Vanda Pharmaceuticals Inc (VNDA) 2025 Q3 法說會逐字稿

Hello, and thank you for standing by. My name is Mark and I will be your conference operator today. At this time, I would like to welcome everyone to the Q3 2025 Vanda Pharmaceuticals Inc earnings conference call. (Operator Instructions)

您好，感謝您的耐心等待。我叫馬克，今天將由我擔任你們的會議接線生。在此，我謹代表 Vanda Pharmaceuticals Inc. 歡迎各位參加 2025 年第三季財報電話會議。（操作說明）

Now, I would like to turn the call over to Kevin Moran, Vanda's Chief Financial Officer. Please go ahead.

現在，我想把電話交給 Vanda 的財務長 Kevin Moran。請繼續。

Thank you, Mark. Good afternoon and thank you for joining us to discuss Vanda Pharmaceuticals third quarter 2025 performance. Our third quarter 2025 results were released this afternoon and are available on the SEC's EDGAR system and on our website www.vandapharma.com. In addition, we are providing live and archived versions of this conference call on our website.

謝謝你，馬克。下午好，感謝各位參加本次關於Vanda Pharmaceuticals 2025年第三季業績的討論。我們於今天下午發布了2025年第三季業績報告，該報告可透過美國證券交易委員會的EDGAR系統以及我們的網站www.vandapharma.com查閱。此外，我們也在網站上提供了本次電話會議的直播和存檔版本。

Joining me on today's call is Dr. Mihael Polymeropoulos, our President, Chief Executive Officer, and Chairman of the Board; and Tim Williams, our General Counsel. Following my introductory remarks, Mihael will update you on our ongoing activities. I will then comment on our financial results before we open the lines for your questions.

今天與我一起參加電話會議的還有我們的總裁、執行長兼董事會主席米哈埃爾·波利梅羅普洛斯博士，以及我們的總法律顧問蒂姆·威廉斯。在我作完開場白之後，米哈埃爾將向大家介紹我們正在進行的工作。接下來，我將對我們的財務表現進行評論，之後我們將開放提問環節。

Before we proceed, I would like to remind everyone that various statements that we make on this call will be forward-looking statements within the meaning of Federal Securities laws. Our forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances, and uncertainties.

在繼續之前，我想提醒大家，我們在本次電話會議上所作的各種陳述將屬於聯邦證券法意義上的前瞻性陳述。我們的前瞻性聲明是基於目前的預期和假設，其中涉及風險、情況變化和不確定性。

These risks are described in the cautionary note regarding forward-looking statements, risk factors, and management's discussion and analysis of financial condition and results of operations, sections of our most recent annual report on Form 10-K as updated by our subsequent quarterly reports on Form 10-Q, current reports on Form 8-K, and other filings with the SEC, which are available on the SEC's EDGAR system and on our website. We encourage all investors to read these reports and our other filings.

這些風險已在關於前瞻性聲明、風險因素以及管理層對財務狀況和經營業績的討論與分析的警示性說明中進行了描述，這些內容已由我們隨後的季度報告（10-Q 表格）、當前報告（8-K 表格）以及向美國證券交易委員會提交的其他文件中進行了更新，這些文件可在 SEC 的 EDGAR 系統和我們的網站上查閱。我們鼓勵所有投資者閱讀這些報告以及我們提交的其他文件。

The information we provide on this call is provided only as of today, and we undertake no obligation to update or revise publicly any forward-looking statements we may make on this call on account of new information, future events, or otherwise except as required by law.

我們在本次電話會議中提供的資訊僅截至今日，除法律要求外，我們不承擔因新資訊、未來事件或其他原因而公開更新或修訂我們在本次電話會議中作出的任何前瞻性陳述的義務。

With that said, I would now like to turn the call over to our CEO, Dr. Mihael Polymeropoulos.

接下來，我想把電話交給我們的執行長米哈埃爾·波利梅羅普洛斯博士。

Thank you very much, Kevin, and good afternoon, everyone. Thank you for joining us to discuss Vanda's third quarter 2025 results. This quarter reflects strong commercial execution, with total net product sales reaching $56.3 million, up 18% year-over-year, led by a 31% increase in Fanapt sales and 35% growth in prescriptions.

非常感謝凱文，大家下午好。感謝您參加本次關於Vanda 2025年第三季業績的討論會。本季反映了強勁的商業執行力，產品淨銷售額達到 5,630 萬美元，年增 18%，其中 Fanapt 銷售額成長 31%，處方量成長 35%。

HETLIOZ continues to deliver stable performance with $18 million in Q3 sales. We're particularly encouraged by our advancing pipeline with multiple near-term regulatory milestones. The Tradipitant NDA for motion sickness under FDA review with the PDUFA target action date of December 30, 2025, the Bysanti NDA for bipolar 1 disorder and schizophrenia also under FDA review with the PDUFA target action date of February 21, 2026. In the anticipated Q4 submission of the Imsidolimab BLA for generalized pustular psoriasis.

HETLIOZ持續維持穩定業績，第三季銷售額達1800萬美元。我們尤其感到鼓舞的是，我們正在推動的研發管線即將迎來多個監管里程碑。用於治療暈動病的 Tradipitant NDA 正在接受 FDA 審查，PDUFA 目標審批日期為 2025 年 12 月 30 日；用於治療雙相情感障礙 1 型和精神分裂症的 Bysanti NDA 也正在接受 FDA 審查，PDUFA 目標審批日期為 2026 年 2 月 21 日。預計在第四季度提交用於治療泛發性膿皰型乾癬的Imsidolimab生物製品許可申請。

We're also investing strategically in our commercial infrastructure, including increased brand visibility through targeted sponsorships with the goal of supporting long-term market leadership and future commercial launches. We believe that these milestones combined with our collaborative framework with the FDA will position Vanda for sustained growth and expand its therapeutic impact in 2026 and beyond.

我們也在對商業基礎設施進行策略性投資，包括透過有針對性的贊助來提高品牌知名度，以支持長期的市場領導地位和未來的商業發布。我們相信，這些里程碑事件，加上我們與FDA的合作框架，將使Vanda在2026年及以後實現持續成長並擴大其治療影響。

On commercial updates. During the third quarter, our Fanapt salesforce further expanded their efforts, and we continued our broader awareness campaign. Fanapt revenue increased by 31% compared to the same period in the prior year driven by the launch of the bipolar I indication. Fanapt is now promoted in the US across all 50 states with a dedicated sales force of approximately 300 representatives.

關於商業更新。第三季度，我們的 Fanapt 銷售團隊進一步擴大了工作範圍，我們也持續進行了更廣泛的宣傳活動。受雙極性情感障礙 I 型適應症上市的推動，Fanapt 的營收比去年同期成長了 31%。Fanapt 目前已在美國所有 50 個州進行推廣，擁有約 300 名銷售代表的專門銷售團隊。

With the expansion of the sales force that was largely completed during the second quarter, we observed a significant increase in activity with the total number of calls growing by more than 20% as compared to the second quarter of 2025 and growing by over 100% compared to Q3 of 2024.

隨著銷售隊伍的擴充（此擴充工作在第二季基本完成），我們觀察到業務活動顯著增加，與 2025 年第二季相比，電話總數成長超過 20%，與 2024 年第三季相比，成長超過 100%。

Since the bipolar launch, demand is measured by total prescriptions, TRx, new prescriptions, NRx, and new-to-brand prescriptions, NBRx, reach new highs in the third quarter. The commercialization of Fanapt is also supported by a broad speakers program operating across the country that educates prescribers on the profile of Fanapt and how to use it.

自雙極性情感障礙藥物上市以來，需求量（以處方總量 TRx、新處方量 NRx 和新品牌處方量 NBRx 衡量）在第三季均創下新高。Fanapt 的商業化也得到了遍布全國的廣泛演講者計劃的支持，該計劃旨在教育處方醫生了解 Fanapt 的特性以及如何使用它。

We're excited by the progress our commercial organization has made as we continue to support the commercialization of Fanapt aiming for further growth in the coming periods.

我們對我們的商業組織的進展感到興奮，我們將繼續支持 Fanapt 的商業化，目標是在未來一段時間內進一步成長。

Total revenue from our three commercial branded products, Fanapt, HETLIOZ, and PONVORY reached $158.9 million in the first nine months of 2025. HETLIOZ continues to be the market share leader despite the availability of three generic products as a testament to the brand loyalty of our patient customers over the last 11 years. We're continued to build out in training of our dedicated PONVORY sales force team addressing prescribers for multiple sclerosis.

2025 年頭九個月，我們三個商業品牌產品 Fanapt、HETLIOZ 和 PONVORY 的總營收達到 1.589 億美元。儘管市面上出現了三種仿製藥，但 HETLIOZ 仍然保持著市場份額領先地位，這證明了過去 11 年來患者客戶對品牌的忠誠度。我們持續加強PONVORY專業銷售團隊的培訓，該團隊致力於為多發性硬化症的處方醫生提供服務。

In the last two quarters, we saw an increase in the underlying patient demand as we intensified our consumer and prescriber awareness programs. During the first nine months of 2025, our direct-to-consumer campaign launched in the first quarter continued to drive meaningful gains in brand awareness for the company and our products Fanapt and PONVORY. We maintain strategic investments in our commercial infrastructure, including increased brand visibility through target sponsorships with a goal of supporting long-term market leadership and future commercial launches.

在過去的兩個季度裡，隨著我們加強消費者和處方醫生意識提升計劃，我們看到潛在的患者需求增加。在 2025 年的前九個月裡，我們在第一季推出的直接面向消費者的活動繼續推動公司及其產品 Fanapt 和 PONVORY 的品牌知名度取得顯著增長。我們持續對商業基礎設施進行策略性投資，包括透過目標贊助提高品牌知名度，以支持長期市場領導地位和未來的商業發布。

Key regulatory clinical updates. Collaborative framework for resolution of disputes with the FDA. On October 1, 2025, we announced a collaborative framework with the US Food and Drug Administration for the resolution of certain disputes regarding HETLIOZ and Tradipitant. Pursuant to the agreement, the FDA will conduct an expedited re-review of the partial clinical hold, preventing long-term clinical status of Tradipitant for the treatment of motion sickness by November 26, 2025.

關鍵監管臨床進展。與FDA解決爭議的合作框架。2025 年 10 月 1 日，我們宣布與美國食品藥物管理局合作，以解決有關 HETLIOZ 和 Tradipitant 的某些爭議。根據該協議，FDA 將加快對部分臨床暫停的重新審查，以防止 Tradipitant 在 2025 年 11 月 26 日之前獲得治療暈動病的長期臨床資格。

The FDA will continue its review of Vanda's new drug application for this indication with the existing prescription drug user [PIAC] target action date of December 30, 2025. The FDA will conduct an expedited re-review of Vanda's supplemental new drug application, sNDA for HETLIOZ for the treatment of jet lag disorder by January 7, 2026, including consideration of alternative or narrowed indications focusing on the sleep related aspects of jet lag disorder.

FDA 將繼續審查 Vanda 針對該適應症的新藥申請，現有處方藥使用者 (PIAC) 目標行動日期為 2025 年 12 月 30 日。FDA 將於 2026 年 1 月 7 日之前對 Vanda 公司用於治療時差症的 HETLIOZ 補充新藥申請 (sNDA) 進行快速復審，包括考慮針對時差症睡眠相關方面的替代或縮小適應症。

Bysanti. The NDA for Bysanti for the acute treatment of bipolar I disorder and the treatment of schizophrenia is under review by the FDA with a PDUFA target action date of February 21, 2026. If approved, exclusivity for Bysanti, including pending patent applications, could extend into 2040s. Bysanti is a new chemical entity which was initially identified as an active metabolite of iloperidone. Vanda discovered that milsaperidone, when administered orally, quickly interconverts to iloperidone.

拜桑蒂。Bysanti 用於治療雙極性情感疾患 I 型和精神分裂症急性期的 NDA 正在接受 FDA 的審查，PDUFA 目標審批日期為 2026 年 2 月 21 日。如果獲得批准，Bysanti 的獨家經營權（包括正在申請的專利）可能會延續到 2040 年代。Bysanti 是一種新的化學實體，最初被鑑定為伊洛哌酮的活性代謝物。Vanda 發現，口服米爾沙哌酮後，會迅速轉化為伊洛哌酮。

In clinical studies, milsaperidone and iloperidone have been shown to be bioequivalent at both low and high doses administered both in single and multiple dose studies. The results of these clinical studies were presented late May at the 2025 American Society of Clinical Psychopharmacology Annual Meeting in Scottsdale, Arizona.

在臨床研究中，米沙哌酮和伊洛哌酮在單次和多次給藥研究中，無論低劑量或高劑量，均表現出生物等效性。這些臨床研究的結果於 5 月下旬在亞利桑那州斯科茨代爾舉行的 2025 年美國臨床精神藥理學會年會上發表。

The Bysanti Phase 3 clinical study for users once daily adjunctive treatment for major depressive disorder is ongoing enrolling patients. Results are expected in 2026. We plan to randomize approximately 500 patients to do a clinical study across approximately 50 sites, and as the number of patients randomized increases, we will be in a better place to estimate the time to completion.

Bysanti 針對重度憂鬱症患者每日一次輔助治療的 3 期臨床研究正在進行中，目前正在招募患者。預計2026年將公佈結果。我們計劃隨機抽取約 500 名患者，在約 50 個地點進行臨床研究。隨著隨機抽取的患者人數增加，我們將能夠更好地估計完成研究所需的時間。

Tradipitant. The NDA for Tradipitant for motion sickness is under review by the FDA with a PDUFA target action date of December 30, 2025. In the fourth quarter of 2024, Vanda initiated a clinical trial studied Tradipitant in the prevention of vomiting induced by GLP-1 analog wegovy semaglutide. The trial is now complete and results are expected in the fourth quarter of 2025.

放射性物質。Tradipitant 用於治療暈動病的 NDA 正在接受 FDA 的審查，PDUFA 目標審批日期為 2025 年 12 月 30 日。2024 年第四季度，Vanda 啟動了一項臨床試驗，研究 Tradipitant 在預防 GLP-1 類似物 wegovy semaglutide 引起的嘔吐方面的療效。試驗現已完成，預計 2025 年第四季公佈結果。

Iloperidone long-acting injectable. The Phase III study of the long-acting injectable formulation of iloperidone in the treatment of schizophrenia and relapsed prevention is ongoing and enrolling patients. We plan to randomize approximately 400 patients into the clinical study across approximately 60 sites. In general, we have seen similar clinical studies run by other organizations, and they take around two years to complete.

伊洛哌酮長效注射劑。治療精神分裂症和預防復發的長效注射劑伊洛哌酮的 III 期研究正在進行中，並招募患者。我們計劃在約 60 個地點隨機抽取約 400 名患者參與臨床研究。一般來說，我們看到其他機構也進行類似的臨床研究，這些研究大約需要兩年才能完成。

As the number of patients randomized increases, we will be in a better place to estimate completion of that study. A clinical study of the long-acting injectable formulation of iloperidone in people with treatment-resistant hypertension is now ongoing and then the plans to begin enrolling patients soon.

隨著隨機分組的患者人數增加，我們將能夠更好地估計研究的完成情況。目前正在進行一項針對難治性高血壓患者的長效注射型伊洛哌酮的臨床研究，並計劃很快開始招募患者。

Imsidolimab. A BLA for imsidolimab in the treatment of a rare orphan disorder, generalized pustular psoriasis, is expected to be submitted to the FDA in the fourth quarter of 2025. PONVORY. Investigation new drug applications for PONVORY in the treatment of psoriasis and ulcerative colitis were accepted by the FDA in the fourth quarter of 2024. Vanda has initiated the psoriasis study and plans to initiate the study in ulcerative colitis in early 2026.

伊米索利單抗。用於治療罕見孤兒疾病－泛發性膿皰型乾癬的伊米多利單抗生物製品許可申請預計將於 2025 年第四季提交給 FDA。龐沃里。2024 年第四季度，美國食品藥物管理局 (FDA) 受理了 PONVORY 用於治療乾癬和潰瘍性結腸炎的新藥申請。Vanda 已啟動乾癬研究，並計劃於 2026 年初啟動潰瘍性結腸炎研究。

Early stage program highlights. VQW-765 and alpha 7 nicotinic acetylcholine receptor by iais currently in clinical development for the treatment of acute performance anxiety in social situations. Vanda has initiated the Phase III program and is enrolling patients. We plan to randomize approximately 500 patients into the clinical study across approximately 30 sites, and if the number of patients of randomization increases, again, we'll be able to estimate time to completion.

早期項目亮點。VQW-765 和 α7 尼古丁乙醯膽鹼受體目前由 iais 公司研發，用於治療社交場合的急性表演焦慮。Vanda公司已啟動三期臨床試驗項目，並正在招募患者。我們計劃在約 30 個地點隨機抽取約 500 名患者參與臨床研究，如果隨機抽取的患者人數增加，我們將能夠再次估算完成時間。

The IND for VCA-894A in the treatment of Charcot-Marie-Tooth disease, axonal type 2S or CMT2S and inherited peripheral neuropathy for which there is no available treatment was accepted by the FDA in 2024. Previously in 2023, VCA-894A was granted orphan drug designation for the same indication. The Phase I clinical study for VCA-894A enrolled the patient who has already received several doses of VCA-894A.

VCA-894A 用於治療 Charcot-Marie-Tooth 病、軸索型 2S 或 CMT2S 以及目前尚無有效治療方法的遺傳性周圍神經病變的 IND 申請於 2024 年獲得 FDA 批准。先前在 2023 年，VCA-894A 因同一適應症被授予孤兒藥資格。VCA-894A 的 I 期臨床研究招募了一位已經接受過數劑 VCA-894A 治療的患者。

With that, I'll turn now to Kevin to discuss our financial results. Kevin?

接下來，我將請凱文來談談我們的財務表現。凱文？

Thank you, Mihael. I'll begin by summarizing our financial results for the first nine months of 2025 before turning to discuss the third quarter of 2025. Total revenues for the first nine months of 2025 were $158.9 million, a 9% increase compared to $145.6 million for the same period in 2024. The increase was primarily due to growth in Fanapt revenue as a result of the bipolar commercial launch. Fanapt net product sales were $84.1 million for the first nine months of 2025, a 24% increase compared to $67.6 million in the same period in 2024.

謝謝你，米哈伊爾。我將先總結我們 2025 年前九個月的財務業績，然後再討論 2025 年第三季的情況。2025 年頭九個月的總營收為 1.589 億美元，比 2024 年同期的 1.456 億美元成長了 9%。成長主要歸功於 Fanapt 的收入成長，這得益於雙相情感障礙藥物的商業化上市。Fanapt 2025 年頭九個月的淨產品銷售額為 8,410 萬美元，比 2024 年同期的 6,760 萬美元成長了 24%。

This increase to net product sales relative to the first nine months of 2024 was attributable to an increase in volume, partially offset by a decrease in price net of deductions. Turning to HETLIOZ. HETLIOZ net product sales were $55 million for the first nine months of 2025, a 3% decrease compared to $56.6 million in the same period in 2024. The decrease in net product sales relative to the first nine months of 2024 was attributable to a decrease in volume. Of note, through the third quarter of 2025, HETLIOZ continues to retain the majority of market share despite generic competition for now over 2.5 years.

與 2024 年頭九個月相比，淨產品銷售額的成長歸因於銷售量的成長，但部分被扣除各項費用後的淨價格下降所抵銷。轉向 HETLIOZ。HETLIOZ 2025 年前九個月的淨產品銷售額為 5,500 萬美元，比 2024 年同期的 5,660 萬美元下降了 3%。與 2024 年頭九個月相比，淨產品銷售額下降是由於銷售下降所致。值得注意的是，截至 2025 年第三季度，儘管仿製藥競爭已持續超過 2.5 年，HETLIOZ 仍保持著大部分市場份額。

And finally, turning to PONVORY. PONVORY net product sales were $19.8 million for the first nine months of 2025, a 7% decrease compared to $21.3 million in the same period in 2024. The decrease in net product sales relative to the first nine months of 2024 was attributable to a decrease in price net of deductions. For the first nine months of 2025, Vanda recorded a net loss of $79.3 million compared to a net loss of $14 million for the same period in 2024. The net loss for the first nine months of 2025 included an income tax benefit of $21.4 million as compared to an income tax benefit of $2.4 million for the same period in 2024.

最後，讓我們來談談龐沃里。2025 年前九個月，PONVORY 的淨產品銷售額為 1,980 萬美元，比 2024 年同期的 2,130 萬美元下降了 7%。與 2024 年頭九個月相比，淨產品銷售額下降是由於扣除各項費用後的價格下降所致。2025 年前九個月，Vanda 錄得淨虧損 7,930 萬美元，而 2024 年同期淨虧損為 1,400 萬美元。2025 年前九個月的淨虧損包括 2,140 萬美元的所得稅優惠，而 2024 年同期所得稅優惠為 240 萬美元。

Operating expenses for the first nine months of 2025 were $269.7 million compared to $176 million for the same period in 2024. The $93.7 million increase was primarily driven by higher SG&A expenses related to spending on Vanda's commercial products as a result of the commercial launches of Fanapt in bipolar disorder and PONVORY and multiple sclerosis and higher R&D expenses primarily related to the exclusive global license agreement with Anaptys for the development and commercialization of imsidolimab, which was entered into during the first quarter of 2025. During 2024 and 2025, we commenced a host of activities as a result of the commercial launches of Fanapt in bipolar disorder and PONVORY in multiple sclerosis, including an expansion of our sales force and the development of prescriber awareness and comprehensive marketing programs. During the first nine months of 2025, our direct-to-consumer campaign launched in the first quarter continued to drive meaningful gains in brand awareness for the company and or products, Fanapt and PONVORY. We maintained strategic investments in our commercial infrastructure, including increased brand visibility through targeted sponsorships with the goal of supporting long-term market leadership and future commercial launches.

2025 年前九個月的營運費用為 2.697 億美元，而 2024 年同期為 1.76 億美元。這項2024 年和 2025 年，隨著 Fanapt（用於治療雙相情感障礙）和 PONVORY（用於治療多發性硬化症）的商業化推出，我們開展了一系列活動，包括擴大銷售隊伍，以及製定處方醫生意識和綜合營銷計劃。在 2025 年的前九個月裡，我們在第一季推出的直接面向消費者的活動繼續推動公司和/或產品 Fanapt 和 PONVORY 的品牌知名度取得顯著增長。我們對商業基礎設施進行了策略性投資，包括透過有針對性的贊助來提高品牌知名度，以支持長期市場領導地位和未來的商業發布。

Vanda's cash, cash equivalents, and marketable securities, referred to as cash, as of September 30, 2025, was $293.8 million, representing a decrease of $80.9 million compared to December 31, 2024, and a decrease of $31.8 million compared to June 30, 2025. The change in cash during the third quarter of 2025 as compared to the second quarter of 2025 was driven by the net loss in the third quarter of 2025 as well as timing of cash received from customers for revenue and related payments of rebates to the payers as well as the timing of cash paid to third parties for services related to operating expenses. Turning now to our quarterly results. Total revenues were $56.3 million for the third quarter of 2025, an 18% increase compared to $47.7 million for the third quarter of 2024 and a 7% increase compared to $52.6 million in the second quarter of 2025. The increase as compared to the third quarter of 2024 was primarily due to growth in Fanapt revenue as a result of the bipolar commercial launch.

截至 2025 年 9 月 30 日，Vanda 的現金、現金等價物和有價證券（統稱現金）為 2.938 億美元，比 2024 年 12 月 31 日減少了 8,090 萬美元，比 2025 年 6 月 30 日減少了 3,180 萬美元。2025 年第三季現金與 2025 年第二季相比的變化，是由於 2025 年第三季淨虧損，以及從客戶處收到的收入現金和向付款人支付的返利款項的時間，以及向第三方支付與營運費用相關的服務款項的時間所致。現在來看我們的季度業績。2025 年第三季總營收為 5,630 萬美元，比 2024 年第三季的 4,770 萬美元成長 18%，比 2025 年第二季的 5,260 萬美元成長 7%。與 2024 年第三季相比，成長主要歸功於 Fanapt 收入的成長，這得益於雙極性情感障礙藥物的商業化上市。

The increase as compared to the second quarter of 2025 was due to both growth in Fanapt revenue as a result of the bipolar launch and higher HETLIOZ revenue. Let me now break this down by product. Fanapt net product sales were $31.2 million for the third quarter of 2025, a 31% increase compared to $23.9 million in the third quarter of 2024 and a 7% increase compared to $29.3 million in the second quarter of 2025. Fanapt total prescriptions, or TRx, as reported by IQVIA Xponent in the third quarter of 2025 increased by 35% compared to the third quarter of 2024 and 11% compared to the second quarter of 2025.

與 2025 年第二季相比，成長是由於 Fanapt 收入因雙極產品上市而成長，以及 HETLIOZ 收入增加。現在讓我按產品來詳細分析一下。Fanapt 2025 年第三季淨產品銷售額為 3,120 萬美元，比 2024 年第三季的 2,390 萬美元成長了 31%，比 2025 年第二季的 2,930 萬美元成長了 7%。根據 IQVIA Xponent 報告，2025 年第三季 Fanapt 的總處方量 (TRx) 比 2024 年第三季增加了 35%，比 2025 年第二季增加了 11%。

Fanapt new patient starts in the third quarter of 2025 as reflected by new-to-brand prescriptions, or NBRx, increased by 147% compared to the third quarter of 2024 and by 14% compared to the second quarter of 2025. The increase in Fanapt revenue between the third quarter of 2025 and the third quarter of 2024 was primarily attributable to an increase in volume, partially offset by a decrease in price net of deductions. The increase in Fanapt revenue between the third quarter of 2025 and the second quarter of 2025 was attributable to an increase in volume, partially offset by a decrease in price net of deductions. These increases in volume were primarily driven by increased total prescription demand as well as increased wholesaler inventory levels. Historically, Fanapt's inventory at wholesalers has ranged between three and four weeks on hand as calculated based off trailing demand.

Fanapt 的新患者在 2025 年第三季開始使用新品牌處方 (NBRx)，與 2024 年第三季相比成長了 147%，與 2025 年第二季相比成長了 14%。Fanapt 2025 年第三季與 2024 年第三季之間的營收成長主要歸因於銷售成長，但部分被扣除費用後的淨價格下降所抵銷。Fanapt 2025 年第三季與 2025 年第二季營收的成長歸因於銷售量的成長，但部分被扣除費用後的淨價格下降所抵銷。銷售成長的主要原因是處方藥總需求增加以及批發商庫存水準提高。根據以往的需求計算，Fanapt 在批發商的庫存通常為三到四周的儲備量。

As of the end of the third quarter of 2025, Fanapt inventory at wholesalers was just above four weeks on hand, which was consistent with the level of inventory weeks on hand as of the fourth quarter of 2024, but slightly above the historic range. Turning to HETLIOZ. HETLIOZ net product sales were $18 million for the third quarter of 2025, a 1% increase compared to $17.9 million in the third quarter of 2024 and an 11% increase compared to $16.2 million in the second quarter of 2025. The increase in net product sales relative to the third quarter of 2024 was primarily attributable to an increase in volumes sold, almost entirely offset by a decrease in price net of deductions. The increase in net product sales relative to the second quarter of 2025 was primarily attributable to an increase in price net of deductions, partially offset by a decrease in volume.

截至 2025 年第三季末，Fanapt 在批發商的庫存略高於四周的庫存量，這與 2024 年第四季的庫存週數水準一致，但略高於歷史範圍。轉向 HETLIOZ。HETLIOZ 2025 年第三季淨產品銷售額為 1,800 萬美元，比 2024 年第三季的 1,790 萬美元成長 1%，比 2025 年第二季的 1,620 萬美元成長 11%。與 2024 年第三季相比，淨產品銷售額的成長主要歸因於銷售量的成長，但幾乎完全被扣除各項費用後的淨價格下降所抵銷。與 2025 年第二季相比，淨產品銷售額的成長主要歸因於扣除各項費用後的淨價格上漲，但部分被銷售下降所抵銷。

HETLIOZ net product sales continue to be impacted by changes in inventory stocking at specialty pharmacy customers from period to period. Going forward, HETLIOZ net product sales may reflect lower unit sales as a result of reduction of the elevated inventory levels at specialty pharmacy customers or may be variable depending on when specialty pharmacy customers need to purchase again. Further, HETLIOZ net product sales may decline in future periods, potentially significantly, related to continued generic competition in the US. Additionally, the company constrained HETLIOZ net product sales for the first nine months of 2025 and for the years ended December 31, 2024, and 2023 to an amount not probable of significant revenue reversal. As a result, HETLIOZ net product sales could experience variability in future periods as the remaining uncertainties associated with variable consideration related to inventory stocking by specialty pharmacy customers are resolved.

HETLIOZ 的淨產品銷售額持續受到專科藥局客戶庫存變化的影響。展望未來，由於專科藥局客戶庫存水準的降低，HETLIOZ 的淨產品銷售額可能會反映較低的單位銷售額，或者可能會因專科藥局客戶何時需要再次購買而有所波動。此外，由於美國仿製藥競爭持續，HETLIOZ 的淨產品銷售額在未來可能會下降，甚至大幅下降。此外，該公司將 2025 年前九個月以及截至 2024 年 12 月 31 日和 2023 年 12 月 31 日止年度的 HETLIOZ 淨產品銷售額限制在不太可能出現重大收入逆轉的金額內。因此，隨著與專科藥房客戶庫存相關的可變考慮因素的剩餘不確定性得到解決，HETLIOZ 的淨產品銷售額在未來時期可能會出現波動。

And finally, turning to PONVORY. PONVORY net product sales were $7 million for the third quarter of 2025, an increase of 20% compared to $5.9 million in the third quarter of 2024 and a decrease of 1% compared to $7.1 million in the second quarter of 2025. The increase in net product sales as compared to the third quarter of 2024 was attributable to an increase in volume. The decrease in net product sales as compared to the second quarter of 2025 was attributable to a decrease in volume sold, almost entirely offset by an increase in price net of deductions. During the second quarter of 2025, there was an increase in net product sales as compared to the first quarter of 2025, which was attributable to an increase in volume sold, a portion of which was driven by increased underlying patient demand, albeit modest, but was also impacted by increased specialty pharmacy and specialty distributor inventory on hand levels above the historic range.

最後，讓我們來談談龐沃里。PONVORY 2025 年第三季淨產品銷售額為 700 萬美元，比 2024 年第三季的 590 萬美元成長 20%，比 2025 年第二季的 710 萬美元下降 1%。與 2024 年第三季相比，淨產品銷售額的成長歸因於銷售量的成長。與 2025 年第二季相比，淨產品銷售額下降的原因是銷售量下降，但扣除各項費用後的價格上漲幾乎完全抵銷了銷售下降的影響。2025 年第二季度淨產品銷售額較 2025 年第一季有所增長，這歸因於銷量的增長，其中一部分是由潛在的患者需求增加所驅動的（儘管增幅不大），但也受到專科藥房和專科分銷商庫存水平高於歷史水平的影響。

The inventory on hand levels remained elevated as of the end of the third quarter of 2025, but had decreased closer to the historic range. As a reminder, we completed the acquisition of the US and Canadian rights to PONVORY in December 2023 and initiated the commercial launch of PONVORY in the third quarter of 2024. As such, this represents the fourth full quarter of PONVORY revenue recognition since the initiation of commercial launch activities and significant progress in diversifying our product mix with innovative and value-generating products. Of note, an amount of variable consideration related to PONVORY net product sales is subject to dispute, of which approximately $3 million was recognized for the three months ended December 31, 2024.

截至 2025 年第三季末，庫存水準仍然較高，但已下降到更接近歷史範圍的水準。提醒一下，我們在 2023 年 12 月完成了對 PONVORY 在美國和加拿大的權利收購，並於 2024 年第三季啟動了 PONVORY 的商業推廣。因此，這是 PONVORY 自啟動商業推廣活動以來確認收入的第四個完整季度，也是我們在透過創新和創造價值的產品實現產品組合多元化方面取得的重大進展。值得注意的是，與 PONVORY 淨產品銷售額相關的可變對價金額存在爭議，其中約 300 萬美元已在截至 2024 年 12 月 31 日的三個月內確認。

For the third quarter of 2025, Vanda reported a net loss of $22.6 million compared to a net loss of $5.3 million for the third quarter of 2024. From an income tax perspective, the net loss for the third quarter of 2025 included an income tax benefit of $5.8 million as compared to an income tax benefit of $0.9 million for the third quarter of 2024. Of note, on the tax side, the company assesses the need for a valuation allowance against its deferred tax assets each quarter through the review of all available positive and negative evidence. The company generated a pretax loss for the quarter ended September 30, 2025. If the company continues to generate pretax losses and/or if the company's projections indicate pretax losses in future periods or if there are meaningful changes to our business operations, the conclusion about the appropriateness of the valuation allowance could change in the future.

2025 年第三季度，Vanda 報告淨虧損 2,260 萬美元，而 2024 年第三季淨虧損為 530 萬美元。從所得稅的角度來看，2025 年第三季的淨虧損包括 580 萬美元的所得稅優惠，而 2024 年第三季的所得稅優惠為 90 萬美元。值得注意的是，在稅務方面，公司每季都會透過審查所有可用的正面和負面證據來評估是否需要對其遞延所得稅資產提列估值準備。該公司截至 2025 年 9 月 30 日的季度出現稅前虧損。如果公司繼續產生稅前虧損，和/或公司預測未來期間將出現稅前虧損，或我們的業務營運發生重大變化，那麼關於估值準備金是否適當的結論將來可能會改變。

An increase in the valuation allowance would result in a noncash income tax expense during the period of change. The current deferred tax assets reflected in the balance sheet as of September 30, 2025, amount to $103.1 million. If it is determined that the company needs a valuation allowance against its deferred tax assets in a future period, the noncash income tax expense recorded during the period of change could be equal to the significant majority of the $103.1 million balance. Operating expenses in the third quarter of 2025 were $87.5 million compared to $58.7 million in the third quarter of 2024. The $28.9 million increase was primarily driven by higher SG&A expenses related to spending on Vanda's commercial products as a result of the commercial launches of Fanapt in bipolar disorder and PONVORY in multiple sclerosis and higher R&D expenses.

估值準備金的增加將在變更期間產生非現金所得稅支出。截至 2025 年 9 月 30 日，資產負債表上反映的當前遞延所得稅資產為 1.031 億美元。如果確定公司在未來某個期間需要對其遞延所得稅資產提列估值準備，則變更期間記錄的非現金所得稅費用可能等於 1.031 億美元餘額的絕大部分。2025 年第三季的營運費用為 8,750 萬美元，而 2024 年第三季的營運費用為 5,870 萬美元。2890萬美元的成長主要是由於Vanda公司在治療雙相情感障礙的Fanapt和治療多發性硬化症的PONVORY的商業化推出，導致其商業產品相關的銷售、管理及行政費用增加，以及研發費用增加。

During 2024 and 2025, we commenced a host of activities as a result of the commercial launches of Fanapt in bipolar disorder and PONVORY in multiple sclerosis, including expansions of our sales force and the development of prescriber awareness and comprehensive marketing programs. During the first nine months of 2025, our direct-to-consumer campaign launched in the first quarter continued to drive meaningful gains in brand awareness for the company and our products, Fanapt and PONVORY. We maintained strategic investments in our commercial infrastructure, including increased brand visibility through targeted sponsorships with the goal of supporting long-term market leadership and future commercial launches. With regards to the launches of Fanapt in bipolar disorder and PONVORY in multiple sclerosis, as I mentioned, the launches were initiated in 2024, and we expect to continue the build-out of our commercial infrastructure with the impact of these commercial efforts expected to contribute to revenue growth in 2025 and beyond. We have already seen significant growth in our commercial activities.

2024 年和 2025 年，隨著 Fanapt（用於治療雙相情感障礙）和 PONVORY（用於治療多發性硬化症）的商業化推出，我們開展了一系列活動，包括擴大銷售隊伍、提高處方醫生意識以及製定全面的營銷計劃。在 2025 年的前九個月裡，我們在第一季推出的直接面向消費者的活動繼續推動公司和我們的產品 Fanapt 和 PONVORY 的品牌知名度取得顯著增長。我們對商業基礎設施進行了策略性投資，包括透過有針對性的贊助來提高品牌知名度，以支持長期市場領導地位和未來的商業發布。關於 Fanapt 用於治療雙相情感障礙和 PONVORY 用於治療多發性硬化症的上市，正如我之前提到的，這些產品已於 2024 年上市，我們預計將繼續完善我們的商業基礎設施，這些商業努力的影響預計將在 2025 年及以後促進收入增長。我們的商業活動已經取得了顯著成長。

Several lead indicators suggest a strong initial and continued market response to our commercial launch of Fanapt for bipolar disorder, including new patient starts as reflected by NBRx, increasing by 147% in the third quarter of 2025 as compared to the third quarter of 2024. In the third quarter of 2025 as compared to the third quarter of 2024, total prescriptions or TRx increased by approximately 35%. Of particular note, Fanapt was one of the fastest-growing atypical antipsychotics in the market through the first nine months of 2025 based on several prescription metrics. Our Fanapt sales force size continues to expand. As of the end of the third quarter of 2024, our sales force numbered approximately 150 representatives.

多項領先指標表明，我們針對雙相情感障礙推出的 Fanapt 獲得了強勁的市場初期和持續反響，包括新患者開始治療（以 NBRx 衡量），2025 年第三季度比 2024 年第三季度增長了 147%。2025 年第三季與 2024 年第三季相比，處方總量或 TRx 增加了約 35%。值得注意的是，根據多項處方指標，在 2025 年前九個月，Fanapt 是市場上成長最快的非典型抗精神病藥物之一。我們的Fanapt銷售團隊規模持續擴大。截至 2024 年第三季末，我們的銷售團隊約有 150 名代表。

And currently, we have approximately 300 representatives following our additional expansion during the second quarter of 2025. These expansions have allowed us to significantly increase our reach and frequency with prescribers. To that end, face-to-face calls in the third quarter of 2025 were more than 20% higher than face-to-face calls in the second quarter of 2025. And face-to-face calls in the third quarter of 2025 were more than twice the face-to-face calls in the third quarter of 2024. In addition to our Fanapt sales force, we have established a specialty sales force to market PONVORY to neurology prescribers around the country.

截至目前，隨著我們在 2025 年第二季進一步擴張，我們擁有約 300 名代表。這些擴張使我們能夠顯著提高與處方醫生的接觸範圍和頻率。為此，2025 年第三季的面對面通話量比 2025 年第二季的面對面通話量高出 20% 以上。2025 年第三季的面對面通話次數是 2024 年第三季的兩倍多。除了我們的 Fanapt 銷售團隊外，我們還組建了一支專門的銷售團隊，向全國各地的神經科處方醫生推銷 PONVORY。

We have grown this sales force to approximately 50 representatives in the third quarter of 2025. Of particular note, PONVORY underlying patient demand increased, albeit modestly, for the second consecutive quarter. Before turning to our financial guidance, I would like to remind folks that with Fanapt, HETLIOZ, and PONVORY already commercially available, and with HETLIOZ for jet lag currently being rereviewed by the FDA and the tradipitant NDA for motion sickness under review by the FDA, the milsaperidone or hopefully to be known under the brand name Bysanti NDA for bipolar I disorder and schizophrenia under review by the FDA and a biologics license application or BLA for imsidolimab expected to be submitted later this year, Vanda could have six products commercially available in 2026. Turning now to our financial guidance. Vanda is providing an update to its prior 2025 guidance.

到 2025 年第三季度，我們的銷售團隊已發展到約 50 名代表。值得注意的是，PONVORY 的潛在患者需求連續第二季成長，儘管增幅不大。在介紹我們的財務指導之前，我想提醒大家，Fanapt、HETLIOZ 和 PONVORY 已經上市，用於治療時差的 HETLIOZ 目前正在接受 FDA 的重新審查，用於治療暈動病的 tradipitant 的新藥申請 (NDA) 正在接受 FDA 的審查，用於治療 I 型雙相情感障礙和精神分裂症希望的新藥申請 (NDA) 以 FDA 的品牌申請新風險為新的情感障礙和精神分裂症希望申請 I 型）為新的情感性申請或精神分裂症希望申請 I 型）。正在接受 FDA 的審查，而 imsidolimab 的生物製品許可申請 (BLA) 預計將於今年稍後提交，到 2026 年，Vanda 可能有六種產品上市。接下來是我們的財務指導。Vanda 對其先前 2025 年的業績指引進行了更新。

Vanda expects to achieve the following financial objectives in 2025. Total revenues from Fanapt, HETLIOZ, and PONVORY of between $210 million and $230 million. This compares to prior guidance of between $210 million and $250 million, year-end 2025 cash of between $260 million and $290 million. This compares to prior guidance of between $280 million and $320 million. This revised revenue range narrowed to the lower end of the original revenue range reflects strong Fanapt revenue growth in 2025 that is expected to grow on a quarterly basis and potentially accelerate with the full impact of the expanded sales force.

Vanda 預計在 2025 年實現以下財務目標。Fanapt、HETLIOZ 和 PONVORY 的總收入在 2.1 億美元至 2.3 億美元之間。這與先前給出的 2.1 億美元至 2.5 億美元的預期，以及 2025 年底 2.6 億美元至 2.9 億美元的現金預期相比有所變化。這與先前2.8億美元至3.2億美元的預期相比有所變化。此次修訂後的收入範圍縮小至原收入範圍的下限，反映了 Fanapt 在 2025 年強勁的收入增長，預計未來將按季度增長，並可能隨著銷售隊伍的擴大而加速增長。

The revised and lowered year-end 2025 cash guidance reflects the impact of the significant investments that Vanda is currently making to facilitate future revenue growth, both in the form of R&D investments and strategic investments in commercial infrastructure, including Vanda's direct-to-consumer campaign launched in the first quarter, which continued to drive meaningful gains in brand awareness for the company and its products as well as increased brand visibility through targeted sponsorships with the goal of supporting long-term market leadership and future commercial launches. With that, I'll now turn the call back to Mihael.

修訂和下調後的 2025 年底現金預期反映了 Vanda 目前為促進未來收入增長而進行的大量投資的影響，這些投資包括研發投資和對商業基礎設施的戰略投資，例如 Vanda 在第一季度推出的直接面向消費者的活動，該活動持續顯著提升了公司及其產品的品牌知名度，並通過有針對性的贊助提高了品牌曝光度，旨在支持未來的商業市場領導地位。這樣，我現在就把電話轉回給米哈埃爾。

Thank you very much, Kevin. At this point we would be happy to answer your question.

非常感謝你，凱文。現在我們很樂意回答您的問題。

We will now begin the question-and-answer session. (Operator Instructions)

現在開始問答環節。（操作說明）

Raghuram Selvaraju, H.C. Wainwright.

拉古拉姆‧塞爾瓦拉朱 (Raghuram Selvaraju)，H.C.溫賴特。

Thanks very much for taking my questions. I was wondering if you could first and foremost comment on some hypothetical scenarios with respect to the interactions with the FDA. And if these ultimately result in approval decisions, particularly as this pertains to tradipitant, when those approvals might occur? Should we expect potential -- the possibility of tradipitant approval sometime in the first half of 2026, if ultimately the interactions with the FDA proceed positively?

非常感謝您回答我的問題。我想請您先就與FDA互動的一些假設情境發表一些看法。如果這些最終導致審批決定，特別是對於傳統藥物而言，這些審批可能何時發生？我們是否可以期待，如果最終與 FDA 的互動進展順利，那麼 tradipitant 有可能在 2026 年上半年獲得批准？

Yes. Thank you very much, Ram. First of all, I would say and I reiterate that we're very pleased with the new collaborative framework that has been established with the FDA. And just as a background, that comes after the significant development of a win in the appellate court by Vanda in August of this year, where we challenged the decision of rejection of HETLIOZ for jet lag without a hearing. And the court canceled the rejection by the FDA and sent it back to the FDA for further proceedings.

是的。非常感謝你，拉姆。首先，我想說，而且我再次重申，我們對與FDA建立的新合作框架感到非常滿意。作為背景，此前 Vanda 在今年 8 月在上訴法院取得了重大勝利，我們對在沒有舉行聽證會的情況下拒絕 HETLIOZ 治療時差的決定提出了質疑。法院撤銷了FDA的駁回決定，並將案件發回FDA進行進一步審理。

This was one of the precipitating factors alongside with the new management at the FDA, where we sat down with them to develop a path forward. And we're very quickly able to agree on several initial steps. And the first one, as we mentioned, is the rereview of the HETLIOZ sNDA for jet lag and a promise to be completed by early January of 2026. On your question on tradipitant, tradipitant review is ongoing. And we expect the decision by December 30, 2026.

這是促成此事的原因之一，另一個原因是 FDA 的新管理層，我們與他們坐下來製定前進的方向。我們很快就就幾個初步步驟達成了一致。正如我們所提到的，第一項是重新審查 HETLIOZ 的時差反應 sNDA，並承諾在 2026 年 1 月初完成。關於您提出的關於tradipitant的問題，tradipitant的評估仍在進行中。我們預計將在 2026 年 12 月 30 日前做出決定。

The reason we are optimistic is that so far there have been no issues raised with the efficacy of the drug. And therefore, we are encouraged that this could lead to approval. One area that's very relevant with the collaborative framework to tradipitant is the reconsideration of the partial clinical hold. And to give context, this is a clinical hold on a longer-term motion sickness study. The initial study lasted 12 months and people could take up to 90 doses.

我們之所以樂觀，是因為到目前為止，還沒有人提出過關於該藥物療效的問題。因此，我們感到鼓舞，認為這可能會獲得批准。與 tradipitant 的合作框架非常相關的一個領域是重新考慮部分臨床暫停。需要說明的是，這是一項長期暈動病研究的臨床暫停。初步研究持續了 12 個月，受試者最多可服用 90 劑。

We asked for an extension of that study with an amendment to further study tradipitant for an additional 12 months and an additional 90 dose within that period. And that is when, about a year ago or so, the FDA objected to that additional extension, suggesting that an additional long-term six-month dog toxicity study is needed. And of course, we have contested that. But now the FDA was willing to reconsider that decision, and that is now with CDER with a promise to issue a decision by end of November. So with that, if cleared, alongside what is almost agreed upon, I would say, efficacy demonstrated for tradipitant motion sickness, we'll be optimistic for an approval by end of this year.

我們要求延長研究，並修改研究方案，以進一步研究 tradipitant 12 個月，並在該期間內增加 90 劑。大約一年前，FDA 反對再次延期，並建議需要進行為期六個月的額外長期犬類毒性研究。當然，我們對此提出了異議。但現在FDA願意重新考慮這項決定，目前已將此事交由CDER處理，並承諾在11月底前做出決定。因此，如果獲得批准，再加上幾乎已達成共識的療效（我認為），即對暈動病的療效已得到證實，我們將樂觀地認為，該藥物將在今年年底前獲得批准。

Okay, thanks. That's very helpful. Secondly, I wanted to ask about PONVORY performance and what you look for in terms of future quarterly growth rate pickup in revenue from this product, particularly given the current investment that you are making in sales and marketing behind the product at this point. Maybe you can give us a sense of what kind of quarterly growth you would expect in terms of net sales for PONVORI over the course of the next two, three quarters? That would be helpful.

好的，謝謝。那很有幫助。其次，我想詢問一下 PONVORY 的表現，以及您對該產品未來季度營收成長率的預期，特別是考慮到您目前對該產品銷售和行銷的投入。您能否大致預測一下，在接下來的兩到三個季度裡，PONVORI 的淨銷售額預計會實現怎樣的季度成長？那會很有幫助。

Thank you.

謝謝。

Yes. I will let Kevin comment on the future growth. But I would say, we're still in the early phase. The sales force that was built to about 50 people is actually a very recent event, in the last quarter or so, fully staffed. The speaker programs are just starting.

是的。關於未來的發展，我將請凱文發表意見。但我想說，我們仍處於早期階段。銷售團隊擴充至約 50 人，實際上是最近才組成的，大約在上個季度左右，人員已全部到位。演講活動才剛開始。

And PONVORY has been a smaller piece of our direct-to-consumer campaign so far. That being said, these are significant investments, and we're investing towards future growth. But I will pass it on to Kevin for his comment.

到目前為止，PONVORY 在我們面向消費者的直接行銷活動中只佔很小一部分。也就是說，這些都是重大投資，我們投資是為了未來的成長。但我會把這個問題轉交給凱文，聽聽他的意見。

Thanks, Mihael. Thanks, Ram, for the question. Just as a bit of reminder on the background here. So we acquired the product from J&J at the end of 2023. And at that point, J&J had ceased support for the product a little over a year prior to that.

謝謝你，米哈埃爾。謝謝Ram的提問。這裡簡單介紹一下背景。因此，我們在 2023 年底從強生公司收購了該產品。而在此之前一年多一點，強生公司就已經停止了對產品的支援。

We completed the transition of the PONVORY product from J&J right at the end of the third quarter of last year, so about a year ago. And what we saw during that period from when J&J ceased commercial support through the first quarter of this year was a decline in the underlying patient demand. And that would be expected given that there wasn't any active support in the market from essentially the end of 2022 through roughly the end of the third quarter of last year. What we've seen in the last two quarters that's very encouraging to us is we've seen increases in the underlying patient demand, both from the first quarter to the second quarter and then again from the second quarter to the third quarter. There's been some buying patterns from the SPs and SDs that have made the quarterly revenue a little bit up or a little bit down depending on the timing of their purchases, but the underlying demand during those two periods is up.

我們在去年第三季末完成了 PONVORY 產品從強生公司的過渡，大約一年前。從強生公司停止商業支援到今年第一季度，我們看到的是潛在患者需求的下降。考慮到從 2022 年底到去年第三季末，市場幾乎沒有任何正面的支撐，這種情況也在意料之中。在過去的兩個季度中，我們看到的基本患者需求增加，這讓我們非常鼓舞，無論是從第一季到第二季度，還是從第二季度到第三季度。SP 和 SD 的一些購買模式使得季度收入略有上升或下降，這取決於他們的購買時機，但這兩個時期內的潛在需求是上升的。

And so for us, that's an encouraging sign that our commercial strategy and support for the product is beginning to take hold. And as Mihael had mentioned, with the recent investment in the commercial sales force that, as I mentioned in my script, was completed during the third quarter of this year, we're hopeful that we'll begin to see that trend continue and potentially increase as we exit this year and head into next year, where we not yet have provided guidance beyond 2025.

因此，對我們來說，這是一個令人鼓舞的跡象，表明我們的商業策略和產品支援開始奏效。正如米哈埃爾所提到的，隨著最近對商業銷售團隊的投資（正如我在稿子中提到的，該投資已於今年第三季度完成），我們希望能夠看到這一趨勢繼續下去，並有可能在今年結束、進入明年之際有所增長。至於2025年以後的情況，我們尚未給出指導意見。

And then just very quickly, two other time line aspects. I was wondering if you could, A, comment on the perspectives for the imsidolimab BLA to receive priority review once it has been submitted to the FDA? And secondly, if you could give us any sense of whether you have revised or more specific timing guidance to provide on the MDD study?

然後，簡單來說，還有兩個時間線上的問題。A，我想請您談談imsidolimab生物製品許可申請（BLA）提交給FDA後，獲得優先審查的可能性？其次，您能否告知我們您是否已修訂或更具體地提供了有關 MDD 研究的時間安排指導？

Thank you.

謝謝。

So Ram, I think your two questions were on the imsidolimab priority review.

所以 Ram，我認為你的兩個問題都與 imsidolimab 的優先審查有關。

Yes. I will address that. But go ahead, Kevin.

是的。我會處理這個問題。凱文，你繼續吧。

And then on the timing for the MDD study, Ram, so maybe I'll take that one second, is what we communicated at this point is that we expect results by the end of next year. But given that we've enrolled patients over the last few quarters, we'd like to see a bit more of kind of a run rate before we provide an exact timing on what period we expect to see the results in. But at this point, we've communicated results by the end of next year and hope to be able to share more as we get a few more quarters under our belt.

關於 MDD 研究的時間安排，Ram，我可能要花一秒鐘時間來回答這個問題，我們目前傳達的訊息是，我們預計在明年年底前得出結果。但鑑於我們在過去幾個季度已經招募了患者，我們希望在給出預計何時能看到結果的確切時間之前，看到更穩定的運行速度。但目前，我們已經公佈了明年年底的業績，並希望在接下來的幾個季度中能夠分享更多資訊。

Yes, that's right. And sites are coming up in the US, but also very recently, we got approval for initiation for a number of sites in Europe. So hopefully, that will accelerate recruitment. Regarding imsidolimab, of course, this is a rare or orphan disorder, and we expect a six-month priority review.

是的，沒錯。美國的網站上線了，而且就在最近，我們還獲得了在歐洲啟動多個網站的批准。希望這能加快招募速度。至於伊米索利單抗，當然，這是一種罕見疾病或孤兒病，我們預計會獲得六個月的優先審查。

Olivia Brayer, Cantor.

奧利維亞·布雷耶，坎托爾。

Hey, good afternoon, guys. Thank you for the questions. Can you talk a little bit about the guidance change this quarter? I mean at the midpoint, it still implies growth for 4Q, but at the lower end of the range, it wouldn't necessarily. So maybe just thoughts around the pushes and pulls of that guidance change and what you're seeing so far into October that helped inform today's update? And then I've got a couple of questions on Bysanti.

嘿，各位下午好。謝謝大家的提問。能談談本季業績指引的變化嗎？我的意思是，如果取中間值，仍然意味著第四季度會成長；但如果取下限值，則不一定如此。所以，您能否談談對此次指導意見變更的推動和阻力，以及您在 10 月至今觀察到的情況，這些情況對今天的更新起到了一定的作用？然後我還有幾個關於拜桑蒂的問題。

Yes, absolutely. Thanks, Olivia, for the question. So a couple of pieces there. And one thing that I commented on in my script was that underlying the guidance for this year is strong Fanapt revenue growth for the year, right, which is, I think, an underpinning of our guidance. But the other thing that's a variable in that consideration is the HETLIOZ revenue, which we've commented on, can be very variable from quarter-to-quarter depending on the timing of our customers' purchases.

是的，絕對的。謝謝奧莉維亞的提問。所以這裡有兩塊碎片。我在腳本中提到的一點是，今年業績指引的基礎是 Fanapt 今年的強勁收入成長，對吧？我認為這就是我們業績指引的基礎。但另一個需要考慮的變數是 HETLIOZ 的收入，正如我們之前提到的，其季度波動可能很大，具體取決於客戶購買的時間。

So what we see there is that the actual underlying demand for HETLIOZ is pretty consistent. As we've mentioned, we maintain the majority of the market share still at this point, even 2.5 years post generic launch. But the actual buying patterns, which translate to the revenue patterns for HETLIOZ can vary from quarter-to-quarter. And if we saw customers not need to buy as much in the fourth quarter, that could put us on the lower end of the revenue range. So that's kind of the dynamic there.

因此，我們看到的是，HETLIOZ 的實際潛在需求相當穩定。正如我們之前提到的，即使在仿製藥上市 2.5 年後，我們仍然保持著大部分市場份額。但實際的購買模式（轉化為 HETLIOZ 的營收模式）可能會因季度而異。如果我們發現顧客在第四季不需要購買那麼多商品，那可能會使我們的收入預期處於較低水準。所以，情況大概就是這樣。

But for Fanapt, what we've seen in the last two quarters is both revenue meaningful growth in both quarters and the underlying demand, which we're highly focused on, right, from a quarter-to-quarter perspective, growing sequentially very strong. So we saw 14% growth Q1 to Q2 and 11% growth Q2 to Q3 from a script perspective. And so we expect to see that continue to grow in Q4 to increase relative to Q3 would be our expectation underlying that guidance.

但對於 Fanapt 而言，我們在過去兩個季度看到的是，營收在兩個季度都實現了有意義的成長，而且我們高度關注的潛在需求，從季度環比來看，也實現了非常強勁的環比增長。從劇本角度來看，我們看到第一季到第二季成長了 14%，第二季到第三季成長了 11%。因此，我們預計第四季將繼續成長，相對於第三季將有所成長，這是我們做出上述預測的基礎。

Super helpful, Kevin. And then is there anything you guys can tell us at this point around just the engagement that you're having with the FDA for your ongoing Bysanti review? Have they indicated wanting to see any additional information as part of your submission package? And anything you can tell us on when you might enter into label discussions for that asset? And then just kind of as a -- I know there's a couple of questions in there, but as a follow-up on the commercial side, as you look out to your PDUFA next year, what's the commercial strategy for actually convincing patients to switch from Fanapt over to this newer product?

凱文真是幫了大忙。那麼，目前你們能否透露一些關於你們與FDA就Bysanti正在進行的審查進行的溝通情況？他們是否表示希望在您的申請資料中看到任何其他資訊？您能否透露一下何時會與唱片公司就該資產的發行進行洽談？然後，我想問一個後續問題——我知道這裡面有幾個問題，但作為商業方面的後續問題，展望明年的 PDUFA，你們的商業策略是什麼，才能真正說服患者從 Fanapt 轉而使用這種更新的產品？

Is there a commercial hook or an incentive that would actually incentivize patients to make the switch before a generic version of Fanapt becomes available?

在 Fanapt 的仿製藥上市之前，是否存在某種商業誘因或激勵措施，能夠真正促使患者改用其他藥物？

Maybe I'll start off with the regulatory update, and I'll let Kevin comment on the commercial strategy. The -- I think we have given an update that so far, the interactions with the division have been quite positive in that there have been no issues raised on the efficacy and the safety of the drug. So that is progressing well. Now in terms of label negotiations, we don't comment if they have started or about to start. But typically, those will precede the PDUFA date by a couple of months or so.

或許我可以先談談監管的最新進展，然後讓凱文對商業策略發表意見。我認為我們已經更新了情況，到目前為止，與該部門的互動非常積極，因為還沒有人提出關於該藥物的療效和安全性的問題。進展順利。至於唱片公司與唱片公司的談判，我們不予置評，無論談判是否已經開始或即將開始。但通常情況下，這些日期會比 PDUFA 日期提前幾個月左右。

Yes. And then, Olivia, on the commercial strategy, we haven't shared, I would say, some key elements of our commercial strategy for Bysanti and the potential transition for Fanapt to Bysanti. But what I would tell you is, as we've talked about in the past, the atypical antipsychotic class is both a highly promotionally sensitive class and also a high switch class. So products that are actively promoted out there, as you know, will do significantly better than products that are not actively promoted. And as part of that, with it being a high switch class, if there are certain commercial tools that are available to prescribers, namely starter packs or titration packs in our case, or commercial co-pay programs, if those programs are available to patients that are starting, they'd be more likely to start on a product that offers those programs versus a product that doesn't.

是的。然後，Olivia，關於商業策略，我想說，我們還沒有分享 Bysanti 商業策略的一些關鍵要素，以及 Fanapt 向 Bysanti 的潛在過渡。但我想告訴你們的是，正如我們過去討論過的，非典型抗精神病藥物既是一類對促銷活動高度敏感的藥物，也是一類容易被濫用的藥物。如你所知，積極推廣的產品會比沒有積極推廣的產品表現得好得多。而且，由於這是一個高轉換率類別，如果處方醫生可以使用某些商業工具，例如我們案例中的起始包或滴定包，或者商業共同支付計劃，如果這些計劃對開始治療的患者可用，那麼他們更有可能選擇提供這些計劃的產品，而不是不提供這些計劃的產品。

So I think both the nature of the class being highly promotionally sensitive and the potential support that could be available for patients, I think will lead to meaningful success on Bysanti when we decide to pull that trigger.

所以我認為，考慮到該課程在推廣方面的高度敏感性以及可能為患者提供的潛在支持，我認為當我們決定啟動 Bysanti 計畫時，這將帶來實質的成功。

And I will add, Olivia, that the longer commercial plan is the addition of indications starting with the adjunct treatment of major depression with actually a key differentiator of how Fanapt has been used so far with a once-a-day dosing, increasing the convenience and hopefully compliance.

奧莉維亞，我還要補充一點，更長遠的商業計劃是增加適應症，首先從輔助治療重度憂鬱症開始，而 Fanapt 目前的使用方式的一個關鍵區別在於每天一次給藥，這增加了便利性，並有望提高依從性。

Okay, thank you both. Appreciate it.

好的，謝謝你們兩位。謝謝。

Andrew Tsai, Jeffries.

Andrew Tsai，傑弗里斯。

Hey, good afternoon, and congrats on the quarter. This is [Matt Barcus] on for Andrew Tsai. First off, for tradipitant in motion sickness, it could be approved on December 30, and then HETLIOZ jet lag could be approved January 7. What would your marketing strategy be for these? And what would the shape of the launch curve look like for these drugs?

嘿，下午好，恭喜你本季取得佳績。我是替安德魯·蔡解說的馬特·巴克斯。首先，用於治療暈動病的tradipitant可能在12月30日獲得批准，然後用於治療時差的HETLIOZ可能在1月7日獲得批准。針對這些產品，你的行銷策略是什麼？這些藥物的上市曲線形狀會是什麼樣的呢？

Yes. Thank you. We're actually very excited for both of these potential approvals because they share in common the consumer-centric focus, both in HETLIOZ in jet lag and tradipitant for motion sickness. We're developing a quite elaborate strategy that will become very consumer-centric, focusing on concierge service for supplying the drug to both of them. And our recent experiences with direct-to-consumer campaigns, but also the elevation of brand awareness of the company are going to be very important and have been strategically designed to be in place in advance of those launches.

是的。謝謝。我們對這兩項潛在的批准感到非常興奮，因為它們都以消費者為中心，無論是用於治療時差的 HETLIOZ，還是用於治療暈動病的 tradipitant。我們正在製定一項非常精細的策略，該策略將以消費者為中心，重點是為他們雙方提供藥品供應的私人服務。我們最近在直接面向消費者的行銷活動方面的經驗，以及公司品牌知名度的提升，都將非常重要，並且已經過策略性設計，以便在這些產品發布之前到位。

We expect if both of them approved in that time frame you mentioned, that we should be able to be in the market by the first half of 2026. And in subsequent interactions, we can discuss a little more about the latest on the total addressable market for both indications. But I will highlight, it is significant and expanded, both of increased travel, but also the unmet need in motion sickness that has not seen a treatment -- a new treatment in the last 45 years.

我們預計，如果這兩項審批都能在您提到的時間範圍內獲得批准，那麼我們應該能夠在 2026 年上半年進入市場。在後續的交流中，我們可以更詳細地討論這兩種適應症的潛在市場規模的最新情況。但我要強調的是，這意義重大且影響深遠，不僅體現在旅行的增加上，也體現在暈動病治療方面尚未得到滿足的需求上——過去 45 年裡一直沒有新的治療方法。

Great. And then for your GLP vomiting study, can you describe that study? Like what does the positive efficacy data look like? And what would be the next steps for the program? And then similarly, for Bysanti, should have like Phase III data in 2026. What kind of measures to efficacy separation do you hope to achieve in that study?

偉大的。那麼，關於您的 GLP 嘔吐研究，您能描述一下這項研究嗎？例如，積極的療效數據是什麼樣的？那麼，該專案的下一步計劃是什麼？同樣，Bysanti 應該會在 2026 年獲得 III 期臨床試驗數據。您希望在該研究中實現哪些療效分離的措施？

Yes. So I will start with the last question. On MDD, like any other study, there is not a threshold of response. We are looking for a positive primary endpoint on the typical clinical scales that will be used. And of course, subsequently, people are doing a responder analysis, trying to identify a portion of patients responding to a certain effect.

是的。那我就從最後一個問題開始回答吧。對於重度憂鬱症，與其他研究一樣，沒有反應閾值。我們希望在將要使用的典型臨床量表上獲得積極的主要終點。當然，隨後人們會進行應答者分析，試圖找出對某種療效有反應的患者族群。

But there is no threshold that is required. But of course, the study is powered to detect a significant minimal threshold of efficacy. Your other question was on the use of tradipitant in preventing the GI, specifically vomiting side effects of Wegovy, semaglutide. And we know that GLP-1 analogs have to be titrated slowly because of the very frequent nausea and vomiting side effects, which actually limits the efficacy at least for a certain period of time. And for a number of patients, around 15% or so, may actually drop out of treatment and obviously the benefit of GLP-1 analogs.

但並沒有設定任何門檻。當然，這項研究旨在檢測出顯著的最低療效閾值。你的另一個問題是關於使用 tradipitant 來預防 Wegovy（司美格魯肽）引起的胃腸道副作用，特別是嘔吐副作用。我們知道，由於噁心和嘔吐的副作用非常頻繁，GLP-1 類似物必須緩慢滴定，這實際上限制了其療效，至少在一段時間內是如此。對於大約 15% 的患者來說，他們可能會停止治療，顯然也無法獲得 GLP-1 類似物的益處。

So this is a well understood and very significant therapeutic issue. The study we have designed, administers tradipitant for a few days prior to initiating a Wegovy injection, which is administered at a much higher dose than the recommended titration dose. Titration dose begins at 0.25 milligrams and escalates in four-week increments. The dose we're using in the study is 1 milligram. And patients are randomized to receive either Wegovy or placebo.

所以這是一個人們已經充分理解且非常重要的治療問題。我們設計的這項研究，在開始注射 Wegovy 之前先給患者服用幾天 tradipitant，而 Wegovy 的注射劑量要比建議的滴定劑量高得多。滴定劑量從 0.25 毫克開始，每四周遞增一次。本研究使用的劑量為 1 毫克。患者被隨機分配接受 Wegovy 或安慰劑治療。

And what we do is we follow these people and measure the efficacy with the number of vomiting episodes and other secondary endpoints like nausea, duration of nausea, et cetera. And as I said, this study has completed now. The sites and data are being monitored and data clean, and we hope soon to be able to analyze the top line results.

我們所做的就是追蹤這些人，並透過嘔吐次數和其他次要終點（如噁心、噁心持續時間等）來衡量療效。正如我所說，這項研究現在已經完成了。我們正在監控網站和數據，並清理數據，希望很快就能分析主要結果。

Understood, thanks.

明白了，謝謝。

That concludes our question-and-answer session. I will not turn the call back over to ban the management for closing remarks.

我們的問答環節到此結束。我不會把電話轉回去禁止管理階層發表總結陳詞。

Thank you very much for joining this call. I will see you at a later time.

非常感謝您參加本次電話會議。我稍後會再見到你。

This conclude this call, you may now disconnect.

通話到此結束，您可以掛斷電話了。