies in next year will also be areas of interest that we would also pursue BD opportunities in. So I can't get really specific yet, but I think that gives you some broad strokes. And when we become more transparent with you next year when we kick off those phase two studies, I think you'll have a better understanding of what those areas are and how that could be pulled through in our BD strategy.

Yeah, David, just that. I think that, you know, the opportunity with BP205 and broader erection space, you know, in broader CNS indications is really what's sort of opening up the aperture from a BD perspective. So, you know, given the excitement there, given the opportunity with BP205, you know, then we see the BD aperture opens up with regards to opportunities in those broad CNS indications as well.

All right. Thanks, guys. That's helpful.

Thanks, David.

Thank you. We will move next with David Wong with Deutsche Bank. Please go ahead.

Hi. Good morning, and thanks for taking my questions. Jeff, let me echo everyone else. You know, it was a pleasure working with you, and I wish you only the best in your next chapter.

Thank you, David.

So in terms of questions, first, noticing a little bit of quarter-over-quarter deceleration for WACICs in terms of the net patient ads. Is there anything to read there? And if you could just remind us and maybe speak to the underlying demand this quarter versus last. And then in terms of the amorphous formulation of the tolicent, where you licensed that in from Novidium. How does that now fit into your lifecycle management plans alongside the Tolleson HD and GR? Thanks a lot.

Hi, David. Thanks for the question. I'm very pleased with quarter-over-quarter results achieving 400 patient ads in third quarter. As you know, over the last six years, WACIX typically has added between one Thank you for joining us. through the end of the year. We're fully on track with our estimates internally through three quarters, very confident in our ability to achieve guidance of 1 to 1.04 billion for the year, and looking forward to hitting that major milestone for the company.

Thanks, Adam. Kumar? Yeah. Good morning, David. Thanks for the question. Regarding amorphous form of pitolosan, this is the form of pitolosan that has an issued patent and is 42. In terms of how it fits within the broader Pitocin franchise, one of the things that we always wanted to explore is that there are certain symptoms like fatigue in broader neuropsychiatric indications and amorphous form of Pitocin offers us that opportunity to look into some of those broader indications that we couldn't pursue with us, for example, WAKIX or Pitiless and HD, where we are specifically looking into rare orphan disorders. Just as an FYI, with WAKIX formulation, we actually did generate positive data, both in sleep and fatigue in myotonic dystrophy, So we have shown there is a proof of concept that histaminergic mechanism of action can be helpful in fatigue, and that's what we want to do. We want to look at certain symptoms in broader neuropsychiatric indications with the amorphous form of patellofent.

And it also gives us the opportunity to explore new formulations with that formulation as well. So not just new indication space, but also with a new route of delivery. A new mode of delivery, right. Thank you, Peter.

Thank you. We will move next with Danielle Brill with Truist. Please go ahead.

Hi, guys. Good morning. Also want to wish you the best, Jeff. It's been great getting to know you over the years and likewise hope to connect again in the future. I just wanted to ask on a I'm sorry, BP205. So you saw a target engagement at 0.1 milligrams and urinary AEs at one in three. So how confident are you that you can get clinically meaningful efficacy below the exposure where these on-target AEs emerge? And do you think this separation is being driven more by Thank you.

Daniel, when you say the separation of EAs, I assume the separation of insomnia that was observed at all four doses, whereas urinary frequency and urgency were observed only at one and three milligram doses. Good question. What we can say, as I mentioned earlier, is the The observation of target engagement at 0.1 mg was not a surprise for us, given the potency of BP205 and what we had seen in the preclinical model. In terms of how we can extrapolate these to efficacy, we will be testing these doses. We haven't disclosed exactly the doses that we'll be testing in sleep-deprived healthy volunteers, and we will see. Ultimately, the goal is to derive efficacy, good efficacy, clinically meaningful efficacy without causing troublesome AEs, and that includes target engagement AEs, which are insomnia, urinary frequency, and urgency.

And if I could just add a perspective, I think people should not expect that we'll completely avoid those target engagement side effects. They are part and parcel of raising the rexin levels, and anything that raises the rexin levels is likely to have those. What we aim to do is have them be low enough where they're not problematic, and that's what we saw in the MAD study after 14 days of repeated dosing. They were mild in severity, they didn't lead to discontinuation, and they were by definition, not problematic. And so that's what we're aiming for in terms of striking the right balance in the doses we select to give us that efficacy that we think that will generate from the strong potency that we have, but also minimize but probably not avoid the on-target AEs.

Yeah, yeah. I was going to mention the same thing, that we're not going to avoid the on-target AEs, but it's the overall, again, back to the overall benefit-risk profile. What we're driving towards, obviously, you know, Danielle, some of the other erection development programs, you're seeing higher rates, you're seeing some of that in the order table label. That is what we are trying to prove out here and achieve. There's an interesting analog in the market, and it's called WAKETS. Wakex has a very favorable overall safety, you know, safety, tolerability, and efficacy profile, you know, risk-benefit profile, which leads to its broad clinical utility. So that is how the development program is designed to sort of demonstrate that with BP205.

Thank you. We will move next with Jason Gerbery with Bank of America. Please go ahead. Hi, this is Melanie on for Jason.

Thanks for taking our question. Just one on the litigation. So if the generic gets a non-efficient ruling on polymorph, can you talk about just potential at-risk launch scenarios that investors should understand heading into 2027? Thanks.

Yeah, a couple of thoughts. First of all, there's two patents that are the subject of the ANDA. One is the polymorph patent that you mentioned. The other one is a method of use patent. And so they are claiming that they do not infringe on the polymorph patent and introduce lots of evidence in the trial that they have an amorphous formulation. and so we'll come back to that in a second. And then the method of use, they're challenging the validity of that patent. And this is an issued patent and issued patents that get screened and approved by the Patent and Trademark Office are presumed valid patents. and so all we have to do is prevail on one of those two. And so then the amorphous trial, after they introduced all this evidence to try to avoid the claim that they're infringing on our polymorph patent, they introduced lots of evidence about amorphous and so we have an exclusively licensed Thank you very much. against AET and Sandoz because it's very clear that they do have an amorphous formulation. So ultimately there's three patents at play here. All we have to do is prevail on one of them, and we believe very strongly that we can prevail on all three, but all we need to do is prevail on one of them. But as mentioned before, we have every right to ask for a preliminary injunction, and so we did that. and that hearing will be scheduled because we think it's important for the judge to hear the amorphous case prior to any generic entering given the obvious connectivity of the amorphous lawsuit to the formulation that AET and Sandoz plan to launch.

Thank you. We will move next with Seoyoon Shim with UBS. Please go ahead.

Seoyoon Shim Hi. Thank you for taking our question and congrats on your retirement and thank you for all the helpful discussion over the years. On the PI proceeding, Given AET's argument that Harmony does not practice the 920 patent with Rekix and that monetary damages could therefore be adequate, can you discuss how you plan to demonstrate the irreparable harm from a potential generic launch to support the PI? And if I can squeeze in on BP205, so you have noted that urinary frequency urgency were only shown at 1 and 3 megs. across the cohorts, the 0.1, 0.6, 0.13 main cohorts. Did you see any dose-dependent trends in insomnia rates as well? Thank you.

Yeah, I'll just quickly mention on the first one, we're not going to be able to reveal to you the strategy and the arguments that we will put forth in the upcoming PI hearing, but all of those documents will be public along the way once we file them, and certainly they will be public during the PI hearing. So I won't disclose any of that now other than to say we feel we have a very strong case. to not only demonstrate irreparable harm, but also the importance of the amorphous trial. And it's important to note that AET and Sandoz have never claimed that our lawsuit is a sham lawsuit, that they argue against the merits. And so we believe that, along with a strong irreparable harm argument, will be laid out in the documents and in front of the court, and we're looking forward to that opportunity.

Thank you, Peter. Hey, good morning for you. Thanks for asking this question. In terms of the relationship between dose and AE, we haven't disclosed that information. These are preliminary data from the multiple ascending dose study. We are still looking into exposure AE relationship, which is much more meaningful than the dose AE relationship. Once we have all of those data, we'll present the full data set at an upcoming medical conference. Thank you.

Thank you. Thank you. This concludes our Q&A session. I would now like to turn the call back to Jeff Dayno for any closing remarks.

Thank you, Nikki. And I just want to thank everyone for joining our call today and for your continued interest in Harmony Biosciences. Thanks and have a great day.

Thank you. This does conclude today's Harmony Biosciences Third Quarter 2026 Financial Results Conference Call. You may now disconnect your lines and have a wonderful day.