Harmony Biosciences Holdings, Inc. (HRMY) 2026 Q1 法說會逐字稿

Hello, and thank you for standing by. My name is Mel, and I will be your conference operator for today. At this time, I would like to welcome everyone to the Harmony Biosciences first quarter 2026 financial results. (Operator Instructions)

您好，感謝您稍候。我叫 Mel，今天將擔任本次電話會議的接線員。此刻，我謹代表公司歡迎各位參加 Harmony Biosciences 2026 年第一季財務業績電話會議。(接線員指示)

I would now like to turn the call over to Brennan Doyle, Head of Investor Relations. Sir, please go ahead.

現在我想把電話交給投資人關係主管 Brennan Doyle。先生，請開始。

Thank you, operator. Good morning, everyone, and thank you for joining us today as we review Harmony Biosciences first quarter 2026 financial results and provide a business update.

謝謝，接線員。各位早安，感謝各位今天加入我們，一同回顧 Harmony Biosciences 2026 年第一季財務業績並提供業務最新進展。

Before we start, I encourage everyone to go to the Investor section of our website to find the materials that accompany our discussions today, including a reconciliation of our GAAP financial measures. 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, Glenn Reicin, Chief Financial Officer, and Peter Anastasiou, Chief Operating Officer.

在開始之前，我鼓勵各位前往我們網站的「投資人」專區，查閱今天討論所搭配的相關資料，包括我們 GAAP 財務衡量指標的調節表。今天與會的講者包括：總裁暨執行長 Jeffrey Dayno 醫師、首席商務長 Adam Zaeske、首席醫療暨科學長 Kumar Budur 醫師、財務長 Glenn Reicin，以及營運長 Peter Anastasiou。

As a reminder, we will be making forward-looking statements today, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties. Our actual results may differ materially, and we undertake no obligation to update these statements even if our circumstances change. We encourage you to consult the risk factors referenced in our SEC filings for additional details.

提醒各位，我們今天將發表前瞻性陳述，這些陳述係基於我們目前的預期與信念。此類陳述受若干風險與不確定性影響。我們的實際結果可能出現重大差異，即使情況改變，我們亦無義務更新這些陳述。我們建議各位參閱我們向 SEC 申報文件中所提及的風險因素，以取得更多細節。

I would now like to turn the call over to our CEO, Dr. Jeffrey M. Dayno. Jeff.

現在我想把電話交給我們的執行長 Jeffrey M. Dayno 醫師。Jeff。

Thank you, Brennan. Good morning, everyone, and thank you for joining our call today. I want to start by highlighting what we have built at Harmony. We are a profitable, self-funding biotech company that continues to operate from a position of strength. We have an exceptionally strong commercial engine, which continues to drive WAKIX growth now in year seven on the market.

謝謝你，Brennan。各位早安，感謝各位今天加入我們的電話會議。我想先強調我們在 Harmony 所打造的成果。我們是一家獲利且可自我資助的生技公司，並持續以強勢地位營運。我們擁有極其強大的商業引擎，推動 WAKIX 在上市第七年仍持續成長。

We have recently solidified our IP position around the pitolisant franchise through a multi-layered approach. We have a robust pipeline centered around BP-205, our potential best-in-class orexin-2 agonist. We have a very strong balance sheet with the capacity and conviction to execute on meaningful business development opportunities. With this solid foundation in place, we are now turning our focus on four key pillars of value creation for shareholders.

我們近期透過多層次的方法，進一步鞏固了 pitolisant 產品系列的智慧財產權（IP）地位。我們擁有以 BP-205 為核心的強健研發管線；BP-205 是我們具潛力的同類最佳 orexin-2 受體致效劑。我們的資產負債表非常穩健，具備能力與決心執行具重大意義的業務開發機會。在這個穩固基礎之上，我們現在將重點聚焦於為股東創造價值的四大關鍵支柱。

In support of this next phase of growth, we have brought in two new members to our management team who further strengthen our ability to execute as we scale. First, I am pleased to welcome our new Chief Financial Officer, Glenn Reicin. Glenn is a seasoned biopharmaceutical executive with extensive experience across publicly traded and privately held companies, guiding them through key growth inflection points. With his experience as a sell-side analyst, investor, and biotech CFO, Glenn brings a strong track record of success in strategic planning, capital markets, and fundraising.

為支持下一階段的成長，我們延攬兩位新成員加入管理團隊，進一步強化我們在擴張規模時的執行能力。首先，我很高興歡迎新任財務長 Glenn Reicin。Glenn 是資深生物製藥產業主管，具備橫跨上市與未上市公司的豐富經驗，並曾協助公司度過多個關鍵成長拐點。憑藉其賣方分析師、投資人以及生技公司財務長的經歷，Glenn 在策略規劃、資本市場與募資方面擁有亮眼的成功紀錄。

Next, welcome to Peter Anastasiou, our new Chief Operating Officer, who brings more than 30 years of experience in the industry and comes into this role after having served on Harmony's board of directors, where he contributed strategic insights across the business during a period of continued growth and operational evolution.

接著，歡迎新任營運長 Peter Anastasiou，他在產業內擁有超過 30 年經驗，並在加入此職務前曾擔任 Harmony 董事會成員，在公司持續成長與營運演進期間，為各項業務提供策略洞見。

Most recently, Peter served as Chief Executive Officer of Capsida Biotherapeutics and previously held multiple leadership roles at Lundbeck, including President of US and Canadian operations and US Chief Commercial Officer for its psychiatry and neurology franchises. I am excited to welcome both Glenn and Peter to the Harmony team. Their combined experience meaningfully strengthens our leadership bench and positions us well to execute on our four strategic pillars of value creation, which I will now walk you through. The first pillar is to protect the pitolisant franchise into the 2030s. We are committed to protecting the pitolisant franchise through a multi-pronged strategy that is based on strong intellectual property protection and exclusivity.

最近，Peter 曾擔任 Capsida Biotherapeutics 的執行長；此前也在 Lundbeck 擔任多項領導職務，包括美國與加拿大營運總裁，以及其精神醫學與神經學產品線的美國首席商務長。我很高興歡迎 Glenn 與 Peter 加入 Harmony 團隊。他們的綜合經驗大幅強化了我們的領導梯隊，並使我們能更好地執行四大策略性價值創造支柱；我現在將逐一說明。第一個支柱是將 pitolisant 產品系列的保護延伸至 2030 年代。我們致力於透過多管齊下的策略保護 pitolisant 產品系列，該策略以強而有力的智慧財產權保護與專屬權為基礎。

Pitolisant's IP estate is multi-layered, covering different formulations, methods of use, and next-generation applications, which support WAKIX exclusivity into 2030, inclusive of six months of pediatric exclusivity, with potential IP protection of the franchise into the 2040s via additional issued patents and pending patent applications.

Pitolisant 的 IP 佈局為多層次，涵蓋不同劑型、使用方法與次世代應用，可支持 WAKIX 的專屬權延續至 2030 年（包含 6 個月的兒科專屬權）；此外，透過已核准專利與待審專利申請，該產品系列的 IP 保護有機會延伸至 2040 年代。

In January, we also acquired an exclusive license from Novitium for certain IP, including their issued patents out to 2042, covering an amorphous form of pitolisant hydrochloride, which provides us with new development opportunities. With regard to the ANDA litigation and the trial that took place in February, we have settled with six of the seven ANDA filers, maintaining LOE until March of 2030, inclusive of six months of pediatric exclusivity.

今年 1 月，我們亦自 Novitium 取得特定 IP 的獨家授權，包括其已核准且有效期至 2042 年的專利，涵蓋 pitolisant hydrochloride（鹽酸 pitolisant）的非晶型態，為我們帶來新的開發機會。關於 ANDA 訴訟以及 2 月進行的審理，我們已與 7 家 ANDA 申請者中的 6 家達成和解，將 LOE 維持至 2030 年 3 月（包含 6 個月的兒科專屬權）。

During the trial in February, AET, the one remaining ANDA filer who has not settled, stated that their product contains an amorphous form of pitolisant hydrochloride rather than a crystalline form covered by our '197 polymorph patent. After learning that, Harmony, along with Novitium, recently filed a patent infringement lawsuit against AET Pharma US and Sandoz alleging infringement of a patent covering an amorphous form of pitolisant hydrochloride.

在 2 月的審理期間，尚未和解、仍為唯一剩餘 ANDA 申請者的 AET 表示，其產品包含的是鹽酸 pitolisant 的非晶型態，而非受我們「197 多晶型專利」涵蓋的結晶型態。得知此事後，Harmony 與 Novitium 近期對 AET Pharma US 與 Sandoz 提起專利侵權訴訟，主張其侵害一項涵蓋鹽酸 pitolisant 非晶型態的專利。

This suit is a new action different from the legal proceeding of the ANDA litigation trial that took place in February, which is ongoing and is being presided over by the same judge. Based on this legal activity, we remain confident in the strength of our IP estate and continue to vigorously protect it through this multi-pronged strategy. Second, we are dedicated to the continued growth of the pitolisant franchise in an evolving market.

本案為一項新的訴訟行動，與 2 月進行且目前仍在進行中的 ANDA 訴訟審理之法律程序不同；兩者由同一位法官審理。基於上述法律進展，我們仍對自身 IP 佈局的強度充滿信心，並將持續透過此多管齊下的策略積極加以保護。第二，我們致力於在不斷演變的市場中，推動 pitolisant 產品系列持續成長。

In Q1, we delivered $215.4 million in net product revenue, up 17% from $184.7 million in the same period last year. This performance reflects continued strong demand, offset by market access headwinds observed every Q1 following three of the strongest consecutive quarters in Harmony Biosciences' history. The average number of patients in Q1 was approximately 8,500, and we exited the quarter with approximately 8,600 average patients on WAKIX.

第一季我們實現淨產品營收 2.154 億美元，較去年同期的 1.847 億美元成長 17%。此表現反映需求持續強勁，但也受到市場准入逆風的抵銷；這類逆風通常在每年第一季出現，且是在 Harmony Biosciences 史上最強勁的連續三個季度之後所觀察到的情況。第一季平均病患數約為 8,500 人，季度末 WAKIX 的平均用藥病患數約為 8,600 人。

These patient numbers are in a market of 80,000 diagnosed patients with narcolepsy, showing the significant market opportunity that remains to support continued growth of WAKIX and the pitolisant franchise. Based on this, we are reiterating our full year net revenue guidance of $1 billion-$1.04 billion.

在一個約有 80,000 名已確診嗜睡症（narcolepsy）病患的市場中，這些病患數據顯示仍存在可觀的市場機會，可支持 WAKIX 及 pitolisant 產品系列的持續成長。基於此，我們重申全年淨營收指引為 10 億至 10.4 億美元。

In addition to the continued growth of WAKIX in the market, our next-gen pitolisant formulation programs are advancing. Pitolisant GR remains on track for NDA submission this quarter with a target PDUFA date in Q1 2027 and is positioned to extend the WAKIX franchise and our leadership in narcolepsy. Pitolisant HD is enrolling in two ongoing Phase 3 registrational trials, one in narcolepsy and one in idiopathic hypersomnia, or IH, designed to expand the franchise with differentiated labeling.

除了 WAKIX 在市場上的持續成長之外，我們的次世代 pitolisant 劑型開發計畫也在推進。Pitolisant GR 仍按計畫於本季提交 NDA，目標 PDUFA 日期為 2027 年第一季，並有望延伸 WAKIX 產品系列及我們在嗜睡症領域的領導地位。Pitolisant HD 正在兩項進行中的第三期註冊性試驗中收案，一項針對嗜睡症，另一項針對特發性嗜睡（idiopathic hypersomnia，IH），旨在以具差異化的標示擴大產品系列。

We have also initiated a new development effort with the amorphous form of pitolisant that we licensed from Novitium. This gives us an opportunity to pursue broader CNS indications. Kumar will share more color on this new opportunity later in the call. Our third pillar of value creation is driving value from our robust pipeline led by BP-205, our potential best-in-class orexin-2 agonist.

我們也已啟動一項新的開發工作，聚焦於我們自 Novitium 授權取得的 pitolisant 非晶型態。這讓我們有機會探索更廣泛的中樞神經系統（CNS）適應症。稍後在電話會議中，Kumar 將就這項新機會提供更多說明。我們第三個價值創造支柱，是從我們強健的研發管線中推動價值，其中以 BP-205（我們具潛力的同類最佳 orexin-2 受體致效劑）為首。

We do not believe our current valuation reflects the strength of our pipeline, especially related to our highly potent and selective orexin 2 receptor agonist, BP-205. This program is on track for top-line data readout from our Phase 1 clinical PK single ascending dose study the middle of this year. Built on a novel chemical scaffold with strong preclinical PK, safety, efficacy, and tox data, BP-205's potential product profile could position it as a highly competitive orexin 2 agonist, not just in narcolepsy and other central disorders of hypersomnolence, but also for broader indications outside of sleep-wake that are not due to orexin deficiency for which potency matters.

我們不認為我們目前的估值反映了我們研發管線的實力，特別是與我們高效力且高度選擇性的食慾素2（orexin 2）受體致效劑 BP-205 相關的部分。該計畫進展順利，預計將於今年年中取得我們第1期臨床藥物動力學（PK）單次遞增劑量研究的主要數據讀出。BP-205 建立在新穎的化學骨架之上，並具備強勁的臨床前 PK、安全性、療效與毒理（tox）數據，其潛在產品特性有望使其成為極具競爭力的食慾素2致效劑，不僅適用於嗜睡症（narcolepsy）及其他中樞性嗜睡過度（hypersomnolence）障礙，也可望用於睡眠—覺醒之外、更廣泛且非因食慾素缺乏所致、而效力至關重要的適應症。

Overall, our robust late-stage pipeline consists of five ongoing Phase 3 registrational trials across five distinct CNS indications, including the two Phase 3 registrational trials with EPX-100 in the rare developmental and epileptic encephalopathies. Kumar will provide more detail on BP-205 and our other pipeline programs during his R&D update.

整體而言，我們強健的後期研發管線包含五項正在進行的第3期註冊性試驗，涵蓋五個不同的中樞神經系統（CNS）適應症，其中包括 EPX-100 用於罕見發育性與癲癇性腦病（developmental and epileptic encephalopathies）的兩項第3期註冊性試驗。Kumar 將在其研發（R&D）更新中，提供更多關於 BP-205 與我們其他管線計畫的細節。

Our fourth value-creating pillar is a renewed emphasis on business development. We are focused on opportunities with revenue potential in the 2028 to 2032 timeframe, prioritizing assets that are in Phase 3 development in registration or on market. We are maintaining our therapeutic areas of interest that include sleep-wake, epilepsy, rare orphan CNS disorders, and CNS adjacencies beyond rare diseases. With about $870 million on the balance sheet, we are moving with urgency to deploy our capital and have clear conviction to execute on strategic business development opportunities.

我們第四個創造價值的支柱，是重新強調業務發展。我們聚焦於在 2028 至 2032 年期間具備營收潛力的機會，優先考量處於第3期註冊開發階段或已上市的資產。我們維持既有的治療領域關注重點，包括睡眠—覺醒、癲癇、罕見孤兒中樞神經系統疾病，以及超越罕見疾病的中樞神經系統相鄰領域。資產負債表上約有 8.7 億美元，我們正以緊迫感推動資本部署，並對執行策略性業務發展機會抱持明確信心。

In summary, I've outlined four pillars of value creation that we believe matter most to investors and will serve as the framework by which our performance will be measured. Next, the team will share with you the highlights of how we are executing on each of these strategic pillars.

總結而言，我已概述我們認為對投資人最重要、並將作為衡量我們績效之架構的四大價值創造支柱。接下來，團隊將與各位分享我們如何在每一項策略支柱上執行的重點成果。

With that, I'll turn the call over to Adam Zaeske, our Chief Commercial Officer, for an update on our commercial performance. Adam?

接下來，我將把電話會議交給我們的首席商務長（Chief Commercial Officer）Adam Zaeske，為各位更新我們的商業表現。Adam？

Thank you, Jeff. Good morning, everyone. We're off to a strong start in the first quarter with WAKIX delivering $215.4 million in net sales. Representing 17% year-over-year growth now in its seventh year on the market, which is in line with the growth required to achieve full year guidance of between $1 billion and $1.04 billion.

謝謝你，Jeff。各位早安。我們在第一季有個強勁的開局，WAKIX 淨銷售額達 2.154 億美元。在上市第七年之際，年增率達 17%，與達成全年 10 億至 10.4 億美元指引所需的成長幅度一致。

WAKIX achieved approximately 8,500 average patients in the first quarter. Q1 typically has lighter patient additions due to seasonal dynamics the entire industry experiences every year. This year, we saw slightly higher market access headwinds than previous years, with a higher level of plan changes, plan switching by consumers, and higher premium increases, which can delay patient starts. That said, we're coming off our strongest ever three consecutive quarters of patient adds.

WAKIX 在第一季達到約 8,500 名平均用藥患者。由於全產業每年都會遇到的季節性因素，第一季通常新增患者較少。今年我們看到相較往年略高的市場准入阻力，包括更高程度的保險計畫變更、消費者更換計畫，以及更高的保費上調，這些都可能延後患者開始用藥。儘管如此，我們剛結束史上最強的連續三個季度新增患者表現。

First quarter demand was actually higher than the first quarter in 2025 and was in line with our recent performance and expectations. In March, we saw a higher level of new prescriptions than all but two months in 2025, and we exited the quarter with 8,600 patients on WAKIX.

第一季的需求實際上高於 2025 年第一季，並與我們近期表現與預期一致。在 3 月，我們看到的新處方量高於 2025 年除兩個月份之外的所有月份，且我們在季度末時 WAKIX 用藥患者數達到 8,600 人。

The driving force behind this continued performance is clear. WAKIX owns a unique and highly differentiated position as the only non-scheduled treatment option for narcolepsy patients. After seven-plus years of clinical experience, healthcare providers are deeply aware of WAKIX.

推動這項持續表現的動力很明確。WAKIX 具備獨特且高度差異化的定位，作為嗜睡症患者唯一的非管制（non-scheduled）治療選項。在超過七年的臨床使用經驗後，醫療照護提供者對 WAKIX 已有深刻認識。

They believe in its combination of efficacy, safety, and tolerability, and low drug-drug interactions, as well as its broad payer coverage, making it a familiar go-to option for any patient with narcolepsy and in any combination with other therapies in a highly polypharmacy market. This will continue to remain true as the market continues to evolve.

他們信賴其療效、安全性與耐受性的組合、較低的藥物—藥物交互作用，以及廣泛的支付方（payer）給付覆蓋，使其在高度多重用藥（polypharmacy）的市場中，成為任何嗜睡症患者、以及可與其他療法任意合併使用的熟悉首選方案。隨著市場持續演變，這一點仍將持續成立。

We've now also completed our field team expansion, which has expanded our presence by roughly 20% across field sales, remote sales, and field reimbursement. This represents the largest expansion and increase in investment in the history of the brand. All of those positions have been hired and are in place as of April 1. In Q2, we will launch a new online portal easing the process to prescribe WAKIX for healthcare providers and office staff.

我們也已完成外勤團隊擴編，使我們在外勤銷售、遠端銷售與外勤給付支援方面的覆蓋約提升 20%。這是該品牌史上最大規模的擴編與投資增加。截至 4 月 1 日，所有職位均已完成招募並到位。在第二季，我們將推出新的線上入口網站，讓醫療照護提供者與診所人員更容易開立 WAKIX 處方。

We will execute significant changes to our reimbursement support process, helping patients to secure a WAKIX prescription faster and with higher success rates. Looking to the future, we're excited about our two lifecycle management strategies to extend and expand the pitolisant franchise. Pitolisant GR will build on the strength of WAKIX safety and tolerability profile and allow patients to gain faster results by starting at a therapeutic dose.

我們將對給付支援流程進行重大調整，協助患者更快、且以更高成功率取得 WAKIX 處方。展望未來，我們對兩項生命週期管理策略感到振奮，這些策略將延伸並擴大 pitolisant 產品線。Pitolisant GR 將建立在 WAKIX 安全性與耐受性優勢之上，並讓患者可從治療劑量起始，以更快獲得效果。

Pitolisant HD or high dose will bring a totally new optimized formulation to the market with up to 2 times the approved dose of WAKIX, all of the benefits of the GR formulation, and differentiated labeling regarding fatigue in narcolepsy and sleep inertia in IH. We're also excited about our orexin compound as we see an opportunity remains for Harmony to deliver an orexin that delivers on the promise of efficacy with a better safety and tolerability profile, once daily dosing, and indications across NT1, NT2, and IH.

Pitolisant HD（高劑量）將以全新、最佳化的劑型推向市場，最高可達 WAKIX 核准劑量的 2 倍，並具備 GR 劑型的所有優勢，同時在標示（labeling）上針對嗜睡症的疲勞（fatigue）與特發性嗜睡症（IH）的睡眠惰性（sleep inertia）提供差異化內容。我們也對我們的食慾素（orexin）化合物感到振奮，因為我們看到 Harmony 仍有機會推出一款食慾素藥物，在實現療效承諾的同時，具備更佳的安全性與耐受性、每日一次給藥，並涵蓋 NT1、NT2 與 IH 等適應症。

To summarize, we're on track to achieve $1 billion-plus in net sales this year, and we're excited about our pipeline with multiple assets that will extend our leadership in sleep wake for at least the next decade.

總結來說，我們正按計畫在今年達成 10 億美元以上的淨銷售額，並對我們的研發管線感到振奮；其中多項資產將在未來至少十年延續我們在睡眠—覺醒領域的領導地位。

I'd like to now turn the call over to our Chief Medical and Scientific Officer, Kumar Budur, to discuss the advancements in our clinical development programs. Kumar?

接下來我想把電話會議交給我們的首席醫學與科學長（Chief Medical and Scientific Officer）Kumar Budur，請他說明我們臨床開發計畫的進展。Kumar？

Thank you, Adam Zaeske. Good morning, everyone, and thank you for joining us today. Q1 2026 was a quarter of continued progress across our pipeline. We have five ongoing Phase 3 registrational clinical trials across five distinct CNS indications. I'll walk you through the key updates. As just noted, orexin is one of the most exciting areas in sleep-wake and broader neuropsychiatric indications.

謝謝你，Adam Zaeske。各位早安，也感謝各位今天加入我們。2026 年第一季是我們研發管線持續取得進展的一季。我們有五項正在進行的第3期註冊性臨床試驗，涵蓋五個不同的中樞神經系統（CNS）適應症。我將帶各位了解關鍵更新。如同剛才提到的，食慾素是睡眠—覺醒以及更廣泛神經精神適應症中最令人振奮的領域之一。

I would like to start with the progress we are making with our orexin-2 receptor agonist, BP-205, an asset we believe has meaningful potential that is not yet reflected in how our pipeline is being viewed today. BP-205, with its unique chemical scaffolding, has demonstrated compelling preclinical potency, selectivity, safety, and efficacy, and a potential for once-a-day dosing, all supportive of a potential best-in-class orexin-2 receptor agonist.

我想先從我們在食慾素2受體致效劑 BP-205 上取得的進展談起；我們認為這項資產具備重要潛力，但目前市場對我們管線的評價尚未反映其價值。BP-205 憑藉其獨特的化學骨架，已展現出具說服力的臨床前效力、選擇性、安全性與療效，並具備每日一次給藥的潛力，這些都支持其成為潛在同類最佳（best-in-class）的食慾素2受體致效劑。

It is the most potent orexin-2 receptor agonist in clinical development and demonstrated wake-promoting effect at the lowest dose tested in the transgenic mouse models for narcolepsy. The high potency gives the flexibility to use low doses and treat all three central disorders of hypersomnolence, that is NT1, NT2, and IH with the same compound. BP-205 also has high selectivity for orexin-2 receptors over orexin-1 receptors and 150 other receptors of interest. We continue to dose healthy volunteers in our Phase 1 SAD MAD PK study in Europe, and we remain on track for Phase 1 SAD PK data in mid 2026.

它是目前臨床開發中效力最強的食慾素2受體致效劑，並在嗜睡症的轉基因小鼠模型中，以所測試的最低劑量即展現促醒效果。高效力帶來以低劑量使用的彈性，並可用同一化合物治療三種中樞性嗜睡過度障礙，也就是 NT1、NT2 與 IH。BP-205 對食慾素2受體相較於食慾素1受體，以及另外 150 個關注受體，亦具有高度選擇性。我們在歐洲持續於第1期 SAD/MAD PK 研究中對健康受試者給藥，並仍按計畫於 2026 年年中取得第1期 SAD PK 數據。

We are also on track for US IND submission in mid 2026 and commence sleep-deprived healthy volunteer study in the second half of this year. As we make progress with our lead asset, BP-205, targeting central disorders of hypersomnolence. We are also working on preclinical experiments in broader neuropsych indications targeting mood, ADHD, cognition, and fatigue.

我們也按計畫於 2026 年年中提交美國 IND，並於今年下半年啟動睡眠剝奪的健康受試者研究。同時，我們正推進我們的主力資產 BP-205，鎖定中樞性嗜睡過度相關疾病。我們也在更廣泛的神經精神適應症上進行臨床前實驗，目標涵蓋情緒、ADHD、認知與疲勞。

Moving to pitolisant and the life cycle opportunities, beginning with Pitolisant GR. We remain on track for NDA submission in Q2 2026 and a target PDUFA date in Q1 2027. About 80%-90% of patients with narcolepsy have GI symptoms related to the pathophysiology of narcolepsy itself. Pitolisant GR is designed with enteric coating meant to reduce the potential for GI side effects in patients prone to GI symptoms. Pitolisant GR demonstrated bioequivalence to WAKIX in our pivotal BE study, and it also allows patients to start at the therapeutic dose range of 17.8 mg without titration, an important clinical differentiation.

接著談 pitolisant 及其產品生命週期機會，首先是 Pitolisant GR。我們仍按計畫於 2026 年第二季提交 NDA，並以 2027 年第一季為目標 PDUFA 日期。約有 80%–90% 的嗜睡症患者有與嗜睡症本身病理生理相關的腸胃道（GI）症狀。Pitolisant GR 採用腸溶包衣設計，旨在降低對於易出現 GI 症狀患者的 GI 副作用風險。在我們的關鍵性 BE 研究中，Pitolisant GR 證實與 WAKIX 具生體相等性，且也讓患者可在無需滴定的情況下，直接以 17.8 mg 的治療劑量範圍起始，這是一項重要的臨床差異化。

Pitolisant HD continues to advance in two Phase 3 registrational trials. ONSTRIDE 1 in narcolepsy and ONSTRIDE 2 in idiopathic hypersomnia. We anticipate top line data in 2027 and a target PDUFA date in 2028. These programs are pursuing differentiated labels, fatigue in narcolepsy and sleep inertia in IH, addressing symptoms for which there are currently no approved treatments.

Pitolisant HD 持續在兩項第三期註冊性試驗中推進。分別為嗜睡症的 ONSTRIDE 1 與特發性嗜睡症的 ONSTRIDE 2。我們預期於 2027 年取得主要結果（top-line data），並以 2028 年為目標 PDUFA 日期。這些計畫追求具差異化的適應症標示：嗜睡症的疲勞，以及 IH 的睡眠惰性（sleep inertia），以解決目前尚無核准治療的症狀。

Both Pitolisant GR and Pitolisant HD have utility patents filed until 2044. We are also optimistic about the novel amorphous form of pitolisant we recently licensed from Novitium, supported by an issued patent through 2042. We believe this could enable new modes of delivery and broaden pitolisant's potential in larger CNS indications. We are currently optimizing formulation with the goal of commencing a Phase 1 PK study.

Pitolisant GR 與 Pitolisant HD 均已申請效用專利，保護期至 2044 年。我們也對近期自 Novitium 授權取得的 pitolisant 新型非晶型態感到樂觀，並有已核發專利支持至 2042 年。我們相信這可望促成新的給藥方式，並擴大 pitolisant 在更大型中樞神經系統（CNS）適應症中的潛力。我們目前正優化配方，目標是啟動第一期 PK 研究。

On pediatric exclusivity for WAKIX, the top-line data from the Phase 3 TEMPO study in Prader-Willi syndrome is anticipated in second half of 2026. A key requirement for achieving pediatric exclusivity, which gives us additional 6-month regulatory exclusivity at the back end of the longest patent for WAKIX. Moving to our epilepsy franchise. EPX-100 continues to advance in two global Phase 3 registrational programs.

關於 WAKIX 的兒科獨占期，Prader-Willi 症候群第三期 TEMPO 研究的主要結果預計於 2026 年下半年公布。這是取得兒科獨占期的一項關鍵要求，可使我們在 WAKIX 最長專利到期後端額外獲得 6 個月的法規獨占期。接著談我們的癲癇產品線。EPX-100 持續在兩項全球第三期註冊性計畫中推進。

The ARGUS study in Dravet syndrome and the LIGHTHOUSE study in Lennox-Gastaut syndrome. We recently presented on-course safety and effectiveness data at the AAN meeting from the open-label extension study in Dravet syndrome that show clinically meaningful reduction in seizures and a favorable safety and tolerability profile. We now have sites actively enrolling patients in India and China in addition to North America and Europe to accelerate recruitment.

分別為 Dravet 症候群的 ARGUS 研究，以及 Lennox-Gastaut 症候群的 LIGHTHOUSE 研究。我們近期在 AAN 年會上發表 Dravet 症候群開放標籤延伸研究的期中安全性與有效性資料，顯示癲癇發作有具臨床意義的降低，且安全性與耐受性表現良好。除北美與歐洲外，我們目前也在印度與中國啟動據點積極收案，以加速招募。

We anticipate top-line data in sub half of 2027 and a target PDUFA in 2028. Finally, on behalf of Harmony Biosciences, 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 dedication and commitment in helping us advance our development programs.

我們預期於 2027 年下半年取得主要結果（top-line data），並以 2028 年為目標 PDUFA。最後，我謹代表 Harmony Biosciences，感謝所有參與我們臨床試驗的患者及其家屬，也感謝臨床研究者與各試驗中心人員的投入與承諾，協助我們推進研發計畫。

I'll now turn the call over to the newest member of our team, CFO Glenn Reicin, for an update on our financial performance. Glenn.

接下來我將把電話會議交給我們團隊最新加入的成員、財務長 Glenn Reicin，為各位更新我們的財務表現。Glenn。

Thank you, Kumar. Good morning, everyone. I'm delighted to join this organization and help contribute to the growth and significant value creation. I should mention that I was drawn to Harmony by the strength of its commercial foundation and self-funding financial model that positions us to build and grow from a place of strength.

謝謝你，Kumar。各位早安。我很高興加入這個組織，並協助推動成長與顯著的價值創造。我也想提到，我之所以被 Harmony 吸引，是因為其商業基礎的強勁，以及自給自足的財務模式，使我們能在優勢基礎上建構並成長。

This morning, we issued our first quarter 2026 earnings release and filed a 10-Q, where you'll find the details of our financial and operating results. We delivered solid financial results that reflect the continued underlying demand for WAKIX and our disciplined approach to managing expenses across the business. For the first quarter of 2026, we reported net revenues of $215.4 million, compared to $184.7 million in the prior year quarter, representing 17% growth.

今天早上，我們發布了 2026 年第一季財報新聞稿並提交了 10-Q，您可在其中找到我們財務與營運結果的詳細資訊。我們交出穩健的財務表現，反映 WAKIX 持續的基本需求，以及我們在全公司範圍內對費用管理的紀律。2026 年第一季，我們報告淨營收為 2.154 億美元，較去年同期的 1.847 億美元成長 17%。

Performance in the quarter reflects the strong underlying demand for WAKIX, partially offset by the seasonal market access headwinds the industry sees at the start of every year. Cost of goods or products sold was 20.7% of net sales and compares with 17.3% one year ago.

本季表現反映 WAKIX 強勁的基本需求，但部分被每年年初產業普遍面臨的季節性市場准入逆風所抵銷。銷貨成本（或產品銷售成本）占淨銷售額 20.7%，相較一年前為 17.3%。

This year-over-year increase in cost of products sold as a percentage of net revenue was almost entirely driven by new royalties related to the Novitium license agreement, providing new development opportunities in broader CNS indications. We reported total operating expenses for the first quarter of $133.6 million, compared to $96.5 million in the same quarter in 2025. The growth in expenses reflects continued investment in R&D and ongoing investments in the commercialization of WAKIX in narcolepsy.

銷貨成本占淨營收比重的年增，幾乎完全由與 Novitium 授權協議相關的新權利金所驅動，該協議為更廣泛的 CNS 適應症帶來新的開發機會。我們第一季總營業費用為 1.336 億美元，較 2025 年同季的 9,650 萬美元增加。費用成長反映我們持續加碼研發（R&D），以及持續投入 WAKIX 在嗜睡症領域的商業化。

These operating expenses also include the costs associated with upfront licensing fees of $32 million, or $0.45 per share on a fully taxed basis, related to the amorphous license agreements. Without these costs, operating expenses were up around 5%. GAAP net income for the first quarter of 2026 was $32.5 million or $0.55 per share.

這些營業費用亦包含與非晶型授權協議相關的一次性前期授權費 3,200 萬美元，按完全稅後基礎計算約為每股 0.45 美元。若不計入上述成本，營業費用約增加 5%。2026 年第一季 GAAP 淨利為 3,250 萬美元，或每股 0.55 美元。

This compares with $45.6 million or $0.78 per share. Of course, that includes $0.45 in costs related to the in-license of the amorphous form of pitolisant and new development opportunities. We ended the first quarter with $878.5 million in cash and cash equivalents. Cash flow generation in the quarter was muted by the licensing fees and a large reduction in accrued expenses and a modest reduction of debt. We ended the quarter with $160 million in debt.

相較之下，去年同期為 4,560 萬美元，或每股 0.78 美元。當然，其中包含與引進 pitolisant 非晶型態及新開發機會相關的每股 0.45 美元成本。第一季末，我們持有現金及約當現金 8.785 億美元。本季現金流生成受到授權費用、大幅降低應計費用，以及小幅減債的影響而較為溫和。季末我們的負債為 1.6 億美元。

Cash flow generation will re-accelerate in the coming quarters. That said, it's our intent to deploy cash into business development with the objectives of enhancing revenues in the 2028 to 2032 timeframe, consistent with our four key pillars of value creation for shareholders.

未來幾季現金流生成將再度加速。即便如此，我們的意圖是將現金投入業務開發，目標是在 2028 至 2032 年期間提升營收，並與我們為股東創造價值的四大支柱一致。

With that, I'd like to turn the call over to Jeff for his closing remarks. Jeff?

接下來，我想把電話會議交給 Jeff，請他做結語。Jeff？

Thank you, Glenn, and again, welcome to the team. In closing, I have shared with you our four pillars of value creation that we feel matter most to investors and will serve as the framework by which our performance will be measured. First, protect the pitolisant franchise into the 2030s. Second, continued growth of the pitolisant franchise in an evolving market.

謝謝你，Glenn，也再次歡迎加入團隊。最後，我已與各位分享我們認為對投資人最重要、並將作為衡量我們表現之框架的四大價值創造支柱。第一，將 pitolisant 產品線保護延伸至 2030 年代。第二，在不斷演變的市場中持續推動 pitolisant 產品線成長。

Third, drive value from our robust pipeline centered around BP-205, our potential best-in-class orexin 2 agonist. Last, a renewed emphasis on business development with our goal to transact. We believe when we execute on these four strategic pillars, we will be well-positioned to bring innovative treatments to patients with unmet medical needs while driving sustained long-term value for our shareholders. Thank you for your attention.

第三，從以 BP-205 為核心的強勁研發管線中創造價值；BP-205 是我們具潛力的同類最佳（best-in-class）orexin 2 受體致效劑。最後，重新強調業務開發，並以達成交易為目標。我們相信，當我們落實這四項策略支柱時，將能在為未被滿足醫療需求的患者帶來創新治療的同時，為股東帶來可持續的長期價值。感謝各位的聆聽。

I will now turn the call back over to the operator for Q&A. Operator?

我現在把電話交回給接線員進行問答。接線員？

(Operator Instructions) David Amsellem, Piper Sandler.

(接線員指示) David Amsellem，Piper Sandler。

Hey, thanks. I have a few questions on BP-205. Just give us a roadmap on how to think about data milestones as we move through 2027, particularly in healthy sleep-deprived volunteers. Secondly, why not just move right into actual narcolepsy 1 and narcolepsy 2 in IH patients in a Phase 1-B, just given that it's become a pretty crowded landscape, just as a way to expedite development.

嗨，謝謝。我有幾個關於 BP-205 的問題。請給我們一個路線圖，說明在推進到 2027 年的過程中，應該如何看待數據里程碑，特別是在健康、睡眠剝奪的受試志願者中。第二，為什麼不在 1b 期直接進入實際的第一型嗜睡症與第二型嗜睡症（在 IH 患者中），考量到這個領域已經相當擁擠，這樣是否能加速開發。

I wanted to get your thought process there. Lastly, with other indications, mood, ADHD, cognition, fatigue, as you alluded to, can you talk about early-stage work that you're going to be doing over the next 12 to 18 months that could help you decide what paths to take in terms of the non-sleep break indications? Thanks.

我想了解你們背後的思考邏輯。最後，關於其他適應症——情緒、ADHD、認知、疲勞——如你們提到的，能否談談未來 12 到 18 個月你們將進行哪些早期階段工作，以協助你們決定在非睡眠/覺醒相關適應症方面要走哪些路徑？謝謝。

Good morning, David. Thank you for your question. With regards to BP-205, first, let me frame overall, you know, our excitement around, you know, the potential opportunity we have, you know, with our orexin-2 agonist. It's really based on, you know, as you've heard us say, the novel chemical scaffold and really the, you know, the highest potency of any orexin-2 agonist in the clinic.

早安，David。謝謝你的提問。關於 BP-205，首先我想先從整體角度來框架一下，也就是我們對於這個 orexin-2 受體致效劑所帶來潛在機會的興奮之情。這主要是基於——正如你們聽我們說過的——其新穎的化學骨架，以及在臨床中的 orexin-2 致效劑裡具有最高的效力。

With that, it gives sort of the differentiated features of with a product profile likely to be, you know, best in class. With regards to timing of the development program and other indications, first, the issue with indications outside sleep-wake and central disorders of hypersomnolence, the opportunity there is that those are not based on a state of orexin deficiency.

因此，它帶來了差異化特徵，使其產品特性很可能成為同類最佳（best in class）。至於開發計畫的時程與其他適應症，首先，對於睡眠-覺醒與中樞性嗜睡障礙以外的適應症，其機會在於：那些並非建立在 orexin 缺乏的狀態之上。

In those conditions, potency matters, where we think we would have a significant opportunity, not just with BP-205, but other compounds that we're working on with our partner, Bioprojet. Now I'll ask Kumar to sort of provide, you know, what the timeline looks like on the current development program. Kumar?

在那些狀況下，效力就很重要；我們認為我們會有顯著的機會，不僅是 BP-205，還包括我們與合作夥伴 Bioprojet 正在研發的其他化合物。接下來我請 Kumar 大致說明目前開發計畫的時間線。Kumar？

Thank you, Jeffrey. Good morning, David Amsellem. You asked several questions. Let me try and answer one by one. In terms of data milestones, we are on track to receive single ascending dose clinical PK data in the middle of this year. We also continue to dose patients in multiple ascending dose study, the food effect study, things like that that are important before we go to the later clinical stage of development.

謝謝你，Jeffrey。早安，David Amsellem。你問了好幾個問題。我試著逐一回答。就數據里程碑而言，我們按計畫在今年年中取得單次遞增劑量（SAD）的臨床藥物動力學（PK）數據。我們也持續在多次遞增劑量（MAD）研究、食物效應研究等項目中給藥，這些都是在進入後期臨床開發前的重要工作。

In terms of your question, why not go straight into clinical proof of concept rather than sleep-deprived healthy volunteer study? Great question, David Amsellem. One thing to remember is BP-205 is the most potent orexin receptor agonist in clinical development. It's good to get a nice bracket around the dose range before we go into clinical proof of concept studies.

至於你問為什麼不直接進入臨床概念驗證（proof of concept），而是先做睡眠剝奪的健康志願者研究？這是個好問題，David Amsellem。有一點要記得，BP-205 是目前臨床開發中效力最強的 orexin 受體致效劑。在進入臨床概念驗證研究之前，先把劑量範圍界定得更清楚是有幫助的。

Also another thing to remember is. This is not going to add to the timeline. This is done in parallel with the multiple ascending dose study and the data we need that before we go into clinical proof of concept studies. You also talked about the other indications. Yes, we are very excited about the profile of BP-205. Most potent orexin receptor agonist.

另外還有一點要記得。這不會拉長整體時間線。這項工作會與多次遞增劑量研究並行進行，而我們在進入臨床概念驗證研究前也需要那些數據。你也提到了其他適應症。是的，我們對 BP-205 的特性非常興奮。它是效力最強的 orexin 受體致效劑。

Jeff alluded to some extent in his response. It's very important that potency translates into efficacy, and we saw that in our preclinical animal models and in other indication, it becomes all the more important because we'll be depending on some of the downstream effects of the orexin receptor agonists in conditions like mood, fatigue, cognition, ADHD. We are conducting several preclinical experiments right now, and as the data becomes available, we'll be able to disclose. Hope that answered all of your questions.

Jeff 在回覆中也提到了一部分。非常重要的一點是：效力必須能轉化為療效；我們在臨床前動物模型中看到了這一點，而在其他適應症上這點更為重要，因為我們將仰賴 orexin 受體致效劑在情緒、疲勞、認知、ADHD 等狀況中的一些下游效應。我們目前正在進行數項臨床前實驗，隨著數據出爐，我們將能對外揭露。希望這回答了你所有的問題。

Yeah. David, final comment on that. I think as I've discussed with the team, given the potential value of this class of compounds, it's our intent to invest in this program with regard to where we are now on additional compounds and look at the broad opportunity with not just BP-205, but other compounds that we're working on. Thanks, David.

是的。David，最後補充一句。我想如同我和團隊討論過的，鑑於這一類化合物的潛在價值，我們的意圖是持續投入這個計畫——就我們目前在其他新增化合物的進展而言——並且不僅著眼於 BP-205，也會評估我們正在研發的其他化合物所帶來的廣泛機會。謝謝，David。

(Operator Instructions) Ami Fadia, Needham.

(接線員指示) Ami Fadia，Needham。

Good morning. Thanks for taking my question. Maybe one main question and a follow-up. You gave some sense about the litigation versus AET/Sandoz, and then there seem to be two trials here. Can you talk about kind of what we can expect in terms of next steps with regards to how the litigation might proceed, and, you know, over the course of the next couple of months?

早安。謝謝讓我提問。我可能有一個主要問題和一個追問。你們提到一些關於與 AET/Sandoz 的訴訟情況，而且這裡似乎有兩個審理程序。能否談談接下來在訴訟可能如何推進方面，我們可以期待哪些下一步，以及在未來幾個月內可能的進展？

A follow-up on the orexin question from earlier. With the sort of higher potency that you've highlighted, how do you see it being differentiated in the sleep-wake area relative to the other orexins that are in development? Can you elaborate a little bit more on the other indications?

另外追問先前關於 orexin 的問題。就你們強調的較高效力而言，你們認為在睡眠-覺醒領域，相較於其他正在開發中的 orexin 藥物，會如何形成差異化？也能否再多談一點其他適應症？

Do you see that, you know, other indications such as ADHD, mood, fatigue, et cetera, being ones where you would study it as a combination treatment with other assets? Do you see it being developed both as a monotherapy and then also explore other combinations? Thank you.

你是否認為像 ADHD、情緒、疲勞等其他適應症，會是你們把它作為與其他資產合併治療來研究的方向？你們是否會同時把它作為單藥治療開發，並且也探索其他合併用藥？謝謝。

Morning, Ami. Then I'll have Kumar address the follow-up on BP-205. I want to take a minute or two to provide clarity with regards to the IP situation around the WAKIX and pitolisant IP estate.

早安，Ami。接著我會請 Kumar 回答關於 BP-205 的追問。我想花一兩分鐘釐清一下關於 WAKIX 與 pitolisant 的智慧財產（IP）布局情況。

Before I provide some detail, I first want to be clear about our position. We believe in the strength of our IP, and we continue to vigorously protect it. It's based on a multi-pronged strategy with pitolisant IP estate, which is also multi-layered. With regard to some of the detail, the detail to provide clarity.

在我提供一些細節之前，我先清楚說明我們的立場。我們相信我們 IP 的強度，並且會持續積極地加以保護。這是基於多管齊下的策略，針對 pitolisant 的 IP 組合（estate），而該組合本身也是多層次的。至於一些細節——提供這些細節是為了釐清。

Recall we settled with six of the seven ANDA filers. AET was the one remaining party who went to trial in February. That legal process continues. It's currently in post-trial briefs. That part of the process will be completed towards the end of May.

回顧一下，我們已與七家 ANDA 申請者中的六家達成和解。AET 是唯一剩下並在二月進入審理的當事方。該法律程序仍在進行中。目前處於庭後書狀（post-trial briefs）階段。這一部分流程將在五月底前後完成。

During the trial in February, AET and Sandoz stated that, you know, the product will contain an amorphous form of pitolisant hydrochloride rather than a crystalline form, which is covered by our '197 polymorph patent. They did that sort of in an effort to work around that IP. We believe that AET and Sandoz infringed our '197 patent, and during the trial, they also admitted to the facts that they infringed the '920 amorphous patent that we licensed from Novitium.

在二月的審理期間，AET 與 Sandoz 表示，其產品將包含 pitolisant hydrochloride 的非晶型（amorphous）形式，而非晶型形式；而晶型形式受到我們的 '197 多晶型（polymorph）專利所涵蓋。他們這麼做某種程度上是為了繞開該 IP。我們認為 AET 與 Sandoz 侵害了我們的 '197 專利；而且在審理中，他們也承認了其侵害我們自 Novitium 授權取得的 '920 非晶型專利的相關事實。

Based on that, when we learned of that at the trial, that is when Harmony and Novitium recently filed the patent infringement lawsuit against AET/Sandoz alleging infringement of the '920 patent covering an amorphous form of pitolisant hydrochloride. That suit is a new and separate action, different from the legal proceedings of the ANDA litigation that took place in February, which is ongoing. That new suit is also being presided over by the same judge.

基於此，當我們在審理中得知該情況時，也就是 Harmony 與 Novitium 近期對 AET/Sandoz 提起專利侵權訴訟之時，主張其侵害涵蓋 pitolisant hydrochloride（鹽酸匹托利桑）非晶形態的 '920 專利。該訴訟是一項新的且獨立的行動，與 2 月進行且仍在持續中的 ANDA 訴訟法律程序不同。該新訴訟亦由同一位法官主審。

That is a new legal proceeding which is just getting started. Based on this multi-pronged strategy, the different factors that I just mentioned, we remain confident in the strength of the IP estate, again, which is multi-layered with multiple components, enabling exclusivity, you know, into 2030, inclusive of six months of pediatric exclusivity. Kumar, over to you.

這是一項剛剛開始的新法律程序。基於這項多管齊下的策略，以及我剛提到的不同因素，我們仍對 IP 資產組合的強度充滿信心；再次強調，這是一個多層次、由多個組成部分構成的組合，可帶來排他性，您知道，一直到 2030 年，並包含 6 個月的兒科排他期。Kumar，交給你。

Thank you, Jeff. Good morning, Ami. In terms of potency, you may have heard me talk about it many, many times in the past as well, why potency matters with orexin 2 receptor agonists. It matters because it gives us the ability or the flexibility to use low doses to target all three central disorders of hypersomnolence. How it could potentially manifest itself in a clinical setting? Well, with low doses, we'll be able to avoid the off-target AEs. That's number one.

謝謝你，Jeff。早安，Ami。就效價（potency）而言，你可能也聽我在過去談過很多很多次，為什麼效價對食慾素 2 受體致效劑很重要。重要之處在於，它讓我們有能力或彈性以低劑量來針對所有三種中樞性嗜睡障礙。它在臨床情境中可能會如何呈現？嗯，使用低劑量，我們將能避免非目標相關的不良事件（AEs）。這是第一點。

The number two is having a high-potent drug. As you know, the doses required for NT2 and IH are relatively larger based on the data that we have. It provides us an opportunity to use the same compound to treat all three central disorders of hypersomnolence, NT1, NT2, and IH, rather than use different compounds or go to high doses, which may actually result in some AEs.

第二點是擁有一個高效價藥物。如你所知，根據我們掌握的數據，NT2 與 IH 所需的劑量相對較大。這讓我們有機會使用同一個化合物來治療所有三種中樞性嗜睡障礙——NT1、NT2 與 IH——而不是使用不同化合物或提高到高劑量，因為那可能實際上會導致一些不良事件（AEs）。

In terms of the combination, that's a great question, Ami. There is a scientific rationale to potentially realize synergistic effects by combining pitolisant, which is a histaminergic drug, with an orexin agonist because the neurocircuitry is such that orexin acts at a higher level, and the neuronal connections between the orexinergic neurons and histaminergic neurons in tuberomammillary nucleus is very well established. This is something that we are very interested in and we are looking into.

至於聯合用藥，這是個很好的問題，Ami。將 pitolisant（這是一種組織胺能藥物）與食慾素致效劑合併使用，從科學上有其理據，可能實現協同效應，因為神經迴路的特性是：食慾素在更上游的層級發揮作用，而且在結節乳頭體核（tuberomammillary nucleus）中，食慾素能神經元與組織胺能神經元之間的神經連結已被充分證實。這是我們非常感興趣、也正在研究的方向。

Gregg Moskowitz, Mizuho.

Gregg Moskowitz，Mizuho。

Okay. Thank you for taking my questions. I've got two. My first just, if we could just talk about the WAKIX ramp right now. My apologies, I a bit late on the call. I know that you're reiterating the guidance for this year, and that you added 100 net patients. Should we expect the balance of the year to pretty much reflect what we've seen in the past in terms of second quarter, third quarter, and fourth quarter dynamics? Is there anything this year as the product matures that we need to be aware of?

好的。謝謝讓我提問。我有兩個問題。第一個是，如果我們現在可以談談 WAKIX 的爬坡（ramp）。抱歉，我稍微晚加入電話會議。我知道你們重申了今年的指引，並且新增了 100 名淨新增患者。我們是否應該預期今年剩餘期間大致會反映過去在第二季、第三季與第四季的動態？隨著產品逐漸成熟，今年是否有任何我們需要留意的事項？

Just secondly, going back to the ongoing litigations that are ongoing, I was curious if you could provide a sense of in terms of the timing of when you decided to sue on this, on a second lawsuit on the potential Novitium IP that you licensed in. I was curious as to why you chose to sue when you did versus perhaps waiting for the outcome of the original ANDA litigation on a view that, at least based on our work, I think there's still a potential chance that you would win. Thanks for my questions.

第二個問題，回到目前仍在進行的訴訟，我想了解一下你們決定就此提起第二起訴訟（針對你們授權引進的潛在 Novitium IP）的時間點。我好奇你們為何選擇在當下提告，而不是等待原本 ANDA 訴訟的結果；至少根據我們的研究，我認為你們仍有可能勝訴。謝謝我的提問。

Good morning, Gregg. With regards to WAKIX performance, let me just sort of frame and then over Adam Zaeske for more commentary. I think we're off to a strong start, you know, with good strong demand that continues for the WAKIX franchise. As well as through the quarter, we saw good momentum, you know, coming out of the first quarter exiting with about 8,600 average patients. With that, you know, we're on track to achieve full year guidance of over $1 billion, and I think Adam Zaeske can provide more color on, you know, the continued growth of the WAKIX franchise.

早安，Gregg。關於 WAKIX 的表現，我先做個框架說明，然後交給 Adam Zaeske 補充更多評論。我認為我們開局強勁，WAKIX 產品線持續有良好且強勁的需求。同時在本季期間，我們看到良好的動能；第一季結束時平均患者數約 8,600 人。在此基礎上，我們正按計畫達成全年超過 10 億美元的指引；我想 Adam Zaeske 可以就 WAKIX 產品線的持續成長提供更多細節。

Thanks, Jeff, good morning, Greg. Thanks for the question. In the first quarter, we achieved $215.4 million in net sales. That represents about 17% growth year-over-year, that is exactly the growth level that we need to achieve in order to hit our full year guidance of $1 billion-$1.04 billion for the full year.

謝謝，Jeff，早安，Greg。謝謝你的問題。第一季我們達成 2.154 億美元的淨銷售額。這代表年增約 17%；這正是我們為了達成全年 10 億至 10.4 億美元全年指引所需要的成長水準。

Greg, as you know, we've talked about this before, we typically see a seasonal headwinds in the first quarter as we start the year, related to market access and payer changes, we saw that again this year, no surprise. Plan changes, consumer switching plans, increases in premiums, you know, these are factors that can delay some patient starts as we start the new calendar year, we saw that again this year.

Greg，如你所知，我們之前談過，通常在每年第一季開始時會看到季節性逆風，與市場准入及付款方變動有關；今年我們也再次看到，並不意外。方案變更、消費者更換保險方案、保費上升等因素，都可能在新曆年開始時延後部分患者啟用治療；今年我們也再次看到這種情況。

That said, underlying demand remains very strong. You know, we're just coming off three consecutive quarters of record growth, and we saw the same level of demand in terms of new prescriptions and new patient starts, consistent with that recent performance.

儘管如此，基本面需求仍然非常強勁。我們剛經歷連續三個季度的創紀錄成長，而在新處方與新患者啟動方面，我們看到的需求水準與近期表現一致。

Actually, first quarter demand this year was even higher than it was a year ago. In March, we saw the highest demand that we've seen in all but two months in 2025. The momentum is there. To answer your question directly, yes, we would expect the remainder of the year to play out similarly as we've seen, really in the last six years in terms of WAKIX performance. That this, first quarter is just down to the typical, you know, start of the year market access headwinds. Thanks for the question.

事實上，今年第一季的需求甚至高於一年前。在 3 月，我們看到的需求是 2025 年除兩個月份之外的最高水準。動能確實存在。直接回答你的問題：是的，我們預期今年剩餘期間的走勢會與過去、就 WAKIX 表現而言、近六年所見的情況相似。第一季的下滑主要只是典型的年初市場准入逆風所致。謝謝你的問題。

Gregg, with regards to the second question on the timing of our lawsuit with Novitium with regards to the amorphous patent, I want to take the opportunity to welcome Peter Anastasiou to the Harmony team, our Chief Operating Officer, who is working very closely with me on all the matters related to IP and the litigation. Peter.

Gregg，關於你第二個問題——我們就 Novitium 的非晶專利提起訴訟的時間點——我想藉此機會歡迎 Peter Anastasiou 加入 Harmony 團隊；他是我們的營運長（Chief Operating Officer），正與我密切合作處理所有與 IP 及訴訟相關的事項。Peter。

Yeah. Hello, everyone. It's a pleasure to be on the call with you. Look forward to meeting those of you I don't know in the very near future. To answer your question in terms of timing. First, let me just say we agree with you that we believe we will prevail in the ANDA case. This filing of this lawsuit in no way reflects any other belief than that. It's in an effort to make sure that we're asserting our full rights. We believe that evidence was introduced that

是的。各位好。很高興能與各位一同參與這通電話會議。也期待在不久的將來與我尚未認識的各位見面。就時間點來回答你的問題。首先，我先說我們同意你的看法：我們相信我們會在 ANDA 案中勝出。提起這起訴訟並不代表我們有任何不同的信念。這是為了確保我們主張我們全部的權利。我們相信已有證據被提出，顯示

That there is infringement on our polymorph patent, and we believe that our method of use patent is absolutely valid. Having said that, during that trial, AET and Sandoz also introduced very clear evidence that they are violating the amorphous patent, the '920 amorphous patent, that we licensed from Novitium.

存在對我們多晶型（polymorph）專利的侵權，而且我們相信我們的方法使用（method of use）專利絕對有效。話雖如此，在該次審理期間，AET 與 Sandoz 也提出了非常明確的證據，顯示他們正在違反我們從 Novitium 授權取得的非晶專利——'920 非晶專利。

When you asked about timing, it was after those facts were entered into evidence in the trial that we, along with our partner, Novitium, decided that we were going to fully assert our rights to defend the IP for pitolisant. As Jeff has said many times, this is a multi-layered approach. That's why we filed suit in April. Again, these are two different cases with two different time courses, and we believe that we will prevail in both cases.

當你問到時點時，是在那些事實於審判中被納入證據之後，我們與合作夥伴 Novitium 一起決定，我們將全面主張我們的權利，以捍衛 pitolisant 的智慧財產權。正如 Jeff 多次提到的，這是一個多層次的方法。這就是我們在四月提起訴訟的原因。再次強調，這是兩個不同的案件，具有兩條不同的時間進程，而我們相信我們將在兩個案件中都勝訴。

That's why we have strong confidence in our exclusivity going into 2030 inclusive of the 6-month exclusivity.

這也是為什麼我們對我們直到 2030 年（包含額外 6 個月獨占期）的獨占權抱持高度信心。

Great. Thank you, Peter. Thanks, Greg.

很好。謝謝你，Peter。謝謝，Greg。

Pete Stavropoulos, Cantor Fitzgerald.

Cantor Fitzgerald 的 Pete Stavropoulos。

Yes, good morning, Jeff, and team. Congrats to Glenn and Peter on joining the team, and thank you for taking our questions. You know, can you touch on EPX-100 for Dravet? The clinical data disclosed at AAN. Can you comment on baseline seizure rates and baseline anti-seizure med use? Sort of, how do they compare to the real world patients and patients enrolled in other Dravet clinical trials? With interim OLE efficacy data, and safety data in hand, you know, what's your view on the emerging benefit risk profile? How competitive do you believe the profile is, and where do you see it fitting into the current landscape? Thank you.

是的，早安，Jeff 與團隊各位。恭喜 Glenn 和 Peter 加入團隊，也謝謝你們回答我們的問題。你們能談談用於 Dravet 的 EPX-100 嗎？在 AAN 公布的臨床數據。你們能評論一下基線發作頻率以及基線抗癲癇用藥的使用情況嗎？也就是說，它們與真實世界患者以及其他 Dravet 臨床試驗入組患者相比如何？在掌握期中 OLE 療效數據與安全性數據的情況下，你們如何看待正在浮現的效益/風險特徵？你們認為這個特徵的競爭力如何，又認為它會在目前的治療版圖中扮演什麼角色？謝謝。

Good morning, Pete. Thanks for your question. Kumar?

早安，Pete。謝謝你的提問。Kumar？

Good morning, Pete. EPX-100 clinical data that was presented at the recent AAN meeting, that's encore data that we had already presented at the AES meeting in December last year. Just to refresh, the data is from the open label extension part of the ARGUS study, the Phase 3 pivotal registration study in Dravet syndrome. What the data showed is that in patients who had at least six months of exposure to EPX-100, we saw a median reduction of 50% in seizures as measured by CMS-28. We also saw 50% of patients experiencing 50% reduction in seizures. Both of these measures are considered clinically meaningful.

早安，Pete。近期 AAN 會議上呈現的 EPX-100 臨床數據，是我們去年 12 月在 AES 會議上已經發表過的延伸數據。簡單回顧一下，這些數據來自 ARGUS 研究的開放標籤延伸（open label extension）部分；ARGUS 是 Dravet 症候群的第三期關鍵性註冊試驗。數據顯示，在至少接受 EPX-100 治療六個月的患者中，以 CMS-28 衡量的癲癇發作中位數降低 50%。我們也看到有 50% 的患者達到癲癇發作降低 50% 的結果。這兩項指標都被視為具有臨床意義。

The other side of the coin is safety and tolerability, which is extremely important in this patient population, given many of these patients are on four to six anti-seizure medications and still have residual seizures. That's exactly how EPX-100 was used in this study as adjunctive therapy.

另一方面是安全性與耐受性，考量到這個患者族群極為重要，因為許多患者同時使用四到六種抗癲癇藥物，仍然有殘餘發作。而在本研究中，EPX-100 正是以輔助治療（adjunctive therapy）的方式使用。

On average, patients were on about four different anti-seizure medications. It doesn't require any special monitoring, which is very important. No echocardiograms, for example. The lab values were really fine, so there is no need to monitor liver function tests, as is often the case with some of the anti-seizure medications.

平均而言，患者大約同時使用四種不同的抗癲癇藥物。它不需要任何特殊監測，這非常重要。例如不需要做心臟超音波（echocardiograms）。實驗室數值表現良好，因此不需要監測肝功能檢查，這在某些抗癲癇藥物上常常是必要的。

More importantly, the tolerability, because a lot of these medicines do cause nausea, vomiting, abdominal cramps, diarrhea in patients up to 20%-30% in some instances. What we saw with EPX-100, the only AE of note was actually diarrhea in about 2% of the patients. The combination of clinically meaningful efficacy, favorable safety and tolerability profile as an adjunctive therapy in a patient population known for refractory seizures position EPX-100 very well from a clinician, from a prescribing algorithm perspective. Hope I answered all of your questions.

更重要的是耐受性，因為許多藥物確實會造成噁心、嘔吐、腹部絞痛、腹瀉，在某些情況下可達 20%–30% 的患者。我們在 EPX-100 看到的，唯一值得注意的不良事件（AE）其實是約 2% 患者出現腹瀉。在一個以難治性癲癇發作著稱的患者族群中，具臨床意義的療效、良好的安全性與耐受性（作為輔助治療）之組合，從臨床醫師與處方決策流程的角度來看，使 EPX-100 的定位非常有利。希望我已回答你所有的問題。

Thanks, Kumar.

謝謝你，Kumar。

Patrick Trucchio, HC Wainwright.

HC Wainwright 的 Patrick Trucchio。

Thanks. Good morning. I was hoping to get a little bit more detail on the BD's strategy, just in terms of the sort of the size and the disease areas that you would be most interested in, particularly as we think about, you know, CNS adjacent diseases beyond rare disease. Separately, as we approach the BP-205 data in the middle of this year, I'm wondering if you can tell us what specific PK parameters and tolerability bar would validate, you know, the best-in-class claim.

謝謝。早安。我希望能更詳細了解一下 BD 的策略，主要是就你們最感興趣的交易規模與疾病領域而言，特別是當我們思考罕見疾病以外、與中樞神經系統（CNS）相鄰的疾病時。另外，隨著我們接近今年年中公布 BP-205 數據，我想請問哪些特定的藥物動力學（PK）參數與耐受性門檻，能夠驗證你們所稱的同類最佳（best-in-class）主張？

Morning, Patrick. Thank you for your questions. Let me first address the question on our BD strategy, then turn it over to Kumar for your second question. I first want to, with regard to the renewed emphasis on business development, just take a minute on the strategy and our thinking there.

早安，Patrick。謝謝你的問題。我先回答關於我們 BD 策略的問題，接著把第二個問題交給 Kumar。首先，關於我們重新強調業務開發，我想花一點時間談談策略以及我們的思考。

It's important to note, I think we have a renewed organizational commitment to transact with regards to business development. This is from the management team to our board, and then obviously the two members of the management team, Peter and Glenn, that bring very relevant experience doing deals and really strengthens the overall ability for us to move this forward and execute on this key priority.

我認為重要的是要注意到，我們在組織層面對於就業務開發進行交易有了新的承諾。這從管理團隊到董事會皆是如此；而且管理團隊中的兩位成員 Peter 與 Glenn 帶來了非常相關的交易經驗，確實強化了我們整體推動並落實這項關鍵優先事項的能力。

Obviously, it's one of BD, and the renewed emphasis is one of our four key pillars of value creation as we see, you know, the urgency and conviction to deploy our capital, put it to work. To generate sustained value. I want to ask, you know, Glenn to comment on thoughts on capacity, where we are there. Peter, with regards to what's the strategic focus of, you know, what we are considering. Glenn?

很明顯，BD 以及重新強調 BD，是我們所認為的四大價值創造支柱之一，因為我們看到運用資本、讓資本投入運作的急迫性與信念，以創造可持續的價值。我想請 Glenn 談談我們的資金/交易承載能力目前如何。Peter 則談談我們正在考量的策略重點是什麼。Glenn？

Yeah. I mean, capacity we actually have quite a bit, given our cash balance and our ability to borrow as well. Obviously, not preferred, but we can always use stock. We have quite a bit of capacity. Size deals, I think are not a limiting factor.

好的。就承載能力而言，考量到我們的現金餘額以及我們也有借款能力，其實我們有相當大的空間。當然這不是首選，但我們也可以使用股票。我們有相當大的承載能力。我認為交易規模不是限制因素。

With regards to strategic focus, it's really, it's an evolution. It's an evolution of our strategy. It's a refinement. It's not a major pivot sort of in the road. Peter, if you want to sort of highlight what we're thinking in that area.

至於策略重點，這其實是一種演進。是我們策略的演進。是一種精煉。並不是道路上的重大轉向。Peter，如果你願意，可以重點說明一下我們在這方面的想法。

Absolutely. There's a number of criteria that we're looking at, but I also want to say we're also willing to be opportunistic and keep an open mind to other opportunities as well. In terms of the areas of focus, it is of course revenue potential, especially near term revenue potential, especially in the 20-32 timeframe. That implies something that's in the Phase 3 or registrational phase, or even on market, quite frankly.

當然。我們正在評估多項標準，但我也想說，我們也願意把握機會，對其他機會保持開放的心態。就聚焦領域而言，當然是營收潛力，尤其是近期營收潛力，特別是在 20-32 年這個時間範圍內。這意味著標的可能處於第三期或註冊階段，甚至坦白說已經上市。

You know, we're big believers that the types of things we should look at are things that are related to our core competencies, and we feel we have many core competencies. Clearly in the sleep-wake space, we've demonstrated a lot of success and will continue to demonstrate success in that space. Because narcolepsy is in the rare orphan CNS space, we believe that capability can be applied there. We've also been building an epilepsy presence, that's an area of focus for us in a variety of different epilepsies.

你知道，我們非常相信我們應該看的類型，是與我們核心能力相關的事物，而我們認為我們有許多核心能力。很明顯在睡眠—覺醒領域，我們已經展現了很多成功，並且會持續在該領域展現成功。因為嗜睡症屬於罕見的孤兒中樞神經系統（CNS）領域，我們相信這項能力也可以應用到那裡。我們也一直在建立癲癇領域的布局，這是我們的聚焦方向之一，涵蓋多種不同的癲癇類型。

Certainly other things that are adjacencies to all of those within the CNS space that we believe we could leverage our core competencies. We are agnostic to deal type. We're looking at M&A, we're looking at licensing, we're looking at collaborations. We have kind of a broad aperture in the way we're thinking about accessing and sourcing some of these deals. I will also say, while our focus is very heavily on near term revenue, we are also in parallel looking at bolt-on opportunities that fit nicely within within our current construct.

當然，在中樞神經系統（CNS）領域內，還有其他與上述各項相鄰的機會，我們相信可以運用我們的核心能力加以發揮。我們不拘泥於交易類型。我們在看併購（M&A）、也在看授權、也在看合作。我們在思考如何取得並尋找這些交易時，視野相當廣。我也想補充，雖然我們的重點非常著重於短期營收，但同時我們也在並行評估一些能與我們現有架構高度契合的附加式（bolt-on）機會。

That hopefully gives you some color. I'll also just end by saying we have a really strong BD team and really strong capabilities that we plan to mobilize and put into action with this renewed focus and commitment from not just this management team, but also the board.

希望這能讓你更了解一些。最後我也想說，我們有一支非常強的商務開發（BD）團隊，以及非常強的能力；在這次重新聚焦與承諾之下，我們計畫把這些能力動員起來並付諸行動，而這份承諾不僅來自管理團隊，也來自董事會。

Yeah. Thanks, Peter. Thanks, Glenn. In addition to the strong business development team, we also have a very strong commercial engine. You know, any of these potential bolt-ons or on-market opportunities, we've always wanted to utilize that commercial engine and put it to work in terms of generating, you know, more revenue. Patrick, I see Kumar to BP-205.

是的。謝謝你，Peter。謝謝你，Glenn。除了強大的商務開發團隊之外，我們也有非常強的商業化引擎。你知道，任何這些潛在的附加式（bolt-on）或已上市（on-market）的機會，我們一直都希望能運用這個商業化引擎，讓它發揮作用以帶來更多營收。Patrick，我看到 Kumar 問到 BP-205。

Good morning, Patrick. Great question on the broader CNS indications. All the central disorders of hypersomnolence are the logical, natural choice for orexin 2 receptor agonist. We are also excited at the potential for orexin 2 receptor agonist in broader CNS indications.

早安，Patrick。關於更廣泛的 CNS 適應症，這是個很好的問題。所有中樞性嗜睡過度（hypersomnolence）的中樞疾病，都是食慾素（orexin）2 受體致效劑的合乎邏輯、自然的選擇。我們也對食慾素 2 受體致效劑在更廣泛 CNS 適應症上的潛力感到興奮。

To a large extent, Lilly's acquisition of Centessa have validated the potential for this class of compounds. We are looking at mood disorders, cognition, fatigue, and ADHD in a preclinical setting. In terms of your question regarding what kind of SAD clinical PK data we would like to see, as we have mentioned earlier, BP-205 has demonstrated a potential best-in-class use in the preclinical setting.

在很大程度上，禮來（Lilly）收購 Centessa 已經驗證了這一類化合物的潛力。我們在臨床前階段評估情緒障礙、認知、疲勞以及 ADHD。至於你問到我們希望看到哪類 SAD（單次遞增劑量）臨床藥物動力學（PK）數據，如同先前提到的，BP-205 在臨床前研究中已展現出成為同類最佳（best-in-class）的潛力。

High potency, great selectivity, favorable preclinical safety pharmacology and toxicology, and potential for once a day dosing. In the clinical PK setting, we'll be looking at Cmax, Tmax, AUC, half-life, safety and tolerability to the extent we can infer based on a single dose study. Thank you.

高效價、極佳選擇性、良好的臨床前安全藥理與毒理，以及具備每日一次給藥的潛力。在臨床 PK 的情境下，我們會關注 Cmax、Tmax、AUC、半衰期，以及在單次劑量研究可推論範圍內的安全性與耐受性。謝謝。

Thanks, Kumar.

謝謝你，Kumar。

Corinne Johnson, Goldman Sachs.

高盛（Goldman Sachs）的 Corinne Johnson。

Yeah, good morning, and thank you. Maybe as you look at business development, you've been highlighting the importance of relatively near-term revenues, but I'm curious where the path to earnings accretion factors in, for deals that you might consider. Separately, could you just expand a little bit on the newest pitolisant formulation and the types of delivery models that that formulation could enable? Thanks.

是的，早安，謝謝。也許在你們看商務開發時，你們一直強調相對較近的營收重要性，但我想了解的是，對於你們可能考慮的交易，「盈餘增厚」（earnings accretion）的路徑在評估中扮演什麼角色。另外，你能否再多談一點最新的 pitolisant 劑型，以及該劑型可能帶來哪些給藥/遞送模式？謝謝。

Good morning, Corinne. Thanks for your question. Glenn?

早安，Corinne。謝謝你的問題。Glenn？

Yeah. In terms of earnings accretion, It's hard to answer that one. What I will represent is obviously you have to be looking at returns on invested capital that are quite substantial, which would, you know, obviously have loading the teams. That would be the main criteria over time. We wouldn't be just doing a deal for the purpose of growth. We obviously have to have financial returns. Hope that answers your question.

是的。關於盈餘增厚，這題很難回答。我能說的是，很明顯你必須看投入資本報酬率（returns on invested capital），而且要相當可觀，這也會牽涉到團隊配置等因素。長期來看，這會是主要的評估標準。我們不會只是為了成長而做交易。我們顯然必須要有財務回報。希望有回答到你的問題。

Thanks, Glenn. Corinne, with regard to the new amorphous form of pitolisant, that was part of the value of the Novitium license. We saw, you know, really an opportunity. We always talked about adjacencies beyond orphan rare with obviously this very strong product, you know, this differentiated, you know, molecule WAKIX.

謝謝你，Glenn。Corinne，關於 pitolisant 的新型非晶型（amorphous）形式，那是 Novitium 授權價值的一部分。我們看到，確實是一個機會。我們一直在談超越孤兒罕見疾病的相鄰領域，而我們顯然擁有一個非常強的產品，也就是這個具差異化的分子 WAKIX。

It's been very successful in the market in narcolepsy and opportunities to go broad. With that, you know, we saw new form and potential new formulations, new modes of delivery to develop, you know, with the Novitium license, the amorphous form. Kumar, additional thoughts on, you know, directionally where we're headed there.

它在嗜睡症（narcolepsy）市場表現非常成功，也有機會拓展到更廣泛的適應症。基於此，我們看到了新的型態以及潛在的新劑型、新的遞送方式可供開發；透過 Novitium 的授權，也就是這個非晶型（amorphous）形式。Kumar，請你補充一些想法，談談我們大方向上要往哪裡走。

Yeah, thanks, Jeff. Karin, to answer your question, good morning, by the way. The physiochemical properties of our amorphous formulation could potentially lend itself to a different mode of oral delivery, resulting in a PK profile that may be more favorable to some of the indications that we plan to target within the broader CNS space. That's all I can say at this stage of development. Right now, we are optimizing the formulation towards the Phase 1 PK study.

好的，謝謝你，Jeff。Karin，回答你的問題，順便說聲早安。我們非晶型劑型的理化性質，可能有助於不同的口服遞送模式，進而形成一個藥物動力學（PK）曲線；對於我們計畫在更廣泛 CNS 領域鎖定的一些適應症而言，這個 PK 曲線可能更有利。在目前的開發階段，我能說的大概就到這裡。目前我們正朝向第一期 PK 研究來優化該劑型。

David Hong, Deutsche Bank.

德意志銀行（Deutsche Bank）的 David Hong。

Hey, this is Sam on for David. Thanks for taking the question. Just a quick one on the OpEx front. Can you help us to think about the trajectory for OpEx through the rest of the year, given the slight uptick in cost of products sold from the Novitium license and the step-up in R&D from the amorphous formulation license as well? Thanks.

嗨，我是 Sam，代替 David 發問。謝謝讓我提問。我想快速問一下營運費用（OpEx）方面。考量到 Novitium 授權使銷貨成本略有上升，以及非晶型劑型授權也使研發（R&D）費用增加，你能否協助我們理解今年剩餘期間 OpEx 的走勢？謝謝。

In terms of gross margins, obviously they're going to be impacted by the Novitium contract. We obviously also have step-up royalties related to Prejex. Nothing abnormal beyond that year-over-year gross net. Anticipate anything tremendous changing there. With respect to R&D, we would in fact expect a ramp-up in R&D expense as we move forward on these trials and accelerate these trials. With respect to, you know, the rest of the P&L, I would not see, you know, substantial increase in run rates. Hope that helps.

就毛利率而言，顯然會受到 Novitium 合約的影響。我們也確實有與 Prejex 相關的分級提高（step-up）權利金。除此之外，年對年（YoY）的毛利/淨額沒有其他異常。不預期那裡會有任何巨大的變化。至於研發（R&D），隨著我們推進這些試驗並加速這些試驗，我們確實預期研發費用會逐步拉升。至於損益表（P&L）的其他部分，我不認為營運費用率（run rates）會有顯著增加。希望有幫助。

Thank you. We have the next question comes from the line of Soyoon Shin of UBS. Your line is now open.

謝謝。下一題來自瑞銀（UBS）的 Soyoon Shin，您的線路已開通。

Good morning. Thank you for taking my question. In Q1, seems like you saw more friction than usual in terms of access, which may have led to the softness in the patient's numbers. Curious if you saw any changes in the discontinuation rate.

早安。謝謝讓我提問。在第一季（Q1），看起來你們在可近性（access）方面遇到比平常更多的阻力，這可能導致病患人數偏軟。想請問你們是否看到停藥率（discontinuation rate）有任何變化？

As a follow-up on the orexin agonist program, now there are several orexin agonists that are either approaching approval or in late-stage trials in narcolepsy and IH. For BP-205, although it has the most potency among the competitor orexin compounds based on preclinical data, seems like the sleep-wake space may be very crowded with a number of orexin agonists by the time 205 launches.

另外追問食慾素（orexin）致效劑計畫：目前已有數個食慾素致效劑在嗜睡症（narcolepsy）與 IH（特發性嗜睡症）領域，正接近核准或處於後期試驗。對 BP-205 而言，雖然根據臨床前數據，它在競品食慾素化合物中效價最高，但到 205 上市時，睡眠—覺醒（sleep-wake）領域可能會因多款食慾素致效劑而變得非常擁擠。

Just curious here, instead of going head-to-head in those core indications, could it make more sense to just prioritize other indication first, where you might have a clearer differentiation or even a first-in-class opportunity? Thank you.

我想請教的是：與其在這些核心適應症正面對決，是否更合理先優先推進其他適應症，在那裡你們可能有更清楚的差異化，甚至有同類首創（first-in-class）的機會？謝謝。

Yeah, thanks for your question. With regards to the Q1 dynamics, let Adam share thoughts on that as well as, in terms of the commercial perspective on the continued opportunity with BP-205.

好的，謝謝你的問題。關於第一季（Q1）的動態，我先請 Adam 也分享一下看法；同時也會從商業化角度談談 BP-205 持續存在的機會。

Okay, sure. Thanks, Jeff. In Q1, we typically see these market access related headwinds. To be clear, you know, our coverage has not changed. We enjoy very broad coverage, over 80% of lives in the US. Actually, that coverage was strengthened in 2025 with some improvements in some of our key payer accounts. That remains the same.

好的，當然可以。謝謝你，Jeff。在第一季，我們通常會看到這些與市場准入相關的逆風。要說清楚的是，你知道，我們的給付覆蓋並沒有改變。我們享有非常廣泛的覆蓋，在美國涵蓋超過 80% 的受保人群。事實上，這項覆蓋在 2025 年因我們部分關鍵付款方帳戶的改善而有所強化。目前仍維持不變。

What happens is, as consumers enter the new calendar year, sometimes they gotta go through co-pay resets, they've gotta reestablish coverage or prior authorizations. Sometimes they switch plans. That dynamic can simply just delay some of the patient starts, which is going to affect your average patients for the quarter. That's something that we see every year. It's really no surprise. You asked specifically around DC rate and persistency.

實際發生的是，當消費者進入新的曆年時，有時他們必須重新計算自付額（co-pay），必須重新建立保險覆蓋或事前授權。有時他們會更換方案。這種動態可能只是延後部分病患開始用藥，進而影響你們該季度的平均病患數。這是我們每年都會看到的情況。其實一點也不意外。你特別問到 DC 比率與持續性（persistency）。

You know, persistency on WAKIX has remained very steady for many years, and we have not seen any meaningful change in that dynamic for a very long time. It's really just these delays in patient starts as we start the new calendar year.

你知道，WAKIX 的持續性多年來一直非常穩定，我們在這個動態上已經很長一段時間沒有看到任何有意義的變化。主要就是在新曆年開始時，病患啟動治療出現這些延遲。

From an orexin standpoint, kind of a commercial perspective around BP-205, I think we're excited that there still is an opportunity to deliver an orexin that can deliver on the promise of orexin-level efficacy, but potentially with a better safety and tolerability profile and once-a-day dosing across all three domains, NT1, NT2, IH, with a single compound. That's really where we're excited and where we're focused. Thanks, Jeff.

從食慾素（orexin）的角度、以 BP-205 的商業觀點來看，我認為我們很興奮，因為仍有機會提供一種食慾素藥物，能實現食慾素等級療效的承諾，但可能具備更好的安全性與耐受性特徵，並且在 NT1、NT2、IH 這三個領域都能以每日一次給藥、用單一化合物達成。這正是我們感到興奮、也是我們聚焦的地方。謝謝你，Jeff。

Yeah. Sure. Thanks, Adam. A final comment on BP-205 and the question. It's not sort of either/or. We see this opportunity in terms of the development program, both looking at central disorders of hypersomnolence with BP-205 and as well as the broader program that we are working on, in addition to some of the broader CNS indications, as Kumar alluded to earlier. Not either/or. We will look to invest in this significant opportunity across the orexin-2 agonist program.

是的。當然。謝謝你，Adam。關於 BP-205 和這個問題的最後補充。這不是非此即彼。我們看到的機會是，就開發計畫而言，一方面以 BP-205 針對中樞性嗜睡障礙（central disorders of hypersomnolence），同時也包括我們正在推進的更廣泛計畫，此外還有一些更廣泛的中樞神經系統（CNS）適應症，如 Kumar 先前提到的。不是非此即彼。我們將尋求在這個重大的機會上投入資源，涵蓋整個食慾素-2 受體致效劑（orexin-2 agonist）計畫。

Jason Gerberry, Bank of America.

Jason Gerberry，美國銀行（Bank of America）。

Hey, guys. Thanks for taking my questions. Just a question and a follow-up just on the WAKIX IP situation. If AET does get a non-infringement, the decision in the second half, just wondering about, thinking about scenarios and what actually are barriers to an at-risk launch in second half 2027.

嗨，各位。謝謝回答我的問題。先問一個問題並追問一下，關於 WAKIX 的智慧財產權（IP）情況。如果 AET 在下半年確實獲得不侵權（non-infringement）的裁決，我想了解一下，在思考各種情境時，究竟有哪些因素會構成 2027 年下半年進行「風險上市」（at-risk launch）的障礙。

Then as a follow-up, just can you talk a little bit about the diligence that you did just to ensure that the I guess this arrangement survives any FTC scrutiny. If you can describe a little bit of the history of the license with Novitium versus the settlement agreement that you reached with them during ANDA litigation. Thanks.

接著追問，你們能否談談為了確保我想這項安排能通過任何 FTC 審查，你們做了哪些盡職調查。如果可以的話，請稍微說明一下與 Novitium 的授權歷史，以及你們在 ANDA 訴訟期間與其達成的和解協議之間的脈絡。謝謝。

Yeah. First on your question with regard to AET and various scenarios. Just as a reminder, the 30-month stay ends in February, and we would expect the February of 2027, to be clear. We would expect that the judge will issue her ruling on the ANDA case somewhere around there.

好的。先回答你關於 AET 與各種情境的問題。提醒一下，30 個月的暫緩期（30-month stay）在 2 月到期，為了說清楚，是 2027 年 2 月。我們預期法官會在那個時間點前後對 ANDA 案件作出裁決。

Then, of course, there's appeal opportunities that both parties have, if for adverse outcomes for either party. Fully expect that there would be appeals. Certainly, we would appeal, if there was an issue there. Also, please keep in mind that this second trial just started, and it could take 24 to 30 months in and of itself, plus an appeals process. That kind of gives you a sense of the timelines.

然後，當然，如果任何一方出現不利結果，雙方都會有上訴的機會。我們完全預期會有上訴。當然，如果那裡出現問題，我們也一定會上訴。另外也請記住，第二個審判才剛開始，單就它本身可能就需要 24 到 30 個月，再加上上訴程序。這大致讓你了解時間表。

In our view, in almost every scenario, we end up with exclusivity that gets us into 2030, again, inclusive of the six-month exclusivity. Hopefully, that gives you some sense of the timelines and the impact. Again, we're going to vigorously defend and use every right that we have to defend our multilayer IP strategy. That's what we're putting in place.

在我們看來，幾乎在所有情境下，我們最終都會擁有可延續到 2030 年的獨占性，並且同樣包含那 6 個月的獨占期。希望這能讓你對時間表與影響有些概念。再次強調，我們會積極捍衛，並運用我們所擁有的每一項權利，來捍衛我們多層次的 IP 策略。這就是我們正在建立的安排。

Thanks, Peter. Jason, I would just add that in terms of AET and an at-risk launch, we, you know, we really can't comment on other parties and what their decisions would be in that regard. With regards to your question about the antitrust aspect, we obviously always, you know, consider that very closely.

謝謝你，Peter。Jason，我補充一下，關於 AET 與風險上市（at-risk launch），我們確實無法評論其他方在這方面會做出什麼決定。至於你問到的反托拉斯（antitrust）面向，我們當然一直都會非常審慎地加以考量。

Most important to remember, when we saw the Novitium license and the amorphous form, the original opportunity we saw was a bona fide development program, which we've already initiated. That was the opportunity when we did that license in January, before what we learned at trial in February. We continue to pursue that business and development opportunity with the Novitium amorphous license.

最重要的是要記住，當我們看到 Novitium 的授權與非晶型（amorphous form）時，我們最初看到的機會是一個真實且正當的開發計畫，而我們已經啟動了。那是在我們 1 月簽下該授權時所看到的機會，當時還早於我們在 2 月審判中得知的內容。我們會持續推進與 Novitium 非晶型授權相關的這項業務與開發機會。

If I may just add to Jeff's point, just on the at-risk launch. Of course, there are legal remedies that we have access to that we would fully implement. See how vigorously we are defending our intellectual property, and we would use every tool available.

如果我可以補充 Jeff 的觀點，關於風險上市（at-risk launch）。當然，我們有可採取的法律救濟，我們會全面加以執行。你們也看到我們捍衛智慧財產權有多麼積極，我們會使用所有可用的工具。

Thank you. That will conclude our question and answer session. I will now turn the call back over to Dr. Jeffrey M. Dayno, CEO, for closing remarks.

謝謝。問答環節到此結束。我現在把電話交回給執行長 Jeffrey M. Dayno 醫師，請他做結語。

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

謝謝你，接線員。謝謝各位對 Harmony Biosciences 的關注，祝各位今天接下來一切順利。

Thank you, ladies and gentlemen. That concludes today's call. Thank you all for joining. You may now disconnect.

謝謝各位女士、先生。今天的電話會議到此結束。感謝各位參與。您現在可以掛線。